Quality detection method of traditional Chinese medicine compound fester-clearing and ulcer-healing decoction

Abstract

The invention discloses a quality detection method of a traditional Chinese medicine compound fester-clearing and ulcer-healing decoction. Chemical components in six medicinal materials including coptis chinensis, frankincense, sanguisorba officinalis, indigo naturalis, catechu and dragon's blood in the fester-clearing and ulcer-healing decoction are qualitatively analyzed by using a UPLC-Q-Exactive Orbitrap-MS / MS analysis method; and determining the contents of epicatechin, catechin, rutin, coptisine and berberine in the fester-clearing and ulcer-healing decoction by using a high performance liquid chromatography method. The UPLC-Q-Exactive Orbitrap-MS / MS analysis method has the advantages of high resolution, good quality precision, strong qualitative ability and the like, and can be used for widely and accurately detecting the chemical components in the complex traditional Chinese medicine compound; high performance liquid chromatography can provide detection results with high accuracy, high sensitivity and good repeatability, operation is simple and easy to implement, methodology verification is passed, the linear relation is good, precision, stability, repeatability, the recovery rate and the like all meet regulations, and the combination of qualitative analysis and quantitative analysis lays a foundation for establishment of the quality standard of the fester-clearing and ulcer-healing decoction.

Description

Technical Field

[0001] The invention belongs to the technical field of drug detection, and in particular relates to a quality detection method for a traditional Chinese medicine compound Qingkui Yuyang prescription. Background Art

[0002] Qingkuiyuyang Decoction is a clinical experience prescription, which is composed of coptis root, frankincense, sanguisorba officinalis, indigo, catechu, and dracona. Coptis root has the effects of clearing away heat and dampness, purging fire and detoxifying; frankincense can promote blood circulation, promote qi and relieve pain; dandelion can cool blood and stop bleeding, detoxify and heal sores; indigo can clear away heat and detoxify, cool blood and eliminate spots; catechu has the effects of promoting blood circulation and stopping pain, stopping bleeding and promoting tissue regeneration; dracona mainly promotes blood circulation and relieves pain, removes blood stasis and stops bleeding, heals sores and promotes tissue regeneration. The combination of these medicines can theoretically play the role of clearing heat and dampness, cooling blood and detoxifying, promoting blood circulation and promoting tissue regeneration to promote ulcer healing.

[0003] As a traditional Chinese medicine, Qingkui Yuyang prescription needs to be prepared into a suitable dosage form by appropriate preparation technology for clinical use, so this prescription is processed by traditional technology. The main active ingredients of Qingkui Yuyang prescription come from six medicinal materials: coptis root, frankincense, sanguisorba officinalis, indigo, catechu, and dragon's blood. In order to study the quality level of Qingkui Yuyang prescription, an efficient detection method needs to be established to conduct qualitative and quantitative research on it. Summary of the invention

[0004] The purpose of the present invention is to design a quality detection method for a traditional Chinese medicine compound Qingkui Yuyang prescription, which can perform extensive and accurate detection of chemical components in a complex traditional Chinese medicine compound.

[0005] In order to achieve the above object, the technical solution adopted by the present invention is as follows:

[0006] A quality detection method for a traditional Chinese medicine compound Qingkui Yuyang prescription, characterized in that the traditional Chinese medicine compound Qingkui Yuyang prescription is composed of six medicinal materials: epicatechin, catechin, rutin, coptisine and berberine, and the specific detection method is as follows:

[0007] S1: Qualitative analysis of six medicinal materials including coptis root, frankincense, sanguisorba officinalis, indigo naturalis, catechu and dragon's blood was performed by UPLC-Q-Exactive Orbitrap-MS / MS analysis method;

[0008] Qualitative analysis includes the following processes:

[0009] Step 1: Chromatographic and mass spectrometric conditions;

[0010] Step 2: Preparation of mixed reference solution:

[0011] Take appropriate amount of berberine, citric acid, quercetin, catechin, isoquercetin, gallic acid, epicatechin, rutin, chlorogenic acid, coptisine, indigo and indirubin reference substances respectively, place them in a brown volumetric flask, dissolve and dilute with methanol, and make up to 25 mL to prepare a 200 μg / mL reference substance stock solution. Take appropriate amount of each reference substance stock solution and dilute it into a mixed reference substance solution of about 5 μg / mL.

[0012] Step 3: Preparation of test solution:

[0013] Weigh the six medicinal materials of Qingkui Yuyang Recipe according to the prescription, add water, extract, combine the filtrate, and concentrate under reduced pressure on a rotary evaporator; accurately transfer the concentrate, place it in a volumetric flask, dilute it with distilled water and make it up to the mark, shake it well, and the Qingkui Yuyang Recipe test solution is obtained;

[0014] After determining the chromatographic-mass spectrometric conditions, take an appropriate amount of the mixed reference solution and the test solution, pass through a 0.22 μm microporous filter membrane, and introduce it into the UPLC-Q-Exactive Orbitrap-MS / MS chromatographic-mass spectrometric instrument for detection. The compounds in the Qingkui Yuyang recipe can be accurately identified based on the chromatographic peaks and mass spectrometric data of the reference, and other compounds can be inferred by comparing with the molecular ions and secondary fragment ions of the natural compound database;

[0015] S2: HPLC was used to determine the contents of epicatechin, catechin, rutin, coptisine and berberine in Qingkuiyuyang decoction;

[0016] The content determination method is as follows:

[0017] Step 1: Chromatographic conditions

[0018] The chromatographic column is Waters C18, 4.6×250 mm, 5 μm, mobile phase: 0.05 mol·L -1 Potassium dihydrogen phosphate solution A: acetonitrile B, wavelength 280nm, flow rate 0.6mL / min, column temperature 30℃, injection volume 10μL, gradient elution.

[0019] Step 2: Preparation of test solution

[0020] Weigh the six medicinal materials of Qingkui Yuyang Decoction according to the prescription, add water, extract, combine the filtrate, and concentrate under reduced pressure on a rotary evaporator; accurately transfer the concentrate, place it in a volumetric flask, dilute it with distilled water and make up to the mark, shake well, and obtain the Qingkui Yuyang Decoction test solution;

[0021] Step 3: Preparation of reference stock solution

[0022] Take appropriate amounts of catechin, epicatechin, rutin, coptisine and berberine reference substances, place them in brown volumetric flasks, dissolve and dilute them with methanol, and make up to 5 mL to prepare 500 μg / mL stock solutions of each reference substance;

[0023] Step 4: Preparation of mixed reference solution

[0024] Take an appropriate amount of each reference substance stock solution and dilute it into a mixed reference substance solution containing about 36.72 μg / mL of catechin, about 9.15 μg / mL of epicatechin, about 10 μg / mL of rutin, about 1.2 μg / mL of coptisine and about 6.4 μg / mL of berberine.

[0025] Furthermore, the Qingkui Yuyang prescription in S1 is composed of six medicinal materials: 4g of Coptis chinensis, 6g of Frankincense, 6g of Sanguisorba officinalis, 3.2g of Indigo naturalis, 3.2g of Catechu, and 4g of Sanguisorba officinalis.

[0026] Furthermore, the HPLC method for measuring the content of the chromatographic column is Waters C18, 4.6×250 mm, 5 μm, mobile phase: 0.05 mol·L -1 Potassium dihydrogen phosphate solution A: acetonitrile B, wavelength is 280nm, flow rate is 0.6mL / min, column temperature is 30℃, injection volume is 10μL, gradient elution is performed; at 0-10min, mobile phase B is 10-20%; at 10-25min, mobile phase B is 20%-30%; at 25-40min, mobile phase B is 30%-35%; at 45-50min, mobile phase B is 35%-40%; at 50-60min, mobile phase B is 40%-10%.

[0027] Furthermore, the chromatography-mass spectrometry method, the chromatographic column is ACQUITY UPLC BEH C 18 , 2.1mm×100mm, 1.7μm, with mobile phase B containing 0.1% formic acid-mobile phase A containing 0.1% formic acid as the mobile phase, flow rate of 0.3mL / min, column temperature of 30℃, injection volume of 10μL, gradient elution; UPLC-Q-Exactive-Orbitrap MS / MS high-resolution mass spectrometry was used for mass spectrometry data acquisition, and the detection mode was Full MS-dd-MS 2 , positive and negative ion modes were scanned simultaneously, the scanning range m / z was 100-1500, the capillary temperature was 320°C; the evaporation temperature was 350°C; the spray voltage was 3500 / 3200V (+ / -); the auxiliary gas flow rate was 10Arb; the sheath gas flow rate was 35Arb; the collision energy was 20, 40, 60, 80%; the full scan resolution was 120000.

[0028] Furthermore, the gradient elution is specifically as follows: at 0-5 min, the mobile phase B is 5%; at 5-20 min, the mobile phase B is increased from 5% to 95%; at 20-30 min, the mobile phase B is 95%; at 30-35 min, the mobile phase B is reduced from 95% to 5%; at 35-40 min, the mobile phase B is 5%.

[0029] Furthermore, the average contents of epicatechin, catechin, rutin, coptisine and berberine in the Qingkui Yuyang recipe were 11.36 mg / g, 7.36 mg / g, 5.06 mg / g, 6.62 mg / g and 3.17 mg / g, respectively.

[0030] The following beneficial effects can be obtained through the above technical solution:

[0031] The present invention first uses UPLC-Q-Exactive Orbitrap-MS / MS analysis method to qualitatively analyze the chemical components in the six medicinal materials of coptis root, frankincense, sanguisorba officinalis, indigo, catechu and blood clotting in Qingkui Yuyang prescription; and then uses high performance liquid chromatography to determine the content of epicatechin, catechin, rutin, coptisine and berberine in Qingkui Yuyang prescription. The UPLC-Q-Exactive Orbitrap-MS / MS analysis method has the advantages of high resolution, good mass accuracy, strong qualitative ability, etc., and can perform extensive and accurate detection of chemical components in complex traditional Chinese medicine compound prescriptions; high performance liquid chromatography can provide detection results with high accuracy, high sensitivity and good repeatability, and the operation is simple and easy, and has passed the methodological verification, and has a good linear relationship, and the precision, stability, repeatability and recovery rate are all in compliance with the regulations. The combination of qualitative and quantitative analysis lays a foundation for the establishment of the quality standard of Qingkui Yuyang prescription. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 This is the total ion current chromatogram of Qingkui Yuyang Formula in positive (A) and negative (B) ion modes;

[0033] Figure 2 It is a comparative chromatogram of blank solution, reference solution and test solution;

[0034] Figure 3 It is the standard curve of epicatechin, catechin, rutin, coptisine and berberine reference substances. DETAILED DESCRIPTION

[0035] The following is attached Figure 1-3 The present invention is further described in conjunction with the embodiments:

[0036] Embodiment 1:

[0037] A quality detection method for Qingkui Yuyang prescription comprises the following steps: firstly using UPLC-Q-Exactive Orbitrap-MS / MS analysis method to qualitatively analyze six medicinal materials in the Qingkui Yuyang prescription, namely, coptis root, frankincense, sanguisorba officinalis, indigo naturalis, catechu, and dragon's blood; and then using high performance liquid chromatography to determine the contents of epicatechin, catechin, rutin, coptisine, and berberine in the Qingkui Yuyang prescription.

[0038] The UPLC-Q-Exactive Orbitrap-MS / MS analysis method was used to conduct qualitative analysis on the six medicinal materials in the Qingkui Yuyang prescription, namely, coptis root, frankincense, sanguisorba officinalis, indigo, catechu, and dragon's blood. Compared with the traditional HPLC and thin layer chromatography qualitative methods, the UPLC-Q-Exactive Orbitrap-MS / MS analysis method has a wider quality detection range, higher sensitivity and peak capacity, and can conduct a large-scale qualitative analysis of complex Chinese medicine compound prescriptions; including the following contents:

[0039] (1) Chromatographic and mass spectrometry conditions

[0040] The chromatographic column is ACQUITY UPLC BEH C 18 (2.1mm×100mm, 1.7μm), acetonitrile containing 0.1% formic acid (mobile phase B)-water containing 0.1% formic acid (mobile phase A) as the mobile phase, flow rate of 0.3mL / min, column temperature of 30℃, injection volume of 10μL, gradient elution, time program as shown in Table 1. UPLC-Q-Exactive-Orbitrap MS / MS high-resolution mass spectrometry was used for mass spectrometry data acquisition, detection mode was Full MS-dd-MS2, positive ion and negative ion mode were scanned simultaneously, the scanning range (m / z) was 100-1500, capillary temperature was 320℃; evaporation temperature was 350℃; spray voltage was 3500 / 3200V (+ / -); auxiliary gas flow rate was 10Arb; sheath gas flow rate was 35Arb; collision energy was 20, 40, 60, 80%; full scan resolution was 120000.

[0041] Table 1 Gradient elution table

[0042]

[0043] (2) Preparation of mixed reference solution:

[0044] Take appropriate amount of berberine, citric acid, quercetin, catechin, isoquercetin, gallic acid, epicatechin, rutin, chlorogenic acid, coptisine, indigo and indirubin reference substances respectively, place them in a brown volumetric flask, dissolve and dilute with methanol, and make up to 25 mL to prepare a 200 μg / mL reference substance stock solution. Take appropriate amount of each reference substance stock solution and dilute it into a mixed reference substance solution of about 5 μg / mL.

[0045] (3) Preparation of test solution

[0046] According to the prescription, weigh 27.6g of the six medicinal materials of Qingkui Yuyang Recipe, add 10 times the amount of water, extract for 60min, extract 3 times, combine the filtrate, and concentrate under reduced pressure (60℃) on a rotary evaporator to 250mL. Accurately transfer 1mL of the concentrate to a 50mL volumetric flask, dilute with distilled water and adjust to the scale, shake well, and the Qingkui Yuyang Recipe test solution (2.2mg / mL) is obtained.

[0047] In this study, UPLC-Q-Exactive Orbitrap-MS / MS technology was used to collect mass spectrometric information of the water extract of Qingkui Yuyang Recipe in positive and negative ion modes. The total ion current chromatogram is shown in Figure 1 . Based on the self-built "Qingkui Yuyang Fang Compound" database and Xcalibur qualitative software, combined with the molecular ions and secondary fragment ions of the compounds, a total of 71 compounds in the traditional Chinese medicine compound Qingkui Yuyang Fang were compared, including 22 flavonoids, 17 alkaloids, 17 organic acids, 4 triterpenes, 2 terpenes, 2 amino acids and 7 other organic compounds. See Table 2. Among them, based on the chromatographic peaks and mass spectrometry data of the reference substance, 12 compounds were accurately identified, including: 5 flavonoids (quercetin, catechin, isoquercetin, epicatechin, rutin), 4 alkaloids (berberine, coptisine, indigo, indigotin) and 3 organic acids (citric acid, gallic acid, chlorogenic acid). By comparing with the molecular ions and secondary fragment ions of the natural compound database, the other 59 compounds were inferred.

[0048] Table 2 Chemical composition information of Qingkui Yuyang prescription

[0049]

[0050]

[0051]

[0052] Example 2 A method for determining the content of Qingkui Yuyang Recipe, comprising the following contents:

[0053] High performance liquid chromatography was used to detect the contents of epicatechin, catechin, rutin, coptisine and berberine in Qingkui Yuyang Recipe. Compared with the traditional ultraviolet spectrophotometry, this step has high accuracy, high sensitivity and good repeatability. It is simple and easy to operate and can be used to determine the contents of multiple components in complex Chinese medicine compound prescriptions. The related research on content determination is as follows:

[0054] (1) Chromatographic conditions

[0055] The chromatographic column is Waters C18 (4.6×250 mm, 5 μm), mobile phase: 0.05 mol·L -1 Potassium dihydrogen phosphate solution (A): acetonitrile (B), wavelength 280nm, flow rate 0.6mL / min, column temperature 30℃, injection volume 10μL, gradient elution, time program as shown in Table 3.

[0056] Table 3 Gradient elution table

[0057]

[0058] (2) Preparation of test solution

[0059] According to the prescription, weigh 27.6 g of the six medicinal materials of Qingkui Yuyang Decoction, add 10 times the amount of water, extract for 60 min, extract 3 times, combine the filtrate, and concentrate to 250 mL under reduced pressure on a rotary evaporator; accurately transfer 1 mL of the concentrate, place it in a 50 mL volumetric flask, dilute it with distilled water and make up to the scale, shake well, and the Qingkui Yuyang Decoction test solution (2.2 mg / mL) is obtained.

[0060] (3) Preparation of reference substance stock solution

[0061] Take appropriate amounts of epicatechin, catechin, rutin, coptisine and berberine reference substances, place them in brown volumetric flasks, dissolve and dilute them with methanol, and make up to 20 mL to prepare 500 μg / mL stock solutions of each reference substance.

[0062] (4) Preparation of mixed reference solution

[0063] Take an appropriate amount of each reference substance stock solution and dilute it into a mixed reference substance solution containing about 36.72 μg / mL of catechin, about 9.15 μg / mL of epicatechin, about 10 μg / mL of rutin, about 1.2 μg / mL of coptisine and about 6.4 μg / mL of berberine.

[0064] Example 3 Investigation of the linear range

[0065] A series of mixed reference solutions of epicatechin, catechin, rutin, coptisine and berberine were prepared respectively, and the samples were injected and measured according to the liquid phase method of "Claim 3". The peak area was used as the ordinate (Y) and the solution concentration (μg / mL) was used as the abscissa (X) to perform linear plotting, and the linear equations of each reference solution were obtained. The results are shown in Tables 4 and Figure 3 , indicating that the linear relationship of each reference solution is good.

[0066] Table 4 Linearity and range

[0067]

[0068] Example 4 Precision Experiment

[0069] The mixed reference solution was continuously sampled 6 times according to the liquid phase method of "Claim 3", and the peak area RSDs of epicatechin, catechin, rutin, coptisine and berberine were calculated to be 0.5%, 0.3%, 1.2%, 2.8% and 1.9%, respectively, indicating that the method has good instrument precision.

[0070] Example 5 Stability Test

[0071] After the test solution was placed at room temperature for 0, 4, 8, 12, 24 and 48 hours, the sample was injected and measured according to the liquid phase method of "Claim 3", and the peak area RSDs of epicatechin, catechin, rutin, coptisine and berberine were calculated to be 2.6%, 1.4%, 9.9%, 6.4% and 3.7%, respectively, indicating that the test solution was stable within 48 hours.

[0072] Example 6 Repeatability

[0073] Six test solutions were prepared in parallel and sampled and measured according to the liquid phase method of "Claim 3". The RSDs of epicatechin, catechin, rutin, coptisine and berberine were calculated to be 4.1%, 4.8%, 8.5%, 5.3% and 3.4%, respectively, indicating that the method had good repeatability.

[0074] Example 7 Sample recovery test

[0075] Accurately pipette the test solution with known epicatechin, catechin, rutin, coptisine and berberine content, and add a certain amount of mixed reference solution. Prepare 6 solutions in parallel and inject and measure according to the liquid phase method of "claim 3". The results are shown in Table 5. The average sample recovery rates of epicatechin, catechin, rutin, coptisine and berberine are 91.97%, 97.94%, 112.09%, 104.74% and 95.65%, respectively, indicating that the accuracy of this method is good.

[0076] Table 5. Sample recovery test results

[0077]

[0078]

[0079] Example 8 Content Determination

[0080] Six test sample solutions were prepared in parallel and tested by the liquid phase method of "Claim 3". The results are shown in Table 6, and the average contents of epicatechin, catechin, rutin, coptisine and berberine were calculated to be 11.36 mg / g, 7.36 mg / g, 5.06 mg / g, 6.62 mg / g and 3.17 mg / g, respectively.

[0081] Table 6 Content determination results

[0082]

[0083] The above are all preferred embodiments of the present invention. For ordinary technicians in this technical field, without departing from the principle of the present invention, various modifications to the present invention in equivalent forms all belong to the protection scope of the claims attached to this application. The above are all preferred embodiments of the present invention. For ordinary technicians in this technical field, without departing from the principle of the present invention, various modifications to the present invention in equivalent forms all belong to the protection scope of the claims attached to this application. The above are all preferred embodiments of the present invention. For ordinary technicians in this technical field, without departing from the principle of the present invention, various modifications to the present invention in equivalent forms all belong to the protection scope of the claims attached to this application.

Claims

1. A quality detection method for a Chinese medicine compound Qingkui Yuyang Decoction, characterized in that: The traditional Chinese medicine compound Qingkui Yuyang prescription is composed of six medicinal materials: epicatechin, catechin, rutin, coptisine and berberine. The specific detection method is as follows: S1: Qualitative analysis of six medicinal materials including coptis root, frankincense, sanguisorba officinalis, indigo, catechu and dragon's blood was performed using UPLC-Q-Exactive Orbitrap-MS / MS analysis method; Qualitative analysis includes the following processes: Step 1: Chromatographic and mass spectrometric conditions; Step 2: Preparation of mixed reference solution: Take appropriate amount of berberine, citric acid, quercetin, catechin, isoquercetin, gallic acid, epicatechin, rutin, chlorogenic acid, coptisine, indigo and indirubin reference substances respectively, place them in a brown volumetric flask, dissolve and dilute with methanol, and make up to 25 mL to prepare a 200 μg / mL reference substance stock solution. Take appropriate amount of each reference substance stock solution and dilute it into a mixed reference substance solution of about 5 μg / mL; Step 3: Preparation of test solution: Weigh the six medicinal materials of Qingkui Yuyang Recipe according to the prescription, add water, extract, combine the filtrate, and concentrate under reduced pressure on a rotary evaporator; accurately transfer the concentrate, place it in a volumetric flask, dilute it with distilled water and make it up to the mark, shake it well, and the Qingkui Yuyang Recipe test solution is obtained; After determining the chromatographic-mass spectrometric conditions, take an appropriate amount of the mixed reference solution and the test solution, pass through a 0.22 μm microporous filter membrane, and introduce it into the UPLC-Q-Exactive Orbitrap-MS / MS chromatographic-mass spectrometric instrument for detection. The compounds in the Qingkui Yuyang recipe can be accurately identified based on the chromatographic peaks and mass spectrometric data of the reference, and other compounds can be inferred by comparing with the molecular ions and secondary fragment ions of the natural compound database; S2: HPLC was used to determine the contents of epicatechin, catechin, rutin, coptisine and berberine in Qingkuiyuyang decoction; The content determination method is as follows: Step 1: Chromatographic conditions The chromatographic column was Waters Symmetry® C18, 4.6×250 mm, 5 μm, and the mobile phase was 0.05 mol·L -1 Potassium dihydrogen phosphate solution A: acetonitrile B, wavelength 280 nm, flow rate 0.6 mL / min, column temperature 30 °C, injection volume 10 μL, gradient elution; Step 2: Preparation of test solution Weigh the six medicinal materials of Qingkui Yuyang Decoction according to the prescription, add water, extract, combine the filtrate, and concentrate under reduced pressure on a rotary evaporator; accurately transfer the concentrate, place it in a volumetric flask, dilute it with distilled water and make up to the mark, shake well, and the Qingkui Yuyang Decoction test solution is obtained; Step 3: Preparation of reference substance stock solution Take appropriate amounts of catechin, epicatechin, rutin, coptisine and berberine reference substances, place them in brown volumetric flasks, dissolve and dilute with methanol, and make up to 5 mL to prepare 500 μg / mL stock solutions of each reference substance; Step 4: Preparation of mixed reference substance solution Take an appropriate amount of each reference substance stock solution and dilute it into a mixed reference substance solution containing about 36.72 μg / mL of catechin, about 9.15 μg / mL of epicatechin, about 10 μg / mL of rutin, about 1.2 μg / mL of coptisine and about 6.4 μg / mL of berberine.

2. The quality detection method of a Chinese medicine compound Qingkui Yuyang Decoction according to claim 1, characterized in that: The Qingkui Yuyang prescription in S1 is composed of six medicinal materials: 4g of Coptis chinensis, 6g of Frankincense, 6g of Sanguisorba officinalis, 3.2g of Indigo naturalis, 3.2g of Catechu, and 4g of Sanguisorba officinalis.

3. The quality detection method of a Chinese medicine compound Qingkui Yuyang Decoction according to claim 1, characterized in that: High performance liquid chromatography method: The chromatographic column was Waters Symmetry® C18, 4.6×250 mm, 5 μm, and the mobile phase was 0.05 mol·L -1 Potassium dihydrogen phosphate solution A: acetonitrile B, wavelength of 280 nm, flow rate of 0.6 mL / min, column temperature of 30°C, injection volume of 10 μL, gradient elution; 0-10 min, mobile phase B was 10-20%; 10-25 min, mobile phase B was 20%-30%; 25-40 min, mobile phase B was 30%-35%; 45-50 min, mobile phase B was 35%-40%; 50-60 min, mobile phase B was 40%-10%.

4. The quality detection method of a Chinese medicine compound Qingkui Yuyang Decoction according to claim 1, characterized in that: Chromatography-mass spectrometry method, the chromatographic column is ACQUITY UPLC BEH C 18 , 2.1mm×100mm, 1.7μm, with mobile phase B containing 0.1% formic acid-mobile phase A containing 0.1% formic acid as the mobile phase, flow rate of 0.3mL / min, column temperature of 30℃, injection volume of 10μL, gradient elution; UPLC-Q-Exactive-Orbitrap MS / MS high-resolution mass spectrometry was used for mass spectrometry data acquisition, and the detection mode was Full MS-dd-MS 2 , positive and negative ion modes were scanned simultaneously, the scanning range m / z was 100~1500, the capillary temperature was 320℃; the evaporation temperature was 350℃; the spray voltage was 3500 / 3200V (+ / -); the auxiliary gas flow rate was 10Arb; the sheath gas flow rate was 35Arb; the collision energy was 20, 40, 60, 80%; the full scan resolution was 120000.

5. The quality detection method of a Chinese medicine compound Qingkui Yuyang Decoction according to claim 4 is characterized in that: The gradient elution is specifically as follows: at 0-5 min, the mobile phase B is 5%; at 5-20 min, the mobile phase B is increased from 5% to 95%; at 20-30 min, the mobile phase B is 95%; at 30-35 min, the mobile phase B is reduced from 95% to 5%; at 35-40 min, the mobile phase B is 5%.

6. The quality detection method of a Chinese medicine compound Qingkui Yuyang Decoction according to claim 1, characterized in that: The average contents of epicatechin, catechin, rutin, coptisine and berberine in Qingkui Yuyang prescription were 11.36 mg / g, 7.36 mg / g, 5.06 mg / g, 6.62 mg / g and 3.17 mg / g, respectively.

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