吲达帕胺缓释制剂评价性抽验结果及质量评价  

Sampling Results and Assessment the Quality of Indapamide Released Preparation

作　　者：罗晓茹 徐江 樊星 芦佳月 

机构地区：[1]中央军委后勤保障部卫生局药品仪器检验所,北京100166

出　　处：《中国药物评价》2017年第4期297-299,共3页Chinese Journal of Drug Evaluation

摘　　要：目的:通过对6个厂家86批吲达帕胺缓释片及胶囊的评价性抽验结果分析,评价吲达帕胺缓释制剂的质量现状。方法:按照国家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进行样品检验,统计分析检验结果。结果:法定检验显示86批样品(包括76批缓释片剂和10批缓释胶囊)全部合格;根据探索性研究显示,在4种释放介质中,不同厂家样品释放行为差异明显,尤其是在p H4.0的释放介质中,缓释胶囊剂与片剂的释出行为明显不同。结论:吲达帕胺缓释制剂质量状况总体评价一般,个别生产企业应进一步优化处方工艺,加强生产管理,提升药品质量。Objective： To evaluate the quality status of Indapamide released preparation through testing 86 batches of Indapamide re- leased tablet and capsule from 6 factories. Methods ： According to the general requirements of national assessment programs, status stand- ard methods are used and combine with the exploratory research to evaluate the quality of Indapamide released preparation by statistical a- nalysis of the results. Results： Statutory test showed 86 batches of samples （76 batches of released tablets, 10 batches of released cap- sules） all qualified; Exploratory studies have shown that the dissolution behavior in samples from different manufacturers are significant difference in 4 kind of solutions different. Especially the dissolution behavior inreleased capsules and releasedtabletsare significant differ- ence in the solutions of pH 4. 0. Conclusion： The most products quality of Indapamide released preparation can basically meet require- ments of current standards; The individual enterprise should further optimize the prescription and productive technology, strengthen the production management to improve the quality of the drug.

关 键 词：吲达帕胺 缓释制剂 评价性抽验 质量评价 

分 类 号：R927.1[医药卫生—药学]