CN115639300A - Construction method and application of anti-inflammatory and detumescent composition characteristic spectrum - Google Patents

Abstract

The invention discloses a method for constructing a characteristic map of an anti-inflammatory and detumescent composition, wherein the anti-inflammatory and detumescent composition mainly comprises the following four components: scutellaria baicalensis, dandelion, isatis root and bunge corydalis herb; the construction method of the anti-inflammatory and detumescent composition characteristic map mainly comprises the following steps: preparing a mixed reference solution; preparing a test solution; injecting the solution into a liquid chromatograph for testing, and establishing a characteristic map of the anti-inflammatory and detumescent composition. The characteristic spectrum comprises 7 characteristic peaks which are respectively (R, S) -215679, eichun, caffeic acid, corydalis edulis, chicoric acid, baicalin, baicalein and wogonin, and belongs to four main medicinal flavors of the anti-inflammatory and detumescent composition. The characteristic spectrum established by the invention has strong characteristics and good repeatability, and the quality of the anti-inflammatory and detumescent composition can be comprehensively evaluated on the basis of substances which exert anti-inflammatory effects in the whole formula, so that the stability and controllability of the product quality of the anti-inflammatory and detumescent composition are effectively ensured.

Description

Construction method and application of anti-inflammatory and detumescent composition characteristic spectrum

Technical Field

The invention relates to the technical field of traditional Chinese medicine quality analysis and detection, in particular to a construction method and application of a characteristic spectrum of an anti-inflammatory and detumescent composition.

Background

The discovery and use of antibiotics is one of the greatest achievements in the 20 th century. With the wide application of antibiotics, antibiotic resistance has become a major concern in the use of drugs. The World Health Organization (WHO) has been concerned about the problem of resistance to antibiotics, which is believed to have become one of the most serious challenges in public health and sustainable medicine. The Chinese herbal medicine has the advantages of wide sources, high safety, small toxic and side effects, mysterious resistance mechanism and the like, can form a Chinese herbal medicine compound preparation with remarkable anti-inflammatory effect through reasonable compatibility and combination, and is expected to become a new way or a new idea for solving the problem of antibiotic resistance.

The anti-inflammatory and detumescence recipe is one of the typical recipes of the traditional Chinese medicine antibiotics and mainly comprises four medicinal materials of dandelion, bunge corydalis herb, isatis root and scutellaria baicalensis, wherein the dandelion in the recipe is cold in nature, bitter and sweet in taste and has the functions of clearing heat, detumescence, inducing diuresis and treating stranguria; ku Di Ding is cold in nature and bitter in taste, and can clear heat and resolve stagnation; radix Isatidis is cold in nature and bitter in taste, and has effects of clearing heat, cooling blood and relieving sore throat; baikal skullcap root, radix Scutellariae is cold in nature and bitter in taste, and has the effects of clearing away heat and toxic material, eliminating dampness and purging pathogenic fire. The four medicines supplement each other and play the roles of clearing away heat and toxic material, resisting inflammation and reducing swelling. The prescription is mostly prepared into Pudilan anti-inflammatory preparation, is commonly used for treating diseases such as furuncle, tonsillitis, pharyngitis, bronchitis and the like in clinic, and has obvious curative effect.

At present, a plurality of manufacturers for producing the Pudilan anti-inflammatory preparation on the market exist, but the quality of each product is different, because the existing commonly used quality detection method evaluation methods such as a thin layer identification method and a content determination method can only detect index components of a single medicinal material, the detection components are limited and long-time consumption is realized, and the quality of the Pudilan anti-inflammatory preparation cannot be comprehensively evaluated from the perspective of the pharmacodynamic component group of the whole formula medicinal material.

In recent years, the characteristic map becomes a powerful means for evaluating the overall quality of the Chinese patent medicine quality standard, a good characteristic map not only gives consideration to the integrity of Chinese patent medicine multi-component detection, but also reflects the characteristic of detecting anti-inflammatory components of various medicinal materials, can better control the internal quality of products, and improves the safety and effectiveness of the products. Therefore, the characteristic map based on the basis of the anti-inflammatory substances is established by combining the anti-inflammatory component groups of the medicinal materials, and the method has important significance for comprehensively evaluating the quality of the anti-inflammatory and detumescent composition.

Disclosure of Invention

Aiming at the defects of the prior art, the invention aims to provide a construction method of a characteristic map of an anti-inflammatory and detumescence composition and application of the characteristic map in quality evaluation of the anti-inflammatory and detumescence composition.

The technical scheme adopted by the invention for solving the technical problem is as follows:

the invention provides a method for constructing a characteristic map of an anti-inflammatory and detumescent composition, wherein the anti-inflammatory and detumescent composition mainly comprises the following components: dandelion, corydalis bungeana, isatis root and scutellaria baicalensis.

The construction method of the characteristic map of the anti-inflammatory and detumescent composition comprises the following steps:

(1) Respectively taking appropriate amount of (R, S) -goitrin, caffeic acid, chicoric acid, corydalis edulis, baicalin, baicalein, and wogonin reference substances, adding solvent, dissolving, and making into mixed reference substance solution;

(2) Extracting the anti-inflammatory and repercussive composition with solvent to obtain test solution;

(3) Injecting a preset amount of reference substance solution and a preset amount of test solution into a liquid chromatograph, wherein the liquid chromatograph uses acetonitrile-methanol (1) as a mobile phase A and uses a phosphoric acid solution as a mobile phase B for gradient elution to establish a characteristic map of the anti-inflammatory and detumescent composition;

wherein, the chromatographic column of the liquid chromatograph takes octadecylsilane chemically bonded silica as a filler;

as an improvement of the technical scheme, in the step (2), the extraction solvent is 70-80% of methanol or 70-80% of ethanol; the extraction method is ultrasonic extraction or reflux extraction.

As an improvement of the technical scheme, the step (2) comprises the following steps:

taking the anti-inflammatory and detumescent composition, grinding, taking 0.4-0.6 g, precisely weighing, placing in a conical flask with a plug, adding 40-60 mL of 70-80% methanol, weighing, heating and refluxing for 30-60 minutes, taking out, cooling, weighing again, complementing the loss weight with 70-80% methanol, shaking uniformly, filtering, taking the subsequent filtrate, and preparing the sample solution.

As an improvement of the technical scheme, the step (2) comprises the following steps:

taking the anti-inflammatory and detumescent composition, grinding, taking 0.4-0.6 g, precisely weighing, placing in a conical flask with a stopper, adding 40-60 mL of 70-80% methanol, weighing, carrying out ultrasonic treatment at the power of 300-400 kW and the frequency of 35-45 kHz for 30-60 minutes, taking out, cooling, weighing again, complementing the loss weight with 70-80% methanol, shaking uniformly, filtering, and taking the subsequent filtrate to prepare a sample solution.

In the improvement of the above technical solution, in the step (3), the volume concentration of the phosphoric acid solution is 0.1%.

As a modification of the above technical solution, in the step (3), the gradient elution is performed according to the following procedure:

0-20 min, wherein the mobile phase A is 10% and the mobile phase B is 90%;

20-35 min, the mobile phase A is 10% → 20%, and the mobile phase B is 90% → 80%;

35-40 min, wherein the mobile phase A is 20% and the mobile phase B is 80%;

40-50 min, the mobile phase A is from 20% → 26%, and the mobile phase B is from 80% → 74%;

50-60 min, the mobile phase A is 26%, and the mobile phase B is 74%;

60-70 min, the mobile phase A is from 26% → 30%, and the mobile phase B is from 74% → 70%;

70-80 min, the mobile phase A is 30%, and the mobile phase B is 70%;

80-110 min, the mobile phase A is from 30% → 50%, and the mobile phase B is from 70% → 50%;

110-120 min, the mobile phase A is 50% → 70%, and the mobile phase B is 50% → 30%;

120-121 min, the mobile phase A is 70% → 80%, and the mobile phase B is 30% → 20%;

121-129 min, wherein the mobile phase A is 80 percent, and the mobile phase B is 20 percent;

129-130 min, the mobile phase A is from 80% → 10%, and the mobile phase B is from 20% → 90%.

As an improvement of the technical scheme, in the step (3), 10 μ L of each of the reference solution and the sample solution is respectively absorbed, the chromatographic column takes octadecylsilane chemically bonded silica as a filler, the length of the chromatographic column is 250mm, the inner diameter of the chromatographic column is 4.6mm, and the particle size of the chromatographic column is 5 μm; the liquid chromatograph uses acetonitrile-methanol (1) as a mobile phase A and uses a 0.1% phosphoric acid solution as a mobile phase B; the flow rate is 1.0mL/min; the column temperature is 30 ℃, and the detection wavelength is 245-289 nm.

As an improvement of the technical scheme, in the step (3), when the detection time is 0 to 18 minutes, the detection wavelength is 245nm; when the detection time is 18-130 minutes, the detection wavelength is 289nm.

As an improvement of the technical scheme, the characteristic map of the anti-inflammatory and detumescence composition comprises 7 characteristic peaks; wherein, the peak corresponding to the baicalin reference substance peak is an S peak, and the relative retention time of each characteristic peak and the S peak is within +/-10% of a specified value; the prescribed values include: peak 1 was 0.13, peak 2 was 0.36, peak 3 was 0.59, peak 4 was 0.74, peak 6 was 1.29, peak 7 was 1.44.

In the invention, the anti-inflammatory and detumescent composition is prepared into a traditional Chinese medicine preparation, and the traditional Chinese medicine preparation comprises but is not limited to tablets, capsules or granules.

Further, the invention provides application of the characteristic spectrum of the anti-inflammatory and detumescence composition in quality evaluation of the traditional Chinese medicine preparation.

Compared with the prior art, the implementation of the invention has the following beneficial effects:

the invention establishes the characteristic map of the anti-inflammatory and detumescent composition for the first time, the characteristic map can fully show the chemical component characteristics of the anti-inflammatory and detumescent composition through wavelength switching and calibration of anti-inflammatory characteristic components, and the limitations of single existing content determination method and weak characteristic detection means are made up. Furthermore, the characteristic peaks detected by the characteristic map belong to all the medicinal flavors of the anti-inflammatory and detumescent composition, the information content is rich, the characteristic is strong, and the quality information of the anti-inflammatory and detumescent composition is comprehensively reflected on the substance basis of the anti-inflammatory effect, so that the aim of comprehensively and effectively controlling the product quality of the anti-inflammatory and detumescent composition can be achieved. Meanwhile, the characteristic map construction method in the invention has good reproducibility, accuracy, reliability and good stability, and is suitable for quality detection of various related traditional Chinese medicine preparations of the anti-inflammatory and detumescence composition.

Drawings

FIG. 1 is a 3D spectrum of a mixed control solution of the present invention;

FIG. 2 is a characteristic diagram of a test sample of the anti-inflammatory and anti-swelling composition at different wavelengths;

FIG. 3 is a characteristic diagram of a test sample of an anti-inflammatory and repercussive composition under different mobile phase systems;

FIG. 4 is a characteristic diagram of the anti-inflammatory and repercussive composition test sample under different elution gradients;

FIG. 5 is a characteristic diagram of a test sample of the anti-inflammatory and anti-swelling composition under different extraction solvents;

FIG. 6 is a characteristic diagram of a test sample of the anti-inflammatory and anti-swelling composition under different extraction modes;

FIG. 7 is a characteristic diagram of the anti-inflammatory and repercussive composition sample at different extraction times;

FIG. 8 is a characteristic map of the anti-inflammatory and repercussive composition test sample under different sampling amounts;

FIG. 9 is a comparison graph of the characteristic profiles of the anti-inflammatory and repercussive composition and a positive control solution in the characteristic profile specificity study of the anti-inflammatory and repercussive composition of the present invention;

FIG. 10 is a comparison graph of the characteristic profiles of the anti-inflammatory and repercussive composition and a negative control sample solution in the characteristic profile specificity study of the anti-inflammatory and repercussive composition of the present invention;

FIG. 11 is a comparison graph of the peak of the anti-inflammatory and repercussive composition reference and the chromatogram of the mixed reference solution in the characteristic spectrum specificity test of the anti-inflammatory and repercussive composition of the present invention;

FIG. 12 is a characteristic diagram of the anti-inflammatory and repercussive composition sample under examination of different column temperatures in the present invention;

FIG. 13 is a characteristic diagram of a sample anti-inflammatory and repercussive composition under examination at different flow rates in accordance with the present invention;

FIG. 14 is a characteristic diagram of the anti-inflammatory and repercussive composition test sample in different chromatographic column studies in the present invention;

FIG. 15 is an overlay and a reference profile of the profile of 20 batches of the anti-inflammatory and anti-swelling composition of the present invention;

figure 16 is a control profile of 20 batches of the anti-inflammatory and anti-swelling composition of the present invention.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be obtained by a person skilled in the art without making any creative effort based on the embodiments in the present invention, belong to the protection scope of the present invention.

The anti-inflammatory and detumescence composition mainly comprises four medicinal materials of dandelion, bunge corydalis herb, isatis root and scutellaria baicalensis, wherein the dandelion in the formula is cold in nature, bitter and sweet in taste, and has the effects of clearing heat, detumescence, inducing diuresis and treating stranguria; the corydalis bungeana is cold in nature and bitter in taste, and can clear heat and dissipate stagnation; radix Isatidis is cold in nature and bitter in taste, and has effects of clearing heat, cooling blood and relieving sore throat; baikal skullcap root, radix Scutellariae is cold in nature and bitter in taste, and has the effects of clearing away heat and toxic material, eliminating dampness and purging pathogenic fire. The four medicines supplement each other and play the roles of clearing away heat and toxic material, resisting inflammation and reducing swelling.

Preferably, the anti-inflammatory and repercussive composition comprises the following components: 10-20 parts of scutellaria baicalensis, 30-50 parts of dandelion, 5-15 parts of isatis root, 10-20 parts of corydalis bungeana and a proper amount of auxiliary materials;

the anti-inflammatory and detumescent composition is prepared into a traditional Chinese medicine preparation, and the traditional Chinese medicine preparation comprises but is not limited to tablets, capsules or granules.

Example 1 creation of a characteristic map of an anti-inflammatory and repercussive composition

1. Apparatus and materials

1.1 An agilent 1260 high performance liquid chromatograph; a DAD detector. Limpid D24UV type ultrapure water meters (Millipore, usa); a mertler ME204 type electronic balance, an MS105DU type electronic balance, an ME303E type electronic balance; a chromatographic column: phenomenex Luna C18 (2) (5)μm；250mm×4.6mm)，Agilent ZORBAX SB-C18(5μm；250mm×4.6mm)，Agela Technologies Venusil XBP C18(L)(5μm；250mm×4.6mm)。

1.2 The reagent acetonitrile (chromatographic purity), methanol (chromatographic purity), water as ultrapure water, and other reagents as analytically pure.

1.3 The test drug (R, S) -goitrin reference substance (batch No. 111753-201706, the content of which is 100%), the caffeic acid reference substance (batch No. 110885-201703, the content of which is 99.7%), the chicoric acid reference substance (batch No. 111752-201703, the content of which is 97.6%), the corynoline reference substance (batch No. 111734-201602, the content of which is 98.2%), the baicalin reference substance (batch No. 110715-201821, the content of which is 95.4%), the baicalein reference substance (batch No. 111595-201808, the content of which is 97.9%), and the wogonin reference substance (batch No. 111514-201706, the content of which is 100%) are purchased from China food and drug verification institute. 15 batches of anti-inflammatory and repercussive composition production samples (batch nos. 20190415, 20191122, 20191129, 20191141, 20200243, 20200253, 20200305, 20200318, 20200811, 20200903, 20200905, 20201021, 20201132, 20201137 and 20201215) were provided by Guangdong Xinbao pharmaceutical science and technology, inc.; radix Isatidis (batch: A200525), herba corydalis Bungeanae (batch: A201102), herba Taraxaci (batch: A201014), and Scutellariae radix (batch: A201023) as positive control medicinal materials; negative samples (lack of radix isatidis), negative samples (lack of herba corydalis bungeanae), negative samples (lack of dandelion), negative samples (lack of scutellaria baicalensis), and negative samples (lack of radix isatidis, herba corydalis bungeanae, dandelion and scutellaria baicalensis).

2. Chromatographic condition and preparation of reference substance solution and sample solution

2.1 Octadecylsilane chemically bonded silica is used as a filler in chromatographic conditions and system adaptability tests; gradient elution was performed as specified in table 1 using acetonitrile-methanol (1; detecting wavelength switching (0-18min, 2458n, 18-130min, 289nm); the column temperature is 35 ℃; the flow rate is 1.0ml/min per minute; the sample injection amount is 10 mu L; the theoretical plate number should not be less than 5000 in terms of peak.

TABLE 1 mobile phase gradient elution Table

2.2 Preparation of reference solutions

Preparation of control solutions: taking a proper amount of (R, S) -goitrin, caffeic acid, chicoric acid, corydalis edulis, baicalin, baicalein and wogonin as reference substances, adding 70% methanol for dissolving, and preparing into a mixed solution containing 10 mu g of (R, S) -goitrin, 30 mu g of caffeic acid, 60 mu g of chicoric acid, 60 mu g of corydalis edulis, 500 mu g of baicalin, 200 mu g of baicalein and 30 mu g of wogonin per ml.

Preparation of positive control solution: according to the prescription process, respectively taking appropriate amount of radix Isatidis, herba Taraxaci, scutellariae radix, and herba corydalis Bungeanae, precisely weighing, placing in a conical flask with a plug, precisely adding 50ml of 70% methanol, weighing, ultrasonically treating (power 400W, frequency 40 kHz) for 30min, cooling, weighing again, supplementing the weight loss with 70% methanol, shaking, filtering, and collecting the subsequent filtrate.

Preparation of negative control solution: according to the prescription process, respectively taking negative samples of the corresponding isatis root, corydalis bungeana, dandelion, scutellaria baicalensis and the four medicinal materials, precisely weighing, placing the samples into a conical bottle with a plug, precisely adding 50ml of 70% methanol, weighing, carrying out ultrasonic treatment (power 400W and frequency 40 kHz) for 30 minutes, cooling, weighing again, complementing the reduced weight with 70% methanol, shaking uniformly, filtering, and taking subsequent filtrate to obtain the medicine.

2.3 Preparation of test solution

Taking a proper amount of the anti-inflammatory and detumescent composition, grinding, taking about 0.5g, precisely weighing, placing in a conical flask with a plug, precisely adding 50ml of 70% methanol, weighing, carrying out ultrasonic treatment (power 400W and frequency 40 kHz) for 30 minutes, cooling, weighing again, complementing the weight loss with 70% methanol, shaking up, filtering, and taking a subsequent filtrate to obtain the composition.

2.4 Assay method

Precisely sucking the reference solution and the sample solution 10 respectivelyµAnd L, injecting the mixture into a liquid chromatograph, and measuring to obtain a characteristic spectrum. In the chromatogram of the test sample, 7 characteristic peaks should be present, and correspond to the retention time of 7 control peaks in the chromatogram peaks of the reference substance of the control sample, specifically, peak 1 is (R, S) -goitrin, peak 2 is caffeic acid, peak 3 is corynoline, peak 4 is chicoric acid, peak 5 is baicalin, peak 6 is baicalein, and peak 7 is wogonin. Selecting the peak corresponding to the baicalin reference product peak as an S peak, and calculating the relative retention time of each characteristic peak and the S peak, wherein the relative retention time is within +/-10% of a specified value; the predetermined values were 0.13 (peak 1), 0.36 (peak 2), 0.59 (peak 3), 0.74 (peak 4), 1.29 (peak 6), and 1.44 (peak 7).

3. Determination of chromatographic conditions

3.1 Selection of detection wavelength

Using DAD detector, sampling reference solution and sample solution, scanning at 190-400 nm to obtain 3D spectrogram (shown in figure 1) of mixed reference, and analyzing ultraviolet absorption of each reference. Based on the maximum absorption wavelength value of each reference substance, chromatographic peak information of the test substance solution under 2458nm, 280nm,289nm and 327nm is respectively collected to obtain a chromatographic contrast diagram of the reference substance and the test substance (see figure 2), and the abundance of the chromatographic peak information of the test substance under each wavelength is further analyzed. The results show that:

(1) FIG. 1 shows that the maximum UV absorption values of the control products are different, wherein (R, S) -goitrin has the maximum absorption at 245nm, corydalis zilian has the maximum absorption at 289nm, baicalin, baicalein and wogonin have the maximum absorption at 280nm, and caffeic acid and chicoric acid have the maximum absorption at 327 nm.

(2) According to the chromatogram (figure 2) information of the test solution under different wavelengths, the chromatogram peak information obtained under 289nm is rich, each contrast peak has high response value, and the impurity interference is less, thus being an ideal detection wavelength. However, the characteristic component (R, S) -goitrin of isatis root can be detected only at 245nm, and all the information of the control peak can be detected at 245nm, but an impurity peak interference phenomenon exists, and the response value of the peak is low, so that the detection is not facilitated.

Therefore, in order to enable the established characteristic map to contain more comprehensive information, a multi-wavelength switching method is adopted, and 245nm and 289nm are selected as corresponding detection wavelengths in different time periods. According to the subsequent research conditions on chromatographic conditions, the detection wavelength is finally determined as follows: when the test time is 0-18 min, the detection wavelength is 245nm; when the testing time is 18-130 min, the detection wavelength is switched to 289nm.

3.2 Examination of Mobile phase

In the experiment, 7 different mobile phase systems of methanol-water, acetonitrile-water, methanol-0.1% phosphoric acid solution, acetonitrile-0.1% phosphoric acid solution, methanol-0.1% formic acid solution, acetonitrile-0.1% formic acid solution and acetonitrile-methanol (1) -0.1% phosphoric acid solution are examined, and chromatograms for examining different mobile phases are shown in fig. 3. The results show that when acetonitrile-methanol (1) -0.1% phosphoric acid solution was selected as the mobile phase system, the separation degree of characteristic peaks of the characteristic pattern was good and the overall baseline was smooth.

3.3 Examination of elution gradient

The experiment inspects the influence of different elution gradients on the characteristic map of the anti-inflammatory and detumescent composition, the used elution gradients are shown in table 2, and the chromatograms of the different gradient inspection are shown in fig. 4.

The results showed that when elution was performed with gradients 1-5, there was impurity interference in some characteristic peaks and poor resolution, such as peak 2, peak 3 with gradient 1, peak 4, peak 5 with gradient 2, etc. When the gradient 6 is used for elution, the separation degree of each characteristic peak is good, the peak shape is good, no impurity interference exists, and the base line of the whole chromatogram is stable, so the gradient 6 is selected as the elution method.

TABLE 2 gradient survey table

4. Examination of method of preparing test sample

4.1 Investigation of extraction solvent

The influence of different solvents on the characteristic spectrum of the anti-inflammatory and detumescent composition is considered, methanol, 70% methanol, 50% methanol, 30% methanol, ethanol, 70% ethanol, 50% ethanol and 30% ethanol (the concentrations are volume concentrations) are respectively used as extraction solvents, the optimal extraction solvent is selected by observing the peak types and the separation degrees of 7 characteristic peaks in the anti-inflammatory and detumescent composition and calculating the total peak area/sample weighing amount of 11 characteristic peaks to compare the influence of different extraction solvents on the characteristic spectrum of the anti-inflammatory and detumescent composition.

Specifically, about 0.5g of the anti-inflammatory and detumescent composition is precisely weighed, 9 groups are parallelly arranged, 1 part of each group is placed in a conical flask with a plug, methanol, 70% methanol, 50% methanol, 30% methanol, ethanol, 70% ethanol, 50% ethanol, 30% ethanol and 50ml of water are precisely added, the weight is weighed, ultrasonic treatment (power 400W and frequency 40 kHz) is carried out for 30 minutes, cooling is carried out, the weight is weighed again, corresponding solvents are used for supplementing the weight, shaking up is carried out, filtering is carried out, a subsequent filtrate is taken, sample injection analysis is carried out according to the chromatographic condition under the item 2.1, and the result is shown in a figure 5 and a table 3.

TABLE 3 examination result table of anti-inflammatory and repercussive composition feature map extraction solvent

The results show that when the extraction solvent is 70% ethanol or 70% methanol, the unit peak area and the unit total peak area of each characteristic peak reach the maximum, which indicates that the extraction rate of the characteristic peaks of the anti-inflammatory and anti-swelling composition is higher by using the two extraction solvents. Further, as a result of further examining the stability of the characteristic peak in the extraction solvent, it was revealed that, with the 70% alcohol ratio as a reference, the stability of baicalin was good when the alcohol ratio was increased, but the extraction rate of a partially water-soluble substance such as peak 1 was decreased, and when the alcohol ratio was decreased, baicalin was easily hydrolyzed and the stability was poor. Therefore, based on the extraction rate and stability of the characteristic peak, the effect is optimal by taking 70% -80% of methanol or 70% -80% of ethanol as an extraction solvent.

4.2 Examination of extraction methods

The influence of different extraction modes on the characteristic spectrum of the anti-inflammatory and detumescence composition is inspected, two extraction modes of ultrasound and reflux are respectively inspected, the peak types and the separation degrees of 7 characteristic peaks are observed, the total peak area/sample weighing of the 7 characteristic peaks is calculated, and the influence of different extraction modes on the characteristic spectrum of the anti-inflammatory and detumescence composition is compared.

Specifically, a proper amount of the anti-inflammatory and detumescent composition is taken, ground, taken about 0.5g, precisely weighed, parallelly arranged in 2 groups, 1 part of each group is placed in a conical flask with a plug, 50ml of 70% methanol is precisely added, the weight is weighed, ultrasonic treatment (power 400W and frequency 40 kHz) is respectively carried out for 30 minutes, heating reflux is carried out for 30 minutes, cooling is carried out, then weighing is carried out, the weight loss is complemented by 70% methanol, shaking is carried out uniformly, filtering is carried out, and a subsequent filtrate is taken, so as to obtain the anti-inflammatory and detumescent composition. The sample injection analysis is carried out according to the chromatographic condition under the item "2.1", and the result is shown in a figure 6 and a table 4.

TABLE 4 characteristic map extraction mode investigation result table of anti-inflammatory and detumescence composition

The result shows that both reflux extraction and ultrasonic extraction can extract target components, the total efficiency of reflux extraction is slightly higher than that of ultrasonic extraction, but ultrasonic extraction has better extraction rate for certain characteristic peaks (such as peak 3 and peak 4), and the extraction mode of ultrasonic treatment is selected in consideration of the simplicity of operation.

4.3 Extraction time review

And (3) examining the influence of the extraction time on the characteristic spectrum of the anti-inflammatory and anti-swelling composition, and comparing the influence of different extraction times on the characteristic spectrum of the anti-inflammatory and anti-swelling composition through the total peak area/sample weighing of 7 characteristic peaks.

Specifically, a proper amount of the anti-inflammatory and detumescent composition is taken, ground, precisely weighed, taken about 0.5g, parallelly weighed, 4 groups are taken, 1 part of each group is placed in a conical flask with a plug, 50ml of 70% methanol is precisely added, the weight is weighed, ultrasonic treatment (power 400W, frequency 40 kHz) is respectively carried out for 15 minutes, 30 minutes, 45 minutes and 60 minutes, cooling is carried out, the weight is weighed again, the lost weight is complemented by 70% methanol, shaking up is carried out, filtering is carried out, and a subsequent filtrate is taken, so that the composition is obtained. The sample injection analysis was carried out under the chromatographic conditions of "2.1", and the results are shown in FIG. 7 and Table 5.

TABLE 5 characterization Profile extraction time study of anti-inflammatory and repercussive compositions

The results show that 30 minutes of extraction can be substantially complete by comparing the extraction effects of different extraction times.

4.4 Sample size investigation

And (3) investigating the influence of the sampling amount on the characteristic spectrum of the anti-inflammatory and detumescence composition, and comparing the influence of different sampling amounts on the characteristic spectrum of the anti-inflammatory and detumescence composition through the total peak area/sample weighing amount of 7 characteristic peaks.

Specifically, a proper amount of the anti-inflammatory and detumescent composition is taken, ground, precisely weighed, placed in a conical flask with a plug, precisely added with 50ml of 70% methanol, weighed, ultrasonically treated (power 400W, frequency 40 kHz) for 30 minutes, cooled, weighed again, supplemented with 70% methanol to make up the lost weight, shaken evenly, filtered, and a subsequent filtrate is taken, thus obtaining the anti-inflammatory and detumescent composition. The sample injection analysis was carried out under the chromatographic conditions of "2.1", and the results are shown in FIG. 8 and Table 6.

TABLE 6 examination of the characteristic pattern of anti-inflammatory and repercussive compositions

The results showed that the extraction rate of the sample was the best when the sample amount was 0.5g, and the sample amount was determined to be 0.5g.

4.5 Determination of method for preparing test sample

According to the experimental result, the pretreatment method of the anti-inflammatory and detumescence composition characteristic map sample is determined as follows:

taking a proper amount of the anti-inflammatory and detumescent composition, grinding, respectively taking about 0.5g of fine powder, precisely weighing, placing in a conical flask with a plug, precisely adding 50ml of 70% methanol, weighing, carrying out ultrasonic treatment (power 400W and frequency 40 kHz) for 30 minutes, cooling, weighing again, complementing the weight loss with 70% methanol, shaking up, filtering, and taking a subsequent filtrate to obtain the anti-inflammatory and detumescent composition.

5. Methodology validation

5.1 Specialization inspection

Respectively taking appropriate amount of (R, S) -goitrin, caffeic acid, chicoric acid, corydalis edulis, baicalin, baicalein, and wogonin reference substances, and preparing reference substance solution and mixed reference substance solution of each reference substance under the condition of '2.2'.

The anti-inflammatory and detumescence composition without each medicinal material is respectively prepared according to the preparation method of the test solution in item 2.3 to obtain a negative sample solution without each medicinal material.

Respectively taking herba Taraxaci, scutellariae radix, radix Isatidis, and herba corydalis Bungeanae as reference medicinal materials, and preparing according to the preparation method of the 2.2 middle-yang reference medicinal material solution to obtain reference medicinal material solution of each medicinal material.

Respectively 10 test solution, negative sample solution without each medicinal material, reference solution for each medicinal material, and reference solution for each referenceμL was injected into a liquid chromatograph, and sample injection analysis was performed under 2.1 chromatographic conditions, and the results are shown in FIGS. 9 to 11.

The result shows that when the medicinal material sources of the characteristic peaks are subjected to attribution, the medicinal material sources of 7 characteristic peaks are subjected to attribution through comparison of positive control medicinal materials, wherein the peak 1 belongs to isatis root, the peak 3 belongs to bunge corydalis herb, the peaks 2 and 4 belong to dandelion, and the peaks 5, 6 and 7 belong to scutellaria baicalensis. Identifying the components of each characteristic peak in the test sample through the peak emergence time of each reference substance solution component, and finally identifying 7 characteristic peaks, wherein the peak 1 is (R, S) -goitrin, the peak 2 is caffeic acid, the peak 3 is corynoline, the peak 4 is chicoric acid, the peak 5 is baicalin, the peak 6 is baicalein, and the peak 7 is wogonin. The herb attribution and component identification results of each characteristic peak are shown in Table 7.

TABLE 7 medicinal material attribution and ingredient identification table of each characteristic peak in Pudilan product

Note: "√" indicates that detection was possible in the positive control solution of the drug substance, and "×" indicates that detection was not possible.

5.2 Precision survey

Taking a proper amount of the anti-inflammatory and detumescent composition, grinding, taking about 0.5g, precisely weighing, preparing a sample solution under the item '4.5', carrying out sample injection analysis under the chromatographic condition under the item '2.1', continuously carrying out sample injection for 6 times, taking a chromatographic peak of baicalin (peak 5) as a reference peak S, calculating the relative retention time of each characteristic peak and the S peak, and calculating the RSD value. The results are shown in Table 8.

TABLE 8 anti-inflammatory and repercussive composition feature Pattern precision test results (relative Retention time)

The result shows that the relative retention time of each characteristic peak and the S peak is calculated by taking the baicalin (peak 5) chromatographic peak as a reference peak S, and the RSD of the relative retention time of each characteristic peak and the S peak is within the range of 0.2-0.4 percent and is less than 3 percent, which indicates that the precision of the instrument is good.

5.3 Repeatability inspection

Taking a proper amount of the anti-inflammatory and detumescent composition, grinding, taking about 0.5g of the anti-inflammatory and detumescent composition, weighing 6 parts of the anti-inflammatory and detumescent composition accurately, preparing a test solution under the item '4.5', carrying out sample injection analysis under the chromatographic condition under the item '2.1', taking a baicalin (peak 5) chromatographic peak as a reference peak S, calculating the relative retention time of each characteristic peak and the S peak, and calculating the RSD value. The results are shown in Table 9.

TABLE 9 repeatability test results (relative retention time) of the characteristic profiles of the anti-inflammatory and repercussive compositions

The result shows that the relative retention time of each characteristic peak and the S peak is calculated by taking the baicalin (peak 5) chromatographic peak as a reference peak S, and the RSD of the relative retention time of each characteristic peak and the S peak is within the range of 0.2-0.5 percent and is less than 3 percent, which indicates that the method has good repeatability.

5.4 Stability survey

Taking a proper amount of the anti-inflammatory and detumescent composition, grinding, taking about 0.5g, precisely weighing, preparing a test solution under the item '4.5', respectively carrying out sample injection analysis for 0 hour, 12 hours, 24 hours, 36 hours, 48 hours, 60 hours and 72 hours under the chromatographic condition under the item '2.1', taking a baicalin (peak 5) chromatographic peak as a reference peak S, calculating the relative retention time of each characteristic peak and the S peak, and calculating an RSD value. The results are shown in Table 10.

TABLE 10 repeat test results (relative retention time) of characteristic profiles of anti-inflammatory and repercussive compositions

The result shows that the RSD of the relative retention time measured by the baicalin (peak 5) chromatographic peak as a reference peak S and the relative retention time measured when the relative retention time measured by each characteristic peak at each set time point and 0 is calculated is within the range of 0.1-0.9 percent and is less than 3 percent, which indicates that the method has good stability.

5.5 Intermediate precision investigation

Operating on different instruments at different time by different analysts, taking a proper amount of the anti-inflammatory and detumescent composition, grinding, taking about 0.5g and 6 parts in parallel, precisely weighing, preparing a sample solution according to the item '4.5', carrying out sample injection analysis according to the chromatographic condition of the item '2.1', taking the chromatographic peak of baicalin (peak 5) as a reference peak S, calculating the relative retention time of each characteristic peak and the S peak, and calculating the RSD value. The results are shown in Table 11.

TABLE 11 intermediate precision test results (relative retention time) of characteristic spectra of anti-inflammatory and repercussive compositions

The result shows that the relative retention time of each characteristic peak and the S peak is calculated by taking the baicalin (peak 5) chromatographic peak as a reference peak S, and the RSD of the relative retention time of each characteristic peak and the S peak is within the range of 0.4-1.6 percent and is less than 3 percent, which indicates that the intermediate precision of the method is good.

5.6 Durability examination

(1) Investigation of different column temperatures

The influence of different column temperatures on the characteristic spectrum of the anti-inflammatory and anti-swelling composition is examined, and the column temperatures of 30 ℃, 35 ℃ and 40 ℃ are respectively examined.

Specifically, a proper amount of the anti-inflammatory and detumescent composition is taken, ground, about 0.5g of the anti-inflammatory and detumescent composition is taken, precisely weighed, a sample solution to be tested is prepared according to item 4.5, the column temperature is respectively set to 30 ℃, 35 ℃ and 40 ℃ according to the chromatographic condition under item 2.1, sample injection analysis is carried out, data are collected, the number of theoretical plates, the separation degree, the retention time and the peak area of each characteristic peak are obtained, the relative retention time and the relative peak area of each characteristic peak and the S peak are calculated by taking the baicalin (peak 5) chromatographic peak as a reference peak S, and the RSD value is calculated. The results are shown in FIG. 12 and Table 12.

TABLE 12 survey results of characteristic spectrum and column temperature of anti-inflammatory and repercussive composition

The results show that when the column temperature is changed by + -5 ℃ at 35 ℃, the relative retention time and the relative peak area of each characteristic peak are changed to different degrees, wherein the change of the relative peak area is obvious. When the column temperature is 30 ℃, interference peaks exist in the peaks 2 and 4; when the column temperature is 40 ℃, interference peaks exist in the peak 1 and the peak 2; and when the column temperature is 35 ℃, each characteristic peak has no interference of a foreign peak, and the peak shape and the separation degree are better than those of other two columns, so that the column temperature of the method is determined to be 35 ℃.

(2) Investigation of different flow rates

The effect of different flow rates on the profile of the anti-inflammatory and anti-swelling composition was examined at flow rates of 0.8mL,0.9mL and 1.0mL per minute.

Specifically, a proper amount of the anti-inflammatory and repercussive composition is taken, ground, about 0.5g of the anti-inflammatory and repercussive composition is taken, precisely weighed, a test solution is prepared under the item "4.5", the flow rates are respectively set to 0.8mL,0.9mL and 1.0mL per minute under the chromatographic condition of the item "2.1", sample injection analysis is carried out, data are collected, the number of theoretical plates of each characteristic peak, the separation degree, the retention time and the peak area are obtained, the relative retention time and the relative peak area of each characteristic peak and the S peak are calculated by taking the baicalin (peak 5) chromatographic peak as a reference peak S, and the RSD value is calculated. The results are shown in FIG. 13 and Table 13.

TABLE 13 characterization Profile flow Rate examination results of anti-inflammatory and repercussive compositions

The results showed that when the flow rate was varied by. + -. 0.1ml/min at 0.9ml/min, the relative retention time and the relative peak area of each characteristic peak were varied greatly. When the flow rate is 0.8mL/min, an interference peak exists in the peak 3, and the separation degree is poor; when the flow rate is 0.9ml/min, interference peaks exist in the peak 2 and the peak 3, and the separation degree is poor; and when the flow rate is 1.0ml/min, each characteristic peak is fast in peak appearance, the separation degree is good, and the method has good peak shape, so that the flow rate of the method is determined to be 1.0ml/min.

(3) Investigation of different chromatographic columns

The influence of different chromatographic columns on the characteristic spectrum of the anti-inflammation and anti-swelling composition is investigated, and the influence is respectively investigated by different brands of chromatographic columns.

Specifically, a proper amount of the anti-inflammatory and detumescent composition is taken, ground into fine powder, about 0.5g of the anti-inflammatory and detumescent composition is taken, precisely weighed, a sample solution is prepared according to item 4.5, different chromatographic columns are replaced according to the chromatographic conditions under item 2.1, and sample injection analysis is carried out. Collecting data to obtain theoretical plate number, separation degree, retention time and peak area of each characteristic peak, calculating relative retention time and relative peak area of each characteristic peak by taking baicalin (peak 5) chromatographic peak as a reference peak S, and calculating RSD value. The experimental results are shown in fig. 14 and table 14.

TABLE 14 characterization chromatogram column examination results of anti-inflammatory and repercussive compositions

Remarking: column 1 was Phenomenex Luna C18 (2) (5)μm;250 mm. Times.4.6 mm), column 2 is Agilent ZORBAX SB-C18 (5)μm;250 mm. Times.4.6 mm), column 3 is Agela Technologies Venusil XBP C18 (L) (5)μm；250 mm×4.6 mm)。

The results show that under the chromatographic method, the column effect of separating each characteristic peak of each chromatographic column is large, wherein the separation effect of the column 2 is the worst, and the separation degree of several control characteristic peaks such as peak 2 (caffeic acid), peak 3 (chicoric acid) and the like is less than 1.5, so that the chromatographic method is not suitable for being applied. The overall separation effect of the column 1 and the column 3 is better, but the RSD of the two in the relative retention time of the separation peak 3 and the peak 4 is larger, and the RSD of the relative peak area of each characteristic peak is also larger, so that the columns 1 and 3 or the like are suggested as the chromatographic columns selected by the method.

5.7 Small knot

The baicalin control peak (peak 5) is used as the reference peak S, and the relative retention time and relative peak area of each characteristic peak and S peak are greatly affected by the column temperature and the flow rate, and preferably, when the column temperature is 35 ℃ and the flow rate is 1.0mL per minute, the resolution, peak pattern and the like of each characteristic peak are good. Since the relative peak area varies greatly, the relative retention time of each characteristic peak is only specified, and the relative peak area is not required.

6. Sample assay

6.1 Determination of anti-inflammatory and detumescent compositions in different batches and different dosage forms

Respectively taking 15 batches of anti-inflammatory and detumescence composition tablet products and 5 batches of capsule products; preparing a sample solution according to the item '4.5', precisely sucking the sample solution, injecting samples according to the chromatographic condition of the item '2.1', measuring, taking a characteristic map overlay chart of 20 batches of the anti-inflammatory and detumescence composition samples as a figure 15, taking a baicalin (peak 5) chromatographic peak as a reference peak S, and calculating the relative retention time of each characteristic peak and the S peak as a table 15 and a table 16.

TABLE 15 batch anti-inflammatory and repercussive composition tablet product profiles (relative Retention time)

TABLE 16 batch anti-inflammatory and repercussive composition tablet product profiles (relative Retention time)

The results show that: the relative retention time RSD value of the characteristic spectrum of 15 batches of anti-inflammatory and detumescence composition tablets is in the range of 0.2-1.1%, and the relative retention time RSD value of the characteristic spectrum of 5 batches of anti-inflammatory and detumescence composition capsules is in the range of 0.0-1.1%. RSD of relative retention time of each characteristic peak of the anti-inflammatory and detumescence composition tablet product and the capsule product is less than 3 percent, which shows that the anti-inflammatory and detumescence composition characteristic spectrum has stability on the detection characteristic peak, and the product quality of different dosage forms produced by the anti-inflammatory and detumescence composition has consistency. The characteristic map is suitable for, but not limited to, anti-inflammatory and detumescence composition tablet and capsule products.

6.2 Establishing characteristic map

The characteristic spectrums of 15 batches of anti-inflammatory and detumescence composition tablet products and 5 batches of anti-inflammatory and detumescence composition capsule products are matched by using a traditional Chinese medicine chromatogram fingerprint spectrum similarity evaluation system, a reference spectrum is generated by taking a baicalin (peak 5) chromatographic peak as a reference peak S according to a median method, and a reference characteristic spectrum of the anti-inflammatory and detumescence composition is established (figure 16).

The research results show that the standard of the characteristic spectrum of the anti-inflammatory and detumescence composition is determined by taking the baicalin (peak 5) chromatographic peak as a reference peak S and referring to the characteristic spectrum results: the established characteristic map should present 7 characteristic peaks of the reference substance solution of the reference substance, baicalin in the reference substance solution is taken as an S peak, the relative retention time of each characteristic peak and the S peak is calculated, the relative retention time of each characteristic peak should be within +/-10% of a specified value, and the specified value is as follows: 0.13 (Peak 1), 0.36 (Peak 2), 0.59 (Peak 3), 0.74 (Peak 4), 1.29 (Peak 6), 1.44 (Peak 7).

In conclusion, the invention establishes the characteristic map of the anti-inflammatory and detumescent composition for the first time, the characteristic map can fully show the chemical component characteristics of the anti-inflammatory and detumescent composition through wavelength switching and calibration of anti-inflammatory characteristic components, and makes up the limitations of single existing content determination method and weak characteristic detection means. Furthermore, the characteristic peaks detected by the characteristic map belong to all the medicinal flavors of the anti-inflammatory and detumescent composition, the information content is rich, the characteristic is strong, and the quality information of the anti-inflammatory and detumescent composition is comprehensively reflected on the substance basis of the anti-inflammatory effect, so that the aim of comprehensively and effectively controlling the product quality of the anti-inflammatory and detumescent composition can be achieved. Meanwhile, the characteristic map construction method provided by the invention has the advantages of good reproducibility, accuracy, reliability and good stability, and is suitable for quality detection of various related traditional Chinese medicine preparations of the anti-inflammatory and detumescence composition.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that various changes and modifications can be made by those skilled in the art without departing from the spirit of the invention, and these changes and modifications are all within the scope of the invention. Therefore, the protection scope of the present patent should be subject to the appended claims.

Claims (10)

1. A construction method of a characteristic map of an anti-inflammatory and detumescent composition is characterized in that the anti-inflammatory and detumescent composition mainly comprises the following components: scutellaria baicalensis, dandelion, isatis root and corydalis bungeana;

the construction method of the anti-inflammatory and detumescence composition characteristic map comprises the following steps:

(1) Respectively taking appropriate amount of (R, S) -goitrin, caffeic acid, chicoric acid, corydalis edulis, baicalin, baicalein, and wogonin reference substances, adding solvent, dissolving, and making into mixed reference substance solution;

(2) Extracting the anti-inflammatory and repercussive composition with solvent to obtain test solution;

(3) Injecting a preset amount of reference substance solution and a preset amount of test solution into a liquid chromatograph, wherein the liquid chromatograph uses acetonitrile-methanol (1) as a mobile phase A and uses a phosphoric acid solution as a mobile phase B for gradient elution to establish a characteristic map of the anti-inflammatory and detumescent composition;

wherein, the chromatographic column of the liquid chromatograph takes octadecylsilane chemically bonded silica as a filler; the gradient elution was performed according to the following procedure:

0-20 min, wherein the mobile phase A is 10% and the mobile phase B is 90%;

20-35 min, the mobile phase A is 10% → 20%, and the mobile phase B is 90% → 80%;

35-40 min, the mobile phase A is 20%, and the mobile phase B is 80%;

40-50 min, the mobile phase A is from 20% → 26%, and the mobile phase B is from 80% → 74%;

50-60 min, the mobile phase A is 26%, and the mobile phase B is 74%;

60-70 min, the mobile phase A is from 26% → 30%, and the mobile phase B is from 74% → 70%;

70-80 min, the mobile phase A is 30%, and the mobile phase B is 70%;

80-110 min, the mobile phase A is from 30% → 50%, and the mobile phase B is from 70% → 50%;

110-120 min, the mobile phase A is 50% → 70%, and the mobile phase B is 50% → 30%;

120-121 min, the mobile phase A is 70% → 80%, and the mobile phase B is 30% → 20%;

121-129 min, wherein the mobile phase A is 80 percent, and the mobile phase B is 20 percent;

129-130 min, the mobile phase A is from 80% → 10%, and the mobile phase B is from 20% → 90%.

2. The method for constructing the characteristic map of the anti-inflammatory and repercussive composition according to claim 1, wherein in the step (2), the extraction solvent is 70 to 80% methanol or 70 to 80% ethanol;

the extraction method is ultrasonic extraction or reflux extraction.

3. The method for constructing a characteristic map of an anti-inflammatory and repercussive composition according to claim 1 or 2, wherein the step (2) comprises: taking the anti-inflammatory and detumescent composition, grinding, taking 0.4-0.6 g, precisely weighing, placing in a conical flask with a plug, adding 40-60 mL of 70-80% methanol, weighing, heating and refluxing for 30-60 minutes, taking out, cooling, weighing again, complementing the loss weight with 70-80% methanol, shaking uniformly, filtering, taking the subsequent filtrate, and preparing the sample solution.

4. The method for constructing a characteristic map of an anti-inflammatory and repercussive composition according to claim 1 or 2, wherein the step (2) comprises: taking the anti-inflammatory and detumescent composition, grinding, taking 0.4-0.6 g, precisely weighing, placing in a conical flask with a stopper, adding 40-60 mL of 70-80% methanol, weighing, carrying out ultrasonic treatment at the power of 300-400 kW and the frequency of 35-45 kHz for 30-60 minutes, taking out, cooling, weighing again, complementing the loss weight with 70-80% methanol, shaking uniformly, filtering, and taking the subsequent filtrate to prepare a sample solution.

5. The method for constructing a characteristic map of an anti-inflammatory and repercussive composition according to claim 1, wherein in step (3), the phosphoric acid solution is present at a concentration of 0.1% by volume.

6. The method for constructing a characteristic map of an anti-inflammatory and repercussive composition according to claim 1, wherein in step (3), 10 μ L of each of the control solution and the test solution is drawn, and the chromatographic column uses octadecylsilane chemically bonded silica as a filler, and has a column length of 250mm, an inner diameter of 4.6mm, and a particle size of 5 μm; the liquid chromatograph uses acetonitrile-methanol (1) as a mobile phase A and uses a 0.1% phosphoric acid solution as a mobile phase B; the flow rate is 1.0mL/min; the column temperature is 30 ℃, and the detection wavelength is 245-289 nm.

7. The method for constructing the characteristic map of the anti-inflammatory and repercussive composition according to claim 1 or 6, wherein in the step (3), the detection wavelength is 245nm when the detection time is 0 to 18 minutes; when the detection time is 18-130 minutes, the detection wavelength is 289nm.

8. The method of constructing an anti-inflammatory and repercussive composition profile of claim 1, wherein the anti-inflammatory and repercussive composition profile comprises 7 characteristic peaks; wherein, the peak corresponding to the baicalin reference substance peak is an S peak, and the relative retention time of each characteristic peak and the S peak is within +/-10% of a specified value; the prescribed values include: peak 1 was 0.13, peak 2 was 0.36, peak 3 was 0.59, peak 4 was 0.74, peak 6 was 1.29, and peak 7 was 1.44.

9. The method for constructing a characteristic map of an anti-inflammatory and repercussive composition according to claim 1, wherein the anti-inflammatory and repercussive composition comprises the following components: 10-20 parts of scutellaria baicalensis, 30-50 parts of dandelion, 5-15 parts of isatis root, 10-20 parts of corydalis bungeana and a proper amount of auxiliary materials;

the anti-inflammatory and detumescence composition is prepared into a traditional Chinese medicine preparation which is tablets, capsules, granules or the like.

10. Use of the method of constructing a profile of an anti-inflammatory and repercussive composition as defined in any one of claims 1 to 9 in the quality assessment of the anti-inflammatory and repercussive composition.

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