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Gamithromycin injection and preparation method thereof

A technology of gamimycin and injection, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., which can solve cumbersome operations, increase of gamimycin degradation impurities, and production cycle Long and other problems, to achieve the effect of easy crystallization

Pending Publication Date: 2021-07-20
BAODING JIZHONG PHARMA +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Unfortunately, when researching products prepared by this recipe process, it was found that the sterilization process resulted in a darker product color and an increase in gaminomycin-degraded impurities
CN 103494780B discloses a freeze-dried powder injection of gamithromycin composition. Although the method overcomes the defects of high viscosity in clinical use and difficult suction and injection of syringes, it is also conducive to improving the stability of gamithromycin , but the freeze-drying process requires high energy consumption, long production cycle, and high cost. It needs to be reconstituted before clinical use, and the operation is cumbersome

Method used

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  • Gamithromycin injection and preparation method thereof
  • Gamithromycin injection and preparation method thereof
  • Gamithromycin injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Embodiment 1 prepares gamimycin injection

[0021] prescription:

[0022]

[0023] Preparation:

[0024] (1) Take 3000ml of ethanol, heat it to 54-56°C, add the prescribed amount of gamimycin, stir to dissolve it, and set aside;

[0025] (2) Add the sulfobutyl ether-beta-cyclodextrin of prescription quantity in 800ml water for injection, stir to make it dissolve; Slowly add it in the gamimycin ethanol solution that step (1) makes, in Inclusion reaction at 54-56°C for 2 hours.

[0026] (3) remove excess ethanol under reduced pressure, and adopt gas chromatography to detect the content of ethanol in the medicinal liquid, cool to room temperature after the ethanol content meets prescription regulations, add the thioglycerol of prescription quantity, water for injection is settled to 1000ml, Add 2 g of activated carbon for needles, stir for 15 minutes, and filter.

[0027] (4) The drug solution is packaged separately, filled with nitrogen, sealed with a gland, and st...

Embodiment 2

[0028] Embodiment 2 prepares gamimycin injection

[0029] prescription:

[0030]

[0031] Preparation:

[0032] (1) Take 2000ml of ethanol, heat it to 52-55°C, add the prescribed amount of gamimycin, stir to dissolve it, and set aside;

[0033] (2) Add the hydroxypropyl-beta-cyclodextrin of prescription quantity in 800ml water for injection, stir and make it dissolve; Slowly add it in the gamimycin ethanol solution that step (1) makes, at 52 Inclusion reaction at -55°C for 2.2 hours.

[0034] (3) Remove excess ethanol by steaming under reduced pressure, and adopt gas chromatography to detect the content of ethanol in the medicinal liquid. When the ethanol content meets the prescription requirements, cool down to room temperature, add the sodium pyrosulfite of the prescription amount, and set the volume to 1000ml with water for injection, add 2g of activated carbon for needles, stirred for 15 minutes, and filtered.

[0035] (4) The drug solution is packaged separately, f...

Embodiment 3

[0036] Embodiment 3 prepares gamimycin injection

[0037] prescription:

[0038]

[0039] Preparation:

[0040] (1) Take 2500ml of ethanol, heat it to 55-58°C, add the prescribed amount of gamimycin, stir to dissolve it, and set aside;

[0041] (2) Add the prescribed amount of sulfobutyl ether-β-cyclodextrin and hydroxypropyl-β-cyclodextrin to 800ml of water for injection in turn, stir to dissolve it; slowly add it to step (1) The obtained gamimycin ethanol solution was subjected to inclusion reaction at 55-58° C. for 2.5 hours.

[0042] (3) remove excess ethanol under reduced pressure, and adopt gas chromatography to detect the content of ethanol in the medicinal liquid, cool to room temperature after the ethanol content meets prescription regulations, add the thioglycerol of prescription quantity, water for injection is settled to 1000ml, Add 2 g of activated carbon for needles, stir for 15 minutes, and filter.

[0043] (4) The medicinal liquid is packaged separately,...

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Abstract

The invention discloses gamithromycin injection and a preparation method thereof, and belongs to the technical field of veterinary pharmaceutical preparations. The gamithromycin injection comprises the following components: gamithromycin, an inclusion agent, an antioxidant, ethanol and water for injection, wherein the inclusion agent is hydroxypropyl-beta-cyclodextrin or sulfobutyl ether-beta-cyclodextrin. According to the injection prepared by carrying out an inclusion reaction on the gamithromycin and the inclusion agent to form an inclusion compound, the defect that the gamithromycin is insoluble in water is overcome, the defects that the gamithromycin injection is easy to crystallize, poor in stability, high in viscosity and serious in animal stress reaction are overcome, and product storage and clinical application are facilitated.

Description

technical field [0001] The invention belongs to the field of veterinary pharmaceutical preparations, and relates to an injection and a preparation method thereof, in particular to a gamimycin injection and a preparation method thereof. Background technique [0002] Gamithromycin (Gamithromycin) is a new generation of semi-synthetic, 15-membered azamacrolide antibacterial drug, which was developed into veterinary injection (trade name Zactran) by Merial of France. In 2010 and 2011, it was approved by the European Medicines Agency (EMA), the Canadian Health Products and Food Administration (HPFB) and the U.S. Food and Drug Administration (FDA) for the prevention and treatment of Mannella hemolyticus, Pasteurella multocida and Respiratory disease in cattle caused by Histophilia somniferus. In 2016, EMA extended the scope of application of gamimycin injection to pigs and sheep for the prevention and treatment of porcine respiratory diseases caused by Actinobacillus pleuropneumo...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/7052A61K47/69A61K47/02A61K47/20A61P31/04
CPCA61K31/7052A61K9/0019A61K9/08A61K47/6951A61K47/20A61K47/02A61P31/04
Inventor 岳永波李伟岭杨芳刘波吴鹏飞罗妍赵盼王金阳
Owner BAODING JIZHONG PHARMA
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