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Preparation process with convenient elimination of defective tetracycline hydrochloride for injection

A tetracycline hydrochloride, preparation technology, applied in the field of medicine, can solve the problem of unqualified finished products of tetracycline hydrochloride for injection, and achieve the effect of avoiding unlabeled and empty loading

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

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Problems solved by technology

[0005] The technical problem to be solved by the present invention is to provide a preparation process of tetracycline hydrochloride for injection that is convenient for removing unqualified products, so as to overcome the unqualified problem of tetracycline hydrochloride for injection finished product that is easily caused by the existing tetracycline hydrochloride preparation process

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  • Preparation process with convenient elimination of defective tetracycline hydrochloride for injection

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Effect test

Embodiment 1

[0022] Such as figure 1 Shown, the preparation technology of the tetracycline hydrochloride for injection that is convenient to reject unqualified product, comprises the following steps:

[0023] 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 ...

Embodiment 2

[0027] Such as figure 1 Shown, the preparation technology of the tetracycline hydrochloride for injection that is convenient to reject unqualified product, comprises the following steps:

[0028] 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 organ...

Embodiment 3

[0032] Such as figure 1 Shown, the preparation technology of the tetracycline hydrochloride for injection that is convenient to reject unqualified product, comprises the following steps:

[0033] 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 ...

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Abstract

The present invention relates to a preparation process with the convenient elimination of defective tetracycline hydrochloride for injection. The preparation process comprises the steps of (1) mixing tetracycline hydrochloride salt and an organic alcohol mixed solvent in proportion, carrying out continuous stirring for 10 minutes in 10 DEG C and then adding hydrochloric acid, carrying out continuous stirring and filtering, moving an obtained filtered liquid into a crystallizer and carrying out heating, adding seed crystal when a system temperature reaches 30 DEG C, carrying out heating continuously to reach 45 DEG C, carrying out constant temperature culturing for 30 minutes, then lowering the temperature of a suspension to 10 DEG C in the speed of 5 DEG C per minute, filtering obtained crystal slurry, and washing the solvent to obtain a tetracycline hydrochloride crystal product, (2) drying the obtained tetracycline hydrochloride crystal product and grinding the tetracycline hydrochloride crystal product into powders, (3) carrying out the preparation process of the tetracycline hydrochloride of making the tetracycline hydrochloride powders into a preparation for injection. According to the preparation process, the problem of defectives tetracycline hydrochloride products for injection caused by slow dissolution speed and preparation process in the existing process of preparing the tetracycline hydrochloride preparation is overcome.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a preparation process of tetracycline hydrochloride for injection which is convenient for rejecting unqualified products. 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 bro...

Claims

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Application Information

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IPC IPC(8): G05B19/05C07C237/26C07C231/24A61K31/65A61K9/14A61P31/04A61P31/12A61P33/02
CPCG05B19/058A61K9/14A61K31/65C07C231/24G05B2219/14006
Inventor 廖成斌卢朝成
Owner CHINA CHENGDU ANIMAL HUSBANDRY IND BIOPHARM
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