国产阿莫西林口服制剂质量评价
发布时间：2018-09-18 08:50
【摘要】：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。
[Abstract]:OBJECTIVE To evaluate the quality status and problems of domestic amoxicillin oral preparations.METHODS According to the general requirements of national evaluation sampling plan,the samples were examined by statutory method combined with exploratory study,and the results were analyzed statistically.Results The statutory results showed that 355 batches of samples(319 batches of capsules,14 batches of tablets,22 batches of dispersed samples). The impurities in different batches of Amoxicillin Capsules from different manufacturers were basically the same, but the distribution and content of these impurities in the products of different manufacturers were greatly changed, and the impurity mass spectra of different dosage forms were also different. The dissolution behavior of Amoxicillin Capsules from different manufacturers was significantly different. The quality of oral preparations can basically meet the requirements of the current standards, while exploratory studies suggest that the current standards are not perfect, and it is suggested that single impurities, such as amoxicillin thiazolic acid, diketopiazine (2R) amoxicillin, amoxicillin closed-loop dimer impurities, should be added under the relevant substance inspection to participate in the principal component control method to determine their contents in the preparations. The limits of the dissolution of Amoxicillin Capsules from different manufacturers are different.
【作者单位】： 贵州省食品药品检验所;
【分类号】：R927
，
本文编号：2247395
[Abstract]:OBJECTIVE To evaluate the quality status and problems of domestic amoxicillin oral preparations.METHODS According to the general requirements of national evaluation sampling plan,the samples were examined by statutory method combined with exploratory study,and the results were analyzed statistically.Results The statutory results showed that 355 batches of samples(319 batches of capsules,14 batches of tablets,22 batches of dispersed samples). The impurities in different batches of Amoxicillin Capsules from different manufacturers were basically the same, but the distribution and content of these impurities in the products of different manufacturers were greatly changed, and the impurity mass spectra of different dosage forms were also different. The dissolution behavior of Amoxicillin Capsules from different manufacturers was significantly different. The quality of oral preparations can basically meet the requirements of the current standards, while exploratory studies suggest that the current standards are not perfect, and it is suggested that single impurities, such as amoxicillin thiazolic acid, diketopiazine (2R) amoxicillin, amoxicillin closed-loop dimer impurities, should be added under the relevant substance inspection to participate in the principal component control method to determine their contents in the preparations. The limits of the dissolution of Amoxicillin Capsules from different manufacturers are different.
【作者单位】： 贵州省食品药品检验所;
【分类号】：R927
，
本文编号：2247395
本文链接：https://www.wllwen.com/yixuelunwen/yiyaoxuelunwen/2247395.html
最近更新
教材专著
