Box-Behnken响应面法优化交泰丸有效部位口服自微乳的制备方法

Preparation of the oral self-microemulsion by effective method of Box-Behnken response surface method

目的采用Box—Behnken响应面法（BBRSM）优化交泰丸有效部位口服自微乳的制备方法。方法考察黄连总碱在各种油相、乳化剂、助乳化剂中的溶解度，绘制伪三元相图，筛选最优处方；以油相、乳化剂、助乳化剂为自变量，粒径、Zeta电位、乳化时间为因变量，通过对自变量中的多元线性回归及多项式拟合，采用Box—Behnken响应面法优化处方，并对乳化后的粒径、Zeta电位、乳化时间进行预测分析。结果处方中蓖麻油、RH-40、乙醇占自微乳处方的含量分别为13．33％、54．07％、32．59％；自微乳的粒径为34．05nm，Zeta电位为23．87mV，乳化时间8．96s；处方的实际值与预测值的偏差分别为-2．14％、4．52％、6．28％。结论用BBRSM优化的交泰丸有效部位自微乳制备方法方便、快速，所建模型的预测性良好。

OBJECTIVE To optimize the preparation method of the oral self - microemulsions for effective delivery of Jiaotai pills by Box - Behnken response surface methodology （BBRSM）. METHODS The effects of total alkaloids in various oil phases, co - emulsi- fiers and emulsifiers were investigated. The pseudo - ternary phase diagram was drawn and the optimal prescription was screened. The BBRSM was used to optimize the formulation by using the multiple linear regression and polynomial fitting in the independent variables, with the oil phase, the emulsifier and the co - emulsifier as the independent variables, the particle size. Zeta potential and emulsification time as the dependent variables. RESULTS The contents of castor oil, RH - 40 and ethanol in the prescription were 13.33% , 54. 07% ,and 32.59% ,respectively. Particle size was 34.05 nm,Zeta potential was 23.87 mV, emulsification time was 8.96 s. The actual value of the prescription and the predicted value of the deviation were - 2.14% ,4.52% ,6.28%. CONCLUSION The preparation method of Jiaotai pill effective part is convenient and fast, and the model has good predictability.