奥硝唑氯化钠注射液与注射用头孢西丁钠配伍稳定性考察

摘要

Objective To study the stability of cefoxitin sodium for injection and omidazole and sodium chloride injection at ambient temperature, in order to provide a scientific basis for rational use of drug in clinical practice. Methods The changes of the contents of cefoxitin and ornidazole were determined simultaneously by RPHPLC-DAD, and the changes of appearance, pH values were observed within 6 hours. Results The detection wave lengths were 318 nm, 237 nm for ornidazole and cefoxitin, the calibration equation was Y0 = 0. 7444X0 + 3.0667 (r =0.9998, n = 6) for ornidazole and Yce = 0. 6549Xce + 6.2667 ( r = 0. 9996, n = 6) for cefoxitin. No significant changes were noted in the contents, appearance and pH value for the mixed solution within 6 hours. Conclusion Cefoxitin sodium for injection can be mixed with ornidazole and sodium chloride injection at ambient temperature within 6 hours.%目的 考察室温[(20±1)℃]下,奥硝唑氯化钠注射液与注射用头孢西丁钠配伍的稳定性,为临床合理用药提供科学依据.方法 采用反相高效液相色谱法-二极管阵列检测器同时测定配伍液中奥硝唑与头孢西丁钠0～6 h内的含量变化,并观察配伍液的外观及pH.结果 奥硝唑与头孢西丁钠的检测波长分别为318、237 nm;奥硝唑与头孢西丁钠的回归方程分别为Y奥=0.7444 X奥+3.0667(r=0.9998,n=6)和Y西=0.6549 X西+6.2667(r=0.9996,n=6),结果 表明在奥硝唑50.8～304.8 mg/L、头孢西丁钠101.6～609.6 mg/L浓度范围内与峰面积呈良好的线性关系;精密度试验测得奥硝唑峰面积相对标准偏差(RSD)为0.58%;头孢西丁钠峰面积RSD为0.65%;重复性试验测得奥硝唑峰面积RSD为0.84%;头孢西丁钠峰面积RSD为0.92%;稳定性试验测得奥硝唑与头孢西丁钠峰面积RSD分别为0.52%、0.89%.6 h内配伍液外观、pH及含量均无明显变化.结论 在室温条件下,奥硝唑氯化钠注射液与注射用头孢西丁钠6 h内可以配伍使用.