Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

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
View PDF4 Cites 0 Cited by
  • 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 process or adopt methods such as inclusion to increase the stability of the preparation, but due to process and prescription reasons, the related substances in the preparation process or storage process have increased significantly, Clinically, patients often have some side effects when taking it

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • 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

Embodiment 1

[0026] A kind of amlodipine besylate tablet, by tablet gross weight percentage, is made up of following composition: 12 parts of amlodipine besylate, 30 parts of microcrystalline cellulose, 50 parts of starch, 70 parts of dextrin, 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 carboxymethyl starch sodium; the excipient is a mixture of carmellose sodium and polyethylene glycol 400 in a mass ratio of 4:7; the solubilizer is anhydrous calcium hydrogen phosphate, solubilizing Tween -80. A mixture of sodium lauryl sulfate in a mass ratio of 4:7:9; the lubricant is magnesium stearate;

[0028] The pH range of microcrystalline cellulose is 6.5-7.0.

[0029] Wetting agent is starch slurry 5% starch.

[0030] The present invention also provides a kind of preparation method of amlodipine besylate tablet, c...

Embodiment 2

[0037] A kind of amlodipine besylate tablet, according to tablet gross weight percentage, is made up of following composition: 20 parts of amlodipine besylate, 40 parts of microcrystalline cellulose, 60 parts of starch, 45 parts of dextrin, 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, 20 parts of wetting agent.

[0038] Among them, the disintegrant is carmellose sodium; the excipient is a mixture of carmellose sodium and polyethylene glycol 400 in a mass ratio of 4:7; A mixture of Wen-80 and sodium lauryl sulfate in a mass ratio of 4:7:9; the lubricant is talcum powder.

[0039] The pH range of microcrystalline cellulose is 6.5-7.0.

[0040] Wetting agent is starch slurry 5% starch.

[0041] The present invention also provides a kind of preparation method of amlodipine besylate tablet, comprises the steps:

[0042] (1) After weighing 20 parts of amlodipine besy...

Embodiment 3

[0048] A kind of amlodipine besylate tablet, according to tablet gross weight percentage, is made up of following composition: 35 parts of amlodipine besylate, 25 parts of microcrystalline cellulose, 70 parts of starch, 60 parts of dextrin, 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, and 50 parts of wetting agent.

[0049] Among them, the disintegrating agent is hydroxypropyl cellulose; the excipient is a mixture of carmellose sodium and polyethylene glycol 400 in a mass ratio of 4:7; the solubilizer is anhydrous calcium hydrogen phosphate, solubilizing Tween -80. A mixture of sodium lauryl sulfate in a mass ratio of 4:7:9; the lubricant is silicon dioxide.

[0050] The pH range of microcrystalline cellulose is 6.5-7.0.

[0051] Wetting agent is starch slurry 5% starch.

[0052] The present invention also provides a kind of preparation method of amlodipine bes...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

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

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
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
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products