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Anti-bronchial asthma doxofylline injection

A technology for bronchial asthma and doxofylline, which is applied in the field of medicine, can solve problems such as discoloration, and achieve the effects of improved stability of preparations, stable and controllable quality, and high stability

Inactive Publication Date: 2016-02-03
李正梅
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The stability of the existing doxofylline injection is generally stored for 2 years, and there are unstable situations such as discoloration, which need to be improved

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Embodiment 1: Preparation of doxofylline crystal

[0022] Dissolve doxofylline in a mixed solvent of methanol and dimethyl sulfoxide whose volume is 6 times the weight of urapidil at 35°C. The volume ratio of methanol to dimethyl sulfoxide is 5:1.5; Add the mixed solvent of butanol and ether whose volume is 9 times of the weight of doxofylline at a high speed, the volume ratio of butanol and ether is 2:3, stir while adding, control the temperature at 35°C, grow the crystal for 3 hours; then Add petroleum ether whose total volume is 7 times the weight of doxofylline at a speed of 20ml / min, and after growing the crystal for 1 hour, cool down to -5°C at a speed of 10°C / hour, and then maintain a stirring speed of 90 rpm Stir for crystallization and crystal growth for 3 hours; filter, wash, and dry under reduced pressure to obtain doxofylline crystal compound.

[0023] The prepared doxofylline crystal is measured by powder X-ray diffractometry, and the X-ray powder diffract...

Embodiment 2

[0024] Embodiment 2: prescription: doxofylline 2.5g, lactic acid 1.5g, 4g polyethylene glycol 400, propylene glycol 6ml, ethanol 1ml, antioxidant 0.03g, EDTA0.001g,

[0025] Preparation method: 1) mix and dissolve doxofylline with polyethylene glycol 400 and propylene glycol, and dissolve the polyethylene glycol 400 and propylene glycol solution of doxofylline; 2) mix and dissolve sodium thiosulfate with appropriate amount of water for injection, Obtain sodium thiosulfate solution; 3) Mix and dissolve lactic acid and an appropriate amount of water for injection to obtain a lactic acid solution; 4) Mix and dissolve EDTA and ethanol to obtain an EDTA ethanol solution; 5) Combine step 2), step 3) and step 4) The prepared solutions were added to the solution prepared in step 1) successively under stirring, mixed and stirred evenly; 6) 0.05% (w / v) activated carbon for needles was added to the solution obtained in step 5), and kept at 60°C Stir and adsorb for 10 minutes, filter and ...

Embodiment 3

[0027] Embodiment 3: prescription: doxofylline 4g, lactic acid 0.5g, 6g polyethylene glycol 400, propylene glycol 3ml, ethanol 1.5ml, antioxidant 0.03g, EDTA0.02g,

[0028] Preparation method: 1) mix and dissolve doxofylline with polyethylene glycol 400 and propylene glycol, and dissolve the polyethylene glycol 400 and propylene glycol solution of doxofylline; 2) mix and dissolve sodium thiosulfate with appropriate amount of water for injection, Obtain sodium thiosulfate solution; 3) Mix and dissolve lactic acid and an appropriate amount of water for injection to obtain a lactic acid solution; 4) Mix and dissolve EDTA and ethanol to obtain an EDTA ethanol solution; 5) Combine step 2), step 3) and step 4) The prepared solutions were added to the solution prepared in step 1) successively under stirring, mixed and stirred evenly; 6) 0.5% (w / v) activated carbon for needles was added to the solution obtained in step 5), and kept at 40°C Stir and adsorb for 30 minutes, filter and de...

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Abstract

The invention discloses anti-bronchial asthma doxofylline injection, and belongs to the technical field of medicine. Doxofylline is a crystal, and the novel crystal form of the doxofylline provided by the invention is different from a crystal form structure of the prior art; experiments find that a compound with the novel crystal form is high in purity, good in fluidity, good in stability, low in purity content, not easy for humidity absorption and safe and reliable in clinic, and powder-injection prepared by utilizing the compound with novel crystal form is good in stability, stable after compatibility with a solvent, extremely low in insoluble particle content, and very suitable for clinical application.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a doxofylline injection for resisting bronchial asthma. Background technique [0002] Doxofylline, a derivative of methylxanthine, is a bronchodilator that acts directly on the bronchi to relax bronchial smooth muscle. By inhibiting the action of phosphodiesterase in smooth muscle cells, it relaxes smooth muscle, thereby achieving the effect of inhibiting asthma. The stability of the existing doxofylline injection generally has a shelf life of 2 years, and there are unstable situations such as discoloration, which need to be improved. Contents of the invention [0003] The object of the present invention is to provide an anti-bronchial asthma doxofylline injection. [0004] In order to accomplish the purpose of the present invention, the technical solution adopted is: [0005] A doxofylline injection for resisting bronchial asthma, the doxofylline injection per unit dose is m...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/522C07D473/08A61K47/34A61P11/06A61P11/08
Inventor 李正梅
Owner 李正梅
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