This invention discloses a preparation process for a homogeneous immunomodulatory
polysaccharide from *
Gynostemma pentaphyllum* and its application in the preparation of anti-
melanoma drugs and immunomodulators, relating to the field of
pharmaceutical manufacturing technology. The preparation process includes four steps: compound
enzyme-
ultrasound synergistic extraction, fractional
alcohol precipitation to remove proteins, DEAE-52
ion exchange
column chromatography, and Sephacryl S-400
gel permeation chromatography purification. The resulting homogeneous
polysaccharide (GOP-3) has a weight-average molecular weight of 12±1 kDa and is composed of
mannose, glucose, and
galactose in a specific ratio. The GOP-3 of this invention has a weight-average molecular weight (Mw) of 12.8 kDa, a dispersion (Mw / Mn) < 1.2, a
uronic acid content of 23.5%, a well-defined structure, and is suitable for
drug application. Furthermore, GOP-3 can significantly promote the
secretion of IL-12 by dendritic cells and induce the differentiation of naive T cells into Th1 cells. Simultaneously, compared with a full-
dose PD-1
monoclonal antibody, the combination of GOP-3 and a half-
dose monoclonal antibody not only reduces the risk of immune-mediated pneumonia caused by
antibody drugs but also increases the
tumor inhibition rate by more than 40%.