Discussion of Quality Control of Chinese Patent Medicine with Animal Ingredients Based on National PostMarket Drug Surveillance

NIE Li-xing1 HU Xiao-ru1 ZHANG Yu-mei1 ZHENG Xiao-wei1 HE Yi1 WANG Fei-fei1 DAI Zhong1 MA Shuang-cheng1 ZHU Jiong1 CHENG Shuang-hong1

(1.National Institutes for Food and Drug Control, Beijing, China 100050)

【Abstract】OBJECTIVE To discuss quality control of Chinese patent medicine with animal ingredients, providing reference for standards improvement, quality supervision and regulated production. METHODS Statutory standards and exploratory studies of Chinese patent medicines with animal ingredients tested in national post market surveillance between 2010 and 2014 were summarized. And technologies and methods developed for specific drugs were analyzed from the perspectives of safety, authenticity, effectiveness and controllability. RESULTS Use of HPLC and GC is becoming more mature. Traditional microscopic and TLC methods can play a positive role in identification of animal drugs without index component. Mass spectrometry has been successfully applied in quality control of Chinese patent medicine with animal ingredients. CONCLUSION National post market surveillance can provide comprehensive and elaborate evaluation on drug quality and can reveal potential risks. It's a powerful measure to promote quality of animal medicine.

【Keywords】 animal medicine; Chinese patent medicine; national post-market drug surveillance; quality control;

【DOI】

【Funds】 Special Program of “Significant New Drug Innovation” in National Twelfth Five-Year Plan (2014ZX09304307-002) National Natural Science Foundation of China (81303194, 81173506)

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This Article

ISSN:1001-2494

CN:11-2162/R

Vol 51, No. 06, Pages 506-512

March 2016

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Article Outline

Abstract

  • 1 Inspection of existing quality standard
  • 2 Exploratory studies
  • 3 Conclusion and suggestion
  • References