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

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.

Abstract：

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.

Stability of cefoxitin sodium for injection mixed with ornidazole and sodium chloride injection

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.