Phenoduopan methanesulphonate medicinal composition and its preparation

A technology of fenoldopam mesylate and composition, which is applied in the direction of drug combination, active ingredient of heterocyclic compounds, powder delivery, etc., can solve problems such as the development and reporting of powder for injection without fenoldopam mesylate, Achieve the effect of being conducive to storage and transportation, stable quality and high safety

Inactive Publication Date: 2007-12-26
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] There is no report on the development of fenoldopam mesylate injection powder at home and abroad

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Under clean conditions, suspend 6.5 grams of fenoldopam mesylate in 800 ml of water for injection, saturate with nitrogen, add 1 gram of acetylcysteine, stir to dissolve the drug completely, and then add 15.7 grams of dihydrogen phosphate Sodium and 40 grams of mannitol were stirred and dissolved, added 0.3% needle and stirred evenly with charcoal to absorb the pyrogen, filtered to decarbonize, added water to 1000 ml, filtered through a 0.22 micron microporous membrane, and packed in 2 ml into sterile vials. The fenoldopam mesylate freeze-dried powder injection containing 10 mg of fenoldopam per bottle is prepared according to the freeze-drying process.

Embodiment 2

[0023] Under clean conditions, suspend 3.75 g of fenoldopam mesylate in 800 ml of water for injection, add 0.4 g of citric acid and stir to dissolve the drug completely, add 2.7 g of sodium dihydrogen phosphate and 60 g of mannitol and stir to dissolve, Add 0.3% needle charcoal and stir evenly to absorb pyrogen, filter to remove carbon, add water to 1000 ml, filter through 0.22 micron microporous membrane, pack 4 ml into sterile vials, and prepare each bottle according to the freeze-drying process Fenoldopam mesylate lyophilized powder injection containing 10 mg of fenoldopam.

Embodiment 3

[0025] Under clean conditions, suspend 13 grams of fenoldopam mesylate in 800 ml of water for injection, add 4 grams of acetylcysteine ​​and stir to dissolve the drug completely, add 67.4 grams of sodium dihydrogen phosphate, and 0.45 grams of sodium metabisulfite Stir and dissolve with 40 grams of mannitol, add 0.3% needles and stir evenly with charcoal to absorb pyrogens, filter and decarbonize, add water to 1000 ml, filter through a 0.22 micron microporous membrane, pack 2 ml into sterile vials, press The fenoldopam mesylate freeze-dried powder injection containing 20 mg of fenoldopam in each bottle is obtained by freezing and preparing.

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PUM

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Abstract

A freeze-dried powder injection of fenoldopam methylsulfonate as the D1-type dopamine receptor excitomotor is prepared from fenoldopam methylsulfonate, the pharmacologically acceptable acidic substance through preparing clear solution and freeze drying.

Description

technical field [0001] The invention relates to a new drug dosage form of a D1 dopamine receptor agonist, in particular to a fenoldopam mesylate freeze-dried powder injection and a preparation method thereof. Background technique [0002] Fenoldopam Mesylate (Fenoldopam Mesylate) is a D1-like dopamine receptor agonist and a fast-acting vasodilator with the chemical name 6-chloro-2,3,4,5-tetrahydro-1 -(4-Hydroxyphenyl)-[1H]-3-benzazepine-7,8-diol methanesulfonate. [0003] Fenoldopam mesylate has a clear vasodilator effect, and is clinically used for emergency treatment of hypertension, and can also be used for short-term (within 4 hours) reduction of blood pressure in pediatric patients in the hospital. The clinical usage is to use 0.9% sodium chloride injection or 5% glucose injection to dilute to 40 micrograms / ml of fenoldopam solution and inject it intravenously. [0004] At present, Abbott's fenoldopam mesylate injection (trade name: Corlopam, concentration of 10 mg / ml...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/55A61K9/19A61P9/08A61P9/12
Inventor 高缘张建军
Owner CHINA PHARM UNIV
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