Transdermal nitrendipine adhesive patch and preparation method thereof

A technology of dipine patch and nitrendipine, which is applied in the direction of pharmaceutical formulation, sheet delivery, drug combination, etc., can solve the problems of unfavorable application, poor mutual binding force between the drug layer and silicon paper, and difficulty in mixing uniformly, so as to facilitate the application , shorten the production time, good overall effect

Active Publication Date: 2012-03-14
蚌埠丰原涂山制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The prepared transdermal nitrendipine patch can be used for the treatment of hypertension, but in the existing preparation method, the selected skeleton materials (high molecular polyisobutene and low molecular polyisobutylene) are dissolved with cyclohexane and take a long time , and it is not easy to mix evenly; the mutual binding force between the drug layer and the silicon paper is also poor, which is not conducive to application

Method used

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  • Transdermal nitrendipine adhesive patch and preparation method thereof
  • Transdermal nitrendipine adhesive patch and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] (1) Take by weighing dehydrated alcohol 30g and dissolve polyacrylic acid resin IV70g, add 200g pressure-sensitive adhesive and stir evenly;

[0036] (2) Take by weighing 10g azone, 30g propylene glycol and 30g dehydrated alcohol join in the 50g nitrendipine and stir;

[0037] (3) Add to item (1), stir for 10 minutes, and homogenize twice at 7mpa with a homogenizer;

[0038] (4) Set the drying temperature of the coating machine to 60°C, control the thickness to 35um, perform coating, and then cover the medical elastic cloth;

[0039] (5) Cut into 4*6cm with a slicer 2 .

[0040] According to the method provided by the national drug standard WS 1-(X-343)-2003Z issued by the State Food and Drug Administration, the content standard range: 80.0%-120.0%, actual detection: 100.4%, content uniformity standard: Less than 15%, actual detection: 9.4%.

Embodiment 2

[0042] (1) Weigh 40g of absolute ethanol to dissolve 87.5g of polyacrylic acid resin IV, add 248.5g of pressure-sensitive adhesive and stir evenly;

[0043] (2) Take by weighing 15g azone, 45g propylene glycol and 40g dehydrated alcohol join in the 50g nitrendipine and stir;

[0044] (3) Add item (2) to item (1), stir for 15 minutes, and homogenize 3 times at 12mpa with a homogenizer;

[0045] (4) Set the drying temperature of the coating machine to 75°C, control the thickness to 45um, perform coating, and then cover the medical elastic cloth;

[0046] (5) Cut into 4*6cm with a slicer 2 .

[0047] The test results are as follows: content standard range: 80.0%-120.0%, actual test: 100.2%, content uniformity standard: less than 15%, actual test: 14.2%.

Embodiment 3

[0049] (1) Take by weighing dehydrated alcohol 50g and dissolve polyacrylic acid resin IV95g, add 350g pressure-sensitive adhesive and stir evenly;

[0050] (2) Take by weighing 25g azone, 60g propylene glycol and 60g dehydrated alcohol join in the 50g nitrendipine and stir;

[0051] (3) Add item (2) to item (1), stir for 25 minutes, and homogenize 4 times at 14mpa with a homogenizer;

[0052] (4) Set the drying temperature of the coating machine to 82°C, control the thickness to 65um, perform coating, and then cover the medical elastic cloth;

[0053] (5) Cut into 4*6cm with a slicer 2 .

[0054] The test results are as follows: content standard range: 80.0%-120.0%, actual test: 99.5%, content uniformity standard: less than 15%, actual test: 10.2%.

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Abstract

The invention relates to a transdermal nitrendipine adhesive patch and a preparation method thereof. The invention prepares a nitrendipine adhesive patch with more uniform drug distribution by selecting polyacrylic acid resin IV as skeleton, simultaneously adopting the skeleton function and adhesive function of the pressure sensitive adhesive to solve the adhesive problem between the drug layer and the substrate layer and using a homogenizer to perform low pressure homogenization to distribute all components evenly. Compared with the prior art, the transdermal nitrendipine adhesive patch of the invention has uniform nitrendipine release rate and better curative effect; and the method of the invention can be used to greatly reduce the production time, increase the production capacity, reduce the energy consumption and simplify the production process.

Description

technical field [0001] The invention relates to pharmaceutical technology, in particular to a percutaneous administration type nitrendipine patch and a preparation method thereof. Background technique [0002] Nitrendipine is a dihydropyridine calcium ion antagonist. Its affinity to blood vessels is greater than that of the myocardium, and it has a stronger selective effect on coronary arteries. It can reduce myocardial oxygen consumption, reduce total peripheral resistance, and lower blood pressure. Protective effect on ischemic myocardium. It is clinically applicable to coronary heart disease and hypertension, and can also be used for congestive heart failure. [0003] In the existing transdermal nitrendipine patch, the main drug nitrendipine is dispersed in the polymer matrix, which has a three-layer structure, and the release of the drug is controlled by the components of the matrix. Chinese patent application 93110600.1 discloses the existing preparation method: 1) mi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/70A61K31/435A61K47/32A61P9/04A61P9/10A61P9/12
Inventor 陈鹏汪洪湖
Owner 蚌埠丰原涂山制药有限公司
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