Studys On The Preparation And Quality Standards Of Zhishixiebaiguizhi Granules

Zhishi Xiebai Guizhi Decoction from" synopsis of the Golden Chamber" chest pain, shortness of breath and cure disease pulse to ninth, by the FAI, Allium macrostemon Bunge, melon, Magnolia and GUI component, with Yang Sanjie, expectorant effect of gas. Used for chest Yang depressed, phlegm qi4interties of chest pain, chest pain, heart and gas, gas in the chest, chest full of gas from the reins, inverse grab heart disease. Modern clinical use for the treatment of cardiovascular disease, gastrointestinal disease, nervous disease, respiratory system disease.Zhishi Xiebai Guizhi granules is directed to" Zhishi Xiebai Guizhi Decoction" by the development of new drugs, the issue from the preparation process, quality standard and stability of three aspects of Zhishi Xiebai Guizhi particles, expanded pharmaceutical research.Study on preparation process of:to extract rate, extract content, the content of total saponins, honokiol and magnolol content, multiple indexes determination, the traditional extraction methods and modern comparative study on extraction process of Zhishi Xiebai Guizhi, formulate granule preparation technology, was studied by single factor and multiple factors orthogonal test, comprehensive evaluation developed reflux extraction, concentration, drying and other steps of the process parameter; granule forming process research, to forming rate, particle size, moisture absorption, liquidity index, type, amount of materials, process conditions were investigated and evaluated, established the prescription, preparation of specifications and storage important conditions.Study on the quality standard of:Zhishi Xiebai Guizhi on quality standard of make full use of modern chromatographic techniques, for the preparation of Allium macrostemon Bunge, melon, Magnolia three herbs established TLC project; on the effective components of magnolol, honokiol and magnolol by high-performance liquid chromatography determination of other projects; appearance characteristics and moisture, granularity, check project also has very good reproducibility and stability. Make Zhishi Xiebai Guizhi granules comprehensively established a quality control system.Preparation of preliminary stability studies:in accordance with the requirements of new drug R&D, Zhishi Xiebai Guizhi granules preliminary stability test, respectively in0,1,2regular,3,5months of preparation, the appearance of TLC identification examination and determination of content, such as testing, the results show that the appearance of the product characteristics, identification, inspection, determination of content the inspection index did not change significantly, consistent with preclinical drug quality standard requirements, the preparation in the storage period of5months, quality stability.