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Objective:To establish the preparatory procedure and the quality standards of Shegan Fuzheng oral liquid. In addition, to investigate it’s pharmacodynamics such as tumor inhibition, immune and analgesic effect.Method:Orthogonal experiment was used to optimize the extraction technology of formulation of Shegan Fuzheng oral liquid. To select optimal preparatory procedure of shegan oral liquid by using orthogonal design Basing on concentration index of belamcandin and belamcandae rhizoma which are premier drug in preparation. Astragalus mongholicus, giant knotweed rhizome, aurantii nobilis pericarpium, Chinese hawthorn were identified by TLC. The content of belamcandin which is the effective substance in the preparation was determined by HPLC. Meanwhile’s stability was observed. We established H22 solid tumor model by mice and randomly divided into 5 groups, including the control group, model group, Shegan high dose group, low dose group and chemotherapy group. Calculated inhibitory rate, the thymus index, spleen index after removal of the tumor and weighing. Using flow cytometry detect the changes of CD3+, CD4+, CD8+T lymphocyte subsets from eye blood. After removal of the eye, the pain threshold of mouse was detected by adjusting the hot plate. Then calculate the increasing percentage of pain threshold. It has statistical significance by comparing differences of pain threshold between the control group and dose group.Result:Optimal preparatory procedure of shegan oral liquid is A1B2C2D2 which means water decocting twice,2 hours at first decoction,1.5 hours at second, water consumption is 8 times of weight of material herb, and ethanol concentration is 50% in sedimentation. The preliminary stability test showed that medicine could be kept for 12 months in normal storage condition. Medicines could be identified by TLC. The Linear correlation of the belamcandin is good in extent of 0.536～2.680μg (r=0.9989, n=6) and the recovery is 96.77% (RSD=1.66%, n=6). The results showed that the mice weight was significantly decreased in model group compared to the control group (P<0.01), the mice weight were increased in all groups, in which model group was significantly higher than control group, Shegan high dose group, low dose group and chemotherapy group, and the high dose group were significant differences compared with model group (P<0.05). The tumor inhibition rates of three groups were 14.2%,9.4%,33.0%, respectively. The spleen and thymus index of mouse were increased in high-dose group, low dose group and chemotherapy group. Then high-dose group has significantly different comparing model group (P<0.05, P<0.01). The high-dose group can increase CD3+, CD4+, CD8+T lymphocyte in the peripheral blood and increase CD4+/CD8+ratio, and has significantly different compared with model group (P<0.05). High doses can increase the pain threshold of mouse, and the control group has statistically significant (P<0.05) compared with before administration.Conclusion:Shegan oral Liquid manufactured by optimal procedure A1B2C2D2 is stable and method of its quality standard is simple, reliable, and specific, and can be used for quality control. In addition, the shegan oral liquid can reduce tumor mass, can increase the pain threshold and percentage of pain threshold as well as the spleen and thymus index of mouse with H22 solid tumor.
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