Fingerprint spectrum and content determination method of refined astragalus turbidity-dissolving preparation

Abstract

The invention provides a fingerprint spectrum and content determination method of a refined astragalus turbidity-dissolving preparation, and belongs to the technical field of traditional Chinese medicines. The construction method comprises the following steps: detecting a test solution containing the refined astragalus turbidity-dissolving preparation by utilizing high performance liquid chromatography, and generating a fingerprint spectrum according to a detection result; an adopted mobile phase A is methanol, and a mobile phase B is a 0.1% phosphoric acid aqueous solution; and carrying out gradient elution by using the mobile phases A and B. The fingerprint spectrum can be used for simultaneously detecting various chemical components in the refined astragalus turbidity-dissolving preparation, is high in separation degree, and can be used for systematically, stably and fully reflecting the quality of a product, so that the quality of the refined astragalus turbidity-dissolving preparation can be effectively controlled. Meanwhile, the construction method is simple and efficient, the detection time can be shortened, the use of a solvent is reduced, the detection cost is further greatly reduced, and the method has high specificity and selectivity on analysis of unknown and known components and is more beneficial to actual production and application.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and in particular, to a fingerprint and content determination method for Jingqi Huazhuo preparation. Background Art

[0002] The prescription of Jingqi Huazhuo preparation is made by extracting and purifying 7 traditional Chinese medicines including Astragalus membranaceus, Polygonatum sibiricum, Polygonatum odoratum, Rhizoma zedoariae, Cynanchum paniculatum, Polygonum cuspidatum, and Centella asiatica. Starting from ascending the clear and descending the turbid, this prescription can replenish qi and lift yang, activate collaterals and resolve turbidity. It is used for the treatment of diabetic nephropathy with spleen-kidney deficiency and blood stasis blocking collaterals. Symptoms include foam in urine, low back pain, frequent urination at night, and proteinuria.

[0003] In the prior art, the quality control research mainly focuses on the content determination of index components in 3 medicinal flavors of this prescription, which requires the combined use of evaporative light scattering detector and ultraviolet detector. The determination method is cumbersome, resulting in a significant increase in detection time and cost. Moreover, only a few components in the prescription are concerned, and the overall quality of the preparation cannot be fully reflected.

[0004] The applicant has studied and established a fingerprint and content determination method using high performance liquid chromatography for quality control to more comprehensively control the product quality.

[0005] The established chromatographic method can quickly and accurately separate 12 characteristic peaks in 3 medicinal materials including Astragalus membranaceus, Polygonum cuspidatum, and Centella asiatica in the product, including 3 peaks identified with known reference substances, namely polydatin, calycosin-7-O-β-D-glucoside, and emodin. The separation effect is good. At the same time, it can accurately quantify the active components polydatin and emodin contained in Polygonum cuspidatum. The linear relationships of each component are good and the recoveries are relatively good, which can meet the technical requirements of simultaneously determining multiple contents and fingerprint.

[0006] In view of the deficiencies in the prior art, the present invention provides a fingerprint and content determination method for Jingqi Huazhuo preparation. Summary of the Invention

[0007] The purpose of the present invention is to provide a fingerprint and content determination method for Jingqi Huazhuo preparation.

[0008] In order to achieve the above object of the present invention, the following technical solutions are specifically adopted:

[0009] In the first aspect, the present invention provides a method for constructing a fingerprint of Jingqi Huazhuo preparation, and the construction method includes the following steps:

[0010] Using high performance liquid chromatography to detect the test solution containing the Jingqi Huazhuo preparation, and generating a fingerprint from the detection result; for the high performance liquid chromatography detection, mobile phase A is methanol, and mobile phase B is 0.1% phosphoric acid aqueous solution; gradient elution is carried out using the mobile phase A and the mobile phase B, and the conditions are as follows:

[0011]

[0012] The percentages in the table are the percentages of each mobile phase in the total volume of the mobile phase respectively.

[0013] Furthermore, in this high performance liquid chromatography (HPLC) detection, the chromatographic column is an octadecylsilane chemically bonded silica gel column; the specification of the octadecylsilane chemically bonded silica gel column is preferably 4.6 mm × 250 mm, 5 μm;

[0014] Furthermore, in this HPLC detection, the column temperature of the chromatographic column is 30 °C;

[0015] Furthermore, the detection wavelengths of this HPLC are 210 nm and 260 nm;

[0016] Furthermore, the injection volume of this HPLC is 5 - 20 μL, preferably 10 μL.

[0017] Furthermore, the flow rate of the mobile phase is 0.9 - 1.1 ml / min, preferably 1.0 ml / min.

[0018] Furthermore, it also includes preparing a reference solution and subjecting the reference solution to this HPLC detection to determine the attribution of each peak in the test solution based on the retention time of the reference solution; the retention time of the reference solution determines the attribution of each peak in the test solution; the reference solution includes polydatin, calycosin-7-O-β-D-glucoside, and emodin.

[0019] Even further, the construction method includes the following steps:

[0020] (1) Preparation of the test solution: Dissolve the Jingqi Huazhuo preparation with methanol;

[0021] (2) Perform HPLC detection: Use an octadecylsilane chemically bonded silica gel column; the mobile phase is: methanol - 0.1% phosphoric acid aqueous solution, column temperature: 25 °C, flow rate: 1.0 mL / min, detection wavelength is 254 nm;

[0022] The gradient elution program is as follows:

[0023]

[0024] The percentages in the table are the percentages of each mobile phase in the total volume of the mobile phase respectively.

[0025] Even further, in step (1), it also includes ultrasonic treatment for 30 min (power 100 W, frequency 40 kHz), then cooling, shaking well, and filtering.

[0026] Further, in step (1), the specifications of the octadecylsilyl-bonded silica gel chromatographic column are 4.6 mm × 250 mm, 5 μm.

[0027] In a second aspect, the present invention provides a fingerprint of the Jingqi Huazhuo preparation. The fingerprint includes 12 common characteristic peaks. Taking the 3rd common characteristic peak as the reference peak, the relative retention times of the 12 common characteristic peaks are respectively:

[0028] The relative retention time of the 1st common characteristic peak is 0.41 ± 10%;

[0029] The relative retention time of the 2nd common characteristic peak is 0.66 ± 10%;

[0030] The relative retention time of the 3rd common characteristic peak is 1.00;

[0031] The relative retention time of the 4th common characteristic peak is 1.04 ± 10%;

[0032] The relative retention time of the 5th common characteristic peak is 1.18 ± 10%;

[0033] The relative retention time of the 6th common characteristic peak is 1.20 ± 10%;

[0034] The relative retention time of the 7th common characteristic peak is 1.28 ± 10%;

[0035] The relative retention time of the 8th common characteristic peak is 1.38 ± 10%;

[0036] The relative retention time of the 9th common characteristic peak is 1.61 ± 10%;

[0037] The relative retention time of the 10th common characteristic peak is 1.84 ± 10%;

[0038] The relative retention time of the 11th common characteristic peak is 1.96 ± 10%;

[0039] The relative retention time of the 12th common characteristic peak is 2.34 ± 10%.

[0040] Further, taking the 3rd common characteristic peak as the reference peak, the relative retention times of the 12 common characteristic peaks in the fingerprint of the Jingqi Huazhuo preparation are respectively:

[0041] The relative retention time of the 1st common characteristic peak is 0.41;

[0042] The relative retention time of the 2nd common characteristic peak is 0.66;

[0043] The relative retention time of the 3rd common characteristic peak is 1.00;

[0044] The relative retention time of the 4th common characteristic peak is 1.04;

[0045] The relative retention time of the common characteristic peak of No. 5 is 1.18;

[0046] The relative retention time of the common characteristic peak of No. 6 is 1.20;

[0047] The relative retention time of the common characteristic peak of No. 7 is 1.28;

[0048] The relative retention time of the common characteristic peak of No. 8 is 1.38;

[0049] The relative retention time of the common characteristic peak of No. 9 is 1.61;

[0050] The relative retention time of the common characteristic peak of No. 10 is 1.84;

[0051] The relative retention time of the common characteristic peak of No. 11 is 1.96;

[0052] The relative retention time of the common characteristic peak of No. 12 is 2.34.

[0053] In a third aspect, the present invention provides an application of a fingerprint of a Jingqi Huazhuo preparation as a standard fingerprint in the detection and quality control of Jingqi Huazhuo preparations.

[0054] Compared with the prior art, the beneficial effects of the present invention at least include:

[0055] The present invention provides an establishment and application of a fingerprint detection method for Jingqi Huazhuo preparations. This fingerprint can simultaneously detect various chemical components in Jingqi Huazhuo preparations, with high resolution, and can systematically and stably fully reflect the quality of the product, thereby being able to effectively control the quality of Jingqi Huazhuo preparations. At the same time, the construction method is simple and efficient, which can shorten the detection time and reduce the use of solvents, thereby greatly reducing the detection cost, and has high specificity and selectivity for the analysis of unknown and known components, which is more conducive to practical production applications. BRIEF DESCRIPTION OF THE DRAWINGS

[0056] Attached Figure 1 : Control fingerprint

[0057] Attached Figure 2 : Characteristic spectrum of the first batch of preparations

[0058] Attached Figure 3 : Characteristic spectrum of the second batch of preparations

[0059] Attached Figure 4 : Characteristic spectrum of the third batch of preparations

[0060] Attached Figure 5 : Linear relationship diagram of polydatin and emodin

[0061] Attached Figure 6 : Identification of characteristic peaks - Astragalus membranaceus

[0062] Appendix Figure 7 : Identification of Characteristic Peaks - Polygonatum sibiricum

[0063] Appendix Figure 8 : Identification of Characteristic Peaks - Polygonatum odoratum

[0064] Appendix Figure 9 : Identification of Characteristic Peaks - Curcuma zedoaria

[0065] Appendix Figure 10 : Identification of Characteristic Peaks - Cynanchum paniculatum

[0066] Appendix Figure 11 : Identification of Characteristic Peaks - Reynoutria japonica

[0067] Appendix Figure 12 : Identification of Characteristic Peaks - Centella asiatica Specific Embodiment

[0068] The following will describe the implementation scheme of the present invention in detail in combination with embodiments. However, those skilled in the art will understand that the following embodiments are only used to illustrate the present invention and should not be regarded as limiting the scope of the present invention. For those not specified in the embodiments, the conventional conditions or the conditions recommended by the manufacturer are followed. For the reagents or instruments without indicating the manufacturer, they are all conventional products that can be obtained through commercial purchase.

[0069] The features and properties of the present invention will be further described in detail in combination with the following embodiments:

[0070] The method for constructing the fingerprint spectrum of Jingqi Huazhuo preparation comprises the following steps:

[0071] ⑴ Type of mobile phase: Methanol is used as mobile phase A, and 0.1% phosphoric acid is used as mobile phase B.

[0072] ⑵ Chromatographic column: C18, 4.6mm×250mm, 5μm

[0073] ⑶ Flow rate: 1.0ml / min

[0074] ⑷ Column temperature: 30°C

[0075] ⑸ Detection wavelength: 210nm for fingerprint spectrum; 260nm for polydatin and emodin

[0076] ⑹ Gradient elution ratio:

[0077]

[0078] (7) Preparation of test solution: Take 3g of the powder of this product, add 25ml of methanol, ultrasonically treat for 30min, filter, and take the continuous filtrate to obtain the test solution.

[0079] (8) Preparation method of reference solution: Weigh an appropriate amount of polydatin reference substance accurately, dissolve it in methanol to make a solution containing 0.1 mg per 1 ml, shake well, and you will get it.

[0080] (9) Preparation of each negative test sample: Take 3 g of each of the negative samples lacking Astragalus membranaceus, Polygonatum sibiricum, Polygonatum odoratum, Curcuma zedoaria, Cynanchum paniculatum, Polygonum cuspidatum, and Centella asiatica, and prepare them according to the preparation method of the test sample solution.

[0081] (10) Preparation of test samples of each single herb: Take 0.5 - 2 g of the herbs of Astragalus membranaceus, Polygonatum sibiricum, Polygonatum odoratum, Curcuma zedoaria, Cynanchum paniculatum, Polygonum cuspidatum, and Centella asiatica, and prepare them according to the preparation method of the test sample solution.

[0082] (11) Preparation of mixed reference solution: Weigh an appropriate amount of calycosin - 7 - O - glucoside reference substance, polydatin reference substance, and emodin reference substance accurately, dissolve them in methanol to make solutions containing 40 μg, 0.1 mg, and 20 μg per 1 ml respectively, and you will get it.

[0083] (12) Determination method: Accurately pipette 10 μl of the reference solution, mixed reference solution, and test sample solution respectively into the liquid chromatograph for determination, and record the chromatogram for 120 minutes.

[0084] Twelve chromatographic peaks corresponding to the control fingerprint chromatogram should appear in the test sample fingerprint chromatogram. Among them, the retention time of the 3rd chromatographic peak corresponds to that of the reference peak (S peak). The relative retention time of each characteristic peak to the S peak should be within 10% of the specified value. The specified values are 0.41 (peak 1), 0.66 (peak 2), 1.00 (peak 3), 1.04 (peak 4), 1.18 (peak 5), 1.20 (peak 6), 1.28 (peak 7), 1.38 (peak 8), 1.61 (peak 9), 1.84 (peak 10), 1.96 (peak 11), 2.34 (peak 12).

[0085] Calculate the contents of polydatin and emodin in the test sample by the external standard method.

[0086] According to the attached Figure 1 control fingerprint chromatogram, the following chromatographic peak attribution table is obtained.

[0087] Chromatographic Peak Attribution Table

[0088]

[0089]

[0090] Determination of Fingerprint Chromatogram in Example 1

[0091] Determine the fingerprint chromatogram of three consecutive batches of samples according to the detection method determined by the above research. The results are as attached Figures 2 - 4 .

[0092] Retention times of chromatographic peaks of 13 batches of preparations

[0093]

[0094] Assay of Example 2

[0095] The assay was performed on three consecutive batches of samples according to the detection method determined by the above research, and the results are shown in the following table.

[0096] Assay results of 3 batches of preparations

[0097]

[0098]

[0099] Example 3 Linearity

[0100] Preparation of polydatin stock solution: An appropriate amount of polydatin reference substance was accurately weighed: 19.13 mg (batch number: 111575 - 201603, content: 87.3%), dissolved in methanol and diluted to a 25 ml volumetric flask, shaken well, and obtained. The concentration was 668.02 μg / ml, and it was used as the linear 7 reference substance solution for detection.

[0101] Preparation of emodin stock solution 1: An appropriate amount of emodin reference substance was accurately weighed: 22.72 mg (batch number: 110756 - 201913, content: 96.0%), dissolved in methanol and diluted to a 25 ml volumetric flask, shaken well, and obtained. The concentration was 872.45 μg / ml. Preparation of emodin stock solution 2: 5 ml of emodin stock solution 1 was accurately pipetted and diluted to a 25 ml volumetric flask with methanol, shaken well, and obtained. The concentration was 174.49 μg / ml.

[0102] Preparation of linear 1 mixed reference substance solution: 3 ml of polydatin stock solution and 2 ml of emodin stock solution were accurately pipetted, diluted to a 10 ml volumetric flask with methanol, shaken well, and obtained. The concentrations were 200.41 μg / ml and 52.35 μg / ml respectively.

[0103] Preparation of linear 2 mixed reference substance solution: 3 ml of linear 1 mixed reference substance solution was accurately pipetted and diluted to a 5 ml volumetric flask with methanol, shaken well, and obtained. The concentrations were 120.24 μg / ml and 31.41 μg / ml respectively.

[0104] Preparation of linear 3 mixed reference substance solution: 2 ml of linear 1 mixed reference substance solution was accurately pipetted and diluted to a 5 ml volumetric flask with methanol, shaken well, and obtained. The concentrations were 80.16 μg / ml and 20.94 μg / ml respectively.

[0105] Preparation of linear 4 mixed reference solution: Accurately pipette 1 ml of linear 1 mixed reference solution, dilute it to a 5-ml volumetric flask with methanol, shake well to obtain a solution with concentrations of 40.08 μg / ml and 10.47 μg / ml respectively.

[0106] Preparation of linear 5 mixed reference solution: Accurately pipette 1 ml of linear 2 mixed reference solution, dilute it to a 5-ml volumetric flask with methanol, shake well to obtain a solution with concentrations of 24.05 μg / ml and 6.28 μg / ml respectively.

[0107] Preparation of linear 6 mixed reference solution: Accurately pipette 1 ml of linear 2 mixed reference solution, dilute it to a 10-ml volumetric flask with methanol, shake well to obtain a solution with concentrations of 12.02 μg / ml and 3.14 μg / ml respectively.

[0108] Inject 10 μl each of linear 1 - 6 mixed reference solutions and polygonum cuspidatum glycoside linear 7 reference solution for detection. Use concentration as the abscissa and peak area as the ordinate for linear calculation. The results are shown in the following figure and table. For polygonum cuspidatum glycoside, within the concentration range of 12.02 - 668.02 μg / ml, there is a good linear relationship between concentration and peak area; for emodin, within the concentration range of 3.14 - 52.35 μg / ml, there is a good linear relationship between concentration and peak area. The linear relationship diagrams of polygonum cuspidatum glycoside and emodin are shown in the appendix Figure 5 。

[0109] Table 3 Investigation results of the linear relationship between polygonum cuspidatum glycoside and emodin

[0110]

[0111] Example 4 Accuracy

[0112] The reserve solution of polygonum cuspidatum glycoside is the same as the reserve solution used for the investigation of the linear relationship (concentration: 668.02 μg / ml).

[0113] Preparation of emodin reserve solution 2: Accurately pipette 5 ml of emodin reserve solution 1 (see the investigation of the linear relationship, concentration: 872.45 μg / ml), dilute it to a 25-ml volumetric flask with methanol, shake well to obtain a solution with a concentration of 174.49 μg / ml.

[0114] Take about 1 g of the same Jingqi Huazhuo Granules sample (batch number: 20231001), accurately weigh it, accurately add 2 ml of the above-mentioned polydatin stock solution and 21 ml of emodin stock solution, in parallel for 6 portions, accurately add 50 ml of 70% ethanol, tightly stopper, weigh, ultrasonically treat for 30 min, cool, weigh again, make up the lost weight with 70% ethanol, shake well, filter, accurately take 25 ml of the subsequent filtrate, evaporate to dryness, dissolve the residue in 70% ethanol and transfer it to a 10-ml volumetric flask, shake well, filter to obtain. Inject for detection respectively, and the results are shown in the following table. The spiked recovery rate range of polydatin is 97.10 - 100.38%, the average spiked recovery rate is 100.49%, and the RSD is 3.35%; the spiked recovery rate range of emodin is 96.42 - 101.20%, the average spiked recovery rate is 99.70%, and the RSD is 1.79%, indicating that this method has good accuracy.

[0115] Table 4 Results of the investigation on spiked recovery rate

[0116]

[0117] Spiked recovery rate calculation formula

[0118]

[0119] The above research results show that the recovery rate of polydatin in each sample is between 90 - 108%, and the recovery rate of emodin is between 85 - 110%, meeting the pharmacopoeia regulations.

[0120] Based on the above research, it is determined that this method can be used for the determination of the contents of polydatin and emodin in Jingqi Huazhuo Granules.

[0121] Example 5 Precision

[0122] Prepare a test solution according to the test sample preparation method, inject continuously for 5 injections for detection, collect the chromatograms, take polydatin as the reference peak, calculate the relative retention time and relative peak area for 12 characteristic peaks. The RSD of the relative retention time is less than 0.05%, and the RSD of the relative peak area is less than 1%; and perform similarity analysis on the chromatographic peaks within 5 - 110 min, set the time window width to 0.5 min, and the similarity results are all greater than 0.99. It shows that the precision of this instrument is good.

[0123] Table 5 Calculation results of relative retention time and relative peak area for precision

[0124]

[0125] Example 6 Stability

[0126] Prepare a test sample solution according to the test sample preparation method, inject and detect it at 0, 2, 4, 6, 8, 12, 16, 20, 24, 36, and 48 h respectively, collect the chromatograms, take polydatin as the reference peak, calculate the relative retention time and relative peak area for 12 characteristic peaks, the relative retention time RSD is less than 0.1%, and the relative peak area RSD is less than 7%; and perform similarity analysis on the chromatographic peaks within 5 - 110 min, set the time window width to 0.5 min, and the similarity results are all greater than 0.99. It shows that the test sample is basically stable within 48 h.

[0127] Table 6 Calculation results of relative retention time and relative peak area for stability

[0128]

[0129]

[0130] Example 7 Repeatability

[0131] Take the same sample, prepare a test sample solution according to the test sample preparation method, make 6 parallel samples, inject and detect them respectively, collect the chromatograms, take polydatin as the reference peak, calculate the relative retention time and relative peak area for 12 characteristic peaks, the results are shown in the following table, the relative retention time RSD is less than 0.2%, and the relative peak area RSD is less than 8%; and perform similarity analysis on the chromatographic peaks within 5 - 110 min, set the time window width to 0.5 min, and the similarity results are all greater than 0.99. It shows that the method has good repeatability.

[0132] Table 7 Calculation results of relative retention time and relative peak area for repeatability

[0133]

[0134]

[0135] The chromatogram is shown in the appendix Figures 6 - 12 .

[0136] The links not detailed in the present invention are all common general knowledge that can be selected by those of ordinary skill in the art. Although the present invention has been described in detail with general descriptions and specific implementation manners above, based on the present invention, some modifications or improvements can be made to it, which are obvious to those of ordinary skill in the art. Therefore, these modifications or improvements made without departing from the spirit of the present invention all fall within the scope of protection of the present invention.

Claims

1. A method for constructing a fingerprint of Jingqi Huazhuo preparation, characterized in that, The construction method includes the following steps: Using high performance liquid chromatography to detect the test solution containing the Jingqi Huazhuo preparation, and generating a fingerprint from the detection results; for the high performance liquid chromatography detection, the mobile phase A is methanol, and the mobile phase B is a 0.1% aqueous phosphoric acid solution; gradient elution is performed using the mobile phase A and the mobile phase B, and the conditions are as follows: The percentages in the table are the percentages of each mobile phase in the total volume of the mobile phase respectively.

2. The construction method according to claim 1, wherein In the high performance liquid chromatography detection, the chromatographic column is an octadecylsilane bonded silica gel chromatographic column; In the high performance liquid chromatography detection, the column temperature of the chromatographic column is 30 °C; The detection wavelengths for the high performance liquid chromatography are 210 nm and 260 nm; The injection volume for the high performance liquid chromatography is 5 - 20 μL.

3. The construction method according to claim 1, characterized in that, The flow rate of the mobile phase is 0.9 - 1.1 ml / min.

4. The construction method according to claim 1, characterized in that It also includes preparing a reference solution, performing the high performance liquid chromatography detection on the reference solution, and determining the attribution of each peak in the test solution according to the retention time of the reference solution; the reference solution includes polydatin, calycosin-7-O-β-D-glucoside, and emodin.

5. The construction method according to any one of claims 1-4, characterized in that, The construction method includes the following steps: (1) Preparation of the test solution: Take the powder of the Jingqi Huazhuo preparation, add methanol, ultrasonically treat, filter, and take the subsequent filtrate to obtain the test solution; (2) Perform high performance liquid detection: Use an octadecylsilane bonded silica gel chromatographic column; the mobile phase is: methanol - 0.1% aqueous phosphoric acid solution, column temperature: 30 °C, flow rate: 1.0 mL / min; The gradient elution program is as follows: The percentages in the table are the percentages of each mobile phase in the total volume of the mobile phase respectively.

6. The construction method according to claim 5, wherein In step (2), the injection volume for the high performance liquid chromatography is further 10 μL.

7. The construction method according to claim 5, characterized in that In step (1), the specification of the octadecylsilane bonded silica gel chromatographic column is further 4.6 mm × 250 mm, 5 μm.

8. A fingerprint spectrum of a Jingqi Huazhuo preparation, characterized in that, The fingerprint includes 12 common characteristic peaks. Taking the 3rd common characteristic peak as the reference peak, the relative retention times of the 12 common characteristic peaks are respectively: The relative retention time of the 1st common characteristic peak is 0.41 ± 10%; The relative retention time of the 2nd common characteristic peak is 0.66 ± 10%; The relative retention time of the 3rd common characteristic peak is 1.00; The relative retention time of the 4th common characteristic peak is 1.04 ± 10%; The relative retention time of the 5th common characteristic peak is 1.18 ± 10%; The relative retention time of the 6th common characteristic peak is 1.20 ± 10%; The relative retention time of the 7th common characteristic peak is 1.28 ± 10%; The relative retention time of the 8th common characteristic peak is 1.38 ± 10%; The relative retention time of the 9th common characteristic peak is 1.61 ± 10%; The relative retention time of the 10th common characteristic peak is 1.84 ± 10%; The relative retention time of the 11th common characteristic peak is 1.96 ± 10%; The relative retention time of the 12th common characteristic peak is 2.34 ± 10%.

9. The fingerprint spectrum according to claim 8, characterized in that, For the fingerprint of the Jingqi Huazhuo preparation, taking the 3rd common characteristic peak as the reference peak, the relative retention times of the 12 common characteristic peaks are respectively: The relative retention time of the 1st common characteristic peak is 0.41; The relative retention time of the 2nd common characteristic peak is 0.66; The relative retention time of the common characteristic peak No. 3 is 1.00; The relative retention time of the common characteristic peak No. 4 is 1.04; The relative retention time of the common characteristic peak No. 5 is 1.18; The relative retention time of the common characteristic peak No. 6 is 1.20; The relative retention time of the common characteristic peak No. 7 is 1.28; The relative retention time of the common characteristic peak No. 8 is 1.38; The relative retention time of the common characteristic peak No. 9 is 1.61; The relative retention time of the common characteristic peak No. 10 is 1.84; The relative retention time of the common characteristic peak No. 11 is 1.96; The relative retention time of the common characteristic peak No. 12 is 2.

34.

10. Application of the fingerprint of the Jingqi Huazhuo preparation according to claim 8 or 9 as a standard fingerprint in the detection and quality control of the Jingqi Huazhuo preparation.

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