The Study Of Preparation Procedure And Quality Standard For Tui Yi Tablets

Objective:①To establish the preparation procedure of Tuiyi Tablets;②To establish the quality standard of Tuiyi Tablets. Methods: (1)extraction procedure:Use baicalin and water extraction with the synthetic score as index to select the optimum water extration process by single factor design and orthogonal design method.Use ferulaic acid,total flavonoids and ethanol extraction with the synthetic score as index to select the optimum ethanol extration process; (2)clarification procedure: Use high-speed centrifμgal method to select the optimum refining process; (3)formation procedure: ligustici herb power as material,use the angle of repose,pile-density,formation and disintergration of tablets to select the optimum formation process. (4)quality standard: the quality standard of Tui yi Tablets was identified by TLC and HPLC. Result: preparation procedure: add 14 times amount of 60% alcohol into ligustici and other two medicinal substances,reflux-extracting for 2 times 2 hours each time,recover ethanol and centrifμge; add 12 times amount of water into baical skullcap root ande other three medicinal substances reflux-extracting on the first time .other two times are adding 10 times amount of water which 1 hour each time. the liquid was condensed into the ratio of 1:4.75 comparing to the medical material,Adding ethanol precipitation combine with water extraction and concentrate,get the solid extract by drying; adding 1/10 of ligustici herb power comparing to crude material and 10% microcrystalline cellulose.adding 1/3 inside and 2/3 outside 10% LHPC.the pellet were made by 93% alcohol,adding 1% of stearil acid-Mg to press tablets.②Angelica in Tui yi tablets made qualitative differentiation with TCL of ligustici,rhizoma,the content of baicalin was understanded with HPLC. Conclusions: It was Proved that oPtimum design of exPeriment Procedure of the extraction,modeling technique and nitial stability study,acute toxicity test is reliable,the Process is controled for quality and noxious ProPerty that will do well datas for new drμg to rePort to a higher authority.