参贝咀嚼片的免疫调节活性及其安全性评价

该研究旨在评价参贝咀嚼片的免疫调节活性和安全性。采用高、中、低三个剂量组（1.20、0.80、0.40 g/kg，以小鼠体质量为基准计），对昆明小鼠进行了30 d的灌胃试验，测定免疫调节活性相关指标包括体质量、脏器/体质量比值、细胞免疫、体液免疫、单核-巨噬细胞功能、NK细胞活性等。其次，以SD大鼠为研究对象，按20.00 g/kg剂量开展急性毒性、遗传毒性（Ames试验，骨髓细胞微核试验，精子畸形试验）以及30 d喂养试验。实验结果表明，各剂量组（1.20、0.80、0.40 g/kg）对小鼠体质量及淋巴器官/体质量比值，均未产生显著性影响。高剂量组（1.20 g/kg）能显著诱发小鼠迟发型变态反应（DTH）且提高小鼠抗体生成细胞数量、巨噬细胞吞噬指数（7.04）以及小鼠血清中溶血素水平（p<0.05）。安全性评价结果表明，在30 d观察期内，不同剂量的参贝咀嚼片对小鼠的体质量、进食量、食物利用率、血液学指标、血液生化学指标以及脏器系数均未产生显著影响，且在受试剂量范围内，参贝咀嚼片无诱发菌株突变和染色体畸变等作用。综上所述，参贝咀嚼片拥有提升免疫力的作用，且安全性良好。

Immune-regulatory Functions and Safety of Chewable Ginseng-Fritillary Bulb Tablet

In this study, the immune-regulatory functions and safety of chewable Ginseng-Fritillary bulb tablets were evaluated in vivo. For the immune-regulatory function evaluation, Kunming mice were administered chewable Ginseng-Fritillary bulb tablets by oral gavage at daily doses of 1.20, 0.80, and 0.40 g/kg (measured by body weight of mouse) for 30 days, and then body weight, organ/body weight ratio, cellular immunity, humoral immunity, monocyte-macrophage function and NK cell activity were measured. To assess the safety of the tablets, the acute toxicity, genotoxicity (via the Ames test, the bone marrow micronucleus test and the mouse sperm malformation test), and the 30-day feeding test were performed by using SD rats under a dose of 20.00 g/kg. The results show that the chewable Ginseng-Fritillary bulb tablets at all tested doses have no significant effects on the body weight and the lymphoid organ/body weight ratio of mice. In the high-dose group (1.20 g/kg), the tablets could significantly induce the delayed-type hypersensitivity (DTH) in mice and increase the number of antibody-producing cells, the macrophage phagocytosis index (7.04), and the serum hemolysin level (p<0.5). Furthermore, the safety evaluation results suggest that the tablets have no significant effects on the body weight, food intake, food utilization rate, hematological indices, blood biochemical indices and organ coefficients of mice. In addition, under the tested doses, no significant mutation or abnormality in the micronucleus formation of bone marrow cells and sperm cells were observed. In conclusion, the chewable Ginseng-Fritillary bulb tablets can enhance immunity reasonably safely.