全国大黄药材及其饮片评价性抽验结果分析与一测多评法研究-中国药事.PDF

中国药事 2018年6月 第32卷 第6期 775 ·质量评价· 全国大黄药材及其饮片评价性抽验结果分析与一测 多评法研究 1,2 1 2 1 2 1 2 1 2 1 2 1 2 , , , , , , （1. 甘肃省药品 李冬华 ，张平 ，张明童 ，杨静 ，马潇 ，宋平顺 ，杨平荣 检验研究院， 兰州 730070；2. 甘肃省中藏药检验检测技术工程实验室，兰州 730070） 摘要 目的： 开展大黄药材及其饮片的全国评价性抽验，不断完善和修订标准方法，保障公众用药安全 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174批大黄药材及其饮片，涉及 142家生产企业。其中152批次合格，22批次不合格，总体合格率为87%。以一测多评方法建立用大黄素同 步测定大黄药材及其饮片中5种蒽醌类成分含量的方法，可以提高检验效率，避免对照品溶解性差异所带 来的测定偏差，解决大黄检验中的实际问题。结论：通过本次抽验，发现大黄药材及其饮片仍然存在一 些质量问题，应进一步加强监管。 关键词： 大黄；中药材；饮片；质量分析；一测多评；高效液相色谱 R927 R931 R932 A 1002-7777(2018)06-0775-09 中图分类号： ； ； 文献标识码： 文章编号： doi:10.16153/j.1002-7777.2018.06.014 Analysis of the Nationwide Random Inspection Results of Rheum officinale and Its Pieces in QAMS Li Donghua1,2, Zhang Ping1,2, Zhang Mingtong1,2, Yang Jing1,2, Ma Xiao1,2, Song Pingshun1,2, Yang Pinrong1,2 (1.Gansu Institute for Drug Control, Lanzhou 730070, China; 2.Gansu Inspection and Testing Technical Engineering Laboratory for Chinese Herbal and Tibetan Medicine, Lanzhou 730070, China) Abstract Objective: To carry out nationwide random inspection of Rheum officinale and its pieces and to revise and improve the standard method in order to ensure the safety and effectiveness of public drug use. Methods: Rheum officinale and its pieces were tested and the exploratory study was carried out according to mandatory standard. Results: A total of 174 batches of Rheum officinale and its pieces were collected from 142 drug manufacturing companies, of which 152 batches were qualified, 22 batches were unqualified, and the overall pass rate was 87%. The five anthraquinones in Rheum officinale and its pieces was determined by using the method of quantitative anal