星点设计-效应面法优化二黄止痛凝胶剂基质处方研究  

Optimization of the matrix formulation of Erhuang analgesic gels by central composite design-response surface methodology

作　　者：周许 涂禾[1] 吴明权 彭伟 朱力阳[1] 刘李梅 Zhou Xu;Tu He;Wu Mingquan;Peng Wei;Zhu Liyang;Liu Limei(Traditonal Chinese Medicine Research Room,Orthopedic Hospital of Sichuan Province,Chengdu 610041,China)

机构地区：[1]四川省骨科医院中药研究室,成都610041

出　　处：《国际中医中药杂志》2021年第10期1000-1005,共6页International Journal of Traditional Chinese Medicine

基　　金：四川省科技厅重点研发项目(2019YFS0541);成都中医药大学"杏林学者"学科人才科研提升计划(YYZX2019019)。

摘　　要：目的优选二黄止痛凝胶剂的基质处方。方法以凝胶剂中卡波姆940、三乙醇胺及甘油量为考察因素,以制剂的外观性状、稳定性、黏度和盐酸小檗碱体外累计释放量为综合评价指标,利用星点设计-效应面法优选最佳处方工艺。结果拟合回归方程为Y=82.25+4.95A+5.19B+1.41C+1.51AB+0.9040AC-0.5319BC-2.92A^(2)-1.80B^(2)-0.1821C^(2),P<0.0001,r值为0.977,方程回归拟合度较高最佳工艺处方:卡波姆940量为1.84%,三乙醇胺量为卡波姆940的1.30倍,甘油量为13.99 g,3批验证试验的平均综合评分为88.56分,与预测值的偏差分别为2.93%、2.85%、1.55%。结论星点设计-效应面法优选的二黄止痛凝胶剂制备工艺稳定,实现了处方优化。Objective To optimize the matrix formulation of Erhuang analgesic gels.Methods Central composite design-response surface methodology was adopted to optimize the best formulation of Erhuang analgesic gels by using carbomer 940,triethanolamine and glycerine as independent variables,the appearance,stability,viscosity and in vitro release of berberine hydrochloride as comprehensive evaluation indices.Results The fitting regressing equation was Y=82.25+4.95A+5.19B+1.41C+1.51AB+0.9040AC-0.5319BC-2.92A^(2)-1.80B^(2)-0.1821C^(2).P value of the model was less than 0.0001,and the correlation coefficient r value was 0.977.The optimal formulation of Erhuang analgesic gels consisted of 1.84%carbomer 940,1.30 times triethanolamine of carbomer 940 and 13.99 grams of glycerine.The average comprehensive scores of three verification experiments was 88.56,and the deviations from the predicted values were 2.93%,2.85%and 1.55%.Conclusion The formulation process by central composite design-response surface methodology was stable and the formulation of Erhuang analgesic gels has been optimized.

关 键 词：中药工艺改进 星点设计-效应面法 二黄止痛凝胶 基质处方 体外释放 

分 类 号：R283.6[医药卫生—中药学]