Omeprazole enteric-coated preparation and preparation method thereof

The invention belongs to the field of medicine, and particularly relates to a proton pump inhibitor, namely an omeprazole enteric-coated preparation, and a preparation method thereof. Due to the fact that the nature of omeprazole is quite unstable, omeprazole can degrade and discolor rapidly if prep...

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Bibliographische Detailangaben
Hauptverfasser: PENG SHOUMING, ZHOU GUIMEI, XIAO PING
Format: Patent
Sprache:eng
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Beschreibung
Zusammenfassung:The invention belongs to the field of medicine, and particularly relates to a proton pump inhibitor, namely an omeprazole enteric-coated preparation, and a preparation method thereof. Due to the fact that the nature of omeprazole is quite unstable, omeprazole can degrade and discolor rapidly if prepared or stored improperly, and medicine efficacy and medication safety are directly influenced. In order to solve the problems, the enteric-coated preparation adopts omeprazole as a main drug and is prepared from three layers of coatings including an alkaline protection layer, an isolation layer and an enteric layer from inside to outside, wherein the alkaline protection layer comprises a film forming agent, a lubricating agent, a light screening agent, an alkaline stabilizing agent and a solvent, and the pH value of a coating solution is 8.0-13.0; the isolation layer comprises a film forming agent, a lubricating agent, a plasticizer, a light screening agent and a solvent, and the pH value of a coating solution is 7.0-8.0; the enteric layer comprises a film forming agent, a plasticizer, a lubricating agent, a light screening agent, a stabilizing agent and a solvent, and the pH value of a coating solution is 5.0-6.0. The omeprazole enteric-coated preparation and the preparation method thereof have the characteristics of short product production period and little influence of environment, temperature, humidity and dust pollution.