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Preparation method of azalide type tulathromvcin injection

A turamycin and injection technology, which is applied in the field of preparation of azacyclic lactone-containing turamycin injection, can solve the problems of long administration time, obvious drug resistance and the like, and achieves fewer administration times, Reduce stress response

Inactive Publication Date: 2009-04-29
PU LIKE BIO ENG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, most of the existing macrolide drugs take a long time to administer, and the drug resistance is obvious

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] 1) Add an appropriate amount of water for injection into the stainless steel liquid mixing tank, and start stirring;

[0031] 2) Add 5100 g of 10% (w / w) hydrochloric acid solution and stir evenly;

[0032] 3) Slowly add 104g tulamycin, stir until dissolved and continue stirring;

[0033] 4) Add 10% (w / w) hydrochloric acid aqueous solution to adjust the pH value to 7.0, and heat the solution to 60°C for about 30 minutes;

[0034] 5) When the solution drops to 25°C, add 500g of propylene glycol and stir evenly;

[0035] 6) Add 10% (w / w) hydrochloric acid aqueous solution to make the pH value reach 5.4, add 5g phenol as preservative;

[0036] 7) adding water for injection to adjust the solution to 1000mL preparation;

[0037] 8) Filter through a 5 micron filter first, then through a 0.45 micron filter;

[0038] 9) The filtered preparation is potted, and sterilized at 121° C. for 30 minutes by a moist heat autoclaving method.

Embodiment 2

[0040] 1) Add an appropriate amount of water for injection into the stainless steel liquid mixing tank, and start stirring;

[0041] 2) Add 5100 g of 10% (w / w) hydrochloric acid solution and stir evenly;

[0042] 3) Slowly add 208g tulamycin, stir until dissolved and continue stirring;

[0043] 4) Add 10% (w / w) hydrochloric acid aqueous solution to adjust the pH value to 7.0, and heat the solution to 70°C for about 15 minutes;

[0044] 5) When the solution drops to 25°C, add 500g of propylene glycol and stir evenly;

[0045] 6) Add 10% (w / w) hydrochloric acid aqueous solution to make the pH value reach 5.4, add 10g phenol as preservative;

[0046] 7) adding water for injection to adjust the solution to 1000mL preparation;

[0047] 8) Filter through a 10 micron filter first, then through a 0.45 micron filter;

[0048] 9) The filtered preparation is potted, and sterilized at 121° C. for 30 minutes by a moist heat autoclaving method.

Embodiment 3

[0050] 1) Add an appropriate amount of water for injection into the stainless steel liquid mixing tank, and start stirring;

[0051] 2) Add 5100 g of 10% (w / w) citric acid solution and stir evenly;

[0052] 3) Slowly add 154g tulamycin, stir until dissolved and continue stirring;

[0053] 4) Add 10% (w / w) citric acid aqueous solution to adjust the pH value to 6.5, and heat the solution to 65°C for about 20 minutes;

[0054] 5) When the solution drops to 25°C, add 500g of propylene glycol and stir evenly;

[0055] 6) Add 10% (w / w) citric acid aqueous solution to make the pH value reach 5.4, add 5g benzyl alcohol preservative;

[0056] 7) adding water for injection to adjust the solution to 1000mL preparation;

[0057] 8) Filter through a 7 micron filter and then through a 0.45 micron filter;

[0058] 9) The filtered preparation is potted, and sterilized at 121° C. for 30 minutes by a moist heat autoclaving method.

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PUM

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Abstract

The invention relates to a preparation method of an injection containing azalide tulathromycin; the injection consists of tulathromycin, hydrochloric acid, propylene glycol, phenol and water used for injection. The preparation method comprises the steps of: adding a proper amount of the water used for injection into a stainless-steel liquid distributing tank, adding 5100g of a 10-percent (w / w) hydrochloric-acid water solution and stirring the solution evenly, slowly adding 104g to 208g of the tulathromycin into the solution, stirring the solution till the tulathromycin is dissolved, adding the 10-percent (w / w) hydrochloric-acid water solution to adjust the pH value to be 4.0 to 7.0, heating the solution to the temperature of 60 DEG C to 70 DEG C for 10min to 30min, adding and evenly stirring 500g of propylene glycol (a cosolvent) when the temperature reaches 25 DEG C, adding the 10-percent (w / w) hydrochloric-acid water solution to regulate the pH value to reach 5.4, adding 5g to 10g of the phenol as a preservative, adding the water used for injection till the total volume of the solution is adjusted to be 1000ml, filtering the solution by a 5-to-10-micron filter and a 0.45-micron filter in sequence, encapsulating the filtered preparation and sterilizing the preparation by a wet-heat high-pressure sterilizing method for 30min at the temperature of 121 DEG C.

Description

technical field [0001] The invention belongs to the technical field of veterinary medicines, and in particular relates to a preparation method of an injection containing nitrogen heterocyclic lactone tulamycin. Background technique [0002] Macrolide antibiotics are effective against a wider range of diseases in mammals caused by bacterial infections. Such as bovine and porcine respiratory diseases, such as Actinobacillus pleuropneumoniae, Pasteurella hemolytica, Pasteurella multocida, Histophilus somnus, Haemophilus somnus, Mycoplasma pneumoniae, Haemophilus parasuis, bronchiectasis Bordetella haemorrhoids, etc. However, most of the existing macrolide drugs are given for a long time, and the drug resistance is obvious. Contents of the invention [0003] In order to solve the above problems, the present invention proposes a preparation method containing azalide tulamycin injection, which utilizes macrolide antibiotics to inhibit microbial in vivo Protein synthesis, with...

Claims

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Application Information

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IPC IPC(8): A61K31/7056A61K9/08A61K47/10A61K47/22A61K47/34A61P31/04
Inventor 刘兴金张许科张晓会谷志勇杨会鲜蔡敏李向阳马占俊
Owner PU LIKE BIO ENG
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