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A kind of adenosylcobalamin freeze-dried preparation composition and preparation method thereof

A technology for adenosylcobalamin and freeze-dried preparations, which is applied in the field of pharmaceutical preparations and achieves the effects of low content of related substances, high stability and low dosage of auxiliary materials

Active Publication Date: 2019-05-14
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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  • A kind of adenosylcobalamin freeze-dried preparation composition and preparation method thereof
  • A kind of adenosylcobalamin freeze-dried preparation composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] Example 1 Freeze-dried preparation composition of adenosylcobalamin for injection of the present invention

[0053] prescription:

[0054] Adenosylcobalamin 505mg,

[0055] Mannitol 25g,

[0056] Isoamyl acetate 0.5mg,

[0057] Sodium metabisulfite 0.2mg,

[0058] Water for injection was added to 500ml.

[0059] Preparation:

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

[0061] 2) Add activated carbon with 0.5% prepared volume for adsorption for 30 minutes and filter;

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

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

[0064] 5) Use 0.22μm filter membrane to sterile filter, divide into 1000 vials, freeze-dry, crimp cap, an...

Embodiment 2

[0069] Example 2 Freeze-dried preparation composition of adenosylcobalamin for injection of the present invention

[0070] prescription:

[0071] Adenosylcobalamin 505mg,

[0072] Mannitol 25g,

[0073] Isoamyl acetate 0.7mg,

[0074] Sodium metabisulfite 1.0mg,

[0075] Water for injection was added to 500ml.

[0076] Preparation:

[0077] Same as Example 1.

Embodiment 3

[0078] Example 3 Freeze-dried preparation composition of adenosylcobalamin for injection of the present invention

[0079] prescription:

[0080] Adenosylcobalamin 505mg,

[0081] Mannitol 25g,

[0082] Isoamyl acetate 1.0mg,

[0083] Sodium metabisulfite 2.0mg,

[0084] Water for injection was added to 500ml.

[0085] Preparation:

[0086] Same as Example 1.

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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 freeze-dried preparation composition of adenosylcobalamin for injection and a preparation method thereof. Background technique [0002] Adenosylcobalamin (Cobamamide) is a congener of cyanocobalt-type vitamin B12. It is one of the two active coenzyme forms of vitamin B12 in the body. It is an important coenzyme for cell synthesis of nucleotides and participates in methyl conversion and folic acid metabolism. Promotes the reduction of methylfolate to tetrahydrofolate; also participates in the tricarboxylic acid cycle, which is very important for the formation of lipoproteins in the 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, which is a necessary factor for the complete formation of nerv...

Claims

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Application Information

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Patent Type & Authority Patents(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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