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Cobamamide freeze-drying preparation composition for injection and preparation method of cobamamide freeze-drying preparation composition

An injection composition, the technology of adenosylcobalamin, applied in the field of medicine, achieves the effect of stable quality and reducing the production of adenosylcobalamin impurities

Active Publication Date: 2022-05-27
李宏 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The stability of the lyophilized preparation of adenosylcobalamin for injection needs to be further improved

Method used

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  • Cobamamide freeze-drying preparation composition for injection and preparation method of cobamamide freeze-drying preparation composition
  • Cobamamide freeze-drying preparation composition for injection and preparation method of cobamamide freeze-drying preparation composition
  • Cobamamide freeze-drying preparation composition for injection and preparation method of cobamamide freeze-drying preparation composition

Examples

Experimental program
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preparation example Construction

[0054] The above-mentioned preparation method of adenosylcobalamin for injection, wherein the weight ratio is preferably: 1 part by weight of adenosylcobalamin and 20-80 parts by weight of excipients; more preferably: 1 part by weight of adenosine Cobalamin and 40-60 parts by weight of excipients.

[0055] In the above-mentioned preparation method of adenosylcobalamin for injection, it is strictly forbidden to use the activated carbon adsorption and filtration step in the preparation process, that is, the above-mentioned preparation method does not include the activated carbon adsorption and filtration step.

[0056] The preparation method of above-mentioned adenosylcobalamin for injection, the prescription also includes pH regulator, specifically can be phosphate, citrate, carbonate, acetate, borate, hydrochloric acid, phosphoric acid, sodium hydroxide etc. One or more of them, preferably hydrochloric acid and sodium hydroxide.

[0057] The preparation method of above-mentio...

Embodiment 1

[0287] The present embodiment provides a kind of adenosylcobalamin for injection, and the prescription is as follows:

[0288]

[0289] Preparation:

[0290] 1) The whole preparation process is carried out under the condition of red light and light intensity of 100LX;

[0291] 2) Add the trehalose in the recipe amount to an appropriate amount of water for injection at 50°C, and stir to dissolve;

[0292] 3) Add the adenosylcobalamin of the recipe quantity, stir to dissolve;

[0293] 4) Dilute to volume with water for injection at 50°C, and adjust pH to 6.5 with NaOH;

[0294] 5) After the medicinal liquid is sterilized and filtered through a 0.22 μm filter element, 0.5 mL of the filtrate is taken and filled in a brown vial;

[0295] 6) Pre-freezing: put the sample into the freeze-drying box, lower the temperature to below -35°C, and keep the temperature for 2 hours;

[0296] 7) sublimation: vacuumize the freeze-drying box to 15Pa, slowly heat up to 5°C, and keep warm fo...

Embodiment 2

[0299] The present embodiment provides a kind of adenosylcobalamin for injection, and the prescription is as follows:

[0300]

[0301] The preparation method is the same as in Example 1.

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Abstract

The invention belongs to the technical field of medicines, and particularly relates to a cobamamide freeze-drying preparation composition for injection and a preparation method thereof. The composition comprises cobamamide and a protective agent, or further comprises at least one optional pH regulator; the protective agent is selected from one or a combination of several of cane sugar, dextran and trehalose. The freeze-dried composition provided by the invention can effectively reduce the generation of cobamamide impurities, is stable in quality, can be stably stored for a long time, and can be blended into any concentration according to clinical requirements.

Description

technical field [0001] The invention relates to a freeze-dried powder injection and a preparation method thereof, in particular to a freeze-dried preparation composition of adenosylcobalamin for injection and a preparation method thereof, belonging to the technical field of medicine. 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 an 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 ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/714A61K47/26A61P3/02A61P7/06A61P25/00A61P25/02A61J3/02
CPCA61K31/714A61K9/19A61K47/26A61P3/02A61P25/00A61P7/06A61P25/02A61J3/02
Inventor 陈沛单李宏高山
Owner 李宏
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