基于AHP-CRITIC混合加权法和星点设计-效应面法的荆防活血乳膏处方优化研究

Optimization of Formulation of Jingfang Huoxue Cream by Central Composite Design- Response Surface Methodology Based on AHP-CRITIC Analysis

目的研究并优选荆防活血乳膏剂的制备工艺。方法以荆防活血乳膏剂的离心稳定性、耐热稳定性、涂抹分散性为考察指标,采用层次分析法(AHP)、基于指标相关性的权重确定方法(CRITIC)、AHPCRITIC混合加权法确定各评价指标的权重系数,并结合星点设计(central composite design,CCD)-效应面优化法筛选荆防活血乳膏处方中出对基质质量影响较大的3个因素硬脂酸、甘油、混合乳化剂(平平加、三乙醇胺)的用量,验证优化后的最佳处方。结果按AHP-CRITIC混合加权法得到离心稳定性、耐热稳定性、涂抹分散性的权重系数分别为0.5216,0.3372,0.1412,最佳处方比例为:硬脂酸4.4 g,甘油14.3 g,混合乳化剂4.2 g,单硬脂酸甘油酯2 g,凡士林8.5 g,二甲基硅油10 g,纯化水20 g,冰片1.5 g(2%),苯甲酸钠0.1%,荆防活血方组方药物提取干膏用量7.5 g(每100 g乳膏中含主药量约10 g)。结论优选出的荆防活血乳膏剂制备工艺经验证简单、合理,所得制剂具有良好的外观性状、涂抹分散性和稳定性。

Objective To optimize the formulation of Jingfang Huoxue Cream.Methods With centrifugal stability,heat stability,coating dispersion as evaluation indexes,the weighting coefficient of each evaluation index was determined by analytic hierarchy process(AHP),criteria importance through intercriteria correlation method(CRITIC)and AHP-CRITIC mixed weighting method,and the amount of stearic acid,glycerol and mixed emulsifier(peregal O-25 and triethanolamine)in the formulation of Jingfang Huoxue Cream was screened by central composite design-response surface methodology.The optimized formulation was validated.Results The weight coefficients of centrifugal stability,heat stability,coating dispersion were 0.5216,0.3372 and 0.1412,respectively,according to AHP-CRITIC mixed weighting method.The optimal formulation was as follows:stearic acid 4.4 g,glycerol 14.3 g,mixed emulsifier 4.2 g,glycerol monostearate 2 g,vaseline 8.5 g,dimethyl silicone 10 g,purified water 20 g,borneol 1.5 g(2%),sodium benzoate 0.1%and dry extract from Jingfang Huoxue Formula 7.5 g,ie every 100 g of cream contained about 10 g of main drug.Conclusion The optimized preparation process of Jingfang Huoxue Cream is proved to be simple and reasonable,and the quality of the preparation has good appearance property,coating dispersion and stability.