Composition for regulating blood fat and application thereof

Abstract

The invention discloses a composition for regulating blood fat and application of the composition. The composition is prepared from the following components in parts by weight: 150 to 250 parts of fructus crataegi, 150 to 250 parts of lotus leaves and 5 to 15 parts of rice bran fatty alkanol. The preparation method comprises the following steps: soaking the hawthorn and the lotus leaf, performing water extraction for multiple times, combining extracting solutions obtained by each water extraction, performing vacuum concentration until the density is 1.16 g / cm < 3 >, performing spray drying to obtain a combined extract, and mixing the obtained combined extract with the rice bran fatty alkanol to obtain the composition for regulating the blood fat. The composition can effectively reduce serum TC, TG and LDL-C of hyperlipidemia mice, and meanwhile, the serum HDL-C level is increased.

Description

Technical Field

[0001] The present application relates to the field of food processing technology, and in particular to a composition for regulating blood lipids and its application. Background Art

[0002] Over the past 30 years, the proportion of hyperlipidemia patients in my country's total population has increased significantly. Currently, modern medicine treats hyperlipidemia primarily through a combination of lifestyle management and medication, with statins, fibrates, and niacin being commonly used. Statins significantly reduce the incidence of cardiovascular events by lowering low-density lipoprotein cholesterol, providing anti-inflammatory effects, and protecting the vascular endothelium. However, long-term use of these drugs can lead to adverse reactions such as dizziness, headaches, and rhabdomyolysis, resulting in poor patient compliance and overall poor treatment outcomes. Healthy lifestyle intervention is a globally recognized strategy for the prevention and treatment of hyperlipidemia. It primarily involves patients self-regulating their dietary nutrition and controlling their intake of sugar and fat, thereby regulating risk factors such as blood lipids, blood pressure, and blood sugar levels. It plays a key role in preventing cardiovascular disease caused by hyperlipidemia. However, since many patients themselves prefer a high-sugar, high-fat diet, self-regulation is less reliable.

[0003] In the Dietary Guidelines for Adults with Hyperlipidemia (2023 Edition) [J]. General Practice Clinical and Education, 2023, 21(07): 581-583. It is pointed out that hyperlipidemia is classified as phlegm-dampness and fat-grease in traditional Chinese medicine. Hyperlipidemia is always a syndrome of deficiency of the root and excess of the superficial, with phlegm and blood stasis as the superficial and deficiency of the body as the root, and two complex syndromes of qi deficiency and blood stasis and phlegm and blood stasis are added.

[0004] Chen Jian, Chen Ming, Sun Yunlan, et al. Screening of a lipid-lowering Chinese herbal formula based on rice bran fatty alkanols [J / OL]. Journal of Yunnan Nationalities University (Natural Science Edition), 1-11 [2025-03-10]. http: / / kns.cnki.net / kcms / detail / 53.1192.N.20240326.1208.002.html. SPF male Kunming mice were used as research subjects. A hyperlipidemia mouse model was established by intraperitoneal injection of 75% egg yolk emulsion to evaluate the lipid-lowering effect of a compound of Panax notoginseng, hawthorn, and rice bran fatty alkanols. The results showed that the blood lipid indicators of the Panax notoginseng + hawthorn group, Panax notoginseng + rice bran fatty alkanol group, and mixture group (Panax notoginseng + hawthorn + rice bran fatty alkanol) were significantly improved compared with the model group. Among them, the mixture group could significantly reduce the levels of TC, TG, and LDL-C in the serum of mice and increase the level of HDL-C, indicating that the compound has a significant lipid-lowering effect.

[0005] CN201910023316.5 provides a composition capable of regulating liver-stomach disharmony, comprising, by mass: 2-8 parts of turmeric, 1-4 parts of rice bran fatty alkyl alcohol, 50-70 parts of hawthorn extract, 20-40 parts of yam extract, 15-25 parts of hericium erinaceus extract, 60-80 parts of black plum extract, 7-14 parts of cassia seed extract, 30-50 parts of green tea extract, and 90-110 parts of fermented composite fruit and vegetable powder. The composition can regulate liver-stomach disharmony, regulate physical fitness, and enhance mechanism ability. It is suitable for obesity of liver-stomach disharmony type. Other routine The weight loss measure can effectively reduce weight, but the composition mainly focuses on reducing the body fat mass by a maximum of more than 10%.

[0006] Rice bran fatty alkanols are naturally present in rice bran wax, which is made from rice bran through saponification, extraction, filtration and other processes. This substance is used in the agricultural, food and medical fields. In the food field, it is mainly used as a nutritional supplement to exert its effects of regulating blood lipids, resisting fatigue, and improving immunity. At the same time, this substance also has the effect of lowering serum cholesterol and triglyceride levels, and can be used to develop lipid-lowering drugs to help patients with hyperlipidemia control their blood lipid levels.

[0007] For example, CN202310831327.2 discloses a gel candy containing rice bran fatty alcohols that can reduce body fat and enhance immunity. In this candy, rice bran fatty alcohols, strong antioxidant astaxanthin and natural ginseng extract are compounded. The three ingredients work synergistically, assisted by yeast beta-glucan and plant sterol esters, to make a gel candy-type food. After taking it for one month, it can reduce the user's body fat rate by 4.9% and increase resting energy consumption.

[0008] Despite the above research, there is still room for further improvement in developing new foods that are beneficial to human health, especially to human blood lipid health and cardiovascular and cerebrovascular health.

[0009] The information disclosed in the background section is only intended to enhance understanding of the overall background of the invention and should not be considered as an admission or any form of suggestion that the information constitutes the prior art already known to a person of ordinary skill in the art. Summary of the Invention

[0010] In response to the above technical problems, the present application provides a composition for regulating blood lipids and its application, which can effectively reduce serum TC, TG and LDL-C in hyperlipidemic mice while increasing serum HDL-C levels.

[0011] The present application provides a composition for regulating blood lipids, which is composed of 150 to 250 parts by weight of hawthorn, 150 to 250 parts by weight of lotus leaves, and 5 to 15 parts by weight of rice bran fatty alkanol.

[0012] The preparation method is as follows: soak hawthorn and lotus leaves, extract them with water for several times, combine the extracts from each extraction, and then concentrate under reduced pressure to a density of 1.16 g / cm 3 , spray drying to obtain a combined extract, and mixing the obtained combined extract with rice bran fatty alkanol to obtain the composition for regulating blood lipids;

[0013] The mass ratio of the combined extract to rice bran fatty alkanol is 82:5-15.

[0014] Preferably, the mass ratio of the combined extract to the rice bran fatty alkanol is 82:10.

[0015] Preferably, it is composed of 6 parts by weight of hawthorn, 6 parts by weight of lotus leaves, and 10 parts by weight of rice bran fatty alkanol.

[0016] Preferably, the soaking conditions are: immersing the hawthorn and lotus leaves in water at room temperature for 30 to 60 minutes.

[0017] Preferably, the concentration under reduced pressure is carried out at 60°C.

[0018] Preferably, the water extraction conditions are: adding water after soaking, heating to 90-95° C., and extracting for 2 hours.

[0019] Preferably, the spray drying conditions are an inlet air temperature of 140-180° C., an outlet air temperature of 80-90° C., and a feed flow rate of 1.2 kg / min for spray drying.

[0020] Preferably, the water extraction is performed twice.

[0021] The blood lipid regulating composition can be prepared into solid beverages, granules, soft capsules, hard capsules, tablets and the like.

[0022] Another aspect of the present application also provides the use of the above composition in preparing food for improving blood lipid levels.

[0023] The beneficial effects of this application include:

[0024] 1) The composition for regulating blood lipids provided in the present application is prepared by compounding hawthorn, lotus leaves and rice bran fatty alkanols and adopting this method. The composition can give full play to the synergistic effect of each substance, thereby playing a good auxiliary lipid-lowering effect on common hyperlipidemia of qi deficiency and blood stasis type, has the effects of digesting food, eliminating accumulation, promoting qi and dispersing blood stasis, and can improve blood lipid levels.

[0025] 2) The composition for regulating blood lipids provided in this application has been found through animal experiments to be effective in treating hyperlipidemic mice. The composition can reduce serum TC by up to 35%, TG by up to 33%, LDL-C by up to 37%, and increase serum HDL-C by up to 12.4%. This composition can significantly reduce serum TC, TG, and LDL-C in hyperlipidemic mice, while increasing serum HDL-C levels. DETAILED DESCRIPTION

[0026] The present invention will be further described in detail below with reference to the embodiments, but the present invention is not limited in any way. Any changes or improvements made based on the teachings of the present invention fall within the scope of protection of the present invention.

[0027] Example

[0028] Unless otherwise specified, the materials and instruments used in the following examples were obtained from commercial channels; the detection methods used were all existing methods unless otherwise specified.

[0029] Example 1 Preparation of Compositions 1#-3#

[0030] 1. Weigh 6 kg of hawthorn and 6 kg of lotus leaves, add 60 L of water, and soak for 30 minutes. Then add another 60 L of water, heat to 93°C, extract for 2 hours, filter, and collect the extract.

[0031] 2. Add 120L of water to the filter residue of step 1, heat to 93°C, stir and extract for 2 hours, filter and collect the extract.

[0032] 3. Combine the extracts from step 1 and step 2, and concentrate under reduced pressure at 60°C to a density of 1.16 g / cm 3 .

[0033] 4. Set the air inlet temperature to 140°C, the air outlet temperature to 90°C, the feed flow rate to 1.2 kg / min, and spray dry to obtain 2.46 kg of extract.

[0034] 5. Weigh 820 g of the extract from step 4 and 50 g of rice bran fatty alkanol, mix them evenly, and obtain composition 1#; weigh 820 g of the extract from step 4 and 100 g of rice bran fatty alkanol, mix them evenly, and obtain composition 2#; weigh 820 g of the extract from step 4 and 150 g of rice bran fatty alkanol, mix them evenly, and obtain composition 3#.

[0035] Example 2 Preparation of Composition 4#

[0036] 1. Weigh 250g of hawthorn and 150g of lotus leaves, add 2L of water, and soak for 60 minutes. Then add 1.2L of water, heat to 95°C, extract for 2 hours, filter, and collect the extract.

[0037] 2. Add 3.2 L of water to the filter residue of step 1, heat to 95°C, stir and extract for 1.5 hours, filter and collect the extract.

[0038] 3. Combine the extracts from step 1 and step 2, and concentrate under reduced pressure at 70°C to a density of 1.10 g / cm 3 .

[0039] 4. The inlet air temperature was set at 180°C, the outlet air temperature was set at 90°C, the feed flow rate was set at 1.2 kg / min, and 86 g of extract was obtained by spray drying.

[0040] 5. Weigh 86 g of the extract from step 4 and 10 g of rice bran fatty alkanol, mix them evenly, and obtain composition 4#.

[0041] Example 3 Preparation of Composition 5#

[0042] 1. Weigh 150g of hawthorn and 250g of lotus leaves, add 2L of water, and soak for 30 minutes. Then add 1.2L of water, heat to 90°C, extract for 2 hours, filter, and collect the extract.

[0043] 2. Add 3.2 L of water to the filter residue of step 1, heat to 90°C, stir and extract for 2 hours, filter and collect the extract.

[0044] 3. Combine the extracts from step 1 and step 2, and concentrate under reduced pressure at 60°C to a density of 1.2 g / cm 3 .

[0045] 4. The inlet air temperature was set at 140°C, the outlet air temperature was set at 80°C, the feed flow rate was set at 1.2 kg / min, and 81 g of extract was obtained by spray drying.

[0046] 5. Weigh 81 g of the extract from step 4 and 10 g of rice bran fatty alkanol, mix them evenly, and obtain composition 5#.

[0047] Example 4-Comparative Example 1 Preparation of Composition D1

[0048] 1. Weigh 200g of hawthorn and 200g of lotus leaves, add 2L of water, and soak for 30 minutes. Then add 2L of water, heat to 93°C, extract for 2 hours, filter, and collect the extract.

[0049] 2. Add 4L of water to the filter residue of step 1, heat to 93°C, stir and extract for 2 hours, filter and collect the extract.

[0050] 3. Combine the extracts from step 1 and step 2, and concentrate under reduced pressure at 60°C to a density of 1.16 g / cm 3 .

[0051] 4. The air inlet temperature was set to 140°C, the air outlet temperature was set to 90°C, the feed flow rate was set to 1.2 kg / min, and 82 g of the extract was obtained by spray drying, namely, composition D1#.

[0052] Example 5 Animal Experiment on the Hypolipidemic Effect of the Composition of the Invention

[0053] 1. Materials

[0054] 1.1 Experimental Animals

[0055] C57BL / 6 mice, male, with body weight of 18 - 22 g, were purchased from Henan Skebes Biotechnology Co., Ltd., and the animal license number was: SCXK(Yu)2020 - 0005. The animals were purchased 1 week before the experiment and placed in a soundproof animal room at a temperature of 25 - 27 °C, with free access to food and water. This study was approved by the Animal Ethics Committee of the Experimental Center of Kunming Longjin Pharmaceutical Co., Ltd.

[0056] ` 1.2 Composition and Reagents of the Invention

[0057] Sample preparation: The compositions prepared in Examples 1 - 3 and Comparative Example 1 (including Composition 1# - 5# and D1#) were prepared by the R & D Center of Kunming Longjin Pharmaceutical Co., Ltd.; the high-fat feed (formulation: 78.5% ordinary feed, 10% lard, 10% egg yolk powder, 1% cholesterol, 0.5% bile salt) was purchased from the Experimental Animal Research Institute of Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital; Rosuvastatin Ezetimibe Tablets, Kunming Longjin Pharmaceutical Co., Ltd., batch number: AAE3899; Tributylphenolaldehyde, Sigma Company, USA, batch number: S0 136;

[0058] Mouse triglyceride (TG), total cholesterol (TC), high-density lipoprotein (HDL-C), and low-density lipoprotein (LDL-C) enzyme-linked immunosorbent assay kits were purchased from Nanjing Jiancheng Bioengineering Institute, batch number: 20250117.

[0059] 1.3 Dosage Design

[0060] The recommended daily dosage of the composition of the invention for humans: 0.1 g of rice bran alkanol, 0.4 g of hawthorn extract, 0.4 g of lotus leaf, and the daily dosage of the composition is 0.9 g / d; calculated based on a human body weight of 60 kg, the human dosage is 0.015 g / kg, and the equivalent dosage for mice is calculated by multiplying by 10 (converted according to body surface area), that is, 0.15 g / kg.

[0061] According to the drug instruction manual, the adult dosage of Rosuvastatin Ezetimibe Tablets is 10 mg once a day, so the maximum daily dosage for humans is 10 mg. Calculated based on a human body weight of 60 kg, the human dosage is 0.167 mg·kg-1. For mice, it is calculated by multiplying the adult dosage by 10, that is, 1.67 mg·kg-1, and in the experiment, the dosage is 2 mg·kg-1.

[0062] 1.4 Instruments

[0063] TGL-16 desktop high-speed centrifuge, Jintan Medical Instrument Factory; vortex mixer, Zhejiang Lecheng Electric Appliance Factory; EPOCH / 2 microplate reader, BioTek, USA; 1 / 100,000 electronic balance, Sartorius Scientific Instruments (Beijing) Co., Ltd.

[0064] 2. Methods

[0065] 2.1 Hyperlipidemia model modeling

[0066] A hyperlipidemia model was established by referring to the literature methods and preliminary experiments: male C57 mice were fed a high-fat diet (formula: 78.5% ordinary diet, 10% lard, 10% egg yolk powder, 1% cholesterol, 0.5% bile salt) for 4 weeks, fasted for 12 hours after 4 weeks, and intraperitoneally injected with 450 mg·kg-1 of tylosin. 24 hours later, the TC value in the serum of the hyperlipidemia model mice was measured, and TC ≥ 5.2 mmol·L-1 indicated that the model was successfully established.

[0067] 2.2 Grouping and Dosing

[0068] Ninety mice were induced to develop a hyperlipidemia model according to the above method. Ten male mice were selected as a normal control group and fed a standard diet. The normal control group mice were intraperitoneally injected with an equal volume of normal saline (0.1 mL / 10 g). Eighty successfully induced hyperlipidemia model mice were randomly divided into eight groups of 10 (failed and redundant animals were excluded): a model group, a positive control group, and six groups receiving the composition. Each group of mice was dosed once daily for one week as follows: the positive control group was gavage-administered rosuvastatin ezetimibe tablets (2.0 mg / kg); the six composition groups were gavage-administered a suspension of the corresponding formulation at a dose of 0.15 g / kg (the composition was prepared with purified water to the corresponding concentration); and the normal control and model groups were gavage-administered with an equal volume of normal saline (0.1 mL / 10 g). After one week of continuous dosing, the mice were fasted for 12 hours, and orbital blood was collected. Serum was separated and stored at -80°C until further use, and various indicators were measured.

[0069] A. Normal control group: ordinary feed + equal volume of normal saline

[0070] B. Model control group high-fat diet + equal volume of normal saline

[0071] C. Positive control group: high-fat diet + rosuvastatin ezetimibe tablet solution (2 mg / kg / d)

[0072] D. Composition 1 high-fat feed + composition 1# solution

[0073] E. Composition 2 group high fat feed + composition 2# solution

[0074] F. Composition 3 group high fat feed + composition 3# solution

[0075] G. Composition 4 group high fat feed + composition 4# solution

[0076] H. Composition 5 group high fat feed + composition 5# solution

[0077] I. Composition 6 groups of high-fat feed + composition D1# solution

[0078] 3. Results

[0079] Determination of blood lipid levels: Blood was collected from the mouse orbits, serum was separated, and the levels of blood lipid indicators were detected using a kit. The test results are shown in Tables 1 and 2.

[0080] Table 1 Results of serum TC and TG levels in hyperlipidemic mice in each group (x±s, n=10)

[0081]

[0082]

[0083] *P<0.05, **P<0.01, compared with the blank group; #P<0.05, ##P<0.01, compared with the model group

[0084] Table 2 Results of serum LDL-C and HDL-C levels in hyperlipidemia mice in each group

[0085]

[0086] *P<0.05, **P<0.01, compared with the blank group; #P<0.05, ##P<0.01, compared with the model group

[0087] After modeling, the serum TC, TG, and LDL-C levels of the model group mice were significantly increased, and there was a significant difference compared with the normal control group (P<0.01), indicating that the hyperlipidemia model was successfully established. After one week of administration, the positive control group and the six dose groups of the composition were able to significantly reduce the serum TC, TG, and LDL-C levels of the hyperlipidemia mice, and at the same time increase the serum HDL-C level, and there was a significant difference compared with the model group (P<0.01 or P<0.05). The results show that: (1) The composition has a significant therapeutic effect on hyperlipidemia;

[0088] (2) The combination of rice bran fatty alkyl alcohol and (hawthorn + lotus leaf) has a synergistic effect. The composition of the present application can significantly improve the blood lipid level of male rats with hyperlipidemia.

[0089] Example 6 Preparation of Compressed Candy:

[0090] Tablet candy formula (1000 tablets):

[0091]

[0092]

[0093] Compositions 1# to 5# were respectively prepared into candies according to the above recipes and the following method.

[0094] Preparation method: Pre-mix erythritol and microcrystalline cellulose with components 1#-5#, then add silicon dioxide, citric acid, and steviol glycosides, mix well, and add mint flavoring. Add magnesium stearate (passed through an 80-mesh sieve), mix well, and press into tablets to obtain the product.

[0095] Although the present invention has been described in detail with reference to the aforementioned embodiments, it is still possible for those skilled in the art to modify the technical solutions described in the aforementioned embodiments, or to make equivalent substitutions for some of the technical features therein. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A composition for regulating blood lipids, characterized in that The invention is composed of 150-250 parts by weight of hawthorn, 150-250 parts by weight of lotus leaves, and 5-15 parts by weight of rice bran fatty alkanol. The preparation method is as follows: soak hawthorn and lotus leaves, extract them with water for several times, combine the extracts from each extraction, and then concentrate under reduced pressure to a density of 1.16 g / cm 3 , spray drying to obtain a combined extract, and mixing the obtained combined extract with rice bran fatty alkanol to obtain the composition for regulating blood lipids; The mass ratio of the combined extract to rice bran fatty alkanol is 82:5-15.

2. The composition for regulating blood lipids according to claim 1, characterized in that The mass ratio of the combined extract to rice bran fatty alkanol is 82:

10.

3. The composition for regulating blood lipids according to claim 1, characterized in that The invention is composed of 200 parts by weight of hawthorn, 200 parts by weight of lotus leaves and 10 parts by weight of rice bran fatty alkanol.

4. The composition for regulating blood lipids according to claim 1, characterized in that The soaking conditions are: immerse the hawthorn and lotus leaves in water at room temperature for 30 to 60 minutes.

5. The composition for regulating blood lipids according to claim 1, characterized in that Concentration under reduced pressure was carried out at 60°C.

6. The composition for regulating blood lipids according to claim 1, characterized in that The water extraction conditions are: add water after soaking, heat to 90-95℃, and extract for 2 hours.

7. The composition for regulating blood lipids according to claim 1, characterized in that The spray drying conditions are as follows: an inlet air temperature of 140-180°C, an outlet air temperature of 80-90°C, and a feed flow rate of 1.2 kg / min for spray drying.

8. The composition for regulating blood lipids according to claim 1, characterized in that The water extraction times were 2 times.

9. The composition for regulating blood lipids according to claim 1, characterized in that The composition is a solid oral preparation selected from tablets, capsules, granules or powders.

10. Use of the composition according to any one of claims 1 to 9 in preparing food for improving blood lipid levels.

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