星点设计-效应面法优化多烯磷脂酰胆碱注射液的处方  

Optimization of the formulation of Polyene phosphatidylcholine injection by Central composite design-response surface method

作　　者：程勐 刘美[1] 闫碧涵 王银艳[1] 储婷[1] 毛声俊[1] 

机构地区：[1]四川大学华西药学院靶向药物及释药系统教育部重点实验室,四川成都610041

出　　处：《华西药学杂志》2014年第6期625-627,共3页West China Journal of Pharmaceutical Sciences

摘　　要：目的优选多烯磷脂酰胆碱(PPC)注射液的处方。方法采用溶剂分散法制备PPC注射液,以PPC与脱氧胆酸钠的质量比、苯甲醇及氯化钠的用量为考察因素;以粒径和PPC的含量为指标,采用星点设计-效应面法优化处方。结果优选的处方为:PPC∶脱氧胆酸钠为1.8∶1,苯甲醇及氯化钠分别为0.8%、0.2%,平均粒径为4.1 nm,PPC含量为91%。经热压灭菌与低温冷藏后,产品符合注射剂的质量要求。结论所得结果可靠,PPC注射液的处方优化成功。OBJECTIVE To optimize the formulation of Polyene phosphatidylcholine（ PPC） injection. METHODS The PPC injection was prepared by solvents diffusion method. Furthermore,the weight ratio of PPC to sodium deoxycholate（ SDC）,the content of benzyl alcohol（ BA） and the content of Na Cl were defined as the independent variables while the size and the percentage content of PPC were defined as the dependent variables. The optimized formulation was determined by Central composite design- response surface method. RESULTS The optimized formulation was PPC∶SDC（ 1. 8∶1） with BA（ 0. 8%） and Na Cl（ 0. 2%）. According to the optimized formulation,PPC injection was prepared,resulting in an average diameter of 4. 11 nm and the PPC of 91. 1%. And the product was up to the quality of injetion after steam sterilization and deepfreeze. CONCLUSION The optimized formulation of PPC injection has been successfully obtained by Central composite design- response surface method and the outcomes are reliable.

关 键 词：多烯磷脂酰胆碱注射液 三元相图 星点设计-效应面法 

分 类 号：R94[医药卫生—药剂学]