丁酸氯维地平脂微球注射液的制备及质量评价  

The preparation and evaluation of clevidipine butyrate lipid microspheres injection

作　　者：荣景宏 吴凡[1] 王芳[1] 陈立江[1] 刘宇[1] 

机构地区：[1]辽宁大学药学院,辽宁沈阳110036

出　　处：《沈阳药科大学学报》2015年第7期503-509,共7页Journal of Shenyang Pharmaceutical University

基　　金：辽宁省教育厅科学研究项目(L2013011);辽宁大学"大学生创新创业训练计划"(X201310140060)

摘　　要：目的制备丁酸氯维地平脂微球注射液,并对所制备的脂微球注射液进行质量评价,确保制剂安全、稳定。方法采用高压均质法制备丁酸氯维地平脂微球注射液,通过单因素考察得到最佳处方和制备工艺,并对制剂进行了理化性质的表征及稳定性考察。结果确定最优处方为丁酸氯维地平0.5 g·L-1、油相大豆油200 g·L-1、乳化剂蛋黄卵磷脂12 g·L-1、稳定剂油酸0.3 g·L-1、等渗调节剂甘油22.5 g·L-1、p H调节剂Na OH以及注射用水适量。油水两相在70℃混合,高速分散机20 000 r·min-1,剪切10次,每次1 min,转移至微射流中103 425 k Pa均质12次,115℃灭菌30 min,即得。结论所设计的工艺可用于制备脂微球注射液。Objective To prepare the clevidipine butyrate lipid microspheres injection and evaluate its quality,in order to ensure the safety and stability of the lipid microspheres injection. Methods High pressure homogenization method was used to prepare the clevidipine butyrate lipid microspheres injection and the optimum prescription and preparation technology was developed through the single factor experiment. The physicochemical property and stability of clevidipine butyrate lipid microspheres injection were studied. Results The optimal prescription was as follows： clevidipine butyrate 0. 5 g·L- 1,soybean as oil phase 200 g·L- 1,egg yolk lecithin as emulsifier 12 g·L- 1,oleic acid as stabilizer 0. 3 g·L- 1,and glycerol as isoosmotic adjusting agent 22. 5 g·L- 1,appropriate amount of Na OH and water as p H regulator and solvent. The oil phase and the water phase were mixed at 70 ℃ by high-speed dispersion machine at 20 000 r·min-1 1for 10 times,each time needs 1 minute. The emulsion was homogenized at a pressure of 103 425 k Pa for 12 times and sterilized at 115 ℃ for 30 minutes. Conclusion The designed process can be used for the preparation of lipid microspheres injection.

关 键 词：丁酸氯维地平 脂微球 高压均质法 稳定性 

分 类 号：R94[医药卫生—药剂学]