2017年国家中药饮片专项抽验质量概况

自2012年原国家食品药品监督管理局组织实施对中药饮片进行专项抽验以来,针对质量问题较多的中药饮片品种,从安全性、有效性等方面进行了深入的分析与研究,开展了系列探索性的研究工作,以实际行动落实“四个最严”的要求,对提升中药饮片质量和安全水平起到了显著的作用。本文针对2017年中药饮片的国家抽验专项工作,对承检的中药饮片质量检测结果进行大数据分析与汇总,探讨目前我国中药饮片的总体质量概况。并针对抽验专项工作中存在的问题提出了相关的意见及建议,为药品监管部门下一步制定和实施监管措施提供技术支持,为提高和完善相关中药材及饮片标准提供技术保障,进而提高中药整体质量,保证公众用药安全。

Summary of Quality of National Special Sampling Test for Traditional Chinese Medicine Decoction Pieces in 2017

In order to take concrete actions to carry out the "four most strict" requirements, a series of exploratory researches had been carried out to research and analyze the safety and efficacy of traditional Chinese medicine decoction pieces with many quality problems and had improved the quality and safety level of the traditional Chinese medicine decoction pieces since the former State Food and Drug Administration organized a special sampling test for traditional Chinese medicine decoction pieces in 2012. All the testing data of the special sampling test for traditional Chinese medicine decoction pieces in 2017 were summarized and analyzed and the overall quality situation of traditional Chinese medicine decoction pieces was discussed. Relevant opinions and suggestions were put forward for the problems of the special sampling test and technical support for drug regulatory authorities to develop and implement regulatory measures in the next step were also suggested. Furthermore, technical support for improving and promoting standards for relevant Chinese herbal medicines and decoction pieces were also put forward in order to improve the overall quality of traditional Chinese medicine and ensure the safety of public medication.