Zhang Ping, Li Ming-Hua, Shi Yan, Cheng Xian-Long, Yan Hua, Liu Wei, Wei Feng, Ma Shuang-Cheng
National Institutes for Food and Drug Control, Beijing 100050, China.
Zhongguo Zhong Yao Za Zhi. 2018 Nov;43(21):4198-4202. doi: 10.19540/j.cnki.cjcmm.2018.0110.
With the rapid development of traditional Chinese medicine (TCM) in China as well as the implementation of the four most strict requirements, the quality of Chinese medicinal materials and decoction pieces had beem improved in recent years, however new problems and challenges were occurred. All the data of Chinese medicinal materials and decoction piece in special inspection,supervision test and evaluation inspection of drug administration department to were summarized and analyzed evaluate and analyze of the quality of Chinese medicinal materials and decoction pieces in 2017. On this basis, the relevant quality control strategies and suggestions were put forward for the relevant departments of China Food and Drug Administration to formulate and implement regulatory measures, furthermore to improve drug standards, and ensure the safety of medication.
随着中医药在中国的快速发展以及“四个最严”要求的实施,近年来中药材及饮片质量有所提高,但也出现了新的问题和挑战。汇总分析了药品监管部门专项检查、监督抽检及评价性抽检中有关中药材及饮片的所有数据,对2017年中药材及饮片质量进行评价分析。在此基础上,提出相关质量控制策略和建议,供国家食品药品监督管理总局相关部门制定和实施监管措施,进一步提高药品标准,确保用药安全。