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目的研究人用皮内注射布氏菌活疫苗的毒理及药效学作用,以评价其可行性。方法对布氏菌活疫苗进行小白鼠急性毒性试验、局部刺激试验、全身过敏试验、长期毒性试验及豚鼠皮肤变态反应试验并免疫小鼠,进行血清抗体检测。结果小鼠皮内注射布氏菌活疫苗的最大耐受量为1·0×109个菌,用布氏菌素注射足底,可引起明显的迟发型变态反应。局部刺激试验,只有注射1·0×109个菌的部位会在48h后化脓,但在1~2周内可自愈。全身过敏试验均未出现任何异常反应,毒性试验、各项血常规、血生化检查均未见显著差异,各脏器组织的病理学检查亦未见病理改变。免疫12周后,对豚鼠骨髓造血细胞亦无影响。对皮内免疫12周的豚鼠作背部皮肤变态反应试验,24~48h结果为阳性。皮内免疫小鼠14d后可测得小鼠体内有抗体产生,50d后测得小鼠体内抗体均呈强阳性,对照组小鼠14d与50d抗体检测均为阴性。结论毒理和药效学试验结果显示,布氏菌活疫苗用皮内注射的途径进行免疫是可行的。
Objective To study the toxicological and pharmacodynamic effects of intradermal injection of live Brucella vaccine to evaluate its feasibility. Methods The live vaccine against brucellosis was tested in acute toxicity test, local irritation test, systemic allergy test, long-term toxicity test and guinea pig skin allergy test, and the mice were immunized. Results The maximum tolerated dose of intradermal injection of live Brucella vaccine in mice was 1.0 × 10 9 bacteria. The injection of brucellin into the soles of feet could cause obvious delayed-type hypersensitivity. In the local irritation test, only sites injected with 1.0 × 10 9 bacteria will purge after 48 h, but may heal within 1 to 2 weeks. There was no abnormal reaction in systemic allergy test. Toxicity test, blood routine examination and blood biochemistry examination showed no significant difference. No pathological examination was found in pathological examination of various organs. After 12 weeks of immunization, there was no effect on the hematopoietic cells of guinea pig bone marrow. Guinea pigs immunized intradermally for 12 weeks for back skin allergy test, 24 ~ 48h results were positive. Antibody production in mice was measured 14 days after intradermal immunization, and the antibody in mice was strongly positive after 50 days. The antibody in 14 days and 50 days in control mice were negative. Conclusion Toxicology and pharmacodynamics test results show that viable intradermal injection of live Brucella vaccine is feasible.