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A kind of enrofloxacin injection and preparation method thereof

A technology for enrofloxacin and injection, applied in the field of enrofloxacin injection and its preparation, capable of solving problems such as poor stability and low formulation cost

Active Publication Date: 2018-02-09
四川鼎尖动物药业有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The object of the present invention is to provide a kind of enrofloxacin injection and preparation method thereof, the enrofloxacin injection prepared by the present invention not only solves the technical problem of its poor stability at low temperature, but also facilitates enrofloxacin injection The curative effect of the liquid can be fully exerted, and it can pass the quality standard test of enrofloxacin injection in the "Chinese Veterinary Pharmacopoeia" 2010 edition. It is a national standard product with low formula cost and easy operation in the production process, suitable for large-scale production

Method used

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  • A kind of enrofloxacin injection and preparation method thereof
  • A kind of enrofloxacin injection and preparation method thereof
  • A kind of enrofloxacin injection and preparation method thereof

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preparation example Construction

[0049] The present invention provides the preparation method of above-mentioned enrofloxacin injection, comprises the following steps:

[0050] (1) After heating part of the water for injection, mix it with enrofloxacin, nicotinamide, an organic solvent, disodium edetate and an antioxidant, and dissolve to obtain a mixed material;

[0051] (2) Adjusting the pH value of the mixed material in step (1) with a pH regulator and mixing it with the rest of the water for injection to obtain enrofloxacin injection.

[0052] In the present invention, part of the water for injection is heated and mixed with enrofloxacin, nicotinamide, organic solvent, disodium ethylenediaminetetraacetic acid and antioxidant, and the mixed material is obtained after dissolving. In the present invention, it is preferred to heat part of the water for injection to 75-85°C, then mix it with enrofloxacin, nicotinamide, organic solvent, disodium edetate and antioxidant, and obtain the mixed material after disso...

Embodiment 1

[0061] (1) Take 60 parts of water for injection and heat it to 75°C, mix it with 10 parts of propylene glycol, 2.5 parts of enrofloxacin, 2 parts of nicotinamide, 0.01 part of edetate disodium and 0.1 part of sodium thiosulfate, and stir to make dissolved to obtain a mixture.

[0062] (2) Use ethanolamine to adjust the pH value of the mixed material to 9.5, add the remaining water for injection to make up to the full amount, and obtain enrofloxacin injection.

[0063] (3) Test the obtained enrofloxacin injection, filter the qualified enrofloxacin injection with a 0.45 μm microporous membrane, fill and seal it in an ampoule, and then extinguish it under circulating steam at 110°C. Bacteria for 40 minutes, cooled to room temperature, packaged, and stored for inspection.

Embodiment 2

[0065] (1) Propylene glycol and ethanol are prepared into a mixed solvent according to the proportion range; take 50 parts of water for injection and heat it to 80°C, and mix it with 20 parts of mixed solvent, 5 parts of enrofloxacin, 4 parts of nicotinamide, and 0.03 parts of ethylenediaminetetraacetic acid Disodium and 0.3 parts of sodium formaldehyde sulfoxylate are mixed and stirred to dissolve to obtain a mixed material; wherein the volume ratio of propylene glycol and ethanol in the mixed solvent is 1.5:1.

[0066] (2) Use 10% sodium hydroxide solution to adjust the pH value of the mixed material to 10, add the remaining water for injection to make up to the full amount, and obtain enrofloxacin injection.

[0067] (3) Test the obtained enrofloxacin injection, filter the qualified enrofloxacin injection with a 0.45 μm microporous membrane, fill and seal it in an ampoule, and then extinguish it under steam at 115°C. Bacteria for 35 minutes, cooled to room temperature, pack...

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Abstract

The invention provides an enrofloxacin injection, comprising following components: 2.5wt%-10wt% of enrofloxacin, 2wt%-10wt% of nicotinamide, 10wt%-30wt% of an organic solvent, 0.01wt%-0.05wt% of disodium ethylenediamine tetraacetic acid, 0.1wt%-0.5wt% of an antioxidant, 0.3wt%-1.4wt% of a pH regulator, and the balance water for injection. After being heated, part of the water for injection is mixed with the enrofloxacin, the nicotinamide, the organic solvent, the disodium ethylenediamine tetraacetic acid and the antioxidant, a mixture is obtained after dissolving, the mixture is mixed with the remaining water for injection after pH of the mixture is adjusted with the pH regulator, and the enrofloxacin injection is obtained. By using the enrofloxacin injection prepared, the technical problem that the enrofloxacin injection has poor stability at low temperature is solved, full play of the therapeutic effect of the enrofloxacin injection is facilitated, the enrofloxacin injection can pass the detection on the quality standard of enrofloxacin injections in Chinese veterinary pharmacopoeia 2010 and is a GB product, formulation cost is low, a production process is easy to operate, and the enrofloxacin injection is suitable for large-scale production in enterprises.

Description

technical field [0001] The invention relates to the technical field of veterinary drugs, in particular to an enrofloxacin injection and a preparation method thereof. Background technique [0002] Enrofloxacin is a fluoroquinolone antibiotic, which is a broad-spectrum bactericidal drug and is widely used in veterinary clinics. Cocci, etc. have bactericidal effect, and have special effects on mycoplasma. Enrofloxacin is mainly excreted through the kidneys, and its metabolism in animals is mainly to remove the ethyl group to become ciprofloxacin. The biggest feature of this drug is the joint action of enrofloxacin and its metabolite ciprofloxacin in animals , which is also an important reason why this drug is better than other similar drugs and is widely used in animals. [0003] Because enrofloxacin itself has a strong bitter taste, when it is used as an oral dosage form, the tolerated dose of animals is relatively low, so it is generally administered in the form of injectio...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/496A61K47/22A61P31/04
Inventor 曾富强詹素琼袁定胜李金良李旭廷曹良
Owner 四川鼎尖动物药业有限责任公司
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