Milrinone lactate injection and preparation method thereof

A technology for milrinone lactate and injections, which is applied in the direction of pharmaceutical formulas, medical preparations with no active ingredients, medical preparations containing active ingredients, etc., and can solve problems such as poor stability and clarity

Active Publication Date: 2012-07-18
北京六盛合医药科技有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In order to solve the problem of poor stability and clarity when lactic acid is used to aid dissolution, the optimal dose of vitamin C and meglumine is added, and the effect is ideal

Method used

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  • Milrinone lactate injection and preparation method thereof
  • Milrinone lactate injection and preparation method thereof
  • Milrinone lactate injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058]

[0059] * Lactic acid is calculated as dry weight

[0060] Preparation Process

[0061] (1) Preparation: The ampoules, liquid preparation containers, etc. should be cleaned as usual for injections, firstly rough wash and then fine wash. The water for injection in the fine wash should be filtered through a 0.45 μm microporous membrane, then dried and sterilized for later use;

[0062] (2) Weighing: Accurately weigh 1.10g of milrinone raw material, 9.0g of sodium chloride, 1.65g of vitamin C, and 1.1g of meglumine according to the prescription, and mark them for later use;

[0063] (3) Dosing: put milrinone and meglumine in a clean dosing tank, add an appropriate amount of water for injection, and stir to fully dissolve milrinone; add the prescribed amount of sodium chloride and vitamin C with a concentration of 89.5 %, the dosage is 1.61g of lactic acid solution (that is, 1.44g of lactic acid calculated on a dry basis), and water for injection is added to 80% of th...

Embodiment 2

[0071]

[0072] * Lactic acid is calculated as dry weight

[0073] Take the active raw material milrinone and meglumine into a clean liquid preparation tank, add an appropriate amount of water for injection, stir to fully dissolve milrinone; add sodium chloride, vitamin C, lactic acid, and add water for injection to the total volume Then use activated carbon to filter out the pyrogen, adjust the pH of the solution to 2.8-3.5 with lactic acid, add water for injection to 1000mL, subpackage, autoclave, and inspect the package to obtain.

Embodiment 3

[0075]

[0076]

[0077] * Lactic acid is calculated as dry weight

[0078] Take the active raw material milrinone and meglumine into a clean liquid preparation tank, add an appropriate amount of water for injection, stir to fully dissolve milrinone; add sodium chloride, vitamin C, lactic acid, and add water for injection to the total volume Then use activated carbon to filter out the pyrogen, adjust the pH of the solution to 2.8-3.5 with lactic acid, add water for injection to 1000mL, subpackage, autoclave, and inspect the package to obtain.

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PUM

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Abstract

The invention discloses a milrinone lactate injection and a production method thereof. Lactic acid is adopted for assisting in dissolving, and the pH value is adjusted, so that hyperchloremia probably caused by excessively high Cl<-> brought by the adoption of hydrochloric acid and the like for adjusting pH is prevented. Sodium chloride or a balanced salt solution is taken as a carrier isotonic agent. A titration method is adopted for metering strictly. The milrinone lactate injection has a reasonable and simple process flow, and the quality is controllable.

Description

technical field [0001] The invention relates to a milrinone lactate injection and a preparation method thereof, belonging to the technical field of medicines. technical background [0002] Milrinone, whose chemical name is 2-methyl-6-oxo-1,6-dihydro-3,4'bipyridine-5carbonitrile, is a phosphodiesterase inhibitor and is a similar drug to amrinone. The mechanism of action is the same as 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 through the inhibition of phosphodiesterase, which increases the concentration of cyclic adenosine monophosphate (CAMP) in myocardial cells, increases intracellular calcium, strengthens myocardial contractility, and increases cardiac output. It has nothing to do with adrenergic receptors or cardiomyocyte Na+, K+-ATPase. Its vasodilator effect may be caused b...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/444A61K47/22A61K47/26A61K47/12A61K47/04A61P9/04A61P9/08
Inventor 蔡翔
Owner 北京六盛合医药科技有限公司
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