氨苄西林胶囊质量分析  

Quality assessment of ampicillin capsules

作　　者：李一兰 王丹 付晓丽 刘旭春 张玲变 周晓溪 Li Yilan;Wang Dan;Fu Xiaoli;Liu Xuchun;Zhang Lingbian;Zhou Xiaoxi(Shanxi Inspection and Testing Center,Taiyuan 030031)

机构地区：[1]山西省检验检测中心,太原030031

出　　处：《中国抗生素杂志》2024年第3期310-316,共7页Chinese Journal of Antibiotics

摘　　要：目的评价目前国产氨苄西林胶囊的质量现状及存在问题。方法按国家药品抽检计划总体要求,采用法定检验方法结合探索性研究对氨苄西林胶囊样品进行检验,通过对杂质谱、溶出度、溶出曲线、原料药对制剂质量的影响和包装材料对制剂质量的影响等项目的考察,分析本品的质量状况。结果按法定标准检验103批次样品,合格率100%,与2016年氨苄西林胶囊国抽结果比较,产品质量总体持续稳定。探索性研究对各杂质的来源与结构进行了确证;溶出度测定方法采用HPLC法检测结果与标准检验排除胶囊壳干扰后结果无明显差异;不同企业样品的溶出曲线存在较大差异;原料药的质量影响制剂质量;不同包装氨苄西林胶囊在相同的放置条件下杂质变化差异较大。结论氨苄西林胶囊质量总体较好,现行质量标准需进一步完善,建议修订溶出度测定方法为HPLC法以消除胶囊壳的干扰;建议企业开展仿制药质量和疗效一致性评价,选用质量更好的原料药,选用防潮效果更好的铝塑铝包装,或者在铝塑泡罩外加防潮袋。Objective This study evaluated the current quality status and existing problems with domestic ampicillin capsules.Methods According to the overall requirements of the national drug sampling plan,the sample of ampicillin capsules was tested using statutory methods combined with exploratory research.The quality status of this product was analyzed by examining impurity profiles,dissolution,dissolution curve,the impact of raw materials on the quality of the products and the impact of packaging materials on the quality of the preparation.Results A total of 103 batches of samples were tested according to the specifications,and all of them complied with regulations.Compared with the results obtained in 2016,the product quality of ampicillin capsules was generally stable.Exploratory research had confirmed the sources and structures of various impurities in the products.There was no significant difference between the results of the HPLC test and those of the standard test after excluding the interference of the capsule shell.The dissolution curves of samples from different manufacturers were significantly different.The quality of the raw materials affected the quality of the products.The impurity changes of ampicillin capsules with different packages varied significantly under the same storage conditions.Conclusion The quality of ampicillin capsules was generally good,and the current specifications needed to be further improved.It was recommended to revise the dissolution determination method to the HPLC method to eliminate the interference from the capsule shell.It was also recommended that enterprises carry out a consistent evaluation of the quality and efficacy of generic drugs,choose better-quality raw materials,choose aluminum foil-plastic-aluminum foil packaging with a better moisture-proof effect,or add a moisture-proof bag to the aluminum-plastic blister.

关 键 词：氨苄西林 质量分析 溶出曲线 胶囊 

分 类 号：R978.1[医药卫生—药品]