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Butylphthalide transdermal patch and preparation method thereof

A butylphthalide and patch technology, applied in the field of medicine, can solve the problems of low oral availability of butylphthalide soft capsules, poor patient compliance of injection dosage forms, complicated injection preparation process, etc., so as to increase the effective availability and reduce the The number of doses and the effect of avoiding adverse reactions

Active Publication Date: 2014-05-14
CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Chinese patent CN200310119336.1 titled "Butylphthalide Soft Capsules and Its Preparation Process" discloses that butylphthalide is dispersed in vegetable oil as the content to prepare soft capsules, but there are problems such as oil leakage and low yield in the production of soft capsules , the more serious problem is the low availability of oral absorption of butylphthalide soft capsules
[0006] Chinese patent CN200510102355.2 titled "Butylphthalide Intravenous Emulsion and Its Application" discloses that butylphthalide is made into intravenous emulsion. Although the emulsion improves the water solubility of butylphthalide, the preparation process requires full aseptic operation and industrialization. Production is difficult and costly
Although the injections that have been marketed overcome the first-pass effect of oral dosage forms and improve the speed of onset of action, the preparation process of injections is complicated, there are many key control points, and the patient compliance of injection dosage forms is poor

Method used

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  • Butylphthalide transdermal patch and preparation method thereof
  • Butylphthalide transdermal patch and preparation method thereof
  • Butylphthalide transdermal patch and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] A kind of butylphthalide transdermal patch comprises the following components by weight percent:

[0049]

[0050] The preparation method of butylphthalide transdermal patch comprises the steps:

[0051] ① Add butylphthalide to ethanol dissolved with a certain amount of PVP K30, and stir evenly;

[0052] ② Dissolve E100 and RODERM MD610 / 607 with acetone and ethyl acetate and stir well;

[0053] ③Mix the above liquids together, add azone, stir evenly, transfer to the coating machine, coat on the anti-adhesive layer, heat up and dry at 40°C for 2 hours, then cover with the backing layer, punch out to a certain size size and specifications. The thickness of the drug-loaded pressure-sensitive adhesive layer can be 20-200 μm.

Embodiment 2

[0055]

[0056]

[0057] The preparation method of butylphthalide transdermal patch comprises the steps:

[0058] ① Add butylphthalide to ethanol dissolved with a certain amount of PVP K30, and stir evenly;

[0059] ②E100 and DUROTAK-2287 were dissolved with acetone and ethyl acetate and stirred evenly;

[0060] ③Mix the above liquids together, add azone, stir evenly, transfer to the coating machine, coat on the anti-adhesive layer, heat up and dry at 40°C for 2 hours, then cover with the backing layer, punch out to a certain size size and specifications. The thickness of the drug-loaded pressure-sensitive adhesive layer can be 20-200 μm.

Embodiment 3

[0062] The appearance, initial adhesion and holding force of the prepared patches were compared and investigated, and 3 patch samples (15cm 2 / piece), and the results are shown in Table 1.

[0063] Table 1 The results of the sample appearance and viscosity characteristics investigation

[0064]

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Abstract

The invention provides a butylphthalide transdermal patch and a preparation method thereof. The butylphthalide transdermal patch comprises a backing layer, an anti-cohesion layer and a medicine-carrying pressure-sensitive adhesive layer containing a main drug of butylphthalide. The medicine-carrying pressure-sensitive adhesive layer is provided by the following components by weight: 20-60 parts of butylphthalide, 30-70 parts of a pressure-sensitive adhesive, 1-9 parts of polyvinylpyrrolidone and 1-9 parts of a penetration enhancer. The transdermal patch provided by the invention can reach relatively excellent appearance and is superior to conventional market products in physical and chemical properties, can reduce toxic and side effects to the maximum limit, enriches effective availability of medicines, improves compliance for pharmacy of patients, reduces frequency of administration, and is convenient for pharmacy of the old and critical patients. A good preparation process is provided by the invention; production cost is reduced; and the preparation method is suitable for large-scale production.

Description

technical field [0001] The invention belongs to the technical field of medicine and relates to a pharmaceutical preparation, in particular to a butylphthalide transdermal patch and a preparation method thereof. Background technique [0002] Butylphthalide, full name 3-butyl-1(H)-isobenzofuranone, also known as apigenin A, is a racemate extracted from celery seed, and can also be synthesized artificially; Butylphthalide is Light yellow clear oily liquid, highly volatile, with celery aroma, boiling point about 290°C; butylphthalide is easily soluble in methanol, soluble in ethanol, ether and chloroform, but insoluble in water; it is mainly used clinically for treatment Mild to moderate ischemic stroke, and the improvement of neurological deficit in patients with acute ischemic stroke. [0003] Because butylphthalide is an oily liquid insoluble in water, its oral availability is low, and it is difficult to make suitable preparations. In order to facilitate medication for the ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/365A61K47/32A61P9/10A61P25/00
Inventor 冯彩霞王世霞修宪李永丰任智楠王红叶
Owner CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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