卡介菌多糖核酸注射液效力实验动物模型致敏原的选择

目的针对目前卡介菌多糖核酸注射液效力试验模型不稳定的现状，比较猪血清、牛血清白蛋白、鸡卵清蛋白3种不同致敏原对小鼠的致敏效果，探讨该动物模型致敏原的选择。方法猪血清、冻干牛血清白蛋白、冻干鸡卵清蛋白腹腔注射致敏小鼠，隔天1次，共3次，末次致敏后14d，尾静脉攻击相同的致敏原，观察小鼠的全身发病情况，记录发病指数。结果牛血清白蛋白的致敏效果最差，猪血清和鸡卵清蛋白致敏效果好，但是反复冻融后的猪血清致敏效果较猪血清效果显著性降低（P〈0．05）。鸡卵清蛋白的致敏浓度选择结果，在5mg/ml的攻击浓度下，动物的发病指数0．5mg／ml致敏浓度组高于0．25mg／ml剂量组和1mg／ml剂量组。结论鸡卵清蛋白更适合用于卡介菌多糖核酸注射液效力试验的致敏原，最佳的致敏浓度和攻击浓度分别为0．5mg／ml和5mg／ml。

Anaphylactogen selection for allergenic animal model of BCG polysaccharide and nucleic acid

Objective To select a better anaphylactogen for allergenic animal model of BCG polysaccharide and nucleic acid from pig serum, BSA and OVA as the current animal model is not always stable during quality control. Methods Pig serum, BSA and OVA were administered i.p. on alternate days for three times，after 14 days for the last time, the same protein was administered intravenously to observe the response of different group animals and record the morbidity index. Results BSA was a worst candidate of anaphylactogen for potency test of BCG-PSN. And pig serum and OVA had a better sensitizing effect. After several rounds of freeze-thawing, the sensitizing ability of pig serum decreased significantly (P < 0.05). OVA was a good alternative for pig serum at the same challenge concentration in mice (5mg/ml). Index of morbidity in group sensitized by 0.5mg/ml was higher than 0.25mg/ml and 1mg/ml in another two groups Conclusions For its excellent stability and sensitizing capability, OVA is a better anaphylactogen for allergenic animal model of BCG polysaccharide and nucleic acid. And the optimal sensitizing and challenging concentrations are 0.5mg/ml and 5mg/ml respectively