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Combined medicament containing telmisartan and aliskiren and preparation method thereof

A technology of telmisartan and medicine, applied in the field of combined medicine containing telmisartan and Aliskiren and its preparation, to achieve the effect of maintaining stability and avoiding interaction

Active Publication Date: 2010-12-29
CHENGDU ZIHAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] At present, there is no report on the combined use of Telmisartan and Aliskiren in the published patent literature and scientific literature

Method used

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  • Combined medicament containing telmisartan and aliskiren and preparation method thereof
  • Combined medicament containing telmisartan and aliskiren and preparation method thereof
  • Combined medicament containing telmisartan and aliskiren and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] The preparation of embodiment 1 medicine of the present invention

[0038] Prescription composition:

[0039]

[0040] operate:

[0041] 1. Dissolve the prescribed amount of telmisartan with the prescribed amount of sodium hydroxide ethanol solution, then spray dry, and pass the dry powder through an 80-mesh sieve. The sifted powder, meglumine, mannitol, microcrystalline cellulose and internally added crospovidone were mixed uniformly in equal increments. Wet granulation with an appropriate amount of 5% starch slurry, drying at 50°C, sizing the granules with a 20-mesh sieve, adding crospovidone and magnesium stearate and mixing to obtain telmisartan layer granules.

[0042] 2. Mix the prescribed amount of Aliskiren with the prescribed amount of microcrystalline cellulose, lactose, and internally added crospovidone in equal increments, and wet granulate with an appropriate amount of 5% starch slurry; dry at 50°C , granulated with a 20-mesh sieve, added crospovidone...

Embodiment 2

[0045] The preparation of embodiment 2 medicines of the present invention

[0046] Prescription composition:

[0047]

[0048] operate:

[0049] 1. Dissolve the prescribed amount of telmisartan with the prescribed amount of sodium hydroxide ethanol solution, then spray dry, pass the dry powder through an 80-mesh sieve, and sieve the powder, meglumine, mannitol, and microcrystalline cellulose Mix with the internally added crospovidone in an equal amount, wet granulate with an appropriate amount of 5% starch slurry, and dry at 50°C. Use a 20-mesh sieve to sieve the granules, add crospovidone and magnesium stearate and mix well to obtain telmisartan layer granules.

[0050] 2. Mix the prescribed amount of Aliskiren with the prescribed amount of microcrystalline cellulose, lactose and internally added crospovidone in an equal and progressive manner, wet granulate with an appropriate amount of 5% starch slurry, and dry at 50°C , granulated with a 20-mesh sieve, added crospovi...

Embodiment 3

[0053] Embodiment 3 preparation of medicine of the present invention

[0054] Prescription composition:

[0055]

[0056] operate:

[0057] 1. Dissolve the prescribed amount of telmisartan with the prescribed amount of sodium hydroxide ethanol solution, then spray dry, pass the dry powder through an 80-mesh sieve, and sieve the powder, meglumine, mannitol, and microcrystalline cellulose Mix with the internally added crospovidone in an equal amount, wet granulate with an appropriate amount of 5% starch slurry, and dry at 50°C. Use a 20-mesh sieve to sieve the granules, add crospovidone and magnesium stearate and mix well to obtain telmisartan layer granules.

[0058] 2. Mix the prescribed amount of Aliskiren with the prescribed amount of microcrystalline cellulose, lactose and internally added crospovidone in an equal and progressive manner, wet granulate with an appropriate amount of 5% starch slurry, and dry at 50°C , granulated with a 20-mesh sieve, added crospovidone ...

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Abstract

The invention relates to application of telmisartan and aliskiren or medicinal salts thereof in preparing a combined medicament for treating hypertension. The invention also provides the combined medicament for treating hypertension, wherein the combined medicament contains unit preparations of different specifications, and the preparations administrated simultaneously, respectively or in turn are prepared from telmisartan and aliskiren or medicinal salts thereof and pharmaceutically acceptable carriers. The invention also provides a preparation method and application of the combined medicament. The medicinal preparations are three-layer tablets so as to avoid interaction of the aliskiren and the telmisartan, improve the medicament stability and facilitate long-term storage. The composition preparations are used for treating medium and high hypertension patients and hypertension patients whose blood pressure cannot be fully controlled after being treated by angiotensin II receptor antagonists or renin inhibitors.

Description

technical field [0001] The invention relates to a combination drug containing telmisartan and aliskiren and a preparation method thereof. technical background [0002] Telmisartan, a white to pale yellow solid, is an angiotensin II receptor antagonist developed for the treatment of hypertension and other medical indications as disclosed in EP-A-502314. It is a non-peptide molecule and its chemical name is: 4'-[(1,4'-dimethyl-2'-propyl-[2,6'-bi-1H-benzimidazole]-1'-yl) Methyl]-[1,1'-biphenyl]-2-carboxylic acid, its molecular formula is: C 33 h 30 N 4 o 2 , its molecular weight is: 514.63, and its structural formula is: [0003] [0004] Telmisartan is prepared and supplied in the free acid form. It is characterized by very poor solubility in aqueous systems in the physiological pH range of the gastrointestinal tract between pH 1-7. As disclosed in WO 00 / 43370, crystalline telmisartan exists in two polymorphic forms with different melting points, under the influence ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4184A61K31/165A61K9/24A61P9/12
Inventor 刘忠荣冯凌刘小军
Owner CHENGDU ZIHAO PHARMA
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