ROLL OF NATURAL PRODUCT IN HERBAL MEDICINES

In 21st century, pharmacognosy has recently been defined as A molecular sciences that explores naturally occurring structure activity relationships with a drug potential The importance of drugs from animal, microbial and higher plants is well established with such natural product also serving as lead compound for templates for total synthetic modification. It has been estimated that 50% of the prescription presently dispensed in US may contain one or more natural product drugs, with this term broadly defined so as to include various types of molecular modification. Several new small molecules natural product derived drugs now introduced in therapy including acarbose, artemether, capsaicin, docetaxel, irinotecan, is useful in variety of diseases like cancer, infectious diseases. In recent review article, some of the scientific challenges that ensuring the safe and effective use of herbal remedies will present the manufactures of these products in terms of bio- avaibility, phyto- equivalence, standardization and other quality control and the performance of properly designed clinical trials leading to new phytomedicines. In US, the passage of the dietary supplement health and education act in 1984 led to the categorization of herbal medicines as dietary supplement for health maintenance Natural product also overcome some problems of modern drugs so as it is widely used in herbal medicines. 1. 2. 3. 4. 5. High cost & long time taken in development of new drugs. Toxicity- A new branch of medicine is termed iatrogenic diseases. Non-renewable sources of basic raw materials. Environment pollution by chemical industry. In adequate, especially in management of certain chronic diseases.

Advantage of plant based drugs. 1. 2. 3. 4. Long history of use & better patient tolerance as well as public acceptance. Renewable resources. Cultivation & processing environment friendly. Plants constitute to be a major source of new lead generation.

5. Local avaibility, especially in developing countries. 6. It is also safe, effective, & low risk of toxicity to health. A natural drug substance offers four vital & appreciable roles in the modern systems of medicines therapy adequately justifying their legitimate presence in the prevailing therapeutics arsenal namely: 1. Serve as extremely useful natural drugs. On a recent survey conducted by the WHO globally, around 20000 medicinal plants are being use profusely either in pharmaceutical industry or in herbal medicines. Interestingly about 1.4% do possess well-established widely proven broadly accepted un-equivocally active constituents The usual success rate of discovering new- drugs from natural sources in solely based not only on the conceptional but also on the implementation of ingenious comprehensive strategies which invariably exploit the untrapped potential of the natural sources. There are four ways by which the above objectives may be accomplished reasonably & legitimately such as 1 2 3 4 Isolation of novel genotypes from marine & terrestrial ecosystems. Genetic engineering creating novel and altered genotypes. Bio-chemical manipulation of selected pathways. Supersensitive & specific selection techniques & evaluation for varied bio- activities.

2. Provide basic compounds affording less toxic & more effective drug molecules. 3. Exploration of biological active phenotypes towards newer and better synthetics drugs. e.g. 1. Chloroquine from quinine used as anti malarial 2. Procaine from cocaine used as local anesthetics. 4 modifications of inactive natural products by suitable biological/ chemical means into potent drugs. E.g. taxol by conversion of 10- dasacetylbaccatin- iii (isolated from the needles of Taxus baccata) 10 dasacetylbaccatin-iii

Synthetic route Taxol Medicinal plants are important sources for pharmaceutical manufacturing. Medicinal plants and herbal medicines account for a significance % of the pharmaceutical market. E.g. in china medicinal plants & their products had a 33.1% share of pharmaceutical herbal market in 1995.

GENERAL STATUS & IMPORTANCE OF HERBAL MEDICINES.

Status of Herbal Medicines The world health organization estimated that 4-billion 80% of the world population use herbal medicine for some aspect of the primary health care. An herbal medicine are a major component in all indigenous peoples traditional medicines & is common element in Ayurvedic, homeopathic, naturopathic, traditional oriental & Native American Indian medicine. The sophistication of herbal remedies used around the world varies with technological advancement of countries that produce & use them. these remedies range from medicinal teas & crude tablets used in traditional medicine to concentrated, standardized extracts produced in modern pharmaceutical facilities & used in modern systems under a physicians supervision. In more developed Asian countries such as Japan, china, India, patent herbal remedies are composed of dried & powdered whole herbs or extract in liquid or tablet form. liquid herb extract are used directly in the form of medicinal syrups, tinctures , cordials, wines. Global market of herbal medicines. There is now an ever increasing interest & demand for herbs & herbal products in the world over. The reason for this renewed interest of herbal product is attributed side effect of modern synthetic products The plant based products also referred as botanicals, phytopharmaceuticals or green pharmaceuticals, herbal cosmetics, perfumes, condiments, confectionaries derived from natural product are now occupying a major share in the world trade & market.

 The global market & industries both have growing rapidly in recent years. Already the global OTC herbal market is more than US 50 billion dollars. Today medicinal plants enjoy great potential for exports. Apart from being a source of mew bioactive molecules, herbal products have great values as therapeutic agent. Herbals Now a day a large number of foreign countries are using herbal medicines for health care of their people. Today the scientists of the world are visualizing a great future plant based drugs for treatments of cancer, AIDS, chronic diseases & viral infections Since plants appear to be an excellent source of new bio-active compounds .thereof, a world wide interest is developing rapidly for phytomedicinal sector. India need not only to protect their medicinal plants wealth from endangering & the known knowledge of traditional systems of medicines like Ayurvedic, Siddha & unani but also need to move on with time pace to generate new knowledge develop new preparations so that they can get marketed , also efforts need to be on, To develop special preparations either as single molecules or of multiple molecules which themselves are not participating. To make existing preparation, trimmer & molecular defined. To search for entirely new herbal preparation based on plants not mentioned in Ayurvedic literature i.e. the preparation based. To investigate synergism amongst various fractions of detoxifires To develop specific preparations which acceptance recovery offer suffering from debilitating diseases.

Importance of herbals medicines Plants are considered to be medicinal of they possess pharmacological activities of possible therapeutic use. The goals of research in this field are especially. The identification of the active principles of medicinal plants & investigation of the extracts in order to ensure that they are safe, effective & of constant activity. The isolation of these active principles and the determination of their structure in order that they may be synthesized, structurally modified or simply extracted more.

1. Usage of herbal drugs in traditional medicines. The indications for the administration of traditional medicines are based on the patient symptoms and not on the underlying diseases, which are usually unknown, further more the concept of diagnosis which presupposes the existence of distinct diseases is usually absent. To take a familiar examples of digitalis purpurea were formerly used in Europe both apothecaries& by doctors for treatment of dropsy that is for a set of symptoms & not for a particular diseases or the treatments of cardiac disorders which causes odema. 2. Harvesting the correct plant family. It is desirable that the amount of plant materials collected at this stage be sufficient for the entire first part of research project so that all procedures may be performed on the same batch

investigation of therapeutic potentials It comes the responsibility of the pharmacologist, since before commencing any chemical investigation. it is necessary to check the presumed activity of the harvested plants. It establishes weather the presumed activity or not. In the latter case this may prevent wasting money on further investigations. It requires the development of a rapid effective pharmacological test. It may provide pharmacological & toxicological information. it is used at this stage to the test of complex extracts.

4 5 6 7 8

Defined identification of the plants. Investigation of the active principles. Classical pharmacological investigation of the bio-molecules. Determination of the chemical structure of bio-molecules. Synthesis & structure modification of the active moiety.

Risks associated with using herbal therapies.

 Because many herbs are collected from various sources world wide, the collector may or may not have specific education in discerning beneficial plants from a similar appearing but dangerous plants. E.g. fox glove being substituted for plantain which leads to digitalis poisoning. There is also concern that some traditional medicines actually include heavy metals such as active ingredients in some Ayurvedic preparation for diabetes & infant colic. Presence of corticosteroids & anti-inflammatory drugs in natural preparations touted as being beneficial for rheumatoid arthritis Cases of liver toxicity, especially from herbs containing pyrrolizidine alkaloids. E.g. comfrey. The Chinese herb nephropathy is well- published phenomenon that occurred in many female patients attending a weight loss center where misidentified Chinese herbs were used. Several of these patients eventually required dialysis & renal transplantation.

WHO POLICY ON HERBAL MEDICINES.

Why herbal medicine? Herbal medicine is being used by about 80% of the world population primarily in the developing countries or primary health care. They have stood the test time for their safely, efficacy, cultural acceptability & lesser side effects. The chemical constituents presents in them are a part of the physiological functions of living flora & hence they are believed to have better compatibility with the human body. Ancient literature also mentions herbal medicines for age-related diseases namely memory loss, oestoposis, diabetic wounds, immune & liver disorders etc. for which no modern medicine or only palliative therapy is available. All herbal drugs made from renewable resources of raw materials by ecofriendly process. Goals & objectives of the WHO guidelines 1. To promote the appropriate use of herbal medicines 2. To encourage the integration of herbal medicines into the mainstream health service delivery system 6

3. To provide basic principles & applicable standard for interested countries and areas in the region to develop a national policy & programmes on herbal medicines. 4. To guide interested countries & areas in the region to develop measures for promoting the appropriate usage of herbal medicines, appropriate to their own situations. 5. To facilitate information exchange on the appropriate use of herbal medicines among policy-makers, researchers & drug administrators. 6. To ensure the safe & effective use of herbal medicines by practioners & consumers. Salient features of WHO guidelines 1. Quality assessment Crude plant materials Plant preparation Finished product 2. Stability shelf life 3. Safety assessment Documentation of safety based on experience or/and toxicology studies. 4. Assessment of efficacy Documented evidence of traditional use or and activity determination (animal, human) Need for guidelines Herbal medicines, however are not necessary always safe simply because they are natural. Some have given rise to serious adverse reactions & some contain chemicals that may produce long term side effects such as carcinogenicity & hepatotoxicity. Herbal medicine will only benefit the health of human beings when they are used appropriately, thus good quality control and standardization of herbal medicines is essential. Furthermore with the increased use of both herbal medicines & modern western pharmaceutical drugs, there is a need to monitor interactions. WHO policy of herbal medicines The world health organization is fully aware of the importance of herbal medicines to many of its member states & supports the use of medicinal plants & their products. 7

 In early 1978, the world health assembly , the WHO governing body, adopted a resolution on drug policies & management of medicinal plants in the health care systems. The world health assembly proposed coordinating efforts through the preparation of an inventory of medicinal plants, the development of criteria & method for proving safety & efficacy of medicinal product & dissemination of relevant information. In 1987, 1988, 1989, three more resolutions were adopted covering the identification, evaluation, preparation, cultivations, utilization, regulation & conservation of medicinal plants. Based on those resolutions WHO policy on herbal medicine may be summarized as follow. WHO is fully aware of the importance of herbal medicines for the health of a large number of the population in todays world herbal medicines are recognized as resources and readily available resources and their appropriate use is encouraged. To promote the proper use of medicinal plants, a comprehensive programme for their identification, evaluation, preparation, cultivation, recognisation as valuable & readily available resources & their appropriate use is encouraged. It is necessary to make a systematic inventory and assessment (preclinical & clinical) of medicinal plants, to introduce measures on the regulation of herbal medicine to ensure quality control of herbal products by using modern techniques, applying suitable standard. As many of the plants that provide traditional & modern drug are threatened with extinction. WHO endorses the call for international corporation & coordination to establish programmes for the conservation of medicinal plants, to ensure that adequate quantities to ensure that medicinal quantities are available for future generations. References 1. Dr. Pulok K. Mukherjee; Quality control of herbal drugs; 1 st edition; 2002; business horizons pharmaceutical publishers. 2. Ashutosh kar Pharmacognosy & Pharmacobiotechnology 1st edition; new age international (P) limited publishers. 3. WHO guidelines. 8

4. THE EASTERN PHARMACIST August; 2000; Development of natural product; Pulok K. Mukherjee, M.K. Samanta; 23. 5. Journal of pharmacy and pharmacognosy; Pharmacognosy in 21 st century; A. Douglas Kinghorn; 135. 6. www.wpsz.com

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