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Preparation method of clonidine controlled-release patch

A technology of clonidine and patch, which is applied in the field of treating children with ADHD, can solve problems such as poor compliance and inconvenient medication, and achieve the effects of convenient and quick use, improved bioavailability, and good stability of physical and chemical properties

Inactive Publication Date: 2016-02-10
ANHUI YELLEN PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The treatment methods of the above-mentioned ADHD medicines are all oral preparations. In the treatment process of ordinary oral preparations, the medication is inconvenient and the compliance is also poor. Most stimulant drugs are included in the scope of psychotropic drug management, and they need to be prescribed by a doctor before they can be used, which directly limits the treatment of this type of ADHD in children. Therefore, it is urgent to develop a new dosage form that is long-term, efficient, safe and low-toxic

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] (1) Weigh 0.4g of the main drug clonidine and 15g of polybutylene pressure-sensitive adhesive, mix them evenly in a homogenizer to form a paste layer, then spread it on wax paper, dry it and paste it The layers are bonded together with the EVA film;

[0035] (2) Weigh 4.0g of the main drug clonidine and 35g of polybutylene pressure-sensitive adhesive,

[0036] Mix 5ml of mineral oil and 1.0g of silicon dioxide in a homogenizer to form a drug storage layer, then coat the drug storage layer on the aluminum-plastic composite film, dry the drug storage layer and attach the EVA film Put them together to form a five-layer structure of aluminum-plastic composite film, drug storage layer, EVA film, adhesive layer, and wax paper in sequence;

[0037] (3) The product obtained in (2) is evenly cut into 1000 pieces, then sterilized and packaged.

Embodiment 2

[0039] (1) Weigh 0.4g of the main drug clonidine and 10g of polybutylene pressure-sensitive adhesive, and mix them evenly in a homogenizer to form a paste layer, then spread it on wax paper, dry it and paste it Layer and microporous membrane are bonded together;

[0040] (2) Weigh 4.0g of the main drug clonidine, 40g of polybutylene pressure-sensitive adhesive, 5ml of mineral oil, and 1.0g of silicon dioxide, and mix them evenly in a homogenizer to form a drug storage layer, and then put the drug storage The layer is coated on the aluminum-plastic composite film, and after drying, the drug store layer and the microporous film are bonded together to form a five-layer structure of a backing layer, a drug store layer, a microporous film, an adhesive layer, and a wax paper;

[0041] (3) The product obtained in (2) is evenly cut into 1000 pieces, then sterilized and packaged.

Embodiment 3

[0043] (1) Weigh 0.4g of the main drug clonidine and 15g of polybutylene pressure-sensitive adhesive, mix them evenly in a homogenizer to form a paste layer, then spread it on wax paper, dry it and paste it Layer and microporous membrane are bonded together;

[0044] (2) Weigh 4.0g of the main drug clonidine and 35g of polybutylene pressure-sensitive adhesive,

[0045] Mix 5ml of mineral oil and 1.0g of silicon dioxide in a homogenizer to form a drug reservoir layer, then coat the drug reservoir layer on the aluminum-plastic composite film, dry the drug reservoir layer and the microporous membrane Paste together to form a five-layer structure of aluminum-plastic composite film, drug storage layer, microporous film, adhesive layer, and wax paper in sequence;

[0046] (3) The product obtained in (2) is evenly cut into 1000 pieces, then sterilized and packaged.

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PUM

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Abstract

The invention discloses a preparation method of a clonidine controlled-release patch. The preparation method specifically includes: weighing active ingredients including clonidine and polybutene pressure-sensitive adhesive, mixing the active ingredients well to form a pasting layer, coating the pasting layer on an anti-adhesion layer, and pasting the pasting layer and a controlled-release layer together after drying; weight the active ingredients including clonidine and polybutene pressure-sensitive adhesive, mixing the active ingredients well to form a drug storehouse layer, coating the drug storehouse layer on a back lining layer, and pasting the drug storehouse layer and the controlled-release layer together after drying; uniformly slitting an obtained production into 1000 pieces, sterilizing, and packaging. The clonidine controlled-release patch has the advantages of safety and reliability.

Description

technical field [0001] The invention relates to a preparation method of a clonidine controlled-release patch, which is applied to the field of treating ADHD in children. Background technique [0002] Hyperactivity in Children (HyperactivityinChildren) is the abbreviation of Hyerkinetic Syndrome of Childhood (HyerkineticSyndromeofChildhood), also known as attention deficit hyperactivity syndrome (ADHD), which is a relatively common children's behavior disorder syndrome. [0003] At present, there are more and more children with ADHD. With the gradual unification of the international diagnostic criteria for ADHD, in recent years, according to surveys and studies, the prevalence of ADHD among children in my country is 4.31%-5.83%. At present, foreign scholars generally believe that the prevalence of ADHD is about 3%-6%. It is roughly estimated that there are tens of millions of children with ADHD in my country. [0004] ADHD is the most common psychological and behavioral diso...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K31/4168A61K47/32A61P25/00
Inventor 顾世海陈伟光
Owner ANHUI YELLEN PHARMA
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