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Nifedipine sustained release tablet and preparation method thereof

A technology of nifedipine and nifedipine, which is applied in pharmaceutical formulations, medical preparations containing active ingredients, pill delivery, etc. It can solve problems such as differences in dissolution rate, lack of indicators such as release rate, and drug release that cannot meet clinical needs. , to achieve the effects of good preparation stability, good release curve, and maintenance of drug concentration

Active Publication Date: 2018-11-23
ZHENGZHOU MINGZE MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Yet in the nifedipine sustained-release tablet of prior art, still exist some problems, for example in " different manufacturers nifedipine sustained-release tablet in vitro release test " (" Journal of Tianjin Medical University ", 17 (4), 2011) It is pointed out that there are significant differences in the dissolution rate of different manufacturers, and most manufacturers still have insufficient indicators such as release rate, so that the release of drugs sometimes cannot meet clinical needs.

Method used

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

Examples

Experimental program
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Effect test

Embodiment 1

[0042] The nifedipine sustained-release tablet of the present invention is composed of a rapid release component A, a supplementary release component B, a sustained release component C and an auxiliary material magnesium stearate (the content of the following components is in g);

[0043] Expressed in parts by weight, the raw material composition of the quick release component A is: 6g of nifedipine, 10g of microcrystalline cellulose, 4g of lactose hydrate, 0.9g of Tween-80 and 6.5g of purified water;

[0044] Expressed in parts by weight, the raw material composition of the supplementary release component B is: 6g of nifedipine, 5g of microcrystalline cellulose, 4g of lactose hydrate, 5g of starch and 6.0g of purified water;

[0045] Expressed in parts by weight, the raw material composition of the slow-release component C is: 8 g of nifedipine, 28 g of microcrystalline cellulose and 1.85 g of ethyl cellulose;

[0046] The dosage of the added auxiliary material magnesium stea...

Embodiment 2

[0049] The preparation method of the embodiment of the present invention 1 nifedipine slow-release tablet, the detailed steps of this preparation method are as follows:

[0050] a. Preparation of quick release component A:

[0051] First, various raw materials were weighed according to the composition of the quick-release component A described in Example 1, and the weighed Tween-80 was dissolved in purified water to obtain an aqueous solution (1); then the remaining other raw and auxiliary materials were fully mixed to obtain a mixture ( 2); Fully mix the aqueous solution (1) and the mixture (2), and use a wet mixing granulator to make a soft material after mixing; use a 20-mesh nylon sieve to granulate the prepared soft material, and granulate the material obtained after granulation Dry at 55°C in the dark, and sieve the dried material with a 20-mesh nylon sieve to obtain the quick-release component A;

[0052] b. Preparation of supplementary release component B:

[0053]Fi...

Embodiment 3

[0060] The nifedipine sustained-release tablet of the present invention is composed of a rapid release component A, a supplementary release component B, a sustained release component C and an auxiliary material magnesium stearate (the content of the following components is in g);

[0061] Expressed in parts by weight, the raw material composition of the quick release component A is: 30g of nifedipine, 50g of microcrystalline cellulose, 20g of lactose hydrate, 4.5g of Tween-80 and 32.5g of purified water;

[0062] Expressed in parts by weight, the raw material composition of the supplementary release component B is: 30g of nifedipine, 25g of microcrystalline cellulose, 20g of lactose hydrate, 25g of starch and 30.0g of purified water;

[0063] Expressed in parts by weight, the raw material composition of the slow-release component C is: 40 g of nifedipine, 140 g of microcrystalline cellulose and 9.25 g of ethyl cellulose;

[0064] The dosage of the added auxiliary material magn...

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Abstract

The invention discloses a nifedipine sustained release tablet and a preparation method thereof. The nifedipine sustained release tablet consists of a rapid released component A, a supplemented released component B, a sustained release component C and an auxiliary material magnesium stearate; the component A consists of nifedipine, microcrystal cellulose, lactose hydrate, a tween-80 and purified water; the component B consists of nifedipine, microcrystal cellulose, lactose hydrate, starch and purified water; and the component C consists of nifedipine, microcrystal cellulose and ethyl cellulose.The preparation method comprises the following steps: firstly separately preparing the component A, the component B and the component C, wherein the prepared three components and the auxiliary material magnesium stearate are mixed to form a mixed material; tabletting the mixed material to obtain medicine tablets; and coating the medicine tablets, and obtaining the nifedipine sustained release tablet. The nifedipine sustained release tablet is prepared by virtue of the preparation method of the invention; and the preparation method is simple, the cost is low, the preparation stability is good,the release curve is better, and the defects in the prior art can be overcome.

Description

1. Technical field: [0001] The invention relates to a sustained-release pharmaceutical preparation, in particular to a nifedipine sustained-release tablet and a preparation method thereof. 2. Background technology: [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): A61K9/22A61K9/30A61K31/4422A61P9/12
CPCA61K9/2054A61K9/2077A61K9/282A61K31/4422A61P9/12
Inventor 郭海波李健徐金英张凤秦晴晴
Owner ZHENGZHOU MINGZE MEDICAL TECH
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