摘要
目的:开展盐酸替罗非班氯化钠注射液与丹红注射液等 6 种中药注射液配伍稳定性研究.方法:采取室温(25℃)条件下考察盐酸替罗非班氯化钠注射液与丹红注射液、苦碟子注射液、银杏达莫注射液、注射用红花黄色素、参麦注射液、灯盏细辛注射液配伍后放置 0、1、2、4、6 h的外观性状、pH值、可见异物、不溶性微粒数、吸收度变化等情况.结果:盐酸替罗非班氯化钠注射液与丹红注射液、苦碟子注射液、银杏达莫注射液、注射用红花黄色素、参麦注射液、灯盏细辛注射液配伍后,各配伍溶液在 6 h内性状均无显著变化,无沉淀、无结晶、无明显可见异物、pH值无明显变化.与银杏达莫注射液、参麦注射配伍后 6 h内的不溶性微粒均超出《中国药典》规定限度.结论:盐酸替罗非班氯化钠注射液与丹红注射液、苦碟子注射液、注射用红花黄色素、灯盏细辛注射液配伍稳定,与银杏达莫注射液、参麦注射液配伍不稳定.
Abstract
Objective:Study on compatible stability of Tirofiban Hydrochloride Sodium Chloride Injection with 6 kinds of Traditional Chinese Medicine Injections.Methods:Appearance,pH value,visible foreign matter and number of insoluble particles of Tirofiban Hydrochloride Sodium Chloride Injection with Danhong injection,Kudiezi injection,Ginkgo Damo injection,safflower yellow for injection,Shenmai injection and Dengzhanxixin were observed at room temperature(25℃)for 0,1,2,4 and 6 hours after the injection was mixed.Results:After Tirofiban Hydrochloride Sodium Chloride Injection is compatible with Danhong Injection,Kudiezi Injection,Ginkgo Damo Injection,Safflower Yellow for Injection,Shenmai Injection and Dengzhan Xixin Injection,There was no significant change in properties with in 6 hours,no precipitation,no crystallization,no obvious visible foreign matter and no obvious change in pH value.The insoluble particles within 6 hours after compatibility with Ginkgo Damo injection and Shenmai injection exceeded the limit specified in the Pharmacopoeia of the People's Republic of China.Conclusion:Tirofiban Hydrochloride Sodium Chloride Injection with Danhong Injection,Kudiezi Injection,Safflower Yellow for Injection and Dengzhan Xixin Injection are compatible and stable.The compatibility with Ginkgo Damo injection and Shenmai injection is unstable.
基金项目
江西省卫生计生委中医药科研项目(2019B059)
维普
万方数据