Construction method and detection method of specific chromatograms of sterculia lychnophora medicinal material, standard decoction and traditional Chinese medicine formula granules

The characteristic map of Pangdahai medicinal materials was constructed through liquid chromatography analysis technology, which solved the problem that Pangdahai medicinal materials was not efficient enough in the existing technology, and achieved effective identification and quality control of Pangdahai medicinal materials of different specifications.

CN119846085AActive Publication Date: 2025-04-18GUANGDONG YIFANG PHARMA
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Patent Information

Application Number
CN202311335001.7
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2023-10-16
Publication Date
2025-04-18
Estimated Expiration
2043-10-16

AI Technical Summary

Technical Problem

There is a lack of efficient and repeatable detection methods suitable for quality analysis of Pangdahai medicinal materials in the prior art, and it is difficult to distinguish Pangdahai medicinal materials of different specifications.

Method used

Through liquid chromatography analysis technology, a characteristic map of Pangdahai medicinal materials, standard decoctions and Chinese medicine formula particles was constructed, and a gradient elution procedure and appropriate mobile phase combination was used to identify Pangdahai medicinal materials and their products from different sources.

Benefits of technology

It has achieved rapid and comprehensive quality testing of Pangdahai medicinal materials, standard decoctions and Chinese medicine formula granules, with good specialization and separation effects, and can effectively distinguish Pangdahai medicinal materials of different specifications.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention relates to the technical field of traditional Chinese medicine analysis, in particular to a construction method and a detection method of specific chromatograms of a scaphium scaphigerum medicinal material, a scaphium scaphigerum standard decoction and a scaphium scaphigerum traditional Chinese medicine formula granule. According to the present invention, the suitable chromatographic condition is established to perform the liquid chromatography analysis on the scaphium scaphigerum standard decoction to construct the characteristic chromatogram, and the obtained characteristic chromatogram has characteristics of good specificity, good separation effect of each characteristic peak, rich chemical information, good characterization of the material transfer from the raw material to the decoction, and good clinical application prospect. The material basis characteristics of the sterculia lychnophora medicinal material to the sterculia lychnophora standard decoction and the sterculia lychnophora traditional Chinese medicine formula granules are fully displayed, and a rapid and comprehensive detection means is provided for the quality of the sterculia lychnophora medicinal material, the
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Description

Technical Field

[0001] The present application relates to the technical field of traditional Chinese medicine detection, and in particular to a method for constructing and detecting characteristic spectra of Sterculia lychnophora, a standard decoction and traditional Chinese medicine formula granules. Background Art

[0002] Sterculia lychnophora is the dried mature seed of Sterculia lychnophora Hance, a plant of the family Sterculiaceae. It is also known as Dahaizi, Annanzi, Dafazi, etc. It is a famous imported fruit-based Chinese medicinal material, which can be used as both medicine and food, and has a high market penetration rate. Sterculia lychnophora is sweet and cold in nature, and enters the lung and large intestine meridians. It has the effects of clearing heat and moistening the lungs, relieving sore throat and opening the voice, and moistening the intestines and relieving constipation. The chemical components of Sterculia lychnophora include polysaccharides, reducing sugars, phenols, tannins, amino acids, peptides, proteins, fats and volatile oils. Round-grained Sterculia lychnophora is of the same genus as Sterculia lychnophora, and is often used to make up the number. Dried and mature olive fruits and green fruits are also easy to mix in.

[0003] Sterculia lychnophora grows in tropical areas, distributed in Vietnam, Indonesia, Malaysia and Thailand. The seeds are oval, olive-shaped, 2 to 3 cm long, 1 to 1.8 cm in diameter, yellow-brown or brown on the surface, with irregular fine wrinkles, the outer layer of the seed coat is extremely thin, brittle, and easy to fall off, the middle layer of the seed coat is black-brown parenchyma, which expands rapidly into a spongy state after contact with water, and the inner layer of the seed coat is slightly leathery, reddish-brown, with a slight odor and a slightly sweet taste. Sterculia lychnophora is best when it is large, hard, brown, with fine wrinkles and luster on the surface. There are two stages in the concentrated listing of new Sterculia lychnophora in China. One is from February to May, the main production area is Vietnam, the fruit shape is relatively round, commonly known as round fruit Sterculia lychnophora, and the other is in July, the main production area is Thailand, the fruit shape is longer, commonly known as long fruit Sterculia lychnophora. The price of long fruit Sterculia lychnophora in the market is generally higher than that of round fruit Sterculia lychnophora, and the two kinds of decoction pieces corresponding to different specifications are often mixed and sold.

[0004] At present, there are few records of the means of quality analysis applied to Sterculia lychnophora. Most reports focus on the study of the components of Sterculia lychnophora. Only some studies on the evaluation of the quality standards of Sterculia lychnophora are conducted. Generally, thin layer chromatography and liquid chromatography are used to detect and identify Sterculia lychnophora medicinal materials. In addition, there is a lack of research on the exclusive components of Sterculia lychnophora, and no research has been conducted on different specifications of Sterculia lychnophora. Although there are literature reports on the use of characteristic spectrum methods for the quality evaluation of Sterculia lychnophora medicinal materials, the method has certain applicability problems and the separation degree is low. Therefore, it is urgent to provide a more efficient and repeatable detection method that is applicable to Sterculia lychnophora.

[0005] In view of this, the technical content of this application is specially proposed. Summary of the invention

[0006] The purpose of this application includes providing a method for constructing a characteristic map and a detection method for Sterculia lychnophora medicinal material, Sterculia lychnophora standard decoction and Sterculia lychnophora Chinese medicine formula granules. The detection method can be used to identify Sterculia lychnophora medicinal materials, their standard decoctions and Chinese medicine formula granules from different sources, and provide a reference for the formulation of Sterculia lychnophora quality standards.

[0007] In a first aspect of the present application, a method for constructing a characteristic spectrum of Sterculia lychnophora medicinal material, Sterculia lychnophora standard decoction or Sterculia lychnophora Chinese medicine formula granules is provided, comprising the following steps:

[0008] Taking a test sample, adding an extraction solvent for extraction, and preparing a test sample solution, wherein the test sample is selected from Sterculia lychnophora medicinal material, Sterculia lychnophora standard decoction or Sterculia lychnophora traditional Chinese medicine formula granules;

[0009] Taking the test solution for liquid chromatography analysis to establish a characteristic spectrum of Sterculia lychnophora medicinal material, Sterculia lychnophora standard decoction or Sterculia lychnophora traditional Chinese medicine formula granules;

[0010] Wherein, the conditions of the liquid chromatography analysis include:

[0011] (1) Mobile phase A is methanol, and mobile phase B is 0.04%~0.06% acid solution;

[0012] (2) Gradient elution is used, and the procedure of gradient elution includes:

[0013] 0-5min, the volume percentage of the mobile phase A increased from 13% to 14%,

[0014] 5min~22min, maintaining the volume percentage of the mobile phase A at 14%,

[0015] From 22min to 37min, the volume percentage of the mobile phase A increased from 14% to 31%.

[0016] From 37min to 50min, the volume percentage of the mobile phase A increased from 31% to 50%.

[0017] From 50 min to 60 min, the volume percentage of the mobile phase B increased from 50% to 85%.

[0018] The second aspect of the present application provides a method for detecting Sterculia lychnophora medicinal material, Sterculia lychnophora standard decoction or Sterculia lychnophora Chinese medicine formula granules, which comprises the following steps:

[0019] Taking the object to be tested, extracting it with an extraction solvent to prepare a solution of the object to be tested;

[0020] The solution of the test product is taken for liquid chromatography analysis to obtain a characteristic spectrum of the test product.

[0021] Wherein, the conditions of the liquid chromatography analysis include:

[0022] 1) Mobile phase A is methanol, and mobile phase B is 0.04%~0.06% phosphoric acid aqueous solution;

[0023] 2) Gradient elution is used, and the procedure of gradient elution includes:

[0024] 0-5min, the volume percentage of the mobile phase A increased from 13% to 14%,

[0025] 5min~22min, maintaining the volume percentage of the mobile phase A at 14%,

[0026] From 22min to 37min, the volume percentage of the mobile phase A increased from 14% to 31%.

[0027] From 37min to 50min, the volume percentage of the mobile phase A increased from 31% to 50%.

[0028] From 50 min to 60 min, the volume percentage of the mobile phase B increased from 50% to 85%.

[0029] The third aspect of the present application provides the use of the characteristic spectrum obtained by the characteristic spectrum construction method of the first aspect of the present application and / or the detection method of the second aspect of the present application in any one of the following (1) to (3):

[0030] (1) Identify the long-fruited Sterculia lychnophora and round-fruited Sterculia lychnophora medicinal materials;

[0031] (2) Identify the standard decoction of long-fruited Sterculia lychnophora and the standard decoction of round-fruited Sterculia lychnophora;

[0032] (3) Identify the Chinese herbal formula granules of long-fruit Sterculia lychnophora and round-fruit Sterculia lychnophora.

[0033] The present application establishes appropriate chromatographic conditions to conduct liquid chromatography analysis on the standard decoction of Sterculia lychnophora and constructs its characteristic spectrum. The obtained characteristic spectrum has good specificity, good separation effect of each characteristic peak, and rich chemical information. It can well characterize the material transfer from the raw material to the decoction, and fully demonstrates the material basis characteristics of Sterculia lychnophora medicinal materials to Sterculia lychnophora standard decoction and Sterculia lychnophora Chinese medicine formula granules, providing a rapid and comprehensive detection method for the quality of Sterculia lychnophora medicinal materials, Sterculia lychnophora standard decoction and Sterculia lychnophora Chinese medicine formula granules.

[0034] The present application conducts a large amount of research on the characteristic components of Sterculia lychnophora and its standard decoction and Chinese medicine formula granules. By establishing appropriate chromatographic conditions, 9 common characteristic peaks are obtained: Peak 1, Peak 2, Peak 3, Peak 4, Peak 5, Peak 6, Peak 7, Peak 8 and Peak 9. The characteristic components of multiple medicines such as protocatechuic acid, protocatechuic aldehyde, catechin, caffeic acid, 4-coumaric acid and ferulic acid are identified (wherein Peak 1 is protocatechuic acid, Peak 2 is protocatechuic aldehyde, Peak 5 is catechin, Peak 6 is caffeic acid, Peak 7 is 4-coumaric acid, and Peak 9 is ferulic acid), which clarifies the intrinsic chemical information of Sterculia lychnophora and can provide an important reference for its quality detection, identification and clinical use. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] In order to more clearly illustrate the specific implementation methods of the present application or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0036] Figure 1 It is the 3D chromatogram of the standard decoction of Sterculia lychnophora in Example 1;

[0037] Figure 2 It is a comparison diagram of the chromatograms obtained by detecting the standard decoction of Sterculia lychnophora in Example 1 under the switching wavelength condition and under the single wavelength condition;

[0038] Figure 3 This is a comparison diagram of the chromatograms obtained under different elution program conditions of the standard decoction of Sterculia lychnophora in Example 1;

[0039] Figure 4 This is a comparison diagram of the chromatograms obtained by detecting the standard decoction of Sterculia lychnophora in Example 1 under different types of mobile phase conditions;

[0040] Figure 5 This is a comparison diagram of the chromatograms obtained by detecting the standard decoction of Sterculia lychnophora in Example 1 under conditions of different concentrations of phosphoric acid eluents;

[0041] Figure 6 It is an overlay of the characteristic spectra of 15 batches of Sterculia lychnophora truncatula detected in Example 1;

[0042] Figure 7 This is a specificity study on the Sterculia lychnophora detection method in Example 1;

[0043] Figure 8 It is an overlay of the characteristic spectra of 10 batches of long-fruited Sterculia lychnophora detected in Example 2;

[0044] Fig. 9This is a control characteristic spectrum of the long-fruited Sterculia lychnophora prepared in Example 2;

[0045] Fig.10 This is the reference characteristic spectrum of the Sterculia lychnophora prepared in Example 2;

[0046] Fig.11 This is a comparison chart of the test results of long-fruited Sterculia lychnophora and round-fruited Sterculia lychnophora in Example 2. DETAILED DESCRIPTION

[0047] The present application will be further described below in conjunction with the embodiments, examples and accompanying drawings. It should be understood that these examples are only used to illustrate the present application and are not intended to limit the scope of the present application. In addition, it should be understood that after reading the content taught in the present application, those skilled in the art may make various changes or modifications to the present application, and these equivalent forms also fall within the scope of protection of the claims attached to the present application.

[0048] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art to which this application belongs. The terms used herein in the specification of this application are only for the purpose of describing specific embodiments and are not intended to limit this application.

[0049] the term

[0050] Unless otherwise specified or incompatible herewith, the terms and phrases used herein shall have the following meanings:

[0051] The terms "and / or", "or / and", and "and / or" used in this article include any one of two or more related listed items, and also include any and all combinations of related listed items, and the arbitrary and all combinations include any two related listed items, any more related listed items, or a combination of all related listed items. It should be noted that when at least three items are connected by at least two conjunctions selected from "and / or", "or / and", and "and / or", it should be understood that in this application, the technical solution undoubtedly includes technical solutions that are all connected by "logical and", and undoubtedly includes technical solutions that are all connected by "logical or". For example, "A and / or B" includes three parallel solutions of A, B and A+B. For example, the technical solution of "A, and / or, B, and / or, C, and / or, D" includes any one of A, B, C, and D (that is, the technical solution that is all connected by "logical OR"), and also includes any and all combinations of A, B, C, and D, that is, the combination of any two or any three of A, B, C, and D, and also includes the combination of four of A, B, C, and D (that is, the technical solution that is all connected by "logical AND").

[0052] Herein, "preferred", "preferable", "better", etc. are only used to describe implementation methods or examples with better effects. It should be understood that they do not constitute limitations on the scope of protection of this application.

[0053] In the present application, "further", "further", "particularly" and the like are used for descriptive purposes to indicate differences in content, but should not be construed as limiting the scope of protection of the present application.

[0054] In the present application, the technical features described in an open manner include closed technical solutions composed of the listed features, and also include open technical solutions containing the listed features.

[0055] In this application, when it comes to numerical intervals (i.e., numerical ranges), unless otherwise specified, the optional numerical distribution is considered continuous within the above numerical interval, and includes the two numerical endpoints (i.e., the minimum and maximum values) of the numerical range, and each numerical value between the two numerical endpoints. Unless otherwise specified, when the numerical interval only refers to integers within the numerical interval, it includes the two endpoint integers of the numerical range, and each integer between the two endpoints. In addition, when multiple ranges are provided to describe features or characteristics, these ranges can be combined. In other words, unless otherwise specified, the ranges disclosed herein should be understood to include any and all subranges included therein.

[0056] In the present application, weight may be μg, mg, g, kg or other mass units known in the chemical industry.

[0057] In this application, "%" means percentage, which refers to the weight ratio; however, the percentage of a solution, unless otherwise specified, refers to the solute contained in 100 mL of the solution in grams; the percentage of an alcohol refers to the volume ratio at 20°C. In addition, the following symbols may be used as needed: % (g / g) means that a solution contains a solute in grams; % (mL / mL) means that a solution contains a solute in milliliters; % (mL / g) means that a solution contains a solute in milliliters; % (g / mL) means that a solution contains a solute in grams.

[0058] Sterculia lychnophora has the effects of clearing heat and moistening the lungs, relieving sore throat and opening voice, and moistening the intestines and relieving constipation. It is usually taken with boiling water or decocted, and its material transfer basis is decoction. However, the current detection methods for Sterculia lychnophora are limited to morphological identification and internal chemical composition identification, which cannot reflect the internal chemical information of Sterculia lychnophora, limiting its application in modern medicine.

[0059] One aspect of the present application relates to a method for constructing a characteristic spectrum of Sterculia lychnophora medicinal materials, Sterculia lychnophora standard decoction or Sterculia lychnophora Chinese medicine formula granules. The characteristic spectrum prepared by this construction method can more comprehensively reflect the intrinsic chemical information of Sterculia lychnophora medicinal materials, Sterculia lychnophora standard decoction and Sterculia lychnophora Chinese medicine formula granules, providing an effective reference for the quality control, identification and clinical use of Sterculia lychnophora medicinal materials.

[0060] In some embodiments of the present application, the method for constructing the finger map of Sterculia lychnophora medicinal material, Sterculia lychnophora standard decoction or Sterculia lychnophora Chinese medicine formula granules comprises the following steps:

[0061] Take a test sample, add an extraction solvent to extract, and prepare a test sample solution, wherein the test sample is selected from Sterculia lychnophora medicinal material, Sterculia lychnophora standard decoction or Sterculia lychnophora traditional Chinese medicine formula granules;

[0062] Taking the test sample solution for liquid chromatography analysis, establishing a characteristic spectrum of Sterculia lychnophora medicinal material, Sterculia lychnophora standard decoction or Sterculia lychnophora traditional Chinese medicine formula granules;

[0063] Among them, the conditions for liquid chromatography analysis include:

[0064] 1) Mobile phase A is methanol, and mobile phase B is 0.04%~0.06% acid solution;

[0065] 2) Gradient elution is used. The procedure of gradient elution includes:

[0066] From 0 to 5 minutes, the volume percentage of mobile phase A increased from 13% to 14%.

[0067] 5min~22min, maintain the volume percentage of mobile phase A at 14%,

[0068] From 22min to 37min, the volume percentage of mobile phase A increased from 14% to 31%.

[0069] From 37min to 50min, the volume percentage of mobile phase A increased from 31% to 50%.

[0070] From 50min to 60min, the volume percentage of mobile phase B increased from 50% to 85%.

[0071] In some embodiments, the conditions for liquid chromatography analysis further include at least one of the following:

[0072] (1) Liquid chromatography analysis is ultra-high performance liquid chromatography analysis;

[0073] (2) The flow rate of gradient elution is 0.8 mL / min~1.2 mL / min;

[0074] (3) The column temperature is 32°C~38°C;

[0075] (4) The injection volume is 2 μL~4 μL.

[0076] In some embodiments, the acid solution of mobile phase B is selected from an aqueous solution of phosphoric acid, an aqueous solution of formic acid and an aqueous solution of acetic acid, and is further an aqueous solution of phosphoric acid, which can obtain characteristic peaks with better separation and clearer peak shapes, while also having a suitable response signal value.

[0077] Furthermore, the concentration of phosphoric acid in the phosphoric acid aqueous solution is 0.04% to 0.06%, which can obtain better chromatographic peak separation effect and have a suitable response signal value and peak shape.

[0078] In some embodiments, in liquid chromatography analysis, the detection wavelength is 265nm~275nm at 0~23min, and the detection wavelength is 320nm~330nm at 23min~60min, so that richer chromatogram peak information and more appropriate response signal values ​​can be obtained, and the baseline is stable and the interference is small.

[0079] In some embodiments, the chromatographic column is a T3 chromatographic column; further, the model of the chromatographic column is Waters Atlantis T3.

[0080] In some embodiments, the liquid chromatography analysis is ultra performance liquid chromatography analysis.

[0081] In some embodiments, the flow rate of gradient elution is 0.8 mL / min to 1.2 mL / min.

[0082] In some embodiments, the column temperature of the chromatographic column is 32°C to 38°C.

[0083] In some embodiments, the injection volume is 2 μL to 4 μL.

[0084] In some embodiments, the extraction solvent of the test sample is an alcohol aqueous solution with an alcohol volume ratio of 60% to 80%;

[0085] Further, the alcohol in the alcohol-water solution is methanol;

[0086] Furthermore, the mass volume ratio of the test sample and the extraction solvent was 1 g:(15~25) mL.

[0087] In some embodiments, the extraction method includes ultrasound;

[0088] Furthermore, the power of ultrasound is 200W~400W and the frequency is 30kHz~50kHz.

[0089] In some preferred embodiments, the conditions for chromatographic analysis include: using an Atlantis T3 chromatographic column (4.6mm×150mm, 3μm); using methanol as mobile phase A, using 0.05% phosphoric acid solution as mobile phase B, and using gradient elution, the gradient elution program includes: 0~5min, the volume percentage of mobile phase A increases from 13% to 14%, 5min~22min, maintaining the volume percentage of mobile phase A at 14%, 22min~37min, the volume percentage of mobile phase A increases from 14% to 31%, 37min~50min, the volume percentage of mobile phase A increases from 31% to 50%, 50min~60min, the volume percentage of mobile phase B increases from 50% to 85%; the flow rate is 1.0mL per minute; the column temperature is 35°C; the detection wavelength is 280nm from 0min to 23min, and the detection wavelength is 325nm from 23min to 60min; the injection volume is 3μL.

[0090] In some embodiments, the method for constructing a characteristic map further comprises the following steps:

[0091] Providing a reference solution, taking the reference solution for liquid chromatography analysis, wherein the conditions for the liquid chromatography analysis are the same as the conditions for the liquid chromatography analysis of the test sample described in any of the above technical solutions;

[0092] The reference solution included protocatechuic acid, protocatechuic aldehyde, catechin, caffeic acid, ferulic acid and 4-coumaric acid.

[0093] In some embodiments, the preparation step of the reference solution includes: taking appropriate amounts of protocatechuic acid, protocatechuic aldehyde, catechin, caffeic acid, ferulic acid, and 4-coumaric acid, and dissolving them in a solvent;

[0094] The solvent is preferably an alcohol aqueous solution with an alcohol volume ratio of 60% to 80%;

[0095] Further, the alcohol in the alcohol-water solution is methanol;

[0096] Furthermore, the mass volume ratio of the total mass of each reference substance to the solvent is (10~40) μg:1mL.

[0097] In some embodiments, the characteristic spectrum of Sterculia lychnophora medicinal material, Sterculia lychnophora standard decoction or Sterculia lychnophora Chinese medicine formula granules includes the following 9 common peaks: peak 1, peak 2, peak 3, peak 4, peak 5, peak 6, peak 7, peak 8 and peak 9, wherein peak 1 is protocatechuic acid, peak 2 is protocatechuic aldehyde, peak 5 is catechin, peak 6 is caffeic acid, peak 7 is 4-coumaric acid, and peak 9 is ferulic acid.

[0098] The present application also relates to a method for detecting Sterculia lychnophora medicinal material, Sterculia lychnophora standard decoction or Sterculia lychnophora Chinese medicine formula granules, which comprises the following steps:

[0099] Taking the object to be tested, extracting it with an extraction solvent to prepare a solution of the object to be tested;

[0100] Taking the solution of the test product for liquid chromatography analysis to obtain the characteristic spectrum of the test product;

[0101] Among them, the conditions for liquid chromatography analysis include:

[0102] 1) Mobile phase A is methanol, and mobile phase B is 0.04%~0.06% phosphoric acid aqueous solution;

[0103] 2) Gradient elution is used. The procedure of gradient elution includes:

[0104] From 0 to 5 minutes, the volume percentage of mobile phase A increased from 13% to 14%.

[0105] 5min~22min, maintain the volume percentage of mobile phase A at 14%,

[0106] From 22min to 37min, the volume percentage of mobile phase A increased from 14% to 31%.

[0107] From 37min to 50min, the volume percentage of mobile phase A increased from 31% to 50%.

[0108] From 50min to 60min, the volume percentage of mobile phase B increased from 50% to 85%.

[0109] In some embodiments, in the method for detecting Sterculia lychnophora medicinal materials, Sterculia lychnophora standard decoction or Sterculia lychnophora traditional Chinese medicine formula granules, the conditions for the liquid chromatography analysis further include at least one of the following:

[0110] (1) The liquid chromatography analysis is ultra-high performance liquid chromatography analysis;

[0111] (2) The flow rate of the gradient elution is 0.8 mL / min to 1.2 mL / min;

[0112] (3) The column temperature is 32°C~38°C;

[0113] (4) The injection volume is 2 μL~4 μL.

[0114] In some embodiments, in the detection method of Sterculia lychnophora medicinal materials, Sterculia lychnophora standard decoction or Sterculia lychnophora traditional Chinese medicine formula granules, the chromatographic column is a T3 chromatographic column;

[0115] Furthermore, the model of the chromatographic column is Waters Atlantis T3.

[0116] In some embodiments, in the detection method of Sterculia lychnophora medicinal materials, Sterculia lychnophora standard decoction or Sterculia lychnophora traditional Chinese medicine formula granules, the extraction solvent is an alcohol aqueous solution with an alcohol volume ratio of 60% to 80%;

[0117] Furthermore, the alcohol in the alcohol aqueous solution is methanol.

[0118] In some embodiments, in the detection method of Sterculia lychnophora medicinal material, Sterculia lychnophora standard decoction or Sterculia lychnophora traditional Chinese medicine formula granules, the extraction method includes ultrasound;

[0119] Furthermore, the power of ultrasound is 200W~400W and the frequency is 30kHz~50kHz.

[0120] In another aspect of the present application, there is provided an application of a characteristic spectrum obtained by the characteristic spectrum construction method described in any of the above technical solutions and / or the detection method described in any of the technical solutions in any of the following (1) to (3):

[0121] (1) Identify the long-fruited Sterculia lychnophora and round-fruited Sterculia lychnophora medicinal materials;

[0122] (2) Identify the standard decoction of long-fruited Sterculia lychnophora and the standard decoction of round-fruited Sterculia lychnophora;

[0123] (3) Identify the Chinese herbal formula granules of long-fruit Sterculia lychnophora and round-fruit Sterculia lychnophora.

[0124] Furthermore, the above identification step includes:

[0125] Take the sample to be tested, add the extraction solvent to extract it, and prepare the sample solution;

[0126] Taking the solution of the test product for liquid chromatography analysis to establish a characteristic spectrum of the test product;

[0127] Compare the characteristic spectrum of the product to be tested with the characteristic spectrum of Sterculia lychnophora medicinal material, Sterculia lychnophora standard decoction or Sterculia lychnophora Chinese medicine formula granules established by the characteristic spectrum construction method described in any of the above technical solutions to achieve identification of the product to be tested;

[0128] Among them, the conditions for liquid chromatography analysis include:

[0129] (1) Mobile phase A is methanol, and mobile phase B is 0.04%~0.06% acid solution;

[0130] (2) Gradient elution is used, and the procedure of gradient elution includes:

[0131] From 0 to 5 minutes, the volume percentage of mobile phase A increased from 13% to 14%.

[0132] 5min~22min, maintain the volume percentage of mobile phase A at 14%,

[0133] From 22min to 37min, the volume percentage of mobile phase A increased from 14% to 31%.

[0134] From 37min to 50min, the volume percentage of mobile phase A increased from 31% to 50%.

[0135] From 50min to 60min, the volume percentage of mobile phase B increased from 50% to 85%.

[0136] In the above identification method, the conditions of liquid chromatography analysis (including the instrument used for analysis, flow rate, column temperature, injection volume, chromatographic column model, etc.) and the extraction solvent and extraction method used in the preparation process of the test solution, etc., refer to the relevant contents of the first aspect or the second aspect of this application and will not be repeated here.

[0137] In some embodiments, in the characteristic spectrum of the Sterculia lychnophora medicinal material, Sterculia lychnophora standard decoction or Sterculia lychnophora Chinese medicine formula granules established by the construction method described in any of the above technical solutions:

[0138] In the characteristic spectrum of Sterculia lycopersicum, standard decoction or its Chinese medicine formula granules, with S peak as reference, the relative peak area of ​​peak 4 is 0~0.15,

[0139] In the characteristic spectrum of Pteris ovatae, standard decoction or its Chinese medicine formula granules, with S peak as reference, the relative peak area of ​​peak 4 is 0.3~2;

[0140] Compare the characteristic spectrum of the product to be tested with the characteristic spectrum of the Sterculia lychnophora medicinal material, Sterculia lychnophora standard decoction or Sterculia lychnophora Chinese medicine formula granules established by the construction method described in any of the above technical solutions:

[0141] In the characteristic spectrum of the test product, taking the S peak as a reference, the relative peak area of ​​peak 4 is 0-0.15, and the test product is selected from Sterculia lychnophora japonica, the standard decoction or the Chinese medicine formula granules thereof;

[0142] In the characteristic spectrum of the test product, taking the S peak as a reference, the relative peak area of ​​peak 4 is 0.3-2, and the test product is selected from Pteris ovataecarpa, standard decoction or its Chinese medicine formula granules.

[0143] The following are some specific embodiments.

[0144] For experimental parameters not specified in the following specific embodiments, reference is made to the instructions given in the present application document, and reference may also be made to experimental manuals in the art or other experimental methods known in the art, or to experimental conditions recommended by manufacturers.

[0145] The raw materials and reagents involved in the following specific examples can be obtained from commercial sources, or can be prepared by those skilled in the art according to known methods.

[0146] Instruments and reagents

[0147] Instruments: Waters ACQUITY H-class, Waters Technology Co., Ltd.; Thermo ultra-high performance liquid chromatograph (Vanquish, Thermo Fisher Scientific); Waters Atlantis T3 chromatographic column (4.6 mm × 150 mm, 3 μm); one-tenth balance (ME204E, Mettler-Toledo); one-hundred-thousandth balance (ABT220-5DM, Guangzhou Dexiang Technology Co., Ltd.); one-millionth balance (XP26, Mettler-Toledo); electronic balance (JJ600, Changshu Shuangjie Testing Instrument Factory); CNC ultrasonic cleaner (KQ500DE, Kunshan Ultrasonic Instrument Co., Ltd.); constant temperature water bath (HWS28, Shanghai Yiheng Technology Co., Ltd.); ultrapure water system (Villi-Q Direct, Merck & Co., Ltd.).

[0148] Reagents: ethanol (Tianjin Fuyu Fine Chemical Co., Ltd.) and methanol (Tianjin Fuyu Fine Chemical Co., Ltd.) were of analytical grade; phosphoric acid (Tianjin Komiou Chemical Reagent Co., Ltd.) and methanol (Merck Co., Ltd.) were of chromatographic grade; water was ultrapure water (self-made in the laboratory). Protocatechuic acid (batch number: 110809-201906, content: 97.7%, China Food and Drug Inspection Institute); protocatechuic aldehyde (batch number: 110810-201909, content: 99.6%, China Food and Drug Inspection Institute); catechin (batch number: 110877-802005, content: 95.1%, China Food and Drug Inspection Institute); caffeic acid (batch number: 110773-201915, content: 99.4%, China Food and Drug Inspection Institute); ferulic acid (batch number: 110885-201703, content: 99.7%, China Food and Drug Inspection Institute); 4-coumaric acid (batch number: 112037-202102, content: 99.7%, China Food and Drug Inspection Institute); Sterculia lychnophora reference medicinal material (batch number: 121287-201704, China Food and Drug Inspection Institute).

[0149] The medicinal materials used in this application have been identified by the Quality Center of Guangdong Yifang Pharmaceutical Co., Ltd. as the dried mature seeds of Sterculia lychnophora Hance, a plant of the Sterculiaceae family. Specific medicinal material information is shown in Table 1.

[0150] Table 1 Information of Sterculia lychnophora

[0151]

[0152] Example 1 Establishment of a characteristic spectrum construction method

[0153] 1.1 Determine the chromatographic conditions

[0154] 1.1.1 Determination of the optimal absorption wavelength

[0155] Take an appropriate amount of standard decoction of Sterculia lychnophora, grind it into powder, take about 0.5g, weigh it accurately, prepare the test solution according to the test solution preparation method under "1.3", perform gradient elution according to the chromatographic conditions under "1.1.4", and the detection methods are full wavelength scanning. The test results are as follows: Figure 1 ,according to Figure 1 The absorbance of the standard decoction of Pangdahai is the highest at 280nm and 325nm. The detection method is adjusted to 280nm, and the detection wavelength is 280nm from 0min to 23min, and 325nm from 23min to 60min. The test results are as follows: Figure 2 ,according to Figure 2 , the wavelength cutting operation is performed (the detection wavelength is 280nm from 0min to 23min, and the detection wavelength is 325nm from 23min to 60min). The chromatogram obtained has more chromatographic peak information, the chromatographic peak is correspondingly larger, and the baseline is stable and the interference is small. Therefore, after comprehensive consideration, the wavelength cutting operation is performed.

[0156] 1.1.2 Determination of elution gradient

[0157] Based on the separation effect of each chromatographic peak, the chromatographic conditions were optimized to determine the best chromatographic conditions. A Waters Atlantis T3 (4.6 mm × 150 mm, 3 μm) chromatographic column was used, methanol was used as mobile phase A, 0.05% phosphoric acid solution was used as mobile phase B, and gradient elution was performed according to the regulations in Table 2; the flow rate was 1.0 mL per minute; the column temperature was 35 °C; the detection wavelength was 280 nm from 0 min to 23 min, and the detection wavelength was 325 nm from 23 min to 60 min; the injection volume was 3 μL.

[0158] Table 2 Gradient elution table

[0159]

[0160] Results Figure 3 As shown ( Figure 3 The question mark icon in the upper left corner indicates that the sample model is "unknown"). The results show that through the optimization of the chromatographic conditions, when the chromatographic conditions are method 4, the separation effect of each characteristic peak is better and the running time is shorter, so the final chromatographic conditions are determined to be method 4.

[0161] 1.1.3 Determination of mobile phase

[0162] The effects of different water phases on each characteristic peak were investigated to determine the best mobile phase. The results are shown in Figure 4 and Figure 5 As shown ( Figure 5 The question mark icon in the upper left corner indicates that the sample model is "unknown"). The results show that the best separation effect of each chromatographic peak can be achieved when 0.05% phosphoric acid is used as the aqueous phase, so methanol-0.05% phosphoric acid was finally selected as the final mobile phase.

[0163] 1.1.4 Determined chromatographic conditions

[0164] According to the above experimental results, the chromatographic conditions of the standard decoction of Pangdahai can be determined as follows: using an Atlantis T3 chromatographic column (4.6mm×150mm, 3μm); using methanol as mobile phase A and 0.05% phosphoric acid solution as mobile phase B, and performing gradient elution according to the provisions in Table 3; the flow rate is 1.0mL per minute; the column temperature is 35℃; the detection wavelength is 280nm from 0min to 23min, and the detection wavelength is 325nm from 23min to 60min; the injection volume is 3μL.

[0165] Table 3 Gradient elution table

[0166] 1.2 Preparation of reference solution

[0167] Take appropriate amount of protocatechuic acid reference substance, protocatechuic aldehyde reference substance, catechin reference substance, caffeic acid reference substance, ferulic acid reference substance, and 4-coumaric acid reference substance, weigh them accurately, and add 70% methanol to make a mixed solution containing 40 μg protocatechuic acid, 10 μg protocatechuic aldehyde, 30 μg catechin, 30 μg caffeic acid, 20 μg ferulic acid, and 10 μg 4-coumaric acid per 1 mL as the reference substance solution.

[0168] 1.3 Preparation of test solution

[0169] Medicinal materials: Take about 1.0 g of sample powder (passed through No. 3 sieve), weigh accurately, place in a stoppered conical flask, accurately add 25 mL of 70% methanol, ultrasonically treat for 30 minutes (power 300 W, frequency 40 kHz), centrifuge, evaporate the supernatant, add 20 mL of water to dissolve the residue, extract with ethyl acetate twice, 60 mL each time, combine the ethyl acetate layers, evaporate to dryness, add 70% methanol to dissolve the residue, and transfer to a 2 mL volumetric flask, add 70% methanol to the scale, shake well, filter, and take the filtrate.

[0170] Standard decoction: Take an appropriate amount of this product, grind it into powder, take about 1.0g, weigh it accurately, put it in a stoppered conical flask, accurately add 25mL of 70% methanol, ultrasonically treat for 30 minutes (power 300W, frequency 40kHz), centrifuge, evaporate the supernatant to dryness, add 20mL of water to dissolve the residue, add ethyl acetate to extract twice, 60mL each time, combine the ethyl acetate layers, evaporate to dryness, add 70% methanol to dissolve the residue, and transfer it to a 2mL volumetric flask, add 70% methanol to the scale, shake well, filter, and take the filtrate.

[0171] Formula granules: Take an appropriate amount of this product, grind it into powder, take about 1.0g, weigh it accurately, put it in a stoppered conical flask, accurately add 25mL of 70% methanol, ultrasonically treat for 30 minutes (power 300W, frequency 40kHz), centrifuge, evaporate the supernatant to dryness, add 20mL of water to dissolve the residue, add ethyl acetate to extract twice, 60mL each time, combine the ethyl acetate layers, evaporate to dryness, add 70% methanol to dissolve the residue, and transfer it to a 2mL volumetric flask, add 70% methanol to the scale, shake well, filter, and take the filtrate to obtain.

[0172] 1.4 Determination method

[0173] Accurately pipette 3 μL of reference solution and test solution respectively, inject into liquid chromatograph, and measure to obtain the result.

[0174] 1.5 Determination of Sterculia lychnophora medicinal material samples

[0175] Take 15 batches of P. cyrtonema (number PY01~PY15), prepare the test solution according to the method in "1.3", and measure it according to the chromatographic conditions determined in "1.1", and obtain the characteristic spectrum superposition of 15 batches of P. cyrtonema, see Figure 6 Taking peak 6 as the reference peak S, the relative retention time and relative peak area of ​​other chromatographic peaks and peak S were calculated. The results are shown in Tables 4 and 5.

[0176] Table 4 Relative retention time of characteristic spectra of 15 batches of Pteris ovata

[0177]

[0178] Table 5 Relative peak areas of characteristic spectra of 15 batches of Pteris ovata

[0179]

[0180] 1.6 Characteristic peak identification

[0181] The test solution was taken for UV spectral analysis. By comparing the UV spectrum with the reference substance, it was finally determined that the components contained in Sterculia lychnophora were peak 1 for protocatechuic acid, peak 2 for protocatechuic aldehyde, peak 5 for catechin, peak 6 for caffeic acid, peak 7 for 4-coumaric acid, and peak 9 for ferulic acid.

[0182] 1.7 Specificity Investigation

[0183] Results Figure 7 The characteristic peaks in the test sample chromatogram have the same chromatographic peaks at the corresponding retention time of the reference solution chromatogram, and there is no negative interference, indicating that the method has good specificity.

[0184] Example 2 Application of differentiating round-fruit Sterculia lychnophora from long-fruit

[0185] 2.1 Characteristic spectrum chromatographic conditions

[0186] The chromatographic column was a Waters Atlantis T3 column (4.6mm×150mm, 3μm), with a flow rate of 1.0mL / min; methanol was used as mobile phase A, 0.05% phosphoric acid was used as mobile phase B, and the gradient elution was 0min~5min, 13%A~14%A; 5min~22min, 14%A; 22min~37min, 14%A~31%A; 37min~50min, 31%A~50%A; 50min~60min, 50%A~85%A; the detection wavelength was 280nm from 0min~23min, and 325nm from 23min~60min, and the column temperature was 35℃; the injection volume was 3μL.

[0187] 2.2 Preparation of reference substance solution

[0188] Take appropriate amount of protocatechuic acid reference substance, protocatechuic aldehyde reference substance, catechin reference substance, caffeic acid reference substance, ferulic acid reference substance and 4-coumaric acid reference substance, weigh accurately, add 70% methanol to make a mixed solution containing 40 μg protocatechuic acid, 10 μg protocatechuic aldehyde, 30 μg catechin, 30 μg caffeic acid, 20 μg ferulic acid and 10 μg 4-coumaric acid per 1 mL as the reference substance solution.

[0189] 2.3 Preparation of reference medicinal material solution

[0190] Take about 1 g of Sterculia lychnophora reference medicinal material, place it in a stoppered conical flask, add 50 mL of water, heat and reflux for 30 minutes, filter, evaporate to dryness, add 25 mL of 70% methanol to the residue, heat and reflux for 30 minutes, centrifuge, take the supernatant and evaporate to dryness, add 20 mL of water to the residue to dissolve it, add ethyl acetate to extract twice, 60 mL each time, combine the ethyl acetate layers, evaporate to dryness, add 70% methanol to dissolve the residue, and transfer it to a 2 mL volumetric flask, add 70% methanol to the scale, shake well, filter, and take the filtrate as the reference solution of the control medicinal material.

[0191] 2.4 Preparation of test solution

[0192] Take about 1.0 g of sample powder (passed through No. 3 sieve), accurately weigh it, place it in a stoppered conical flask, accurately add 25 mL of 70% methanol, ultrasonically treat for 30 minutes (power 300 W, frequency 40 kHz), centrifuge, evaporate the supernatant, add 20 mL of water to dissolve the residue, extract with ethyl acetate twice, 60 mL each time, combine the ethyl acetate layers, evaporate to dryness, add 70% methanol to dissolve the residue, and transfer it to a 2 mL volumetric flask, add 70% methanol to the scale, shake well, filter, and take the filtrate to obtain.

[0193] 2.5 Comparison of the characteristic spectra of round-fruited Sterculia lychnophora and long-fruited Sterculia lychnophora

[0194] In addition, 10 batches of long-fruited Sterculia lychnophora (No. PC01~PC10) were collected and tested according to the chromatographic conditions under "2.1". The test results are shown in Tables 6~7. The overlay of the characteristic spectra of the 10 batches of long-fruited Sterculia lychnophora is shown in Tables 6~7. Figure 8 .

[0195] The “Chinese Medicine Chromatographic Characteristic Spectrum Similarity Evaluation System (2012.0 Version)” recommended by the Chinese Pharmacopoeia Committee was used to process the characteristic spectra of 10 batches of long-fruited Sterculia lychnophora and 15 batches of round-fruited Sterculia lychnophora medicinal material samples in “Example 1”, and the common peaks were identified to establish the long-fruited Sterculia lychnophora control characteristic spectrum ( Fig. 9 ) and the comparative characteristic spectrum of the medicinal material of Pteris ovata ( Fig.10 ).

[0196] Comparison of the test results of long-fruited Sterculia lychnophora and round-fruited Sterculia lychnophora ( Fig.11 ) It can be seen that all batches of round-fruited Sterculia have 10 characteristic peaks, while most batches of long-fruited Sterculia lack peak 4, and some have detected peak 4 but the peak signal intensity is low. According to the test results of this application, in the chromatogram of long-fruited Sterculia, with the S peak as a reference, the relative peak area of ​​peak 4 is 0~0.15, while in the chromatogram of round-fruited Sterculia, with the S peak as a reference, the relative peak area of ​​peak 4 is 0.3~2. The value of the peak area of ​​peak 4 relative to the S peak can be used as the basis for distinguishing long-fruited Sterculia and round-fruited Sterculia.

[0197] ① Determination results of characteristic spectrum of long-fruited Sterculia lychnophora

[0198] Table 6 Relative retention time of characteristic spectra of 10 batches of long-fruited Sterculia lychnophora

[0199]

[0200] Table 7 Relative peak areas of characteristic spectra of 10 batches of long-fruited Sterculia lychnophora

[0201] All documents mentioned in this application are cited as references in this application, just as each document is cited as reference separately. Unless they conflict with the application purpose and / or technical solution of this application, the cited documents involved in this application are cited with all contents and all purposes. When the cited documents are involved in this application, the definitions of relevant technical features, terms, nouns, phrases, etc. in the cited documents are also cited. When the cited documents are involved in this application, the examples and preferred methods of the cited relevant technical features can also be incorporated into this application as references, but are limited to the implementation of this application. It should be understood that when the cited content conflicts with the description in this application, the present application shall prevail or be modified adaptively according to the description of this application.

[0202] The technical features of the above-mentioned implementation modes and examples can be combined in any appropriate manner. To make the description concise, not all possible combinations of the technical features in the above-mentioned implementation modes and examples are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0203] The above-described embodiments only express several implementation methods of the present application, but they cannot be understood as limiting the scope of the patent application. It should be pointed out that, for those of ordinary skill in the art, without departing from the concept of the present application, several variations and improvements can also be made, which all belong to the protection scope of the present application. In addition, it should be understood that after reading the above-mentioned teaching content of the present application, those skilled in the art can make various changes or modifications to the present application, and the equivalent forms obtained also fall within the protection scope of the present application. It should also be understood that the technical solutions obtained by those skilled in the art on the basis of the technical solutions provided in the present application through logical analysis, reasoning or limited experiments are all within the protection scope of the claims attached to the present application. Therefore, the protection scope of the patent of the present application shall be based on the attached claims, and the description and drawings may be used to explain the contents of the claims.

Claims

1. A method for constructing a characteristic spectrum of Sterculia lychnophora medicinal materials, Sterculia lychnophora standard decoction or Sterculia lychnophora Chinese medicine formula granules, characterized in that: The steps include: Taking a test sample, adding an extraction solvent for extraction, and preparing a test sample solution, wherein the test sample is selected from Sterculia lychnophora medicinal material, Sterculia lychnophora standard decoction or Sterculia lychnophora traditional Chinese medicine formula granules; Taking the test solution for liquid chromatography analysis to establish a characteristic spectrum of Sterculia lychnophora medicinal material, Sterculia lychnophora standard decoction or Sterculia lychnophora traditional Chinese medicine formula granules; Wherein, the conditions of the liquid chromatography analysis include: (1) Mobile phase A is methanol, and mobile phase B is 0.04%~0.06% acid solution; (2) Gradient elution is used, and the procedure of gradient elution includes: 0-5min, the volume percentage of the mobile phase A increased from 13% to 14%, 5min~22min, maintaining the volume percentage of the mobile phase A at 14%, From 22min to 37min, the volume percentage of the mobile phase A increased from 14% to 31%. From 37min to 50min, the volume percentage of the mobile phase A increased from 31% to 50%. From 50 min to 60 min, the volume percentage of the mobile phase B increased from 50% to 85%.

2. The method for constructing the characteristic spectrum of the Sterculia lychnophora medicinal material, Sterculia lychnophora standard decoction or Sterculia lychnophora traditional Chinese medicine formula granules according to claim 1, characterized in that: The conditions of the liquid chromatography analysis also include at least one of the following: (1) The liquid chromatography analysis is ultra-high performance liquid chromatography analysis; (2) The flow rate of the gradient elution is 0.8 mL / min to 1.2 mL / min; (3) The column temperature is 32°C~38°C; (4) The injection volume is 2 μL~4 μL.

3. The method for constructing the characteristic spectrum of the Sterculia lychnophora medicinal material, Sterculia lychnophora standard decoction or Sterculia lychnophora Chinese medicine formula granules as claimed in claim 2, characterized in that: The chromatographic column is a T3 chromatographic column.

4. The method for constructing the characteristic spectrum of the Sterculia lychnophora medicinal material, Sterculia lychnophora standard decoction or Sterculia lychnophora traditional Chinese medicine formula granules according to claim 1, characterized in that: The extraction solvent is an alcohol aqueous solution with an alcohol volume ratio of 60% to 80%; Furthermore, the alcohol in the alcohol aqueous solution is methanol.

5. The method for constructing the characteristic spectrum of the Sterculia lychnophora medicinal material, Sterculia lychnophora standard decoction or Sterculia lychnophora Chinese medicine formula granules according to claim 1, characterized in that: The extraction method includes ultrasound; Furthermore, the power of ultrasound is 200W~400W and the frequency is 30kHz~50kHz.

6. The method for constructing the characteristic spectrum of the Sterculia lychnophora medicinal material, Sterculia lychnophora standard decoction or Sterculia lychnophora traditional Chinese medicine formula granules according to claim 1, characterized in that: The method further comprises the following steps: preparing a reference solution, and taking the reference solution for liquid chromatography analysis; The conditions of the liquid chromatography analysis are as defined in any one of claims 1 to 5; The reference solution includes protocatechuic acid, protocatechuic aldehyde, catechin, caffeic acid, ferulic acid and 4-coumaric acid.

7. The method for constructing the characteristic spectrum of the Sterculia lychnophora medicinal material, Sterculia lychnophora standard decoction or Sterculia lychnophora Chinese medicine formula granules according to any one of claims 1 to 6, characterized in that: The characteristic spectrum of the Sterculia lychnophora medicinal material, Sterculia lychnophora standard decoction or Sterculia lychnophora Chinese medicine formula granules includes the following 9 common peaks: peak 1, peak 2, peak 3, peak 4, peak 5, peak 6, peak 7, peak 8 and peak 9, wherein peak 1 is protocatechuic acid, peak 2 is protocatechuic aldehyde, peak 5 is catechin, peak 6 is caffeic acid, peak 7 is 4-coumaric acid, and peak 9 is ferulic acid.

8. A method for detecting Sterculia lychnophora medicinal materials, Sterculia lychnophora standard decoction or Sterculia lychnophora Chinese medicine formula granules, characterized in that: The steps include: Taking the object to be tested, extracting it with an extraction solvent to prepare a solution of the object to be tested; Taking the solution of the test product for liquid chromatography analysis to obtain a characteristic spectrum of the test product; Wherein, the conditions of the liquid chromatography analysis include: 1) Mobile phase A is methanol, and mobile phase B is 0.04%~0.06% phosphoric acid aqueous solution; 2) Gradient elution is used, and the procedure of gradient elution includes: 0-5min, the volume percentage of the mobile phase A increased from 13% to 14%, 5min~22min, maintaining the volume percentage of the mobile phase A at 14%, From 22min to 37min, the volume percentage of the mobile phase A increased from 14% to 31%. From 37min to 50min, the volume percentage of the mobile phase A increased from 31% to 50%. From 50 min to 60 min, the volume percentage of the mobile phase B increased from 50% to 85%.

9. The method for detecting the Sterculia lychnophora medicinal material, Sterculia lychnophora standard decoction or Sterculia lychnophora Chinese medicine formula granules as claimed in claim 8, characterized in that: The conditions of the liquid chromatography analysis also include at least one of the following: (1) The liquid chromatography analysis is ultra-high performance liquid chromatography analysis; (2) The flow rate of the gradient elution is 0.8 mL / min to 1.2 mL / min; (3) The column temperature is 32°C~38°C; (4) The injection volume is 2 μL~4 μL.

10. The method for detecting the Sterculia lychnophora medicinal material, Sterculia lychnophora standard decoction or Sterculia lychnophora Chinese medicine formula granules as claimed in claim 9, characterized in that: The chromatographic column is a T3 chromatographic column.

11. The method for detecting the Sterculia lychnophora medicinal material, Sterculia lychnophora standard decoction or Sterculia lychnophora Chinese medicine formula granules as claimed in claim 8, characterized in that: The extraction solvent is an alcohol aqueous solution with an alcohol volume ratio of 60% to 80%; Furthermore, the alcohol in the alcohol aqueous solution is methanol.

12. The method for detecting the Sterculia lychnophora medicinal material, Sterculia lychnophora standard decoction or Sterculia lychnophora Chinese medicine formula granules as claimed in claim 8, characterized in that: The extraction method includes ultrasound; Furthermore, the power of ultrasound is 200W~400W and the frequency is 30kHz~50kHz.

13. Use of the characteristic spectrum obtained by the method for constructing the characteristic spectrum according to any one of claims 1 to 7 and / or the detection method according to any one of claims 8 to 12 in any one of the following (1) to (3): (1) Identify the long-fruited Sterculia lychnophora and round-fruited Sterculia lychnophora medicinal materials; (2) Identify the standard decoction of long-fruited Sterculia lychnophora and the standard decoction of round-fruited Sterculia lychnophora; (3) Identify the Chinese herbal formula granules of long-fruit Sterculia lychnophora and round-fruit Sterculia lychnophora.

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