CN114878706A - Quality consistency evaluation method for three preparations of Shengxuebao compound - Google Patents

Abstract

The invention discloses a quality consistency evaluation method of three preparations of a hematogenesis treasure compound, belonging to the technical field of quality consistency evaluation and control of Chinese patent medicines. The rapid evaluation method comprises the following steps: preparing 17 mixed reference substance solutions, preparing water sample samples, performing ultra-high performance liquid chromatography analysis, and finally achieving the purpose of rapidly evaluating the quality consistency of the three preparations of the compound Shengxuebao after statistical analysis. The evaluation method is simple, convenient and easy to operate, rapid, comprehensive and good in repeatability, and provides scientific basis for further development and research of the Xuebao compound. The accurate detection of the fingerprint method established by the method not only reflects the overall quality profile of the compound preparations such as decoction, granules, mixture and the like, but also provides reference for the three formulations of the Xuebao compound and the subsequent quality control research thereof and lays a foundation for the subsequent difference research of pharmacodynamics. Therefore, the research result of the invention has guiding significance for comprehensively controlling the quality of the compound preparation of the Shengxuebao.

Description

Quality consistency evaluation method for three preparations of Shengxuebao compound

Technical Field

The invention relates to the technical field of Chinese patent medicine quality evaluation and control, in particular to a consistency evaluation method of three blood-producing compound preparations.

Background

The compound Shengxuebao preparation is prepared with seven kinds of Chinese medicinal materials, including white peony root, prepared fleeceflower root, astragalus root, mulberry fruit, privet fruit, eclipta, east Asian tree fern rhizome, etc. and has the obvious functions of nourishing liver and kidney, benefiting vital energy, promoting blood production, etc.

In the prior art, according to the formula of the hematogenesis treasure traditional Chinese medicine, hematogenesis treasure preparations of various formulations are prepared, and the hematogenesis treasure preparations on the market mainly comprise decoction, granules, mixture and the like. The decoction is the most direct and effective dosage form in the traditional Chinese medicine dosage forms and the most approved classic dosage form of the famous old Chinese medical science, and the traditional Chinese medicine decoction can be used for thousands of years, and has the characteristics of flexible formula, capability of meeting the requirements of differential treatment of the Chinese medical science, simple and convenient preparation method, realization of self-preparation of patients, convenient administration in divided dosage, good absorption, quick response and the like; however, the preparation has short validity period, easy rancidness, inconvenient storage and carrying, and the like, and needs to be innovated. The traditional Chinese medicine granule solidifies the original decoction, hardly changes the composition ratio of the original main medicine components of the decoction, not only maintains the original advantages, but also overcomes the defects of temporary decoction, time consumption, energy consumption, easy mildew after long-term storage and the like before the decoction is taken. The Chinese medicinal mixture is an oral liquid preparation which is prepared by concentrating an original decoction to a required concentration and packaging the concentrated original decoction in a divided dose, not only maintains the original advantages of the decoction, but also overcomes the defects of temporary formula, decoction and the like of the decoction.

Because the hematogenesis treasure has complex components, the single component of the hematogenesis treasure basically has difficulty in reflecting the whole curative effect. However, the existing quality standard of the existing Xueshengbao preparation only measures the content of a single index component, other effective components are not monitored, certain limitation exists, and the quality level of the Xueshengbao preparation cannot be comprehensively reflected. Therefore, an accurate determination method is urgently needed, the invention establishes a method for simultaneously determining the contents of 17 components in the Shengxuebao, further evaluates the consistency of the transmission rule and quality among different dosage forms, scientifically controls the macroscopic quality of the Chinese herbal compound, and further lays a certain foundation for guiding clinical medication.

Disclosure of Invention

The invention aims to provide a quality consistency evaluation method of three blood-producing compound preparations so as to solve the problems in the prior art.

In order to achieve the purpose, the invention provides the following scheme: the quality consistency evaluation method of the three preparations of the Shengxuebao compound is characterized by comprising the following steps:

(1) preparation of 17 mixed control solutions: respectively weighing 17 reference substances of paeoniflorin, specnuezhenide, astragaloside, 2,3,5,4' -tetrahydroxystilbene-2-0-beta-D glucoside, luteolin, wedelolactone, ecliptin A, apigenin, emodin, physcion, calycosin, formononetin, kaempferol, resveratrol, protocatechuic acid and protocatechuic aldehyde, and adding methanol for dissolving to prepare mixed reference substance solutions with the concentration of each reference substance of 0.1-0.6 mg/L;

(2) preparing three water sample samples of preparation: preparing hematogenesis treasure compound into hematogenesis treasure decoction, granules and mixture respectively, diluting with water to prepare water sample test products of the three preparations, wherein the crude drug content concentration in the water sample test products is 1.0 mg/mL;

(3) respectively taking the mixed reference substance solution in the step (1) and the water sample test sample in the step (2) for ultra-high performance liquid chromatography analysis to obtain a UPLC detection method for simultaneously determining the contents of 17 chemical components in the Shengxuebao, a compound UPLC fingerprint spectrum library of the Shengxuebao and characteristic spectra of three preparations;

(4) meanwhile, the traditional fingerprint spectrum similarity method and the total quantity statistical moment similarity method are combined for statistical analysis, and finally the rapid evaluation of the quality consistency of the three preparations is realized.

Further, the preparation method of the compound decoction for generating blood comprises the following steps: uniformly mixing 645 parts by weight of prepared fleece-flower root, 807.5 parts by weight of glossy privet fruit, 807.5 parts by weight of mulberry, 807.5 parts by weight of yerbadetajo herba ecliptae, 645 parts by weight of white paeony root, 645 parts by weight of astragalus root and 645 parts by weight of rhizoma cibotii, crushing, soaking in water, heating and extracting, and filtering to obtain the compound decoction for generating blood, wherein the water sample preparation detection is carried out without changing the composition and properties of the decoction.

Further, the soaking time is 20min, and the heating extraction time is 1 h.

Further, the conditions of the ultra high performance liquid chromatography analysis are as follows: the chromatographic column is C18 aqueous column with the diameter of 2.1X 150mm and the diameter of 1.8 mu m; the mobile phase is acetonitrile and 0.04 percent phosphoric acid water; the flow rate is 0.3 mL/min; the column temperature is 30 ℃; the detection wavelength is 220 nm; the amount of sample was 1.0. mu.L.

Further, gradient elution is adopted for a mobile phase in the ultra-high performance liquid chromatography, and the specific proportion is set as follows:

a-acetonitrile: 26% in 0-54 min, 35% in 54-59 min and 80% in 59-75 min;

b-0.04% phosphoric acid water: 74% in 0-54 min, 65% in 54-59 min and 20% in 59-75 min.

The invention discloses the following technical effects:

(1) the evaluation method is simple, convenient and easy to operate, rapid, comprehensive and good in repeatability, and provides scientific basis for further research of the Shengxuebao compound. The accurate detection by using the fingerprint method not only reflects the overall quality profile of the compound preparations such as decoction, granules, mixture and the like, but also provides reference for the three dosage forms of the Xuebao compound and the subsequent quality control research thereof and lays a foundation for the subsequent difference research of pharmacodynamics. Therefore, the research result of the invention has guiding significance for comprehensively controlling the quality of the compound preparation of the Shengxuebao.

(2) The invention establishes the characteristic fingerprint spectrum of the Shengxuebao compound prescription and evaluates the quality attribute transmission rule of the three dosage forms of the Shengxuebao. The characteristic fingerprint of the Shengxuebao compound is established by adopting an ultra-performance liquid chromatography-PDA method, a determination method for simultaneously determining the content of 16 components is established, and the content and the difference of the components in the three dosage forms are determined and analyzed. And fingerprint similarity analysis is carried out by adopting a traditional Chinese medicine chromatogram fingerprint similarity evaluation system (2012 edition) and a total quantity statistical moment similarity method, and the quality attribute transfer rule of the three dosage forms of Shengxuebao is comprehensively evaluated. The total amount of 16 components of the hematogenesis treasure decoction, the granule and the mixture is 5.4986, 2.282 and 1.4166mg/g respectively; the decoction is used as a reference fingerprint, and the similarity between the granule and the mixture is 0.888 and 0.799 respectively. The detected amounts of 16 total components are decreased in three dosage forms of decoction, granules and mixture in turn, and the total amount statistical moment parameters and the similarity result show that the total dissolved amounts of all the components of the three dosage forms also show the same rule. The invention discloses that the traditional Chinese medicine decoction is the most traditional and effective classical formulation from the aspect of scientific microscopic substances and the traditional Chinese medicine components, and then the granules and the mixture lay the foundation for the quality standard and the promotion research of the Xuebao compound preparation.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings needed in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art to obtain other drawings without creative efforts.

Fig. 1 is an ultra-high performance liquid chromatogram of a hematopoiesis capsule compound decoction, a hematopoiesis capsule compound granule, a hematopoiesis capsule compound mixture and a mixed reference substance in example 1 of the present invention;

fig. 2 is a characteristic fingerprint spectrum of the hematopoiesis promotion compound decoction, the hematopoiesis promotion compound granule and the hematopoiesis promotion compound mixture in embodiment 1 of the invention;

fig. 3 is a graph showing the elution amount of a single component of the shengxuebao compound decoction, the shengxuebao compound granule and the shengxuebao compound mixture in example 2 of the present invention.

Detailed Description

Reference will now be made in detail to various exemplary embodiments of the invention, the detailed description should not be construed as limiting the invention but as a more detailed description of certain aspects, features and embodiments of the invention.

It is to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. Further, for numerical ranges in this disclosure, it is understood that each intervening value, between the upper and lower limit of that range, is also specifically disclosed. Every smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in a stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although only preferred methods and materials are described herein, any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention. All documents mentioned in this specification are incorporated by reference to disclose and describe the methods and materials in connection with which they pertain. In case of conflict with any incorporated document, the present specification will control.

It will be apparent to those skilled in the art that various modifications and variations can be made in the specific embodiments of the present disclosure without departing from the scope or spirit of the disclosure. Other embodiments will be apparent to those skilled in the art from consideration of the specification. The specification and examples are exemplary only.

As used herein, the terms "comprising," "including," "having," "containing," and the like are open-ended terms that mean including, but not limited to.

Example 1

The quality consistency evaluation method of the three preparations of the Shengxuebao compound comprises the following steps:

1. material

(1) Instrument for measuring the position of a moving object

ACQUITY UPLC (Waters, USA, including quaternary high pressure gradient pumps, vacuum degassers, autosampler, column oven, diode array detector, Empower2 chromatography workstation), C18 aqueous column (T3100A 1.8.8 μm 2.1 × 150mm, Waters), MD205DU electronic analytical balance, SB 5200DT ultrasound cleaner (Ningbo New Ganoderma Biotech Co., Ltd.).

2. Reagent

(1) Prepared fleece flower root, astragalus root, mulberry, ligustrum japonicum, yerbadetajo, root of herbaceous peony and cibot rhizome are purchased from large pharmacy of common people in Hunan province;

(2) the sources of the control are shown in table 1:

TABLE 1

(3) Methanol (lot 21075141), acetonitrile (lot 1903517) were both chromatographically pure, Tedia corporation, USA; phosphoric acid (batch No. 20190629-2), analytically pure, Hunan Hui hong reagent, Inc.; the water is Yibao pure water; 0.22 μm microporous filter membrane.

2. Establishing method

(1) Preparation of hematogenesis treasure compound decoction water sample test article

645g of prepared fleece-flower root, 807.5g of glossy privet fruit, 807.5g of mulberry, 807.5g of yerbadetajo herb, 645g of white paeony root, 645g of astragalus and 645g of east Asian tree fern rhizome are crushed into 50 meshes, 10L of water is added for soaking for 20min, then the mixture is heated and dynamically extracted for 1h at 95 ℃, cooled to 50 ℃ and filtered to obtain compound hematogenesis treasure decoction, the compound hematogenesis treasure decoction is heated and concentrated, the hematogenesis treasure compound decoction is obtained after pressure filtration and volume fixing to 5002.5mL, and the hematogenesis treasure compound decoction is diluted by 1000 times by adding purified water to obtain a sample of the hematogenesis treasure compound decoction water sample containing 1.0mg/mL of crude drug.

(2) Preparation of water sample test sample of hematogenesis treasure compound granule

A. Preparing the hematogenesis treasure compound granule: taking 400mL (crude drug amount is 1.0g/mL) of the hematogenesis compound decoction prepared in the step (1), concentrating at 60 ℃ to obtain 50g of clear paste (crude drug amount is 400g) with the relative density of about 1.30, adding 140g of sucrose and 10g of povidone, and granulating to obtain the hematogenesis compound granule.

B. Taking a proper amount of Shengxuebao granules, mixing uniformly, grinding, precisely weighing 0.25g (crude drug amount is 0.50g), adding 400mL of purified water, carrying out ultrasonic treatment for 15min, shaking up, filtering, fixing the volume to 500mL, thus obtaining a sample of the compound Shengxuebao granules water sample containing 1.0mg/mL of crude drug, and refrigerating for later use.

(3) Preparation of compound mixture water sample test article for hematogenesis

A. The preparation of the compound mixture of Shengxuebao: and (2) taking 1000mL (crude drug amount is 1g/mL) of the hematogenesis treasure compound decoction prepared in the step (1), and concentrating at 60 ℃ until the residual amount of the liquid medicine is 100mL (crude drug amount is 1000g) to obtain the hematogenesis treasure compound mixture.

B. Precisely measuring 1mL of Shengxuebao mixture, placing the mixture in a conical flask with a plug, adding 90mL of purified water for ultrasonic treatment for 15min, fixing the volume to 100mL, shaking up to obtain a primary diluent, then taking 1mL of the primary diluent, adding 90mL of purified water for ultrasonic treatment for 15min, fixing the volume to 100mL, filtering to obtain a compound Shengxuebao mixture water sample containing 1.0mg/mL of crude drug, and refrigerating for later use.

(4) Preparation of mixed control solution: accurately weighing paeoniflorin, specnuezhenide, astragaloside IV, 2,3,5,4' -tetrahydroxystilbene-2-0-beta-D glucoside, luteolin, wedelolactone, ecliptin A, apigenin, emodin, physcion, calycosin, formononetin, kaempferol, resveratrol, protocatechuic acid and protocatechualdehyde reference substances, respectively placing the reference substances into a measuring flask, adding methanol to dissolve and ultrasonically process for 20min, fixing the volume to a scale, shaking up uniformly to obtain a reference substance solution with the mass concentration of 0.1-0.6 mg/L, mixing according to the required mass concentration, and refrigerating for later use.

(5) And (3) performing ultra-high performance liquid chromatography (UPLC) detection on the water sample test product of the hematogenesis complex decoction, the water sample test product of the hematogenesis complex granule, the water sample test product of the hematogenesis complex mixture and the mixed reference substance solution prepared in the steps (1) to (4).

Specific chromatographic conditions were as follows:

a chromatographic column: c18 aqueous column 2.1X 150mm, 1.8 μm;

mobile phase: acetonitrile and 0.04% phosphoric acid water (0.04g phosphoric acid to 100mL water);

flow rate: 0.3 mL/min;

column temperature: 30 ℃;

detection wavelength: 220 nm;

sample introduction amount: 1.0. mu.L.

Gradient elution is adopted for the mobile phase, and the specific proportion is set as follows:

acetonitrile: 26% in 0-54 min, 35% in 54-59 min, and 80% in 59-75 min;

0.04% phosphoric acid water: 74% in 0-54 min, 65% in 54-59 min and 20% in 59-75 min.

The UPLC chromatogram of compound decoction, compound granule, mixture, and mixed control solution is shown in FIG. 1.

As can be seen from the UPLC chromatogram (fig. 1) of the mixed control solution, the 17 controls showed better separation at 220nm wavelength, which in turn is: protocatechuic acid, protocatechualdehyde, salidroside, paeoniflorin, calycosin, stilbene glycoside, luteolin, specnuezhenide, resveratrol, luteolin (calycosin, quercetin), wedelolactone, apigenin, kaempferol, formononetin, ecliptin A, emodin and physcion. Wherein the calycosin, quercetin and luteolin chromatogram peaks are overlapped, but the maximum absorption wavelengths are different.

FIG. 2 is a characteristic fingerprint of a water sample test sample of Shengxuebao compound decoction, a water sample test sample of Shengxuebao compound granule, and a water sample test sample of Shengxuebao compound mixture.

As can be seen from FIG. 2, the common peaks of the three dosage forms are mainly paeoniflorin, calycosin, stilbene glycoside, luteolin, specnuezhenide and resveratrol. The common peaks are obvious and concentrated in 28-46 min, so that the characteristic fingerprint spectrum of the Shengxuebao compound prescription is preliminarily determined to be the spectrum.

Example 2

The content of a single component in the Shengxuebao compound is determined:

(1) linear relationship of control

Precisely weighing protocatechuic acid, protocatechualdehyde, salidroside, paeoniflorin, calycosin, stilbene glycoside, luteolin, specnuezhenide, resveratrol, luteolin, calycosin, wedelolactone, formononetin, ecliptin A, emodin and physcion reference substances, respectively placing the reference substances into a measuring flask, adding methanol to dissolve and ultrasonically treating for 20min, fixing the volume to a scale, shaking up uniformly to obtain a reference substance solution with the mass concentration of 0.1-0.6 mg/L, and refrigerating for later use.

(2) The prepared standard substances are respectively subjected to Ultra Performance Liquid Chromatography (UPLC) detection under the same chromatographic condition, and the linear relation of each substance is calculated, and the result is shown in Table 2.

TABLE 2 Linear equation and Linear Range of control

Name of reference substance	Linear equation of equations	Linear Range (μ g/mL)
			Protocatechuic acid	y＝5.48E-08x+1.56E-04(r＝0.9999)	2.07-115
Protocatechualdehyde	y＝1.43E-07x+1.47E-04(r＝0.9999)	13.5-129
			Salidroside	y＝2.40E-07x-9.51E-05(r＝0.9999)	10.3-128
Paeoniflorin	y＝5.00E-06x+3.35E-02(r＝0.9999)	52.0-100
			Calycosin	y＝1.05E-07x+2.17E-03(r＝0.9999)	2.60-23.0
Stilbene glucoside	y＝1.03E-07x+5.29E-02(r＝0.9999)	61.9-570
			Luteolin glycoside	y＝2.47E-07x-3.33E-02(r＝0.9999)	42.0-190
Specnuezhenide	y＝2.00E-08x+3.71E-02(r＝0.9997)	40.0-100
			Resveratrol	y＝4.01E-06x+2.64E-02(r＝0.9999)	9.20-36.0
Luteolin	y＝7.09E-06x+9.97E-03(r＝0.9999)	423-1210
			Calycosin	y＝5.02E-06x-1.78E-03(r＝0.9999)	11.3-118
Wedelolactone	y＝7.45E-08x+1.40E-04(r＝0.9999)	0.13-14.0
			Formononetin	y＝1.89E-07x-5.92E-04(r＝0.9999)	9.00-28.0
Tropaeolumoside A	y＝2.44E-06x-2.06E-03(r＝0.9999)	10.0-57.0
			Emodin	y＝3.81E-08x+3.04E-04(r＝0.9999)	1.47-19.0
Emodin methyl ether	y＝4.93E-08x+1.35E-04(r＝0.9999)	0.13-10.0

(2) Precision test

The 16 kinds of control solutions were sampled in succession for 6 times according to the method of example 1, and the chromatograms were recorded. The relative retention time and the RSD of the relative peak area of each control article are calculated to be less than 5.0 percent by taking protocatechuic acid as a reference peak, which indicates that the precision of the instrument is good.

(3) Repeatability test

The sample introduction of the water samples of the decoction, the granule and the mixture prepared in example 1 is repeated 6 times according to the method in example 1, and the RSD of the relative retention time and the relative peak area of each common peak is less than 5.0%, which indicates good repeatability.

(4) Stability test

Samples of the decoction, the granules and the mixture water samples prepared in example 1 are respectively taken and subjected to sample injection measurement for 0, 2, 4, 6, 8, 12 and 24 hours according to the method in example 1, and the RSD of the common peak relative retention time and the relative peak area is less than 5.0 percent, which indicates that the sample solution is stable within 24 hours.

(5) Single component content determination

The dissolution of the single components in the three dosage forms is measured by using the obtained standard curves of 16 control substances with good linearity, the measurement result is shown in table 3, and the comparison of the contents of the three dosage forms is shown in fig. 3.

TABLE 3 detected amounts (mg/g) of 16 single components of the three dosage forms

As can be seen from table 3 and fig. 3, the content recurrence rule of 12 components from protocatechuic acid to formononetin is decoction > granule > mixture, except that resveratrol and piceid a are not detected; the content recurrence rule of emodin is granule and mixture; physcion is only detected in the granules; the total amount detected by 16 reference substances also shows the content recurrence rule of decoction, granules and mixture. Therefore, the quality of the compound decoction for generating blood is superior to that of granules and that of granules is superior to that of mixture in terms of the content of the 16 reference substances.

Effect example 1

Fingerprint similarity evaluation

(1) Similarity evaluation by traditional pharmacopoeia method

The fingerprint spectrums of the decoction, the granule and the mixture sample are introduced into a traditional Chinese medicine chromatogram fingerprint spectrum similarity evaluation system (2012 version) developed by the national pharmacopoeia committee, the similarity calculation is carried out on the UPLC fingerprint spectrums of different types of shengxuebao preparations, the quality change conditions of the three types of shengxuebao preparations are evaluated, and the calculation results are shown in table 4.

TABLE 4 fingerprint similarity values of three dosage forms Shengxuebao

	Decoction preparation	Granules	Mixture agent	Comparison fingerprint
					Decoction preparation	1	0.888	0.799	0.971
Granules	0.888	1	0.947	0.969
					Mixture agent	0.799	0.947	1	0.912
Comparison fingerprint	0.971	0.969	0.912	1

(2) Total statistic moment parameter analysis and similarity evaluation thereof

Calculating three parameters (total zero-order moment AUC) of the UPLC fingerprint total statistical moment of the three dosage forms by using the total statistical moment parameter and the similarity analysis method thereof _T Total first moment MRT _T Total second moment VRT _T ) The results are shown in Table 5, along with their similarities.

TABLE 5 Total statistic moment similarity method calculation results

From the calculation results of the fingerprint similarity among batches in the three formulations (table 4), it can be seen that the similarity values among the batches of the hematogenesis treasure decoction, the granule and the mixture are all 0.9-1.0, which indicates that the processes and the quality of the three formulations of the hematogenesis treasure compound are relatively stable.

The similarity results between the three dosage forms are calculated by using a traditional Chinese medicine chromatogram fingerprint similarity evaluation system (table 4), and the similarity values are calculated by using a total statistical moment parameter and a similarity method (table 5), and as can be seen from tables 4 and 5, the fingerprint similarity between the three dosage forms is not high, the similarity between the decoction and the granules is 0.888/0.898 (similarity evaluation system/total statistical moment similarity), the similarity between the decoction and the mixture is 0.799/0.884, and the similarity between the granules and the mixture is 0.947/0.959. The result shows that the total amount of the dissolved components of the three dosage forms also presents a gradient, namely decoction and granules are mixed. It is further described that the decoction is the most conventionally effective one, and the granule is obtained by solidifying the raw decoction without substantially changing the composition ratio of the original microscopic substances, while the mixture is slightly changed, probably because some precipitated components are discarded to achieve a certain concentration during concentration to cause a slight change in the composition ratio of the inherent components of the raw decoction.

In addition, the evaluation method is simple, convenient and easy to operate, rapid, comprehensive and good in repeatability, and provides scientific basis for further research of the Xuekao compound. The accurate detection by using the fingerprint method not only reflects the overall quality profile of the compound preparations such as decoction, granules, mixture and the like, but also provides reference for the three dosage forms of the Xuebao compound and the subsequent quality control research thereof and lays a foundation for the subsequent difference research of pharmacodynamics. Therefore, the research result of the invention has guiding significance for comprehensively controlling the quality of the compound preparation of the Shengxuebao.

The above-described embodiments are merely illustrative of the preferred embodiments of the present invention, and do not limit the scope of the present invention, and various modifications and improvements of the technical solutions of the present invention can be made by those skilled in the art without departing from the spirit of the present invention, and the technical solutions of the present invention are within the scope of the present invention defined by the claims.

Claims (5)

1. The quality consistency evaluation method of the three preparations of the Shengxuebao compound is characterized by comprising the following steps:

(1) preparation of 17 mixed control solutions: respectively weighing 17 reference substances of paeoniflorin, specnuezhenide, astragaloside, 2,3,5,4' -tetrahydroxystilbene-2-0-beta-D glucoside, luteolin, wedelolactone, ecliptin A, apigenin, emodin, physcion, calycosin, formononetin, kaempferol, resveratrol, protocatechuic acid and protocatechuic aldehyde, and adding methanol for dissolving to prepare mixed reference substance solutions with the concentration of each reference substance of 0.1-0.6 mg/L;

(2) preparing three water sample samples of preparation: preparing hematogenesis treasure compound into hematogenesis treasure decoction, granules and mixture respectively, diluting with water to prepare water sample test products of the three preparations, wherein the crude drug content concentration in the water sample test products is 1.0 mg/mL;

(3) respectively taking the mixed reference substance solution in the step (1) and the water sample test sample in the step (2) for ultra-high performance liquid chromatography analysis to obtain a UPLC detection method for simultaneously determining the contents of 17 chemical components in the Shengxuebao, a compound UPLC fingerprint spectrum library of the Shengxuebao and characteristic spectra of three preparations;

(4) meanwhile, the traditional fingerprint spectrum similarity method and the total quantity statistical moment similarity method are combined for statistical analysis, and finally the rapid evaluation of the quality consistency of the three preparations is realized.

2. The quality consistency evaluation method according to claim 1, wherein the preparation of the shengxuebao compound decoction specifically comprises the following steps: uniformly mixing 645 parts by weight of prepared fleece-flower root, 807.5 parts by weight of glossy privet fruit, 807.5 parts by weight of mulberry, 807.5 parts by weight of yerbadetajo herba ecliptae, 645 parts by weight of white paeony root, 645 parts by weight of astragalus root and 645 parts by weight of rhizoma cibotii, crushing, soaking in water, heating for extraction, and filtering to obtain the compound decoction for generating blood.

3. The method according to claim 2, wherein the soaking time is 20min and the heating extraction time is 1 h.

4. The method for evaluating quality consistency according to claim 1, wherein the conditions for the ultra high performance liquid chromatography analysis are: the chromatographic column is C18 aqueous column, 2.1 × 150mm, 1.8 μm; the mobile phase is acetonitrile and 0.04 percent phosphoric acid water; the flow rate is 0.3 mL/min; the column temperature is 30 ℃; the detection wavelength is 220 nm; the amount of sample was 1.0. mu.L.

5. The method for evaluating the quality consistency according to claim 4, wherein gradient elution is adopted for a mobile phase in the ultra-high performance liquid chromatography, and the specific proportion is set as follows:

a-acetonitrile: 26% in 0-54 min, 35% in 54-59 min and 80% in 59-75 min;

b-0.04% phosphoric acid water: 74% in 0-54 min, 65% in 54-59 min and 20% in 59-75 min.

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