香丹注射液与葡萄糖注射液配伍后不溶性微粒变化的考察

Indissoluble particle changes of Xiangdan injection mixed-up with glucose injection

目的:通过实验观察静脉滴注香丹注射液与5％葡萄糖配伍后,不溶性微粒增加的程度,寻找香丹注射安全的剂量,降低不良反应发生。方法:将香丹注射液、5％葡萄糖注射液各3批随机配对,按4mL:250mL、10mL:250 mL、20mL:250 mL、30mL:250 mL、40mL:250 mL、50mL:250 mL 6种比例混合后,采用《中国药典》方法,检查其不溶性微粒。结果:3组结果均显示,香丹注射液与5％葡萄糖注射液配伍后,不溶性微粒显著增加,且幅度随着香丹注射液比例的提高而增加。结论:应加快香丹注射液质量标准的修订和控制香丹注射液的用量,是降低香丹注射液不良反应发生的有效途径。

Objective: To investigate indissoluble particle of the mixed solution of Xiangdan injection and 5% Glucose injection mixed. It's safety dose was found to decrease harmful reaction. Methods:Six difficult proportions solutions mixing Xiangdan injection with 5% glucose injection were provided:4mL : 250 mL、10mL : 250 mL、20mL : 250 mL、30mL : 250 mL、40mL : 250 mL、50mL : 250 mL. According to Chinese Pharmacopoeia, The indissoluble particle was tested. Results:The indissoluble particle increased obviously along with proportion of Xiangdan injection increased. Conclusion: We must revise quality standard and control dose of Xiangdan injection as fast as possible. It is effective way to decrease harmful reaction of Xiangdan injection.