注射用灯盏花素与7种临床常用输液配伍稳定性研究  

Study on the Stability of Compatibility of Breviscapine for Injection with 7 Common Clinical Infusions

作　　者：陈虹 郭昌贵 唐燕 赖芸 李德勋 孙荣飞 CHEN Hong;GUO Changgui;TANG Yan;LAI Yun;LI Dexun;SUN Rongfei(Centralized Dispensation Center of Intravenous Medicines,Zhaotong Hospital of Traditional Chinese Medicine,Zhaotong,Yunnan Province,657000 China;Zhaotong Food and Drug Inspection Institute,Zhaotong,Yunnan Province,657000 China)

机构地区：[1]云南省昭通市中医医院静脉用药集中调配中心,云南昭通657000 [2]昭通市食品药品检验所,云南昭通657000

出　　处：《中外医疗》2021年第14期7-12,共6页China & Foreign Medical Treatment

基　　金：云南省科技厅应用基础研究-中医联合专项(面上)项目[2017FF116(-050)]。

摘　　要：目的考察注射用灯盏花素与7种临床常用输液,即0.9%氯化钠注射液(0.9%NS)、5%葡萄糖注射液(5%GS)、10%葡萄糖注射液(10%GS)、5%葡萄糖氯化钠注射液(5%GNS)、复方氯化钠注射液(CoNS)、转化糖注射液及10%果糖注射液配伍后的稳定性。方法以注射用灯盏花素说明书推荐的剂量,分别用7种临床常用输液溶解并稀释后制得的成品输液,在光照与遮光条件下置于常温、高温、低温环境中考察其外观性状、pH、不溶性微粒及主要有效成分成分含量的变化情况。结果注射用灯盏花素与7种临床常用输液配伍8 h内pH无明显变化;除注射用灯盏花素与转化糖、果糖注射液的配伍液产生了絮状沉淀,不溶性微粒不符合药典对静脉输液的要求外,与其余5种常用输液配伍后外观无明显变化,不溶性微粒在0.5~1 h内较高,1~5 h内基本符合药典规定;注射用灯盏花素与5%GNS、转化糖及10%果糖注射液的配伍液,野黄芩苷的含量变化较大,在其余配伍液中较稳定。结论转化糖注射液、10%果糖注射液不可用作注射用灯盏花素的溶媒。Objective To investigate breviscapine for injection and 7 common infusions in clinical practice,namely 0.9%sodium chloride injection(0.9%NS),5%glucose injection(5%GS),10%glucose injection(10%GS),5%glucose and sodium chloride injection(5%GNS),compound sodium chloride injection(CoNS),invert sugar injection and 10%fructose injection after compatibility.Methods According to the recommended dosage of scutellarin for injection,the finished infusions were prepared by dissolving and diluting 7 common clinical infusions respectively,and placed in normal temperature,high temperature and low temperature environment under light and shading to investigate its appearance,properties and pH,changes in the content of insoluble particles and main active ingredients.Results The pH of scutellarin for injection was compatible with 7 common clinical infusions within 8 hours without significant changes;except for the compatibility of scutellarin for injection with invert sugar and fructose injection,flocculent precipitation occurred.In addition to the requirements,there is no obvious change in appearance after being compatible with the other 5 common infusions.The insoluble particles are relatively high within 0.5~1 h,and basically meet the pharmacopoeia regulations within 1~5 h;breviscapine for injection is combined with 5%GNS,invert sugar and 10%fructose injection,the content of wild baicalin varies greatly,and it is relatively stable in the other compatibility solutions.Conclusion Invert sugar injection and 10%fructose injection can not be used as a solvent for breviscapine for injection.

关 键 词：注射用灯盏花素 配伍稳定性 温度 光照 遮光 时间 

分 类 号：R289.1[医药卫生—方剂学]