Pazufloxacin mesilate xylitol injection and preparation method thereof

A technology of pazufloxacin mesylate and methanesulfonic acid, which is applied in the direction of pharmaceutical formulas, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc., and can solve the problem of cloudy solutions and poor water solubility of pazufloxacin , Not suitable for packing alkaline solution and other problems

Active Publication Date: 2013-05-22
四川美大康佳乐药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Due to the poor water solubility of pazufloxacin, crystallization occurs at lower temperatures, and at the same time when the pH is high, the solution tends to become turbid. In addition, pazufloxacin is alkaline and easily soluble in acidic water. Pazufloxacin mesylate Zhufloxacin is the methanesulfonate of Pazufloxacin, and the traditional glass bottle packaging is not suitable for dispensing alkaline solutions, which have become the main factors that produce visible foreign matter

Method used

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  • Pazufloxacin mesilate xylitol injection and preparation method thereof
  • Pazufloxacin mesilate xylitol injection and preparation method thereof
  • Pazufloxacin mesilate xylitol injection and preparation method thereof

Examples

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Effect test

Embodiment 1

[0053] The pazufloxacin mesylate xylitol injection provided in this embodiment comprises the following components:

[0054] Pazufloxacin mesylate 3g;

[0055] Xylitol 50g;

[0056] Methanesulfonic acid is used to adjust the pH value to 3.2;

[0057] Add water for injection to 1000ml.

[0058] The preparation method of pazufloxacin mesylate xylitol injection comprises the steps:

[0059] (1), weigh pazufloxacin mesylate and xylitol for adjusting isotonicity according to the amount of the components, add 60% water for injection, and stir until the main ingredient is completely dissolved;

[0060] (2) Add 0.02% activated carbon for needles to the aqueous solution of pazufloxacin mesylate in step (1), stir continuously under the heating condition of 60°C±5°C for 15 minutes, and filter the solution while it is hot to decarbonize , the filtrate was allowed to cool to room temperature;

[0061](3), detect the content of above-mentioned solution, and regulate solution pH to 3.2 w...

Embodiment 2-8

[0105] The pazufloxacin mesylate xylitol injection of embodiment 2-8 comprises the following components respectively:

[0106]

[0107] The test conclusion of embodiment 2-8: the PH scope of optimal production of pazufloxacin mesylate xylitol injection is 3.06~3.30, and the packing form of its injection adopts non-PVC co-extrusion infusion bag and polypropylene blending upright Packaging containers such as plastic infusion bags, polypropylene infusion bottles, etc. can ensure the quality of the products. If bottled in glass, it cannot be stored at low temperatures.

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Abstract

The invention discloses a pazufloxacin mesilate xylitol injection which is characterized by containing the components as follows: 1g to 10g of pazufloxacin mesilate and 43g to 100g of xylitol, wherein methanesulfonic acid is used for regulating the PH value to 2.0 to 6.0, and water for injection is added to reach 1000ml. Furthermore, the invention further provides a preparation method of the pazufloxacin mesilate xylitol injection. Compared with the prior art, the pazufloxacin mesilate xylitol injection and the preparation method thereof have the advantage that: the isomer and relevant substances of the pazufloxacin mesilate xylitol injection under illumination and at high temperature are within the qualified scope by means of study and test on thermal stability, light stability and low temperature.

Description

technical field [0001] The invention relates to the field of injections, in particular to a pazufloxacin mesylate xylitol injection and a preparation method thereof. Background technique [0002] Pazufloxacin mesylate is a new generation of fluoroquinolone antibacterial drug researched and developed by Japan Toyama Chemical Industry Co., Ltd. It was first listed in Japan in April 2002. Pazufloxacin is the key intermediate of Pazufloxacin Mesylate, which is the base material and the main part of the molecular structure. The structural formula of Pazufloxacin is as follows: [0003] Molecular weight: 318.2997 [0004] Pazufloxacin has poor water solubility, and its solubility in water is greatly increased after being made into mesylate. Pazufloxacin mesylate is a new type of fluoroquinolone antibacterial drug. Its main mechanism of action is to achieve antibacterial effect by inhibiting the activity of bacterial DNA helicase enzyme topoisomerase IV and hindering the replic...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/5383A61K47/10A61P31/04
Inventor 张祝君秦方云李梅王琴
Owner 四川美大康佳乐药业有限公司
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