An amlodipine besylate tablet and a preparing method thereof

A technology of amlodipine besylate tablets and amlodipine besylate, which is applied in the field of pharmaceuticals, can solve the problems of increased substances, side effects of patients, poor stability, etc., and achieve improved dissolution rate, good fluidity, and particle compressibility and good fluidity

Inactive Publication Date: 2017-08-29
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

[0003] However, at present, amlodipine besylate has poor stability to humidity, heat and light, especially unstable under high humidity or high temperature conditions, and related substances increase significantly in the preparation process
Existing amlodipine besylate tablets adopt dry compression

Method used

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  • An amlodipine besylate tablet and a preparing method thereof
  • An amlodipine besylate tablet and a preparing method thereof
  • An amlodipine besylate tablet and a preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0025] Example 1

[0026] An amlodipine besylate tablet, based on the total weight percentage of the tablet, consists of the following ingredients: 12 parts amlodipine besylate, 30 parts microcrystalline cellulose, 50 parts starch, 70 parts dextrin, and mannitol 15 parts, 12 parts of solubilizer, 20 parts of disintegrant, 10 parts of crospovidone, 5 parts of lubricant, 4 parts of excipient, 40 parts of ethanol, 35 parts of wetting agent.

[0027] Among them, the disintegrant is sodium starch glycolate; the excipient is a mixture of sodium carboxymethyl cellulose and polyethylene glycol 400 in a mass ratio of 4:7; the solubilizer is anhydrous calcium hydrogen phosphate, solubilizing Tween -80. Sodium lauryl sulfate is a mixture of 4:7:9 by mass ratio; lubricant is magnesium stearate;

[0028] The PH value of microcrystalline cellulose ranges from 6.5 to 7.0.

[0029] The wetting agent is starch slurry 5% starch.

[0030] The invention also provides a preparation method of amlodipine be...

Example Embodiment

[0036] Example 2

[0037] An amlodipine besylate tablet, based on the total weight percentage of the tablet, consists of the following ingredients: 20 parts amlodipine besylate, 40 parts microcrystalline cellulose, 60 parts starch, 45 parts dextrin, and mannitol 30 parts, 10 parts of solubilizer, 17 parts of disintegrant, 5 parts of crospovidone, 8 parts of lubricant, 2 parts of excipient, 30 parts of ethanol, and 20 parts of wetting agent.

[0038] Among them, the disintegrant is sodium carboxymethyl cellulose; the excipient is a mixture of sodium carboxymethyl cellulose and polyethylene glycol 400 in a mass ratio of 4:7; the solubilizer is anhydrous calcium hydrogen phosphate, solubilizing spit. The mixture of Wen-80 and sodium lauryl sulfate in a mass ratio of 4:7:9; the lubricant is talc.

[0039] The PH value of microcrystalline cellulose ranges from 6.5 to 7.0.

[0040] The wetting agent is starch slurry 5% starch.

[0041] The invention also provides a preparation method of aml...

Example Embodiment

[0047] Example 3

[0048] An amlodipine besylate tablet, based on the total weight percentage of the tablet, consisting of 35 parts of amlodipine besylate, 25 parts of microcrystalline cellulose, 70 parts of starch, 60 parts of dextrin, and mannitol 20 parts, 15 parts of solubilizer, 25 parts of disintegrant, 7 parts of crospovidone, 10 parts of lubricant, 5 parts of excipient, 50 parts of ethanol, 50 parts of wetting agent.

[0049] Among them, the disintegrant is hydroxypropyl cellulose; the excipient is a mixture of sodium carboxymethyl cellulose and polyethylene glycol 400 in a mass ratio of 4:7; the solubilizer is anhydrous calcium hydrogen phosphate, solubilizing Tween -80. Sodium lauryl sulfate is a mixture of 4:7:9 by mass ratio; the lubricant is silica.

[0050] The PH value of microcrystalline cellulose ranges from 6.5 to 7.0.

[0051] The wetting agent is starch slurry 5% starch.

[0052] The invention also provides a preparation method of amlodipine besylate tablets, which...

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PUM

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Abstract

An amlodipine besylate tablet and a preparing method thereof are provided. The tablet comprises, based on the total weight of the tablet, 12-35 parts of amlodipine besylate, 25-40 parts of microcrystalline cellulose, 50-70 parts of starch, 45-70 parts of dextrin, 15-30 parts of mannitol, 10-15 parts of a solubilizer, 17-25 parts of a disintegrating agent, 5-10 parts of cross-linked polyvinylpolypyrrolidone, 5-10 parts of a lubricating agent, 2-5 parts of an excipient, 30-50 parts of ethanol and 20-50 parts of a wetting agent. The table is slow-release, and has low side effects on the stomach and intestine. A preparing process is simple.

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] However, at present, amlodipine besylate has poor stability to humidity, heat and light, especially unstable under high humidity or high temperature conditions, and related substances increase significantly during the preparation process. Existing amlodip...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4422A61K47/36A61K47/38A61K47/10A61P9/12
CPCA61K9/2031A61K9/2054A61K9/2059A61K9/2095A61K31/4422
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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