Azelnidipine tablets and preparation method thereof

A technology of Azelnidipine and Dipine Tablets, which is applied in the field of Azelnidipine Tablets and its preparation, can solve the problems of difficulty in guaranteeing the stability of Azelnidipine, partial acidity of β-cyclodextrin, etc., and reduce the types of excipients and the dissolution rate Improvement and good stability

Active Publication Date: 2013-08-14
NANJING CHIA TAI TIANQING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the bioavailability is significantly improved and increased compared with the common preparation of Azedipine, the β-cyclodextrin is acidic, which makes it difficult to guarantee the stability of Azedipine

Method used

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  • Azelnidipine tablets and preparation method thereof
  • Azelnidipine tablets and preparation method thereof
  • Azelnidipine tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023]

[0024] Preparation Process:

[0025] (1) Dissolve azedipine, acrylic resin E and tromethamine in absolute ethanol, dry under reduced pressure, pass the dry matter through a 100-mesh sieve to obtain a solid dispersion, and set aside;

[0026] (2) Pass sodium carboxymethyl starch, microcrystalline cellulose and lactose through a 100-mesh sieve, and set aside;

[0027] (3) Prescription quantity Weigh the sieved solid dispersion, sodium carboxymethyl starch, microcrystalline cellulose, lactose, and magnesium stearate, mix well, and press into tablets.

Embodiment 2

[0029]

[0030] Preparation Process:

[0031] (1) Dissolve azedipine, acrylic resin E, and tromethamine in absolute ethanol, dry under reduced pressure, pass the dry matter through a 100-mesh sieve to obtain a solid dispersion, and set aside;

[0032] (2) Pass sodium carboxymethyl starch, crospovidone, and microcrystalline cellulose through a 100-mesh sieve, and set aside;

[0033] (3) Prescription quantity Weigh the sieved solid dispersion, sodium carboxymethyl starch, crospovidone, microcrystalline cellulose, and magnesium stearate, mix well, and press into tablets.

Embodiment 3

[0035]

[0036] Preparation Process:

[0037] (1) Dissolve azedipine, acrylic resin E and tromethamine in absolute ethanol, dry under reduced pressure, pass the dry matter through a 100-mesh sieve to obtain a solid dispersion, and set aside;

[0038] (2) Pass sodium carboxymethyl starch and pregelatinized starch through a 100-mesh sieve, and set aside;

[0039] (3) Prescription quantity Weigh the sieved solid dispersion, sodium carboxymethyl starch, pregelatinized starch, and sodium stearate fumarate, mix well, and press into tablets.

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PUM

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Abstract

The invention discloses azelnidipine tablets and a preparation method thereof; and the azelnidipine tablets are prepared by evenly mixing a solid dispersion and pharmaceutically acceptable auxiliary materials, and then tabletting the mixture. The solid dispersion is prepared from azelnidipine, acrylic resin E and tromethamine by using a solvent evaporation method. The preparation method does not need extra alkaline matters, thus reducing the types of the auxiliary materials; the tablet dissolution rate is obviously improved; and the azelnidipine tablets are good in stability, simple in technology and easy in industrial mass production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an azelnidipine tablet and a preparation method thereof. Background technique [0002] At present, hypertension has become the main killer that endangers human health, and patients with hypertension account for about 50% of cardiovascular cases. According to statistics from the National Ministry of Health, there are 130 million hypertensive patients in my country, and the incidence rate increases by 25% every 10 years, with an increase of more than 3 million people every year. Azedipine is a new generation of L-type calcium channel selective antagonist, which has clinical advantages such as good antihypertensive effect, does not affect heart rate, can improve renal function, and has few side effects. Therefore, providing an azeldipine pharmaceutical composition and further preparing it into various oral dosage forms such as tablets, capsules, dispersible tablets, et...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4427A61K47/32A61K47/18A61P9/12
Inventor 王宽起梁波
Owner NANJING CHIA TAI TIANQING PHARMA
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