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THE PHARMA REVIEW (JULY - AUGUST 2011)

Significance of Study of Validation Parameters of Marketed Polyherbal Formulation

*S.K.Bais, A.V.Chandewar, S.M.Charjan, D.W.Wargantiwar, C.K.Gadewar

Abstract
Polyherbal formulations as mentioned in classical texts of Ayurveda are used by number of pharmaceutical companies. It is very difficult to understand the theme of Polyherbal preparation as a number of ingredients may vary from 2 to 25 or more. The situation is very further worsened by the multiple uses of these formulations as mentioned in Ayurveda. These are generally the mixtures of extracts, pulps, juices, secretions and exudations or powders of medicinal herbs in solid, liquid or semisolid forms with or without suitable base. Quality assurance needed to establish confidence that the quality functions are being performed adequately. It is one of the most important departments of pharmaceutical companies that develop and follow internal standard operating procedures (SOPs), directed towards assuring the quality, safety, purity and effectiveness of the drug products. HPTLC fingerprints are often employed during product and process development to establish proper extraction procedures to standardize extracts and to detect changes or degradations in the material during formulation. Sample preparation during analysis involves extraction step that is why fingerprints of raw material and a preparation can be different. So, concrete methods of quality control in terms of modern methodologies are needed to be developed for traditional system of medicines.
Ayurveda and herbal medicine
Ayurveda is one of the oldest still extant, health traditions in the world. Ayurveda is based on Sankhya philosophy which means ‘rational enquiry into the nature of the truth’. Sanskrit meaning of Ayu is life and Veda is knowledge or science. Charak Samhita (1000 BC) and Sushrut Samhita (100 AD) are the main classics. Ayurveda materia medica gives detailed descriptions of over 1500 herbs and 10,000 formulations. Madhav Nidan (800 AD) a diagnostic classic provides over 5000 signs and symptoms. Life in Ayurveda is conceived as the union of body, senses, mind and soul. The concept of Prakriti or human constitution plays a central role in understanding health and disease in Ayurveda which is similar to modern pharmacogenomics. With over 400,000 registered Ayurvedic practitioners, Government of India, Department of AYUSH (Ayurveda, Yoga, Unani, Siddha and Homeopathy) has responsibility to regulate quality, education and practice1. Herbal medicines have been enjoying world wide use. However, one of the impediments in the acceptance of the ayurvedic formulation is lack of standard quality control profiles2. The plants used in Ayurveda and other Indian system of medicines may be of interest to find new leads for treating different diseases. Approaches like high-throughput screening, phytochemical profiling, quality controls and standardization of raw materials and finished products, clinical trials, herbal therapeutics, pharmacokinetics and herbal pharmacovigilance will not only help to prove the rationale of using these systems but also to get maximum benefits of the natural resources3.

 

 

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