不同厂家华法林钠片的质量评价  

Quality Evaluation of Warfarin Sodium Tablets from Different Pharmaceutical Manufacturers

作　　者：黎月玲[1] 古淑仪[1] 陈青青[2] 

机构地区：[1]广州市红十字会医院,广州市510220 [2]广东药学院,广州市510006

出　　处：《中国药房》2010年第13期1223-1225,共3页China Pharmacy

摘　　要：目的:评价不同厂家华法林钠片的质量。方法:参照美国药典(USP30)、英国药典(BP2003)等相关质量标准,从含量、含量均匀度、有关物质及溶出度指标考察A、B、C、D4个厂家的产品质量,并对溶出度数据进行方差分析和多重比较。结果:4厂家产品的含量和含量均匀度指标均符合USP30的要求;但在有关物质方面,4厂家产品所含未知杂质含量均大于BP2003规定的限度(0.5%);A、B、D厂产品的溶出度均符合USP30的规定(>标示量的80%),C厂产品溶出度低于60%。除A厂与D厂外,其余不同厂家产品之间的溶出度两两比较均具有极显著性差异(P>0.01),溶出度结果多重比较显示A厂=D厂>B厂>C厂。结论:4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。OBJECTIVE： To evaluate the quality of Warfarin sodium tablets from different pharmaceutical manufacturers. METHODS： The quality of Warfarin sodium tablets from A, B, C and D manufacturers were investigated in respects of content, content uniformity, related substances and dissolution according to related standards stated in United State Pharmacopeia （USP 30） and British Pharmacopeia （BP 2003）. Variance analysis and multiple comparisons were applied to evaluate the dissolution of Warfafin sodium tablets. RESULTS： The content and content uniformity of Warfarin sodium tablets from four pharmaceutical manufacturers were all met the requirements specified in USP 30. But the contents of unknown impurity in tablets from four manufactory were all higher than the specification stated in BP 2003 （0.5%）. The dissolution of tablets from A, B, and C manufacturers were in line with the standard stated in USP 30 （ 〉80% of labeled amount） while the dissolution of tablets from C manufacturer was lower than 60%. There was significant difference in the dissolution of tablets from B and C manufacturers （P〉0.01）. The dissolution of tablets from A and D manufacturers were same to each other while both of them were larger than those from B and C manufacture. CONCLUSIONS： The qualities of Warfarin sodium tablets from four manufacturers are different from one another. The quality of products from A and D manufacturers are superior to those from manufacturer B. The products from manufacturer C are the worst.

关 键 词：华法林钠片 厂家 质量 评价 

分 类 号：R927.11[医药卫生—药学] R973.2