应用Box-Behnken设计-响应面法优化复方白鲜皮软膏剂的成型工艺  

Optimization of the Molding Process of Compound Baixianpi Ointment Using the Box-Behnken Design-response Surface Methodology

作　　者：杨娟 甄世福 袁文珺 柴露露 陈娟江 魏其云 YANG Juan;ZHEN Shifu;YUAN Wenjun;CHAI Lulu;CHEN Juanjiang;WEI Qiyun(Lanzhou Hospital of Traditional Chinese Medicine,Lanzhou 730050,China;Gansu Provincial Hospital of Traditional Chinese Medicine,Lanzhou 730050,China;College of Pharmacy,Lanzhou University,Lanzhou 730000,China)

机构地区：[1]兰州市中医医院,甘肃兰州730050 [2]甘肃省中医院,甘肃兰州730050 [3]兰州大学药学院,甘肃兰州730000

出　　处：《西部中医药》2025年第4期1-5,共5页Western Journal of Traditional Chinese Medicine

基　　金：兰州市卫生健康科技发展项目(2019-025)。

摘　　要：目的:优选复方白鲜皮湿疹方的软膏剂成型工艺。方法:通过预实验,以软膏外观均匀度、稳定性、涂展性为评价指标进行综合评分,从油脂性、水溶性和乳剂型(W/O型和O/W型)基质中筛选出最佳基质类型;采用单因素实验和Box-Behnken设计-响应面法优选制备工艺,对油相和水相的用量进行优化,确定最佳的基质处方。结果:Box-Behnken响应面模型P<0.0001,失拟项P>0.05,该模型显著性高且拟合程度良好;经Design-Expert软件分析,最优制备工艺参数为:白凡士林1.600 g,羊毛脂1.102 g,液状石蜡1.799 g,甘油3.600 g,根据实际制备情况,选取白凡士林1.60 g,羊毛脂1.10 g,液状石蜡1.79 g,甘油3.60 g;工艺验证试验的OD平均值为8.66,与预测值有较小偏差,3批样品的综合评分均大于25,表明软膏剂的稳定性、涂布性、均匀性良好。结论:运用Box-Behnken设计-响应面法优选的复方白鲜皮软膏剂成型工艺稳定可行。Objective:To optimize the molding process for the ointment of compound Baixianpi(dictamni cortex)eczema formula.Methods:The uniformity,stability,and spreadability of ointment were used as evaluation indicators to conduct the comprehensive scoring in the pre-experiment,and the best matrix type was selected from the oil-based,water-soluble and emulsion(W/O type and O/W type)matrix;Single factor experiment and Box-Behnken design-response surface methodology were used to optimize the preparation process,including the amount of oil phase and water phase,and then to determine the best matrix prescription.Results:The Box-Behnken design-response surface model P<0.0001,and P>0.05 for the test of lack-of-fit,indicating high significance and good fit;The analysis using Design-Expert software revealed that the optimal parameters of the preparation process were:petrolatum 1.600 g,lanolin 1.102 g,liquid paraffin 1.799 g and glycerin 3.600 g,based on actual preparation conditions,1.60 g of petrolatum,1.10 g of lanolin,1.79 g of liquid paraffin,and 3.60 g of glycerin were selected;the average OD value from the process validation trials was 8.66,with a small deviation from the predicted value,the comprehensive scores for all three batches of samples were greater than 25,indicating good stability,spreadability,and uniformity of the ointment.Conclusion:The molding process of compound Baixianpi ointment,optimized by Box-Behnken design-response surface methodology,is stable and feasible.

关 键 词：复方白鲜皮软膏剂 基质 Box-Behnken设计-响应面法 成型工艺 

分 类 号：R283[医药卫生—中药学]