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. 2014 Nov 27;6(4):256–264. doi: 10.1016/S1674-6384(14)60040-X

Biopotency Assays: an Integrated Application to Quality Control of Chinese Materia Medica

Yin Xiong a,b, Dan Yan a, Jia-bo Wang a, Xiao-he Xiao a,b,*
PMCID: PMC7128317  PMID: 32288760

Abstract

The current quality control (QC) pattern for Chinese materia medica (CMM) lacks suitable methods and indicators to evaluate their safety and efficacy effectively, which impedes the smooth development of CMM. In this review, main problems of the current QC pattern for CMM, principally focused on the content determination of constituents, were summarized and the inspiration from the QC of biological products was introduced. With the aim at introducing a suitable tool to the QC of CMM, biopotency assay and its feasibility in the QC pattern for CMM were analyzed and confirmed by relevant researches with years of practice. From the applications of biopotency assays in the QC of CMM in the last 10 years, we propose that biopotency assays should be an integral part of the QC pattern for CMM, for these assays can make the QC indicators related to the clinical safety and efficacy, supplementing the existed QC system of CMM.

Key words: biopotency assays, Chinese materia medica, efficacy, indicator, quality control

Footnotes

Available online: October 28, 2014

Fund: National Natural Science Foundation of China(81274026), China Scholarship Council, Open Research Fund of the State Key Laboratory Breeding Base of Systematic Research, Development and Utilization of Chinese Medicinal Resources, China Postdoctoral Science Foundation(2013M532130)

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