Piperacillin sodium and tazobactam sodium sterile powder injection and preparation method thereof

Abstract

The invention provides a piperacillin sodium and tazobactam sodium sterile powder injection, which comprises the following components: 6 to 8 parts of piperacillin sodium, 1 part of tazobactam sodium, 40 to 80 parts of mannitol, 10 to 30 parts of vitamin C, 8 to 15 parts of sodium pyrosulfite and 5 to 10 parts of glycine. A preparation method for the piperacillin sodium and tazobactam sodium sterile powder injection comprises the following steps of dissolving all the components in water for injection under inert gas shielding; adding activated carbon for decoloration, and then, filtering to remove the activated carbon; performing refined filtration with a microporous filtering film of 0.22mum to 0.80mum; performing freeze drying to obtain the piperacillin sodium and tazobactam sodium sterile powder injection. Compared with the prior art, the sterile powder injection has the characteristics that the stability of the sterile powder injection is effectively improved by adopting a stabilizer which consists of the mannitol, the vitamin C, the sodium pyrosulfite and the glycine, piperacillin sodium and tazobactam sodium are basically unchanged in stability during preparation and storage; the polymer content is low, the product is guaranteed to be qualified within the period of validity, and the curative effect and the safety in clinical application are guaranteed; the preparation method is simple, low in cost and suitable for industrial mass production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a piperacillin sodium-tazobactam sodium sterile powder injection and a preparation method thereof. Background technique [0002] Piperacillin is a broad-spectrum semi-synthetic penicillin antibiotic that has been widely used in clinic. Due to the long-term use and improper use of piperacillin, the therapeutic effect of piperacillin is declining, which affects the application of piperacillin to a large extent. Tazobactam sodium is a lactamase inhibitor and belongs to the third-generation antibacterial potent synergist. Combining it with piperacillin or cefoperazone can enhance the efficacy and prolong the action time of the two. When tazobactam sodium is used in combination with piperacillin sodium, it produces a significant synergistic effect, and is widely used in the treatment of severe systemic and local infections, abdominal infection, lower respiratory tract in...

AI Technical Summary

Problems solved by technology

[0005] The piperacillin sodium-tazobactam sodium compound preparation described in the above-mentioned published patents has the same defect of poor preparation stability as the marketed compound preparation, and cannot meet the quality requirements of the validity period, which seriously affects the clinical efficacy

Moreover, because the piperacillin sodium-tazobactam sodium compound preparation belongs to antibiotic drugs, it is easy to cause allergic reactions, leading to skin rashes or anaphylactic shock, which is extremely harmful to patients.

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