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Preparation technology avoiding reduction of tetracycline hydrochloride technical original drug property

A technology of tetracycline hydrochloride and preparation process, applied in the field of medicine, can solve the problems such as the reduction of the efficacy of the original tetracycline hydrochloride, and achieve the effects of avoiding the reduction of the efficacy of the original tetracycline hydrochloride and the performance damage.

Inactive Publication Date: 2016-01-20
CHINA CHENGDU ANIMAL HUSBANDRY IND BIOPHARM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The technical problem to be solved by the present invention is to provide a preparation process that avoids reducing the drug properties of the original tetracycline hydrochloride, so as to overcome the problem that the existing tetracycline hydrochloride preparations tend to reduce the efficacy of the original tetracycline hydrochloride for injection during the preparation process

Method used

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  • Preparation technology avoiding reduction of tetracycline hydrochloride technical original drug property

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Effect test

Embodiment 1

[0023] Such as figure 1 Shown, avoid reducing the preparation technology of the original drug property of tetracycline hydrochloride, comprise the following steps:

[0024] 1) Preparation of tetracycline hydrochloride: Mix tetracycline hydrochloride urea double salt with organic alcohol mixed solvent at a ratio of 1g: 6mL, stir continuously at 10°C for 10 minutes, add hydrochloric acid, and filter after continuous stirring; transfer the obtained filtrate into a crystallizer After heating up, add seed crystals when the system temperature reaches 30°C, continue to heat up to 45°C, and incubate at a constant temperature for 30 minutes; then lower the temperature of the suspension to 10°C at a cooling rate of 5°C / min; filter the obtained crystal slurry, wash with a solvent, Obtain tetracycline hydrochloride crystal product; The mol ratio of effective HCl in described tetracycline hydrochloride urea double salt and hydrochloric acid is 1:1; Described organic solvent mixed agent is ...

Embodiment 2

[0028] Such as figure 1 Shown, avoid reducing the preparation technology of the original drug property of tetracycline hydrochloride, comprise the following steps:

[0029] 1) Preparation of tetracycline hydrochloride: Mix tetracycline hydrochloride urea double salt with organic alcohol mixed solvent in a ratio of 1g: 8mL, stir continuously at 15°C for 10min, add hydrochloric acid, and filter after continuous stirring; transfer the obtained filtrate into a crystallizer After the temperature rises, when the system temperature reaches 35°C, add seed crystals, continue to heat up to 50°C, and incubate at a constant temperature for 30 minutes; then lower the temperature of the suspension to 15°C at a rate of 8°C / min; filter the obtained crystal slurry, and wash with a solvent. Obtain tetracycline hydrochloride crystal product; The mol ratio of effective HCl in described tetracycline hydrochloride urea double salt and hydrochloric acid is 1:2; Described organic solvent mixture is t...

Embodiment 3

[0033] Such as figure 1 Shown, avoid reducing the preparation technology of the original drug property of tetracycline hydrochloride, comprise the following steps:

[0034]1) Preparation of tetracycline hydrochloride: Mix tetracycline hydrochloride urea double salt with organic alcohol mixed solvent in a ratio of 1g: 10mL, stir continuously at 18°C ​​for 10min, add hydrochloric acid, and filter after continuous stirring; transfer the obtained filtrate into a crystallizer After heating up, add seed crystals when the system temperature reaches 35°C, continue to heat up to 48°C, and incubate at a constant temperature for 30 minutes; then lower the temperature of the suspension to 18°C ​​at a cooling rate of 6°C / min; filter the obtained crystal slurry, wash with a solvent, Obtain tetracycline hydrochloride crystal product; The mol ratio of effective HCl in described tetracycline hydrochloride urea double salt and hydrochloric acid is 1:2; Described organic solvent mixture is the m...

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Abstract

The invention relates to a preparation technology avoiding reduction of tetracycline hydrochloride technical original drug property. The preparation technology comprises the following steps that a tetracycline hydrochloride wet product is prepared; the prepared tetracycline hydrochloride wet product is dried and ground into powder. A preparation technology of tetracycline hydrochloride comprises the steps that reagent bottles used for containing the tetracycline hydrochloride powder are cleaned firstly; then the tetracycline hydrochloride powder is quantitatively filled into the cleaned reagent bottles according to specifications, and nitrogen is fed into the bottles; the bottles are covered with pretreated rubber plugs, and then cap binding treatment is conducted through aluminum caps to make products sealed; inner tags sticking, packing and light inspection are sequentially conducted on the reagent bottles which are subjected to cap binding; then outer tags stick to packing boxes, and inspection and packing are conducted. By means of the preparation technology avoiding reduction of the tetracycline hydrochloride technical original drug property, the problem that the effect of a tetracycline hydrochloride technical original drug for injection is prone to reduction by means of an existing preparation technology of the tetracycline hydrochloride is solved.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a preparation process for avoiding reducing the drug properties of tetracycline hydrochloride original drug. Background technique [0002] The molecular formula of tetracycline hydrochloride is: C 22 h 24 N 2 o 8 • HCl, molecular weight 480.91. Yellow crystal, odorless. Bitter. Hygroscopic. When exposed to light, the color gradient becomes darker. Soluble in water, in methanol. Ethanol, insoluble in ether, hydroxyl. It is an antibacterial substance isolated from the culture solution of the actinomycetes Streptomycesaureofaciens, and it is effective against Gram-positive bacteria, negative bacteria, Rickettsia, filter viruses, spirochetes and even protozoa. It has a good inhibitory effect, but it is ineffective against Mycobacterium tuberculosis and Proteus. [0003] Tetracycline hydrochloride is the first generation of tetracycline antibiotics. It has broad-spectrum a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07C237/26C07C231/24A61K31/65A61K9/14A61P31/04A61P33/02
Inventor 廖成斌卢朝成
Owner CHINA CHENGDU ANIMAL HUSBANDRY IND BIOPHARM
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