中文摘要：

目的优化注射用Cheliensisin A冻干乳剂的处方。方法以高压乳匀法制备乳剂,加适当冻干保护剂冻干,以冻干制剂的外观、加水复溶情况、粒径及多相分散系数（PDI）为指标,采用星点设计-效应面优化法确定较优处方。结果大豆磷脂、中链脂肪酸酯和Cheliensisin A的浓度分别为4%、15%和0.2%时,制得的Cheliensisin A冻干乳剂外观结实、光滑平整;加水再分散性好;粒径为168±5 nm;PDI为0.133±0.070;适合静脉给药。结论应用星点设计-效应面优化法能够快速方便地筛选出Cheliensisin A冻干乳剂的较优处方。

英文摘要：

OBJECTIVE To determine the optimized formulation of Cheliensisin A freezing - dried submicron emulsion for intravenous injection. METHODS According to the apperance, redispersion, size and poly dispersive index （PDI） of the preparations, the optimized formulation was determined by Central composite design - response surface methodology. RESULTS The obtained Cheliensisin A submicron emulsion had qualified appearance, and easy to be redispersed with an average diameter of 168 ± 5 nm （PDI, 0. 133 ± 0.070）, when the correspondent percentage of soybean phosphatidy cholin （PC）, medium chain triglycerides （MCT） and Cheliensisin A were 4%, 15%, and 0.2%, respectively. CONCLUSION The optimized formulation of freezing - dried Cheliensisin A submicron emulsion for intravenous injection could be obtained quickly and conveniently by the central composite design - response surface methodology.