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A kind of preparation method of omeprazole sodium bicarbonate capsule

A technology for sodium bicarbonate and omeprazole, which is applied in the field of making omeprazole sodium bicarbonate capsules, can solve the problems of large particle size of omeprazole, influence on the therapeutic effect of medicines, cumbersome mixing process, etc. Dosage, simplify the mixing process of raw materials, improve the effect of treatment effect

Active Publication Date: 2015-09-30
XIAMEN ENCHENG PHARMA CO LTD
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  • Description
  • Claims
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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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  • A kind of preparation method of omeprazole sodium bicarbonate capsule
  • A kind of preparation method of omeprazole sodium bicarbonate capsule
  • A kind of preparation method of omeprazole sodium bicarbonate capsule

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Embodiment Construction

[0029] One of the best embodiments of the present invention, such as figure 1 Shown in —4, the particle size of omeprazole raw material is finer, D 90 ≤20μm, D 50 ≤10μm, in order to ensure the consistency of product dissolution, and the particle size of raw materials D 10 Control greater than 1 μm.

[0030] Sodium bicarbonate can quickly neutralize gastric acid in the stomach and protect omeprazole from being degraded by gastric acid. In order to ensure the dissolution rate of sodium bicarbonate, we pass it through a 100-mesh sieve.

[0031] Magnesium stearate is selected as the lubricant in the prescription. Through the prescription screening, when the magnesium stearate in each capsule is 3 mg, the production process requirements can be met, and the filling capacity of the capsules has a good difference.

[0032] The dosage of croscarmellose sodium in each capsule is 20 mg.

[0033] In order to ensure the quality of the product, the mixing proce...

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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...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/48A61K33/00A61P1/04A61J3/07A61K31/4439
Inventor 王立兴乐云峰张锦聪王斌
Owner XIAMEN ENCHENG PHARMA CO LTD
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