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Phenoduopan methanesulphonate medicinal composition and its preparation

A technology of fenoldopam mesylate and its composition, which is applied in the direction of active ingredients of heterocyclic compounds, freeze-dried transportation, powder transportation, etc., and can solve the problems of development and reporting of fenoldopam mesylate-free injection powder , to achieve the effect of being conducive to storage and transportation, stable quality and high safety

Inactive Publication Date: 2006-09-13
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 milliliters of water for injection, ventilate with nitrogen, add 1 gram of acetylcysteine, stir to dissolve the drug completely, and then add 15.7 grams of diphosphate Sodium hydrogen and 40 grams of mannitol are stirred and dissolved, add 0.3% needle and stir evenly with charcoal to absorb the pyrogen, filter to decarbonize, add water to 1000 ml, filter through a 0.22 micron microporous membrane, and pack 2 ml into sterile vials , prepared according to the freeze-drying process to obtain fenoldopam mesylate freeze-dried powder injection containing 10 mg of fenoldopam per bottle.

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 milliliters of water for injection, add 4 grams of acetylcysteine ​​and stir to dissolve the drug completely, add 67.4 grams of sodium dihydrogen phosphate, 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 per bottle was prepared by freeze-drying process.

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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 Applications(China)
IPC IPC(8): A61K31/55A61K9/19
Inventor 高缘张建军
Owner CHINA PHARM UNIV
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