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Nifedipine controlled release composition and preparation method thereof

A composition and nitrobenzene technology, applied in the field of medicine, can solve the problems of affecting product quality, organic solvent residues, not being well solved, etc., and achieve the effects of avoiding raw material aggregation, removing acetone residues, and improving production efficiency

Active Publication Date: 2014-02-12
CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, the organic solvent residue in the coating solution is also one of the problems affecting product quality, which has not been well resolved.

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0071] The preparation of the drug-containing layer, the specific prescription components are as follows:

[0072] .

[0073] i) Preparation of suspension for granulation: Weigh purified water, add the prescribed amount of binder while stirring, stir until the binder is completely swollen, add nifedipine while stirring to form a suspension, pass through 200 mesh Sieve, rinse the screen with purified water, merge into the suspension, keep stirring, and set aside;

[0074] ii) Take polyoxyethylene by weighing and add in the fluidized bed granulator, preheat;

[0075] iii) top spray granulation;

[0076] iv) After stopping the liquid spraying, dry, and the particles pass through a 24-mesh sieve;

[0077] v) Add the prescribed amount of magnesium stearate and mix well.

[0078] The particle size distribution is shown in the table below:

[0079] .

Embodiment 2

[0081] The preparation of the booster layer, the specific prescription components are as follows:

[0082] .

[0083] i) Preparation of solutions and suspensions for granulation

[0084] ① Preparation of sodium chloride solution: Dissolve the prescribed amount of sodium chloride in purified water and set aside;

[0085] ② Adhesive solution: Weigh purified water, add the prescribed amount of adhesive while stirring, stir until completely dissolved, and set aside;

[0086] ii) Take polyoxyethylene by weighing and add in the fluidized bed granulator, preheat;

[0087] iii) top spray granulation, successively spray sodium chloride solution and binder solution into polyoxyethylene;

[0088] iv) After stopping the liquid spraying, dry, and the particles pass through a 24-mesh sieve;

[0089] v) Add the prescribed amount of magnesium stearate and mix well.

[0090] The particle size distribution is shown in the table below:

[0091] .

Embodiment 3

[0106] Embodiment 3 Tablet comparative investigation

[0107] The granules in the prescription B of Example 1 and the prescription B of Example 2 and the mixed powders in Comparative Example 1 and Comparative Example 2 were selected respectively, and the same double-layer tablet press was used to compress the double-layer tablet with the same parameters, and the results are shown in the following table Shown:

[0108] serial number Drug-containing layer booster layer result Ⅰ Embodiment 1 prescription B Embodiment 2 prescription B There is no mixture of two layers of color, and almost no flower flakes are found. Ⅱ Comparative example 1 Comparative example 2 The colors are mixed, and the flower flakes are obvious. Ⅲ Embodiment 1 prescription B Comparative example 2 There are white spots and plaques on the surface of the yellow layer. Ⅳ Comparative example 1 Embodiment 2 prescription B There are yellow spots on the surface o...

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Abstract

The invention relates to a nifedipine controlled release composition, which is composed of a bilayer tablet core and a semipermeable membrane controlled release coating. The bilayer tablet core comprises a drug-containing layer and a boost layer. The drug-containing layer of the composition employs an aqueous suspension to perform granulation, and the boost layer employs an aqueous solution to perform granulation. The bilayer tablet core of the composition involves no coloring agent, and the coating film is prepared by coating solution spray. The invention also relates to a preparation method of a nifedipine controlled release tablet. The method includes: drug-containing layer granulation, boost layer granulation, bilayer tablet core preparation, coating and laser drilling. The nifedipine controlled release composition prepared by the invention has the advantages of uniform particle distribution, good tabletting effect, even content, low organic solvent residual rate and good dissolving effect, and the preparation method is simple and feasible, thus being beneficial to industrial application.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a nifedipine composition and a preparation method thereof, in particular to a nifedipine controlled-release composition and a preparation method thereof. Background technique [0002] Nifedipine is the first generation of calcium antagonists. It is an antihypertensive and angina pectoris drug. It is one of the best-selling drugs in the world. Controlled-release preparations can prolong the duration of drug action, reduce the peak-valley phenomenon of blood drug concentration, and increase patient compliance. From this analysis, it is very suitable to make nifedipine into a controlled-release preparation. Internationally renowned pharmaceutical companies Bayer and Pfizer have both developed nifedipine controlled-release tablets with trade names of ADALAT and PROCARDIA respectively, and the technologies they use are all push-pull osmotic pump controlled-release tablets. In recent ...

Claims

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Application Information

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IPC IPC(8): A61K9/24A61K9/36A61K31/4422A61P9/10A61P9/12
Inventor 张志宏金丽丽张素娟杨丽霞张旭陈勇军耿佳张璇
Owner CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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