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Technique of preparing amlodipine besylate tablets

A kind of technology of amlodipine besylate tablet and amlodipine besylate, which is applied in the field of medicine, can solve the problems of clinical application influence, enhanced hydrophobicity of tablets, low dissolution rate of amlodipine besylate, etc., and achieve improvement Intrinsic quality and curative effect, improving fineness and uniformity, and improving the dissolution rate of finished products

Active Publication Date: 2008-04-16
YANGZIJIANG PHARMA GROUP SHANGHAI HAINI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But, because amlodipine besylate is slightly soluble in water, the dissolution rate of amlodipine besylate prepared by general method is relatively low, which is not suitable for rapid onset of action of medicine, and has certain influence on clinical application
Thereby, adopt improved method to prepare amlodipine besylate, for example, can improve its stripping by micronization, but this method has defect, in actual preparation, after hydrophobic material pulverizes, with the reduction of particle size , the surface free energy increases, and the particles are prone to re-agglomeration, so the actual efficiency of crushing is not high; on the other hand, due to the small particle size of hydrophobic materials and the increase of specific surface area, the hydrophobicity of tablets will also Enhanced, but not conducive to the dissolution of the tablet

Method used

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Experimental program
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Embodiment Construction

[0028] (1) Formula: (calculated on the basis of 1,000,000 plain tablets)

[0029] Amlodipine besylate 7.086kg

[0030] Microcrystalline cellulose 124.0kg

[0031] Calcium hydrogen phosphate 63.0kg

[0032] Carboxymethyl starch sodium 4.0kg

[0033] Magnesium Stearate 2.0kg

[0034] The filler is: microcrystalline cellulose, calcium hydrogen phosphate

[0035] The disintegrant is sodium carboxymethyl starch, the lubricant is magnesium stearate

[0036] The above raw and auxiliary materials are sold by domestic manufacturers

[0037] Firstly, amlodipine besylate was crushed through 100 mesh, and microcrystalline cellulose and calcium hydrogen phosphate were crushed through 80 mesh. Then amlodipine besylate and sodium starch glycolate are mixed, sieved and mixed into microcrystalline cellulose and calcium hydrogen phosphate. Mix evenly through a fluidized bed one-step granulator, and the air volume during granulation is 854-964m 3 / h; the spray speed is 75rpm; the spray p...

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PUM

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Abstract

A preparation technology of amlodipine besylate is disclosed in the present invention, the technology is with amlodipine besylate, filler, disintegrating agent, lubricant etc. as main components. By using grinding and sieving; reasonably controlling particle water; repeatedly feeling fluidized bed granulating technology parameter, controlling spraying speed, spraying pressure and air quantity, under the situation of non-affecting tablet content and hardness, increasing the solubility of product greatly, thereby promoting the internal quality and curative effect of the product.

Description

Technical field: [0001] The invention relates to the technical field of medicine, in particular to a preparation process for improving the dissolution rate of amlodipine besylate tablets. Background technique: [0002] Amlodipine besylate is a calcium influx blocker, which has antihypertensive effects and relieves angina pectoris, and has been used clinically. But, because amlodipine besylate is slightly soluble in water, so the dissolution rate of amlodipine besylate prepared by general method is relatively low, it is not suitable for rapid onset of action of medicine, and clinical application has certain influence. Thereby, adopt improved method to prepare amlodipine besylate, for example, can improve its stripping by micronization, but this method has defect, in actual preparation, after hydrophobic material pulverizes, with the reduction of particle size , the surface free energy increases, and the particles are prone to re-agglomeration, so the actual efficiency of cru...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4422A61K47/38A61P9/12
Inventor 周庆武姚盛纪标唐开勇
Owner YANGZIJIANG PHARMA GROUP SHANGHAI HAINI PHARMA
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