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Moxifloxacin injection preparation

A technology of moxifloxacin and moxifloxacin hydrochloride, applied in the field of pharmaceutical preparations, can solve the problems of poor operability, high production cost, low sterility assurance level and the like, and achieve the effects of high safety and stable preparation

Active Publication Date: 2014-11-12
TIANJIN CHASE SUN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The moxifloxacin sodium chloride solution described in Chinese patent ZL00811427.7 has the problem of poor solubility of moxifloxacin hydrochloride
This is poor in control operability in industrial production, and the production cost is high
[0009] On the other hand, world patent WO2007037330, Chinese patent application 2004100533214, Chinese patent application 200510093595.0, and Chinese patent application 200510092828.5 disclose freeze-dried preparations containing moxifloxacin or quinolones, but those skilled in the art can easily understand that freeze-dried preparations cannot Autoclave sterilization, compared with the injection solution, has a lower level of sterility assurance, higher production costs, and needs to be reconstituted with a solvent before use, which is inconvenient to use
[0010] Therefore, the prior art has the problems of poor water solubility of moxifloxacin, poor operability of production control, high production cost or unstable product quality when additives are used

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Embodiment 1, moxifloxacin hydrochloride injection

[0044]

[0045] Preparation:

[0046] (1) Take 90% of the prescribed amount of water, cool it to 60°C, weigh the prescribed amount of moxifloxacin hydrochloride, put it in a container and stir until it is completely dissolved.

[0047] (2) Take the test solution of (1) and adjust the pH to 4.0-4.5 with 0.1mol / L hydrochloric acid solution.

[0048] (3) Add 0.1% activated carbon (w / v) and keep warm for 30 minutes. The 5um titanium filter is decarburized once, the 0.22um water membrane is finely filtered twice, one membrane at a time, and the semi-finished product is inspected.

[0049] (4) Filling (20ml brown ampoule bottle), fusion sealing.

[0050] (5) Sterilize at 116°C for 30 minutes.

[0051] (6) Check Cheng.

[0052] (7) Packaging.

Embodiment 2

[0053] Embodiment 2,, moxifloxacin hydrochloride injection

[0054]

[0055] Preparation:

[0056] (1) Take 90% of the prescribed amount of water, cool it to 60°C, weigh the prescribed amount of moxifloxacin hydrochloride, put it in a container and stir until it is completely dissolved.

[0057] (2) Take the test solution of (1) and adjust the pH to 4.25 with 0.1mol / L hydrochloric acid solution.

[0058] (3) Add 0.1% activated carbon (w / v), keep warm for 30 minutes, decarburize the 5um titanium filter once, fine filter twice with the 0.22um water membrane, one membrane each time, and inspect the semi-finished product.

[0059] (4) Filling (20ml brown ampoule bottle), fusion sealing.

[0060] (5) Sterilize at 116°C for 30 minutes.

[0061] (6) Check Cheng.

[0062] (7) Packaging.

Embodiment 3

[0063] Embodiment 3, moxifloxacin hydrochloride injection

[0064]

[0065] Preparation:

[0066] (1) Take 90% of the prescribed amount of water, cool it to 60°C, weigh the prescribed amount of moxifloxacin hydrochloride, put it in a container and stir until it is completely dissolved.

[0067] (2) Take the test solution of (1) and adjust the pH to 4.25 with 0.1mol / L hydrochloric acid solution.

[0068] (3) Add 0.1% activated carbon (w / v), keep warm for 30 minutes, decarburize the 5um titanium filter once, fine filter twice with the 0.22um water membrane, one membrane each time, and inspect the semi-finished product.

[0069] (4) Filling (20ml brown ampoule bottle), fusion sealing.

[0070] (5) Sterilize at 116°C for 30 minutes.

[0071] (6) Check Cheng.

[0072] (7) Packaging.

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PUM

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Abstract

The invention relates to a moxifloxacin injection preparation which comprises moxifloxacin or salts thereof or hydrates of the salts, and a PH regulating agent for regulating a PH value of a solution. The moxifloxacin injection preparation is stable in quality, and is safe and reliable.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a novel moxifloxacin hydrochloride injection and a preparation method thereof. Background technique [0002] Moxifloxacin hydrochloride is the fourth-generation 8-methoxyfluoroquinolone antibacterial drug with ultra-broad-spectrum antibacterial activity developed by Bayer Company in Germany. Moxifloxacin has shown broad-spectrum antibacterial activity in vitro against Gram-positive bacteria, Gram-negative bacteria, anaerobes, acid-fast bacteria, and atypical microorganisms such as Mycoplasma, Chlamydia, and Legionella. The antibacterial mechanism is to interfere with II and IV topoisomerases. Topoisomerases are key enzymes that control DNA topology and are involved in DNA replication, repair and transcription. [0003] Clinically, 0.5 to 4 hours after oral administration of 400 mg, the peak value is 3.1 mg / L. After oral administration of 400mg once a day, the peak conc...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/4709A61P31/04
Inventor 董凯李宝齐王瑞卿韩志东
Owner TIANJIN CHASE SUN PHARM CO LTD
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