摘要
目的:研究水蛭抗凝血活性效价单位的定义,并考察对照药材的按定义的赋值方法和赋值的适用性。方法:先理论设计出抗凝血效价的单位定义:在50μL家兔血浆中加入20μL水蛭溶液的比例下,使家兔空白血浆的部分活化凝血酶原时间(APTT)延长0.5倍,1 mL血浆中需要的量为1个效价单位(U);在此定义下可推算出利用浓度-APTT测定值计算效价赋值的公式;然后联合5家实验室对蚂蝗对照药材和菲牛蛭对照药材进行赋值测定和统计,将赋值结果对药材和制剂的适用性进行考察。结果:5家实验室按统一的标准操作规程,均可采用效价定义的公式,利用APTT的延长值测定出蚂蝗对照药材和菲牛蛭对照药材的抗凝血活性,经统计蚂蟥对照药材的赋值为每1 g的抗凝血活性为325 U、菲牛蛭对照药材的赋值为每1 g的抗凝血活性为295 U;这2种对照药材赋值后,分别适用于蚂蝗、日本医蛭药材和制剂的抗凝血活性测定。结论:水蛭的抗凝血效价定义是科学合理的,能够通过试验进行赋值,赋值对药材和制剂均具有适用性。
Objective:To study the definition of the potency unit of the anticoagulant activity of leech,and to investigate the method of assigning values according to the definition and the applicability of the reference materials.Methods:The unit of anticoagulant potency was theoretically designed as follows:at 50μL added 20μL to rabbit plasma in the proportion of leech solution,the partial activated prothrombin time(APTT)of rabbit blank plasma was prolonged by 0.5 times,and the amount required in 1 mL plasma was a titer unit.Under this definition,the formula for calculating the potency assignment by using the concentration APTT measured value could be deduced.Then,five laboratories were combined to determine and count the assignment of the control medicinal materials of leech and phenanthrene leech,and the applicability of the assignment results to the medicinal materials and preparations was investigated.Results:According to the unified standard operating procedures,the five laboratories could use the formula defined by potency,and use the extension value of APTT to determine the anticoagulant activity of leech control and phenanthrene ox leech control.According to statistics,the value of leech control was 325 units per 1 g,and the value of phenanthrene ox leech control was 295 units per 1 g.After assignment,the two reference materials were applicable to the determination of anticoagulant activity of leech,Japanese medical leech and preparations respectively.Conclusion:The definition of anticoagulant potency of leech is scientific and reasonable.It can be assigned by experiments.The assignment is applicable to both medicinal materials and preparations.
作者
胡宇驰
肖斯婷
杨文良
郭玉东
许华玉
李波
高华
张媛
唐黎明
张素慧
朴晋华
王婷婷
张蕻
芮菁
华晓东
侯娟
杨天骄
HU Yu-chi;XIAO Si-ting;YANG Wen-liang;GUO Yu-dong;XU Hua-yu;LI Bo;CAO Hua;ZHANG Yuan;TANG Li-ming;ZHANG Su-hui;PIAO Jin-hua;WANG Ting-ting;ZHANG Hong;RUI Jing;HUA Xiao-dong;HOU Juan;YANG Tian-jiao(Beijing Institute for Drug Control,NMPA Key Laborratory for Safety Research and Evaluation of Innovative Drug,Beijing Key Laboratory of Analysis and Evaluation on Chinese,Beijing 102206,China;Chinese Pharmacopoeia Commission,Beijing 100061,China;National Institutes for Food and Drug Control,Beijing 102629,China;Shanghai Institute for Food and Drug Control,Shanghai 200233,China;Shanxi Inspection and Testing Center,Taiyuan 030006,China;Tianjing Institute for Drug Control,Tianjing,300070,China)
出处
《药物分析杂志》
CAS
CSCD
北大核心
2023年第5期837-848,共12页
Chinese Journal of Pharmaceutical Analysis
基金
国家药典委员会药品标准提高研究项目(2016453)。
