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Method for preparing tigecycline for injection

A technology for tigecycline and injection is applied in the field of preparation of tigecycline for injection to achieve the effects of avoiding the generation of impurities, ensuring quality and ensuring the safety of medication

Inactive Publication Date: 2013-07-17
CHENGDU BAIYU PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] However, in the tigecycline freeze-dried powder injection prepared by the above method, the impurity content is still high, and further research is still needed to reduce the impurity content and improve the stability.

Method used

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  • Method for preparing tigecycline for injection
  • Method for preparing tigecycline for injection
  • Method for preparing tigecycline for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Embodiment 1 The preparation of tigecycline freeze-dried powder injection of the present invention

[0029] prescription:

[0030]

[0031]

[0032] Preparation Process:

[0033] Take 80% water for injection, fill it with nitrogen, control the residual oxygen ≤ 2mg / L, add anhydrous sodium sulfite and dextran 70 respectively, stir until completely dissolved, cool down to 2-10°C, add tigecycline, stir until completely dissolved , use hydrochloric acid to adjust the pH value of the solution to 4.5-5.5, add water to the specified scale, add activated carbon, stir and absorb for 10 minutes, filter through a 0.22μm microporous membrane until clarified, fill according to 2ml / bottle, pre-freeze for 2-4 hours, and store at low temperature After freeze-drying for 18-24 hours, take out the stopper and cover it.

Embodiment 2

[0034] Embodiment 2 Preparation of tigecycline freeze-dried powder injection of the present invention

[0035] prescription:

[0036]

[0037] Preparation Process:

[0038] Take 80% water for injection, fill it with nitrogen, control the residual oxygen ≤ 2mg / L, add sodium bisulfite and dextran 40 respectively, stir until completely dissolved, cool down to 2-10°C, add tigecycline, stir until completely Dissolve, adjust the pH value of the solution to 4.5-5.5 with hydrochloric acid, add water to the specified scale, add activated carbon, stir and absorb for 10 minutes, filter through a 0.22μm microporous membrane until clarified, fill in 2ml / bottle, and pre-freeze for 2-4 hours. Freeze-dry at low temperature for 18-24 hours, then take out the stopper and cover it.

Embodiment 3

[0039] Embodiment 3 Preparation of tigecycline freeze-dried powder injection of the present invention

[0040] prescription:

[0041]

[0042] Preparation Process:

[0043] Take 80% water for injection, fill it with nitrogen, control the residual oxygen amount to ≤2mg / L, add sodium metabisulfite and dextran 20 respectively, stir until completely dissolved, cool down to 2-10°C, add tigecycline, stir until completely dissolved, Use hydrochloric acid to adjust the pH value of the solution to 4.5-5.5, add water to the specified scale, add activated carbon, stir and absorb for 10 minutes, filter through a 0.22μm microporous membrane until clarified, fill in 2ml / bottle, pre-freeze for 2-4 hours, and freeze at low temperature After drying for 18-24 hours, take out the plug and cover it.

[0044] The samples of the above examples 1-3 are detected, and the total impurities and epimer content in the finished product are determined, and the detection results are shown in the followi...

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Abstract

The invention discloses a method for preparing tigecycline for injection. The method comprises the following steps: (1) taking water for injection, adding an excipient and an antioxidant, and dissolving; (2) adding tigecycline at the temperature of 2-10 DEG C, regulating the pH value to be 4.5-5.5 after complete dissolving, and fixing the volume; (3) filtering until the solution is clarified after activated carbon adsorption; and (4) filling, performing freeze drying, and packaging to obtain the powder injection, wherein nitrogen is filled until the residual oxygen in the water is less than or equal to 2mg / L in the steps (1) to (3), the antioxidant is sodium hydrogen sulfite, anhydrous sodium sulfite, sodium pyrosulfite and vitamin C, and the excipient is dextran or lactose. In the process of preparing the tigecycline freeze-dried powder injection, various process parameters are controlled and adjusted, the content of impurities and epimers in the product is obviously reduced, the mass of the preparation for injection is ensured, the impurities are reduced or avoided, and the administration safety of the injection product is guaranteed.

Description

technical field [0001] The invention relates to a preparation method of tigecycline for injection. Background technique [0002] Tigecycline belongs to a new class of glycylcycline antibiotics, and tigecycline is a new class of antibiotics—glycylcycline (glycylcycline), which is mainly used for the treatment of gram-negative and positive pathogenic bacteria, anaerobic bacteria, methicillin-resistant Staphylococcus aureus (MRSA) infection and methicillin-sensitive Staphylococcus aureus (MSSA) infection caused by complicated intra-abdominal infection, skin and skin tissue infection (cSSSI, pneumococcal infection, etc. This product Successfully developed by Wyeth, and first approved for marketing in the United States in July 2005, it is used for the treatment of complicated adult intra-abdominal infection (cIAI) and complicated skin and soft tissue infection (cSSSI), including complicated appendicitis and burn infection , intra-abdominal abscess, deep soft tissue infection and...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/65A61K47/26A61P31/04
Inventor 孙毅秦观红田阿娟
Owner CHENGDU BAIYU PHARMA CO LTD
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