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Nifedipine sustained-release preparation and preparation thereof

A technology of nifedipine and sustained-release preparations, applied in the field of medicine, can solve the problems of unsatisfactory long-term stability, mixed quality and low bioavailability, and achieve the advantages of reducing the number of medications, taking them conveniently, and uniformly dispersing the dosage 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

Nifedipine tablets were first developed by Bayer in Germany, and later it was found that the bioavailability of ordinary nifedipine tablets was low and irregular in clinical application, and it was easy to cause heart and brain perfusion blood flow caused by too fast or too low blood pressure drop. If it is too low, it will induce angina pectoris, acute myocardial infarction and cerebral infarction. Later, Bayer Company of Germany developed nifedipine slow-release preparation instead of tablet for clinical treatment
[0003] At present, the number of generic oral preparations of nifedipine in my country is huge, and the quality is mixed. The existing nifedipine sustained-release preparations exist under different pH conditions, which cannot well protect the sustained-release properties of the drug from being affected. Long-term Unsatisfactory stability problem

Method used

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  • Nifedipine sustained-release preparation and preparation thereof
  • Nifedipine sustained-release preparation and preparation thereof
  • Nifedipine sustained-release preparation and preparation thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0035] Embodiment 1, a kind of nifedipine sustained-release preparation

[0036] The nifedipine sustained-release preparation comprises the following components and parts by mass thereof:

[0037] 15 parts of nifedipine, 15 parts of slow-release agent, 7 parts of binder, 50 parts of filler, 0.3 part of glidant, 3 parts of disintegrant, 0.2 part of magnesium stearate; Sodium, crospovidone and polyacrylic acid are composed of 10:6:3 by mass ratio; the binder is composed of polyvinyl alcohol and polyvinylpyrrolidone by 5:2 by mass ratio; the filler is composed of microcrystalline cellulose and The compressible starch is composed of a mass ratio of 5:2; the glidant is silicon dioxide; and the disintegrant is crospovidone.

[0038] The preparation method of described nifedipine sustained-release preparation, the steps are as follows:

[0039] S1 Grinding nifedipine to a particle size D90 of 10 μm to obtain nifedipine powder;

[0040] S2 respectively pulverize the sustained-relea...

Embodiment 2

[0045] Embodiment 2, a kind of nifedipine sustained-release preparation

[0046] The nifedipine sustained-release preparation comprises the following components and parts by mass thereof:

[0047] 20 parts of nifedipine, 25 parts of slow-release agent, 10 parts of binder, 70 parts of filler, 0.5 part of glidant, 5 parts of disintegrant, 0.6 part of magnesium stearate; Sodium, crospovidone and polyacrylic acid are composed of 15:3:1 by mass ratio; the binder is composed of polyvinyl alcohol and polyvinylpyrrolidone by 8:1 by mass ratio; the filler is composed of compressible starch, The mass ratio of mannitol and lactose is 10:5:3; the glidant is talc; the disintegrant is composed of sodium carboxymethyl starch and sodium lauryl starch in a mass ratio of 1:5.

[0048] The preparation method of described nifedipine sustained-release preparation, the steps are as follows:

[0049]S1 Grinding nifedipine to a particle size D90 of 50 μm to obtain nifedipine powder;

[0050] S2 re...

Embodiment 3

[0055] Embodiment 3, a kind of nifedipine sustained-release preparation

[0056] The nifedipine sustained-release preparation comprises the following components and parts by mass thereof:

[0057] 18 parts of nifedipine, 22 parts of sustained-release agent, 8 parts of binder, 62 parts of filler, 0.4 part of glidant, 4 parts of disintegrant, 0.4 part of magnesium stearate; Sodium, crospovidone and polyacrylic acid are composed of 12:5:2 by mass ratio; the binder is composed of polyvinyl alcohol and polyvinylpyrrolidone by 6:1 by mass ratio; the filler is composed of microcrystalline cellulose, Compressible starch and mannitol are formed in a mass ratio of 7:4:2; the glidant is silicon dioxide; the disintegrant is composed of carboxymethylcellulose calcium and sodium lauryl starch in a mass ratio of 9 :2 composition.

[0058] The preparation method of described nifedipine sustained-release preparation, the steps are as follows:

[0059] S1 Grinding nifedipine to a particle si...

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Abstract

The invention belongs to the technical field of medicines, and specifically relates to a nifedipine sustained-release preparation and preparation thereof. The nifedipine sustained-release preparationincludes, by mass in parts, 15-20 parts of nifedipine, 15-25 parts of a sustained-release preparation, 7-10 parts of an adhesive, 50-70 parts of a filling agent, 0.3-0.5 part of a flow aid, 3-5 partsof a disintegrating agent and 0.2-0.6 part of magnesium stearate. The provided nifedipine sustained-release preparation is convenient in taking, lasting in curative effect and saft and reliable, and can reduce the frequency of medication; the nifedipine sustained-release preparation has good sustained-release performance under different pH conditions, so that the nifedipine sustained-release preparation can withstand the environmental changes in different parts of the gastrointestinal tract in the body; and the nifedipine sustained-release preparation has good long-term stability and is stablein product quality.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a nifedipine slow-release preparation and its preparation. Background technique [0002] The chemical name of nifedipine is 2,6-dimethyl-4(2-nitrophenyl-1,4-dihydro-3,5-pyridine-dicarboxylic acid dimethyl ester, and the molecular formula is C 17 h 18 N 2 o 6 . It is clinically used to prevent and treat various types of coronary heart disease and angina pectoris, and is also suitable for various types of hypertension, and has a good effect on intractable and severe hypertension. Biopharmaceuticals are classified as Class II, low solubility, high permeability drugs. Nifedipine tablets were first developed by Bayer in Germany, and later it was found that the bioavailability of ordinary nifedipine tablets was low and irregular in clinical application, and it was easy to cause heart and brain perfusion blood flow caused by too fast or too low blood pressure drop. If...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K47/32A61K47/38A61K47/36A61K31/4422A61P9/12
CPCA61K9/2054A61K9/2059A61K9/2027A61K9/205A61K9/2095A61K31/4422A61P9/12
Inventor 赵先亮颜东么亚娟
Owner JINAN LIMIN PHARMA
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