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Azilsartan tablets and preparation process thereof

An azilsartan tablet and tablet technology, applied in the field of pharmaceutical preparations, to achieve the effects of simple preparation process, less stringent particle size requirements, and rapid dissolution

Active Publication Date: 2015-01-28
NANJING CHIA TAI TIANQING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The above patented technology only solves some of the problems of Azilsartan tablets, but fails to provide an Azilsartan tablet with simple process, rapid dissolution, uniform content and stable quality

Method used

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  • Azilsartan tablets and preparation process thereof
  • Azilsartan tablets and preparation process thereof
  • Azilsartan tablets and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025]

[0026]

[0027] Preparation Process:

[0028] Azilsartan is jet-milled, the crushing pressure is 0.3Mpa, D90=52 microns, the prescribed amount is weighed, then mixed with the prescribed amount of microcrystalline cellulose KG1000 in a multi-motion mixer, and then crospovidone is added , lactose, and magnesium stearate are evenly mixed, and compressed on a rotary tablet machine with a direct compression process.

Embodiment 2

[0030]

[0031] Preparation Process:

[0032] Azilsartan is jet-pulverized, the crushing pressure is 0.4Mpa, D90=38 microns, the prescribed amount is weighed, then mixed with the prescribed amount of microcrystalline cellulose KG1000 in a multi-motion mixer, and then the prescribed amount of cross-linked Povidone, lactose 100, and talc powder are mixed evenly, and compressed by direct compression on a rotary tablet machine.

Embodiment 3

[0034]

[0035] Preparation Process:

[0036] Azilsartan is jet-milled, the crushing pressure is 0.3Mpa, D90=50 microns, the prescribed amount is weighed, then mixed with the prescribed amount of microcrystalline cellulose KG1000 in a multi-motion mixer, and then the prescribed amount of cross-linked Povidone, lactose 80, and magnesium stearate are uniformly mixed and compressed on a rotary tablet machine with a direct compression process.

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PUM

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Abstract

The invention discloses azilsartan tablets and a preparation process thereof. The tablets comprise azilsartan, microcrystalline cellulose KG1000 and other pharmaceutically acceptable auxiliary materials and are prepared by pressing by adopting a dry-process direct tabletting process. According to the preparation, the content of azilsartan is uniform, and drugs are rapidly dissolved out within 5 minutes. In addition, the preparation process of the preparation is simple, raw materials are not needed to be specially crushed, the granularity requirement is not strict, complex preparation equipment is not needed, and large-scale industrial production is easily realized.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a solid oral preparation, in particular to a tablet containing azilsartan and a preparation process thereof. Background technique [0002] Azilsartan is an angiotensin II receptor antagonist drug for the treatment of hypertension. It is mostly used for the treatment of hypertension and is currently the only angiotensin II receptor antagonist (sartan) drug in the late clinical stage. . The drug was launched by Japan's Takeda Pharmaceutical Company in 2012, and its efficacy in the clinical stage is remarkable. [0003] Azilsartan's chemical name is 2-ethoxy-1-[[2'-(4,5-dihydro-5-oxo-1,2,4-oxadiazol-3-yl ) biphenyl-4-yl] methyl] benzimidazole-7-carboxylic acid, almost insoluble in water, belongs to insoluble medicine, and the solubility in water is less than 9 μ g / ml, and its chemical structural formula is as follows: [0004] [0005] Because a...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4245A61P9/12
Inventor 王苏东赵爱超
Owner NANJING CHIA TAI TIANQING PHARMA
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