基于物质组体外释放特征的肉蔻五味丸制备工艺条件筛选  

Selectivity of Preparation Conditions of Roukouwuwei Pills Based on In Vitro Release Characteristics of Substance Group

作　　者：宋晓玲[1] 蒋晓磊 王辉峥 闫暾 宋淼[1] 刘全礼[1] SONG Xiao-ling;JIANG Xiao-lei;WANG Hui-zheng;YAN Tun;SONG Miao;LIU Quan-li(Baotou Medical College,Baotou 014040)

机构地区：[1]包头医学院,包头014040

出　　处：《北方药学》2020年第8期14-18,共5页Journal of North Pharmacy

基　　金：内蒙古自然科学基金(联合)项目[2016MS(LH)0823];包头医学院科学研究基金项目(BYJJ-QM201781);包头医学院科学研究基金项目(BYJJ-QM201632)。

摘　　要：目的:应用物质组整体释放动力学方法作为质量控制方法对肉蔻五味丸的制备工艺条件进行筛选。方法:泛制不同工艺条件的肉蔻五味丸,以物质组代替单成分,采用桨法进行释放度实验,绘制累计释放曲线,对溶出曲线进行数学模型拟合,分析肉蔻五味丸释药机制;对溶出曲线进行相似因子(f 2)拟合,分析不同制备工艺的肉蔻五味丸质量差异,找出最佳制备工艺条件。结果:不同工艺条件制备的肉蔻五味丸物质组体外释放存在差异,数学模型拟合以Weibull模型拟合度最高,释药机制可能是以骨架溶蚀的机制释药。综合相似因子(f 2)拟合分析得出肉蔻五味丸最佳工艺条件为:药粉细度应在100目以上,水丸机转速设定为50r/min^60r/min,烘干温度以45℃~55℃为宜。结论:物质组整体释放动力学方法可以作为质量控制手段对肉蔻五味丸制备工艺条件进行筛选。该研究为完善肉蔻五味丸的制备工艺提供了科学依据。Objective To Select the preparation process conditions of Roukouwuwei Pills by using the substance group holistic release kinetics method as a quality control method.Methods The Roukouwuwei Pills of different technological conditions were prepared.Substance groups were used instead of single ingredients.The paddle method was used for the release experiment,the cumulative release curve was drawn,and the dissolution curve was fitted with a mathematical model to analyze the release mechanism of Roukouwuwei Pills.The similarity factor(f 2)was fitted to the dissolution curve,the quality difference of the Roukouwuwei pills with different preparation processes was analyzed,and the best preparation process conditions were found.Results There were differences in the in vitro release of the Roukouwuwei Pills prepared by different technological conditions.The mathematical model fits the Weibull model with the highest degree of fit.The release mechanism may be based on the mechanism of matrix corrosion.A comprehensive similarity factor(f 2)fitting analysis shows that the best process conditions for Roukouwuwei pills are:the fineness of the powder should be above 100 mesh,the speed of the water pill machine is set to 50r/min^60r/min,and the drying temperature is 45℃~55℃is suitable.Conclusion The holistic release kinetics method of the substance group can be used as a quality control method to Select the preparation process conditions of Roukouwuwei pills.The research provides a scientific basis for perfecting the preparation process of Roukouwuwei pills.

关 键 词：肉蔻五味丸 物质组 释放特征 相似因子 

分 类 号：R284.2[医药卫生—中药学]