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Strong solution-type moxifloxacin hydrochloride injection and preparation method thereof

A technique for moxifloxacin hydrochloride and injection, which is applied in the field of moxifloxacin hydrochloride concentrated solution injection and its preparation, and can solve problems such as solubility, poor stability, and supersaturation of moxifloxacin hydrochloride

Active Publication Date: 2015-04-08
CHENGDU GUOHONG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] One of the technical problems to be solved in the present invention is that moxifloxacin hydrochloride is supersaturated in a concentrated solution, and the solubility and stability are poor.

Method used

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  • Strong solution-type moxifloxacin hydrochloride injection and preparation method thereof
  • Strong solution-type moxifloxacin hydrochloride injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0098] Raw material name 66 dosage content (g / ml) / molar concentration

[0099] Moxifloxacin Hydrochloride 29.09g (equivalent to Moxifloxacin 26.66g) 2.67%

[0100] Aspartic acid 13.31g 0.1mol / L

[0101] Appropriate amount of sodium hydroxide

[0102] Add water for injection to 1000ml

[0103] Take 700ml of water for injection, add the prescribed amount of aspartic acid, heat and stir to dissolve, add sodium hydroxide solution to pH 4.80, add the prescribed amount of moxifloxacin hydrochloride, stir to dissolve, add water for injection to 1000ml. Filter through a 0.22 μm microporous membrane, fill in 15ml / bottle, and sterilize by autoclaving at 121°C for 15 minutes.

Embodiment 2

[0105] Name of raw and auxiliary materials Amount of 50 sticks Content (g / ml) / molar concentration

[0106] Moxifloxacin Hydrochloride 21.82g (equivalent to Moxifloxacin 20g) 2%

[0107] Aspartic acid 6.66g 0.05mol / L

[0108] Appropriate amount of sodium hydroxide

[0109] Add water for injection to 1000ml

[0110] Take 700ml of water for injection, add the prescribed amount of aspartic acid and moxifloxacin hydrochloride, heat and stir to dissolve, add sodium hydroxide solution to pH 4.40, add water for injection to 1000ml. Filter through a 0.22 μm microporous membrane, fill in 20ml / bottle, and sterilize by autoclaving at 121°C for 15 minutes.

Embodiment 3

[0112] Raw material name 45 dosage content (g / ml) / molar concentration

[0113] Moxifloxacin Hydrochloride 19.66g (equivalent to Moxifloxacin 18g) 1.8%

[0114] Aspartic acid 1.33g 0.01mol / L

[0115] Potassium hydroxide appropriate amount

[0116] Add water for injection to 1000ml

[0117] Take 300ml of water for injection, add the prescribed amount of aspartic acid, heat and stir to dissolve, add potassium hydroxide solution to pH 4.00, take another 500ml of water for injection, add the prescribed amount of moxifloxacin hydrochloride, heat and stir to dissolve, stir and mix the two solutions , add water for injection to 1000ml, filter through a 0.22 μm microporous membrane, fill with 22.2ml / bottle, and sterilize by autoclaving at 121°C for 15min.

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Abstract

The invention relates to a strong solution-type moxifloxacin hydrochloride injection containing a non-sulfur-containing amino acid or a pharmaceutically acceptable salt thereof, and preparation method thereof. The solvent used in the strong solution-type moxifloxacin hydrochloride injection is smaller in dosage, with better security, and simultaneously has a more significant effect for improving solubility and stability of the moxifloxacin hydrochloride strong solution; the quality of prepared injections is more stable; and preparation process is simple, and easy to operate.

Description

technical field [0001] The invention relates to pharmaceutical preparations, in particular to a moxifloxacin hydrochloride concentrated solution injection and a preparation method thereof. Background technique [0002] Moxifloxacin is the fourth generation of fluoroquinolone antibiotics. Because of its broad antibacterial spectrum, low drug resistance, strong antibacterial effect, long half-life, and low phototoxicity, it has become a very effective anti-infective agent. The original manufacturer of moxifloxacin is Bayer Company of Germany. Moxifloxacin tablets were first launched in Germany in June 1996 under the trade name Avelox; in December of the same year, it was approved by the US FDA for marketing. In November 2001, Moxifloxacin Hydrochloride Sodium Chloride Injection was approved by the US FDA and launched in China in 2005 under the trade name of Aifule. Compared with other dosage forms, injections have the advantages of not being affected by pH, enzymes, food, etc...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/4709A61K47/18A61P31/04
Inventor 汪飞郭礼新黄毅
Owner CHENGDU GUOHONG PHARMA
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