Discussion of quality control of chinese patent medicine with animal ingredients based on national post-market drug surveillance / 中国药学杂志

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.