注射用炎琥宁与注射用头孢曲松钠配伍的稳定性研究

Study on the Stability of Mixture of Potassium Sodium Dehydroandrographolide Succinate for Injection with Ceftriaxon Injection

目的:考察注射用炎琥宁与注射用头孢曲松钠在0.9%氯化钠注射液中的配伍稳定性。方法:采用高效液相色谱法,以Venusil XBP-C_(18)色谱柱,乙腈-0.02 mol·L^(-1)磷酸二氢钾-10%四丁基氢氧化铵(pH 5.0)(38:60.5:1.5)为流动相,252 nm为检测波长,测定注射用炎琥宁与注射用头孢曲松钠配伍后在室温下6 h内的含量变化,并观察和检测配伍液的外观及pH值变化。结果:配伍液pH值及含量无明显变化,但颜色随时间变化逐渐加深。结论:注射用炎琥宁与注射用头孢曲松钠在0.9%氯化钠注射液可配伍使用,但应在4 h内用完。

Objective： To study the stability of the mixture of potassium sodium dehydroandrographolide succinate for injection with ceftriaxon injection in 0.9% sodium chloride injection. Method： HPLC method was adopted in which the Venusil XBP-C18 was used as the chromatographic column, acetonitrile-0.02 mol· L-1 potassium dihydrogen phosphate -10% tetrabutylammonium hydroxide solution （ pH 5.0） （38：60.5： 1.5 ） as the mobile phase with detection wavelength at 252 nm. The contents were determined after mixing of potassium sodium dehydroandrographolide succinate with ceftriaxon injection in 0.9% sodium chloride injection under the room temperature within 6 hours, and the appearance of the solution was observed and its pH value was determined. Result： No significant differences were found In terms of pH value and the contents of the mixed solution, but The colour changes as necessary gradually deepens. Conclusion： The mixture of potassium sodium dehydroandrographolide succinate with ceftriaxon injection in 0.9% sodium chloride injection can be used at room temperature, but must be injected during 4 hours.