Detection method for antioxidant in ceftriaxone sodium for injection

A technology of ceftriaxone sodium and antioxidants, which is applied in the field of medicine and biology, can solve the problems of affecting the clarity of the solution, and there is no substantial breakthrough in the compatibility of rubber stoppers and ceftriaxone sodium, and achieve the practical effect of the method

Inactive Publication Date: 2014-12-10
SICHUAN PHARMA
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Problems solved by technology

[0004] In recent years, studies have found that the compatibility of rubber stoppers with ceftriaxone sodium is the main reason for the cloudiness of the solution clarity during storage of ceftriaxone sodium for injection, but it is affected by factors such as the stability of the drug itself, the circulation and storage environment of the drug, etc. , There has been no substantial breakthrough in the compatibility of rubber stoppers and ceftriaxone sodium. Later, it was found in research that one of the ingredients of medicinal butyl rubber stoppers, the antioxidant 2,6-tert-butyl-4 -Methyl-phenol or BHT can be detected in ceftriaxone sodium for injection, and it is found that the antioxidant BHT is one of the substances that affect the solution clarity of ceftriaxone sodium

Method used

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Embodiment 1

[0019] The assay method of antioxidant in ceftriaxone sodium for injection comprises the following steps:

[0020] (1) Establish a linear equation to establish the detection range of concentration and peak area with good linearity: Dissolve 10.8mg of BHT in a 50ml volumetric flask, dissolve it with acetone and dilute to the scale of the volumetric flask to obtain the initial concentration solution of BHT, take 1ml Place the initial concentration solution of BHT in a 50ml volumetric flask, dilute it to the scale of the volumetric flask with acetone, configure a BHT solution with a concentration of 1 / 50 of the initial concentration of BHT solution, and then draw 0.5, 1.0, 2.5, and 5.0ml respectively Put the BHT solution in four 10ml volumetric flasks, add acetone and dilute to the scale to prepare four different concentration solutions, and then take 20 microliters of the four different concentration solutions and inject them into the liquid chromatograph to obtain four different...

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Abstract

The invention discloses a detection method for an antioxidant in ceftriaxone sodium for injection. According to the method, the antioxidant in ceftriaxone sodium for injection can be detected in an appropriate detection concentration through the establishment of a linear equation and the determination of precision degree, so that the product quality of the ceftriaxone sodium for injection can be further controlled in an auxiliary mode; the method is practical and simple, and a new direction of controlling the product quality of the ceftriaxone sodium for injection is developed.

Description

[0001] technical field [0002] The invention relates to the field of medical biology, in particular to a method for determining antioxidants in ceftriaxone sodium for injection. Background technique [0003] Ceftriaxone sodium is a new, best-selling, broad-spectrum third-generation semi-synthetic cephalosporin antibiotic. The drug is a semi-synthetic third-generation cephalosporin, which has strong antibacterial activity against most Gram-positive and negative bacteria. Bacteria, Proteus, Diplococcus and Staphylococcus aureus, etc. This medicinal product is stable to beta-lactamases. Clinically, it is mainly used for meningitis, pneumonia, skin and soft tissue infection, peritonitis, urinary system infection, gonorrhea, liver and gallbladder infection, surgical trauma, sepsis and genital infection of sensitive bacterial infection. It has been used as the first-line drug for the treatment of gonorrhea. [0004] In recent years, studies have found that the compatibility o...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 包莹刘萍陈继源
Owner SICHUAN PHARMA
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