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A kind of milrinone lactate composition

A technology of lactic acid milrinone and a composition, applied in the field of medicine, can solve the problems of complex preparation method of lactic acid milrinone freeze-dried powder injection, unsuitable for large-scale industrial production, long production cycle, etc., and is suitable for large-scale production. , The effect of low production cost and low content of related substances

Active Publication Date: 2019-03-05
HAINAN HERUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The preparation method of the milrinone lactate freeze-dried powder injection of the present application is complex, the production cycle is long, the preparation conditions are strict, and the cost is high, so it is not suitable for large-scale industrial production

Method used

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  • A kind of milrinone lactate composition
  • A kind of milrinone lactate composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] The preparation of embodiment 1 milrinone crystal

[0034] (1) Mix and dissolve the crude milrinone, ethanol, acetone and water at a mass volume ratio of 7g: 83ml: 57ml: 105ml, slowly heat to 94°C, fully stir and dissolve evenly;

[0035] (2) add active carbon decolouring 4.5 hours then, the quality of active carbon is 8% of milrinone crude product, suction filtration while hot, remove active carbon;

[0036] (3) The solution obtained by suction filtration was stirred at a stirring rate of 6 rpm, cooled to 34° C., and the cooling rate was 2° C. / min. When the filtrate was lowered to room temperature, deionized water was added dropwise to it under an ultrasonic field, until the crystals are precipitated;

[0037] (4) Turn off the ultrasonic field, let stand for 27 hours, filter, wash with ethanol, and dry to obtain the milrinone crystals.

[0038] The obtained milrinone crystal uses Cu-Kα ray to measure the X-ray powder diffraction spectrum that obtains as figure 1 sho...

Embodiment 2

[0039] The preparation of embodiment 2 milrinone crystals

[0040] (1) Mix and dissolve the crude milrinone, ethanol, acetone and water at a mass volume ratio of 6g: 80ml: 55ml: 100ml, slowly heat to 90°C, stir well and dissolve evenly;

[0041] (2) Then add activated carbon for decolorization for 4 hours, the quality of activated carbon is 7% of the crude product of milrinone, suction filtration while hot, removes activated carbon;

[0042](3) The solution obtained by suction filtration was stirred at a stirring rate of 5 rpm, cooled to 32° C., and the cooling rate was 2° C. / min. When the filtrate was lowered to room temperature, deionized water was added dropwise thereto under an ultrasonic field, until the crystals are precipitated;

[0043] (4) Turn off the ultrasonic field, let stand for 26 hours, filter, wash with ethanol, and dry to obtain the milrinone crystals.

[0044] The X-ray powder diffraction spectrum obtained by measuring the obtained milrinone crystals using...

Embodiment 3

[0046] (1) Mix and dissolve the crude milrinone, ethanol, acetone and water at a mass volume ratio of 8g: 85ml: 60ml: 110ml, slowly heat to 98°C, fully stir and dissolve evenly;

[0047] (2) add activated carbon decolouring 5 hours then, the quality of activated carbon is 9% of milrinone crude product, suction filtration while hot, removes activated carbon;

[0048] (3) The solution obtained by suction filtration was stirred at a stirring rate of 9 rpm, cooled to 35° C., and the cooling rate was 3° C. / min. When the filtrate was lowered to room temperature, deionized water was added dropwise thereto under an ultrasonic field, until the crystals are precipitated;

[0049] (4) Turn off the ultrasonic field, let stand for 28 hours, filter, wash with ethanol, and dry to obtain the milrinone crystals.

[0050] The X-ray powder diffraction spectrum obtained by measuring the obtained milrinone crystals using Cu-Kα rays is basically consistent with that of Example 1.

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Abstract

The invention discloses a milrinone lactate composition. The milrinone lactate composition consists of milrinone, lactic acid, sodium chloride, vitamin E and glutathione. The invention also provides a novel milrinone crystal. The milrinone lactate composition, which is prepared from the milrinone crystal, is relatively good in stability, good in clarifying transparency after being preserved for a long time and low in content of related materials, and a preparation method is simple, low in production cost and applicable to large-scale production; and the milrinone lactate composition provided by the invention, which is added with the vitamin E and the glutathione, can take a better effect on treating cardiac failure.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a milrinone lactate composition. Background technique [0002] Milrinone is a new type of non-cardiac glycoside, non-catecholamine cardiotonic drug, and is a therapeutic agent for congestive heart failure developed by Sterling Company of the United States. The chemical name of milrinone is 2-methyl-6 oxygen-1, 6-dihydro-3,4'bipyridine-5carbonitrile is a phosphodiesterase inhibitor, and it is a drug of the same class as amrinone. Its mechanism of action is the same as that of amrinone. Sexual inotropic effect and vasodilator effect, but its effect is 10-30 times stronger than amrinone. [0003] Milrinone is mainly suitable for short-term intravenous administration of congestive heart failure. New research shows that milrinone can also be used for cardiopulmonary bypass low cardiac output syndrome, relieve bypass vasospasm, and improve cardiac function in patients wi...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K9/08A61K31/444A61K38/06A61K47/18A61K47/22A61P9/04C07D213/85A61K31/355
CPCA61K9/0019A61K9/08A61K9/19A61K31/355A61K31/444A61K38/06A61K47/183A61K47/22C07D213/85A61K2300/00
Inventor 钟正明
Owner HAINAN HERUI PHARMA
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