生脉注射液(新工艺)各组分致Beagle犬类过敏反应实验研究  

Experimental study on anaphylactoid reactions induced by different components of Shengmai injection(new production process) on Beagle dogs

作　　者：何萍[1] 李峰杰[1] 唐仁茂[2] 李贻奎[1] 郝伟[1] 丛旭东[2] 余学钊[1] 曹苏闽[2] 

机构地区：[1]中国中医科学院西苑医院实验研究中心,北京100091 [2]江苏苏中药业集团股份有限公司,江苏姜堰225500

出　　处：《中国中药杂志》2012年第13期1880-1884,共5页China Journal of Chinese Materia Medica

基　　金：国家"重大新药创制"科技重大专项(2009ZX09301-005)

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。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 in- jected with 5% glucose injection, Ginseng Radix et Rhizoma Rubra extract, Ophiopogonis Radix extract, Schisandrae Chinensis Fruc- tus extract, Schisandrae Chinensis Fructus distillate, Shengmaifang, 0. 2% tween 80. The changes of each dog were observed from in- jection 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 rain 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 reac- tions, while there was no significant increasement of serum histamine. Other groups were observed with no typical anaphylactoid reac- tions. 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.

关 键 词：生脉注射液 BEAGLE犬 类过敏反应 

分 类 号：R285[医药卫生—中药学]