Composition containing soyabean lecithin and silybum marianum extract and application of composition in preparation of liver protection products

Abstract

The invention discloses a composition containing soybean phospholipid and a silybum marianum extract and application of the composition in preparation of liver protection products, and relates to the technical field of biological medicines. Comprising the following raw materials in parts by weight: 8-12 parts of MCT oil organic nanocrystals, 3-5 parts of microencapsulated MCT oil, 15-20 parts of soybean oligosaccharides, 10-20 parts of a sustained-release protein matrix, 10-20 parts of composite dietary fibers and 2-6 parts of plant active ingredients. The composition containing the soyabean lecithin and the silybum marianum extract is high in bioavailability, sufficient in stability and remarkable in liver injury repairing effect.

Description

Technical Field

[0001] This invention relates to the field of biomedical technology, and in particular to a composition containing soybean lecithin and milk thistle extract and its application in the preparation of liver-protecting products. Background Technology

[0002] The liver is a vital metabolic organ, susceptible to damage from drugs, alcohol, toxins, and other factors. The pathological mechanisms of liver damage involve multiple pathways, including oxidative stress, lipid metabolism disorders, and excessive release of inflammatory factors. Existing liver-protecting products are mostly based on single ingredients (such as milk thistle extract), which suffer from low bioavailability, limited target sites, insufficient formulation stability, and limited efficacy.

[0003] To address the aforementioned issues, Chinese invention patent CN116270781B discloses a silymarin phospholipid complex, its preparation method, and its application in reducing liver damage. The preparation method of the silymarin phospholipid complex includes: Step 1: dissolving silymarin extract, dihydromyricetin, and phospholipids in an organic solvent. Step 2: stirring the solution until it becomes clear. Step 3: drying the clear solution under reduced pressure, then pulverizing and sieving to obtain a solid powder. The content of silymarin is 20%-40%, and the content of dihydromyricetin is 15%-20%. The two work synergistically to protect the liver, significantly enhancing the efficacy. Furthermore, the addition of dihydromyricetin reduces reaction time and temperature to some extent, lowers production energy consumption, increases the utilization rate of organic solvents, and simplifies the process, thereby reducing production costs. However, its synergistic mechanism has a target blind spot, and there are bottlenecks in formulation stability and bioavailability.

[0004] Soybean lecithin, as a natural emulsifier, exhibits good biocompatibility and membrane protection. Studies have shown that soybean lecithin can improve the dispersibility and stability of poorly soluble drugs by forming liposomes or micelle structures. For example, Chinese patent CN1233318C discloses a silymarin soft capsule using soybean lecithin as a carrier, which significantly improves the bioavailability of silymarin. However, the dosage range of soybean lecithin in this formulation is relatively wide (4%-50%), the optimal ratio is not clearly defined, and no systematic study has been conducted on the synergistic effect with milk thistle extract.

[0005] It is evident that developing a multi-target synergistic composition containing soybean lecithin and milk thistle extract with high bioavailability, good stability, and significant repair effect on liver damage, and its application in the preparation of liver-protective products, has very important clinical significance. Summary of the Invention

[0006] The purpose of this invention is to overcome the shortcomings of the prior art and provide a composition containing soybean lecithin and milk thistle extract with high bioavailability, good stability, and significant repair effect on liver damage, as well as its application in the preparation of liver-protecting products.

[0007] To achieve the above objectives, the technical solution adopted by the present invention is: a composition containing soybean lecithin and milk thistle extract, comprising the following raw materials in parts by weight: 10-15 parts milk thistle extract nanocrystals, 5-10 parts milk thistle extract liposomes, 30-50 parts soybean lecithin, 5-10 parts curcumin, 3-5 parts MCT oil, 1-3 parts soybean oligosaccharides, 0.8-1.2 parts vitamin E, and 20-25 parts other excipients.

[0008] Preferably, the preparation method of the milk thistle extract nanocrystals includes the following steps: adding polyvinylpyrrolidone to purified water and stirring evenly to obtain a PVP dispersion; adding milk thistle extract to the PVP dispersion and magnetically stirring at 500-800 rpm for 15-20 min to form a suspension; pumping the suspension into a homogenizer and circulating it 5 times at a pressure of 48-52 MPa to break up large particle aggregates, then adjusting the pressure to 98-102 MPa and circulating it 15 times, with each circulation lasting 2 minutes, and maintaining the material temperature ≤30℃ through jacket water cooling during the process; then transferring the nanocrystal suspension to a freeze dryer for freeze drying to obtain milk thistle extract nanocrystals.

[0009] Preferably, the polyvinylpyrrolidone is PVP K30.

[0010] Preferably, the ratio of polyvinylpyrrolidone to purified water is 5 g / L; and the ratio of milk thistle extract to PVP dispersion is 1 g: 10 mL.

[0011] Preferably, the method for preparing milk thistle extract liposomes includes the following steps: adding milk thistle extract, soybean lecithin and cholesterol to chloroform, mixing evenly, removing chloroform by rotary evaporation to form a thin film, adding phosphate buffer solution at pH 7.4, and hydrating by rotary hydration in a 37°C water bath for 30 minutes to form multilayer liposomes; then sonicating for 25-35 minutes, followed by ultracentrifugation, membrane granulation, and freeze-drying to obtain milk thistle extract liposomes.

[0012] Preferably, the ratio of milk thistle extract, soybean lecithin, cholesterol, chloroform, and phosphate buffer is 5g:3g:1g:90mL:100mL.

[0013] Preferably, the power of the ultrasound is 200-300W.

[0014] Preferably, the other excipients are hydroxypropyl methylcellulose, mannitol, and hydroxypropyl-β-cyclodextrin mixed in a mass ratio of (10-15):(5-7):(3-5).

[0015] Another object of the present invention is to provide the application of the composition containing soybean lecithin and milk thistle extract in the preparation of a liver-protecting product, wherein the liver-protecting product is a soft capsule.

[0016] Due to the application of the above technical solution, the present invention has the following beneficial effects:

[0017] (1) The composition containing soybean lecithin and milk thistle extract disclosed in this invention is the first to combine milk thistle extract nanocrystals and liposomes in a specific ratio to form a "rapid-release + sustained-release" biphasic delivery system. The nanocrystals, with their small particle size advantage, can be rapidly absorbed through intestinal epithelial cells, achieving rapid drug onset; the liposomes release the drug slowly through membrane fusion, prolonging the duration of action. This combination solves the problems of short duration of drug effect caused by the rapid release of single nanocrystals and the delayed onset of action of single liposomes, and significantly improves the bioavailability compared with the single drug delivery system in the prior art.

[0018] (2) The composition containing soybean lecithin and milk thistle extract disclosed in this invention not only improves the solubility of fat-soluble components (silybin and vitamin E) but also promotes the dispersibility of nanocrystals and liposomes in the intestine. Vitamin E forms an antioxidant "iron triangle" with curcumin and milk thistle extract. Vitamin E scavenge cell membrane lipid free radicals, curcumin inhibits intracellular ROS generation, and silybin enhances glutathione activity. The three work synergistically to significantly reduce the MDA content in liver tissue.

[0019] Soy oligosaccharides, as prebiotics, regulate gut microbiota and reduce endotoxin translocation. Together with soybean phospholipids, they form a gut-liver axis protection mechanism that repairs hepatocyte membranes, thus overcoming the shortcomings of existing technologies that only focus on the liver and neglect the gut microenvironment.

[0020] (3) The composition containing soybean lecithin and milk thistle extract disclosed in this invention, wherein hydroxypropyl methylcellulose, mannitol and hydroxypropyl-β-cyclodextrin are compounded in a specific ratio, serves both as a freeze-drying protectant to maintain the stability of the nano-drug delivery system and further enhances the water solubility of milk thistle extract through the inclusion effect of cyclodextrin. This multifunctional excipient system reduces the incompatibility between components compared with traditional single excipients, thus prolonging the stability of the formulation.

[0021] (4) The composition containing soybean lecithin and milk thistle extract disclosed in this invention is made from the following raw materials in parts by weight: 10-15 parts milk thistle extract nanocrystals, 5-10 parts milk thistle extract liposomes, 30-50 parts soybean lecithin, 5-10 parts curcumin, 3-5 parts MCT oil, 1-3 parts soybean oligosaccharides, 0.8-1.2 parts vitamin E, and 20-25 parts other excipients; through the mutual cooperation and synergistic effect of the raw materials, the composition has high bioavailability, sufficient stability, and significant repair effect on liver damage. Detailed Implementation

[0022] The following description is intended to disclose the invention and enable those skilled in the art to implement it. The preferred embodiments described below are merely examples, and other obvious variations will occur to those skilled in the art.

[0023] Example 1

[0024] A composition containing soybean lecithin and milk thistle extract, comprising the following raw materials in parts by weight: 10 parts milk thistle extract nanocrystals, 5 parts milk thistle extract liposomes, 30 parts soybean lecithin, 5 parts curcumin, 3 parts MCT oil, 1 part soybean oligosaccharide, 0.8 parts vitamin E, and 20 parts other excipients.

[0025] The preparation method of the milk thistle extract nanocrystals includes the following steps: adding polyvinylpyrrolidone (PVP) to purified water and stirring until homogeneous to obtain a PVP dispersion; adding milk thistle extract to the PVP dispersion and magnetically stirring at 500 rpm for 15 minutes to form a suspension; pumping the suspension into a homogenizer and circulating it 5 times at 48 MPa to break up large particle aggregates, then adjusting the pressure to 98 MPa and circulating it 15 times, with each circulation lasting 2 minutes, maintaining the material temperature ≤30℃ during the process using jacketed water cooling; then transferring the nanocrystal suspension to a freeze dryer for freeze drying to obtain milk thistle extract nanocrystals; wherein the PVP is PVP K30; the ratio of PVP to purified water is 5 g / L; and the ratio of milk thistle extract to PVP dispersion is 1 g:10 mL.

[0026] The preparation method of the milk thistle extract liposomes includes the following steps: milk thistle extract, soybean lecithin and cholesterol are added to chloroform, mixed evenly, and then the chloroform is removed by rotary evaporation to form a thin film. A phosphate buffer solution with pH=7.4 is added, and the mixture is hydrated by rotary evaporation in a 37°C water bath for 30 minutes to form multilayer liposomes. The mixture is then sonicated for 25 minutes, followed by ultracentrifugation, membrane granulation, and freeze-drying to obtain the milk thistle extract liposomes. The ratio of milk thistle extract, soybean lecithin, cholesterol, chloroform and phosphate buffer solution is 5g:3g:1g:90mL:100mL. The ultrasonic power is 200W.

[0027] The other excipients are hydroxypropyl methylcellulose, mannitol, and hydroxypropyl-β-cyclodextrin mixed in a mass ratio of 10:5:3.

[0028] The use of the composition containing soybean lecithin and milk thistle extract in the preparation of a liver-protecting product, wherein the liver-protecting product is a soft capsule.

[0029] Example 2

[0030] A composition containing soybean lecithin and milk thistle extract, comprising the following raw materials in parts by weight: 12 parts milk thistle extract nanocrystals, 6 parts milk thistle extract liposomes, 35 parts soybean lecithin, 6 parts curcumin, 3.5 parts MCT oil, 1.5 parts soybean oligosaccharides, 0.9 parts vitamin E, and 21 parts other excipients.

[0031] The preparation method of the milk thistle extract nanocrystals includes the following steps: adding polyvinylpyrrolidone (PVP) to purified water and stirring until homogeneous to obtain a PVP dispersion; adding milk thistle extract to the PVP dispersion and magnetically stirring at 600 rpm for 16 min to form a suspension; pumping the suspension into a homogenizer and circulating it 5 times at 49 MPa to break up large particle aggregates, then adjusting the pressure to 99 MPa and circulating it 15 times, with each circulation lasting 2 minutes, maintaining the material temperature ≤30℃ during the process using jacketed water cooling; then transferring the nanocrystal suspension to a freeze dryer for freeze drying to obtain milk thistle extract nanocrystals; wherein the PVP is PVP K30; the ratio of PVP to purified water is 5 g / L; and the ratio of milk thistle extract to PVP dispersion is 1 g:10 mL.

[0032] The preparation method of the milk thistle extract liposomes includes the following steps: milk thistle extract, soybean lecithin and cholesterol are added to chloroform, mixed evenly, and then the chloroform is removed by rotary evaporation to form a thin film. Phosphate buffer solution with pH=7.4 is added, and the mixture is rotated and hydrated in a water bath at 37°C for 30 minutes to form multilayer liposomes. The mixture is then sonicated for 27 minutes, and then subjected to ultracentrifugation, membrane granulation, and freeze-drying to obtain milk thistle extract liposomes. The ratio of milk thistle extract, soybean lecithin, cholesterol, chloroform and phosphate buffer solution is 5g:3g:1g:90mL:100mL. The ultrasonic power is 230W.

[0033] The other excipients are hydroxypropyl methylcellulose, mannitol, and hydroxypropyl-β-cyclodextrin mixed in a mass ratio of 12:5.5:3.5.

[0034] The use of the composition containing soybean lecithin and milk thistle extract in the preparation of a liver-protecting product, wherein the liver-protecting product is a soft capsule.

[0035] Example 3

[0036] A composition containing soybean lecithin and milk thistle extract, comprising the following raw materials in parts by weight: 13 parts milk thistle extract nanocrystals, 7.5 parts milk thistle extract liposomes, 40 parts soybean lecithin, 7 parts curcumin, 4 parts MCT oil, 2 parts soybean oligosaccharides, 1 part vitamin E, and 23 parts other excipients.

[0037] The preparation method of the milk thistle extract nanocrystals includes the following steps: adding polyvinylpyrrolidone (PVP) to purified water and stirring until homogeneous to obtain a PVP dispersion; adding milk thistle extract to the PVP dispersion and magnetically stirring at 650 rpm for 18 minutes to form a suspension; pumping the suspension into a homogenizer and circulating it 5 times at 50 MPa to break up large particle aggregates, then adjusting the pressure to 100 MPa and circulating it 15 times, with each circulation lasting 2 minutes, and maintaining the material temperature ≤30℃ through jacket water cooling during the process; then transferring the nanocrystal suspension to a freeze dryer for freeze drying to obtain milk thistle extract nanocrystals; wherein the polyvinylpyrrolidone is PVP K30; the ratio of polyvinylpyrrolidone to purified water is 5 g / 1 L; and the ratio of milk thistle extract to PVP dispersion is 1 g:10 mL.

[0038] The preparation method of the milk thistle extract liposomes includes the following steps: milk thistle extract, soybean lecithin and cholesterol are added to chloroform, mixed evenly, and then the chloroform is removed by rotary evaporation to form a thin film. A phosphate buffer solution with pH=7.4 is added, and the mixture is hydrated by rotary evaporation in a 37°C water bath for 30 minutes to form multilayer liposomes. The mixture is then sonicated for 30 minutes, followed by ultracentrifugation, membrane granulation, and freeze-drying to obtain the milk thistle extract liposomes. The ratio of milk thistle extract, soybean lecithin, cholesterol, chloroform and phosphate buffer solution is 5g:3g:1g:90mL:100mL. The ultrasonic power is 250W.

[0039] The other excipients are hydroxypropyl methylcellulose, mannitol, and hydroxypropyl-β-cyclodextrin mixed in a mass ratio of 13:6:4.

[0040] The use of the composition containing soybean lecithin and milk thistle extract in the preparation of a liver-protecting product, wherein the liver-protecting product is a soft capsule.

[0041] Example 4

[0042] A composition containing soybean lecithin and milk thistle extract, comprising the following raw materials in parts by weight: 14 parts milk thistle extract nanocrystals, 9 parts milk thistle extract liposomes, 45 parts soybean lecithin, 9 parts curcumin, 4.5 parts MCT oil, 2.5 parts soybean oligosaccharides, 1.1 parts vitamin E, and 24 parts other excipients.

[0043] The preparation method of the milk thistle extract nanocrystals includes the following steps: adding polyvinylpyrrolidone (PVP) to purified water and stirring until homogeneous to obtain a PVP dispersion; adding milk thistle extract to the PVP dispersion and magnetically stirring at 750 rpm for 19 min to form a suspension; pumping the suspension into a homogenizer and circulating it 5 times at 51 MPa to break up large particle aggregates, then adjusting the pressure to 101 MPa and circulating it 15 times, with each circulation lasting 2 minutes, and maintaining the material temperature ≤30℃ through jacket water cooling during the process; then transferring the nanocrystal suspension to a freeze dryer for freeze drying to obtain milk thistle extract nanocrystals; wherein the PVP is PVP K30; the ratio of PVP to purified water is 5 g / L; and the ratio of milk thistle extract to PVP dispersion is 1 g:10 mL.

[0044] The preparation method of the milk thistle extract liposomes includes the following steps: milk thistle extract, soybean lecithin and cholesterol are added to chloroform, mixed evenly, and then the chloroform is removed by rotary evaporation to form a thin film. A phosphate buffer solution with pH=7.4 is added, and the mixture is hydrated by rotary evaporation in a 37°C water bath for 30 minutes to form multilayer liposomes. The mixture is then sonicated for 33 minutes, followed by ultracentrifugation, membrane granulation, and freeze-drying to obtain the milk thistle extract liposomes. The ratio of milk thistle extract, soybean lecithin, cholesterol, chloroform and phosphate buffer solution is 5g:3g:1g:90mL:100mL. The ultrasonic power is 280W.

[0045] The other excipients are hydroxypropyl methylcellulose, mannitol, and hydroxypropyl-β-cyclodextrin mixed in a mass ratio of 14:6.5:4.5.

[0046] The use of the composition containing soybean lecithin and milk thistle extract in the preparation of a liver-protecting product, wherein the liver-protecting product is a soft capsule.

[0047] Example 5

[0048] A composition containing soybean lecithin and milk thistle extract, comprising the following raw materials in parts by weight: 15 parts milk thistle extract nanocrystals, 10 parts milk thistle extract liposomes, 50 parts soybean lecithin, 10 parts curcumin, 5 parts MCT oil, 3 parts soybean oligosaccharides, 1.2 parts vitamin E, and 25 parts other excipients.

[0049] The preparation method of the milk thistle extract nanocrystals includes the following steps: adding polyvinylpyrrolidone (PVP) to purified water and stirring until homogeneous to obtain a PVP dispersion; adding milk thistle extract to the PVP dispersion and magnetically stirring at 800 rpm for 20 minutes to form a suspension; pumping the suspension into a homogenizer and circulating it 5 times at 52 MPa to break up large particle aggregates, then adjusting the pressure to 102 MPa and circulating it 15 times, with each circulation lasting 2 minutes, and maintaining the material temperature ≤30℃ through jacket water cooling during the process; then transferring the nanocrystal suspension to a freeze dryer for freeze drying to obtain milk thistle extract nanocrystals; wherein the polyvinylpyrrolidone is PVP K30; the ratio of polyvinylpyrrolidone to purified water is 5 g / L; and the ratio of milk thistle extract to PVP dispersion is 1 g:10 mL.

[0050] The preparation method of the milk thistle extract liposomes includes the following steps: milk thistle extract, soybean lecithin and cholesterol are added to chloroform, mixed evenly, and then the chloroform is removed by rotary evaporation to form a thin film. Phosphate buffer solution with pH=7.4 is added, and the mixture is rotated and hydrated in a water bath at 37°C for 30 minutes to form multilayer liposomes. The mixture is then sonicated for 35 minutes, and then subjected to ultracentrifugation, membrane granulation, and freeze-drying to obtain milk thistle extract liposomes. The ratio of milk thistle extract, soybean lecithin, cholesterol, chloroform and phosphate buffer solution is 5g:3g:1g:90mL:100mL. The ultrasonic power is 300W.

[0051] The other excipients are hydroxypropyl methylcellulose, mannitol, and hydroxypropyl-β-cyclodextrin mixed in a mass ratio of 15:7:5.

[0052] The use of the composition containing soybean lecithin and milk thistle extract in the preparation of a liver-protecting product, wherein the liver-protecting product is a soft capsule.

[0053] Comparative Example 1

[0054] A composition containing soybean lecithin and milk thistle extract is substantially the same as in Example 1, except that curcumin, soybean oligosaccharides and MCT oil are not added.

[0055] Comparative Example 2

[0056] A composition containing soybean lecithin and milk thistle extract is basically the same as that in Example 1, except that an equal amount of milk thistle extract is not used to replace milk thistle extract nanocrystals and milk thistle extract liposomes.

[0057] To further illustrate the beneficial technical effects of the compositions containing soybean lecithin and milk thistle extract involved in the various embodiments of the present invention, relevant performance tests were conducted on the compositions containing soybean lecithin and milk thistle extract involved in Example 1 and Comparative Examples 1-2; the test results are shown in Table 1, and the test methods are as follows:

[0058] Animal model: SPF-grade male SD rats (200±20g) were randomly divided into 5 groups (n=10): normal control group, model group, Example 1 group, Comparative Example 1 group, and Comparative Example 2 group. The model group and the drug treatment group were intraperitoneally injected with CCl4 (1mL / kg, 20% olive oil solution) twice a week for 4 consecutive weeks to establish a liver injury model.

[0059] Dosage regimen: During modeling, Group 1 of Example 1 was administered the composition of Example 1 of this invention, Group 1 of Comparative Example 1 was administered the composition of Comparative Example 1, and Group 2 of Comparative Example 2 was administered the composition of Comparative Example 2, all at a dose of 0.2 g / kg by gavage, once daily. The normal control group and the model group were administered an equal volume of physiological saline.

[0060] detection indicators

[0061] Liver function: After the last administration, serum samples were taken to measure ALT and AST.

[0062] Stability test: Accelerated test (40℃, RH 75%) for 6 months, and the retention rate of milk thistle extract was determined by HPLC.

[0063] Table 1. Performance test results of compositions containing soybean lecithin and milk thistle extract

[0064] project ALT(U / L) AST(U / L) 6-month retention rate of milk thistle extract (%) normal group 35.3 38.7 — Model group 198.5 176.3 — Example 1 Group 52.1 55.3 96.8 Comparative Example 1 84.3 89.1 88.7 Comparative Example 2 121.8 113.6 72.5

[0065] As can be seen from Table 1, the compositions containing soybean lecithin and milk thistle extract involved in the various embodiments of the present invention have better repair effects and stability on liver damage compared with the comparative products; the combined use of curcumin, soybean oligosaccharides, MCT oil, milk thistle extract nanocrystals and milk thistle extract liposomes is beneficial to improving the above properties.

[0066] The above embodiments are only for illustrating the technical concept and features of the present invention. Their purpose is to enable those skilled in the art to understand the content of the present invention and implement it accordingly. They should not be used to limit the scope of protection of the present invention. All equivalent changes or modifications made in accordance with the spirit and essence of the present invention should be covered within the scope of protection of the present invention.

Claims

1. A composition comprising soybean phospholipids and milk thistle extract, characterized in that, The composition comprises the following ingredients by weight parts: 10-15 parts of the nano-crystal of the extract of Silybum marianum, 5-10 parts of the liposome of the extract of Silybum marianum, 30-50 parts of soybean phospholipid, 5-10 parts of curcumin, 3-5 parts of MCT oil, 1-3 parts of soybean oligosaccharide, 0.8-1.2 parts of vitamin E, and 20-25 parts of other auxiliary materials.

2. The composition containing soybean phospholipid and milk thistle extract according to claim 1, characterized by, The preparation method of the nano-crystal of the extract of Silybum marianum comprises the following steps: adding polyvinylpyrrolidone into purified water, stirring uniformly to obtain a PVP dispersion; adding the extract of Silybum marianum into the PVP dispersion, and magnetically stirring at a speed of 500-800 rpm for 15-20 min to form a suspension; The suspension is pumped into a homogenizer, first cycled 5 times at a pressure of 48-52 MPa to break the large particle aggregates, then the pressure is adjusted to 98-102 MPa, and cycled 15 times, with each cycle time being 2 min, and the material temperature is maintained ≤30 ℃ by jacket water cooling during the process; then the nano-crystal suspension is transferred to a freeze dryer for freeze drying to obtain the nano-crystal of the extract of Silybum marianum.

3. The composition containing soybean phospholipid and milk thistle extract according to claim 2, characterized by, The polyvinylpyrrolidone is PVP K30.

4. The composition comprising soybean phospholipid and milk thistle extract according to claim 2, characterized by, The amount ratio of the polyvinylpyrrolidone to the purified water is 5 g / 1 L; and the amount ratio of the extract of Silybum marianum to the PVP dispersion is 1 g:10 mL.

5. The composition comprising soybean phospholipid and milk thistle extract according to claim 1, characterized by, The preparation method of the liposome of the extract of Silybum marianum comprises the following steps: adding the extract of Silybum marianum, soybean phospholipid and cholesterol into chloroform, mixing uniformly, and then removing the chloroform by rotary evaporation to obtain a film; adding a phosphate buffer with pH=7.4, and rotating and hydrating in a 37 ℃ water bath for 30 min to form a multilayer liposome; then ultrasonicating for 25-35 min, and then sequentially performing ultracentrifugation, membrane filtration and particle size adjustment, and freeze drying to obtain the liposome of the extract of Silybum marianum.

6. The composition containing soybean phospholipid and milk thistle extract according to claim 5, characterized by, The amount ratio of the extract of Silybum marianum, soybean phospholipid, cholesterol, chloroform and phosphate buffer is 5 g:3 g:1 g:90 mL:100 mL.

7. The composition comprising soybean phospholipid and milk thistle extract according to claim 5, characterized by, The power of the ultrasonication is 200-300 W.

8. The composition comprising soybean phospholipid and milk thistle extract according to claim 1, characterized by, The other auxiliary materials are a mixture of hydroxypropyl methylcellulose, mannitol and hydroxypropyl-β-cyclodextrin in a mass ratio of (10-15):(5-7):(3-5).

9. Use of the composition containing soybean phospholipid and the extract of Silybum marianum according to any one of claims 1-8 in the preparation of a liver-protecting product.