Quality analysis of domestic erythromycin estolate tablets and granules
Objective This study assessed the quality of erythromycin estolate tablets and granules in China.Methods The nationwide erythromycin estolate tablets and granules were tested according to the official specification.The overall quality was analyzed using statistical methods.The products from different manufacturers were compared.Based on the special survey and the determination results,some methods of erythromycin estolate in specification,i.e.,components and related substances,dissolution,and assay were optimized.Results A total of 23 batches of erythromycin estolate tablets from 4 manufacturers and 154 batches of erythromycin estolate granules from 16 manufacturers underwent testing.A total of 176 batches met the specified requirements,resulting in a pass rate of 99.4％.The optimal HPLC method was used to detect the components and related substances of erythromycin estolate raw materials and preparations.The revised dissolution method was used to test the dissolution curves of samples from 20 companies.The hydrolysis conditions should be selected in the assay according to the formulation and technology,which could ensure the accuracy of the content determination.Conclusion The quality of erythromycin estolate tablets and granules was with acceptable in general.The official specification of erythromycin estolate tablets and granules needs to be further improved.
Erythromycin estolate tabletsErythromycin estolate granulesQuality analysisSampling test
NETL
NSTL
万方数据
