Preparation method of proton pump inhibitor enteric-coated tablet

Abstract

The invention discloses a preparation method of a proton pump inhibitor enteric-coated tablet. The proton pump inhibitor enteric-coated tablet consists of a medicated tablet core, an isolating layer and an enteric-coated layer, wherein the medicated tablet core consists of active ingredients, filling agents, disintegrating agents, stabilizing agents, adhesion agents, surface active agents and lubricating agents; the isolating layer consists of film-forming agents, pore-foaming agents and hydrophobic materials; and the enteric-coated layer consists of an enteric-coated material, plasticizers, antisticking agents and light-screening agents. The formula and the preparation technology of the isolating layer are key and core technologies of controlling in-vitro release of drugs. By control on the formula and the preparation technology of the isolating layer and weight increment of the isolating layer, the releasing rate of the proton pump inhibitor enteric-coated tablet in different dissolution media with pH (potential of hydrogen) 1.2, pH 6.0, pH 6.8 and pH 8.0 and water. A prepared proton pump inhibitor enteric-coated tablet product is stable in quality and has a good market prospect.

Description

technical field [0001] The invention belongs to the field of pharmacy, and relates to a proton pump inhibitor enteric-coated tablet and a preparation method thereof. Background technique [0002] Proton pump inhibitors are benzimidazole compounds used for the treatment of peptic ulcer, esophageal reflux disease, gastrinoma syndrome and Helicobacter pylori. So far, the proton pump inhibitors that have been listed abroad include Omeprazole (Omeprazole), Esomeprazole (Esomeprazole), Pantoprazole (Pantoprazole), Levopantoprazole (S-pantoprazole), Rabe Rabeprazole, Dexrabeprazole, Lansoprazole, Dexlansoprazole, Ilaprazole, etc., domestic marketed proton pump inhibitors There are omeprazole, esomeprazole, pantoprazole, lansoprazole, rabeprazole, etc., and dex-rabeprazole, dex-lansoprazole, etc. are being applied for registration. Omeprazole was launched in the United States in 1988 and is the earliest benzimidazole proton pump inhibitor on the market. [0003] The invention pat...

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Problems solved by technology

[0059] The difference between the above patent and the present invention is that the above patent regards the isolation layer as an isolation between the alkaline environment of the drug-containing tablet core and the acidic environment of the enteric material, and the film-forming material of the isolation layer selected is basically Opadry. Water-soluble materials are mainly used, and there is no systematic and in-depth study on the relationship between the formulation, process and weight gain of the isolation layer and the in vitro release rate. It is worth mentioning that for BCS classification II, that is, drugs with low solubility and high permeability Generally speaking, the in vitro drug release in different dissolution media has a very close relationship with the bioavailability and efficacy of the drug.

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