致孔剂及其用量对盐酸吗啡渗透泵片体外释放度的影响  

Effects of Pore-Forming Agents and Their Dosage on the in Vitro Release of Morphine Hydrochloride Osmotic Pump Tablets

作　　者：张玲玲 阙晓 蒲婷 杨宇林 王书兰 罗立骏 侯立新 ZHANG Lingling;QUE Xiao;PU Ting;YANG Yulin;WANG Shulan;LUO Lijun;HOU Lixin(Southwest Pharmaceutical Co.,Ltd.,Chongqing,China 400038;Chongqing Institute for Food and Drug Control·NMPA Key Laboratory for Quality Monitoring of Narcotic Drugs and Psychotropic Substances,Chongqing,China 401121)

机构地区：[1]西南药业股份有限公司,重庆400038 [2]重庆市食品药品检验检测研究院·国家药品监督管理局麻醉精神药品质量监测重点实验室,重庆401121

出　　处：《中国药业》2024年第17期16-20,共5页China Pharmaceuticals

基　　金：重庆市技术创新与应用发展专项面上项目[CSTB2022TIAD-GPX0071]。

摘　　要：目的比较不同致孔剂及其用量对盐酸吗啡渗透泵片体外释放度的影响。方法采用湿法制粒制备片芯,半透膜包衣,比较半透膜层中不同致孔剂及其用量对盐酸吗啡渗透泵片体外释放度的影响。结果不同致孔剂对盐酸吗啡渗透泵片的溶出均有促进作用,盐酸吗啡渗透泵片体外释放度随致孔剂用量的增加而增加,相同用量的致孔剂对盐酸吗啡渗透泵片体外释放度的影响从大至小依次为聚乙二醇6000>聚乙二醇4000>聚乙二醇400>聚乙烯吡咯烷酮K30>羟丙基纤维素。结论不同致孔剂及其用量对盐酸吗啡渗透泵片释放度的影响有较大差异。该研究中以聚乙二醇400为优选致孔剂,释放效果较好,重复性良好。Objective To compare the effects of different pore-forming agents and their dosages on the in vitro release of Morphine Hydrochloride Osmotic Pump Tablets.Methods The tablet cores were prepared with the wet granulation method and coated with semi-permeable film.The effects of different pore-forming agents and their dosages in the semi-permeable film on the in vitro release of Morphine Hydrochloride Osmotic Pump Tablets were compared.Results Different pore-forming agents had a promoting effect on the dissolution of Morphine Hydrochloride Osmotic Pump Tablets.The in vitro release rate of Morphine Hydrochloride Osmotic Pump Tablets increased with the increase in the dosage of pore-forming agents.The effect of the same dosage of pore-forming agent on the in vitro release rate of Morphine Hydrochloride Osmotic Pump Tablets was in the order of polyethylene glycol 6000>polyethylene glycol 4000>polyethylene glycol 400>polyvinyl pyrrolidone K30>hydroxypropyl cellulose.Conclusion There are significant differences in the effects of different pore-forming agents and their dosages on the release rate of Morphine Hydrochloride Osmotic Pump Tablets.In this study,polyethylene glycol 400 is selected as the preferred pore-forming agent with good release effect and good repeatability.

关 键 词：致孔剂 用量 盐酸吗啡渗透泵片 体外释放度 

分 类 号：R917[医药卫生—药物分析学] R971.1[医药卫生—药学]