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Bioassay:An Uncomplicated Methodologies for Ensure Safety of Traditional formulations


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1 Mahakal Institute of Pharmaceutical Studies, Ujjain (M.P.) 456664, India
     

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In the recent years' there has been a great demand for the plant derived traditional formulations in the developed countries. These formulations are increasingly being required as medicinal products, nutraceuticals, and cosmetics. India has one of the 12th mega biodiversities in the world and having great assets of traditional systems of medicines (Ayurveda, Siddha and Unani). One of the major region for the India's inadequate execution is that our products are not backed by rigorous scientific studies to established their safity, efficacy, and standards. For the purpose of develops safety, efficacy, and standards, the importance of standardization of Traditional formulation and crude drugs is now well understood by the consumers as well as the industry. Standardization helps in effective quality control during commercial production of Traditional formulations. During the last few years' emphasis has been laid on chemical methods of standardization, based on physical chemical assay, chromatographic analysis and various spectroscopic techniques. Most of these are qualitative methods though many Traditional formulation and crude plant material have been standardized quantitavely using HPLC, HPTLC, GC and these methods are used as an effective quality control perameters. In such cases chemical marker have been isolated and characterized, in several plant materials spectroscopic method of standardization have also been found to be usefull. However, marker compound based standardization has not been effective since these markers are not biologically active constituents in the most of the cases. All the methods are accounts for a single chemical entity or a group of chemical compounds, but in many plants the activity may be attributed to different type of compounds that act synergistically to show the biological activity. There fore the standardization by chemical methods, although used widely, may not prove to be a complete way of standardization for Traditional formulation and further needs biological standardization.
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  • Bioassay:An Uncomplicated Methodologies for Ensure Safety of Traditional formulations

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Authors

Karunakar Shukla
Mahakal Institute of Pharmaceutical Studies, Ujjain (M.P.) 456664, India

Abstract


In the recent years' there has been a great demand for the plant derived traditional formulations in the developed countries. These formulations are increasingly being required as medicinal products, nutraceuticals, and cosmetics. India has one of the 12th mega biodiversities in the world and having great assets of traditional systems of medicines (Ayurveda, Siddha and Unani). One of the major region for the India's inadequate execution is that our products are not backed by rigorous scientific studies to established their safity, efficacy, and standards. For the purpose of develops safety, efficacy, and standards, the importance of standardization of Traditional formulation and crude drugs is now well understood by the consumers as well as the industry. Standardization helps in effective quality control during commercial production of Traditional formulations. During the last few years' emphasis has been laid on chemical methods of standardization, based on physical chemical assay, chromatographic analysis and various spectroscopic techniques. Most of these are qualitative methods though many Traditional formulation and crude plant material have been standardized quantitavely using HPLC, HPTLC, GC and these methods are used as an effective quality control perameters. In such cases chemical marker have been isolated and characterized, in several plant materials spectroscopic method of standardization have also been found to be usefull. However, marker compound based standardization has not been effective since these markers are not biologically active constituents in the most of the cases. All the methods are accounts for a single chemical entity or a group of chemical compounds, but in many plants the activity may be attributed to different type of compounds that act synergistically to show the biological activity. There fore the standardization by chemical methods, although used widely, may not prove to be a complete way of standardization for Traditional formulation and further needs biological standardization.