RESUMO
OBJECTIVE: To evaluate the allergenicity of Reduning injection and intermediate using ultrafiltration and the mouse spleen cell proliferation assay. METHODS: The samples obtained by 3 kd ultra-filtration, were incubated with mouse spleen mononuclear cells for 3 d, and then the trypan blue staining was used to count the alive cells for the evaluation ol drug allergenicity. RESULTS: Effect of No. 1 of Reduning intermediate was strongest to stimulate proliferation of mononuclear cells, and then actions of No. 2-5 decreased in turn, after the refining processing. CONCLUSION: A four-step refining process reduces the stimulated actions of Reduning intermediates on the mononuclear cell proliferation. Most Reduning injection have no this action, but several batches ol samples with known clinical allergic reaction have the stimulated actions on the mononuclear cell proliferation. Ultrafiltration-mononuclear cell proliferation assay could be used for the determination of macromoleeular substances from Reduning injection.