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Azilsartan medoxomil potassium combination and preparation method thereof

A technology of azilsartan medoxomil potassium and azilsartan medoxomil, which is applied in the field of pharmaceuticals and can solve problems such as preparation difficulties

Inactive Publication Date: 2015-11-25
SUNSHINE LAKE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Under the method for preparing preparation under usual neutral conditions, it is relatively difficult to prepare the azilsartan medoxomil potassium pharmaceutical preparation meeting the above requirements

Method used

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  • Azilsartan medoxomil potassium combination and preparation method thereof
  • Azilsartan medoxomil potassium combination and preparation method thereof
  • Azilsartan medoxomil potassium combination and preparation method thereof

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specific Embodiment approach

[0043] In order to enable those skilled in the art to better understand the technical solutions of the present invention, some non-limiting examples are further disclosed below to further describe the present invention in detail.

[0044] The mannitol, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose and magnesium stearate used in the present invention meet the standards of pharmaceutical excipients in the Chinese Pharmacopoeia 2010 edition.

Embodiment 1

[0046]Weigh 335g of mannitol, 44.8g of croscarmellose sodium and 142.2g of azilsartan medoxomil potassium, mix them evenly and place them on the Chongqing Zilong fluidized bed to preheat to 40°C, and then start the process at 35±3 Spray a mixed solution made of 12.2g hydroxypropyl cellulose, 1.2g citric acid and appropriate amount of water under the condition of ℃, the pH value is about 2.53, and dry on a fluidized bed, and then carry out granulation on a QUADRO granulator, Pass 055R sieve. 3.3 g of magnesium stearate and 62.4 g of microcrystalline cellulose were added and mixed together uniformly to obtain a mixture. Finally the resulting mixture was pressed into a composition with a hardness of 90N.

[0047] Composition of the preparation (370.1 mg per tablet)

[0048]

Embodiment 2

[0050] Weigh 329.0g of mannitol, 29.0g of croscarmellose sodium and 144.7g of azilsartan medoxomil potassium, mix them evenly and place them on the Chongqing Zilong fluidized bed to preheat to 40°C, and then start at 35± Spray a mixed solution made of 24.1g hydroxypropyl cellulose, 1.7g citric acid and appropriate amount of water at 3°C, the pH value is about 2.46, dry it on a fluidized bed, and then granulate it on a QUADRO granulator , through 055R sieve. 12.1 g of magnesium stearate and 59.6 g of microcrystalline cellulose were added and mixed together uniformly to obtain a mixture. Finally the resulting mixture was pressed into a tablet with a hardness of 90N.

[0051] Composition of the composition (359.5 mg per tablet)

[0052]

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Abstract

The invention provides an azilsartan medoxomil potassium combination which has angiotensin II receptor antagonism. Azilsartan medoxomill is enabled to have high stability and dissolubility by adding pH control agent. The invention further provides a method for preparing the combination.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to a composition comprising azilsartan medoxomil potassium, a pH control agent and pharmaceutically acceptable auxiliary materials and a preparation method thereof. Background technique [0002] Azilsartan medoxomil potassium, whose chemical name is (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 2-ethoxy-1-[(2 '-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)biphenyl-4-yl]methyl)-1H-benzimidazole-7-carboxylic acid Potassium ethyl ester. Its structure is as follows: [0003] [0004] Azilsartan medoxomil potassium is disclosed in the patent document (WO2005 / 080384, wherein the relevant technology is cited as a reference), has angiotensin II receptor antagonistic effect, and is a drug for treating hypertension. [0005] Azilsartan medoxomil potassium is unstable under neutral conditions, and its solubility in solid pharmaceutical preparations is relatively low under its stable pH condition. Azilsartan...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/12A61K31/4245A61K9/20A61P9/12
Inventor 赵锋黄芳芳游劲松
Owner SUNSHINE LAKE PHARM CO LTD
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