维生素K_1与维生素C等药物配伍的稳定性研究

A disquisition on stability of mixture of VitaminK1 and VitaminC et

目的研究维生素K1注射液与注射用维生素C(唯西)、注射用肌苷(奇方能)等在葡萄糖(葡萄糖氯化钠)注射液中配伍的稳定性;方法采用高效液相色谱法测定维生素K1注射液在葡萄糖(葡萄糖氯化钠)注射液中与注射用维生素C(唯西)、注射用肌苷(奇方能)等配伍前后溶液的含量,并观察配伍溶液的外观、pH值、微粒以及含量的变化。色谱柱:HypersilBOSC18柱(4.6mm×200mm,5μm);流动相:无水乙醇-乙醚(95:5);柱温:25℃;检测波长:254nm;流速:1.0ml/min;进样量:10μl。结果维生素K1注射液,在葡萄糖(葡萄糖氯化钠)注射液中与注射用维生素C(唯西)、注射用肌苷(奇方能)等配伍后,5h内溶液的含量、pH值、微粒等均产生明显的变化;结论维生素K1注射液在葡萄糖(葡萄糖氯化钠)注射液中与注射用维生素C(唯西)、注射用肌苷(奇方能)等配伍后,溶液的稳定性较差,维生素K1注射液不宜与注射用维生素C(唯西)等药物配伍。

Objective To discuss stability of mixture of Vitamin K1 and VitaminC et in the glucose injection. Methods A HPLC method was applied to determine concentration of Vitamin K1 in the mixture and to observe the change of mixture at the appearance, pH, particulate and concentration.The column was Hypersil BOS C18 （4.6mm×200mm,5um）,the mobil phase was ethanol absolute-aether （95：5）and detected wave-length was 254nm,the flow rate was 1.0ml/min; Results In the 5 hours Vitamin K1 had obvious change at the appearance, pH, particulate and concentration. Conclusion It is not stability to the mixture of Vitamin K1 and VitaminC, Inosine et in the glucose injection. The Vitamin K1 used singleness in the glucose injection.