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The Construction Method and Application of Weiyangning Fingerprint

A technology of fingerprint spectrum and construction method, applied in the field of quality monitoring of traditional Chinese medicine, can solve the problem of not being able to fully characterize the chemical characteristics and quality of Weiyangning Pills

Active Publication Date: 2021-07-30
GUANGZHOU BAIYUNSHAN CHENLIJI PHARMA FAB CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] However, the above drug standards are for the identification of individual components, and cannot fully characterize the chemical characteristics and quality of Weiyangning Pills

Method used

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  • The Construction Method and Application of Weiyangning Fingerprint
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  • The Construction Method and Application of Weiyangning Fingerprint

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0109] Condition exploration and optimization of the construction method of Weiyangning fingerprint.

[0110] In this example, the effects of different chromatographic columns, mobile phase systems, detection wavelengths, column temperatures, flow rates, and injection volumes on chromatograms were investigated; the effects of sample extraction methods, extraction solvents, and extraction time on components were investigated.

[0111] (1) Inspection of chromatographic column

[0112] 1. Method.

[0113] Under the same chromatographic conditions, the system applicability of Waters symmetry C18 chromatographic column, Agilent XDB plus C18 chromatographic column and Phenomenex Luna C18 chromatographic column under the same specification (4.6×250mm, 5μm) was investigated.

[0114] Extraction method: Take 3g of Weiyangning pills, pulverize them, accurately weigh them, place them in a 50ml Erlenmeyer flask, add 25ml of methanol precisely, weigh them, and process them ultrasonically ...

Embodiment 2

[0221] Methodological investigation on the fingerprint detection method of Weiyangning.

[0222] (1) Precision.

[0223] Take Weiyangning Pills (batch number F51001), prepare 1 part of the test sample with reference to the above-mentioned determination method, continuously inject 6 times, measure the chromatograms, and merge and superimpose the gained chromatograms, as shown Figure 32 shown.

[0224] Among the common characteristic peaks, with No. 14 peak hesperidin as the reference peak, its retention time and peak area were set as 1, and the changes of the relative retention time and relative peak area of ​​each common characteristic peak were investigated respectively. The times are shown in Table 2 below, and the relative peak areas are shown in Table 3.

[0225] Table 2. Precision versus retention time

[0226]

[0227]

[0228] Table 3. Precision relative to peak area

[0229] Total peak number 1 2 3 4 5 6 RSD% 1 0.464 0.460 0.431 0.4...

Embodiment 3

[0251] Establishment of Weiyangning fingerprint.

[0252] According to the fingerprint detection method established above, 10 batches of Weiyangning pills (S1-S10) were detected, and the Weiyangning pills chromatogram Common patterns, overlaid chromatograms see Figure 35 shown. And calibrated the 32 common peaks in the HPLC reference spectrum with the relative retention time, such as Figure 36 As shown, it is the fingerprint of Weiyangning.

[0253] Among the above-mentioned 10 batches of test samples detection spectra, among the common characteristic peaks of the fingerprints, No. 14 peak (hesperidin absorption peak) has a larger peak area, better separation and stability, so this hesperidin chromatographic peak is selected as the reference peak. The relative retention times of the common characteristic peaks of the above-mentioned 10 batches of test products are shown in Table 8 below, and the relative peak areas are shown in Table 9.

[0254] Table 8. Relative retenti...

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Abstract

The invention relates to a method for constructing a fingerprint of Weiyangning and its application, and belongs to the technical field of traditional Chinese medicine quality monitoring. The construction method comprises the following steps: (1) weighing one of the reference substances of norisoboldine, paeoniflorin, liquiritin, hesperidin, galangalin, galangin, and α-cyperone (2) take several batches of Weiyangning Pills as the test sample, and prepare corresponding batches of the test solution; (3) draw the above-mentioned reference product solution and several batches of the test sample solution The test solution is injected into a high-performance liquid chromatograph for determination under predetermined liquid phase conditions, and the Weiyangning fingerprint spectrum composed of the above-mentioned common characteristic peaks is constructed. The construction method of the above-mentioned Weiyangning fingerprint spectrum is based on the retention time and peak area of ​​the reference peak corresponding to the reference product, and the relative retention time and relative peak area of ​​other common characteristic peaks are analyzed, so that the multiple groups of Weiyangning A comprehensive evaluation of the complex system of points.

Description

technical field [0001] The invention relates to the technical field of traditional Chinese medicine quality monitoring, in particular to a method for constructing a fingerprint of Weiyangning and its application. Background technique [0002] Traditional Chinese medicine compositions (Chinese patent medicines) based on the theory of traditional Chinese medicine generally have a variety of medicinal flavor components; during the preparation process of the pharmaceutical composition, different components may react with each other, resulting in more complex components of the pharmaceutical composition. It is difficult to reflect the chemical characteristics of the composition as a whole due to the limited amount of information only by qualitative or quantitative detection of one or several components. [0003] With the development of modern analytical techniques, fingerprints have become an effective means to evaluate the overall quality of multi-component traditional Chinese m...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06G01N2030/047
Inventor 刘敏石洪超彭富全杨能英何风雷
Owner GUANGZHOU BAIYUNSHAN CHENLIJI PHARMA FAB CO LTD