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Tilmicosin stabilizing agent and preparation method thereof

A technology for tilmicosin and stable preparation, which is applied in the field of preparation of tilmicosin medicaments, can solve the problems of low content of active ingredients, short shelf life, poor stability and the like, and achieves the effects of stable properties and good curative effect

Active Publication Date: 2012-09-12
DINGZHENG XINXING BIOTECH TIANJIN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in an acidic environment, the stability of tilmicosin injection is poor, so the shelf life of the injection is short, which is not conducive to clinical use, and the active ingredient content of the injection is low, and large doses of injection are required during use. Inconvenient and irritating to the animal body

Method used

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  • Tilmicosin stabilizing agent and preparation method thereof
  • Tilmicosin stabilizing agent and preparation method thereof
  • Tilmicosin stabilizing agent and preparation method thereof

Examples

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preparation example Construction

[0028] The preparation method of the above-mentioned stable preparation of Tilmicosin includes the following steps:

[0029] (1) Add Tilmicosin to the solvent to form a suspension;

[0030] The solvent is a mixture of one or more of purified water, absolute ethanol, ethyl acetate or propylene glycol.

[0031] (2) Add a penetration cosolvent to the suspension of step (1) to form a light yellow translucent suspension;

[0032] (3) Continue to add the osmotic co-solvent, and perform an ultrasonic water bath at a temperature of 30-60 degrees Celsius to obtain a light yellow transparent solution;

[0033] (4) Add lye and acid to the light yellow solution of step (3) to adjust the pH to 7;

[0034] (5) Add antioxidants;

[0035] (6) Add chelating agent;

[0036] (7) Perform sterilization filtration with 0.22 micron membrane;

[0037] (8) Add purified water and make the volume to 100 ml to obtain the finished product.

Embodiment 1

[0039] (1) Add 30 g of Tilmicosin to 50 ml of solvent to form a suspension;

[0040] The solvent is a mixture of 20 ml propylene glycol, 10 ml ethyl acetate and 20 ml purified water.

[0041] (2) Add 5 g of purified terephthalic acid and 10 g of sodium lauryl sulfate to the suspension of step (1) to form a light yellow translucent suspension;

[0042] (3) Continue to add 12 g of purified terephthalic acid and 8 g of sodium lauryl sulfate, and perform an ultrasonic water bath at a temperature of 30 degrees Celsius to obtain a light yellow transparent solution;

[0043] (4) Add 7 ml of sodium hydroxide solution with a concentration of 0.01 mol / l and 3 ml of arginine solution with a concentration of 0.2 mol / l to the light yellow solution of step (3), and adjust the pH to 7;

[0044] (5) Add 0.4 g of sodium thiosulfate;

[0045] (6) Add 0.2 g of ethylenediaminetetraacetic acid;

[0046] (7) Perform sterilization filtration with 0.22 micron membrane;

[0047] (8) Add purified water and make the...

Embodiment 2

[0051] (1) Add 50 g of Tilmicosin to 50 ml of solvent to form a suspension;

[0052] The solvent was a mixture of 30 ml propylene glycol, 10 ml ethyl acetate and 10 ml purified water.

[0053] (2) Add 20g of Span-80 and 5g of cholesterol to the suspension of step (1) to form a light yellow translucent suspension;

[0054] (3) Continue to add 10g of Span-8, and perform an ultrasonic water bath at a temperature of 45 degrees Celsius to obtain a light yellow transparent solution;

[0055] (4) Add 5 ml of sodium hydroxide solution with a concentration of 0.01 mol / l to the light yellow solution of step (3) to adjust the pH to 7;

[0056] (5) Add 0.4 g of sodium thiosulfate;

[0057] (6) Add 0.2 g of ethylenediaminetetraacetic acid;

[0058] (7) Perform sterilization filtration with 0.22 micron membrane;

[0059] (8) Add purified water and make the volume to 100 ml to obtain the finished product.

[0060] The active ingredient content of Tilmicosin is 50%.

[0061] The pH of the pale yellow soluti...

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Abstract

The invention relates to a tilmicosin stabilizing preparation. The preparation is neutral and comprises the following components in each 100 ml: 20-50 g of tilmicosin, 30-50 g of penetration cosolvent, 0.2-0.4 g of antioxidant and 0.2 g of chelating agent. According to the invention, the tilmicosin, the penetration cosolvent, the antioxidant and the chelating agent are integrated together to form a faint yellow homogeneous solution, and the pH (Potential of Hydrogen) is 7; when the tilmicosin stabilizing preparation is stored, the character is stable; when the tilmicosin stabilizing preparation is used, an animal organism does not have adverse reactions; the time of reaching a blood concentration peak is much shorter than that of a traditional injection solution, and a tissue seepage force is 4-5 times as much as that of the traditional injection solution, so that the tilmicosin stabilizing preparation is one stable preparation with good curative effects.

Description

Technical field [0001] The invention relates to the technical field of preparation of tilmicosin preparations, in particular to a stable preparation of tilmicosin and a preparation method thereof. Background technique [0002] Tilmicosin is a special macrolide antibiotic for animals. It has good antibacterial activity against Gram-positive bacteria, Gram-negative bacteria, anaerobic cocci, Legionella, mycoplasma, chlamydia, etc. Linear bacilli, Pasteurella and livestock and poultry Mycoplasmas have strong activity and are widely used in the prevention and treatment of diseases such as bovine mastitis, pig Mycoplasma pneumonia and livestock and poultry Mycoplasma infections. They are sensitive to more than 95% of hemolytic Pasteurella. Pharmacology The effect is 3 to 5 times higher than that of drugs such as tylosin and erythromycin thiocyanate. [0003] Since tilmicosin does not dissolve in water, during clinical use, people use co-solvents to increase the solubility of til...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/706A61K47/20A61P31/04
Inventor 刘鼎阔董惠峰张俊霞张勇王立红张凤洪
Owner DINGZHENG XINXING BIOTECH TIANJIN
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