金银花及山银花提取物体外溶血与凝集试验比较研究  

Comparative Study on Hemolysis and Cohesion Effects of Lonicerae Japonicae Flos and Lonicerae Flos Extracts in vitro Test

作　　者：代宝强[1] 李思迪[1] 盛益华[1] 张广平[1] 马丽娜[1] 叶祖光[1] 

机构地区：[1]中国中医科学院中药研究所,北京100700

出　　处：《中国现代中药》2016年第11期1458-1462,共5页Modern Chinese Medicine

基　　金：国家"重大新药创制"科技重大专项(2014ZX09304-307;2015ZX09501004)

摘　　要：目的:比较金银花与山银花在溶血性方面的安全性,以及比较体外试管法(肉眼观察法)及改良的体外溶血试验法(分光光度法)的检测敏感性。方法:依据《中华人民共和国药典》2010年版一部附录XIII H溶血与凝聚检查法,参照国家食品药品监督管理局制定的《化学药物刺激性、过敏性和溶血性研究技术指导原则》相关内容,采用体外试管法(肉眼观察法)及改良的体外溶血试验法(分光光度法)比较分析金银花与山银花的溶血反应。结果:金银花提取物各稀释浓度在应用经典方法检测情况下均未发生溶血;而山银花提取物浓度越高、实验观察时间越长,发生溶血情况越多;分光光度法较之肉眼观察法对溶血程度有了量化认识,因而更加准确,特别是对边缘样品更能说明问题。结论:在中药注射剂的应用中,金银花提取物在安全性方面较之山银花具有较大优势,而山银花存在诸多安全隐患,在选择忍冬科中药材(金银花、山银花等)进行中药注射剂的应用或生产时,必须避免混用或误用山银花;溶血试验中分光光度法在敏感度方面优于肉眼观察法。Objective： To compare security of hemolysis between Lonicerae Japonicae Flos and Lonicerae Flos and sensitivity of external test tube method and improved hemolysis test as well. Methods： According to Chinese Pharmacopoeia 2010 Edition Appendix XIII H hemolysis and cohesion test and research technical guidelines of chemical excitant, allergic and hemolytic, compare and analysis hemolytic reaction between Lonicerae Japonicae Flos and Lonicerae Flos by external test tube method and improved hemolysis test. Results： Hemolysis did not occur in all of the concentration dilutions of Lonicerae Japonicae Flos extract by the classical method. However, the more hemolysis occurred by the higher concentration dilution of Lonicerae Flos and the longer observation time. Compared with external test tube method, spectrophotometry is more accurate for observing degree of hemolysis, especially for boundary samples. Conclusion： In application of Chinese traditional medicinal injections, Lonicerae Japonicae Flos extract has more advantages in security, so Lonicerae Flos must be avoid to be used in applying and producing Chinese traditional medicinal injections. Spectrophotometry is more sensitive than external test tube method in hemolysis test.

关 键 词：金银花 山银花 溶血 

分 类 号：R917[医药卫生—药物分析学]