Nifedipine sustained-release tablet and production process thereof

A technology for nifedipine and nifedipine, which is applied in the field of medicine, can solve the problems of uneven drug dose dispersion, unstable sustained release, easy burst release and the like, so as to avoid burst release phenomenon, uniform drug dose dispersion and lasting curative effect. Effect

Active Publication Date: 2020-09-11
JINAN LIMIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, the existing nifedipine sustained-release tablets still have problems such as unstable sustained-release, sudden release phenomenon, and uneven dispersion of the drug dose in the nifedipine sustained-release tablets.

Method used

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  • Nifedipine sustained-release tablet and production process thereof
  • Nifedipine sustained-release tablet and production process thereof
  • Nifedipine sustained-release tablet and production process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Embodiment 1, a kind of nifedipine sustained-release tablet

[0035] The nifedipine sustained-release tablet comprises the following components and parts by mass thereof:

[0036] 20 parts of nifedipine, 13 parts of slow-release agent, 3 parts of blocking agent, 72 parts of filler, 1 part of disintegrating agent, 0.3 part of glidant, 0.5 part of lubricant; the slow-release agent is hypromellose base cellulose; the blocker is composed of sodium carboxymethyl cellulose and chitosan oligosaccharide with an average molecular weight of 3000 in a mass ratio of 7:3; the filler is microcrystalline cellulose; the disintegrant is cross-linked Lipovidone; the glidant is composed of magnesium stearate and silicon dioxide in a mass ratio of 1:4; the lubricant is glyceryl monostearate.

[0037] The production technology of described nifedipine slow-release tablet is:

[0038] S1 Grinding nifedipine to a particle size D90 of 10 μm to obtain nifedipine powder;

[0039] S2 Pulverize ...

Embodiment 2

[0043] Embodiment 2, a kind of nifedipine slow-release tablet

[0044] The nifedipine sustained-release tablet comprises the following components and parts by mass thereof:

[0045] 20 parts of nifedipine, 20 parts of slow-release agent, 5 parts of blocker, 76 parts of filler, 2 parts of disintegrant, 0.7 part of glidant, 1 part of lubricant; the slow-release agent is hypromellose base cellulose; the blocker is composed of sodium carboxymethylcellulose and chitosan oligosaccharide with an average molecular weight of 3000 in a mass ratio of 10:2; the filler is microcrystalline cellulose; the disintegrant is carboxymethyl cellulose Calcium methylcellulose; the glidant is composed of magnesium stearate and silicon dioxide in a mass ratio of 1:6; the lubricant is talcum powder.

[0046] The production technology of described nifedipine slow-release tablet is:

[0047] S1 Grinding nifedipine to a particle size D90 of 50 μm to obtain nifedipine powder;

[0048] S2 Pulverize the s...

Embodiment 3

[0052] Embodiment 3, a kind of nifedipine sustained-release tablet

[0053] The nifedipine sustained-release tablet comprises the following components and parts by mass thereof:

[0054] 20 parts of nifedipine, 18 parts of slow-release agent, 4 parts of blocker, 74 parts of filler, 1.2 parts of disintegrant, 0.5 part of glidant, 0.6 part of lubricant; base cellulose; the blocker is composed of sodium carboxymethyl cellulose and chitosan oligosaccharide with an average molecular weight of 3000 in a mass ratio of 8:3; the filler is microcrystalline cellulose; the disintegrant is composed of Lipovidone and sodium lauryl starch are composed of 5:2 by mass ratio; the glidant is composed of magnesium stearate and silicon dioxide by mass ratio of 1:5; the lubricant has an average molecular weight of 2000 of polyethylene glycol.

[0055] The production technology of described nifedipine slow-release tablet, step is as follows:

[0056] S1 Grinding nifedipine to a particle size D90 of...

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Abstract

The invention belongs to the technical field of medicines and particularly relates to a nifedipine sustained-release tablet and a production process thereof. The provided nifedipine sustained-releasetablet is prepared from components in parts by mass as follows: 20 parts of nifedipine, 13-20 parts of a sustained-release agent, 3-5 parts of a retardant, 72-76 parts of a filling agent, 1-2 parts ofa disintegrating agent, 0.3-0.7 part of a fluidizer and 0.5-1 part of a lubricant. The provided nifedipine sustained-release tablet is stable in drug release, can guarantee full release within 24 hours and maintain necessary blood-drug concentration and avoids the sudden release phenomenon. Besides, the prepared nifedipine sustained-release tablet is uniform in drug dispersion.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a nifedipine sustained-release tablet and a production process thereof. Background technique [0002] With the development of the pharmaceutical industry and the advancement of science, the development of pharmaceutical preparations is becoming more and more diverse, and the level of preparation technology is also getting higher and higher. The development of sustained and controlled release preparations has set off a certain climax in recent years. The varieties and specifications of sustained-release and controlled-release preparations at home and abroad are also increasing. [0003] Nifedipine, as a common clinical drug for treating hypertension and angina pectoris, has definite curative effect and is usually used as the drug of choice. Nifedipine is a blocker of calcium ion channels with a dihydropyridine structure. Its structure leads to poor water solubility ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K47/38A61K47/36A61K31/4422A61P9/12A61P9/10
CPCA61K9/2054A61K9/205A61K9/2095A61K31/4422A61P9/12A61P9/10
Inventor 侯念磊常罡李盟张伟
Owner JINAN LIMIN PHARMA
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