Study Of Preparation Process And Quality Standard Of Ruanmai TongYu Granules

Ruanmai TongYu Granules composed of Salvia, Epimedium and many other herbs, it was used in the clinical years under the guidance of the theory of Chinese medicine-based Chinese herbal compound decoction, with the effect of Bushentianjing, blood circulation, phlegm meridians, clinically proven, efficacy of carotid atherosclerosis due to ischemic brain disease. According to the needs of modern medication, the subject of the theory of Chinese medicine under the guidance of the prototype decoction converted into granules, the granules used in the preparation process, quality standards and stability before the clinical pharmacy was investigated experimentally.This topic according to the prescription of the taste of Chinese herbal medicine in the physical and chemical properties, using the single factor test and orthogonal test method for preparation of granules in the process of extraction, purification, concentration and filtered molding process, ultimately determine the best route of preparation technology, namely:The Salvia, leeches plus6times the amount of70%ethanol extracted two times, each1.5hours, filtration, combined filtrate spare. Residue, together with the the epimedium, Ganoderma lucidum, turmeric remaining herbs with a12-fold amount of water, which was extracted three times, each time1.0hours, filtration, and the filtrates were combined, and the filtrate was concentrated to a suitable extent to room temperature, add a certain concentration concentrated ethanol solution containing alcohol amounted to60%of the mix, refrigerated overnight, filtered impurity, the filtrate with alcohol extract combined vacuum recovery of ethanol to no alcohol taste, concentrated to a relative density of1.30to1.35thick dip cream, at80℃drying, crushing, and for a powder. Powder:dextrin=3:1ratio feeding,80%ethanol as a wetting agent, the amount of25%, mixed evenly through a80-mesh sieve,60℃dry3h, whole, the particle1000g, that is, too. Distributed into the pouch, bag13g.Quality Standard of part of the character identification of the finished granules routine examination and the determination of granules index components were studied. Salvia through each other, Ganoderma lucidum, turmeric and mulberry leaf herbs TLC method to establish the the the TLC chromatographic conditions and income of the four herbs quality standard text; routine inspection items include the determination of moisture, load difference inspection, particle size and particle dissolves check; indicators tanshinone IIA content Determination by high performance liquid chromatography, school visits and measurement results of a systematic approach to determine tanshinone ⅡA content of the granules limit.Of the Stability left at room temperature samples examined three batches of test samples3months of the study. As a result, the three batch samples of character, identification, examination and content determination results shall comply with quality standards, the preliminary showed that the preparation process is feasible and stable quality.