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A kind of pharmaceutical composition containing levamlodipine besylate

A technology of levamlodipine besylate and a composition is applied in the field of preparation of pharmaceutical compositions and tablets thereof, and can solve the problems of humidity, thermal instability, increased impurities, increased impurities, etc., and achieves good stability and production. Simple and easy to operate effect

Active Publication Date: 2017-08-15
长春海悦药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Although there are several patents for levamlodipine besylate tablets, levamlodipine besylate is insoluble in water, unstable to humidity and heat, and will change color when the drying temperature exceeds 40°C, so it is obtained by wet granulation process The tablet dissolves well, other patents or use inclusion methods to increase the stability of raw materials, but the process is complicated, and it will also be in contact with water during the preparation process and heated during the drying process, which will inevitably increase impurities; or use tablet packaging The method of film coating reduces its hygroscopicity and increases its stability during storage. However, it adopts a wet granulation process, which will also increase impurities during the preparation process, and the moisture-proof coating will also have a certain impact on dissolution.

Method used

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  • A kind of pharmaceutical composition containing levamlodipine besylate
  • A kind of pharmaceutical composition containing levamlodipine besylate
  • A kind of pharmaceutical composition containing levamlodipine besylate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0069] prescription

[0070] Levoamlodipine Besylate 10g

[0071] Sodium stearoyl lactylate 3.6g

[0072] Starch 35g

[0073] dry starch 4g

[0074] Micronized silica gel 1.8g

[0075] Povidone 5g.

[0076] Preparation

[0077] (1) After mixing levamlodipine besylate and sodium stearoyl lactylate, stir evenly to obtain a powdery solid;

[0078] (2) Mix the powder obtained in step (1) with starch and dry starch evenly, add povidone to make a suitable soft material, and granulate with a 20-mesh sieve;

[0079] (3) Mix dry starch and micropowder silica gel with the dry granules obtained in step (2), and compress into tablets to obtain levamlodipine besylate tablets.

Embodiment 2

[0081] prescription

[0082] Levoamlodipine Besylate 15g

[0083] Sodium stearoyl lactylate 4.5g

[0084] Lactose 38g

[0085] Sodium carboxymethyl starch 8g

[0086] Talc powder 2.8g

[0087] Povidone 6g.

[0088] Preparation

[0089] (1) After mixing levamlodipine besylate and sodium stearoyl lactylate, stir evenly to obtain a powdery solid;

[0090] (2) Mix uniformly with lactose and carboxymethyl starch sodium to the powder obtained in step (1), add povidone to make a suitable soft material, and granulate with a 20-mesh sieve;

[0091] (3) Sodium carboxymethyl starch and talcum powder are mixed with the dry granules obtained in step (2), and compressed into tablets to obtain levamlodipine besylate tablets.

Embodiment 3

[0093] prescription

[0094] Levoamlodipine Besylate 20g

[0095] Sodium stearoyl lactylate 4.0g

[0096] 45g powdered sugar

[0097] Low-substituted hydroxypropyl cellulose 12g

[0098] Micronized silica gel 2.5g

[0099] Povidone 7.6g.

[0100] Preparation

[0101] (1) After mixing levamlodipine besylate and sodium stearoyl lactylate, stir evenly to obtain a powdery solid;

[0102] (2) Mix the powder obtained in step (1) with powdered sugar and low-substituted hydroxypropyl cellulose evenly, add povidone to make a suitable soft material, and granulate with a 20-mesh sieve;

[0103] (3) Low-substituted hydroxypropyl cellulose and micropowder silica gel are mixed with the dry granules obtained in step (2), and compressed into tablets to obtain levamlodipine besylate tablets.

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PUM

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Abstract

The invention belongs to the technical field of medicine, and specifically relates to a pharmaceutical composition containing levamlodipine besylate, the pharmaceutical composition contains levamlodipine besylate, povidone, a filler, a disintegrating agent and The lubricant also contains sodium stearoyl lactylate. The product of the present invention has good stability, high optical purity, complete dissolution, and more excellent product quality; the product of the present invention is simple and easy to operate and is suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a pharmaceutical composition containing levamlodipine besylate and a preparation method of a tablet thereof. Background technique [0002] Levoamlodipine besylate, chemical name (-)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4- Dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate is a calcium channel blocker that blocks the entry of extracellular calcium ions through the calcium channel (slow channel) of the cell membrane in cardiac muscle and vascular smooth muscle cells, directly relaxes vascular smooth muscle, and has antihypertensive effects. [0003] Patent 200910192965.4 Inclusion of levamlodipine besylate with β-cyclodextrin increases the solubility and dissolution rate of the drug and improves the stability of the drug. [0004] Patent 200910147904.6 discloses a levoamlodipine besylate tablet and a preparation method thereof. Conta...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4422A61K47/14A61P9/12
Inventor 徐璐田晶王小雪张春苗
Owner 长春海悦药业股份有限公司
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