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Doxofylline composition for injection

A doxofylline and composition technology, applied in the field of freeze-dried compositions for injection containing doxofylline and melatonin, can solve the problems of low absolute bioavailability, short maintenance time in vivo, large individual differences, etc. , to achieve the effect of improving bioavailability, reducing the first-pass effect, and clearing quickly

Inactive Publication Date: 2013-10-23
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although MT has a variety of physiological functions and pharmacological effects, it has unstable oral absorption kinetics, rapid distribution and clearance, and t 1 / 2 Short (30-50min), large individual differences, strong first-pass effect, low absolute bioavailability (1%-37%), and short maintenance time in vivo (1-3h)

Method used

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  • Doxofylline composition for injection
  • Doxofylline composition for injection
  • Doxofylline composition for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Embodiment 1. Preparation of doxofylline composition freeze-dried powder for injection, in 1000 pieces

[0019] prescription

[0020]

[0021] 2. Preparation process

[0022] a) Add 100g of doxofylline to 1500ml of water for injection and stir to dissolve, then add 0.6g of melatonin and stir evenly;

[0023] b) Add 1.8g of melatonin and 8.79g of moderately substituted hydroxypropyl-β-cyclodextrin into 500ml of water for injection, stir at 50°C for 6 hours, and detect that the encapsulation rate of melatonin is greater than 90%;

[0024] c) After mixing the solutions of groups a and b above, add NaOH solution to adjust the pH value to 8.2, add 0.1% activated carbon and stir for 30 minutes to filter out the activated carbon, and then filter the liquid through 0.45 μm and 0.22 μm microporous membranes to detect the content of intermediates, According to doxofylline, 100mg per bottle;

[0025] d) Fill according to the test requirements, put it into a freeze dryer afte...

Embodiment 2

[0026] Embodiment 2, preparation of doxofylline composition freeze-dried powder for injection, in 1000 pieces

[0027] 1. Prescription

[0028]

[0029] 2. Preparation process

[0030] a) Add 100g of doxofylline to 1500ml of water for injection and stir to dissolve, then add 1g of melatonin and stir evenly;

[0031] b) Add 3g of melatonin and 14.66g of moderately substituted hydroxypropyl-β-cyclodextrin into 500ml of water for injection, stir at 50°C for 6 hours, and detect that the encapsulation rate of melatonin is greater than 90%;

[0032] c) After mixing the solutions of groups a and b above, add NaOH solution to adjust the pH value to 8.2, add 0.1% activated carbon and stir for 30 minutes to filter out the activated carbon, and then filter the liquid through 0.45 μm and 0.22 μm microporous membranes to detect the content of intermediates, According to doxofylline, 100mg per bottle;

[0033] d) Fill according to the test requirements, put it into a freeze dryer afte...

Embodiment 3

[0034] Embodiment 3, preparation of doxofylline composition freeze-dried powder for injection, in 1000 pieces

[0035] 1. Prescription

[0036]

[0037]

[0038] 2. Preparation process

[0039] a) Add 100g of doxofylline to 1500ml of water for injection and stir to dissolve, then add 0.8g of melatonin and stir evenly;

[0040] b) Add 2.4g of melatonin and 11.73g of medium-substituted hydroxypropyl-β-cyclodextrin into 500ml of water for injection, stir at 50°C for 5 hours, and detect that the encapsulation rate of melatonin is greater than 90%;

[0041] c) After mixing the solutions of groups a and b above, add NaOH solution to adjust the pH value to 8.2, add 0.1% activated carbon and stir for 30 minutes, filter out the activated carbon, and then filter the liquid through 0.45 μm and 0.22 μm microporous membranes to detect the content of intermediates , according to doxofylline, 100mg per bottle;

[0042] d) Fill according to the test requirements, put it into a freeze...

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Abstract

The invention provides a doxofylline composition for injection and relates to the technical fields of drug and drug production. The main components of the composition are doxofylline and melatonin, wherein the melatonin comprises a quick release part and a slow release part coated with cyclodextrin. By adopting the doxofylline composition for injection provided by the invention, the treatment effect of doxofylline on bronchial diseases is improved; the defects of instability, quick distribution and removal, caused by oral administration and absorption of MT (melatonin) are avoided; the first-pass effect of MT is reduced; the quick release-slow release combined administration design accords with the secreting characteristics of the MT; the problem of a short half-life period of the MT is solved; and the bioavailability of the product is improved.

Description

Technical field: [0001] The invention relates to the technical field of medicine and medicine manufacture, in particular to a doxofylline composition for injection, and more specifically, to a freeze-dried composition for injection containing doxofylline and melatonin. Background technique: [0002] Bronchial asthma (abbreviation: asthma) is a kind of common disease, frequently-occurring disease. At present, there are about 300 million asthmatics in the world, and about 30 million asthmatics in China. Asthma is an important disease that affects people's physical and mental health. If the treatment is not timely or standardized, asthma may be fatal. With standardized treatment, nearly 80% of asthma patients can be well controlled with current treatment methods. Work and life are hardly affected by the disease. Comprehensive treatment methods should be adopted for asthma treatment , including avoidance of allergens and other asthma triggers, standardized drug therapy, specif...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/522A61K9/19A61K47/40A61P11/06A61K31/4045
Inventor 汪六一汪金灿郝结兵李彪吴函峰
Owner HAINAN WEI KANG PHARMA QIANSHAN
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