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Compound omeprazole capsule, and preparation method and detection method thereof

A technology for omeprazole and a detection method is applied in the field of compound omeprazole capsules and preparation thereof, and can solve the problems of inability to find, incomplete detection indicators, and inability to fully exert drug effects.

Active Publication Date: 2013-10-09
GUIZHOU XINBANG PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

No disintegrating agent was added to the prescription of this application. It was found through research that due to the untimely disintegration of sodium bicarbonate, omeprazole was destroyed by gastric acid, and the release of omeprazole was not enough, so that the drug effect could not be fully exerted.
Therefore, there is no inspection of acid resistance in the disclosed quality detection method, so that the method cannot find the problem caused by the untimely disintegration of sodium bicarbonate, and its detection index is not complete

Method used

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  • Compound omeprazole capsule, and preparation method and detection method thereof
  • Compound omeprazole capsule, and preparation method and detection method thereof
  • Compound omeprazole capsule, and preparation method and detection method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0402]Embodiment 1: Each compound omeprazole capsule is made of 20mg omeprazole, 1100mg sodium bicarbonate, 30mg croscarmellose sodium and 10mg magnesium stearate. Weigh 1100mg of sodium bicarbonate and 20mg of croscarmellose sodium, and mix uniformly with equal increment method; add 20mg omeprazole, mix uniformly with equal increment method, and pulverize through a 200 mesh sieve; 95% ethanol solution is used as a binder to prepare soft materials, granulated with a 24-mesh screen, dried at 60°C, and granulated with a 60-mesh screen; 10 mg of magnesium stearate and 10 mg of croscarmellose sodium are added to the obtained granules , mix evenly, and put into capsules.

Embodiment 2

[0403] Embodiment 2: Each compound omeprazole capsule is made of 40mg omeprazole, 1100mg sodium bicarbonate, 30mg croscarmellose sodium and 10mg magnesium stearate. Weigh 1100mg of sodium bicarbonate and 20mg of croscarmellose sodium, and mix uniformly with equal increment method; add 40mg omeprazole, mix uniformly with equal increment method, and pulverize through a 200 mesh sieve; 95% ethanol solution is used as a binder to prepare soft materials, granulated with a 24-mesh screen, dried at 60°C, and granulated with a 60-mesh screen; 10 mg of magnesium stearate and 10 mg of croscarmellose sodium are added to the obtained granules , mix evenly, and put into capsules.

Embodiment 3

[0404] Embodiment 3: the complete detection method of compound recipe omeprazole capsule of the present invention is:

[0405] (1) Properties: This preparation is white or off-white powder;

[0406] (2) Content determination:

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Abstract

The invention discloses a compound omeprazole capsule, and a preparation method and a detection method thereof. The capsule is prepared by: in parts by weight, 20 parts of omeprazole, 1100 parts of sodium bicarbonate, 30 parts of cross linked sodium carboxymethyl cellulose and proper amount of magnesium stearate; or the capsule is prepared by 40 parts of omeprazole, 1100 parts of sodium bicarbonate, 30 parts of cross linked sodium carboxymethyl cellulose and proper amount of magnesium stearate. Aiming at the deficiency of the prior art The formulation, the preparation technology and the detection method of the conventional compound omeprazole capsule are optimized, the compound omeprazole capsule of the invention exhibits more substantial curative effect for diseases comprising peptic ulcer, gastroesophageal reflux disease and the like caused by gastric hyperacidity; a systematic, integrated and effective component discrimination and content determination method is established, thereby the medicine quality is effectively controlled, and thus the clinic curative effect is guaranteed.

Description

technical field [0001] The invention relates to a compound omeprazole capsule, a preparation method and a detection method thereof, and belongs to the technical field of western medicine. Background technique [0002] Compound omeprazole capsule is a compound preparation composed of omeprazole and sodium bicarbonate. Omeprazole is a proton pump inhibitor and sodium bicarbonate is an antacid. Omeprazole can irreversibly bind to the sulfhydryl group of H+, K+-ATPase (also known as proton pump) to form a complex of sulfenamide and proton pump, thereby inhibiting the enzyme activity and blocking the final step of gastric acid secretion , thereby inhibiting the secretion of gastric acid. Oral sodium bicarbonate can quickly neutralize or buffer gastric acid, so the pH in the stomach rises rapidly to relieve the symptoms caused by high gastric acid. Among them, the antacid sodium bicarbonate can increase the pH value in the stomach to protect the proton pump inhibitor omeprazole...

Claims

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Application Information

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IPC IPC(8): A61K33/00A61K47/38A61K9/48A61P1/04G01N30/02G01N31/16G01N31/02G01N21/33A61K31/4439
Inventor 张观福
Owner GUIZHOU XINBANG PHARMACEUTICAL CO LTD
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