Quality control aspects of herbs and botanicals in developing countries: Coleus forskohlii Briq a case study

摘要

Objective: Current trend of commercialization of herbal medicines draw a huge need of maintaining their quality. The declaration of quality, safety and efficacy of medicinal plants as well as poly-herbal formulations has become an important issue. Hence, qualitative and quantitative analysis of herbal drugs and formulations viz., fingerprint profiles and quantification of the various markers become key factors of quality control. Materials and Methods: Present investigation is a detailed report for quality control of well-known herb Coleus forskohlii Briq, which includes physicochemical parameter determination, safety evaluation, microscropical evaluation, and chromatographic fingerprinting as well. Results: Physico-chemical characters were evaluated according to Indian Pharmacopoeia, further microscopic evaluation of transverse section of Coleus reveals that periderm, secondary phloem, and wide secondary xylem cylinder, which occupies major portion of the root fragmentary. Chromatographic fingerprint profiles of Coleus have been generated, and a marker based standardization strategy was adopted; using different analytical technique like high-performance thin layer chromatography, high-performance liquid chromatography and gas chromatography-mass spectroscopy to maintain quality and ensure safety as well as efficacy. Conclusion: These advancements in modern techniques of analysis can lead to effective quality control of Coleus as well as other herbs. Present report can act as pioneer for quality control of modern herbal medicine. KEY WORDS: Coleus forskohlii , gas chromatography-mass spectroscopy, quality control, standardization, thin layer chromatography The plants are indispensable to man for his life. The three important necessities of life – food, cloth and shelter are supplied to man by plant kingdom and act as a complete storehouse of remedies to cure all kind of disease in man.[ 1 ] Men learnt to use plants as healers of different ailments with the beginning of civilisation, since then very vast knowledge concerning therapeutic properties of different plants has accumulated. According to one estimate, 80% of the world population still depends on herbal products for their primary healthcare needs. With the growing interest in plant-based medicine over the last 20 years, herbal medicine has been enjoying people's attention throughout the world. Plectranthus barabatus ( Coleus forskohlii Briq, Family: Lamiaceae) is also an important medicinal plant, which is mainly distributed in few developing countries viz. India, Pakistan, Sri Lanka, and Brazil. Preparations of Coleus species have long been used in Ayurvedic and traditional systems of medicine, particularly in the treatment of epilepsy, conjunctivitis, abdominal colic, etc.[ 2 ] The C. forskohlii contains forskolin, which has been demonstrated to posses hypotensive, spasmolytic, cardiotonic and antiplatelet activity.[ 3 , 4 ] Large-scale production of herbal medicine is the current scenario but, along with the commercialization of herbal medicines there is a huge need of maintaining their quality. There are and there should be proper rules and regulations for maintaining the quality standards of herbal medicines. The assertion of quality, safety and efficacy of medicinal plants and poly-herbal formulations has become an important issue. The advancements in modern methods of analysis and the development of their application have made it possible to solve many of these problems. Phytochemical profiles have to be generated and a multiple-marker-based standardization strategy needs to be adopted to minimize batch-to-batch variation and to maintain quality and ensure safety and efficacy.[ 5 ] In present investigation, quality control analysis of C. forskohlii roots was carried out and generated a proper guidelines for the quality control of a medicinal plant, which includes physicochemical parameter determination, safety evaluation, microscropical evaluation, chromatographic fingerprinting using various analytical techniques and quantitative estimation of known marker constituent.