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Tigecycline freeze-dried injection

A technology of freeze-dried powder injection and tigecycline, which is applied in the direction of freeze-dried delivery, tetracycline active ingredient, powder delivery, etc. It can solve the strict requirements on preparation and infusion time, inconvenient patients' drug safety, tigecycline Poor stability and other problems, to achieve the effect of uniform and stable quality, thorough moisture drying and good stability

Active Publication Date: 2011-03-23
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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

Method used

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  • Tigecycline freeze-dried injection
  • Tigecycline freeze-dried injection
  • Tigecycline freeze-dried injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] prescription

[0023]

[0024] Weigh the prescribed amount of tigecycline, dextran, sodium citrate and anhydrous sodium sulfite, first put the dextran in a sterile container, add 80% water for injection to dissolve it, and add citrate after the water for injection cools to 4°C Sodium citrate and anhydrous sodium sulfite, dissolve and stir evenly, then add tigecycline, stir to dissolve and mix evenly, adjust the pH to 7.8 with 1mol / L hydrochloric acid or 1mol / L sodium hydroxide solution, then add 0.1 % of activated carbon for needles, stirred and adsorbed for 30 minutes, decarbonized by suction filtration, and after the intermediate inspection was qualified, add water for injection to make up to full volume. The solution is filtered through two 0.22μm microporous membranes and then sent to the sterile room, filled in vials, half-plugged with butyl rubber stoppers, placed in a plate, placed in a freeze-drying box, closed the box door, and turned on for refrigeration ,...

Embodiment 2

[0026] prescription

[0027]

[0028]

[0029] Weigh the prescribed amount of tigecycline, dextran, sodium citrate and anhydrous sodium sulfite, first put the dextran in a sterile container, add 80% water for injection to dissolve it, and add citrate after the water for injection cools to 2°C Sodium citrate and anhydrous sodium sulfite, dissolve and stir evenly, then add tigecycline, stir to dissolve and mix evenly, adjust pH to 8.0 with 1mol / L hydrochloric acid or 1mol / L sodium hydroxide solution, then add 0.1 % of activated carbon for needles, stirred and adsorbed for 30 minutes, decarbonized by suction filtration, and after the intermediate inspection was qualified, add water for injection to make up to full volume. The solution is filtered through two 0.22μm microporous membranes and then sent to the sterile room, filled in vials, half-plugged with butyl rubber stoppers, placed in a plate, placed in a freeze-drying box, closed the box door, and turned on for refriger...

Embodiment 3

[0031] prescription

[0032]

[0033]Weigh the prescribed amount of tigecycline, dextran, sodium citrate and anhydrous sodium sulfite, put the dextran in a sterile container, add 80% water for injection to dissolve it, and add citrate after the water for injection is cooled to 6°C Sodium citrate and anhydrous sodium sulfite, dissolve and stir evenly, then add tigecycline, stir to dissolve and mix evenly, adjust the pH to 7.0 with 1mol / L hydrochloric acid or 1mol / L sodium hydroxide solution, then add 0.1 % of activated carbon for needles, stirred and adsorbed for 30 minutes, decarbonized by suction filtration, and after the intermediate inspection was qualified, add water for injection to make up to full volume. The solution is filtered through two 0.22μm microporous membranes and then sent to the sterile room, filled in vials, half-plugged with butyl rubber stoppers, placed in a plate, placed in a freeze-drying box, closed the box door, and turned on for refrigeration , us...

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PUM

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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 powderinjection 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 ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61P31/04A61K31/65A61K9/19
Inventor 赵俊叶东陈卫东盛琼波
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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