枸橼酸莫沙必利片体外溶出度的研究  

Study on the dissolution rate of Mosapride Citrate Tablets in vitro

作　　者：张卫敏[1] 王博[2] 李洪起[2] 连潇嫣[2] 任晓文[2] 

机构地区：[1]天津中医药大学研究生院,天津300193 [2]天津药物研究院制剂工程中心,天津300193

出　　处：《中国医药导报》2013年第8期127-129,共3页China Medical Herald

基　　金：国家科技重大专项课题(编号2012ZX09105102)

摘　　要：目的通过测定进口药的枸橼酸莫沙必利片(商品名:加斯清)及国产样品的体外溶出度,为药品的质量和指导临床合理用药提供科学依据。方法依据国家标准[WS1-(X-287)-2003Z]和进口药品注册标准(JX20080288)的体外溶出度的规定,采用紫外分光光度法分别测定加斯清及国产样品在模拟胃液(0.1 mol/L盐酸)和人工肠液(pH=6.8磷酸缓冲液)中的溶出度。结果加斯清及国产样品在模拟胃液中的溶出度均较好,10 min后溶出度均大于90%;加斯清在人工肠液中的溶出度优于国产样品:45 min时的溶出度大于80%,符合进口药品注册标准(JX20080288),而国产样品A、B、C在人工肠液中60 min时的溶出度均低于50%,不符合进口药品注册标准(JX20080288)。结论加斯清及国产样品在模拟胃液的溶出度均较好,而在人工肠液中的溶出度加斯清优于国产样品。Objective To evaluate the quality of different Mosapride Citrate Tablets（Gasmotin and domestic preparations） and provide the evidence for the application of Mosapride in clinic.Methods According to the National Standards WS1-（X-287）-2003Z and the Imported Drug Registration Standards JX20080288,the dissolution rates of different Mosapride citrate tablets were determined in simulated gastric fluid（0.1 mmol/L HCl） and artificial intestinal fluid（phosphate buffer,pH=6.8）.Absorbance of the drug was determined by UV spectrophotometer.Results The dissolution rates of all the preparations were more than 90% after 10 minutes in simulated gastric fluid.The dissolution rate of Gasmotin was better than the domestic preparations in artificial intestinal fluid and more than 80% of Mosapride Citrate was dissolved in 45 minutes,which satisfied the Imported Drug Registration Standards JX20080288. While domestic preparations were dissolved less than 50% in 60 minutes.Conclusion The dissolution rate of Gasmotin is better than that of domestic preparations in artificial intestinal fluid.All of the tested preparations have an excellent dissolution in simulated gastric fluid.

关 键 词：枸橼酸莫沙必利 溶出度 模拟胃液 人工肠液 加斯清 

分 类 号：R284.2[医药卫生—中药学]