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New method for detecting compound ceftazidime and sulbactam sodium

A technology of ceftazidime and sulbactam sodium, which is applied in the detection field of the new compound ceftazidime and sulbactam sodium, can solve the problems of not being affected by another component and the like

Inactive Publication Date: 2010-02-17
XIANGBEI WELMAN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] There were relatively mature test methods for ceftazidime and sulbactam sodium before (Peng Jun et al., 2001; ), but since there was no compound preparation before, in practice, a single component was tested, so for the compound after the two are mixed The inspection needs to establish a new detection method. Such a detection method must be able to detect the content of a single component and related impurities in the compound at the same time. At the same time, the determination of a single component by this detection method cannot be affected by another component. Specific sensitivity, easy operation and other requirements, and can inspect the product quality under the conditions of preparation factories and local testing institutions or hospitals, we have established a new detection method for compound ceftazidime sulbactam sodium in response to such requirements

Method used

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  • New method for detecting compound ceftazidime and sulbactam sodium

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

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

[0006] "Ceftazidime-Sulbactam Sodium for Injection" was used in the experiment, the ratio was 2:1, and the specification was 2.0g. Due to simple loading changes in other formulations and specifications, there was no significant difference in the source of raw materials and the preparation process. Therefore, the proportion and specification samples were used for research.

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

[0008] 1. Identification test:

[0009] There are sodium ions in the compound, so it should show the flame reaction of sodium salt when burning. 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] Carbonate Chemical Identification

[0011] Because the ceftazidime raw material of this product...

Embodiment 2 3

[0013] 2. Detection test

[0014] Test sample acidity inspection: take the test sample and add water for injection to make a solution containing 100 mg per ml, and measure it with an acidity meter. As a result, the pH of the test sample is between 5.5-7.5, which is a qualified product.

[0015] 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.

[0016] 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 was a clear liquid with...

Embodiment 2

[0020] Embodiment two, the analysis of preparation and quality control method

[0021] 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 ceftazidime (or sulbactam sodium).

[0022] 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 corresponding detection method for impuri...

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Abstract

The invention provides a new method for detecting compound ceftazidime and sulbactam sodium, which can detect the content of two single ingredients and relative impurities in the ceftazidime and sulbactam sodium compound at the same time. The method prevents mutual interference and influence of two single ingredients, is characterized by simple and easy operation, strong specificity, high sensitivity, large linear range and excellent stability, and can be used for detecting compound preparation and raw materials.

Description

Background of the invention: [0001] Ceftazidime (Ceftazidime) is the third-generation semi-synthetic cephalosporin antibiotic successfully developed by Callaghan et al. in 1978. It is characterized in that it has a bactericidal effect on Pseudomonas aeruginosa, Enterobacter, anaerobic bacteria, and Bacillus fragilis; At the same time, it still has great antibacterial activity against various Gram-positive and negative bacteria; it is very stable and safe to enzymes, has few side effects and has a wide antibacterial spectrum, so it is considered to be an ideal substitute for aminoglycoside antibiotics. This product has been on the market for many 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 (Liu Yuting, 2004). Due to a large number and wide range of clinical applications, and even the emergence of abuse in recent years, ceftazidime-resistant bacteria have emerged clinically, such as ...

Claims

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Application Information

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IPC IPC(8): G01N33/15G01N30/02
Inventor 王霆邓桂兴马宏强孙明杰
Owner XIANGBEI WELMAN PHARMA CO LTD
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