CN112526045A - Method for simultaneously detecting or identifying effective components in heart-soothing and lipid-lowering tablets - Google Patents

Abstract

The invention provides a method for simultaneously detecting or identifying effective components in a heart-soothing and lipid-lowering tablet, which comprises the following steps: preparing a test solution, preparing a reference solution and measuring by high performance liquid chromatography. The invention saves the detection time and the detection cost, simultaneously realizes the analysis of the relevance of the three components in the heart-soothing and lipid-lowering tablet, and realizes the comprehensive evaluation and control of the quality of the heart-soothing and lipid-lowering tablet, thereby providing a more comprehensive and reliable basis for the authenticity identification and the internal quality detection of the heart-soothing and lipid-lowering tablet, and ensuring the stability of the product quality and the safety and the effectiveness of clinical medication. The method has the advantages of good stability, good repeatability, high recovery rate and strong specificity.

Description

Method for simultaneously detecting or identifying effective components in heart-soothing and lipid-lowering tablets

Technical Field

The invention relates to a method for detecting or identifying active ingredients in a heart-soothing and lipid-lowering tablet, in particular to a method for simultaneously detecting or identifying active ingredients in a heart-soothing and lipid-lowering tablet, and belongs to the field of medicine detection.

Background

The heart-soothing and lipid-lowering tablet is a medicine approved by the State food and drug administration and is prepared by 11 medicines of salvia miltiorrhiza, hawthorn, giant knotweed, kudzuvine root, red paeony root and the like. The salvia miltiorrhiza bunge is mainly used in the prescription to cool blood, remove weakness, promote blood circulation and relieve pain, and is a monarch drug; the hawthorn fruit can promote the circulation of qi and remove blood stasis, and the giant knotweed rhizome can remove blood stasis and relieve pain is used as a ministerial drug, so that the effects of promoting the circulation of qi and removing blood stasis, and promoting blood circulation and relieving pain of the monarch drug are enhanced. A film-coated tablet is prepared by extracting effective components with modern extraction method, and its preparation method is disclosed in Chinese patent CN 103690750B.

The current standard of the heart-soothing and lipid-lowering tablet is collected in the WS3-B-2799 + 2002 standard of the food and drug administration, and the thin-layer identification and content determination method of the heart-soothing and lipid-lowering tablet is not established in the standard. Chinese patent CN10951978B discloses a method for detecting the quality of a Shuxin Jiangzhi tablet, which is characterized in that emodin in giant knotweed rhizome and paeoniflorin in red paeony root in a formula are identified by thin-layer chromatography, and the content of polydatin in the preparation is determined by high performance liquid chromatography. The technical method disclosed in patent CN10951978B is simple and effective, but the quality of the heart-soothing and lipid-lowering tablet is not comprehensively and effectively controlled, and related researches on monarch drugs of the preparation are not carried out.

The maximum absorbances of puerarin, polydatin and salvianolic acid B are all inconsistent, the difference of the detection wavelength of single components is large, and synchronous detection of the three substances is not researched in the published literature.

Since the puerarin and the polydatin have relatively similar molecular structures and relatively similar physical property solubilities, the conventional thin layer development conditions, such as trichloromethane-methanol-water (7:2.5:0.25), can detect one of the two substances respectively, but if one preparation formula contains the two substances simultaneously, the two substances interfere with each other, so that the detection method is not specific. In the currently published detection methods, a thin-layer chromatography for simultaneously detecting puerarin and polydatin does not exist.

Disclosure of Invention

In order to solve the technical problems and comprehensively and effectively control the product quality, the invention provides a method for simultaneously detecting or identifying the effective components in the heart-soothing and lipid-lowering tablet, and a large number of tests show that the puerarin and the polydatin in the preparation are qualitatively and quantitatively detected, and the salvianolic acid B is quantitatively detected. The technical scheme of the invention is as follows:

a method for simultaneously detecting or identifying effective components in SHUXINJIANGZHI tablet comprises puerarin, polydatin, and salvianolic acid B; the detection method comprises the following steps:

step (1) preparation of a test solution:

accurately weighing a certain mass of the heart-soothing and lipid-lowering tablets in a measuring flask, adding an ethanol solution to scale, shaking up, performing ultrasonic treatment, and filtering to obtain the heart-soothing and lipid-lowering tablet;

step (2) preparation of reference solution:

precisely weighing appropriate amount of puerarin, polydatin, and salvianolic acid B reference substances, and adding diluted ethanol to obtain mixed reference solution containing puerarin, polydatin, and salvianolic acid B;

and (3) determining by high performance liquid chromatography:

the chromatographic conditions were as follows:

c18, 4.6X 150mm, 5 μm column; the flow rate is 1.0ml/min, and the column temperature is 30 ℃; the detection wavelength is 306 nm; the sample amount is 10 mul; the theoretical plate number is more than 5000; carrying out gradient elution by using a flowing A-acetonitrile and a B-phosphoric acid aqueous solution with the mass percentage of 0.05-0.2 percent according to the following table:

and respectively sucking 10-20 mu L of the mixed reference substance solution and the test sample solution, injecting into a liquid chromatograph, and measuring to obtain the test solution.

Further, in the step (1), 0.2-0.5 g of the heart-soothing and lipid-lowering tablets are taken and placed in a 10ml measuring flask, and 45-55% of ethanol solution in percentage by mass is added.

Further, in the step (1), the ultrasonic treatment process comprises the following steps: the power is 250W, the frequency is 50kHz, and the treatment time is 20 min.

Further, in the step (2), a mixed control solution containing 190 μ g of puerarin per 1ml, 75 μ g of polydatin per 1ml and 240 μ g of salvianolic acid B per 1ml is prepared.

Further, the preparation of the control solution also includes the preparation of a negative control solution: precisely weighing negative samples lacking puerarin, polydatin and salvianolic acid B0.3 g, placing into a 10ml measuring flask, adding diluted ethanol to scale, shaking, treating with ultrasonic treatment at power of 250W and frequency of 50kHz for 20min, and filtering with 0.45 μm microporous membrane.

Further, in the step (3), the separation degrees of the puerarin, the polydatin and the salvianolic acid B are more than 1.5.

The invention also relates to a method for simultaneously detecting or identifying the effective components in the heart-soothing and lipid-lowering tablet, wherein the effective components comprise the root of kudzu vine and the rhizome of giant knotweed; the authentication method comprises the following steps:

step (1) preparation of a test solution:

taking the heart-soothing and lipid-lowering tablets, grinding, precisely weighing 3-6 g, adding 20ml of methanol, carrying out ultrasonic treatment for 20 minutes, filtering, and concentrating the filtrate to 10ml to be used as a test solution; taking 3g of negative samples of the radix puerariae and polygonum cuspidatum medicinal materials, grinding, adding 20ml of methanol, carrying out ultrasonic treatment for 20 minutes, filtering, and concentrating the filtrate to 10ml to be used as a negative sample solution;

step (2) preparation of reference solution:

taking puerarin and polydatin reference substances, and adding methanol to obtain 1mg solution per 1ml as reference substance solution;

step (3), thin layer identification:

performing thin-layer chromatography, and collecting the test solution and the negative sample solution of radix Puerariae and rhizoma Polygoni Cuspidati; dropping 2-5 μ l of puerarin and polydatin reference solutions on the same high-efficiency silica gel G thin-layer plate respectively to form strips with the length of 5mm, developing with chloroform-methanol-ethyl acetate-water mixed solution as developing agent, taking out, air drying, fumigating in ammonia vapor for 5 min, and inspecting under the ultraviolet lamp 365 nm.

Further, in the step (3), the mass ratio of chloroform-methanol-ethyl acetate-water is 8:9.5:26: 4.

compared with the prior art, the invention has the following beneficial effects:

(1) the method provided by the invention solves the problem that puerarin and polydatin interfere with each other in a thin-layer detection method in the same preparation, and effectively improves the specificity of the detection method. And the purpose of multi-component linkage detection is also achieved. The established thin-layer identification method can be used for simultaneously carrying out identification and inspection on puerarin and polydatin, and the method is strong in specificity, effective and accurate.

(2) The invention adopts the high performance liquid chromatography to simultaneously measure the contents of puerarin, polydatin and salvianolic acid B for the first time. The detection time and the detection cost are saved, the analysis on the relevance of the three components in the heart-soothing and lipid-lowering tablet is realized, and the quality of the heart-soothing and lipid-lowering tablet is comprehensively evaluated and controlled, so that a comprehensive and reliable basis is provided for the authenticity identification and the internal quality detection of the heart-soothing and lipid-lowering tablet, and the stability of the product quality and the safety and the effectiveness of clinical medication are ensured. The method has the advantages of good stability, good repeatability, high recovery rate and strong specificity.

(3) The content determination method for the simultaneous detection of the three effective components and the identification method for the two effective components, which are established by the invention, have profound significance for the subsequent quality control of the variety, can greatly improve the efficiency in the product detection process and reduce the material consumption in the detection process, and can be used for the subsequent quality control of the variety.

Drawings

FIG. 1 is a high performance liquid chromatogram of a blank solvent;

FIG. 2 is a high performance liquid chromatogram of a negative sample solution;

FIG. 3 is a high performance liquid chromatogram of a control solution;

FIG. 4 is a high performance liquid chromatogram of a sample solution of a heart-soothing and lipid-lowering tablet;

FIG. 5 is a thin-layer identification fluorescence spectrum of a Shuxin Jiangzhi tablet sample;

in the figure: 1. puerarin reference substance; 2. polydatin reference substance; 3. radix puerariae and polygonum cuspidatum double-yin samples are lacking;

4-6: shuxin Jiangzhi tablets (batch numbers: 20161102, 20170404, 20170701); 7. a laboratory sample;

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is described in further detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention. The examples do not specify particular techniques or conditions, and are performed according to the techniques or conditions described in the literature in the art or according to the product specifications. The reagents or instruments used are not indicated by the manufacturer, and are all conventional products available by purchase.

Instrument and reagent

Agilent 1200-series high performance liquid chromatograph (Agilent technologies, Inc.), LC-2030 high performance liquid chromatograph (Shimadzu corporation), SK3300H ultrasonic cleaner (power 180W, frequency 53kHz, Shanghai Ke ultrasonic instruments, Inc.), BSM120.4 electronic balance (0.1mg, Shanghai electronics, Inc.), Waters Sunfire C18 liquid chromatography column (4.6 × 150mm, 5 μm, Watts, Inc., XY-C18 II 5 μm liquid chromatography column (4.6 × 250mm, Midamura technologies, Inc.).

Radix Salviae Miltiorrhizae, fructus crataegi, rhizoma Polygoni Cuspidati, radix Puerariae, flos Carthami, Bulbus Allii Macrostemi, semen Persicae, caulis Spatholobi, lignum Dalbergiae Odoriferae, and radix Paeoniae Rubra are all purchased from Yunnan Lvsheng Chinese medicinal science and technology Gmbycis; puerarin (batch number: 95.4%, 110752-; the heart-soothing and lipid-lowering tablets (batch numbers: 20161102, 20170404 and 20170701) are all produced by Yunnan botanical drug industry Co.

Example 1HPLC determination of Puerarin, Polydatin, Salvianolic acid B content

The method for simultaneously detecting the effective components in the heart-soothing and lipid-lowering tablets comprises the following steps:

1. preparation of control solutions: accurately weighing appropriate amount of puerarin, polydatin, and salvianolic acid B, and adding diluted ethanol to obtain mixed control solution containing puerarin 190 μ g per 1ml, polydatin 75 μ g per 1ml, and salvianolic acid B240 μ g per 1 ml.

2. Preparation of a test solution: precisely weighing 0.3g of SHUXINJIANGZHI tablet, placing in a 10ml measuring flask, adding diluted ethanol to scale, shaking, treating with ultrasonic wave at power of 250W and frequency of 50kHz for 20min, and filtering with 0.45 μm microporous membrane.

3. Preparation of negative control solution: precisely weighing negative samples lacking puerarin, polydatin and salvianolic acid B0.3 g, placing into a 10ml measuring flask, adding diluted ethanol to scale, shaking, treating with ultrasonic treatment at power of 250W and frequency of 50kHz for 20min, and filtering with 0.45 μm microporous membrane.

4. Selection of detection wavelength: literature search is carried out on puerarin, polydatin and salvianolic acid B at common detection wavelengths, and as a result, the puerarin has the maximum absorption peak at 250nm, the polydatin has the maximum absorption peak at 306nm and the salvianolic acid B has the maximum absorption peak at 286nm, which are the common detection wavelengths. Through a large number of experiments, the maximum absorption wavelengths of the above components are combined, and the above wavelengths are considered, and as a result, it is found that all the components can be stably detected at 306nm, and the loss is small, so 306nm is selected as the detection wavelength of the present embodiment.

5. Chromatographic conditions and system applicability test: octadecylsilane chemically bonded silica is used as a filling agent; acetonitrile is taken as a mobile phase A, a phosphoric acid aqueous solution with the mass percent of 0.1% is taken as a mobile phase B, and gradient elution is carried out according to the specification in the following table; the flow rate was 1.0ml per minute; the column temperature was 30 ℃. The separation degree of puerarin, polydatin and salvianolic acid B should be greater than 1.5. The number of theoretical plates is not less than 5000. Wherein the gradient elution is performed as follows:

6. blank test: taking three negative samples of the radix puerariae, the polygonum cuspidatum and the salvia miltiorrhiza bunge to perform determination according to the method in the step 3; as a result, the sample solution of the triple-negative sample has no chromatographic peak at the retention time of the main peak of the reference solution, i.e., other raw and auxiliary materials in the formula have no interference on the determination of the contents of puerarin, polydatin and salvianolic acid B, so that the method can be used for simultaneously determining the contents of puerarin, polydatin and salvianolic acid B in the heart-soothing lipid-lowering tablet, and the blank solvent high performance liquid chromatogram is shown in figure 1.

7. Negative sample interference test: taking three negative samples of the radix puerariae, the polygonum cuspidatum and the salvia miltiorrhiza bunge to perform determination according to the method in the step 3; as a result, the sample solution of the three-negative sample has no chromatographic peak at the retention time of the main peak of the reference solution, namely, other raw and auxiliary materials in the prescription have no interference on the determination of the contents of puerarin, polydatin and salvianolic acid B, so the method can be used for simultaneously determining the contents of puerarin, polydatin and salvianolic acid B in the heart-soothing lipid-lowering tablet. The negative control high performance liquid chromatogram is shown in FIG. 2.

8. Linear investigation: precisely weighing 0.00950g, 0.00227g and 0.03029g of puerarin reference, polydatin reference, salvianolic acid B reference, placing in a 25ml volumetric flask, adding appropriate amount of diluted ethanol, dissolving by ultrasonic, fixing volume, shaking up, and making into a mixed reference of 380 μ g/ml puerarin, 90.8 μ g/ml polydatin and 1211.6 μ g/ml salvianolic acid B for use. Precisely measuring the concentrated solutions 0.05ml, 0.1ml, 0.2ml, 0.4ml, 0.8ml and 1.0ml, respectively placing the solutions in 10ml volumetric flasks, adding diluted ethanol to a constant volume, shaking up, injecting the solution into a high performance liquid chromatograph, and measuring according to the method 4, wherein the linear relation of puerarin in the range of 19.0-380.0 mu g/ml, polydatin in the range of 4.54-90.80 mu g/ml and salvianolic acid B in the range of 60.58-1211.60 mu g/ml is good. The results are shown in tables 1-3.

TABLE 1 results of Linear examination of Puerarin

TABLE 2 Linear examination of Polydatin

TABLE 3 Linear examination of Salvianolic acid B

9. Precision investigation: precisely measuring 10 μ l of mixed reference solution under special investigation items, injecting into liquid chromatograph, and continuously feeding sample for 6 times. The results showed that puerarin RSD was 0.260%, polydatin RSD was 0.173%, and salvianolic acid B RSD was 0.657%. The results are shown in Table 4.

TABLE 4 results of precision examination

10. And (3) repeatability inspection: preparing 6 parts of parallel test solution according to the method in the step 3, precisely sucking 10 mu l of the test solution, injecting the sample solution into a liquid chromatograph, and measuring.

The results show that: the average content of puerarin is 0.725%, the RSD is 1.95%, the average content of polydatin is 0.107%, the RSD is 1.87%, the average content of salvianolic acid B is 1.064%, the RSD is 1.89%, and the repeatability of the sample solution is good. The results are shown in Table 5.

TABLE 5 results of repeated examinations

11. And (3) stability investigation: preparing a sample solution according to the step 3, precisely sucking 10 mu l of the solution for 0h, 2h, 4h, 6h, 8h, 10h and 12h respectively, and injecting the solution into a liquid chromatograph. The result shows that the test solution is stable within 12h at room temperature, the RSD value of puerarin is 1.06%, the RSD value of polydatin is 1.655%, and the RSD value of salvianolic acid B is 1.46%. The results are shown in Table 6.

TABLE 6 sample stability test results

Time of standing	Content of puerarin%	Content of polydatin%	Salvianolic acid B%
				0h	0.713	0.112	1.099
2h	0.714	0.109	1.077
				4h	0.725	0.107	1.053
6h	0.730	0.108	1.069
				8h	0.729	0.108	1.058
10h	0.731	0.107	1.058
				12h	0.729	0.107	1.070
RSD％	1.06	1.55	1.46

12. And (3) sample recovery rate: respectively and precisely weighing 0.3g of experimental sample and 6 parts in total, precisely adding 2ml of standard solution (56.36 mu g/ml of puerarin, 78 mu g/ml of polydatin and 942 mu g/ml of salvianolic acid B) into each part, preparing a sample solution according to 2.3, and precisely weighing 10 mu l of sample solution to enter a high performance liquid chromatograph for peak area measurement. As a result, the average recovery rate of puerarin was 102.32%, the average recovery rate of RSD was 0.926% (n ═ 6), the average recovery rate of polydatin was 98.88%, the average recovery rate of RSD was 0.865% (n ═ 6), the average recovery rate of salvianolic acid B was 102.028%, and the average recovery rate of salvianolic acid B was 0.807% (n ═ 6). The results are shown in Table 7.

TABLE 7 sample recovery test results (n ═ 6)

The high performance liquid chromatogram of the negative sample solution is shown in FIG. 2, the high performance liquid chromatogram of the reference solution is shown in FIG. 3, and the high performance liquid chromatogram of the test sample solution of the heart-soothing and lipid-lowering tablet sample is shown in FIG. 4.

Example 2HPLC determination of Puerarin, Polydatin, Salvianolic acid B content in Shuxin Jiangzhi tablet

The method for simultaneously detecting the effective components in the heart-soothing and lipid-lowering tablets comprises the following steps:

1. preparation of a control solution and preparation of a negative control solution: the same as in example 1.

2. Preparation of a test solution: the test samples SXJZ-20190301, SXJZ-20190302, SXJZ-20190303 and the products 20161102, 20170404 and 20170701 sold on the market are taken, and the preparation method is the same as that of the products 20161102, 20170404 and 20170701

Example 1.

3. Chromatographic conditions and system applicability test: the same as in example 1.

4. The determination method comprises the following steps: respectively sucking 10 μ L of the mixed reference solution and sample solution, injecting into liquid chromatograph, and measuring.

5. As a result: the components all reach the baseline analysis requirement, the theoretical plate numbers of puerarin, polydatin and salvianolic acid B are all more than 5000, and the separation degrees are all more than 1.5. The specific values are shown in Table 8.

TABLE 8 content of three laboratory samples and commercial products

Sample batch number	Content of puerarin%	Content of polydatin%	Content of salvianolic acid B%
				SXJZ-20190301	0.740	0.115	1.163
SXJZ-20190302	0.728	0.116	1.164
				SXJZ-20190303	0.722	0.102	1.149
20161102	0.251	0.010	0.276
				20170404	0.407	0.011	0.337
20170701	0.346	0.008	0.165

Example 3 thin layer identification of the same puerarin and polydatin

This example identifies 3 batches of product (batch numbers: 20161102, 20170404, 20170701), 1 batch of laboratory samples as follows:

taking the heart-soothing and lipid-lowering tablets, grinding, precisely weighing 5g, adding 20ml of methanol, carrying out ultrasonic treatment for 20 minutes, filtering, and concentrating the filtrate to 10ml to be used as a test solution.

Taking 3g of negative samples of the radix puerariae and the polygonum cuspidatum, grinding, adding 20ml of methanol, carrying out ultrasonic treatment for 20 minutes, filtering, and concentrating the filtrate to 10ml to obtain a negative sample solution.

Separately adding methanol into puerarin and polydatin reference substance to obtain 1mg solution per 1ml as reference substance solution.

According to a thin-layer chromatography test, sucking 5 mu l of each of the 4 solutions, respectively dropping the 4 solutions on the same high-efficiency silica gel G thin-layer plate to form strips with the length of 5mm, taking trichloromethane-methanol-ethyl acetate-water as a developing agent and the mass ratio of the trichloromethane-methanol-ethyl acetate-water being 8:9.5:26:4, developing, taking out, drying in the air, fumigating in ammonia vapor for 5 minutes, and inspecting under the ultraviolet lamp of 365 nm.

In the thin layer identification test sample chromatogram, fluorescent spots with the same color are respectively displayed on the corresponding positions of the control sample chromatogram. The negative sample has no spot at the corresponding position, and the negative sample has no interference. The test of 3 batches of products and 1 batch of laboratory samples all meet the standard, as shown in figure 5.

The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.

Claims (8)

1. A method for simultaneously detecting or identifying active ingredients in a heart-soothing and lipid-lowering tablet is characterized by comprising the following steps: the effective components comprise puerarin, polydatin and salvianolic acid B; the detection method comprises the following steps:

step (1) preparation of a test solution:

accurately weighing a certain mass of the heart-soothing and lipid-lowering tablets in a measuring flask, adding an ethanol solution to scale, shaking up, performing ultrasonic treatment, and filtering to obtain the heart-soothing and lipid-lowering tablet;

step (2) preparation of reference solution:

precisely weighing appropriate amount of puerarin, polydatin, and salvianolic acid B reference substances, and adding diluted ethanol to obtain mixed reference solution containing puerarin, polydatin, and salvianolic acid B;

and (3) determining by high performance liquid chromatography:

the chromatographic conditions were as follows:

c18, 4.6X 150mm, 5 μm column; the flow rate is 1.0ml/min, and the column temperature is 30 ℃; the detection wavelength is 306 nm; the sample amount is 10 mul; the theoretical plate number is more than 5000; carrying out gradient elution by using a flowing A-acetonitrile and a B-phosphoric acid aqueous solution with the mass percent of 0.05-0.2% according to the following table:

and respectively sucking 10-20 mu L of the mixed reference substance solution and the test sample solution, injecting into a liquid chromatograph, and measuring to obtain the test solution.

2. The method for simultaneously detecting or identifying the effective components in a heart-soothing and lipid-lowering tablet according to claim 1, wherein the method comprises the following steps: in the step (1), 0.2-0.5 g of the heart-soothing and lipid-lowering tablets are taken and placed in a 10ml measuring flask, and 45-55% of ethanol solution in percentage by mass is added.

3. The method for simultaneously detecting or identifying the effective components in a heart-soothing and lipid-lowering tablet according to claim 1, wherein the method comprises the following steps: in the step (1), the ultrasonic treatment process comprises the following steps: the power is 250W, the frequency is 50kHz, and the treatment time is 20 min.

4. The method for simultaneously detecting or identifying the effective components in a heart-soothing and lipid-lowering tablet according to claim 1, wherein the method comprises the following steps: in the step (2), a mixed control solution containing 190 mu g of puerarin per 1ml, 75 mu g of polydatin per 1ml and 240 mu g of salvianolic acid B per 1ml is prepared.

5. The method for simultaneously detecting or identifying the effective components in a heart-soothing and lipid-lowering tablet according to claim 1, wherein the method comprises the following steps: the preparation of the control solution also includes the preparation of a negative control solution: accurately weighing 0.3g of negative samples lacking puerarin, polydatin and salvianolic acid B, placing in a 10ml measuring flask, adding diluted ethanol to scale, shaking up, performing ultrasonic treatment with power of 250W and frequency of 50kHz for 20min, and filtering with a 0.45 mu m microporous membrane to obtain the final product.

6. The method for simultaneously detecting or identifying the effective components in a heart-soothing and lipid-lowering tablet according to claim 1, wherein the method comprises the following steps: in the step (3), the separation degrees of the puerarin, the polydatin and the salvianolic acid B are more than 1.5.

7. The method for simultaneously detecting or identifying the effective components in a heart-soothing and lipid-lowering tablet according to claim 1, wherein the method comprises the following steps: the effective components comprise radix Puerariae and rhizoma Polygoni Cuspidati; the authentication method comprises the following steps:

step (1) preparation of a test solution:

taking the heart-soothing and lipid-lowering tablets, grinding, precisely weighing 3-6 g, adding 20ml of methanol, carrying out ultrasonic treatment for 20 minutes, filtering, and concentrating the filtrate to 10ml to be used as a test solution; taking 3g of negative samples of the radix puerariae and polygonum cuspidatum medicinal materials, grinding, adding 20ml of methanol, carrying out ultrasonic treatment for 20 minutes, filtering, and concentrating the filtrate to 10ml to be used as a negative sample solution;

step (2) preparation of reference solution:

taking puerarin and polydatin reference substances, and adding methanol to obtain 1mg solution per 1ml as reference substance solution;

step (3), thin layer identification:

performing thin-layer chromatography, and collecting the test solution and the negative sample solution of radix Puerariae and rhizoma Polygoni Cuspidati; dropping 2-5 μ l of puerarin and polydatin reference solutions on the same high-efficiency silica gel G thin-layer plate respectively to form strips with the length of 5mm, developing with chloroform-methanol-ethyl acetate-water mixed solution as developing agent, taking out, air drying, fumigating in ammonia vapor for 5 min, and inspecting under the ultraviolet lamp 365 nm.

8. The method for simultaneously detecting or identifying the effective components in a heart-soothing and lipid-lowering tablet according to claim 7, wherein: in the step (3), the mass ratio of the trichloromethane to the methanol to the ethyl acetate to the water is 8:9.5:26: 4.

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