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Levamlodipine besylate tablets and preparation method thereof

A technology of L-benzenesulfonic acid and dipine tablets, which can be used in pill delivery, cardiovascular system diseases, drug combination, etc., can solve the problems of unstable drug quality, high-temperature damage, etc., and achieve less impurities, low production cost, and simple operation. Effect

Inactive Publication Date: 2015-01-07
SHIHUIDA PHARMA GRP (JILIN) LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the preparation of levamlodipine besylate tablets is usually carried out by mixing the main drug and excipient powders and directly compressing the tablets. During the boiling drying process, the active ingredients of traditional wet granulation drugs are easily damaged by high temperature, which leads to the deterioration of drug quality. unstable

Method used

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  • Levamlodipine besylate tablets and preparation method thereof

Examples

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Comparison scheme
Effect test

Embodiment 1

[0018] A preparation method of levamlodipine besylate, the method consists of the following steps:

[0019] Mix starch and sodium carboxymethyl starch, add it to the binder dextrin, and granulate to obtain blank granules without active ingredients; dry the prepared granules at 60°C, when the moisture content of the granules reaches 1-3%. Collect the material and granulate with a fast granulator;

[0020] Dissolving levamlodipine besylate in absolute ethanol to make levamlodipine besylate ethanol solution, spraying it into dry granules and adding additional excipients (magnesium stearate), mixing, and drying at room temperature;

[0021] The content of levamlodipine besylate in the mixed granules was measured, and the mixed granules with qualified content were compressed into tablets to make levamlodipine besylate tablets.

[0022] Get the prepared Levoamlodipine Besylate Tablets, and detect the total impurities of the Levoamlodipine Besylate Tablets. The sample had a total i...

Embodiment 2

[0027] Preparation of Levoamlodipine Besylate Tablets

[0028] Excipient granulation: mix lactose and croscarmellose sodium and add it to the binder starch to granulate; dry the granules at 70°C, collect the granules when the moisture content of the granules reaches 1-3%, and use fast Whole grain machine;

[0029] Dissolving levamlodipine besylate in absolute ethanol to make levamlodipine besylate ethanol solution, spraying it into dry granules and adding additional auxiliary materials (talc powder), mixing, and drying at normal temperature;

[0030] The content of levamlodipine besylate in the mixed granules was measured, and the mixed granules with qualified content were compressed into tablets to make levamlodipine besylate tablets.

[0031] Get the prepared levamlodipine besylate tablet sample, and detect the total impurities of the levamlodipine besylate tablet. The sample had a total impurity of 0.16%.

[0032] Judging from the detection results of the total impuritie...

Embodiment 3

[0037] A preparation method of levamlodipine besylate, the method consists of the following steps:

[0038] Excipient granulation: mix mannitol and crospovidone and add it to the binder hydroxypropyl cellulose to granulate; dry the prepared granules at 80°C, and collect when the moisture content of the granules reaches 1-3%. The material is granulated with a fast granulator;

[0039] Dissolving levamlodipine besylate in absolute ethanol to make levamlodipine besylate ethanol solution, spraying it into dry granules and adding additional auxiliary materials (silicon dioxide), mixing, and drying at room temperature;

[0040] The content of levamlodipine besylate in the mixed granules was measured, and the mixed granules with qualified content were compressed into tablets to make levamlodipine besylate tablets.

[0041] Get the prepared levamlodipine besylate tablet sample, and detect the total impurities of the levamlodipine besylate tablet. The sample had a total impurity of 0...

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Abstract

The invention provides levamlodipine besylate tablets and a preparation method thereof. According to the method, a diluent and a disintegrant are added into an adhesive, and a wet process is adopted for mixing granulation; drying and granular straightening are performed; a levamlodipine besylate ethanol solution is sprayed to granules, external accessories are added, mixing and drying at room temperature are performed, and a product is prepared after tableting. The prepared levamlodipine besylate tablets contain a few impurities and are high in stability.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a levoamlodipine besylate tablet and a preparation method thereof. Background technique [0002] Levoamlodipine besylate, chemical name: (S)-(-)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)- 1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate is the first chiral resolution optically pure drug in China and the first chiral resolution antihypertensive drug in the world , used alone or in combination with other drugs, has the effect of antihypertensive and treating angina pectoris, and has been used clinically. The pharmacological effects are (1) This product is a calcium influx blocker (that is, a calcium channel blocker or a calcium ion antagonist), which blocks the calcium ion channel (slow channel) of extracellular calcium ion passing through the cell membrane in cardiac muscle and vascular smooth muscle into cells. (2) This product directl...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4422A61P9/12A61P9/10
Inventor 操玉平杨彦玲薛传校
Owner SHIHUIDA PHARMA GRP (JILIN) LTD
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