Proton pump inhibitor enteric-coated preparation and coating system and preparation method thereof
The invention belongs to the field of medicines and particularly relates to a proton pump inhibitor enteric-coated preparation and a coating system and a preparation method thereof. The proton pump inhibitor is very unstable in property and quickly degraded and discolored due to improper preparation...
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Zusammenfassung: | The invention belongs to the field of medicines and particularly relates to a proton pump inhibitor enteric-coated preparation and a coating system and a preparation method thereof. The proton pump inhibitor is very unstable in property and quickly degraded and discolored due to improper preparation or storage, 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 the proton pump inhibitor as a main drug is prepared by three coatings which are respectively an alkaline protective layer, an isolating layer and an enteric-coated 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; the pH value of a coating liquid 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 the coating liquid is 7.0-8.0; the enteric-coated layer comprises a film forming agent, a plasticizer, an opacifying agent, a stabilizer and a solvent, and the pH value of the coating liquid is 5.0-6.0. The preparation provided by the invention has the characteristics of short production cycle and less influence by environment, temperature and humidity and dust pollution. |
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