Studies On Preparation Process Of JianPiKaiWei Granule

Jianpikaiwei granule,which is made from Panax ginseng,Atractylodes macrocephala, Poria cocos, Glycyrrhiza uralensis and other four Chinese medicinal herbs, has the function of enlivening the spleen and regulating the stomach.It is mainly applied to treat the symptoms of weakness of the spleen and stomach ,dyspepsia,abdominal flatulence,loose stool and etc.In order to provide a new drug with the features of convenience,fast,small dosage and good effect for the patients,the experimental study has been carried out systematically on its preparation .1.Using the transferring rate of ginsenosides,ginsenoside Rg1, ginsenoside Re and extraction ratio as indexes, we selected the optimum extraction conditions with alcohol by the orthogonal test which selected alcohol content, alcohol volume,extraction time as examing factors.The optimum alcohol extraction conditions were established as follows: refluxed two times, adding 8 folds and 6 folds solvent volume respectively, each time for one and half hours .2.With the quantity of β-CD ,inclusion temperature and time as examing factors,using the ultizision ratio of oil from Rhizoma Atractylodes and Citrus reticulata, the oil-bearing ratio and the yield of inclusion compound as indexes,we selected the optimum preparation conditions for inclusion by the orthogonal text, which were:1:8(V/W) (the ratio of oil toβ-CD),50℃(the inclusion temperature ), 4 hours( the inclusion time).3.With soaked time, solvent volume and extracted time as examing factors,usingthe transferring rate of glycyrrhizic acid and extraction ratio as indexes,we selected the optimum water extaction conditions by the orthogonal text,which were:dipped 45 minutes, then extracted three times,adding 12 folds,10 folds and 10 folds solvent volume respectively, each time for two hours .4.With the content changes of ginsenosides ,ginsenoside Rg1, Re and glycyrrhizic acid as indexes, we studied on the processes of concentration and dryness by contrast experiment. The optimum processes were obtained as follows: temperature of dryness of alcohol extract within 60℃after enriched by decompression, concentration temperate of water extract within 100℃and dryness temperature within 70℃.5.Contrast experiment was carried out on the adjuvant and the manufacturing process of granule.According to the experiment results, we chose the lactose as adjuvant and 3% PVP solution of EtOH as binder.6.By assessing the hygroscopicity of the dry granule,we decided that the moisture of the producing environment should be controlled under 68%.