【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。更多还原

【Abstract】 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.更多还原