目的 观察小鼠肌内注射氢氧化铝佐剂的毒性反应。方法 取50只无特定病原体级KM小鼠，其中10只雌性小鼠做预实验，剩余40只（雌雄各半）随机分为给药组和生理盐水对照组，将高浓度（13 mg/mL）氢氧化铝佐剂，按260 mg/kg给药剂量单次肌内注射给药，观察给药后14 d内动物的死亡情况及毒性反应，并于实验结束后进行实验动物全身器官大体解剖及病变组织病理学检查。结果 给药组20只小鼠腿部肌内注射后活动正常，14 d内无死亡。给药组雌性小鼠体重在给药后2、3 d低于对照组且差异有统计学意义（t值分别为2.23和2.61，P值均小于0.05），雄性小鼠体重在给药后2、3、7、14 d低于对照组且差异有统计学意义（t值分别为4.04、3.93、2.25、3.04，P值均小于0.05），给药组小鼠摄食量在给药后1 d低于对照组且差异有统计学意义（t=4.21，P<0.01），给药组小鼠饮水量在给药后1、3 d低于对照组且差异有统计学意义（t值分别为3.29、3.49，P值均小于0.01）。肉眼观察给药组小鼠的给药部位均可见直径约2 mm白色结节，其他组织未见明显病变；病理检查结果显示给药组动物注射部位肌纤维部分变性坏死、炎性细胞浸润、部分结缔组织增生、少量巨核细胞形成，注射部位少量出血。对照组小鼠在实验过程中未见任何异常。结论 小鼠单次肌内注射高剂量氢氧化铝佐剂对注射部位肌肉有一定刺激性，给药组小鼠摄食和饮水量减少、体重减轻，未见其他异常。

Objective To observe the toxic reaction of aluminum hydroxide adjuvant intramuscular injection in mice.Methods In 50 specific pathogen free grade KM mice, preliminary experiments were performed with 10 female mice, and the remaining 40 mice (half males and half females) were randomly divided into treatment group and saline control group. High concentration (13 mg/mL) aluminum hydroxide adjuvant was administered by single intramuscular injection at dosage of 260 mg/kg. Mortality and toxic reactions were observed within 14 d after administration, and gross anatomy of systemic organs and histopathological examination of lesions were performed at the end of the study.Results The 20 mice in treatment group moved normally after intramuscular injection in the leg, and there was no death within 14 d.The body weight of female mice in treatment group was statistically significantly lower than that of control group on the 2nd and 3rd day after administration (t values were 2.23 and 2.61, respectively, P < 0.05), and the body weight of male mice in treatment group was statistically significantly lower than that of control group on the 2nd,3rd,7th and 14th day after administration (t values were 4.04, 3.93, 2.25 and 3.04, respectively, P < 0.05). The food intake of mice in treatment group was statistically significantly lower than that of control group on the 1st day after administration (t = 4.21, P < 0.01), and the water intake of mice in treatment group was statistically significantly lower than that of control group on the 1st and 3rd day after administration (t values were 3.29 and 3.49, respectively, P < 0.01). A white nodule with ~2 mm diameter was observed at the administration site of mice in treatment group, and no obvious pathological changes were observed in other tissues. Pathological examination showed that mice in treatment group presented partial degeneration and necrosis of muscle fibers, infiltration of inflammatory cells,partial proliferation of connective tissues and formation of a small number of megakaryocytes， as well as a small amount of bleeding at the injection site. The mice in control group showed no abnormality during the experiment.Conclusion A single intramuscular injection of high-dose aluminum hydroxide adjuvant in mice can cause muscle irritation at the injection site to a certain extent, food intake and water consumption reduction, and body weight loss, but no other abnormalities.