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A kind of preparation method of novel anti-infective drug

An anti-infection and drug technology, applied in the field of medicine, can solve the problems of easy residue, high impurity content in products, and increase in impurity content, and achieve the effects of reducing product impurity content, reducing impurity content, and reducing degradation impurities

Active Publication Date: 2015-09-23
SHANDONG LUOXIN PHARMA GRP HENGXIN PHARMA CO LTD
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  • Abstract
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  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The fine cefazedone sodium obtained in the prior art has problems such as high water content and high impurity content, and the preparation process also has problems such as complicated operation, high cost, low yield, and large pollution
[0005] For example, in CN101584671A, the cefazedone sodium solid is dissolved in water, and after activated carbon decolorization and filtration, acetone crystallization is added in the filtrate, and the crystals are filtered and dried to obtain cefazedone sodium crystals. method to control moisture, there are problems such as low drying efficiency and difficulty in reproducing moisture control of different batches of products
[0006] CN102924482A discloses a kind of preparation method of low water content cefazedone sodium, has following shortcoming: (1) adopt sodium methylate as salt-forming solvent, alkalinity is too strong, makes cefazedone β-lactam ring easy to be destroyed, impurity High content, strong corrosiveness, and large pollution; (2) using isopropanol as a crystallization solvent, with a high boiling point and low volatility, which is easy to remain in the product and increase the impurity content; (3) ultrasonic crystallization is used in the crystallization process Oscillatory seeding method produces seeds
This preparation method is loaded down with trivial details operation, high to equipment requirement, pollution is big, cost is also high, and the obtained product impurity content is high, and yield is low; (4) preparation method yield is low, only 85%

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] A kind of preparation method of novel anti-infective drug cefazedone sodium, the steps are as follows:

[0031] (1) Salt formation: Aseptically treat the reaction kettle, filter and utensils used, add 1096.9g (2mol) cefazinone, 164g (2mol) sodium acetate and 4.39L anhydrous methanol into the 50L reaction kettle, stir To dissolve completely, control the temperature at 10-30°C;

[0032] (2) Decolorization: Add 11g of activated carbon into the reaction solution, stir and absorb for 30 minutes, filter the titanium rod for decarbonization, and pass the filtrate through a 0.22 μm microporous membrane for further decarbonization and sterilization, and keep the temperature of the filtrate at 10-30°C;

[0033] (3) Crystallization: the filtrate is transferred to the 50L crystallization tank in the 10,000-class local 100-class clean area, and slowly drips 5.48L of ethanol at a rate of 20L / H to the filtered filtrate under stirring conditions until the system is turbid. After cryst...

Embodiment 2

[0036] A kind of preparation method of novel anti-infective drug cefazedone sodium, the steps are as follows:

[0037] (1) Salt formation: Aseptically treat the reaction kettle, filter and utensils used, and add 1096.9g (2mol) cefazedone, 196.8g (2.4mol) sodium acetate and 6.58L anhydrous methanol into a 50L reaction kettle , stir to dissolve completely, and control the temperature at 10-30°C;

[0038] (2) Decolorization: Add 22g of activated carbon into the reaction solution, stir and absorb for 30 minutes, filter the titanium rod for decarbonization, and pass the filtrate through a 0.22μm microporous membrane for further decarbonization and sterilization, and keep the temperature of the filtrate at 10-30°C;

[0039] (3) Crystallization: the filtrate is transferred to the 50L crystallization tank in the 10,000-class local 100-class clean area, and slowly add 6.58L of ethanol dropwise to the filtered filtrate at a rate of 20L / H under agitation until the system is turbid. Afte...

Embodiment 3

[0042] A kind of preparation method of novel anti-infective drug cefazedone sodium, the steps are as follows:

[0043] (1) Salt formation: Aseptically treat the reaction kettle, filter and utensils used, and add 1096.9g (2mol) cefazedone, 213.2g (2.6mol) sodium acetate and 8.78L anhydrous methanol into the 50L reaction kettle , stir to dissolve completely, and control the temperature at 10-30°C;

[0044] (2) Decolorization: Add 32.9g of activated carbon into the reaction solution, stir and adsorb for 30 minutes, filter the titanium rod for decarbonization, and pass the filtrate through a 0.22μm microporous membrane for further decarbonization and sterilization, and keep the temperature of the filtrate at 10-30°C;

[0045] (3) Crystallization: the filtrate is transferred to the 50L crystallization tank in the local 100-class clean area of ​​10,000 grades, and slowly drips 8.77L of ethanol at a rate of 20L / H to the filtered filtrate under stirring conditions until the system bec...

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Abstract

The invention relates to a preparation method of a novel anti-infective drug. The preparation method comprises the following steps: (1) salifying, namely putting cefazedone and a sodium acetate solvent in absolute methanol to have a salifying reaction, and controlling the temperature in the range of 10-30 DEG C after the cefazedone is completely dissolved, (2) decoloring, namely adding active carbon to a reaction liquid, stirring and decoloring, and removing the active carbon by filtering, keeping the temperature of the filtrate in the range of 10-30 DEG C, and then re-filtering; (3) crystalizing, namely slowly and dropwise adding a certain amount of ethanol to the filtered filtrate at a rate of 20L / H under a stirring condition until the system is turbid, growing crystals for 0.5 to 1 hour, next, adding a certain amount of acetone, growing crystals for 0.5 to 1 hour, and then reducing the temperature to 5 DEG C at a temperature reducing rate of 5-15 DEG C per hour, and stirring by keeping the stirring speed in the range of 80-120r / min for crystallization, and growing the crystals for 1-3 hours; and (4) drying, namely filtering and washing the filter cake, and drying to obtain refined cefazedone sodium. Compared with the prior art, the preparation method is simple to operate, low in cost and high in yield, and pollution is greatly reduced; and the obtained refined cefazedone sodium is low in moisture content, low in impurity content and high in stability.

Description

technical field [0001] The invention belongs to the technical field of medicines, and relates to a preparation method of a novel anti-infection drug, in particular to a preparation method of cefazedone sodium. Background technique [0002] Infectious diseases are a common and frequently-occurring disease in clinical practice. According to the report of the World Health Organization (WHO), the number of deaths from infectious diseases is as high as 33.3% of the total number of deaths from various causes. Cephalosporins are the most widely used first-line drugs in clinical practice. In recent years, due to the abuse of antibiotics, many "super bacteria" have emerged, and the problem of bacterial drug resistance has become increasingly serious. The "Administrative Measures for the Clinical Application of Antibacterial Drugs" officially implemented by the state restricts the clinical application of the third-generation and fourth-generation cephalosporins with strong alternati...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07D501/36C07D501/04C07D501/12
CPCC07D501/04C07D501/12C07D501/36
Inventor 宋丽丽李晓峰冯秀英
Owner SHANDONG LUOXIN PHARMA GRP HENGXIN PHARMA CO LTD
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