Method for controlling acidity of piperacillin sodium and tazobactam sodium for injection

A technology of piperacillin sodium and tazobactam sodium, applied in the field of medicine, can solve problems such as increased risk of bleeding, preparation stability and insoluble particles that cannot be solved, and blood coagulation mechanism disorders

Inactive Publication Date: 2014-10-08
JIANGSU HAIHONG PHARMA
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  • Claims
  • Application Information

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Problems solved by technology

5. Combination of this drug with anticoagulant drugs such as heparin, coumarin, and indanedione may cause coagulation disorder and increase the risk of bleeding
Invention patent CN102018713B discloses a piperacillin/tazobactam pharmaceutical composition, in which the weight ratios of piperacillin sodium to tazobactam sodium are 8:1, 4:1 and 2: 1. Use the method of ion exchange resin to exchange HT in piperacillin acid and tazobactam acid with Na+ to obtain the pharmaceutical composition of piperacillin acid sodium and tazobactam acid sodium, and there is no carbon dioxide in the composition Residue, after being prepared into a preparation, the drug piperacillinate sodium and tazobactam sodium composition is obtained, but the carbo

Method used

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Embodiment Construction

[0009] The method for controlling the acidity of piperacillin sodium tazobactam sodium for injection comprises the following steps:

[0010] 1. The weight ratio of piperacillinate sodium to tazobactam sodium is 2:1;

[0011] 2. Take the weight ratio of ion exchange resin to water as 1:25, mix with piperacillin acid and sodium tazobactam together or separately, and the alkali added in the process of salt formation needs to be prepared into a concentrated alkali solution. Add while stirring;

[0012] 3. Control the acidity of the liquid medicine after press filtration, the acidity of the liquid medicine is controlled at 5.8-6.2, filter, and the filtrate is prepared into water injections, infusions, powder injections or freeze-dried powder injections according to the conventional requirements of pharmacy.

[0013] The key of the present invention is that the alkali added in the salt-forming process needs to be prepared into an alkali solution with a suitable concentration, and t...

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Abstract

The invention relates to a method for controlling the acidity of piperacillin sodium and tazobactam sodium for injection. The method is characterized by comprising the following steps of: (1) determining the weight ratio of piperacillin sodium to tazobactam sodium at 2:1; (2) determining the weight ratio of ion exchange resin to water at 1:25, mixing with one or two of piperacillin sodium and tazobactam sodium, and adding alkali in a salifying process while stirring, wherein the alkali is prepared into an alkali solution with certain concentration; (3) controlling the acidity of liquid medicine subjected to filter pressing at 5.8-6.2, filtering, and preparing filtrate into a liquid injection, an infusion solution, a powder injection and a freeze-dried powder injection according to a pharmaceutic conventional requirement. According to the method, the pH value is 6.13, the moisture is 0.7%, and the bacterial endotoxin content of every 1 mg of a product is less than 0.060 EU; the acidity of a finished product is 5.8-6.5, so that the stability of the product is enhanced, and the compliance of the medication of a patient is changed.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a method for reducing related substances of piperacillin sodium and tazobactam sodium for injection. Background technique [0002] Piperacillin / tazobactam is a compound broad-spectrum antibiotic composed of piperacillin sodium and β-lactamase inhibitor tazobactam sodium. Combination of this drug with aminoglycosides such as amikacin, gentamicin or tobramycin has antibacterial effects against Pseudomonas, Serratia, Klebsiella, indole-positive Proteus, Proteus Sensitive strains of Weedenella, other Enterobacteriaceae, and Staphylococcus have a synergistic bactericidal effect. 2. The combination of this drug and some cephalosporins has a synergistic antibacterial effect on certain sensitive strains of Escherichia coli, Pseudomonas, Klebsiella and Proteus. 3. When this drug is used in combination with probenecid, probenecid can reduce the excretion of piperacillin in renal tubules...

Claims

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Application Information

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IPC IPC(8): A61K47/02A61K31/496A61P31/04A61K31/431
Inventor 李汉荣许前辉
Owner JIANGSU HAIHONG PHARMA
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