Study On The Preparation Process And Quality Standard Of Invigorating Spleen And Resolving Dampness Grains

The Invigorating Spleen and Resolving Dampness clinical decoction come from the clinical experience prescription of Shanghai Traditional Chinese Medicine Professor Ma Guitong. It's made of Radix astragali praeparata cum melle,Fructus alpiniae oxyphyllae,Radix paeoniae alba,Rhizoma Atractylodis Macrocephalae,Radix Saposhnikoviae,Pericarpium citri reticulatae,Fructus amomi,Poria,Radix linderae,Radix et rhizoma glycyrrhizae praeparata cum melle and have 30 years of clinical application of basic. This prescription has good curative to irritable bowel syndrome of deficiency of the spleen.This study is mainly based on the clinical prescription to change the dosage forms through the modern means. It is necessary to preserve the original effect, but also to adapt to modern society drug concept. Meanwhile, in order to ensure the safety of preparation, stable and controllable, we must establish the quality control standards that form of this dosage forms. Therefore, we study the prescription systematically about the preparation process and quality standards. Now its about the objective methods, results and conclusions:Objective1.To determine the preparation process of Invigorating Spleen and Resolving Dampness Grains.2.To study the quality standard of Invigorating Spleen and Resolving Dampness Grains.3.To investigate the preliminary stability of Invigorating Spleen and Resolving Dampness Grains at room temperature.Methods1.First, through the pharmacodynamics experiments, pairs of three different extraction solvent (method), a method for traditional water decoction, a method for ethanol reflux method, a method for the low-temperature dynamic extraction-freezing concentration method, to choose the best extraction solvent (method); and then followed by orthogonal test method to evaluate the extraction and purification technology on the basis of astragaloside content and the yield of extration for further optimization. Through the choice of dosage forms, auxiliary materials and the wetting agent to determine the preparation process of Invigorating Spleen and Resolving Dampness Grains.2.Through methodological study, establish the quality evaluation system of Invigorating Spleen and Resolving Dampness Grains. Applying the thin-layer chromatography(TLC)to identify the Radix Saposhnikoviae,Pericarpium citri reticulatae,Radix linderae and Radix et rhizoma glycyrrhizae praeparata cum melle in Invigorating Spleen and Resolving Dampness Grains. Applying the high performance liquid chromatography(HPLC)to measure the content of astragaloside in Radix astragali praeparata cum melle and paeoniflorin in Radix paeoniae alba. Qualitative identification and quantitative control combined to control the quality of preparation.3.According to remaining samples observation method, investigate the preliminary stability of Invigorating Spleen and Resolving Dampness Grains in three months at room temperature, through three batches of samples with forms, identification, moisture content, particle size, microorganism limits and determination of effective ingredients as the evaluation.Results1.Study on preparation process of Invigorating Spleen and Resolving Dampness Grains: use the medicinal material with compound pieces, to add 10 times of water, decoct for 3 times, each time with 0.5h; merging the drug liquid, centrifugal 15 minutes with 3000r/min, and then concentrate to contain the amount of crude 1.0g/ml. When it cooled down to room temperature, adding the 95% ethanol slowly while stirring. Adjust the concentration to 60%, closed put it aside for 36h; filtering, washing the precipitation with a small amount of ethanol, and combined the washing liquid and the filtrate. Decompression recovery to the non-alcohol taste, and continue to concentrate until thick paste, drying into a dry paste at 80℃with the vacuum drying. Then crushed, over 60 mesh to the dry powder; mixed evenly with dry powder:lactose=1:1 ratio, with 70% ethanol as the wetting agent, make into granule, drying, adjust the granulation and is OK.2.Study on the quality standard: to identify the Radix Saposhnikoviae,Pericarpium citri reticulatae,Radix linderae,Radix et rhizoma glycyrrhizae praeparata cum melle and Rhizoma Atractylodis Macrocephalae in preparation by TLC, but the Rhizoma Atractylodis Macrocephalae is not identified. Measured by HPLC per gram of grains containing Radix astragali praeparata cum melle to astragaloside should not less than 0.15mg/g; with Radix paeoniae alba to paeoniflorin should not less than 0.75mg/g. Qualitative identification and quantitative control combined to control the quality of preparation.3.Study on preparation preliminary stability: through the observing experiments of remaining sample, three batches of samples in plastic conditions, the preliminary stability is well in three months.ConclusionStudies have shown that the preparation process of Invigorating Spleen and Resolving Dampness Grains are reasonable and feasible, the quality evaluation system are comprehensive and reliable, and the three batchs of samples are stable in three months at room temperature.