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Children type azlocillin sodium and low-sodium carrier pharmaceutical composition

A technology of azlocillin sodium and composition, applied in the field of children's azlocillin sodium and low-sodium carrier pharmaceutical composition, can solve the problems of occurrence of degradation products, easy discoloration of appearance, poor stability, etc., to simplify steps and improve clinical performance. Good application quality and stability

Inactive Publication Date: 2015-09-30
ZHEJIANG CHANGDIAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the prepared azlocillin sodium still exhibits poor stability, and is unstable to heat, acidic environment, and alkaline environment. It is manifested in problems such as easy discoloration in appearance, reduced content, and occurrence of degradation products. The reason for the occurrence may be that azlocillin sodium Influence of some impurities in the finished product of cillin sodium that cannot be removed by crystallization

Method used

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  • Children type azlocillin sodium and low-sodium carrier pharmaceutical composition
  • Children type azlocillin sodium and low-sodium carrier pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Add 400ml of acetone, 80ml of water and 100g of azlocillinic acid into the reactor, stir at 25°C until dissolved, add dropwise 100ml of 0.2g / ml anhydrous sodium acetate ethanol solution within 30 minutes while stirring; continue stirring for 30min, and grow crystals , filtered with suction, washed with acetone, and dried under vacuum at 40°C to obtain crude azlocillin sodium.

[0044] Weigh 100 g of the crude product of azlocillin sodium, add 1000 ml of purified water, raise the temperature to 30°C until completely dissolved, add 10 g of activated carbon, stir to decolorize, and filter to obtain the filtrate.

[0045] Add 5ml of ethyl acetate to the above filtrate under stirring, transfer to a 1000ml pressure-resistant container, make sure it is full and the air bubbles are removed, seal the container, oscillate, freeze at -20°C for 2 hours, and take it out.

[0046] Separate the liquid from the solid, discard the ethyl acetate solution, transfer to a crystallization ta...

Embodiment 2

[0048] Add 300ml of acetone, 100ml of water and 100g of azlocillinic acid into the reactor, stir at a temperature of 25°C until dissolved, add 110ml of 0.2g / ml anhydrous sodium acetate ethanol solution dropwise within 30 minutes while stirring; continue stirring for 30min, and grow crystals , filtered with suction, washed with acetone, and dried under vacuum at 45°C to obtain crude azlocillin sodium.

[0049] Weigh 100 g of crude azlocillin sodium, add 500 ml of purified water, heat up to 30°C until completely dissolved, add 7 g of activated carbon, stir to decolorize, and filter to obtain the filtrate.

[0050] Add 5ml of chloroform to the above filtrate under stirring, transfer it to a 500ml pressure-resistant container, make sure it is full and the air bubbles are removed, seal the container, oscillate, freeze at -15°C for 5 hours, and take it out.

[0051]Separate the liquid from the solid, discard the chloroform solution, transfer to the crystallization tank after the ice...

Embodiment 3

[0053] Add 200ml of acetone, 150ml of water and 100g of azlocillinic acid into the reactor, stir at 25°C until dissolved, add 124ml of 0.2g / ml anhydrous sodium acetate ethanol solution dropwise within 30 minutes while stirring; continue stirring for 30min, and grow crystals , filtered with suction, washed with acetone, and dried under vacuum at 50°C to obtain crude azlocillin sodium.

[0054] Weigh 100 g of the crude product of azlocillin sodium, add 350 ml of purified water, raise the temperature to 30°C until completely dissolved, add 3 g of activated carbon, stir to decolorize, and filter to obtain the filtrate.

[0055] Add 2.3ml of ethyl acetate and 2.3ml of chloroform mixed solvent to the above filtrate under stirring, transfer to a 350ml pressure-resistant container, make sure it is full and air bubbles are removed, seal the container, oscillate, freeze at -10°C for 8 hours, and then take it out.

[0056] Separate the liquid from the solid, and discard the mixed solutio...

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Abstract

The present invention relates to a children type azlocillin sodium pharmaceutical composition, especially to a combination application package, wherein the composition is an azlocillin sodium and low-sodium carrier infusion pharmaceutical combination preparation, which comprises azlocillin sodium for injection and a low-sodium carrier infusion, wherein the low-sodium carrier infusion contains a glucose and sodium chloride injection (15-200:1), a glucose, sodium chloride and potassium chloride injection (15-200:1:0-1) and the like. According to the present invention, the clinical application steps are simplified compared with the compatible mixing use of the azlocillin sodium and the low-sodium carrier infusion; and the clinical risk caused by the excessive sodium positioned in the blood and incapable of being metabolized due to the children kidney achieving the immature development state is reduced so as to improve the clinical application quality and the safety of the children medication are improved.

Description

technical field [0001] The invention relates to a pharmaceutical composition of children's azlocillin sodium and a low-sodium carrier, belonging to the field of medicinal chemistry. Background technique [0002] Azlocillin sodium, English name: AzlocillinSodium, original research product name: Cyclone, listed by Badrich Company, Chinese name is (2S,5R,6R)-3,3-Dimethyl-6-[[[[( 2-oxo-1-imidazolidinyl)carbonyl]amino]phenylacetyl]amino]-7-oxo-4-thia-1-azabicyclo[3,2,0]heptane-2- Sodium carboxylate. This product is a penicillin antibiotic, the third-generation broad-spectrum semi-synthetic penicillin, effective against G+ bacteria, G- bacteria and anaerobic bacteria, and can strongly fight against Pseudomonas aeruginosa. It is suitable for infections caused by Gram + bacteria, Gram - bacteria and anaerobic bacteria. Effective against Pseudomonas aeruginosa infection. It is clinically applied to various infections caused by sensitive Gram-negative bacteria and positive bacteri...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/431A61K47/26A61K47/04A61P31/04C07D499/68C07D499/16C07D499/18
Inventor 陈宇东厉达中
Owner ZHEJIANG CHANGDIAN PHARMA
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