【摘要】 目的:对新工艺生脉注射液各组分进行Beagle犬类过敏反应实验研究,进一步探讨新工艺生脉注射液致敏原因。方法:选用类过敏反应的敏感动物Beagle犬,随机分为7组,每组3只,分别注射5%葡萄糖注射液、红参提取液、麦冬提取液、五味子提取液、五味子蒸馏液、生脉方、0.2%聚氧乙烯脱水山梨醇单油酸酯(吐温-80)溶液。观察给药前至给药后24 h各犬的变化,根据反应症状轻重判定级别。给药前及停药后10 min取血,ELISA方法检测血清组胺含量,并结合反应症状级别,综合判定药物的致敏性。结果:红参提取液组1只犬出现不典型类过敏反应症状,2只犬血清组胺含量升高1倍以上,诱发Beagle犬类过敏反应为可疑;0.2%吐温-80组各犬均出现类过敏反应症状,但血清组胺含量未见明显升高,诱发Beagle犬类过敏反应为可疑;其余各组药物未诱发Beagle犬类过敏反应。结论:新工艺生脉注射液所致Beagle犬轻度类过敏反应可能与所含红参提取液及0.2%吐温-80有关。更多还原

【Abstract】 Objective: To evaluate the sensitization effect of different components of Shengmai injection(new production process) on Beagle dogs.Method: Beagle dogs were randomly divided into 7 groups,3 in each group.Each group was respectively injected with 5% glucose injection,Ginseng Radix et Rhizoma Rubra extract,Ophiopogonis Radix extract,Schisandrae Chinensis Fructus extract,Schisandrae Chinensis Fructus distillate,Shengmaifang,0.2% tween 80.The changes of each dog were observed from injection before until 24 hours after injection,and the response level was determined according to the severity of the symptoms.Blood samples were collected before injection and at 10 min after injection for measuring histamine content in plasma by ELISA.Sensitization of the injection was comprehensively determined by combined the response level of symptoms and the histamine level.Result: One dog of Ginseng Radix et Rhizoma Rubra extract group showed untypical symptoms of anaphylactoid reactions,and serum histamine of two dogs increased more than doubled.The Beagle dogs administrated with 0.2% tween 80 showed typical symptoms of anaphylactoid reactions,while there was no significant increasement of serum histamine.Other groups were observed with no typical anaphylactoid reactions.Conclusion: The sensitization effect of Shengmai injection(new production process) may be associated with Ginseng Radix et Rhizoma Rubra extract and 0.2% tween 80.更多还原