注射用环孢素A亚微乳的制备  

Preparation of cyclosporine A submicron emulsion for injection

作　　者：袁悦[1] 李英[1] 李三鸣[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》2006年第12期982-985,共4页Chinese Journal of New Drugs

基　　金：沈阳市科技计划(1053125-1-37)

摘　　要：目的:制备静脉注射用环孢素A亚微乳。方法:采用高压匀质法制备环孢素A亚微乳,以离心稳定性参数、药物含量和Zeta电位作为评价指标,通过正交设计试验对处方进行了优化。在最佳处方的基础上,考察工艺因素对乳剂的影响。结果:在优化处方及工艺条件下,所制备的环孢素A亚微乳稳定性良好,可以通过热压灭菌,热压灭菌后的平均粒径为(124．7±15．1)nm。结论:该处方及工艺可行,制得的环孢素A亚微乳可达到静脉注射使用的要求。Objective： To prepare cyclosporine A submicron emulsion for intravenous injection. Methods： The cyclosporine A submicron emulsion was prepared by a high-pressure homogenization. The emulsions were characterized by the stability index of centrifugation, cyclosporine A concentration and Zeta potential of the emulsions. The formulation was optimized with orthogonal experimental design and the factors affecting the stability of the emulsions were then assessed. Results： The optimal cyclosporine A submicron emulsion remained stable after sterilization by steam under pressure. The mean particle size of the sterilized cyclosporine A submicron emulsion was （124.7±15.1 ）nm. Conclusion： The cyclosporine A submicron emulsion met the criteria used for intravenous administration.

关 键 词：环孢素A 亚微乳 高压匀质 热压灭菌 泊洛沙姆 

分 类 号：R979.5[医药卫生—药品] R944.11[医药卫生—药学]