Research on the Supervision Strategy Based on the Analysis of the Quality Status of Chinese Patent Medicines in the National Drug Sampling and Testing in 2021
10.13748/j.cnki.issn1007-7693.20223234
- VernacularTitle:基于2021年国家药品抽检中成药质量状况分析的监管策略研究
- Author:
ZHU Jialiang
1
;
LI Wenli
2
;
WANG Chong
1
;
ZHU Jiong
1
;
DAI Zhong
1
;
MA Shuangcheng
1
Author Information
1. National Institutes for Food and Drug Control, Beijing 100050, China;
2. Hunan Institute for Drug Control, Changsha 410001, China
- Publication Type:Journal Article
- Keywords:
national drug sampling and testing;
Chinese patent medicine;
quality status;
supervision strategy
- From:
Chinese Journal of Modern Applied Pharmacy
2023;40(18):2584-2590
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To put forward suggestions on strengthening the quality supervision of Chinese patent drugs and preventing and controlling safety risks by analyzing the current quality situation and quality risks of sampling inspection of Chinese patent drugs. METHODS Reviewed the quality status of Chinese patent drugs for national drug sampling and testing over the past years, introduced the supervision concept and mode of Chinese patent drugs, conducted an overall analysis of the overall quality of Chinese patent drugs for national drug sampling and testing in 2021, focused on the mining and analysis of the main quality problems and risks identified. RESULTS Although the qualified rate of sampling inspection of Chinese patent medicines had shown a positive trend year by year, through exploratory research, it was found that there were still some potential quality risks in the quality of Chinese patent medicines in terms of process prescriptions, internal control standards, raw medicinal materials, excipients, harmful substance residues, illegal addition, etc. CONCLUSION Drug quality sampling and testing plays an important role in strengthening the quality and safety supervision of traditional Chinese medicine. According to the characteristics of different industrial chains of traditional Chinese medicine, different regulatory strategies should adopt, build a more scientific and reasonable regulatory model for Chinese patent medicine, and improve the quality control level and industry standards of Chinese patent medicine.
