基于“药辅合一”的中药复方缓释制剂研究——以芍药甘草胃漂浮片为例  

Study on the Traditional Chinese Medicine Compound Sustained-release Preparation based on the Unification of Medicines and Excipients——A Case Study of Shaoyao Gancao Intragastric Floating Tablets

作　　者：杜平[1] 刘文[1] 卿勇军[1] 姚晓艳[1] 金阳[1] 陈淮臣 何利 DU Ping;LIU Wen;QING Yong-jun;YAO Xiao-yan;JIN Yang;CHEN Huai-chen;HE Li(Guiyang College of Traditional Chinese Medicine,Guiyang 550002,China)

机构地区：[1]贵阳中医学院,贵州贵阳550002

出　　处：《中药材》2018年第10期2403-2407,共5页Journal of Chinese Medicinal Materials

基　　金：贵州省教育厅创新群体重大项目(黔教合KY字[2017]040)

摘　　要：目的:制备芍药甘草胃漂浮缓释片,探讨以壳聚糖为主要辅料制备中药复方缓释制剂的可行性。方法:以片剂成型性为评价指标,单因素考察压片方法、药物辅料混合等工艺环节,找出影响壳聚糖辅助药物成型的关键因素;以芍药内酯苷、芍药苷、甘草苷、甘草酸铵4个成分在8 h内的平均累积释放度为评价指标,进行L_9(3~4)正交试验,优选芍药甘草胃漂浮片成型工艺。结果:药物辅料混合方法对芍药甘草胃漂浮片成型性有显著影响,压片方法影响不明显;经优选所得处方可使芍药甘草胃漂浮片持续释药时间>8 h,持漂时间>12 h。结论:以壳聚糖为主要辅料进行中药复方缓释制剂制备工艺研究具有一定的可行性,本研究中影响片剂成型的关键因素为药物与辅料混合。Objective:To prepare intragastric floating sustained-release tablets of Shaoyao gancao,and to discuss the feasibility of chitosan as the main excipient for the traditional Chinese medicine sustained-release preparation.Methods:Taking the tablet formability as evaluation index,the preparation steps such as tabletting method,mixture of pharmaceutical and materials and so on were investigated by single factor in order to find out the key factor of chitosan assisted drugs molding.Taking the average cumulative release of albiflorin,paeoniflorin,liquiritin and ammonium glycyrrhetate within 8 hours as evaluation index,molding process was optimized by L9(34)orthogonal experient.Results:The mixing method of pharmaceutical and excipients had a significant effect on the formability of Shaoyao gancao floating tablets,but the influence of tabletting method was not obvious.After optimization,the continuous release time of Shaoyao gancao intragastric floating tablets was more than 8 h,and the holding time was more than 12 h.Conclusion:It is feasible to use chitosan as the main excipient in the preparation of sustained-release tablets of traditional Chinese medicine.In this study,the key factor to affect tablet molding is the mixing of pharmaceutical and excipients.

关 键 词：药辅合一 芍药甘草汤 胃漂浮缓释片 壳聚糖 

分 类 号：R283.6[医药卫生—中药学]