地西泮亚微乳注射液处方及制备工艺的研究  

Optimal formulation and preparation of diazepam submicronized emulsion for injection

作　　者：王艳娇[1] 王涛[1] 李芳[1] 何海冰[1] 

机构地区：[1]沈阳药科大学药学院,沈阳110016

出　　处：《中国新药杂志》2007年第2期142-146,共5页Chinese Journal of New Drugs

摘　　要：目的:确定地西泮亚微乳注射液的制备处方及工艺。方法:采用二级高压均质法制备地西泮亚微乳注射液,分别考察了高压均质条件,油相组成,乳化剂及稳定剂用量,pH调节,灭菌过程对制剂稳定性的影响。结果:采用15%油相(MCT与LCT等比例混合),1.2%豆磷脂,0.06%油酸钠,2.5%甘油,均质前调节至pH 8.0,以20℃,80 MPa压力均质6-10次,所制备的地西泮亚微乳注射液在4-25℃下12个月内理化性质没有明显变化。结论:本品具有良好的物理化学稳定性。Objective ： To optimize the formulation and preparation procedure of diazepam submicronized emulsion for injection. Methods： Diazepam submicronized emulsion was prepared by a twostage pressure homogenization. A few factors to impact the optimal preparative procedure, including homogenization condition, composition of oil phase, quantify of emulsifier and stabilizer, pH value and sterilization procedure, were investigated. Results： The optimal formulation was made of oil phase 15% （w/w）with LCT-MCT （ 1：1 ） , soybean lecithin 1.2% , oleate sodium 0. 06% and glycerin 2.5%. The other optimal conditions included pH 8.0 before homogenization and homogenous pressure of 80 MPa 6 - 10 times at 20 ℃. Diazepam submicronized emulsion for injection was stable at 4 - 25 ℃ for 1 year. Conclusion： The optimal diazepam submicronized emulsion for injection was attainable.

关 键 词：地西泮 亚微乳 处方 制备工艺 

分 类 号：R944.1[医药卫生—药剂学] R971.6[医药卫生—药学]