Abstract��
OBJECTIVE To evaluate the quality differences of generic clarithromycin tablets manufactured by domestic pharmaceuticals with the original product. METHODS Based on three basic elements of drugs (safety, efficacy and quality controllability), comparison and evaluation of the quality were performed on related substances, dissolution and content. RESULTS In related substances and content, domestically produced generic drugs and the original product were all conform to standard of Ch.P 2010, but there were differences in dissolution.CONCLUSION Compared with the original product, there has space for domestically produced generic drugs to improve the safety and quality controllability. Further research is necessary to confirm whether the bioavailability, bioequivalence and efficacy of generic products are completely consistent with the original product.
WANG Biao,
ZHANG Cui-Lian,
MEI Dan-*
.Comparison of Content,Related Compound A and Dissolution of Clarithromycin Tablets from Different Manufacturers[J] Chinese Pharmaceutical Journal, 2014,V49(21): 1933-1938
��
[1]
MEI D, LI D K. The quality evaluation of drugs on the market [J].J China Pharm(�й�ҩ��),2000,11(6):244-245.[2] NIGHTINGALE C H.A survey of quality of generic clarithromycin products from 13 countries [J]. Clin Drug Invest, 2000, 19(4): 293-305.[3] XU X Y,TU X D,JIANG S G, et al. Development of clarithromycin sustained-release tablets[J].J Chin Pharm Univ (�й�ҩ�ƴ�ѧѧ��), 2003, 34(2):132-136.[4] YASUO N, SHIGERU I, TSUGUCHIKA Y, et al. Physicochemical properties and stability in the acidic solution of a new macrolide antibiotic, clarithromycin,in comparison with erythromycin[J]. Chem Pharm Bull,1992,40(3):725-728.
2014, Vol. 49 