Study On The Preparation And Quality Standard Of Liuweidihuang Biological Alcohol Soluble Tablets

Objective: Liuweidihuang decoction metabolized by photosynthetic bacteria(LW-PSB) is the use of photosynthetic bacteria metabolized liuweidihuang decoction.Using photosynthetic bacteria biological transformation function to changing liuwei dihuang therapeutic material basis,early research shows that antiaging effect of LW-PSB is superior of liuweidihuang decoction.In order to ensure the stability of LW-PSB, drug dose reduction, improve patient compliance with medication,while on the basis of maintaining efficacy,the LW-PSB’s alcohol-soluble part of the extract develop into a Tablet, and preparing the draft quality standard, and provide the basis for new drug application.Methods: 1.The preparation of LW-PSB Research group of early optimizing photosynthetic bacterial metabolism of liuweidihuang decoction can be prepared of LW-PSB; 2.Alcohol precipitation technology of LW-PSB An orthogonal test was adopted to optimize alcohol precipitation process. 3.The LW-PSB of alcohol soluble portion effects on fecundity and life span of Drosophila melanogaster Using wild type Drosophila Drosophil melanogaster as experimental subjects,the LW-PSB alcohol soluble parts experimental study on fecundity and life span of Drosophila melanogaster. 4.The LWPSB alcohol-soluble part of Tablet preparation Visit tabletting conditions, core particle mass prescription and semi-finished products, optimizing film coating formulation and process conditions. 5.Study on the quality standard of alcohol-soluble part of the Tablet of LW-PSB In accordance with the Pharmacopoeia(2010 Edition) relating to Tablet quality inspection of the relevant provisions, the establishment of paeonol by TLC and determination of paeonol, total sugar content, improve its quality standard. 6.Preliminary stability studies alcohol soluble part of the LW-PSB tablet Film-coated tablets for high temperature, high humidity, strong light irradiation test and accelerated testing, stability key check project studied film-coated tablets.Results:1.Alcohol precipitation technology of LW-PSB. Take liquid concentrations of 0.25g/m L biological preparations for of liuwei dihuang amount, add 90% of ethanol, water and stir, to a final concentration of 65%, the temperature at 25 ℃ alcohol 24 h, centrifugal, abandoned to the sediment, supernatant ethanol recovery solid content for 72%, relative density is 1.375(80℃) heavy crude extract. 2.The LW-PSB alcohol-soluble part of core design. 39% of LW-PSB alcohol soluble portion extracts, 49.4% microcrystalline cellulose, silica gel powder 1%, 5% of Crospovieone(PVPP) and 5% of Carboxymethylstach Sodium(CMS-Na) was added before making powder, 5%PVP K-30(95% alcohol) solution is the right amount, magnesium stearate, 0.6%. 3.The best process parameters are LW-PSB alcohol soluble part of the film-coated tablet. Air inlet temperature 45-50 ℃, temperature 40-45 ℃, peristaltic pump pressure is 3-4bar, coating fluid velocity 3m L/min, gun-a distance of 20 cm, coated pans RPM 50-60 rpm, curing temperature is 40℃, curing time 8h. 4.Study on the quality standard of the LW-PSB alcohol-soluble part of the Tablet. LW-PSB alcohol-soluble part of the appearance of the tablets, weight variation, disintegration time meets the requirements, and prepared the draft quality standard. 5.LW-PSB alcohol soluble part of Tablet stability test result. LW-PSB dissolved some tablets in a range of alcohol under the condition of high temperature, high humidity, glare, tablets all indices did not change significantly.Conclusion: Optimization of biological preparations for of liuwei dihuang alcohol soluble portion of film-coated tablets forming a stable, quality can be controlled. Research on guarantee of liuwei dihuang bio-efficacy on the basis of alcohol, removing large amounts of starch, pectin, gum, protein, polysaccharide, phlegmatic, pigments and other impurities, it is made from film-coated tablets, improving the bad smell, and ensure stable quality control of liuweidihuang biological agents, provide the basis for new drug application, and provide the basis for new drug application.