喜炎平注射液安全性评价

Safety Evaluation of Xiyanping Injection

目的:对喜炎平注射液进行异常毒性、过敏反应安全性评价,同时建立异常毒性、过敏反应安全性评价试验方法。方法:根据《中国药典》2010年版一部附录"中药注射剂安全性检查法应用指导原则"的要求及相关项目的技术规范进行试验。结果:按每只小鼠尾静脉注射0.5ml样品溶液,结果实验小鼠均无异常反应;按豚鼠腹腔注射0.5ml/只和静脉注射1.0ml/只作为本品的致敏剂量和激发剂量,结果试验豚鼠均未出现过敏反应。结论:本次对喜炎平注射液进行的异常毒性和致敏反应的安全性评价符合规定,安全性评价的试验方法可行。

Objective：to research and establish safety evaluation of the abnormal toxicity test and allergic reaction of Xiyanping Injection.Method：the detection method is according to guideline for the application of safety tests for injiection of traditional Chinese Medicine in the appendix of Chinese Pharmacopoeia 2005 edition one.Result：inject 0.5 ml of the test solution into a tail vein of each of mice,none of the mice shows unsue toxicity;inject intraperitoneally 0.5ml and intravenously 1.0ml of the test solution into each of guinea pigs as sensitization and challenge dose,none of guinea pigs shows allerigic reaction.Conclusion：the safety evaluation of the undue toxicity test and allergic reaction of Xiyanping Injection meet the requirement of the test,and the method of safety evaluation is feasible.