The Study On Preparation And Quality Standards Of Sanjiemingmu Granules

Objective: to research the technology of preparation and establish the quality standards of the granules. Methods: 1) use the method of HPLC determine the content of peoniflorin and alcohol extraction rate of extractum as the index ,select the top radix paeoniae rubra, spica prnuellae et. eight species of medical materials to sure the aqueous alcohol extraction technology Parameter; 2)use the method of HPLC determine the contents of salvianolic acid B and water extraction rate of extractum as the index , select the top Salvia m iltiorrhiza Bge, Safflower, Thallus japonica drug ingredients to sure the aqueous water extraction technology parameter; 3) use the contents of peoniflorin remain rate and alcohol extraction rate of extractum as the index, studying the refined technology of alcohol extractions; 4) use the contents of salvianolic acid B of remain rate and water extraction rate of extractum as the index,studying the refined technology of water extractions; 5) researching the moulding technology of sanjiemingmu granules; 6) Qualitative test with thin-layer chromatography was performed on Sanjiemingmu granules, with all species of medical materials, use the Method of HPLC to measure the content of salvianolic acid B, and make out the quality standard. Result: 1) The optimum alcohol extraction process preparation to reflux it 10times the volume of 80% ethanol,extracte three times,1 hour each time; 2) The optimum water extraction proceduret is to reflux it with 20-fold water for 2 times 0.5 hour each time; 3) The purification technology of alcohol extraction concentrate and the proportion of medicine and physic liquor was 1:10. add 10%-fold B of ZTC +1-Ⅱ,the inclusion temperature was 60℃for 1h,and tnen add 5%-fold A of ZTC +1-Ⅱ,the inclusion temperature was 60℃for 1h. waters cold preservation for 24 hours, centrifugate 2 minnites; 4)The purification technology of water extraction concentrate and the proportion of medicine and physic liquor was 1:4, brachyte -ly centrifugate 4000 r·min-1, centrifugate 10 minnites; 5) Use 20% Zedoary Turmeric power,5‰beetsugar as supplementary material and 92% ethanol as bond to measure Sanjiemingmu granules's moulde technology ; 6) To set up the qualitative differentiation with the method of TLC of Prunella,rhizoma chuanxiong,radix paeoniae rubra,flos sophorae,the content of salvianolic acid B was understanded with HPLC. the method of salvianolic acid B with HPLC: mobile phase: acetonitrile-0.2% acid(23. 5︰76. 5), detect wavelength : 286nm.Conclusion:It was proved that optimum design of experiment procedure of the extraction,modeling technique and nitial stability study,acute toxicity text is reliable,the Process is controlled for quality and noxious property that will do well datas for new drugs to report to a higher authority.