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Lyophilized powder injection of levofloxacin mesylate and preparation method thereof

A technology of levofloxacin mesylate and levofloxacin, which is applied in the field of medicine, can solve the problems of poor stability, easy decomposition and discoloration, and achieves the effects of good stability, convenient use and good stability

Inactive Publication Date: 2006-11-22
湖北科益药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Currently, levofloxacin mesylate in small needles and large infusions are on the market, but the aqueous solution of levofloxacin mesylate has poor stability and is easily decomposed and discolored when exposed to light. The small needles and large infusions need to be stored away from light

Method used

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  • Lyophilized powder injection of levofloxacin mesylate and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] Dissolve 40g of glucose in water for injection (30°C) to make a 50wt% concentrated glucose solution, adjust the pH to 3.8-4.0 with 1mol / L hydrochloric acid, add 0.3g of activated carbon for needles to 100ml of concentrated glucose solution, heat and boil with steam for 30 Minutes, cooled to 50°C, filtered and decarbonized to obtain glucose filtrate.

[0016] 200g (in C 18 h 20 FN 3 o 4 Total) levofloxacin mesylate (C 18 h 20 FN 3 o 4 ·CH 3 SO 3 H·H 2 O) Add to the glucose filtrate, add water for injection until levofloxacin mesylate dissolves, adjust the pH to 3.5-4.5, add water for injection to 2000g; add 10g of activated carbon for needles, stir at 60°C for 30 minutes, filter and decarbonize; Membrane coarse filtration and fine filtration. Fill in 1000 bottles, freeze-dry, cork and cover.

Embodiment 2

[0018] Take 60g of glucose and dissolve it in hot water for injection (60°C) to make a 60wt% concentrated glucose solution, adjust the pH to 3.8-4.0 with 1mol / L hydrochloric acid, add 0.3g of active carbon for needles to 100ml of concentrated glucose solution, heat to boil with steam After 30 minutes, cool to 50°C, filter and decarbonize to obtain glucose filtrate.

[0019] 300g (in C 18 h 20 FN 3 o 4 Total) levofloxacin mesylate (C 18 h 20 FN 3 o 4 ·CH 3 SO 3 H·H 2 O) Add to the glucose filtrate, add water for injection until levofloxacin mesylate is dissolved, adjust the pH to 3.5-4.5, add water for injection to 3000g; add 15g of activated carbon for needles, stir at 60°C for 30 minutes, filter and decarbonize; Membrane coarse filtration and fine filtration. Fill in 1000 bottles, freeze-dry, cork and cover.

Embodiment 3

[0021] Take 30g of glucose and dissolve it in hot water for injection (100°C) to make a 70wt% glucose concentrated solution, adjust the pH to 3.8-4.0 with 1mol / L hydrochloric acid, add 0.3g of activated carbon for needles to 100ml of glucose concentrated solution, heat to boil with steam After 30 minutes, cool to 50°C, filter and decarbonize to obtain glucose filtrate.

[0022] 300g (in C 18 h 20 FN 3 o 4 Total) levofloxacin mesylate (C 18 h 20 FN 3 o 4 ·CH 3 SO 3 H·H 2 O) Add to the glucose filtrate, add water for injection until levofloxacin mesylate is dissolved, adjust the pH to 3.5-4.5, add water for injection to 3000g; add 15g of activated carbon for needles, stir at 60°C for 30 minutes, filter and decarbonize; Membrane coarse filtration and fine filtration. Fill in 1000 bottles, freeze-dry, cork and cover.

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Abstract

The freeze dried levofloxacin mesilate powder for injection consists of levofloxacin mesilate as active component and pharmaceutically acceptable excipient. The preparation process of the freeze dried levofloxacin mesilate powder for injection includes the following steps: dissolving excipient in water for injection, regulating pH value to 3.8-4.0, adding injection purpose active carbon and boiling through steam heating, cooling and filtering to eliminating active carbon, adding levofloxacin mesilate, regulating pH value to 3.0-4.5, adding water for injection, eliminating pyrogen, filtering, washing, drying, and freeze drying to obtain the freeze dried levofloxacin mesilate powder for injection. Or, The preparation process includes the following steps: dissolving excipient and levofloxacin mesilate in water for injection, regulating pH value to 3.0-4.5, eliminating pyrogen, filtering, washing, drying, and freeze drying to obtain the freeze dried levofloxacin mesilate powder for injection. The present invention has high stability and use convenience.

Description

technical field [0001] The invention relates to levofloxacin mesylate freeze-dried powder injection and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Levofloxacin mesylate is a fluoroquinolone anti-infective drug, its molecular formula: C 18 h 20 FN 3 o 4 ·CH 3 SO 3 H·H 2 O, molecular weight: 475.49 The chemical structural formula is: [0003] [0004] Levofloxacin mesylate is the mesylate of levofloxacin. Its clinical efficacy is similar to that of levofloxacin. Its antibacterial spectrum is the same as that of ofloxacin, but its antibacterial effect is twice as strong and its toxicity is lower. It has wide clinical application and less adverse reactions. Popular with doctors and patients. Levofloxacin mesylate has good water solubility and is suitable for making injection preparations. At present, there are levofloxacin mesylate small needles and large infusions on the market, but the aqueous solution ...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/5383A61K47/26A61P31/04
Inventor 吴小玉周利娟艾鸣哲曹勇吴佳
Owner 湖北科益药业股份有限公司
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