摘要
目的:以丹红注射液的抗血小板聚集活性为切入点,旨在建立丹红注射液的生物活性测定法,以期量化丹红注射液的药理作用,并优化现有的中药注射液质量评价体系。方法:以诱导剂为花生四烯酸(arachidonic acid),丹红注射液剂间比1∶0.8,血小板数500×10^(9)个·L^(-1),在体外抑制血小板聚集的生物作用为试验系,实施量效关系考察与效价定义,而后通过量反应平行线法计算效价,建立丹红注射液的生物活性测定法,同时进行方法学考察验证该方法的可行性与适用性。结果:丹红注射液在64%~100%的浓度范围内呈现较显著的量效关系,且由效价定义得到的丹红注射液标准品效价为1350 U·mL^(-1);其余7个不同批次的供试品效价分别为1320.6、1397.4、1407.5、1445.2、1278.4及1234.6 U·mL^(-1)。结论:基于抗血小板聚集活性建立的丹红注射液生物活性测定法操作简便,精确度高,同时以效价测定的方式量化了丹红注射液的关键活性,可为现有中药质量控制方法的改进与扩充提供借鉴。
Objective:Taking the anti-platelet aggregation activity of Danhong injection as the breakthrough point,to establish a bioassay method for Danhong injection,in order to quantify the pharmacological effect of Danhong injection and optimize the existing quality evaluation system of traditional Chinese medicine injection.Methods:Arachidonic acid was used as the inducer,the dose ratio of Danhong injection was 1∶0.8,and the platelet count was 500×10^(9)L^(-1).The inhibition of platelet aggregation in vitro by Danhong injection was used as the experimental system,to examine the dose-effect relationship and define the valence,and then thevalences were calculated by the dose-response parallel line method,and the bioassay method of Danhong injection was developed.At the same time,the feasibility and applicability of the method were verified by methodological investigation.Results:The results showed that Danhong injection displayed a significant dose-effect relationship within the concentration range of 64%-100%,and the valence of Danhong injection standard obtained from the valence definition was 1350 U·mL^(-1).The valences of the remaining seven different batches of the test articles were 1320.6,1397.4,1407.5,1445.2,1278.4 and 1234.6 U·mL^(-1),respectively.Conclusion:The established bioassay method of Danhong injection based on anti-platelet aggregation activity is simple to operate and highly accurate,while quantifying the key activity of Danhong injection by valence determination,which provides a reference for the improvement and expansion of current quality control methods for traditional Chinese medicine.
作者
李瑞吉
王婷婷
刘金辉
于尚玥
娄天宇
马贝贝
梁耀月
左泽平
田时秋
李依林
裴海鸾
林兆洲
王志斌
LI Rui-ji;WANG Ting-ting;LIU Jin-hui;YU Shang-yue;LOU Tian-yu;MA Bei-bei;LIANG Yao-yue;ZUO Ze-ping;TIAN Shi-qiu;LI Yi-lin;PEI Hai-luan;LIN Zhao-zhou;WANG Zhi-bin(School of Chinese Materia Medica,Beijing University of Chinese Medicine,Beijing 102488,China;Beijing Zhongyan Tongrentang Medicine Research&Development Co.,Ltd.,Beijing 100071,China)
出处
《药物分析杂志》
CAS
CSCD
北大核心
2022年第10期1763-1770,共8页
Chinese Journal of Pharmaceutical Analysis
基金
北京中医药大学科研发展基金(2019-ZXFZJJ-099)。
关键词
丹红注射液
血小板聚集
生物活性测定法
效价
质量控制
中药注射液
抑制率
Danhong injection
platelet aggregation
bioassay method
valence
quality control
Chinese medicine injection
inhibition rate