Preparation Technology Of Liver-aid Tablet And Its Stability Investigation

"Liver-aid tablet" is mainly made from Bupleurum,Artemisia capillaris Thunb,Radix Isatidis,Schisandra Chinensis,Pulvis Fellis Suis,mung bean,which is the national essential drugs.It has remarkable clinical effect and is used for the treatment of chronic hepatitis and forepart hepetocirrhosis.The traditional extraction technology and preparation technology of"liver-aid tablet"are relatively backward,thus have potential for secondary development.The new technology of "liver-aid tablet" is the secondary development based on the original technology,which conducts systematic research on extraction technology,preparation technology and stability of "liver-aid tablet" 's new technology during the research process,so as to provide the scientific basis for the secondary development of "liver-aid tablet".(1)The extraction technology:using supercritical-CO2 fluid to extract the active ingredient ofSchisandra Chinensis,and through orthogonal experiment,determining the optimum extraction technology of Schisandrin in "liver-aid tablet" are 25Mpa of extraction pressure,45? of extraction temperature,and 2.5 h of extraction time.The obvious advantage of supercritical-CO2 fluid method are that there is no residual solvent,the extraction technology is simple,the extraction time is short,and the utilization of raw material is high,all ofwhich have greatly simplifiedthe production process.The experimental results show that using supercritical-CO2 fluid to extract the active ingredient ofSchisandra Chinensis hasgood extraction results,which is stable and feasible.(2)Molding technology:wetting agent,disintegrating agent and lubricant are the main excipients in the preparation technology.This paper employs the single factor method to determine the optimum wetting agent,disintegrating agent and lubricant:80%ethanol is used as wetting agent,magnesium stearate is used as as lubricant,sodium carboxymethyl starch is used as disintegrating agent,and the addition method of disintegrating agent isextemal addition method.Using film coating technology to substitute the original sugar coating and L9(34)orthogonal experiment is adopted to determine the optimum coating technology parameters for coating liquid concentration is 12%,coating liquid spray rate is 160 ml/min,inlet air temperature is 80?,and coating pan'srotate speed is 4 r/min.The experimental results show that the molding technology is effective,stable and feasible.(3)Stability investigation:producing three batches of "liver-aid tablet" according to the improved technology,and carrying out 6-month to accelerated stability experiment and 12-month the long-term stability experiment on the experimental sample,the experimental results show that such as the data of the character,weight variation,disintegration time and content of"liver-aid tablet" sample accord with pharmacopoeia standards;the "liver-aid tablet" produced by the improved new technology has stable quality,which shows that the improved the improved preparation technologyis reasonable and its product quality is stable.The experimental result of this paper provides a theoretical basis for the industrial production after the improvement of "liver-aid tablet" technology,which lays a good foundation for the development and research of new drugs.