肿节风注射液安全性实验评价

目的：对肿节风注射液进行异常毒性、溶血与凝聚试验、过敏反应安全性实验评价。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肿节风注射液,结果实验小鼠均无异常反应;溶血与凝聚试验供试品管中的溶液在3小时内不发生溶血和凝聚;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：本肿节风注射液进行的异常毒性、溶血与凝聚试验和致敏反应的安全性评价符合规定。

Zhong Jie Feng Injection Experiment Evaluation of the Safety

Objective：Zhong Jie Feng injection to abnormal toxicity 、hemolytic and cohesion tests、allergic reaction experimental evaluation of the safey.Method：according to 《Vhina Pharmacopoeia》 2010 edition part Ⅰappendix ＂Chinese medicine injection application secuity checks guidelines＂ related to the project requirements and test specifications.Result：mice were injected per 0.5ml Zhong Jie Feng injection reesults there was no abnormal reaction in mice;hemolysis and cohesion tests,the solution for the test quality control does not occur within 3hours hemolysis and cohesion;each guinea pig by intraperitoneal injection and intravenous injection of 0.5ml each 1.0ml,as the product of the sensitization dose and excited dose,test results were not an allergic reaction in guinea pigs.Conclusion：abnormal toxicity、 hemolytic and cohesion tests、allergic reaction to Zhong Jie Feng injection for safety evaluation of compliance.