| Objective: Through the experiment, to the traditional Chinese medicine tradition compound prescription Wu tou soup's extraction process, the preparation formation craft as well as the quality specification conducts the research, prepares membrane- controlled slow release condensed-pellet, provides the theory basis for the traditional Chinese medicine slow release preparation's research。Method: With the single survey and orthogoral experiment design to optimize the extraction method and extraction craft of Radix Aconiti Preparata, as guided by the rate of Aconiti total alkaloids'extraction. As guided by the rate of Ephedrine hy- drochloride, to optimize the tegerther extraction method and extraction craft of Ep he- drine, Radix Patoniae, Alba Radix Astragali and Radix Glycyrhizae.Ethylcellulose (EC), Diethyl Phthalate(DEP) and Polyethy-lene Glyol-400(PEG-400) were selected as the coating materials. The thinchness of the membrane, quantity of plasticizer and the porosity- making agent were confirmed the main factors which effect the release rate. Uniform design was used to optimize the membrane for-mulation. The thin layer chromatography and the HPLC chromatography were used to research the WouTou soup membrane-controlled slow release condensed-pellet's quality specifica- tion.Results: The experimental result indicated that, the optimal WouTou soup membrane-controlled slow release condensed-pellet's effective component, extrac- tion craft, the preparation formation craft and the coating craft are stable, are feasible, The slow release condensed- pellets'release pattern was in accord with Higuchi order Kinetics. At the same time, drafts the quality specification can control its quality effecttively.Conclution: After the modification, the WouTou soup membrane-controlled slow release condensed- pellet had eccellent release profiles. The results has provided cer- tain theory reference for research of the traditional Chinese compound prescriptions'slow release preparation. |
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