正交试验优化复方粉背雷公藤凝胶剂处方

Formulation Optimization of Compound Tripterygium Hypoglaucum Gel by Orthogonal Test

目的:优化复方粉背雷公藤凝胶剂处方。方法:以成型性、光泽度、均匀度、黏度、pH、涂展性、稳定性等组成的综合评分(总分15.0分)为指标,以卡波姆940、丙二醇、三乙醇胺及药材提取液等在处方中的用量为考察因素,设计正交试验优化复方粉背雷公藤凝胶剂处方,并进行验证试验。结果:优化处方为卡波姆940 1.0 g、氮酮2.0 g、亚硫酸氢钠0.4 g、提取液50 m L、丙二醇10g、三乙醇胺1.0 g,加水至100 g。验证试验结果显示所制凝胶综合评分均值为14.8(RSD=1.35%,n=3)。结论:优化处方所制复方粉背雷公藤凝胶成型性好,质量符合要求。

OBJECTIVE:To optimize the formulation of Compound tripterygium hypoglaucum gel. METHODS:Using the comprehensive score(total score was 15.0)composed by forming property,glossiness,uniformity,viscosity,pH,spreadable property and stability as indexes,using the usage amount of carbomer 940,propylene glycol,triethanolamine and extracts in formula as study factors,orthogonal test was designed to optimized the formulation of Compound tripterygium hypoglaucum gel,and the verification test was conducted. RESULTS:The optimal matrix formulation was as follow as carbomer 940 1.0 g,azone 2.0 g,sodium bisulfite 0.4 g,extracts 50 m L,propylene glycol 10 g,triethanolamine 1.0 g,adding water to 100 g. The average comprehensive score of the gel in verification test was 14.8(RSD=1.35%,n=3). CONCLUSIONS:The optimized formulation of Compound tripterygium hypoglaucum gel shows good forming property,the quality meets the requirements.