The Preformulation Study Of Omeprazole

• Main Author: 徐文益
• Other Authors: 陳甘霖
• Format: Others
• Language: zh-TW
• Published: 1997
• Online Access: http://ndltd.ncl.edu.tw/handle/93200066417105953793

碩士 === 國防醫學院 === 藥學研究所 === 85 === 　　Omeprazole is a new class of antiulcer drug, and is thought believed to be the inhibitor H+/K+-ATPase. On clinical trial, it used to treat gastric ulcer, duodenal ulcer, and Zollinger-Ellison Syndrome. Our study attemp to develope a new dosage form of Omeprazole in order to braek though the patent of Omeprazole. Our research work have been focused on: 　　1.The physicochemical and other derived properties of Omeprazole were determined. Those properties such as spectroscopy, melting point, solubility were discussed. 　　2.A stabilit indicating HPLC procedure for the determination of Omeprazole was described. The degraded samples was analyzed by HPLC with C-18 column. The peak purity of Omeprazole in C-18 chromatogram was checked by Diode Array Detector (DAD). 　　3.Using a stability indicating HPLC assay method, the effect of pH's, buffers (citrate, phosphate, and glycine), temperatures, solvents, the presents of hydrogen peroxide, and light on the stability of Omeprazole aqueous solution has been studied. Their decomposition reaction followed pseudo-first-order kinetic model. 　　4.The pH-log (rate) profile of Omeprazole is described. 　　5.After the drug-oil stability study, various quantity of oil were added to form thin film in the inner side of capusule to prevent the contact between water present in capsule and Omeprazole. We also study the influence of oil on dissolution of Omeprazole. 　　6.In vivo study, we compare the difference between the figure of blood concentrationand in-vitro dissolution profile.