Traditional Chinese medicine composition containing schaftoside as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of medicines, and particularly relates to a schaftoside-containing traditional Chinese medicine composition as well as a preparation method and application thereof. The schaftoside-containing traditional Chinese medicine composition is prepared from the following raw materials: desmodium styracifolium, liquorice, cimicifugae foetidae, gentiana algida and deionized water. The purity, the extraction rate and the stability of schaftoside in the desmodium styracifolium extract are improved by optimizing extraction, purification and other processes, and when the schaftoside is used for preparing the traditional Chinese medicine composition, the stability and the bioavailability of a pharmaceutical preparation can be improved, the occurrence rate of adverse reactions is remarkably reduced, and the safety of the traditional Chinese medicine composition is improved. The traditional Chinese medicine composition provides a safer and more effective treatment choice for patients, is suitable for being applied to the field of medicines, and has certain effects of immunization, inflammation resistance, oxidation resistance, blood fat reduction and the like.

Description

Technical Field

[0001] The invention belongs to the technical field of medicines, and particularly relates to a Chinese medicine composition containing schaftoside and a preparation method and application thereof. Background Art

[0002] Schaftoside, as a flavonoid compound found in a variety of Chinese herbal medicines, has significant biological activity. It can not only inhibit the expression of TLR4 and Myd88, but also reduce the expression and phosphorylation of Drp1 and reduce mitochondrial fission, thereby showing a variety of pharmacological effects such as anti-inflammatory, antibacterial and choleretic. However, despite the important biological activity of schaftoside, there are still a series of technical problems in its extraction and purification process, such as low extraction efficiency, great purification difficulty, poor stability, etc., which limit its wide application in traditional Chinese medicine compositions. At the same time, in actual medicines, only schaftoside as an effective substance has limited medicinal effects.

[0003] Therefore, there is an urgent need to develop an efficient, stable and easy-to-operate extraction and purification method to extract schaftoside, and to compound other effective ingredients with synergistic effects to comprehensively improve the efficacy and practicality of the traditional Chinese medicine composition. Summary of the invention

[0004] The purpose of the present invention is to provide a Chinese medicine composition containing schaftoside and a preparation method and application thereof. By optimizing extraction and purification processes, the purity, extraction rate and stability of schaftoside in a Herba Lysimachiae Desmodium extract are improved, and the schaftoside is compounded with other Chinese medicine extracts for preparing the Chinese medicine composition, which can not only improve the stability and bioavailability of the drug preparation, but also significantly reduce the incidence of adverse reactions, thereby providing patients with a safer and more effective treatment option, and having certain immune, anti-inflammatory, antioxidant, lipid-lowering and other effects.

[0005] In order to achieve the above object, the present invention provides the following technical solutions:

[0006] A Chinese medicinal composition containing schaftoside, the preparation raw materials of which include schizonepeta tenuifolia, liquorice, cimicifuga heracleifolia and gentiana dasyphylla.

[0007] Preferably, the mass ratio of the herb Desmodium strychnifolium, liquorice, cimicifuga heracleifolia and gentiana scabra is 1:(2-4):(0.5-1.5):(1-3).

[0008] Preferably, the raw materials for preparing the above-mentioned Chinese medicine composition containing schaftoside also include deionized water.

[0009] The inventors found that by selecting Herba Lysimachiae, Radix Glycyrrhizae, Rhizoma Cimicifugae, and Gentiana Alba as the main raw materials of the Chinese medicine composition, the prepared Chinese medicine composition can have certain immune, anti-inflammatory, anti-oxidation, and lipid-lowering effects, and is suitable for application in the field of medicine. This may be because the active ingredients in these four important ingredients have a synergistic effect, which can improve immunity, anti-inflammatory, anti-oxidation, and lipid-lowering effects by promoting the proliferation and differentiation of immune cells, scavenging free radicals, inhibiting the release of inflammatory mediators and reducing inflammatory reactions, regulating lipid metabolism, and inhibiting lipid synthesis. Among them, the anti-inflammatory effect is particularly significant. This may be because the four traditional Chinese medicines are rich in a variety of flavonoids, such as schaftoside, liquiritin, glycyrrhizin, cimicifuga, isoorientin, etc. These flavonoids work synergistically, on the one hand, they can act on different inflammatory pathways (such as NF-κB pathway, MAPK pathway, etc.) and targets, thereby more comprehensively inhibiting inflammatory reactions, and on the other hand, they can jointly inhibit the activation of inflammatory cells (such as macrophages, neutrophils, etc.) and the release of inflammatory mediators (such as IL-1, IL-6, TNF-α, etc.). In addition, it is also possible to inhibit the overreaction of the immune system by regulating the functions of immune cells (such as T cells, B cells, etc.). In addition to inhibiting inflammatory reactions, the flavonoid compounds in the Chinese medicine of the present invention may also accelerate the recovery process by promoting inflammation regression and tissue repair, which helps to reduce tissue damage and dysfunction after inflammation. Considering that most of the active ingredients required by the present invention are flavonoid compounds, the extraction method of all Chinese medicines is consistent, which not only saves costs, but also is simple to operate, has high product purity, and strong medicinal properties. However, schaftoside has poor stability and is easy to decompose, so it is prepared separately.

[0010] The preparation method of the Chinese medicine composition containing schaftoside comprises the following steps:

[0011] S1. Prepare Desmodium strychnifolium extract from Desmodium strychnifolium, and mix licorice, cimicifuga heracleifolia, and Gentiana scabra to prepare a mixed extract;

[0012] S2, respectively embedding the Herba Lysimachiae extract and the mixed extract to obtain the Herba Lysimachiae extract-embedded material and the mixed extract-embedded material;

[0013] S3, mixing the Herba Lysimachiae extract-embedded material, the mixed extract-embedded material and deionized water to obtain a crude preparation;

[0014] S4. After the crude preparation is precipitated with alcohol, it is filtered through a ceramic membrane, sterilized, and sealed to obtain a Chinese medicinal composition containing schaftoside.

[0015] Taking Desmodium strychnifolium as an example, the specific operation method of step S1 is as follows:

[0016] A1. Dry the Herba Lysimachiae, grind it through a 40-mesh sieve, and reflux extract it twice with a 65% to 75% ethanol solution, each time for 1 to 2 hours, filter it, and combine the two extracts to obtain an extract;

[0017] A2. Adjust the pH of the extract to 1-2 with hydrochloric acid, keep it at 75-85°C for 1 hour, let it stand at room temperature for 10-14 hours, centrifuge, wash the precipitate with water, 50% ethanol aqueous solution, and 95% ethanol aqueous solution in sequence until it is neutral, evaporate the ethanol solution, and dry it at 55-65°C to obtain a crude extract;

[0018] A3, dissolving the crude extract in water, passing it through a macroporous resin at a flow rate of 2.5-3.5 BV / h, eluting with 3-5 BV of water and 2-4 BV of 50% ethanol solution in sequence, collecting the eluate, concentrating and drying under reduced pressure to obtain an isolate 1;

[0019] A4. Dissolve the isolate in 75% to 85% ethanol aqueous solution, perform secondary separation using a chromatographic column, collect the sample after elution, concentrate and dry to obtain the extract.

[0020] The preparation method of the mixed extract is the same as the preparation method of the Desmodium sibiricum extract; the only difference is that licorice, cimicifuga and gentiana dasyphylla are used to replace Desmodium sibiricum in the preparation of the mixed extract, and the rest are the same.

[0021] Preferably, the solid-liquid ratio of the crude extract to water is 1 g:10 mL; the solid-liquid ratio of the isolate 1 to the ethanol-water solution is 1 g:10 mL.

[0022] Preferably, the macroporous resin is a non-polar macroporous resin with an average pore diameter of 8.5-9 nm, a pore volume of 1.35-1.65 mL / g, and a specific surface area of ​​≥600 m2 / g.

[0023] In some preferred embodiments, the macroporous resin is purchased from Shandong Shoucheng Chemical Co., Ltd., HPD100.

[0024] The inventors found that when preparing the crude extract, adjusting the pH of the extract to be acidic, especially when the pH is 1, can increase the content of schaftoside and other flavonoids in the Chinese medicine composition. This is because flavonoids are generally weakly acidic, and their dissociation can be inhibited in an acidic environment, so that they are in molecular form in the solvent and are more easily freed. By selecting a specific resin to enrich and purify the crude extract and eluting under specific conditions, the content of schaftoside and total flavonoids can be further increased. This is because HPD100 resin is a non-polar macroporous adsorption resin, and this non-polar property makes it have a good affinity for flavonoid molecules with weaker polarity. The non-polar part in the molecular structure of flavonoids can interact with the non-polar surface of the resin, thereby achieving effective adsorption. In addition, HPD100 resin has a porous structure, and these pores provide abundant adsorption sites for flavonoid molecules. At the same time, the ethanol concentration should not be too high. High concentration of ethanol may cause the destruction of the structure of flavonoid compounds or poor elution effect of low concentration of ethanol, which may affect the content of flavonoid compounds in the product. Through the specific extraction and purification steps of the present invention, a large amount of impurities in traditional Chinese medicine are removed and effective ingredients such as schaftoside and other flavonoid compounds are retained, thereby improving the purity and stability of the extract.

[0025] Preferably, the chromatographic column is composed of phenyl filler and silica gel matrix filler; the mass ratio thereof is 1:(0.5-2); further preferably, it is 1:1.

[0026] Preferably, the particle size of the phenyl filler is 8-12 μm, and the pore size is 28-32 nm.

[0027] Preferably, the silica gel matrix filler has a particle size of 4-6 μm and a pore size of 28-32 nm.

[0028] In some preferred embodiments, the phenyl filler and the silica gel matrix filler are purchased from the Kromasil brand of Akzo Nobel Company of Sweden.

[0029] The inventors found that by using a specific phenyl filler and a silica matrix filler to fill a chromatographic column, flavonoid compounds such as schaftoside can be further purified and separated, and the stability of the Chinese medicine composition and the content of flavonoid compounds such as schaftoside can be improved. This may be because the two fillers have a synergistic effect. On the one hand, the benzene ring on the surface of the phenyl filler can produce a π-π conjugated interaction with the benzene ring structure in the flavonoid compound, thereby enhancing the adsorption capacity of the flavonoid compound, and the phenyl filler can also be combined with the target compound through hydrophobic interactions, hydrogen bonds and other forces, further improving the separation effect. On the other hand, the silanol (Si-OH) on the surface of the silica matrix filler can form a hydrogen bond with the hydroxyl (-OH) in the flavonoid compound, thereby enhancing the adsorption of the flavonoid compound. At the same time, the silica matrix also provides a stable support structure, so that the chromatographic column can still maintain stable separation performance under high pressure and high speed mobile phase conditions. In addition, by selecting fillers with different particle sizes, the two fillers have certain complementarity in chemical properties, surface properties and pore size distribution, which can expand the separation range and improve the separation purity.

[0030] Preferably, the column temperature of the chromatographic column is 40°C.

[0031] Preferably, the flow rate during elution in step A4 is 0.6-1.0 mL / min, the mobile phase is water containing 0.1% formic acid (A) and acetonitrile containing 0.1% formic acid (B), and the gradient elution program is: 0-0.6 min, 15% B; 0.6-1.5 min, 15%-90% B; 1.5-1.51 min, 90%-15% B; 1.51-2.0 min, 15% B.

[0032] The specific steps of the embedding treatment are: dissolving hydroxypropyl-β-cyclodextrin in water to prepare a hydroxypropyl-β-cyclodextrin solution with a mass concentration of 10% to 15%, adding the extract, stirring at 50 to 60° C. for 1 to 2 hours, standing at 0 to 4° C. for 20 to 24 hours, filtering, and drying at 60° C. to obtain the embedding material.

[0033] Preferably, the mass ratio of the extract to hydroxypropyl-β-cyclodextrin is 1:(8~12).

[0034] However, the flavonoid compounds in the extract are relatively insoluble in water, especially schaftoside, which is not only insoluble in water, but also unstable and easy to fail. Using it to prepare a Chinese medicine composition not only affects the stability of the Chinese medicine composition, but also causes the effective substances to be removed in the filtering step of step S4, affecting the efficacy of the Chinese medicine composition. The inventors found that by using hydroxypropyl-β-cyclodextrin to embed the Desmodium sibiricum extract and the mixed extract, the stability of the Chinese medicine composition and the content of the effective ingredients can be greatly improved. This may be because the hydroxypropyl-β-cyclodextrin inclusion complex can separate and enclose drug molecules (such as schaftoside and liquiritin) in the cavity of cyclodextrin. This embedding method can effectively avoid adverse reactions such as hydrolysis, oxidation, isomerization, and polymerization of drug molecules, thereby protecting the drug molecules from contact with molecules in the surrounding environment and significantly improving the stability of the drug. The effective ingredients extracted by the present invention, such as schaftoside, liquiritin, glycyrrhizin, cimicifuga glycoside, isorientin, etc., are often less water-soluble. By embedding with hydroxypropyl-β-cyclodextrin, the solubility of these ingredients can be significantly improved, thereby avoiding being filtered out in the subsequent further purification process, increasing the content of the effective ingredients in the Chinese medicine composition, and improving its bioavailability. In the embedding process, it is necessary to control the concentration, embedding time, temperature and other conditions of the embedding solution. Too high concentration, temperature and time may cause damage to the embedded object.

[0035] The Chinese medicine composition containing schaftoside can be applied in the medical field and has certain immune, anti-inflammatory, antioxidant, lipid-lowering and other effects.

[0036] Compared with the prior art, the advantages and beneficial effects of the present invention are:

[0037] 1. The present invention provides a Chinese medicine composition containing schaftoside. By optimizing extraction and purification processes, the purity, extraction rate and stability of schaftoside in Desmodium strychnifolium extract are improved. The Chinese medicine composition is used to prepare the Chinese medicine composition, which can not only improve the stability and bioavailability of the pharmaceutical preparation, but also significantly reduce the incidence of adverse reactions, thereby providing patients with a safer and more effective treatment option. The prepared Chinese medicine composition is suitable for application in the medical field and has certain immune, anti-inflammatory, antioxidant, lipid-lowering and other effects.

[0038] 2. The present invention selects Herba Lysimachiae, Radix Glycyrrhizae, Rhizoma Cimicifugae and Gentiana Alba as the main raw materials of the traditional Chinese medicine composition, so that the prepared traditional Chinese medicine composition has certain immune, anti-inflammatory, antioxidant and lipid-lowering effects, and is suitable for application in the medical field.

[0039] 3. When preparing the crude extract, the pH of the extract is adjusted to be acidic, especially when the pH is 1, which can increase the content of schaftoside and other flavonoid compounds in the traditional Chinese medicine composition.

[0040] 4. The present invention can further increase the content of schaftoside and total flavonoid compounds by selecting a specific resin to enrich and purify the crude extract and eluting under specific conditions.

[0041] 5. The present invention uses specific phenyl fillers and silica gel matrix fillers to fill the chromatographic column, which can further purify and separate flavonoid compounds such as schaftoside, thereby improving the stability of the traditional Chinese medicine composition and the content of flavonoid compounds such as schaftoside therein.

[0042] 6. By using hydroxypropyl-β-cyclodextrin to embed the Desmodium styracifolium extract and the mixed extract, the stability of the traditional Chinese medicine composition and the content of the active ingredients can be greatly improved. DETAILED DESCRIPTION

[0043] The technical solutions in the embodiments of the present invention are described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0044] The raw materials used in the present invention are all commercially available, specifically:

[0045] Macroporous resin, non-polar, average pore size 8.5~9nm, pore volume 1.35~1.65mL / g, specific surface area ≥600m 2 / g, purchased from Shandong Shoucheng Chemical Co., Ltd., HPD100.

[0046] The phenyl filler has a particle size of 8-12 μm and a pore size of 28-32 nm; the silica gel matrix filler has a particle size of 4-6 μm and a pore size of 28-32 nm; both are purchased from the Kromasil brand of Akzo Nobel, Sweden.

[0047] Example 1

[0048] The present embodiment provides a Chinese medicine composition containing schaftoside, and the raw materials for preparing the composition are 300 g of Desmodium sibiricum, 900 g of Licorice, 300 g of Cimicifuga heracleifolia, 600 g of Gentiana candidum, and 1500 mL of deionized water.

[0049] The preparation method of the Chinese medicine composition containing schaftoside comprises the following steps:

[0050] S1. Prepare Desmodium strychnifolium extract from Desmodium strychnifolium, and mix licorice, cimicifuga heracleifolia, and Gentiana scabra to prepare a mixed extract;

[0051] S2, respectively embedding the Herba Lysimachiae extract and the mixed extract to obtain the Herba Lysimachiae extract-embedded material and the mixed extract-embedded material;

[0052] S3, mixing the Herba Lysimachiae extract-embedded material, the mixed extract-embedded material and deionized water to obtain a crude preparation;

[0053] S4. After the crude preparation is precipitated with alcohol, it is filtered through a ceramic membrane, sterilized, and sealed to obtain a Chinese medicinal composition containing schaftoside.

[0054] Taking Desmodium strychnifolium as an example, the specific operation method of step S1 is as follows:

[0055] A1. Dry the Herba Lysimachiae, grind it through a 40-mesh sieve, and extract it twice with 70% ethanol solution under reflux, each time for 1 h, filter, and combine the two extracts to obtain an extract;

[0056] A2. The extract was adjusted to pH 1 with hydrochloric acid, kept at 80°C for 1 hour, and then allowed to stand at room temperature for 12 hours. The extract was centrifuged, and the precipitate was washed with water, 50% ethanol aqueous solution, and 95% ethanol aqueous solution in sequence until neutral. The ethanol solution was evaporated, and the extract was dried at 60°C to obtain a crude extract.

[0057] A3, dissolving the crude extract in water, passing it through a macroporous resin at a flow rate of 3BV / h, eluting with 4BV of water and 3BV of 50% ethanol solution in sequence, collecting the eluate, concentrating and drying under reduced pressure to obtain an isolate 1;

[0058] A4. Dissolve the separated substance in 80% ethanol aqueous solution, perform secondary separation using a chromatographic column, collect the sample after elution, concentrate and dry to obtain the extract.

[0059] The preparation method of the mixed extract is the same as the preparation method of the Desmodium sibiricum extract.

[0060] In the A3, the solid-liquid ratio of the crude extract to water is 1 g:10 mL; the solid-liquid ratio of the isolate 1 to the ethanol aqueous solution is 1 g:10 mL.

[0061] In the A4, the chromatographic column is composed of phenyl filler and silica gel matrix filler; the mass ratio thereof is 1:1.

[0062] The column temperature of the chromatographic column is 40°C.

[0063] The flow rate during elution in step A4 is 0.8 mL / min, the mobile phase is water containing 0.1% formic acid (A) and acetonitrile containing 0.1% formic acid (B), and the gradient elution program is: 0-0.6 min, 15% B; 0.6-1.5 min, 15%-90% B; 1.5-1.51 min, 90%-15% B; 1.51-2.0 min, 15% B.

[0064] In S2, the specific steps of the embedding treatment of Desmodium Styrax extract-embedding material and mixed extract-embedding material are: dissolving hydroxypropyl-β-cyclodextrin in water to prepare a hydroxypropyl-β-cyclodextrin solution with a mass concentration of 12%, adding the extract, stirring at 55°C for 1.5h, standing at 2°C for 22h, filtering, and drying at 60°C to obtain the embedding material.

[0065] The mass ratio of the extract to hydroxypropyl-β-cyclodextrin is 1:10.

[0066] Example 2

[0067] The difference between this embodiment and embodiment 1 is that the raw materials for preparing the Chinese medicine composition containing schaftoside are 500 g of Desmodium sibiricum, 900 g of Licorice, 300 g of Cimicifuga heracleifolia, 600 g of Gentiana dahurica, and 1500 mL of deionized water.

[0068] Example 3

[0069] The difference between this embodiment and embodiment 1 is that the chromatographic column is composed of phenyl filler and silica gel matrix filler; the mass ratio thereof is 2:3.

[0070] Comparative Example 1

[0071] The difference between this ratio and Example 1 is that the raw materials for preparing the Chinese medicinal composition containing schaftoside are 300 g of Lysimachia suspensa, 300 g of Cimicifuga heracleifolia, 600 g of Gentiana dahurica, and 1500 mL of deionized water.

[0072] Comparative Example 2

[0073] The difference between this ratio and Example 1 is that the raw materials for preparing the Chinese medicinal composition containing schaftoside are 300 g of Desmodium strychnifolium, 300 g of Licorice, 300 g of Cimicifuga heracleifolia, 300 g of Gentiana dahurica, and 1500 mL of deionized water.

[0074] Comparative Example 3

[0075] The difference between this ratio and Example 3 is as follows: A2, the extract is adjusted to pH 4 with hydrochloric acid, kept at 80°C for 1 hour, and then allowed to stand at room temperature for 12 hours, centrifuged, and the precipitate is washed with water, 50% ethanol aqueous solution, and 95% ethanol aqueous solution in sequence until neutral, the ethanol solution is evaporated, and dried at 60°C to obtain a crude extract.

[0076] Comparative Example 4

[0077] The difference between this ratio and Example 1 is that the macroporous resin is a polar macroporous resin with an average pore size of 1.3-1.4 nm and a specific surface area of ​​480-520 m 2 / g.

[0078] The macroporous resin was purchased from Bengbu Sanyi Technology Co., Ltd., A-8.

[0079] Comparative Example 5

[0080] The difference between this ratio and Example 6 is that the chromatographic column is composed of phenyl filler.

[0081] Comparative Example 6

[0082] The difference between this ratio and Example 1 is that the preparation method of the Chinese medicine composition containing schaftoside comprises the following steps:

[0083] S1. Prepare Desmodium strychnifolium extract from Desmodium strychnifolium, and mix licorice, cimicifuga heracleifolia, and Gentiana scabra to prepare a mixed extract;

[0084] S2, mixing the Herba Lysimachiae Extract, the mixed extract and deionized water to obtain a crude preparation;

[0085] S3. After the crude preparation is precipitated with alcohol, it is filtered through a ceramic membrane, sterilized, and sealed to obtain a Chinese medicinal composition containing schaftoside.

[0086] Comparative Example 7

[0087] The difference between this ratio and Example 1 is that the specific operation method of step S1 is as follows:

[0088] A1. Dry the Herba Lysimachiae, grind it through a 40-mesh sieve, and extract it twice with 70% ethanol solution under reflux, each time for 1 h, filter, and combine the two extracts to obtain an extract;

[0089] A2. The extract was adjusted to pH 1 with hydrochloric acid, kept at 80°C for 1 hour, and then allowed to stand at room temperature for 12 hours. The extract was centrifuged, and the precipitate was washed with water, 50% ethanol aqueous solution, and 95% ethanol aqueous solution in sequence until neutral. The ethanol solution was evaporated, and the extract was dried at 60°C to obtain a crude extract.

[0090] A3. Dissolve the crude extract in water, pass it through a macroporous resin at a flow rate of 3BV / h, and elute it with 4BV of water and 3BV of 50% ethanol solution in sequence. Collect the eluate, concentrate and dry it under reduced pressure to obtain the extract.

[0091] Comparative Example 8

[0092] The difference between this ratio and Example 1 is that hydroxypropyl-β-cyclodextrin is dissolved in water to prepare a hydroxypropyl-β-cyclodextrin solution with a mass concentration of 12%, the extract is added, stirred at 80°C for 3 hours, allowed to stand at 4°C for 22 hours, filtered, and dried at 60°C to obtain Scutellaria baicalensis extract-embedded material and Forsythia suspensa extract-embedded material, respectively.

[0093] Performance Testing

[0094] The mass percentage of shafoside in the extract of Styrax chinensis was tested with reference to the method in patent CN 102329312 A; the total flavonoid content in the Chinese medicine composition was tested with reference to DB13 / T 385-1998 "Determination of total flavonoids (rutin) in food"; the mouse ear swelling experiment was conducted with reference to the method in the paper "Study on the anti-inflammatory effect of Gentiana dahurica" ​​published by Yang Fang et al., and the inhibition rate of the Chinese medicine composition on mouse ear swelling was tested. The higher the inhibition rate, the better the anti-inflammatory effect. The solid content of the Chinese medicine composition was tested with a Chinese medicinal material solid content detector. The lower the solid content, the less impurities the product has and the higher the stability. The results are shown in Table 1.

[0095] Table 1 Measurement results

[0096]

[0097] According to statistics, the Chinese medicine composition containing saftoside prepared by Examples 1 to 10 of the present invention has high purity of saftoside in the extract of Herba Lysimachiae, high content of total flavonoids in the product, low solid content, and significant anti-inflammatory effect. Comparative Example 1 does not add licorice, the proportion of each Chinese medicine component in Comparative Example 2 is not right, the pH of Comparative Example 3 is low, the macroporous resin of Comparative Example 4 does not meet the requirements, Comparative Example 5 does not have a silica matrix filler, Comparative Example 6 does not carry out embedding treatment, Comparative Example 7 does not carry out secondary separation and purification, and the embedding temperature and time of Comparative Example 8 are too high. The total flavonoid content in the prepared Chinese medicine composition is low, the solid content is high, the inhibition rate of mouse ear swelling is low, and the anti-inflammatory effect is poor. Therefore, the raw materials and methods described in this application are used to improve the purity of saftoside in the extract of Herba Lysimachiae, and it is used to prepare a Chinese medicine composition, which can not only improve the stability of the pharmaceutical preparation, but also have certain immune, anti-inflammatory, antioxidant, and lipid-lowering effects.

[0098] The above is a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A Chinese medicine composition containing schaftoside, It is characterized in that The preparation raw materials include scutellaria baicalensis, liquorice, cimicifuga heracleifolia and gentiana scabra; the mass ratio of scutellaria baicalensis, liquorice, cimicifuga heracleifolia and gentiana scabra is 1:(2-4):(0.5-1.5):(1-3).

2. A method for preparing the Chinese medicine composition containing schaftoside according to claim 1, It is characterized in that The following steps are involved: S1. Prepare Desmodium strychnifolium extract from Desmodium strychnifolium, and mix licorice, cimicifuga heracleifolia, and Gentiana scabra to prepare a mixed extract; S2, respectively embedding the Herba Lysimachiae extract and the mixed extract to obtain the Herba Lysimachiae extract-embedded material and the mixed extract-embedded material; S3, mixing the Herba Lysimachiae extract-embedded material, the mixed extract-embedded material and deionized water to obtain a crude preparation; S4. After the crude preparation is precipitated with alcohol, it is filtered through a ceramic membrane, sterilized, and sealed to obtain a Chinese medicinal composition containing schaftoside.

3. A method for preparing the Chinese medicine composition containing schaftoside according to claim 2, It is characterized in that In step S1, the specific steps of preparing the Desmodium Styracifolium extract include: A1. Dry the Herba Lysimachiae, grind it through a 40-mesh sieve, and reflux extract it twice with a 65% to 75% ethanol solution, each time for 1 to 2 hours, filter it, and combine the two extracts to obtain an extract; A2. Adjust the pH of the extract to 1-2 with hydrochloric acid, keep it at 75-85°C for 1 hour, let it stand at room temperature for 10-14 hours, centrifuge, wash the precipitate with water, 50% ethanol aqueous solution, and 95% ethanol aqueous solution in sequence until it is neutral, evaporate the ethanol solution, and dry it at 55-65°C to obtain a crude extract; A3, dissolving the crude extract in water, passing it through a macroporous resin at a flow rate of 2.5-3.5 BV / h, eluting with 3-5 BV of water and 2-4 BV of 50% ethanol solution in sequence, collecting the eluate, concentrating and drying under reduced pressure to obtain an isolate 1; A4. Dissolve the separated substance in 75% to 85% ethanol aqueous solution, perform secondary separation using a chromatographic column, collect the sample after elution, concentrate and dry to obtain the extract.

4. The method for preparing the Chinese medicine composition containing schaftoside according to claim 3, It is characterized in that The macroporous resin is a non-polar macroporous resin with an average pore size of 8.5-9 nm, a pore volume of 1.35-1.65 mL / g, and a specific surface area of ​​≥600 m 2 / g.

5. The method for preparing the Chinese medicine composition containing schaftoside according to claim 3, It is characterized in that The chromatographic column is composed of phenyl filler and silica gel matrix filler; the mass ratio thereof is 1:(0.5-2).

6. A method for preparing the Chinese medicine composition containing schaftoside according to claim 5, It is characterized in that The particle size of the phenyl filler is 8-12 μm, and the pore size is 28-32 nm; the particle size of the silica gel matrix filler is 4-6 μm, and the pore size is 28-32 nm.

7. The method for preparing the Chinese medicine composition containing schaftoside according to claim 3, It is characterized in that The flow rate during elution in step A4 is 0.6-1.0 mL / min, the mobile phase is water containing 0.1% formic acid (A) and acetonitrile containing 0.1% formic acid (B), and the gradient elution program is: 0-0.6 min, 15% B; 0.6~1.5 min, 15%~90% B; 1.5~1.51min, 90%~15%B; 1.51~2.0 min, 15%B.

8. The method for preparing the Chinese medicine composition containing schaftoside according to claim 3, It is characterized in that The specific steps of the embedding treatment are: dissolving hydroxypropyl-β-cyclodextrin in water to prepare a hydroxypropyl-β-cyclodextrin solution with a mass concentration of 10% to 15%, adding the extract, stirring at 50 to 60° C. for 1 to 2 hours, standing at 0 to 4° C. for 20 to 24 hours, filtering, and drying at 60° C. to obtain the embedding material.

9. The method for preparing the Chinese medicine composition containing schaftoside according to claim 8, It is characterized in that The mass ratio of the extract to hydroxypropyl-β-cyclodextrin is 1:(8-12).

10. Use of the traditional Chinese medicine composition containing schaftoside according to claim 1 in the field of medicine.

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