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Milrinone composition for injection and its preparation process

A technology for milrinone and agricultural injections, which is applied in the directions of drug combinations, medical preparations containing active ingredients, and pharmaceutical formulas

Inactive Publication Date: 2008-05-28
ZHEJIANG ZHENYUAN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There is no report on the development of milrinone injection powder at home and abroad

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] Under clean conditions, put 2g of L-aspartic acid into the liquid dispensing device, add 50°C water for injection into 800ml of water for injection and stir to dissolve, cool to room temperature, add 2g of milrinone and stir for about 30 minutes to make it fully dissolved, and put in 40g Dissolve mannitol, add 0.3% needle and stir with charcoal to evenly absorb pyrogen, filter to decarbonize, add water to a sufficient amount, filter through 0.22um microporous membrane to obtain 2 mg / ml milrinone solution. Pack 2.5ml into vials, freeze-dry for 72 hours to make sterile freeze-dried powder injection. The specification is 5mg / bottle.

Embodiment 2

[0054] Dissolve 2g of tartaric acid in 800ml of water for injection in a clean liquid preparation device and stir to dissolve, add 2g of milrinone and stir for about 1 hour to completely dissolve, add 20g of lactose and stir to dissolve, add 0.3% needle and stir evenly with charcoal to absorb pyrogen , decarbonized by filtration, added water to a sufficient amount, and filtered through a 0.22um microporous membrane to obtain a 2 mg / ml milrinone solution. Pack 2.5ml into vials, freeze-dry for 72 hours to make sterile freeze-dried powder injection. The specification is 5mg / bottle.

Embodiment 3

[0056] Under clean conditions, put 2.5g of L-aspartic acid into the liquid dispensing device, add 50°C water for injection into 800ml of water for injection and stir to dissolve, cool to room temperature, add 2.5g of milrinone and stir for about 30 minutes to completely dissolve, Add 50g of mannitol to dissolve, add 0.3% needles and stir with charcoal to evenly absorb pyrogens, filter for decarbonization, add water to a sufficient amount, and filter through a 0.22um microporous membrane to obtain a 2.5mg / ml milrinone solution. Pack 2ml into vials, freeze-dry for 72 hours to make sterile freeze-dried powder injection. The specification is 5mg / bottle.

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PUM

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Abstract

The present invention provides one kind of freeze dried high concentration milrinone powder for injection and its preparation process. The freeze dried milrinone powder for injection contains: milrinone in 2-10 weight portions; pharmaceutically acceptable acid matter, which is L-aspartic acid, tartaric acid, citric acid, glutamic acid or their combination, in the amount of 0.25-4 times weight of milrinone; and pharmaceutically acceptable carrier in 15-100 weight portions. The freeze dried milrinone powder for injection may be dissolved in water to form injection of milrinone in 2-10 mg / ml concentration, and has high stability.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a composition for milrinone injection and a preparation method thereof. Background technique [0002] Milrinone is a phosphodiesterase inhibitor, suitable for acute and chronic refractory congestive heart failure caused by various reasons that are ineffective or ineffective in digitalis, diuretics, and vasodilators. Because milrinone is insoluble in water, the concentration of milrinone injection for clinical application is relatively small, only 1mg / ml, and the commonly used specifications are 5ml: 5mg and 10ml: 10mg, and the volume of the injection solution is relatively large. There is no report on the development of milrinone injection powder at home and abroad. [0003] Therefore, there is an urgent need in this field to develop injections with higher milrinone concentration and preparation methods thereof. Contents of the invention [0004] The purpose of the ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/444A61K9/19A61P9/04
Inventor 任秉钧张建军章明鹊徐小佩
Owner ZHEJIANG ZHENYUAN PHARMA CO LTD
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