Omeprazole and sodium bicarbonate core-covering tablet

A technology of sodium bicarbonate and omeprazole, which is applied in the field of packaged chips containing active ingredients of omeprazole and sodium bicarbonate, can solve problems such as affecting qualitative and quantitative analysis results, disorderly disintegration, and reducing effects, and achieves Easy inspection and quality control, reduced degradation products, improved stability

Inactive Publication Date: 2014-02-26
HEILONGJIANG FUHE HUAXING PHARMA GROUP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The disadvantages of the above-mentioned capsules are that omeprazole and sodium bicarbonate exist in the same capsule, which has the following disadvantages: 1. The two may come into contact outside the body, which leads to (1) due to the uniformity of multi-component mixing (2) During product testing, it is difficult to determine the content of each component due to mutual interference, which affects the results of qualitative and quantitative analysis; (3) During long-term storage, due to possible chemical compatibility changes between components, it is easy to produce By-products, reducing effects or increasing side effects, product stability is not ideal
2. Because omeprazole and sodium bicarbonate are made into granules, they cause disordered disintegration in the stomach, so that when omeprazole disintegrates, the local part neutralized by sodium bicarbonate has failed

Method used

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  • Omeprazole and sodium bicarbonate core-covering tablet
  • Omeprazole and sodium bicarbonate core-covering tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Embodiment 1: as figure 1 As shown in the omeprazole sodium bicarbonate core-coated tablet A, the drug-containing tablet core 2 contains 6.7 mg omeprazole, and the peripheral drug-containing layer 1 contains 366.7 mg of sodium bicarbonate and contains immediate-release auxiliary materials. The tablet core 2 and The drug-containing layers 1 are all circular.

Embodiment 2

[0029] Embodiment 2: Omeprazole sodium bicarbonate core-coated B sheet is substantially the same as Example 1, and the difference is that the drug-containing tablet core contains 13.3mg omeprazole, and the drug-containing layer on the periphery contains 366.7mg of sodium bicarbonate and Contains sustained-release excipients.

Embodiment 3

[0030] Embodiment 3: as figure 2 The shown omeprazole sodium bicarbonate core-coated tablet C is a rectangle with rounded corners. The drug-containing tablet core 2 contains 10 mg of omeprazole, and the drug-containing layer 1 on the periphery contains 550 mg of sodium bicarbonate and contains immediate-release excipients.

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PUM

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Abstract

The invention relates to a core-covering tablet containing active ingredients of omeprazole and sodium bicarbonate. The core-covering tablet comprises a peripheral medicine-containing layer (1) and a medicine-containing tablet core (2) located in the middle of the medicine-containing layer, wherein sodium bicarbonate serves as the medicine active ingredient of the peripheral medicine-containing layer (1), while omeprazole serves as the active ingredient of the medicine-containing tablet core (2); the peripheral medicine-containing layer (1) fastens the medicine-containing tablet core (2); the medicine-containing tablet core (2) is coaxial with the core-covering tablet. According to the core-covering tablet, all the active ingredients are nearly not contacted each other, so that the core-covering tablet is high in stability and convenient to process; more importantly, an omeprazole-sodium bicarbonate compound preparation with qualified relevant substances can be gained without strictly controlling intermediate-related substances. Moreover, the sodium bicarbonate layer can be quickly disintegrated to adjust and produce relatively high pH in stomach, and then the omeprazole tablet core is disintegrated under such condition, thus the damage of gastric acid to omeprazole can be reduced.

Description

technical field [0001] The invention relates to a packaged chip, in particular to a packaged chip containing active ingredients of omeprazole and sodium bicarbonate. Background technique [0002] The U.S. FDA has approved the compound immediate-release proton pump inhibitor omeprazole sodium bicarbonate capsules (trade name: Zegerid) from Santarus, with specifications including 40mg / 1100mg and 20mg / 1100mg. The mechanism of action of this compound immediate-release drug is: after oral administration, sodium bicarbonate can cause the pH in the stomach to rise rapidly, thereby protecting the uncoated omeprazole from being degraded by gastric acid in the stomach, which also temporarily stimulates gastric antrum G The cells secrete gastrin. Oral administration of sodium bicarbonate solution can lead to an increase in circulating gastrin levels within 30 minutes. Elevated levels of circulating gastrin stimulate the total number of parietal cells and H+ / K+-ATPase functional molec...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K33/00A61P1/04A61K31/4439
Inventor 吴光彦
Owner HEILONGJIANG FUHE HUAXING PHARMA GROUP
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