Pantoprazole sodium freeze-drying medicinal composition for injection and preparation method thereof

Abstract

The invention relates to a pantoprazole sodium freeze-drying medicinal composition for injection and a preparation method thereof. The pantoprazole sodium freeze-drying medicinal composition for injection comprises the following components in part by weight: 1 part of pantoprazole sodium, 0.01 to 0.1 part of mannitol, 0.02 to 0.03 part of natrium adetate, 0.07 to 0.10 part of sodium sulfite and 0 to 0.1 part of sodium citrate. In the method, the stability of the solution of the pantoprazole sodium is improved, related matters of the solution of the pantoprazole sodium in the process of preparation, packaging or freeze-drying during preparation are not increased obviously, the content of the related matters is not reduced obviously; the prepared pantoprazole sodium freeze-drying powder injection is good in stability in the process of transportation and storage; solution mixed with the injection during clinical use can be placed for a long time, so that the clinical use is more convenient; and simultaneously, hidden troubles of the medication safety of patients due to the increase of impurities (related matters) and the problem of the curative effect on the patients due to content reduction are reduced greatly.

Description

technical field The invention relates to a freeze-dried pharmaceutical composition of pantoprazole sodium for injection and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique Pantoprazole Sodium (Pantoprazole Sodium), chemical name: 5-difluoromethoxy-2-[(3,4-dimethoxy-2-pyridyl)methyl]-sulfinyl-1H- Benzimidazole Sodium Salt. Pantoprazole sodium is a proton pump inhibitor antiulcer drug. Pantoprazole Sodium Injection is mainly used for peptic ulcer bleeding, acute gastric mucosal injury caused by non-steroidal anti-inflammatory drugs and ulcer bleeding under stress, general anesthesia or major surgery, and debilitated comatose patients to prevent gastric acid reflux and Treatment of diseases such as aspiration pneumonia. Pantoprazole sodium has poor stability and is very sensitive to light, heat, oxygen, water, etc., especially in acidic conditions, its chemical structure can undergo destructive changes, discoloration ...

AI Technical Summary

Problems solved by technology

The object of the present invention is to provide a kind of pantoprazole sodium freeze-dried pharmaceutical composition for injection and preparation method thereof at the above deficiencies, by which the stability of pantoprazole sodium solution can be greatly improved, whether it is during preparation The related substances of pantoprazole sodium solution have no obvious increase and content decrease during preparation, sub-package or freeze-drying process, and the stability of the prepared pantoprazole sodium freeze-dried powder injection is good in the process of transportation and storage , the compatible solution can be placed for a long time in clinical use, which makes clinical use more convenient, and also greatly reduces the hidden dangers caused by the increase of impurities (related substances) to the patient's drug safety and the curative effect caused by the decrease of the content.

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