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Application of a 5-hydroxymethylfurfural dimer in drug safety control

A technology of hydroxymethylfurfural dimer and medicine, which is applied in the field of medicine to achieve the effect of simple sample pretreatment, accurate detection results and short analysis time

Active Publication Date: 2019-12-13
INST OF MATERIA MEDICA CHINESE ACAD OF MEDICAL SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although in some cases, the content of 5-HMF dimer in the preparation is significantly lower than that of 5-HMF or other 5-HMF polymers or other 5-HMF derivatives, but the immune adverse reactions produced by it are significantly stronger than that of 5-HMF. -HMF or other 5-HMF polymers or other 5-HMF derivatives

Method used

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  • Application of a 5-hydroxymethylfurfural dimer in drug safety control
  • Application of a 5-hydroxymethylfurfural dimer in drug safety control
  • Application of a 5-hydroxymethylfurfural dimer in drug safety control

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0067] Embodiment 1. Mouse direct popliteal lymph node test (d-PLNA model) detects the immunotoxicity of 5-HMF monomer and dimer

[0068] 1 Purpose: To prepare a uniform solution of 5-HMF monomer and dimer in the present invention, to observe and compare the immune response after subcutaneous injection of the test substance in the toes of mice, and to quickly detect the immunotoxicity of the test substance , to provide a reference for the safety of glucose injection and traditional Chinese medicine injection containing 5-HMF monomer and dimer. The direct popliteal lymph node test is currently recognized as a sensitive method for detecting small molecule allergens, but it is not sensitive to small molecule haptens.

[0069] 2 Test articles and reagents

[0070]Sodium phenytoin (diphenylhydantoin, DPH); 5-HMF monomer (purity: 99%); 5-HMF dimer (purity > 98%); 0.9% normal saline (normal saline, NS); DMSO; PBS buffer.

[0071] 3 experimental animals

[0072] SPF grade Balb / c mi...

Embodiment 2

[0088] Example 2. Study on Immunotoxicity and Mechanism of 5-HMF Dimer by Mouse Reporter Antigen Popliteal Lymph Node Test

[0089] 1 purpose: the 5-HMF dimer among the present invention and two kinds of reporter antigens (TNP-Ficoll and TNP-OVA) are subcutaneously injected to mouse toe part, observe the immune response that mouse popliteal lymph node produces, detect The immunotoxicity and mechanism of 5-HMF dimer provide a reference for the safety and quality control of 5-HMF dimer glucose injection and traditional Chinese medicine injection. The mouse reporter antigen popliteal lymph node test is currently recognized as a sensitive method for the detection of small molecule haptens.

[0090] 2. Test articles and reagents

[0091] Diphenylhydantoin (DPH); 5-HMF monomer (purity: 99%); 5-HMF dimer (purity >98%); TNP-Ficoll; TNP-OVA; TNP-BSA; 0.9% saline; DMSO; PBS buffer.

[0092] Flow cytometry antibodies: PERCP-CY5.5anti-mouse CD3e, FITC anti-mouse CD4, PE anti-mouse CD8a...

Embodiment 3

[0128] Example 3. Quantitative detection of 5-HMF dimer in commercially available glucose injection and traditional Chinese medicine injection

[0129] 1 Instruments and reagents

[0130] Agilent 1200Series HPLC (Agilent, USA); Zorbax SB-C18 (150mm×2.1mm, 5μm) chromatographic column; API4000 mass spectrometer (ABSciex, USA), equipped with ESI ion source; electronic analytical balance (xp 205, Mei Teller-Toledo Instruments Ltd); Eppendorf micropipettes and pipettes. 5-HMF dimer (purity>98%); Chinese medicine injection and glucose injection are commercially available drugs; methanol and formic acid (chromatographically pure) were purchased from Merck Company; experimental water was Wahaha purified water.

[0131] 2 sample preparation

[0132] 2.1 Preparation of reference solution

[0133] Accurately weigh 3.35 mg of 5-HMF dimer reference substance into a 10 mL volumetric flask, add 1 mL of methanol for ultrasonic dissolution, dilute to the mark with the initial mobile phase, ...

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Abstract

The invention relates to application of a 5-hydroxymethylfurfural (HMF) dimer in drug safety control. The inventor finds that the main harmful substance in glucose injection and traditional Chinese medicine injection is the 5-HMF dimer, and the 5-HMF dimer has significant immunotoxicity, so that the product safety can be effectively controlled by detecting the content of the 5-HMF dimer in drugs. Furthermore, the invention also relates to an analytical method for quantitative detection of the 5-HMF dimer. The method adopts liquid chromatographic separation and an electrospray ionization tandem mass spectrometry multi-reaction monitoring (MRM) mode, and has the characteristics of being high in sensitivity and good in repeatability.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to the application of a 5-hydroxymethylfurfural dimer in drug safety control. Background technique [0002] In recent years, with the occurrence of adverse reactions caused by traditional Chinese medicine injections and glucose-containing injections in clinical practice, especially after the "emergency suspension of Houttuynia cordata injection" in 2006, traditional Chinese medicine injections and glucose-containing injections The safety of the system is getting more and more attention. Strengthening the quality control of traditional Chinese medicine injections and glucose-containing injections, and improving the quality standards are the key links to improve the clinical safety of traditional Chinese medicine injections and glucose-containing injections. [0003] Known in the prior art in the art, 5-hydroxymethylfurfural (C 6 h 6 o 3 , formula 1), is the main degradation prod...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/027
Inventor 臧清策再帕尔·阿不力孜贺玖明靳洪涛林铌高杨张瑞萍林生王爱平林琳范潇予
Owner INST OF MATERIA MEDICA CHINESE ACAD OF MEDICAL SCI
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