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Levamlodipine beaylate tablets and preparation method thereof

A technology of levamlodipine besylate and levo-amlodipine besylate, applied in the field of levamlodipine besylate tablets and its preparation, can solve tablet compressibility, friability, tablet weight difference, and content uniformity , Dissolution is difficult to control, poor stability and other problems, to achieve the effect of good tablet weight difference, good compressibility and simple production process

Inactive Publication Date: 2010-06-09
HONGYI SCI & TECH CO LTD NANCHANG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Although levamlodipine besylate orally disintegrating tablets and levamlodipine besylate dispersible tablets have been disclosed in the prior art, the production of existing tablets is limited by conditions such as technology, equipment, etc., making the tablets The compressibility, friability, tablet weight difference, content uniformity, and dissolution rate of the preparation are not easy to control, and the stability is relatively poor. There is no levamlodipine besylate tablet produced by improving process technology and equipment disclosed in the literature. Especially Levoamlodipine Besylate Tablets with good compressibility, friability, tablet weight difference, content uniformity, excellent dissolution performance and stable quality

Method used

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  • Levamlodipine beaylate tablets and preparation method thereof
  • Levamlodipine beaylate tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Levoamlodipine Besylate 3.5g

[0041] 70g pregelatinized starch

[0042] Low-substituted hydroxypropyl cellulose 30g

[0043] Cross-linked polyvinylpyrrolidone 8.5g

[0044] Magnesium Stearate 3g

[0045]

[0046] Makes 1000 pieces

[0047] Preparation

[0048] Weigh respectively levamlodipine besylate, pregelatinized starch, low-substituted hydroxypropyl cellulose, cross-linked polyvinylpyrrolidone, magnesium stearate according to the prescription quantity, mix well, pulverize, pass through an 80 mesh sieve, and mix well , placed in a powder feeder for a new type of tablet press, the dry powder is directly pressed into tablets, packed, and ready to be obtained.

Embodiment 2

[0050] Levoamlodipine Besylate 3.5g

[0051] Lactose 70g

[0052] Low-substituted hydroxypropyl cellulose 30g

[0053] Cross-linked polyvinylpyrrolidone 8.5g

[0054] Magnesium Stearate 3g

[0055]

[0056] Makes 1000 pieces

[0057] Preparation

[0058] Weigh respectively levamlodipine besylate, lactose, low-substituted hydroxypropyl cellulose, cross-linked polyvinylpyrrolidone, and magnesium stearate according to the prescription amount, mix well, pulverize, pass through a 80-mesh sieve, mix well, and place in a new In the powder feeder for the tablet machine, the dry powder is directly compressed into tablets, packed, and ready to be obtained.

Embodiment 3

[0060] Levoamlodipine Besylate 3.5g

[0061] Mannitol 70g

[0062] Low-substituted hydroxypropyl cellulose 30g

[0063] Cross-linked polyvinylpyrrolidone 8.5g

[0064] Magnesium Stearate 3g

[0065]

[0066] Makes 1000 pieces

[0067] Preparation

[0068] Weigh respectively levamlodipine besylate, mannitol, low-substituted hydroxypropyl cellulose, cross-linked polyvinylpyrrolidone, and magnesium stearate according to the prescription amount, mix well, pulverize, pass through an 80-mesh sieve, mix well, and place In the powder feeder for the new tablet press machine, the dry powder is directly compressed into tablets, packaged, and ready to be obtained.

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Abstract

The invention discloses levamlodipine beaylate tablets which is prepared by comprising the following raw materials in parts by weight: 1-20 parts of levamlodipine beaylate, 20-150 parts of filling agent, 10-100 parts of disintegrating agent and 1-10 parts of lubricant. The preparation method of the levamlodipine beaylate tablets comprises the following steps of: evenly mixing the raw materials, crushing, screening with a 60-100 mesh sieve, evenly mixing, and preparing the levamlodipine beaylate tablets in a novel powder feeder for a tablet machine by using a direct dry powder tablet compressing method. Compared with the traditional tablet production technology, the levamlodipine beaylate tablets of the invention have the advantages of favorable compressibility, friability and tablet weight variation, uniform content and stable quality.

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] 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. Clinical application Levoamlodipine besylate tablet mainly has two effects: one effect is to treat hypertension, and is used for mild and moderate hypertensive patients (used alone or in combination with other drugs). Another effect is the treatment of angina, especially idiopathic angina (alone or in combination with other drugs). Levoamlodi...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K31/4422A61P9/12A61P9/10
Inventor 刘智许军钱进陶琳穆正义廖新华王晓霞周治洋熊水根刘孝乐
Owner HONGYI SCI & TECH CO LTD NANCHANG
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