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Biapenem medicine detection method

A technology of biapenem and detection method, which is applied in the field of biapenem drug detection, can solve the problems of less research on quality detection, and achieve the effect of large application value and accurate determination

Active Publication Date: 2016-01-27
CISEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although Biapenem has a better curative effect and its pharmacological effects have been studied by many, but its quality testing is less studied

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] 【Properties】The test product of biapenem is white to light yellow crystal or crystalline powder; odorless.

[0019] Biapenem is easily soluble in formic acid, slightly soluble in water, and almost insoluble in methanol, ethanol or ether.

[0020] For specific rotation, take the test sample of biapenem, accurately weigh it, add water to dissolve and quantitatively dilute to make a solution containing about 10 mg of biapenem in every 1 ml, and determine according to the law (Chinese Pharmacopoeia 2005 edition two appendix VIE), compared with Curl is -27° to -34°.

[0021] [Identification] (1) Take 10 mg of biapenem test product, add 2 ml of water to dissolve, add 3 ml of hydroxylamine hydrochloride test solution, shake well, let it stand for 3 minutes, add 1 ml of acid ferric sulfate ammonium test solution, shake well, and it will appear reddish brown .

[0022] (2) Take biapenem for the test, and make a solution containing 20 μg of biapenem per 1 ml with water. Measur...

Embodiment 2

[0045] 【Properties】The test product of biapenem is white to light yellow crystal or crystalline powder; odorless.

[0046] Biapenem is easily soluble in formic acid, slightly soluble in water, and almost insoluble in methanol, ethanol or ether.

[0047] For specific rotation, take the test sample of biapenem, accurately weigh it, add water to dissolve and quantitatively dilute to make a solution containing about 10 mg of biapenem in every 1 ml, and determine according to the law (Chinese Pharmacopoeia 2005 edition two appendix VIE), compared with Curl is -27° to -34°.

[0048] [Identification] (1) Take 10 mg of biapenem test product, add 2 ml of water to dissolve, add 3 ml of hydroxylamine hydrochloride test solution, shake well, let it stand for 3 minutes, add 1 ml of acid ferric sulfate ammonium test solution, shake well, and it will appear reddish brown .

[0049] (2) Take biapenem for the test, and make a solution containing 20 μg of biapenem per 1 ml with water. Measur...

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PUM

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Abstract

The invention discloses a Biapenem medicine detection method and belongs to the technical field of medicine detection. The method comprises detection of Biapenem content, detection of total impurity content, detection of polymer impurities in medicine, and detection of substance A and substance B contents in medicine. The effective medicine and impurities are highly effectively separated mainly by employing liquid chromatogram technology. The detection method can be employed for highly effective, quick and accurate determination of effective substances and concrete contents of impurities in Biapenem medicine. The detection method is employed to detect quality of Biapenem medicine, and has great application value for production and quality monitoring of the Biapenem medicine.

Description

technical field [0001] The invention belongs to the technical field of drug detection, and in particular relates to a method for detecting biapenem. Background technique [0002] Biapenem is a synthetic carbapenem antibiotic with the chemical name (1R,5S,6S)-2-[(6,7-dihydro-5H-pyrazole[1,2-a][1 ,2,4]-triazolium-6-yl)thio]-6-[(R)-1-hydroxyethyl]-1-methylcarbapillin-2-ene-3-carboxylate. Biapenem is white to light yellow crystal or crystalline powder, odorless, easily soluble in formic acid, slightly soluble in water, almost insoluble in methanol, ethanol or ether. Staphylococcus, Streptococcus, Pneumococcus, Enterococcus, Moraxella, Coliform, Citrobacter, Klebsiella, Enterobacter, Serratia, Proteus, Haemophilus influenzae, Pseudomonas aeruginosa, Actinomycetes, Peptostreptococcus, Bacteroides, Prevotella, and Fusobacterium were all sensitive to apenem. Therefore, sepsis, pneumonia, lung abscess caused by sensitive bacteria, secondary infection caused by chronic respiratory ...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 杜振新卢秀莲
Owner CISEN PHARMA
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