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Nifedipine tablet and preparation method thereof

A technology of nifedipine and dipine tablets, which is applied in the direction of pharmaceutical formulas, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc., can solve the problems of low dissolution rate of nifedipine and unsatisfactory dissolution effect, etc. To achieve the effect of improving the dissolution effect and good dissolution rate

Pending Publication Date: 2019-02-19
北京鑫开元医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The purpose of the present invention is to overcome the above-mentioned deficiencies of the prior art, to provide a kind of nifedipine, aiming to solve the problems such as the existing nifedipine dissolution rate is low, the dissolution effect is not ideal

Method used

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  • Nifedipine tablet and preparation method thereof
  • Nifedipine tablet and preparation method thereof
  • Nifedipine tablet and preparation method thereof

Examples

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preparation example Construction

[0034] On the other hand, the embodiment of the present invention also provides a kind of preparation method of nifedipine tablet, comprises the steps:

[0035] Step S10: micronizing the raw material, superfinely pulverizing the nifedipine raw material, the particle size of the nifedipine after micronization is not greater than 15 μm;

[0036] Step S20: preparation of ingredients, weighing filler, disintegrant, nifedipine, surfactant and coloring agent according to the batch dosage;

[0037] Step S30: Wet granulation, preparing a binder solution, mixing the prepared ingredients with the binder solution, drying, and then sieving to obtain granules;

[0038] Step S40: total mixing, weighing the lubricant, and mixing the particles with the lubricant;

[0039] Step S50: tablet pressing, using a punch for tablet pressing.

[0040] In the preparation method of nifedipine tablets provided in this example, the particle size of nifedipine is controlled to be no more than 15 μm by mic...

Embodiment 1

[0071] Prepared per 10,000 pieces

[0072] Nifedipine tablet comprises the composition of following mass percent:

[0073]

[0074] In this embodiment, the filler includes lactose monohydrate, cornstarch and microcrystalline cellulose SH802, the total weight ratio of which is 89.5%.

[0075] The preparation method of the nifedipine sheet provided by the present embodiment is:

[0076] Step S1: the raw material is micronized, and the nifedipine raw material is ultrafinely pulverized by a jet mill for use. The particle size of the nifedipine after micronization ranges from 5 μm to 15 μm.

[0077] Step S2: Preparation of ingredients, weighing 538g of lactose monohydrate, 609.6g of cornstarch, 289g of microcrystalline cellulose SH802, 80.6g of nifedipine, 22.4g of croscarmellose sodium, 22.4g of croscarmellose sodium, and 16g of sodium base sulfate and 5g of sunset yellow for later use.

[0078] Step S3: wet granulation, first weigh 37.5g of povidone K30, dissolve the povido...

Embodiment 2

[0088] Prepared per 10,000 pieces

[0089] Nifedipine tablet comprises the composition of following mass percent:

[0090]

[0091]

[0092] In this embodiment, the filler includes lactose monohydrate, cornstarch and microcrystalline cellulose SH802, the total weight ratio of which is 83.9%.

[0093] The preparation method of the nifedipine sheet provided by the present embodiment is:

[0094] Step S1: the raw material is micronized, and the nifedipine raw material is ultrafinely pulverized by a jet mill for use. The particle size of the nifedipine after micronization ranges from 5 μm to 15 μm.

[0095] Step S2: Preparation of ingredients, weighing 538g of lactose monohydrate, 519.8g of corn starch, 289g of microcrystalline cellulose SH802, 80.6g of nifedipine, 80g of croscarmellose sodium, 80g of croscarmellose sodium, and Sodium sulfate 48g and sunset yellow 5g are for later use.

[0096] Step S3: wet granulation, first weigh 37.5g of povidone K30, dissolve the povi...

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Abstract

The invention belongs to the field of medicine, and particularly relates to a nifedipine tablet and a preparation method thereof. The preparation method of the nifedipine tablet comprises the following steps that a raw material is micronized, wherein a nifedipine raw material is subjected to superfine grinding, and the grain size of the micronized nifedipine is not more than 15 micrometers; auxiliary materials are prepared, wherein a filler, a disintegrating agent, the nifedipine, a surfactant and a coloring agent are weighed according to the batch feeding amount; wet granulation is performed,wherein a binder solution is prepared, and the prepared auxiliary materials and the binder solution are mixed and dried, and then granulated through a sieve to obtain granules; total mixing is performed, wherein a lubricating agent is weighed, and the granules are mixed with the lubricating agent; tabletting is performed by adopting a punch. The nifedipine raw material is micronized to control the particle size of the nifedipine to be not more than 15 micrometers, and the auxiliary materials such as the disintegrating agent, the surfactant and the coloring agent are added during preparation,so that the finally obtained nifedipine tablet has a higher dissolution rate, and the dissolution effect of the nifedipine tablet is effectively improved.

Description

technical field [0001] The invention belongs to the field of medicines, and in particular relates to a nifedipine tablet and a preparation method thereof. Background technique [0002] Nifedipine was discovered in 1969 and approved for use in the United States in 1981. It is available as a generic drug and is on the World Health Organization's Model List of Essential Medicines, one of the most important medicines needed by an essential health system. Nifedipine is a dihydropyridine calcium antagonist, which is one of the calcium antagonists. It 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 Altered plasma calcium ion concentration. Nifedipine can delay the sinoatrial node function and atrioventricular conduction of the isolated heart; electrophysiological studies have not found that this product has the effect of delaying atrioventri...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/38A61K47/20A61K47/12A61K31/4422A61P9/12A61P9/10
CPCA61K9/2013A61K9/2054A61K9/2095A61K31/4422A61P9/10A61P9/12
Inventor 潘海群葛志敏孙丽娜霍志强
Owner 北京鑫开元医药科技有限公司