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Standardization Strategies for Herbal Drugs-An Overview

Standardization Strategies for Herbal Drugs-An Overview

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03/14/2013

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 Research J. Pharm. and Tech. 1(4): Oct.-Dec. 2008, ,
310
 ISSN 0974-3618
 
www.rjptonline.org
 
 REVIEW ARTICLE
Standardization Strategies for Herbal Drugs-An Overview
Neeli Rose Ekka*. Kamta Prasad Namdeo and Pradeep Kumar Samal
SLT Institute of Pharmaceutical Sciences, Guru Ghasidas University ,Bilaspur (CG.)*Corresponding Author E-mail
:
 
nreekkarose@ yahoo.co.in
ABSTRACT:
 
Eighty of world population is dependent on herbal drugs and to enter into the global market it is vital to maintain its quality.The quality of herbal drugs is the sum of all factors which contribute directly or indirectly to the safety, effectiveness andacceptability of the product .Standardization of drugs means confirmation of its identity and determination of its quality andpurity. Initially the crude drugs were identified by comparison only with the standard description available. At present due toadvancement in the chemical knowledge of crude drugs various methods like botanical, chemical, spectroscopic andbiological methods are used for estimating active constituents present in the crude drugs in addition to its physical constants.
KEY WORDS:
 
Standardization, quality, purity, herbal products.
INTRODUCTION:
A system to ensure that every packet of medicine that isbeing sold has the correct substances in the correctamount and will induce its therapeutic effect this isknown as standardization.It is very important that a system of standardization isestablished for every plant medicine in the marketbecause the scope for variation in different batches of medicine is enormous. Plant material may vary in itsphytochemical content and therefore in its therapeuticeffect according to different places of collection, withdifferent times in a year for collection, with collection atthe same time and places but in different years and withdifferent environmental factors surrounding thecultivation of a particular medicinal plant. Adding to thisvariability is the fact that in herbal medicine severalplants may be used together in the same preparation. Thismeans that there should be a quality control test for theentire preparation to ensure quality of the product.World Health Organization (WHO) encourages,recommends and promotes traditional /herbal remedies innational health care programmes because these drugs areeasily available at low cost, safe and people have faith inthem. The WHO assembly in number of resolutions hasemphasized the need to ensure quality control of medicinal plant products by using modern techniques andapplying suitable standards.
1-2
Received on 01.09.2008 Modified on 10.11.2008Accepted on 12.12.2008 © RJPT All right reserved
 Research J. Pharm. and Tech. 1(4): Oct.-Dec. 2008; Page 310-312
 
PHARMACOPOEIAL STANDARDS
3-7
:
The authenticity, quality and purity of herbal drugs areestablished by reference given in pharmacopoeia. Thepharmacopoeia prescribes (numerical value) likestructural, analytical, physical standards for the drugs.The important standards mentioned in pharmacopoeia areshown in figure 1.A critical examination and identification of crude drugs isrequired in manufacturing of herbal formulation becauseof great diversity and variability in their chemicalcharacters. To overcome this problem all thepharmacopoeias have laid down certain standards.Specific tests for certain plant materials are given below.Volatile oil content Hemolytic activity Foaming index Bittervalue Tannin content. Fat content Acid valueSaponificationvalue Iodine value Assay forAluminium/ Arsenic /Borate/Calcium. Camphor/ Chloride/Copper/ Gold/Iron.Lead/Magnesium/ Mercury/Phosphate. Potassium/Silica/ Silver/Sodium.Sulpher/Sulphate/Tin.
PHYTOCHEMICAL ASSAY
8-19
:
Most of the drugs have definite specific chemicalconstituents to which their biological or pharmacologicalactivity is attributed. Qualitative and quantitativecharacterization of the active ingredient should be assayedusing biomarkers. Defining of the biomarker has to bevery specific and a lot of insight has to go into it beforedeclaring any distinct molecule. Additionally the mixtureshould be analyzed to develop finger print profile. Ageneral protocol followed for chemical assay for herbaldrugs is shown in figure 2.
 
 Research J. Pharm. and Tech. 1(4): Oct.-Dec. 2008, ,
311
 
Figure 1. Standardization parameters for plant drugs
Isolation of compounds Column chromatographyPartition chromatography Thin layer chromatography Gasliquid chromatography High performance liquidchromatography High performance thin layerchromatography.
Figure 2. Phyto chemical evaluation of herbal drugs
PROCESS CONTROL OF HERBAL DRUGS:
Drugs are manufactured from different raw materials byusing different methods or process. Some impurities areincorporated into the material during the manufacturingprocess. Multiple-step procedure which producesintermediate compounds. In- process control providesinformation on general characters, identification test andother applicable tests such as inorganic and heavy metalimpurity, microbial limit, and pesticide reside besides,safety, assay and stability. In addition to the foregoingportions of the initial final and in process samples areused for collecting average run samples for the qualitycontrol laboratory to perform final batch analysis andrelease. Process control is shown in figure 3.
CONTROL OF FINISHED PRODUCT:
Specification for finished product should be defined. Finaltesting of finished product is made in the quality controllaboratories. These tests are designed to determinecompliance with specifications. Thus the testing of thefinished product for compliance with predeterminedstandard prior to release of the product for packaging andsubsequent distribution is a critical factor for quality
MicroscopicexaminationTotal ashvalue
Radioact
MoisturecontentHeavymetalscontentsRefractiveindexPesticideresidueMicrobialcountForeignmatterExtractivevalue
Macrosc
Authenticity,
quality,
ViscosityMeltingpointLoss ondryingSpecificgravityDensity
Pharmacopoeial standards
Estimation of activeprinciples
Phytochemistry
Large scale isolation of active studiesSolventextractionIsolation of compounds bychromatographyStructuralelucidation byIR, MS, UVNMRsectroscoFingerprinting of plant drugsIsolation of chemicalmarkers forfixingpharmacopoeialstandards of single andcompoundformulations

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