On Prepration Process Of Jianweiyuchang Tablet

Jianweiyuchang Tablet.which is made from Radix Ast ragali and Herba Taraxaci,is an effective prescription in treating Chronic Ulcerative Colitis.The author has made a systematic study on its preparetion,and the study has laid the foundations for quality standards and further developing it into a new Colon coating tablet preparation.1.Study of the extractionAccording to the compatibility experiment,the extracton line was confirmed, that was,Rhizoma Coptidis and Radix Notoginseng being ethanol extracted. Atractylodes rhizome and Nutmeg were extracted oil by water. Radix Ast ragali and Herba Taraxaci were watered.On the basis of these studies,with the transferring ratio of Berberine hydrochloride and notoginsenosides as optimization targets,the optimum ethanol extraction confirmed by Uniform design was:2 times of refluxing with 60% ethanol,9、7 times of ethanol-adding amount and 2.5、2.0 hours of refluxing time respectinely. In addition, with the Volatile oils extracting ratio of Atractylodes rhizome and Nutmeg as index. The optimum extraction confirmed was:45 minutes of soaking,8 times of water-adding and 6 hours of refluxing time.The optimum preparation conditions for inclusion were established as:oil:β-CD was 1:12, the stirring time was for 3 hours at 60℃.With the content of caffeic acid and extracting ratio as index,the optimum water extraction confirmed by the orthogonal test was:30 minutes of soaking,3 times of refluxing with water, 10、8、8 times of water-adding amount and 2.5、2.0、2.0 hours of refluxing time respectinely. 2.Study of the purificationThrough some mono-factors experiment. With transferring ratio of extracting、Polysaccharide and caffeic acid as index,The optimized clarification conditions by Chitosan flocculantion method was made:Decotion was concentrated to at 1:5(g:ml);1ml/g 1% Chitosan flocculanting agent was added after keeping the temperature at 60℃and the rate of stirring at 150r/min for 10min,then Decoction of the herb was filtered after 24 hours. The optimized clarification conditions by ethanol subsiding method was made: Decotion was concentrated to relative density with 1.09 and adding 95% ethanol to 60% ethanol of the herb,then Decoction of the herb was filtered after 24 hours.Through the comparing of the two clarification methods.the result showed that the process of ethanol subsiding method was better than that of Chitosan of flocculation.The former can decrease extracting ratio and dosage for making coating tablet.3.Study of the concentration and desiccationWith contrast experiment on the effects of different temperature on the alteration of contents of Berberine hydrochloride and coffeic acid after vacuum and spray drying.the author got the following results:the herb was spray dried with 160℃and concentrating to relative density with 1.09.4.Study of the preparation processWith the disintegrant ratio,and parameters of making Granules and Tablets, the author obtained the optimized prescription:dried powder:microcystalline cellulose:lactose=15:3:3.2% PVP (K30) 85% alcohol(wetting agent).2% Silicii Doxydum (diluent),1% Magnesium Stearate (glidants).