Amlodipine besylate tablet and preparation method thereof

A technology of amlodipine besylate tablets and amlodipine besylate, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., and can solve the problem of unstable dissolution and taking by patients. Side effects, instability and other problems, to achieve excellent stability, good compressibility and fluidity, and improve the effect of dissolution rate

Inactive Publication Date: 2018-12-11
江苏黄河药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] But, amlodipine besylate has instability to humidity, light, and existing amlodipine besylate sheet all adopts dry process or adopts methods such as clathrate to increase the stability of preparation, yet its stripping is unstable , so that clinical patients often have some side effects when taking it

Method used

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  • Amlodipine besylate tablet and preparation method thereof

Examples

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Comparison scheme
Effect test

Embodiment 1

[0023] A kind of amlodipine besylate tablet, by tablet gross weight percentage, is made up of following composition: 15 parts of amlodipine besylate, 40 parts of microcrystalline cellulose, 13 parts of L-tyrosine, 25 parts of solubilizing agent 15 parts of disintegrant, 8 parts of crospovidone, 3 parts of lubricant, 10 parts of excipient, 30 parts of ethanol.

[0024] Wherein, the disintegrant is carboxymethyl starch sodium; the excipient is a mixture of carmellose sodium and polyethylene glycol 400 in a mass ratio of 2:5; the solubilizer is anhydrous calcium hydrogen phosphate, solubilizing Tween -80. A mixture of sodium lauryl sulfate in a mass ratio of 1:3:5; the lubricant is magnesium stearate; the pH value of microcrystalline cellulose is 6.5.

[0025] A kind of preparation method of amlodipine besylate sheet, described method comprises the steps:

[0026] (1) After weighing 15 parts of amlodipine besylate, 40 parts of microcrystalline cellulose, 13 parts of L-tyrosine, ...

Embodiment 2

[0030] A kind of amlodipine besylate tablet, by tablet gross weight percentage, is made up of following composition: 20 parts of amlodipine besylate, 30 parts of microcrystalline cellulose, 10 parts of L-tyrosine, 15 parts of solubilizing agent 20 parts of disintegrant, 10 parts of crospovidone, 2 parts of lubricant, 8 parts of excipient, 40 parts of ethanol.

[0031] Among them, the disintegrant is carmellose sodium; the excipient is a mixture of carmellose sodium and polyethylene glycol 400 in a mass ratio of 2:5; A mixture of Wen-80 and sodium lauryl sulfate in a mass ratio of 1:3:5; the lubricant is talc; the pH value of microcrystalline cellulose is 7.

[0032] The present invention also provides a kind of preparation method of amlodipine besylate tablet, and method comprises the steps:

[0033] (1) After weighing 20 parts of amlodipine besylate, 30 parts of microcrystalline cellulose, 10 parts of L-tyrosine, 15 parts of solubilizer, and 10 parts of crospovidone by weigh...

Embodiment 3

[0037] A kind of amlodipine besylate tablet, by tablet gross weight percentage, is made up of following composition: 30 parts of amlodipine besylate, 60 parts of microcrystalline cellulose, 20 parts of L-tyrosine, 20 parts of solubilizing agent 5 parts, 30 parts of disintegrant, 5 parts of crospovidone, 5 parts of lubricant, 5 parts of excipient, 50 parts of ethanol.

[0038] Wherein, the disintegrant is hydroxypropyl cellulose; the excipient is a mixture of carmellose sodium and polyethylene glycol 400 in a mass ratio of 2:5; the solubilizer is anhydrous calcium hydrogen phosphate, solubilizing Tween -80. A mixture of sodium lauryl sulfate in a mass ratio of 1:3:5; the lubricant is silicon dioxide; the pH value of the microcrystalline cellulose is 6.8.

[0039] The present invention also provides a kind of preparation method of amlodipine besylate tablet, described method comprises the steps:

[0040] (1) After weighing 30 parts of amlodipine besylate, 60 parts of microcryst...

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Abstract

The invention provides an amlodipine besylate tablet and a preparation method thereof, wherein the tablet comprises, by weight, 15-30 parts of amlodipine besylate, 30-60 parts of microcrystalline cellulose, 10-20 parts of L-tyrosine, 15-25 parts of a solubilizer, 15-30 parts of a disintegrant, 5-10 parts of a crospovidone, 2-5 parts of a lubricant, 5-10 parts of an excipient, and 30-50 parts of ethanol. According to the present invention, the tablet has characteristics of slow release, low gastrointestinal side-effect and simple preparation process.

Description

technical field [0001] The invention belongs to the field of medicines, and in particular relates to an amlodipine besylate tablet and a preparation method thereof. Background technique [0002] In recent years, with the improvement of people's living standards, the incidence of hypertension has also been increasing, and high blood pressure can cause damage to the heart, brain, kidneys and other human organs, which in turn lead to cardiovascular diseases. According to surveys, cardiovascular diseases It has become one of the frequent diseases that endanger human health. Research and development of a drug that can effectively treat hypertension has always been the unremitting pursuit of scholars at home and abroad. [0003] Amlodipine besylate is a third-generation dihydropyridine calcium antagonist. The contraction of cardiac muscle and smooth muscle depends on extracellular calcium ions entering cells through specific ion channels. Compared with similar antihypertensive dr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4422A61K47/18A61K47/38A61K47/32A61K47/10A61P9/12
CPCA61K9/2013A61K9/2054A61K9/2059A61K31/4422
Inventor 朱正标陶元明张汉华李苗苗范小雪
Owner 江苏黄河药业股份有限公司
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