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Telmisartan tablet preparation and preparation method thereof

A technology for telmisartan and tablets, which is applied in the field of preparation of telmisartan tablets, can solve problems such as inability to dissolve quickly, and achieve the effects of rapid drug dissolution, high dependence, and simple preparation process

Inactive Publication Date: 2013-08-28
NANJING ZHENGKUAN MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The inventor creatively crushed the raw materials of sodium lauryl sulfate and telmisartan together by airflow, which solved the problem of drug agglomeration after crushing, and the dissolution rate was further improved, but it still could not be dissolved quickly, which may be related to the granulation process. The telmisartan raw material produces aggregation and limits the rapid stripping of medicine, so the inventor further creatively uses micronized lactose as a carrier, and then mixes with the mixed powder of micronized sodium lauryl sulfate and telmisartan raw material , granulation, it was found that the dissolution rate was greatly improved, and it was completely dissolved within 5 minutes

Method used

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  • Telmisartan tablet preparation and preparation method thereof
  • Telmisartan tablet preparation and preparation method thereof
  • Telmisartan tablet preparation and preparation method thereof

Examples

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Effect test

Embodiment 1

[0022]

[0023] Preparation Process

[0024] (1) Sieve Telmisartan and Sodium Lauryl Sulfate, and jet pulverize to obtain micropowder A, D90=13.5 microns;

[0025] (2) Pulverize the lactose by jet to obtain micropowder B, D90=12.8 microns;

[0026] (3) Mix the micropowder A and the micropowder B evenly, add an appropriate amount of pure water to granulate, dry at 50°C, and granulate with a 20-mesh sieve to obtain drug-containing granules;

[0027] (4) Mix the drug-containing granules with crospovidone, sodium carboxymethyl starch, magnesium stearate and micropowder silica gel, and directly press into tablets.

Embodiment 2

[0029]

[0030] Preparation Process

[0031] (1) Sieve telmisartan and sodium lauryl sulfate, and jet pulverize to obtain micropowder A, D90=9.8 microns;

[0032] (2) Air-jet pulverizing the lactose to obtain micropowder B, D90=10.4 microns;

[0033] (3) Mix the micropowder A and the micropowder B evenly, add an appropriate amount of pure water to granulate, dry at 55°C, and sieve with 20 mesh to granulate to obtain drug-containing granules;

[0034] (4) Mix the drug-containing granules with crospovidone and magnesium stearate evenly, and directly press into tablets.

Embodiment 3

[0036]

[0037] Preparation Process

[0038] (1) Sieve Telmisartan and Sodium Lauryl Sulfate, and jet pulverize to obtain micropowder A, D90=10.5 microns;

[0039] (2) Pulverize the lactose by jet to obtain micropowder B, D90=9.7 microns;

[0040] (3) Mix the micropowder A and the micropowder B evenly, add an appropriate amount of pure water to granulate, dry at 45°C, and sieve with 30 mesh to granulate to obtain drug-containing granules;

[0041] (4) Mix the drug-containing granules with croscarmellose sodium and magnesium stearate evenly, and directly press into tablets.

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Abstract

The invention discloses a telmisartan tablet preparation and a preparation method thereof. The tablet preparation is prepared through uniformly mixing drug-containing granules with a pharmaceutically acceptable excipient and then tabletting, wherein the drug-containing granules are prepared through uniformly mixing telmisartan and sodium dodecyl sulfate, micronizing the mixture, uniformly mixing the mixture with micronized lactose and then carrying out wet granulation. The preparation disclosed by the invention does not contain alkaline materials, is rapid in drug dissolution and is simple in preparation process, thereby being suitable for being produced in a large scale.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a preparation method of a telmisartan tablet. Background technique [0002] Telmisartan is one of the ideal drugs for the treatment of hypertension. It is a structurally unique non-peptide angiotensin II receptor antagonist. Its affinity to AT1 receptor is more than 3000 of that of AT2 receptor. times. It selectively blocks the binding of angiotensin II to AT1 receptors in many tissues (such as vascular smooth muscle and adrenal glands), thereby blocking the vasoconstriction and aldosterone secretion of angiotensin II, except for the treatment of mild to moderate It also has the functions of regulating sugar and fat production and metabolism. [0003] Telmisartan is almost insoluble in water and pH 3-9 aqueous solution, slightly soluble in strong acid and soluble in strong alkali. Due to these characteristics, there is often a problem of poor dissolution when prepa...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/20A61K47/26A61K31/4184A61P9/12
Inventor 不公告发明人
Owner NANJING ZHENGKUAN MEDICAL TECH
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