摘要
目的考察喜炎平注射液与5%葡萄糖注射液、10%葡萄糖注射液、0.9%氯化钠注射液溶媒不同比例配伍的稳定性,以及与常用联合用药盐酸氨溴索氯化钠注射液、注射用五水头孢唑林钠、注射用炎琥宁、注射用辅酶A的配伍稳定性情况。方法室温下,将喜炎平注射液分别与5%葡萄糖注射液、10%葡萄糖注射液、0.9%氯化钠注射液及盐酸氨溴索氯化钠注射液、注射用五水头孢唑林钠、注射用炎琥宁、注射用辅酶A进行配伍,考察配伍后0~4 h内配伍溶液的性状、pH值、不溶性微粒、主要成分含量的变化情况。结果喜炎平注射液与5%、10%葡萄糖注射液和0.9%氯化钠注射液配伍后,性状、pH值、不溶性微粒、主要成分含量在0~4 h内无显著变化,但以较高浓度30 ml︰250 ml比例配伍后4 h内不溶性微粒超出《中华人民共和国药典》的规定限度。喜炎平注射液与注射用炎琥宁配伍时,pH值在0 h明显升高但在4 h内保持稳定;分别与盐酸氨溴索氯化钠注射液、注射用辅酶A配伍后4 h内的不溶性微粒均出现超出《中华人民共和国药典》规定限度;分别与注射用炎琥宁、注射用辅酶A配伍时,主成分含量均下降约8%。结论喜炎平注射液与5%葡萄糖注射液、10%葡萄糖注射液或0.9%氯化钠注射液配伍后稳定性良好,可配伍使用,但需注意配伍比例,应控制250 ml溶媒配伍的喜炎平注射液用量不大于20 ml;喜炎平注射液与注射用五水头孢唑林钠的配伍稳定性相对较好,与其他三种不宜在配伍时混合使用。
Objective To study the compatible stability of Xiyanping injection in different ratios with 5%dextrose injection,10%dextrose injection and 0.9%sodium chloride injection solvents,as well as with the commonly used concomitant drugs,ambroxol hydrochloride and sodium chloride injection,cefazolin sodium pentahydrate for injection,potassium sodium dehydroandrographolide succinate for injection and coenzyme A for injection.Methods Xiyanpin injection was combined with 5%dextrose injection,10%dextrose injection,0.9%sodium chloride injection and ambroxol hydrochloride and sodium chloride injection,cefazolin sodium pentahydrate for injection,potassium sodium dehydroandrographolide succinate for injection,and coenzyme A for injection at room temperature.The changes in the description,pH value,insoluble particles,and content of major ingredients of the compatible solution were investigated at 0 to 4 h after combination.Results When Xiyanping injection was combined with 5%dextrose injection,10%dextrose injection and 0.9%sodium chloride injection,there were no significant changes in the description,pH value,insoluble particles and content of majoringredients at 0 to 4 h.However,the insoluble particles exceeded the specified limit of the Chinese Pharmacopoeia within 4 h after combination in the higher concentration ratio of 30 ml︰250 ml.The pH value increased significantly at 0 h but remained stable at 4 h when Xiyanping injection was combined with potassium sodium dehydroandrographolide succinate for injection;The insoluble particles exceeded the specified limit of Chinese Pharmacopoeia within 4 h when Xiyanping injection was combined with ambroxol hydrochloride and sodium chloride injection and coenzyme A for injection respectively;The content of majoringredients decreased by about 8%when Xiyanping injection was combined with potassium sodium dehydroandrographolide succinate for injection and coenzyme A for injection respectively.Conclusion Xiyanping injection with 5%dextrose injection,10%dextrose injection or 0.9%sodium chl
作者
刘地发
方礼
刘明颖
余水平
刘尧奇
刘芳芳
邓双炳
LIU Difa;FANG Li;LIU Mingying;YU Shuiping;LIU Yaoqi;LIU Fangfang;DENG Shuangbing(State Key Laboratory of Innovative Natural Medicine and TCM Injections,Jiangxi,Ganzhou 341000,China;Ji'nan University,Guangdong,Guangzhou 510632,China;Jiangxi Qingfeng Pharmaceutical Co.LTD.,Jiangxi,Ganzhou 341000,China)
出处
《中国医药科学》
2021年第17期65-69,共5页
China Medicine And Pharmacy
基金
国家中药标准化项目(ZYBZH-C-JX-41)
江西省重点研发计划项目(20161ACG70006)
江西省赣州市科技计划项目(赣市科发[2019]60号)。
关键词
喜炎平注射液
溶媒
药品配伍
稳定性
Xiyanping injection
Solvents
Compatibility of drugs
Stabilit y