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Transdermal Ligustrazine plaster and its prepn

A technology of transdermal patch and ligustrazine, which is applied in the field of transdermal patch containing ligustrazine and its preparation, which can solve the problems of blood drug concentration fluctuation, difficulty in persistence, slow progress, etc., and achieve stable blood drug concentration and quality , the effect of ensuring safety

Inactive Publication Date: 2003-07-30
FUDAN UNIV +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, the dosage form of ligustrazine is relatively single, and the domestic and foreign marketed varieties are only ordinary tablets and injections. 100mg, 2 times / day, and intravenous infusion and intravenous injection should be carried out slowly; oral administration of 50mg / tablet, 2 tablets / time, 3 times / day
Such frequent medication will bring a lot of inconvenience to patients, it is difficult to persist, and it is easy to cause fluctuations in blood drug concentration and cause side effects

Method used

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  • Transdermal Ligustrazine plaster and its prepn
  • Transdermal Ligustrazine plaster and its prepn
  • Transdermal Ligustrazine plaster and its prepn

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] The transdermal patch described in this example is an adhesive skeleton patch, consisting of a three-layer structure of a backing layer, a protective layer, and a drug-containing adhesive skeleton. The materials used in each layer are as follows:

[0037] Backing layer: non-woven fabric

[0038] Protective layer: polyester film

[0039] Drug-containing adhesive matrix:

[0040] The adhesive skeleton preparation components are (100 stickers):

[0041] Polyacrylic resin pressure sensitive adhesive 30g

[0042] Ligustrazine 15g

[0043] Oleic acid 2g

[0044] The polyacrylic resin pressure-sensitive adhesive preparation components are as follows:

[0045] Polyacrylic resin IV 20g

[0046] Succinic acid 1g

[0047] Dibutyl phthalate 10g

[0048] Acetone 80ml

[0049] Prepare as follows:

[0050] 1. Preparation of polyacrylic resin pressure-sensitive adhesive: Dissolve the amount of succinic acid in acetone, then add polyacrylic resin and stir to dissolve, and fina...

Embodiment 2

[0053] The transdermal patch described in this example is an adhesive layer rate-limiting patch, consisting of a backing layer, a protective layer, a drug-containing adhesive skeleton, and an adhesive layer. The materials used in each layer are as follows:

[0054] Backing layer: polyester film

[0055] Protective layer: PTFE film

[0056] Controlled Release Membrane: Polypropylene Microporous Membrane

[0057] Adhesive layer: blank silicone pressure sensitive adhesive

[0058] Drug-containing viscose skeleton:

[0059] The drug-containing adhesive skeleton preparation components are (100 stickers):

[0060] Silicone pressure sensitive adhesive 30g

[0061] Ligustrazine 15g

[0062] Azone 1.5g

[0063] Prepare as follows:

[0064] 1. Preparation of drug-containing skeleton layer: dissolve silicone pressure-sensitive adhesive, ligustrazine and Azone with ethyl acetate, adjust and coat on the backing layer, control the coating thickness, dry at 70°C, and then use The pol...

Embodiment 3

[0068] The transdermal patch described in this example is a filled and closed patch consisting of a five-layer structure of a backing layer, a protective layer, a release-controlling film, an adhesive layer, and a drug reservoir. The materials used in each layer are as follows:

[0069] Backing layer: composite aluminum foil

[0070] Protective layer: polyester film

[0071] Controlled Release Membrane: Ethylene-vinyl acetate membrane (EVA)

[0072] Adhesive layer: silicone pressure sensitive adhesive

[0073] Drug storage:

[0074] Depot preparation components (100 stickers, 0.8g per sticker)

[0075] Ligustrazine 5-40%

[0076] Carbomer 1-5%

[0077] Appropriate amount of sodium hydroxide

[0078] Ethanol 5-10%

[0079] Glycerin 5-20%

[0080] Azone 2-10%

[0081] Tween 80 1-3%

[0082] water up to 80g

[0083] Prepare as follows:

[0084] 1. Preparation of the reservoir:

[0085] (1) Take carbomer and add 2 / 3 of the water to make it fully swell. After the carbo...

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PUM

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Abstract

The present invention belongs to the field of pharmaceutical technology and relates to transdermal Ligustrazine plaster and its preparation. It has Ligustrazine phosphate or Ligustrazine as active medicinal component and consists of medicine storing back, adhering layer, release controlling film, back lining layer and protective layer. It is superior to available Ligustrazine preparation forms inmedicine releasing are, transdermal rate and lasting release time, and has the features of determined curative effect, stable quality, high safety, etc. Animal experiments show that the plaster can retard the effect of ischemic to cerebral damage, inhibit thrombosis caused by tissue damage, prevent and treat cerebral embolism and maintain balanced medicine density in blood for 24 hr; and has light irritation to skin, no irritability and no toxic reaction.

Description

technical field [0001] The invention belongs to the field of pharmacy and relates to a transdermal patch containing ligustrazine and a preparation method thereof. Background technique [0002] Ligustrazine (Tetramethylpyrazine, Ligustrazine) is an alkaloid monomer extracted and separated from the rhizome of Ligusticum umbelliferum in the early 1970s by Chinese pharmaceutical workers. Ligustrazine is a colorless prismatic crystal with the molecular formula C 8 h 12 N 2 , molecular weight 136, melting point 80°C-82°C. Ligustrazine has calcium antagonistic effect, and is a new type of calcium antagonist. It has pharmacological effects such as dilating blood vessels, increasing coronary blood flow, cerebral blood flow, improving circulation, increasing myocardial contractility, and preventing cell damage caused by ischemia, hypoxia and reperfusion. In addition, it can pass through the blood-brain barrier, inhibit platelet aggregation and reduce platelet activity. Clinical ...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K31/4965A61M37/00A61P9/10
Inventor 沈腾徐惠南翁伟宇张建芳
Owner FUDAN UNIV
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