Composition with function of facilitating in-vivo fat control or weight loss as well as preparation method and application of composition

Abstract

The invention relates to the technical field of food and / or medicine, and provides a composition beneficial to controlling body fat or losing weight as well as a preparation method and application of the composition, and the composition comprises the following raw materials in parts by weight: 1.8-2.8 parts of rhizoma curcumae longae; 1.8 to 2.8 parts of semen cassiae; 1.2 to 1.8 parts of hawthorn; 1.2 to 1.8 parts of lotus leaf; 1.2 to 1.8 parts of plantain herb; 0.6 to 0.9 part of folium sennae; 1.2 to 1.8 parts of white kidney bean extract and 1.2 to 1.8 parts of L-carnitine tartrate. The composition provided by the invention has a weight-losing effect, meets the new requirements of people on health, is beneficial to improving the life quality of people, and has a good market prospect.

Description

Technical Field

[0001] This invention relates to the field of food and / or pharmaceutical technology, specifically to a composition that helps control body fat or promote weight loss, its preparation method, and its application. Background Technology

[0002] Obesity is a chronic metabolic disease characterized by excessive fat accumulation in the body, reaching a level that endangers health. Its incidence has increased dramatically in recent years, with surveys showing that at least 500 million people worldwide are overweight. Obesity leads to metabolic and endocrine abnormalities and is often a significant contributing factor to various diseases, such as cardiovascular disease, type 2 diabetes, hyperlipidemia, hypertension, and stroke. The World Health Organization currently considers obesity one of the top ten diseases threatening human health, impacting not only quality of life but also placing a heavy burden on society.

[0003] Most weight loss products currently use laxatives, which generally have side effects. Common side effects include gastrointestinal discomfort, nausea, vomiting, increased flatulence, urgency to defecate, and steatorrhea (fatty stools). In severe cases, fecal incontinence may even occur. Weight loss through medication can lead to dependence, and weight rebounds immediately upon discontinuation.

[0004] Traditional Chinese medicine (TCM) weight loss, also known as natural drug weight loss, is widely promoted due to its low toxicity and side effects and natural health benefits. Current research shows that TCM therapy for obesity has few toxic side effects. By regulating the internal organs, it helps patients lose weight and improve their quality of life, and has gradually become a commonly used clinical treatment for obesity.

[0005] Therefore, seeking a safer, more effective, and long-term suitable weight-loss composition containing traditional Chinese medicine ingredients is of great practical significance. Summary of the Invention

[0006] The purpose of this invention is to provide a composition that helps control body fat or promote weight loss, as well as its preparation method and application.

[0007] To achieve the above-mentioned objectives, the present invention provides the following technical solution:

[0008] A composition having the function of helping to control body fat or lose weight comprises the following raw materials in parts by weight: 1.8 to 2.8 parts turmeric; 1.8 to 2.8 parts cassia seed; 1.2 to 1.8 parts hawthorn; 1.2 to 1.8 parts lotus leaf; 1.2 to 1.8 parts plantain; 0.6 to 0.9 parts senna leaf; 1.2 to 1.8 parts white kidney bean extract; and 1.2 to 1.8 parts L-carnitine tartrate.

[0009] Furthermore, the composition having the function of helping to control body fat or lose weight includes the following raw materials in parts by weight: 1.8 parts turmeric; 2.8 parts cassia seed; 1.2 parts hawthorn; 1.8 parts lotus leaf; 1.2 parts plantain; 0.9 parts senna leaf; 1.2 parts white kidney bean extract and 1.8 parts L-carnitine tartrate.

[0010] Furthermore, the composition having the function of helping to control body fat or lose weight includes the following raw materials in parts by weight: turmeric 2.8 parts; cassia seed 1.8 parts; hawthorn 1.8 parts; lotus leaf 1.2 parts; plantain 1.8 parts; senna leaf 0.6 parts; white kidney bean extract 1.8 parts and L-carnitine tartrate 1.2 parts.

[0011] Furthermore, the composition having the function of helping to control body fat or lose weight includes the following raw materials in parts by weight: turmeric 2.3 parts; cassia seed 2.3 parts; hawthorn 1.5 parts; lotus leaf 1.5 parts; plantain 1.5 parts; senna leaf 0.75 parts; white kidney bean extract 1.5 parts and L-carnitine tartrate 1.5 parts.

[0012] The present invention also provides a method for preparing the above-mentioned composition having the function of helping to control body fat or lose weight, comprising the following steps:

[0013] (1) Take turmeric, cassia seed, lotus leaf, hawthorn, plantain and senna leaf, add water and reflux extract twice, filter and obtain extract;

[0014] (2) The extract was concentrated under reduced pressure to a relative density of 1.05-1.15 (60℃) to obtain an extract, which was then dried to obtain a dry extract;

[0015] (3) Crush the dry paste, sieve it to obtain dry paste powder, crush L-carnitine tartrate, sieve it to obtain L-carnitine tartrate powder.

[0016] (4) The obtained dry powder, L-carnitine tartrate powder and white kidney bean extract together constitute the composition.

[0017] Further, in step (1), the extraction time is 1.0 to 2.0 hours each time, and 8 to 10 times the amount of water is added each time; in step (2), the temperature for vacuum concentration is 50 to 80°C, and the vacuum degree is 0.03 to 0.09 MPa; in step (2), the drying method is vacuum oven drying, the temperature is 60 to 80°C, and the vacuum degree is 0.04 to 0.10 MPa; or the drying method is vacuum belt drying, the heating plate temperature is 110 to 120°C, and the vacuum degree is 0.04 to 0.10 MPa, and the moisture content of the obtained dry paste is ≤7.0%.

[0018] Furthermore, in step (2), the yield of the obtained dry extract is 15% to 21%; each gram of the obtained dry extract contains an equivalent amount of raw medicinal material of 4.76 to 6.67 grams.

[0019] The present invention also provides an application of the above composition having the function of helping to control body fat or lose weight in the preparation of drugs, health foods or functional foods.

[0020] In addition, the present invention also provides a health food, comprising the above composition having the function of helping to control body fat or lose weight.

[0021] Furthermore, the dosage form of the health food is a granule, a tablet or a capsule.

[0022] Under the guidance of traditional Chinese medicine theory and combined with modern medical theory, the present invention designs the above composition having the function of helping to control body fat or lose weight, which is composed of turmeric, cassia seed, lotus leaf, hawthorn, plantain herb, senna leaf, white kidney bean extract and L-carnitine tartrate. The compatibility mechanism of monarch, minister, assistant and envoy is as follows:

[0023] Monarch drug turmeric: pungent, bitter, warm. It belongs to the spleen and liver meridians. It has the effects of promoting blood circulation and qi movement, dredging meridians and reducing fat. "Modern Practical Chinese Medicine": "It is an aromatic stomachic and has a disinfection effect on the biliary tract and liver." Turmeric enters the spleen meridian to strengthen the spleen and dredge the meridians, enters the liver meridian to promote blood circulation and qi movement. Aromatic strengthening of the spleen makes the meridians unobstructed, the pivot smooth and the body light.

[0024] Minister drug cassia seed: sweet, bitter, salty, slightly cold. It belongs to the liver and large intestine meridians. It has the effects of clearing heat and moistening the intestines, reducing fat and relieving constipation. "Common Chinese Herbal Medicine Handbook": "Clearing the liver and improving eyesight, promoting diuresis and relieving constipation." Cassia seed is a wonderful product for clearing heat and moistening the intestines, reducing fat and relieving constipation. It can interfere with the absorption of fat and carbohydrates and is one of the most commonly used drugs for weight loss. Cassia seed has the effects of promoting gastrointestinal motility and removing internal stools. Combined with turmeric, it plays the roles of reducing blood lipid, losing weight and relieving constipation.

[0025] Minister drug lotus leaf: bitter, flat. It belongs to the liver, spleen and stomach meridians. It has the effects of strengthening the spleen and removing dampness, reducing fat and moistening the intestines, reducing lipid and losing weight. "Compendium of Materia Medica": "Generating primordial qi and benefiting the spleen and stomach." "General Treatise on the Understanding of Herbs": "Promoting digestion and appetizing, stopping bleeding and astringing essence." "Essentials of Treatment": "Taking lotus leaf makes people thin and weak. Taking it alone can eliminate the qi of yang edema." Lotus leaf enters the spleen, stomach and liver meridians and has the effect of strengthening the spleen and removing dampness. It is effective for spleen deficiency and dampness obstruction or stomach heat and dampness obstruction caused by obesity. Combined with the monarch drug, it plays the roles of strengthening the spleen and promoting diuresis, reducing swelling and fat.

[0026] Hawthorn, a primary ingredient: sour, sweet, and slightly warm in nature. It enters the spleen, stomach, and liver meridians. It has the effects of strengthening the stomach and aiding digestion, as well as reducing fat and promoting weight loss. Hawthorn's enhanced digestive and relieving effects are often used for indigestion caused by excessive meat consumption, and for incomplete diarrhea. *Daily Materia Medica* states: "It resolves food stagnation, promotes the flow of qi, strengthens the stomach and widens the diaphragm, and eliminates blood stasis and lumps." *Yunnan Materia Medica* states: "It resolves meat stagnation, lowers qi; treats acid reflux and lumps." *Compendium of Materia Medica* states: "It resolves food stagnation, eliminates meat stagnation, treats abdominal masses, phlegm retention, abdominal distension, acid reflux, and blood stasis with pain and distension." *New Materia Medica* states: "It treats spleen deficiency with damp heat, resolves food stagnation, and promotes urination and defecation." Hawthorn has the effects of resolving food stagnation, strengthening the spleen, and promoting bowel movements. Its lipase content promotes the digestion of fatty foods, and when combined with lotus leaves, it enhances the effects of strengthening the spleen, aiding digestion, and reducing fat and promoting weight loss.

[0027] Plantain (Plantago asiatica): Sweet, cold. Enters the liver, kidney, lung, and small intestine meridians. Has diuretic and digestive effects. The *Diannan Materia Medica* states: "Clears stomach heat, promotes urination, and reduces edema." Traditional Chinese medicine theory indicates that "obese people often have phlegm and dampness," and "obese white people often have dampness." Plantain enters the liver and kidney meridians, possessing diuretic, dampness-removing, phlegm-reducing, and swelling-reducing effects. Combined with other herbs, it strengthens the spleen, promotes diuresis, dries dampness, and resolves phlegm, helping to regulate the internal organs and endocrine system, improving blood circulation, eliminating excess water, metabolic waste, and toxins, and accelerating metabolism.

[0028] Senna leaves, used as an adjuvant: sweet, bitter, and cold in nature. It enters the large intestine meridian. It has the effects of promoting bowel movement, reducing fat, and facilitating urination. *New Compendium of Medicinal Herbs* states: "It clears heat, benefits the intestines, and promotes bowel movements." *Modern Practical Chinese Medicine* states: "It treats food stagnation, abdominal distension, and constipation." Obesity is often caused by excessive consumption of sweet and fatty foods, leading to stagnation of oily substances in the gastrointestinal tract. Senna leaves, entering the large intestine meridian, can regulate bowel movements, promote urination, and reduce fat.

[0029] White kidney bean extract: White kidney bean extract can be used in nutritional health foods for weight management and blood sugar management. It has effects such as starch blocking, blood sugar regulation assistance, spleen and stomach strengthening, and optimized digestive function.

[0030] This invention utilizes medicinal herbs that are both food and medicine, known for their lipid-lowering and weight-loss effects. The principal herb, turmeric, is aromatic and strengthens the spleen. It is paired with the assistant herbs, cassia seed, which clears heat, moistens the intestines, reduces fat, and promotes bowel movements. Lotus leaf aids the spleen and stomach, and reduces edema. Hawthorn promotes digestion, strengthens the stomach, regulates qi, disperses blood stasis, and reduces turbidity and lipids, assisting and enhancing the spleen-strengthening and fat-reducing effects of turmeric. The adjuvant herbs, plantain and senna leaf, promote urination and bowel movements, further enhancing the diuretic and laxative effects of the principal and assistant herbs. The combined effects of all the herbs work by strengthening the spleen, resolving phlegm, and promoting bowel movements. Through methods of promoting digestion and purging, it adjusts the body's organs to restore their original functions, converting excess body fat into energy and promoting energy metabolism, thereby achieving healthy weight loss.

[0031] Compared to existing technologies, the composition provided by this invention, which helps control body fat or promote weight loss, is composed of a dry extract powder of water extracts of turmeric, cassia seed, lotus leaf, hawthorn, plantain, and senna leaf, combined with L-carnitine tartrate powder and white kidney bean extract in a specific ratio. This composition can reduce the body weight and fat mass of model rats. The components exhibit a synergistic effect, resulting in a composition that helps control body fat. The composition provided by this invention, as an active ingredient, can be used in the preparation of foods, health foods, or pharmaceuticals with weight-loss effects, meeting people's new health needs, helping to improve their quality of life, and possessing excellent market development prospects. Attached Figure Description

[0032] Figure 1 The data refers to the body weight of mice in Experiment Example 2 of this invention;

[0033] Figure 2 This is a Micro-CT image of visceral fat and subcutaneous fat in mice in Experiment Example 2 of this invention;

[0034] Figure 3 This refers to the fat volume index of mice in Experiment Example 2 of this invention. Detailed Implementation

[0035] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0036] Example 1

[0037] A composition that helps control body fat or promotes weight loss is made from the following ingredients in parts by weight: 230g turmeric; 230g cassia seed; 150g hawthorn; 150g lotus leaf; 150g plantain; 75g senna leaf; 150g white kidney bean extract; and 150g L-carnitine tartrate.

[0038] The preparation method of this composition, which helps control body fat or promote weight loss, is as follows:

[0039] (1) Weigh out turmeric, cassia seed, lotus leaf, hawthorn, plantain and senna leaf according to the formula ratio, add water and reflux twice, each time for 1.5 hours, add 9 times the amount of water each time, filter and obtain the extract;

[0040] (2) The extract was concentrated under reduced pressure (concentration temperature was 60℃, vacuum degree was 0.06MPa) to a relative density of 1.05~1.15 (60℃) to obtain an extract. The extract was dried in a vacuum oven at 60℃ and vacuum degree was 0.09MPa to obtain a dry extract (moisture content ≤7.0%).

[0041] (3) Crush the dry paste and sieve it (sieve mesh: 80 mesh) to obtain dry paste powder. Crush L-carnitine tartrate and sieve it (sieve mesh: 80 mesh) to obtain L-carnitine tartrate powder.

[0042] (4) The obtained dry powder, L-carnitine tartrate powder and white kidney bean extract together constitute the composition.

[0043] Example 2

[0044] A composition having the function of helping to control body fat or lose weight comprises the following ingredients in parts by weight: 180g turmeric; 280g cassia seed; 120g hawthorn; 180g lotus leaf; 120g plantain; 90g senna leaf; 120g white kidney bean extract; and 180g L-carnitine tartrate.

[0045] The preparation method of this composition, which helps control body fat or promote weight loss, is as follows:

[0046] (1) Weigh out turmeric, cassia seed, lotus leaf, hawthorn, plantain and senna leaf according to the formula ratio, add water and reflux extract twice, each time for 1.0 hour, add 10 times water each time, filter to obtain extract;

[0047] (2) The extract was concentrated under reduced pressure (concentration temperature was 80℃, vacuum degree was 0.03MPa) to a relative density of 1.05~1.15 (60℃) to obtain an extract. The extract was dried in a vacuum oven at 80℃ and vacuum degree was 0.04MPa to obtain a dry extract (moisture content ≤7.0%).

[0048] (3) Crush the dry paste and sieve it (sieve mesh: 80 mesh) to obtain dry paste powder. Crush L-carnitine tartrate and sieve it (sieve mesh: 80 mesh) to obtain L-carnitine tartrate powder.

[0049] (4) The obtained dry powder, L-carnitine tartrate powder and white kidney bean extract together constitute the composition.

[0050] Example 3

[0051] A composition having the function of helping to control body fat or lose weight comprises the following ingredients in parts by weight: 280g turmeric; 180g cassia seed; 180g hawthorn; 120g lotus leaf; 180g plantain; 60g senna leaf; 180g white kidney bean extract; and 120g L-carnitine tartrate.

[0052] The preparation method of this composition, which helps control body fat or promote weight loss, is as follows:

[0053] (1) Weigh out turmeric, cassia seed, lotus leaf, hawthorn, plantain and senna leaf according to the formula ratio, add water and reflux extract twice, each time for 2.0 hours, add 8 times the amount of water each time, filter to obtain extract;

[0054] (2) The extract was concentrated under reduced pressure (concentration temperature was 50℃, vacuum degree was 0.09MPa) to a relative density of 1.05~1.15 (60℃) to obtain an extract. The extract was then dried under vacuum belt drying at a heating plate temperature of 120℃ and a vacuum degree of 0.04Mpa to obtain a dry extract (moisture content ≤7.0%).

[0055] (3) Crush the dry paste and sieve it (sieve mesh: 80 mesh) to obtain dry paste powder. Crush L-carnitine tartrate and sieve it (sieve mesh: 80 mesh) to obtain L-carnitine tartrate powder.

[0056] (4) The obtained dry powder, L-carnitine tartrate powder and white kidney bean extract together constitute the composition.

[0057] Example 4

[0058] A composition having the function of helping to control body fat or lose weight comprises the following ingredients in parts by weight: 230g turmeric; 230g cassia seed; 150g hawthorn; 150g lotus leaf; 150g plantain; 75g senna leaf; 150g white kidney bean extract; and 150g L-carnitine tartrate.

[0059] The preparation method of this composition, which helps control body fat or promote weight loss, is as follows:

[0060] (1) Weigh out turmeric, cassia seed, lotus leaf, hawthorn, plantain and senna leaf according to the formula ratio, add water and reflux extract twice. The first extraction is 1.8 hours and 10 times the amount of water is added. The second extraction is 1.2 hours and 8 times the amount of water is added. Filter to obtain the extract.

[0061] (2) The extract was concentrated under reduced pressure (concentration temperature was 65℃, vacuum degree was 0.08MPa) to a relative density of 1.05~1.15 (60℃) to obtain an extract. The extract was then dried under vacuum belt drying at a heating plate temperature of 110℃ and a vacuum degree of 0.08MPa to obtain a dry extract (moisture content ≤7.0%).

[0062] (3) Crush the dry paste and sieve it (sieve mesh: 80 mesh) to obtain dry paste powder. Crush L-carnitine tartrate and sieve it (sieve mesh: 80 mesh) to obtain L-carnitine tartrate powder.

[0063] (4) The obtained dry powder, L-carnitine tartrate powder and white kidney bean extract together constitute the composition.

[0064] Example 5

[0065] A health food product comprising the composition obtained in Example 1, which has the function of helping to control body fat or lose weight.

[0066] The composition, which helps control body fat or promotes weight loss, is combined with necessary excipients and formulated into tablets using conventional Chinese medicine preparation methods.

[0067] Example 6

[0068] A health food product comprising the composition obtained in Example 2, which has the function of helping to control body fat or lose weight.

[0069] The composition, which helps control body fat or promotes weight loss, is combined with necessary excipients and prepared into granules using conventional Chinese medicine preparation methods.

[0070] Example 7

[0071] A health food product comprising the composition obtained in Example 3, which has the function of helping to control body fat or lose weight.

[0072] The composition, which helps control body fat or promotes weight loss, is combined with necessary excipients and formulated into capsules using conventional Chinese medicine preparation methods.

[0073] Comparative Example 1

[0074] A composition, compared to Example 1, with the removal of plantain and white kidney bean extracts, is specifically made from the following raw materials in parts by weight: 230g turmeric; 230g cassia seed; 150g hawthorn; 150g lotus leaf; 75g senna leaf and 150g L-carnitine tartrate.

[0075] The preparation method of this composition, which helps control body fat or promote weight loss, is as follows:

[0076] (1) Weigh out turmeric, cassia seed, lotus leaf, hawthorn and senna leaf according to the formula ratio, add water and reflux extract twice, each time for 1.5 hours, add 9 times the amount of water each time, filter to obtain extract;

[0077] (2) The extract was concentrated under reduced pressure (concentration temperature was 60℃, vacuum degree was 0.06MPa) to a relative density of 1.05~1.15 (60℃) to obtain an extract. The extract was dried in a vacuum oven at 60℃ and vacuum degree was 0.09MPa to obtain a dry extract (moisture content ≤7.0%).

[0078] (3) Crush the dry paste and sieve it (sieve mesh: 80 mesh) to obtain dry paste powder. Crush L-carnitine tartrate and sieve it (sieve mesh: 80 mesh) to obtain L-carnitine tartrate powder.

[0079] (4) The obtained dry powder and L-carnitine tartrate powder together constitute the composition.

[0080] Comparative Example 2

[0081] A composition, compared to Example 1, in which plantain is replaced with mulberry leaf and white kidney bean extract is replaced with button mushroom extract, is specifically made from the following raw materials in parts by weight: 230g turmeric; 230g cassia seed; 150g hawthorn; 150g lotus leaf; 150g mulberry leaf; 75g senna leaf; 40g button mushroom extract and 150g L-carnitine tartrate.

[0082] The preparation method of this composition, which helps control body fat or promote weight loss, is as follows:

[0083] (1) Weigh out turmeric, cassia seed, lotus leaf, hawthorn, mulberry leaf and senna leaf according to the formula ratio, add water and reflux twice, each time for 1.5 hours, add 9 times the amount of water each time, filter and obtain the extract;

[0084] (2) The extract was concentrated under reduced pressure (concentration temperature was 60℃, vacuum degree was 0.06MPa) to a relative density of 1.05~1.15 (60℃) to obtain an extract. The extract was dried in a vacuum oven at 60℃ and vacuum degree was 0.09MPa to obtain a dry extract (moisture content ≤7.0%).

[0085] (3) Crush the dry paste and sieve it (sieve mesh: 80 mesh) to obtain dry paste powder. Crush L-carnitine tartrate and sieve it (sieve mesh: 80 mesh) to obtain L-carnitine tartrate powder.

[0086] (4) The obtained dry powder, L-carnitine tartrate powder and button mushroom extract together constitute the composition.

[0087] Comparative Example 3

[0088] A composition, compared to Example 1, in which plantain is replaced with Alisma plantago-aquatica, white kidney bean extract is replaced with epigallocatechin gallate (EGCG), and senna leaf is replaced with ginkgo leaf, is specifically made from the following ingredients in parts by weight: turmeric 230g; cassia seed 230g; hawthorn 150g; lotus leaf 150g; Alisma plantago-aquatica 150g; ginkgo leaf 75g; epigallocatechin gallate (EGCG) 20g and L-carnitine tartrate 150g.

[0089] The preparation method of this composition, which helps control body fat or promote weight loss, is as follows:

[0090] (1) Weigh out turmeric, cassia seed, lotus leaf, hawthorn, alisma and ginkgo leaf according to the formula ratio, add water and reflux twice, each time for 1.5 hours, add 9 times the amount of water each time, filter and obtain the extract;

[0091] (2) The extract was concentrated under reduced pressure (concentration temperature: 60 °C, vacuum degree: 0.06 MPa) to a relative density of 1.05 - 1.15 (60 °C) to obtain an extract paste, and the extract paste was dried in a vacuum oven at a temperature of 60 °C and a vacuum degree of 0.09 Mpa. After drying, a dry paste was obtained (moisture content ≤ 7.0%);

[0092] (3) The dry paste was pulverized and sieved (sieve mesh size: 80 mesh) to obtain dry paste powder, and L-carnitine tartrate was pulverized and sieved (sieve mesh size: 80 mesh) to obtain L-carnitine tartrate powder;

[0093] (4) The obtained dry paste powder, L-carnitine tartrate powder and EGCG together constituted the composition.

[0094] Test Example 1

[0095] In order to better verify the characteristics of the composition of the present invention, an animal experiment study on the weight loss function of the composition of Example 1 was carried out.

[0096] 1. Materials

[0097] 1.1 Experimental materials

[0098] The test substance was composed of a compound Chinese medicine extract of turmeric, cassia seed, hawthorn, lotus leaf, plantain herb, and senna leaf, L-carnitine tartrate, and white kidney bean extract. Among them, the compound Chinese medicine extract of turmeric, cassia seed, hawthorn, lotus leaf, plantain herb, and senna leaf was from Shijiazhuang Yiling Pharmaceutical Co., Ltd., L-carnitine tartrate was provided by Kaiyuan Hengtai Nutrition Technology Co., Ltd., and white kidney bean extract was from Yunnan Tianbao Hua Bio-Resources Development Co., Ltd. The preparation method of the extract was: turmeric, cassia seed, hawthorn, lotus leaf, plantain herb, and senna leaf were decocted with water to obtain it, and each gram of the extract contained 5.24 g of crude drug. High-calorie model feed (provided by Jiangsu Xietong Pharmaceutical Bioengineering Co., Ltd., adding 15% sucrose, 15% lard, appropriate amounts of casein, calcium hydrogen phosphate, stone powder, etc. to the maintenance feed), animal balance, dissection instruments, sodium pentobarbital.

[0099] 1.2 Experimental animals

[0100] 85 SPF-grade SD healthy male rats provided by Shanghai Slake Experimental Animal Co., Ltd. were selected. The production license number of the experimental animals was SCXK (Shanghai) 2017 - 0005, and the certificate number was 20170005072144.

[0101] 2. Methods

[0102] 2.1 Animal grouping, model establishment and dosage of administration

[0103] 2.1.1 Grouping and model establishment

[0104] After 7 days of observation under the barrier system, rats were randomly divided into two groups according to their body weight. Ten rats were given a maintenance diet as a blank control group, while the remaining 75 rats were given a high-calorie model diet. Food intake, spilled food, and uneaten food were recorded weekly, and body weight was measured. After 2 weeks of feeding, rats given the high-calorie diet were ranked according to weight gain. The obese resistant rats with the lowest weight gain were culled, and 50 obese sensitive rats were selected and given a high-calorie diet for another 6 weeks. The blank control group was given a maintenance diet concurrently.

[0105] Fifty obese-sensitive rats were randomly divided into a model control group and four experimental groups (n=10 per group). One experimental group received the test substance corresponding to the composition prepared according to Example 1 of this invention. Only data related to Example 1 are shown in this invention, i.e., the data from the Example 1 group. Feed intake, spilled feed, and uneaten feed were recorded weekly, and rats were weighed once a week. The model control group and each experimental group were fed a high-calorie model diet, while each experimental group was administered the test sample via gavage for six consecutive weeks.

[0106] 2.1.2 Dosage setting and sample preparation

[0107] The dosage for this experiment was designed based on the daily dose of raw medicinal materials. During the experiment, the dosage was converted to the extract and administered by gavage at 10 times the human dose.

[0108] The experimental groups were administered gavage at a dose of 0.81 g / kg, while the blank group and the model group were given the same volume of sterile water. The rats in each dose group were administered gavage at a dose of 10 mL / kg body weight, as shown in the table below, once a day for 6 consecutive weeks.

[0109] Table 1

[0110] Group Blank control group Model control group Example 1 Group Dosage (g / kg·bw) 0 0 0.81 Preparation concentration mg / mL 0 0 81

[0111] 2.2 Indicator Testing

[0112] Record the animals' weight weekly, calculate weight gain, food intake, and total calorie intake (food intake × calories per kilogram of feed). At the end of the 6th week, anesthetize the animals with 1% sodium pentobarbital (0.5 mL / 100 g BW), dissect them, and collect the perirenal fat and peritesticular fat, and weigh them.

[0113] 2.3 Statistical Processing

[0114] Data from each group are expressed as mean ± standard deviation (%) The results indicate that statistical analysis was performed using SPSS 15.0 statistical software and a t-test, with a significance level of P < 0.05.

[0115] 3 Results

[0116] 3.1 Body weight and weight gain of rats after modeling

[0117] Table 2 shows that there was no statistically significant difference in initial body weight between the blank control group and the model group (P > 0.05), indicating that the initial body weight of the rats was relatively balanced among the groups. At the end of 2 weeks of modeling, the body weight and total weight gain of the selected model rats were higher than those of the blank control group (P < 0.05), indicating that the selected rats were obesity-sensitive. At the end of 6 weeks of modeling, the body weight and total weight gain of the selected model rats were higher than those of the blank control group, and the difference was statistically significant (P < 0.05), indicating successful modeling (see Table 3).

[0118] Table 2. Body weight and weight gain of rats at the end of 2 weeks of modeling ( )

[0119]

[0120] Table 3. Body weight and weight gain of rats at the end of 6 weeks of modeling ( )

[0121]

[0122] Note: Compared with the blank control group, ** indicates P < 0.01, * indicates P < 0.05.

[0123] 3.2 Effects of the test sample on weight gain in rats

[0124] As shown in Table 4, there was no difference in body weight among the rats before the experiment. As the experiment progressed, the weight gain of the rats in each group changed. The weight gain of the model control group in week 2 was higher than that of the blank control group (P < 0.05). The weight gain and total weight gain of the Example 1 group in week 3 were both lower than those of the model control group (P < 0.05), indicating that the Example 1 group was effective after 3 weeks of gavage administration of the test sample.

[0125] Table 4. Effects of the tested samples on weight gain in rats ( )

[0126]

[0127] Note: Compared with the model control group, ** indicates P < 0.01, and * indicates P < 0.05.

[0128] 3.3 Effects of the test samples on food intake, food utilization rate and caloric intake in rats

[0129] As shown in Table 5, there were no significant differences in weekly food intake and total food intake between the model control group and the blank control group (P > 0.05). There were also no significant differences in weekly food intake and total food intake between the Example 1 group and the model control group, indicating that administering the test sample to the obese rats in the Example 1 group had no effect on their food intake.

[0130] In week 2, the food utilization rate and total food utilization rate of the model control group were higher than those of the blank control group (P < 0.05). In week 3, the food utilization rate and total food utilization rate of the Example 1 group were lower than those of the model control group (P < 0.05); the total calorie intake of rats in the model control group was higher than that of the blank control group (P < 0.05), while there was no significant difference in total calorie intake between the Example 1 group and the model control group (P > 0.05). The effects of the test samples on food utilization rate and calorie intake of rats are shown in Table 6.

[0131] Table 5. Effects of the test samples on food intake in rats ( )

[0132]

[0133] Table 6. Effects of the tested samples on food utilization and calorie intake in rats ( )

[0134]

[0135] 3.4 Effects of the test sample on body fat in rats

[0136] In Example 1, after oral administration of the test sample to rats for 6 weeks, the weight of peritesticular and perirenal fat in the rats was measured. As shown in Table 7, the peritesticular and perirenal fat weight of the rats in the model control group was higher than that in the blank control group (P < 0.05), while the peritesticular and perirenal fat weight of the rats in Example 1 group was lower than that in the model control group, and the difference was statistically significant (P < 0.05).

[0137] Table 7. Effects of the tested samples on body fat in rats ( )

[0138]

[0139]

[0140] 4. Conclusion

[0141] This study was conducted strictly in accordance with the weight-loss function evaluation method in Appendix 8 of the State Food and Drug Administration's document

[2012] No. 107. Different doses of a compound of traditional Chinese medicine extracts—turmeric, cassia seed, hawthorn, lotus leaf, plantain, and senna leaf—were combined with two modern nutritional components: L-carnitine tartrate and white kidney bean extract. The results, tested in an obese rat model, demonstrated that the composition of this invention helps control body fat. The addition of a certain amount of L-carnitine tartrate and white kidney bean extract to the composition significantly improved the weight-loss effect. L-carnitine tartrate is a stable compound existing in the form of L-carnitine salt. L-carnitine is closely related to the metabolism of human organs and tissues, and can improve the body's utilization of fat and promote fat decomposition. L-carnitine acts as a carrier, transporting medium- and long-chain fatty acids from the extramitochondrial membrane to the intramitochondrial membrane in the form of acylcarnitine, where they undergo β-oxidation in the mitochondrial matrix to achieve the effect of fat degradation. The α-amylase inhibitor in white kidney bean extract can block the digestion and absorption of starchy foods, and reduce the conversion of carbohydrates into lipids by regulating lipid metabolism disorders, thereby promoting fat consumption and achieving the effect of weight loss.

[0142] Experimental Example 2

[0143] To further verify the weight loss efficacy of the composition of the present invention, an obese mouse model was used, and the changes in subcutaneous fat and visceral fat in each group of mice were observed using Micro-CT imaging technology. The study verified the functional role of the compositions corresponding to Example 1 and Comparative Examples 1 to 3 in controlling body fat.

[0144] 1. Materials

[0145] 1.1 Sample

[0146] 1.1.1 Sample components: The compositions prepared according to Example 1 and Comparative Examples 1 to 3;

[0147] 1.1.2 Dosage: The dosage in this experiment was designed based on the daily intake of raw medicinal materials. The dosage was converted to the extract dosage during the experiment, as detailed below:

[0148] Table 8

[0149]

[0150]

[0151] Note: The extraction rate of the Chinese herbal medicine was 19.2% in Example 1, 17.6% in Comparative Example 1, 18.3% in Comparative Example 2, and 20.4% in Comparative Example 3.

[0152] 1.2 Main Instruments and Reagents

[0153] Dissection instruments;

[0154] DT2000 Electronic Balance, Shuangjie Instrument Testing Factory, Changshu City, Jiangsu Province;

[0155] ME104E Mettler Precision Balance, Mettler-Toledo Instruments (Shanghai) Co., Ltd.;

[0156] Sodium Pentobarbital, Merck Group, Batch No. P11011;

[0157] Normal Saline, Shijiazhuang No. 4 Pharmaceutical Co., Ltd., Batch No. 2301273204;

[0158] Quantum GX2 Micro-CT Small Animal In-Vivo Imaging System, Shanghai PerkinElmer Instruments Co., Ltd.

[0159] 1.3 High-Calorie Model Feed

[0160] Add 15.0% sucrose, 15.0% lard, and appropriate amounts of casein, etc. to the maintenance feed. Except for crude fat, the moisture, crude protein, crude fat, crude fiber, crude ash, calcium, phosphorus, and calcium:phosphorus of the model feed meet the national standards of the maintenance feed.

[0161] 1.4 Experimental Animals

[0162] Select 85 healthy adult male SPF-grade mice, provided by Beijing Vital River Laboratory Animal Technology Co., Ltd. The production license number of the experimental animals is SCXK (Beijing) 2021-0006, the certificate number is 110011231109690916, and the animal ethics number is N2023139.

[0163] 2. Experimental Methods

[0164] 2.1 Grouping and Administration

[0165] 2.1.1 Grouping and Modeling

[0166] The experimental animals are fed with maintenance feed in the central barrier system at a temperature of 20°C - 26°C and a relative humidity of 40% - 70% for 7 days (adaptation period). The experimental animal use license number is SYXK (Hebei) 2020-003. The irradiated and sterilized maintenance feed for experimental mice is provided by Beijing Huafukang Biotech Co., Ltd., and the production license is Jing Si Zheng (2018) 06073.

[0167] After the adaptation period, the animals are randomly grouped by body weight into a blank control group and a model group. 10 mice are given maintenance feed as the blank control group, and 75 mice are given high-calorie model feed as the model group. Record the food intake, scattered food amount, and remaining food amount once a week, and weigh the body weight once a week.

[0168] After two weeks of feeding, the 75 model group mice fed a high-calorie diet were ranked according to their weight gain, and the obese resistant mice with the lowest weight gain were eliminated. The 50 obese sensitive mice selected were then fed a high-calorie model diet for another 6 weeks, while the blank control group was fed a maintenance diet.

[0169] After the modeling period, 50 obese-sensitive mice were randomly divided into 5 groups according to their body weight: a model control group and four subgroups (corresponding to Example 1, Comparative Example 1, Comparative Example 2, and Comparative Example 3, respectively). Food intake, spilled food, and uneaten food were recorded weekly, and body weight was measured once a week. The model control group and the four subgroups (n=10 per group) were given a high-calorie model diet, while the blank control group (n=10) was given a maintenance diet. The four subgroups were administered the test sample via gavage, while the model control group and the blank control group were given an equal volume of the corresponding solvent. The test sample was administered for 6 weeks.

[0170] 2.1.2 Dosage and Sample Preparation

[0171] The mice were divided into six groups: a blank control group, a model control group, and six comparative groups: Example 1, Comparative Example 1, Comparative Example 2, and Comparative Example 3. Each group contained 10 mice, and the sample dose was equivalent to 10 times the recommended human dose, as shown in the table below.

[0172] Table 9

[0173]

[0174] The sample preparation is shown in the table below.

[0175] Table 10

[0176]

[0177] The test sample was administered for 6 weeks by gavage once daily.

[0178] 2.2 Indicator Testing

[0179] Body weight, weight gain, food intake, total calories ingested (food intake × calories per kilogram of feed), food utilization rate, body fat weight (testicular and perirenal fat pads), and fat / body weight. Micro-CT monitoring.

[0180] After the experiment, the body weight was measured, and the patient was anesthetized with 1% sodium pentobarbital (0.5ml / 100g BW). The perirenal fat and peritesticular fat were dissected, weighed, and the fat / body ratio was calculated.

[0181] Weight data collection:

[0182] Mouse weight data were collected weekly. After 6 weeks, the mice were weighed and then anesthetized by an abdominal injection of 1% sodium pentobarbital (0.5 ml / 100 g BW).

[0183] Micro-CT monitoring:

[0184] After anesthetizing the mice, they were scanned using a Micro-CT scanner. The scanning parameters were as follows: scanning voltage 90kV, current 88μA, imaging field of view 36mm×36mm, detector mode High resolution, scan time 4min, and abdominal adipose tissue selected as the region of interest (ROI). After scanning, the image analysis software (Caliper Analyze 12.0) included with the Micro-CT was used to perform 3D reconstruction and volume measurement of the adipose tissue image. All volume parameters were standardized for overall mass, i.e., fat volume index = fat volume (mm²). 3 ) / body weight (g).

[0185] 3. Results

[0186] 3.1 Effects on mouse body weight

[0187] After 12 weeks of intervention, the body weight data of mice in each group were measured, as follows: Figure 1 As shown, compared with the model control group, the weight of mice in Example 1 and Comparative Examples 1-3 was significantly reduced, and the weight reduction effect of Example 1 was more significant, indicating that the composition of the present invention has the function of weight loss.

[0188] 3.2 Effects on visceral and subcutaneous fat accumulation in mice

[0189] Micro-CT enables visualization of visceral and subcutaneous fat in mice, such as... Figure 2 As shown, the black (green) portion represents visceral fat, and the gray (yellow) portion represents subcutaneous fat. Compared with the model control group, the Example 1 group and the Comparative Examples 2 and 3 groups significantly reduced visceral fat and / or subcutaneous fat in mice; Figure 3 As shown, compared with the model control group, the fat volume index (fat specific gravity) of mice was significantly reduced in Example 1 group and Comparative Examples 2 and 3 groups, with the effect of Example 1 group being more significant. This indicates that the composition of the present invention has the function of controlling body fat.

[0190] The data above shows that this invention uses traditional Chinese medicines such as turmeric, cassia seed, hawthorn, lotus leaf, plantain, and senna leaf as the basic formula, and adds L-carnitine tartrate and white kidney bean extract, which can have a synergistic effect on weight loss. The composition provided by this invention achieves a synergistic effect in controlling body fat (visceral fat and subcutaneous fat) by compounding specific components in a specific ratio. It can be applied to the preparation of health foods, functional foods, or medicines that help control body fat or promote weight loss, thus meeting people's daily needs for health.

[0191] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions or improvements made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A composition having the function of helping to control body fat or lose weight, characterized in that, The ingredients include the following parts by weight: turmeric 1.8–2.8 parts; cassia seed 1.8–2.8 parts; hawthorn 1.2–1.8 parts; lotus leaf 1.2–1.8 parts; plantain 1.2–1.8 parts; senna leaf 0.6–0.9 parts; white kidney bean extract 1.2–1.8 parts; and L-carnitine tartrate 1.2–1.8 parts.

2. The composition as described in claim 1, which has the function of helping to control body fat or lose weight, is characterized in that, The ingredients include the following parts by weight: 1.8 parts turmeric; 2.8 parts cassia seed; 1.2 parts hawthorn; 1.8 parts lotus leaf; 1.2 parts plantain; 0.9 parts senna leaf; 1.2 parts white kidney bean extract; and 1.8 parts L-carnitine tartrate.

3. The composition as described in claim 1, which has the function of helping to control body fat or lose weight, is characterized in that... The ingredients include the following parts by weight: turmeric 2.8 parts; cassia seed 1.8 parts; hawthorn 1.8 parts; lotus leaf 1.2 parts; plantain 1.8 parts; senna leaf 0.6 parts; white kidney bean extract 1.8 parts and L-carnitine tartrate 1.2 parts.

4. The composition as described in claim 1, which has the function of helping to control body fat or lose weight, is characterized in that, The ingredients include the following parts by weight: turmeric 2.3 parts; cassia seed 2.3 parts; hawthorn 1.5 parts; lotus leaf 1.5 parts; plantain 1.5 parts; senna leaf 0.75 parts; white kidney bean extract 1.5 parts and L-carnitine tartrate 1.5 parts.

5. A method for preparing the composition according to any one of claims 1 to 4, which has the function of helping to control body fat or lose weight, characterized in that, Includes the following steps: (1) Take turmeric, cassia seed, lotus leaf, hawthorn, plantain and senna leaf, add water and reflux extract twice, filter to obtain extract; (2) The extract was concentrated under reduced pressure to a relative density of 1.05-1.15 (60℃) to obtain an extract, which was then dried to obtain a dry extract; (3) Crush the dry paste, sieve it to obtain dry paste powder, crush L-carnitine tartrate, sieve it to obtain L-carnitine tartrate powder. (4) The obtained dry powder, L-carnitine tartrate powder and white kidney bean extract together constitute the composition.

6. The method for preparing the composition as described in claim 5, which has the function of helping to control body fat or lose weight, is characterized in that, In step (1), the extraction time is 1.0 to 2.0 hours each time, and 8 to 10 times the amount of water is added each time; in step (2), the temperature of vacuum concentration is 50 to 80℃, and the vacuum degree is 0.03 to 0.09 MPa; in step (2), the drying method is vacuum oven drying, the temperature is 60 to 80℃, and the vacuum degree is 0.04 to 0.10 MPa; or the drying method is vacuum belt drying, the heating plate temperature is 110 to 120℃, and the vacuum degree is 0.04 to 0.10 MPa.

7. The method for preparing the composition as described in claim 5, which has the function of helping to control body fat or lose weight, is characterized in that, In step (2), each gram of the resulting dry extract contains 4.76 to 6.67 grams of raw medicinal material.

8. The use of the composition according to any one of claims 1 to 4, which has the function of helping to control body fat or lose weight, in the preparation of pharmaceuticals, health foods or functional foods.

9. A health food product, characterized in that, The composition comprising any one of claims 1 to 4 having the function of helping to control body fat or lose weight.

10. The health food product as described in claim 9, characterized in that, The dosage form of the health food is granules, tablets, or capsules.

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