A method for detecting a Jianweixiaoshi tablet and its blood-entering components, a quality standard for Jianweixiaoshi tablets, a target analysis method and application thereof

Abstract

The present invention provides a method for detecting a Jianwei Xiaoshi tablet and its blood-entering components, a quality standard for Jianwei Xiaoshi tablets, a target analysis method and application, and belongs to the technical field of drug component analysis. The detection method of the Jianwei Xiaoshi tablets provided by the present invention comprises the following steps: extraction, ultra-high performance liquid chromatography-mass spectrometry analysis, establishment of a specific local component database, acquisition of a potential component list, and data analysis and verification. The method can also be used to detect the blood-entering components of the Jianwei Xiaoshi tablets, thereby providing an effective method for studying the potential mechanism of action of the Jianwei Xiaoshi tablets in treating functional dyspepsia, and has good application prospects in the detection of Jianwei Xiaoshi tablets and the study of effective components.

Description

Technical Field

[0001] The invention belongs to the technical field of drug component analysis, and relates to a stomach-strengthening and digestion-promoting tablet and a detection method for its blood-entering components, a quality standard of the stomach-strengthening and digestion-promoting tablet, a target analysis method and an application thereof. Background Art

[0002] Functional dyspepsia (FD) is a common functional gastrointestinal disease with postprandial fullness, early satiety, epigastric pain or epigastric burning as the main clinical manifestations, but no organic lesions of the digestive system were found after a comprehensive examination. Functional dyspepsia has a high incidence, recurrent attacks and is difficult to cure, which seriously reduces the quality of life of patients and brings a heavy burden to patients. The main drugs currently used to treat functional dyspepsia include gastrointestinal motility drugs, acid inhibitors, antidepressants and anti-Helicobacter pylori drugs. In addition, traditional Chinese medicine also plays an important role in the treatment of functional dyspepsia.

[0003] Traditional Chinese medicine has the characteristics of multiple components, multiple targets, and few side effects, which have unique advantages compared with Western medicine. However, traditional Chinese medicine currently generally faces the problem of "unclear ingredients and unknown mechanisms of action". In recent years, the emergence and rise of ultra-high performance liquid chromatography-mass spectrometry (UPLC-MS) has provided a powerful tool for the analysis of complex components of traditional Chinese medicine. UPLC-MS's extremely high resolution, excellent sensitivity, and powerful chromatographic separation capabilities can complete the qualitative analysis of trace components in complex matrices with high quality, and is widely used in the material basis research of traditional Chinese medicine.

[0004] Jianweixiaoshi tablets are mainly composed of Radix Pseudostellariae, Pericarpium CitriReticulatae, Rhizoma Dioscoreae, Fired Hordei Fructus Germinatus and Crataegi Fructus. They are a commonly used drug for the treatment of functional dyspepsia with good therapeutic effects, but their material basis and mechanism of action are still unclear.

[0005] However, existing technologies have failed to achieve ultra-high performance liquid chromatography-mass spectrometry analysis of Jianwei Xiaoshi tablets and provide a research method for Jianwei Xiaoshi tablets and their blood-entering components and potential mechanisms of action. Summary of the invention

[0006] In view of this, in view of the problem that existing technologies have not been able to achieve ultra-high performance liquid chromatography-mass spectrometry analysis of Jianwei Xiaoshi Tablets, and to provide a research method for Jianwei Xiaoshi Tablets and their blood-entering components and potential mechanisms of action, the present invention aims to provide a detection method for Jianwei Xiaoshi Tablets and their blood-entering components, quality standards for Jianwei Xiaoshi Tablets, target analysis methods and applications.

[0007] To achieve the above-mentioned object of the invention, on the one hand, the present invention provides a method for detecting a stomach-strengthening and digestion-promoting tablet, comprising the following steps:

[0008] S1, extraction: the sample to be tested, Radix Pseudostellariae, dried orange peel, Chinese yam, roasted malt and hawthorn are mixed with solvents respectively, and extracted to obtain the sample to be tested extract, Radix Pseudostellariae extract, dried orange peel extract, Chinese yam extract, roasted malt extract and hawthorn extract respectively;

[0009] S2, ultra-high performance liquid chromatography-mass spectrometry analysis: The test sample extract obtained in step S1, the Pseudostellariae Radix extract, the dried orange peel extract, the yam extract, the roasted malt extract and the hawthorn extract are subjected to ultra-high performance liquid chromatography-mass spectrometry analysis to obtain data 1, data 2, data 3, data 4, data 5 and data 6 respectively;

[0010] S3. Establish a specific local component database: retrieve the components contained in Radix Pseudostellariae, dried orange peel, Chinese yam, roasted malt and hawthorn and their molecular formula, monoisotopic mass number and mass spectrum secondary fragment information to establish a specific local component database;

[0011] S4, obtaining a list of potential components: performing data matching on the data 2, data 3, data 4, data 5 and data 6 obtained in step S2 and the specific local component database obtained in step S3 to obtain a list of potential components;

[0012] S5. Data analysis and verification: Based on the potential component list obtained in step S4, retrieve the data 1 obtained in step S2 for data analysis and verification.

[0013] Preferably, in step S1, the sample to be tested is a stomach-strengthening and digestion-promoting tablet.

[0014] Preferably, in step S1, the sample to be tested, Radix Pseudostellariae, dried orange peel, yam, roasted malt and hawthorn are in the form of powder.

[0015] Preferably, in step S1, the solvent is at least one of methanol, ethanol and acetone.

[0016] More preferably, and as an example of the present invention, in step S1, the solvent is methanol.

[0017] Preferably, in step S1, the sample to be tested, Pseudostellaria heterophylla, dried orange peel, Chinese yam, roasted malt and hawthorn are mixed with a solvent respectively as follows:

[0018] Mix 0.5 mg of the sample powder to be tested, 0.5 mg of Pseudostellariae Radix Powder, 0.5 mg of Tangerine Peel Powder, 0.5 mg of Dioscorea Oppositae Powder, 0.5 mg of Rhizoma Dioscoreae ... and 0.5 mg of Hawthorn Powder with 2 mL of methanol respectively.

[0019] Preferably, in step S1, the extraction includes soaking, ultrasonic extraction, centrifugation to obtain supernatant, and filtration.

[0020] More preferably, and as an example of the present invention, in step S1, the extraction is specifically as follows:

[0021] After soaking overnight, ultrasonic extraction was performed for 1 hour, and the supernatant was collected after centrifugation at 13000 rpm and filtered using a 0.22 μm filter membrane.

[0022] Preferably, in step S2, the chromatographic conditions of the ultra-high performance liquid chromatography include:

[0023] Chromatographic column: C18 column;

[0024] Column temperature: 38-42°C;

[0025] Flow rate: 0.33-0.37 mL min -1 ;

[0026] Mobile phase A: 0.1% by mass formic acid aqueous solution; mobile phase B: acetonitrile.

[0027] More preferably, and as an example of the present invention, in step S2, the chromatographic conditions of the ultra-high performance liquid chromatography are as follows:

[0028] Ultra-high performance liquid chromatography: Vanquish Duo UHPLC liquid chromatography system;

[0029] Chromatographic column: HYPERSIL GOLD C18 2.1mm×100mm, 1.9μm;

[0030] Column temperature: 40°C;

[0031] Flow rate: 0.35 mL min -1 ;

[0032] Mobile phase A: 0.1% formic acid aqueous solution; Mobile phase B: acetonitrile;

[0033] Injection volume: 5 μL;

[0034] Gradient elution scheme: 0-1min, 90% mobile phase A + 10% mobile phase B; 1-2min, 90%-85% mobile phase A + 10%-15% mobile phase B; 2-8min, 85%-80% mobile phase A + 15%-20% mobile phase B; 8-15min, 80%-72% mobile phase A + 20%-28% mobile phase B; 15-40min, 72%-36% mobile phase A + 28%-64% mobile phase B; 40-41min, 36%-2% mobile phase A + 64%-98% mobile phase B; 41-43min, 2% mobile phase A + 98% mobile phase B; 43-44min, 2%-90% mobile phase A + 98%-10% mobile phase B; 44-46min, 90% mobile phase A + 10% mobile phase B.

[0035] Preferably, in step S2, the mass spectrometry conditions of the mass spectrometry include:

[0036] Sheath gas flow rate: 37-39Arb;

[0037] Auxiliary gas flow rate: 10Arb;

[0038] Capillary temperature: 318-322℃;

[0039] Auxiliary gas heater temperature: 295-305℃;

[0040] Spray voltage: 3.88-3.92 kV;

[0041] Scan mode: Full MS / dd-MS 2 .

[0042] More preferably, and as an example of the present invention, in step S2, the mass spectrometry conditions of the mass spectrometry are:

[0043] Mass spectrometer: Q Exactive Plus Q-orbittap mass spectrometer in positive ion mode;

[0044] Sheath gas flow rate: 38Arb;

[0045] Auxiliary gas flow rate: 10Arb;

[0046] Capillary temperature: 320℃;

[0047] Auxiliary gas heater temperature: 300℃;

[0048] Spray voltage: 3.9 kV;

[0049] Scan mode: Full MS / dd-MS 2 ;

[0050] Scan range: m / z 100-1500;

[0051] Full scan resolution: 70000; AGC target value: 10 6 ;Maximum injection time: 100ms;

[0052] MS 2 Scanning resolution: 17500; AGC target value: 10 5 ;Maximum injection time: 50ms;

[0053] Normalized collision energy: 20%, 40% and 60%.

[0054] Preferably, in step S3, the search is selected from at least one of academic literature search, TCMSP database search, and HMDB database search.

[0055] More preferably, and as an example of the present invention, in step S3, the search is academic literature search, TCMSP database search and HMDB database search.

[0056] Preferably, and as an example of the present invention, in step S3, the establishment of a specific local component database is specifically:

[0057] Based on the retrieved components contained in Pseudostellaria baicalensis, dried tangerine peel, Chinese yam, roasted malt and hawthorn and their molecular formulas, monoisotopic mass numbers and mass spectrometry secondary fragmentation information, the exclusive local component databases of Pseudostellaria baicalensis, dried tangerine peel, Chinese yam, roasted malt and hawthorn were established respectively using TraceFinder software.

[0058] Preferably, in step S4, the data matching is specifically performed by using primary mass spectrum matching, secondary mass spectrum matching and isotope peak matching.

[0059] Preferably, in step S5, the data analysis and verification specifically includes:

[0060] Import the data 1 obtained in step S2 into the TraceFinder software, select the specific local component database established in step S3 for data matching, and the matching items include primary mass spectrum matching, secondary mass spectrum matching and isotope peak matching; further check and confirm the component matching results of Jianwei Xiaoshi Tablets based on the potential component list obtained in step S4.

[0061] On the other hand, the present invention provides a quality standard for Jianwei Xiaoshi tablets. The Jianwei Xiaoshi tablets are tested according to the above-mentioned detection method, and the test results are analyzed to obtain the names, retention times and sources of the ingredients in the Jianwei Xiaoshi tablets.

[0062] Preferably, the names, retention times and sources of ingredients in the stomach-strengthening and digestion-promoting tablets include:

[0063]

[0064]

[0065] More preferably, the ingredient names, retention times and ingredient sources in the stomach-strengthening and digestion-promoting tablets also include:

[0066]

[0067]

[0068]

[0069]

[0070] Here, # indicates that the component exists in isomers.

[0071] On the other hand, the present invention provides the application of the above detection method and the above quality standard in the detection of ingredients in Jianwei Xiaoshi tablets.

[0072] In another aspect, the present invention provides a method for detecting blood components of Jianwei Xiaoshi tablets, comprising the following steps:

[0073] T1. Take the plasma of the subject before taking Jianweixiaoshi tablets, mix it with solvent, extract it, and obtain supernatant A;

[0074] T2, taking the plasma of the subject after taking the Jianwei Xiaoshi tablets in step T1, mixing it with a solvent, extracting it, and obtaining a supernatant B;

[0075] T3, using the supernatant A obtained in step T1 and the supernatant B obtained in step T2 as the supernatant of the sample to be tested, respectively, and using the above-mentioned detection method to perform detection, and respectively obtaining result A and result B;

[0076] T4: Based on the in vitro component analysis results of the Jianwei Xiaoshi Tablets, compare the results A and B obtained in step T3 to obtain the blood components of the Jianwei Xiaoshi Tablets.

[0077] The subjects include but are not limited to mice, rats, cats, rabbits, humans, etc.

[0078] Preferably, in step T1, the subject is a rat.

[0079] In another aspect, the present invention provides a target analysis method for Jianwei Xiaoshi tablets, comprising the following steps:

[0080] E1. Using a detection method to detect the blood-entering components of Jianwei Xiaoshi Tablets, and obtaining the blood-entering components of Jianwei Xiaoshi Tablets;

[0081] E2. Collect the targets corresponding to the blood-entering components of Jianwei Xiaoshi Tablets obtained in step E1 to obtain a blood-entering component target set, retrieve the functional dyspepsia-related targets to obtain a functional dyspepsia target set, and take the intersection of the blood-entering component target set and the functional dyspepsia target set to obtain a blood-entering component-dyspepsia-related target set;

[0082] E3. Constructing a visualization network using the blood component target set, functional dyspepsia target set, and blood component-dyspepsia-related target set obtained in step E2, and performing protein-protein interaction analysis using the blood component-dyspepsia-related target set obtained in step E2;

[0083] E4. Perform pathway enrichment analysis using the blood-entering component-indigestion-related target set obtained in step E2.

[0084] Preferably, in step E1, the blood-transmitting components of the Jianwei Xiaoshi tablets include:

[0085] p-Coumarin, linalool, feruloyl agmatine, naringin, schaftoside, naringin, hesperidin, aglabin, Pseudostellariae cyclopeptide A, isosakura glycosides, citrus glycosides, Pseudostellariae cyclopeptide B, monohydroxy-hexamethoxyflavone, isocitrullin, Pseudostellariae cyclopeptide B, hesperidin, aurantium, yam III, 5,7,3',4'-tetramethoxyflavone, nobiletin, 5,6,7,4'-tetramethoxyflavone, 3,5,6,7,8,3',4'-heptyloxyflavone, tangeretin.

[0086] Preferably, in step E2, the collection is specifically: by collecting and predicting relevant targets of blood components in the TCMSP database and the SwissTargetprediction database; the retrieval is specifically: searching for functional dyspepsia related targets through the OMIM-gene Map database, the Drugbank database, the TTD database, the GeneCards database and the DisGeNET database.

[0087] Preferably, in step E3, the construction of the visualization network is specifically: using Cytoscape software to construct a component-target-disease visualization network; the protein-protein interaction analysis is specifically: importing the blood-entering component-dyspepsia-related target set into the STING website for protein-protein interaction analysis, and screening the core targets of Jianwei Xiaoshi Tablets for the treatment of functional dyspepsia.

[0088] Preferably, in step E4, the pathway enrichment analysis is specifically as follows: importing the blood component-dyspepsia-related targets into the DAVID database for Go pathway analysis and KEGG pathway enrichment analysis to determine the key signaling pathways for Jianwei Xiaoshi Tablets to treat functional dyspepsia.

[0089] Preferably, the core targets include:

[0090] Histamine receptor H2, serotonin receptor 4, serotonin receptor 1A, dopamine receptor D4, dopamine receptor D2 and inflammation-related targets.

[0091] More preferably, the key signaling pathway includes at least one of the following pathways: PI3K-Akt signaling pathway, MAPK signaling pathway, TNF signaling pathway, serotonergic synapse, T cell receptor signaling pathway, calcium ion signaling pathway, mTOR signaling pathway, Toll-like receptor signaling pathway, B cell receptor signaling pathway, cAMP signaling pathway, IL-17 signaling pathway, cholinergic synapse, AMPK signaling pathway, NF-κB signaling pathway and dopaminergic synapse.

[0092] More preferably, the key signaling pathways include: PI3K-Akt signaling pathway, MAPK signaling pathway, TNF signaling pathway, serotonergic synapse, T cell receptor signaling pathway, calcium ion signaling pathway, mTOR signaling pathway, Toll-like receptor signaling pathway, B cell receptor signaling pathway, cAMP signaling pathway, IL-17 signaling pathway, cholinergic synapse, AMPK signaling pathway, NF-κB signaling pathway and dopaminergic synapse.

[0093] On the other hand, the present invention also provides the application of the above-mentioned target analysis method in the production of products for treating functional dyspepsia.

[0094] Compared with the prior art, the present invention has the following beneficial effects:

[0095] (1) The present invention provides a method for detecting the ingredients of Jianwei Xiaoshi Tablets by using ultra-high performance liquid chromatography, thereby achieving simultaneous and efficient identification and detection of multiple effective ingredients in Jianwei Xiaoshi Tablets.

[0096] (2) Based on the in vitro component identification results of five single medicinal materials, the present invention clarified the in vitro component composition of Jianwei Xiaoshi Tablets, analyzed its blood-entering components, and further clarified the potential pharmacodynamic material basis of Jianwei Xiaoshi Tablets.

[0097] (3) Based on the components entering the blood, the present invention uses network pharmacology research methods to explore the potential mechanism of action of Jianwei Xiaoshi Tablets in treating functional dyspepsia. For the first time, the material basis of Jianwei Xiaoshi Tablets is comprehensively explained, and the potential mechanism of action of Jianwei Xiaoshi Tablets is preliminarily explored, providing a basis and basis for further research on Jianwei Xiaoshi Tablets. BRIEF DESCRIPTION OF THE DRAWINGS

[0098] Figure 1 This is the BPI chromatogram of comparative example 1 for the detection of Jianweixiaoshi tablets.

[0099] Figure 2 This is the BPI chromatogram of the test of Jianweixiaoshi tablets in comparative example 2.

[0100] Figure 3a It is the BPI chromatogram of the Jianweixiaoshi tablets extract in Example 1.

[0101] Figure 3b is the extracted ion chromatogram of the standard.

[0102] Figure 3c yes Figure 3b A fine structure diagram of the extracted ion chromatogram of the standard.

[0103] Figure 4a This is the secondary mass spectrum of the representative component proline.

[0104] Figure 4b This is the secondary mass spectrum of the representative ingredient hordenine.

[0105] Figure 4c This is the secondary mass spectrum of the representative ingredient vanillin.

[0106] Figure 4d This is the secondary mass spectrum of the representative ingredient aurantium.

[0107] Figure 4e This is the secondary mass spectrum of the representative ingredient yam III.

[0108] Figure 4f This is the secondary mass spectrum of the representative ingredient nobiletin.

[0109] Figure 5 This is the Venn relationship diagram of targets related to Jianwei Xiaoshi Tablets and targets related to functional dyspepsia.

[0110] Figure 6 It is a "component-target-disease" network diagram, in which the meanings of the component codes are as follows:

[0111] JWXST-01: p-Coumarin; JWXST-02: Rosacid; JWXST-03: Feruloyl Agmatine; JWXST-04: Rutin; JWXST-05: Schaftoside; JWXST-06: Naringin; JWXST-07: Hesperidin; JWXST-08: Aglabin; JWXST-09 Pseudostellariae Cyclopeptide A; JWXST-10: Isocherrin; JWXST-11: Citrus glycoside; JWXST-12: Pseudostellariae Cyclopeptide B; JWXST-13: Monohydroxy-hexamethoxy JWXST-14: Isonaginsenoside; JWXST-15: Radix Pseudostellariae Cyclopeptide B; JWXST-16: Hesperidin; JWXST-17: Auriculariacin; JWXST-18: Yam III; JWXST-19: 5,7,3',4'-tetramethoxyflavone; JWXST-20: Nobiletin; JWXST-21: 5,6,7,4'-tetramethoxyflavone; JWXST-22: 3,5,6,7,8,3',4'-heptyloxyflavone; JWXST-23: Tangeretin.

[0112] Figure 7 This is the PPI analysis chart of Jianweixiaoshi tablets in treating functional dyspepsia.

[0113] Figure 8 This is the Go analysis diagram of Jianwei Xiaoshi Tablets, where the serial numbers represent the following meanings:

[0114] No. 1. GO: 0007165 ~ signal regulation; No. 2. GO: 0043066 ~ negative regulation of apoptosis; No. 3. GO: 0006468 ~ protein phosphorylation; No. 4. GO: 0008284 ~ positive regulation of cell proliferation; No. 5. GO: 0009410 ~ response to exogenous stimuli; No. 6. GO: 0010628 ~ positive regulation of gene expression; No. 7. GO: 0043410 ~ positive regulation of MAPK cascade pathway; No. 8. GO: 005189 7~Positive regulation of protein kinase B signal; No. 9.GO:0030335~Positive regulation of cell migration; No. 10.GO:0070374~Positive regulation of ERK1 and ERK2 cascade pathways; No. 11.GO:0005886~Plasma membrane; No. 12.GO:0005737~Cytoplasm; No. 13.GO:0005634~Nucleus; No. 14.GO:0005829~Cytosol; No. 15.GO:0005654~Nucleoplasm; No. 16.GO :0016020 ~ Cell membrane; Serial number 17.GO:0005887 ~ Internal components of the plasma membrane; Serial number 18.GO:0005576 ~ Extracellular region; Serial number 19.GO:0005615 ~ Extracellular space; Serial number 20.GO:0009986 ~ Cell surface; Serial number 21.GO:0005515 ~ Protein binding; Serial number 22.GO:0042802 ~ Specific protein binding; Serial number 23.GO:0005524 ~ ATP binding; Serial number 24 .GO:0004712~Protein serine / threonine / tyrosine kinase activity; Serial number 25.GO:0004672~Protein kinase activity; Serial number 26.GO:0019899~Enzyme binding; Serial number 27.GO:0042803~Protein homodimerization activity; Serial number 28.GO:0004674~Protein serine / threonine kinase activity; Serial number 29.GO:0005102~Receptor binding; Serial number 30.GO:0019901~Protein kinase binding.

[0115] Fig. 9 This is the KEGG analysis chart of Jianweixiaoshi tablets. DETAILED DESCRIPTION

[0116] The following non-limiting examples can enable those skilled in the art to more fully understand the present invention, but do not limit the present invention in any way. The following content is only an exemplary description of the scope of the present invention, and those skilled in the art can make various changes and modifications to the invention of the present invention based on the disclosed content, and they should also fall within the scope of the present invention.

[0117] The present invention is further described below by way of specific examples. The various chemical reagents used in the examples of the present invention are obtained through conventional commercial channels unless otherwise specified. Unless otherwise specified, the contents described below are all weight contents. Unless otherwise specified, it is understood that the process is carried out at room temperature.

[0118] The stomach-strengthening and digestion-promoting tablets used in the present invention are from Jiangzhong Pharmaceutical Co., Ltd. (batch number: 22105001).

[0119] Example 1

[0120] In vitro component analysis of single medicinal materials and Jianweixiaoshi tablets.

[0121] The Jianweixiaoshi tablets, Pseudostellariae Radix, Dried Tangerine Peel, Roasted Malt, Chinese Yam and Hawthorn were ground into powders by a grinder. 0.5 mg of Jianweixiaoshi tablets powder / Pseudostellariae Radix Powder / Dried Tangerine Peel Powder / Roasted Malt Powder / Chinese Yam Powder / Hawthorn Powder were accurately weighed, mixed with 2 mL of methanol, soaked overnight and ultrasonically extracted for 1 hour, centrifuged at 13000 rpm, and the supernatant was collected and filtered with a 0.22 μm filter membrane for UPLC-MS (ultra-performance liquid chromatography-mass spectrometry) analysis.

[0122] The chromatographic analysis and high-resolution mass spectrometry data acquisition of the samples were performed using a Vanquish Duo UHPLC liquid phase system (Thermo Fisher Scientific, USA) in series with a Q Exactive Plus Q-orbittap mass spectrometer (Thermo Fisher Scientific, USA) in positive ion mode. The liquid phase conditions were as follows:

[0123] Chromatographic separation was performed using a HYPERSIL GOLD C18 column (2.1 mm × 100 mm, 1.9 μm) at 40°C with a mobile phase consisting of water (A) containing 0.1% formic acid and acetonitrile (B) at a flow rate of 0.35 mL min -1 The gradient elution was performed at a flow rate of . The gradient elution scheme was as follows: 0-1min, 10% B; 1-2min, 10%-15% B; 2-8min, 15%-20% B; 8-15min, 20%-28% B; 15-40min, 28%-64% B; 40-41min, 64%-98% B; 41-43min, 98% B; 43-44min, 98%-10% B; 44-46min, 10% B. The injection volume was 5 μL.

[0124] The mass spectrometry parameters were set as follows: sheath gas flow rate: 38 Arb; auxiliary gas flow rate: 10 Arb; capillary temperature: 320°C, auxiliary gas heater temperature: 300°C; spray voltage: 3.9 kV. Full MS / dd-MS was used.2 The data were collected in scanning mode with a scanning range of m / z 100-1500. The full scan resolution was 70000 and the AGC target value was 10 6 , the maximum injection time is 100ms. MS 2 Scan resolution is 17500, AGC target value is 10 5 , the maximum injection time is 50 ms, and the normalized collision energy (NCE) is 20%, 40% and 60%.

[0125] The Xcalibur TM3.0 software (Thermo Fisher Scientific, USA) was used to control the Q-Exactiveplus mass spectrometer for data acquisition. The possible components contained in Pseudostellariae Radix, Dried Tangerine Peel, Chinese Yam, Roasted Malt and Hawthorn were retrieved and collected through academic literature retrieval, TCMSP database (https: / / old.tcmsp-e.com / tcmsp.php) and HMDB database (https: / / hmdb.ca / ), as well as the molecular formula, monoisotopic mass number and mass spectrometry secondary fragment information of these components. Based on the collected information, the TraceFinder software (Thermo Fisher Scientific, USA) was used to establish the exclusive local component databases of Pseudostellariae Radix, Dried Tangerine Peel, Chinese Yam, Roasted Malt and Hawthorn, which were used for the identification of the components of single medicinal materials and Jianwei Xiaoshi Tablets. Finally, the UPLC-MS raw data collected by the Xcalibur software were imported into the TraceFinder software for component matching to obtain a list of potential components. Based on the list of potential components, the chromatographic peaks, accurate mass numbers and secondary mass spectrometry fragment information of the potential components were retrieved in Xcalibur for further data analysis and verification.

[0126] Comparative Example 1

[0127] Compared with Example 1, no exclusive single medicinal material component database was established, and the gradient elution scheme was changed to the following, and the other detection conditions were the same.

[0128] 0-1min, 10%B; 1-23min, 10%-98%B; 23-25min, 98%B; 25-26min, 98%-10%B; 26-28min, 10%B.

[0129] In Comparative Example 1, the chromatogram of Jianwei Xiaoshi Tablets is as follows: Figure 1 As shown. It can be seen that under this condition, the chromatographic separation effect of Jianwei Xiaoshi Tablets is not good, and the difficulty of component identification increases. The database selected for component comparison is not specific, and the accuracy of component identification results is low.

[0130] Comparative Example 2

[0131] Compared with Example 1, the method of ultrasonic extraction for Jianwei Xiaoshi Tablets was changed from soaking overnight and then ultrasonic extraction for 1 hour to not soaking overnight and ultrasonic extraction for 0.4 hours. No exclusive single herbal medicine component database was established, and the gradient elution scheme was changed to the following:

[0132] 0-1min, 10% B; 1-5min, 10%-20% B; 5-20min, 20%-45% B; 20-40min, 45%-64% B; 40-41min, 64%-98% B; 41-43min, 98% B; 43-44min, 98%-10% B; 44-50min, 10% B; the other detection conditions are the same.

[0133] In Comparative Example 2, the chromatogram of Jianwei Xiaoshi Tablets is as follows: Figure 2 As shown. Under this condition, the extraction effect of Jianwei Xiaoshi Tablets was not good, and few chromatographic peaks were detected by UPLC-MS. Although the total liquid phase separation time was longer, the chromatographic separation effect was still not ideal due to the unreasonable elution gradient setting. The database selected for component comparison was not specific, and the accuracy of component identification results was low.

[0134] Example 2

[0135] Analysis of blood components of Jianweixiaoshi tablets.

[0136] Nine male Sprague-Dawley rats, weighing (200 ± 20 g), were purchased from Changsha Tianqin Biotechnology Co., Ltd. and kept under standard laboratory conditions with free access to food and water. The animal experiment was approved by the Experimental Animal Ethics Committee of Jiangzhong Pharmaceutical Co., Ltd. (20231120). The nine rats were randomly divided into a blank group, a 10-minute group, and a 30-minute group (3 rats in each group). The blank group was used to collect blank whole blood, and the 10-minute group and the 30-minute group were used to collect whole blood 10 minutes and 30 minutes after gavage of Jianwei Xiaoshi tablets, respectively, with a dose of 3 g / kg. The collected whole blood was centrifuged at 4000 rpm for 10 minutes to obtain plasma, which was stored in a -20°C refrigerator for use.

[0137] Mix equal volumes of plasma from each rat in each experimental group. Then, take 1 mL of the mixed plasma from the 10-minute group and the 30-minute group and mix them again. Take 1 mL of the mixed plasma, slowly add 4 mL of methanol, vortex for 5 minutes, centrifuge at 13,000 rpm for 10 minutes, and collect the supernatant for UPLC-MS analysis. The sample preparation method of blank plasma is the same as above.

[0138] The plasma samples were analyzed by UPLC-MS using the method provided in Example 1.

[0139] Example 3

[0140] Network pharmacology research.

[0141] Network pharmacology was conducted based on blood components. The relevant targets of blood components were collected and predicted in the TCMSP database (https: / / tcmsp-e.com / ) and SwissTarget prediction database (http: / / www.swisstargetprediction.ch / ). Functional dyspepsia-related targets were retrieved through OMIM-gene Map (https: / / omim.org / ), Drugbank (https: / / www.drugbank.com / ), TTD (https: / / db.idrblab.net / ttd / ), GeneCards (https: / / www.genecards.org / ) and DisGeNET (https: / / www.disgenet.org / ). The collected component-related targets and disease-related targets were intersected, and the intersection targets were selected for subsequent analysis.

[0142] "Component-target-disease" visual network construction and core target screening.

[0143] Using Cytoscape software, a "component-target-disease" visualization network was constructed based on blood components, functional dyspepsia, and the intersection targets of blood components and functional dyspepsia. The intersection targets were imported into the STRING (https: / / string-db.org / ) website for protein-protein interaction analysis to screen the potential core targets of Jianwei Xiaoshi Tablets for the treatment of functional dyspepsia.

[0144] Go and KEGG pathway enrichment analysis.

[0145] The intersection targets of blood components and functional dyspepsia were imported into the DAVID database for Go and KEGG pathway enrichment analysis to explore the potential action pathways of Jianwei Xiaoshi tablets in the treatment of functional dyspepsia.

[0146] Effect example

[0147] 1. In vitro component analysis of 5 single medicinal materials

[0148] 1.1 Construction of a proprietary local database

[0149] Jianweixiaoshi tablets are composed of Radix Pseudostellariae, dried tangerine peel, Chinese yam, hawthorn and stir-fried malt. In order to clarify the composition of Jianweixiaoshi tablets, the in vitro components of Radix Pseudostellariae, dried tangerine peel, Chinese yam, hawthorn and stir-fried malt were first analyzed to improve the accuracy of the component identification results. Therefore, local databases exclusive to the five single medicinal materials were constructed as the basis for component screening and identification. First, potential components that may belong to Radix Pseudostellariae, dried tangerine peel, Chinese yam, hawthorn and stir-fried malt were collected through literature and TCMSP database retrieval. Then, the molecular formula, monoisotopic mass number and secondary mass spectrometry fragmentation information of these potential components were collected from the HMDB database, MassBank database and published papers. Finally, the above information was imported into TraceFinder software to construct exclusive component databases of Radix Pseudostellariae, dried tangerine peel, Chinese yam, hawthorn and stir-fried malt.

[0150] 1.2 Identification of in vitro components of Radix Pseudostellariae, Pericarpium Citri Reticulatae, Rhizoma Dioscoreae, Roasted Malt and Fructus Hawthorne

[0151] The raw data collected by UPLC-MS was imported into TraceFinder software, and based on the self-built single-herb component database, component matching was performed through the component screening mode to obtain a list of potential components. Then, the component screening results were further analyzed and confirmed based on two criteria: the error of the accurate mass number was less than 5ppm, and the secondary mass spectrometry fragment information was highly matched with the measured or database predicted spectrum.

[0152] 2. Analysis of in vitro ingredients of Jianweixiaoshi tablets

[0153] Based on the identification results of Radix Pseudostellariae, Pericarpium Citri Reticulatae, Rhizoma Dioscoreae, Rhizoma Dioscoreae, Rhizoma Maltodici and Fructus Crataegi, the chemical components of the extract of Jianweixiaoshi Tablets were further analyzed. The components that can be detected in both single herbs and Jianweixiaoshi Tablets are considered to be potential components of Jianweixiaoshi Tablets. In addition to the accurate mass number and secondary mass spectrometry fragmentation information, the retention time error of the same component in single herbs and Jianweixiaoshi Tablets extract is also used as a judgment criterion to improve the accuracy of the identification results. Since the data acquisition time span of single herbs, Jianweixiaoshi Tablets and rat plasma is large, the retention time window is set to ±60s to adapt to the changes in the instrument status. Based on the above rules, a total of 104 components were identified in Jianweixiaoshi Tablets, including 51 flavonoid components, 11 cyclic peptide components, 6 amino acid components, 5 coumarin components, 7 organic acids and their derivatives, 5 lipids and lipid molecules, 2 purine components, 2 saponin components, 2 terpenoid components and 13 other components, as shown in the following table.

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[0156]

[0157]

[0158]

[0159]

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[0162]

[0163] Among them, CP: dried tangerine peel; TZS: pseudoginseng; SY: Chinese yam; CMY: roasted malt; SZ: hawthorn; a indicates the component compared with the standard; # This means that the component exists as isomers.

[0164] As shown in the table above, there are 19 ingredients from Pseudostellariae Radix, 18 ingredients from roasted malt, 16 ingredients from hawthorn, 17 ingredients from yam, and 63 ingredients from dried tangerine peel. 23 ingredients were further compared and confirmed with the standard. Figure 3a The extracted ion chromatogram of the standard is shown in Figure 3b and Figure 3c The secondary mass spectra of representative components are shown in Figure 4a , Figure 4b , Figure 4c , Figure 4d , Figure 4e and Figure 4f In fact, the retention time deviation of most components is less than 15 s.

[0165] 3. Analysis of blood components of Jianweixiaoshi tablets

[0166] The components of traditional Chinese medicine are complex and diverse, and the components that can be absorbed into the blood are more likely to be potential active ingredients. Elucidating the blood-entering components of traditional Chinese medicine is the basis for conducting pharmacokinetic and pharmacological mechanism studies. Therefore, based on the results of in vitro chemical component analysis of Jianwei Xiaoshi Tablets, this study identified the blood-entering components of Jianwei Xiaoshi Tablets and further clarified the material basis of its efficacy. A total of 29 potential blood-entering components were detected in the plasma of rats, and their detailed information is shown in the table below.

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[0168]

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[0171]

[0172]

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[0176] Among them, CP: dried tangerine peel; TZS: pseudoginseng; SY: yam; CMY: roasted malt; SZ: hawthorn; a indicates the ingredient compared with the standard.

[0177] Six amino acid compounds, including arginine, valine, proline, leucine, phenylalanine and tryptophan, were detected in rat plasma. Except for tryptophan, the other five amino acids are widely present in Radix Pseudostellariae, Crataegus pinnatifida, Dioscorea opposita and malt. However, amino acids are also widely present in the blood and tissues of humans and animals. It is difficult to distinguish whether the amino acids detected in the plasma of administration are derived from Jianweixiaoshi tablets. This issue needs to be further explored in subsequent work. In addition to the six amino acids, the remaining 23 components can be detected in Jianweixiaoshi tablets and administration plasma, but not in blank plasma. Among them, Radix Pseudostellariae Cyclopeptide A, Radix Pseudostellariae Cyclopeptide B and Radix Pseudostellariae Cyclopeptide B are derived from Radix Pseudostellariae, p-coumarin and feruloyl agmatine are derived from malt, linalool and schaftoside are derived from Crataegus pinnatifida, hesperidin and tangeretin are derived from dried tangerine peel and Crataegus pinnatifida, aglabin is derived from dried tangerine peel and Dioscorea opposita, and the remaining 12 components are all derived from dried tangerine peel. These components may be the key active ingredients of Jianweixiaoshi tablets for the treatment of functional dyspepsia.

[0178] 4 Network Pharmacology

[0179] 4.1 Collection of relevant targets for Jianweixiaoshi tablets and functional dyspepsia

[0180] Traditional Chinese medicine has the characteristics of "multiple components, multiple targets, and multiple pathways", which makes it have excellent clinical efficacy, but also brings great challenges to the study of its mechanism of action. With the emergence and development of network pharmacology, this powerful tool has been widely used in the study of the mechanism of action of traditional Chinese medicine. Network pharmacology can help us intuitively understand the complex mechanism of action of multiple components of traditional Chinese medicine through visualizing the network. Therefore, the network pharmacology research method was used to explore the potential mechanism of action of Jianwei Xiaoshi Tablets in the treatment of functional dyspepsia.

[0181] In addition to the 6 amino acids, the remaining 23 blood-entering components were selected for network pharmacology research to improve the accuracy of the research results. A total of 556 targets related to the blood-entering components of Jianwei Xiaoshi Tablets were collected, and the "Jianwei Xiaoshi Tablets-target" network was constructed.

[0182] A total of 2817 functional dyspepsia-related gene targets were obtained through database retrieval, and 826 targets were screened for further study based on confidence. The intersection of the 826 disease targets and the 556 Jianwei Xiaoshi Tablet-related targets was taken, and 169 common gene targets between Jianwei Xiaoshi Tablet and functional dyspepsia were obtained ( Figure 5 ), and selected these intersection targets for "component-target-disease" network construction and protein-protein interaction (PPI) analysis.

[0183] 4.2 “Component-target-disease” network construction and PPI analysis

[0184] Based on the common targets of blood components and functional dyspepsia, a visual “component-target-disease” network was constructed and displayed in Figure 6 , where the meanings of the component codes are as follows: JWXST-01: p-coumarin; JWXST-02: linalool; JWXST-03: feruloyl agmatine; JWXST-04: naringin; JWXST-05: schaftoside; JWXST-06: naringin; JWXST-07: hesperidin; JWXST-08: aglabin; JWXST-09: cyclopeptide A of Pseudostellariae; JWXST-10: isosakura glycoside; JWXST-11: citrus glycoside; JWXST-12: cyclopeptide B of Pseudostellariae; JWXST-13 : Monohydroxy-hexamethoxyflavone; JWXST-14: Isonaginsenoside; JWXST-15: Pseudostellariae Cyclopeptide B; JWXST-16: Hesperidin; JWXST-17: Auriculariacin; JWXST-18: Yam III; JWXST-19: 5,7,3',4'-tetramethoxyflavone; JWXST-20: Nobiletin; JWXST-21: 5,6,7,4'-tetramethoxyflavone; JWXST-22: 3,5,6,7,8,3',4'-heptyloxyflavone; JWXST-23: Tangeretin.

[0185] The "component-target-disease" network consists of 193 nodes (1 disease, 23 chemical components and 169 gene targets) and 793 edges. At present, the treatment of functional dyspepsia is mainly symptom relief. The drugs used to treat functional dyspepsia mainly include antacids, prokinetic drugs, antidepressants and anti-Helicobacter pylori drugs. Therefore, histamine receptor H2 (HRH2), 5-hydroxytryptamine receptor 4 (HTR4), 5-hydroxytryptamine receptor 1A (HTR1A), dopamine receptor D4 (DRD4) and dopamine receptor D2 (DRD2) are closely related to the treatment of functional dyspepsia. These targets may be the key targets for Jianwei Xiaoshi tablets to treat functional dyspepsia. The key targets and related blood-entering components are shown in the table below.

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[0187]

[0188] Histamine receptor H2 antagonists (H2RAs), such as cimetidine, ranitidine, and roxatidine, are representative antacids. H2RAs can reduce gastric acid secretion by blocking HRH2 in gastric parietal cells and are widely used in clinical practice. In this study, aglabin, which is derived from tangerine peel and yam, is closely related to HRH2, and this component may help inhibit gastric acid secretion.

[0189] Gastrointestinal motility promoting drugs such as HTR4 agonists and DRD2 antagonists are important drugs for the treatment of functional dyspepsia. Domperidone and metoclopramide are two commonly used DRD2 antagonists, which are approved for the treatment of gastroparesis in many countries. Endogenous dopamine can inhibit the release of acetylcholine (ACh), resulting in decreased gastric and proximal small intestinal motility. DRD2 antagonists can enhance gastrointestinal motility and promote gastric emptying by promoting the release of ACh. Network pharmacology results show that p-coumarin, feruloyl agmatine, aglabin, yam III and 5,6,7,4'-tetramethoxyflavone are closely related to DRD2. p-coumarin and feruloyl agmatine are derived from roasted malt, yam III is derived from yam, 5,6,7,4'-tetramethoxyflavone is derived from tangerine peel, and aglabin is derived from tangerine peel and yam. These ingredients may promote gastrointestinal motility and gastric emptying by acting on DRD2.

[0190] HTR4 agonists can also increase gastrointestinal motility and promote gastric emptying by promoting the release of ACh. HTR4 agonists represented by mosapride are widely used in my country to treat functional dyspepsia. It is reported that mosapride can increase gastric tolerance and promote gastric emptying in humans and rats. The p-coumarin in roasted malt is closely related to HTR4. P-coumarin may act on HTR4 to increase gastrointestinal motility and promote gastric emptying.

[0191] Symptoms of dyspepsia are closely related to stress, and patients with anxiety or depression have more severe dyspepsia symptoms than other patients. Tandospirone citrate is a 5HT1A agonist commonly used to treat generalized anxiety disorder. A randomized controlled clinical trial showed that tandospirone citrate can improve the discomfort symptoms of patients with functional dyspepsia. 5HT1A is the target of Pseudostellariae Cyclotide B from Pseudostellariae Radix, Yamfoetidin III from Dioscorea opposita, and Aglabin from Tangerine Peel and Dioscorea opposita. These ingredients may alleviate dyspepsia symptoms by relieving anxiety and depression in patients.

[0192] DRD4 is involved in the regulation of multiple brain functions, and DRD4 ligands can regulate depression, anxiety, and cognitive dysfunction. Some researchers have reported that DRD4 in the lateral habenula can regulate depression-related behaviors in Parkinson's rats. It is reported that the CO2 supercritical extract of tangerine peel (mainly flavonoids) has antidepressant effects, significantly reduces the monoamine oxidase content of stressed mice, and significantly shortens the immobility time of mice in the tail suspension test and forced swimming test. The results of network pharmacology studies showed that DRD4 is a potential target of aglabin, monohydroxyhexamethoxyflavone, isocinerin, hesperidone, hesperidone, 5,7,3',4'tetramethoxyflavone, 5,6,7,4'-tetramethoxyflavone, 3,5,6,7,8,3',4'-heptamethoxyflavone, and tangeretin. The above 8 ingredients are all from tangerine peel, and these ingredients may also be the main active ingredients of Jianwei Xiaoshi Tablets for regulating mood and anti-depression.

[0193] In addition to the above key targets, PPI analysis was used to further explore the potential core targets of Jianwei Xiaoshi Tablets in the treatment of functional dyspepsia. PPI analysis results showed that inflammation-related targets such as AKT1, TNF, PTGS2, MAPK3 and ESR1 had strong interactions with other targets ( Figure 7 ). This result suggests that there may be a connection between inflammatory response and functional dyspepsia.

[0194] 4.3 Pathway enrichment analysis

[0195] Through Go and KEGG pathway enrichment analysis, the potential pathways of Jianwei Xiaoshi Tablets in the treatment of functional dyspepsia were explored. Go enrichment analysis results showed that signal transduction, negative regulation of apoptotic process, protein phosphorylation, positive regulation of cell proliferation and response to xenobiotic stimulus played prominent roles. The top 10 important entries of biological processes, cellular components and molecular functions are shown in Figure 8 KEGG pathway enrichment analysis yielded 177 signaling pathways, of which the top 15 key pathways are shown in Fig. 9 PI3K-Akt signaling pathway, MAPK signaling pathway, TNF signaling pathway, serotonergic synapse, T cell receptor signaling pathway, calcium signaling pathway, mTOR signaling pathway, Toll-like receptor signaling pathway, B cell receptor signaling pathway, cAMP signaling pathway, IL-17 signaling pathway, cholinergic synapse, AMPK signaling pathway, NF-κB signaling pathway and dopaminergic synapse may be the key signaling pathways regulated by Jianwei Xiaoshi Tablets in the treatment of functional dyspepsia.

[0196] Dopamine, serotonin (also known as 5-hydroxytryptamine), and acetylcholine (ACh) play a vital role in regulating gastrointestinal motility. The transmission of the above neurotransmitters requires the participation of dopaminergic synapses, serotonergic synapses, and cholinergic synapses, respectively. In addition, the calcium ion signaling pathway is also closely related to this process. Changes in calcium ion concentration play an important regulatory role in the release of neurotransmitters and synaptic transmission. As a key signaling molecule, calcium ions are also involved in the regulation of many key processes such as cell migration, gastrointestinal epithelial cells, and smooth muscle contraction. In addition, ghrelin is an important gastrointestinal hormone produced by gastric endocrine cells, which plays a key role in regulating appetite and gastric motility. Studies have reported that mTOR in gastric antral tissue can affect the expression of ghrelin. Therefore, dopaminergic synapses, serotonergic synapses, cholinergic synapses, calcium ion signaling pathways, and mTOR signaling pathways may be key pathways for regulating gastrointestinal motility.

[0197] Intestinal inflammation, as a potential cause of functional dyspepsia, has attracted more and more attention from researchers in recent years. Some literature reports that duodenal inflammation may be a potential trigger and therapeutic target for functional dyspepsia. Patients with functional dyspepsia are accompanied by mild duodenal inflammation and increased duodenal mucosal permeability. Increased intestinal permeability facilitates the passage of intraluminal antigens through the epithelium, thereby causing immune and inflammatory responses, leading to repeated attacks of gastrointestinal symptoms. In addition, some researchers have reported that mild chronic inflammation of the gastrointestinal tract can persist for several months after acute gastrointestinal infection. Chronic inflammation and immune responses secondary to gastrointestinal infection can lead to destruction of intestinal barrier integrity, dysfunction of the enteric nervous system, and visceral hypersensitivity. The prevalence of functional dyspepsia after gastrointestinal infection is 3.8 times that of functional dyspepsia. These studies have emphasized the role of inflammation and immune response in the treatment of functional dyspepsia.

[0198] PI3K-Akt signaling pathway, MAPK signaling pathway, TNF signaling pathway, cAMP signaling pathway, T cell receptor signaling pathway, Toll-like receptor signaling pathway, B cell receptor signaling pathway, IL-17 signaling pathway, AMPK signaling pathway and NF-κB signaling pathway are closely related to inflammation and immune response. It has been reported that Poria extract can improve functional dyspepsia by inhibiting Toll-like receptor signaling pathway. D-galacturonic acid can reduce the inflammatory response and intestinal mucosal permeability in rats with functional dyspepsia and reduce the expression of TLR2, TLR4 and NF-κB. Some research results also show that the MAPK signaling pathway may be a potential target for the treatment of functional dyspepsia. Therefore, these pathways may relieve the symptoms of functional dyspepsia by regulating inflammation and immune response. In summary, the results of pathway enrichment analysis show that the anti-functional dyspepsia effect of Jianwei Xiaoshi Tablets may be achieved by regulating neurotransmitters and gastrointestinal hormones related to inflammation, immune response and gastrointestinal motility.

[0199] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, rather than to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions of the technical solution of the present invention by ordinary technicians in this field do not deviate from the essence and scope of the technical solution of the present invention.

Claims

1. A method for detecting a stomach-strengthening and digestion-promoting tablet, characterized in that: The following steps are involved: S1, extraction: the sample to be tested, Radix Pseudostellariae, dried orange peel, Chinese yam, roasted malt and hawthorn are mixed with solvents respectively, and extracted to obtain the sample to be tested extract, Radix Pseudostellariae extract, dried orange peel extract, Chinese yam extract, roasted malt extract and hawthorn extract respectively; S2, ultra-high performance liquid chromatography-mass spectrometry analysis: The test sample extract obtained in step S1, the Pseudostellariae Radix extract, the dried orange peel extract, the yam extract, the roasted malt extract and the hawthorn extract are subjected to ultra-high performance liquid chromatography-mass spectrometry analysis to obtain data 1, data 2, data 3, data 4, data 5 and data 6 respectively; S3. Establish a specific local component database: retrieve the components contained in Radix Pseudostellariae, dried orange peel, Chinese yam, roasted malt and hawthorn and their molecular formula, monoisotopic mass number and mass spectrum secondary fragment information to establish a specific local component database; S4, obtaining a list of potential components: performing data matching on the data 2, data 3, data 4, data 5 and data 6 obtained in step S2 and the specific local component database obtained in step S3 to obtain a list of potential components; S5, data analysis and verification: according to the potential component list obtained in step S4, retrieve the data 1 obtained in step S2 for data analysis and verification; Wherein, in step S1, the extraction is specifically as follows: soaking overnight and then ultrasonically extracting for 1 hour, centrifuging at 13000 rpm, collecting the supernatant, and filtering with a 0.22 μm filter membrane; In step S2, the chromatographic conditions of the ultra-high performance liquid chromatography include: Mobile phase A: 0.1% formic acid aqueous solution; Mobile phase B: acetonitrile; Gradient elution scheme: 0-1min, 90% mobile phase A + 10% mobile phase B; 1-2min, 90%-85% mobile phase A + 10%-15% mobile phase B; 2-8min, 85%-80% mobile phase A + 15%-20% mobile phase B; 8-15min, 80%-72% mobile phase A + 20%-28% mobile phase B; 15-40min, 72%-36% mobile phase A + 28%-64 % mobile phase B; 40-41min, 36%-2% mobile phase A + 64%-98% mobile phase B; 41-43min, 2% mobile phase A + 98% mobile phase B; 43-44min, 2%-90% mobile phase A + 98%-10% mobile phase B; 44-46min, 90% mobile phase A + 10% mobile phase B; In step S2, the mass spectrometry conditions of the mass spectrometry include: sheath gas flow rate: 37-39Arb; Auxiliary gas flow rate: 10Arb; Capillary temperature: 318-322℃; Auxiliary gas heater temperature: 295-305℃; Spray voltage: 3.88-3.92 kV; Scan mode: Full MS / dd-MS 2 .

2. The detection method according to claim 1, characterized in that: In step S1, the sample to be tested is a stomach-strengthening and digestion-promoting tablet, the sample to be tested, Pseudostellaria heterophylla, dried orange peel, Chinese yam, roasted malt and hawthorn are in the form of powder, and the solvent is at least one of methanol, ethanol and acetone.

3. The detection method according to claim 1, characterized in that: In step S2, the chromatographic conditions of the ultra-high performance liquid chromatography include: Chromatographic column: C18 column; Column temperature: 38-42°C; Flow rate: 0.33-0.37 mL min -1 .

4. The detection method according to claim 1, characterized in that: In step S3, the search is selected from at least one of academic literature search, TCMSP database search, and HMDB database search; The specific steps of establishing a local ingredient database are as follows: Based on the retrieved components contained in Pseudostellaria baicalensis, dried tangerine peel, Chinese yam, roasted malt and hawthorn and their molecular formulas, monoisotopic mass numbers and mass spectrometry secondary fragmentation information, the exclusive local component databases of Pseudostellaria baicalensis, dried tangerine peel, Chinese yam, roasted malt and hawthorn were established respectively using TraceFinder software.

5. The detection method according to claim 1, characterized in that: In step S4, the data matching is specifically as follows: Data matching was performed using primary mass spectrum matching, secondary mass spectrum matching, and isotope peak matching; In step S5, the data analysis and verification is specifically as follows: Import the data 1 obtained in step S2 into the TraceFinder software, select the specific local component database established in step S3 for data matching, and the matching items include primary mass spectrum matching, secondary mass spectrum matching and isotope peak matching; further check and confirm the component matching results of Jianwei Xiaoshi Tablets based on the potential component list obtained in step S4.

6. Application of the detection method according to any one of claims 1 to 5 in quality control of Jianwei Xiaoshi tablets, characterized in that: The Jianwei Xiaoshi tablets are tested according to the detection method according to any one of claims 1 to 5, and the test results are analyzed to obtain the names, retention times and sources of the ingredients in the Jianwei Xiaoshi tablets.

7. The use according to claim 6, characterized in that: The names, retention times and sources of ingredients in the stomach-strengthening and digestion-promoting tablets include:

8. The use according to claim 7, characterized in that: The names, retention times and sources of ingredients in the stomach-strengthening and digestion-promoting tablets also include: in, # This means that the component exists as isomers.

9. A method for detecting blood components of Jianweixiaoshi tablets, characterized in that: The following steps are involved: T1. Take the plasma of the subject before taking Jianweixiaoshi tablets, mix it with solvent, extract it, and obtain supernatant A; T2, taking the plasma of the subject after taking the Jianwei Xiaoshi tablets in step T1, mixing it with a solvent, extracting it, and obtaining a supernatant B; T3, using the supernatant A obtained in step T1 and the supernatant B obtained in step T2 as the supernatant of the sample to be tested, respectively, and using the detection method described in any one of claims 1 to 5 for detection, and obtaining result A and result B respectively; T4: Based on the in vitro component analysis results of the Jianwei Xiaoshi Tablets, compare the results A and B obtained in step T3 to obtain the blood components of the Jianwei Xiaoshi Tablets.

10. A target analysis method for a stomach-strengthening and digestion-promoting tablet, characterized in that: The following steps are involved: E1. Using the detection method described in claim 9 to detect the blood-entering components of Jianwei Xiaoshi Tablets, to obtain the blood-entering components of Jianwei Xiaoshi Tablets; E2. Collect the targets corresponding to the blood-entering components of Jianwei Xiaoshi Tablets obtained in step E1 to obtain a blood-entering component target set, retrieve the functional dyspepsia-related targets to obtain a functional dyspepsia target set, and take the intersection of the blood-entering component target set and the functional dyspepsia target set to obtain a blood-entering component-dyspepsia-related target set; E3. Constructing a visualization network using the blood component target set, functional dyspepsia target set, and blood component-dyspepsia-related target set obtained in step E2, and performing protein-protein interaction analysis using the blood component-dyspepsia-related target set obtained in step E2; E4. Perform pathway enrichment analysis using the blood component-dyspepsia-related target set obtained in step E2.

11. The target analysis method according to claim 10, characterized in that: In step E1, the blood-transmitting components of the Jianwei Xiaoshi tablet include: p-Coumarin, linalool, feruloyl agmatine, naringin, schaftoside, naringin, hesperidin, aglabin, Pseudostellariae cyclopeptide A, isosakura glycosides, citrus glycosides, Pseudostellariae cyclopeptide B, monohydroxy-hexamethoxyflavone, isocitrullin, Pseudostellariae cyclopeptide B, hesperidin, aurantium, yam III, 5,7,3',4'-tetramethoxyflavone, nobiletin, 5,6,7,4'-tetramethoxyflavone, 3,5,6,7,8,3',4'-heptyloxyflavone, tangeretin.

12. The target analysis method according to claim 10, characterized in that: In step E2, the collection specifically includes: By collecting and predicting the relevant targets of blood components in the TCMSP database and SwissTarget prediction database; The search is specifically: Functional dyspepsia-related targets were searched through the OMIM-gene Map database, Drugbank database, TTD database, GeneCards database and DisGeNET database.

13. The target analysis method according to claim 10, characterized in that: In step E3, the construction of the visualization network specifically comprises: using Cytoscape software to construct a component-target-disease visualization network; The protein-protein interaction analysis specifically includes: importing the blood component-dyspepsia related target set into the STING website to perform protein-protein interaction analysis, and screening the core targets of Jianwei Xiaoshi Tablets for the treatment of functional dyspepsia; In step E4, the pathway enrichment analysis is specifically as follows: the blood-entering components-dyspepsia-related targets are imported into the DAVID database for Go pathway analysis and KEGG pathway enrichment analysis to determine the key signaling pathways for the treatment of functional dyspepsia with Jianwei Xiaoshi tablets.

14. The target analysis method according to claim 13, characterized in that: The core targets include: Histamine receptor H2, serotonin receptor 4, serotonin receptor 1A, dopamine receptor D4, dopamine receptor D2 and inflammation-related targets.

15. The target analysis method according to claim 13, characterized in that: The key signaling pathway includes at least one of the following pathways: PI3K-Akt signaling pathway, MAPK signaling pathway, TNF signaling pathway, serotonergic synapse, T cell receptor signaling pathway, calcium ion signaling pathway, mTOR signaling pathway, Toll-like receptor signaling pathway, B cell receptor signaling pathway, cAMP signaling pathway, IL-17 signaling pathway, cholinergic synapse, AMPK signaling pathway, NF-κB signaling pathway and dopaminergic synapse.

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