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Prepnaring method for freeze dried tigecycline powder for injection

A technology of tigecycline and freeze-dried powder injection, which is applied in the field of preparation of freeze-dried powder injection for injection, and can solve the problems of high antioxidant efficiency, not worth promoting, and compatibility changes

Inactive Publication Date: 2007-06-27
合肥信风科技开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The preparation of tigecycline freeze-dried powder for injection uses water for injection as a solvent. Because there is a large amount of oxygen in the water, tigecycline is easily oxidized during the preparation. If the method of adding antioxidants is used to solve the problem of oxidative degradation , there will be the following two problems: 1. The type of antioxidant selected, the selected antioxidant must have the characteristics of solubility, low dosage, and high antioxidant efficiency, and at the same time cannot produce compatibility changes with this product; 2. Safety In order to solve the sex problem, the selected antioxidant should not only have the characteristics of general injection medicine excipients, but also require that the product after redox reaction must be non-toxic and harmless to the human body. The selected antioxidant should be non-irritating to blood and blood vessels to ensure drug safety
The application of antioxidants in preparations, especially injections, generally has certain potential safety hazards in clinical medication.
Therefore, it is not worth advocating to use the method of adding antioxidants to solve the problem of oxidative degradation.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Take 200ml of water for injection at a temperature of 20±1°C, and inject clean CO into the liquid 2 Gas for about 15 minutes, add 5 g of tigecycline, stir gently until it is completely dissolved, add 200 mg (0.1% water for injection volume) of activated carbon for needles, and continue to pass clean CO into the solution. 2 Gas and maintain a low-speed uniform stirring state for 30 minutes, rough filter decarbonization, and then filter through a 0.45μm microporous membrane, and continue to pass clean CO into the filtrate 2 The gas is filtered through a 0.22μm microporous membrane for about 10 minutes, and is divided into 10ml controlled antibiotic bottles with a filling volume of 2.0ml / bottle. After 4 hours of pre-freezing, it is placed in a freeze dryer for 36 hours of freeze-drying, capped, and tied. Aluminum cap.

Embodiment 2

[0019] Take 300ml of water for injection at a temperature of 16±1°C, and inject clean N into the liquid. 2 Gas for about 30 minutes, add 5 g of tigecycline, stir gently until it dissolves completely, add 300 mg (0.1% water for injection volume) of activated carbon for needles, continue to pass through the solution with clean N 2 and maintain a low-speed uniform stirring state for 20 minutes, coarsely filter and decarbonize, and then filter through a 0.45μm microporous membrane, and continue to pass clean N into the filtrate. 2 Air for about 30 minutes, filter through a 0.22μm microporous membrane, pack in 10ml controlled antibiotic bottles, the filling volume is 3.0ml / bottle, after 5 hours of pre-freezing, enter the freeze dryer for 36 hours of freeze-drying, press the cap, tie Aluminum cap.

Embodiment 3

[0021] Take 80ml of water for injection at a temperature of 13±1°C, and inject clean CO into the liquid 2 Gas for about 15 minutes, add 2.0 g of tigecycline, stir gently until it is completely dissolved, add 80 mg (0.1% volume of water for injection) of activated carbon for needles, and continue to pass clean CO into the solution. 2 Gas and maintain a low-speed uniform stirring state for 30 minutes, rough filter decarbonization, and then filter through a 0.45μm microporous membrane, and continue to pass clean CO into the filtrate 2 The gas is filtered through a 0.22μm microporous membrane for about 10 minutes, and is divided into 10ml controlled antibiotic bottles with a filling volume of 4.0ml / bottle. After 4 hours of pre-freezing, it is placed in a freeze dryer for 48 hours of freeze-drying, capped, and tied. Aluminum cap.

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PUM

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Abstract

The present invention relates to preparation process of freeze dried tigecycline powder for injection. The preparation process includes the following steps: introducing clean treated air into water for injection at 5-30deg.c to replace its oxygen, adding tigecycline through stirring for dissolving, adding active carbon for injection in 0.1 g / 100ml while further introducing clean air and stirring for 15-30 min, coarse filtering to eliminate active carbon, filtering with 0.45 micron microporous membrane, introducing clean air into the filtrate, filtering with 0.22 micron microporous membrane, packing in 5-15 ml size antibiotic ampoule, pre-freezing for 3-6 hr, freeze drying for 24-48 hr, covering, and rolling aluminum cap. The present invention has raised clinical safety.

Description

technical field [0001] The invention relates to a preparation method of freeze-dried powder for injection, in particular to a preparation method of Tigecycline freeze-dried powder for injection. Background technique [0002] Tigecycline is a new class of antibiotics—glycylcycline (glycylcycline), which is mainly used to treat infections caused by Gram-negative and positive pathogens, anaerobic bacteria, methicillin-resistant Staphylococcus aureus (MRSA) and Complicated intra-abdominal infection, skin and skin tissue infection (cSSSI), pneumococcal infection, etc. caused by methicillin-sensitive Staphylococcus aureus (MSSA) infection. This product was successfully developed by Wyeth, and was approved for marketing in the United States for the first time in July 2005. The dosage form is freeze-dried powder injection for injection. The dosage for clinical usage is that the patient first injects 100 mg of this product intravenously, and then injects 50 mg every 12 hours. . Tig...

Claims

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Application Information

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IPC IPC(8): A61K31/65A61K9/08A61K9/19A61P31/04A61J3/00
Inventor 宗国军高嵩查大俊钟成勤
Owner 合肥信风科技开发有限公司
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