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目的:建立适用于注射剂类过敏评价的动物模型。方法:大鼠静脉注射含0.6%伊文思蓝(EB)的生理盐水溶液,10 min后,背部皮内注射受试物50μL,20 min后,测量皮内蓝斑直径和伊文思蓝渗出量,以评价类过敏反应程度。结果:生理盐水注射液(NS)、5%葡萄糖注射液造成很小的皮内蓝斑。阳性对照物Compound 48/80可导致局部毛细血管通透性显著增高和水肿,从而引起较大的蓝斑和EB大量渗出。采用临床上可发生类过敏反应的多种中、西药注射剂验证了本模型和评价方法的可靠性和敏感性,检测结果与临床一致。结论:大鼠皮肤类过敏试验方法与临床一致性。该方法敏感、可靠,适宜于注射剂临床前类过敏反应评价、注射剂生产过程中的安全性检测、上市产品抽验、致敏原筛选、类过敏反应发生机制研究以及类过敏防治方法研究等。
Objective: To establish an animal model suitable for the evaluation of allergy to injection. Methods: Rats were intravenously injected with saline solution containing 0.6% Evans blue (EB). After 10 min, 50 μL of the test substance was injected into the dorsal skin. After 20 min, the intradermal plaque diameter and Evans blue exudation , To evaluate the degree of allergic reaction. Results: Saline injection (NS), 5% dextrose injection caused very small intradermal blue spots. The positive control, compound 48/80, resulted in markedly increased local capillary permeability and edema, causing large blushing and EB exudation. The clinical and allergic reactions can be used in a variety of Chinese and Western medicine injection to verify the reliability and sensitivity of the model and evaluation methods, the test results consistent with the clinical. Conclusion: The method and clinical consistency of skin allergy test in rats. The method is sensitive and reliable and is suitable for the evaluation of preclinical allergic reactions in injection, safety testing in the injection production process, sampling of the listed products, screening of the allergens, the mechanism of anaphylactoid reactions and the study of the prevention and treatment methods of allergens.