摘要
目的:建立双黄连注射液不良反应样品筛查方法,为产品质量控制、临床安全用药提供参考。方法:采用鞣质检测和细胞响应谱法对双黄连注射液正常与不良反应样品进行筛查,以改良干酪素法进行鞣质检测,另选取肥大细胞RBL-2H3作为模式生物,使用xCELLigence实时细胞分析系统对双黄连注射液诱导的RBL-2H3脱颗粒效应进行了实时监测。结果:鞣质检测无法有效区分正常样品与不良反应的样品,细胞响应谱法可准确分辨不良反应样品。结论:基于肥大细胞脱颗粒效应的细胞响应谱方法操作简便、高通量、准确可靠,为双黄连注射液质量控制和临床安全用药提供参考。
Objective:To establish a screening method for Shuanghuanglian injection samples with adverse effect,shedding new light on its quality control clinical safety.Method:Modified casein based tannin assay and cell response spectrum were carried out Shuanghuanglian injection samples with or without adverse effects.Selecting mast cell RBL-2H3 as model cell-line,its degranulation effect induced by Shuanghuanglian injection was monitored in real time by a xCELLigence real-time cell analysis system.Result:Rather than tannin assay,cell response spectrometry could effectively distinguish normal and adverse effects samples.Conclusion:The cell response spectrum method based on mast cell degranulation effect is simple,high throughput,accurate and reliable,providing a technical basis for the quality control and medication safety of Shuanghuanglian injection.
作者
戴卉卿
高进
曹智铭
关建丽
Dai Huiqing;Gao Jin;Cao Zhiming;Guan Jianli(Jiaheng(Hengqin,Zhuhai)Pharmaceutical Technology Co.,Ltd.,National Engineering Research Center for Modernization of Traditional Chinese Medicine Large Variety Cultivation Branch Center,Zhuhai 519000;Henan Fusen Pharmaceutical Co.,Ltd.,National Engineering,Research Center for Modernization of Traditional Chinese Medicine Medical and Nursing Integration Sub Center,Nanyang 474450,China)
出处
《广东化工》
CAS
2023年第22期145-147,129,共4页
Guangdong Chemical Industry
关键词
双黄连注射液
鞣质
细胞响应谱
质量控制
shuanghuanglian injection
tannin
cell response spectrum
quality control
