Benzene sulfonic acid levo-amlodipine pill and preparation method thereof

A kind of technology of levamlodipine besylate and levamlodipine besylate, applied in the field of levamlodipine besylate tablet and preparation thereof, can solve the problems such as no document discloses levamlodipine besylate tablet and the like, achieves Good product stability, good practicability, and improved dissolution rate

Inactive Publication Date: 2009-10-21
NANCHANG HELIOEAST PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Although amlodipine besylate or levamlodipine orally disintegrating tablets, or amlodipine besylate dispersible tablets are disclosed in the prior art, th...

Method used

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  • Benzene sulfonic acid levo-amlodipine pill and preparation method thereof
  • Benzene sulfonic acid levo-amlodipine pill and preparation method thereof
  • Benzene sulfonic acid levo-amlodipine pill and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Levoamlodipine Besylate 2.5g (calculated as Levoamlodipine)

[0028] Lactose 80g

[0029] Low-substituted hydroxypropyl cellulose 30g

[0030] Cross-linked polyvinylpyrrolidone 5g

[0031] Magnesium Stearate 1.5g

[0032]

[0033] Press 1000 tablets (theoretical tablet weight 0.12g tablet)

[0034] Preparation:

[0035] (1) According to the above formula, weigh the raw materials and auxiliary materials, mix them by double dispersion and dilution method, and put them in a high-speed ultrafine pulverizer for 1-2 minutes, so that the pulverized mixed powder can pass through a sieve of more than 100 mesh. Obtain uniform mixed fine powder for subsequent use.

[0036] (2) Use ethanol aqueous solution as a wetting agent.

[0037] (3) Stir the wetting agent to the mixed fine powder under each prescription and mix evenly, and make a soft material, use a 16-18 mesh sieve to make granules, and dry in a 60°C oven for 3-4 h...

Embodiment 2

[0040] Levoamlodipine Besylate 5.0g (calculated as Levoamlodipine)

[0041] Lactose 80g

[0042] Low-substituted hydroxypropyl cellulose 26.5g

[0043] Cross-linked polyvinylpyrrolidone 5g

[0044]Magnesium Stearate 1.5g

[0045]

[0046] Press 1000 tablets (theoretical tablet weight 0.12g tablet)

[0047] Preparation:

[0048] (1) According to the above prescription formula, weigh the raw materials and auxiliary materials (except external auxiliary materials) and mix them by double dispersion and dilution method, and put them in a high-speed ultra-fine pulverizer for 1-2 minutes, so that the pulverized mixed powder can pass through 100 mesh above the sieve. Obtain uniform mixed fine powder for subsequent use.

[0049] (2) Use ethanol aqueous solution as a wetting agent.

[0050] (3) Stir the wetting agent to the mixed fine powder under each prescription and mix evenly, and make a soft material, use a 1...

Embodiment 3

[0053] Levoamlodipine Besylate 2.5g (calculated as Levoamlodipine)

[0054] Lactose 70g

[0055] Low-substituted hydroxypropyl cellulose 37g

[0056] Cross-linked polyvinylpyrrolidone 8g

[0057] Magnesium stearate (additional) 1.5g

[0058]

[0059] Press 1000 tablets (theoretical tablet weight 0.12g tablet)

[0060] Preparation:

[0061] (1) According to the above prescription formula, weigh the raw materials and auxiliary materials (except external auxiliary materials) and mix them by double dispersion and dilution method, and put them in a high-speed ultra-fine pulverizer for 1-2 minutes, so that the pulverized mixed powder can pass through 100 mesh above the sieve. Obtain uniform mixed fine powder for subsequent use.

[0062] (2) Use ethanol aqueous solution as a wetting agent.

[0063] (3) Stir the wetting agent to the mixed fine powder under each prescription and mix evenly, and make a soft material, use a 16-18 me...

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Abstract

The invention discloses benzene sulfonic acid levo-amlodipine pills and a preparation method thereof. On the basis of 1000 pills, the benzene sulfonic acid levo-amlodipine pill comprises 1-10g of benzene sulfonic acid levo-amlodipine, preferably 2.5g; 50-100g of lactose, preferably 67-87g and most preferably 80g; 5-55g of low-substituted hydroxy propyl cellulose, preferably 20-40g and particularly preferred 30g; 2-20g of crosslinked polyethylene ketopyrrolidine, preferably 5g; and 0.5-2.5g of magnesium stearate, preferably 1.5g. The benzene sulfonic acid levo-amlodipine pills have more than 95 percent of dissolution rate and good production 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 is white or off-white powder, its chemical name is (S)-(-)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-( 2-Chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate; molecular formula: C 20 h 25 N 2 o 5 Cl·C 6 h 6 o 3 S, is a 1,4-dihydropyridine calcium antagonist. 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. [0003] Chengdu Shengnuo Technology Development Co., Ltd. disclosed a kind of amlodipine besylate orally disintegrating tablet and its preparation method in Chinese patent application CN 1546024A (disclosure date is November 17, 2004), and its compositi...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4422A61K47/26A61K47/38A61P9/10A61P9/12
Inventor 刘智
Owner NANCHANG HELIOEAST PHARMA
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