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Children pharmaceutical composition containing ceftazidime and low-sodium carrier

A technology of ceftazidime and its composition, which is applied in the field of medicinal chemistry, can solve the problems of many impurities, obvious side effects, and low purity of active ingredients, and achieve the effects of low impurities, improved solubility, and improved clinical application quality

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

[0004] At present, some methods for preparing ceftazidime preparations have been disclosed at home and abroad, but the ceftazidime preparations made by these methods have problems such as low purity of active ingredients, too many impurities, and obvious side effects caused thereby.

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] (1) Control the temperature at 10-15°C, weigh 100g of ceftazidime dihydrochloride crude product, add 1000ml of water, stir until completely dissolved, add 10g of activated carbon, stir for decolorization, and filter;

[0038] (2) Control the temperature at 0°C to 5°C, add 20% sodium hydroxide dropwise to adjust the pH to 6.2±0.2, add 10ml of ethyl acetate, stir slowly for 5 hours, pass through an organic filter membrane and transfer to a 1000ml pressure-resistant container to ensure that it is full And remove the air bubbles, seal the container, shake, and freeze at -18°C for 8 hours before taking it out;

[0039] (3) Liquid-solid separation, after the ice melts, transfer to a crystallization tank, control the temperature at 0°C to 5°C and stir slowly, add hydrochloric acid to adjust the pH to 2.5±0.2, and react for 10 hours; add 5000ml of acetone dropwise, Stir at a slow speed for 30 minutes, continue to grow crystals for 1 hour, filter with suction, wash with acetone,...

Embodiment 2

[0041] (1) Control the temperature at 10-15°C, weigh 100g of ceftazidime dihydrochloride crude product, add 1000ml of water, stir until completely dissolved, add 10g of activated carbon, stir for decolorization, and filter;

[0042] (2) Control the temperature at 0°C to 5°C, add 20% sodium carbonate dropwise to adjust the pH to 6.0±0.2, add 10ml of chloroform, stir slowly for 5 hours, pass through an organic filter membrane and transfer to a 1000ml pressure-resistant container to ensure that it is full and the air bubbles are removed , seal the container, oscillate, and freeze at -18°C for 8 hours before taking it out;

[0043] (3) Liquid-solid separation, after the ice melts, transfer to a crystallization tank, control the temperature at 0°C to 5°C and stir slowly, add hydrochloric acid to adjust the pH to 2.5±0.2, and react for 10 hours; add 5000ml of acetone dropwise, Stir at a slow speed for 30 minutes, continue to grow crystals for 1 hour, filter with suction, wash with a...

Embodiment 3

[0045] (1) Control the temperature at 10-15°C, weigh 100g of ceftazidime dihydrochloride crude product, add 1000ml of water, stir until completely dissolved, add 10g of activated carbon, stir for decolorization, and filter;

[0046] (2) Control the temperature at 0°C to 5°C, add 20% sodium hydroxide dropwise to adjust the pH to 6.3±0.2, add 7ml of ethyl acetate, stir slowly for 5 hours, pass through an organic filter membrane and transfer to a 1000ml pressure-resistant container to ensure that it is full And remove the air bubbles, seal the container, shake, and freeze at -18°C for 8 hours before taking it out;

[0047] (3) Liquid-solid separation, after the ice melts, transfer to a crystallization tank, control the temperature at 0°C to 5°C and stir slowly, add hydrochloric acid to adjust the pH to 2.5±0.2, and react for 10 hours; add 5000ml of acetone dropwise, Stir at a slow speed for 30 minutes, continue to grow crystals for 1 hour, filter with suction, wash with acetone, ...

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Abstract

The invention relates to a children pharmaceutical composition containing ceftazidime, namely a pharmaceutical combined preparation containing ceftazidime and a low-sodium carrier infusion solution and particularly relates to a combined package. The children pharmaceutical composition comprises ceftazidime 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 ceftazidime 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 ceftazidime and a low-sodium carrier, belonging to the field of medicinal chemistry. Background technique [0002] Ceftazidime is a third-generation cephalosporin antibiotic created by GlaxoSmithKline. The original trade name is Fordaxin. It has a strong effect on Gram-positive or negative bacteria. Pseudomonas aeruginosa, Escherichia coli, Klebsiella, Proteus, Enterococcus, Salmonella, Shigella, Neisseria gonorrhoeae, Neisseria meningitidis, Staphylococcus aureus, hemolytic streptococcus, pneumococcus and other Aerobacter has strong antibacterial activity, especially for Pseudomonas aeruginosa, ceftazidime is the most effective antibiotic, and its medicinal injection is a sterile mixture of ceftazidime pentahydrate and sodium carbonate or arginine. [0003] In order to ensure the safety of human medicine, for ceftazidime antibiotics, it is required that the content of ceftazidim...

Claims

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Application Information

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IPC IPC(8): A61K31/546A61K47/26A61K47/02A61K9/08A61P31/04B65D81/32
Inventor 陈宇东厉达中
Owner ZHEJIANG CHANGDIAN PHARMA
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