丹红注射液与奥拉西坦注射液配伍稳定性研究  

Study on Compatible Stability of Danhong Injection Combined with Oxiracetam Injection

作　　者：李伟霞[1] 赵娅[1] 唐进法[1] 张辉[1] 曹英杰[1] 孟祥乐[1] 李学林[1] LI Wei-xia;ZHAO Ya;TANG Jin-fa;ZHANG Hui;CAO Ying-jie;MENG Xiang-le;LI Xue-lin(The First Hospital Attached to Henan Universily of TCM,Zhengzhou,Henan,China,450001)

机构地区：[1]河南中医药大学第一附属医院,河南郑州450001

出　　处：《河南中医》2018年第7期1113-1117,共5页Henan Traditional Chinese Medicine

基　　金：河南省科技攻关项目(编号:102102310077)

摘　　要：目的:通过对丹红注射液与奥拉西坦注射液在临床常用(溶媒9 ng·L^(-1)氯化钠注射液、50 ng·L^(-1)的葡萄糖注射液)中配伍后的混合溶液性状、pH值、不溶性微粒数和两种注射液中主要成分含量变化4个方面评价其配伍稳定性,为两者的临床合理使用提供依据。方法:采用酸度计和不溶性微粒测试仪测定丹红注射液与奥拉西坦注射液在两种常用溶媒中配伍后4 h内的性状变化、pH值和不溶性微粒数;采用超高效液相色谱法测定两种注射液配伍后7个主要成分的含量变化。结果:丹红注射液与奥拉西坦注射液在两种溶媒中配伍后性状均为棕黄色的澄清透明液体,4 h内颜色和澄明度无明显变化,pH值相对稳定,不溶性微粒数符合药典标准。以9 ng·L^(-1)氯化钠注射液为溶媒进行配伍时,丹红注射液中3种有机酸(对香豆酸、迷迭香酸和丹酚酸B)和奥拉西坦注射液中奥拉西坦在配伍后4 h的含量变化范围>5.0%,分别为5.9%、6.1%、5.7%和10.6%,其余成分的含量相对稳定,但7种成分在配伍后1 h内的含量变化范围均<5.0%,较为稳定;以50 ng·L^(-1)为溶媒进行配伍时,7个成分在配伍后4 h内含量变化范围均<5.0%,较为稳定。结论:丹红注射液与奥拉西坦注射液可在9 ng·L^(-1)氯化钠注射液和50 ng·L^(-1)葡萄糖注射液中配伍使用,但首选以50ng·L^(-1)的葡萄糖注射液作为溶媒,以9 ng·L^(-1)氯化钠注射液为溶媒时,尽量在配伍后1 h内使用完毕。Objective： The compatibility stability of mixture solution,pH value,insoluble particle number and content of main components of two kinds of injection in the 4 aspects of the compatibility of Danhong injection and Oxiracetam Injection in the combination of common solvent mass fraction of 9 ng·L-1 Sodium Chloride Injection and 50 ng·L-1 in Glucose Injection,which are commonly used in the clinic It provides the basis for the rational use of both of them. Methods： An acidity meter and an insoluble particle tester were used to determine the changes within 4 hours,pH values and insoluble particles in the combination of Dan Hong injection and Oxiracetam Injection in two kinds of common solvents,and the content changes of the 7 main components were determined by ultra high performance liquid chromatography（ HPLC） after their compatibility. Results： After the compatibility of Danhong Injection and Oxiracetam Injection in two kinds of solvent,they were brown clear transparent liquid,the color and clarity within 4 hours did not change obviously,the pH value was relatively stable,and the number of insoluble particles conformed to the standard of Pharmacopeia. The content changes of 3 organic acids（ Coumaric acid,rosemary acid and salvianolic acid B） in Danhong Injection and Oxiracetam in Oxiracetam Injection（ after being combined with 9 ng·L-1 Sodium Chloride Injection） were over 5. 0%,5. 9%,6. 1%,5. 7% and 10. 6% respectively,and the content of the remaining components was relatively stable. But the content of the 7 components within one hour after compatibility was less than 5. 0%,and it was more stable. When the mass fraction 50 ng·L-1 was used as the solvent,the contenst of 7 components in the compatibility within 4 hour after compatibility were less than 5. 0%,and more stable. Conclusion： Danhong Injection and Oxiracetam Injection can be used together in the mass fraction of 9 ng·L-1 Sodium Chloride Injection and 5% GS,but the first choice was Glucose Injection with a mass fraction of 50 ng·L-

关 键 词：丹红注射液 奥拉西坦注射液 理化配伍 稳定性 超高效液相色谱 

分 类 号：R284.3[医药卫生—中药学]