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Method for detecting beta-lactam antibiotics in enterovirus 71 inactivated vaccine

A technology of lactams and enteroviruses, which is applied in the field of antibiotic residue detection in vaccines, can solve the problems of unreported detection methods, and achieve the effects of good reproducibility and high sensitivity

Pending Publication Date: 2021-06-22
NAT INST FOR FOOD & DRUG CONTROL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, there is no report on the detection methods of various β-lactam antibiotics in vaccines

Method used

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  • Method for detecting beta-lactam antibiotics in enterovirus 71 inactivated vaccine
  • Method for detecting beta-lactam antibiotics in enterovirus 71 inactivated vaccine
  • Method for detecting beta-lactam antibiotics in enterovirus 71 inactivated vaccine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] 1. Chemicals and reagents

[0035]Reference substances faropenem (batch number 130532-201301, purity 80.3%), cefadroxil (batch number 130431-201203, purity 94.8%), oxacillin (batch number 130482-201402, purity 90.4%), cefixime (batch number 130503- 201706, purity 89.2%), cefepime (batch number 130524-201404, purity 83.5%), latamoxef (batch number 130590-201702, purity 84.3%), cefodizime (batch number 130520-201803, purity 89.8%), penicillin (batch number 130437-201707, purity 94.1%), amoxicillin (batch number 130409-201913, purity 86.9%), cephalothin (batch number 130407-200707, purity 96.1%), flucloxacillin (batch number 130529-202002, purity 92.6%) ), cefmenoxime (batch number 130525-201001, purity 94.6%), cefotiam (batch number 130565-201703, purity 80.7%), cefpiramide (batch number 130505-201301, purity 92.5%), cephalexin (batch number 130408- 201411, purity 94.4%), cefaclor (batch number 130481-201606, purity 95.3%), cefazolin (batch number 130421-201204, purity 9...

Embodiment 2

[0057] Optimization and efficiency of embodiment 2 extraction conditions

[0058] In the pre-treatment of the vaccine, the method of concentrating the vaccine in an ultrafiltration centrifuge tube and recovering the filtrate was first tried, but the matrix effect of this method was too large, and the purpose of extracting the target antibiotic was not achieved. We adopted a simple and rapid pretreatment solvent precipitation method, and used live attenuated varicella vaccine as a matrix to explore the effects of ethanol, methanol, and acetonitrile as precipitants. When the volume ratio of precipitant to vaccine was 1:1, the three kinds Precipitants, all have high matrix effects, and obvious matrix interference peaks can be seen, try to increase the amount of precipitants added, reduce matrix effects, and finally determine that precipitants should be added to live attenuated varicella vaccine (0.5mL / dose) The volume is 3 times of its specification, and the precipitation phenome...

Embodiment 3

[0059] The optimization of embodiment 3 liquid quality conditions

[0060] In this example, try to use the following three chromatographic columns: ACE Excel 5 C18 (75mm×2.1mm, 5μm), Shiseido CAPCSLL PAK C18 MG (150mm×2.0mm, 5μm), Shiseido CAPCSLL PAK C18 MG (75mm×2.0mm, 5 μm), the chromatographic conditions were optimized. The results showed that when the ACE Excel 5 C18 (75mm×2.1mm, 5μm) column was used, the amoxicillin peak split and the tailing was serious; when the Shiseido CAPCSLL PAK C18 MG (150mm×2.0mm, 5μm) was used as the The peak shape is sharp and the resolution is good; in order to shorten the retention time of each antibiotic, a Shiseido CAPCSLL PAK C18 MG (75mm×2.0mm, 5μm) chromatographic column was also used, but the peak shape of each antibiotic under this chromatographic column is relatively broad; so the final Choose Shiseido CAPCSLL PAK C18 MG (150mm×2.0mm, 5μm) chromatographic column.

[0061]For the choice of mobile phase, mobile phase A: 5mM ammonium f...

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Abstract

The invention provides a method for detecting beta-lactam antibiotics in an enterovirus 71 inactivated vaccine, and the method for simultaneously detecting 40 beta-lactam antibiotics in the EV71 inactivated vaccine is established for the first time by adopting a liquid chromatograph-mass spectrometer. The method realizes high-throughput screening of residual antibiotics, has the characteristics of high speed, accuracy, high sensitivity and short operation time, and adopts an MRM scanning mode to reduce the generation of false positive. The 40 beta-lactam antibiotics in the vaccine are qualitatively and quantitatively analyzed at the same time, a new thought is provided for establishing a method for detecting other antibiotic residues in the vaccine, and a guarantee is provided for guaranteeing the quality of the vaccine. Meanwhile, antibiotic residues in different vaccine development stages can be detected, the antibiotic residues in different stages can be mastered, adjustment can be made in time, and huge loss caused by unqualified final products is avoided.

Description

technical field [0001] The invention relates to the detection of antibiotic residues in vaccines, in particular to a detection method for β-lactam antibiotics in enterovirus 71 inactivated vaccines. Background technique [0002] As a preventive product among biological products, vaccines are mainly made by artificially attenuating, inactivating or genetic engineering methods of pathogenic microorganisms (such as bacteria, viruses, spirochetes, etc.) and their metabolites. In the process of production and storage, in order to ensure the quality of the product, some antibiotics are often added to inhibit the infection of bacteria, chlamydia, and mycoplasma, resulting in antibiotic residues, which lead to some adverse reactions. The International Council for Harmonization (ICH) controls the residues of antibiotics in vaccines as process impurities in technical requirements for registration of pharmaceuticals for human use; the United States Pharmacopoeia, European Pharmacopoeia...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/06G01N30/88
CPCG01N30/06G01N30/88
Inventor 刘颖尹利辉杨青姚尚辰许明哲张庆生胡忠玉方鑫陈国庆冯艳春田冶张夏朱俐崇小萌马步芳赵瑜江志钦
Owner NAT INST FOR FOOD & DRUG CONTROL
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