The Improvement Of Shugan Tablet Preparation Process And Quality Standard

Shugan tablet is the second level national protection of varieties of traditionalChinese Medicine which is composed of12Chinese herbal medicines include FructusAmomi, Rhizoma Corydalis, pericarpium citri reticulatae, Schwann chinaberry fruitand agilawood etc. Shugan tablet’s function are to aid digestion, to Shu qi appetite, toeliminate stagnation, analgesia and relieving restlessness. The shugan tablet play aimportant role in treatment in stagnation of qi. The currently product process ofshugan tablet could not fit the needs of modern TCM. There is no exclusive qualitycontrol index in shugan tablet quality control criterion.In this paper, we optimize the process of shugan tablet production and developthe exclusive quality control and test method.we determine the optimal condition for the extraction, granulation and coatingparameter by orthogonal experiments. The main results are as follows.（1）The extraction method of agilawood, radix aucklandiae, radix paeoniae alba,zedoary, fructus aurantii and cortex magnoliae officinalis are:Reflux extracting the agilawood by anhydrous ethanol of2hours in the first time and60%ethanol of2hours for the second and third times.Reflux extracting the radix aucklandiae, radix paeoniae alba, zedoary, fructus aurantiiand cortex magnoliae officinalis by60%ethanol of2hours for3times.（2）The optimal parameter of Fluidized-bed granulation are the relative densityof extractum is1.15～1.25g/cm3, the material temperature is20～50℃, the speed ofthe peristaltic pump is20～35rad/min, atomization pressure is0.2～0.4MPa.（3）The optimal parameter of film coating are the concentration of cotingsolution is6%, the flow of coting solution is120ml/min, the temperature of tablets is30~40℃, the rotation rate of coting pan is6～8rad/min.Through scale production test, the updated process product are consistent withthe evaluation indexes and are superior to the original process product in productappearance, disintegration time limit and tablet hardness, weight difference, microbiallimits, and product quality is stable and suitable for actual production.We also developed the thin-layer chromatography of pericarpium citri reticulatae,radix aucklandiae, cortex magnoliae officinalis, radix paeoniae alba for shugan tablet.We take the HPLC method to determine the content of hovenia dulcis by usingquantitative determination of naringin as indicator and the content limitation is morethan1.0mg/tablet. The chromatographic conditions are: Shim-pack VP-ODS C18 chromatographic column(150×4.6mm，5μm), mobile phase of methanol-water-aceticacid(33:65:2), the detection wavelength:284nm, the temperature of column is35℃,theoretical plate number calculated on naringin peak should be not less than3000.The detection method for shugan tablet is operable and exclusive which is provedby screening test and method durability investigation.Through the research, we optimized the production technology of shugan tablet,improved the content of active ingredients in products, and realized the qualitative andquantitative control of the product by improving the product quality standards.