Composition containing modified starch for preventing and / or treating hyperlipemia and application thereof

By combining short-chain fatty acids with starch to form modified starch, and taking advantage of its sustained release and targeted delivery properties in the gastrointestinal tract, the problem of existing hyperlipidemia treatment drugs with high side effects and poor efficacy has been solved, and side effects have been achieved. Small but effective treatment of hyperlipidemia.

CN119345222APending Publication Date: 2025-01-24SHANDONG SHANWEI IMMUNOTECH CO LTD +1
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Patent Information

Application Number
CN202411176981.5
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-08-26
Publication Date
2025-01-24

AI Technical Summary

Technical Problem

The existing hyperlipidemia treatment drugs have problems with large side effects and poor efficacy, and an urgent need for a treatment method with small side effects but good results.

Method used

The modified starch is used as the main ingredient. By combining short -chain fatty acids with starch to form modified starch, using its slow release and targeted delivery characteristics in the gastrointestinal tract to reduce the triglyceride and cholesterol level in the body.

Benefits of technology

Modified starch not only reduces triglycerides and cholesterol, but also improves metabolic conditions, fights inflammation, and reduces uric acid levels with minimal side effects, improved sensory properties, and better palatability.

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Abstract

The invention relates to the field of biological medicine, in particular to a modified starch-containing composition for preventing and / or treating hyperlipemia and application thereof. The invention discloses the application of the modified starch in preparation of hyperlipemia medicines, foods and health-care foods for the first time, provides a composition containing the modified starch, and provides a new choice for prevention and / or treatment of hyperlipemia. The composition provided by the invention can significantly reduce triglyceride and cholesterol in the body, has no significant difference from the existing medicines for treating hyperlipidemia, but has very small side effects compared with the existing hyperlipidemia medicines, and has wide application prospects in the field of hyperlipidemia treatment.
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Description

Technical Field

[0001] The present invention relates to the field of biomedicine, and in particular to a composition containing modified starch for preventing and / or treating hyperlipidemia and application thereof. Background Art

[0002] Hyperlipidemia, also known as high blood lipids or dyslipidemia, usually refers to elevated triglycerides and (or) total cholesterol, elevated low-density lipoprotein cholesterol and reduced high-density lipoprotein cholesterol in plasma. Therefore, when treating hyperlipidemia, the treatment goal is often achieved by reducing the levels of triglycerides and (or) total cholesterol in plasma.

[0003] The treatment of hyperlipidemia mainly includes lifestyle intervention and drug therapy. Lifestyle changes include improving eating habits and increasing physical activity. Drug treatments mainly include statins, fibrates and high-purity fish oil. Currently, the most commonly used drugs mainly include drugs that lower triglycerides, including fenofibrate, lovastatin, simvastatin, atorvastatin, etc. However, these drugs are often accompanied by side effects such as abdominal pain, increased ALT / SGPT levels, increased AST / SGOT levels, back pain and headache. In severe cases, they can also cause pancreatitis, deep vein thrombosis, pulmonary embolism and other diseases.

[0004] Currently, there is an urgent need for a product with few side effects but good effect in treating hyperlipidemia. Summary of the invention

[0005] In view of the shortcomings and deficiencies of the prior art, the present invention provides a composition with few side effects but good effect in preventing and / or treating hyperlipidemia and its application. The details are as follows:

[0006] It should be noted that the modified starch described in the present invention is chemically modified starch, specifically esterified starch obtained by esterifying starch with short-chain fatty acids. In a specific embodiment of the present invention, a method for preparing modified starch using starch is provided.

[0007] The first aspect of the present invention discloses the use of modified starch in the preparation of medicines and foods and health foods for preventing and / or treating hyperlipidemia. In an embodiment of the present invention, the hyperlipidemia includes one or more of hypertriglyceridemia, hypercholesterolemia and combined hyperlipidemia.

[0008] The second aspect of the present invention provides a composition for preventing and / or treating hyperlipidemia, the composition comprising modified starch. In an embodiment of the present invention, the human intake of the modified starch is 15 mg / kg to 4.5 g / kg per day; preferably, the human intake of the modified starch is 150 mg / kg to 3.7 g / kg per day, and more preferably, the human intake of the modified starch is 150 mg / kg to 3.0 g / kg per day.

[0009] In the composition of the present invention, the main raw materials of the modified starch include starch and short-chain fatty acids. In an embodiment of the present invention, the short-chain fatty acid is selected from at least one of formic acid, acetic acid, propionic acid, butyric acid, isobutyric acid, valeric acid and isovaleric acid; preferably, the short-chain fatty acid is selected from at least one of acetic acid, propionic acid and butyric acid. The starch includes at least one of corn starch, pea starch, bean starch, potato starch, oat starch, rice starch, rye starch, sago starch, cassava starch, wheat starch and sorghum starch. The composition of the present invention also includes excipients acceptable in the fields of medicines, foods and health foods. Preferably, the excipients include at least one of sucrose, microcrystalline cellulose, methylcellulose, magnesium stearate, cysteine ​​hydrochloride, carboxymethyl cellulose and vitamins.

[0010] The third aspect of the present invention provides the use of the composition in the preparation of medicines and foods and health foods for preventing and / or treating hyperlipidemia. Preferably, the hyperlipidemia includes one or more of hypertriglyceridemia, hypercholesterolemia and combined hyperlipidemia.

[0011] The fourth aspect of the present invention provides a method for preparing medicines, foods and health foods for preventing and / or treating hyperlipidemia, wherein the method comprises the step of using the modified starch or composition of the present invention as the main effective ingredient to prepare medicines, foods and health foods for preventing and / or treating hyperlipidemia.

[0012] The mechanism of action of the modified starch or composition of the present invention in reducing triglycerides in the body is as follows:

[0013] 1. Currently, the direct use of short-chain fatty acids has the main disadvantages of large dosage, increased sodium intake, short half-life, strong odor, etc. The purpose of using short-chain fatty acids and starch together (loading short-chain fatty acids on starch to make modified starch) is to utilize the performance of modified starch to resist stomach and small intestine digestion, deliver short-chain fatty acids to the colon in a targeted manner, and play a role of sustained release, so that the short-chain fatty acids in the body are maintained at a stable level;

[0014] 2. Modified starch can improve metabolism by improving fasting blood sugar levels, serum free fatty acid levels and insulin levels; modified starch can also improve inflammation and reduce the level of endotoxin LPS (lipopolysaccharide);

[0015] 3. Modified starch can increase the activity of TG degrading enzymes such as liver lipase and lipoprotein lipase. These enzymes play a key role in the metabolism of TG, and increasing their activity helps accelerate the decomposition and clearance of TG. Modified starch can also reduce the activity of fatty acid synthase (FAS). FAS is a key enzyme in fatty acid synthesis. Reducing its activity can reduce the synthesis of fatty acids, thereby reducing the production of TG.

[0016] Modified starch may reduce TG levels through the combined effects of the above-mentioned mechanisms, including improving metabolic status, anti-inflammation, increasing lipase activity and reducing fatty acid synthase activity.

[0017] The metabolites of the modified starch of the present invention are mainly short-chain fatty acids, carbon dioxide and water, and have almost no side effects.

[0018] The modified starch or composition of the present invention has good effects on lowering blood sugar, improving inflammation level and improving uric acid level while reducing cholesterol and triglyceride in the body.

[0019] The beneficial effects of the present invention include but are not limited to:

[0020] 1. The present invention discloses for the first time the use of modified starch in the preparation of medicines, foods and health foods for preventing and / or treating hyperlipidemia, especially in the preparation of medicines, foods and health foods for preventing and / or treating hypertriglyceridemia and hypercholesterolemia;

[0021] 2. The present invention provides a novel composition for preventing and / or treating hyperlipidemia and its use. Compared with the method of directly using short-chain fatty acids or short-chain fatty acid salts, the modified starch used in the present invention has a better effect under the same dosage conditions, and avoids the problems of strong odor and short half-life of short-chain fatty acids, improves sensory properties, and is more palatable;

[0022] 3. The present invention provides a new composition for preventing and / or treating hyperlipidemia and its use. Compared with existing drugs for preventing and / or treating hyperlipidemia, the composition of the present invention has no significant difference in effect, but has extremely small side effects, providing a new choice for patients with hyperlipidemia and having broad application prospects in the field of preventing and / or treating hyperlipidemia. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] The drawings described herein are used to provide a further understanding of the present invention and constitute a part of the present invention. The exemplary embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation of the present invention. In the drawings:

[0024] Figure 1 is a schematic diagram of the result of one way anova statistics of butyrate concentration in the portal vein blood of mice in Example 1 of the present invention;

[0025] Figure 2 is a schematic diagram of the result of one way anova statistics of butyrate concentration in the colon contents of mice in Example 1 of the present invention;

[0026] Figure 3 is a schematic diagram of the test results of improving glucose metabolism in 6-week-old rats in Example 2 of the present invention, Figure 3 A is a schematic diagram of the test results of fasting blood glucose level. Figure 3 B is a schematic diagram of the test results of serum free fatty acid levels. Figure 3 C is a schematic diagram of the test results of insulin levels;

[0027] Figure 4 is a schematic diagram of the test results of improving the inflammatory condition of 6-week rats in Example 2 of the present invention, Figure 4 A is a schematic diagram of the detection results of the inflammatory factor IL-1β. Figure 4 B is a schematic diagram of the detection results of the inflammatory factor IL-6. Figure 4 C is a schematic diagram of the detection results of the inflammatory factor TNF-α;

[0028] Figure 5 This is a schematic diagram of the detection results of the LPS level of the toxin in the inflammatory condition of 6-week rats in Example 2 of the present invention. Figure 5 A is a schematic diagram of the detection results of LPS levels in rat feces. Figure 5 B is a schematic diagram of the detection results of LPS levels in rat serum;

[0029] Figure 6 This is a schematic diagram of the test results of improving uric acid levels in 6-week-old rats after intervention in Example 2 of the present invention;

[0030] Figure 7 This is a schematic diagram of the test results of triglyceride levels in rats after 6 weeks of intervention in Example 3 of the present invention;

[0031] Figure 8 This is a schematic diagram of the test results of cholesterol levels in rats after 6 weeks of intervention in Example 5 of the present invention. DETAILED DESCRIPTION

[0032] The present invention is described in detail below with reference to the examples, but the present invention is not limited to these examples. Unless otherwise specified, the raw materials and catalysts in the examples of the present invention are purchased from commercial sources. Unless otherwise specified, the percentages in the examples are all mass fractions.

[0033] The reagents used in the present invention are as follows, with the brand in front and the product number behind:

[0034] Blood lipid test: TC: Prilep E1005; LDL: Solebo BC5335; TG: Prilep E1003;

[0035] Fasting blood glucose FBG: Prilep E1010;

[0036] Uric acid UA: Prilep E2039;

[0037] Endotoxin LPS: Xiamen Limulus Biosciences EC80545S;

[0038] FFA: Solebao BC0595;

[0039] Insulin: PTG KE20008;

[0040] IL-1β: abcam ab255730; IL-6: abcam ab234570; TNF-α: abcam ab236712;

[0041] Hepatic Lipase (HL): Solebo BC2385;

[0042] Lipoprotein Lipase (LPL): Solebo BC2445;

[0043] Fatty acid synthase FAS: Solebo BC0555;

[0044] High amylose corn starch: Ingredion Hi-maize 260;

[0045] Corn starch: Gusong;

[0046] Wheat starch: Gusong;

[0047] Potato starch: Gusong.

[0048] Example 1 Preparation of modified starch and evaluation of colon targeted delivery effect

[0049] 100g of high amylose corn starch (HAMS) was added to distilled water, stirred at room temperature for 30min, the pH value of the reaction solution was adjusted to 8.0-10.0 with NaOH (concentration of 1M) solution, and then 15-70g of one or more combinations of acetic anhydride, propionic anhydride, and butyric anhydride were added. When the anhydride was added, NaOH solution (concentration of 1M) was added to ensure that the pH of the reaction solution was maintained in a stable alkaline range (pH value of 8.0-10.0). Modified starches such as acetylated high amylose corn starch (HAMSA), propionylated high amylose corn starch (HAMSP), butyrylated high amylose corn starch (HAMSB), acetate propionate disubstituted high amylose corn starch (HAMSAP), acetate butyrate disubstituted high amylose corn starch (HAMSAB), propionate butyrate disubstituted high amylose corn starch (HAMSPB), and acetate propionate butyrate trisubstituted high amylose corn starch (HAMSAPB) were obtained.

[0050] 100g corn starch (MS) is added to distilled water, stirred at room temperature for 30min, the pH value of the reaction solution is adjusted to 8.0-10.0 with NaOH (concentration of 1M) solution, and then 15-70g of one or more combinations of acetic anhydride, propionic anhydride, and butyric anhydride are added. When the anhydride is added, NaOH solution (concentration of 1M) needs to be added to ensure that the pH of the reaction solution is maintained in a stable alkaline range (pH value of 8.0-10.0). Modified starches acetylated corn starch (MSA), propionylated corn starch (MSP), butyrylated corn starch (MSB), acetate propionate disubstituted corn starch (MSAP), acetate butyrate disubstituted corn starch (MSAB), propionate butyrate disubstituted corn starch (MSPB) and acetate propionate butyrate trisubstituted corn starch (MSAPB) are obtained.

[0051] 100g wheat starch (WHS) is added to distilled water, stirred at room temperature for 30min, and the pH value of the reaction solution is adjusted to 8.0-10.0 with NaOH (concentration of 1M) solution, and then 15-70g of one or more combinations of acetic anhydride, propionic anhydride, and butyric anhydride are added. When the anhydride is added, NaOH solution (concentration of 1M) needs to be added to ensure that the pH of the reaction solution is maintained in a stable alkaline range (pH value of 8.0-10.0). Modified starches acetylated wheat starch (WHSA), propionylated wheat starch (WHSP), butyrylated wheat starch (WHSB), acetate propionate disubstituted wheat starch (WHSAP), acetate butyrate disubstituted wheat starch (WHSAB), propionate butyrate disubstituted wheat starch (WHSPB) and acetate propionate butyrate trisubstituted wheat starch (WHSAPB) are obtained.

[0052] 100g potato starch (POS) is added to distilled water, stirred at room temperature for 30min, the pH value of the reaction solution is adjusted to 8.0-10.0 with NaOH (concentration is 1M) solution, and then 15-70g of one or more combinations of acetic anhydride, propionic anhydride, and butyric anhydride are added. When the anhydride is added, NaOH solution (concentration is 1M) needs to be added to ensure that the pH of the reaction solution is maintained in a stable alkaline range (pH value is 8.0-10.0). Modified starch acetylated potato starch (POSA), propionylated potato starch (POSP), butyrylated potato starch (POSB), acetate propionic acid disubstituted potato starch (POSAP), acetate butyric acid disubstituted potato starch (POSAB), propionate butyric acid disubstituted potato starch (POSPB) and acetate propionate butyric acid trisubstituted potato starch (POSAPB) are obtained.

[0053] Butyrylated starch prepared from different starch raw materials was added at a ratio of 15% as mouse feed. Eight-week-old mice were randomly divided into 6 groups according to their body weight, with 12 mice in each group: control group, HAMSB group, MSB group, WHSB group, POSB group and sodium butyrate saline (NaB) group. The mouse feces and portal vein blood were collected after one week of feeding.

[0054] Example 2 Effect of modified starch on reducing triglyceride (TG)

[0055] The animal experiment was divided into 10 groups. All experimental animals were 6-week-old SD rats (purchased from Vital River), with 10 rats in each group, and the intervention time was 6 weeks. The NC group was used as the normal control group and fed with ordinary feed; the HTG group was used as the disease model group and fed with 60% high-fructose feed (feed with 60% energy from fructose). The HAMSA, HAMSP, HAMSB, HAMSAP, HAMSAB, HAMSPB and HAMSAPB groups were modified starch treatment groups, and 15% mass fraction of modified starch was added to the 60% high-fructose feed respectively. The sodium acetate (NaA), sodium propionate (NaP), sodium butyrate (NaB), sodium ethylpropionate (NaAP), sodium ethylbutyrate (NaAB), sodium propionate (NaPB) and sodium propionate (NaAPB) groups were short-chain fatty acid salt gavage treatment groups with the same short-chain fatty acid intake as the modified starch treatment group. The fenofibrate group served as the treatment effect control group, using the clinical first-line TG-lowering drug fenofibrate, and was fed a 60% high-fructose diet like the HTG group. The NC, HTG, HAMSA, HAMSP, HAMSB, HAMSAP, HAMSAB, HAMSPB and HAMSAPB groups were gavaged with sterile PBS 1mL / mouse daily. The sodium acetate (NaA) group was gavaged with sodium acetate 1.44g / kg (volume of 2mL) daily, the sodium propionate (NaP) group was gavaged with sodium propionate 1.67g / kg (volume of 2mL) daily, the sodium butyrate (NaB) group was gavaged with sodium butyrate 1.80g / kg (volume of 2mL) daily, the sodium ethoxypropionate (NaAP) group was gavaged with sodium acetate 0.72g / kg and sodium propionate 0.84g / kg (volume of 2mL) daily, and the sodium ethoxypropionate (NaAP) group was gavaged with sodium acetate 0.72g / kg and sodium propionate 0.84g / kg (volume of 2mL) daily. The (NaAB) group was gavaged with 0.72 g / kg sodium acetate and 0.90 g / kg sodium butyrate (volume 2 mL) daily, the sodium propionate butyrate (NaPB) group was gavaged with 0.84 g / kg sodium propionate and 0.90 g / kg sodium butyrate (volume 2 mL) daily, and the sodium propionate butyrate (NaAPB) group was gavaged with 0.48 g / kg sodium acetate, 0.56 g / kg sodium propionate, and 0.60 g / kg sodium butyrate (volume 2 mL) daily. The fenofibrate group was gavaged with 100 mg / kg fenofibrate (volume 1 mL) daily. Every other week, the data of blood lipids, blood sugar, uric acid, endotoxin, etc. were detected with a biochemical detection kit, and the data for a total of 6 weeks were counted. The information of each group in the animal experiment is shown in Table 1.

[0056] Table 1

[0057]

[0058]

[0059] The test results are shown in Table 1. The high fructose diet significantly increased the serum TG level of SD rats. The intervention groups of HAMSA, HAMSP, HAMSB, HAMSAP, HAMSAB, HAMSPB, and HAMSAPB could reduce the serum TG level of rats to varying degrees. Among them, HAMSB had the best effect, and its efficacy was not inferior to that of fenofibrate, a first-line drug for reducing TG in clinical practice. Moreover, the intervention groups of modified starch HAMSA, HAMSP, HAMSB, HAMSAP, HAMSAB, HAMSPB, and HAMSAPB had a better effect on reducing triglycerides than the short-chain fatty acid salt NaA, NaP, NaB, NaAP, NaPB, NaAB, and NaAPB groups.

[0060] Depend on Figure 3-6 It can be seen that the modified starch of the present invention has a good effect in lowering blood sugar, improving inflammation level and improving uric acid level while reducing triglycerides in the body.

[0061] Example 3 Effect of the mass fraction of modified starch on the triglyceride-lowering effect (TG)

[0062] The animal experiment was divided into 7 groups, all experimental animals were 6-week-old SD rats (purchased from Vital River), 10 in each group, and the intervention time was 6 weeks. HAMSA, HAMSP and HAMSB, HAMSAP, HAMSAB, HAMSPB, and HAMSAPB groups were treatment groups (i.e., groups 3-9 in Table 1), and 0.1%, 1%, 5%, 10%, 15%, 20%, 25%, 30%, and 35% mass fractions of modified starch were added to 60% high fructose feed (the daily dose of modified starch ingested by rats was calculated to be 0.1g / kg, 1g / kg, 5g / kg, 10g / kg, 15g / kg, 20g / kg, 25g / kg, 30g / kg, and 35g / kg according to the amount of feed consumed by rats). The fenofibrate group was used as the treatment effect control group, using the clinical first-line TG-lowering drug fenofibrate, and fed with 60% high fructose feed like the HTG group. The HAMSA, HAMSP, HAMSB, HAMSAP, HAMSAB, HAMSPB, and HAMSAPB groups were gavaged with 1 mL of sterile PBS per rat every day. The data of triglyceride in rats were measured after 6 weeks of intervention.

[0063] According to the statistical results, ( Figure 7), 1% to 30% by mass of modified starch has an effect on reducing triglycerides, and as the mass fraction of modified starch increases, its effect on reducing triglycerides gradually increases. When the mass fraction of modified starch is 30%, the effect is saturated and no longer increases. That is, when the daily intake of SD rats is 0.1g / kg to 30g / kg, it has a good effect on reducing triglycerides in SD rats. When the amount of modified starch is more than 30g / kg, the effect will no longer increase. Therefore, from a cost perspective, it is recommended that the daily intake of SD rats be 0.1g / kg to 30g / kg. According to "Dose Issues in Pharmacological Experimental Design" on pages 202-203 of "Pharmacological Experimental Methodology" compiled by Xu Shuyun (People's Medical Publishing House, third edition), the daily intake for humans is: 15mg / kg to 4.5g / kg.

[0064] Example 4 Effect of modified starch on cholesterol reduction (TC)

[0065] The animal experiment was divided into 10 groups. All experimental animals were 6-week-old SD rats (purchased from Vital River), with 10 rats in each group. Obese rat models and normal rat models were established. Obese rats were fed with a high-fat diet (60% of energy came from fat) for 14 weeks, and normal rats were fed with a normal diet (10% of energy came from fat) for 14 weeks. The NC group was used as a normal control group and fed with a normal diet; the HFD group was used as a disease model group and fed with a 60% high-fat diet. The HAMSA, HAMSP, HAMSB, HAMSAP, HAMSAB, HAMSPB and HAMSAPB groups were modified starch treatment groups, and 15% modified starch was added to the 60% high-fat diet. The sodium acetate (NaA), sodium propionate (NaP), sodium butyrate (NaB), sodium ethylpropionate (NaAP), sodium ethylbutyrate (NaAB), sodium propionate (NaPB) and sodium propionate (NaAPB) groups were short-chain fatty acid salt gavage treatment groups with the same short-chain fatty acid intake as the modified starch treatment group. The sodium acetate (NaA) group was gavaged with 1.44 g / kg sodium acetate (volume 2 mL) per day, the sodium propionate (NaP) group was gavaged with 1.67 g / kg sodium propionate (volume 2 mL) per day, the sodium butyrate (NaB) group was gavaged with 1.80 g / kg sodium butyrate (volume 2 mL) per day, the sodium ethoxypropionate (NaAP) group was gavaged with 0.72 g / kg sodium acetate and 0.84 g / kg sodium propionate (volume 2 mL) per day, and the sodium ethoxybutyrate group was gavaged with 0.72 g / kg sodium acetate and 0.84 g / kg sodium propionate (volume 2 mL) per day. The (NaAB) group was gavaged with 0.72g / kg sodium acetate and 0.90g / kg sodium butyrate (volume 2mL) daily, the sodium propionate butyrate (NaPB) group was gavaged with 0.84g / kg sodium propionate and 0.90g / kg sodium butyrate (volume 2mL) daily, and the sodium acetyl propionate butyrate (NaAPB) group was gavaged with 0.48g / kg sodium acetate, 0.56g / kg sodium propionate and 0.60g / kg sodium butyrate (volume 2mL) daily. The lactulose (LA) group was used as the treatment effect control group, and was gavaged with 0.004mL (2.668mg) / g of lactulose stock solution, and was fed with 60% high-fat feed like the HFD group. The blood lipid content of rats in each group was tested after feeding for 6 weeks. The information of each group in the animal experiment is shown in Table 2.

[0066] Table 2

[0067]

[0068] The results are shown in Table 3. As shown in Table 3, the cholesterol (TC) of the HFD group was significantly higher than that of the NC group, and the cholesterol of the HAMSA, HAMSP and HAMSB, HAMSAP, HAMSAB, HAMSPB, and HAMSAPB intervention groups was significantly lower than that of the HFD group, and the modified starch HAMSA, HAMSP and HAMSB, HAMSAP, HAMSAB, HAMSPB, and HAMSAPB intervention groups had a better effect on lowering cholesterol than the short-chain fatty acid salt NaA, NaP, NaB, NaAP, NaPB, NaAB, and NaAPB groups, proving that the modified starch of the present invention has a significant effect on lowering serum cholesterol (TC).

[0069] Table 3

[0070]

[0071]

[0072] Example 5 Effect of the mass fraction of modified starch on cholesterol

[0073] The animal experiment was divided into 7 groups, all experimental animals were 6-week-old SD rats (purchased from Weitong Lihua), 10 in each group, and an obese rat model was constructed. Obese rats were fed with a high-fat diet (60% of energy comes from fat) for 14 weeks, and HAMSA, HAMSP and HAMSB, HAMSAP, HAMSAB, HAMSPB, and HAMSAPB groups were treatment groups, and 0.1%, 1%, 5%, 10%, 15%, 20%, 25%, 30%, and 35% mass fractions of modified starch were added to the 60% high-fat diet (the dosage of modified starch ingested by rats per day was calculated to be 0.1g / kg, 1g / kg, 5g / kg, 10g / kg, 15g / kg, 20g / kg, 25g / kg, 30g / kg, and 35g / kg according to the amount of feed consumed by rats). The blood lipid content of rats was tested after each group was fed for 6 weeks.

[0074] According to the statistical results, ( Figure 8), 1% to 30% by mass of modified starch has an effect on lowering cholesterol, and as the mass fraction of modified starch increases, its cholesterol-lowering effect gradually increases. When the mass fraction of modified starch is 30%, the effect is saturated and no longer increases. That is, when the daily intake of SD rats is 0.1g / kg to 30g / kg, it has a good effect on lowering cholesterol in SD rats. When the amount of modified starch is more than 30g / kg, the effect will no longer increase. Therefore, from a cost perspective, it is recommended that the daily intake of SD rats be 0.1g / kg to 30g / kg. According to "Dose Issues in Pharmacological Experimental Design" on pages 202-203 of "Pharmacological Experimental Methodology" compiled by Xu Shuyun (People's Medical Publishing House, third edition), the daily intake of humans is 15mg / kg to 4.5g / kg.

[0075] Example 6 Verification of the effects of other modified starches.

[0076] The modified corn starch MSA, MSP, MSB, MSAP, MSAB, MSAPB, MSABP, modified wheat starch WHSA, WHSP, WHSB, WHSAP, WHSAB, WHSAPB, WHSABP, modified sorghum starch POSA, POSP, POSB, POSAP, POSAB, POSAPB, POSABP in Example 1 were used to replace HAMSA, HAMSP, HAMSB, HAMSAP, HAMSAB, HAMSPB, and HAMSAPB in Examples 2 and 4, and the experimental steps of Examples 2 and 4 were repeated. The results are shown in Tables 4 and 5.

[0077] Table 4

[0078]

[0079]

[0080] Table 5

[0081]

[0082]

[0083] The results show that the modified starches MSA, MSP, MSB, MSAP, MSAB, MAPB, MSABP prepared from common corn starch, the modified starches WHSA, WHSP, WHSB, WHSAP, WHSAB, WHSAPB, WHSABP prepared from wheat starch, and the modified starches POSA, POSP, POSB, POSAP, POSAB, POSAPB, POSABP prepared from sorghum starch are slightly weaker than the modified starches prepared from high-amylose corn starch in reducing cholesterol and triglycerides, but are better than the effects of the short-chain fatty acid salts NaA, NaP, NaB, NaAP, NaPB, NaAB, and NaAPB groups. The above are only embodiments of the present invention, and the scope of protection of the present invention is not limited by these specific embodiments, but is determined by the claims of the present invention. For those skilled in the art, the present invention may have various changes and variations. Any modifications, equivalent substitutions, improvements, etc. made within the technical ideas and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. Application of modified starch in medicines, foods and health foods for preventing and / or treating hyperlipidemia.

2. The use according to claim 1, characterized in that: The hyperlipidemia includes one or more of hypertriglyceridemia, hypercholesterolemia, and combined hyperlipidemia.

3. A composition for preventing and / or treating hyperlipidemia, characterized in that: The composition comprises the modified starch for use according to claim 1.

4. The composition according to claim 3, characterized in that The human intake of the modified starch is 15 mg / kg to 4.5 g / kg per day.

5. The composition according to claim 3, characterized in that The main raw materials of the modified starch include starch and short-chain fatty acids.

6. The composition according to claim 5, characterized in that The starch includes at least one of corn starch, pea starch, bean starch, potato starch, oat starch, rice starch, rye starch, sago starch, tapioca starch, wheat starch and sorghum starch.

7. The composition according to claim 5, characterized in that The short-chain fatty acid is selected from at least one of formic acid, acetic acid, propionic acid, butyric acid, isobutyric acid, valeric acid and isovaleric acid; preferably, the short-chain fatty acid is selected from at least one of acetic acid, propionic acid and butyric acid.

8. The composition according to claim 5, characterized in that The composition includes a composition in which one short-chain fatty acid replaces one starch, and / or a composition in which multiple short-chain fatty acids replace one starch, and / or a composition in which one short-chain fatty acid replaces multiple starches, and / or a composition in which multiple short-chain fatty acids replace multiple starches.

9. The composition according to claim 3, characterized in that The composition also includes auxiliary materials acceptable in the fields of medicine, food and health food. Preferably, the auxiliary materials include one or more of sucrose, microcrystalline cellulose, methyl cellulose, magnesium stearate, cysteine ​​hydrochloride, carboxymethyl cellulose and vitamins.

10. Use of the composition according to any one of claims 3 to 9 in the preparation of medicines, foods and health foods for preventing and / or treating hyperlipidemia.