Preparation method of high-concentration long-acting doxycycline injection adopting low organic solvent

Abstract

The invention discloses a preparation method of high-concentration doxycycline injection adopting a small amount of organic solvent, and relates to a high-concentration doxycycline injection. The high-concentration doxycycline injection contains the following components in percentage by mass: doxycycline, povidone, magnesium chloride, organic solvent and disodium metabisulfite, and has constant volume by adding water for injection. The preparation method comprises the following steps: (1) adding the povidone in a proper amount of water for injection to be heated to a proper temperature and stirred to completely dissolve, thus preparing povidone aqueous solution; (2) dissolving anti-oxidant in the povidone aqueous solution obtained in step 1; (3) then dissolving the magnesium chloride in the solution obtained in step 2; (4) slowly adding the doxycycline in the solution obtained in step 3, reducing the temperature to 15-25 DEG C, and adding and stirring the organic solvent to dissolve completely; and (5) adding ethanolamine, adjusting to be proper, and obtaining the high-concentration doxycycline injection by the steps of constant volume with the water for injection and the like. In the invention, stable high-concentration doxycycline injection can be prepared by using less organic solvent, thus saving the production cost.

Description

Technical Field

[0001] The invention relates to a high-concentration doxycycline injection, in particular to a method for preparing a high-concentration long-acting doxycycline injection with a low organic solvent.

Background technique

[0002] Doxycycline injection is one of the most commonly used veterinary antibiotic injections. Under the premise of ensuring effective treatment, high-concentration injections are more and more popular due to their convenience in use. However, At present, doxycycline injections generally have higher organic solvents in the preparation process, resulting in higher product costs. However, for high-concentration doxycycline injections, the content of organic solvents in the injection is higher. The patent with application number 200810044667.6 which is closer to this patent relates to a high-concentration doxycycline injection (10%-25% based on doxycycline), and the amount of organic solvent used is 60%-70%. Significantly reduce the amount of ...

Examples

Embodiment 1

[0033] Example 1: Preparation of 10% doxycycline injection:

[0034] Take 5gPVPK 30 Dissolve in 50ml of 60℃ water for injection, add 0.6g sodium metabisulfite and stir until completely dissolved, add 10g magnesium chloride, stir until completely dissolved, slowly add 10g doxycycline, stir at 15℃ until mixed, add 10g ethanol and stir until completely dissolved , Then adjust the pH to 8.5 with ethanolamine, dilute the volume to 100ml with water for injection, filter potting, 10ml / piece, sterilize, and package it.

Embodiment 2

[0035] Example 2: Preparation of 10% doxycycline injection;

[0036] Take 5gPVPK 30 Dissolve in 50ml of 60℃ water for injection, add 0.6g sodium metabisulfite and stir until completely dissolved, add 10g magnesium chloride, stir until completely dissolved, slowly add 10g doxycycline, stir at 15℃ until mixed, add 10g ethanol and stir until completely dissolved , Then adjust the pH to 7.5 with ethanolamine, dilute the volume to 100ml with water for injection, filter potting, 10ml / piece, sterilize, and pack it.

Embodiment 3

[0037] Example 3: Preparation of 10% doxycycline injection;

[0038] Take 5gPVPK 30 Dissolve in 50ml of 60℃ water for injection, add 0.6g sodium metabisulfite and stir until completely dissolved, add 10g magnesium chloride, stir until completely dissolved, slowly add 10g doxycycline, stir at 15℃ until mixed, add 10g ethanol and stir until completely dissolved , Then adjust the pH to 9.0 with ethanolamine, dilute the volume to 100ml with water for injection, filter potting, 10ml / piece, sterilize, and pack it.

Technical Field

[0001] The invention relates to a high-concentration doxycycline injection, in particular to a method for preparing a high-concentration long-acting doxycycline injection with a low organic solvent.

Background technique

[0002] Doxycycline injection is one of the most commonly used veterinary antibiotic injections. Under the premise of ensuring effective treatment, high-concentration injections are more and more popular due to their convenience in use. However, At present, doxycycline injections generally have higher organic solvents in the preparation process, resulting in higher product costs. However, for high-concentration doxycycline injections, the content of organic solvents in the injection is higher. The patent with application number 200810044667.6 which is closer to this patent relates to a high-concentration doxycycline injection (10%-25% based on doxycycline), and the amount of organic solvent used is 60%-70%. Significantly reduce the amount of ...

Examples

Embodiment 1

[0033] Example 1: Preparation of 10% doxycycline injection:

[0034] Take 5gPVPK 30 Dissolve in 50ml of 60℃ water for injection, add 0.6g sodium metabisulfite and stir until completely dissolved, add 10g magnesium chloride, stir until completely dissolved, slowly add 10g doxycycline, stir at 15℃ until mixed, add 10g ethanol and stir until completely dissolved , Then adjust the pH to 8.5 with ethanolamine, dilute the volume to 100ml with water for injection, filter potting, 10ml / piece, sterilize, and package it.

Embodiment 2

[0035] Example 2: Preparation of 10% doxycycline injection;

[0036] Take 5gPVPK 30 Dissolve in 50ml of 60℃ water for injection, add 0.6g sodium metabisulfite and stir until completely dissolved, add 10g magnesium chloride, stir until completely dissolved, slowly add 10g doxycycline, stir at 15℃ until mixed, add 10g ethanol and stir until completely dissolved , Then adjust the pH to 7.5 with ethanolamine, dilute the volume to 100ml with water for injection, filter potting, 10ml / piece, sterilize, and pack it.

Embodiment 3

[0037] Example 3: Preparation of 10% doxycycline injection;

[0038] Take 5gPVPK 30 Dissolve in 50ml of 60℃ water for injection, add 0.6g sodium metabisulfite and stir until completely dissolved, add 10g magnesium chloride, stir until completely dissolved, slowly add 10g doxycycline, stir at 15℃ until mixed, add 10g ethanol and stir until completely dissolved , Then adjust the pH to 9.0 with ethanolamine, dilute the volume to 100ml with water for injection, filter potting, 10ml / piece, sterilize, and pack it.

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