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Nifedipine controlled release tablet and preparation method thereof

A nitrobenzene and tablet technology, applied in the field of pharmaceutical preparations, can solve problems affecting the release behavior of controlled-release tablets, unfavorable preparation and storage, and prolonged drying time

Pending Publication Date: 2020-12-15
南京易亨制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the low melting point of PEO, which is only 63°C-67°C, its thermal stability is poor, which is not conducive to the preparation and storage of large-scale production. For example, the drying temperature should not exceed 40°C during the granulation process, and solvent drying is relatively difficult. , if the drying is relatively complete, it will prolong the drying time; in addition, the storage temperature of the tablet should not be too high, which will cause corresponding changes in the physical and chemical properties of PEO, which will affect the release behavior of the controlled-release tablet; In the process, due to the high rotation speed of the tablet, the friction between the dies generates a lot of heat, so that the temperature of the tablet reaches 50°C, and sticking will occur during the process. Therefore, the temperature of the equipment needs to be controlled during the process.

Method used

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  • Nifedipine controlled release tablet and preparation method thereof
  • Nifedipine controlled release tablet and preparation method thereof
  • Nifedipine controlled release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] A kind of preparation method of nifedipine controlled-release tablet in the present embodiment, comprises the steps:

[0052] 1) Put the prescribed amount of polyvinylpyrrolidone and the prescribed amount of nifedipine into a low-shear V-shaped mixer for mixing, and mix for 30 minutes to obtain a mixed powder;

[0053] 2) The mixed powder obtained in step 1) is prepared by hot-melt extrusion to prepare a solid dispersion, pulverized, and passed through an 80-mesh sieve;

[0054] 3) Add the hypromellose of the prescribed amount to the solid dispersion powder obtained in step 2), mix in a low-shear V-type mixer, and mix for 30 minutes to obtain the mixed powder of the drug-containing layer;

[0055] 4) Put the prescribed amount of povidone and colloidal silicon dioxide into a low-shear V-shaped mixer for mixing for 30 minutes;

[0056] 5) Add the magnesium stearate of the prescription amount to the mixed powder obtained in step 4), mix in a low-shear V-shaped mixer, and ...

Embodiment 2

[0062] A kind of preparation method of nifedipine controlled-release tablet in the present embodiment, comprises the steps:

[0063] 1) Put the prescribed amount of vinylpyrrolidone-vinyl acetate copolymer and the prescribed amount of nifedipine into a low-shear V-type mixer for mixing, and mix for 30 minutes to obtain a mixed powder;

[0064] 2) The mixed powder obtained in step 1) is prepared by hot-melt extrusion to prepare a solid dispersion, pulverized, and passed through an 80-mesh sieve;

[0065] 3) Add the hypromellose of the prescribed amount to the solid dispersion powder obtained in step 2), mix in a low-shear V-type mixer, and mix for 30 minutes to obtain the mixed powder of the drug-containing layer;

[0066] 4) Put hypromellose, povidone and colloidal silicon dioxide in the prescribed amount into a low-shear V-type mixer for mixing, and mix for 30 minutes;

[0067] 5) Add the magnesium stearate of the prescription amount to the mixed powder obtained in step 4), ...

Embodiment 3

[0072] A kind of preparation method of nifedipine controlled-release tablet in the present embodiment, comprises the steps:

[0073] 1) Put the prescribed amount of polyvinylpyrrolidone and the prescribed amount of nifedipine into a low-shear V-shaped mixer for mixing, and mix for 30 minutes to obtain a mixed powder;

[0074] 2) The mixed powder obtained in step 1) is prepared by hot-melt extrusion to prepare a solid dispersion, pulverized, and passed through an 80-mesh sieve;

[0075] 3) Add the hypromellose of the prescribed amount to the solid dispersion powder obtained in step 2), mix in a low-shear V-type mixer, and mix for 30 minutes to obtain the mixed powder of the drug-containing layer;

[0076] 4) Put hypromellose, povidone and colloidal silicon dioxide in the prescribed amount into a low-shear V-type mixer for mixing, and mix for 30 minutes;

[0077] 5) Add the magnesium stearate of the prescription amount to the mixed powder obtained in step 4), mix in a low-shear...

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Abstract

The invention belongs to the field of pharmaceutical preparations, and particularly relates to a preparation method of a nifedipine controlled release tablet. The method comprises the following stepsof mixing water-soluble matrix components with moderate glass transition temperature, carrying out hot-melt extrusion, and mixing a prepared solid dispersion with one or more adhesives; mixing an osmotic pressure promoter, one or more adhesives, and optionally, a lubricant and a flow aid in a boosting layer; and pouring the total mixed particles of a drug-containing layer and the boosting layer into a hopper of a double-layer tablet press, pressing the drug-containing layer firstly, then pressing the boosting layer, then performing controlled release coating, and next carrying out laser drilling. The preparation process is beneficial to prolonging the storage period of the product and realizing industrial production, and under the design of the controlled-release preparation, the medicinecan maintain and even improve the release rate of nifedipine capable of providing the required blood concentration, and the bioavailability of medicine is improved.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a nifedipine controlled-release tablet, which can provide a drug with low solubility, nifedipine, to enter the gastrointestinal tract at a certain controlled release rate and to control the release of active ingredients. The release of the drug is carried out, and the invention also relates to a preparation method of its controlled release preparation. Background technique [0002] Nifedipine is a dihydropyridine calcium channel antagonist developed by Bayer, which can simultaneously relax coronary arteries in normal blood supply areas and ischemic areas, antagonize spontaneous or ergonovine-induced coronary artery spasm, increase The delivery of myocardial oxygen in patients with coronary artery spasm can relieve and prevent coronary artery spasm, inhibit myocardial contraction, reduce myocardial metabolism, reduce myocardial oxygen consumption, relax peripheral resist...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K9/44A61K31/4422A61P9/04A61P9/10A61P9/12
CPCA61K31/4422A61K9/2086A61K9/2095A61K9/2072A61K9/2886A61P9/12A61P9/10A61P9/04
Inventor 朱学东陈女贞周礼明封思阳
Owner 南京易亨制药有限公司