Comparison of Quality Evaluation of Cefuroxime Axetil Tablets from 4 Pharmaceutical Factories / 中国药房

ABSTRACT

OBJECTIVE:To evaluate the quality of cefuroxime axetil tablets from four pharmaceutical factories. METHODS:3 batches of samples of each factory were collected from A,B,C,D pharmaceutical factories. The quality of them were evaluated according to Chinese Pharmacopeia(2005 edition)with contents,isomers,moisture,weight variation and in vitro dissolution as indexes. The dissolution parameters(T50,Td,m)were adopted for variance analysis. RESULTS:Contents,isomers,moisture, weight variation and in vitro dissolution of samples from four pharmaceutical factories were up to standard. There was no significant difference in dissolution parameter T50 among four pharmaceutical factories;the difference of parameters(Td,m)was very significant. There was relatively significant difference in parameters(Td,T50)of 3 batches from B factory. CONCLUSION:The quality of cefuroxime axetil tablets from four pharmceutical factories is almost in line with standards stated in Chinese Pharmacopeia while samples from B factory need to be improved in uniformity.