Content determination method of polymer in cephalosporin antibiotic drug

A method of determination, antibiotic technology, applied in the field of polymer content determination in cephalosporin antibiotics, can solve the problem of low polymer accuracy

Inactive Publication Date: 2018-05-11
SINOPHARM ZHIJUN (SHENZHEN) PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0003] The 2015 edition of the "Chinese Pharmacopoeia" contains more than 10 kinds of cephalosporin antibiotic raw materials and the determination methods of high molecular polymers in injections. The traditional molecular exclusion chromatography is basically used, and Sephadex G-10 chromatography is used. Column, eluted with phosphate buffered saline as mobile phase, but the accuracy of calculating the polymer content in cephalosporin antibiotic drugs is low

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  • Content determination method of polymer in cephalosporin antibiotic drug
  • Content determination method of polymer in cephalosporin antibiotic drug
  • Content determination method of polymer in cephalosporin antibiotic drug

Examples

Experimental program
Comparison scheme
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Embodiment 1

[0057] The content assay method of polymer in the cefathiamidine raw material of the present embodiment is as follows:

[0058] (1) Accurately weigh 20 mg of cefathiamidine raw material, place it in a 20 mL measuring bottle, dissolve it in water, and use it as the test solution.

[0059] (2) Precisely pipette 1 mL of the test solution, dilute it with water to 100 mL, and use it as a control solution.

[0060] (3) according to high performance liquid chromatography, need testing solution and contrast solution are detected respectively, to obtain the chromatogram of need testing solution (such as figure 2 Shown) and the chromatogram of contrast solution, wherein, chromatographic condition is: chromatographic column is TSK-GELG2000SW XL Gel chromatographic column (7.8mm ID × 30cm, 5μm), the filler is spherical silica gel, and the pore diameter of the filler is The mobile phase is a mixture of ammonium acetate aqueous solution and acetonitrile, the volume ratio of ammonium ace...

Embodiment 2

[0080] The content assay method of polymer in the cefathiamidine raw material of the present embodiment is as follows:

[0081] (1) Accurately weigh 20 mg of cefathiamidine raw material, place it in a 20 ml measuring bottle, dissolve it in water, and use it as the test solution.

[0082] (2) Accurately pipette 1ml of the test solution and dilute it with water to 100ml as a control solution.

[0083] (3) according to high performance liquid chromatography, need testing solution and contrast solution are detected respectively, to obtain the chromatogram of need testing solution (such as Figure 4 Shown) and the chromatogram of contrast solution, wherein, chromatographic condition is: chromatographic column is TSK-GELG2000SW XL Gel chromatographic column (7.8mm ID × 30cm, 5μm), the filler is spherical silica gel, and the pore diameter of the filler is The mobile phase is a mixture of ammonium acetate aqueous solution and acetonitrile, the volume ratio of ammonium acetate aqueo...

Embodiment 3

[0087] The assay method of polymer in the cefathiamidine for injection of the present embodiment is as follows:

[0088] (1) Accurately weigh 20 mg of cefathiamidine for injection, place it in a 20 mL measuring bottle, dissolve it in water, and use it as the test solution.

[0089] (2) Precisely pipette 1 mL of the test solution, dilute it with water to 100 mL, and use it as a control solution.

[0090] (3) according to high performance liquid chromatography, need testing solution and contrast solution are detected respectively, to obtain the chromatogram of need testing solution (such as Figure 5 Shown) and the chromatogram of contrast solution, wherein, chromatographic condition is: chromatographic column is TSK-GELG2000SW XL Gel chromatographic column (7.8mm ID × 30cm, 5μm), the filler is spherical silica gel, and the pore diameter of the filler is The mobile phase is a mixture of ammonium acetate aqueous solution and acetonitrile, the volume ratio of ammonium acetate a...

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Abstract

The invention relates to a content determination method of a polymer in a cephalosporin antibiotic drug. The content determination method of the polymer in the cephalosporin antibiotic drug comprisesthe following steps: detecting a test sample solution and a reference solution respectively according to a high-performance liquid chromatography, so as to obtain a chromatogram of the test sample solution and a chromatogram of the reference solution, wherein the test sample solution is a solution containing the cephalosporin antibiotic drug, the reference solution is a diluted solution of the test sample solution and chromatographic conditions are as follows: a mobile phase is a mixed solution of a water solution of ammonium acetate and acetonitrile, and a chromatographic column is a gel chromatographic column; calculating the content of the polymer in the cephalosporin antibiotic drug by adopting a main component self-control method according to the chromatogram of the test sample solution and the chromatogram of the reference solution. An experiment proves that the content determination method has relatively high accuracy in determination of the content of the polymer in the cephalosporin antibiotic drug.

Description

technical field [0001] The invention relates to the field of drug analysis, in particular to a method for determining the content of polymers in cephalosporin antibiotic drugs. Background technique [0002] Cephalosporin antibiotics have become one of the most widely used antibacterial drugs in clinical practice due to their advantages of broad antibacterial spectrum, strong antibacterial activity and less side effects. The most common adverse reaction in its clinical application is allergic reaction. The 2016 National Adverse Drug Reaction Monitoring Annual Report pointed out that among the suspected drugs involved in the annual adverse drug reaction event report, anti-infective drugs accounted for 43.9% of the total number of cases of chemical drugs. The antibiotic allergen is not the drug itself, but the high molecular polymer formed by its degradation, which irreversibly binds to the macromolecular carrier in the body, causing an antigen-antibody reaction, resulting in ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/06G01N30/74G01N30/86
CPCG01N30/06G01N30/74G01N30/8634
Inventor 丁梅钟佳胜周向荣陈淑琳王磊泮卫红陈振阳
Owner SINOPHARM ZHIJUN (SHENZHEN) PHARMA CO LTD
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