ABSTRACT
Objective To evaluate the similarity of dissolution profiles of self-produced and original drug cefuroxime axetil tab-lets.Methods Based on the dissolution detection method in the Chinese Pharmacopoeia,the dissolution behaviors of the self-pro-duced preparation and original drug were investigated in pure water,0.1 mol/L hydrochloric acid,0.05 mol/L hydrochloric acid, pH4.5 and pH6.8 medium and the rotation speed of 50,25,75 r/mim.The stripping curves were evaluated by the f2 factor method. Results In the rotation speed of 50 r/min,the f2 factors in different mediums were 57.65,79.17,73.56,66.83 and 62.33 respec-tively;the medium was 0.1 mol/L hydrochloric acid with the rotation speed of 25,75 r/min,the f2 factors were 65.35 and 78.48 re-spectively.Conclusion The stripping curves of self-produced preparation and original drug are similar under various conditions.
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.
ABSTRACT
OBJECTIVE:To study the dry granulating technology in the preparation of cefuroxime axetil tablets so as to establish the preparative method.METHODS:With granule size,fluidity and yield as indexes to optimize the dry granulating technology for cefuroxime axetil tablets,and a comparative study was conducted on quality and stability of the samples prepared by wet process.RESULTS:The optimum conditions for the dry granulating technique were as follows:hydraulic pressure = 2.5～3 MPa,extrusion rate = 15～20 r?min-1,powder feed rate=200～300 g?min-1.The extrusion thickness was controlled at 1～2 mm.By circular dry granulating method,the proportion of qualified granules(16～30 meshes) was as high as above 90%,with an angle of repose of 30? and good mobility,and the yield was about 94%,with all indexes in line with the standards specified in Chinese Pharmacopoeia(2005 edition) in the accelerated test and permanent stability test.CONCLUSION:The optimized technological parameters and the mildly readjusted formulation can meet the requirements for the dry granulation method,with the stability of the product superior to that by wet method,and this method has a good reproducibility and shorter production cycle.