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Injection tildipirosin composition freeze-dried powder and method for preparing same

A technology of tediloxine and a composition, which is applied in the field of freeze-dried powder of tediloxine composition for injection and its preparation, can solve the problems of high gastrointestinal irritation, low bioavailability, high temperature instability, etc. Easy to store and use, improve water solubility and high stability

Inactive Publication Date: 2016-11-09
QILU ANIMAL HEALTH PROD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Currently, Tedirosin Injection There are the following disadvantages: unstable to high temperature, in the production process because it cannot tolerate high temperature, only filter sterilization process can be used, and the temperature requirement is high in the process of transportation, storage and use; non-aqueous solvent accounts for about 50% in the injection The ratio and viscosity are relatively high, the preparation production and filtration process takes a long time, and the requirements for the filtration system are high; in clinical use, the operation of syringe suction and injection site administration is difficult, and the animal injection site is painful and irritating.
However, the oral dosage form has the disadvantages of low bioavailability and greater irritation to the gastrointestinal tract

Method used

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  • Injection tildipirosin composition freeze-dried powder and method for preparing same
  • Injection tildipirosin composition freeze-dried powder and method for preparing same
  • Injection tildipirosin composition freeze-dried powder and method for preparing same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] A lyophilized powder of Tedirosin composition for injection, which is prepared by freeze-drying the raw material liquid, and each liter of the raw material liquid is composed of the following components:

[0041] Tedirosin 4g, citric acid 0.9g, mannitol 6g, lactose 3g; sodium hydroxide to adjust the pH value to 4.8, water for injection to 100ml.

[0042] The preparation method of the above-mentioned Tedirosin composition freeze-dried powder for injection, the steps are as follows:

[0043] Take the prescribed amount of Tedirosin, citric acid, mannitol, and lactose, add it to the prescribed amount of water for injection, stir to dissolve, then adjust the pH value to 4.8 with sodium hydroxide, and filter it with a 0.22 μm filter membrane. Aseptically dispense 10ml per bottle. Then, first lower the temperature to -40°C, and maintain the low temperature for 2 hours, so that the samples are fully frozen, and then turn on the vacuum system, so that the vacuum degree of the f...

Embodiment 2

[0045]A lyophilized powder of Tedirosin composition for injection, which is prepared by freeze-drying the raw material liquid, and each liter of the raw material liquid is composed of the following components:

[0046] Tedirosin 4g, L-malic acid 1g, mannitol 8.5g; sodium hydroxide to adjust the pH value to 5.2, water for injection to 100ml.

[0047] The preparation method of the above-mentioned Tedirosin composition freeze-dried powder for injection, the steps are as follows:

[0048] Take the prescribed amount of Tedirosin, L-malic acid, and mannitol, add it to the prescribed amount of water for injection, stir to dissolve, then adjust the pH value to 5.2 with sodium hydroxide, filter aseptically with a 0.22 μm filter membrane, press Each bottle is aseptically subpackaged in 10 ml, and the freeze-drying step is the same as that in Example 1.

Embodiment 3

[0050] A lyophilized powder of Tedirosin composition for injection, which is prepared by freeze-drying the raw material liquid, and each liter of the raw material liquid is composed of the following components:

[0051] Tedirosin 18g, DL-tartaric acid 1.2g, mannitol 4g; adjust the pH value to 5.1 with sodium hydroxide, and dilute the volume to 100ml with water for injection.

[0052] The preparation method of the above-mentioned Tedirosin composition freeze-dried powder for injection, the steps are as follows:

[0053] Take the prescribed amount of Tedirosin, DL-tartaric acid, and mannitol, add it to the prescribed amount of water for injection, stir to dissolve, then adjust the pH value to 5.1 with sodium hydroxide, filter aseptically with a 0.22 μm filter membrane, and press each Bottles of 10ml aseptically dispensed. Then, first lower the temperature to -30°C and maintain the low temperature for 3 hours to fully freeze the sample, then turn on the vacuum system to make the...

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Abstract

The invention relates to injection tildipirosin composition freeze-dried powder and a method for preparing the same. The injection tildipirosin composition freeze-dried powder is characterized in that raw material liquid is subjected to freeze-drying to obtain the injection tildipirosin composition freeze-dried powder and comprises tildipirosin, organic acid and excipients. The injection tildipirosin composition freeze-dried powder and the method have the advantages that the sterile injection tildipirosin composition freeze-dried powder can be prepared by the aid of the method and can be dissolved in sterile physiological saline to obtain solution during clinical use, the solution is low in viscosity and easy to suck and inject, the injection tildipirosin composition freeze-dried powder is easy and convenient to clinically use and little in irritation on animals, and accordingly the service stability, safety and convenience of the injection tildipirosin composition freeze-dried powder can be improved.

Description

technical field [0001] The invention relates to a tedirosin composition freeze-dried powder for injection and a preparation method thereof, belonging to the technical field of veterinary injection preparations. Background technique [0002] Tedirosin is the latest macrolide semi-synthetic antibiotic for animals, which is a derivative of tylosin. Tedirosin is a broad-spectrum antibacterial drug. Its mechanism of action is the same as that of other macrolides. It can bind to the ribosomal 50S subunit of sensitive bacteria and inhibit transpeptidation and / or mRNA displacement. The synthesis and extension of peptide chains affect the synthesis of bacterial proteins, and then play a bacteriostatic and bactericidal role. Tedirosin macrolide ring on C 20 and C 30 There are two piperidinyl groups on C 5 There is a carbonyl aminoglycoside on it, Tedirosin is the world's first macrolide antibiotic with these three amino substituents, these three special groups make Tedirosin more ...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/706A61K47/12A61K47/26A61P31/04A61P11/00
CPCA61K9/19A61K9/0019A61K31/706A61K47/12A61K47/26
Inventor 王海挺邹宇云史春云王甜王金美孔梅吴连勇
Owner QILU ANIMAL HEALTH PROD
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