Method for preparing injection-grade oxytetracycline

A technology of oxytetracycline and injection grade is applied in the field of preparation of injection grade oxytetracycline to achieve the effects of reducing types and contents, qualified quality standards and lowering production costs

Inactive Publication Date: 2012-12-12
CHIFENG AOBEISI MEDICAL SCI & TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It is a product produced by biological fermentation. Although a series of impurity removal processes are adopted in the later stage of fermentation, there will still be a small amount of protein impurities in the final product, so it cannot be used as a raw material for injection-grade

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0031] (1) Dissolve 10 grams of oral grade oxytetracycline in 200ml of methanol, slowly add methanol-hydrochloric acid solution dropwise until dissolved, stir for 10 minutes, add 2.0g of 767 carbon powder, stir for 20 minutes, carry out coarse filtration, and then carry out membrane Filtrate, add methanol-hydrochloric acid solution to the filtrate at 10°C-30°C to adjust pH = 1-2, crystallize at 20°C-25°C for 3 hours, and filter with suction to obtain the wet product of oxytetracycline hydrochloride;

[0032] (2) Dissolve the wet product of oxytetracycline hydrochloride in purified water, stir for 10 minutes, filter the solution with a membrane, and wash the upper layer with purified water until the effluent is colorless, combine the filtrates, and store at 20-25°C Slowly add 10% sodium hydroxide solution dropwise under stirring, adjust the pH to 5-6 to obtain oxytetracycline base crystals, stir for 15 minutes, filter, wash the upper layer with purified water until the effluent ...

example 2

[0036] (1) Dissolve 10g of oral grade oxytetracycline in 150ml of methanol, slowly add methanol-hydrochloric acid solution dropwise until dissolved, stir for 15 minutes, add 1.5g of 767 carbon powder, stir for 20 minutes, carry out coarse filtration, and then perform membrane Filtrate, add methanol-hydrochloric acid solution to the filtrate at 10°C to 30°C to adjust pH=1 to 2, crystallize at 15°C to 20°C for 4 hours, and filter with suction to obtain the wet product of oxytetracycline hydrochloride;

[0037] (2) Dissolve the wet product of oxytetracycline hydrochloride in purified water, stir for 15 minutes, filter the solution with a membrane, and wash the upper layer with purified water until the effluent is colorless. Slowly add 10% sodium hydroxide solution dropwise under stirring at ℃, adjust the pH to 5-6 to obtain oxytetracycline base crystals, stir for 15 minutes, filter, wash the upper layer with purified water until the effluent is neutral, filter and dry to obtain ox...

example 3

[0041] (1) Dissolve 10 grams of oral grade oxytetracycline in 120ml of methanol, slowly add methanol-hydrochloric acid solution dropwise until dissolved, stir for 15 minutes, add 0.8g of 767 carbon powder, stir for 20 minutes, perform coarse filtration, and then perform membrane Filtrate, add methanol-hydrochloric acid solution to the filtrate at 10°C-30°C to adjust pH = 1-2, crystallize at 5°C-10°C for 5 hours, and filter with suction to obtain the wet product of oxytetracycline hydrochloride;

[0042] (2) Dissolve the wet product of oxytetracycline hydrochloride in purified water, stir for 20 minutes, filter the solution with a membrane, after filtration, wash with purified water until the effluent is colorless, combine the filtrates, and stir at 10°C to 15°C Slowly add 10% sodium hydroxide solution dropwise to adjust the pH to 5-6 to obtain oxytetracycline base crystals, stir for 15 minutes, filter, wash the upper layer with purified water until the effluent is neutral, and ...

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PUM

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Abstract

The invention discloses a method for preparing an injection-grade oxytetracycline, which mainly comprises the following steps: directly dissolving the active pharmaceutical ingredient oral-grade oxytetracycline, and decolorizing with activated carbon to remove impurities; and converting oxytetracycline salt into oxytetracycline alkali without adding any flocculant, carrying out vacuum drying and the like. The technical process disclosed by the invention is simple and convenient to operate, and achieves the standard for injection-grade oxytetracycline; and the yield is enhanced by more than 5% as compared with the traditional technique.

Description

technical field [0001] The invention relates to a method for preparing injection-grade oxytetracycline, in particular to a method for preparing oral-grade oxytetracycline into injection-grade oxytetracycline. Background technique [0002] Oxytetracycline is a broad-spectrum tetracyclic antibiotic, commonly known as oxytetracycline, oxytetracycline, etc. It is often used for rickettsial disease, mycoplasma pneumonia, chlamydia infection, and also for mild infection caused by sensitive Gram-positive cocci and negative bacilli. It is a product produced by biological fermentation. Although a series of impurity removal processes are adopted in the later stage of fermentation, there will still be a small amount of protein impurities in the final product, so it cannot be used as a raw material for injection-grade oxytetracycline. In the detection method, the detection standard is: the solubility of methanol should be qualified, there is no precipitation of flocs, and the solution ...

Claims

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Application Information

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IPC IPC(8): C07C237/26C07C231/24
Inventor 王风刚寇凤芹李晓磊陈青云段开红万永青
Owner CHIFENG AOBEISI MEDICAL SCI & TECH CO LTD
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