Ceftriaxone sodium compound entity for children and preparation for ceftriaxone sodium compound entity for children

A technology for ceftriaxone sodium and compound, which is applied in the field of ceftriaxone sodium compound entity and its preparation for children, can solve the problems of residual solvent, occurrence of degradation products, content reduction, etc., so as to improve extraction efficiency, reduce impurity content, improve The effect of solubility

Inactive Publication Date: 2015-09-23
ZHEJIANG CHANGDIAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The stability of ceftriaxone sodium is relatively poor, and it is unstable to heat, acidic environment, and alkaline environment. It is manifested in problems such as easy discolor

Method used

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  • Ceftriaxone sodium compound entity for children and preparation for ceftriaxone sodium compound entity for children
  • Ceftriaxone sodium compound entity for children and preparation for ceftriaxone sodium compound entity for children
  • Ceftriaxone sodium compound entity for children and preparation for ceftriaxone sodium compound entity for children

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] (1) Weigh 100g of ceftriaxone crude product, add 1000ml of water, heat up to 30°C until completely dissolved, add 10ml of ethyl acetate under stirring, transfer to a 1000ml pressure-resistant container, ensure that it is full and remove air bubbles, seal the container, oscillate, and control Take out after freezing at -18°C for 8 hours;

[0027] (2) Liquid-solid separation, after the ice melts, add 10g of activated carbon, stir and decolorize, filter;

[0028] (3) Transfer the filtrate to a crystallization tank, control the temperature at 10-15°C, add 5000ml of acetone dropwise for about 1 hour under the protection of nitrogen, stir at a slow speed for 30min, continue to grow crystals for 1h, filter with suction, wash with acetone, and dry in vacuo at 40°C; Preparations of different specifications (0.25g / bottle, 0.5g / bottle, 1.0g / bottle, 2.0g / bottle) are sub-packaged, and the temperature and humidity of the controlled environment are 20-24°C, and the humidity is less th...

Embodiment 2

[0030] (1) Weigh 100g of ceftriaxone crude product, add 1000ml of water, heat up to 30°C until completely dissolved, add 10ml of chloroform under stirring, transfer to a 1000ml pressure-resistant container, ensure that it is full and remove air bubbles, seal the container, oscillate, and control the temperature- Freeze at 18°C ​​for 3 hours and take out;

[0031] (2) liquid-solid separation, the liquid phase removes the organic phase, and after the ice melts, the water phase is combined, 10 g of activated carbon is added, stirred for decolorization, and filtered;

[0032] (3) Transfer the filtrate to a crystallization tank, control the temperature at 10-15°C, add 5000ml of acetone dropwise for about 1 hour under the protection of nitrogen, stir at a slow speed for 30min, continue to grow crystals for 1h, filter with suction, wash with acetone, and dry in vacuo at 40°C; Preparations of different specifications (0.25g / bottle, 0.5g / bottle, 1.0g / bottle, 2.0g / bottle) are sub-packag...

Embodiment 3

[0034] (1) Weigh 80g of ceftriaxone crude product, add 1000ml of water, heat up to 30°C until completely dissolved, add 5ml of ethyl acetate under stirring, transfer to a 1000ml pressure-resistant container, ensure that it is full and remove air bubbles, seal the container, oscillate, and control Take out after freezing at -18°C for 8 hours;

[0035] (2) Liquid-solid separation, after the ice melts, add 10g of activated carbon, stir and decolorize, filter;

[0036] (3) Transfer the filtrate to a crystallization tank, control the temperature at 10-15°C, add 5000ml of acetone dropwise for about 1 hour under the protection of nitrogen, stir at a slow speed for 30min, continue to grow crystals for 1h, filter with suction, wash with acetone, and dry in vacuo at 40°C; Preparations of different specifications (0.25g / bottle, 0.5g / bottle, 1.0g / bottle, 2.0g / bottle) are sub-packaged, and the temperature and humidity of the controlled environment are 20-24°C, and the humidity is less than...

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Abstract

The invention provides a ceftriaxone sodium compound entity for children. A structural formula of the ceftriaxone sodium compound entity is as follows: formula as shown in the specification. The ceftriaxone sodium compound entity is prepared by the following steps: (1) dissolving a ceftriaxone crude product into water, adding activated carbon, stirring and discoloring, and filtering; (2) adding an extraction agent into filtrate to obtain a mixture, transferring and filling the mixture into a pressure-resistant container, and carrying out temperature-controlled freezing on the mixture and taking out the mixture after removing air bubbles; and (3) removing an organic phase of the mixture, dropwise adding acetone at 10-15 DEG C after solids are molten, slowly stirring, growing crystals, filtering, washing, carrying out vacuum drying and packaging preparations of different specifications. Compared with ceftriaxone sodium prepared by a conventional process, the ceftriaxone sodium prepared by the preparation method has the advantages of few impurities, high stability and the like.

Description

technical field [0001] The invention relates to a ceftriaxone sodium compound entity and preparation thereof for children, belonging to the field of medicinal chemistry. Background technique [0002] Ceftriaxone sodium, also known as ceftriaxone, the original research product name: Rocephine, is a new, long-acting, broad-spectrum third-generation semi-synthetic cephalosporin, belonging to β-lactam antibiotics, by inhibiting the synthesis of bacterial cell walls And play a bactericidal effect. It has strong antibacterial activity against most Gram-positive and negative bacteria. The antibacterial spectrum includes Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, Enterobacter aerogenes, Proteus, Diococcus and Staphylococcus aureus Wait. Clinically, it is mainly used for meningitis, pneumonia, skin and soft tissue infection, peritonitis, urinary system infection, gonorrhea, liver and gallbladder infection, surgical trauma, sepsis and ge...

Claims

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Application Information

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IPC IPC(8): C07D501/36C07D501/12A61K31/546A61K9/19A61P31/04
CPCA61K9/0019A61K9/19A61K31/546C07D501/12C07D501/36
Inventor 陈宇东厉达中
Owner ZHEJIANG CHANGDIAN PHARMA
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