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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 study the anaphylactic reaction of Beagle dogs in various components of Shengmai Injection, and to explore the reason of Shengmai injection of new technology. Methods: Beagle dogs with allergic reactions were randomly divided into 7 groups with 3 rats in each group. 5% glucose injection, red ginseng extract, Ophiopogon japonicus extract, Schisandra chinensis extract, Schisandra sp., Pulse side, 0.2% polyoxyethylene sorbitan monooleate (Tween-80) solution. Observed before administration to 24 h after administration of each dog’s changes, according to the severity of the reaction to determine the level. Blood samples were collected before administration and 10 min after drug withdrawal, and serum histamine levels were measured by ELISA. Combined with the level of response symptoms, the sensitivities of the drugs were comprehensively determined. Results: One of the dogs in the red ginseng extract group showed symptoms of atypical anaphylaxis. The serum histamine content in the two dogs was more than doubled, which caused suspicion of allergic reaction in Beagle dogs. The dogs in 0.2% Tween-80 group Appeared allergic reaction symptoms, but no significant increase in serum histamine content induced Beagle dog allergy was suspicious; the rest of the drug group did not induce Beagle dog allergic reactions. Conclusion: The mild allergic reaction in Beagle dogs induced by Shengmai injection may be related to the extract of red ginseng and 0.2% Tween-80.