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A kind of levamlodipine besylate tablet and its preparation process

A technology of levorotatory and dipine tablets of benzenesulfonate, which is applied in the fields of medical preparations with non-active ingredients, cardiovascular system diseases, non-active ingredients of polymer compounds, etc., can solve the problem of low blood drug concentration, slow absorption, and overall blood drug concentration. Low level and other problems, to achieve the effect of high cumulative release, good stability and high bioavailability

Active Publication Date: 2017-10-24
SUZHOU DAWNRAYS PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, because amlodipine besylate is almost insoluble in water, it is slowly absorbed in the human body. Generally, the peak blood concentration is reached 6-12 hours after taking the drug, and the overall level of the blood drug concentration is low, especially the initial blood drug concentration after administration. very low concentration

Method used

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  • A kind of levamlodipine besylate tablet and its preparation process
  • A kind of levamlodipine besylate tablet and its preparation process
  • A kind of levamlodipine besylate tablet and its preparation process

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Embodiment 1: the preparation of levamlodipine besylate tablet

[0031]

[0032] Wherein, the solid dispersion of levamlodipine besylate contains 10 parts of levamlodipine besylate, 25 parts of polyvinylpyrrolidone, 50 parts of β-cyclodextrin, and 15 parts of soybean lecithin;

[0033] Preparation Process:

[0034] (1) Mix levamlodipine besylate, polyvinylpyrrolidone, β-cyclodextrin, and soybean lecithin, and then place them in a grinding device for grinding. After grinding, the particle size is required to be less than 40 μm, to obtain L-amlodipine besylate Clodipine solid dispersion;

[0035] (2) get the levamlodipine besylate solid dispersion prepared in step (1), guar gum, Tween 80, crospovidone, filler and mix uniformly;

[0036] (3) use 90% ethanol to make soft materials, sieve 18-24 mesh to granulate, and dry the wet granules at 50-80°C;

[0037] (4) Sieve through a 18-24 mesh, add hydroxypropyl starch, lubricant, sweetener, and compress into tablets.

Embodiment 2

[0038] Embodiment 2: the preparation of levamlodipine besylate tablet

[0039]

[0040]

[0041] Among them, the solid dispersion of levamlodipine besylate contains 15 parts of levamlodipine besylate, 37.5 parts of polyvinylpyrrolidone, 75 parts of β-cyclodextrin, and 22.5 parts of soybean lecithin;

[0042] Preparation Process:

[0043] (1) Mix levamlodipine besylate, polyvinylpyrrolidone, β-cyclodextrin, and soybean lecithin, and then place them in a grinding device for grinding. After grinding, the particle size is required to be less than 40 μm, to obtain L-amlodipine besylate Clodipine solid dispersion;

[0044] (2) get the levamlodipine besylate solid dispersion prepared in step (1), guar gum, Tween 80, crospovidone, filler and mix uniformly;

[0045] (3) use 90% ethanol to make soft materials, sieve 18-24 mesh to granulate, and dry the wet granules at 50-80°C;

[0046] (4) Sieve through a 18-24 mesh, add hydroxypropyl starch, lubricant, sweetener, and compress in...

Embodiment 3

[0047] Embodiment 3: the preparation of levamlodipine besylate tablet

[0048]

[0049] Among them, the solid dispersion of levamlodipine besylate contains 20 parts of levamlodipine besylate, 50 parts of polyvinylpyrrolidone, 100 parts of β-cyclodextrin, and 30 parts of soybean lecithin;

[0050] Preparation Process:

[0051] (1) Mix levamlodipine besylate, polyvinylpyrrolidone, β-cyclodextrin, and soybean lecithin, and then place them in a grinding device for grinding. After grinding, the particle size is required to be less than 40 μm, to obtain L-amlodipine besylate Clodipine solid dispersion;

[0052] (2) get the levamlodipine besylate solid dispersion prepared in step (1), guar gum, Tween 80, crospovidone, filler and mix uniformly;

[0053] (3) use 90% ethanol to make soft materials, sieve 18-24 mesh to granulate, and dry the wet granules at 50-80°C;

[0054] (4) Sieve through a 18-24 mesh, add hydroxypropyl starch, lubricant, sweetener, and compress into tablets. ...

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PUM

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Abstract

The invention relates to a levamlodipine besylate tablet. The levamlodipine besylate tablet comprises levamlodipine besylate solid dispersion, guar gum, a bulking agent, disintegrant and surfactant. The levamlodipine besylate solid dispersion comprises levamlodipine besylate, polyvinylpyrrolidone, beta-cyclodextrin and granulesten. The levamlodipine besylate tablet has the advantages of being high in accumulative dissolution rate and bioavailability, good in stability, simple in preparation technology, suitable for industrial production and the like.

Description

technical field [0001] The invention belongs to the field of western medicine preparations, in particular to a tablet containing levamlodipine besylate solid dispersion. Background technique [0002] Amlodipine besylate has two isomers, left-handed and right-handed. The calcium ion antagonistic activity of the left-handed isomer is 1000 times that of the right-handed isomer and twice that of the racemic isomer. Levoamlodipine besylate is the left-handed form of amlodipine besylate, which is a 1,4-dihydropyridine calcium ion antagonist or slow channel blocker, and is currently a commonly used drug for the treatment of hypertension. Levamlodipine besylate is white or off-white powder, easily soluble in methanol and ethanol, slightly soluble in water; its English name is LevamlodipineBesylate, and its chemical name is (S)-(-)3-ethyl-5- Methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate , the molecular formula is C...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/22A61K31/4422A61K47/32A61K47/24A61K47/26A61K47/36A61K47/40A61P9/12A61P9/10
Inventor 樊国峰颜培钢张国成黄东
Owner SUZHOU DAWNRAYS PHARM CO LTD
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