精制红花注射液与右旋糖苷-40葡萄糖注射液的配伍稳定性探讨

Study on compatible stability of Rifine Safflower injection and Dextran 40 Glucose injection

目的:考察精制红花注射液与右旋糖苷-40葡萄糖注射液的配伍稳定性。方法:将配伍液分别放置于室温(18℃～24℃)和模拟夏季高温(38±1)℃,在0,2,4,6,24h观察其外观、pH值、不溶性微粒及红花注射液和右旋糖苷-40含量变化。结果:6h内pH值、外观、含量无明显变化,但2μm和5μm以上微粒数有所增加;24h配伍液出现浑浊,pH值下降,各粒径微粒数均有明显增加,模拟夏季高温(38±1)℃的红花注射液还出现了新的吸收峰。结论:精制红花注射液与右旋糖苷-40葡萄糖注射液配伍,在本试验条件下6h内尚稳定,但随着时间延长,实验温度增高时配伍液不稳定,建议应分开使用。

Objective:To study the compatible stability of Rifine Safflower injection and Dextran 40 Glucose injection.Methods:Placed the mixed injection under normal indoor temperature(18℃～24℃)and imitative high temperature(38±1)℃,observed the external appearence,pH values,dismeltable particle amounts and the contents of Rifine Safflower injection and Dextran 40 Glucose injection in 0,2,4,6,24h.Results:The pH values,external appearence and the contents showed no significant changes,but the dismeltable particles whose diameter was bigger than 2μm or 5μm increased.In 24h,the mixed injection became turbid,pH values declined,the amount of dismetable particles had a significant change.Conclusion:Rifine Safflower injection mixed with Dextran 40 Glucose injection could keep stable under the experiment within 6h.But with time going on and experiment's temperature increasing,the mixed injection became unstable,so the two injections had better be used separately.