法莫替丁注射液的制备工艺  

Preparation Process of Famotidine Injections

作　　者：罗宏 吴军 邹意琼 

机构地区：[1]西南药业股份有限公司药物研究所,重庆400038

出　　处：《中国药师》2013年第8期1144-1147,共4页China Pharmacist

摘　　要：目的:制备法莫替丁注射液。方法:采用正交设计试验对处方工艺进行研究,并将按照确定的处方工艺中试的三批样品进行影响因素和长期试验。结果:最佳助溶剂、活性炭浓度和灭菌温度分别L-门冬氨酸、0.01%和115℃保温30 min。结论:按该方法制备的法莫替丁注射液,完全符合质量标准。Objective.-To prepare famotidine injections.Method：The orthogonal design was used to optimize the formula and the preparation process.Three batches of the injections prepared according to the optimal formula and preparation process were inspected by stressing testing and long-term testing.Result：The optimal preparation process was as follows;L-aspartic acid as the cosovelt,the amount of activated carbon was 0.01%,and the best sterilization condition was 115℃for 30 minutes.Conclusion：The injections prepared by the optimized method are in full compliance with the quality standards.

关 键 词：法莫替丁注射液 助溶剂 灭菌温度 含量测定 处方 

分 类 号：R944.11[医药卫生—药剂学]