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Ofloxacin injection and preparation process thereof

A technology of ofloxacin and ofloxacin, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problem of low solubility of ofloxacin and inconvenience in clinical use , affecting product quality and other issues, to achieve the effect of convenient transportation, convenient clinical use, and high product quality

Active Publication Date: 2010-04-14
ANHUI FENGYUAN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The dosage forms of ofloxacin injection used in the market and clinical use are mainly large-volume injections (i.e. large infusions), and the preparation of small-volume injections (i.e. water injections) has the problems of low solubility of ofloxacin and product crystallization
The process reported in the literature uses hydrochloric acid as a co-solvent for ofloxacin, but problems such as product crystallization and visible foreign matter are common during storage and clinical use, which affect product quality, cause great inconvenience to clinical use, and bring pain to patients. Safety Hazards and Hazards

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Ofloxacin 50g, edetate disodium 0.1g, acetic acid 50mL, propylene glycol 100mL. The preparation method consists of the following steps:

[0022] 1. Take 300mL of water for injection, add it into the container, add the ratio of ofloxacin and edetate disodium, and stir to form solution A.

[0023] 2. Add the proportioned acetic acid to dissolve in the above solution A to form solution B.

[0024] 3. Add the propylene glycol of the ratio to the above solution B and stir evenly to form solution C.

[0025] 4. Add activated carbon to solution C and stir, then let it stand for decarbonization.

[0026] 5. Add water for injection to 1000mL.

[0027] After the above-mentioned prepared solution is finely filtered, filled, sterilized and packaged, a qualified finished product of ofloxacin injection is obtained. The finished product capacity is 2mL.

Embodiment 2

[0029] Ofloxacin 60g, edetate disodium 0.2g, acetic acid 60mL, propylene glycol 200mL. The preparation method consists of the following steps:

[0030] 1. Take 300mL of water for injection, add it into the container, add the ratio of ofloxacin and edetate disodium, and stir to form solution A.

[0031] 2. Add the proportioned acetic acid to dissolve in the above solution A to form solution B.

[0032] 3. Add the propylene glycol of the ratio to the above solution B and stir evenly to form solution C.

[0033] 4. Add activated carbon to solution C and stir, then let it stand for decarbonization.

[0034] 5. Add water for injection to 1000mL.

Embodiment 3

[0036] Ofloxacin 70g, edetate disodium 0.3g, acetic acid 70mL, propylene glycol 300mL. The preparation method consists of the following steps:

[0037] 1. Take 300mL of water for injection, add it into the container, add the ratio of ofloxacin and edetate disodium, and stir to form solution A.

[0038] 2. Add the proportioned acetic acid to dissolve in the above solution A to form solution B.

[0039] 3. Add the propylene glycol of the ratio to the above solution B and stir evenly to form solution C.

[0040] 4. Add activated carbon to solution C and stir, then let it stand for decarbonization.

[0041] 5. Add water for injection to 1000mL.

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PUM

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Abstract

The invention discloses an ofloxacin injection which is prepared by ofloxacin, acetic acid, disodium tetracemate, propylene glycol and water for injection. The invention solves the problem that an ofloxacin injection hydro-acupuncture is easy to crystallize through adopting the acetic acid as cosolvent and improving the dissolvability of ofloxacin by adding the propylene glycol to regulate the polarity of solution. The injection provided by the invention has excellent quality stability, solves the problem of crystallization commonly existed in products of ofloxacin injection hydro-acupuncture, solves the weaknesses of instability and short retention period of injection, reduces the number of insoluble particles in medicine solution, and provides the effective guarantee for the safe use in clinics.

Description

technical field [0001] The invention relates to a pharmaceutical preparation, in particular to an ofloxacin injection and a preparation method thereof. Background technique [0002] Ofloxacin is a third-generation quinolone antibacterial drug. Its antibacterial activity, blood concentration, bioavailability, and biological half-life are all in the forefront of other fluoroquinolones, and adverse reactions are relatively rare. Ofloxacin has the advantages of broad antibacterial spectrum, strong antibacterial activity, and no cross-resistance with other antibacterial drugs. For most bacteria of Enterobacteriaceae such as Citrobacter, cloacae, Enterobacter aerogenes, Escherichia coli, Klebsiella, Proteus, Salmonella, Shigella, Vibrio, Yersinia, etc. have a good antibacterial effect, and also have antibacterial activity against multi-drug resistant bacteria. High antibacterial activity against penicillin-resistant Neisseria gonorrhoeae, Haemophilus influenzae and Moraxella sp....

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/5383A61K47/12A61K47/10A61P31/04
Inventor 李保琴汪洪湖
Owner ANHUI FENGYUAN PHARM CO LTD
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