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Enrofloxacin injection and preparation method thereof

A technology of enrofloxacin and injection, which is applied in the field of medicine to achieve the effect of improving stability, excellent sustained release effect and high stability

Active Publication Date: 2019-03-08
TIANJIN ZHONGSHENG TIAOZHAN BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The invention provides enrofloxacin injection and a preparation method thereof, which effectively solves the problems existing in the current enrofloxacin injection through the preparation method of the invention

Method used

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  • Enrofloxacin injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] An enrofloxacin injection, comprising the following components:

[0032] 20wt% enrofloxacin;

[0033] 30wt% propylene glycol;

[0034] 12wt% acetic acid;

[0035] 5 wt% meglumine;

[0036] 4 wt% hydroxymethyl cellulose;

[0037] The rest is water for injection.

[0038] Its preparation method consists of the following steps:

[0039] (1) Take 40% of the total amount of water for injection and heat it to 80°C, add the prescribed amount of meglumine and hydroxymethylcellulose until dissolved;

[0040] (2) After adding enrofloxacin and propylene glycol to the solution in step (1) and mixing, use ultrasonic treatment for 8 minutes; add 10wt% acetic acid during the ultrasonic treatment to adjust the pH value of the mixed solution to 5.8;

[0041] (3) coarse filtration with a 0.45 μm microporous membrane;

[0042] (4) Add water for injection to the full amount, and fine filter with a 0.22 μm microporous membrane;

[0043] (5) Pack the filtered solution.

Embodiment 2

[0045] An enrofloxacin injection, comprising the following components:

[0046] 20wt% enrofloxacin;

[0047] 30wt% propylene glycol;

[0048] 12wt% acetic acid;

[0049] 5 wt% meglumine;

[0050] 4 wt% hydroxymethyl cellulose;

[0051] Sodium bisulfite content is 0.2wt%;

[0052] EDTA-2Na content is 0.03wt%;

[0053] The rest is water for injection.

[0054] Its preparation method comprises the following steps:

[0055] (1) Take 40% of the total amount of water for injection and heat it to 80°C, add the prescribed amount of meglumine and hydroxymethylcellulose until dissolved;

[0056] (2) dissolve the antioxidant and the chelating agent of prescription quantity with the water for injection of 20% of total amount, add in the solution in step (1) under stirring state;

[0057] (3) After adding enrofloxacin and propylene glycol to the solution in step (2) and mixing, adopt ultrasonic treatment for 8 minutes; add 10wt% acetic acid in the process of ultrasonic treatment to...

Embodiment 3

[0062] An enrofloxacin injection, comprising the following components:

[0063] 10wt% enrofloxacin;

[0064] 30wt% propylene glycol;

[0065] 12wt% acetic acid;

[0066] 12wt% meglumine;

[0067] 5 wt% hydroxymethyl cellulose;

[0068] The rest is water for injection. Its preparation method is identical with embodiment 1.

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Abstract

The invention discloses a preparation method of an enrofloxacin injection. The method comprises the steps as follows: (1) heating 40% of injection water to 80 DEG C by water, and adding a prescriptionamount of meglumine and hydroxymethyl cellulose to be dissolved; (2) dissolving a prescription amount of an antioxidant and a chelating agent by 20% of injection water, and adding the solution to thesolution in step (1) in a stirring state; (3) adding enrofloxacin and propylene glycol to the solution in step (2), mixing the substances, and performing ultrasonic treatment for 5-10 min; adding 8wt%-13wt% of acetic acid during ultrasonic treatment to adjust the pH value of the mixed solution to 5.4-6.8; (4) performing rough filtration by a 0.45 mu m microporous filtration membrane; (5) adding injection water to the total amount, and performing fine filtration by a 0.22 mu m microporous filtration membrane; (6) packaging the filtered solution. The preparation method effectively solves the technical problems of the existing enrofloxacin injection.

Description

technical field [0001] The application relates to the technical field of medicine, in particular, to an enrofloxacin injection and a preparation method thereof. Background technique [0002] Enrofloxacin can be used as a drug for animals. It has a long half-life in animals and has good tissue distribution. It is a broad-spectrum antibacterial agent and has antibacterial effects on Gram-positive bacteria, negative bacteria and mycoplasma. It is used in the control of vibriosis and colibacillosis in farmed fish. [0003] There are some deficiencies in the current enrofloxacin injection and its preparation method. Firstly, the solubility of enrofloxacin in water is low; secondly, at present, adding sodium hydroxide is the main way to improve the solubility, but because the injection is more alkaline after sodium hydroxide is added, and the biological environment in the animal body is Weakly acidic, so it is more irritating to animals; third, the traditional enrofloxacin injec...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/10A61K47/26A61K47/38A61K31/496A61P31/04
CPCA61K9/0019A61K9/08A61K31/496A61K47/10A61K47/26A61K47/38A61P31/04
Inventor 王建程雪娇王猛余贵菊
Owner TIANJIN ZHONGSHENG TIAOZHAN BIOTECH
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