摘要
目的将生物检定技术应用于水蛭抗凝血活性的测定,探讨反映水蛭生物活性的质量控制方法。方法采用肝素钠作为对照品,选择活化部分凝血酶时间值作为抗凝活性评价依据,对宽体金线蛭、日本医蛭、菲牛蛭、棒纹牛蛭的抗凝活性进行测定,测定结果分别用标准曲线法和生物检定统计法计算。结果 4种水蛭活性部分凝血酶时间法的量效关系曲线与肝素的量效关系曲线类似,突跃范围呈平行关系,上述特点符合生物检定的要求,以肝素钠作为标准品,采用生物检定技术活性部分凝血酶时间法测定水蛭等的抗凝活性是可行的。结论活化部分凝血酶时间值可以全面反映水蛭的抗凝血作用,测定结果对临床使用更具指导意义。生物检定技术应用于中药质量评价,是对现有中药质量标准控制方法良好的补充。
OBJECTIVE To assay the anticoagulant activity of leeches by using biological standardization method with the aim to explore the quality control method which can reflect the biological activity. METHODS Heparin was used as the reference substance, and APTT value was used as the index of anticoagulant activity evaluation. Four species of leeches were determined, including Hirudo nipponia Whitman, Poecilobdella manillensis Lesson, Poecilobdella javanica Wahlberg, and Whitmania pigra Whitman. The determination results were calculated with standard curve and bioassay statistics. RESULTS The concentration-response curves of APTT of the four species of leeches were similar to that of heparin, and their variation ranges were parallel. CONCLUSION APTT values can reflect the comprehensive anticoagulant activity of different species of leeches, which may have more clinical significance. Biological standardization is a good supplement to the current quality control methods, also a proper technology for the quality control of TCM.
出处
《中国药学杂志》
CAS
CSCD
北大核心
2015年第3期258-262,共5页
Chinese Pharmaceutical Journal
基金
科技部重大新药创制项目"中药质量安全检测和风险控制技术平台"(2014ZX09304-307-002)
关键词
生物检定
水蛭
宽体金线蛭
日本医蛭
菲牛蛭
棒纹牛蛭
抗凝血活性
活化部分凝血酶时间
biological standardization
leech
Whitmania pigra Whitman
Hirudo nipponia Whitman
Poecilobdella manillensis Lesson
Poecilobdella javanica Wahlberg
anticoagulant activity
APTT
作者简介
肖凌，女，博士研究生，副主任药师研究方向：中药新药活性成分及质量标准研究
通讯作者：陈科力，男，教授，博士生导师 研究方向：中药资源和质量研究 Tel：（027）87272513 E-mail：kelichen@126．com
