生脉注射液(新工艺)致食蟹猴类过敏反应实验研究

Experimental study on anaphylactoid reactions induced by Shengmai injection(new production process) on Cynomolgus monkey

目的:对新、旧2种工艺生产的生脉注射液致食蟹猴类过敏反应的致敏性进行比较研究。方法:食蟹猴随机分为4组,分别为5%葡萄糖注射液组、旧工艺生脉注射液组、新工艺生脉注射液组及阳性对照药组。观察给药前至给药后24 h各猴的变化;给药前及停药后10 min取血,检测血清组胺含量;给药前及停药后10 min测定血压及心率,综合判定药物的致敏性。结果:旧工艺生脉注射液导致食蟹猴出现典型的类过敏反应症状,但是血清组胺未升高1倍以上;新工艺生脉注射液可诱发食蟹猴出现不典型的类过敏反应症状,血清组胺未升高。结论:旧工艺生产的生脉注射液可诱发食蟹猴出现典型的类过敏反应,其致敏性强;改进工艺后的新生脉注射液引发食蟹猴类过敏反应症状出现时间晚,程度轻,对食蟹猴的致敏性降低。

Objective： To compare the anaphylactoid effect of old Shengmai injection and new Shengmai injection on Cynomol- gus monkey. Method： Cynomolgus monkeys were randomly divided into 4 groups, and were respectively injected with 5% glucose in- jection, old Shengmai injection, new Shengmai injection, positive control drug. The changes of each monkey were observed from injec- tion before until 24 hours after injection, and the response level was determined according to the severity of the symptoms. Blood sam- ples were collected before injection and at 10 min after injection for measuring histamine content in plasma. Blood pressure and heart rates were detected before injection and at 10 min after injection. Sensitization of the injection was comprehensively determined by com- bined the response level of symptoms and the histamine level. Result： The Cynomolgus monkeys administrated with old Shengmai in- jection showed typical symptoms of anaphylactoid reactions and the content of serum histamine is not more than doubled. The Cynomol- gus monkeys administrated with new Shengmai injection showed untypical symptoms of anaphylaetoid reactions and the content of serum histamine did not rise. Conclusion： The old Shengmai injection can induce typical anaphylactoid reactions on Cynomolgus monkeys, and the sensitization ability is strong. The symptoms of anaphylactoid reactions induced by the new Shengmai injection appeared later and showed lesser degree with the sensitization lower.