生脉注射液(新工艺)致Beagle犬类过敏反应实验研究

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.

Experimental Study on Anaphylactoid Reactions Induced by Shengmai Injection(New Production Process)on Beagle Dogs

Objective: To compare the sensitization effect of old Shengmai injection and new Shengmai injection on Beagle dogs. Method: Beagle dogs were randomly divided into 3 groups, 3 dogs in each group. Each group was injected with 5% glucose injection, old Shengmai injection and new Shengmai injection. The changes of each dog were observed from injection before and after injection until 24 hours, and the response level were 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: The old Shengmai injection led to beagle dogs showing typical symptoms of anaphylactoid reactions and elevating serum histamine times.The old Shengmai injection caused Beagle dogs anaphylactoid reactionis was positive. The new Shengmai injection led to Beagle dogs showing untypical symptoms of anaphylactoid reactions and elevating serum histamine times.It caused Beagle dogs anaphylactoid reaction was suspicious. Conclusion: The old Shengmai injection can induce typical anaphylactoid reactions on beagle dogs, and the sensitization is strong. Compared with the old Shengmai injection, the symptoms of anaphylactoid reactions induced by the new Shengmai injection appeared later and showed lesser degree. The sensitization to beagle dogs can bereduced.