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目的:评价鱼腥草注射液及其辅料吐温80(Tween80)和羟丙基-β-环糊精(HP-β-CD)的致敏性。方法:通过静脉注射不同剂量药液,观察药后食蟹猴的行为学变化,检测给药前、后血清中组胺的含量。结果:高浓度Tween80诱发显著的行为异常,组胺显著升高。含有Tween80的鱼腥草注射液原制剂在所用浓度及剂量下,给药后未出现明显的行为异常,但组胺明显升高。HP-β-CD溶液及含有HP-β-CD的鱼腥草新制剂未见明显行为异常和组胺升高。结论:Tween80具有明显的的致敏性、毒性和溶血性,特别是在提高浓度时表现更明显。给予高浓度、大剂量的HP-β-CD,未出现明显的致敏性、毒性和溶血性等不良反应。
Objective: To evaluate the allergenicity of Houttuynia cordata Thunen 80 and hydroxypropyl-β-cyclodextrin (HP-β-CD). METHODS: The intravenous injection of different doses of drug solution was used to observe the behavioral changes of cynomolgus monkeys after drug treatment. The content of histamine in serum before and after administration was detected. RESULTS: High concentrations of Tween80 induced significant behavioral abnormalities and histamine significantly increased. The original formulation of Houttuynia injection containing Tween80 showed no obvious behavioral abnormality after administration at the concentration and dose used, but histamine was significantly elevated. HP-β-CD solution and Houttuynia cordata containing HP-β-CD showed no obvious abnormal behavior and increased histamine. Conclusion: Tween80 has obvious allergenicity, toxicity and hemolytic activity, especially in increasing concentration. Given high- and high-dose HP-β-CD, no obvious adverse reactions such as allergenicity, toxicity and hemolysis were observed.