NEED OF POLYHERBAL FORMULATIONS AND ITS STANDARDIZATION: A REVIEW

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1 WORLD JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES Shinde et al. S JIF Impact Factor Volume 5, Issue 11, Review Article ISSN NEED OF POLYHERBAL FORMULATIONS AND ITS STANDARDIZATION: A REVIEW *Jyotsna S. Shinde, Sonali S. Khurde, Suchita L. Suchita, Sushmita S. Chavan, Sonali B. Hulmajge Channabaseshwar Pharmacy College, Latur. Article Received on 07 Sep. 2016, Revised on 28 Sep. 2016, Accepted on 19 Oct DOI: /wjpps *Corresponding Author Jyotsna S. Shinde Channabaseshwar Pharmacy College, Latur ABSTRACT Nature has been a source of medicinal agents for more than thousands of years and herbal therapy predominates in traditional systems of medicine. Active constituent in the polyherbal combination act as synergistic manner. so best combination of poly-herbal combination provide higher activity against a disease. Also, poly-herbal formulation having multiple types of molecules against a disease/complication so different molecules cure a disease by different mechanism so provide a complete therapy against a disease condition. The present review deals with need of the various polyherbal formulations. Information on traditional herbal formulations was documented in the form of research and review articles in various journals. The aim of this review is to summarize the different types of herbs used for the preparation of polyherbal formulations, their therapeutic potentials including clinical and preclinical results along with their safety and efficacy. This review will facilitate to gain all about the standardization and evaluation of polyherbal formulations which will insist the young researchers for future research to protect human beings from various types of diseases and may serves as a natural gold for the promotion of mankind. KEY WORDS: Polyherb, traditional medicine, polyherbal therapy, standardization, safety. INTRODUCTION Herbal products are of interest to many patients and health care practitioners because more than 70% of World s population is rely on herbal medicines for part of their primary health care system. In different regions and cultures, herbal products are used as single herb, combination of herbs, or combination of herb(s) and drug(s). Due to several side effects of allopathic medicine, in recent years there has been an increase in the use of herbal medicine Vol 5, Issue 11,

2 by the majority of population throughout the World. Polyherbal formulations with various active principles and properties have been used from ancient days to treat a wide range of human diseases. Polyherbal formulations are collection of therapeutic entities thatare formulated and prepared on the basis of the healing properties of individual ingredients with respect to the condition of sickness. Such herbal constituents with diverse pharmacological activities principally work together in a dynamic way to produce maximum therapeutic benefits with minimum side effects. Nevertheless, these traditional medicinal preparations gradually lost their popularity and foothold among people due to the fast therapeutic action of allopathic system of medicine. In recent years however, renewed interest has grown on traditional herbal remedies because of many side effects observed by using synthetic drugs in allopathic medicine. At the same Bariket al. / A Review on Therapeutic Potential of Polyherbal Formulation time, WHO also recommends further research on traditional system of medicine. [1,2] Herbal medicines are the oldest remedies known to mankind. Herbs had been used by all cultures throughout history but India has one of the oldest, richest and most diverse cultural living traditions associated with the use of medicinal plants1. In the present scenario, the demand for herbal products is growing exponentially throughout the world and major pharmaceutical companies are currently conducting extensive research on plant materials for their potential medicinal value. In many journals, national and international we find an increasing number of research publications based on herbal drugs. Many analysis based studies regarding pharmacological research in India2,3,4 have been conducted in the past. Diabetes is the world s largest endocrine disease involving metabolic disorder of carbohydrate, fat and protein. According to the WHO projections, the prevalence of diabetes is likely to increase by 35%5. Statistical projections about India suggest that the number of diabetics will rise from 15 million in 1995 to 57 million in the year of 2025 making it the country with the highest number of diabetics in the world6. In the present work we have developed anti diabetic polyherbal formulations and assessed their potential in the treatment of diabetes. [3] STANDARDIZATION OF HERBAL FORMULATION Standardization of herbal formulations is essential in order to assess of quality drugs, based on the concentration of their active principles, physical, chemical, phyto-chemical, standardization, and In-vitro, In-vivo parameters. The quality assessment of herbal Vol 5, Issue 11,

3 formulations is of paramount importance in order to justify their acceptability in modern system of medicine One of the major problems faced by the herbal industry is the unavailability of rigid quality control profiles for herbal materials and their formulations. In India, the department of Ayush, Government of India, launched a central scheme to develop a standard operating procedures for the manufacturing process to develop pharmacopeial standards for ayurvedic preparations. The subject of herbal drug standardization is massively wide and deep. There is so much to know and so many seemingly contradictory theories on the subject of herbal medicines and their relationship with human physiology and mental function. India needs to explore the medicinally important plants. This can be achieved only if the herbal products are evaluated and analyzed using sophisticated modern techniques of standardization. World Health Organization (WHO) encourages recommends and promotes traditional/herbal remedies in natural health care programmes because these drugs are easily available at low cost, safe and people have faith in 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. [4] India can emerge as the major country and play the lead role in production of standardized, therapeutically effective ayurvedic formulation. India needs to explore the medicinally important plants. This can be achieved only if the herbal products are evaluated and analyzed using sophisticated modern techniques of standardization such as UV-visible, TLC, HPLC, HPTLC, GC-MS, spectrofluorimetric and other methods. These guidelines for the assessment of herbal medicines are intended to facilitate the work of regulatory authorities, scientific bodies and industry in the development, assessment and registration of such products. The assessment should reflect the scientific knowledge gathered in that field. Such assessment could be the basis for future classification of herbal medicines in different parts of the world. Other types of traditional medicines in addition to herbal products may be assessed in a similar way. The advancement of analytical techniques will serve as a rapid and specific tool in the herbal research, thereby, allowing the manufacturers to set quality standards and specifications so as to seek marketing approval from regulatory authorities for therapeutic efficacy, safety and shelf- life of herbal drugs. The effective regulation and control of herbal medicines moving in international commerce also requires close liaison between national institutions that are able Vol 5, Issue 11,

4 to keep under regular review all aspects of production and use of herbal medicines, as well as to conduct or sponsor evaluative studies of their efficacy, toxicity, safety, acceptability, cost and relative value compared with other drugs used in modern medicine. [5,6] This involves adjusting the herbal drug preparation to a defined content of a constituent or a group of substances with known therapeutic activity by adding excipients or by mixing herbal drugs or herbal drug preparations. Botanical extracts made directly from crude plant material show substantial variation in composition, quality, and therapeutic effects. Standardized extracts are high-quality extracts containing consistent levels of specified compounds, and they are subjected to rigorous quality controls during all phases of the growing, harvesting, and manufacturing processes. No regulatory definition exists for standardization of dietary Supplements. As a result, the term standardization may mean many different things. Some manufacturers use the term standardization incorrectly to refer to uniform manufacturing practices, but following a recipe is not sufficient for a product to be called standardized. Therefore, the presence of the word standardized on a supplement label does not necessarily indicate product quality. When the active principles are unknown, marker substances should be established for analytical purposes and standardization. Marker substances are chemically defined constituents of a herbal drug that are important for the quality of the finished product. Ideally, the chemical markers chosen would also be the compounds that are responsible for the pharmacological effects in the body. There are two types of standardization. In the first category, true standardization, a definite phytochemical or group of constituents is known to have activity. Ginkgo with its 26% ginkgo flavones and 6% terpenes is a classic example. These products are highly concentrated and no longer represent the whole herb, and are now considered as phytopharmaceuticals. In many cases they are vastly more effective than the whole herb. However the process may result in the loss of efficacy and the potential for adverse effects and herb drug interactions may increase. The other type of standardization is based on the guarantee of the manufacturers for the presence of a certain percentage of marker compounds which are not indicators of therapeutic activity or quality of the herb. [7,8] WHO GUIDELINES FOR QUALITY STANDARDIZED HERBAL FORMULATIONS 1) Quality control of crude drugs material, plant preparations and finished products. 2) Stability assessment and shelf life. 3) Safety assessment; documentation of safety based on experience or toxicological studies. 4) Assessment of efficacy by ethno medical information and biological activity evaluation Vol 5, Issue 11,

5 NEED OF POLYHERBAL FORMULATION In the global perspective, there is a shift towards the use of medicine of herbal origin, as the dangers and the shortcoming of modern medicine are getting more apparent. It is the cardinal responsibility of the regulatory authorities to ensure that consumers get the medication, which guarantees purity, safety, potency and efficacy. Th e regulatory authorities rigidly follow various standards of quality prescribed for raw materials and finished products in pharmacopoeias, formularies and manufacturing operation through statutory imposed good manufacturing practices. These procedure logically wou ld apply to al l types of medication whether included in modern system of medicine or one of the traditional systems. Though herbal products have become increasingly popular throughout the world, one of the impediments in its acceptance is the lack of standard quality control profile. The quality of herbal medicine that is, the profile of the constituents in the final product has implications in efficacy and safety. However, due to the complex nature and inherent variability of the constituents of plant-based drugs, it is difficult to establish quality control parameter though modern analytical technique are expected to help in circumventing this problem. Furthermore, the constituents responsible for the claimed therapeutic effects are frequently unknown or only partly explained. This is further complicated by the use of combination of herbal ingredients as being used in traditional practice. It is common to have as many as five different herbal ingredients in one product. Thus batch to batch variation starts from the collection of raw material itself in the absence of any reference standard for identification. These variations multiply during storage and further processing. Hence for herbal drugs and products, standardization should encompass the entire field of study from cultivation of medicinal plant to its clinical. Now a day s Ayurvedic practitioners are totally depends upon mediators for drug collection. Proper identification of drug, adulteration, and availability are major problems faced by herbal industry. Actual availability of drug & finished products which are available in market; proportion of this is a big question mark. Some Ayurveda practitioners prepare their own medicines, so raw drugs used & quality of product which is prepared differs and it is questionable. So it is necessary to conduct uniform rules for preparing drug. [9,10,11] COMPARISION OF POLYHERBAL FORMULATION WITH ALOPATHY The plant products are now becoming more popular than the synthetic allopathic drugs due to their low toxicity and long standing experience of use in the traditional literatures like the Ayurvedic. Due to side effects of synthetic steroidal contraceptives, interest has been focused Vol 5, Issue 11,

6 on the indigenous plants for possible contraceptive effect. Although the contraceptives containing estrogen and progesterone are effective and popular, due to the risk associated to these drugs have increased the need for suitable product from indigenous medicinal plants that can be used as alternative of pills. One of the greatest arguments against traditional medicine is the lack of scientific proof of its effectiveness. There is insufficient scientific investigation on most of the claims made by the traditional medicine practitioners. [10] There is another problem of Safety. People think that traditional herbs are safe and harmless since they are natural and are not invented in the laboratory. But use of these herbs may possibly expose the patient to unknown dangers. [12, 13] For example aristolochic acid and other components within herbs can cause adverse renal effects and renal toxicity. [14] Some herbal remedies used to treat liver disease may be hepatotoxic themselves. [15] There is also possible serious reaction between herbal therapy and biomedical medications. A survey says that most patients do not inform their physician that they are taking herbal treatment. This may result in serious and fatal reaction. The most common published and worst herb drug reaction is of St John s wort (Hypericum perforatum) and drugs that are metabolized by cytochrome P450, CYP 3A4 isoenzymes used without informing their physicians patients use St John s wort to treat depression. This may have varies adverse effects. The woman taking oral contraceptives with St John s wort may cause breakthrough menstrual bleeding, unexpected pregnancy. Other problem with traditional medicine is the lack of hygiene and precise dosage. [16] CONCLUSION In the developing countries increased cost of medicine as well as their side effects has become a great task when the public health is concerned. The scientific advancement carries with it the improvement in polyherbal formulations, through the study of various phytoconstituents and discovery of useful herbs combinations which work synergistically to produce desirable effect. Today, the renaissance of polyherbal formulations has occurred the world over, owing to its comparable efficacy, fewer side effects and better acceptability than allopathic drugs. Most of the time, they produce satisfactory effect and safety, making them one of the highly selected drugs of choice. Nonetheless, public's inadequate knowledge and misconception on the safety of polyherbal formulations may result in the opposite effect such as toxicity and undesired interaction. Poor regulatory control and manufacturers irresponsibility has also affected the quality of the polyherbal formulations manufactured, which can be dangerous to the consumers health. For this, preventive and corrective steps are crucial to reduce the hazardous risks, including the practice of strict regulatory control Vol 5, Issue 11,

7 and public education on the correct use of polyherbal formulations. Only with correct and rational use, Ayurvedic polyherbal formulations can exert the best effect in human health. Investigations have been carried out from time to time to develop different types of polyherbal formulations to enhance the overall therapeutic potential of the formulation. In this review, we have presented information about various polyherbal formulations, their pharmacological properties along with their evaluation parameters which will be helpful for further investigation of other therapeutic potential and mechanism of action of these polyherbal formulations. REFERENCES 1. Wills RB, Bone K, Morgan M. Herbal products: Active constituents, Modes of action and quality control. Nutr Res Rev. 2000; 13: Gohil PV, Mehta AA. Evaluation of Mast Cell Stabilizing and Anti-Anaphylactic Activity of Polyherbal Formulation. Adv Bio Res. 2011; 5(6): Bhatt N, Ayurvedic drug industry challenges of today andtomorrow, Proceeding of the first national symposium of Ayurvedic drug industry, organized by ADMA, New Delhi, 1998 Aug. 4. Satheesh Madhavi NN, Kumud Upadhya, Asha bishti. Phytochemical screening and standardization of poly herbal formulation for Dyslipidemia. Indian journal of physiology and pharmacology, 2011; 3(3). 5. Arun Rasheed, Anvesh Mari. Formulation, Characterization and Comparative Evaluation of Kasisa Bhasma. A Herbo- Mineral Indian Traditional Medicine. Journal of Complementary and Integrative Medicine. 6. Arun Rasheed, K.V. Satyanarayana. Chemical and pharmacological standardization of Ashwagandhadi lehyam: An ayurvedic formulation. Journal of Complementary and Integrative Medicine. 7. AOAC (2005). Official Methods of Analysis of AOAC International, 18th edn. AOAC International, Gaithersburg, MD. 8. Barnes J, Anderson LA, Phillipson JD. Herbal medicine. 3rd Edition, Pharmaceutical Press, London. 2007; General Guidelines for Methodologies on Research and Evaluation of Traditional WHO/EDM/5. Dr. Kalyani Jadhav, Standardization of Ayurvedic Drugs, Satyanveshnama Vol 5, Issue 11,

8 10. Arun Rasheed, A Review on standardization of herbal formulations, Inter. J. of Phytotherapy, 2012; 2(2): WHO. Quality Control Methods for Medicinal Plant Materials. World Health Organization, Geneva, 1992TRM/2000.1, Distr.: General, Original: English. 12. Census of India report (May 2011), Rodger W. M., Baird D. T., Induction of therapeutic abortion in early pregnancy with Mifepristone in combination with prostaglandins pessary. Lancer. Dec., 1981; 19: Maria B., Stampf F., Goepp A. et. al., Termination of early pregnancy by a single dose of Mifepristone (RU 486), a progesterone antagonist. Eur. J. Obsfet.Gynaecol. Repr. Biol. 1988; 28: Kirk-Othmer Encyclopedia of Chemical Technology. 4th ed. Volumes 1: New York, NY. John Wiley and Sons, 1991-Present., p. V22: 903 (1996) Khoo SK., Cancer risks and the contraceptive pill. What is the evidence after nearly 25 years of use? Med J Aust. Feb 17, 1986; 144(4): W D Odell, An analysis of the reported association of oral contraceptives to thromboembolic disease. West 1975 Jan; 122(1): Lidegaard O., Smoking and use of oral contraceptives: impact on thrombotic diseases. Am J Obstet Gynecol Jun; 180(6 Pt 2): S Vol 5, Issue 11,