Tigecycline freeze-dried injection

Abstract

The invention relates to a tigecycline freeze-dried powder injection, which consists of tigecycline, dextran, sodium sulfite and sodium citrate according to the following weight proportion: 10 portions of the tigecycline, 10 to 90 portions of the dextran, 0.1 to 3 portions of anhydrous sodium sulfite, and 0.1 to 3 portions of the sodium citrate. The pH value of the tigecycline freeze-dried powder injection is between 7.0 and 9.0. The preparing process comprises the following steps: firstly, dissolving the dextran by 80 percent of water for injection; secondly, adding the sodium citrate and the anhydrous sodium sulfate into the mixture after cooling; thirdly, adding the tigecycline into the mixture after dissolving and evenly stirring the sodium citrate and the anhydrous sodium sulfate, and mixing the mixture evenly; and fourthly, regulating the pH to between 7.0 and 9.0, adding a needle activated carbon into the mixture, stirring and adsorbing the mixture, removing the activated carbon from the mixture, and fixing the capacity. The solution is filtered through two microporous membranes and then are filled in a cillin bottle, and the tigecycline freeze-dried powder injection is obtained through semi-stoppering, spanning, freeze-drying, introducing nitrogen, performing tamponade, taking out the injection from a box, rolling a mouth, passing the quality inspection, and packaging.

Description

technical field [0001] The present invention relates to a tigecycline freeze-dried powder injection, which can be used as complex adult intra-abdominal infection (cIAI) and complex skin and soft tissue infection (cSSSI), including complex appendicitis, burn infection, intra-abdominal abscess, deep Drugs for the treatment of soft tissue infections and ulcer infections. Background technique [0002] Drug-resistant bacteria, especially Methicillin-Resistant Staphylococcus aureus (MRSA) infection, is raging and spreading in seven major pharmaceutical market regions in the world. According to the British national audit report, the incidence of MRSA infection in Europe is rising, with the highest incidence in the UK, Ireland, Greece and Italy, and a high incidence in intensive care units. In the United States, community-acquired MRSA infections are on the rise, and in UK hospitals, MRSA infections are also extremely common. According to recent research data, 9% of patients with ...

AI Technical Summary

Problems solved by technology

[0008] Tigecycline is less stable, and its solution is prone to oxidative degradation and epimerization and destruction, and heating will accelerate the destruction. The common solution is to prepare tigecycline into a lyophilized powder injection, but we found that even if it is The preparation of freeze-dried preparations cannot guarantee the stability during its preparation, transportation and storage, and the related substances of its preparations still increase significantly, and there are strict requirements on preparation and infusion time during clinical use, which is extremely inconvenient and harmful to Patient drug safety poses hidden dangers

Existing known technology also does not improve the suggestion of above defective

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