Dexamethasone sodium phosphate powder injection and production method thereof

Abstract

The invention discloses a dexamethasone sodium phosphate powder injection and a production method thereof. The method for preparing the dexamethasone sodium phosphate powder injection comprises the following steps of: 1) dissolving dexamethasone sodium phosphate in an organic solvent to obtain a medicinal solution (1); and 2) performing sterilization and pyrogen removal on the medicinal solution (1), directly filling into an injection bottle, removing the organic solvent from the filled injection bottle by adopting a reduced-pressure drying method, capping and packaging, and recovering the organic solvent at the same time.

Description

Technical field: [0001] The invention relates to a corticosteroid injection, in particular to a production process of dexamethasone sodium phosphate powder injection. Background technique: [0002] Dexamethasone sodium phosphate (DEXAMETHASONE SODIUM PHOSPHATE, referred to as "de sodium") is an adrenocortical hormone drug. It has anti-inflammatory, anti-allergic, anti-rheumatic and immunosuppressive effects, and is widely used in the treatment of allergic and autoimmune inflammatory diseases. Such as connective tissue disease, active rheumatism, rheumatoid arthritis, lupus erythematosus, severe bronchial asthma, severe dermatitis, ulcerative colitis, acute leukemia, etc. It is also used for some serious infections, poisoning, and malignant lymphoma. treat. The common dosage form is sodium desalination injection. Due to the different production processes of desalination, the excipients used in the formulations of domestic and foreign desalination injections are also differ...

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Problems solved by technology

[0008] It can be seen from this that although the amount of propylene glycol used in each dexamethasone sodium phosphate injection is not large, there are still certain risks, especially when used for a long time or in large quantities, the potential harm to the human body is relatively large

[0009] In addition to injections, currently commercially available dexamethasone sodium phosphate injections also have freeze-dried powder injections, which can avoid some of the problems caused by the above injections. However, the preparation of freeze-dried powder injections requires a large investment and high energy consumption. For dexamethasone For a commonly used drug such as sodium phosphate injection, the preparation of freeze-dried powder injection will greatly increase its production cost, and the preparation of powder injection will inevitably add various excipients, such as mannitol, lactose, etc. These excipients In addition to further increasing the cost of the preparation, the addition of the drug may also have a potential adverse effect on the safety of the drug

If the method of directly dispensing sterile raw materials is adopted, because the commonly used doses (1mg, 2mg, 5mg) of dexamethasone sodium phosphate are too small, it is difficult to ensure the stability of the loading under the conditions of existing preparation equipment

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