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Preparation method of cobamamide lyophilized preparation for injection

A technology for adenosylcobalamin and freeze-dried preparations, which is applied in the field of preparation of adenosylcobalamin freeze-dried preparations for injection, and can solve problems such as stabilizer human health hazards, poor control of light-proof conditions, and unsatisfactory product stability. , to improve the stability of the

Inactive Publication Date: 2012-03-21
NORTH CHINA PHARMA COMPANY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, since it is impossible for operators to work in a completely dark environment, and the dark conditions are not easy to control, the stability of the product is still not ideal even with the addition of stabilizers
Furthermore, the stabilizer will bring potential hazards to human health.

Method used

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  • Preparation method of cobamamide lyophilized preparation for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] Under a 50 lux red light, weigh an appropriate amount of adenosylcobalamin 1000mg and mannitol 30000mg, add it to water filled with nitrogen, stir to dissolve it, add 0.1% (g / ml) activated carbon, stir, take a sample, and detect the intermediate , coarse filtration, fine filtration, and packed in brown vials (adenosylcobalamin 10mg / support). Nitrogen protection. Arrange them in a freeze-drying box and freeze-dry them. After completion, fill the freeze-drying bottles with nitrogen gas, stopper them and take them out of the box.

[0015] Freeze-drying process:

[0016] Put the medicine into the front box of the freeze dryer, close the box door, and start to cool the front box. When the temperature of the product drops to -40°C, keep it warm for 2 hours, and then start to cool the back box. When the temperature of the back box is cooled to below -45°C, Start vacuuming, and when the vacuum reaches 8-10Pa, start to heat up. The plate temperature was raised to -5°C, and th...

Embodiment 2

[0018] Under a 20 lux red light, weigh an appropriate amount of adenosylcobalamin 500mg and mannitol 30000mg, add it to water filled with carbon dioxide gas, stir to dissolve, add 0.1% (g / ml) activated carbon, stir, sample, intermediate Detection, coarse filtration, fine filtration, and packing in brown vials (adenosylcobalamin 5mg / branch). Carbon dioxide gas protection. Arrange them in a freeze-drying box and freeze-dry them. After completion, fill the freeze-drying bottles with carbon dioxide gas and plug them out of the box.

Embodiment 3

[0022] Example 3 The drug quality stability test prepared by different production methods, the test results are shown in Table 1.

[0023] Table 1

[0024]

[0025] Experimental results show that the quality stability of the product prepared by the method of the present invention is better.

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Abstract

The invention discloses a preparation method of cobamamide lyophilized preparation for injection. The preparation method of cobamamide lyophilized preparation for injection comprises following steps that medicine components include, by weight, 0.5-1 parts of cobamamide and 30 parts of mannitol; the cobamamide and the mannitol are weighed under a red light lamp with the illumination intensity of 20 lux to 50 lux, are added into water filled with inert gas and are stirred so as to be dissolved, 0.1% to 0.2% of activated carbon is added into mixture of the cobamanide, the mannitol and the water, and then mixture of the activated carbon, the cobamanide, the mannitol and the water is finely filtered, charged separately, filled with inert gas to be protected and then is lyophilized. Chemical stabilizing agent such as bacteriostat, complexing agent, opacifier and the like is not used in the preparation method. The preparation method not only is convenient for work of operators, but also can prevent stability of the quality of products from being affected due to inappropriate light shielding methods, and simultaneously, stability of the products is improved.

Description

Technical field: [0001] The invention relates to a preparation method of a pharmaceutical preparation, in particular to a preparation method of adenosylcobalamin freeze-dried preparation for injection. Background technique: [0002] Adenosylcobalamin, also known as adenosine coenzyme vitamin B12, chemically named 5,6-dimethylbenzimidazolyl-5-deoxyadenosylnucleosylcobalamin, is one of the active coenzyme forms of vitamin B12. Adenosylcobalamin was mainly used in the treatment of pernicious anemia in the early stage, and it was also used in combination with folic acid to treat various megaloblastic anemia and anemia caused by antifolate drugs. It was also used in nervous system diseases. In the past ten years, its application scope has been continuously expanded, and it is also commonly used in the treatment of radiculitis, multiple neuritis, peripheral neuritis, ophthalmoplegia and other diseases. Its application in the fields of liver disease, cancer, chronic atrophic gastr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/714A61P7/06A61P25/00A61P21/00A61P1/16A61P35/00A61P1/04A61P15/00
Inventor 张西果张辛庭刘书睿赵霞段瑞婷徐永刚
Owner NORTH CHINA PHARMA COMPANY
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