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Substance conformation of tigecycline and method for preparing same

A tigecycline and substance technology, applied in the field of tigecycline's substance form and its preparation, can solve problems such as easy oxidation, difficulty in ensuring stability, unstable properties of tigecycline, etc., and achieve the goal of reducing toxic and side effects Effect

Inactive Publication Date: 2008-03-05
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

In order to remove the organic solvents contained therein, various methods for removing organic solvents are often used, but because tigecycline itself is unstable and easy to oxidize, it is difficult to ensure that the usual organic solvent removal methods can remove both organic solvents and ensure its stability

Method used

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  • Substance conformation of tigecycline and method for preparing same

Examples

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Effect test

Embodiment 1

[0019] Example 1 Take 100ml of water for injection at a temperature of 18.5°C, and inject clean CO into the liquid. 2 Gas for about 15 minutes, add 2.5g of the initial product of tigecycline, stir gently until it is completely dissolved, add 100mg (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 for about 15 minutes, filtered through a 0.22 μm microporous membrane, moved to a disk, pre-frozen for 4 hours, and then freeze-dried for 36 hours in a freeze dryer to obtain the product.

Embodiment 2

[0020] Example 2 Take 100ml of water for injection at a temperature of 21.3°C, and inject clean N 2 Gas for about 15 minutes, add 2.5 g of tigecycline, stir gently until it dissolves completely, add 100 mg (0.1% volume of water for injection) of activated carbon for needles, continue to pass through the solution with clean N 2 and maintain a low-speed uniform stirring state for 120 minutes, coarsely filter and decarbonize, and then filter through a 0.45μm microporous membrane, and continue to pass clean N into the filtrate. 2 Inhale for about 120 minutes, filter through a 0.22 μm microporous membrane, move to a disk, pre-freeze for 5 hours, and freeze-dry for 36 hours in a freeze dryer to obtain the product.

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Abstract

The present invention relates to the matter form and preparation process of tigecycline. The amorphous tigecycline is prepared through the following steps: taking water for injection at proper temperature and introducing clean air to replace oxygen dissolved in water, adding tigecycline through slight stirring for dissolving, adding proper amount of active carbon for injection while introducing clean air, filtering to eliminate active carbon, introducing clean air to the filtrate, filtering in microporous filter membrane, pre-cooling, and freeze drying. Thus prepared amorphous tigecycline contains no organic solvent and no organic solvent caused side effect.

Description

technical field [0001] The invention relates to a substance form of tigecycline and a preparation method thereof, in particular to an amorphous substance (non-crystal) of tigecycline and a preparation method thereof. technical background [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 for the first time, and was first approved for marketing in the United States in July 2005 in the form of lyophilized powder for injection (specification 50 mg). [0003] Tigecycline is an orange-yellow powder, and it has various crystal forms. Because different organic solv...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07C237/26C07C231/24
Inventor 宗国军查大俊高嵩
Owner 合肥信风科技开发有限公司
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