A kind of pantoprazole sodium enteric-coated tablet and preparation method thereof

Abstract

The invention provides a pantoprazole sodium enteric-coated tablet. The pantoprazole sodium enteric-coated tablet is prepared by coating a pantoprazole sodium tablet with an isolation layer and an enteric-coated layer, wherein the pantoprazole sodium tablet comprises the following components in percentage by weight: 35-45% of pantoprazole sodium, 30-59% of a filling agent, 0.2-3% of a binder, 8.1-18% of a disintegrant, 5-15% of a stabilizer and 0.2-1.5% of a lubricant. According to the pantoprazole sodium enteric-coated tablet and the preparation method thereof provided by the invention, a dissolution curve of the pantoprazole sodium enteric-coated tablet in each of four dissolution media is consistent with that of an originally developed preparation, thereby being in line with the requirements of consistency evaluation; and furthermore, the stability of the pantoprazole sodium enteric-coated tablet is better than that of the originally developed preparation.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a pantoprazole sodium enteric-coated tablet and a preparation method thereof. Background technique [0002] Pantoprazole sodium (trade name Pantoloc) is the third proton pump inhibitor listed after omeprazole and lansoprazole, due to the presence of pantoprazole sodium on the pyridine ring and benzimidazole ring The substituent group is different from omeprazole and lansoprazole, which determines its differences in biochemical, pharmacokinetic, pharmacological and other properties, making it more selective and different. That is, pantoprazole sodium can specifically inhibit the secretion of microtubules formed by the apical membrane of the parietal cells and the H on the tubular vesicles in the cytoplasm. + 、K + -ATPase, causing irreversible inhibition of the enzyme, thereby effectively inhibiting the secretion of gastric acid, not only non-competitively inh...

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Problems solved by technology

It can be deduced from the patent that the specification of its enteric-coated tablet is 20mg, and its release behavior is compared with that of the original preparation developed by India Ruidi (India Ruidi’s product specification is 20mg, compared with Japan’s Takeda’s 40mg product, the dissolution curve is different), which belongs to The Chinese generic drug of Reddy, India; in addition, it can be seen from its examples that the product did not strictly follow the requirements of China's "Generic Drug Consistency Evaluation" for comparison of dissolution curves in four dissolution media, and did not meet the quality control stipulated by the state Require

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