三七总皂苷(PNS)肠溶缓释片制备工艺及体外释放研究  

Optimization of Preparation Technology Research and release in vitro on Panax Notoginseng Saponins (PNS) Enteric-Coated Sustained-Release Tablets

作　　者：张琳[1,2] 赵凤平 王云红 张传辉[4] 闫丹[1] 江敏瑜[1] 杨荣平 ZHANG Lin;ZHAO Feng-ping;WANG Yun-hong;ZHANG Chuan-hui;YAN Dan;JIANG Min-yu;YANG Rong-ping(College of Pharmacy,Chengdu University of Traditional Chinese Medicine,Chengdu 611137,China;College of Pharmacy ,Southwest University,Chongqing 400715,China;Chongqing Institute for Food and Drug Control,Chongqing 401121,China;Chongqing Academy of Chinese Traditional Materia Medica,Chongqing 400065,China)

机构地区：[1]成都中医药大学药学院,四川成都611137 [2]西南大学药学院,重庆400715 [3]重庆市食品药品检验检测研究院,重庆401121 [4]重庆市中药研究院,重庆400065

出　　处：《时珍国医国药》2019年第4期861-865,共5页Lishizhen Medicine and Materia Medica Research

基　　金：重庆市"121"科技支撑示范工程(cstc2014fazktjcsf10016)

摘　　要：目的制备三七总皂苷(PNS)肠溶缓释片,考察其体外释放度。方法以辅料羟丙基甲基纤维素(HPMC_(K15M))和微晶纤维素(MCC)的用量为自变量,以药物累积释放度总评分为因变量,采用中心复合设计-效应面法,优选PNS缓释片的最佳工艺参数;以羟丙基甲基纤维素酸酞酯(HPMCP)为肠溶衣材料,采用单因素法考察包肠溶衣过程。结果最佳工艺参数为:PNS∶HPMC _(K15M)∶MCC用量比为∶100∶51∶92,片芯:HPMCP为100∶8,压片数量1000片,每片0.26 g,此条件药物累积释放度综合评分为97.74,与理论预测值基本吻合。结论优化工艺稳定、可行,具有一定的应用价值。Objective To prepare the PNS enteric-coated sustained-release tablets, investigate its release in vitro. Methods Excipients dosage of HPMCK15M and MCC as independent variables, the overall evaluation of the accumulation release of the drug as dependent variable, central composite design-response surface method was used to optimize the process parameters of PNS sustained-release tablets. Enteric coating material was HPMCP, the process of coating was investigated by single-factor method.Results The best process parameters: the dosage of PNS:HPMCK15M:MCC was 100:51:92, the dosage of tablet core :HPMCP was 100:8,tabletted 1000 pieces, each piece was 0.26 g, with the condition that overall evaluation of the accumulation release of the drug was 97.74,the experimental values agreed with which predicted. Conclusion The optimization technology was proved to be stable, feasible and valuable.

关 键 词：三七总皂苷( PNS) 缓释片 肠溶衣 中心复合设计-效应面法 体外释放 

分 类 号：R283[医药卫生—中药学]