目的:比较生脉注射液工艺改进前后对动物的类过敏反应的差异,以探讨提高生脉注射液安全性的可能性。方法:小鼠耳廓血管通透性分析:将ICR小鼠随机分成不同实验组,分别一次性静脉注射含有0.4%伊文思蓝(EB)的5%葡萄糖注射液、Compound 48/80溶液或工艺改进前后的不同浓度生脉注射液。给药后30 min记录各组动物耳廓血管通透性增高反应的阳性率,进行耳廓蓝染程度评分,并定量测定耳廓伊文思蓝渗出量。大鼠皮肤血管通透性试验:即动物先静脉注射给予0.6%伊文思蓝生理盐水溶液,10 min后再从背部皮内注射给予上述受试物,每个点注射50μL药液,20 min后处死大鼠,测量皮肤内的蓝色斑点大小,并定量测定其中伊文思蓝渗出量。结果:生脉注射液原工艺16.7 mL.kg-1组(相当于临床剂量的1.67倍剂量)的小鼠可见耳廓血管通透性明显增高,而10 mL.kg-1的生脉注射液(相当于临床等倍剂量)组未见明显的耳廓血管通透性增高;新工艺16.7 mL.kg-1组的耳廓通透性增高程度较相同剂量原工艺组明显减轻。原工艺生脉注射液皮内注射后,在注射部位导致明显的渗出、水肿,从而形成较大的蓝斑,有一定剂量关系。新工艺在注射局部也可造成一定程度的蓝斑,但蓝斑直径较原工艺组减小,皮肤伊文思蓝渗出量减少,说明新工艺的皮肤类过敏反应较轻。结论:生脉注射液原工艺有明显增高血管通透性的作用,提示有致类过敏作用;改进工艺后其导致血管通透性增高的不良作用减轻,提示改进工艺可减轻类过敏反应。 OBJECTIVE: To compare the difference of anaphylactoid responses to animals before and after Shengmai injection, in order to explore the possibility of improving the safety of Shengmai injection. Methods: The mice auricle vascular permeability analysis: ICR mice were randomly divided into different experimental groups, respectively, a single intravenous injection of 0.4% Evans blue (EB) in 5% glucose injection, Compound 48/80 solution or technology Before and after improving the different concentrations of Shengmai injection. The positive rate of vascular permeability enhancement of auricles of each group was recorded 30 min after the administration, the score of blue-ear auricle was scored, and the amount of Evans blue exudate of auricle was quantitatively determined. Rats skin vascular permeability test: Animals were given intravenous injection of Evans blue 0.6% intravenous solution, after 10 min and then from the back of the intradermal injection of the test substance, each injection of 50μL liquid, 20min later The rats were sacrificed, the blue spot size in the skin was measured, and the amount of Evans Blue ooze was quantitatively determined. Results: The Shengmai injection of the original process 16.7 mL.kg-1 group (equivalent to 1.67 times the clinical dose of the dose) showed auricular vascular permeability was significantly increased, and 10 mL.kg-1 Shengmai injection (Equivalent to the clinical equivalent dose) no significant increase in the auricle vascular permeability; new technology 16.7 mL.kg-1 group increased auricle permeability than the same dose of the original process group significantly reduced. Shengmai injection of the original process intradermal injection, resulting in the injection site significantly exudate, edema, resulting in a larger blue spot, there is a certain dose relationship. The new process can also cause a certain degree of locus coeruleus in the injection site, but the diameter of the locus coeruleus is smaller than that of the original process group, and the amount of Evans blue exudation of the skin is reduced, indicating that the skin allergic reaction of the new process is lighter. CONCLUSION: Shengmai injection has obvious effect of increasing vascular permeability in the original technology, which suggests that there is anaphylactoid allergy. The adverse effects caused by improved vascular permeability after treatment are alleviated, suggesting that improving the process can reduce the allergic reaction.