Stomach Granules Pharmaceutical Research

Stomach intestine dyskinesis is a kind of disease which is common and occurs frequently, including functional dyspepsia, Gastroesophageal reflux disease, Gastroparesis and irritable bowel syndrome, etc. The pathogenesis is not very clear and is probably related with neurohormone , dietary, helicobacter pylori infection and gastric acid effect. In modern time, with the severe competition of society and fast growing of life pace, incidence rate of stomach intestine dyskinesis is soaring dramatically. Therefore, it is very meaningful to explore the empirical formulas of Chinese medicine and develop them to Chinese patent medicine according to the new drug standard.The prescription of Weishu granule comes from a proved effective recipe that hasbeen used for many years by doctor Qiu Ming-yi. It consists of Raidix Paeoniae Alba, Bupleurum chinense, Radix GlycyrrhizaeFructus Aurantii Immaturus, Fructus Citri Sarcodactylis, etc, and it has effect on treating the stomach intestine dyskinesis patients with the symptoms such as astric cavity inflated, eructation, scorching hot in stomach, dry mouth and bitter taste of mouth, etc.This project is to study preparation process, quality standard and preliminary stability of "Weishu granule". The work of study on the pharmacodynamics and mechanism of action was finished by some member else in the research group.Study of preparation process: 1. Optimize extracting method. The best factors for extracting volatile oil from Fructrs Amomi and Fructus Aurantii Immaturus in the prescription were made certain. The best condition for volatile oil inclusion with β -CD was studied; Process that Rhizoma Coptidis and other materials in the prescription are separated decocted was made certain by comparing extraction rate of Rhizoma Coptidis berberine between separated decocting process and mixed decocting process; Optimize the decocting process of materials(except Rhizoma Coptidis) in the prescription using the quantity of dry slurry and quantity of peoniflorin in the dry slurry as index by orthogonal experiment. The process decocting Rhizoma Coptidis berberine from Rhizoma Coptidis was optimized by the orthogonal experiment. 2. Optimize chitosan clarifying purification process by orthogonal experiment, in which quantity of dry slurry, remaining rate of peoniflorin and polysaccharide in the dry slurry and clarity were selected as indexes of optimization process and the result shows that chitosan clarifying purification process is superior to the purification process of alcohol precipitation. 3 Optimize the forming process of granule, the species as well as the quantity of excipients were determinated. In the study of preparation process, HPLC was used to determine the content of peoniflorin and UV spectrophotometry was used to determine the contents of Rhizoma Coptidis berberine and polysaccharide.