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Children pharmaceutical composition containing ceftriaxone sodium and low-sodium carrier

A technology of ceftriaxone sodium and composition, which is applied in the field of children's ceftriaxone sodium and low-sodium carrier pharmaceutical composition, can solve the problems of poor stability of ceftriaxone sodium, occurrence of degradation products, easy discoloration of appearance, etc. Clinical application quality, less impurities, and the effect of reducing impurity content

Inactive Publication Date: 2015-09-09
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 discoloration of appearance, lower content, and occurrence of degradation products. The reason for the occurrence may be that some impurities, Reasons such as residual solvent in the crystal form

Method used

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  • Children pharmaceutical composition containing ceftriaxone sodium and low-sodium carrier
  • Children pharmaceutical composition containing ceftriaxone sodium and low-sodium carrier
  • Children pharmaceutical composition containing ceftriaxone sodium and low-sodium carrier

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] (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;

[0038] (2) Liquid-solid separation, after the ice melts, add 10g of activated carbon, stir and decolorize, filter;

[0039] (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

[0041] (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;

[0042] (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;

[0043] (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

[0045] (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;

[0046] (2) Liquid-solid separation, after the ice melts, add 10g of activated carbon, stir and decolorize, filter;

[0047] (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 relates to a children pharmaceutical composition containing ceftriaxone sodium, namely a pharmaceutical combined preparation containing ceftriaxone sodium and a low-sodium carrier infusion solution, and particularly relates to a combined package. The children pharmaceutical composition comprises ceftriaxone sodium for injection and the low-sodium carrier infusion solution. The low-sodium carrier infusion solution contains a glucose and sodium chloride injection (15-200):1, a glucose and sodium chloride potassium chloride injection (15-200):1: (0-1) and the like. Compared with a mixture of ceftriaxone sodium and the low-sodium carrier infusion solution, the children pharmaceutical composition has the advantages that clinical application steps are simplified, clinical risks generated because kidneys of children are not developed to be mature and overmuch sodium in blood cannot be metabolized are reduced, and the clinical application quality and safety performance of children medication are improved.

Description

technical field [0001] The invention relates to a pharmaceutical composition of children's type ceftriaxone sodium and a low-sodium carrier, 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 tra...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/546A61K47/26A61K47/04C07D501/36C07D501/12A61P31/04
Inventor 陈宇东厉达中
Owner ZHEJIANG CHANGDIAN PHARMA
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