Azelnidipine medicinal composition and its preparing method

A kind of composition and medicine technology, applied in azelnidipine pharmaceutical composition, the treatment field of hypertension, can solve the problem such as dissolution rate decline

Inactive Publication Date: 2008-01-16
BEIJING SIHUAN KEBAO PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This research tries to adopt the method mentioned in this patent to prepare the azelnidipine pharmaceutical composition, and finds that after the obtained composition is further prepared into tablets, capsules or dispersible tablets, although it shows better storage stability, but with With the prolongation of storage time, various dosage forms show a trend of decreasing dissolution rate
Although the dissolution decline trend is still within the qualified range, it still leaves hidden dangers for industrialized large-scale production and subsequent marketing of drugs

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Preparation Process:

[0033] 1. Azhedipine and calcium hydrogen phosphate pass through a 120-mesh sieve; talcum powder and magnesium stearate pass through a 60-mesh sieve; other auxiliary materials pass through a 80-mesh sieve for later use;

[0034] 2. After weighing the prescribed amount of Azendipine and lactose and mixing evenly, dissolve the prescribed amount of Tween 80 in a small amount of water (concentration is about 23%) and add it to mix evenly, then mix with calcium hydrogen phosphate, low-substituted hydroxypropyl fiber Sodium acetate and sodium acetate are mixed homogeneously according to the principle of increasing in equal amounts, to obtain mixture I;

[0035] 3. Mixture I uses water as a wetting agent to make a soft material, and passes through a 18-mesh sieve to granulate. Wet granules are blast-dried in an oven at 50°C, and sieved with a 24-mesh sieve after completion;

[0036] 4. Add talcum powder and magnesium stearate in the prescribed p...

Embodiment 2

[0040] Preparation Process:

[0041] 1. Azhedipine and calcium hydrogen phosphate are passed through a 120-mesh sieve; magnesium stearate is passed through a 60-mesh sieve; other auxiliary materials are passed through a 80-mesh sieve for later use;

[0042] 2. Weigh the prescribed amount of Azendipine and mix it with lactose evenly, dissolve the prescribed amount of Tween 80 in a small amount of water (concentration is about 23%) and add it to mix evenly, then mix with calcium hydrogen phosphate, low-substituted hydroxypropyl cellulose Mix uniformly with sodium acetate according to the principle of equal addition, to obtain mixture I;

[0043] 3. Mixture I uses water as a wetting agent to make a soft material, and passes through a 18-mesh sieve to granulate. Wet granules are blast-dried in an oven at 50°C, and sieved with a 24-mesh sieve after completion;

[0044] 4. Add the prescribed proportion of magnesium stearate to the dried granules, and mix well;

[0045] 5. ...

Embodiment 3

[0048] Preparation Process:

[0049] 1. Azhedipine is passed through a 120-mesh sieve; magnesium stearate is passed through a 60-mesh sieve; other excipients are passed through a 80-mesh sieve for later use;

[0050] 2. Weigh the prescribed amount of Azendipine and mix it evenly with lactose, dissolve the prescribed amount of Tween 80 in a small amount of water (concentration is about 23%) and add it to mix evenly, then mix it with microcrystalline cellulose, some low-substituted hydroxypropyl Cellulose and sodium acetate are mixed homogeneously according to the principle of increasing in equal amounts to obtain mixture I;

[0051] 3. Mixture I uses water as a wetting agent to make a soft material, and passes through a 18-mesh sieve to granulate. Wet granules are blast-dried in an oven at 50°C, and sieved with a 24-mesh sieve after completion;

[0052] 4. Add the prescribed proportion to the dried granules, plus some low-substituted hydroxypropyl cellulose and magnesi...

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PUM

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Abstract

The invention relates to a compound for treating hypertensive, particularly relating to a calcium ion antagonist drug complex with full dissolution, good stability and high bioavailability. The invention is characterized in that the complex contains (A) calcium channel antagonist, (B) alkaline excipient with effective dose and (C) non-ionic surfactant; wherein (A):(B):(C) is ranged from 0.1:1:1 to 10:1:1.

Description

technical field [0001] The present invention relates to a pharmaceutical composition containing azendipine, which can be used in the treatment of hypertension. In particular, the present invention relates to an azeldipine pharmaceutical composition with complete dissolution, good stability and high bioavailability. 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 annual increase of more than 3 million people. Azedipine is a new generation of L-type calcium channel selective antagonist. This product has clinical advantages such as good antihypertensive effect, does not affect heart rate, can improve renal function, and has few side effects. Therefore, pro...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4427A61K47/34A61P9/12A61K47/26
Inventor 廖娟
Owner BEIJING SIHUAN KEBAO PHARM CO LTD
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