Oral disintegration tablet of Amlodipine mesylate maleic acid, and preparation method

A technology of amlodipine maleate and orally disintegrating tablets, which is applied in the field of orally disintegrating amlodipine maleate tablets and its preparation, to achieve the effect of being easy to take and pack and carry

Inactive Publication Date: 2005-11-16
HANGZHOU MINSHENG PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But they are all ordinary tablets, taste

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] The formulation of the present invention consists of the following components by weight percentage:

[0029] Amlodipine Maleate 5.0g

[0030] Microcrystalline Cellulose 50.0g

[0031] Mannitol 100.0g

[0032] Cross-linked polyvinylpyrrolidone 9.0g

[0033] Sodium bicarbonate 4.0g

[0034] Citric acid 4.0g

[0035] Aspartame 1.5g

[0036] Mint essence 0.56g

[0037] Orange flavor 1.0g

[0038] Micronized silica gel 2.0g

[0039] Magnesium Stearate 1.0g

[0040] A total of 1000 pieces were made

[0041] The dosage form is prepared by direct compression technology using conventional tablet pharmaceutical equipment. The specific preparation method is as follows: Amlodipine maleate, microcrystalline cellulose, mannitol, cross-linked polyvinylpyrrolidone, sodium bicarbonate, citric acid, aspartame, peppermint essence, orange essence are respectively Weigh, pass through an 80-mesh sieve and mix evenly; then mix with magnesium stearate and micropowder silica gel, sie...

Embodiment 2

[0043] The formulation of the present invention consists of the following components by weight percentage:

[0044] Amlodipine Maleate 5.0g

[0045] Fast flowing lactose (Flowlac  ) 150.0g

[0046] Croscarmellose Sodium 9.0g

[0047] Aspartame 1.8g

[0048] Mint essence 0.5g

[0049] Magnesium Stearate 1.0g

[0050] A total of 1000 pieces were made

[0051] The dosage form is prepared by direct compression technology using conventional tablet pharmaceutical equipment. The specific preparation method is as follows: amlodipine maleate, fast flow lactose (Flowlac  ), croscarmellose sodium, aspartame and peppermint essence were weighed respectively according to the amount, passed through an 80 mesh sieve and mixed evenly; then mixed with magnesium stearate, sieved and mixed evenly, and then the intermediate was carried out For content determination, directly compress the tablet according to the specified amount to obtain an orally disintegrating tablet.

Embodiment 3

[0053] The formulation of the present invention consists of the following components by weight percentage:

[0054] Amlodipine Maleate 5.0g

[0055] Microcrystalline Cellulose 80.0g

[0056]Mannitol 88.0g

[0057] Aspartame 1.8g

[0058] Mint essence 0.5g

[0059] Orange flavor 1.0g

[0060] Micronized silica gel 2.0g

[0061] Magnesium Stearate 1.0g

[0062] A total of 1000 pieces were made

[0063] The dosage form is prepared by direct compression technology using conventional tablet pharmaceutical equipment. The specific preparation method is as follows: Weigh amlodipine maleate, microcrystalline cellulose, mannitol, aspartame, peppermint flavor, and orange flavor respectively according to the amount, pass through an 80-mesh sieve and mix evenly; Magnesium fatty acid and micropowder silica gel are mixed, sieved and mixed evenly, and then the content of this intermediate is determined, and it is directly compressed into tablets according to the specified amount to ob...

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PUM

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Abstract

An oral disintegrating tablet of amlodipine maleate is prepared from amlodipine maleate, filler, disintegrant, effervescent agent, flavouring, lubricant and flowing aid through conventional process.

Description

technical field [0001] The invention belongs to pharmaceutical preparations, and relates to an orally disintegrating tablet suitable for treating hypertension and angina pectoris, in particular to an orally disintegrating tablet of amlodipine maleate and a preparation method thereof. Background technique [0002] Hypertension and angina pectoris are common and frequently-occurring diseases, which seriously endanger human life and health, and patients need continuous medication for life, so the research and development of such drugs has always been the focus of the global pharmaceutical industry. Amlodipine Maleate (Amlodipine Maleate, the chemical name is rac-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6- Methyl-3,5-pyridinedicarboxylic acid-3-ethyl-5-methyl ester maleate) is a calcium channel blocker with remarkable antihypertensive effect and is the first-line drug for the treatment of hypertension and angina pectoris. It only needs to be taken once a day to ...

Claims

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Application Information

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IPC IPC(8): A61K31/4422
Inventor 张文伟郑文谢纲
Owner HANGZHOU MINSHENG PHARM CO LTD
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