The Pharmaceutical Research Of Shuangbai Campsule

This investigation was conducted according to the legislation of technical guidelines oftraditional Chinese Drug Research of the State Food and Drug Administration. The bestpreparation process of Shuangbai Capsule was determined by experimental study. Technicalstandards of quality control were established and quality stability of three batches in the testsample was studied in order to ensure the safety and effectiveness of clinical application.Single factor and multi-factor experimental methods were used in the study of the preparationprocess on the base of prescription indications and property of pharmaceutical ingredients.The best preparation process was selected as followed: Lily, Stemona, polygonatum weresoaked with water (8times) for2hours, then Ardisia was added and the materials werecontinually to soak for0.5hour. After boiling for1hour, the liquid was removed and the water(6times) was added at the second and third time, then boiling materials for1hourrespectively. Combined boiling liquid of three times, then, ZTC1+1natural clarifying agentscan be used to purify the extract of Traditional Chinese Medicine. The supernatant wasconcentrated to the relative density of1.20to1.25(60℃) clear extract and cooled, which wasdried at the condition of0.08MPa vacuum and60℃. Microcrystalline cellulose (12.5%) wasadded and the Shuangbai Capsule was obtained by grinding, mixing, sifting, encapsulating.Test results of three batches of samples of general preparation based on this preparationprocess conformed to the provision of capsules in《Chinese Pharmacopoeia》published in2010.Thin-layer chromatography was used to study the quality standards. Specificity andreproducibility identity projects were established to test Lily, Stemona in the preparation. Thepots of position and colour in the test chromatogram were consistent to that in the referencestandard chromatographic respectively. The content of Bergenin（C14H16O9） of Ardisia wasdetermined by HPLC. Methodology inspection results conformed to the provision. Contentlimits were definited according to investigation results. The content of Bergenin of Ardisiawas not less than1.2mg per grain. Established the method for determining dissolution rate ofArdisia in Shuangbai Capsule in vitro Method. The artificial gastric juice was used as thedissolution medium and50r·min-1as rate of rotation with paddle method. HPLC was used to determine Ardisia’s content. Result was that the dissolution rate of Ardisia was higher than70%of labelled amount in Shuangbai Capsule at30min. This method was steady, andsuitable for the test of the dissolution of Ardisia in Shuangbai Capsule. Quality and stabilityexperiment of three batches in the test sample was carried out by high temperature, highhumidity, bright light test, accelerated stability test and long-term stability test. The resultshowed that quality stability of shuangbai capsule was favorable in6months.