Novel method for detecting piperacillin sodium and sulbactam sodium for compound injection

A technology of piperacillin sodium and sulbactam sodium is applied in the detection field of new compound injection piperacillin sodium and sulbactam sodium, which can solve the problems of reducing the antibacterial activity of piperacillin sodium and the like

Inactive Publication Date: 2010-10-06
XIANGBEI WELMAN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Most of these drug-resistant bacteria work by producing β-lactamase to degrade piperacillin, which reduces the antibacterial activity of piperacillin sodium

Method used

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  • Novel method for detecting piperacillin sodium and sulbactam sodium for compound injection
  • Novel method for detecting piperacillin sodium and sulbactam sodium for compound injection
  • Novel method for detecting piperacillin sodium and sulbactam sodium for compound injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0005] Example 1. Preliminary detection of compound raw materials and preparations

[0006] "Piperacillin Sodium Sulbactam Sodium for Injection" was used in the experiment, the ratio was 2:1, and the specification was 1.5g. Due to the simple loading changes in other formulations and specifications, there was no significant difference in the source of raw materials and the preparation process. difference. Therefore, the proportion and specification samples were used for research.

[0007] The test sample is white, off-white or slightly yellowish white powder, and the following various tests are carried out.

[0008] 1. Identification test:

[0009] The two components, sulbactam and piperacillin, exist in the form of sodium salt, and should show a flame reaction of sodium salt when burned. Take platinum wire, moisten it with hydrochloric acid, dip it in this product, burn it in a colorless flame, and the flame will appear bright yellow.

[0010] The two components, sulbactam...

Embodiment 2 3

[0011] 2. Detection test

[0012] Test sample acidity inspection: take the test sample and add water for injection to make a solution containing 150mg per ml, and measure it with an acidity meter. As a result, the pH of the test sample is between 4.0-6.5, which is a qualified product.

[0013] Clarity inspection of the test sample solution: take 5 bottles of the test sample, add water to make a solution containing about 0.1g of this product per 1ml, compare it with No. 1 turbidity standard solution, and check the clarity. Results The test sample was a clear liquid, which did not exceed No. 1 turbidity standard solution, and the clarity met the relevant regulations, so it was a qualified sample.

[0014] Test sample solution color inspection: take 5 bottles of test sample, add water to dissolve, place in a 25ml Nessler colorimetric tube, add water to dilute to 10ml, and compare with the yellow hue standard colorimetric solution. Results The test sample is a clear liquid, the c...

Embodiment 2

[0018] Embodiment two, the analysis and quality control method of compound raw material and preparation

[0019] In order to control the quality of the product, it is necessary to analyze and study the possible impurities in the product. Since there is no previous experience of mixing the two substances together, the existing information only has a test method for the relevant impurities in a single piperacillin sodium (or sulbactam sodium).

[0020] Although such an inspection method is effective for the inspection of a single substance, it is not clear whether it can inspect the relevant impurities in the mixture, because whether the two main components will affect each other's detection after being prepared into a mixed preparation, and whether the two impurities will also affect the detection of the other. There are many uncertain factors in the detection of the other party, and a large number of experiments are required to verify. Therefore, we have established a corresp...

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Abstract

The invention discloses a novel high performance liquid chromatography (HPLC) method, which can detect the content and relevant impurities of two single components in the compound preparation of piperacillin sodium and sulbactam sodium simultaneously, and the two components do not interfere and influence each other. The method has the advantages of simple operation, strong specificity, high sensitivity, wide linear range, and high stability, and can be used for detecting compound preparations and materials.

Description

Background of the invention: [0001] Piperacillin sodium is a semi-synthetic penicillin antibiotic with broad-spectrum antibacterial activity. Piperacillin is effective against Enterobacteriaceae such as Escherichia coli, Proteus, Serratia, Klebsiella, Enterobacter, Citrobacter, Salmonella and Shigella, as well as Pseudomonas aeruginosa Other Gram-negative bacteria, such as Monas, Acinetobacter, Haemophilus influenzae, and Neisseria, all have good antibacterial effects. This product also has a certain antibacterial activity against Enterococcus, Group A, Group B hemolytic streptococcus, Streptococcus pneumoniae and staphylococci that do not produce penicillinase. Many anaerobic bacteria, including Bacteroides fragilis and Clostridium, are also sensitive to piperacillin. The mechanism of action of piperacillin is to exert a bactericidal effect by inhibiting the synthesis of bacterial cell walls. [0002] Due to the large and extensive clinical application, and even the emerge...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02A61K31/496A61K31/43
Inventor 孙明杰邓桂兴王霆马宏强
Owner XIANGBEI WELMAN PHARMA CO LTD
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