Abstract: 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.