Method for controlling amount of remaining oxygen in powder injection preparation

Abstract

The invention discloses a method for controlling the amount of remaining oxygen in a powder injection preparation, and the method comprises the steps that nitrogen from a liquid nitrogen storage tank or a nitrogen generator enters a filter through a conveying tube to be purified; the nitrogen purified in the previous step is filled in a powder injection package bottle by a nitrogen charging head; an included angle between 15 degrees to 75 degrees is formed between a gas outlet tube and a wall of the powder injection package bottle in the nitrogen charging process; and the bottle is sealed by a gland after being filled with the nitrogen. According to the method, as the included angle formed between the gas outlet tube of the nitrogen charging head and the wall of the powder injection package bottle is controlled, the nitrogen is blown out at a certain angle; the nitrogen is well charged into a container; furthermore, the nitrogen gas does not blow a powdery drug at the bottom of the bottle directly; the powdery drug is not blown out of the bottle; the method can reduce the amount of the remaining oxygen in the bottle significantly; the amount of the remaining oxygen is controlled to be less than 1.2%; and the stability of the drug is improved effectively.

Description

technical field [0001] The invention relates to the technical field of air-filled packaging, in particular to a method for controlling the residual oxygen content of a powder injection preparation. Background technique [0002] At present, in order to ensure the stability of drug quality, in the production process of drugs, all means and methods must be adopted to improve the stability of drugs. For example, drugs that are sensitive to water and acid and alkali can be made into sterile powder injections. If it is oxidized, minimize the time and possibility of the drug’s exposure to oxygen. Cephalosporin powder injection is a special product that is very sensitive to relative humidity. It is necessary not only to control the range of the labeled content of the product, but also to control the purity of the product. Any change in any parameter may have a negative impact on the purity of the product, reducing the Its stable powder for injection is a production process in which...

AI Technical Summary

Problems solved by technology

During the use of the above-mentioned nitrogen filling device, it was found that the nitrogen filling head has a linear structure, so that when filling the powder or injection container with nitrogen, the outlet pipe of the nitrogen filling head is vertically placed in the container, and the nitrogen is blown directly to the powder from the air outlet. Insufficient nitrogen filling often occurs, so that the oxygen content in the bottle is relatively high after nitrogen filling, or the powder in the bottle is directly blown up, which affects the stability of the sample

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