Method for measuring content of Shenqi blood sugar reducing preparation and application thereof in overall quality control

A technology of Shenqi lowering blood sugar and determination method, which is applied in the field of drug quality control, can solve the problems of not reflecting the quality level of compound preparations, reagents pollute the environment, and poor selectivity, and achieve scientific and comprehensive internal quality, high quantitative accuracy of mass spectrometry, and good quality. The effect of quality level

Active Publication Date: 2017-03-22
ZHEJIANG UNIV OF TECH
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  • Summary
  • Abstract
  • Description
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  • Application Information

AI Technical Summary

Problems solved by technology

Most of the above methods are only qualitative and quantitative analysis of one or two components in the Shenqi hypoglycemic preparation, which cannot reflect the quality level of the entire compound preparation, and each has its own shortcomings, such as: poor selectivity, low sensitivity, reagent pollution, etc.
HPLC-Q-MS has become a good platform for the separation and analysis of complex systems and the identification

Method used

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  • Method for measuring content of Shenqi blood sugar reducing preparation and application thereof in overall quality control
  • Method for measuring content of Shenqi blood sugar reducing preparation and application thereof in overall quality control
  • Method for measuring content of Shenqi blood sugar reducing preparation and application thereof in overall quality control

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] The optimization of the chromatographic separation conditions of the Shenqi hypoglycemic preparation includes the following steps:

[0057] The effect of different elution gradients on the separation of chemical components of the test solution of Shenqi hypoglycemic preparation was investigated.

[0058] (1) Chromatographic column: Agilent ZORBAX SB-Aq C18 column (4.6 × 250mm i.d., 5 μm); mobile phase: acetonitrile is used as mobile phase A, and 0.1% formic acid aqueous solution is used as mobile phase B; the elution method is : Linear gradient elution, see Table 1 for elution program 1; column temperature: 30°C; flow rate: 1.0mL / min; detection wavelength: 203nm. The obtained liquid chromatogram is shown in the appendix figure 1 , it can be seen from the figure that this elution procedure cannot completely elute the components in Shenqi Jiangtang Granules from the chromatographic column.

[0059] Table 1. Elution Program 1

[0060]

[0061] (2) Chromatographic col...

Embodiment 2

[0065] The construction and application of HPLC-Q-MS content determination method of Shenqi hypoglycemic preparation includes the following steps:

[0066] (1) Instruments and reagents:

[0067] Agilent 1290 High Performance Liquid Chromatograph (Agilent Technologies Co., Ltd.), Agilent 6120 Single Quadrupole Mass Spectrometer (Agilent Technologies Co., Ltd.), KQ-250DE CNC Ultrasonic Cleaner (Kunshan Ultrasonic Instrument Co., Ltd.), R210+V700 Rotary evaporator (Switzerland, BUCHI), AR224CN electronic balance (Ohaus Instrument Co., Ltd.), a set of pipette gun (Dalong Xingchuang Experimental Instrument Co., Ltd.), chromatographic column: Agilent ZORBAX SB-Aq C18 column (4.6 ×250mmi.d., 5μm);

[0068] Test drug: reference substance

[0069] Table 3. Compound information of 10 reference substances and internal standard Tanshinone IIA

[0070]

[0071] Shenqi Jiangtang Granules: Produced by Shandong Lunan Hopu Pharmaceutical Factory, approved by the State Drug Administration...

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Abstract

The invention provides a method for measuring the content of a Shenqi blood sugar reducing preparation. The method is used for measuring the content of 10 active ingredients in the Shenqi blood sugar reducing preparation: ginsenoside Rb1, ginsenoside Rc, ginsenoside Rd, ginsenoside Rg1, ginsenoside Re, astragaloside, deoxyschizandrin, schisandrol A, schisandrol B. In the invention, with the guidance of blood sugar reducing activity of a compound, multiple active substances in the compound are detected, and the quality level of the whole compound preparation can be reflected better; meanwhile, a Q-MS ion monitoring mode is selected for content measurement, and the mass spectrum quantification has high accuracy, specificity and sensitivity and is superior to traditional HPLC analysis method; and moreover, fingerprint is established according to the liquid phase diagrams of different batches of Shenqi blood sugar reducing preparations obtained by the method, the similarity is evaluated, the inherent quality of the Shenqi blood sugar reducing preparation product is evaluated more scientifically and comprehensively, and a basis is provided for establishing a quality standard of higher level.

Description

[0001] (1) Technical field [0002] The invention belongs to the field of drug quality control, and in particular relates to a method for determining the multi-component content of Shenqi hypoglycemic preparations by high performance liquid chromatography-single quadrupole mass spectrometry (HPLC-Q-MS), and to the method obtained by the method. The construction of fingerprints from liquid chromatograms of Shenqi hypoglycemic preparations also involves the application of this method in the overall quality control of Shenqi hypoglycemic preparations. [0003] (2) Background technology [0004] Diabetes Mellitus (DM) belongs to the category of "Diabetes Mellitus" in traditional Chinese medicine: "Those who are thirsty and drink a lot of water, urinate frequently, and are fat-free and sweet like bran are all Diabetes Diseases." The International Diabetes Federation (IDF) pointed out that there are currently 415 million adult diabetic patients in the world, and 318 million people ar...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 张慧张晓静颜继忠姜慧洁
Owner ZHEJIANG UNIV OF TECH
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