基于模糊数学综合评价法结合响应曲面优化柴黄片制剂工艺  

Optimizing the Preparation Process of Chaihuang Tablets Based on Fuzzy Comprehensive Evaluation Method Combined with Response Surface

作　　者：张微 纪红英 邵明杰 窦希波 郭田甜 毕艳艳 王善栋 林凤 ZHANG Wei;JI Hong-ying;SHAO Ming-jie;DOU Xi-bo;GUO Tian-tian;BI Yan-yan;WANG Shan-dong;LIN Feng(Lunan Houpu Pharmaceutical Co.,Ltd.,Linyi 276006,China;State Key Laboratory of Generic Manufacture Technology of Traditional Chinese Medicine,Linyi 276006,China;Shandong Center for Food and Drug Evaliation&Inspection,Jinan 250014,China)

机构地区：[1]鲁南厚普制药有限公司,山东临沂276006 [2]中药制药共性技术国家重点实验室,山东临沂276006 [3]山东省食品药品审评查验中心,山东济南250014

出　　处：《现代中药研究与实践》2022年第3期79-83,共5页Research and Practice on Chinese Medicines

基　　金：山东省重点研发计划(重大科技创新工程:2020CXGC010505)。

摘　　要：目的优化中药柴黄片的制剂工艺。方法以柴黄片为研究对象,利用模糊数学综合评价法结合响应曲面模型对柴黄片制粒及压片工艺过程进行评价优化,并筛选出最优柴黄片制剂工艺参数。结果柴黄片的制剂工艺方案为88%乙醇作为润湿剂,料液比为54%,崩解剂采用2%羧甲基淀粉钠内加法加入、1%羧甲基淀粉钠外加法加入,助流剂硬脂酸镁用量为0.3%。结论模糊数学综合评价法结合响应曲面模型可为柴黄片制剂工艺提供科学、合理、可行的指导。Objective To optimize the preparation process of Chaihuang tablets.Methods Chaihuang tablets are used as the research object.The process of granulation and compression of Chaihuang tablets is evaluated by fuzzy comprehensive evaluation method combined with response surface model for obtaining the optimal process parameters of Chaihuang tablets.Results The best preparation process of Chaihuang tablets is obtained.The wetting agent is 88%ethanol,the liquid-solid ratio of material is 54%,the dosage of retention aid magnesium stearate is 0.3%,the disintegrating agent is 3%sodium carboxymethyl starch,of which 2%is added internally,and 1%is added externally.Conclusion The comprehensive evaluation method of fuzzy mathematics combined with response surface model provides a scientific,reasonable and feasible index for the optimization of process parameters of Chaihuang tablets.

关 键 词：柴黄片 制剂工艺 模糊数学综合评价法 响应曲面 

分 类 号：R283.3[医药卫生—中药学]