星点设计-效应面法优化四磨汤滴丸的制备工艺  

Optimization of Extraction of Simotang Dropping Pills(四磨汤滴丸) by Central Composite Design/Response Surface Method

作　　者：胡立志[1] 王青[1] HU Li-zhi;WANG Qing(The Second Affiliated Hospital of Hu'nan University of Chinese Medicine,Changsha Hu'nan 410005,China)

机构地区：[1]湖南中医药大学第二附属医院,湖南长沙410005

出　　处：《中医药导报》2018年第24期98-101,共4页Guiding Journal of Traditional Chinese Medicine and Pharmacy

摘　　要：目的:优化四磨汤滴丸的制备工艺。方法:以滴丸的外观质量、溶散时限及丸重差异变异系数的总评值OD作为综合评定指标,在单因素试验的基础上,采用3因素4水平星点试验,考察滴距、基质与药物比、药液温度和冷凝液温度对四磨汤滴丸制备工艺的影响,对试验数据进行多元线性、二项式方程拟合,建立回归模型,通过效应面法确定最佳工艺并进行预测分析和试验验证。结果:四磨汤滴丸的制备工艺最佳条件为:以泊洛沙姆-188为基质,二甲基硅油∶液体石蜡(4∶1)为冷却剂,滴距8.0 cm,基质与药物比4∶1,药液温度82.0℃,冷凝液温度4.5℃,滴制口径2.5 mm,滴速为20 d/min为最佳条件。结论:本方法可用于四磨汤滴丸的制备工艺优化,建立的模型具有良好的预测性。Objective:To optimize the extraction of Simotang Dropping Pills (四磨汤滴丸).Methods:The optimum extraction process was selected with Single-factor test and the central composite design/response surface method,with the overall desirability (OD)values of the shape of pill,the difference of pill dissolution and mass as indicators,and through examing the dropping distance,proportion of matrix and drug,the temperature of drug fluids and refrigerant to select the best dropping conditions,the results were fitted by multi-linear equation and second-order polynomial equation,and the optimal inclusion process was predicted according to formulation.Results:The best technological parameters of Simotang Dropping Pills were as follows:Poloxamer-188 as matrix, proportion of dimethicone and Liquid paraffin (4:1)as refrigerant,drop distance was 8 cm,proportion of matrix and drug (4:1),temperature of drug fluids was 82℃,temperature of refrigerant was 4.5℃,the diameter of dropper was 2.5 mm,20dropping per minute.Conclusion:Using the central composite design-response surface method to optimize the extraction of Simotang Dropping Pills has a good prediction.

关 键 词：四磨汤滴丸 星点设计 效应面法 制备工艺 

分 类 号：R284[医药卫生—中药学]