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目的:对新、旧两种工艺生产的生脉注射液致Beagle犬类过敏反应的致敏性进行比较研究。方法:选用类过敏反应的敏感动物Beagle犬,随机分为3组,每组3只,分别注射5%葡萄糖注射液、旧工艺生脉注射液、新工艺生脉注射液。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:旧工艺生脉注射液导致Beagle犬出现典型的类过敏反应症状,且血清组胺升高1倍以上,综合判定旧工艺生脉注射液致Beagle犬类过敏反应为阳性;新工艺生脉注射液可诱发Beagle犬出现不典型的类过敏反应症状,血清组胺升高1倍以上,综合判定新工艺生脉注射液诱发Beagle犬类过敏反应为可疑。结论:旧工艺生产的生脉注射液可诱发Beagle犬出现典型的类过敏反应,其致敏性强。与旧工艺生脉注射液相比,改进工艺后的生脉注射液引发Beagle犬类过敏反应症状出现时间晚,程度轻,对Beagle犬的致敏性降低。
OBJECTIVE: To compare the allergenicity of Beagle dogs with allergic reactions induced by Shengmai Injection produced by the two new and old techniques. Methods: Beagle dogs with allergic reaction were randomly divided into 3 groups with 3 rats in each group. The rats were injected with 5% glucose injection, Shengmai injection and Xinmei injection respectively. 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: Shengmai Injection caused the typical allergic reactions in Beagle dogs, and the serum histamine increased more than one time. It was concluded that the anaphylactic reactions of Beagle dogs caused by the old Shengmai injection were positive. Injection can induce atypical anaphylactoid symptoms in Beagle dogs, serum histamine increased more than 1 times, a comprehensive determination of the new technology Shengmai injection induced Beagle dog allergic reactions as suspicious. Conclusion: Shengmai injection produced by the old technology can induce typical anaphylactoid reaction in Beagle dogs with strong sensitization. Compared with the Shengmai Injection of the old technique, the symptom of the allergic reaction in Beagle dogs caused by the improved Shengmai Injection after treatment is late, mild and the sensitization to Beagle dogs is reduced.