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Tigecycline-containing sterile packaged preparation for injection

A technology for tigecycline and injection, which is applied in the direction of tetracycline active ingredients, antibacterial drugs, powder delivery, etc. It can solve the problems of unclean protein removal, increased allergic reactions, life-threatening, etc., and achieves simple preparation process and long shelf life. , high safety effect

Active Publication Date: 2010-12-22
SHIJIANGZHUANG ZHIHENG PHARMACY TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Adding the excipient lactose will make the stability better, but lactose is derived from milk, which may contain protein that cannot be removed, which will increase the allergic reaction
Anaphylaxis is a serious adverse reaction that can be life-threatening

Method used

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  • Tigecycline-containing sterile packaged preparation for injection
  • Tigecycline-containing sterile packaged preparation for injection
  • Tigecycline-containing sterile packaged preparation for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] Embodiment 1, preparation of tigecycline solvent crystalline solid (sterile raw material)

[0049] Weigh 10g of tigecycline crude product into the reaction flask, add 10ml of methanol and 10ml of acetone mixed solution, keep stirring at 25°C for 1 hour, then slowly cool down to 0°C, keep stirring at 0°C for 1 hour, sterile filter, use A small amount of cold acetone and methanol mixed solution (1:1) washed the filter cake, and dried under reduced pressure to obtain a primary refined product.

[0050] Weigh 5g of the above primary refined product, add 250ml of dichloromethane, stir, heat and reflux for half an hour, filter aseptically, filter out the insoluble matter, and use the filtrate for later use. Slowly stir and cool the filtrate to 0°C until crystallization occurs, then continue to stir at 0°C for 4 hours , sterile filtered, washed with a small amount of cold dichloromethane, and dried under reduced pressure to obtain the sterile raw material of tigecycline.

Embodiment 2

[0051] Embodiment 2, preparation of tigecycline hydrochloride solvent crystalline solid (sterile raw material)

[0052]Weigh the fine tigecycline into the reaction kettle, add dichloromethane at a volume ratio of 1:12; keep stirring at 25°C for 1 hour, add hydrogen chloride methanol solution at a molar ratio of 1:1.1, continue stirring for 3 hours, and remove Bacterial filtration, drying under reduced pressure to obtain sterile raw material of tigecycline hydrochloride.

Embodiment 3

[0053] Embodiment 3, preparation of tigecycline hydrochloride solvent crystalline solid (sterile raw material)

[0054] Weigh the tigecycline fine product into the reaction kettle, add 2-butanone at a volume ratio of 1:10; keep stirring at 25°C for 1 hour, add concentrated hydrochloric acid at a molar ratio of 1:1, continue stirring for 4 hours, and remove Bacterial filtration, drying under reduced pressure to obtain sterile raw material of tigecycline hydrochloride.

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PUM

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Abstract

The invention belongs to the field of pharmaceuticals and relates to a tigecycline-containing sterile packaged preparation for injection. The sterile powder of tigecycline is prepared by a solvent crystallization method. Each preparation contains 10 to 500mg of sterile powder of tigecycline or sterile powder of tigecycline salt.

Description

technical field [0001] The invention belongs to the field of pharmacy and relates to an injection-used aseptic packaging preparation containing tigecycline. Background technique [0002] Tigecycline, a tetracycline antibiotic that is an analog of minocycline, is used against resistant bacteria and has been found to be effective when other antibiotics have failed. Such as methicillin-resistant Staphylococcus aureus, penicillin-resistant Streptococcus pneumoniae, vancomycin-resistant Enterococcus, etc., which are still active. [0003] Tigecycline is an antibiotic with broad-spectrum antibacterial activity. However, tigecycline is not very stable. The patent CN200680021384.9 applied by Wyeth pointed out that tigecycline is difficult to manufacture because it is easy to degrade (including oxidative degradation by atmospheric oxygen) and easy to form epimers. In the preparation process of tigecycline for injection, it is necessary to dissolve tigecycline in water that is sparg...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K31/65A61P31/04
Inventor 路翠罗王颖赵军旭
Owner SHIJIANGZHUANG ZHIHENG PHARMACY TECH CO LTD
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