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Stable moxifloxacin hydrochloride injection

A technology of moxifloxacin hydrochloride and moxifloxacin, which can be applied to medical preparations containing active ingredients, respiratory diseases, organic active ingredients, etc., can solve the problems of further improvement of stability, destruction of physiological environment, adverse reactions and the like, Achieve the effect of being conducive to large-scale industrial production, low industrialization cost, and reducing toxic and side reactions

Inactive Publication Date: 2012-09-26
CHONGQING PHARMA RES INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the prior art, the stability of moxifloxacin hydrochloride injection is improved by adding other inorganic or organic salts, but these inorganic or organic salts may damage the physiological environment and produce unexpected adverse reactions during clinical use
[0021] Although moxifloxacin hydrochloride sodium chloride solution is a relatively stable moxifloxacin hydrochloride solution in the prior art, its stability still needs to be further improved

Method used

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  • Stable moxifloxacin hydrochloride injection
  • Stable moxifloxacin hydrochloride injection
  • Stable moxifloxacin hydrochloride injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Moxifloxacin hydrochloride injection, containing 1.6mg / ml moxifloxacin hydrochloride and 42mg / ml xylitol.

[0045]

[0046] Take moxifloxacin hydrochloride and xylitol of the prescribed amount in the container, add an appropriate amount of water for injection and stir to dissolve it; adjust the pH to 4.31 with hydrochloric acid or sodium hydroxide solution, add water for injection to 6000ml; add 0.5% (g / v) Activated carbon, stirred for 30 minutes; first decarbonized by 0.45 μm filter, and then finely filtered by 0.22 μm to obtain the filtrate; respectively poured the filtrate into the packaging for injection, sealed; sterilized at 121° C. for 15 minutes to obtain moxifloxacin hydrochloride injection finished product.

Embodiment 2

[0048] Moxifloxacin hydrochloride injection, containing 0.4mg / ml moxifloxacin hydrochloride and 10mg / ml xylitol.

[0049]

[0050] Take moxifloxacin hydrochloride and xylitol of prescription quantity in container, add appropriate amount of water for injection and stir to make it dissolve; Regulate pH to 4.52 with hydrochloric acid or sodium hydroxide solution, add water for injection to 6000ml; Add 0.5% (g / v) Activated carbon, stirred for 30 minutes; first decarbonized by 0.45 μm filter, and then finely filtered by 0.22 μm to obtain the filtrate; respectively poured the filtrate into the packaging for injection, sealed; sterilized at 121° C. for 15 minutes to obtain moxifloxacin hydrochloride injection finished product.

Embodiment 3

[0052] Moxifloxacin hydrochloride injection, containing moxifloxacin hydrochloride 8mg / ml, xylitol 200mg / ml.

[0053]

[0054] Take moxifloxacin hydrochloride and xylitol of the prescribed amount in a container, add an appropriate amount of water for injection and stir to dissolve it; adjust the pH to 4.37 with hydrochloric acid or sodium hydroxide solution, add water for injection to 6000ml; add 0.5% (g / v) Activated carbon, stirred for 30 minutes; first decarbonized by 0.45 μm filter, and then finely filtered by 0.22 μm to obtain the filtrate; respectively poured the filtrate into the packaging for injection, sealed; sterilized at 121° C. for 15 minutes to obtain moxifloxacin hydrochloride injection finished product.

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Abstract

The invention relates to a stable moxifloxacin hydrochloride injection, which concretely contains moxifloxacin hydrochloride and xylitol. The injection can be in the forms of an injection, a transfusion and a freeze-drying powder injection. By the adoption of the stable moxifloxacin hydrochloride injection, stability of moxifloxacin hydrochloride-related substances, solution color, insoluble microparticles and the like during preparation, storage and usage processes of a moxifloxacin hydrochloride glucose or moxifloxacin hydrochloride sodium chloride injection in the present products or technologies is improved. The preparation process has no demanding requirements on equipment and is easy for industrial production.

Description

technical field [0001] The field of pharmaceutical preparations of the present invention specifically relates to a stable moxifloxacin injection, which contains moxifloxacin or a pharmaceutically acceptable salt, such as hydrochloric acid, and xylitol. The injection can be injection, freeze-dried powder injection and transfusion. Background technique [0002] The chemical structural formula of Moxifloxacin hydrochloride (Moxifloxacin) is: [0003] [0004] Chemical name: 1-cyclopropyl-7-(S,S-2,8-diazabicyclo[4.3.0]nonan-8-yl)-6-fluoro-8-methoxy-4-oxo -1,4-Dihydro-3-quinolinecarboxylic acid hydrochloride. [0005] Moxifloxacin hydrochloride is light yellow or yellow crystalline powder, hardly soluble in water and methanol, insoluble in ethanol. [0006] Moxifloxacin Hydrochloride Injection is a yellow clear liquid. [0007] Moxifloxacin hydrochloride injection is mainly used to treat adults with upper and lower respiratory tract infections. Examples include acute sinu...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K9/19A61K31/4709A61P31/04A61P11/00A61P17/02
Inventor 张涛邓杰姚铃虹宗太丽
Owner CHONGQING PHARMA RES INST
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