Preparation process of pantoprazole sodium for injection

Abstract

The invention relates to a preparation process of pantoprazole sodium for injection. The preparation process comprises the following steps of preparing a solution, filling, freeze-drying, full-pressure plugging treatment and discharging from a box, wherein the step of preparing the solution comprises the steps of weighing and mixing; adjusting the pH value; adsorbing impurities; and carrying out secondary sterilization and filtration. The filling step comprises the steps of filling according to the prescription amount; performing self-inspection; and performing sample recovering. The freeze-drying step comprises the following steps of pre-freezing; performing primary drying; and performing secondary drying, wherein the temperature of a shelf is reduced to -50 + / -10 DEG C in a staged manner during pre-freezing; specifically, reducing the temperature to -10 + / -10 DEG C within 7.5 minutes and kept for 7.5 minutes; then reducing the temperature to -20 + / -10 DEG C within 7.5 minutes and keeping the temperature for 7.5 minutes; then reducing the temperature to -35 + / -10 DEG C within 15 minutes and keeping the temperature for 15 minutes; and then reducing the temperature to -50 + / -10 DEG C within 30 minutes and keeping the temperature for 30 minutes. By applying the preparation process, the process is simple, relatively few auxiliary materials are used, and the stability of the final finished product is relatively good.

Description

technical field [0001] The invention relates to the field of medicine preparation, in particular to a preparation process of pantoprazole sodium for injection. Background technique [0002] Pantoprazole Sodium (PantoprazoleSodium), chemical name: 5-difluoromethoxy-2-[(3,4-dimethoxy-2-pyridyl)]-sulfinyl-1H-benzimidazole sodium salt. Pantoprazole sodium is a new generation of proton pump inhibitors (PPI) following omeprazole and lansoprazole, and is the first-line treatment for peptic ulcer disease. After being marketed globally, it immediately became a specific drug for the treatment of acid-related digestive system dysfunction diseases due to its strong and long-lasting acid suppression effect, high ulcer healing rate, few adverse reactions and few drug interactions. Pantoprazole sodium injection is mainly used for peptic ulcer bleeding, acute gastric mucosal injury caused by non-steroidal anti-inflammatory drugs, ulcer bleeding under stress, general anesthesia or major su...

AI Technical Summary

Problems solved by technology

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 and polymerization, so it is not suitable for making water for injection , suitable for making freeze-dried powder injection

[0003] In order to ensure the stability of pantoprazole sodium, the prior art usually adds a lot of auxiliary materials, but the addition of too many auxiliary materials will increase the safety risk of medication, so the products with national approval numbers currently on the market still use mannitol, edide, etc. Disodium diacetate is mainly used as auxiliary material, although adopting these two common and higher safety auxiliary materials of mannitol and edetate disodium ensures the safety of medication, it has little significance for improving the stability of pantoprazole sodium, Therefore the stability of pantoprazole sodium is poor in the preparation technology of prior art

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