喜炎平注射液与溶媒及四种注射剂的配伍稳定性考察

Study on the compatible stability of Xiyanping injection with solvents and four injections

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 chloride injection has a good compatible stability,and can be used in combination,but the ratio of the combination should be noted,and the dosage of Xiyanping injection with 250 ml of solvent should be controlled to be no more than 20 ml.The compatible stability of Xiyanping injection with cefazolin sodium pentahydrate for injection is relatively good,and Xiyanping injection is not suitable to be in combination with the other three injections.