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

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

Example Embodiment

[0070] Example 1

[0071] For 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 prescription amount of binder while stirring, stir until the binder is fully swelled, add nifedipine while stirring to form a suspension, pass 200 mesh Sieve, rinse the sieve with purified water, merge into the suspension, keep stirring, and set aside;

[0074] ii) Weigh polyoxyethylene into the fluidized bed granulator and preheat;

[0075] iii) Top spray granulation;

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

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

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

[0079] .

Example Embodiment

[0080] Example 2

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

[0082] .

[0083] i) Preparation of granulation solution and suspension

[0084] ① Preparation of sodium chloride solution: the prescribed amount of sodium chloride is dissolved in purified water for use;

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

[0086] ii) Weigh polyoxyethylene into the fluidized bed granulator and preheat;

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

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

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

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

[0091] .

Example Embodiment

[0106] Example 3 Comparison of tablet pressing

[0107] The granules in the formulation B of Example 1 and the formulation B of Example 2 and the mixed powders in Comparative Example 1 and Comparative Example 2 were selected respectively, and the double-layer tablet was pressed using the same double-layer tablet press with the same parameters. The results are as follows Shown:

[0108] Numbering Medicated layer Boost layer result Ⅰ Example 1 Prescription B Example 2 Prescription B There is no mixed color of the two layers, and almost no flakes are found. Ⅱ Comparative example 1 Comparative example 2 The colors are mixed, and the phenomenon of flower pieces is obvious. Ⅲ Example 1 Prescription B Comparative example 2 There are white spots and patches on the surface of the yellow layer. Ⅳ Comparative example 1 Example 2 Prescription B There are yellow spots on the surface of the white layer.

[0109] Using the drug-containing layer and booster layer obtained by the preparatio...

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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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