Nifedipine composition and preparation method thereof

A technology of nifedipine and a composition, applied in the field of medicine, can solve the problems of low reproducibility, too slow release, residual organic solvent, etc., and achieve the effects of good ductility and thermoplasticity, stable release curve, and continuous release curve

Inactive Publication Date: 2011-04-27
ZHEJIANG ANGLIKANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Although the above technical solutions can achieve a certain effect of first solubilization and then slow release, the preparation method is too cumbersome, the production cycle is long, the probability of quality problems is relatively high, and the phenomenon of slow release or burst release is very easy to occur.
The traditional solid dispersion technology is prepared by melting method or solvent method. However, due to the complex process, low reproducibility, and organic solvent residues in the preparation method, it is difficult to promote industrialization.

Method used

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  • Nifedipine composition and preparation method thereof
  • Nifedipine composition and preparation method thereof
  • Nifedipine composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] The preparation of embodiment 1 crude drug tablet

[0023] Prescription: Nifedipine 10g, microcrystalline cellulose 180g, magnesium stearate 1.5g. Preparation method: mix the raw and auxiliary materials evenly, and directly compress into tablets.

Embodiment 2

[0024] Embodiment 2 solvent method prepares solid dispersion

[0025]

[0026] Preparation

[0027] The prescribed amount of nifedipine, hydroxypropyl cellulose ( HPC EF, Ashland, USA) and microcrystalline cellulose excipients were dissolved in absolute ethanol, mixed evenly, removed from absolute ethanol, dried at 60°C for 24 hours, pulverized to a suitable particle size, mixed with magnesium stearate, and compressed into tablets. Get nifedipine.

Embodiment 3

[0028] Embodiment 3 hot-melt extrusion method prepares solid dispersion

[0029]

[0030] Extrusion temperature setting: 100°C-120°C-120°C-120°C-120°C

[0031] Preparation

[0032] The prescribed amount of nifedipine, hydroxypropyl cellulose ( HPC EF, Ashland, USA) and microcrystalline cellulose auxiliary materials are placed in the co-rotating twin-screw extruder TE-20 (Nanjing Coperon Keya Co., Ltd.), and the temperature from each section of the machine to the head is set respectively, and the screw speed is 40RPM. The extruded product is cooled, crushed to a suitable particle size, mixed with magnesium stearate, and pressed into tablets to obtain nifedipine tablets.

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Abstract

The invention belongs to the technical field of medicine, and relates to a nifedipine composition and a preparation method thereof. The novel nifedipine composition contains nifedipine, solid dispersion carrier hydroxy propyl cellulose and a release speed regulator, and is prepared by hot-melt extrusion technology. The composition has the advantages of simple preparation process, short production cycle, high repeatability and no organic solvent residues, and is easy for industrial mass production; and the prepared composition can slowly and constantly release the nifedipine to play a role in controlling the medicament concentration in a body and reducing occurrence of side effect.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a nifedipine composition and a preparation method thereof. Background technique [0002] Many drugs have been screened by high-throughput in the pharmaceutical industry, but most of them have to give up further clinical research due to poor bioavailability. An important factor contributing to this difficulty is poor bioavailability due to low solubility and dissolution. In clinical practice, high doses are often required to achieve the expected curative effect, which leads to the occurrence of undesired side effects. [0003] At present, improving the desired properties of the poorly soluble drug includes, but is not limited to, the following technical means: particle size reduction, liquid formulation, co-solvent, complexation, co-crystallization, and solid dispersion, etc. [0004] Nifedipine (Nifedipine, NFP) is a dihydropyridine calcium ion antagonist, which is widely used c...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4422A61K47/38A61P9/12A61P9/10A61J3/00
Inventor 徐成苗周军马海岭张科园杨国栋
Owner ZHEJIANG ANGLIKANG PHARMA
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