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MALDI-TOF-MS based high-throughput analysis method for single-particle capsule drug

A technology of MALDI-TOF-MS and analysis method, which is applied in the direction of material analysis, analysis materials, and measuring devices through electromagnetic means, which can solve the problems of unused drug main components and achieve drug screening and high-throughput Effects of Drug Screening

Active Publication Date: 2019-12-20
SHANDONG ANALYSIS & TEST CENT
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The inventors found that at present, MALDI-TOF-MS has not been used in the field of analysis of the main components of drugs in capsule drugs

Method used

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  • MALDI-TOF-MS based high-throughput analysis method for single-particle capsule drug
  • MALDI-TOF-MS based high-throughput analysis method for single-particle capsule drug
  • MALDI-TOF-MS based high-throughput analysis method for single-particle capsule drug

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] The MALDI-TOF-MS analysis method of active pharmaceutical ingredient in diclofenac sodium capsule, comprises the following steps:

[0039] (1) Instruments and reagents

[0040] The mass spectrometer used in the embodiment of the present invention is Bruker rapifleX MALDI Tissuetyper system; the balance used is Mettler Toledo XS 105 electronic balance.

[0041] The reagents used are chromatographically pure acetonitrile, methanol and ethanol from Merck, Germany; the standard used is the chromatographic standard product of diclofenac sodium from Chengdu Durst Biotechnology Co., Ltd.; the matrix used is 2,5-dihydroxybenzene from Sigma. Formic acid (DHB) and alpha-cyano-4-hydroxycinnamic acid (CHCA) matrix.

[0042] The drug samples were collected from a pharmaceutical factory in Nanjing, and the drug samples were in granular form.

[0043] (2) Sample preparation

[0044] The diclofenac sodium standard substance was made into a standard solution with a concentration of 1...

Embodiment 2

[0065] The MALDI-TOF-MS analysis method of active pharmaceutical ingredients in itraconazole capsules comprises the following steps:

[0066] (1) Instruments and reagents

[0067] The mass spectrometer used in the embodiment of the present invention is Bruker rapifleX MALDI Tissuetyper system; the balance used is Mettler Toledo XS 105 electronic balance.

[0068] The reagents used were chromatographically pure acetonitrile, methanol and ethanol from Merck, Germany; the standard used was itraconazole chromatographic standard from Chengdu Durst Biotechnology Co., Ltd.; the matrix used was DHB and CHCA from Sigma.

[0069] The drug samples were collected from a pharmaceutical factory in Chengdu, and the drug samples were in granular form.

[0070] (2) Sample preparation

[0071] Acetonitrile, methanol and ethanol were used to prepare standard itraconazole standard solutions with a concentration of 1.0 mg / mL.

[0072] DHB and CHCA were respectively prepared with methanol / water ...

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Abstract

The invention discloses an MALDI-TOF-MS-based high-throughput analysis method for single-particle capsule drug. The method comprises the following steps: applying a sample of a drug main component standard substance solution on a target plate, drying, carrying out matrix sample application, and carrying out MALDI-TOF-MS analysis detection; adhering drug particles in a to-be-detected capsule to thetarget plate through a conductive double faced adhesive tape, and directly performing MALDI-TOF-MS analysis and detection; and identifying the authenticity of the to-be-detected capsule by comparingthe drug particles of the to-be-detected capsule with a MALDI-TOF-MS graph of the drug main component standard substance. When the MALDI-TOF-MS method is adopted for detecting the single-particle medicine, matrix is not used, pretreatment is not carried out, detection is directly carried out, use of an organic solvent is avoided to the maximum extent, and due to the fact that a complex pretreatment process is not needed, the analysis and detection time is greatly shortened.

Description

technical field [0001] The invention relates to the technical field of drug analysis, in particular to a MALDI-TOF-MS-based high-throughput analysis method for capsule single-particle drugs. Background technique [0002] The information disclosed in this background section is only intended to increase the understanding of the general background of the present invention, and is not necessarily taken as an acknowledgment or any form of suggestion that the information constitutes the prior art already known to those skilled in the art. [0003] The control of drug quality is crucial to the health and life safety of the people, and it is one of the important issues related to the national economy and people's livelihood. However, nowadays drug safety problems occur frequently, and adulterated drugs and even counterfeit drugs seriously threaten people's drug safety. In order to effectively reduce and prevent the occurrence of drug safety problems in a timely manner, it is necess...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N27/64G01N30/02G01N30/72
CPCG01N27/64G01N30/02G01N30/72
Inventor 谢含仪陈相峰赵燕芳李慧娟赵梅王珊珊
Owner SHANDONG ANALYSIS & TEST CENT
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