消癌平注射液与3种注射液的配伍稳定性研究
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篇名: 消癌平注射液与3种注射液的配伍稳定性研究
TITLE:
摘要: 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40 mL,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160 mL配伍,在室温(约25 ℃)和高温(40 ℃)下,分别于0、1、2、4、8、12、24、48 h观察各配伍液的外观,检测其pH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48 h内,各配伍液均为棕黄色液体;与0.9%氯化钠注射液配伍24 h后,配伍液由棕黄色变为红棕色,但无沉淀生成。各配伍液的pH均无明显变化(RSD<1%,n=8);粒径≥25 μm的微粒数均符合2015年版《中国药典》的规定,但粒径≥10 μm的微粒数在配制后48 h时均超出药典规定范围。配制后48 h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24 h内使用。
ABSTRACT: 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 40 mL was compatible with 5% Glucose injection, 10% Glucose injection or 0.9% Sodium chloride injection 160 mL, 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; pH 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 48 h after Xiao’aiping injection was compatible with 5% Glucose injection or 10% Glucose injection; 24 h after mixed with 0.9% Sodium chloride injection, the mixture changed from brownish yellow to reddish brown, but no precipitation was found. The pH value of mixtures had no significant change (RSD<1%,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 48 h after mixing, the relative contents of tenacissoside A and tenacissoside I in mixtures had no significant change (RSD<2%,n=8). CONCLUSIONS: The mixture should be used up within 24 h after Xiao’aiping injection combined with 5% Glucose injection, 10% Glucose injection or 0.9% Sodium chloride injection.
期刊: 2017年第28卷第23期
作者: 王祁民,白万军,安静,李倩,李颖,李宵,郭彩会,董占军
AUTHORS: WANG Qimin,BAI Wanjun,AN Jing,LI Qian,LI Ying,LI Xiao,GUO Caihui,DONG Zhanjun
关键字: 消癌平注射液;配伍稳定性;通关藤苷A;通关藤苷I
KEYWORDS: Xiao’aiping injection; Compatible stability; Tenacissoside A; Tenacissoside I
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