Method for establishing HPLC (High Performance Liquid Chromatography) fingerprint spectrum of heart-soothing and lipid-lowering tablets and fingerprint spectrum thereof

Abstract

The invention discloses a method for establishing an HPLC (High Performance Liquid Chromatography) fingerprint spectrum of a heart-soothing and lipid-lowering tablet, which comprises the following steps: preparing a reference substance solution and a test sample solution, determining HPLC chromatographic conditions and preparing an HPLC standard fingerprint spectrum. Meanwhile, the invention discloses an HPLC standard fingerprint spectrum of the heart-soothing and lipid-lowering tablet obtained by the method, the fingerprint spectrum has 15 peaks, and 6 common peaks are identified through a reference substance. The method is simple, convenient and good in stability and reproducibility, obtained spectrum characteristic peaks are comprehensive, the quality of the heart-soothing and lipid-lowering tablets can be comprehensively evaluated and controlled through comparison of standard fingerprint spectrum common peaks, the internal quality of the preparation can be accurately evaluated, and the safety and effectiveness of clinical medication are ensured.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine preparation analysis. This invention discloses a method for establishing the HPLC fingerprint of Shuxin Jiangzhi tablets and its fingerprint. Background Technology

[0002] Shuxin Jiangzhi Tablets are a medication used to treat symptoms such as qi and blood stagnation, phlegm and dampness obstruction, chest tightness and heart pain, palpitations, insomnia, epigastric fullness and fatigue. It uses *Salvia miltiorrhiza* and hawthorn as the principal herbs, which invigorate blood circulation, remove blood stasis, and lower lipids. It uses peach kernel, safflower, red peony root, *Polygonum cuspidatum*, and *Spatholobus suberectus* as the assistant herbs, which remove blood stasis, lower lipids, unblock meridians, and relieve pain. The adjuvant herbs *Allium macrostemon*, *Dalbergia odorifera*, kudzu root, and barley pollen have the effects of regulating qi, relieving chest tightness and pain, promoting yang, removing turbidity, and lowering lipids. The combined effects of these herbs are to invigorate blood circulation, remove blood stasis, promote yang, remove turbidity, regulate qi, and relieve pain. The active ingredients and their weight ratios are as follows: 183g of Salvia miltiorrhiza, 31.4g of buckwheat pollen, 171.4g of hawthorn, 34.3g of Polygonum cuspidatum, 34.3g of Pueraria lobata, 34.3g of Carthamus tinctorius, 34.3g of Allium macrostemon, 11.4g of Prunus persica, 34.3g of Spatholobus suberectus, 17g of Dalbergia odorifera, and 34.3g of Paeonia lactiflora.

[0003] Shuxin Jiangzhi tablets are a traditional Chinese medicine compound preparation. Traditional Chinese medicine preparations contain multiple herbs and have complex chemical components. These chemical components produce an overall therapeutic effect, which is a crucial indicator of whether a traditional Chinese medicine preparation can exert its efficacy. Therefore, effective quality control is a vital foundation for ensuring its clinical efficacy. The quality control of Shuxin Jiangzhi tablets refers to the "Ministry of Health Drug Standards for Traditional Chinese Medicine Compound Preparations, Volume 14, WS3-B-2799-97". The testing mainly involves physicochemical and ultraviolet spectrophotometric identification. However, due to the numerous components of Shuxin Jiangzhi tablets, identification alone cannot comprehensively reflect the overall quality of the preparation. Therefore, to ensure and stabilize product quality, a comprehensive study of its quality testing and control methods is necessary.

[0004] The HPLC fingerprint study of Shuxin Jiangzhi tablets can identify 6 common peaks, providing a method for establishing the fingerprint spectrum of Shuxin Jiangzhi tablets. This method effectively reflects the integrity and complexity of the chemical components of Shuxin Jiangzhi tablets, enabling comprehensive evaluation and control of the formulation quality, thereby ensuring the safety and effectiveness of clinical use. Summary of the Invention

[0005] The purpose of this invention is to provide a method for establishing a fingerprint spectrum of Shuxin Lipid-Lowering Tablets. Specifically, this method prepares a test solution of Shuxin Lipid-Lowering Tablets, separates and detects it using HPLC, thereby obtaining a standard fingerprint spectrum of Shuxin Lipid-Lowering Tablets. This enables comprehensive and multi-faceted detection, improves its quality testing system, and demonstrates good stability and durability. Furthermore, it provides a reliable basis for identifying the authenticity and intrinsic quality of Shuxin Lipid-Lowering Tablets, ensuring clinical efficacy.

[0006] This invention discloses a method for establishing an HPLC fingerprint of a lipid-lowering tablet, characterized by comprising the following steps:

[0007] 1) Preparation of reference and test solutions: Weigh out sodium tanshinone, puerarin, polygalactoside, salvianolic acid B, emodin, and tanshinone II. A Dissolve an appropriate amount of reference standard in methanol to prepare a reference standard solution;

[0008] 2) Take 10 tablets of Shuxin Jiangzhi Pian, remove the film coating, grind them into a fine powder, mix them evenly, weigh them accurately, add 20 ml of 75% methanol, reflux in a water bath for 30 min, cool them, filter them through a 0.45 μm microporous membrane, and collect the filtrate.

[0009] HPLC chromatographic conditions were determined as follows: octadecylsilane-bonded silica gel was used as the packing material; acetonitrile was used as mobile phase A, and 0.1% phosphoric acid solution was used as mobile phase B, with gradient elution; detection wavelength: 275 nm, flow rate: 1.0 ml / min, column temperature: 25 ℃.

[0010] 3) Preparation of fingerprint chromatograms: The reference solution and the test solution were analyzed by HPLC to obtain the HPLC fingerprint chromatogram of the test solution;

[0011] 4) Import the HPLC fingerprint data of the test solution into the software "Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine 2012 Edition" recommended by the National Pharmacopoeia Commission. Using the fingerprint of one of the test solutions as a reference fingerprint, the standard fingerprint of Shuxin Jiangzhi tablets is generated by averaging.

[0012] The test solution was prepared as follows: Take 10 tablets of Shuxin Jiangzhi Pian, remove the film coating, weigh accurately, grind finely, mix well, take about 0.72g, weigh accurately, place in a stoppered conical flask, accurately add 20ml of 75% methanol, heat in a water bath under reflux for 30 minutes, cool, shake well, filter through a 0.45μm microporous membrane, and collect the filtrate to obtain the test solution.

[0013] Step 3) specifically includes: taking the test solution of the same batch of Shuxin Jiangzhi tablets, injecting it 6 times consecutively, and recording the chromatogram;

[0014] Take the test solution of the same batch of Shuxin Jiangzhi tablets and inject it at 0, 2, 6, 10, 18 and 24 h respectively, and record the chromatograms;

[0015] Simultaneously, prepare 6 test solutions of Shuxin Jiangzhi tablets, inject them separately, and record the chromatograms.

[0016] Step 2) The chromatographic column is a Waters Symmetry C18 Column.

[0017] The chromatographic column in step 2) has a size of 4.6 × 250 mm and a diameter of 5 μm.

[0018] The gradient elution conditions described in step 2) are as follows:

[0019] The main components of the Shuxin Jiangzhi tablets include Salvia miltiorrhiza, buckwheat pollen, hawthorn, Polygonum cuspidatum, kudzu root, safflower, Allium macrostemon, peach kernel, Spatholobus suberectus, Dalbergia odorifera, and Paeonia lactiflora. Fifteen batches of Shuxin Jiangzhi tablets samples were prepared into test solutions according to the above method, separated and detected by HPLC, and analyzed using the "Similarity Evaluation System for Chromatographic Fingerprints of Traditional Chinese Medicine 2012 Edition" software recommended by the National Pharmacopoeia Commission to obtain the HPLC standard fingerprint of Shuxin Jiangzhi tablets.

[0020] The fingerprint spectrum obtained in this invention has 15 common peaks. Using salvianolic acid B as the reference peak, the relative retention times of these common peaks are as follows: 0.116, 0.185, 0.283, 0.378, 0.476, 0.489, 0.611, 0.786, 0.915, 0.958, 0.990, 1.031, 1.591, and 1.633. Through comparison with reference standards, six common peaks were identified: sodium tanshinone (peak 2), puerarin (peak 5), polygalactoside (peak 8), salvianolic acid B (peak 12), emodin (peak 14), and tanshinone II. A (Peak No. 15).

[0021] Compared with the prior art, the beneficial effects of this application include:

[0022] This invention provides a method for establishing an HPLC fingerprint of Shuxin Lipid-Lowering Tablets. Based on the compositional characteristics of the starting components of Shuxin Lipid-Lowering Tablets, the optimal HPLC conditions are selected, resulting in a fingerprint with high resolution, good peak shape, and good separation of all characteristic chromatographic peaks. It exhibits good stability and a large number of characteristic peaks, enabling a comprehensive and accurate evaluation of the quality of Shuxin Lipid-Lowering Tablets. This method is suitable for controlling the quality of Shuxin Lipid-Lowering Tablets products.

[0023] 1) The detection method of this invention uses salvianolic acid B as a reference peak and identifies 15 common peaks that constitute the fingerprint spectrum of Shuxin lipid-lowering tablets. From the common peaks, six chemical components, including sodium tanshinone, puerarin, polygalactosidase, salvianolic acid B, emodin, and tanshinone IIA, are identified, making the fingerprint spectrum richer and more comprehensive.

[0024] 2) The HPLC fingerprint spectrum of Shuxin Lipid-Lowering Tablets established in this invention overcomes the shortcomings of existing technologies, which have single detection indicators and cannot reflect the intrinsic quality. The method for establishing the HPLC fingerprint spectrum of Shuxin Lipid-Lowering Tablets provided has high precision and good reproducibility. By comparing the presence or absence of common peaks in the obtained fingerprint spectrum, the quality of Shuxin Lipid-Lowering Tablets can be comprehensively evaluated, effectively ensuring the quality of the finished product. Attached Figure Description

[0025] Figure 1 This is the HPLC mixed control chromatogram of the Shuxin Lipid-Lowering Tablets described in Example 1 of the present invention.

[0026] Among them, sodium tanshinone (peak 2), puerarin (peak 5), polygalactoside (peak 8), salvianolic acid B (peak 12), emodin (peak 14), and tanshinone II. A (Peak No. 15).

[0027] Figure 2 This is the HPLC standard fingerprint of the Shuxin Jiangzhi tablets described in Example 1 of the present invention.

[0028] Icons 1-15 represent 15 common peaks, including sodium tanshinone (peak 2), puerarin (peak 5), polygalactoside (peak 8), salvianolic acid B (peak 12), emodin (peak 14), and tanshinone II. A (Peak No. 15).

[0029] Figure 3 This is an overlay of the HPLC fingerprint chromatograms of 15 batches of Shuxin Jiangzhi tablets described in Example 1 of the present invention.

[0030] Among them, sodium tanshinone (peak 2), puerarin (peak 5), polygalactoside (peak 8), salvianolic acid B (peak 12), emodin (peak 14), and tanshinone II. A (Peak No. 15).

[0031] Figure 4 , 5 This is a schematic diagram of HPLC comparison of the test solution obtained by extracting the Shuxin Jiangzhi tablet sample with different solvents as described in Example 2 of the present invention.

[0032] Figure 6 , 7 Figures 8 and 9 are comparative schematic diagrams of HPLC chromatograms obtained using different gradient elution conditions as described in Example 3 of the present invention. Detailed Implementation

[0033] To make the objectives, technical solutions, and advantages of this application clearer and more explicit, the technical solutions in the embodiments will be clearly and completely described below in conjunction with the accompanying drawings.

[0034] Example 1

[0035] Establishment of the standard fingerprint spectrum for Shuxin Lipid-Lowering Tablets

[0036] 1. Instruments and reagents

[0037] 1.1 Instruments

[0038] The high-performance liquid chromatograph was a HITACHI Primaide, and the balance was an ESJ30-5A (Shanghai Precision Instruments Co., Ltd.).

[0039] 1.2 Test Drugs

[0040] 15 batches of Shuxin Lipid-Lowering Tablets were tested. The batch numbers are shown in Table 1. Acetonitrile was of chromatographic grade, water was purified water, and the other reagents were of analytical grade.

[0041] Table 1. Sample batch numbers of Shuxin Lipid-Lowering Tablets

[0042] 2. Methods and Results

[0043] 2.1 Chromatographic conditions: Waters Symmetry C18 column (4.6×250mm, 5μm), column temperature 25℃, flow rate 1.0ml / min, detection wavelength 275nm, injection volume of reference standard 30μl; mobile phase: acetonitrile as mobile phase A, 0.1% phosphoric acid solution as mobile phase B.

[0044] Perform gradient elution according to the table below:

[0045] 2.2 Preparation of reference and test solutions.

[0046] Weigh out appropriate amounts of sodium tanshinone, puerarin, polygalactoside, salvianolic acid B, emodin, and tanshinone IIA reference standards, dissolve them in methanol, and use them as reference solution.

[0047] Take 10 tablets of Shuxin Jiangzhi Pian, remove the film coating, grind them into a fine powder, mix them evenly, weigh them accurately, add 20 ml of 75% methanol, reflux in a water bath for 30 min, cool, filter through a 0.45 μm microporous membrane, and collect the filtrate to obtain the test solution.

[0048] 2.3 Establishment of fingerprint patterns.

[0049] The above-mentioned reference solution and test solution were separately injected into an HPLC chromatographic system to determine the HPLC fingerprint chromatograms of 15 batches of Shuxin Jiangzhi Tablets. The results were analyzed and compared to obtain the HPLC standard fingerprint chromatogram of Shuxin Jiangzhi Tablets composed of their common characteristic peaks. The chromatogram of the mixed reference solution is shown below. Figure 1 As shown, the HPLC fingerprint of Shuxin Lipid-Lowering Tablets is as follows: Figure 2As shown, taking salvianolic acid B as the reference peak, the relative retention times of its common peaks are successively: 0.116, 0.185, 0.283, 0.378, 0.476, 0.489, 0.611, 0.786, 0.915, 0.958, 0.990, 1.031, 1.591, 1.633. Among them, sodium danshensu (peak 2), puerarin (peak 5), polydatin (peak 8), salvianolic acid B (peak 12), emodin (peak 14), tanshinone II A (peak 15).

[0050] The HPLC fingerprints of 15 batches of Shuxin Jiangzhi Tablets were imported into the software "Similarity Evaluation System for Chromatographic Fingerprints of Traditional Chinese Medicines 2012 Edition" recommended by the Pharmacopoeia Commission of China for analysis, and chromatogram matching was carried out to determine that 15 common peaks are the characteristic peaks constituting the fingerprints of Shuxin Jiangzhi Tablets. Taking salvianolic acid B as the reference peak, the relative retention times of the common peaks of the samples are listed in Table 2, and the similarity calculation results of 15 batches of Shuxin Jiangzhi Tablets and the standard fingerprint are listed in Table 3.

[0051] Table 2 Relative retention times of common peaks of 15 batches of Shuxin Jiangzhi Tablets

[0052] Table 3 Similarity calculation results of 15 batches of Shuxin Jiangzhi Tablets

[0053] Example 2

[0054] The selection of the extraction solvent for the test solution of Shuxin Jiangzhi Tablets in the present invention was investigated.

[0055] Take 10 tablets of Shuxin Jiangzhi Tablets, remove the film coating, grind them finely, mix evenly, weigh accurately, add 20 ml of 75% methanol and methanol respectively, reflux in a water bath for 30 minutes, cool, filter through a 0.45 μm microporous filter membrane, take the subsequent filtrate to obtain the test solution. According to the HPLC test method for the fingerprints of Shuxin Jiangzhi Tablets in Example 1 above, the results show that using 75% methanol can extract more water-soluble components in Salvia miltiorrhiza, and the effect is better, as Figure 4 、 5 shown.

[0056] Example 3

[0057] The gradient elution conditions for the fingerprint detection method of Shuxin Jiangzhi Tablets in the present invention were investigated.

[0058] According to the test method for the fingerprints of Shuxin Jiangzhi Tablets in Example 1 above, different gradient elution conditions were set as follows:

[0059] Gradient elution method 1 Time (minutes) Mobile phase A (%) Mobile phase B (%) 0~30 10→20 90→80 30~35 20→35 80→65 35~60 35→59 65→41 60~100 59→80 41→20 100~101 80→10 20→90 101~110 10 90

[0060] Gradient elution method 2 Time (minutes) Mobile phase A (%) Mobile phase B (%) 0~10 5→10 95→90 10~30 10→20 90→80 30~40 20→35 80→65 40~60 35→60 65→40 60~100 60→80 40→20 100~101 80→5 20→95 101~110 5 95

[0061] Gradient elution method 3 Time (minutes) Mobile phase A (%) Mobile phase B (%) 0~10 5 95 10~15 5→10 95→90 15~20 10→15 90→85 20~30 15→20 85→80 30~45 20 80 45~55 20→35 80→65 55~75 35→55 65→45 75~105 55→80 45→20 105~106 80→5 20→95 106~120 5 95

[0062] like Figure 6 , 7 As shown in Figure 8, different gradient elution conditions are particularly important for the separation of adjacent peaks of puerarin (peak 5), and can also make the overall peak shape smoother.

[0063] Example 4

[0064] The methodological validation of the fingerprint spectrum detection method for Shuxin Jiangzhi tablets in this invention was performed, and the detection method and performance index results are as follows:

[0065] 1. Precision experiment.

[0066] Take the sample (P2112032), prepare the test solution according to the method in section 2.2, and inject it 6 times consecutively. With tanshinone B as the reference peak, the RSD% of the relative retention time of the common peaks 1-15 was calculated to be <1.90. At the same time, the similarity of each chromatographic fingerprint spectrum was calculated to be greater than 0.9 using the software "Similarity Evaluation System for Chromatographic Fingerprints of Traditional Chinese Medicine 2012 Edition", indicating that the instrument precision is good.

[0067] Table 4. Retention Time Results of Precision Experiment

[0068] Table 5. Similarity results of precision experiments

[0069] 2. Stability test

[0070] Take the sample (P2112032), prepare the test solution according to the method in section 2.2, and inject it at 0, 2, 6, 10, 18, and 24 h. With tanshinone B as the reference peak, the RSD% of the relative retention time of the common peaks 1-15 was calculated to be <0.73. At the same time, the similarity of each chromatographic fingerprint was calculated to be greater than 0.9 using the software "Similarity Evaluation System for Chromatographic Fingerprints of Traditional Chinese Medicine 2012 Edition", indicating that the test solution was stable within 24 hours.

[0071] Table 6. Results of relative retention times in stability experiments.

[0072] Table 7 Stability Similarity Results

[0073] 3. Reproducibility Experiment

[0074] Take sample (P2112032), accurately measure 6 portions, prepare test solutions according to the method in section 2.2, and inject them separately. With tanshinone B as the reference peak, calculate the RSD% of the relative retention time of the common peaks 1-15, which is <0.82. At the same time, use the software "Similarity Evaluation System for Chromatographic Fingerprints of Traditional Chinese Medicine 2012 Edition" to calculate that the similarity of each chromatographic fingerprint is greater than 0.9, indicating that the method has good reproducibility.

[0075] Table 8. Relative retention time results of reproducibility experiments.

[0076] Table 9 Reproducibility Similarity Results

[0077] 4. Durability assessment

[0078] (1) Column temperature change

[0079] Following the construction method described in section 2.1, column temperatures were set to 23, 25, or 27°C, with all other conditions remaining the same, to obtain the corresponding fingerprint chromatograms of Shuxin Jiangzhi tablets. Using Danshensu B as the reference peak, the RSD% of the relative retention times of the common peaks 1-15 was calculated to be <2.67. Simultaneously, the similarity of each chromatographic fingerprint chromatogram was calculated to be greater than 0.9 using the "Similarity Evaluation System for Chromatographic Fingerprints of Traditional Chinese Medicine 2012 Edition" software, indicating that the method has good robustness.

[0080] Table 10 Results of Durability Test Column Temperature Changes and Retention Time

[0081] Table 11. Similarity Results of Durability Column Temperature Variation

[0082] (2) Flow velocity change

[0083] Following the construction method in section 2.1, flow rates were set to 0.95, 1.0, or 1.05 ml / min, with all other conditions remaining the same, to obtain the corresponding fingerprint chromatograms of Shuxin Jiangzhi tablets. Using Danshensu B as the reference peak, the RSD% of the relative retention times of the common peaks 1-15 was calculated to be <1.74. At the same time, the similarity of each chromatographic fingerprint chromatogram was calculated to be greater than 0.9 using the "Similarity Evaluation System for Chromatographic Fingerprints of Traditional Chinese Medicine 2012 Edition" software, indicating that the method has good robustness.

[0084] Table 12 Results of Durability Flow Rate Changes Relative to Retention Time

[0085] Table 13 Results of Durability Flow Rate Changes Relative to Retention Time

[0086] Analysis of all the above test results shows that the relative standard deviation of the relative retention time of each common peak is less than 3%, indicating that the construction method of the embodiment has good robustness and application value. The above research results show that the method of the embodiment has good precision, stability, reproducibility, and robustness, conforms to the requirements of fingerprint spectrum construction methods, and can be used for qualitative identification of the fingerprint spectrum of Shuxin Jiangzhi tablets.

[0087] The above description is merely a preferred embodiment of the present invention and is not exhaustive, nor does it limit the present invention. Therefore, the detailed description of the embodiments above is not intended to limit the scope of protection claimed in this application. Equivalent substitutions or modifications made by those skilled in the art without creative effort should be included within the scope of protection of the present invention.

Claims

1. A method for establishing the HPLC fingerprint of a lipid-lowering tablet, characterized in that, Includes the following steps: Preparation of reference and test solutions: Weigh out sodium tanshinone, puerarin, polygalactoside, salvianolic acid B, emodin, and tanshinone II. A Dissolve an appropriate amount of reference standard in methanol to prepare a reference standard solution; Take 10 tablets of Shuxin Jiangzhi Pian, remove the film coating, grind them into a fine powder, mix them evenly, weigh them accurately, add 20 ml of 75%~100% methanol, reflux in a water bath / ultrasonic extraction for 30 min, cool, filter through a 0.45 μm microporous membrane, and collect the filtrate to obtain the product. HPLC chromatographic conditions were determined as follows: octadecylsilane-bonded silica gel was used as the stationary phase; acetonitrile was used as mobile phase A, and 0.1% phosphoric acid solution was used as mobile phase B, with gradient elution; detection wavelength: 230–367 nm; flow rate: 1.0 ml / min; column temperature: 25 ℃. Preparation of fingerprint chromatograms: The reference solution and the test solution were analyzed by HPLC to obtain the HPLC fingerprint chromatogram of the test solution; The HPLC fingerprint data of the test solution was imported into the software "Similarity Evaluation System for Chromatographic Fingerprints of Traditional Chinese Medicine (2012 Edition)" recommended by the National Pharmacopoeia Commission. The fingerprint of one of the test solutions was used as a reference fingerprint, and the standard fingerprint of Shuxin Jiangzhi tablets was generated by averaging.

2. The method for establishing according to claim 1, characterized in that, Step 1) The test solution is prepared as follows: Take 10 tablets of Shuxin Jiangzhi Pian, remove the film coating, weigh accurately, grind finely, mix well, take about 0.72 g, weigh accurately, place in a stoppered conical flask, accurately add 20 ml of 75% methanol, heat in a water bath under reflux for 30 minutes, cool, shake well, filter through a 0.45 μm microporous membrane, and take the filtrate to obtain the test solution.

3. The method for establishing according to claim 1, characterized in that, Step 3) specifically includes: taking the test solution of the same batch of Shuxin Jiangzhi tablets, injecting it 6 times consecutively, and recording the chromatogram; Take the test solution of the same batch of Shuxin Jiangzhi tablets and inject it at 0, 2, 6, 10, 18 and 24 h respectively, and record the chromatograms; Simultaneously, prepare 6 test solutions of Shuxin Jiangzhi tablets, inject them separately, and record the chromatograms.

4. The method for establishing according to claim 1, characterized in that, Step 2) The chromatographic column is a Waters Symmetry C18 Column.

5. The method for establishing according to claim 1, characterized in that, The chromatographic column has a specification of 4.6 × 250 mm and 5 μm.

6. The method for establishing according to claim 1, characterized in that, The detection wavelength described in step 2) is 275nm.

7. The method for establishing according to claim 1, characterized in that, The gradient elution conditions described in step 2) are as follows:

8. The method for establishing according to claim 1, characterized in that, The main ingredients of the Shuxin Jiangzhi tablets include Salvia miltiorrhiza, buckwheat pollen, hawthorn, Polygonum cuspidatum, kudzu root, safflower, Allium macrostemon, peach kernel, Spatholobus suberectus, Dalbergia odorifera, and Paeonia lactiflora. In step 4), it was confirmed that the fingerprint spectrum of the Shuxin Jiangzhi tablets had 15 common peaks. Taking salvianolic acid B as the reference peak, the relative retention times of the common peaks were as follows: 0.116, 0.185, 0.283, 0.378, 0.476, 0.489, 0.611, 0.786, 0.915, 0.958, 0.990, 1.031, 1.591, and 1.

633.

9. The fingerprint spectrum of the Shuxin Jiangzhi tablets as described in claims 1-8, characterized in that, The fingerprint spectrum contained 15 common peaks, of which 6 were identified: sodium tanshinone (peak 2), puerarin (peak 5), polygalactoside (peak 8), salvianolic acid B (peak 12), emodin (peak 14), and tanshinone II. A (Peak No. 15).

10. A method for quality testing of a soothing and lipid-lowering tablet, characterized in that, Includes the following steps: Prepare the chromatographic peaks of the sample to be tested; The chromatographic peak of the tested Yangzhi is compared with the fingerprint spectrum of Shuxin Jiangzhi tablets described in claim 8. If the similarity is greater than 0.9, it indicates that the quality of the tested sample is qualified.

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