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Milrinone lyophilized powder for injection and preparation method thereof

A technology for freeze-dried powder and injection, applied in the field of milrinone freeze-dried preparations and its preparation, can solve the problem that the stability of water injection is not as stable as that of freeze-dried powder injection, and achieve fine frozen crystals, good stability, and fast dissolution Effect

Inactive Publication Date: 2006-12-20
SHANGHAI SINE PHARMA LAB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] There are loading dose and maintenance dose, and it is controlled according to body weight and infusion rate, so the amount of milrinone required by different groups of people is different; in addition, although there is milrinone injection (5ml: 5mg) on ​​the market , can be diluted with glucose or sodium chloride before use, but the stability of this variety of water injection is not as stable as freeze-dried powder injection

Method used

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  • Milrinone lyophilized powder for injection and preparation method thereof

Examples

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Comparison scheme
Effect test

example 1

[0030] Example 1. (1000 pieces)

[0031] Milrinone 5g

[0032] Mannitol 50g

[0033] Adjust pH to 2.5 with lactic acid or sodium hydroxide

[0034] Add water for injection to 1000ml

[0035] Dissolve milrinone in 750ml of water for injection, add lactic acid or sodium hydroxide to adjust the pH to 2.5, and sonicate for 20 minutes until it is completely dissolved. Then add mannitol and stir for 20 minutes to fully dissolve. Add water for injection to full volume. Then filter with a sterilizing filter, fill in a control antibiotic glass bottle, stopper the plate and put it in a freeze dryer. Pre-freezing: Put the subpackaged medicines on the inner partition of the freeze-drying box for pre-freezing, and keep the product temperature for 2 hours after the temperature drops to -40°C. Sublimation stage: When the vacuum degree in the drying box reaches below 13.33Pa (0.1mmg column), turn off the freezer, heat slowly through the partition, and properly heat the partition to -12°...

Embodiment 3～4

[0036] Embodiment 3~4 (1000)

[0037] Milrinone 20g

[0038] Glucose 600g

[0039] Adjust pH to 3.0 with lactic acid or sodium hydroxide

[0040] Add water for injection to 6000ml

[0041] Dissolve the prescribed amount of milrinone in 4500ml of water for injection, add an appropriate amount of lactic acid or sodium hydroxide to adjust the pH to 3.0, and sonicate for 20 minutes until it is completely dissolved. Then add glucose, stir for 20min to fully dissolve. Add water for injection to full volume. Then filter with a sterilizing filter, fill in a control antibiotic glass bottle, stopper the plate and put it in a freeze dryer. Pre-freezing: Put the subpackaged medicines on the inner partition of the freeze-drying box for pre-freezing, and keep the product temperature for 3 hours after dropping to -40°C. Sublimation stage: When the vacuum degree in the drying box reaches below 13.33Pa (0.1mmg column), turn off the freezer, heat slowly through the partition...

Embodiment 5～6

[0042] Embodiment 5~6 (1000)

[0043] Milrinone 1g

[0044] Mannitol 40g

[0045] Adjust pH to 2.7 with lactic acid or sodium hydroxide

[0046] Add water for injection to 400ml

[0047] Dissolve the prescribed amount of milrinone in 3 / 4 volume of water for injection, add appropriate amount of lactic acid or sodium hydroxide to adjust the pH value to 2.7, and sonicate for 20 minutes until completely dissolved. Then add mannitol and stir for 20 minutes to fully dissolve. Add water for injection to full volume. Then filter with a sterilizing filter, fill in a control antibiotic glass bottle, stopper the plate and put it in a freeze dryer. Pre-freezing: Put the subpackaged medicines on the inner partition of the freeze-drying box for pre-freezing, and keep the product temperature for 2 hours after the temperature drops to -40. Sublimation stage: When the vacuum degree in the drying box reaches below 13.33Pa (0.1mmg column), turn off the freezer, heat slow...

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Abstract

The invention relates to an injection Milrinone freeze powder and relative preparation, which is characterized in that: it comprises active Milrinone and pH adjuster; the content of pH adjuster can make the pH value before freezing the powder at 2.5-3.0. The invention can make frozen product with fine crystal, and quick soluble speed, with uniform component and better stability.

Description

technical field [0001] The invention relates to a milrinone preparation, in particular to a milrinone freeze-dried preparation and a preparation method thereof. Background technique [0002] The milrinone compound was first invented by Stering Drug Company, and its injection was first launched in the United States in 1987 under the trade name PRIMACOR  . Its chemical name, 2-methyl-6-oxo-1,6-dihydro-[3,4'bipyridine]-5formonitrile, its structural formula is: [0003] [0004] English name: Milrinone For Injection [0005] Molecular formula: C 12 h 9 N 3 o [0006] Molecular weight: 211.22 [0007] Milrinone is a phosphodiesterase inhibitor, a drug of the same class as amrinone, and its mechanism of action is the same as that of amrinone. Oral and intravenous injection are effective, 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 ...

Claims

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Application Information

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IPC IPC(8): A61K31/444A61K9/19A61P9/04
Inventor 陈佩丽谭颖朱正鸣乌旭琼雷仕庆
Owner SHANGHAI SINE PHARMA LAB
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