Pantoprazole sodium enteric-coated preparation and preparation method thereof

The invention belongs to the field of medicines and particularly relates to a pantoprazole sodium enteric-coated preparation and a preparation method thereof. Pantoprazole sodium is very unstable in property and can be quickly degraded and discolored if being improperly prepared or stored, so that t...

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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 medicines and particularly relates to a pantoprazole sodium enteric-coated preparation and a preparation method thereof. Pantoprazole sodium is very unstable in property and can be quickly degraded and discolored if being improperly prepared or stored, so that the curative effect and medication safety of the drug are directly affected. In order to solve the problem, the enteric-coated preparation which takes pantoprazole sodium as a main drug is prepared by three coatings. The coatings are respectively an alkaline protective layer, an isolating layer and an enteric layer from inside to outside, wherein the alkaline protective layer comprises a film-forming agent, a lubricant, an opacifying agent, an alkaline stabilizer and a solvent, and the pH value of a coating solution is 8.0-13.0; the isolating layer comprises a film-forming agent, a lubricant, a plasticizer, an opacifying agent and a solvent, and the pH value of a coating solution is 7.0-8.0; and the enteric layer comprises a film-forming agent, a plasticizer, a lubricant, an opacifying agent, a stabilizer and a solvent, and the pH value of the coating solution is 5.0-6.0. The pantoprazole sodium enteric-coated preparation provided by the invention has the characteristics of short production period of products and little influence from environment, temperature and humidity and dust pollution.