Songling Xumakang capsule characteristic chromatogram and construction method and application thereof
By adopting the HPLC method combined with gradient elution technology in the quality testing of Songling Blood Capsules to optimize the flow phase and chromatographic conditions, the problem of the overlap and separation of color spectrum peaks in the existing technology has been solved. Separation and quantitative analysis improve the accuracy and reliability of detection.
Patent Information
- Application Number
- CN202411930472.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-12-26
- Publication Date
- 2025-01-24
AI Technical Summary
The prior art has problems of overlapping chromatographic peaks, insufficient resolution, and inaccurate quantification in the quality detection of Songling Xuemaikang Capsules, especially due to the solvent effect and peak deformation caused by methanol as an extraction solvent.
High-performance liquid chromatography (HPLC) combined with gradient elution technology was used, using methanol, acetonitrile and 0.2% acetic acid aqueous solution as mobile phases. By optimizing the gradient elution program and chromatographic conditions, the concentration of the main components in Songling Xuemaikang capsules was improved. Chromatographic peak resolution.
Efficient separation and quantitative analysis of ingredients such as puerarin, puerarin-7-xylosidin and 3'-methoxypuerarin in Songling Xuemaikang capsules were achieved, improving the sensitivity and specificity of detection and ensuring quality control. accuracy.
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Figure CN119355179A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of quality detection of traditional Chinese medicines, and in particular to a characteristic spectrum of Songling Xuemaikang capsules, a construction method thereof and an application thereof. Background Art
[0002] Songling Xuemaikang Capsule is a Chinese patent medicine preparation. Its main ingredients are fresh pine leaves, kudzu root, pearl layer powder, etc. It has the effects of calming the liver and suppressing yang, calming the heart and tranquilizing the nerves. It is used for headache, dizziness, irritability, palpitations, insomnia caused by hyperactivity of liver yang; hypertension and primary hyperlipidemia with the above symptoms.
[0003] Existing technology (Suo Yaran. Study on the quality control of Pueraria root in Songling Xuemaikang capsules [D]. 2019.) established an HPLC fingerprint detection method for Songling Xuemaikang capsules, using methanol as the sample pretreatment extraction solvent, octadecylsilane bonded silica gel as the stationary phase for chromatographic separation, and a UV detector for analysis and detection; the mobile phase is a mixture of solvent A and solvent B, the solvent A is acetonitrile, and the solvent B is acetic acid aqueous solution. However, after the above method was reproduced, it was found that some peaks overlapped, and the separation degree did not meet the quantitative requirements, which would lead to inaccurate quantification of chromatographic peak compounds. Using methanol as the extraction solvent will result in a solvent effect, resulting in a poor peak shape, which is not conducive to separation.
[0004] Chinese patent publication number CN103123343A discloses a quality control method for Songling Xuemaikang capsules, which includes ultrasonically dissolving the contents of Songling Xuemaikang capsules with a 50% (v / v) methanol aqueous solution, mobile phase A is a 0.1% (v / v) formic acid aqueous solution, and mobile phase B is acetonitrile. However, the peak separation of this method does not reach baseline separation.
[0005] Chinese patent publication number CN106556650A discloses a quality inspection method for Songling Xuemaikang capsules, which includes ultrasonic treatment of the contents of Songling Xuemaikang capsules with an ethanol-water solution, and the mobile phase is an acetonitrile-ammonium acetate buffer solution. However, this method only considers the content determination of two indicator components, and cannot accurately and comprehensively control the quality of Songling Xuemaikang capsules.
[0006] Therefore, it is necessary to re-optimize the detection method of Songling Xuemaikang Capsules, improve the detection and separation effects of each main chromatographic peak, and effectively control the quality of Songling Xuemaikang Capsules. Therefore, it is very necessary to develop a characteristic spectrum of Songling Xuemaikang Capsules that can solve the above technical problems and its construction method and application. Summary of the invention
[0007] The purpose of the present invention is to overcome the deficiencies of the prior art and provide a characteristic spectrum of Songling Xuemaikang Capsules with high separation, strong specificity and high sensitivity, as well as a construction method and application thereof.
[0008] The present invention is achieved through the following technical solutions: A method for constructing a characteristic spectrum of Songling Xuemaikang Capsule comprises the following steps: (1) Preparation of the test solution: Take the contents of Songling Xuemaikang Capsules, add a solvent for extraction, the solvent is water or methanol solution; filter, take the filtrate, and obtain the test solution; (2) Construction of the characteristic spectrum of Songling Xuemaikang Capsules: The test sample solution was injected into a liquid chromatograph and determined using high performance liquid chromatography (HPLC) to obtain the characteristic spectrum of Songling Xuemaikang Capsules; Chromatographic conditions: Gradient elution was performed using mobile phase A, mobile phase B, and mobile phase C. Mobile phase A was methanol, mobile phase B was acetonitrile, and mobile phase C was 0.2% acetic acid aqueous solution; The procedure of the gradient elution is as follows: 0-6 minutes, the amount of mobile phase A is 0%, the amount of mobile phase B is 5%, and the amount of mobile phase C is 95%; 6-15 minutes, mobile phase A dosage is 0-16%, mobile phase B dosage is 5-4%, mobile phase C dosage is 95-80%; 15-30 minutes, mobile phase A is 16%, mobile phase B is 4%, and mobile phase C is 80%; 30-52 minutes, mobile phase A dosage is 16-20%, mobile phase B dosage is 4%, mobile phase C dosage is 80-76%; 52-85 minutes, mobile phase A dosage is 20-70%, mobile phase B dosage is 4-15%, mobile phase C dosage is 76-15%; Among them, the sum of the amounts of mobile phase A, mobile phase B and mobile phase C is 100%.
[0009] The percentages in the present invention are all by volume unless otherwise specified.
[0010] In some embodiments of the present invention, the extraction method in step (1) includes ultrasonic extraction or reflux extraction.
[0011] In some preferred embodiments of the present invention, the time of ultrasonic extraction in step (1) is 10-60 minutes, more preferably 30 minutes.
[0012] In some embodiments of the present invention, the mass volume ratio of the content of Songling Xuemaikang capsule to the solvent in step (1) is 1 g:32-320 mL, and more preferably 1 g:80 mL.
[0013] In some embodiments of the present invention, after the ultrasonic extraction in step (1) is completed, the mixture is cooled and solvent is added to make the volume constant.
[0014] In some preferred embodiments of the present invention, the mass volume ratio of the contents of the Songling Xuemaikang capsule to the test solution in step (1) is 1 g:40-400 mL, and more preferably 1 g:100 mL.
[0015] In some embodiments of the present invention, the chromatographic conditions in step (2) further include using octadecylsilane bonded silica gel as filler in the chromatographic column.
[0016] In some embodiments of the present invention, the chromatographic conditions in step (2) further include at least one of the following conditions: Detector: UV; Detection wavelength: 250nm; Flow rate: 0.5-1mL / min; Column temperature: 20-35°C; Injection volume: 5-20 μL.
[0017] In some preferred embodiments of the present invention, the chromatographic conditions in step (2) further include at least one of the following conditions: Flow rate: 0.7 mL / min; Column temperature: 30°C; Injection volume: 5 μL.
[0018] The present invention also relates to a characteristic spectrum of Songling Xuemaikang Capsules constructed by the above-mentioned construction method.
[0019] In some embodiments of the present invention, the characteristic spectrum of Songling Xuemaikang Capsule contains 9 peaks, which are: Peak 1: shikimic acid; Peak 2: puerarin-4'-OD-glucoside; Peak 3: daidzein-4',7-diglucoside; Peak 4: 3-hydroxypuerarin; Peak 5: puerarin; Peak 6: puerarin-7-xyloside; Peak 7: 3'-methoxypuerarin; Peak 8: puerarin apiglycoside; Peak 9: daidzein.
[0020] The present invention also relates to the application of the above-mentioned Songling Xuemaikang Capsule characteristic spectrum in the quality detection of Songling Xuemaikang Capsule.
[0021] The beneficial effects of the present invention are: The present invention can realize the quantitative analysis of quality markers including puerarin, puerarin-7-xyloside and 3'-methoxypuerarin. The method for constructing the characteristic spectrum of Songling Xuemaikang Capsule of the present invention can be used as a fingerprint spectrum analysis method for overall quality control of Songling Xuemaikang Capsule, and can also be used as a quantitative detection method for the quality marker of the drug.
[0022] The HPLC method provided by the present invention can effectively separate the chromatographic peaks of the main components in Songling Xuemaikang Capsule, avoiding the problem of inaccurate quantification caused by overlapping chromatographic peaks. It has high sensitivity and strong specificity, and the inspection results are reliable and accurate. It is beneficial to provide technical means for the quantitative determination of the main chromatographic peaks in the characteristic spectrum of Songling Xuemaikang Capsule, thereby performing quality control thereof. BRIEF DESCRIPTION OF THE DRAWINGS
[0023] Figure 1 This is the characteristic spectrum of Songling Xuemaikang Capsules constructed in Example 1 of the present invention.
[0024] Figure 2 This is the characteristic spectrum of Songling Xuemaikang Capsules constructed by using pure water as the extraction solvent in Example 2 of the present invention.
[0025] Figure 3 This is the characteristic spectrum of Songling Xuemaikang Capsules constructed by using 10% methanol as the extraction solvent in Example 2 of the present invention.
[0026] Figure 4 This is the characteristic spectrum of Songling Xuemaikang Capsules constructed by using 30% methanol as the extraction solvent in Example 2 of the present invention.
[0027] Figure 5 This is the characteristic spectrum of Songling Xuemaikang Capsules constructed by using 70% methanol as the extraction solvent in Example 2 of the present invention.
[0028] Figure 6 This is the characteristic spectrum of Songling Xuemaikang Capsules constructed by using 90% methanol as the extraction solvent in Example 2 of the present invention.
[0029] Figure 7 This is the characteristic spectrum of Songling Xuemaikang Capsules constructed by using 100% methanol as the extraction solvent in Example 2 of the present invention.
[0030] Figure 8 This is the characteristic spectrum of Songling Xuemaikang Capsules constructed by ultrasound for 10 minutes in Example 3 of the present invention.
[0031] Fig. 9 This is the characteristic spectrum of Songling Xuemaikang Capsules constructed by ultrasound for 60 minutes in Example 3 of the present invention.
[0032] Fig.10 The characteristic spectrum of Songling Xuemaikang Capsules constructed in Example 4 of the present invention is obtained when the mass volume ratio of the contents of Songling Xuemaikang Capsules to the test solution is 1g:40mL.
[0033] Fig.11 The characteristic spectrum of Songling Xuemaikang Capsules constructed in Example 4 of the present invention is obtained when the mass volume ratio of the contents of Songling Xuemaikang Capsules to the test solution is 1g:200mL.
[0034] Fig.12 The characteristic spectrum of Songling Xuemaikang Capsules constructed in Example 4 of the present invention is obtained when the mass volume ratio of the contents of Songling Xuemaikang Capsules to the test solution is 1g:400mL.
[0035] Fig.13 This is the characteristic spectrum of Songling Xuemaikang Capsules constructed in Example 5 of the present invention.
[0036] Fig.14 This is the characteristic spectrum of Songling Xuemaikang Capsules constructed at a flow rate of 0.5 mL / min in Example 6 of the present invention.
[0037] Fig.15 This is the characteristic spectrum of Songling Xuemaikang Capsules constructed at a flow rate of 0.6 mL / min in Example 6 of the present invention.
[0038] Fig.16 This is the characteristic spectrum of Songling Xuemaikang Capsules constructed at a flow rate of 0.8 mL / min in Example 6 of the present invention.
[0039] Fig.17 This is the characteristic spectrum of Songling Xuemaikang Capsules constructed at a flow rate of 1.0 mL / min in Example 6 of the present invention.
[0040] Fig.18 This is the characteristic spectrum of Songling Xuemaikang Capsules constructed at a column temperature of 20°C in Example 7 of the present invention.
[0041] Fig.19 This is the characteristic spectrum of Songling Xuemaikang Capsules constructed at a column temperature of 25°C in Example 7 of the present invention.
[0042] Fig. 20 This is the characteristic spectrum of Songling Xuemaikang Capsules constructed at a column temperature of 35°C in Example 7 of the present invention.
[0043] Fig.21 This is the characteristic spectrum of Songling Xuemaikang Capsules constructed with an injection volume of 10 μL in Example 8 of the present invention.
[0044] Fig. 22 This is the characteristic spectrum of Songling Xuemaikang Capsules constructed with an injection volume of 15 μL in Example 8 of the present invention.
[0045] Fig.23 This is the characteristic spectrum of Songling Xuemaikang Capsules constructed with an injection volume of 20 μL in Example 8 of the present invention.
[0046] Fig.24 This is the characteristic spectrum of Songling Xuemaikang Capsules constructed by using methanol as the extraction solvent in Comparative Example 1 of the present invention.
[0047] Fig.25This is the characteristic spectrum of Songling Xuemaikang Capsules constructed by using 50% methanol as the extraction solvent in Comparative Example 1 of the present invention.
[0048] Fig.26 This is the characteristic spectrum of Songling Xuemaikang Capsules constructed in Comparative Example 2 of the present invention.
[0049] Fig. 27 This is the characteristic spectrum of Songling Xuemaikang Capsules constructed in Comparative Example 3 of the present invention.
[0050] Fig.28 This is the characteristic spectrum of Songling Xuemaikang Capsules constructed in Comparative Example 4 of the present invention. DETAILED DESCRIPTION
[0051] The present invention will be further described below in conjunction with specific embodiments, and the advantages and features of the present invention will become clearer as the description proceeds. However, these embodiments are exemplary only and do not constitute any limitation to the scope of the present invention. It should be understood by those skilled in the art that the details and forms of the technical solution of the present invention may be modified or replaced without departing from the spirit and scope of the present invention, but these modifications and replacements all fall within the scope of protection of the present invention.
[0052] Example 1 The test solution was prepared by HPLC, with octadecylsilane bonded silica gel as filler, mobile phase A, mobile phase B and mobile phase C for gradient elution, and detection was performed on the detector. Solvent A was methanol, solvent B was acetonitrile, and solvent C was 0.2% acetic acid aqueous solution.
[0053] The test solution is prepared as follows: take the contents of Songling Xuemaikang Capsules under the item of filling volume difference, mix well, take 0.25g, accurately weigh, put into a 25mL volumetric flask, add 20mL of 50% methanol solution, ultrasonically treat for 30 minutes, cool, dilute to the mark with 50% methanol solution, shake well, filter, and take the filtrate to obtain; Take a sample of the test solution, perform HPLC analysis, and record the chromatogram.
[0054] The chromatographic conditions are as follows: Instrument: Agilent 1260; Chromatographic column: octadecylsilane bonded silica gel as filler (Ultimate, Plus-C18, 5 μm, 4.6 × 250 mm); Mobile phase A: methanol; Mobile phase B: acetonitrile; Mobile phase C: 0.2% acetic acid in water; Detector: UV; Detection wavelength: 250nm; Flow rate: 0.7 mL / min; Column temperature: 30°C; Injection volume: 5 μL; The linear gradient elution program is shown in Table 1.
[0055] Table 1 Gradient elution program
[0056] The characteristic spectrum of Songling Xuemaikang Capsule constructed in Example 1 is as follows Figure 1 As shown. Among them, peak 1: shikimic acid; peak 2: puerarin-4'-OD-glucoside; peak 3: daidzein-4',7-diglucoside; peak 4: 3-hydroxypuerarin; peak 5: puerarin; peak 6: puerarin-7-xyloside; peak 7: 3'-methoxypuerarin; peak 8: puerarin apiglycoside; peak 9: daidzein. This detection method can effectively separate the chromatographic peaks of the main components in Songling Xuemaikang Capsules, and the separation degree of peak 6 and peak 7 meets the quantitative requirements, providing a basis for the content determination of the main components of Songling Xuemaikang Capsules.
[0057] Example 2 Extraction solvent investigation The only difference from Example 1 is that the extraction solvents are different during the preparation of the test solution, and the other conditions are the same, as shown in Table 2. The chromatograms of each extraction solvent are shown in Figure 2-Figure 7 shown.
[0058] Table 2 Extraction solvent investigation
[0059] Example 3 Ultrasound time study The difference from Example 1 is that the ultrasonic time during the preparation of the test solution is different, which is 10 minutes or 60 minutes, and the other conditions are the same. The chromatograms of different ultrasonic times are as follows Figure 8-Figure 9 shown.
[0060] Example 4 Extraction multiple investigation The only difference from Example 1 is the amount of solvent added during the preparation of the test solution, and the other conditions are the same, as follows: The test solution is prepared as follows: take the contents of Songling Xuemaikang Capsules under the item of filling difference, mix well, take 0.25g, accurately weigh, and place in 3 portions, respectively, in 10mL (1g:40mL), 50mL (1g:200mL), and 100mL (1g:400mL) volumetric flasks, add 8mL (1g:32mL), 40mL (1g:160mL), and 80mL (1g:320mL) of 50% methanol solution, ultrasonically treat for 30 minutes, cool, make up to the scale with 50% methanol solution, shake well, filter, and take the filtrate to obtain.
[0061] Chromatogram Figure 10-12 shown.
[0062] Example 5 Investigation of extraction methods The only difference from Example 1 is the different extraction method during the preparation of the test solution, and the other conditions are the same, as follows: Take the contents of Songling Xuemaikang Capsules under the item of filling volume difference, mix well, take 0.25g, accurately weigh, put into a 25mL volumetric flask, add 20mL of 50% methanol solution, reflux extraction for 30 minutes, cool, make up to the scale with 50% methanol solution, shake well, filter, and take the filtrate to obtain.
[0063] Chromatogram Fig.13 shown.
[0064] Example 6 Flow rate investigation The only difference from Example 1 is the flow rates in the chromatographic conditions, which are 0.5 mL / min, 0.6 mL / min, 0.8 mL / min, and 1.0 mL / min respectively; the other conditions are the same. The chromatograms of different flow rates are shown in Figure 1. Figure 14-17 shown.
[0065] Example 7 Column temperature investigation The only difference from Example 1 is that the column temperature in the chromatographic conditions is different, which are: 20°C, 25°C, and 35°C; the other conditions are the same. The chromatograms of different column temperatures are shown in Figure 1. Figure 18-Figure 20 shown.
[0066] Example 8 Sample volume investigation The only difference from Example 1 is the different injection volumes in the chromatographic conditions, which are 10 μL, 15 μL, and 20 μL respectively; the other conditions are the same. The chromatograms of different injection volumes are shown in Figure 1. Figure 21-23 shown.
[0067] Comparative Example 1 The characteristic map of Songling Xuemaikang Capsules was constructed with reference to the existing technology (Suo Yaran. Research on quality control of Pueraria lobata in Songling Xuemaikang Capsules [D]. 2019.).
[0068] The test solution is prepared as follows: take about 0.1 g of the contents of Songling Xuemaikang Capsules, accurately weigh it, put it into a conical flask, add 50 mL of methanol (or 50% methanol solution) to extract, weigh it, ultrasonicate for 30 minutes, let it stand at room temperature, weigh it, make up the loss with methanol, shake it well, filter it, pass the filtrate through a 0.45 um microporous filter membrane, take the filtrate, and obtain the sample test solution.
[0069] Chromatographic conditions: Agilent 1260 chromatograph; octadecylsilane bonded silica gel as filler (Ultimate, Plus-C18, 5μm, 4.6×250mm); mobile phase: acetonitrile (A)-0.2% acetic acid aqueous solution (B), gradient elution (0-21min, 9%-12%A; 21-23min, 12%A; 23-32min, 12%-15%A; 32-62min, 15%-30%A; 62-70min, 30%-95%A), flow rate 0.8mL / min, detection wavelength 250nm, column temperature 30℃, injection volume 10μL.
[0070] During the preparation of the test solution, methanol was used as the extraction solvent to obtain the following spectrum: Fig.24 As shown, the spectrum obtained by using 50% methanol solution as the extraction solvent is as follows Fig.25 As shown. Fig.24 and Fig.25 It can be seen that the chromatographic conditions of Comparative Example 1 use acetonitrile and 0.2% acetic acid aqueous solution as the mobile phase, the separation of Peak 5 (main peak, puerarin) and its adjacent chromatographic peaks is poor, and the separation of Peak 6 and Peak 7 does not meet the quantitative requirements.
[0071] The Figure 1 and Comparative Example 1 Figure 24-25 By comparison, Example 1 has the following advantages: 1) The separation degree between Peak 5 (main peak, puerarin) and its adjacent chromatographic peaks is significantly improved, which is more conducive to achieving the quality control of puerarin under the requirements of the pharmacopoeia; (2) Peak 6 (puerarin-7-xyloside) and Peak 7 (3'-methoxypuerarin) achieve baseline separation, which is conducive to the quality control of these two quality markers.
[0072] Comparative Example 2 The only difference from Example 1 is the gradient elution program, and the other conditions are the same. The gradient elution program is shown in Table 3.
[0073] Table 3 Mobile phase gradient elution program
[0074] Chromatogram Fig.26 The results show that the separation of peaks 6 and 7 becomes worse after changing the elution procedure.
[0075] Comparative Example 3 The only difference from Example 1 is the type of chromatographic column, using octadecylsilane bonded silica gel as the filler (Ultimate, AQ-C18, 5 μm, 4.6×300 mm), and the other conditions are the same. The chromatogram is shown in FIG. Fig. 27 The results show that after changing the column type, the separation between peaks 3 and 4 becomes worse, and the 300 mm length column is an uncommon model.
[0076] Comparative Example 4 The difference from Example 1 is only in the mobile phase composition and elution procedure. During the elution process, the amount of 0.2% acetic acid aqueous solution remains unchanged, and mobile phase A and mobile phase B are used for gradient elution. Solvent A is methanol, and solvent B is 0.2% acetic acid aqueous solution. The gradient elution procedure is shown in Table 4.
[0077] Table 4 Mobile phase gradient elution program
[0078] Chromatogram Fig.28 The results show that after changing the mobile phase composition to two phases, the separation of peaks 3 and 4 becomes worse.
[0079] In summary, the present invention can realize the quantitative analysis of quality markers including puerarin, puerarin-7-xyloside and 3'-methoxypuerarin. The method for constructing the characteristic spectrum of Songling Xuemaikang Capsule of the present invention can be used as a fingerprint spectrum analysis method for the overall quality control of Songling Xuemaikang Capsule, and can also be used as a quantitative detection method for the quality markers of the drug.
[0080] The above detailed description is a specific description of one feasible embodiment of the present invention. The embodiment is not intended to limit the patent scope of the present invention. Any equivalent implementation or modification that does not deviate from the present invention should be included in the scope of the technical solution of the present invention.
Claims
1. A method for constructing a characteristic spectrum of Songling Xuemaikang Capsule, characterized in that: The steps include: (1) Preparation of test solution: Take the contents of Songling Xuemaikang Capsules, add solvent to extract, filter, and take the filtrate to obtain the test solution; (2) Construction of the characteristic spectrum of Songling Xuemaikang Capsules: The test sample solution was injected into a liquid chromatograph and measured using high performance liquid chromatography to obtain the characteristic spectrum of Songling Xuemaikang Capsules; The solvent is water or methanol solution; Chromatographic conditions: Gradient elution was performed using mobile phases A, B and C. Mobile phase A was methanol, mobile phase B was acetonitrile, and mobile phase C was 0.2% acetic acid aqueous solution. The procedure of the gradient elution is as follows: 0-6 minutes, the amount of mobile phase A is 0%, the amount of mobile phase B is 5%, and the amount of mobile phase C is 95%; 6-15 minutes, mobile phase A dosage is 0-16%, mobile phase B dosage is 5-4%, mobile phase C dosage is 95-80%; 15-30 minutes, mobile phase A is 16%, mobile phase B is 4%, and mobile phase C is 80%; 30-52 minutes, mobile phase A dosage is 16-20%, mobile phase B dosage is 4%, mobile phase C dosage is 80-76%; 52-85 minutes, mobile phase A dosage is 20-70%, mobile phase B dosage is 4-15%, mobile phase C dosage is 76-15%; Among them, the sum of the amounts of mobile phase A, mobile phase B and mobile phase C is 100%.
2. The construction method according to claim 1, characterized in that: The extraction method in step (1) includes ultrasonic extraction or reflux extraction.
3. The construction method according to claim 1, characterized in that: The extraction time in step (1) is 10-60 minutes.
4. The construction method according to claim 1, characterized in that: The mass volume ratio of the contents of the Songling Xuemaikang capsule to the solvent in step (1) is 1 g:32-320 mL.
5. The construction method according to claim 1, characterized in that: After the extraction in step (1) is completed, the mixture is cooled and solvent is added to make up the volume.
6. The construction method according to claim 5, characterized in that: The mass volume ratio of the contents of Songling Xuemaikang Capsules to the test solution in step (1) is 1 g:40-400 mL.
7. The construction method according to claim 1, characterized in that: The chromatographic conditions in step (2) also include using octadecylsilane bonded silica gel as filler in the chromatographic column.
8. The construction method according to claim 1, characterized in that: The chromatographic conditions in step (2) further include at least one of the following conditions: Detector: UV; Detection wavelength: 250nm; Flow rate: 0.5-1mL / min; Column temperature: 20-35°C; Injection volume: 5-20 μL.
9. The characteristic spectrum of Songling Xuemaikang Capsule constructed by the construction method described in any one of claims 1 to 8.
10. The characteristic spectrum of Songling Xuemaikang Capsule according to claim 9, characterized in that: The characteristic spectrum of Songling Xuemaikang Capsule contains 9 peaks, which are: Peak 1: shikimic acid; Peak 2: puerarin-4'-OD-glucoside; Peak 3: daidzein-4',7-diglucoside; Peak 4: 3-hydroxypuerarin; Peak 5: puerarin; Peak 6: puerarin-7-xyloside; Peak 7: 3'-methoxypuerarin; Peak 8: puerarin apiglycoside; Peak 9: daidzein.
11. Application of the characteristic spectrum of Songling Xuemaikang Capsules according to claim 9 or 10 in quality inspection of Songling Xuemaikang Capsules.
Citation Information
Patent Citations
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