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目的了解不同厂家注射用头孢哌酮/舒巴坦的质量,以指导临床医师选择抗菌药物。方法分别采用高效液相色谱法对4种不同厂家的注射用头孢哌酮/舒巴坦进行含量的测定,同时将4种产品采用M-H琼脂稀释法对60株临床菌株进行最低抑菌浓度的测定。结果样品1~4的头孢哌酮含量分别为89.11%、100.49%、95.04%和91.09%;舒巴坦的含量分别为90.98%、75.93%、98.98%和78.09%;4样品中样品的杂质峰数目分别为5、4、4、5个;杂质峰面积百分比分别占8.01%、2.94%、2.04%、10.76%;不同样品之间MIC、MIC50、MIC90的浓度梯度有2~3倍差值。结论不同厂家的药物成分含量、杂质含量和抑菌浓度均存在不同,在临床实践过程中,应该对不同厂家生产的同一类抗菌药物进行疗效及安全性监测。
Objective To understand the quality of cefoperazone / sulbactam for injection in different manufacturers to guide clinicians to choose antibacterials. Methods The contents of cefoperazone / sulbactam for injection in four different manufacturers were determined by high performance liquid chromatography (HPLC), respectively. The minimum inhibitory concentration of 60 strains of clinical isolates was determined by MH agar dilution method . Results The cefoperazone contents of samples 1 to 4 were 89.11%, 100.49%, 95.04% and 91.09%, respectively. The contents of sulbactam were 90.98%, 75.93%, 98.98% and 78.09% respectively. The number of impurity peak area accounted for 8.01%, 2.94%, 2.04% and 10.76%, respectively. The concentration gradient of MIC, MIC50 and MIC90 varied from 2 to 3 times in different samples. Conclusion Different manufacturers have different drug content, impurity content and bacteriostatic concentration. In the course of clinical practice, the same type of antibacterial drugs produced by different manufacturers should be monitored for efficacy and safety.