Pharmaceutical composition containing amrinone and preparation method and application thereof

A composition and amrinone technology, applied in the directions of medical preparations containing active ingredients, medical preparations without active ingredients, drug combinations, etc.

Active Publication Date: 2010-12-29
HAINAN HUALON PHARM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] The purpose of the present invention is to find a reasonable and effective formula and process of amrinone to overcome the problems existing in the existing preparations, expecting to produce small-capacity injection preparations with stable and controllable quality, especially the freeze-dried powder dosage form

Method used

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  • Pharmaceutical composition containing amrinone and preparation method and application thereof
  • Pharmaceutical composition containing amrinone and preparation method and application thereof
  • Pharmaceutical composition containing amrinone and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0081] 1 dosing solution:

[0082] a. Weigh 50.0g of amrinone, 100.0g of mannitol, and 1.5g of sodium metabisulfite in a sterile room, and place them in a liquid mixing tank, add 70% of the liquid for injection (cooled to room temperature), stir, and slowly drop Adjust the pH to 3.50-4.0 with lactic acid, after the adjustment, add water for injection to the full amount, and measure the pH (should be 3.5-4.0).

[0083] b. Add 0.05% (w / v) medicinal charcoal to the solution, stir and adsorb for about 20 minutes, and decarbonize by filtering with a 0.45 μm sterile microporous membrane.

[0084] c. Intermediate product detection (pH and content).

[0085] d. After passing the test, fine filter with a 0.22 μm sterile microporous membrane. According to the content, the filtrate was divided into sterilized 7ml control antibiotic glass bottles (50mg / bottle), and half stoppered.

[0086] 2 freeze-dried

[0087] a. Pre-freezing, put the subpackaged medicine in a freeze-drying box, an...

Embodiment 2

[0101] 1 dosing solution:

[0102] a. Weigh 50.0 g of amrinone, 150.0 g of mannitol, and 2.0 g of sodium metabisulfite in a sterile room according to the prescription amount, place them in a liquid mixing tank, add 70% water for injection (cooled to room temperature), stir, and slowly Add lactic acid dropwise to adjust the pH to 3.20-3.30. After the adjustment, add water for injection to the full amount, and measure the pH (should be 3.20-3.30).

[0103] b. Add 0.05% (w / v) medicinal charcoal to the solution, stir and adsorb for about 20 minutes, and decarbonize by filtering with a 0.45 μm sterile microporous membrane.

[0104] c. Intermediate product detection (pH and content).

[0105] d. After passing the test, fine filter with a 0.22 μm sterile microporous membrane. According to the content, the filtrate was divided into sterilized 7ml control antibiotic glass bottles (50mg / bottle), and half stoppered.

[0106] 2 freeze-dried

[0107] a. Pre-freezing, put the subpackage...

Embodiment 3

[0112] 1 dosing solution:

[0113] a. Weigh 50.0 g of amrinone, 160.0 g of mannitol, and 2.0 g of sodium metabisulfite in a sterile room according to the prescription amount, place them in a liquid mixing tank, add 70% water for injection (cooled to room temperature), stir, and slowly Slowly add lactic acid to adjust the pH to 3.10-3.30. After the adjustment, add water for injection to the full amount, and measure the pH (should be 3.10-3.30).

[0114] b. Add 0.05% (w / v) medicinal charcoal to the solution, stir and adsorb for about 20 minutes, and decarbonize by filtering with a 0.45 μm sterile microporous membrane.

[0115] c. Intermediate product detection (pH and content).

[0116] d. After passing the test, fine filter with a 0.22 μm sterile microporous membrane. According to the content, the filtrate was divided into sterilized 7ml control antibiotic glass bottles (50mg / bottle), and half stoppered.

[0117] 2 freeze-dried

[0118] a. Pre-freezing, put the subpackaged ...

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Abstract

The invention provides a pharmaceutical composition containing amrinone and a preparation method and an application thereof. The composition comprises 1 part of amrinone, 0.5-5 parts of vascular regulator, 0.01-0.1 part of antioxidant, 2-10 parts of stabilizer and a pH regulator, wherein the antioxidant is sodium pyrosulfite, the stabilizer is one or the combination of mannitol and sorbitol, and the vascular regulator is mannitol. The composition is mainly used for preparing medicines for treating cardiovascular and cerebrovascular diseases, cardiac insufficiency and the like.

Description

technical field [0001] The invention relates to pharmaceutical preparations in the field of medicine, in particular to the formulation, preparation process and application of a small-capacity preparation of an injection composition containing amrinone. Background technique [0002] Amrinone, a cardiac drug. [0003] Chemical name: 5-amino-(3,4'-bipyridinium)-6(1H)-one. [0004] Structural formula: [0005] [0006] Molecular weight: 187.20 [0007] Molecular formula: C 10 h 9 N 3 O. [0008] Properties: Pale yellow needle crystal. not soluble in water. Mp.294~297°C (decomposition). [0009] It belongs to the non-catechols in the non-cardiac glycoside positive inotropic drugs. Its function is to inhibit the intracellular phosphodiesterase, increase the intracellular cAMP, and lead to the enhancement of myocardial contractility and vasodilation. Amrinone is a representative of non-catechol phosphodiesterase inhibitor cardiotonic drugs, suitable for short-term trea...

Claims

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Application Information

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Patent Type & AuthorityApplications(China)
IPC IPC(8): A61K31/444A61K31/047A61K9/19A61K47/12A61K47/02A61P9/00A61P9/04A61P9/10
Inventor陈益智
OwnerHAINAN HUALON PHARM