Abstract:

To improve the clarity and stability of Xiaojianzhong mixture, the activated charcoal impurity removal process was selected to purify Xiaojianzhong mixture. The orthogonal test evaluation method was used; the evaluation factors were the amount of activated charcoal, boiling time, and the temperature of the solution during charcoal removal. Furthermore, the transfer rates of paeoniflorin and dry matter were used as evaluation indicators. Variance and visual analyses as well as accelerated stability tests were conducted to optimize the activated charcoal purification process for Xiaojianzhong mixture.In order to carry out these above experiments, three batches of Xiaojianzhong mixture preparations were produced for long-term stability testing. Results showed that the optimal parameters for the activated charcoal boiling purification process of Xiaojianzhong mixture preparations were 0.4% activated charcoal usage, 30 min of activated charcoal boiling time, and a liquid temperature of 100 ℃ during filtration. The average transfer rates of paeoniflorin and dry matter in expanded production under these process conditions were 75.24% and 89.08%, respectively. The optimal activated charcoal boiling purification process obtained from this test can ensure the clarity and stability of Xiaojianzhong mixture preparations while maximizing the retention of paeoniflorin and dry matter, thereby ensuring stable and uniform drug efficacy. This study provides a scientific and reasonable basis forclarifying and optimizing the parameters of the activated charcoal boiling purification process for Xiaojianzhong mixture.

Key words: Xiaojianzhong mixture, activated charcoal, HPLC, paeoniflorin, dry matter