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Child type piperacillin tazobactam sodium and low-sodium carrier pharmaceutical composition

A technology of tazobactam sodium and piperacillin sodium, which is applied in the direction of drug delivery, active ingredients of heterocyclic compounds, antibacterial drugs, etc., can solve the problems of degradation products, easy discoloration of appearance, and content reduction, and achieve simplified steps , Improve the quality of clinical application, the effect of small toxic and side effects

Inactive Publication Date: 2015-09-16
ZHEJIANG CHANGDIAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the prepared piperacillin 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 may be that piperacillin sodium Influence of some impurities in the finished product of cillin sodium that cannot be removed by crystallization

Method used

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  • Child type piperacillin tazobactam sodium and low-sodium carrier pharmaceutical composition
  • Child type piperacillin tazobactam sodium and low-sodium carrier pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Add 1523ml of acetone in the reactor, add 120 grams of piperacillin, stir and dissolve, add gac, stir for 20 minutes, filter, the filtrate is added dropwise sodium acetate ethanol solution, sodium acetate ethanol solution consists of 20.2 grams of sodium acetate, 70.8ml of purified water and 384ml of absolute ethanol was mixed and dissolved to form, after the dropwise addition was completed, the reaction was incubated for 2 hours, filtered, the filter cake was washed with acetone, and vacuum-dried to obtain 111.4 grams of piperacillin sodium crude product.

[0045] Weigh 100 g of the crude piperacillin 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.

[0046] 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,...

Embodiment 2

[0050] Add 1523ml of acetone in the reactor, add 120 grams of piperacillin, stir and dissolve, add gac, stir for 20 minutes, filter, the filtrate is added dropwise sodium acetate ethanol solution, sodium acetate ethanol solution consists of 20.2 grams of sodium acetate, 70.8ml of purified water and 384ml of absolute ethanol was mixed and dissolved to form, after the dropwise addition was completed, the reaction was incubated for 2 hours, filtered, the filter cake was washed with acetone, and vacuum-dried to obtain 111.4 grams of piperacillin sodium crude product. .

[0051] Weigh 100 g of the crude piperacillin 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.

[0052]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, ...

Embodiment 3

[0056] Add 1523ml of acetone in the reactor, add 120 grams of piperacillin, stir and dissolve, add gac, stir for 20 minutes, filter, the filtrate is added dropwise sodium acetate ethanol solution, sodium acetate ethanol solution consists of 20.2 grams of sodium acetate, 70.8ml of purified water and 384ml of absolute ethanol was mixed and dissolved to form, after the dropwise addition was completed, the reaction was incubated for 2 hours, filtered, the filter cake was washed with acetone, and vacuum-dried to obtain 111.4 grams of piperacillin sodium crude product.

[0057] Weigh 100 g of crude piperacillin 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.

[0058] 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, s...

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Abstract

The invention relates to a child type piperacillin tazobactam sodium pharmaceutical composition, namely a piperacillin tazobactam sodium and low-sodium carrier pharmaceutical composited preparation for transfusion, in particular to combined application package. The pharmaceutical composition comprises piperacillin tazobactam sodium for injection and a low-sodium carrier for transfusion. The low-sodium carrier for transfusion comprises sodium chloride and dextrose injection (15-200:1), glucose and sodium chloride potassium chloride injection (15-200:1:0-1) and the like. Compared with compatible and mixed use of piperacillin tazobactam sodium and the low-sodium carrier, clinical application steps are simplified; the clinical risk which is caused by the problem that the kidneys of children are not mature and have no capacity of metabolizing excessive sodium in blood is reduced, and clinical application quality and safety of pediatric drugs are improved.

Description

technical field [0001] The invention relates to a pharmaceutical composition of piperacillin-tazobactam sodium for children and a low-sodium carrier, belonging to the field of medicinal chemistry. Background technique [0002] Piperacillin sodium, the chemical name is (2S,5R,6R)-3,3-dimethyl-6-[(4-ethyl-2,3-dioxo-1-piperazinecarboxamido)benzene Acetylamino]-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid sodium salt. Molecular formula: C23H26N5NaO7S, molecular weight: 539.54. [0003] Piperacillin is a semi-synthetic penicillin antibiotic. The effect on Gram-positive bacteria is similar to that of ampicillin, and it has a good antibacterial effect on Enterococcus, and it also has a certain effect on some Bacteroides and Clostridium. It has a strong effect on Gram-negative bacteria, and its antibacterial spectrum includes Neisseria gonorrhoeae, Escherichia coli, Proteus, Klebsiella pneumoniae, Pseudomonas aeruginosa, Citrobacter, Enterobacter, Haemophilus, etc. ...

Claims

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Application Information

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IPC IPC(8): A61K31/496A61K47/04A61K47/26A61K9/08A61P31/04A61K31/431
Inventor 陈宇东厉达中
Owner ZHEJIANG CHANGDIAN PHARMA
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