Cobamamide freeze-drying preparation composition for injection and preparing method thereof

A technology for adenosylcobalamin and freeze-dried preparations is applied in the field of pharmaceutical preparations to achieve the effects of less amount of auxiliary materials, low content of related substances and high stability

Active Publication Date: 2016-01-27
HEBEI ZHITONG BIOLOGICAL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In the prior art, CN201010270773.3, 201310245278.0, etc. have carried out some research on adenosylcobalamin freeze-dried preparations, but have not yet provided effective solutions to problems such as stability in adenosylcobalamin freeze-dried preparations

Method used

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  • Cobamamide freeze-drying preparation composition for injection and preparing method thereof
  • Cobamamide freeze-drying preparation composition for injection and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] Embodiment 1 Adenosylcobalamin freeze-dried preparation composition for injection of the present invention

[0053] prescription:

[0054] Adenosylcobalamin 505mg,

[0055] Mannitol 25g,

[0056] Isoamyl acetate 0.5mg,

[0057] Sodium metabisulfite 0.2 mg,

[0058] Add water for injection to 500ml.

[0059] Preparation:

[0060] 1) Add the prescribed amount of mannitol, isoamyl acetate, and sodium metabisulfite to an appropriate amount of water for injection at 45~50°C, and stir to dissolve;

[0061] 2) Add activated carbon with a volume of 0.5% to absorb for 30 minutes and filter;

[0062] 3) Dilute the water for injection to 500ml, lower the temperature of the liquid medicine to 5-9°C, and adjust the pH to 5.5-7.5;

[0063] 4) Add the prescribed amount of adenosylcobalamin, stir until fully dissolved, and adjust the pH to 5.5-7.0;

[0064] 5) Use a 0.22 μm filter membrane to filter aseptically, divide into 1,000 vials, freeze-dry, crimp the cap, and pack.

...

Embodiment 2

[0069] Embodiment 2 Adenosylcobalamin freeze-dried preparation composition for injection of the present invention

[0070] prescription:

[0071] Adenosylcobalamin 505mg,

[0072] Mannitol 25g,

[0073] Isoamyl acetate 0.7mg,

[0074] Sodium metabisulfite 1.0 mg,

[0075] Add water for injection to 500ml.

[0076] Preparation:

[0077] With embodiment 1.

Embodiment 3

[0078] Embodiment 3 Adenosylcobalamin freeze-dried preparation composition for injection of the present invention

[0079] prescription:

[0080] Adenosylcobalamin 505mg,

[0081] Mannitol 25g,

[0082] Isoamyl acetate 1.0 mg,

[0083] Sodium metabisulfite 2.0 mg,

[0084] Add water for injection to 500ml.

[0085] Preparation:

[0086] With embodiment 1.

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PUM

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Abstract

The invention provides a cobamamide freeze-drying preparation composition for injection and a preparing method thereof. The cobamamide freeze-drying preparation composition for injection is prepared from cobamamide, mannitol, isoamyl acetate, sodium pyrosulfite and the like. The cobamamide freeze-drying preparation composition for injection has the advantages of being high in stability, low in related substance content, suitable for industrial production and the like.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a novel adenosylcobalamin freeze-dried preparation composition for injection and a preparation method thereof. Background technique [0002] Adenosylcobalamin (Cobamamide) is the congener of cyanocobalamin-type vitamin B12. It is one of the two active coenzyme forms of vitamin B12 in the body. Promote the reduction of methylfolate to tetrahydrofolate; also participate in the tricarboxylic acid cycle, which is very important for the formation of lipoproteins in nerve myelin, and can make thiol enzymes in a dry active state, thereby participating in a wide range of protein and fat metabolism. Adenosylcobalamin can promote the development and maturation of red blood cells, and is an essential factor for the complete formation of nerve sheaths and spinal cord fibers and the maintenance of epithelial cell functions in the digestive system. The chemical name of ade...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/714A61K47/26A61P25/00A61P3/00A61P1/00
Inventor 夏彤赵兰李金红齐兴忠俞东升郭超张云升
Owner HEBEI ZHITONG BIOLOGICAL PHARMA
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