提高注射用法莫替丁澄清度的探讨

目的探讨注射用法莫替丁的澄清度。方法设计不同试验同时考察冻干曲线、药液pH、辅料甘露醇量、配料工艺及瓶、胶塞对本品澄清度的影响。结果不同冻干曲线下的制品澄清度有差异，不同药液pH、辅料甘露醇量、配料工艺及瓶、胶塞对澄清度影响很小。结论本品澄清度与冻干曲线的再干燥（二次升华）温度和时间有关，与药液pH、辅料甘露醇量、配料工艺及瓶、胶塞无关；能为大生产提供参考依据。

Clarity improvement in famotidine for injection

Objective To improve the clarity of famotidine for injection. Methods Different trials were designed to determine the effect of lyophilizing curve, pH of solution, use of mannitol, formulations, vials and stoppers on clarity. Results Different lyophilizing curves led to differences in clarity. The pH of solution, use of mannitol, formulations, vials and stoppers had little impact on clarity. Conclusion Clarity of this product is affected by the temperature and time of second sublimation of lyophilizing curve There is no effect from pH of solution, use of mannitol, formulations, vials and stoppers. It can serve as a reference for mass production.