Nifedipine controlled release composition and preparation method thereof

A technology of composition and nitrobenzene, which is applied in the direction of drug combination, drug delivery, pharmaceutical formulation, etc., can solve the problems of unsatisfactory stable release and high cost, achieve a good release curve, prevent product aging, and stabilize formulations Good results

Active Publication Date: 2013-01-02
DEZHOU DEYAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] However, although the release rate of the nifedipine controlled-release tablet provided by this patent meets the regulations, it is not completely satisfactory in terms of stable release, and in order to obtain a satisfactory release rate, a special process is used to prepare it, resulting in a significant increase in cost

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

[0028] Weigh each raw material according to the amount in Table 1.

[0029] 1) Drug layer granulation: This step is carried out in the dark, first pass the components of the above drug layer through a 60-mesh sieve, then mix nifedipine, povidone and carbomer evenly, and add them to the fluidized bed middle; spray the above-mentioned amount of polysorbate 80 aqueous solution to granulate; increase the bed temperature to dry; after drying, the granules pass through a 20-mesh sieve for granulation; then add the above-mentioned amount of magnesium stearate, mix well, and set aside;

[0030] 2) Push layer granulation: first pass each component of the above push layer through a 60-mesh sieve, and then press sodium carboxymethyl starch, hypromellose, carbomer, sodium chloride, copovidone and red iron oxide Mix the prescription amount evenly, add to the fluidized bed; spray into purified water to granulate; increase the bed temperature to dry; pass the dried granules through a 20-mesh...

Embodiment 2-4

[0036] Except that the amount of each raw material is weighed according to Table 1, other method steps are all the same as in Example 1. The nifedipine controlled release compositions of Examples 2-4 were prepared.

[0037] Table 1

[0038]

[0039]

[0040] Wherein, all numerical values ​​are the dosage of nifedipine per 1000 tablets, and the unit is g.

[0041] In addition, commercially available Baixintong was purchased as the reference substance 1, and an asymmetric sheet was made according to Example 2 of CN102151253A as the reference substance 2.

[0042] Test product performance through experiments.

[0043] (1) Content uniformity

[0044] Content uniformity can be used to determine the extent to which a single dose of drug content deviates from the labeled amount. Each tablet of this product contains 30 mg of nifedipine. According to the regulations of the Chinese Pharmacopoeia 2010 edition, there is no need to check the content uniformity. However, since thi...

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Abstract

The invention relates to a controlled release pharmaceutical formulation, and in particular relates to a nifedipine controlled release composition and a preparation method thereof. The nifedipine controlled release composition is simple in preparation process, low in cost, good in formulation stability and excellent release rate, can be used for effectively preventing product ageing, and is stable in release after being stored for a long time.

Description

technical field [0001] The invention relates to a controlled-release pharmaceutical preparation, in particular to a nifedipine controlled-release composition and a manufacturing method thereof. Background technique [0002] Nifedipine is a dihydropyridine calcium antagonist, which can selectively inhibit the transmembrane transport of calcium ions into cardiomyocytes and smooth muscle cells, and inhibit the release of calcium ions from the intracellular pool without changing the plasma calcium ion concentration. One of the safe and effective first-line antihypertensive drugs. [0003] However, since the late 1980s, it has been proved by medical practice that common preparations of nifedipine reflexively cause increased heart rate and activate the sympathetic nervous system, which is not conducive to the control of myocardial ischemia and heart failure; medication requirements. As the third generation of pharmaceutical preparations, sustained and controlled release preparat...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/24A61K9/44A61K31/4422A61P9/12
Inventor 卞建钢潘秀芝牟金香李成文谢俊兰李红梅李清平
Owner DEZHOU DEYAO PHARMA
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