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Construction Method and Application of Standard Fingerprint of Xiaoer Fupi Granules

A standard fingerprint, the technology of supporting the spleen in children, applied in the direction of instruments, measuring devices, scientific instruments, etc., to achieve the effect of good evaluation and control

Active Publication Date: 2021-02-23
湖南时代阳光药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] There is no clear report on the quality control method of Xiaoer Fupi Granules in the prior art. Therefore, in order to more comprehensively and effectively control the quality of Xiaoer Fupi Granules and ensure its curative effect, a quality control method for Xiaoer Fupi Granules is provided. It is of great significance to comprehensively and effectively control its quality

Method used

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  • Construction Method and Application of Standard Fingerprint of Xiaoer Fupi Granules
  • Construction Method and Application of Standard Fingerprint of Xiaoer Fupi Granules
  • Construction Method and Application of Standard Fingerprint of Xiaoer Fupi Granules

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Example 1: Optimum fingerprint test of Xiaoer Fupi Granules.

[0043] Xiaoer Fupi Granules are made from 6 traditional Chinese medicines of Atractylodes macrocephala, tangerine peel, hawthorn, codonopsis pilosula, lotus seeds, and poria cocos. It has the effect of invigorating the spleen and stomach and helping digestion. In this experiment, the fingerprints of the prescription Chinese medicines were studied, and the varieties and quality of Chinese medicines could be grasped from the overall characteristics.

[0044] Instruments and reagents

[0045] LC-20AT high-performance liquid chromatography (Shimadzu Corporation of Japan); analytical balance (Mettler-Toledo Instruments (Shanghai) Co., Ltd.); constant temperature water bath (Jiangsu Jintan Zhongda Instrument Factory); electronic temperature regulation Electric heating mantle (Tianjin Tester Instrument Co., Ltd.); centrifuge (Jintan Zhongda Instrument Factory, Jiangsu); pipette (Baide Laboratory Instrument (Suzhou...

Embodiment 2

[0061] Embodiment 2: the investigation of chromatographic conditions

[0062] Selection of mobile phase: Ulimate XB-C18 was fixed as the chromatographic column, compared methanol-water, isocratic elution in different proportions, acetonitrile-0.1% phosphoric acid, isocratic elution in different proportions and different gradient elution systems. The results showed that ②Acetonitrile-0.1% phosphoric acid, gradient elution, had a good separation effect on various components of Xiao'er Fupi Granules, and could provide rich chromatographic information. The thermodynamic and compressibility factors of the methanol-water system can easily lead to baseline drift during gradient elution; and the column pressure of the methanol-water system is relatively high, while that of acetonitrile-water is relatively good. Therefore, acetonitrile-0.1% phosphoric acid was determined as the mobile phase.

[0063] Selection of gradient elution program: fix the chromatographic column as Ulimate XB-C...

Embodiment 3

[0070] Embodiment 3: the selection of wavelength

[0071] The detection wavelength was investigated by ultraviolet detector, and the chromatograms under the conditions of 220nm, 240nm, 260nm, 280nm, 300nm, 310nm, 320nm, 330nm, 340nm and 360nm were compared. After comparison, it is found that the maximum absorption wavelength of hesperidin, which is known as the marker component of Xiaoer Fupi Granules, is 283nm, but 280nm is not the best wavelength for fingerprints, because under this condition, the peak height and area of ​​hesperidin are too large , other peaks are not obvious and cannot be identified, and the peak heights of the peaks in the spectrogram are inconsistent. When the detection wavelength is 330nm, the peak heights of the peaks in the spectrogram are coordinated, and all peaks can be identified. At this time, the spectrogram presents the most abundant information, so the detection wavelength is determined to be 330nm, see the attached Figure 3a and Figure 3b...

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Abstract

The invention discloses a method for constructing a standard fingerprint of Xiaoer Fupi Granules and its application, comprising the following steps: (1) making solution A from samples of Xiaoer Fupi Granules in different production batches, and using high performance liquid chromatography method to obtain the fingerprints of several Xiaoer Fupi granules; determine the peak positions and peak areas of the common peaks of the fingerprints of Xiaoer Fupi granules, and use the peak positions and peak areas of these common peaks as the standard fingerprints of Xiaoer Fupi granules Spectrum; (2) Obtain the fingerprint of the Xiaoer Fupi granule sample to be tested according to the same preparation method; (3) Compare the fingerprint of the Xiaoer Fupi granule sample to be tested with the standard fingerprint of Xiaoer Fupi granule. This method is based on the standard fingerprint of Xiaoer Fupi Granules, and a new quality detection method for Xiaoer Fupi Granules can be obtained, which can be used to better evaluate and control the quality of Xiaoer Fupi Granules.

Description

technical field [0001] The invention relates to a method for constructing a standard fingerprint of Xiaoer Fupi Granules and an application thereof, belonging to the field of quality control of traditional Chinese medicines. Background technique [0002] Xiaoer Fupi Granules are made from 6 traditional Chinese medicines of Atractylodes macrocephala, tangerine peel, hawthorn, codonopsis pilosula, lotus seeds, and poria cocos. It has the effect of invigorating the spleen and stomach and helping digestion. [0003] Fingerprint of traditional Chinese medicine refers to the use of certain analysis methods to obtain a common peak spectrum that can calibrate the characteristics of traditional Chinese medicine and can comprehensively reflect the situation of the main components of the preparation. It is a comprehensive, macroscopic, holistic and quantifiable identification method. At present, the use of traditional Chinese medicine fingerprints to evaluate the batch consistency of t...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/88G01N30/02
CPCG01N30/02G01N30/88G01N2030/027G01N2030/8809
Inventor 唐纯玉彭艳梅龚年春黄小青钟露苗王雄龙
Owner 湖南时代阳光药业股份有限公司
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