注射用炎琥宁稳定性探究

Stability of Potassium Sodium Dehydroandroandrographolide Succinate for Injection

为了考察注射用炎琥宁与不同溶剂配伍后溶液的质量稳定性及溶剂不同pH值对注射用炎琥宁溶液性状的影响,模拟临床用药浓度,分别放置0、4、8 h后检测注射用炎琥宁的性状、pH值、不溶性微粒、有关物质、含量;结果表明:注射用炎琥宁分别用5%、10%葡萄糖注射液,5%、0.9%氯化钠注射液溶解后,其溶液性状、pH、不溶性微粒、含量、有关物质,在0、4、8 h均几乎无变化;但在较低pH溶液环境下出现絮状物;说明注射用炎琥宁配制后至少可以存放8 h,但在较低的pH溶液环境下易出现絮状物或呈浑浊状。

To investigate the stability of potassium sodium dehydroandroandrographolide succinate for injection after it was mixed with different solvents and under different pH solutions, we dissolved the agents into different solutions, and the property, pH value, insoluble particles, related substances and contents were detected respectively at 0, 4, 8 hours after the preparation. The results demonstrated that there was no change in property and clarity of the solution, pH value, insoluble particles, related substances and contents at 0, 4, 8 hours after potassium sodium dehydroandroandrographolide succinate for injection was mixed with 5% glucose injection, 10% glucose injection, 5% sodium chloride, 0.9% diluted sodium chloride injection. However, unfortunately, floccus was observed when the pH value decreased to three. Therefore, the quality of the solution can be guaranteed after being stored for at least eight hours after preparation, although floccus or turbidity state is prone to occur in the solution with low pH value.