多西他赛注射液质量分析  

Analysis of Docetaxel Injection Quality

作　　者：何虹 孙煜 曾庆花 李智明 黄慧 朱健萍 HE Hong;SUN Yu;ZENG Qing-hua;LI Zhi-ming;HUANG Hui;ZHU Jian-ping(Guangxi Institute for Food and Drug Control,Guangxi Nanning 530021,China)

机构地区：[1]广西壮族自治区食品药品检验所,广西南宁530021

出　　处：《中国药物评价》2023年第4期289-294,共6页Chinese Journal of Drug Evaluation

基　　金：2021年国家药品抽检计划项目No.国药监药管[2021]1号,序号24;广西药品监督管理局科研计划项目[编号:桂药监科[2022]-037号(直属)]。

摘　　要：目的:评价多西他赛注射液的质量现状及存在问题。方法:按照法定标准对样品进行检验,并进行探索性研究,对数据结果进行统计分析。结果:按现行方法检验40批次样品,结果均合格,合格率为100%。经探索研究发现部分批次样品使用的未覆膜胶塞,检出抗氧剂并超过人每日允许暴露量(Permitted Daily Exposure,PDE);国内制剂的粒径分布与原研制剂不一致;国内制剂的释药速率与原研制剂存在一定差异;部分企业的样品中检出枸橼酸,与企业的处方及说明书不符。结论:目前国内多西他赛注射液的总体质量较好,部分企业生产工艺需要改进。Objective:To evaluate the quality status of Docetaxel Injection and analyze the existing problems.Methods:The samples were determined by the statutory standard,while the exploratory studies were carried out.All of the results were statistically analyzed.Results:40 batches of testd samples were all qualified according to the current method.However,established on the exploration study,some batches of samples were found that the amount of antioxidant was over the PDE by using uncoated rubber plug,the particle size distribution and the release rate show a different status to the original preparation,citric acid were detected in some samples which is not consistent with the drug instructions.Conclusion:Most of domesic produced Docetaxel Injection has a relatively good quality while some enterprises needs to improved the production process to make a better quality.

关 键 词：多西他赛注射液 质量分析 抽检 

分 类 号：R927.11[医药卫生—药学]