消癌平注射液与3种注射液的配伍稳定性研究

Study on Compatible Stability of Xiao'aiping Injection Combined with 3 Kinds of Injections

目的:考察消癌平注射液与3种常用注射液的配伍稳定性。方法:参照药品说明书,取消癌平注射液各40mL,分别与5%葡萄糖注射液、10%葡萄糖注射液、0.9%氯化钠注射液各160mL配伍,在室温(约25℃)和高温(40℃)下,分别于0、1、2、4、8、12、24、48h观察各配伍液的外观,检测其p H和不溶性微粒数,并采用高效液相色谱法测定各配伍液中通关藤苷A和通关藤苷I的含量。结果:在上述条件下,消癌平注射液与5%葡萄糖注射液、10%葡萄糖注射液配伍后48h内,各配伍液均为棕黄色液体;与0.9%氯化钠注射液配伍24h后,配伍液由棕黄色变为红棕色,但无沉淀生成。各配伍液的p H均无明显变化(RSD<1%,n=8);粒径≥25μm的微粒数均符合2015年版《中国药典》的规定,但粒径≥10μm的微粒数在配制后48h时均超出药典规定范围。配制后48h内,各配伍液中通关藤苷A和通关藤苷I的相对百分含量均无明显变化(RSD<2%,n=8)。结论:消癌平注射液与5%葡萄糖注射液、10%葡萄糖注射液、0.9%氯化钠注射液配伍后,均应在24h内使用。

OBJECTIVE：To investigate the compatible stability of Xiao＇aiping injection combined with 3 kinds of common injections. METHODS：Referring to package inserts,Xiao＇aiping injection 40mL was compatible with 5% Glucose injection,10%Glucose injection or 0.9% Sodium chloride injection 160mL,respectively. At room temperature（about 25 ℃）and high temperature（40 ℃）,the appearance of mixtures were observed at 0,1,2,4,8,12,24,48 h;p H value and the number of insoluble particles were detected. The contents of tenacissoside A and tenacissoside I in mixtures were determined by HPLC. RESULTS：Under above condition,the mixtures were brownish yellow liquid within 48h after Xiao＇aiping injection was compatible with 5%Glucose injection or 10% Glucose injection;24h after mixed with 0.9% Sodium chloride injection,the mixture changed from brownish yellow to reddish brown,but no precipitation was found. The p H value of mixtures had no significant change（RSD1%,n=8）. The number of particles ≥25 μm was in line with the requirements of Chinese Pharmacopeia（2015 edition）. Forty-eight hours after mixing,the number of particles ≥10 μm in the mixtures exceeded the pharmacopoeia limits. Within 48h after mixing,the relative contents of tenacissoside A and tenacissoside I in mixtures had no significant change（RSD2%,n=8）. CONCLUSIONS：The mixture should be used up within 24h after Xiao＇aiping injection combined with 5% Glucose injection,10%Glucose injection or 0.9% Sodium chloride injection.