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本文以破伤风类毒素(tetanus toxoid,TT)为研究对象,对比自制的无针粉末注射系统与普通皮下注射方式给药对小鼠的免疫效果。考察氢氧化铝吸附破伤风类毒素(Al(OH)3-TT)粉末的制备工艺,并采用光学显微镜和激光粒度分析仪等考察其微粉学性质。结果表明,增加盐浓度、延长吸附时间均可提高吸附药量。NaCl浓度为0.4mol·L-1吸附效果较好,大于0.8mol·L-1,蛋白会发生盐析;反应10min后吸附量趋于稳定。体系pH值及温度在考察的范围内对吸附药量影响不大。根据优化后工艺制备的Al(OH)3-TT平均粒径为(60.6±4.4)μm。将自制的Al(OH)3-TT无针粉末注射剂与普通皮下注射剂对比,采用酶联免疫吸附法(ELISA)检测破伤风抗毒素IgG抗体浓度。结果表明,Al(OH)3-TT(含TT30μg)无针粉末注射小鼠,4周后破伤风抗毒素IgG抗体浓度为(6.19±0.52)U·L-1,8周后为(10.70±0.78)U·L-1,而普通皮下注射组(含TT20μg)分别为(4.25±0.58)、(7.48±0.57)U·L-1,提示自制的Al(OH)3-TT无针粉末注射剂免疫原性较好,为进一步开发破伤风类毒素无针粉末注射剂提供了技术参考。
In this paper, tetanus toxoid (TT) was used as a research object to compare the immune effect of self-made needle-free powder injection system and ordinary subcutaneous injection on mice. The preparation process of aluminum (I) hydroxide-adsorbing tetanus toxoid (Al (OH) 3-TT) powder was investigated and its micropowder properties were investigated by optical microscope and laser particle size analyzer. The results showed that increasing the salt concentration and prolonging the adsorption time could increase the adsorption dose. NaCl concentration of 0.4mol·L-1 adsorption effect is better, greater than 0.8mol·L-1 protein salinization occurs; the amount of 10min after the reaction tends to be stable. The pH and temperature of the system had little effect on the amount of adsorbed drug in the investigated range. The average particle diameter of Al (OH) 3-TT prepared by the optimized process is (60.6 ± 4.4) μm. The homemade Al (OH) 3-TT needle-free powder injection was compared with ordinary hypodermic injection, and the concentration of tetanus antitoxin IgG was detected by enzyme-linked immunosorbent assay (ELISA). The results showed that the concentration of tetanus antitoxin IgG antibody was (6.19 ± 0.52) U · L-1 after 4 weeks and was (10.70 ± 0.78) after 1 and 8 weeks after Al (OH) 3-TT ) U · L-1, while the common subcutaneous injection group (TT20μg) were (4.25 ± 0.58) and (7.48 ± 0.57) U · L-1, Which has good original character and provides a technical reference for further developing tetanus toxoid needle-free powder injection.