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[Guideline principle and technical requirement for preparing traditional Chinese medicine reference drug]
Li-Xing Nie1, Zhong Dai1, Shuang-Cheng Ma1
1National Institutes for Food and Drug Control, Beijing 100050, China.
Abstract:
Traditional Chinese medicine (TCM) reference drug is a new form of TCM standard reference substance. The purpose of this guideline is to guide the establishment of the reference drug and standardize its investigation and application in national drug standards. Definition of TCM reference drug was specified and relating guideline and technical requirement were introduced in this paper. Its application in quality control of TCM was analyzed and the developing train was proposed. There is a wide prospect for the application of reference drug in quality control of TCM. Thus it has practical significance to explore and conduct the quality evaluation system by using TCM reference drug as the reference substance.
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