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Method for preparing glycylcycline freezing-dried powder injection

A technology of tigecycline and freeze-dried powder injection, which is applied in the field of preparation of tigecycline, can solve the problems of low dosage of antioxidant efficiency, unworthy of use, potential safety hazards, etc., and achieves safer clinical medication and clinical medication. Safety and stability-enhancing effects

Inactive Publication Date: 2008-04-30
合肥信风科技开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The method of adding antioxidants to solve the problem of oxidative degradation must consider the following two issues: 1. The type of antioxidant selected, the selected antioxidant must have the characteristics of solubility, low dosage, and high antioxidant efficiency , at the same time, it cannot produce compatibility changes with this product; 2. Safety issues. In addition to the characteristics of general injection excipients, the selected antioxidant must also be non-toxic and harmless to the human body after redox reactions. , at the same time, as an intravenous injection in direct contact with blood, the selected antioxidant should be non-irritating to blood and blood vessels to ensure drug safety
However, the application of antioxidants in preparations, especially injections, generally has certain hidden dangers in clinical drug safety, and it is not worth promoting their use.

Method used

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  • Method for preparing glycylcycline freezing-dried powder injection

Examples

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Comparison scheme
Effect test

Embodiment 1

[0023] Example 1 Take 2.5g of tigecycline, add about 80ml of water for injection (water temperature 20.4°C), stir to dissolve, adjust the pH value of the solution to 5.48 with 0.3mol / L hydrochloric acid solution, add water for injection to 100ml, shake well, add 100mg (0.1% volume of water for injection) of activated carbon for injection, stirred for about 30 minutes, coarsely filtered and decarbonized, then filtered through 0.45 μm and 0.22 μm microporous membranes respectively, and distributed in 10ml controlled antibiotic bottles, the filling volume is 2.0ml / bottle, after pre-freezing for 4 hours, put it into a freeze dryer for 36 hours to freeze-dry, press the cap, and tie the aluminum cap to get this product.

Embodiment 2

[0024] Example 2 Take 2.5g of tigecycline, add about 80ml of water for injection (water temperature 20.4°C), stir to dissolve, adjust the pH value of the solution to 5.46 with 0.2mol / L sulfuric acid solution, add water for injection to 100ml, shake well, add 100mg (0.1% volume of water for injection) of activated carbon for injection, stirred for about 30 minutes, coarsely filtered and decarbonized, then filtered through 0.45 μm and 0.22 μm microporous membranes respectively, and distributed in 10ml controlled antibiotic bottles, the filling volume is 2.0ml / bottle, after pre-freezing for 4 hours, put it into a freeze dryer for 36 hours to freeze-dry, press the cap, and tie the aluminum cap to get this product.

Embodiment 3

[0025] Example 3 Take 2.5g of tigecycline, add about 80ml of water for injection (water temperature 20.4°C), stir to dissolve, adjust the pH value of the solution to 5.40 with 0.5mol / L tartaric acid solution, add water for injection to 100ml, shake well, add 100mg (0.1% volume of water for injection) of activated carbon for injection, stirred for about 30 minutes, coarsely filtered and decarbonized, then filtered through 0.45 μm and 0.22 μm microporous membranes respectively, and distributed in 10ml controlled antibiotic bottles, the filling volume is 2.0ml / bottle, after pre-freezing for 4 hours, put it into a freeze dryer for 36 hours to freeze-dry, press the cap, and tie the aluminum cap to get this product.

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Abstract

The invention relates to a tigecycline freeze dried for injection and a process for preparation, which comprises taking some tigecycline, charging injection water in proper temperature to dissolve the tigecycline, regulating the pH level of the solution to acidity with pH modifier, charging 0.1%(g / 100ml) cubage of activated charcoal for pin, churning up for 15-30 minutes, preliterating and decarbonizing, then filtrating by filter membrane with micropores of 0.45mum, 0.22mum split charging, pre freezing, cryodesiccating, stressing the top, and putting aluminium cover. The pH modifier is one or multiple kind of inorganic acid or organic acid. The tigecycline freeze dried for injection has the advantages of more steady, safe clinical application, and simple operational process.

Description

technical field [0001] The invention relates to a preparation method of tigecycline, in particular to a preparation method of tigecycline I freeze-dried powder for injection. Background technique [0002] [0003] Tigecycline is a new class of antibiotics—glycylcycline (glycylcycline), which is mainly used to treat infections caused by Gram-negative and positive pathogens, anaerobic bacteria, methicillin-resistant Staphylococcus aureus (MRSA) and Complicated intra-abdominal infection, skin and skin tissue infection (cSSSI), pneumococcal infection, etc. caused by methicillin-sensitive Staphylococcus aureus (MSSA) infection. This product was successfully developed by Wyeth, and its dosage form is freeze-dried powder for injection. [0004] Tigecycline is an orange-yellow crystalline powder. The dry solid powder is relatively stable in sealed storage at room temperature, but its aqueous solution is extremely unstable, mainly because the phenolic hydroxyl group in I is prone...

Claims

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Application Information

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IPC IPC(8): A61K31/65A61K9/19A61K47/04A61K47/12A61K47/20A61K47/22A61P31/04
Inventor 宗国军查大俊高嵩钟成勤
Owner 合肥信风科技开发有限公司
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