Stability of Compound Kushen Injection in Two Kinds of Infusion Solution / 中国药师

ABSTRACT

Objective:To study the stability of compound Kushen mixed liquid to provide reliable evidence for safe clinical drug application.Methods:Compound Kushen injection was mixed respectively with 0.9% sodium chloride injection and 5% glucose injection,and then placed under the different conditions for 0,1,2,4,8,12,24 and 48 h.HPLC was conducted to determine the content changes of four components in compound Kushen mixed liquid,and the appearance,pH and insoluble particles were observed as well.Results:The mixed liquid of compound Kushen with 0.9% sodium chloride injection was stable in 48 h without the influence of light and temperature.However,the mixed liquid of compound Kushen with 5% glucose injection had poorer stability with storage time shorter than 12 h at room temperature and 2 h at high temperature.Conclusion:The stability of the mixed liquid of compound Kushen is closely related to the pH value of solvent.0.9% Sodium chloride injection is recommended as the solvent,and the mixed liquid should be used up in 48 h.