2016年全国当归饮片评价性抽验结果分析

目的：开展当归饮片的全国评价性抽验，不断完善和修订标准方法，保障公众的用药安全和有效。方法：依据法定标准进行检验，并开展探索性研究。结果：共收到192批当归饮片，涉及163家生产企业。其中173批次合格，19批次不合格，总体合格率90%。建立当归饮片中阿魏酸、藁本内酯和正丁烯基苯酞的含量测定方法，用以建立和完善当归饮片质量标准。解决当归检验中的实际问题。结论：通过本次抽验，发现当归饮片仍存在一些质量问题，建议加强监管。

Analysis of the nationwide random inspection result of Angelica sinensis in 2016

OBJECTIVE To perform the national sample and test for Angelica sinensis pieces, continuously improve and modify the standard method to ensure the safety and effective of use drugs in the public.METHODS Through testing of mandatory standard, Angelica sinensis was tested and exploratory study was performed.RESULTS Totally 192 batches of Angelica sinensis, included 163 drug manufacturers, were received. There were 173 batches qualified and 19 batches unqualified, with a pass rate of 90%. The assay method was established to determine contents of ferulic acid, ligustilide and n-butylidenephthalide to establish and improve the quality standard of Angelica sinensis pieces, solve the problem in testing Angelica sinensis.CONCLUSION This testing of Angelica sinensis shows some quality problem in Angelica sinensis pieces, suggeseting that the supervision and management should be improved.