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目的:通过检测组胺释放考察19种临床常用中药注射剂致大鼠腹腔原代肥大细胞脱颗粒情况,为评价中药注射剂致类过敏性提供参考。方法:应用荧光法检测组胺,并进行条件优化以适用于中药注射剂所致肥大细胞释放组胺的检测。分离大鼠腹腔肥大细胞,分别将19种中药注射剂、阳性药C48/80和肥大细胞混合孵育1h,采用优化的荧光法检测组胺,再计算组胺释放率并进行统计学分析。结果:荧光法检测组胺最佳缩合反应时间为3 min,终止反应后7.5~30 min缩合物稳定性好;采用间接检测组胺释放率与直接检测组胺释放率两方法结果间无显著差异。痰热清、清开灵、参麦、丹参、血塞通、参附、双黄连、生脉、香丹、热毒宁、复方当归等11种中药注射剂致肥大细胞释放组胺作用明显。脉络宁、黄芪、艾迪、醒脑静、黄芪多糖、红花、盐酸川芎嗪、参芪等8种注射剂未见明显致肥大细胞释放组胺作用。结论:中药注射剂引发的过敏样反应可能大多为类过敏,检测组胺释放分析原代肥大细胞脱颗粒试验可以为评价中药注射剂的致类过敏性提供参考。
OBJECTIVE: To investigate the degranulation of primary mast cells in the peritoneal cavity of 19 kinds of commonly used Chinese traditional medicine injections by detecting histamine release, and to provide a reference for evaluating the allergenicity induced by traditional Chinese medicine injection. Methods: Histamine was detected by fluorescence method and optimized for the detection of histamine release from mast cells induced by Chinese injection. The rat peritoneal mast cells were isolated, and 19 kinds of traditional Chinese medicine injection, C48 / 80 positive drug and mast cells were mixed and incubated for 1 hour respectively. Histamine was detected by the optimized fluorescence method. Then histamine release rate was calculated and analyzed statistically. Results: The optimal reaction time for histamine detection by fluorometry was 3 min, and the stability of the condensate was good at 7.5-30 min after termination of the reaction. There was no significant difference between the two methods using indirect detection of histamine release rate and histamine release rate . 11 kinds of traditional Chinese medicine injections such as Tanreqing, Qingkailing, Shenmai, Danshen, Xuesaitong, Shenfu, Shuanghuanglian, Shengmai, Xiangdan, Renduining and compound Angelica could obviously release histamine from mast cells. There was no obvious histamine release from 8 kinds of injections such as Mailuoning, Astragalus, Aidi, Xingnaojing, Astragalus Polysaccharides, safflower, ligustrazine hydrochloride and Shenqi. CONCLUSION: Allergic reactions induced by traditional Chinese medicine injections may be mostly allergic. Detection of histamine release assay of primary mast cell degranulation test may provide a reference for the evaluation of the allergenicity induced by traditional Chinese medicine injection.