Tulobuterol patch and preparation method thereof

A technology of tulobuterol and patch, applied in the field of tulobuterol patch and preparation thereof, can solve the problems of not being suitable for nighttime asthma prevention and treatment, unable to play a long-term treatment, insufficient drug release in the later period, etc. Moderate viscosity, good solubility, simple and easy preparation process

Active Publication Date: 2013-09-04
MICROBE EPIDEMIC DISEASE INST OF PLA MILITARY MEDICAL ACAD OF SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The tulobuterol patch prepared by conventional methods has too fast permeation rate in the early stage and insufficient drug release in the later stage, so it cannot achieve the purpose of long-term treatment, especially not suitable for the prevention and treatment of nocturnal asthma and "sedimentation", so it is made Chronopharmaceutical transdermal absorption preparation is the focus of preparation research

Method used

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  • Tulobuterol patch and preparation method thereof
  • Tulobuterol patch and preparation method thereof
  • Tulobuterol patch and preparation method thereof

Examples

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Effect test

Embodiment 1

[0031] Embodiment 1, preparation tulobuterol controlled-release patch

[0032] Weigh high molecular weight polyisobutylene B50 (1.5g, Daelim, South Korea), low molecular weight polyisobutylene PB1300 (1g, Daelim, South Korea) and plasticizer naphthene oil NAPHSOL200 (1ml) of the prescription amount, in a 150ml round bottom flask, add n-hexane An appropriate amount of alkanes (accounting for about 50% of the solute mass) was heated at 50°C under reflux and stirred for 5 hours to form a uniform viscous semi-solid fluid. Then add an appropriate amount of tulobuterol, stir evenly, and make 8.4 mg / ml uniformly mixed drug-containing colloid. The patch was prepared according to the volume ratio of the drug-containing colloid coated by the inner and outer coatings of 2:1, wherein the inner layer was close to the backing (EH-1203, Kedebao Feather Nonwovens (Suzhou) Co., Ltd.), and the outer layer was close to the covering Film (anti-adhesive layer), first on the backing layer (4.5*11....

Embodiment 2

[0038]In the two-layer coating method, the volume ratio of the drug-containing colloid coated by the inner layer (close to the backing) and the outer layer (close to the cover film) is changed to 1: 3 to prepare a patch (the total drug-containing colloid amount of the coating is simultaneously an example 1), all the other are prepared according to the method in Example 1. The drug content of the obtained tulobuterol sustained-release patch is 1mg / 5.06cm 2 .

Embodiment 3

[0040] In the two-layer coating method, the volume ratio of the drug-containing colloid coated by the inner layer (close to the backing) and the outer layer (close to the cover film) is changed to 3: 1 to prepare a patch (the total drug-containing colloid amount of the coating is simultaneously an example 1), all the other are prepared according to the method in Example 1. The drug content of the obtained tulobuterol sustained-release patch is 1mg / 5.06cm 2 .

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Abstract

The invention discloses a tulobuterol patch and a preparation method thereof. The tulobuterol patch consists of a back lining layer, a medicine-carrying pressure-sensitive adhesive layer and an anti-adhesive layer, wherein the medicine-carrying pressure-sensitive adhesive layer has a double-layer structure; and in the double-layer structure, a mass ratio of one layer which contacts the back lining layer and the other layer which contacts the anti-adhesive layer is (1:3)-(3:1). The preparation method comprises the following steps of: dissolving tulobuterol and a pressure-sensitive adhesive auxiliary material in a good solvent; and during preparation, coating two layers, namely coating a first layer, placing at room temperature, so that the solvent is volatilized fully, and coating a second layer to obtain a percutaneous absorption-type tulobuterol patch. The preparation process for the tulobuterol percutaneous absorption preparation is simple and can be used for producing the tulobuterol patch; and by the prepared tulobuterol patch, medicines can be released slowly at a constant speed, so the tulobuterol patch meets the requirements of preparations for treating asthma diseases.

Description

technical field [0001] The invention relates to a tulobuterol patch and a preparation method thereof. Background technique [0002] Tulobuterol was developed by Tanabe Seigaku (Tanabe) Pharmaceutical Co., Ltd. in Japan in 1982. tulobuterol is selective beta 2 Agonists, which stimulate beta 2 -AG receptor relaxes bronchial smooth muscle and promotes bronchial cilia movement to finally achieve anti-asthma effect. Moreover, tulobuterol has few systemic side effects, and its stimulating effect on the heart is 1 / 1000 of that of isoproterenol or 1 / 100 of that of salbutamol. It is widely used in clinical bronchial asthma, acute and chronic bronchitis, emphysema, Treatment of respiratory obstructive diseases such as silicosis and pneumoconiosis. [0003] Tulobuterol has a molecular weight of 227.7, a melting point of 91.6, and an oil-water partition coefficient of 1.03. It is relatively stable in solution without degradation products. The above physical and chemical properties ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/70A61K31/137A61K47/32A61P11/08A61P11/06
Inventor 王洪权李海晶张东娜丁建新窦媛媛徐力昆郭永建宋亚彬唐玲杨柳
Owner MICROBE EPIDEMIC DISEASE INST OF PLA MILITARY MEDICAL ACAD OF SCI
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