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Gluconic acid enoxacin and preparation method of powder and injection preparation thereof

A technology of gluconic acid and enoxacin, applied in the field of medicine, can solve problems such as slow reaction and poor product quality, and achieve the effects of improving yield, simple preparation process and improving synthesis efficiency

Inactive Publication Date: 2009-03-11
HAINAN LINGKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Aiming at the shortcomings of slow reaction and poor product quality in the prior art of using enoxacin and glucono-d-lactone directly in water to dissolve the injection, the purpose of the present invention is to provide a kind of enoxa gluconate How to make a star

Method used

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  • Gluconic acid enoxacin and preparation method of powder and injection preparation thereof
  • Gluconic acid enoxacin and preparation method of powder and injection preparation thereof
  • Gluconic acid enoxacin and preparation method of powder and injection preparation thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0017] The preparation of embodiment 1 enoxacin gluconate

[0018] (1) Add 100g of glucono-δ-lactone and 3800g of purified water into the three-necked bottle, then dissolve 185g of enoxacin in an appropriate amount of absolute ethanol, add it to the three-necked bottle, stir and react at 60°C for 30 minutes in the dark, and the reaction is complete , filter, add 3000g of absolute ethanol, stir for 20min, place in a refrigerator at 3 to 4°C for freezing and crystallization for 18h, filter, then wash the filter cake with an appropriate amount of absolute ethanol, and vacuum-dry at 60°C for 3 hours to obtain Enoxagluconate Shaxing crude product 238.3g;

[0019] (2) Put 238.3g of enoxacin gluconate crude product and 3177ml of 70% (v / v) ethanol solution into the reaction flask, heat to 70°C, stir to dissolve all the solids, and add 0.3% (g / ml) of total volume Activated carbon 10.24g, stirred for 30min, hot filtered, the filtrate was frozen and crystallized in a refrigerator at 3-4...

Embodiment 2

[0020] The preparation of embodiment 2 enoxacin gluconate

[0021] (1) Add 100g of glucono-δ-lactone and 3800g of purified water into a three-necked bottle, then dissolve 185g of enoxacin in an appropriate amount of absolute ethanol, add it to the three-necked bottle, stir and react at 50°C in the dark for 60 minutes, and the reaction is complete , filter, add 3000g of absolute ethanol, stir for 60min, place in a refrigerator at 3 to 4°C for freezing and crystallization for 16h, filter, then wash the filter cake with an appropriate amount of absolute ethanol, and vacuum-dry at 40°C for 6 hours to obtain Enoxagluconate Shaxing crude product 242.5g;

[0022] (2) Put 242.5g of enoxacin gluconate crude product and 3637ml of 70% (v / v) ethanol solution into the reaction flask, heat to 65°C, stir to dissolve all the solids, and add 0.1% (g / ml) of total volume Activated carbon 3.45g, stirred for 10min, hot filtered, the filtrate was frozen and crystallized in a refrigerator at 3-4°C ...

Embodiment 3

[0024] Get the refined product of enoxacin gluconate prepared in Example 1 and pack it under 100-grade clean conditions in a sterile room. Enoxacin powder for injection.

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Abstract

A method for preparing gluconate enoxacin comprises the following steps: glucono-delta-lactone is dissolved in water, and enoxacin is dissolved in absolute ethyl alcohol; the obtained two mixtures are added to a there-neck bottle and stirred away from light for reaction; the obtained solution is filtered, then added with the absolute ethyl alcohol, recrystallized at low temperature, filtered, rinsed, and dried in vacuum to obtain a gluconate enoxacin crude product; then the gluconate enoxacin crude product is dissolved, absorbed, filtered, washed and dried into powder injection. The method for preparing the gluconate enoxacin has the advantages of short reaction time, high production efficiency and stable quality.

Description

technical field [0001] The invention relates to a preparation method of enoxacin gluconate, in particular to a preparation method of enoxacin gluconate powder for injection, which belongs to the technical field of medicine. Background technique [0002] Enoxacin is the third-generation fluoroquinolone compound, which has the characteristics of broad antibacterial spectrum, convenient administration, wide distribution in the body, good clinical curative effect, and low price. It is positive to most Gram-negative bacilli and Staphylococcus aureus, etc. Bacteria have a strong killing effect. Oxidative decomposition occurs in the preparation process of enoxacin-related preparations, and the stability is poor, while the preparation of soluble enoxacin compounds has greatly improved stability, and related preparations with guaranteed quality can be prepared. [0003] Enoxacin gluconate is a soluble salt compound of enoxacin, which has the same antibacterial activity as enoxacin. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/496A61K31/366A61K9/14A61P31/04
Inventor 王明
Owner HAINAN LINGKANG PHARMA CO LTD
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