星点设计效应面法优化盐酸文拉法辛油包水乳剂处方  

Optimization of Preparation for Venlafaxine Hydrochloride W/O Emulsion by Central Composite Design-Response Surface Methodology

作　　者：王可可[1,2] 易丽昕[3] 姜明燕[1,2] 

机构地区：[1]中国医科大学附属第一医院药学部,沈阳110001 [2]中国医科大学药学院,沈阳110001 [3]中国医科大学附属第四医院药学部,沈阳110032

出　　处：《医药导报》2015年第5期644-648,共5页Herald of Medicine

摘　　要：目的采用星点设计效应面法优化盐酸文拉法辛油包水乳剂处方,以获得稳定的乳状液。方法分别考察了乳化剂、盐酸文拉法辛、聚乙二醇和氯化钠用量对乳剂黏度、离心破坏率和平均粒径等指标的影响。用线性方程和二次多项式描述各指标及总评"归一值"与4个因素之间的数学关系,根据总评"归一值"的最佳数学模型描绘效应面,选择最佳处方,并进行预测分析。结果 4个因素和3个评价指标及总评"归一值"之间存在定量关系。优选的最佳处方:乳化剂P135为0.48 g,盐酸文拉法辛0.40 g,聚乙二醇0.26 g及氯化钠0.025 g。优化处方各指标的预测值和目标值接近。结论所建立的模型预测性良好,可用于优化盐酸文拉法辛油包水乳剂处方,并获得性质稳定的乳状液。Objective To optimize the formulations of venlafaxine hydrochloride （ VH ） emulsions by using central composite design-response surface methodology. Methods The effect of amounts of Arlacel P135, VH, PEG-400, and NaCl on the emulsion viscosity, centrifugation breakage, and mean diameter was systemically investigated, respectively. The desirable formulation that combining these three response variables was constructed. Linear equations and a second-order polynomial equation were fitted to the data, and the outcome equation was used to predict the responses in the optimal region. Results There was a quantitative relationship between 4 factors and 3 evaluation indexes and evaluation the “desirability” . The optimal formulation of the VH emulsion were as follows：taking 0. 48 g of Arlacel P135, 0. 40 g of VH, 0. 26 g of PEG-400, and 0. 025 g of NaCl. The experimental values of the response variables were highly closed to the predict values. Conclusion The model presents good prediction and can be used to optimize the preparation of VH emulsion, which obtaining stable W/O emulsion.

关 键 词：文拉法辛 盐酸 星点设计 效应面 油包水乳液 乳化-超声分散法 

分 类 号：R971.4[医药卫生—药品] TQ460.6[医药卫生—药学]