不同生产企业元胡止痛片质量评价与探索性研究  

Quality Evaluation and Exploratory Research of Yuanhu Zhitong Tablets from Different Manufacturers

作　　者：高宇明 肖开春 刘森 李华仙 李丹 吴秀清 GAO Yuming;XIAO Kaichun;LIU Sen;LI Huaxian;LI Dan;WU Xiuqing(Sichuan Ziyang Inspection and Testing Center for Food and Drug Control,Ziyang,Sichuan,China 641399)

机构地区：[1]四川省资阳市食品药品检验检测中心,四川资阳641399

出　　处：《中国药业》2021年第12期63-67,共5页China Pharmaceuticals

摘　　要：目的评价并比较不同生产企业的元胡止痛片质量。方法收集四川省内流通的元胡止痛片(含糖衣片和薄膜衣片),依据法定标准进行检验,及对染色剂金胺O进行检测,并进行标准外研究。结果21家生产企业的197批次(去除重复后共100批)产品合格率为97.46%;5批次(3个批号)产品检出金胺O,均为同一企业生产;其他问题包括,标准延胡索薄层色谱鉴别展开系统分离度较差,且部分企业产品未检出全部主斑点,不同批样品指标成分延胡索乙素、欧前胡素含量差异大;标准外研究中,197批次样品重金属及有害元素检测合格率为100.0%,二氧化硫残留量限度合格率为84.0%,且未检出对乙酰氨基酚、阿司匹林、萘普生、双氯芬酸钠、吲哚美辛等止痛成分。结论元胡止痛片总体质量良好,但不同企业产品之间的质量参差不齐,部分企业产品仍存在质量风险,应进一步加强监管。Objective To evaluate and compare the quality of Yuanhu Zhitong Tablets from different manufacturers.Methods Yuanhu Zhitong Tablets(including sugar-coated tablets and film-coated tablets)circulated in Sichuan Province were collected and tested according to the legal standards.The auramine O was detected and the off standard research was carried out.Results The qualified rate of 197 batches(100 batches after removing duplication)of Yuanhu Zhitong Tablets from 21 manufacturers was 97.46%.Auramine O was detected in five batches(three lot numbers)of Yuanhu Zhitong Tablets,which were all produced by the same manufacturers.Other problems included the poor resolution of the standard thin-layer chromatography(TLC)identification system of Corydalis yanhusuo,and not all the main spots were detected in products of some manufacturers,and the content of tetrahydropalmatine and imperatorin in different batches of samples varied greatly.The results of off standard research showed that the qualified rate of heavy metal and harmful elements in 197 batches of samples was 100.00%,the qualified rate of sulfur dioxide residue limit was 84.0%,and no analgesic components such as paracetamol,aspirin,naproxen,diclofenac sodium and indomethacin were detected.Conclusion The overall quality of Yuanhu Zhitong Tablets is good,but the quality of products from different manufacturers is uneven.Some manufacturers still have quality risks.Therefore,supervision should be further strengthened.

关 键 词：元胡止痛片 质量评价 金胺O 标准外研究 重金属 药品监管 

分 类 号：R932[医药卫生—生药学] R284.1[医药卫生—药学]