法莫替丁微乳的研制及其质量评价  

Preparation of famotidine microemulsion and its quality evaluation

作　　者：叶海英[1] 张忠义[1] 高申[2] 鲁莹[2] 汪艳[1] 

机构地区：[1]第一军医大学珠江医院药材科,广东广州510282 [2]第二军医大学药学院药剂教研室,上海200433

出　　处：《第一军医大学学报》2003年第1期68-70,共3页Journal of First Military Medical University

摘　　要：目的研制法莫替丁微乳制剂并对其质量进行评价,建立质量控制标准。方法通过相图研究及大鼠在体肠吸收实验进行处方筛选,并测定制剂的形态、粒径分布、含量及稳定性。结果成功筛选出吸收较好的微乳处方,制备的微乳透射电镜下为球状液滴,平均粒径为65 nm,高效液相色谱法含量测定的平均回收率为97.63%,平均相对标准差(RSD)为0.72%。结论法莫替丁微乳制备简单,质量稳定,检测方法可靠,重现性好。Objective To study the preparation of famotidine microemulsion (FM) and its quality evaluation, thereby to establish the quality-control criteria for this preparation. Methods The formulations of the FM were optimized by studying the pseudoternary phase diagrams and its absorption in rat jejunum using in situ perfusion method. The morphology, particle size distribution, famotidine concentration and stability of the FM were studied. Results The optimization of formulation was completed successfully. Electron microscopy presented the FM as small spherical drops, with a mean diameter of 65 nm. The average recovery as determined by high-performance liquid chromatography was 97.63%, its mean RSD being 0.72%. Conclusion The FM is easy to prepare with consistent quality, whose reliable determination method may be easily reproduced.

关 键 词：法莫替丁 微乳剂 表面活性剂 质量评价 高效液相色谱法 

分 类 号：R944.1[医药卫生—药剂学]