Milrinone pharmaceutical composition and preparation method thereof

A technology of composition and pesticide, applied in the field of milrinone pharmaceutical composition and its preparation, can solve problems affecting product quality, increasing production cost, etc.

Inactive Publication Date: 2016-06-15
YANGZIJIANG PHARMA GROUP SHANGHAI HAINI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Excessive feeding causes a large increase in production costs, and while activated carbon ad

Method used

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  • Milrinone pharmaceutical composition and preparation method thereof
  • Milrinone pharmaceutical composition and preparation method thereof
  • Milrinone pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] prescription composition

[0033]

[0034] Preparation Process

[0035] ⑴ Concentrated

[0036] First weigh 1 g of milrinone, add 2.56 g of L-lactic acid (calculated as dry weight of lactic acid), and stir at 70°C for 5 minutes to fully dissolve milrinone in L-lactic acid to form milrinone lactic acid.

[0037] Then add an appropriate amount of water for injection at 70°C, add 9.0g of sodium chloride, and after stirring thoroughly, add water for injection to 800ml.

[0038] ⑵ Depyrogenation

[0039] A hollow fiber membrane column made of polyvinylidene fluoride with a molecular weight cut-off range of 6000 Daltons is used for ultrafiltration.

[0040] ⑶ rare match

[0041] Add water for injection to 1000ml, and use L-lactic acid solution to adjust the pH value of the liquid to within the range of 2.8 to 3.4. Check the intermediate, and fine filter through a 0.2μm filter membrane after passing the test.

[0042] ⑷ Filling

[0043] The fine filtrate is filled in...

Embodiment 2

[0047] prescription composition

[0048]

[0049] Preparation Process

[0050] ⑴ Concentrated

[0051]A Weigh 1 g of milrinone, add 2.9 g of L-malic acid, and stir at 70°C for 5 min to fully dissolve milrinone in L-lactic acid to form milrinone malate.

[0052] B Add an appropriate amount of water for injection at 70°C, add 9.0g of sodium chloride, and stir thoroughly, then add water for injection to 800ml.

[0053] ⑵ Depyrogenation

[0054] A hollow fiber membrane column made of polyvinylidene fluoride with a molecular weight cut-off range of 6000 Daltons is used for ultrafiltration.

[0055] ⑶ rare match

[0056] Add water for injection to 1000ml, and use L-lactic acid solution to adjust the pH value of the liquid to within the range of 2.8 to 3.4. Check the intermediate, and fine filter through a 0.2μm filter membrane after passing the test.

[0057] ⑷ Filling

[0058] The fine filtrate is filled into ampoules with a specification of 5ml or 10ml.

[0059] ⑸ Steri...

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PUM

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Abstract

The invention discloses a milrinone pharmaceutical composition. Either L-lactic acid or L-malic acid is used as a cosolvent and a pH value regulator, and an ultra-filtration method is adopted for filtering. The milrinone pharmaceutical composition provided by the invention can improve hyperchloremia caused by excessive Cl- and the like generated from the adoption of inorganic acid and can improve metabolic disorders and even acidosis caused by D-lactic acid or lactic acid. The process for preparing the milrinone pharmaceutical composition provided by the invention is simple to operate and is capable of improving medication safety.

Description

technical field [0001] The invention relates to a pharmaceutical composition, in particular to a milrinone pharmaceutical composition containing an organic acid and a preparation method thereof. Background technique [0002] Milrinone is a synthetic second-generation PDEⅢ inhibitor with the chemical name of 2-methyl-6-oxyl-1,6-dihydro-(3,4′-bipyridine)-5-methanol Nitrile, a bipyridine derivative of amrinone. It is clinically suitable for acute and chronic refractory congestive heart failure caused by various reasons that are ineffective or ineffective in digitalis, diuretics, and vasodilators. The mechanism of action is the same as that of amrinone, both oral and intravenous injection are effective, and it has both positive inotropic effect and vasodilator effect. But its effect is 10 to 30 times stronger than amrinone. Well tolerated. The positive inotropic effect of milrinone is mainly through the inhibition of phosphodiesterase, which increases the concentration of cy...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/444A61K47/14A61P9/04
Inventor 郑璐吴斌李玲玲姚书扬高苇叶龙王文丰蔡秋莲
Owner YANGZIJIANG PHARMA GROUP SHANGHAI HAINI PHARMA
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