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Novel filling mixed shielding gas of sterile powder used for injection

A technology of sterile powder and protective gas, which is applied in powder transportation, antibacterial drugs, drug combination, etc., and can solve the problems affecting the preservation and validity period of antibiotic preparations, poor chemical stability, etc.

Pending Publication Date: 2021-09-07
郎俊娜
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The clinical effect of ceftazidime avibactam sodium for injection has been verified and affirmed, but the chemical stability of the two main components of ceftazidime avibactam sodium for injection is poor, which affects the preservation and validity period of this antibiotic preparation

Method used

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  • Novel filling mixed shielding gas of sterile powder used for injection
  • Novel filling mixed shielding gas of sterile powder used for injection
  • Novel filling mixed shielding gas of sterile powder used for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] The prescription adopted is: ceftazime pentahydrate / sodium carbonate mixture 2.635g (equivalent to ceftazime 2g); avibactam sodium 0.551g (equivalent to avibactam 0.5g); 2.635g ceftazime pentahydrate / sodium carbonate mixture contains Sodium carbonate 239.6 mg.

[0017] Process method: Weigh according to the above prescription, put into bottles of suitable size (such as 20ml vials), fill with protective gas, stopper and cover. Wherein, the protective gas composition is a volume ratio of nitrogen: carbon dioxide = 80:20.

Embodiment 2

[0019] Prescription technology is with embodiment 1.

[0020] The protective gas composition is changed to a volume ratio of nitrogen: carbon dioxide = 65:35.

Embodiment 3

[0022] Prescription technology is with embodiment 1.

[0023] The protective gas composition is changed to a volume ratio of nitrogen: carbon dioxide = 90:10.

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PUM

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Abstract

The invention relates to the field of medicine storage, and provides a novel filling mixed shielding gas of sterile powder used for injection, and specifically, the shielding gas is mixed gas of inert gas and carbon dioxide; the inert gas is one of nitrogen, helium or argon or is the mixture of more of the nitrogen, the helium or the argon; preferably, the nitrogen is used as the inert gas; the ratio of the nitrogen to the carbon dioxide is 65: 35-90: 10; and the shielding gas is applied to the ceftazidime avibactam sodium for injection. According to the method, the purpose of efficiently removing the residual oxygen in the headspace of the product is realized by adding the filling shielding gas at a special ratio, more importantly, the stability of the raw materials in a storage process is further enhanced through the way, and meanwhile, no negative influence is caused on the key quality attributes of the product.

Description

technical field [0001] The invention relates to the field of medicine storage, and in particular provides a novel filling mixed protective gas for sterile powder for injection. Background technique [0002] Sterile powder for injection refers to the raw drug or the sterile powder or block made of the raw material drug and suitable excipients for the preparation of injection solution with a sterile solution before use, which can be prepared with a suitable solvent for injection and then injected. Intravenous infusion can also be prepared after intravenous infusion. Sterile powders for injection are generally stored in vials. In the production of chemically unstable sterile powder products for injection, in addition to adding antioxidants, protective agents, etc. to the product, it is more common and practical to inject relatively inert gas, inert gas, etc. into the drug in the bottle. To replace the air (oxygen) in the bottle, these relatively inert gases or inert gases are...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/04A61K9/14A61K31/546A61K31/439A61P31/04A61P1/00A61P11/00
CPCA61K47/02A61K9/14A61K31/546A61K31/439A61P31/04A61P1/00A61P11/00A61K2300/00
Inventor 张相国朗俊娜
Owner 郎俊娜