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Compound telmisartan amlodipine besylate medicinal composition and preparation method thereof

A technology of amlodipine besylate and amlodipine besylate solid, which is applied in the field of telmisartan amlodipine besylate amlodipine besylate pharmaceutical composition and its new preparation, and can solve the problem of amlodipine besylate amlodipine besylate Problems such as low dissolution rate of clodipine

Active Publication Date: 2012-04-18
天津汉一医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

CN101052381A discloses adopting tablet technology to prepare this pharmaceutical preparation, but does not propose adopting solid dispersion technology to solve the technical problem that the dissolution rate of amlodipine besylate is low

Method used

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  • Compound telmisartan amlodipine besylate medicinal composition and preparation method thereof
  • Compound telmisartan amlodipine besylate medicinal composition and preparation method thereof
  • Compound telmisartan amlodipine besylate medicinal composition and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0087] Tablet prescription composition, each 1000 tablets are composed as follows:

[0088] Particle A

[0089] Amlodipine besylate solid dispersion 43.747g

[0090] Microcrystalline cellulose 62.253g

[0091] Low-substituted hydroxypropyl methylcellulose 12g

[0092] Appropriate amount of water

[0093] Composition of amlodipine besylate solid dispersion

[0094] Amlodipine besylate 6.944g

[0095] Povidone K30 34.720g

[0096] Polysorbate 80 2.083g

[0097] Particle B

[0098] Telmisartan 40g

[0099] Meglumine 12g

[0100] Sodium hydroxide 4g

[0101] Lactose 50g

[0102] Croscarmellose Sodium 10g

[0103] Appropriate amount of water

[0104] Magnesium Stearate 1g

[0105] Preparation Process

[0106] 1) Preparation of amlodipine besylate solid dispersion: Take amlodipine besylate, povidone K30 and polysorbate 80 respectively, add dehydrated alcohol, stir and dissolve, evaporate under reduced pressure to remove dehydrated alcohol, Vacuumize, dry overnight, g...

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Abstract

The invention discloses a compound telmisartan amlodipine besylate medicinal composition. The composite is a tablet which is prepared by the following steps: preparing amlodipine besylate into amlodipine besylate solid dispersion by a solid-state dispersion technology; and preparing the amlodipine besylate solid dispersion and telmisartan into the composite. The tablet improves the dissolubility of primary medicine, promotes the medicament to be quickly disintegrated, prevents dissolution influence of meglumine to the amlodipine besylate, simultaneously improves the absorptivity in blood, andimproves the bioavailability of the primary medicine. The tablet has excellent curative effect to hypertension symptoms.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a telmisartan amlodipine besylate pharmaceutical composition and a new preparation method thereof. Background technique [0002] Telmisartan [0003] The chemical name is: 4-{[2-n-propyl-4-methyl-6-(1-methylbenzimidazol-2-yl)benzimidazol-1-yl]methyl}biphenyl-2 -carboxylic acid [0004] Molecular formula: C 33 h 30 N 4 o 2 [0005] Molecular weight: 514.62 [0006] Telmisartan is a new antihypertensive drug and a specific angiotensin II receptor (AT type I) antagonist. Compared with other antihypertensive drugs, telmisartan has the following characteristics: specificity of receptor action, significant antihypertensive effect, good diuretic effect, can improve myocardial stenosis, drug safety, and tolerance Good 1 time a day, easy to take. [0007] Amlodipine [0008] The chemical name is: 3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4422A61K31/4184A61K47/38A61K9/20A61P9/12
Inventor 严洁黄欣
Owner 天津汉一医药科技有限公司
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