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A kind of adenosylcobalamin compound and its pharmaceutical composition

A technology of adenosylcobalamin and composition, which is applied in the field of pharmaceutical compositions containing the adenosylcobalamin, which can solve the problems of uneven and fine sample appearance, poor preparation stability, complex process, etc., and achieve uniform and fine appearance , improved stability and good resolubility

Inactive Publication Date: 2016-08-24
CHANGSHA BOYA MEDICINE TECH DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For example: Chinese Patent Application No. 201310350844.4 discloses a freeze-dried powder preparation of adenosylcobalamin, including adenosylcobalamin, dextran 40, mannitol, and sodium chloride, and its dosage is 1g:10g:10~30g:10 ~30g, the adenosylcobalamin freeze-dried powder prepared by this patent has many kinds of excipients, and its appearance is good, but the dextran 40 needs to be dissolved in hot water, the process is complicated, and it needs to be cooled to below zero during the freeze-drying process 70 ℃, and then sublimation, the energy consumption is too high, more importantly, there are reports in the literature (Japan Pharmaceutical Additives Association. Japanese Pharmaceutical Additives. 2007 Edition [S]. Japan: Yaoji Daily, 2007.) Dextran The maximum dosage of 40 intramuscular injection is 5.1mg per day. If the method of use is three times a day, one each time, the dosage of dextran 40 will greatly exceed the safe dosage range
[0007] Chinese Patent Application No. 201310245278.0 discloses a lyophilized preparation of adenosylcobalamin for injection. Its components include adenosylcobalamin and mannitol, and its dosage is 0.52g:25g. The lyophilized powder injection uses relatively few excipients , but the appearance of the sample prepared according to this patent is not uniform and delicate, and the stability of the preparation is not very good, requiring very strict storage conditions

Method used

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  • A kind of adenosylcobalamin compound and its pharmaceutical composition
  • A kind of adenosylcobalamin compound and its pharmaceutical composition
  • A kind of adenosylcobalamin compound and its pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] Preparation of adenosylcobalamin compound:

[0054] (1) Add 50 g of adenosylcobalamin solid into 150 mL of a mixed solvent of isopropanol and pyridine, the volume ratio of isopropanol and pyridine in the mixed solvent is 4.0:1.0, and dissolve the adenosylcobalamin solid at room temperature;

[0055] (2) Add 800mL ether to the solution obtained in step (1), while stirring, the stirring rate is controlled at 1600r / min;

[0056] (3) After adding diethyl ether, cool down to -10°C within 5 minutes, and stand at -10°C for 11 hours to precipitate crystals, filter, and wash the filter cake twice with ether (150mL each time). After drying under vacuum for 4 hours, adenosylcobalamin crystalline compound was obtained.

[0057] The adenosylcobalamin compound uses Cu-Kα 1 X-ray powder diffraction for radiographic measurements such as figure 1 shown.

Embodiment 2

[0059] Preparation of adenosylcobalamin compound:

[0060] (1) Add 50 g of adenosylcobalamin solid into 150 mL of a mixed solvent of isopropanol and pyridine, the volume ratio of isopropanol and pyridine in the mixed solvent is 5.0:1.0, and dissolve the adenosylcobalamin solid at room temperature;

[0061] (2) Add 500mL ether to the solution obtained in step (1), while stirring, the stirring rate is controlled at 1800r / min;

[0062] (3) After adding ether, cool down to -15°C within 3 minutes, and let it stand at -15°C for 10 hours to precipitate crystals, filter, and wash the filter cake twice with ether (150mL each time). After drying under vacuum for 3 hours, adenosylcobalamin crystalline compound was obtained.

[0063] The adenosylcobalamin compound uses Cu-Kα 1 Radiographic X-ray powder diffraction showed that, with the attached figure 1 The results shown match.

Embodiment 3

[0065] Preparation of adenosylcobalamin compound:

[0066] (1) Add 50 g of adenosylcobalamin solid into 150 mL of a mixed solvent of isopropanol and pyridine, the volume ratio of isopropanol and pyridine in the mixed solvent is 2.0:1.0, and dissolve the adenosylcobalamin solid at room temperature;

[0067] (2) add 600mL ether in the solution that step (1) obtains, stir simultaneously, stirring rate is controlled at 1500r / min;

[0068] (3) After adding ether, cool down to -10°C within 6 minutes, and stand at -10°C for 10 hours to precipitate crystals, filter, and wash the filter cake twice with ether (150mL each time), at a temperature of 35°C After drying under vacuum for 2 hours, adenosylcobalamin crystalline compound was obtained.

[0069] The adenosylcobalamin compound uses Cu-Kα 1 Radiographic X-ray powder diffraction showed that, with the attached figure 1 The results shown match.

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Abstract

The invention discloses an adenosylcobalamin compound, the X-ray powder diffraction of which is shown in Figure 1. The invention also discloses the pharmaceutical composition of the adenosylcobalamin compound. The chemical property of the adenosylcobalamin of the present invention is stable, the compound has good stability, and can have a stronger effect in treating neurological diseases. Moreover, the adenosylcobalamin composition of the present invention has simple components and good safety, and the prepared adenosylcobalamin for injection has a uniform and delicate freeze-drying property, good resolubility and good stability.

Description

technical field [0001] The invention relates to an adenosylcobalamin compound, a preparation method of the adenosylcobalamin compound, and a pharmaceutical composition containing the adenosylcobalamin compound. Background technique [0002] Adenosylcobalamin (Cobamamide) is a cyanocobalamin-type vitamin B 12 Congeners of B 12 The metabolites in the body are substances necessary for cell growth and proliferation and to maintain the integrity of nerve myelin sheaths. Compared with vitamin B 12 It has higher biological activity and bioavailability, and can be directly absorbed and utilized by the human body. Adenosylcobalamin has strong activity, strong affinity with tissue cells, and has a long retention in the body. It is an important coenzyme for cell synthesis of nucleotides and participates in methyl conversion and folic acid metabolism in the body. It promotes the reduction of methyl folic acid to tetrahydrofolate, and also participates in The tricarboxylic acid cycle ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07H23/00C07H1/00A61K31/714A61K9/19A61P25/02A61P27/02A61P3/10
Inventor 蒋银妹
Owner CHANGSHA BOYA MEDICINE TECH DEV
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