Pages: 454-459
Year: 2017 Issue:  6
Journal: Chinese Journal of Antibiotics
Abstract: Objective To evaluate the quality status of domestic sulbenicilin sodium for injection.Methods According to the general requirements of national drug assessment programs,using statutory testing methods and combining with the exploratory research to examine sample and evaluate the quality status of sulbenicilin sodium for injection by statistical analysis of the results.Results Statutory tests showed 72 batches of samples were all qualified.The exploratory research results showed that the dextrorotatory enantiomer (D-) of sulbenicilin had more obvious antibacterial activity than the laevoisomer (L+).The principal impurities were characterized and the origination of the impurities were deduced by the examination of related substances and the stability study.The moisture content had an important effect on the related substances and the polymer of sulbenicilin.Conclusion At present,the quality of domestic sulbenicilin sodium for injection meets the requirements of the current statutory standard.The current statutory standard should be further improved by increasing the examination of sulbenicilin enantiomer,improving the limit of moisture content,including the information of impurity structures.An improvement was put forward to promote the quality by material optimization.