国产氨苄西林丙磺舒胶囊的质量评价

Quality analysis of ampicillin and probenecid capsules

目的评价国内不同厂家生产的氨苄西林丙磺舒胶囊的质量现状及存在的问题。方法按照国家评价性抽验计划总体要求,采用法定检验方法与探索性研究相结合,对抽验样品进行研究,统计分析检验结果。结果按照法定标准检验抽取的38批次样品,5批不合格,不合格率为13.2%,不合格项为溶出度和含量测定,不合格样品均产自E企业。法定标准检验发现现行标准不统一,存在有关物质方法梯度设置不合理,计算方法不合理,溶出度测定方法不可行等问题。探索性研究新建了杂质谱分析方法,对主要杂质的来源与结构进行确证,新建了杂质归属分区域计算法测定有关物质的方法和溶出度测定法。按探索性研究检验,10批不合格,不合格率为26.3%,不合格项为有关物质、溶出度和含量测定。结论氨苄西林丙磺舒胶囊现行质量标准基本可行,部分检验项目方法待完善,药品质量状况一般。建议企业改善生产工艺,提高药品质量。

Objective To evaluate the suitability of the statutory standards and the quality of ampicillin and probenecid capsules of different domestic manufacturers.Methods According to the general requirements of national assessment program,the statutory standard method combined with exploratory researches were used to evaluate the quality of ampicillin and probenecid capsules.Results According to the statutory standards for the examination of the 38 batches,the unqualified rate was 13.2%,and the unqualified items were dissolution and content determination,and the unqualified products came from enterprise E.The standard test results showed that current standards were not uniform.There were some problems,such as unreasonable setting of material gradient,unreasonable calculation method and infeasible determination method of dissolution.The impurity profile was established.The sources and structures of major impurities and were confirmed.A new method for the determination of related substances in ampicillin and probenecid capsules using the impurity-based sub-region calculation method and the method for dissolution were established.According to the exploratory researches for the examination of the 38 batches,the unqualified rate was 26.3%,and the unqualified items were dissolution and the related substances.Conclusion Current standards can basically control the quality of the drug,but some items need to be improved.The quality of ampicillin and probenecid capsules were generally acceptable.It was suggested that enterprises improve the production process and improve the quality of drugs.