采用定制设计法设计中药外用乳剂处方

Customized Design Method to Design the Prescription of Traditional Chinese Medicine Emulsion for External Use

目的:筛选中药亚微乳制剂的最佳处方。方法:通过单因素试验筛选,确定油相为大豆油,乳化剂为卵磷脂,助乳化剂为吐温80和丙二醇。以乳剂中大豆油的用量(X_(1))、卵磷脂的用量(X_(2))、吐温80的用量(X_(3))、丙二醇的用量(X_(4))为因素。以粒径(Y)为效应。采用JMP软件进行定制试验设计,确定各因素试验水平,生成试验表,依次试验取得结果输入表格,计算各回归方程和影响因素的P值,通过预测刻画器预测关键因素最佳数值,确定最佳处方。结果:选用定制试验设计法安排试验,筛选出用于治疗靶向药物皮疹的最佳处方:大豆油为15 ml,卵磷脂为3.75 g,吐温80为3 ml,丙二醇为8 ml时,预测最小粒径为103.72 nm。结论:采用定制试验设计的方法进行中药亚微乳制剂处方筛选,试验效率高,结果可靠。

Objective:To screen the best prescription of traditional Chinese medicine submicron emulsion preparation.Methods:Single-factor experiment was used to determine soybean oil as the oil phase,lecithin as the emulsifier,and Tween 80 and propylene glycol as the co-emulsifier.The amount of soybean oil(X_(1)),the amount of lecithin(X_(2)),the amount of Tween 80(X_(3))and the amount of propylene glycol(X_(4))in the emulsion were used as the factors,and the particle size(Y)was employed as the effect.The JMP software was used to customize the experimental design,determine the test level of each factor,generate the test table,and then obtain the result input form in order,calculate the P value of each regression equation and the influencing factors,and predict the best value of the key factor by predicting the profiler to determine the best prescription and process.Results:The experiment was arranged by custom test design method to screen out the best prescription and process of traditional Chinese medicine external emulsion for treating target drug rash.Soybean oil was 15 ml,lecithin was 3.75 g,Tween 80 was 3 ml and propylene glycol was 8 ml.The predicted minimum particle size was 103.72 nm.Conclusion:The method of customary experimental design is used to prescribe the formulation of traditional Chinese medicine submicron emulsion preparation,and the test efficiency is high and the result is reliable.