Preparation Of QingRe DaYu Granules And Oral Liquid

QingRe DaYu formula consists of Radix Rehmanniae, Rhizoma AnemarrhenaeFructus Jujubae,etc. It possesses the efficacy of clearing away heat and activatingblood. It is applicable to cure Hepatic Cirrhosis in view of various causes according tothe traditional Chinese medicine.The thesis is about optimizing extraction conditions and refining process byorthogonal design, studying preparation technology, standard quality and stability aswell.Study factors that affect volatile oil. The result shows that volatile oil is mostwith the condition: 8 folds of water, influx for 6h. Establish optimum inclusionprocess through orthogonal test, and Recovery ratio of volatile oil is regarded asindex. Optimum condition is composed of is 1:9, inclusion time is 20 min, withinclusion temperature of 20℃, 30kHz.The optimum extraction process, which was selected by orthogonal table L₉(3⁴),was as follows: water extracting twice, the amount of water for decoction was 8times as much as herbs and herbs was marinated 1h before decocted, 1 hour eachtime. The best clarifying technique as follow: 1% chitin solution was added into thedecoction which was concentrated to 4: 1 (material: decoction volume), in amountof 6%. Percolation was used to extract Rhizoma Zingiberis with its conditions asfollow: take 70% ethanol as solvent, the amount of solvent was 15 times of herbs,flow rate was 1-3 ml·min^-1.The refined decoction was concentrated to the extent that its relative densitywas 1.20(60℃). Drying spray was used to make the concentrated liquor intopowder. Preparation experimental results suggested that it was suitable to use 90%ethanol and 20% lactose to make granules of good flow ability and deliquescentability.Extracting technology refers to granules. The optimum absorbing clarification process for Oral Liquid is as follow: the mixture, the extraction of RhizomaZingiberis and decoction, was concentrated to 5:1 (material: decoction volume), then1% ZTC was added into the decoction with amount of 8%. The study of preparationprocess shows: 1.1%Tween-80 was mix with the volatile oil before it was added intothe decoction.0.1%Sodium cyclamate and 0.1%Ethyl paraben were added into theconcentrated liquor.Established TLC methods to identify Radix Rehmanniae,RhizomaAnemarrhenae,Fructus Jujubae,Flos Caryophylli in granules and oral liquidsrespectively. And all items were tested and up to standard according to the ChinesePharmacopoeia (2005). Adopted HPLC to detect Catalpol and Bacailin content insample and carried mythology review at the same time. The results showed: theaverage recovery rate were 99.36%,100.59%, RSD were 1.12%,1.59% forgranules;98.80%,99.63%, RSD 1.20%,0.83% for oral liquid; The methods wereexact and reliable. According to Thermostatic accelerated test results, the granulesand Oral Liquid are of good stability.