Preparation Of Amorphous Scrubopril Washing Tablets With Amorphous

Clopidogrel Hydrogen Sulfate(CHS) is a new antiplatelet drug which can able to inhibit the gathering of the platelet ADP-P2Y12 receptors.The curative effect of the CHS is superior than the same kind of other drugs. In this paper, we prepare the amorphous CHS enteric-coated tablet through improving solid dispersion technique,which can not only breakthough the patent restriction,but also improve its dissolution and reduce the risk of stomach bleeding and lay the foundation for its availability in clinical application.The specific research contents of this paper are as follows:1. To establish the vitro analysis methods of the CHSMethodologies was established to determine the dissolution,the content and related substances of the CHS coated tablets by improving the ultravioet spectrophotometry(UV) and the high performance liquid chromatography(HPLC).Results show that methods are sensitive, specific and the methodologies met the requirements of determination.2. To study on the preparation methods and the stability of the amorphous CHS tabletIn this experiment, we select type Ⅱ of the CHS as the raw material. Firstly select the preparation of the amorphous CHS named solid dispersion, then screened the best optimum prescription by improving the orthogonal experiment.3. To preparation of the amorphous CHS enteric coated tablets systemThe CHS chip core was prepared by direct powder compression method. We get the optimal prescription of the amorphous CHS tablet core by uniting the single factor investigation and the central composite design-response surface methodology. We selected Eudragit L100-55 as the enteric coated materials, it is feasible, simple and good reproducibility and the dissolution rate is in line with the requirements of the Chinese Pharmacopoeia.4. To Study on the quality standard of the CHS enteric coated tabletTo establish the quality standard of the tablet and verify of the standard.5. Preliminary stability of the CHS enteric coated tabletsTo test and determine the effective period by investigating the influencing factors of stability test, 6 months’ acceleration, quality changes of the 12 months’ long trials.