中国药房2017,Vol.28Issue(23):3204-3208,5.DOI:10.6039/j.issn.1001-0408.2017.23.10
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
摘要
Abstract
OBJECTIVE:To investigate the compatible stability of Xiao'aiping injection combined with 3 kinds of common in-jections. 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 tempera-ture(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:Un-der 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). For-ty-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). CON-CLUSIONS: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.关键词
消癌平注射液/配伍稳定性/通关藤苷A/通关藤苷ⅠKey words
Xiao'aiping injection/Compatible stability/Tenacissoside A/Tenacissoside Ⅰ分类
医药卫生引用本文复制引用
王祁民,白万军,安静,李倩,李颖,李宵,郭彩会,董占军..消癌平注射液与3种注射液的配伍稳定性研究[J].中国药房,2017,28(23):3204-3208,5.基金项目
河北省医学科学研究重点课题计划项目(No.20170245) (No.20170245)