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Levofloxacin injection and preparation method thereof

A technology for levofloxacin and injection, which is applied in the field of levofloxacin injection and its preparation, can solve the problems of low effective content, poor solubility of levofloxacin, discomfort for livestock and poultry, etc., and achieves the effects of high effective component content, good therapeutic effect and stable properties

Active Publication Date: 2014-12-03
DINGZHENG XINXING BIOTECH TIANJIN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, the injections with levofloxacin as the active ingredient on the market are levofloxacin hydrochloride or lactate. The main reason is that due to the poor solubility of levofloxacin, it must be prepared into soluble hydrochloride or milk A homogeneous injection solution can be formed only after acid salt
However, the effective content of the injection in the form of salt is low, and it must be injected multiple times, which is likely to cause discomfort to livestock and poultry

Method used

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  • Levofloxacin injection and preparation method thereof
  • Levofloxacin injection and preparation method thereof

Examples

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preparation example Construction

[0023] The preparation method of above-mentioned levofloxacin injection, comprises the following steps:

[0024] (1) Add levofloxacin to water at 40°C, and add sodium hydroxide at a rate of 0.1mol / min until levofloxacin is completely dissolved;

[0025] (2) Add chelating agent in the transparent solution of step (1);

[0026] (3) Add lactic acid or butyric acid to the solution in step (2) to continuously precipitate crystals in the solution until the solution becomes an emulsion;

[0027] (4) Continue to add lactic acid or butyric acid in the emulsion of step (3) to convert the emulsion into a transparent solution;

[0028] (5) Dilute the transparent solution in step (4) with water to obtain a finished product.

[0029] Wherein, step (5) is followed by 0.22 μm microporous membrane filtration. Chelating agent is EDTA-Na metal chelating agent.

Embodiment 1

[0031] A preparation method of levofloxacin injection comprises the following steps:

[0032] (1) Add 10 grams of levofloxacin to 50 ml of water for injection at 40°C, and then add a total of 5 g of hydrogen peroxide at the set speed

[0033] NaCl, stirred until levofloxacin was completely dissolved;

[0034] (2) Add 0.2 grams of EDTA-Na metal chelating agent;

[0035] (3) Gradually add 5ml of 0.2M lactic acid, and stir slowly to make the solution continue to precipitate and crystallize until the solution becomes an emulsion, continue to add 5ml of lactic acid and gradually stir to make the emulsion gradually turn into a transparent solution;

[0036] (4) Dilute to 100 ml with purified water, filter through a 0.22 μm microporous membrane and fill.

[0037] In the above process, the water for injection at 40°C is used in step (1) to assist the dissolution of levofloxacin, and the speed of 0.1mol / min and solid sodium hydroxide are used to finely control the amount of sodium hy...

Embodiment 2

[0041] A preparation method of levofloxacin injection comprises the following steps:

[0042] ⑴Add 15g of levofloxacin to 50ml of water for injection at 40°C, then add a total of 8g of sodium oxide according to the set speed, and stir until levofloxacin is completely dissolved;

[0043] (2) Add 0.2 grams of EDTA-Na metal chelating agent;

[0044] (3) Gradually add 10 ml of 0.1M butyric acid and stir slowly to make the solution crystallize continuously until the solution becomes an emulsion, continue to add 8 ml of butyric acid and gradually stir to make the emulsion gradually turn into a transparent solution;

[0045] (4) Dilute to 100 ml with purified water, filter through a 0.22 μm microporous membrane and fill.

[0046] After testing, the prepared levofloxacin injection is a light yellow transparent solution with a pH value of 7.0, and the content of the active ingredient levofloxacin in the injection is 15% of the total weight of the injection solution.

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Abstract

The invention relates to a levofloxacin injection. The levofloxacin injection is characterized in that the injection is a faint yellow solution, the pH value of the injection is 6.0-7.5, and the injection comprises the following ingredients in parts by weight: 10-20 parts of levofloxacin, and 0.1-0.3 part of chelating agent. The preparation method comprises the steps: firstly, mixing and dissolving levofloxacin and sodium hydroxide into water, then adding the chelating agent, and finally adding one or two of lactic acid and butyrate, so as to enable the solution to form a faint yellow transparent solution which is stable in property and has no crystallization separation after being stored for a long time. The transparent solution is faintly acidy, and suitable for biological environment in livestock and poultry organisms, is non-irrtant, and livestock and poultry can not be maladaptive, the levofloxacin effective component is high in content and can be directly absorbed by the livestock and poultry organisms, and the single-time administration treatment effect is good.

Description

technical field [0001] The invention belongs to the technical field of levofloxacin preparations, in particular to a levofloxacin injection and a preparation method thereof. Background technique [0002] Levofloxacin is a new generation of optically active quinolone antibacterial agent. Its main mechanism of action is to hinder the activity of DNA helicase, and its strength is twice that of ofloxacin. Levofloxacin has a broad-spectrum antibacterial effect on Gram-positive bacteria and negative bacteria including anaerobic bacteria. Intestinal bacteria including Escherichia coli, Klebsiella, Serratia, Proteus, glucose non-fermenting Gram-negative flora including Pseudomonas aeruginosa, Haemophilus influenzae , Neisseria gonorrhoeae, etc. have shown strong antibacterial activity. [0003] At present, the injections with levofloxacin as the active ingredient on the market are levofloxacin hydrochloride or lactate. The main reason is that due to the poor solubility of levoflox...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/5383A61K47/18A61K47/12A61K47/02A61P31/04
Inventor 刘鼎阔王立红赵云英赵晶晶张俊霞
Owner DINGZHENG XINXING BIOTECH TIANJIN
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