注射用头孢哌酮舒巴坦钠的质量评价

Quality evaluation of Cefoperazone Sodium and Sulbactam Sodium for Injection

目的考察不同厂家注射用头孢哌酮舒巴坦钠在同一温度、湿度下的稳定性,进而对其质量评价。方法建立HPLC法测定不同厂家的注射用头孢哌酮舒巴坦钠的初始含量、高温加速及引湿后含量,并比较其性状及含量变化的情况。结果初始含量合格率为90.91%,高温及高湿条件下样品含量及性状变化显著。结论不同厂家生产的注射用头孢哌酮舒巴坦钠的质量差异显著。

OBJECTIVE To investigation the stability of product from 11 different pharmaceutical enterprises in the same temperature or humidness situation.METHODS The contents of Cefoperazone Sodium and Sulbactam Sodium for Injection was determined by HPLC.RESULTS 90.91% of incipient contents were up to standard,during megatemperature accelerated test and hygroscopicity test,the contents decreased markedly.CONCLUSION There are significant differences of quality.