法莫替丁注射液有关物质检查的探讨  

Study on Determination of Related Substances in Famotidine Injection

作　　者：黄武军 黄庆 李洁 胡琤 

机构地区：[1]江西制药有限责任公司,330052

出　　处：《中国药品标准》2007年第5期57-59,共3页Drug Standards of China

摘　　要：目的:对法莫替丁注射液的有关物质检查进行探讨。方法:采用法莫替丁注射液含量测定的高效液相色谱条件进行有关物质检查,并对样品进行灭菌条件试验、高温试验、加速试验和长期试验。结果:该色谱条件可用于法莫替丁注射液有关物质检查,温度对于法莫替丁注射液有关物质影响较大;在贮藏过程中,法莫替丁注射液有关物质的量会增加。结论:建议法莫替丁注射液质量标准中增订有关物质检查项。Objective：To study on the determination of related substances in Famotidine Injection. Methods：The HPLC condition in Assay of Famotidine Injection was used to determine the related substances,and the sterilization condition, high temperature test,accelerated test and long-term test for the sample were carried out. Results ：This HPLC condition could be used to determine the related substances in Famotidine Injection and the temperature could affected the related substances in Famotidine Injection. In the period of storage,the amount of the related substances in Famotidine Injection would be increased. Conclusions：The Related Substanced item was suggested to be added in the Specification of Famotidine Injection.

关 键 词：法莫替丁注射液 有关物质检查 高效液相色谱条件 含量测定 组胺H2受体阻滞药 

分 类 号：R977[医药卫生—药品]