The invention belongs to the technological field of the Chinese
medicine, particularly relating to an extraction and separation processes of the active ingredients with the active function of treating the
chronic glomerulonephritis. The mullein indican is the
active compound researched and developed for many years in our research institute; the mullein indican is extracted, separated and refined from the
digitalis leaf and is an
active compound with the function of treating the
chronic glomerulonephritis. The invention is the
research result of many years held and developed by the Chinese
Medicine Research Department of the Chinese
Medicine Research Institute of China and is supported by the special fund of the Central Institute of the National Science and Technology Department; now the compound has been approved by the State
Food and Drug Administration Bureau as the novel
drug and the mechanism research of the treatment of the
chronic nephritis has been completed; the pre-
clinical research work includes the main pharmacodynamic experiment, the production technology experiment (including the industrialized extraction and separation processes), the
quality control standard, the experiment of the affecting factors of the quality, the experiment of the long-term stability, the
acute toxicity of the rat, the experiment of the long-term
toxicity, the teratogenic and mutagenic experiment, the general pharmacological experiment, the
pharmacokinetics experiment, and so on. The
digitalis leaf is mainly produced in the Huaiqing area of the Henan province, and is also grown wild and cultivated in the Shaanxi, Hebei and other places of China.