注射用头孢西丁钠与盐酸氨溴索注射液在0.9氯化钠注射液中的配伍稳定性考察

摘要

Objective To study the compatibility of cefoxitin sodium for injection with ambroxol hydrochloride injection at room temperature [(20 ± 1)℃]. Methods The contents of cefoxitin and ambroxol hydrochloride were determined by RP-HPLC-DAD,and appearance,pH value were observed within 6 hours. Results No significant changes were found in the contents,appearance and pH value in the mixed solution within 6 hours. Conclusion Cefoxitin sodium for injection can be mixed with ambroxol hydrochloride injection at ambient temperature [(20 ±1) ℃] within 6 hours.%目的 考察室温[(20±1)℃]下,注射用头孢西丁钠与盐酸氨溴索注射液在0.9%氯化钠注射液中的配伍稳定性.方法 采用反相高效液相色谱法-二极管阵列检测器测定0～6 h内配伍液中头孢西丁与盐酸氨溴索的含量变化,并观察配伍液的外观及pH.结果 头孢西丁与盐酸氨溴索的检测波长分别为237、247 nm;色谱峰保留时间分别为4.2、11.1 min;理论塔板均不低于6000,各峰之间的分离度不低于3.0.头孢西丁与盐酸氨溴索的回归方程分别为y头=0.6548X头-0.1795,r=0.9994(n=6),线性范围为25.4～254.0 mg/L;Y氨=0.5736X氨-1.0384,r=0.9995(n=6),线性范围为37.3～373.0 mg/L.头孢西丁与盐酸氨溴索精密度试验的峰面积相对标准偏差(RSD)分别为0.55%、0.60%;重复性试验的峰面积RSD分别为0.84%、0.91%;稳定性试验的峰面积RSD分别为0.85%、0.63%.6 h内配伍液外观、pH及含量均无明显变化.结论 在室温[(20±1)℃]条件下,注射用头孢西丁钠与盐酸氨溴索注射液6 h内可以配伍使用.