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Gamithromycin injection and preparation method thereof

A gamimycin and injection technology, which is applied in the direction of pharmaceutical formula, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problem of high irritation at the injection site, high production cost, complicated process, etc. problem, to achieve the effect of remarkable effect, stable property and simple process

Active Publication Date: 2013-12-25
TIANJIN ZHONGSHENG TIAOZHAN BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Gamithromycin (Gamithromycin), trade name Zactran, belongs to the macrolide antibiotics, mainly used in the treatment of cattle infections caused by bacterial pathogens such as Pasteurella hemolytica, Pasteurella multocida and histophilia disease, has the advantages of fast absorption, wide distribution in the body, low residual in the body, and high safety, and has no adverse reaction reports, and has broad application prospects in veterinary clinics. It is produced by the French Merial Company. A preparation method of garamimycin, which is insoluble in water, and currently approved to use glycerin as a solvent injection (containing 150mg / mL garamimycin), that is, using glycerin as a solvent and succinic acid as a cosolvent, Thioglycerol is used as a preservative. However, glycerin as a solvent is more irritating to the injection site, and the production cost is higher and the process is complicated. Therefore, it is very important to develop a water-soluble injection of gamithromycin.

Method used

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  • Gamithromycin injection and preparation method thereof

Examples

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Effect test

Embodiment 1

[0022] A kind of gamimycin injection, is made up of gamimycin, phosphoric acid, sodium bisulfite and water for injection, wherein in every 100ml solution, gamimycin 15g, phosphoric acid 5ml, sodium bisulfite 0.5g, all the other are Water for injection, its preparation method comprises the following steps:

[0023] (1) Dissolve phosphoric acid in water for injection;

[0024] (2) Continue to add gamimycin and stir to dissolve it;

[0025] (3) Then add sodium bisulfite, adjust the pH to 6.0 with NaOH, constant volume, filter, and sterilize.

Embodiment 2

[0027] A kind of gamimycin injection, is made up of gamimycin, phosphoric acid, sodium thiosulfate and water for injection, wherein in every 100ml solution, gamimycin 25g, phosphoric acid 9ml, sodium thiosulfate 0.2g, all the other are Water for injection, its preparation method comprises the following steps:

[0028] (1) Dissolve phosphoric acid in water for injection;

[0029] (2) Continue to add gamimycin and stir to dissolve it;

[0030] (3) Then add sodium thiosulfate, adjust the pH to 5.0 with NaOH, constant volume, filter, and sterilize.

Embodiment 3

[0032] A gamimycin injection, composed of gamimycin, phosphoric acid, sodium pyrosulfite and water for injection, wherein in every 100ml solution, 35g of gamimycin, 15ml of phosphoric acid, 0.1g of sodium pyrosulfite, and the rest are water for injection, and The preparation method comprises the following steps:

[0033] (1) Dissolve phosphoric acid in water for injection;

[0034] (2) Continue to add gamimycin and stir to dissolve it;

[0035] (3) Then add sodium metabisulfite, adjust the pH to 4.0 with NaOH, constant volume, filter, and sterilize.

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Abstract

The invention discloses a gamithromycin injection and a preparation method thereof. The gamithromycin injection is prepared from the components including gamithromycin, a cosolvent, an antioxidant and water for injection, and is characterized by comprising 5-35 g of gamithromycin, 1-15 ml of the cosolvent, 0.1-0.5 g of the antioxidant and the balance of water for injection in every 100 ml injection. The preparation method comprises the steps as follows: dissolving the cosolvent in the water for injection, continuously adding gamithromycin and stirring to enable the gamithromycin to be dissolved, then adding the antioxidant to adjust pH to be 4.0-6.0, filtering and sterilizing, so that the gamithromycin injection is obtained. The gamithromycin injection is stable in properties, fast in absorption, remarkable in effect and simple in the preparation method, has less irritation to an injection part, effectively solves the problem that the gamithromycin is indissolvable in water, and meets the requirement of mass industrial production.

Description

technical field [0001] The invention relates to a traditional Chinese medicine composition and a preparation method thereof, in particular to a gamimycin injection and a preparation method thereof. Background technique [0002] Gamithromycin (Gamithromycin), trade name Zactran, belongs to the macrolide antibiotics, mainly used in the treatment of cattle infections caused by bacterial pathogens such as Pasteurella hemolytica, Pasteurella multocida and histophilia disease, has the advantages of fast absorption, wide distribution in the body, low residual in the body, and high safety, and has no adverse reaction reports, and has broad application prospects in veterinary clinics. It is produced by the French Merial Company. A preparation method of garamimycin, which is insoluble in water, and currently approved to use glycerin as a solvent injection (containing 150mg / mL garamimycin), that is, using glycerin as a solvent and succinic acid as a cosolvent, Thioglycerol is used as ...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/7052A61K47/04A61P31/04
Inventor 王猛王勇程雪娇王建朱士江焦晓军焦伟丽余贵菊姜淋洁甄盼盼
Owner TIANJIN ZHONGSHENG TIAOZHAN BIOTECH
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