大豆异黄酮复合胶囊的毒理学安全评价

本研究依据食品安全性毒理学评价程序和方法对大豆异黄酮复合胶囊进行30 d大鼠喂养实验,各剂量组(166.7、333.3、666.7mg/kg.bw)对大鼠一般生理体症、行为、大便、皮毛等均未见异常。各剂量组体重、食物利用率、血液常规、脏器系数与对照组比较无显著性意义(P>0.05),血液生化指标(丙氨基酸氨基转移酶、总草转氨酶、尿素氮、肌酐、总蛋白、白蛋白、血糖、总胆固醇和甘油三酯)无显著性意义(P>0.05);各剂量组大鼠主要脏器病理检查结果大致相同,未见特殊病理改变。小鼠抗氧化试验各剂量组(67.0、133.0、200.0 mg/kg.bw)血清MDA含量(6.73±1.14、6.48±0.77、5.99±0.80 nmol/mL)显著低于老龄对照组(7.13±1.16nmol/mL),红细胞SOD活力(6.49±0.41、6.74±0.50、7.22±0.34×103Nu/mL)显著高于老龄对照组(6.29±0.88×103Nu/mL)。因此,在本实验条件下,大豆异黄酮复合胶囊是安全且具有抗氧化功效的。

The Toxicological Assessment on Safety of Compound Capsule of Soy Isoflavone

30 days feeding test was used in this study to assessment the safety of compound capsule of soy isoflavone according to the procedures for toxico logical assessment of food. the physical signs, behavior,stooll and fur of the rat in each dose (166.7, 333.3, 666.7 mg/kg?bw) No abnormal phenomen was found in the samples. Compared with control group, the weight, food utilization rate, blood routine, organ coefficients and biochemical indexes of the rat in each dose were no significant differences (P>0.05)..Blood biochemical indicators (ALT, AST, BUN, Crea, TP, ALB, GLU, T-cho and TG) were not significant (P>0.05). The pathologic examination of main organs was the same, and no special pathological changes were found. As compared with the model aging control group (7.13±1.16 nmol/mL), all dose groups (67.0,133.0 and 200.0 mg/kg?bw) was significantly lower in the levels of serum MDA content for the experiment of antioxidation effects in mice, Erythrocyte SOD activity (6.49±0.41, 6.74±0.50, 7.22±0.34, ×103Nu/mL) were significantly higher than the control group (6.29±0.88 ×103Nu/mL).Therefore, the soybean isoflavone compound capsule was safe and had a significant antioxidant in this study.