[Studies on key processes of Fufang Kushen injection].

OBJECTIVE: To study the key processes of Fufang Kushen injection for technical upgrading. METHOD: Total alkaloids (sum of matrine, oxymatrine, sophoridine and oxysophoridine) and macrozamin were selected as quality evaluation markers. The key processes of percolation with acetic acid and discoloration with activated carbon were optimized by orthogonal experiment design, and process of purification with alcohol was investigated by single factor method. RESULT: The optimal condition of percolation process is as follows: the medicinal materials are soaked for 9 h with 4 times water containing 0.8% acetic acid, then percolation starts at flow-rate of 5 mL x min(-1) x kg(-1) and adding 2 times 0.8% acetic acid solution is added at the same velocity. Purification process is that the concentrated solution is precipitated by 60%, 80% and 90% alcohol in turn. Discoloration process is that 6 activated carbon is added into the solution which is heated at 60 degrees C for 20 minutes. CONCLUSION: The optimal extraction process is not only simple, saving the industrial cycle, reducing the potential risk, but also decreasing the acetic acid amount to guarantee the acid-insoluble ash as well as the functional ingredients.