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目的:明确华蟾素注射液中可疑致敏原成分,为上市中药注射剂过敏原的筛查提供新的实验方法。方法:首先在临床上收集华蟾素注射液过敏患者血清;同时将华蟾素注射液中的可疑致敏原与牛血清白蛋白偶联合成人工抗原,在体外重现华蟾素注射液在人体内的过敏反应过程,利用血清学检测及激光共聚焦显微镜技术,检测RBL-2H3细胞被诱导脱颗粒释放组胺及TNF-α浓度的变化,与华蟾素注射液人体内过敏反应所产生的检测结果进行比对。结果:RBL-2H3肥大细胞组胺释放率、组胺及TNF-α浓度测定显示,脂蟾毒配基-BSA组、过敏患者血清组(用药后)组与标准对照组相比,差异均无显著性;华蟾酥毒基-BSA组、空白对照组与标准对照组相比,差异均有显著性(P<0.05)。结论:临床上收集的华蟾素注射液过敏患者血清中的过敏原成分应为脂蟾毒配基。
Objective: To determine the components of suspected cinobufacini injection and to provide a new experimental method for the screening of the allergens of Chinese traditional medicine injection. Methods: Firstly, the serum of cinobufacini injection hypersensitive patients was collected clinically. At the same time, the antigen was conjugated with bovine serum albumin (BSA) in the cinobufacini injection and the cinobufacini injection was reconstituted in vitro Human allergic reaction process, the use of serological tests and laser scanning confocal microscopy to detect RBL-2H3 cells were induced degranulation release of histamine and TNF-α concentration changes with cinobufagin injection produced by human allergic reactions The test results were compared. Results: The histamine release rate, the concentration of histamine and TNF-α in RBL-2H3 mast cells showed that there was no difference between the control group and the control group The difference was significant (P <0.05). Compared with the control group, the expression of cinobufagin-BSA group and blank control group were significantly different (P <0.05). Conclusion: The allergen in the serum of cinobufotalin injection allergic patients should be adiponectin.