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e - ISSN – 2249-7552
Print ISSN – 2229 7502
*G. Balammal, M. Sekar Babu, P. Jayachandra Reddy
Department of Pharmaceutical Analysis,
Krishna Teja Pharmacy College, Chadalawada Nagar, Tirupati-517605, Andhra Pradesh, India.

Review Article

The World Health Assembly has emphasized the need to ensure the quality of medicinal plant
products by using modern control techniques and applying suitable standards. These resolutions describe a
series of tests for assessing the quality of medicinal plant materials. The tests are designed primarily for use
in national drug quality control laboratories in developing countries, and complement those described in the
international pharmacopeia, which provide quality specifications only for the few plant materials that are
included in the WHO Model List of Essential Drugs. This review does not constitute a herbal
pharmacopeia, but a collection of test procedures to support the development of national standards based on
local market conditions, with due regard to existing national legislation and national and regional norms.

Keywords: Medicinal Plants, Standardization, Modern Control Techniques.

INTRODUCTION popularity and extensive use during the last

―Health for all‖ is a dream and a goal decade, traditional medicine has not been
which humanity at large shares and strives for. officially recognized in most countries.
Unfortunately, it has now been proven without Consequently, education, training and research in
doubt that modern pharmaceuticals are and will this area have not been accorded due attention
remain out of reach for a large proportion of the and support. The quantity and quality of the
human population for the foreseeable future. safety and efficacy data on traditional medicine
This has created an appreciation and a need for are far from sufficient to meet the criteria needed
the use of other sources of human knowledge to to support its use world-wide. The reasons for the
provide common health benefits. Alternative and lack of research data are due to not only to health
traditional medicines, largely herbal in nature, care policies, but also to a lack of adequate or
are now regarded as important but underutilized accepted research methodology for evaluating
tools against disease. traditional medicine‖.
The traditional herbal medicines and In general, one or two markers or
their preparations have been widely used for pharmacologically active components in herbs
thousands of years in many oriental countries, and or herbal mixtures were currently employed
such as in China, Korea, Japan, etc. However, for evaluating the quality and authenticity of
one of the characteristics of oriental herbal herbal medicines, in the identification of the
medicine preparations is that all the herbal single herb or HM preparations, and in assessing
medicines, either presenting as single herbs or as the quantitative herbal composition of an herbal
collections of herbs in composite formula, are product. This kind of the determination, however,
extracted with boiling water during the does not give a complete picture of a herbal
decoction process. This may be the main reason product, because multiple constituents are usually
why quality control of oriental herbal drugs is responsible for its therapeutic effects. These
more difficult than that of western drug. As multiple constituents maywork ‗synergistically‘
pointed in ―General Guidelines for and could hardly be separated into active parts.
Methodologies on Research and Evaluation of Moreover, the chemical constituents in
Traditional Medicines (World Health component herbs in the HM products may vary
Organization, 2000)‖ [1], ―Despite its existence depending on harvest seasons, plant origins,
and continued use over many centuries, and its drying processes and other factors.

Corresponding Author: G. Balammal Email:

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Thus, it seems to be necessary to determine most can be separated into many relatively simple sub-fractions.
of the phytochemical constituents of herbal products in Furthermore, the recent approaches of applying hyphenated
order to ensure the reliability and repeatability of chromatography and spectrometry such as high-
pharmacological and clinical research, to understand their performance liquid chromatography–diode array detection
bioactivities and possible side effects of active compounds (HPLC–DAD), gas chromatography–mass spectroscopy
and to enhance product quality control [2]. Thus, several (GC–MS), capillary electrophoresis-diode array detection
chromatographic techniques, such as high-performance (CE-DAD), HPLC–MS and HPLC–NMR, could provide
liquid chromatography (HPLC), gas chromatography (GC), the additional spectral information, which will be very
capillary electrophoresis (CE) and thin layer helpful for the qualitative analysis and even for the on-line
chromatography (TL ), can be applied for this kindof structural elucidation. With the help of the spectral
documentation. In this way, the full herbal product could be information the hyphenated instruments show greatly
regarded as the active ‗compound‘. The concept of improved performances in terms of the elimination of
phytoequivalence was developed in Germany in order to instrumental interferences, retention time shift correction,
ensure consistency of herbal products. According to this selectivity, chromatographic separation abilities,
concept, a chemical profile, such as a chromatographic measurement precision. If hyphenated chromatography is
fingerprint, for a herbal product should be constructed and further combined with chemometric approaches, clear
compared with the profile of a clinically proven reference pictures might be developed for chromatographic
product. In 2004, the Chinese State Food and Drug fingerprints obtained. These excellent properties are the so-
Administration (SFDA) will regulate the compositions of called dimension advantages proposed by Booksh and
liquid injection with HM ingredients using stringent quality Kowalski. A chemical fingerprint obtained by hyphenated
procedures such as chemical assay and standardization. chromatography, out of question, will become the primary
Fingerprints of HM liquid injections are compulsorily tool for quality control of herbal medicines [5].
carried out for this purpose. In addition, among the various
experimental techniques, chromatographic methods are Historical practices
highly recommended for finding out the fingerprints of Historical practices determine the way herbal
these products. By definition, a chromatographic fingerprint medicines are formulated and used. During the past two
of a HM is, in practice, a chromatographic pattern of the decades, there has been an increasing interest in the
extract of some common chemical components of industrialized nations to use medicinal plants. Sources of
pharmacologically active and or chemically characteristics. details are pharmacopoeias, indigenous knowledge,
This chromatographic profile should be featured by the scientific literature, and other documented sources. Herbal
fundamental attributions of ―integrity‖ and ―fuzziness‖ or medicine use is based on historical medicinal practices. In
―sameness‖ and ―differences‖ so as to chemically represent some cases (e.g., China), there are well-defined procedures
the HM investigated [3]. It is suggested that with the help that are well documented in pharmacopoeias dating back
of chromatographic fingerprints obtained, the nearly 2000 years and other monographs. However, this is
authentication and identification of herbal medicines can be not always the case, and in a number of countries the
accurately conducted (―integrity‖) even if the amount knowledge base is constantly being eroded. Indigenous
and/or concentration of the chemically characteristic people generally state that herbal medicines must be
constituents are not exactly the same for different samples prepared in the traditional way to be described as herbal
of this HM (hence, ―fuzziness‖) or, the chromatographic medicine. The ongoing need to catalogue actual uses of
fingerprints could demonstrate both the ―sameness‖ and medicinal plants continues. Several well-known medicines
―differences‖ between various samples successfully. Thus, are derived from plants. These include morphine, digitoxin,
we should globally consider multiple constituents in the taxol, colchicine, and L-hyoscyamine.
HM extracts, and not individually consider only one and/or
two marker components for evaluating the quality of the The plant processing encompasses drying,
HM products. However, in any HMand its extract, there are mechanical disruption, and solvent extraction (aqueous or
hundreds of unknown components and many of them are in organic solvent, e.g., ethanol), and will influence the final
low amount. quality of the herbal product. Analytical procedures can be
used to determine the active constituents that are present in
Moreover, there usually exists variability within herbal substances. Standardized extracts are prepared with
the same herbal materials [4]. Consequently, to obtain ethanol and may be referred to as phytomedicines.
reliable chromatographic fingerprints that represent Differences in levels of active constituents in herbal
pharmacologically active and chemically characteristic substances may be dependent on both locality of collection
components is not an easy or trivial work. Fortunately, and annual growth cycles of the source herbs. Herbal
chromatography offers very powerful separation ability, products are defined as herbal materials that are
such that the complex chemical components in HM extracts administered to patients and are mixtures of herbal

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substances and other constituents [6]. The importance of Substitution and misidentification of herbal substances
herbal medicine practices is indicated by the fact that about Risks associated with herbal medicine products
80 % of the developing world‘s population depends on were first reported for medicinal plants of the Asteraceae
traditional medicine for their primary healthcare. The family, Hypericin and Aristolochia genus, and kava-kava.
scientific evaluation of safety and efficacy of herbal A number of cases of inadvertent or deliberate substitution
products and medicinal preparation is thus of vital of the constituents of Chinese herbal preparations are cited
importance from both medicinal and economic in the literature. For example, Siberian ginseng
perspectives. Consideration of the growing importance of (Eleutherococcus senticosus), American ginseng (Panax
herbal medicine and other herbal preparations, concerns quinquefolium), and Japanese ginseng (Panax pseudo-
about the safety and claimed efficacy of many herbal ginseng) have been substituted for Korean or Chinese
products, and lack of proper scientific evaluation resulted in ginseng (Panax ginseng). Sometimes the substitute has a
IUPAC supporting the current project with the objective of much greater toxicity than the original material. Examples
preparing protocols on safety, efficacy, standardization, and of substitution resulting in an adverse effect include
documentation of herbal medicine. These protocols are reported cases of hepatitis with jin bu huan, renal fibrosis
presented here. Further details of these topics will be due to Aristolochia fangchi, and podophyllin poisoning due
published soon in a monograph. to Podophyllum emodi. Table 3 lists reported substitutions
in Chinese herbal medicines. Acute hepatitis by a Chinese
SAFETY OF HERBAL MEDICINE herb shou-wu-pian, mainly containing Polygonum
Herbal medicines are generally regarded as safe multriflorum, has also been reported.
based on their long-standing use in various cultures.
However, there are case reports of serious adverse events Cases of hepatitis related to consumption of jin bu
after administration of herbal products. In a lot of cases, the huan (Lycopodium serratum) were reported in seven
toxicity has been traced to contaminants and adulteration. patients in the United States. Jin bu huan is used for pain
However, some of the plants used in herbal medicines can relief and insomnia. The reaction developed after an
also be highly toxic. As a whole, herbal medicines can have average of 20 weeks of therapy and was resolved in most
a risk of adverse effects and drug–drug and drug–food patients in a mean of 8 weeks. The information enclosed
interactions if not properly assessed. Assessment of the with the preparation indicated that the product contained 30
safety of herbal products, therefore, is the first priority in % levoalkaloid from Polygala chinensis, but analysis
herbal research. There are various approaches to the suggested a more toxic substitute [21,22], an alkaloid from
evaluation of safety of herbal medicines. The toxic effects Stephania and Corydalis genera and not from Polygala.
of herbal preparation may be attributed mainly to the
following: A number of cases of interstitial renal fibrosis
• inherent toxicity of plant constituents and ingredients caused by presence of aristolochic acid have occurred.
• manufacturing malpractice and contamination More than 70 cases of renal failure following ingestion of a
slimming preparation containing Chinese herbs were
Evaluation of the toxic effects of plant constituents identified in Belgium between January 1989 and January
of herbal formulation requires detailed phytochemical and 1994. Of these, 30 progressed to terminal renal failure.
pharmacological studies. It is, however, safe to assume that, Nephropathy was characterized by extensive interstitial
based on human experiences in various cultures, the use of fibrosis with atrophy and loss of the tubules. There was also
toxic plant ingredients has already been largely eliminated the suspicion of increased renal malignancies in these
and recent reports of toxicity could largely be due to patients [8].
misidentification and overdosing of certain constituents.
The preparation was known to contain Stephania
Contaminants in herbal medicine tetrandra and Magnolia officinalis, but initial investigations
Potential contaminants of herbal medicines include suspected substitution of Aristolochia fangchi for S.
microorganisms, microbial toxins, pesticides, fumigation tetrandra due to possible mistakes in nomenclature.
agents, radioactivity, and the presence of toxic compounds Aristolochia spp. contain aristolochic acid, which is
of toxic metals [7]. Some of these contaminants have been nephrotoxic in animals and humans [9]. Incidentally,
identified by the Committee for Proprietary Medicinal features of Balkan endemic nephropathy, a severe renal side
Products (CPMP) of the European Community (EC) for use effect in which aristolochic acid has been suggested as a
in controlling the purity of herbal medications in the possible cause, are similar to those reported in Belgium.
European Union (EU). The CPMP Guidelines highlight the
need for good control of starting materials and the finished Assessment of toxicity
product and emphasize the importance of good For herbal products, analysis of the active
manufacturing practice. pharmaceutical ingredients may be best approached by

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analysis of one or more hypothesized active ingredients, criteria for public health. The understanding of risk
analysis of a chemical constituent that constitutes a sizeable assessment and implementation and management are two
percentage of total ingredients, and chemical fingerprinting sequential steps where assessment is first undertaken
of ingredients. Toxicity investigation will also be required followed by development of a management tool based on
because the analysis alone is unlikely to reveal the identified risks. In many cases, a complete risk assessment
contributions to toxicity itself. In assessing toxicity of an may not be undertaken for practical reasons. In such cases,
herbal medicine, the dose chosen is very important. decision-making tools are developed to provide a risk-
Toxicity assessment involves one or more of the following based approach that acts as a framework. The outcome of
techniques: the risk assessment process is, therefore, to determine
• in vivo techniques whether risk characterization identifies any significant
• in vitro techniques aspect of the toxicant(s) in any particular herbal product.
• cell line techniques
• micro-array and other modern techniques Challenges
• standardization A key challenge is to objectively assess conflicting
• techniques to adequately model toxicity toxicological, epidemiological, and other data and the
verification of herbal materials used. This requires use of
The issues of mixtures and deviation from the audit process to identify potential contaminants in
conventional pharmacological approaches remain a major herbal products. The following key issues remain.
problem, along with the consequences of using the wrong • management within ranges of risk
source plants or ingredients, variable content of active • communication of uncertainty
constituents, and a narrow therapeutic window with herbal • pharmacovigilance
medicines. Concurrent contamination with any one of the • understanding why addition of harmful additives works
toxic metals, bacteria, viruses, or pesticides may also occur. • evaluating ―drug‖ interactions
• constraints with clinical trials and people available
Risk assessment approach
The risk assessment procedure considers the following EFFICACY OF HERBAL MEDICINE
steps in risk characterization: The efficacy of medicine is the measure of its
• hazard identification ability to improve health and well-being. This is a central
• dose–response assessment issue in the modern debate about herbal medicine. The use
• exposure assessment of herbal remedies is often justified by their long history of
usage—from prehistoric time in some cases. But, age-old
Risk characterization enables the estimation of any wisdom does not necessarily guarantee that the product in
adverse effect and provides a means of devising risk question is efficacious with reasonable specificity. The term
management, if appropriate. Risk management can then be ―efficacious‖, however, has a relative meaning as it may be
applied on the basis of the assessments given below: interpreted differently by the practitioners of traditional
medicine (of which herbal medicine is a type) and the
Risk assessment is a process that enables proponents of so-called modern medicine (conventional
management and communication tools to be developed to medicine). Traditional medicine usually takes a ―holistic‖
control any adverse effects of pesticide applications during approach where the physical, spiritual (which includes
cultivation and storage of medicinal herbs [10]. It mental), and most often social well-being of an individual
comprises the discrete steps of identification of source and are treated. Thus, the medicinal value of an herbal product
hazard, dose response, exposure, and calculation of risk. may be intimately related to its nutritional and
There are acceptable risk management concepts which can psychological aspects. Although this philosophy is not
be applied to public health and the environment, arising consciously followed by many traditional practitioners
from exposure to pesticides. There are two groups at risk, nowadays, it remains a natural corollary of their system that
namely, (i) workers handling herbal products, and (ii) the efficacy of their intervention cannot simply be judged
people using herbal products. In the risk assessment by physiological and biochemical indicators. Modern
process, studies need to take into account formulation of the medicines, on the other hand, are relatively more focused
herbal products and their bioavailabilities. It is necessary to on particular diseases based on specific etiopathological
combine quality application data with chronic toxicity data. entities. WHO has defined health in terms of both physical
However, these are rarely available for most herbal and mental well-being. However, modern medical practice
products. Currently accepted procedures in Australia [11] usually emphasizes only physical well-being. In recent
and by the USEPA enable the formalized approach of risk times, the trend in the right direction is to develop more of
assessment to be applied when required. Calculation of an integrated approach of treatment involving physical,
dose enables recommendations to be made regarding safety mental, and social well-being. One way to bridge the

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philosophical gap between these two systems (and thus to observation, but that alone does not make science. The
adopt more of an integrated approach) is the WHO concept same rules apply for herbal products and conventional
of health, which emphasizes the best part of both systems. therapies. Although the desired or expected health
Through this ―one system of medicine‖ we may be able to outcomes of different treatments will vary, how evidence of
design appropriate indicators of efficacy and the practical the effectiveness of each treatment is gathered is basically
methodology to test them. This will, however, require the same. The design of a study determines the strength of
openness and understanding from both sides. the evidence, subject selection, randomization, mode of
treatment, controlling, confounding variables, and reporting
Assessment of efficacy of results. Usually the following tools are applied for
Herbal medicines are inherently different from testing the efficacy of drugs: (a) anecdotal reports, (b) case
conventional pharmacological treatments, but presently reports, (c) case series, and (d) randomized clinical trials
there is no way to assess their efficacy other than by [12].
currently used conventional clinical trial methodologies, in
which efficacy is conventionally assessed by clinical, • Anecdotal reports are usually not taken into account in
laboratory, or diagnostic outcomes: conventional medicine, but they are important components
of the efficacy assessment in herbal medicine. This is due
• Clinical outcomes include parameters such as improved to the fact that lots of herbs have remained unexplored and
morbidity and mortality, reduced pain or discomfort, that knowledge about their usefulness is often limited to
improved appetite and weight gain, reduction of blood individual practitioners or tribes, sometimes, living in
pressure, reduction of tumor size or extent, and improved isolated communities or peripheral locations. There should
quality of life. be an immediate concerted effort to collect these anecdotal
• Laboratory/other diagnostic outcomes include parameters reports as much of this knowledge is disappearing with
such as reduction of blood glucose, improvement of time. Organization of these anecdotal reports into well-
hemoglobin status, reduction of opacity as measured by designed case series may provide useful data on the
radiological or imaging techniques, and improvement in efficacy of a large group of herbal agents.
electrocardiogram (ECG) findings. One of the crucial
questions is whether these two groups of efficacy measures • Case reports are the starting point for efficacy (or
are sufficient for assessing the efficacy of herbal medicines. toxicity) tests of many drugs, as evident from the contents
In particular, it is argued that socioeconomic, cultural, and of many reputable clinical journals. In one systematic
psychological variables should be integrated with the review, they account for over one-third of all articles
clinical and diagnostic parameters in assessing the efficacy published in medical journals [45]. These can represent the
of herbal medicine. Socioeconomic variables are major first clues in the identification of new diseases, new
issues also in modern medicine, but in this system these are interventions, or previously unknown adverse effects. Case
normally separated from the biological outcome and reports can be retrospective (data collected from previous
integration are discussed only at the level of health system experiences or records) or prospective (follow-up from a
analysis, not at the efficacy level. Given the fact that most baseline) in nature. The latter may again be divided into
of the users of herbal medicine in developing countries observational (collection of data by passive observation) or
have limited accessibility to and affordability for modern interventional (adjusting the system by standardized design)
medicine, it would be natural to agree in favor of a greater in nature.
emphasis on socioeconomic variables in this system of
medicine. While this approach is attractive from a social • Case series are collections of individual case reports,
and political point of view, it is still difficult to incorporate organized to explore a particular association. The collection
it into the practical assessment of efficacy of a particular of a case series, rather than relying on a single case report,
herbal medicine. There is, however, scope to utilize the can mean the difference between formulating a useful
flexibility inherent in the modern scientific method for hypothesis or merely documenting an interacting medical
conducting studies on herbal medicines. oddity. Case series may be retrospective or prospective
(observational or interventional) in nature, as explained in
Methodology and tools for assessment of efficacy case reports.
As far back as the 4th century BCE, Aristotle in
his famous book Organon defined the essence of scientific • Randomized clinical trials (with double-blind ones being
knowledge [42]. According to him, to create scientific the gold standard) are the ultimate measure of efficacy in
knowledge, it is important to critically observe an event as conventional medicine. Substantial efforts and resources are
well as study its cause. Thus, in medicine, it is not only necessary for such trials.
sufficient to show that an intervention works, it is also Plants synthesize substances that are useful for the
essential to explain how it works. Science starts with maintenance of health in humans and other animals. Plants

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synthesize a variety of phytochemicals most of them are analysis, Pharmacopoeia of the People‘s Republic of China,
derivatives of a few biochemical motifs. All plants produce etc. still use TLC to provide first characteristic fingerprints
chemical compounds as part of their normal metabolic of herbs. Rather, TLC is used as an easier method of initial
activities. These include primary and secondary screening with a semiquantitative evaluation together with
metabolites. The functions of secondary metabolites are other chromatographic techniques. As there is relatively
varied. For example, some secondary metabolites are toxins less change in the simple TLC separation of herbal
used to deter predation, and others are pheromones used to medicines than with instrumental chromatography, only a
attract insects for pollination. brief summary is given here, and for further details about
TLC the readers could consult references [14].
Botanicals are highly complex mixtures of
compounds covering a broad range of substance classes and TLC has the advantages of many-fold possibilities
exhibit natural variability. These include alkaloids, of detection in analyzing herbal medicines. In addition,
phenolics, terpenoids, steroids, glycosides etc. TLC is rather simple and can be employed for multiple
sample analysis. For each plate, more than 30 spots of
Due to low toxicity and known pharmacological samples can be studied simultaneously in one time. Thus,
activity, herbal drugs have been popularly and extensively the use of TLC to analyze the herbal medicines is still
used for many centuries. Sick animals tend to forage plants popular. With the help of the CAMAG video store system
rich in secondary metabolites, such as tannins and alkaloids (CAMAG, Switerland) and TLCQA-UV methods, it is
[13]. Since these phytochemicals often have antiviral, possible to get useful qualitative and quantitative
antibacterial, antifungal and antihelminthic properties, a information from the developed TLC plate. One can
plausible case can be made for self-medication by animals observe that, in reference, the four samples of Cordyceps
in the wild. Herbal drugs, singularly and in combinations, sinensis from the joint products of China and Japan
contain a myriad of compounds in complex matrices in cooperation have more valuable medical effect compared to
which no single active constituent is responsible for the others as they contained the most effective component
overall efficacy. The quality control and quality assurance cordycepin. Moreover, with the help of image analysis and
still remains a challenge because of the high variability of digitized technique developed in computer science, the
chemical components involved. Due to natural variability, evaluation of similarity between different samples is also
chemical analysis of plant material is a great challenge and possible.
requires special approaches. Planner chromatography is
most versatile option for the required identification tests for In summary, the advantages of using TLC to
the quality control of herbal products. In its traditional construct the fingerprints of herbal medicines are its
form, thin layer chromatography (TLC) is frequently used simplicity, versatility, high velocity, specific sensitivity and
for the analysis of botanical raw materials. Thin layer simple sample preparation. Thus, TLC is a convenient
chromatography has a long record in almost all method of determining the quality and possible adulteration
pharmacopeias for its use in the identification of herbal of herbal products. It is worth noting that the technique of
medicines. The Visualization of the entire pattern of TLC is also being updated in progress. A recent paper [15]
compounds present in an herbal drug (socalled gave a very good review on this respect. It summarized the
fingerprinting) is important in the quality and stability progress in forced-flow planar chromatography (FFPC) and
testing of herbal products. The TLC fingerprint with a demonstrated the importance of the different techniques
visible pattern of bands provides fundamental data and is like rotation planar chromatography (RPC), overpressured-
typically used to demonstrate the consistency and stability layer chromatography (OPLC), and electroplanar
of herbal materials. The advantages of using TLC to chromatography (EPC). A simple, but powerful preparative
construct the fingerprints of herbal medicines are its forced-flow technique was also reported; in this technique
simplicity, versatility, high velocity, specific sensitivity and hydrostatic pressure is used to increase mobile-phase
simple sample preparation. Thus, TLC is a convenient velocity. Parallel- and serially-coupled layers open up new
method of determining the quality and possible adulteration vistas for the analysis of a large number of samples (up to
of herbal products. 216) for high throughput screening and for the analysis of
very complex matrices. Some applications, relating to
Thin layer chromatography different classes of substances, were given to demonstrate
TLC was the common method of choice for herbal the versatility of the various FFPC techniques.
analysis before instrumental chromatography methods like
GC and HPLC were established. Even nowadays, TLC is STANDARDIZATION OF HERBAL MEDICINE
still frequently used for the analysis of herbal medicines Traditional medicine implies knowledge and
since various pharmacopoeias such as American Herbal practice of herbal healing for the prevention, diagnosis, and
Pharmacopoeia (AHP), Chinese drug monographs and elimination of physical, mental, or social imbalance [16].

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The costs for health care are rising at an alarming which can reliably profile the phytochemical composition,
rate throughout the world. At the same time, the world including quantitative analyses of marker/bioactive
market for phytopharmaceuticals is growing steadily. The compounds and other major constituents, is a major
World Bank estimates that trade in medicinal plants, challenge to scientists. Without consistent quality of a
botanical drug products, and raw materials are growing at phytochemical mixture, a consistent pharmacological effect
an annual rate of between 5 and 15 %. The proportion of is not expected. Resurgence of interest and the growing
plant-derived drugs differs from country to country. For market of herbal medicinal products necessitate strong
example, while approximately 25 % of prescriptions in the commitment by the stakeholders to safeguard the consumer
United States contained plant-derived active ingredients, 40 and the industry. Standardization is the first step for the
% of the drugs on the German list of medicines (―Rote establishment of a consistent biological activity, a
List‖) were based on plant material. In some countries such consistent chemical profile, or simply a quality assurance
as Malaysia, the plant origins of routinely prescribed program for production and manufacturing. Therefore, the
medicines are easily accessed and well documented. Herbs, EU has defined three categories of herbal products:
used as medicine, are also regulated under different  those containing constituents (single compounds or
categories throughout the world. Institutionally prepared families of compounds) with known and experienced
formulas are often readily available without prescription. In therapeutic activity that are deemed solely responsible for
some European countries, standardized concentrated clinical efficacy;
extracts are regulated as drugs which can be obtained by  those containing chemically defined constituents
prescription only. Herbs are considered to be dietary possessing relevant pharmacological properties which are
supplements in the United States and therefore are likely to contribute to the clinical efficacy; and
subjected to a very limited form of regulation and  those in which no constituents have been identified as
oversight. It is a common observation that people being responsible for the therapeutic activity.
diagnosed with incurable chronic disease states such as Standardization as defined in the text for guidance on the
diabetes, arthritis, and AIDS turned to herbal therapies for a quality of herbal medicinal products means adjusting the
sense of control and mental comfort from taking action. herbal drug preparation to a defined content of a constituent
Herbal product studies cannot be considered scientifically or group of substances with known therapeutic activity. The
valid if the product tested has not been authenticated and European Medicines Agency (EMEA) makes the
characterized in order to ensure reproducibility in the distinction between constituents with known therapeutic
manufacturing of the product in question. Several studies activity which can be used to standardize a biological effect
have indicated quantitative variations in marker and marker compounds which allow standardization on a
constituents in herbal preparations. Moreover, many set amount of the chosen compound. The EMEA defines
dangerous and lethal side effects have recently been marker compounds as chemically defined constituents of a
reported, including direct toxic effects, allergic reactions, herbal drug which are of interest for control purposes,
effects from contaminants, and interactions with drugs and independent of whether they have any therapeutic activity
other herbs. Of the 10 most commonly used herbs in the or not. Examples of markers are the valerenic acids in
United States, systematic reviews have concluded that only Valeriana officinalis L., gingkolides and flavonoids in
4 are likely to be effective and there is very limited Ginkgo biloba L., and hypericin and hyperforin in
evidence to evaluate the efficacy of the approximately 20 Hypericum perfoliatum L. [18].
000 other available herbal products.
Protocols for standardization of herbal drugs
Recent surveys reported in the American news In order to assure a consistent and acceptable
media indicated that a large percentage of the public would quality herbal product, care should be taken right from the
like to see products supported by science, which means identification and authentication of herbal raw materials to
products supported by clinical research. This means the verification process of final product. The following
consumers are increasingly demanding products of known parameters are recommended.
quality. This is where the public standards enter into the
picture. There is a strong demand and need to accelerate the Recommended protocols
research in phytomedicine [17]. Standardized herbal It is desirable to establish a document database
products of consistent quality and containing well-defined containing information on each approved medicinal herb or
constituents are required for reliable clinical trials and to herbal medicine. A central digital document database which
provide consistent beneficial therapeutic effects. is regularly updated and which contains this information
with linkages to references in other databases like
Pharmacological properties of an herbal NAPRALERT should be established for easy access by all
formulation depend on phytochemical constituents present beneficiaries, producers, and stakeholders. The knowledge
therein. Development of authentic analytical methods base for an herb or herbal medicine, promoted for wider

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use, should be strengthened and expanded so that there is a • plant identification: family, genus, species (including
sound scientific basis for each use. This would require the cultivar, if any) with synonyms and older names where
presentation of data for each herb, used in herbal medicine applicable; English (common) name(s); local name
including: • herbarium voucher; specimen number and date with
• plant identification, including cultivar with voucher collector‘s name and identity
specimen • age of the herb (maturity/ flowering plant, etc.)
• plant, preferably voucher stored in a herbarium, for • location of cultivation/collection including altitude and
future reference longitude/latitude (GPS)
• age of the herb (maturity/flowering plant, etc.) • fertilizers/pesticides used (if any)
• location of cultivation, including altitude and • time of harvest including time after application of
longitude/latitude (GPS) pesticides (if applicable)
• fertilizers/pesticides used, if any • storage conditions of the plant before sale
• time of harvest, including time after application of • drying process
pesticides (if applicable) • certificate confirming the above
• storage conditions of the plant, before sale
• drying process Composite herbal medicine
• certificate, confirming the above Apart from details on each herb as outlined for single plant,
Apart from details on each herb, details regarding the details regarding the manufacture of the composite herbal
manufacture of the herbal medicine including the following medicine, including the following data, should be made
data should be made available: available:
• protocol or pharmacopoeia or method used for • protocol or pharmacopoeia or method used for
producing the medicine producing the medicine
• plant or plants (for multi-plant herbal medicine) used • plant or plants (for multi-plant herbal medicine) used
• part of plant used in medicine • part of plant or plants used in the medicine
• vehicle used for producing drug/medicine, e.g., alcohol • vehicle used for producing the drug/medicine, e.g.,
or water (with composition if a mixed solvent); type of alcohol or water (with composition if a mixed
preservative used, if any, and amount Where plants are • solvent); type of preservative used, if any, and amount
purchased, documents maintained by the supplier regarding • excipients (if any) used, amount
the herb should be made available by the manufacturer. • major constituents: carbohydrates, protein, fat, dietary
• Prepare monographs for traditionally used herbal fiber, inorganic material, binder, total energy value per
medicines in a suitable format. mass (kcal/g or kJ/g)
• Legislate to ensure that manufacturers provide relevant • suggested dose, number of times to be used, how many
data on herbs and manufacturing processes. days to be used
• Initiate programs to conserve biological resources. • probable side effects/precautions to be taken,
• Work toward amending TRIPS to include protection of contraindications, restrictions for children, pregnancy,
IPR contained in indigenous knowledge and to make the nursing mothers, etc.
development of herbal medicines attractive to • storage: at x °C, room temperature, away from heat,
pharmaceutical companies. sun, etc.
• Legislate to establish standards in herbal medicine • stability; shelf life; best before date
manufacturing and ensure their implementation. • cautionary note, if any
• Patents involving biological resources should be
granted only if the source of material is specified and Screening of Herbal Drugs
reference made to the material transfer agreement. Where Once the botanical identity of a herb is established,
pharmaceutical companies are prepared to develop herbal the next step is phytochemical screening, which involves
medicines into standardized novel preparations with proven bioassays, extraction, purification, and characterization of
efficacy, the companies could be provided with IPR, while the active constituents of pharmaceutical importance [22].
assuring other stakeholders of a fair share of benefits on the The herb or herbal drug preparation in its entirety is
basis of efficacy or shelf-life being an inventive step. As regarded as the active substance. These constituents are
most herbal medicines are prepared from more than one either of known therapeutic activity or are chemically
plant material, it is imperative that documentation should defined substances or a group of substances generally
be made both on single medicinal plants and on composite accepted to contribute substantially to the therapeutic
herbal preparations [19-21]. activity of a herbal drug. In any program in which the end
product is to be a drug, some type of pharmacological
Single plants screening, or evaluation, must obviously be done.

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Pharmacological screening programs are not The technology of plant medicinal screening
without problems. Ideally the active principles should be processes has even advanced to enzyme isolation. The
isolated, preferably using bioassay guided isolation enzymes that cause the disease are first isolated and the
processes, which can be problematic. The ideal plant extracts are tested to determine if they block enzyme
pharmacological screen would be to identify those extracts action. An enzyme immunoassay for the quantification of
or pure compounds that are highly active and nontoxic. femtomole quantities of therapeutically important alkaloids
Such a screen is rare to find. Failure to duplicate has been established. Ethanolic extracts, tinctures, and pure
pharmacological results is another problem. plant compounds from commercially available herbs have
been analyzed for their in vitro cytochrome P450 3A4
There are many pharmacological screening tests (CYP3A4) inhibitory capability via a fluorometric
available. In the random selection program of the National microtiter plate assay. These studies indicate that high-
Cancer Institute (NCI) in the US, plants are randomly throughput screening methods for assessing CYP3A4
selected, extracted, and the extracts are evaluated against inhibition by natural products have important implications
one or more in vitro tumor systems and in vitro cytotoxicity for predicting the likelihood of potential herb–drug
tests. An extension of this procedure is to isolate interactions. Higher plants contain both mutagens and
metabolites or ―active compounds‖ from the plant that had antimutagens and are susceptible to mutagenesis, but
shown most promising activity and subject them to screening programs for the detection of antimutagenesis
pharmacological tests. In another approach, plants rarely employ higher plant systems. However, using
containing specific types or classes of chemical modified screening tests to detect antimutagenic agents,
compounds, for example alkaloids, are tested. Simple tests higher plants have been shown to contain a variety of
such as color reactions are carried out on various parts of structurally novel antimutagenic agents [24]. Short-term
the plant in the field, and assays are carried out in the bacterial and mammalian tissue culture systems are the
laboratories. In terms of cost–benefit ratio, these ―shotgun‖ standard methods employed.
approaches are considered to be very unsatisfactory.
Labeling of Herbal Products
Another method involves random collection of The quality of consumer information about the
plants and subjection of their extracts to several broad product is as important as the finished herbal product.
screening methods and pharmacological tests. The success Warnings on the packet or label will help to reduce the risk
of this method depends on the number of samples assayed, of inappropriate uses and adverse reactions. The primary
adequate funding, and appropriate predictable bioassay source of information on herbal products is the product
protocols. Broad-based empirical screening, which is time label. Currently, there is no organization or government
consuming and expensive, can detect novel activities but is body that certifies an herb or a supplement as being labeled
not suited for screening large numbers of samples. correctly. It has been found that herbal remedy labels often
Diagnosis by observation, a method introduced by the cannot be trusted to reveal what is in the container. Studies
―father‖ of medicine, Hippocrates, is still one of the most of herbal products have shown that consumers have less
powerful tools of today‘s physicians. In vitro screening than a 50% chance of actually getting what is listed on the
methods, though restricted to the detection of defined label, and published analyses of herbal supplements have
activities, are simpler and more useful. found significant differences between what is listed on the
label and what is in the bottle. The word ―standardized‖ on
Recently, biochemical and receptor–ligand binding a product label is no guarantee of higher product quality,
assays have gathered momentum. This has been made since there is no legal definition of the word
possible by the increasing availability of human receptors ―standardized.‖ Consumers are often left on their own to
from molecular cloning, and extracts and compounds can decide what is safe and effective for them and the lack of
be tested for binding directly to the presumed therapeutic consistent labeling on herbal products can be a source of
target pro tein. Clone receptors can be expressed in a consumer frustration. Certain information such as ―the
functional state linked to receptor proteins in cells such as product has been manufactured according to
yeast, and this has been made possible by applications of Pharmacopoeia standards,‖ listing of active ingredients and
molecular biology. Combined with automated amounts, directions such as serving quantity (dosage) and
instrumentation and computer databases, hundreds of such frequency of intake of the drug, must be in cluded on the
assays can be completed in relatively short periods of time. labels of all herbal products and packages. The label should
These screening processes are successfully used by also indicate the method of extraction and relative amount
international agencies such as the National Cancer Institute of macerate and menstruum used, and possible side effects.
(NCI) in the United States and the Central Drug Research It should indicate that the product‘s content has been
Institute in India [23]. standardized to contain a particular amount of a specified
biochemical constituent. Standardization gives the buyers a

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measure of potency by which to judge the quality of the supplements are not regulated [26]. In many countries these
product and to compare dosage with those indicated by medicines are not required to pass any regulatory analysis
clinical trials. This will also ensure that the correct herb has to be sold as health food supplements.
been used. In addition to the above information, the label It is clear that the herbal industry needs to follow strict
should include the name and origin of the product, its guidelines and that regulations are needed. The food and
intended use, net quantity of contents, other ingredients drug administrations that regulate prescription drugs only
such as herbs and amino acids, and additives, for which no review a herbal product if the item is suspected of being
daily values have been established, storage conditions, shelf harmful or if the label contains a medical claim. Although
life or expiry date, warnings, disclaimer, and name and research is being done, it is very limited and only a few
address of manufacturer, packer or distributor. A herb herbal drugs have been studied adequately by well-
categorized as a nutritional supplement cannot claim any controlled clinical trials. Even though evidence should
health benefits or ―disease claims‖ on the label, leaving the always be presented to support claims of products, most
consumer with little information [25]. herbs are still marketed with little or no research. To be
registered as drugs, these products need to be tested to
Marketing plays a big role in the use of herbal prove their safety and clinical efficacy. However, so far,
products and the media help significantly to provide few programs have been established to study the safety and
information about natural health products. One of the efficacy of herbal medicines as originally proposed in the
problems with mass media ―propaganda‖ is scientific WHO guidelines for the assessment of herbal medicines
inconsistency. Unless the packaging contains a medical [27].
claim, herbal products are not reviewed by any government
agency. Food and drug administrations that regulate The future of herbal drugs is overshadowed by the
prescription drugs only review a herbal product if the item pervading lack of regulatory control. In 1993, the WHO
is suspected of being harmful or if the label contains sponsored a symposium on the use of medicinal plants. The
medical claims. Scientists use several approaches to result was a standard guideline for the assessment of herbal
evaluate botanical dietary supplements for their potential medicines and a recommendation that governments of the
health benefits and safety risks, including their history of world should protect medicinal plants, improve regulation
use and laboratory studies using cell or animal models. of herbal medicines, and respect traditional medicine
Studies involving people can provide information that is approaches.
relevant as to how botanical dietary supplements are used.
More recently the Health Directorate of Canada
Policies and Regulations developed a new regulatory framework for natural health
It is a widely held myth that modern drugs are products, which came into effect in January 2004. Among
dangerous foreign chemicals with side effects, while other things, the new regulations call for improved labeling,
herbals are natural, gentle and safe. The truth is that some good manufacturing practices, product and site licensing,
herbs can be dangerous and can bring about serious and provision of a full range of health claims that will be
diseases and even lead to death. Unlike conventional drugs, supported by evidence. However, even in Canada, the only
herbal products are not regulated for purity and potency and regulatory requirements enforced are that all products
this could cause adverse effects and can even lead to drug intended for medicinal use, including natural health
interactions. There are fewer studies on herbal medicines products, are issued a Drug Identification Number (DIN).
than on conventional drugs, mainly because, unlike These numbers are not required for raw materials such as
synthetic chemicals, herbs cannot be patented, so there is bulk herbs.
little money to be made by funding such research. It is
important that consumers are made aware of interactions In the US, access to herbal medicines is restricted
herbs might have with other drugs they are taking. by FDA regulations. Before any new chemical or herbal
Unfortunately this information is not available with herbals. drug is approved, research must prove that it is both safe
Herbals are also frequently adulterated with prescription and effective. As a result of these restrictions, packages of
drugs. In certain countries, herbal products used for herbal medicines are labeled as food supplements, which do
diagnosis, cure, mitigation, treatment, or prevention of not require pre-approved testing. Food supplements cannot
disease are normally treated as drugs, and hence regulated make any healing claims or issue warnings about potential
by legislation. risks. In the US, plant-based derivatives already appear in a
quarter of the prescription medicines produced. However,
However, in most countries, including the United many other plants with healing properties are shunned by
States, such legislation does not exist and in fact, most the medical community despite scientific data from other
botanical products are marketed as dietary supple ments. countries showing their effectiveness. The misconception
Herbal products categorized as nutritional or dietary that herbs are old fashioned and unscientific has helped to

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promote a general distrust of phytotherapy. molecular biological assays into the screening of plant
extracts, single isolated compounds thereof and
Botanical Council contends that, in many cases, phytopreparations; and (3) the performance of further
herbal medicines are safer than prescription drugs. placebo- controlled, mono- or double-blind, clinical trials,
According to the Council, herbal medicines react more paralleled or followed by pharmacokinetic and
slowly and often include their own antidotes to counteract bioavailability studies [28]. Herbs are still marketed
any toxic effects. With proper enforcement of regulations, without sufficient research but evidence must always be
more products that are legitimate will enter the market and shown to consumers to support claims of products. More
the consumers will see justifiable claims on labels. In fact, clinical studies are needed and doctors, along with other
it is predicted that appropriate regulations will rejuvenate professionals, should work towards on untangling this
the market in response to growing concerns about the herbal maze. Standards should be developed for each
regulatory environment for herbal remedies. natural health product and the same regulatory standards
that apply to manufactured pharmaceuticals should apply
Trends and Developments equally to herbal products as well. Unlike conventional
The rationalization of the new multidrug and drugs, herbal products are not regulated for purity and
multitarget concept of therapy in classical medicine is potency and this could cause adverse effects and drug
likely to have great implications on the future basic interactions. Herbal manufacturing processes should be
research in phytomedicine and evidence-based refined in order to improve the purity, safety and quality of
phytotherapy. It requires concerted cooperation between products and the herbal industry needs to follow strict
phytochemists, molecular biologists, pharmacologists, and guidelines, for herbal products are now classified as
clinicians, with the aim of using modern high-tech methods medicines. Manufacturers and producers tend to resist these
for standardization of phytopreparations, of integrating new laws because such laws will increase cost, which will have
molecular biological assays into the screening of plant to be passed on to consumers, and thus the appeal or herbal
extracts and plant constituents, and of increasing studies on drugs might then be lost. The media help significantly to
the efficacy proof of phytopreparations using controlled provide information about natural health products to
clinical trials. This should be paralleled or followed by consumers. One of the biggest problems with many mass
pharmacokinetic and bioavailability studies. One major media stories today is scientific inconsistency. With proper
concern will be the investigation of the multivalent and enforcement of regulations, more products that are
multitarget actions of plant constituents and standardized legitimate will come to the market and the consumer will
extracts, with the aim of rationalizing the therapeutic see justifiable claims on labels and these regulations will
superiority of many plant extracts over single isolated rejuvenate the market. Herbal medicines still have value
constituents. because they have a long history. Finally, it is sometimes
asked whether natural health food stores require legislation.
Increased effort in three major research areas will The answer should be yes. Promoting herbal products for
be crucial: (1) efforts to develop suitable standardization medical conditions should be regulated in a similar fashion
methods for phytopreparations; (2) the integration of to shops that dispense pharmaceutical products [29].

1. Authentication The first stage is identification of the plant species or botanical verification by the currently
accepted Latin binomial name and synonyms. The steps involved in authentication are taxonomic,
and macroscopic and microscopic studies. Records should be maintained for stage of collection,
parts of the plant collected, regional status, botanical identity such as phytomorphology,
microscopial, and histological analysis, taxonomical identity, etc.
2. Physical Physical tests include organoleptic evaluation (sensory characters such as taste, appearance, odor,
parameters feel of the drug, etc.), viscosity, moisture content, pH, disintegration time, friability, hardness,
flowability, sedimentation, and ash value.
3. Chromatographic Sophisticated modern techniques of standardization such as UV–vis spectrophotometry, TLC,
and spectroscopic HPTLC, HPLC, NMR, near infrared spectroscopy provide quantitative and semiquantitative
evaluation information about the main active constituents or marker compounds present in the crude drug or
herbal products. Markers play an important role in fingerprinting of herbs. Quality of drug can also
be assessed by chromatographic fingerprint.
4. Microbiological Microbiological contamination can be measured according to methods described in the Romanian
parameters Pharmacopoeia, as well as in the British Pharmacopoeia. Microbiological analysis includes
analysis of limits of E. coli and molds, total viable aerobic count, total enteriobacteria and their
count, aflatoxin analysis.

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5. Pesticide residue Standard limits of pesticides have been set by WHO and FAO (Food and Agricultural
analysis Organization). Some common pesticides that cause harm to human beings, such as DDT, BHC,
toxaphene, and aldrin, should be analyzed.
6. Heavy metal Toxic metals such as Cu, Zn, Mn, Fe, and particularly Cd, As, Pb and Hg should be analyzed. In
analysis the analysis of metals, their speciation is to be taken into consideration.

Plant materials are used throughout the developed United States, many European and Asian countries have
and developing world as home remedies, in over-the- taken a more holistic approach to researching the efficacy
counter drug products, and as raw material for the of herbal remedies.
pharmaceutical industry, and they represent a substantial
proportion of the global drug market. Therefore, it is Companies supplying standardized extracts with
essential to establish internationally recognized guidelines the greatest degree of quality control typically offer the
for assessing their quality. Certain herbs have become highest quality products. Most standardized extracts are
popular over the years, but the public, medical currently made under strict guidelines set forth by
practitioners, and the media still have a poor understanding individual members of the European Community (EC) as
of herbal medicine. Evidence is emerging on the dangers of well as those proposed by the EC. The EC production of
herbs. As in most situations, the truth lies hidden under the standardized extracts serves as a model for quality control
media hype, poorly understood science, and exaggerated processes for all forms of herbal preparations. Herbal
claims. Seeing herbal medicines as either panaceas or products and nutritional supplements are not the same.
poisons blinds us to the reality that in most cases they are Most herbal remedies in the United Kingdom and the
neither! Lack of experience, information, and education United States are sold as food supplements [138]. Thus,
about herbs make consumers, physicians, and other they evade regulation of their safety. The possibility of
orthodox health care providers easy victims of market herb–drug interactions is important but ―under-research‖ is
exploitation and herbal myths. There is no rational reason an issue.
behind the tendency to equate ―natural‖ with
―harmlessness.‖ The fact that something is natural does not The test procedures cannot take account of all
necessarily make it safe or effective. In addition, a lack of possible impurities. Common sense and good
knowledge of phytochemistry leads to misinterpretation and pharmaceutical practice should be applied in deciding
misunderstanding. It is very likely that some herbs will whether an unusual substance not detectable by the
have side effects, interact with other medications, and be prescribed tests can be tolerated. The international
toxic. Information on isolated constituents should not be pharmacopeia provides quality specifications only for the
applied directly to the whole herb and studies on in vitro few plant materials that are included in the WHO Model
forms should not be confused with oral administration. The List of Essential Drugs [14, 15, 52, 146].
gold standard for proof of efficacy for a medication is the
controlled double-blind trial, which can offer proof of There is a lack of open interpretation in the area of
activity and effectiveness. In addition to this, well-designed safety and efficacy, especially for bibliographic studies.
unblended and clinical trials, epidemiological, animal, and Such interpretations are particularly relevant for herbal
phytochemical studies can provide useful information on medicinal products because they have been used for long
the herbal drug. It is not uncommon for studies to be carried periods of time, sometimes over centuries, and a wealth of
out on animals and the results extrapolated to humans even literature is available. It is desirable that this documented
though they have different metabolic processes. Many knowledge is exploited in order to avoid unnecessary tests
herbs have not been subjected to this type of study. We do with animals and clinical trials. Scientific evaluation of the
not fully understand how many of these herbal medicines traditional knowledge is needed.
work, or do we know which component is pharmaceutically
active. Even though herbal remedies may be effective, with In many societies much of the knowledge resides
rationing looming in virtually all health care systems, the in the hand of the healers, where oral transmission of
question whether herbal medicines can save money is information is the unwritten rule. In most cases, the
important. Not all plant medicines are cheap. Botanicals are information is not documented. As a result, in many
not patentable (they can be patented for use); hence herbal regions, this knowledge is endangered because the younger
remedies are not viable candidates for the existing drug generation is unwilling to carry on the profession of the
approval processes. Pharmaceutical companies will not risk elders. Knowledge that has been refined over thousands of
a loss, and herbal producers, especially in developing years of experimentation with herbal medicine is being lost.
countries, lack the financial resources even to consider A major research opportunity in this field would be to
conducting research or seeking approval. In contrast to the catalogue information on herbal medicines by traditional

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healers in cultures where these skills are normally rationalizing the therapeutic superiority of many plant
transmitted through an apprentice system [141]. extracts over single isolated constituents. Phytomedicine
and chemosynthetic pharmaceutical research find
Opinion about the safety, efficacy, and the themselves in a race to develop new medicines, with fewer
appropriateness of medicinal herbs varies widely among or no side effects, for therapeutic and preventive application
medical and health professionals in countries where herbal in illness for which causality-based treatments are
remedies are used. In most cases the safety and efficacy of nonexistent or imperfect [154].
drugs of herbal origin cannot be attributed to one single
chemical constituent. Various pharmaceutical particulars, It has now become evident that there is need for a
including the production and collection of the starting holistic approach to health care, and the untapped potential
material and the extraction procedures, need to be assessed. of traditional medicines should be utilized. However, this
Some professionals, however, accept historical, empirical will not be easy, as it requires a thorough search for
evidence as the only necessary criterion for the efficacy of medicinal plants, proper guidelines for their identification,
herbal medicines. Others would ban all herbal remedies as validation of the scientific methods of isolation of active
dangerous or of question able value. Herbal medicines have ingredients, preclinical evaluation of their pharmacological
the potential for improving public health at low cost. and toxicological profiles, and clinical evidence of their
Phytomedicines, if combined with preventive medical usefulness. Clinical trials should be conducted to establish
practice, could be a cost-effective, practical way to shift facts such as the average effective dose for any drug, as
modern health care from treatment to prevention. well as potential side effects a compound may cause. In
short, these herbal drugs need to be analyzed in the same
Two paradigm shifts in medicine characterize the way as any modern drug, that is with randomized controlled
beginning of the twenty-first century: the gradual clinical trials. As doctors and researchers continue to
renunciation of the long-standing reliance on explore the safety and effectiveness of herbal medicines,
monosubstance therapy in favor of a multidrug therapy and more is learned about both their promises and their pitfalls.
the transition to a new kind of multitarget therapy, through
which the interference of drugs with protective, repair, and At the same time, legislators at the national level
immunostimulatory mechanisms of the human body, rather should continue to press for effective laws to protect
than with single disease- causing agents, gains more and consumers from potentially harmful herbal drugs. In the
more importance. Phytomedicine research has a good mean time, your own scrutiny and curiosity are your best
chance of contributing to these new strategies through the protection. Quality control for efficacy and safety of herbal
development of new and better drugs for an evidence-based products is of utmost importance. The assurance of the
and rational phytotherapy. One major concern will be to safety of a herbal drug requires monitoring of the quality of
investigate the multivalent and multitarget actions of plant the finished product as well as the quality of the consumer
constituents and standardized extracts, with the aim of information on the herbal remedy.

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