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Child-type medicinal composition with ampicillin sulbactam sodium and low-sodium carrier

A technology for ampicillin-sulbactam sodium and ampicillin sodium, applied in the field of medicinal chemistry, can solve the problems of poor stability of ampicillin sodium, the occurrence of degradation products, easy discoloration of appearance, etc., and achieves less allergic reaction, less impurities and good clarity Effect

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

However, the prepared ampicillin sodium still exhibits poor stability, and is unstable to heat, partial acid environment, and partial alkali environment, and shows problems such as easy discoloration of the appearance, reduction of content, and occurrence of degradation products. The reason for occurrence may be ampicillin sodium Some impurities in the finished product cannot be removed by crystallization

Method used

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  • Child-type medicinal composition with ampicillin sulbactam sodium and low-sodium carrier

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Add 527ml of dichloromethane and 123ml of triethylamine into the reactor, stir evenly, cool down to 0°C, add 200g of ampicillin, and stir until completely dissolved. After the solution was sterilized by membrane filtration, the pipeline through which ampicillin passed during the filtration was rinsed with a mixture of 260ml of dichloromethane and 16ml of triethylamine, and the filtrate and washing solution were combined.

[0047] Add 140 grams of sodium isooctanoate to 609 ml of methyl acetate, and stir until completely dissolved. After the solution is sterilized by membrane filtration, the pipeline through which sodium isooctanoate passes through is rinsed with 200 ml of methyl acetate, and the filtrate and washing liquid are combined.

[0048] Cool the ampicillin solution to -5°C, add 1% sodium isooctanoate solution under rapid stirring, and after stirring for 10 minutes, slowly raise the temperature of the solution to 15°C while stirring, stir for 30 minutes, keep wa...

Embodiment 2

[0054] Add 527ml of dichloromethane and 123ml of triethylamine into the reactor, stir evenly, cool down to 0°C, add 200g of ampicillin, and stir until completely dissolved. After the solution was sterilized by membrane filtration, the pipeline through which ampicillin passed during the filtration was rinsed with a mixture of 260ml of dichloromethane and 16ml of triethylamine, and the filtrate and washing solution were combined.

[0055] Add 140 grams of sodium isooctanoate to 609 ml of methyl acetate, and stir until completely dissolved. After the solution is sterilized by membrane filtration, the pipeline through which sodium isooctanoate passes through is rinsed with 200 ml of methyl acetate, and the filtrate and washing liquid are combined.

[0056] Cool the ampicillin solution to -8°C, add 2% sodium isooctanoate solution under rapid stirring, stir for 10 minutes, slowly increase the solution temperature to 12°C while stirring, stir for 30 minutes, keep warm at 12°C, and th...

Embodiment 3

[0062] Add 527ml of dichloromethane and 123ml of triethylamine into the reactor, stir evenly, cool down to 0°C, add 200g of ampicillin, and stir until completely dissolved. After the solution was sterilized by membrane filtration, the pipeline through which ampicillin passed during the filtration was rinsed with a mixture of 260ml of dichloromethane and 16ml of triethylamine, and the filtrate and washing solution were combined.

[0063] Add 140 grams of sodium isooctanoate to 609 ml of methyl acetate, and stir until completely dissolved. After the solution is sterilized by membrane filtration, the pipeline through which sodium isooctanoate passes through is rinsed with 200 ml of methyl acetate, and the filtrate and washing liquid are combined.

[0064] Cool the ampicillin solution to -10°C, add 3% sodium isooctanoate solution under rapid stirring, stir for 10 minutes, slowly increase the solution temperature to 10°C while stirring, stir for 30 minutes, keep warm at 10°C, and t...

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Abstract

The invention relates to a child-type ampicillin-sulbactam-sodium medicinal composition, i.e. a medicinal combined preparation with ampicillin sulbactam sodium and low-sodium carrier infusion fluid, especially combined application package comprising the ampicillin sulbactam sodium and the low-sodium infusion carrier fluid. The low-sodium carrier infusion fluid comprises glucose and sodium chloride injection fluid (15-200:1) and glucose and sodium-chloride potassium-chloride injection fluid (15-200:1:0-1) and the like. The child-type medicinal composition has the advantages that compared with the compatible and mixing use of the ampicillin sulbactam sodium and the low-sodium carrier infusion fluid, the clinical application steps are simplified, the clinical risks caused by incapability of metabolizing excessive sodium in blood since the kidney of a child is not matured are reduced and the clinical application quality and safety of child administration are improved.

Description

technical field [0001] The invention relates to a pharmaceutical composition of ampicillin-sulbactam sodium for children and a low-sodium carrier, belonging to the field of medicinal chemistry. Background technique [0002] Ampicillin sodium, chemical name: (2S, 5R, 6R)-3,3-dimethyl-6[(R)-2-amino-2-phenylacetamido]-7-oxo-4-sulfur Generation-1-amobicyclo[3.2.0]heptane-2-potassium acid sodium salt. Molecular formula: [0003] C16H18N3NaO4S, molecular weight: 371.39. Ampicillin sodium is one of the earliest semi-synthetic penicillin antibiotics, suitable for the treatment of infections caused by sensitive bacteria. Typical indications include: sinusitis, otitis media, epiglottitis, bacterial pneumonia and other upper and lower respiratory tract infections; urinary tract infection, pyelonephritis; peritonitis, cholecystitis, endometritis, pelvic cellulitis and other intra-abdominal infections; Bacterial bacteremia; skin, soft tissue, bone, joint infection; gonococcal infecti...

Claims

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Application Information

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IPC IPC(8): A61K47/26A61K47/02A61K9/08A61K31/43A61P31/04C07D499/68C07D499/18
Inventor 陈宇东厉达中
Owner ZHEJIANG CHANGDIAN PHARMA
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