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A kind of 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 excellent sustained release effect, improved stability and high stability

Active Publication Date: 2020-02-14
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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  • A kind of 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] 5wt% meglumine;

[0036] 4wt% hydroxymethyl cellulose;

[0037] The rest is water for injection.

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

[0039] (1) get the water for injection of 40% of the total amount and heat to 80 ℃, add the meglumine and hydroxymethyl cellulose of the recipe quantity to dissolve;

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

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

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

[0043] (5) Dispense the filtration solution.

Embodiment 2

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

[0046] 20wt% enrofloxacin;

[0047] 30wt% propylene glycol;

[0048] 12wt% acetic acid;

[0049] 5wt% meglumine;

[0050] 4wt% hydroxymethyl cellulose;

[0051] The content of sodium bisulfite is 0.2wt%;

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

[0053] The rest is water for injection.

[0054] Its preparation method comprises the following steps:

[0055] (1) get the water for injection of 40% of the total amount and heat to 80 ℃, add the meglumine and hydroxymethyl cellulose of the recipe quantity to dissolve;

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

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

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] 5wt% hydroxymethyl cellulose;

[0068] The rest is water for injection. The preparation method is the same as that of Example 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 present application relates to the field of medical technology, in particular, to an enrofloxacin injection and a preparation method thereof. Background technique [0002] Enrofloxacin can be used as an animal drug. It has a long half-life in animals and good tissue distribution. It is a broad-spectrum bacteriostatic agent. It has bacteriostatic effect on Gram-positive bacteria, negative bacteria and mycoplasma. It is used in the control of vibrio and colibacillosis in farmed fish. [0003] At present, enrofloxacin injection and its preparation method have some shortcomings. First, the solubility of enrofloxacin in water is relatively low; secondly, the solubility of enrofloxacin is mainly improved by adding sodium hydroxide. It is weakly acidic, so it is more irritating to animals; third, traditional enrofloxacin injection is less stable and prone to crystallization; fourth, enrofloxacin injection has fast drug effect, but low persistence, there...

Claims

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Application Information

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Patent Type & Authority Patents(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