International Journal of Green and Herbal Chemistry

E-ISSN: 2278-3229 IJGHC, March-2014-May-2014; Vol.3, No.2, 788-795. International Journal of Green and Herbal Chemistry An International Peer Review...
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E-ISSN: 2278-3229

IJGHC, March-2014-May-2014; Vol.3, No.2, 788-795.

International Journal of Green and Herbal Chemistry An International Peer Review E-3 Journal of Sciences

Available online atwww.ijghc.com

Section B: Herbal Chemistry Review Article

CODEN (USA): IJGHAY

Modern Aspect of Research and Development activities for Herbal Medicines of Ayurveda Sameet Masand, ** Swati madan ***S.K. Balian* *Department of Rasa Shastra and Bhaishajya Kalpana, R.G.G.P.G. Ayurveda College, Paprola. **Department of Pharmacognosy Amity Institute of Pharmacy Noida, ***Department of Rasa Shastra and Bhaishajya Kalpana, R.G. Government P. G. Ayurvedic College, Paprola, Ayurved Pharmacopeia Committee, Department of AYUSH, GOI, Former-Manager, Government Ayurvedic Pharmacy, Jogindernagar (H.P), India Received: 03 May 2014; Revised: 15 May 2014; Accepted: 21 May 2014

Abstract: In India, Ayurveda is the oldest existing medical system is recognized by W.H.O and is widely practiced. Drug & Cosmetic Act 1940 govern the Ayurvedic, Unani, Siddha system of Medicine, which also incorporates the regulatory and recommendatory standards for these drugs. Research and development activities are necessary for pharmaceutical industry to face the serious challenges in the path of standardization for Herbal Medicines of Ayurveda. There is urgent need of research and development activities for herbal medicine of Ayurveda in order to meet international acceptance and quality assurance. Biological variation in crude drugs invites the need of standardization of herbal drugs which can be achieved by new researches and development activities. It includes modern quality assessment system, Reverse 788 IJGHC, March-2014-May-2014; Sec. B, Vol.3, No.2, 788-795.

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pharmacology which offers efficient development platforms for herbal formulations. The herbal medicinal products are complex mixtures, formulated from the naturally existing various substances like juices, gums, fatty oils, essential oils, exudates and extracts of plants. So, great efforts are required to ensure a constant and adequate quality. The research and development activities are performed by Reverse Pharmacology and by transferring all the information mentioned in the classical books of Ayurveda on modern aspects. The research and the standardization of Herbal Medicines of Ayurveda start with a well-defined plant material through a defined extraction procedure and ends with quantitative method for one or more active ingredients. Scientific method of identification and quality control operation for assessment of Herbal Medicines of Ayurveda can be developed on modern lines which lead for global acceptance of Ayurveda. Keywords: Reverse pharmacology, Taxonomy, Chemical markers, thin layer chromato graphy, Biological library.

INTRODUCTION The research and development activity of Herbal Medicines of Ayurveda is required to ensure the efficacy and safety of Phytomedicine by determining the different contents of active alkaloids, safety assessment, therapeutic efficacy, product information and promotion. This can be performed by transferring all the information mentioned in the classical books of Ayurveda regarding identification, selection of quality herbs, method of preparation of formulation and quality assessment in terms of modern assessment. After interpreting all the procedures for quality control of phytomedicines in terms of modern systems; concrete methods of identification and quality assessment in terms of modern methodologies may be developed by making use of modern information and technology available. The quality control and development of Herbal Medicines of Ayurveda can be done in three stages. 1. 2.

3.

Classical methods: All the information mentioned in classics of Ayurveda regarding identification and quality assessment of formulation may be studied and documented properly. Transferring classical knowledge on modern line: All the classical knowledge available in the book regarding identification, nomenclature, source, selection of herbs, method of preparation of formulation and quality assessment may be interpreted clearly on scientific grounds with regard to modern assessment. Modern quality assessment system: Classical procedure of identification and quality assessment in terms of modern system may further be evaluated by Assay part of standardization by chemical and biological profiling. In this way, chemical and biological effects could be assessed and curative values may be established. Safety for use may also evaluate through these parameters.

Classical methods are used for Reverse Pharmacology and Comparison of classical knowledge on modern parameters which gives new criteria to establish the quality control and procedure to ensure the safety and efficacy of pharmaceutical products. Methods for development includes the use of taxonomy to know about the name, place, origin of plant. Chromatographic finger printing (TLC, HPTLC, Gas chromatography, Column Chromatography) are used for identification of herbs in complex mixture of 789 IJGHC, March-2014-May-2014; Sec. B, Vol.3, No.2, 784-795.

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Ayurvedic Formulation by specific chemical marker compounds. Some crude drugs have the established efficacy which can be used as evidence to make the standard for other drugs. By developing the biological libraries and databases for chemical markers, purity, identity, adulterants, substituents, pesticide residue etc. may be evaluated. AIMS AND OBJECTIVES There is urgent need for research and development activities for Herbal Medicines of Ayurveda so as to follow International quality assurance regulations. The Herbal Medicines of Ayurveda available in commercial market still lack to quality certificates which do not reveal about the contents of active ingredients or about necessary standardization procedure. W.H.O. has emphasized the need to ensure quality control of Herbal Medicines by using modern techniques and by applying suitable standards1. Overall, the biological variations in crude drugs invite attention for standardization of dosage form preparations. The clinical evaluation is necessary to assure acceptable safety and efficacy. Therefore, the development of parameters for quality control of Ayurvedic Drugs is a big task involving biological evaluation for a particular disease area, chemical profiling of Raw Material and laying down specification for the finished product. MATERIAL AND METHODS Modern quality assessment system: Following information regarding raw material may be collected and documented. Name: Classical name, official name, botanical name, local name. Part: Name of part of plant containing active principle of drug. e.g. Zingiberene in tuber of ginger. Geographical habitat: Actual place from which the raw herb was collected. Season of crop: Actual season during which the raw herb was grown. Time of collection: Actual time when the raw herb was collected. Year of collection: Actual year when raw herb was collected in natural Pesticides/Insecticides: Used during cultivation, flowering season, growing time.

condition.

Fresh/Dried: Condition in which the herb is collected or used in formulation. Form: The form in which the material was collected e.g. liquid state, powder form, exudates etc. Chromatographic fingerprinting: Quality control of herbal medicine is a tedious and difficult job. Herbal medicines differ from that of the conventional drugs and so some innovative methods are to be given importance for the sake of quality assessment of herbal drugs.2 Therefore Thin Layer Chromatography, High Performance Liquid Chromatography, Gas Chromatography, Column Chromatography are having great importance in this modern era. Chemical markers are available in the market for quality assessment of single plant drug and multiple plant drug or formulated herbal drugs. These markers are used to ensure the quality of drug or product assessment. TYPES OF MARKERS Analytical marker: Plants main constituents or active constituents of plant extract. 790 IJGHC, March-2014-May-2014; Sec. B, Vol.3, No.2, 784-795.

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Negative markers: Unwanted constituents as toxins. Chemical marker may be defined as substance or group of substances that are specific for medicinal plant and used as chemical entity present in the plant material which may serve as characteristic fingerprints for that alkaloid responsible for biological efficacy of plant. Table-1: Bioactive components available on modern parameters in context of Herbal Medicines of Ayurveda.3 Sr. No.

Bioactive component

Plant

1.

Aloin

Aloe barbadensis

2.

Anethene

Anethum sowa

3.

Berberine

Berberis aristata

4

Catechuic acid

Acacia catechu

5

Catechin

Acacia catechu

6

Embelin

Embelia ribes

7

Glycyrrhizin

Glycyrrhiza glabra

8

Zingiberene

Zingiber officinale

9

Zingiberol

Zingiber officinale

10

Plumbagin

Plumbago zeylanica

11

Punarnvine

Boerhaavia diffusa

12

Piperine

Piper longum

13.

Piperolongumine

Piper longum

14

Ricin

Ricinus communis

15

Vasicine

Adhatoda vasica

16

Valepotriates

Valeriana wallchi

17

Picrorhizin

Picrorhiza kurroa

18

Withaferin A

Withania somnifera

19

Trigogenin

Trigonella foenum Graecum

20

Valerine

Valeriana wallchi

21

Wedelolactone

Eclipta alba

Three attributes like Authenticity, Purity and Assay are responsible for standardization of drug. Authenticity is related with right identity of plant which can be verified by gross morphology, microscopy, chemical analysis etc. Purity is related with no adulterants in plant material which may be evaluated by pharmacognostic evaluations, like shape of stomata, calcium oxalate crystals and extractive values e.g. ash values. Assay is the chemical and biological profiling of the plant material responsible for 791 IJGHC, March-2014-May-2014; Sec. B, Vol.3, No.2, 784-795.

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curative and safety values. Chemical profiling is very important for standardization of plant material and finger prints can be utilized with known analytical procedures. In Ayurvedic systems of medicines, the Ayurvedic drugs are to be taken as whole or processed extracts thereof. The general techniques of extraction of medicinal plants include maceration, infusion, percolation, digestion, decoction, hot continuous extraction (soxhlet), aqueous alcoholic extraction by fermentation(such as asavas), counter current extraction(CCE), microwave assisted extraction, ultra sound extraction (sonication), super critical fluid extraction (SFE) etc. such extraction techniques separate out soluble plant metabolites leaving behind insoluble cellular marc. Table-2: Ayurvedic crude drugs having established efficacy5. Plant Psoralea corylifolia

Part Sd.

Component Psoralen Bakuchiol

Indications Anti-leucoderma, antibacterial Hepatoprotective Hepato protective Anti- diabetic Anti-diabetic

Picrorhiza kurroa Phyllanthus niruri Momordica charanita Pterocarpus marsupium Trigonellafoenum Graecum Gymnema sylvestre Eugenia jambolana Acorus calamus Adhatoda zeylanica Andrographis paniculata Asparagus racemosus Azadirachta indica Bacopa monnieri Boerhaavia diffusa

Tr. Rt. Pl. Fr. St. Bk.

Picroside Xylopyranoside Gallic acid Sterodial glycosides, Polypeptides Kino tannic acid, pterostilbene

Sd.

Anti-diabetic

Lf. Sd. Rz. Rt. Lf. Rt. Lf.

Trigonelline, Fenugreekine, Choline Gymnemic acid Peptidolglycan, Ellagic acid Acorin, Calamene Vasicie Andrographolide

Rt. St. Bk. Lf. Pl. Rt.

Shatavarin- I Margosine, Nimbidin Bacosides Punarnavine

Butea frondosa Centella asiatica

Sd. Bk. Fl. Pl.

Palasonin Asiaticosides

Curcuma longa Commiphora mukul Holarrhena antidysentrica

Rz. Exd. Sd. Bk.

Curcumin Guggulsteron Conessine

Anti abortifacient Anti-malarial Memory enhancer Anti-inflammatory, diuretic Anti-helminthic Psychotropic, skin diseases Anti-inflammatory Anti-obesity Anti dysentric

Anti-diabetic Anti-diabetic Tranquilizer Brondho dilator Hepato protective

The products so, obtained from plants are relatively complex mixtures of a number of groups of plant metabolites. Extracts may be exposed to ethylene oxide for fumigation or low dose gamma radiation for the purpose of avoiding microbial contamination. In cases where the extracts are fumigated, the final extracts exposed shall meet the residual levels of ethylene dioxide limits as applicable. Herbs treated with low dose of gamma radiation shall meet national regulation related to such a treatment and shall be labeled as per law.4 Therefore, it is clear that concept of synergy is absolutely established and it is true that not one pure compound but a set of compounds is responsible for valuable biological activity 792 IJGHC, March-2014-May-2014; Sec. B, Vol.3, No.2, 784-795.

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of plant material. Thus, it is very important that plant material may be evaluated for a set of compounds rather than one single compound. Therefore, marker compound may be chemically characterized and be linked to biological activity of plant material. This would lead to definite proof of co-relation between pressure of these compounds and biological activity. As when we achieve distinct chromatographic profile with 6–7 characteristic compounds for all plant materials to be used for Herbal Medicines of Ayurveda then we can assure for the production of quality Ayurvedic products. Thus this would be final stage for the development of Ayurvedic drugs which would be accepted globally. The WHO guidelines for assessment of herbal medicines are intended to facilitate the work to be carried out by Regulatory Authorities, Scientific Bodies and Industries in the Development, Assessment and Registration of such products. Some of the Ayurvedic crude drugs are thus acceptable which have pharmacological and clinical support for efficacies are given as below: Table-3: Few Herbal/Phytomedicines of Ayurveda are Most Popular in Europe after standardization is mentioned5 as below: Plant Allium sativum

Part Bulb

Component Allicin Allicetion

Vitis vinifera

Sd.

Valeriana officinalis

Rt.

Hypericum perforatum

Lf., Fl.

Piperdine, Pyridine, Isoquinoline Sesquiterpenes, volepotriates Hyperforin adhyperforin

Ginko biloba

Lf.

Curcuma longa Withania somnifera Syzygiumar omaticum Momordia charantia

Rz. Rt. Rl, Bd. Fr.

Aleo barbedensis Boswellia serrate

Lf. Pulp Oleoresin

Flavonoids and ginkgolidesq Curcuminoids Withanolides Tellimagrandin II Momorcharin momorcidin Aloin Beta boswellic acid

Indications Hypo cholesterolemic, antimicrobial Antioxidant, CVS, diseases Sedative Mild depression, nervousness Treatment of circulatory insufficiency. Anti-inflammatory Antioxidant Anti-herpes virus Anti-diabetic Burns Ostearthritis

DISCUSSION Study is conducted so that the Herbal Medicines of Ayurveda may be standardized and developed on modern techniques by applying suitable standards so that Herbal Medicine of Ayurveda may become Most Popular Medicines in International Trade. Thus the Ayurvedic medicines may be standardized with following objectives: 1. To develop libraries for biological/ chemical markers for chemical identification of material through chemo profiling. 793 IJGHC, March-2014-May-2014; Sec. B, Vol.3, No.2, 784-795.

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2. To develop databases for identification, authentication, habitat, storage, morphological characters, microscopic study with well-defined botanical and phytochemical characteristics. 3. To develop methods as such to prevent contamination of fungi, bacteria etc. of raw herbs before manufacturing on modern lines. 4. To develop detailed standard operative procedures for all Herbal medicines as per A.P.I. 5. To develop standards for extracts and formulation through chemo-profiling and bio-profiling for all Herbs as per A.P.I. 6. To develop standards for purity, identification, adulterants, substitutes, pathogenic bacteria, heavy metals, pesticides residue and aflotoxins. 7. To develop different dosage forms of Ayurvedic medicine on modern lines. 8. To develop method of administration with various anupana. 9. To develop efficacy profile of different parts of plants as well as to include new plants as ayurvedic drugs. 10. To promote cultivation using good agricultural practices to maintain quality of herbal medicines of Ayurveda. 11. To facilitate collation of exchange of information, establishing of regional data bases on plants as well as monitoring of development of herbal medicines of Ayurveda. 12. To organize workshops for training on quality control of herbal medicines and exchange of ideas and experiences at technical and management level. 13. To initiate the development and adoption of strategies, policies and methodologies for an integrated approach towards development of quality herbal medicines. 14. To conduct systematic surveys and exploration of natural resources to have assured supply of quality raw material for herbal medicine of Ayurveda. 15. To promote initiative leading to the development of indigenous skills and capabilities to adopt innovate methods of establishing quality control of herbal medicine. 16. To develop establishment at national and international levels of information networks covering technical and other aspects and inter-institutional links for development of quality herbal medicine. 17. To develop Pharmacopoeial standards for all finished medicines as per A.P.I standards. 18. To develop such methods helpful for the stability of medicines. 19. To develop bioactivity protocols for Ayurvedic products with the help of biomarkers. 20. To develop safety assessment for Ayurvedic medicine as per WHO guidelines. 21. To mention complete product information for the consumer. 22. To develop Packaging, Labeling and Storage as per guidelines of D and C Act 1940.6 23. To develop detailed pharmacological evaluations. 24. To develop Pharmacodynamics and Pharmacokinetics studies (Analysis). 25. To develop Registration by the National Drug Authority. CONCLUSION Scientific method of identification and quality control operation for assessment of Herbal Medicines of Ayurveda can be developed on modern lines which would lead for global acceptance of Herbal medicine of Ayurveda.

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ACKNOWLEDGEMENT The authors are highly thankful to Prof. Y. K. Sharma, Dean and Principal, Rajiv Gandhi Govt. P.G. Ayurvedic College, Paprola for his support towards the study and valuable suggestions in preparing the manuscript. REFERENCES 1. 2. 3. 4. 5. 6.

Quality control methods for herbal material W.H.O. 31. WWW.pharmainfo.net Chromatographic fingerprinting analysis for herbal medicines: A quality control tool by S. Sohan. Chitlange, 2008, 6(2). http://em.m.wikipedia.org/wiki Dated 28/04/2014. API, Part- I, Vol, 8. List of medicinal plants– rational/wiki.org/wiki D and C Act 1940.

*Corresponding author: S.K. Balian; Department of Rasa Shastra And Bhaishajya Kalpana, R.G.G.P.G. Ayurveda College, Paprola.

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