Study on Compatibility Stability of Ulinastatin for Injection with 2 Commonly Used Solvents in the Infusion Pump

VernacularTitle:注射用乌司他丁与2种常用溶剂在输液泵中的配伍稳定性考察
Author: Shuyu LIN ; Huizhen GAN ; Yutang LI ; Danting PAN ; Zhimin CHEN
Keywords: Ulinastatin; HPGFC; Content; Compatibility; Stability; Infusion pump
From: China Pharmacy 2017;28(8):1041-1044
CountryChina
Language:Chinese
Abstract: OBJECTIVE:To investigate the compatibility stability of Ulinastatin for injection with 2 commonly used solvents in the infusion pump.METHODS:After Ulinastatin for injection 500 000 U was respectively added into 0.9％ Sodium chloride injection and 5％ Glucose injection 50 mL,the appearance of the mixture at 25 ℃,37 ℃ were observed at 0,1,2,4,8,12,24 h,re spctively,pH value and the number of insoluble particles were measured.The relative percentage of ulinastatin in the mixture was determined by HPGFC.RESULTS:Under this condition,the appearance and pH value of the mixture had no significant change within 24 h;the number of particles ≥10 μm was lower than 25 particle/mL,and that ≥25 μm was lower than 3 particle/mL,which was in line with the pharmacopeia standard.The relative percentage of ulinastatin within 24 h ranged 99.45％-102.55％.CONCLUSIONS:After mixed with 0.9％ Sodium chloride injection and 5％ Glucose injection,Ulinastatin for injection keep stable within 24 h at 25 ℃,37 ℃ and can be used for continuous administration in the infusion pump.