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Tildipirosin injection and preparation method thereof

A technology for tediloxine and injection, which is applied in pharmaceutical formulations, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc. It can solve the problems of unstable chemical properties, limited clinical application, temperature sensitivity, etc. , to achieve the effects of cheap raw materials, broad application prospects and stable formulation properties

Inactive Publication Date: 2016-09-07
SHANGHAI TONGREN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The drug has many advantages such as animal-specific, less dosage, one-time administration, full treatment, super long elimination half-life, high bioavailability, low residue, etc., but its chemical properties are unstable and difficult to dissolve in water. Contains a double bond structure, so Tedirosin is sensitive to light and temperature, which greatly limits its clinical application

Method used

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  • Tildipirosin injection and preparation method thereof
  • Tildipirosin injection and preparation method thereof
  • Tildipirosin injection and preparation method thereof

Examples

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preparation example Construction

[0028] The preparation method of Tediroxin injection of the present invention, its main feature is that described preparation method comprises the following steps:

[0029] Step (1): Take the tedirosin according to the mass percentage, mix and dissolve it with the propylene glycol to obtain the first solution;

[0030] Step (2): Dissolve the pH adjuster in an appropriate amount of water to obtain the second solution;

[0031] Step (3): adding the second solution into the first solution, stirring evenly and adjusting the pH to about 4-7;

[0032] Step (4): add water for injection to 100%, and filter through a microporous membrane;

[0033] Step (5): filling in aseptic workshop.

[0034] Wherein said tediroxin injection is aseptic filling.

Embodiment 1

[0036] Weigh each raw material with the following mass percentage (take the total amount as 100mL as an example):

[0037]

[0038] Take the prescribed amount of propylene glycol and add the prescribed amount of Tedirosin to dissolve; add the prescribed amount of citric acid water to adjust the pH to about 4-7, add water for injection to 100%, filter and divide to obtain the Tedirosin injection.

Embodiment 2

[0040] Weigh each raw material with the following mass percentage (take the total amount as 100mL as an example):

[0041]

[0042] Take the prescribed amount of propylene glycol and add the prescribed amount of Tedirosin to dissolve; add the prescribed amount of citric acid water to adjust the pH to about 4-7, add water for injection to 100%, filter and divide to obtain the Tedirosin injection.

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PUM

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Abstract

The invention relates to a tildipirosin injection. The injection comprises the following components in percentages by mass: 4-20% of tildipirosin, 1-9% of a pH regulator, 30-50% of an organic solvent, and the balance of water for injection, the sum of the mass percentages of the components is 100%. The invention also relates to a preparation method of the tildipirosin injection. By the tildipirosin injection and the preparation method thereof, a preparation technology is simple, raw materials are low in cost and easy to obtain, and the properties of a preparation are stable. The tildipirosin injection is suitable for industrial mass production, and therefore, the application prospect is wide.

Description

technical field [0001] The invention relates to the technical field of veterinary antibiotics, in particular to a macrolide semi-synthetic antibiotic veterinary pharmaceutical preparation, specifically a Tediroxin injection and a preparation method thereof. Background technique [0002] Tildipirosin is the latest animal-specific macrolide semi-synthetic antibiotic developed by foreign companies, and it is a derivative of tylosin. On March 8, 2011, the European Commission for Veterinary Medicines (CVMP) approved the market authorization application of Intervet's sterile injection solution (trade name Zuprevo) with Tedirosin as the main component. At present, the high incidence and mortality of respiratory diseases are the primary problems faced by the global pig and cattle breeding industry. During the breeding process, the global losses caused by respiratory diseases are as high as more than 300 million US dollars. Tedirosin is a broad-spectrum antibacterial drug, which has...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/10A61K47/12A61K31/706A61P31/04
CPCA61K9/08A61K9/0019A61K31/706A61K47/10A61K47/12
Inventor 何林华程飞秦佳琪
Owner SHANGHAI TONGREN PHARM CO LTD
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