| Shi-Shen Capsule is mainly composed of dendrobium officinale and American ginseng. It's function is to enhance immunity so it is suitable for low immunity people. Based on TCM theory, dendrobium officinale, as the masterwork of yin-reinforcing, regenerate body fluid, nourish yin and clear heat. American ginseng has the efficiency of invigorating qi, nourishing yin, clearing heat and regenerating body fluid so it is the first choice of reinforcing qi. Morden pharmacological studies have shown that dendrobium polysaccharide is the main active component of dendrobium officinale which can enhance the immune system, reduce blood sugar and resist oxibation. Ginsenoside is the main active component of American ginseng which can inhibit central nervous system, resist oxibation, relive fatigue, decrease serum lipids and enhance immune. Therefore, both TCM theory and morden pharmacological studies support the immunity increasing ability of dendrobium and American ginseng. But at present, the pharmacological effects of dendrobium combined with American ginseng have not been researched. Now, both dendrobium and American ginseng are all regarded as health food. The safety researches of combining the use of dendrobium and American ginseng have not yet been done.To take up the slack of these two fields, we have been researching and studying deeply on the pharmacodynamics and toxicology of the shi-shen capsule to provide basic research data for the safety and efficiency of clinic applications. The main contents and results are as follows The first part, Study on the pharmacodynamics of shi-shen capsuleFrist Experimental study of the effect of shi-shen capsule on immune function in normal mice.According to the procedure and methods in the Technical Standards for Testing & Assessment of Health Food (2003 edition), we study the immune function of shi-shen capsule by cellular immune function test, humoral immune test, mononuclear macrophage system test and NK cell activity test. The experimental results show that shi-shen capsule in different does groups (1.06g/kg, 0.53g/kg,0.27g/kg equivalent to 113.2,75.5,37.7 times of clinical dosage of adults respectively) could enhance the capacity of spleen cell proliferation which were induced by ConA, could strengthen the delayed hypersensitivity, could enhance the phagocytesis function of macrophage, could increase serum hemolysin,the cell secreting antibody level and NK cell activity of mouse. The results showed that shi-shen capsule is capable of enhancement of normal mice's immune function.Sceond Experimental study of the effect of shi-shen capsule on the immunologic function in immunosuppressive mice.Immune compromised mice were established by injection with cyclophosphamide, and then were treated by gavage with shi-shen capsule for 14 days. Delayed type hypersensitivity, carbon clearance, hemolytic plaque and serum hemolysin test were employed to evaluade the effects of non-specific and specific immunologic function of immunosuppressed mice. The experimental results show that all the indexes in the model group were reduced. shi-shen capsule high concentration group could strengthen the delayed hypersensitivity, could enhance the phagocytesis function of macrophage,could increase serum hemolysin.The results showed that shi-shen capsule boost humoral and cellular immunity of immunosuppressive mice. The second part, Study on toxicology of shi-shen capsuleBased on the observations of acute toxicity test and thirty days feeding study for mice and rats along with genetic test, which has provide the theorotic basis of shi-shen capsule for clinical application. Genetic test includes three major test: Ames test, bone marrow cell micronucleus test and mice sperm abnormality test. In acute toxicity test (MTD test), the animals were administered by intragastric infusion at single dose of 6.0g/kg(equivalent to 113 times of clinical dosage of adults), and were observed for 14 days. During the test of experimental, there were not any poisoning and death cases. The oral MTD in mice and rats was over 6.0g/kg, which suggested no acute toxicity. In the thirty days feeding study, shi-shen capsule was administered at dose of 6.0,4.0,2.0g/kg(equivalent to 113.2, 75.5,37.7 times of clinical dosage of adults respectively) respectively for 30 days. There were not significantly different in rats body weight, food intake, food consumption, hematology, serum biochemistry and organ coefficient between three drug treated groups and control group (P>0.05). Pathological examination in the high dose group demonstrated that the liver, kidney, spleen, gastrointestinal tract, testis, ovary was not found histopathological changes.In Ames test, the number of the reverse mutant of shi-shen capsule in different does groups was not more than 2 times of that in control group. The result of Ames test for shi-shen capsule was negative. In bone marrow cell micronucleus test and mice sperm abnormality test, after gastric administration of shi-shen capsule at dose of 4.0,2.0,1.0g/kg, there was no obvious difference in micronuclear rates or teatosperm rate compared with normal mice(P>0.05), which were significantly lower than cyclophosphamide group. The experimental results indicated that shi-shen capsule have no evident genetic toxicity to adult mice.All of these results suggested that shi-shen capsule belongs to actually non-toxic substance with no genetic toxicity. The no observed adverse effect level (NOAEL) of shi-shen capsule was 6.0g/kg. shi-shen capsule was safety for animals. shi-shen capsule can enhance normal the immune of normal mice and immunosuppressive mice. |
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