Research J. Pharm. and Tech. 1(4): Oct.-Dec.

2008, ,

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 and acceptability of the product .Standardization of drugs means confirmation of its identity and determination of its quality and purity. Initially the crude drugs were identified by comparison only with the standard description available. At present due to advancement in the chemical knowledge of crude drugs various methods like botanical, chemical, spectroscopic and biological 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 is being sold has the correct substances in the correct amount and will induce its therapeutic effect this is known as standardization. It is very important that a system of standardization is established for every plant medicine in the market because the scope for variation in different batches of medicine is enormous. Plant material may vary in its phytochemical content and therefore in its therapeutic effect according to different places of collection, with different times in a year for collection, with collection at the same time and places but in different years and with different environmental factors surrounding the cultivation of a particular medicinal plant. Adding to this variability is the fact that in herbal medicine several plants may be used together in the same preparation. This means that there should be a quality control test for the entire preparation to ensure quality of the product. World Health Organization (WHO) encourages, recommends and promotes traditional /herbal remedies in national health care programmes because these drugs are easily available at low cost, safe and people have faith in them. The WHO assembly in number of resolutions has emphasized the need to ensure quality control of medicinal plant products by using modern techniques and applying suitable standards.1-2 Received on 01.09.2008 Accepted on 12.12.2008 Modified on 10.11.2008 RJPT All right reserved PHARMACOPOEIAL STANDARDS3-7 : The authenticity, quality and purity of herbal drugs are established by reference given in pharmacopoeia. The pharmacopoeia prescribes (numerical value) like structural, analytical, physical standards for the drugs. The important standards mentioned in pharmacopoeia are shown in figure 1. A critical examination and identification of crude drugs is required in manufacturing of herbal formulation because of great diversity and variability in their chemical characters. To overcome this problem all the pharmacopoeias have laid down certain standards. Specific tests for certain plant materials are given below. Volatile oil content Hemolytic activity Foaming index Bitter value Tannin content. Fat content Acid valueSaponification value Iodine value Assay forAluminium/ Arsenic /Borate/Calcium. Camphor/ Chloride/Copper/ Gold/Iron. Lead/Magnesium/ Mercury/Phosphate. Potassium/Silica/ Silver/Sodium.Sulpher/Sulphate/Tin. PHYTOCHEMICAL ASSAY8-19 : Most of the drugs have definite specific chemical constituents to which their biological or pharmacological activity is attributed. Qualitative and quantitative characterization of the active ingredient should be assayed using biomarkers. Defining of the biomarker has to be very specific and a lot of insight has to go into it before declaring any distinct molecule. Additionally the mixture should be analyzed to develop finger print profile. A general protocol followed for chemical assay for herbal drugs is shown in figure 2.

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Figure 1. Standardization parameters for plant drugs

Microscopic examination Total ash value

Authenticity,

Macrosc
Extractive value

quality, purity

Radioact

Pharmacopoeial standards

Foreign matter

Moisture content

Microbial count

Heavy metals contents Refractive index Viscosity Loss on drying

Specific gravity

Density

Pesticide residue

Melting point

Isolation of compounds Column chromatography Partition chromatography Thin layer chromatography Gas liquid chromatography High performance liquid chromatography High performance thin layer chromatography.
Figure 2. Phyto chemical evaluation of herbal drugs Finger printing of plant drugs Solvent extraction

Estimation of active principles

Isolation of chemical markers for fixing pharmacopo eial standards of single and compound formulations

Phytochemistry

Isolation of compounds by chromatography

PROCESS CONTROL OF HERBAL DRUGS: Drugs are manufactured from different raw materials by using different methods or process. Some impurities are incorporated into the material during the manufacturing process. Multiple-step procedure which produces intermediate compounds. In- process control provides information on general characters, identification test and other applicable tests such as inorganic and heavy metal impurity, microbial limit, and pesticide reside besides, safety, assay and stability. In addition to the foregoing portions of the initial final and in process samples are used for collecting average run samples for the quality control laboratory to perform final batch analysis and release. Process control is shown in figure 3. CONTROL OF FINISHED PRODUCT: Specification for finished product should be defined. Final testing of finished product is made in the quality control laboratories. These tests are designed to determine compliance with specifications. Thus the testing of the finished product for compliance with predetermined standard prior to release of the product for packaging and subsequent distribution is a critical factor for quality

Large scale isolation of active studies Structural elucidation by IR, MS, UV NMR spectroscopy

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assurance. This testing along with in process testing, assures that each unit contains the amount of drug claimed on the label, that all of the drug in each unit is available for complete absorption, that the drug is stable in the formulation in its specific final container closure system for its expected shelf life and that dosage units. themselves contain no toxic foreign substances. The label of herbal medicine should have all the particulars required by national regulations. The label and package insert should have at least the following information. Name of the product. List of active ingredient together with Latin botanical name and their quantities. Dosage form. Indication. Dosage for adults, children and elderly. Mode of administration. Duration of use. Major adverse effects, if any. Over dosage information. Contraindication, warning precautions and major drug interactions. Use during pregnancy and lactation. Expiry date. Batch /lot number. Name, address of the manufacturer together with authorization number.
Figure 3. Flow chart of process control of herbal drugs Collection of herbal Source

REFERENCES:
1. Chaudhury RR, Herbal medicine for human health. World Health Organization Geneva, CBS publishers and distributors LTD New Delhi, 1999 Raina MK, Quality control of herbal and herbo-mineral formulations. Indian journal of natural products, 2003; 19: 11-15. Quality control methods for medicinal plant materials (WHO). Geneva, A.T.T.B.S. Publishers and distributor Delhi 2002. Ansari SH, Pharmacognosy. Tata publishers, 2003. Kokate CK, Gokhale SB. Pharmacognosy. Nirali prakashan, Delhi 2004. Sharma PP, How to practice GMPs Vandana publications , 1995. Stahl E. Thin layer chromatography. Springer verlag Berlin Heidel berg, New York, Springer international student edition, 1969. Herbone JB. Phytochemical methods Chapman and Hall, London, New York, 2nd edition 1928. Saraswathy A, Standardization of siddha drugs, Ancient Science of life, 1994; 1, 2: 53-60. Ahirwal B, Ahirwal D and Ram A., Evaluation of standards and quality control parameters of herbal drugs. Souvenir, recent trends in herbal therapy, 2006; 25-29. Wallis TE, Practical Pharmacognosy, J. A. Churchill Ltd., London 1667. Clarke ECG, Isolation and identification of drugs The Pharmaceutical press, London, 1967. Brain K. R. and Turner T.D. Practical Evaluation of phytopharmaceuticals. Wright Scientechnica Bristol 1975. Indian pharmacopoeia Vol I and II, 3rd Ministry of Health, Govt of India, New Delhi. 1985. Wallis CJ. Practical Biology, William Heinemann Medical Books Ltd., 1958. Datta A C. Test book of Botany, Oxford University press Calcutta, 1982. Wagner S. Bladt and E M Z Gainski, Plant drug analysis , A Thin layer chromatograpy atlas, New Delhi, 1984. World Health Organization (WHO), International pharmacopoeia, Geneva Switzerland, 2001. Gupta MK and Sharma PK. Test Book of Pharmacognosy, Ayurvedic formulations, Pragati Prakashan Meerut Vol II, Ist edition, 2007

2.

3.

4. 5. 6. 7.

8. 9. 10.

11. 12. 13.

Storage of raw Compounding

Raw material Manufacturing

Proper storage In process analysis

14. 15. 16.

Analysis

Processed Material

Proper storage

17. 18. 19.

Stability studies

Finished product

Proper container

CONCLUSION:
The pharmacopoeial standards in Ayurvedic Pharmacopoeia of India are not adequate enough to ensure the quality of plant materials since the materials received in the manufacturing premises are not in a condition that effective microscopic examination can be done. Therefore chemical, methods, instrumental methods and then layer chromatographic analysis would determine the proper quality of plant material Thus we can ensure consistent quality of herbal product through following. Use of approved quality of all raw materials. Use of all approved packing material. Standardized and well validated methods of processing and manufacture. Complete finished product quality control testing.

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