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目的研究5个不同厂家生产的清开灵注射液及清开灵注射液各组分和辅料静脉注射的致敏性。方法一次性给予Beagle犬静脉恒速注射5种厂家生产的清开灵注射液及其各组成成分和辅料,观察给药后Beagle犬的行为学变化,检测血中组胺、IgE、IgG、IgM、嗜酸粒细胞阳离子蛋白(ECP)和白细胞介素-4(IL-4)的含量变化。结果根据行为异常评分和组胺、IgE、IgG、IgM、ECP和IL-4等含量变化,有3个药厂生产的清开灵注射液及栀子提取物和胆酸综合判断为类过敏反应阳性。结论3个药厂生产的清开灵注射液可引起类过敏反应,而栀子提取物和胆酸可能是引起类过敏反应的有关物质。
Objective To study the sensitization of intravenous injection of Qingkailing Injection and Qingkailing Injection from 5 different manufacturers. Methods Beagle dogs were given a one-time intravenous injection of Qingkailing Injection and its components and excipients produced by five manufacturers to observe the behavioral changes of Beagle dogs after administration. Histamine, IgE, IgG, IgM , Eosinophil cationic protein (ECP) and interleukin-4 (IL-4) content changes. Results According to the behavioral abnormality scores and histamine, IgE, IgG, IgM, ECP and IL-4 content changes, there are three pharmaceutical Qingkailing injection and Gardenia extract and bile acid synthesis as anaphylactoid reaction Positive. Conclusions Qingkailing injection produced by 3 pharmaceutical factories can cause anaphylactoid reactions, while gardenia extract and cholic acid may be related substances that cause allergic reaction.