CAJ | 학술논문

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。优选的最佳处方为乳化剂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。
목적：채용성점설계효응면법우화염산문랍법신유포수유제처방，이획득은정적유상액。방법분별고찰료유화제、염산문랍법신、취을이순화록화납용량대유제점도、리심파배솔화평균립경등지표적영향。용선성방정화이차다항식묘술각지표급총평“귀일치”여4개인소지간적수학관계，근거총평“귀일치”적최가수학모형묘회효응면，선택최가처방，병진행예측분석。결과4개인소화3개평개지표급총평“귀일치”지간존재정량관계。우선적최가처방위유화제0.48 g、염산문랍법신0.40 g、취을이순0.26 g급록화납0.025 g。우화처방각지표적예측치화목표치접근。결론소건립적모형예측성량호，가용우우화염산문랍법신유포수유제처방，병획득성질은정적유상액。
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.