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Tulobuterol containing pressure-sensitive adhesive, transdermal paster, and its preparing method and use

A technology of hot-melt pressure-sensitive adhesive and transdermal penetration enhancer, which is applied in the direction of medical preparations containing active ingredients, pharmaceutical formulas, organic active ingredients, etc., and can solve the problems of low drug transdermal rate, environmental and personnel hazards, and process operations. Complicated problems, to achieve the effect of preventing asthma attack, fast coating speed and long storage time

Active Publication Date: 2007-01-31
YABAO PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Chinese patents ZL96198929.7 and ZL98126197.3 both disclose two kinds of tulobuterol patches. Chinese patent ZL96198929.7 uses tulobuterol microcrystals with an average particle size of 2-20um to be suspended in synthetic rubber. The operation is complicated, the reliability is poor, and the required drug dose is large. Since the drug exists in the rubber pressure-sensitive adhesive in the form of microcrystals instead of dissolved form, the drug transdermal rate is small
The dosage of medicine used in this process is large, organic solvents are needed in the preparation process, the production process is complicated, the investment in equipment is large, and it causes serious environmental and personnel hazards

Method used

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  • Tulobuterol containing pressure-sensitive adhesive, transdermal paster, and its preparing method and use
  • Tulobuterol containing pressure-sensitive adhesive, transdermal paster, and its preparing method and use
  • Tulobuterol containing pressure-sensitive adhesive, transdermal paster, and its preparing method and use

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] [Prescription] (based on 1000 tablets)

[0046] Tulobuterol 0.5g, propylene glycol 10g, hot-melt pressure-sensitive adhesive 39.5g.

[0047] Process: Add the drug to propylene glycol to dissolve, heat the pressure-sensitive adhesive to 110°C to melt, add the drug-containing solution, mix well, apply it on the anti-adhesive layer, cover it with the backing layer after cooling, and punch it into 3.3cm~ 3.0cm that is, each tablet contains tulobuterol 1%.

[0048] Said pressure-sensitive adhesive has a melting point of 100°C. YY-100 pressure-sensitive adhesive from Shanghai Yuanjing Adhesive Material Co., Ltd. is used, and its components and parts by weight are:

[0049] 100 parts of polyurethane, 100 parts of petroleum resin, 2 parts of white oil, 20 parts of naphthenic oil, 1 part of zinc N, N-dibutylcarbamate.

Embodiment 2

[0051] [Prescription] (based on 1000 tablets)

[0052] Tulobuterol 2.5g, ethanol 5g, hot-melt pressure-sensitive adhesive 42.5g.

[0053] Process: Add the drug to ethanol to dissolve, heat the pressure-sensitive adhesive to 110°C to melt, add the drug-containing solution, mix well, apply it on the anti-adhesive layer, cover it with the backing layer after cooling, and punch it into 3.3cm~ 3.0cm is available.

[0054] Said pressure-sensitive adhesive has a melting point of 100°C. YY-90 pressure-sensitive adhesive from Shanghai Yuanjing Adhesive Material Co., Ltd. is used, and its components and parts by weight are:

[0055] 100 parts of hydrogenated styrene, 100 parts of rosin, 2 parts of white oil, 50 parts of naphthenic oil, 1 part of zinc N, N-dibutylcarbamate.

Embodiment 3

[0057] in vitro skin penetration test

[0058] 1. Skin treatment

[0059] Ex vivo skin of nude mice: Two-week-old nude mice were killed by neck dislocation, the skin was peeled off, subcutaneous fat was carefully removed, and the mice were refrigerated at -30°C for later use. Thaw and rinse with saline before use.

[0060] Human isolated skin: The human breast skin within 2 hours after surgery was removed from the subcutaneous fat layer, washed with normal saline, and then refrigerated at -30°C for later use.

[0061] 2. Transdermal test

[0062] The transdermal test was carried out using a Franz transdermal diffusion cell, and the temperature of the water bath was 32°C. Stirring speed 500prm, transdermal area 2.8cm 2 , the volume of the receiving pool is 7.5ml, and the receiving solution is 40% PEG400-normal saline solution.

[0063] Paste the patch of Example 1 on the stratum corneum of the skin, fix it on the receiving pool, sample 0.5 ml regularly, and supplement the ...

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Abstract

The present invention discloses a transcutaneous plaster containing tulobuterol, its preparation method and application. The pressure-sensitive adhesive used by said invention is a hot-melt pressure-sensitive adhesive whose melting point is 50-250 deg.C. the described hot-melt pressure-sensitive adhesive is an adhesive made up by using thermoplastic polymer as main raw material, and hs the hot-melting and pressure-sensitive double characteristics. Said product contains no organic solvent, and its coating speed is quick, and its cost is low.

Description

technical field [0001] The invention relates to a transdermal patch and a preparation method, in particular to tulobuterol transdermal patch and a preparation method. Background technique [0002] Tulobuterol, also known as tobuterol and clobuterol, is a selective β2 receptor agonist, which has a strong and long-lasting expansion effect on bronchial smooth muscle, but a weaker stimulating effect on the heart. Clinical use shows that this product not only has obvious anti-asthma effects, but also has some anti-asthma and expectorant effects. Generally, it takes effect 5-10 minutes after oral administration, and the effect can last for 4-6 hours. It is mainly used for the prevention and treatment of bronchial asthma and asthmatic bronchitis. The dosage forms of tulobuterol hydrochloride mainly include tablets and cough syrup for children. [0003] Chinese patents ZL96198929.7 and ZL98126197.3 both disclose two kinds of tulobuterol patches. Chinese patent ZL96198929.7 uses tu...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/70A61K31/137A61P11/06A61P11/10A61P11/00
Inventor 王浩侯惠民
Owner YABAO PHARMA GRP CO LTD
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