2017年防风通圣丸评价性抽验结果及分析  

Results and Analysis of Evaluative Selective Acceptance Test of Fangfeng Tongsheng Pills in 2017

作　　者：缑慧君 任杰 卢军 许雪峰 杨滢 李帆 Gou Huijun;Ren Jie;Lu Jun;Xu Xuefeng;Yang Ying;Li Fan(Hanzhong Testing and Inspection Center for Food and Drug Control,Hanzhong,Shannxi,China 72300)

机构地区：[1]陕西省汉中市食品药品检验检测中心,陕西汉中723000

出　　处：《中国药业》2018年第15期29-33,共5页China Pharmaceuticals

摘　　要：目的评价防风通圣丸的产品质量。方法按评价性抽验计划总体要求,采用法定检验方法结合探索性研究对19个生产企业的60批次样品进行检验,分析检验结果,并评价防风通圣丸的质量现状。结果防风通圣丸检验合格率为100.00%;建立了甘草、桔梗的薄层鉴别方法,增加了防风通圣丸的薄层鉴别;增加重金属、砷盐的检查限度,以全面控制防风通圣丸的安全性。结论该品种现行标准基本可行,质量控制较好但不全面。建议防风通圣丸增加甘草、桔梗的鉴别和重金属、砷盐的安全性限度检查。Objective To evaluate the quality of Fangfeng Tongsheng Pills. Methods According to the general requirements of evaluative selective acceptance test project,60 batches of samples from 19 manufacturers were detected by using statutory test methods combined with the exploratory research. The detection results were analyzed and the quality status quo of Fangfeng Tongsheng Pills was evaluated.Results The qualification rate of Fangfeng Tongsheng Pills was 100.00%,the TLC methods of Radix liquiritiae and Radix platycodonis were established, the TLC identification of Fangfeng Tongsheng Pills was established, the heavy metals and arsenic salt limits were established in order to control the safety of Fangfeng Tongsheng Pills in an all-round way. Conclusion The existing standard of Fangfeng Tongsheng Pills is basically feasible with better quality control but not comprehensiven. It is suggested that the identification of Radix liquiritiae and Radix platycodonis and safety limit test of the heavy metals and arsenic salt should be added in standard of Fangfeng Tongsheng Pills.

关 键 词：防风通圣丸 评价性抽验 质量评价 

分 类 号：R284.1[医药卫生—中药学] R286.0[医药卫生—中医学]