Pharmaceutical Research Of Jiechangning Colon-targeted Dripping Pill

The research chose patent chinese medicine-jiechangning as model for good effecting in treating ulcerative colitis(UC). Astragalus polyose and saponine in the formula were supposed to be processed as gastric release unit, while matrine and oxymatrine as colon release unit, from the perspective of modern herbal formula release system. We aimed at obtaining jiechangning compound release preparation with stomach and colon dual release characteristics and probing into the common topic of designing thought, preparing method and evaluating technology for compund release preparation.We carried out the research in examining the character, TCL, content determ-ination for semi-finished product according to herb property, and set up quality standards for the semi-finished product.Matrine, oxymatrine and molding material were mixed to a scale, and made into dripping pill. The one factor method was used to inspect the kinds of dripping pill, ratio of material and drug, material temperature, kinds of condensing agent, condensing agent temperature, dripping distance and dripping speed. Based on the one factor study, the factors-ratio of material and drug, material temperature and dripping speed, which influenced the process chiefly were chosen to optimize parameters for the orthogonal test. And then moulding process was finally determined. Coating materials-Eudragit S100, Eudragit L100 and EC were used relatively for preparing two colon-specific drugs-pH dependent type and combination of PH dependent type and time lag type. And at last coat for stomach dissolving part, by using astragalus polyose, astragaloside and fitting accessorial material.We have set up TLC method for indentifying astragaloside, matrine and oxymatrine, by indentifying the finished product, and established quantitative criteria by determining the content with Visible-UV and HPLC. And then we observed rotating speed of agitating valve and pH of dissolvent to explore its release degree in vitro and build the determining method for release degree in vitro. The result showed that the stability for combination of pH dependent type and time lag type was better than PH dependent type. The former one was obversed under sweep electron microscope to study the drug release mechanism. From the microscope examination, the release of the dripping pill was proved to be the same as the original design. At the same time, BaSO4 shadowgraph technique was applied to check the release speed in vivio for the colon targeting preparation of combination of PH dependent type and time lag type. The result showed the preparation can get the effect of colon release basically.