Azelnidipine quick-releasing drug preparation and preparation method

A technology for azeldipine and pharmaceutical preparations, applied in the field of azeldipine rapid release pharmaceutical preparations and preparations, can solve the problems such as the dosage forms that do not disclose the rapid release of drugs, and achieve the effects of being beneficial to storage stability, high dissolution, and avoiding damage

Active Publication Date: 2012-06-27
CHENGDU HENGRUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, none of these patents discloses a dosage form capable of achieving rapid drug release.

Method used

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  • Azelnidipine quick-releasing drug preparation and preparation method
  • Azelnidipine quick-releasing drug preparation and preparation method
  • Azelnidipine quick-releasing drug preparation and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] A kind of quick-release pharmaceutical preparation of Azedipine, comprises the component of following weight:

[0025]

[0026] The preparation method is as follows: uniformly mix azedipine, anhydrous lactose, microcrystalline cellulose, disintegrant and lubricant, pass through a 100-mesh sieve, repeat the mixing for 3 times, and then compress into tablets.

Embodiment 2

[0028] A kind of quick-release pharmaceutical preparation of Azedipine, comprises the component of following weight:

[0029]

[0030] The preparation method is the same as in Example 1.

Embodiment 3

[0032]

[0033] The preparation process is the same as in Example 1.

[0034] At the same time, the Azeldipine tablet prepared by the ordinary wet method was selected as Comparative Example 1, and the Azeldipine tablet prepared by the ordinary dry method was selected as Comparative Example 2.

[0035] Get the sample prepared by the present embodiment and comparative example, according to Chinese Pharmacopoeia 2010 edition two X C first method for dissolution rate assay, with 50% ethanol aqueous solution 500ml as solvent, rotating speed is 75 revs / min per minute, after 45 minutes Measuring the amount of drug dissolution, test 6 tablets under the same conditions, the results are as follows.

[0036] sample

[0037] It can be seen that the difference is significant, and the dissolution rate of the fast-release drug prepared by the present invention is 14.3% to 16.2% higher than that of samples prepared by common wet and dry granulation methods.

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PUM

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Abstract

The invention discloses an azelnidipine quick-releasing drug preparation, which comprises the following components by mass percent: 2-12 percent of azelnidipine, 25-45 percent of anhydrous lactose, 40-60 percent of microcrystalline cellulose, 2-10 percent of disintegrating agent and 1-3 percent of lubricating agent. The invention also discloses a preparation method of azelnidipine quick-releasing tablets. The azelnidipine quick-releasing drug preparation prepared by the invention has high dissolution, and the dissolution can be more than 10 percent higher than that of a sample prepared by the common wet and dry granulation. The azelnidipine quick-releasing drug preparation can achieve an effect of quick releasing and has better application prospect in the clinical.

Description

technical field [0001] The invention relates to a dosage form of a medicine and a preparation method thereof, in particular to an azedipine fast-release medicine preparation and a preparation method thereof, belonging to the pharmaceutical industry. Background technique [0002] Azedipine belongs to the dihydropyridine calcium channel antagonists, the structural formula is as follows, it specifically binds to the cell membrane L-calcium channel, and blocks the voltage-dependent influx of calcium ions through the L-calcium channel. In vitro studies have shown that azelnidipine can inhibit the contraction of isolated rat arteries triggered by calcium ions. Animal studies have shown that a single dose of azedipine can reduce the arterial pressure of spontaneously hypertensive rats in a dose-dependent manner, and repeated administration can sustainably reduce the arterial pressure without showing drug tolerance. Human studies have shown that oral administration of 8-16 mg of az...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4427A61K47/38A61P9/12
Inventor 朱德其陆泽润
Owner CHENGDU HENGRUI PHARMA
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