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Novel method for measuring compound cefotaxime sodium sulbactam sodium

A technology of thioxime sodium sulbactam sodium and cefotaxime sodium is applied in the detection field of the new compound cefotaxime sodium sulbactam sodium, which can solve the problems that the determination cannot be affected by another component and is unstable

Inactive Publication Date: 2009-12-02
XIANGBEI WELMAN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But from the point of view of the formulation, because cefotaxime sodium contains a certain amount of water, and sulbactam sodium degrades when it encounters water, it is unstable. If the two are simply mixed together, the stability problem of the product cannot be solved. Solve the stability problem of the product in the preparation process
At the same time, since there is no compound preparation before, all single components are tested, and the compound test after the two are mixed needs to establish a new detection method. Such a detection method can detect the content of a single component and related impurities in the compound. At the same time, this test The determination of a single component of the method cannot be affected by another component, and it can meet the requirements of specific sensitivity and easy operation, and can check the product quality in the preparation factory and local testing institutions or hospitals. To meet such requirements, we have established A new method for detecting compound cefotaxime sodium sulbactam sodium

Method used

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  • Novel method for measuring compound cefotaxime sodium sulbactam sodium
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  • Novel method for measuring compound cefotaxime sodium sulbactam sodium

Examples

Experimental program
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Effect test

Embodiment 1

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

[0006] The experiment used "cefotaxime sodium and sulbactam sodium for injection", the ratio was 2:1, and the specification was 1.5g. Due to the simple loading changes of 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 cefotaxime, both 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 s...

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 4.5-5.5, 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. Because 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 cefotaxime 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 relates to a novel high performance liquid chromatogram (HPLC) method, which can simultaneously detect the content of two single ingredients and relevant impurities in the cefotaxime sodium sulbactam sodium compound. The two ingredients have no interferences or influences. The method has easy operation, strong specificity, high sensitivity, large linear range and good stability, and can be used for detecting a compound preparation and raw materials.

Description

Background of the invention: [0001] Cefotaxime sodium (CTX) is the first third-generation cephalosporin developed by the German company Hoechst in 1977. It is used to treat infectious diseases caused by a variety of Gram-positive and negative bacteria. It has the characteristics of broad antibacterial spectrum, strong antibacterial activity, less tissue distribution and low toxicity. This product has been on the market for nearly 30 years and has been used in many countries and regions around the world. It has been widely praised and is still the first-line clinical drug. [0002] Due to the massive and extensive clinical application, and even the emergence of abuse in recent years, drug-resistant bacteria resistant to cefotaxime have emerged clinically. Most of these drug-resistant bacteria work by producing β-lactamase to degrade cefotaxime, which reduces the antibacterial activity of cefotaxime sodium. The combination of β-lactamase inhibitors developed for this situation...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/26G01N30/50G01N30/74
Inventor 王霆邓桂兴孙明杰马宏强
Owner XIANGBEI WELMAN PHARMA CO LTD
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