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External application preparation containing tulobuterol pharmaceutical composition

A technology for external preparations and compositions, which is applied in the field of pharmaceutical preparations, and can solve problems such as the decrease in the solubility of synthetic rubber adhesives, the loss of active ingredients, and the impact on the efficacy of drugs

Active Publication Date: 2018-08-17
BEIJING TIDE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the drug's initial transdermal rate is slow, and long-term storage is that the solubility of tulobuterol to synthetic rubber adhesives is reduced, and the microcrystals produced are insoluble in adhesives, have poor stability, and are prone to crystallization.
At the same time, synthetic rubber is very irritating to the skin, and long-term use can easily cause skin allergies
[0005] In order to solve the problem of stability and sustained release of tulobuterol, researchers have improved the materials of the adhesive, such as using polyacrylic pressure-sensitive adhesive or polyisobutylene pressure-sensitive adhesive, but the preparation method used needs to The pressure-sensitive adhesive is dissolved in an organic solvent, and then the solvent is removed. This method inevitably leads to the loss of active ingredients when the solvent is volatilized, which affects the efficacy of the drug.
Document CN03129630.0 discloses a drug storage preparation that does not contain organic solvents. The patch prepared according to the technology disclosed in this document is prone to crystallization, and the drug penetration rate cannot meet the clinical drug standards.

Method used

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  • External application preparation containing tulobuterol pharmaceutical composition
  • External application preparation containing tulobuterol pharmaceutical composition
  • External application preparation containing tulobuterol pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039]

[0040] Preparation method: dissolve the prescribed amount of tulobuterol in crotamiton, add amino acid, and stir evenly; mix the prescribed amount of colloid evenly, add the above-mentioned uniformly mixed solution into the container containing the colloid, Stir for 1-3 hours, and stir evenly; apply the mixed paste evenly on the anti-adhesive layer, cover with a backing layer, dry, and cut into required sizes to obtain the patch prepared by the present invention.

Embodiment 2

[0042]

[0043]Preparation method: dissolve the prescribed amount of tulobuterol in crotamiton, add amino acid, and stir evenly; add the prescribed amount of petroleum resin into the above solution, and mix evenly; add the above uniformly mixed solution to the container In a container with colloid, stir for 1-3 hours, and stir evenly; apply the mixed paste evenly on the anti-adhesive layer, cover the backing layer, dry, and cut it into the required size to obtain the preparation of the present invention. patch.

Embodiment 3

[0045]

[0046] Preparation method: dissolve the prescribed amount of tulobuterol in crotamiton, add amino acid, and stir evenly; add the prescribed amount of vitamin E into the above solution, and mix evenly; add the above-mentioned uniformly mixed solution into the container In a container with colloid, stir for 1-3 hours, and stir evenly; apply the mixed paste evenly on the anti-adhesive layer, cover the backing layer, dry, and cut it into the required size to obtain the preparation of the present invention. patch.

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PUM

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Abstract

The present invention discloses an external application preparation containing a tulobuterol pharmaceutical composition, particularly a skin external application preparation containing a tulobuterol and crotamiton pharmaceutical composition. According to the present invention, by adding crotamiton, the solubility of tulobuterol is increased, the use of organic solvents is effectively avoided, theactive substance loss caused by the evaporation of the organic solvent is reduced, and the stability of the preparation is increased, such that the treatment effect of the drugs cannot be affected inthe case of the long-term storage while the environmental pollution is reduced, and the adverse reactions of the patient after the medication are reduced.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an external preparation for skin, in particular to an external preparation containing tulobuterol pharmaceutical composition and a preparation method thereof. Background technique [0002] Tulobuterol (also known as clobuterol, Tulobuternl), is a selective beta 2 - Receptor agonist, which has a strong and long-lasting effect on dilating bronchial smooth muscle, but has a weak stimulating effect on the heart. It has certain anti-allergic effects, promotes bronchial cilia movement, and relieves cough and expectorant. It is used to relieve bronchial asthma, acute and chronic bronchitis, Emphysema, silicosis, pneumoconiosis [0003] and other symptoms of respiratory obstruction. There has been great progress in the development of tulobuterol dosage forms. Aerosols, tablets, dry syrup, ointments, emulsions and patches of tulobuterol have been developed both at home and ab...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K31/137A61K47/32A61K47/18A61P11/06A61P11/00
CPCA61K9/7053A61K9/7061A61K31/137A61K47/18A61K47/183
Inventor 赵焰平何伊欣李辙杨娜周丽莹刘亚男
Owner BEIJING TIDE PHARMA
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