正交设计金英黄归液透皮剂的制备

Preparation of jin-ying-huang-gui-ye transdermal Agent by Orthogonal Experiment Design

为了考查影响金英黄归液透皮剂的因素及透过效果,本试验将基质配方、乳化剂、温度作为可变因素,选用L9(34)正交表进行试验,研究影响金英黄归液透皮剂制备的因素,采用离心试验、耐寒耐热试验、加速试验考查其稳定性,应用透皮扩散池采用紫外分光光度法研究其透过率。结果显示,基质配方、乳化剂、温度对透皮剂分层时间和性能的影响不显著(P>0.05),其影响顺序为基质用量>温度>乳化剂用量,在耐寒耐热、离心和加速试验中未见分层破乳、霉败、色泽和均匀性改变等现象,其稳定性良好;其透过率为15.1μg/cm2.h,这将为生产上制备透过率好稳定的金英黄归液透皮剂提供良好的试验数据。

To investigate the penetration effect of Jin-Ying-Huang-Gui transdermal agent, matrix formulation, emulsifier, and temperature were chosen as variable factors, L9 （34） orthogonal array was selected to study the impact on the preparation of Jin-Ying-Huang-Gui transdermal agent, and we further examined the stability by centrifugal test, cold and heat test, acceleration test and transmissivity by ultraviolet spectrophotometry. The results showed that the effect of matrix formulation, emulsifier, and temperature on delamination and performance of the transdermal agent was not significant （P〉0.05）, with the mount of matrix temperature the mount of emulsifier. In the cold and heat, centrifugal and acceleration test, there were no hierarchical breaking, lost mold, changes in color, and uniformity of the phenomenon. Its stability was good and transmittance was 15.1μg/cm2 . h. These data have provided good experimental data for the massive preparation of Jin-Ying-Huang-Gui transdermal agent.