国产阿莫西林口服制剂质量评价

Quality assessment of domestic amoxicillin oral preparations

目的评价国产阿莫西林口服制剂的质量现状及存在问题。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。结果法定检验结果显示355批样品(其中319批胶囊,14批片剂,22批分散片)全部合格;不同厂家不同批次阿莫西林胶囊样品中杂质的种类基本一致,但这些杂质在不同厂家产品中分布及含量有较大变化,同时不同剂型的杂质谱也不尽相同;不同生产厂家胶囊之间溶出行为差异显著。结论目前国产阿莫西林口服制剂的产品质量基本能符合现行标准要求;而探索性研究提示现行标准不完善,建议有关物质检查项下增加阿莫西林噻唑酸、二酮哌嗪(2R)阿莫西林、阿莫西林闭环二聚体杂质等单个杂质参与主成份对照法定量,以规定它们在制剂中的限度;不同厂家的阿莫西林胶囊存在不同的溶出特性。

Objective To evaluate the suitability of statutory standard and the quality condition of domestic amoxicillin oral preparations. 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 amoxicillin oral preparations by statistical analysis of the results. Results Statutory test showed 355 batches of samples （319 batches of capsules, 14 batches of tablets, 22 batches of dispersible tablets） all qualified; experimental results show that kinds of impurities from different batches of different manufacturers amoxicillin capsules were roughly the same, but the distribution of these impurities in the product and the contents of different manufacturers have a greater change, the impurity profile of different dosage from are similar but not identical; the dissolution behavior in capsules from different manufacturers are significant difference. Conclusion At present, the quality of domestic amoxicillin oral preparations can basically meet requirements of current standards; while exploratory study suggests that the current standard is imperfect, increasing amoxicillin thiazole acid, diketopiperazine （2R） amoxicillin and amoxicillin closed loop dimer involved in the method of the control of the main ingredient quantitative in the entries of related substances, and define their limits in the formulation. Amoxicillin capsules of different manufacturers have different dissolution characteristics.