| Objective: To study the preparation procedure and quality standard of Xinyu Tiepian. Methods: The extracting conditions of Herba Asari and Fructus Evodiae were optimized by the orthogonal design, using the extraction rates of volatile oils, evodiamine and rutaecarpine as standards. The moldability and the cumulative permeation amounts of evodiamine and rutaecarpine were taken as standards to select the optimum bases and penetration enhancers, the quality standard of Xinyu Tiepian was established based on its thin layer chromatography (TLC) and the content limit of rutaecarpine. Results: Herba Asari, macerated for 1 hour with water 8 times the amount of dry plant, was distilled for 3 hours, the volatile oils distilled were then mixed with equal aerosil (mL:g);Fructus Evodiae was extracted with 8 times the amount of 80% ethanol under reflux for 2 times, 2 hours each, and the extract was then condensed, desiccated and smashed. Three batches of Xinyu Tiepian were produced using polyethylene glycol as bases by fusion method, and our preparation procedure was proved steady, reasonable and feasible. An HPLC method was established to determine the content of rutaecarpine, And by which a contet limit of our product was made. Also, TLC methods for the identification of Herba Asari and Fructus Evodiae in this prescription were provioded. Xinyu Tiepian was testified to have a good stability by observations of the reserved samples for 6 months. Conclusion: The preparation procedure and quality standard of Xinyu Tiepian were steady, reasonable and feasible. |
