用于卡介菌多糖核酸制剂效力实验的小鼠模型的建立

Establishment of a mouse model for the potency test of BCG polysaccharide nucleic acid preparation

目的建立用于卡介菌多糖核酸制剂效力实验的小鼠模型。方法选用猪血清、牛血清白蛋白、卵白蛋白作为致敏原，腹腔注射BALB／c小鼠以建立I型变态反应动物模型，并通过在卡介菌多糖核酸制剂效力实验中应用建立的小鼠模型来验证其可行性。采用t检验对测定结果进行统计学分析。结果猪血清、牛血清白蛋白和卵白蛋白均可作为致敏原致敏BALB／c小鼠，但牛血清白蛋白和卵白蛋白的致敏效果优于猪血清。卡介菌多糖核酸制剂效力实验显示，牛血清白蛋白实验组与对照组间的小鼠发病分值差异具有统计学意义（t=3．22，P=0．0045），表明牛血清白蛋白致敏小鼠建立的动物模型可更好地反映卡介菌多糖核酸制剂的效力。结论牛血清白蛋白致敏小鼠建立的动物模型可用于卡介菌多糖核酸制剂效力实验。

Objective To establish a mouse model for the potency test of BCG polysaccharide nucleic acid （BCG-PSN） preparation. Methods Pig serum, bovine serum albumin （BSA） and ovalbumin were chosen as allergens. BALB/c mice were inoculated intraperitoneally with pig serum, BSA or ovalbumin to establish an animal model of type I allergy. The feasibility of the established mouse model was validated by application of the model in the potency test of BCG-PSN preparation. The statistical analysis of the results was made by t test. Results Pig serum, BSA and ovalbumin could be used as allergens to sensitize BALB/c mice, but sensitization of BSA and ovalbumin was stronger than that of pig serum. The potency test of BCG- PSN preparation showed that the disease scores of mice between BSA treatment group and control group were statistically significant （t =3.22 ,P =0. 0045 ）. The results suggested that the mouse model sensitized by BSA was optimal for detecting effect of BCG-PSN preparation. Conclusion The mouse model sensitized by BSA can be used for the potency test of BCG-PSN preparation.