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Child type amoxicillin sulbactam sodium and low-sodium carrier medicine composition

A technology for amoxicillin sulbactam sodium and amoxicillin sodium, which is applied in the field of medicinal chemistry, can solve the problems of poor stability and high impurities of amoxicillin sodium, and achieve the effects of good clarity, low impurities and good solubility

Inactive Publication Date: 2015-10-07
ZHEJIANG CHANGDIAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Routinely prepared amoxicillin sodium has disadvantages such as poor stability and high impurities, and clinical use of children will cause great risks

Method used

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  • Child type amoxicillin sulbactam sodium and low-sodium carrier medicine composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Add 507ml of absolute ethanol and 123ml of triethylamine into the reactor, stir evenly, cool down to 0°C, add 200g of amoxicillin, and stir until completely dissolved. After the solution is sterilized by membrane filtration, the pipeline through which amoxicillin passes during filtration is rinsed with a mixture of 260ml of absolute ethanol and 16ml of triethylamine, and the filtrate and washing solution are combined.

[0046] Add 140 g of sodium isooctanoate to 609 ml of methyl acetate, and stir at a temperature of 18° C. 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.

[0047] Add the sodium isooctanoate solution to the amoxicillin solution under constant stirring, cool the crystallization solution to 0-5°C, add 0.2 g of amoxicillin sodium seed crystals, keep warm at 0-5°C, and sti...

Embodiment 2

[0053] Add 507ml of absolute ethanol and 123ml of triethylamine into the reactor, stir evenly, cool down to 0°C, add 200g of amoxicillin, and stir until completely dissolved. After the solution is sterilized by membrane filtration, the pipeline through which amoxicillin passes during filtration is rinsed with a mixture of 260ml of absolute ethanol and 16ml of triethylamine, and the filtrate and washing solution are combined.

[0054] Add 140 g of sodium isooctanoate to 609 ml of methyl acetate, and stir at a temperature of 18° C. 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.

[0055] Add the sodium isooctanoate solution into the amoxicillin solution under constant stirring, cool the crystallization solution to 0-5°C, add 0.4 g of amoxicillin sodium seed crystals, keep warm at 0-5°C, and s...

Embodiment 3

[0061] Add 507ml of absolute ethanol and 123ml of triethylamine into the reactor, stir evenly, cool down to 0°C, add 200g of amoxicillin, and stir until completely dissolved. After the solution is sterilized by membrane filtration, the pipeline through which amoxicillin passes during filtration is rinsed with a mixture of 260ml of absolute ethanol and 16ml of triethylamine, and the filtrate and washing solution are combined.

[0062] Add 140 g of sodium isooctanoate to 609 ml of methyl acetate, and stir at a temperature of 18° C. 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.

[0063] Add the sodium isooctanoate solution to the amoxicillin solution under constant stirring, cool the crystallization solution to 0-5°C, add 0.6 g of amoxicillin sodium seed crystals, keep warm at 0-5°C, and sti...

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PUM

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Abstract

The invention relates to a child type amoxicillin sulbactam sodium medicine composition, namely an amoxicillin sulbactam sodium and low-sodium carrier transfusion medicine combination preparation, and in particular to combined application packaging. The medicine composition comprises amoxicillin sulbactam sodium for injection and a low-sodium carrier transfusion solution. The low-sodium carrier transfusion solution contains a sodium chloride and dextrose injection (15-200:1), a glucose and sodium chloride potassium chloride injection (15-200:1:0-1) and the like. According to the composition, compared with the mode that the amoxicillin sulbactam sodium and the low-sodium carrier transfusion are mixed and used in a compatibility manner, the clinical application steps are simplified; and clinic risks caused by the fact that the kidney of a child is not mature, so that the child does not have the ability to metabolize excessive sodium in blood are reduced, and the clinic application quality and the clinic application safety of child pharmacy are improved.

Description

technical field [0001] The invention relates to a pharmaceutical composition of children's type amoxicillin-sulbactam sodium and a low-sodium carrier, belonging to the field of medicinal chemistry. Background technique [0002] Amoxicillin sodium, the chemical name is (2S,5R,6R)-3,3-dimethyl-6-[(R)-(-)-2-amino-2-(4-hydroxyphenyl)acetamido ]-Sodium 7-oxo-4thia-1-azabicyclo(3.2.0)heptane-2-carboxylate. Molecular formula: C16H18N3NaO5S, molecular weight: 387.40. Amoxicillin sodium is a semi-synthetic penicillin antibiotic, suitable for the treatment of the following diseases: 1. Otitis media, sinusitis, pharyngitis, tonsillitis, etc. Respiratory infection. 2. Urinary tract infection caused by Escherichia coli, Proteus mirabilis or Enterococcus faecalis. 3. Skin and soft tissue infection caused by hemolytic streptococcus, staphylococcus or Escherichia coli. 4. Acute bronchitis, pneumonia and other lower respiratory tract infections caused by hemolytic Streptococcus, Strepto...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/26A61K47/04C07D499/86C07D499/68C07D499/16A61K31/43A61P31/04
Inventor 陈宇东厉达中
Owner ZHEJIANG CHANGDIAN PHARMA
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