Method for producing omeprazole sodium bicarbonate capsule

Abstract

The invention provides a method for producing an omeprazole sodium bicarbonate capsule. 40 mg omeprazole comprises the following raw and auxiliary materials in unit: 40 mg of omeprazole, 1100 mg of sodium bicarbonate, 20-30 mg of cross-linked carboxymethyl cellulose sodium, and 1-5 mg of magnesium stearate; the particle size distribution of omeprazole is as follows: D10 is more than or equal to 1 mum, D50 is less than or equal to 10 mum, and D90 is less than or equal to 20 mum; the particle size of sodium bicarbonate is more than 100 meshes. 20 mg omeprazole comprises the following raw and auxiliary materials in unit: 20 mg of omeprazole, 1100 mg of sodium bicarbonate, 20-30 mg of cross-linked carboxymethyl cellulose sodium, and 1-5 mg of magnesium stearate; the particle size distribution of omeprazole is as follows: D10 is more than or equal to 1 mum, D50 is less than or equal to 10 mum, and D90 is less than or equal to 20 mum; the particle size of sodium bicarbonate is more than 100 meshes. The method provided by the invention has the beneficial effects hat the particle size of omeprazole is controlled in a smaller range, the unit amount of magnesium stearate is reduced, and the therapeutic effect of drugs is improved; a raw material mixing process in the production process is simplified.

Description

technical field [0001] The invention relates to a preparation method of omeprazole sodium bicarbonate capsules. Background technique [0002] Omeprazole Sodium Bicarbonate Capsules is a compound preparation composed of omeprazole and sodium bicarbonate. Omeprazole belongs to the benzimidazole-substituted class of drugs that inhibit gastric acid secretion, without anticholinergic or H 2 Histamine acts by specifically inhibiting the H + -K + -ATPase system to achieve the effect of inhibiting gastric acid secretion. Omeprazole is also known as a proton pump inhibitor because the enzyme system is also known as the proton pump on the gastric mucosa, and it blocks the final step in gastric acid secretion. The intensity of its action is dose-related, and it has an inhibitory effect on both basal and stimulated gastric acid secretion. Animal experiments have shown that omeprazole can exist in the gastric mucosa for more than one day after disappearing rapidly in the plasma. O...

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Problems solved by technology

[0006] The above disadvantages are that the particle size of omeprazole is relatively large, and the amount of magnesium stearate used as a lubricant is relatively large, which will affect the therapeutic effect of the drug, and the mixing process in the production process is more cumbersome

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