法莫替丁注射液的研制  

The study of Famotidine Injection

作　　者：邓巧君 李健和[2] 曹俊华[2] 

机构地区：[1]长沙市八医院药剂科,湖南长沙410100 [2]中南大学湘雅二医院药学部,湖南长沙410011

出　　处：《中国当代医药》2010年第18期5-8,共4页China Modern Medicine

摘　　要：目的:制备法莫替丁注射液,建立其质量控制方法,并考察其稳定性和安全性。方法:优化处方组成与制备工艺,并进行性状、鉴别、检查等质量研究,采用高效液相色谱法测定有关物质和含量,影响因素试验、加速试验和长期试验考察其稳定性,血管刺激性试验、溶血性试验以及过敏性试验评价其用药的安全性。结果:样品经酸、碱、氧化、热、光照破坏后所产生的杂质峰均能与主峰有效分离,最低检测限为1.0ng。法莫替丁在80.32～120.48μg/ml的浓度范围内与峰面积成良好的线性关系,平均回收率为99.76%,RSD为0.73%。恒温加速试验6个月和长期留样试验12个月,其性状、pH值、有关物质、可见异物、含量等均未见明显改变。结论:该制剂处方合理,制备工艺简便可行,质量可控,稳定性良好,用药安全。Objective： To prepare famotidine injection,establish its quality control and determine its stability and safety. Methods： Some work was done to optimize the prescription and preparation technology. The character, identification and examination et al were tested.The content and the related materials of famotidine injection were determined by HPLC.Stress testing, accelerated testing and long-term testing were done to study its stability. The safety was evaluated by testing the vessel stimulation, haemolyticus and hypersensitivity.Results：The method had an effective separation of the main component from impurities which produced after a series of destruction test,such as acid, alkalization,oxidation,light and thermal destruction.The detective limit was 1.0 ng. The linear relation of famotidine was excellent within the range of 80.32-120.48 μg/ml, and the average recovery rate was 99.76% with RSD was 0.73%. No obvious changes were observed at 6 month of an accelerated test or 12 month of long-term storage test. Conclusion： The preparation is reasonable in formulation, simple and convenient in preparation technique, accurate in quality control, good in stablility, and safe in application.

关 键 词：法莫替丁注射液 制备 质量控制 稳定性 安全性 

分 类 号：R943[医药卫生—药剂学]