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Clonidine adhesive patch and preparation method thereof

A technology of clonidine and cola, which is applied in the field of pharmaceutical preparations in the medical field, can solve the problems of foreign body sensation, no clonidine patch, and poor effect of long-term controlled release, and achieve the effect of preventing sudden release

Active Publication Date: 2016-03-02
哈尔滨瀚钧现代制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there is a problem that the transdermal absorption of clonidine patches changes due to temperature changes and time during storage. At present, there is no effective countermeasure against this problem, and there is no real long-acting controlled-release clonidine patch.
Merck's clonidine patch is suitable for the skin structure of Western populations, but not suitable for Asian skin types, and Merck's clonidine patch has a low release rate
In China, there is a long-acting clonidine patch patent disclosure, but in the comparative test, it is found that the effect of its long-acting controlled release is not good. On the 4th day, the drug has basically been released, and the purpose and effect of long-acting controlled release have not been achieved, and the skin tolerance of the drug patch is not good, and there is a foreign body sensation when it is attached to the skin, and it is easy to fall off

Method used

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  • Clonidine adhesive patch and preparation method thereof
  • Clonidine adhesive patch and preparation method thereof
  • Clonidine adhesive patch and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0087] 1. Composition of clonidine patch (1000 patches):

[0088]

[0089] 2. the preparation method of clonidine patch, comprises the following steps:

[0090] (1) Clonidine layer preparation: take the clonidine of formula quantity, put 80% quantity in ball mill (100ml tank) and mix according to the ratio of 1:1-8 (W:V) with B, the size grinding ball ratio is (10-30): (20-50), rotating speed is 200~400rpm, grinds 2~12 hours, obtains the paste that clonidine content is 20% (wt), and this clonidine is divided into the clonidine of 20% amount Micropowder (0.8g) and 80% clonidine paste (3.2g);

[0091] (2), the clonidine micropowder of above-mentioned 20% amount is mixed with acrylic pressure-sensitive adhesive 87-2287, is coated on the release material composite film, is dried, and is pressed and coated into clonidine composite film together with controlled-release film; Wherein drying It is a five-section temperature-controlled drying process, that is, the drying process i...

Embodiment 2

[0096] 1. Composition of clonidine patch (1000 patches):

[0097]

[0098] 2. the preparation method of clonidine patch, comprises the following steps:

[0099] (1) Clonidine layer preparation: Weigh the clonidine of the formula amount, put 80% of the amount in a ball mill (100ml tank) and mix it with n-heptane according to the ratio of 1:1-8 (W:V), the size of the grinding ball Ratio is (10-30):(20-50), rotating speed is 200~400rpm, grinds 2~12 hours, obtains the paste that clonidine content is 20% (wt), and this clonidine is divided into 20% amount Clonidine micropowder (0.8g) and the clonidine paste (3.2g) of 80% amount;

[0100] (2), the clonidine micropowder of above-mentioned 20% amount is mixed with acrylic pressure-sensitive adhesive 87-2287, is coated on the release material composite film, is dried, and is pressed into clonidine composite film together with controlled-release film; Wherein drying is Five-section temperature control, that is, the drying process i...

Embodiment 3

[0104] 1. Composition of clonidine patch (1000 patches):

[0105]

[0106] 2. the preparation method of clonidine patch, comprises the following steps:

[0107](1) Clonidine layer preparation: Weigh 80% of the clonidine in the formula and place it in a ball mill (100ml tank) and mix it with n-heptane at a ratio of 1:1-8 (W:V). For (10-30): (20-50), rotating speed is 200~400rpm, grinds 2~12 hours, obtains the paste that clonidine content is 20% (wt), and this clonidine is divided into the cola of 20% amount Clonidine paste (3.2g) of clonidine powder (0.8g) and 80% amount;

[0108] (2), the clonidine micropowder of above-mentioned 20% amount is mixed with acrylic pressure-sensitive adhesive 87-2287, is coated on the release material composite film, is dried, and is pressed and coated into clonidine composite film together with controlled-release film; Wherein drying It is a five-section temperature-controlled drying process, that is, the drying process is divided into five ...

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Abstract

The invention provides a clonidine adhesive patch capable of stably lowering blood pressure in long term, made from clonidine. A drug carrier is made of medicinal pressure-sensitive adhesive, a controlled release film, a lined film, and a release agent composite film, wherein a weight ratio of the clonidine to the pressure-sensitive adhesive is 1:6-1:12; by unit dose of clonidine 4g, all the controlled release film, the lined film and the release agent composite film are 0.4 m<2>. The pressure-sensitive adhesive has long-term action and controlled release, good tolerance, no foreign body sensation but breathability and rarity of dropping, effective components can be released at constant speed through the skin within 7 days, and in an application course of 7 days, the skin has no foreign body sensation but good sensation.

Description

technical field [0001] The invention relates to medicinal preparations in the field of medicine, in particular to a clonidine patch and a preparation method thereof. Background technique [0002] Clonidine is alpha 2 Receptor-stimulating centrally acting antihypertensive drug. Clonidine is an imidazoline derivative synthesized in the early 1960s, belonging to α 2 Adrenergic receptor agonists, and their oral tablets are widely used clinically as antihypertensive drugs. However, general oral administration has the disadvantages of unstable blood drug concentration, different individuals taking the medicine, the same dosage but different effects, and some medicines have disadvantages such as easy addiction. [0003] It is also commercially available in the form of ointments or patches made with clonidine. In the case of the clonidine patch, after it is attached to the skin, it can continue to exert its medicinal effect for as long as one week. However, there is a problem t...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K31/4168A61K47/32A61P9/12
CPCA61K9/7061A61K31/4168
Inventor 李细海
Owner 哈尔滨瀚钧现代制药有限公司
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