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• 药品评价-安全性研究 • 上一篇    下一篇

吲达帕胺缓释制剂评价性抽验结果及质量评价

罗晓茹   

  1. 军委后勤保障部卫生局药品仪器检验所
  • 收稿日期:2017-04-01 修回日期:2017-04-01 出版日期:2017-08-25 发布日期:2017-08-25

Sampling Results and Assessment the Quality of Indapamide released preparation

  1. Institute for Drug and Instrument Control Health Dept GLD of PLA
  • Received:2017-04-01 Revised:2017-04-01 Online:2017-08-25 Published:2017-08-25

摘要: 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pH4.0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。

Abstract: Abstract Objective: To evaluate the quality status of Indapamide released preparation through testing 86 batches of Indapamide released tablet and capsule from 6 factories. Methods: According to the general requirements of national assessment programs, status standard methods are used and combine with the exploratory research to evaluate the quality of Indapamide released preparation by statistical analysis of the results. Results: Statutory test showed 86 batches of samples (76 batches of released tablets,10 batches of released capsules) 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 difference in the solutions of pH4.0.Conclusion:The most products quality ofIndapamide released preparation can basically meet requirements 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.