芪黄栓制备工艺研究  

Preparation process research of Qihuang Suppository

作　　者：付鹏 李争艳[2] 李江 李青[2] 陈凌云 余晓玲[2] FU Peng;LI Zheng-yan;LI Jiang;LI Qing;CHEN Ling-yun;YU Xiao-ling(Yunnan University of Chinese Medicine,Kunming 650500,China;Kunming Municipal Hospital of Traditional Chinese Medicine,Kunming 650500,China)

机构地区：[1]云南中医药大学,昆明650500 [2]昆明市中医医院,昆明650500

出　　处：《中华中医药杂志》2020年第10期5160-5163,共4页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：昆明市中药(民族药)医院制剂研发科技创新团队(No.2018-1-R-17245);昆明市医院制剂质量控制模式创新中心(No.2019-1-N-25318000002943)。

摘　　要：目的:优选芪黄栓提取工艺和成型工艺。方法:采用HPLC方法测定毛蕊异黄酮葡萄糖苷含量,以毛蕊异黄酮葡萄糖苷转移率、干膏得率为综合指标,在单因素试验的基础上进行正交试验优选出最佳提取工艺。采用对比试验,以外观形态、硬度、融变时限及释放度实验为综合指标,优选出栓剂最佳成型工艺。结果:芪黄栓的最佳提取工艺为12倍量水,提取2次,每次2h;最佳成型工艺为采用热熔法制备,以PEG400∶PEG4000∶甘油(5∶6∶1,m/m/m)混合为基质,药物与基质比为1∶4(m/m)。结论:优选的提取工艺和成型工艺稳定可行。Objective:To optimize the extraction process and forming process of Qihuang Suppository.Methods:Determination of the content of isoflavoneglucoside was measured by HPLC method.The optimal extraction process was optimized by orthogonal test based on the single factor test based on the transfer rate of flavonoid glycosides and the yield of dry paste.Using contrast test,the appearance of shape,hardness,melting time limit,release test as a comprehensive index,preferably the best forming process of suppository.Results:Optimum extraction conditions were as follows:extracted 2 times with 12 folds of water for 2 h each time.Optimum forming process:prepared by hot melt method,using PEG400∶PEG4000∶glycerol(5∶6∶1,m/m/m)as the matrix,the ratio of drug to substrate was 1∶4(m/m).Conclusion:The preferred extraction process and forming process are stable and feasible.

关 键 词：芪黄栓 毛蕊异黄酮葡萄糖苷 正交试验 释放度 提取工艺 成型工艺 聚乙二醇 基质 

分 类 号：TQ461[化学工程—制药化工]