含灵芝多糖的复方制剂免疫调节功能及安全性评价

Immunomodulatory Function and Safety Evaluation of Compound Preparation Containing Ganoderma lucidum Polysaccharides

目的:评价含灵芝多糖的复方制剂免疫调节功能及安全性。方法:参照保健食品检验与评价技术规范(2003版),通过测定正常小鼠淋巴细胞增殖能力、耳肿胀程度、溶血空斑数、吞噬百分率和吞噬指数、自然杀伤(NK)细胞活性,分别从细胞免疫、体液免疫及非特异性免疫综合评价含灵芝多糖的复方制剂免疫调节功能;通过小鼠急性经口毒性试验、细菌回复突变(Ames)试验和大鼠30 d喂养试验综合评价其安全性。结果:在细胞免疫试验中,受试物对刀豆蛋白A(ConA)诱导的淋巴细胞增殖能力和耳肿胀程度均无显著影响(P>0.05);在体液免疫试验中,受试物低剂量组(0.17 g/kg)、中剂量组(0.33 g/kg)、高剂量组(1.00 g/kg)分别使小鼠抗体生成细胞数目提高10.98%、12.08%、17.63%(P<0.05);在非特异性免疫试验中,受试物中剂量组、高剂量组能显著提高单核巨噬细胞的吞噬能力(P<0.05)和NK细胞活性(P<0.01)。受试物对雌雄小鼠急性经口剂量最大耐受量(MTD)均大于42.56 g/kg,属无毒级物质;Ames试验结果阴性,未见致突变作用;大鼠30 d喂养试验中,受试物各剂量组对大鼠体质量、周食物利用率、血常规指标、血液生化学指标及主要脏器系数均未产生显著影响(P>0.05),组织学检查未发现明显病理变化。结论:含灵芝多糖的复方制剂可以调节小鼠免疫功能,作为保健食品食用是安全的。

Objective:To evaluate the immunomodulatory function and safety of compound preparation containing Ganoderma lucidum polysaccharides.Methods:According to the Technical Standards for Testing and Assessment of Health Food(2003 Edition),the immunomodulatory function of compound preparation containing Ganoderma lucidum polysaccharides was evaluated comprehensively from cellular immunity,humoral immunity and non-specific immunity by measuring the ability of lymphocyte proliferation,degree of ear swelling,number of hemolytic plaques,phagocytic percentage,phagocytic index and natural killer(NK)cells activity in normal mice.Its safety was evaluated comprehensively by acute oral toxicity test in mice,Ames test and 30 d feeding test in rats.Results:In cellular immunity test,the tested substance had no significant effect on lymphocyte proliferation induced by concanavalin A and degree of ear swelling(P>0.05).In the humoral immunity test,the low dose group(0.17 g/kg),the middle dose group(0.33 g/kg)and the high dose group(1.00 g/kg)could increase the level of antibody-producing cells by 10.98%,12.08%,17.63%(P<0.05).In the non-specific immunity test,the middle dose group and the high dose group could significantly increase the phagocytosis ability of mononuclear macrophages(P<0.05)and the activity of NK cells(P<0.01).The maximum tolerance dose(MTD)of the tested substance to the acute oral dose of both male and female mice was more than 42.56 g/kg,which belonged to non-toxic substances.The results of Ames test were negative and no mutagenicity was found.In the 30 d feeding test,each dose group had no significant effect on body weight,weekly food utilization rate,blood routine index,blood biochemical index and main organ coefficient(P>0.05),and no obvious pathological changes were found by histological examination.Conclusion:Compound preparation containing Ganoderma lucidum polysaccharides had a positive effect on immunomodulatory function in mice,and it had a good safety as a health food.