摘要
目的:优选法莫替丁注射液的制备工艺,以期提高其稳定性和安全性。方法:选取有关物质、pH为评价指标,对样品进行影响因素和稳定性实验,考察在不同浓度条件下不同种类缓冲盐溶液(pH=5.7)对法莫替丁注射液的影响。结果:加入0.05mol/L乙酸-乙酸钠缓冲液可有效提高法莫替丁注射液的稳定性。结论:该优选工艺简单有效,稳定性好,质量可控。
Objective: To optimize the preparation process of famotidine injection to improve its stability and safety. Methods:Re- lated substances and pH value as evaluation index,the iniections were inspected by influencing factors and stability experiments . To evaluate the influences of buffered saline solutions on the stability of the injection(pH= 5.7) different types and concentrations of solutions were prepared. Results:Adding 0.05mol/L acetic acid-sodium acetate buffer solution the stability of famotidine injection was effectively improved. Conclusion:The improved process is good in stability, controllable in quality, simple and effective.
出处
《亚太传统医药》
2015年第16期36-38,共3页
Asia-Pacific Traditional Medicine
关键词
法莫替丁注射液
工艺制备
缓冲盐溶液
Famotidine Injection
Screened Process
Stability
Buffer Solution