Children type sulbenicillin sodium and low-sodium carrier pharmaceutical composition

A technology of sulfenbenicillin sodium and a composition is applied in the field of children's sulfenbenicillin sodium and a low-sodium carrier pharmaceutical composition, which can solve the problems of poor performance stability of sulfenbenicillin sodium, occurrence of degradation products, easy discoloration of appearance, etc. Improve the quality of clinical application, improve solubility, and good clarity

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 sulfbenicillin sodium prepared by the above method has poor performance stability, and is unstable to heat, acidic environment, and alkaline environment. It is manifested in problems such as easy discoloration of the a

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Weigh 100 g of the crude product of sulfbenicillin sodium, add 1000 ml of purified water, heat up to 30°C until completely dissolved, add 10 g of activated carbon, stir to decolorize, and filter to obtain the filtrate.

[0042] 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.

[0043] Separate the liquid from the solid, discard the ethyl acetate solution, transfer to a crystallization tank after the ice melts, add 5000ml of acetone dropwise at 5°C for about 1 hour, stir at a slow speed for 30 minutes, continue to grow crystals for 1 hour, filter with suction, wash with acetone, After vacuum drying at 40°C, the finished product of sulbenicillin sodium was obtained with a purity of 99.4%.

Embodiment 2

[0045] Weigh 100 g of the crude product of sulfbenicillin 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.

[0046] 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.

[0047] Separate the liquid from the solid, discard the chloroform solution, transfer to the crystallization tank after the ice melts, add 2000ml of acetone dropwise at 5°C for about 1 hour, stir at a slow speed for 30min, continue to grow crystals for 1h, filter with suction, wash with acetone, 45°C After vacuum drying, the finished product of sulbenicillin sodium was obtained with a purity of 99.5%.

Embodiment 3

[0049] Weigh 100 g of the crude product of sulfbenicillin sodium, add 350 ml of purified water, heat up to 30°C until completely dissolved, add 3 g of activated carbon, stir to decolorize, and filter to obtain the filtrate.

[0050] 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.

[0051] Separate the liquid from the solid, and discard the mixed solution of ethyl acetate and chloroform. After the ice melts, transfer it to a crystallization tank, add 1050ml of acetone dropwise at 5°C for about 1 hour, stir at a slow speed for 30 minutes, continue to grow crystals for 1 hour, and filter with suction. After washing with acetone and vacuum drying at 50°C, the finished product of sulbenicillin sodium was obtained with a purity of 99.4%.

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Abstract

The present invention relates to a children type sulbenicillin sodium pharmaceutical composition, especially to a combination application package, wherein the composition is a sulbenicillin sodium and low-sodium carrier infusion pharmaceutical combination preparation, which comprises sulbenicillin 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 sulbenicillin 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 type sulbenicillin sodium and a low-sodium carrier, belonging to the field of medicinal chemistry. Background technique [0002] Sulbenicillin Sodium, English name: Sulbenicillin Sodium, original product name: Liracillin. Its chemical name is (2S,5R,6R)-3,3-dimethyl-6-(2-phenyl-2-sulfoacetamido)-7-oxo-4-thia-1-aza Bicyclo[3.2.0]heptane-2-carboxylic acid disodium salt. Molecular formula: C16H16N2Na2O7S2, molecular weight: 458.42. [0003] Sulbenicillin sodium belongs to semi-synthetic penicillin antibiotics, which are effective against Enterobacteriaceae such as Escherichia coli, Proteus, Enterobacter, Citrobacter, Salmonella and Shigella, as well as Pseudomonas aeruginosa , Haemophilus influenzae, Neisseria and other Gram-negative bacteria have antibacterial effect. This product also has antibacterial activity against hemolytic Streptococcus, Streptococcus pneumoniae and staphyloco...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/43A61K47/04A61K47/26C07D499/62C07D499/18A61P31/04
Inventor 陈宇东厉达中
Owner ZHEJIANG CHANGDIAN PHARMA
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