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Method for measuring isomer impurity ginsenoside RK1 in ginsenoside RZ1 raw material or preparation

A technology of ginsenosides and isomers, applied in the field of drug analysis, can solve the problems of poor reproducibility, inability to meet drugs, immature development of two-dimensional liquid chromatography, etc., and achieve the effect of high resolution

Active Publication Date: 2017-12-22
文利军
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, those skilled in the art know that the development of two-dimensional liquid chromatography is very immature, the reproducibility is poor, and it cannot meet the strict requirements of drug quality control.

Method used

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  • Method for measuring isomer impurity ginsenoside RK1 in ginsenoside RZ1 raw material or preparation
  • Method for measuring isomer impurity ginsenoside RK1 in ginsenoside RZ1 raw material or preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Embodiment 1: mobile phase is aqueous methanol

[0029] 1. Test material

[0030] Waters2695 liquid chromatograph (Waters, USA);

[0031] Sartorius electronic balance (Germany Sartorius);

[0032] Column: Waters XBridge TM C18 chromatographic column (5μm, 4.6×250mm; Waters, USA);

[0033] Ginsenoside RZ 1 and ginsenoside RK 1 The standard products are self-made, and the purity is greater than 98%;

[0034] Methanol, 85% phosphoric acid and triethylamine are chromatographically pure, water is deionized water, and carboxymethyl-β-cyclodextrin is analytically pure.

[0035] 2. Test method and test results

[0036] 2.1 Solution preparation

[0037] Chromatographic peak positioning solution: prepared containing ginsenoside RZ 1 or ginsenoside RK 1 single standard solution, concentration 0.1mg / mL.

[0038] System Suitability Solution: Formulating Ginsenoside RZ 1 and ginsenoside RK 1 The mixed standard solution with a concentration of 0.5 mg / mL was used as the...

Embodiment 2

[0061] Embodiment 2: mobile phase is acetonitrile aqueous solution

[0062] 1. Test material

[0063] Waters2695 liquid chromatograph (Waters, USA);

[0064] Sartorius electronic balance (Germany Sartorius);

[0065] Column: Waters XBridge TM C18 chromatographic column (5μm, 4.6×250mm; Waters, USA);

[0066] Ginsenoside RZ 1 and ginsenoside RK 1 The standard products are self-made, and the purity is greater than 98%;

[0067] Acetonitrile, 85% phosphoric acid, and triethylamine are chromatographically pure, water is deionized water, and carboxymethyl-β-cyclodextrin is analytically pure.

[0068] 2. Test method and test result

[0069] 2.1 Solution preparation

[0070] Chromatographic peak positioning solution: prepared containing ginsenoside RZ 1 or ginsenoside RK 1 single standard solution, concentration 0.1mg / mL.

[0071] System Suitability Solution: Formulating Ginsenoside RZ 1 and ginsenoside RK 1 The mixed standard solution with a concentration of 0.5 mg / m...

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Abstract

The invention relates to a method for measuring isomer impurity ginsenoside RK1 in a ginsenoside RZ1 raw material or preparation. A stationary phase adopts octadecylsilane chemically bonded silica, carboxymethyl-beta-cyclodextrin is added to a mobile phase, chromatographic parameters are shown as follows: a chromatographic column adopts an octadecylsilane chemically bonded silica chromatographic column; the mobile phase is formed by mixing 0.2% phosphoric acid water solution and methanol in the volume ratio being 44:56 or by mixing 0.2% phosphoric acid water solution and acetonitrile in the volume ratio being 52:48, is adjusted with trimethylamine until the pH is 7.2, also contains carboxymethyl-beta-cyclodextrin with the concentration being 0.1 g / L and subjected to gradient elution; the flow speed is 1.0 mL / min; the column temperature is 38-42 DEG C; the detection wavelength is 203 nm. By means of the provided HPLC (high performance liquid chromatography) method, ginsenoside RZ1 and ginsenoside RK1 can be effectively separated only through gradient elution by adding an isomer selective agent carboxymethyl-beta-cyclodextrin to the mobile phase, the separation degree is high, and the method is verified to be qualified.

Description

technical field [0001] The invention relates to drug analysis, in particular to a method for determining ginsenoside RZ 1 Isomer impurity ginsenoside RK in raw materials or preparations 1 Methods. Background technique [0002] The applicant's research found that ginsenoside RZ 1 It can effectively promote the osteogenic differentiation of bone marrow mesenchymal stem cells. Ginsenoside RZ 1 It was first isolated from heat-processed ginseng by Korean scholar Sang Myung LEE (reference: Ginsenosides from Heat Processed Ginseng, Chem Pharm Bull, 2009), and it is derived from ginsenoside RG 3 Dehydrated. [0003] Ginsenoside RZ 1 There are two isomers, ginsenoside RK 1 and RG 5 , the chemical structural formulas and biodegradation pathways of the three are as follows: [0004] [0005] Ginsenoside RG 3 Ginsenoside RK is obtained by elimination reaction of C20 hydroxyl and C21 hydrogen 1 , Ginsenoside RG 3 The C20 hydroxyl group and the C22 hydrogen are eliminated t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/047
Inventor 孙玉鹤杨勇彭雨泽
Owner 文利军
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