【作者】 黎月玲； 古淑仪； 陈青青；

【Author】 LI Yue-ling~1,GU Shu-yi~1,CHEN Qing-qing~2(1.Guangzhou Red Cross Hospital, Guangzhou,510220 China,2.Guangdong Pharmaceutical University,Guangzhou, 510006 China)

【机构】 广州市红十字会医院； 广东药学院；

【摘要】 目的:评价不同厂家华法林钠片的质量。方法:参照相关质量标准,从含量、含量均匀度、有关物质及溶出度指标考察四个厂家的产品质量,并对溶出度试验结果进行方差分析和多重比较。结果:四厂家产品的含量和含量均匀度指标均符合美国药典(USP 30)的要求;但有关物质检查显示,四厂家的产品所含未知杂质含量均大于英国药典(BP 2003)规定的限度(0.5%);溶出度方面,A、B、D厂产品的溶出度均符合美国药典(USP 30)的规定(>标示量的80%),但C厂产品溶出度低于60%。不同厂家之间的溶出度具有极显著差异(p<0.01),溶出度结果多重比较显示:A厂=D厂>B厂>C厂。结论:四厂家的华法林钠片在质量上存在一定差异。总体质量评价为:A与D厂好于B厂,更优于C厂,C厂的产品质量最差。更多还原

【Abstract】 OBJECTIVE:To evaluate quality of warfarin sodium tablets from different pharmaceutical manufacturers and to provide information for rational selection and secure medication in hospitals. METHODS:Quality of warfarin sodium tablets was investigated by such index as content of warfarin sodium,uniformity of content,related substances and dissolution,which were measuered according to related standards.And analysis of variance(ANOVA) and multiple comparisons were applied to evaluation in dissolution.RESULTS:Content of warfarin sodium and uniformity of content of products from 4 manufacturers all met the requirements of U.S.Pharmacopeia,but contents of unknown related substances all exceeded the limitation ruled by British Pharmacopeia.And dissolutions of products from manufacturer A,B,D were up to U.S.Pharmacopeia(not less than 80%of the labeded amount) while that of manufacturer C was less than 60%.ANOVA showed significant difference in dissolutions(p <0.01) and multiple comparisons educed the following ranking:A=D>B>C.CONCLUSION:Quality of warfarin sodium tablets from 4 manufacturers is different.And it’s elicited that products from manufacturer A and D are superior to those from manufacturer B,and products from manufacturer C are the worse.更多还原