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Doxofylline venous injection with small volume as well as preparation method and quality control method thereof

A technology for intravenous injection and doxofylline, which is applied in medical formulas, measuring devices, medical preparations of non-active ingredients, etc., can solve the problems of large volume and achieve good safety and a wide range of options

Active Publication Date: 2010-02-17
HEILONGJIANG FUHE HUAXING PHARMA GROUP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Although, it is well known to those skilled in the art to adjust the osmotic pressure of injection by substances such as sodium chloride and glucose, such as commercially available 100ml large-capacity doxofylline sodium chloride or glucose injection, the clinical osmotic pressure problem Some improvements have been obtained, but due to the addition of a large amount of non-isotonic doxofylline solution (20--30 milliliters, the osmotic pressure is 20mOsmol / kg), the solution will become a hypotonic solution and the injected volume is larger (130 ml)

Method used

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  • Doxofylline venous injection with small volume as well as preparation method and quality control method thereof
  • Doxofylline venous injection with small volume as well as preparation method and quality control method thereof
  • Doxofylline venous injection with small volume as well as preparation method and quality control method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Example 1 Each 10ml: containing 0.1g doxofylline, adjust isotonicity with sodium chloride

[0023] Labeled prescription:

[0024] Doxofylline 100g

[0025] Sodium chloride 81g

[0026] Add water to 10000ml

[0027] - - - - - - - - - - - - - - - - - - -

[0028] Make 1000 sticks

[0029] Take 6000ml of water for injection, heat up, and add 115g of doxofylline under stirring (the amount of doxofylline absorbed by activated carbon is 15%, so add 15 grams more than the prescription amount, the following is for convenience of description, no longer note) and chlorination Sodium 81g, when the temperature of the liquid rises to about 80°C, add 5g of activated carbon after the powder is completely dissolved, continue stirring for 10 minutes, wait for the temperature to drop to 40°C, filter to remove carbon, and obtain a concentrated solution. Take the concentrated solution and add water for injection to make up to 10000ml, stir evenly, filter through a microporous membrane...

Embodiment 2

[0030] Example 2 Each 10ml: containing 0.1g doxofylline, adjust isotonicity with glucose

[0031] Labeled prescription:

[0032] Doxofylline 100g

[0033] Glucose 450g

[0034] Add water to 10000ml

[0035] - - - - - - - - - - - - - - - - - - - -

[0036] Make 1000 sticks

[0037] Take 6000ml of water for injection, heat up, add 115g of doxofylline and 450g of glucose under stirring, wait until the temperature of the liquid rises to about 80°C, add 5g of activated carbon after the medicine powder is completely dissolved, continue stirring for 10 minutes, wait until the temperature drops to 40°C, Filtrate to remove charcoal to obtain a concentrated solution. Take the concentrated solution and add water for injection to make up to 10000ml, stir evenly, and filter through a microporous membrane until the clarity is qualified, then take a sample to check the content and pH value. The content should be 95-105% of the labeled amount, and the pH value should be 4.5-5.5. Put it...

Embodiment 311

[0038] The preparation method of embodiment 311 is the same as that of embodiment 1 or 2, the difference is the consumption of doxofylline, the consumption and type of isotonic agent

[0039] Example 3

[0040] Example 7

[0041] The beneficial effects of the present invention will be further illustrated by test examples below.

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PUM

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Abstract

The invention discloses Doxofylline venous injection with a small volume and a preparation method thereof. The preparation unit of the isotonic small volume of doxofylline venous injection is 1-20ml,the weight percentage concentration of doxofylline is 1-4 percent, and the isotonic value of the venous injection is 257-340mosmol / kg. The invention enlarges the optional range of clinical applicationof doxofylline and provides the isotonic doxofylline venous injection with favorable security.

Description

technical field [0001] The invention relates to a small volume intravenous injection of doxofylline, in particular to an isotonic small volume injection of doxofylline and a preparation method thereof. Background technique [0002] Doxofylline is a xanthine anti-asthma drug. In the 1980s, it was listed by the Italian ABC company. The dosage forms listed abroad include small-volume injections, tablets and syrups. Among them, the use of small-volume injections is intravenous drip after dilution, and there is no way of intravenous injection. [0003] In China, in 2000, Heilongjiang Huaxing Pharmaceutical Group Co., Ltd. developed and marketed doxofylline injection (large volume and small volume), tablets, and later developed various dosage forms such as sustained-release capsules, granules, and oral solutions. , the listing of the above dosage forms has greatly enriched the clinical administration forms of doxofylline. However, for the treatment of asthma, the most clinically...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/52A61K47/26A61K47/10A61K47/02A61K47/36A61P11/06G01N13/04
Inventor 吴光彦
Owner HEILONGJIANG FUHE HUAXING PHARMA GROUP
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