Inspection method for cefodizime sodium polymer for injection

A technology of cefodizime sodium and inspection methods, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve problems such as potential safety hazards and affecting product stability, and achieve the effect of promoting product quality and promoting improvement

Inactive Publication Date: 2014-11-26
SICHUAN PHARMA
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  • Summary
  • Abstract
  • Description
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AI Technical Summary

Problems solved by technology

[0003] And influence cefodizime sodium, because the impurity such as cefodizime sodium related substance and cefodizime sodium polymer, is easy to cause the allergic reaction of medicine, causes the potential safety hazard of using medicine, especially cefodizime sodium is in the process of production and storage, easily Produce cefodizime sodium related substances and cefodizime sodium polymers, which affect the stability of the product

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] The inspection method of cefodizime sodium polymer for injection first establishes a linear equation to determine the range of injection volume, and then uses a glucose gel chromatographic column to perform gradient elution with ultraviolet light at 254nm in the analysis of polymer impurities. Among them, pH7.0 The 0.1mol / L phosphate buffer solution is used as mobile phase A, deionized water is used as mobile phase B, the flow rate is 1.5ml / min, mobile phase A is used as the mobile phase for determination, and mobile phase B is used as the mobile phase for establishing the linear equation , and use self-control external standard method to measure the polymer content of cefodizime sodium for injection.

[0016] Glucose gel is used as filler, and a packing column with an inner diameter of 1.3-1.6 cm and a height of 30-40 cm is used.

[0017] The gradient elution is 0-20min, mobile phase A95%→85%; 20-40min, mobile phase A85%→80%; 40-45min, mobile phase A80%→95%; 45-50min, ...

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Abstract

The invention discloses an inspection method for cefodizime sodium polymer for injection. The inspection method disclosed by the invention has the advantages that the amount of related substances of cefodizime sodium for injection is measured by a gradient elution method, more impurities can be detected, and the discovering of the quality problem in a pharmaceutical product is facilitated, so that the improvement of the quality of a product is improved.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a method for inspecting cefodizime sodium polymer for injection. Background technique [0002] Cefodizime sodium is a third-generation broad-spectrum semi-synthetic cephalosporin jointly developed by Hoest and Russell. Cefodizime sodium not only has broad-spectrum antibacterial activity and long-acting effect, but also has immunomodulatory activity that other third-generation semi-synthetic cephalosporins do not have. This is mainly because cefodizime sodium contains a unique substituent of 2-mercapto-4-methyl-5-thiazoleacetic acid. Clinically, it is mainly used for upper and lower urinary tract infections, lower respiratory tract infections, and gonorrhea caused by staphylococcus, streptococcus and most Gram-negative bacteria. [0003] And influence cefodizime sodium, because the impurity such as cefodizime sodium related substance and cefodizime sodium polymer, is e...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 王强张静文刘萍
Owner SICHUAN PHARMA
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