马来酸桂哌齐特注射液在输液中超说明书配伍的稳定性考察

Compatibility of the off-label use of cinepazide maleate for injection with different infusion solvents

目的考察马来酸桂哌齐特注射液在不同输液溶媒中超说明书配伍的稳定性,供临床使用时参考。方法观察马来酸桂哌齐特注射液(320 mg)在5%葡萄糖注射液(100 mL、250 mL)、0.9%氯化钠注射液(100 mL、250 mL)、果糖注射液(250 mL)和转化糖注射液(250 mL)中于25℃放置8 h内外观、不溶性微粒、pH的变化情况,并通过HPLC法测定桂哌齐特在各种溶媒中的含量变化情况。结果配伍液中马来酸桂哌齐特的外观、不溶性微粒、pH和含量均无明显变化。结论马来酸桂哌齐特注射液与这6种输液配伍后8 h内稳定,可在临床推广应用。

Objective To study the stability of the off-label use of cinepazide maleate injection in different infusion solvents, and to provide reference for the rational use of cinepazide maleate in clinics. Methods We observed the off-label use of 320 mg cinepazide maleate in 5% glucose injection （100 mL and 250 mL）, 0.9% sodium chloride injection （100 mL and 250 mL）, fructose injection （250 mL） and invert sugar injection （250 mL） at 25 ~C for 8 h. The changes in appearance, insoluble particles, and the pH were observed or tested. The contents of cinepazide in the infusion solvents at various test points were measured by HPLC. Results There was little change in the mixture in appearance, insoluble particles, pH value and the con- tent of cinepazide maleate within 8 h. Conclusion The mixture is stable within 8 h, and can be applied in clinical practice.