摘要
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 evalute the allergenicities of Houttuynia cordata injections and Tween 80（Tween80） and hydroxypropyl-β-cyclodextrin（HP-β-CD）.Method：Through intravenous injection of different doses of Houttuynia cordata injections and Tween80 and HP-β-CD to Rhesus Macaque,it was observed the behavioral changes and measured the concentrationns of histamine in serum with ELISA.Results：Tween80 can reduce abnormal behavior significantly after administration,histamine significantly increases.Houttuynia cordata injection containing Tween80 at the concentrationns of 20mg/kg does not appear obviously abnormal behavior after administration,but histamine significantly increases.HP-β-CD and Houttuynia cordata injection containing HP-β-CD does not induce abnormal behavior and significantly increase in histamine.Conclusion：Tween80 possesses the obvious allergenicity,toxicity and hemolysis,especially the higher concentration of Tween80.However,a high concentration and large doses of HP-β-CD does not appear obviously adverse reactions such as allergenicity,toxicity and haemolytic.
出处
《中药药理与临床》
CAS
CSCD
北大核心
2009年第6期55-57,共3页
Pharmacology and Clinics of Chinese Materia Medica
基金
中药注射剂的安全性评价研究,国家十一五科技支撑计划资助(2006BAI14B05)
