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Preparation technology for improving purity of doxycycline hyclate injection

A technique for preparing doxycycline hydrochloride and its preparation technology, which is applied in the field of preparation technology for improving the purity of doxycycline hydrochloride injection, and can solve the problems of slow dissolution rate and doxycycline hydrochloride containing impurities, so as to improve the purity and overcome the dissolution problem. Slower speed, avoiding the effect of impurities

Inactive Publication Date: 2016-02-03
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 based on improving the purity of doxycycline hydrochloride injection, to overcome the slow dissolution rate of existing doxycycline hydrochloride preparations in the preparation process and the doxycycline hydrochloride for injection caused by the preparation process. The problem of cycline containing impurities

Method used

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  • Preparation technology for improving purity of doxycycline hyclate injection

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Effect test

Embodiment 1

[0025] Such as figure 1 Shown, based on improving the preparation technology of doxycycline hydrochloride injection purity, comprises the following steps:

[0026] 1) Preparation of doxycycline hydrochloride: Grind 5 g of doxycycline hydrochloride into powder with a ball mill, then dissolve the powder in water to form solution A; the percentage of doxycycline in the doxycycline hydrochloride The content is 15%; Dissolve 10g of ethyl cellulose in ethanol to form solution B; under the premise of stirring, gradually pour solution A into solution B, and solution A will form emulsion C after solution B is dispersed; gelatin Dissolve in distilled water in a 60°C water bath to make a protection solution D, keep the temperature at 30°C for use; add emulsion C dropwise to the protection solution D under stirring to form a solution E, raise the water bath from 30°C to 50°C, and stir The organic solvent is volatilized; then E is suction-filtered and washed with water to obtain a doxycyc...

Embodiment 2

[0030] Such as figure 1 Shown, based on improving the preparation technology of doxycycline hydrochloride injection purity, comprises the following steps:

[0031] 1) Preparation of doxycycline hydrochloride: Grind 5 g of doxycycline hydrochloride into powder with a ball mill, then dissolve the powder in water to form solution A; the percentage of doxycycline in the doxycycline hydrochloride The content is 20%; Dissolve 15g of ethyl cellulose in ethylene glycol to form solution B; under the premise of stirring, gradually pour solution A into solution B, and solution A forms emulsion C after solution B is dispersed; Dissolve gelatin and distilled water in an 80°C water bath to make protection solution D, keep the temperature at 30°C for use; add emulsion C dropwise to protection solution D under stirring to form solution E, and raise the water bath from 30°C to 50°C , stirred to volatilize the organic solvent, then E was suction filtered and washed to obtain a doxycycline hydr...

Embodiment 3

[0035] Such as figure 1 Shown, based on improving the preparation technology of doxycycline hydrochloride injection purity, comprises the following steps:

[0036]1) Preparation of doxycycline hydrochloride: Grind 6 g of doxycycline hydrochloride into powder with a ball mill, then dissolve the powder in water to form solution A; the percentage of doxycycline in the doxycycline hydrochloride The content is 25%; Dissolve 12g of ethyl cellulose in dichloromethane to configure solution B; under the premise of stirring, gradually pour solution A into solution B, and solution A forms emulsion C after solution B is dispersed; Dissolve gelatin and distilled water in a 70°C water bath to make protection solution D, keep the temperature at 30°C for use; add emulsion C dropwise to protection solution D under stirring to form solution E, and raise the water bath from 30°C to 50°C , stirring to volatilize the organic solvent; then E is suction filtered and washed to obtain a doxycycline h...

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Abstract

The invention relates to a preparation technology for improving the purity of a doxycycline hyclate injection. The preparation technology comprises following steps: grinding doxycycline hyclate into powder by the use of a ball mill, and dissolving the powder in water so as to form a solution A; dissolving ethyl cellulose in an organic solvent so as to form a solution B; pouring the solution A into the solution B under a stirring condition, wherein an emulsion is formed after the solution A disperses in the solution B; dissolving gelatin in distilled water under a water-bath condition at 60-80 DEG C so as to prepare a protection solution D which is standby at the constant temperature of 30 DEG C; drooping the emulsion C into the protection solution D under a stirring condition so as to form a solution E, and stirring the solution under a condition that the temperature of the water-bath is raised to 50 DEG C from 30 DEG C so that the organic solvent volatilizes; and then performing suction filtration on the solution E, washing the solution E, and drying the solution E so as to obtain the white powder doxycycline hyclate. According to the invention, problems that the dissolving speed is relatively slow in a conventional preparation process of doxycycline hyclate preparations and the doxycycline hyclate for injection contains impurities in the conventional preparation process are solved.

Description

technical field [0001] The invention relates to the field of medical technology, in particular to a preparation process based on improving the purity of doxycycline hydrochloride injection. Background technique [0002] Doxycycline hydrochloride is a broad-spectrum semi-synthetic tetracycline antibiotic. Its antibacterial spectrum is similar to that of tetracycline, but its antibacterial effect is 10 times stronger. The medicine has strong water solubility, good absorption and wide distribution, and has many clinical applications and good effects. Microorganisms have close cross-resistance to this drug and tetracycline, oxytetracycline, etc. Oral absorption is good. It is mainly used for upper respiratory tract infection, tonsillitis, biliary tract infection, lymphadenitis, cellulitis, etc. caused by sensitive gram-positive bacteria and gram-negative bacilli. Wait. It can still be used to treat cholera, and also to prevent falciparum malaria and leptospirosis infection. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61J3/02
CPCA61J3/02
Inventor 廖成斌卢朝成
Owner CHINA CHENGDU ANIMAL HUSBANDRY IND BIOPHARM
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