Plant-derived water-soluble silicon-based lipid metabolism modulating composition and method of preparation thereof

Abstract

This invention belongs to the field of pharmaceutical technology, and particularly relates to a lipid metabolism regulating composition based on plant-derived water-soluble silicon and its preparation method. The preparation method includes continuously heating diatomaceous earth as a plant-derived silica at high temperature to decompose and vaporize it, collecting the vaporized silicon components; burning the vaporized silicon components to extract water-soluble silicon crystals; and dissolving the water-soluble silicon crystals in pure water to form a water-soluble silicon solution containing metasilicic acid and silicon dioxide. This invention uses natural diatomaceous earth as raw material, and obtains high-purity water-soluble silicon crystals through high-temperature decomposition, vaporization, and combustion purification processes. Then, through precise concentration control, a lipid metabolism regulating composition with a reasonable ratio of metasilicic acid and silicon dioxide is obtained, and the process is stable and controllable.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical technology, and in particular relates to a lipid metabolism regulating composition based on plant-derived water-soluble silicon and its preparation method. Background Technology

[0002] Cardiovascular disease is one of the leading causes of death, with hypercholesterolemia being a core risk factor. Hypercholesterolemia is characterized by abnormally elevated levels of total cholesterol, triglycerides, and low-density lipoprotein cholesterol (LDL-C), and decreased levels of high-density lipoprotein cholesterol (HDL-C). Long-term hypercholesterolemia can induce serious cardiovascular and cerebrovascular events such as atherosclerosis, coronary heart disease, and cerebral infarction. Commonly used lipid-lowering drugs in clinical practice include statins, ezetimibe, and bile acid sequestrants. While these drugs have clear lipid-lowering effects, long-term use can easily lead to muscle toxicity, liver damage, intestinal discomfort, and drug resistance. Furthermore, some patients have poor tolerance to these drugs. Therefore, developing safe, effective, and long-term usable functional lipid-lowering ingredients has significant clinical value and market demand.

[0003] Silicon is an essential trace element for the human body, participating in the structural maintenance of connective tissue, bones, and blood vessel walls. It possesses physiological activities such as antioxidation, regulation of lipid metabolism, protection of the gastrointestinal tract, and regulation of intestinal flora. Natural silicon mostly exists in crystalline or water-insoluble forms, with low bioavailability and difficulty in being absorbed and utilized by the human body. Metasilicic acid, as a soluble form of silicon, is a major source of silicon that is easily bioavailable to humans. Studies have found that metasilicic acid can exert an anti-atherosclerotic effect by increasing high-density lipoprotein cholesterol concentration and decreasing low-density lipoprotein cholesterol and triglyceride levels.

[0004] Therefore, developing a water-soluble silicone lipid metabolism regulating composition using natural plant-derived silicon as raw material can effectively make up for the technical shortcomings of existing lipid-lowering products and silicon-based functional ingredients, and provide a safe and effective new solution for dietary intervention in hypercholesterolemia and cardiovascular diseases. Summary of the Invention

[0005] The main objective of this invention is to provide a lipid metabolism regulating composition based on plant-derived water-soluble silicon and its preparation method, so as to overcome the shortcomings of the prior art.

[0006] To achieve the aforementioned objectives, the technical solution adopted by this invention includes: According to a first aspect of the present invention, a method for preparing a lipid metabolism regulating composition based on plant-derived water-soluble silicon is provided, comprising the following steps: Diatomaceous earth, as a plant-derived silica, is continuously heated at a temperature of 1750-1850°C to decompose and vaporize it, and the vaporized silicon components are collected. The vaporized silicon component is burned at 1200-1400°C to remove impurities and extract water-soluble silicon crystals. The water-soluble silicon crystals are dissolved in pure water to form a water-soluble silicon solution containing metasilicic acid and silicon dioxide; The concentration of metasilicic acid in the water-soluble silicon solution was adjusted to 13.9-15.9 g / L and the concentration of silicon dioxide to 9.4-11.4 g / L to obtain a lipid metabolism regulating composition; the mass concentration ratio of metasilicic acid to silicon dioxide in the composition was 1.33-1.53:1.

[0007] Furthermore, the pH value of the water-soluble silicon solution is 5.5-6.5.

[0008] Furthermore, the silica content in the diatomaceous earth is 80-95%.

[0009] According to a second aspect of the present invention, a lipid metabolism regulating composition based on plant-derived water-soluble silicon is provided, which is prepared by any of the above-described preparation methods, wherein the lipid metabolism regulating composition contains a metasilicic acid concentration of 13.9-15.9 g / L, a silicon dioxide concentration of 9.4-11.4 g / L, and a mass concentration ratio of metasilicic acid to silicon dioxide of 1.33-1.53:1.

[0010] Furthermore, the lipid metabolism regulating composition has an in vitro adsorption rate of cholesterol greater than or equal to 35.27%, an in vitro adsorption rate of coprostinol greater than or equal to 39.63%, an in vitro adsorption rate of lithocholic acid greater than or equal to 24.86%, and an in vitro adsorption rate of deoxycholic acid greater than or equal to 41.64%.

[0011] Furthermore, the lipid metabolism regulating composition reduced plasma total cholesterol levels by 9.36-10.03%, triglyceride levels by 33.92-41.85%, and non-high-density lipoprotein cholesterol levels by 17.12-22.77% in animal models of hypercholesterolemia.

[0012] Furthermore, the lipid metabolism regulating composition promotes the excretion of fecal neutral sterols in a hypercholesterolemia animal model, wherein the total excretion of neutral sterols is increased by 29.98-80.01%.

[0013] Furthermore, the lipid metabolism regulating composition increases the content of short-chain fatty acids in the intestine, including acetic acid, propionic acid, and butyric acid, in a hypercholesterolemia animal model, and increases the relative abundance of short-chain fatty acid-producing bacteria, including *Eubacterium* spp. norank_f__norank_o__Clostridia_UCG-014 and Ileibacterium .

[0014] Furthermore, the lipid metabolism regulating composition reduced the area of ​​atherosclerotic plaques by 15.55-19.15% in an animal model of hypercholesterolemia.

[0015] Furthermore, the lipid metabolism regulating composition reduced liver cholesterol levels by more than 21.64% in an animal model of hypercholesterolemia.

[0016] Compared with the prior art, the advantages of the present invention include: This invention provides a lipid metabolism regulating composition based on plant-derived water-soluble silicon and its preparation method. The method uses natural diatomaceous earth as raw material, employing high-temperature decomposition, gasification, and combustion purification processes to obtain high-purity water-soluble silicon crystals. Through precise concentration control, a lipid metabolism regulating composition with a reasonable ratio of metasilicic acid to silicon dioxide is obtained, and the process is stable and controllable. This lipid metabolism regulating composition, through physical adsorption, can efficiently adsorb cholesterol, coprolites, lithocholic acid, and deoxycholic acid in vitro, and promote the excretion of neutral sterols, bile acids, and saturated fatty acids in feces in vivo, thereby reducing cholesterol absorption at its source. This lipid metabolism regulating composition can significantly reduce plasma total cholesterol, triglyceride, and non-high-density lipoprotein cholesterol levels in individuals with hypercholesterolemia, reduce liver cholesterol levels, and decrease the area of ​​atherosclerotic plaques, exhibiting significant preventive and ameliorative effects on hypercholesterolemia and related cardiovascular diseases. Attached Figure Description

[0017] Various other advantages and benefits will become apparent to those skilled in the art upon reading the following detailed description of preferred embodiments. The accompanying drawings are for illustrative purposes only and are not intended to limit the invention. Furthermore, the same reference numerals denote the same parts throughout the drawings. In the drawings: Figure 1 The image shows the adsorption effect of the lipid metabolism regulating composition prepared in the embodiments of the present invention on lithocholic acid and deoxycholic acid. Figure 2 The plasma lipid TC concentration levels of each group of hamsters at week 0 and week 6; Figure 3 The plasma lipid TG concentration levels of each group of hamsters at week 0 and week 6; Figure 4 The plasma HDL-C concentration levels of each group of hamsters at week 0 and week 6; Figure 5 The plasma lipid Non-HDL-C concentration levels of each group of hamsters at week 0 and week 6; Figure 6 The plasma lipid HDL-C / TC ratio of each group of hamsters at week 0 and week 6; Figure 7 The plasma lipid Non-HDL-C / HDL-C ratios of each group of hamsters at week 0 and week 6; Figure 8 A graph comparing the amount of neutral sterols excreted in the feces of hamsters in different groups during animal experiments; Figure 9 This is a graph comparing the amount of bile acid excreted in the feces of hamsters in different groups during animal experiments. Detailed Implementation

[0018] In view of the shortcomings of the prior art, the inventors of this invention, through long-term research and extensive practice, have proposed the technical solution of this invention. The following will further explain and illustrate this technical solution, its implementation process, and its principles.

[0019] The present invention will now be described in further detail with reference to specific embodiments. The given embodiments are merely illustrative of the invention and not intended to limit its scope. The embodiments provided below can serve as a guide for further improvements by those skilled in the art and do not constitute a limitation on the invention in any way.

[0020] Unless otherwise specified, the experimental methods used in the following embodiments are conventional methods, performed according to the techniques or conditions described in the literature in this field or according to the product instructions. Unless otherwise specified, the materials used in the following embodiments are commercially available.

[0021] This invention provides a method for preparing a lipid metabolism regulating composition based on plant-derived water-soluble silicon, comprising the following steps: Diatomaceous earth, as a plant-derived silica, is continuously heated at a temperature of 1750-1850℃ to decompose and vaporize it, and the vaporized silicon components are collected. The vaporized silicon component is burned at 1200-1400℃ to remove impurities and extract water-soluble silicon crystals. The water-soluble silicon crystals are dissolved in pure water to form a water-soluble silicon solution containing metasilicic acid and silicon dioxide; The concentration of metasilicic acid in the water-soluble silicon solution was adjusted to 13.9-15.9 g / L and the concentration of silicon dioxide to 9.4-11.4 g / L to obtain a lipid metabolism regulating composition; the mass concentration ratio of metasilicic acid to silicon dioxide in the composition was 1.33-1.53:1.

[0022] In the preparation method of this invention, diatomaceous earth is used as the plant-derived silica raw material. Diatomaceous earth has a natural porous structure and a high silica content, and high-purity water-soluble silica crystals can be obtained after high-temperature treatment. Heating at 1750-1850℃ fully decomposes and vaporizes the silica in the diatomaceous earth, followed by combustion treatment at 1200-1400℃, which effectively removes carbonaceous matter and other volatile impurities, resulting in high-purity water-soluble silica crystals. By precisely controlling the concentration and ratio of metasilicic acid and silica, the active ingredients in the composition are maintained within a synergistic range, which is beneficial for exerting optimal lipid metabolism regulation.

[0023] Preferably, the pH value of the water-soluble silicon solution is 5.5-6.5. This pH range is beneficial for maintaining the stable dissolution of metasilicic acid and silicon dioxide in water, preventing the active components from precipitating out.

[0024] Preferably, the silica content in the diatomaceous earth is 80-95%. Higher purity diatomaceous earth raw materials help to improve the content of active ingredients and batch stability of the final product.

[0025] The present invention also provides a lipid metabolism regulating composition based on plant-derived water-soluble silicon, which is prepared by the above preparation method. The lipid metabolism regulating composition contains a metasilicic acid concentration of 13.9-15.9 g / L, a silicon dioxide concentration of 9.4-11.4 g / L, and a mass concentration ratio of metasilicic acid to silicon dioxide of 1.33-1.53:1.

[0026] The active ingredients in the lipid metabolism regulating composition of this invention are mainly metasilicic acid and silicon dioxide. Metasilicic acid is the most common form of silicon in water and the main form in which organisms absorb silicon, making it easily utilized by the human body; silicon dioxide has a large specific surface area and strong adsorption capacity. When the two coexist at specific concentrations and ratios, they can produce a synergistic lipid metabolism regulating effect.

[0027] The present invention has confirmed through acute oral toxicity tests that the median lethal dose of the lipid metabolism regulating composition is greater than 5000 mg / kg body weight, which falls within the category of practically non-toxic and has good food safety.

[0028] The lipid metabolism regulating composition of this invention exhibits significant adsorption capacity for cholesterol and bile acids in vitro. Experiments show that the composition achieves an in vitro adsorption rate of ≥35.27% for cholesterol, ≥39.63% for coprostinol, ≥24.86% for lithocholic acid, and ≥41.64% for deoxycholic acid. This adsorption is primarily achieved through physical adsorption, utilizing the porous structure and large specific surface area of ​​silica to adsorb cholesterol and cholesterol metabolites onto its surface, thereby reducing their absorbable concentration in the intestine.

[0029] The lipid metabolism regulating composition of this invention exhibited a significant lipid-lowering effect in an animal model of hypercholesterolemia. Syrian golden hamsters were used as a hypercholesterolemia model, and were fed a high-cholesterol diet concurrently with the composition of this invention for six weeks. Experimental results showed that the composition effectively reduced plasma lipid levels, specifically reducing total cholesterol by 9.36-10.03%, triglyceride by 33.92-41.85%, and non-high-density lipoprotein cholesterol by 17.12-22.77%. Simultaneously, the composition increased the ratio of high-density lipoprotein cholesterol to total cholesterol and decreased the ratio of non-high-density lipoprotein cholesterol to high-density lipoprotein cholesterol, suggesting a potential reduction in the risk of cardiovascular disease.

[0030] The lipid metabolism regulating composition of this invention significantly promotes the excretion of fecal lipids in an animal model of hypercholesterolemia. Experimental results show that the composition promotes the excretion of fecal neutral sterols, increasing the total excretion of neutral sterols by 29.98-80.01%; it promotes the excretion of fecal total bile acids, increasing the total bile acid excretion by more than 32.41%; and it also promotes the excretion of fecal saturated fatty acids. These results are corroborated by in vitro adsorption experiments, confirming that the composition of this invention reduces the absorption of cholesterol and cholesterol metabolites in the intestine through physical adsorption, promoting their excretion via the fecal route.

[0031] The lipid metabolism regulating composition of this invention can modulate the intestinal flora structure and improve the intestinal microecology in an animal model of hypercholesterolemia. 16S rRNA high-throughput sequencing analysis showed that the composition can increase the β-diversity of the intestinal flora and improve its structure. Specifically, the composition can increase the content of short-chain fatty acids in the intestine, including acetic acid, propionic acid, and butyric acid, and increase the relative abundance of short-chain fatty acid-producing bacteria, including *Eubacteriaceae*. norank_f__norank_o__Clostridia_UCG-014 and Ileibacterium Short-chain fatty acids are important metabolites produced by the fermentation of undigested polysaccharides by gut microbiota. They can inhibit the absorption of cholesterol in the intestine and promote the excretion of cholesterol, thereby regulating the body's cholesterol metabolism.

[0032] The lipid metabolism regulating composition of this invention can effectively prevent the occurrence of atherosclerosis in an animal model of hypercholesterolemia. Experimental results show that the composition can reduce the area of ​​atherosclerotic plaques by 15.55-19.15%, indicating that it can inhibit the formation of atherosclerotic plaques and has a preventive effect on cardiovascular diseases.

[0033] The lipid metabolism regulating composition of this invention can reduce liver cholesterol levels in animal models of hypercholesterolemia, with a reduction of not less than 21.64%. The liver is the core hub of cholesterol metabolism, and reducing liver cholesterol levels helps maintain cholesterol homeostasis and reduces the release of cholesterol into the bloodstream.

[0034] To better understand the technical solution of the present invention, the following detailed discussion is provided in conjunction with specific embodiments.

[0035] Example 1

[0036] This embodiment provides a method for preparing a lipid metabolism regulating composition: Diatomaceous earth with a silica content of 85% was used as a plant-derived silica raw material. It was placed in a heating device and continuously heated at 1800℃ to decompose and vaporize the diatomaceous earth. The vaporized silicon components were then collected.

[0037] The collected gasified silicon components were burned at 1300℃ to remove carbon and other volatile impurities, and water-soluble silicon crystals were extracted.

[0038] The extracted water-soluble silicon crystals were dissolved in pure water and stirred thoroughly to form a water-soluble silicon solution containing metasilicic acid and silicon dioxide.

[0039] The concentrations of metasilicic acid and silica in a water-soluble silica solution were adjusted to 14.9 g / L and 10.4 g / L, respectively. The mass ratio of metasilicic acid to silica was measured to be 1.43:1, and the pH of the solution was 6.0, thus obtaining a lipid metabolism regulating composition.

[0040] Example 2

[0041] This embodiment provides a method for preparing a lipid metabolism regulating composition: Diatomaceous earth with a silica content of 80% was used as a plant-derived silica raw material. It was placed in a heating device and continuously heated at a temperature of 1750℃ to decompose and vaporize the diatomaceous earth. The vaporized silicon components were then collected.

[0042] The collected gasified silicon components were burned at 1200℃ to remove carbon and other volatile impurities, and water-soluble silicon crystals were extracted.

[0043] The extracted water-soluble silicon crystals were dissolved in pure water and stirred thoroughly to form a water-soluble silicon solution containing metasilicic acid and silicon dioxide.

[0044] The concentrations of metasilicic acid and silica in a water-soluble silica solution were adjusted to 13.9 g / L and 9.4 g / L, respectively. The mass ratio of metasilicic acid to silica was measured to be 1.33:1, and the pH of the solution was 5.5, thus obtaining a lipid metabolism regulating composition.

[0045] Example 3

[0046] This embodiment provides a method for preparing a lipid metabolism regulating composition: Diatomaceous earth with a silica content of 95% was used as a plant-derived silica raw material. It was placed in a heating device and continuously heated at a temperature of 1850℃ to decompose and vaporize the diatomaceous earth. The silicon components after vaporization were collected.

[0047] The collected gasified silicon components were burned at 1400℃ to remove carbon and other volatile impurities, and water-soluble silicon crystals were extracted.

[0048] The extracted water-soluble silicon crystals were dissolved in pure water and stirred thoroughly to form a water-soluble silicon solution containing metasilicic acid and silicon dioxide.

[0049] The concentrations of metasilicic acid and silica in a water-soluble silica solution were adjusted to 15.9 g / L and 11.4 g / L, respectively. The mass ratio of metasilicic acid to silica was measured to be 1.53:1, and the pH of the solution was 6.5, thus obtaining a lipid metabolism regulating composition.

[0050] Example 4: Safety evaluation of the lipid metabolism regulating composition The safety of the lipid metabolism regulating composition prepared in Example 1 was evaluated using an acute oral toxicity test. SPF-grade ICR mice, half male and half female, weighing 18-22g, were used as experimental animals. The animals were fasted overnight but provided with normal water. The test substance was administered orally via gavage at a dose of 5000 mg / kg body weight over a single 24-hour period.

[0051] After administration of the test substance, the symptoms of poisoning in mice were observed at 30 minutes, 2 hours, and 4 hours, and then observed once daily for 14 consecutive days. During the observation period, no obvious signs of poisoning were observed in the experimental animals, and no animal deaths were observed. At the end of the experiment, gross necropsy was performed on all mice, and no abnormalities were found. The results indicate that the median lethal dose (LD50) of the lipid metabolism regulating composition of the present invention is greater than 5000 mg / kg body weight, which belongs to the practically non-toxic category according to the toxicity classification standard, and has good food safety.

[0052] Example 5: In vitro cholesterol adsorption experiment of the lipid metabolism regulating composition To verify the physical adsorption capacity of the lipid metabolism regulating composition of the present invention for cholesterol, in vitro adsorption experiments were conducted with different doses and concentrations.

[0053] Different dosage experiments: 0.5g, 1g, and 2g of the lipid metabolism regulating composition prepared in Example 1 were weighed and mixed with 19g of cholesterol model oil, respectively. The mixtures were then shaken in a light-shielded incubator at 50℃ and 350rpm for 12 hours. After centrifugation, the supernatant was collected, and the cholesterol content was determined by gas chromatography. The results showed that the cholesterol content in the blank control group was 37.90mg / g. The cholesterol content decreased by 13.16% in the 0.5g group, 27.31% in the 1g group, and 30.13% in the 2g group. The highest dosage resulted in an 18.57% greater decrease compared to the lowest dosage.

[0054] Experiments at different concentrations: The lipid metabolism regulating composition prepared in Example 1 was diluted to 1750 ppm and 3500 ppm, respectively. The 7000 ppm stock solution was used as the high concentration group. These solutions were mixed with cholesterol model oil, and the cholesterol content was measured according to the method described above. The results showed that the cholesterol content in the 7000 ppm group decreased by 35.27%, which was significantly better than that in the low concentration group.

[0055] The above results indicate that the lipid metabolism regulating composition of the present invention has a significant physical adsorption effect on cholesterol, and the adsorption effect increases with increasing dosage and concentration.

[0056] Example 6: In vitro adsorption experiment of the lipid metabolism regulating composition on neutral sterols and bile acids. Neutral sterol adsorption experiment: Model oils were prepared by adding coprostadone and dihydrocholesterol separately to lard. These oils were then mixed with the lipid metabolism regulating composition obtained in Example 1 and subjected to adsorption treatment according to the method in Example 5. The content was determined by gas chromatography. The results showed that the composition of the present invention achieved an adsorption rate of 39.63% for coprostadone, and while there was a decreasing trend in the adsorption of dihydrocholesterol, there was no significant difference.

[0057] Bile acid adsorption experiment: Lithocholic acid and deoxycholic acid were separately added to 50% ethanol solution to prepare acidic model liquids, which were then mixed with the lipid metabolism regulating composition prepared in Example 1. The mixture was shaken in a light-shielded incubator at 50°C and 350 rpm for 12 hours. After centrifugation, the supernatant was collected, and the content was determined by gas chromatography. The results showed that the composition of the present invention had an adsorption rate of 24.86% for lithocholic acid and an adsorption rate of 41.64% for deoxycholic acid.

[0058] Figure 1 This is a graph showing the adsorption effect of the lipid metabolism regulating composition prepared in Example 6 of the present invention on lithocholic acid and deoxycholic acid. Figure 1 As can be seen, compared with the control group, the composition of the present invention has a significant adsorption effect on both lithocholic acid and deoxycholic acid, with a higher adsorption rate for deoxycholic acid, indicating that the composition of the present invention has a good binding ability for secondary bile acids in bile acids.

[0059] The above results indicate that the lipid metabolism regulating composition of the present invention has a significant adsorption effect on coprostinol in neutral sterols and lithocholic acid and deoxycholic acid in bile acids.

[0060] Example 7: Lipid-lowering effect of the lipid metabolism regulating composition on hamsters with hypercholesterolemia. Animal model establishment: Forty male SPF-grade Syrian golden hamsters (6-8 weeks old, weighing 90-110g) were randomly divided into 5 groups (n=8 per group): blank control group (NCD, fed a cholesterol-free basal diet), high-cholesterol model group (HCD, fed a high-cholesterol diet containing 1.5% cholesterol), low-dose group (ALD, fed a high-cholesterol diet supplemented with 2.5g / kg of the composition of this invention), high-dose group (AHD, fed a high-cholesterol diet supplemented with 5g / kg of the composition of this invention), and positive control group (PCD, fed a high-cholesterol diet supplemented with 5g / kg of cholestyramine). The animals were fed continuously for 6 weeks, with body weight and food intake monitored weekly. Blood samples were collected at weeks 0, 3, and 6 to measure blood lipid levels.

[0061] Lipid level measurement: Plasma total cholesterol, triglycerides, and high-density lipoprotein cholesterol levels were measured using a kit, and non-high-density lipoprotein cholesterol levels and corresponding ratios were calculated.

[0062] Figure 2-7 This image shows plasma lipid levels in hamsters from each group in Example 7 of this invention at weeks 0 and 6. At the initial week (week 0), the plasma lipid levels in the five groups of hamsters were similar with no significant difference. As the experiment progressed to week 6, compared to the NCD group, the plasma lipid levels in the HCD group were significantly increased (p < 0.05): TC (29.5%), TG (64.49%), Non-HDL-C (43.39%), and the Non-HDL-C / HDL-C ratio (38.10%). This demonstrates that after 6 weeks of high-cholesterol dietary intervention, a hamster hypercholesterolemia model was successfully established and can be used for further analysis. Figure 2 It was found that at week six, compared with HCD, the TC level decreased by 9.36% in the low-dose water-soluble silica group (p < 0.05) and by 10.03% in the high-dose group (p < 0.05), but the decrease was not significant compared with the cholestyramine positive control group. This indicates that water-soluble silica can inhibit the increase in plasma TC levels in hamsters induced by a high-cholesterol diet. Figure 3 It was found that at week six, compared with the HCD group, the ALD group showed a 33.92% decrease in TG levels (p < 0.05), while the AHD group showed a significant 41.85% decrease in TG levels (p < 0.05), and the PCD group showed a 38.60% decrease. The percentage decrease in the AHD group was greater than that in the PCD group. This indicates that water-soluble silica has an inhibitory effect on increasing triglyceride levels in hamsters on a high-cholesterol diet. Figure 4 It was learned that although AHD and ALD showed no significant difference from the HCD group in week 6, they exhibited an upward trend, indicating that water-soluble silica had a relatively small impact on hamster plasma HDL-C levels (p > 0.05). Non-HDL-C is a novel lipid assessment indicator, referring to the total cholesterol content in the circulatory system, excluding HDL, including all lipoproteins that contribute to atherosclerosis, such as LDL, VLDL, and their residual particles. The Non-HDL-C / HDL-C ratio is considered an important indicator for assessing cardiovascular disease risk, providing a more comprehensive reflection of atherosclerosis risk and potentially improving the accuracy of disease diagnosis and risk assessment. Therefore, combining this with... Figure 5 , Figure 7 Compared with the HCD group, plasma Non-HDL-C levels were reduced by 17.12% and 22.77% in the ALD and AHD groups, respectively (p < 0.05). In the Non-HDL-C / HDL-C ratio, compared with the HCD group, the ALD and AHD groups showed reductions of 22.76% and 28.97%, respectively (p < 0.05). These results indicate that dietary water-soluble silica can reduce plasma Non-HDL-C levels and the Non-HDL-C / HDL-C ratio, potentially reducing the risk of cardiovascular disease. The HDL-C / TC ratio is an important indicator for assessing cardiovascular disease risk; a higher HDL-C / TC ratio generally suggests a lower cardiovascular disease risk. Figure 6 The study revealed that the AHD group showed a 21.95% increase compared to the HCD group (p < 0.05), while the low-dose group, although showing an upward trend, did not exhibit a significant difference. This demonstrates that water-soluble silica supplementation can reduce the risk of CVD.

[0063] Liver cholesterol level determination: After the experiment, the animals were sacrificed, and liver tissue was collected. The liver cholesterol content was determined by gas chromatography. The results showed that compared with the high cholesterol model group, the liver cholesterol level in the high-dose group was reduced by 21.64%, while the low-dose group showed a decreasing trend but no significant difference.

[0064] Atherosclerotic plaque area determination: Aortic tissue was collected and stained with Oil Red O staining. Plaque area was quantified using the ImageJ image analysis platform. The results showed that, compared with the high cholesterol model group, the atherosclerotic plaque area in the low-dose group and the high-dose group decreased by 15.55% and 19.15%, respectively.

[0065] Fecal lipid assay: Feces were collected from weeks 3 to 6, freeze-dried and ground, and the contents of neutral sterols, bile acids and fatty acids were determined.

[0066] Figure 8 This is a graph showing the amount of neutral sterols excreted in the feces of hamsters in each group of Example 7 of the present invention. From... Figure 8 It can be seen that, compared with the high cholesterol model group (HCD), the total fecal neutral cholesterol excretion in both the low-dose group (ALD) and the high-dose group (AHD) was significantly increased in a dose-dependent manner. The results showed that, compared with the high cholesterol model group, the total fecal neutral cholesterol excretion in the low-dose group and the high-dose group increased by 29.98% and 80.01%, respectively.

[0067] Figure 9 This is a graph showing the excretion of bile acids in the feces of hamsters in each group of Example 7 of the present invention. From... Figure 9 As can be seen, compared with the high cholesterol model group (HCD), the total bile acid excretion in the high-dose group (AHD) was significantly increased, while the low-dose group showed an upward trend but no significant difference. The results showed that the total bile acid excretion in the high-dose group increased by 32.41%.

[0068] In addition, fecal fatty acid measurements showed that the total fatty acid excretion in the high-dose group increased by 45.83%, especially the excretion of saturated fatty acids.

[0069] The above results indicate that the lipid metabolism regulating composition of the present invention reduces plasma and liver cholesterol levels and inhibits the formation of atherosclerotic plaques by promoting the excretion of fecal neutral sterols, bile acids and fatty acids, reducing cholesterol absorption in the intestine.

[0070] The above descriptions are merely some embodiments of the present invention. It should be noted that those skilled in the art can make other modifications and improvements without departing from the inventive concept of the present invention, and these all fall within the protection scope of the present invention.

Claims

1. A method for preparing a lipid metabolism regulating composition based on plant-derived water-soluble silicon, characterized in that, Includes the following steps: Diatomaceous earth, as a plant-derived silica, is continuously heated at a temperature of 1750-1850°C to decompose and vaporize it, and the vaporized silicon components are collected. The vaporized silicon component is burned at 1200-1400°C to remove impurities and extract water-soluble silicon crystals. The water-soluble silicon crystals are dissolved in pure water to form a water-soluble silicon solution containing metasilicic acid and silicon dioxide; The concentration of metasilicic acid in the water-soluble silicon solution was adjusted to 13.9-15.9 g / L and the concentration of silicon dioxide to 9.4-11.4 g / L to obtain a lipid metabolism regulating composition; the mass concentration ratio of metasilicic acid to silicon dioxide in the composition was 1.33-1.53:

1.

2. The preparation method according to claim 1, characterized in that, The pH value of the water-soluble silicon solution is 5.5-6.

5.

3. The preparation method according to claim 1, characterized in that, The silica content in the diatomite is 80-95%.

4. A lipid metabolism regulating composition based on plant-derived water-soluble silicon, characterized in that, The lipid metabolism regulating composition is prepared by the preparation method according to any one of claims 1-3, wherein the concentration of metasilicic acid is 13.9-15.9 g / L, the concentration of silica is 9.4-11.4 g / L, and the mass concentration ratio of metasilicic acid to silica is 1.33-1.53:

1.

5. The lipid metabolism regulating composition according to claim 4, characterized in that, The lipid metabolism regulating composition has an in vitro adsorption rate of cholesterol greater than or equal to 35.27%, an in vitro adsorption rate of coprostinol greater than or equal to 39.63%, an in vitro adsorption rate of lithocholic acid greater than or equal to 24.86%, and an in vitro adsorption rate of deoxycholic acid greater than or equal to 41.64%.

6. The lipid metabolism regulating composition according to claim 4, characterized in that, The lipid metabolism regulating composition reduced plasma total cholesterol levels by 9.36-10.03%, triglyceride levels by 33.92-41.85%, and non-high-density lipoprotein cholesterol levels by 17.12-22.77% in animal models of hypercholesterolemia.

7. The lipid metabolism regulating composition according to claim 4, characterized in that, The lipid metabolism regulating composition promotes the excretion of fecal neutral sterols in a hypercholesterolemia animal model, with the total excretion of neutral sterols increasing by 29.98-80.01%.

8. The lipid metabolism regulating composition according to claim 4, characterized in that, The lipid metabolism regulating composition increases the content of short-chain fatty acids, including acetic acid, propionic acid and butyric acid, in the intestine of a hypercholesterolemia animal model, and increases the relative abundance of short-chain fatty acid producing bacteria, including Eubacterium, Clostridia UCG-014 and Ileibacterium.

9. The lipid metabolism regulating composition according to claim 4, characterized in that, The lipid metabolism regulating composition reduced the area of ​​atherosclerotic plaques by 15.55-19.15% in an animal model of hypercholesterolemia.

10. The lipid metabolism regulating composition according to claim 4, characterized in that, The lipid metabolism regulating composition reduced liver cholesterol levels by more than 21.64% in an animal model of hypercholesterolemia.

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