| Xiao Chaihu decoction is a representative classic prescription of Shanghan Lun written by Chinese medical sage Zhang Zhongjing,which has the effect of nourishing the heat dissipation and soothing liver and stomach.Zhou Aijun chief physician of Dongguan Hospital of traditional Chinese medicine took Xiao Chaihu Decoction as basic prescription,adding ginger,coptis root,Poria,Atractylodes various drugs to compose modified Xiao Chaihu decoction,clinically treating hundreds of gastric ulcer and gastritis patients,the curative effect is remarkable.In order to make better use of the clinical effect of modified Xiao Chaihu decoction,Dongguan Hospital of traditional Chinese medicine and our laboratory combine production with teaching and research.This thesis conducted pharmaceutical and relevant pharmacological research on Jiawei Xiaochaihu granule,laying a solid foundation for declaring new hospital preparation of modified Xiaochaihu granule.The optimum technology of extracting modified Xiao Chaihu decoction was studied by using orthogonal test.Researching on the formatoin techniques of modified xiaochaihu decoction granules by modern preparation techniques,obtaining reliable technical parameters.With pilot test it can transition to large-scale production.Taking example from the normalization of quality criteria of Chinese patent medicine in chinese pharmacopoeia(2015),studying on the quality analysis of modified XiaoChaihu decoction.Systematically studying the TLC,different inspection,determing the main index effective compositions of main traditional Chinese medicine of the component.Making perfectquality standardization,and it can effectively control the quality of the preparation.According to the relevant technical requirements of the preliminary stable research on new traditional Chinese medicine issued by the State Food and Drug Administration,wes tudied the preliminary stability about long-storage specimen test and accelerated high temperature experimentation of modified Xiaochaihu granules.The investigation results show that the quality of modified Xiaochaihu granules can meet the requirements,this would be the equivalent of the preparation keeping stable quality within two years.For the efficacy of Xiaocaihu Decoction in clinically treating gastric lesions and ulcers,carrying out the study of anti Helicobacter pylori and anti-inflammatory efficacy test.The research results show that the prescription has significant effect,so as to provide scientific experimental foundation for the expected clinical effect of modified Xiaochaihu granules.At the sametime acute toxicity experiment of Modified Xiaochaihu granules were carried out,the maximum dose is equivalent to 109 times of clinical dosage,it showed little toxicity and more safety of the preparation.This study provides the modern pharmacological basis for the development of the hospital preparation of Modified Xiao Chaihu granules. |