Preparation, Quality Standard And Stability Test Research Of Simotang Granules

Chinese medicine, simotang granules, are created according to simotang oral solution, which has been sold in the market; The principal constituents of this proved recipe include RADIX AUCKLANDIAE, FRUCTUS AURANTII, RADIX LINDERAE, SEMEN ARECAE and so on; According to the pharmacology, the recipe can improve wriggling movement of the stomach and intestines, secretion of digesting fluid, remove the overaccumulation in the stomach and intestines. In early time, this recipe could be used to prevent and control the babies indigestion; Later, it was used to prevent distension of the abdomen in the senior citizen;Recently, it can restore digestion of the stomach and intestines, the curative effect is remarkable, safe and reliable. Simotang oral solution was a kind of fluid preparation with worse stability, when laying aside for a long time, it will produce the precipitation; Further more, the preparation of oral solution need the higher equipment requst.Simotang oral solution rooted from the " National Chinese Patent Drugs Standard Assembly Internal medicine spleen stomach Fascicle". Concerns its granules, we do not see the research report and application, therefore, we change the oral solution into the granules, according to its excellence: a small volume \good quality\ reasonable price \convenience taking. At the same time, the production cost is reduced, and the different patients'request can be satisfied very well.This article explored the preparation method of simotang granules, formulated its quality specification, and conducted the investigation of its stability, in favor of its industrialisation and clinical utilization. The main content includes:1. explored and optimized the prescription design and the preparation craft of simotang granules, from the inspection of distilling time, volatile matter, the watering multiple choice, the extraction relative density choice, to the preparation shape craft and so on, we conducted an abroad research, and then the best preparation craft was confirmed.2. formulated the quality specification draft of simotang granules. Tentatively we have determined the prescription design of simotang granules\preparation method\the character, the distinction, the inspection, the content determination, the function and main avail, the usage and the oral amount, the specification, store and so on; Simultaneity, established the method of determination the content of the naringin, the effective component of simotang granules.3. carried on 12 months long-term and accelerative stability test research of simotang granules. According to the accelerative test results, simotang granules, were packed by the compound membrane made from the polyester/aluminum/polyethylene; Under 40℃, RH75% condition, laid aside for 6 months, the quality was stable; According to the long-term room temperature test results, under the room temperature condition, simotang granules were packed by the same thing, keeps 12 months, the quality was stable via test, the experimental results tallied well with the quality specification draft of simotang granules.