Traditional Chinese medicine composition for regulating and controlling appetite of human body on fat intake and preparation method of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for regulating and controlling fat intake appetite of a human body and a preparation method. The traditional Chinese medicine composition is prepared from radix rehmanniae recen, radix ophiopogonis, radix pseudostellariae, rheum officinale, Chinese yam, astragalus membranaceus, safflower carthamus and peach kernels. The preparation method comprises the following steps: soaking the radix rehmanniae recen, the radix ophiopogonis, the radix pseudostellariae, the radix astragali, the Chinese yam and the flos carthami in water, decocting, and filtering the decoction to obtain a first extracting solution; adding ethanol into rheum officinale and peach kernels for reflux extraction to obtain a second extracting solution; mixing the first extracting solution and the second extracting solution, recovering ethanol, and concentrating the obtained mixed extracting solution under reduced pressure to obtain thick paste; and granulating the thick paste, drying, sieving, standing, spraying ethanol on the surface, uniformly mixing, and airing to obtain the traditional Chinese medicine composition. The preparation process of the preparation is simple, the preparation is stable, excessive intake of high-fat food can be effectively prevented, occurrence and development of related metabolic diseases such as obesity, hyperlipidemia and diabetes mellitus can be reduced, and the preparation conforms to the thought of'prevention before illness and change of illness' of traditional Chinese medicine, and has good and wide application prospects.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine compositions, and in particular relates to a traditional Chinese medicine composition for regulating human body's appetite for fat intake and a preparation method thereof. Background Art

[0002] As people's living standards continue to improve, the dietary structure has also undergone major changes. The proportion of high-fat and high-calorie diets has continued to increase, causing the incidence of related metabolic diseases such as obesity, hyperlipidemia, and diabetes to rise year by year.

[0003] Eating is a vital physiological behavior for maintaining life, and taste plays a crucial role in flavor identification and appetite stimulation during eating. Behavioral studies have found that readily available, abundant, delicious foods rich in fat and sugar are highly appealing to both humans and animals. This spontaneous lipid preference was previously thought to be an early recognition of lipid foods by the oral cavity, primarily stemming from oral somatic sensations such as smell and touch. However, excluding smell, oral somatic sensations, and post-absorptive signals, taste is the key factor in this phenomenon. The perception of fat taste primarily relies on specific receptor proteins in taste buds, such as CD36 and GPR120, which detect dietary lipids in the mouth and trigger neural signals. Abnormal fat taste is closely linked to the pathology of metabolic diseases such as obesity. Impaired function of fat taste receptors can lead to excessive intake of high-fat foods, exacerbating energy metabolism imbalances.

[0004] Traditional Chinese Medicine (TCM) posits that under normal physiological conditions, appetite is determined by "stomach qi," while dietary preferences (appetite) originate from the heart. Patients with metabolic disorders such as obesity and impaired glucose metabolism often favor fatty and sweet foods. This accumulation in the body generates heat, leading to excessive "stomach qi" and the development of stomach fire. The Stomach Meridian of Foot Yangming connects to the heart, and stomach fire disturbs the mind, leading to an excessive appetite and a vicious cycle. Regulating fat preferences is key to maintaining balanced fat metabolism and preventing excessive fat intake.

[0005] Modern research shows that drugs such as metformin and GLP-1 receptor agonists can indirectly affect the body's choice of high-fat foods by regulating the appetite center, fat metabolism or intestinal flora, but they have many adverse reactions and are not easily accepted by patients.

[0006] How to utilize the Chinese medicine theory of "preventing illness before it occurs and preventing complications after illness" and the treasure trove of Chinese medicine to develop Chinese medicine compositions that can nourish qi and yin, clear away heat and activate blood circulation, have good therapeutic effects in regulating glucose and lipid metabolism, and can effectively control the body's preference for fat intake (appetite). No relevant information is available in existing literature. Summary of the Invention

[0007] The purpose of the present invention is to provide a Chinese medicine composition for regulating human body's appetite for fat intake and a preparation method thereof. The technical solution of the present invention is achieved as follows: A traditional Chinese medicine composition for regulating human body's appetite for fat intake comprises: 20g-30g of raw rehmannia root, 15g-20g of ophiopogon japonicus, 15g-30g of pseudostellaria root, 5g-6g of rhubarb, 10g-12g of yam, 15g-30g of astragalus root, 12g-15g of safflower and 6g-10g of peach kernel.

[0008] A method for preparing a traditional Chinese medicine composition for regulating human appetite for fat intake, the method comprising the following steps: Step 1. Slice the Chinese yam and perform a pretreatment to prevent starch gelatinization. Add water to the Chinese yam, raw rehmannia root, ophiopogon japonicus, Pseudostellaria chinensis, astragalus root, Chinese yam, and safflower after starch gelatinization and decoct them three times. Combine the decoctions and filter the decoctions; concentrate under reduced pressure to obtain a thick paste, stir, and let stand to obtain a first extract. Step 2. Add 75%-80% v / v ethanol to the rhubarb and peach kernel and reflux extract to obtain a second extract; Step 3. Mixing the first extract and the second extract, recovering ethanol, and concentrating the resulting mixed extract under reduced pressure to obtain a thick paste; Step 4. granulate the thick paste, dry it, and sieve it; transfer the dried and sieved granular powder into a sealed container and let it stand, spray ethanol on the surface after standing, mix it evenly, and dry it to obtain the traditional Chinese medicine composition.

[0009] The beneficial effects of the present invention are as follows: Huoxue Jiangtang Yin, a traditional Chinese medicine composition consisting of raw rehmannia root, ophiopogon japonicus, pseudoginseng, rhubarb, yam, astragalus root, safflower, and peach kernel, has the functions of invigorating qi and nourishing yin, clearing heat and activating blood circulation, and has excellent therapeutic effects on regulating glucose and lipid metabolism, effectively controlling fat appetite (preference). The preparation process of the composition is simple and the preparation is stable. The resulting product has excellent fat preference regulation, can effectively prevent excessive intake of high-fat foods, and reduce the occurrence and progression of metabolic diseases such as obesity, hyperlipidemia, and diabetes. This aligns with the Traditional Chinese Medicine principle of "preventing illness before it occurs and preventing complications after illness occurs" and has promising and broad application prospects.

[0010] The present invention will be described in detail below with reference to the accompanying drawings Attachment Figure 1 This figure shows the effect of the combination drug of the present invention on the behavior of prediabetic rats.

[0011] Attachment Figure 2 This is a graph showing the effect of the combined drug of the present invention on the fat preference rate of prediabetic rats.

[0012] Attachment Figure 3This figure shows the effect of the combined drug of the present invention on the sugar and lipid metabolism of prediabetic rats.

[0013] Attachment Figure 4 This figure shows the effect of the combined drug of the present invention on the expression of proteins related to the CD36 feeding signaling pathway in the small intestinal epithelial tissue of prediabetic rats.

[0014] Attachment Figure 5 This is a graph showing the effect of the combined drug of the present invention on the sugar and fat preference rates of type 2 diabetic rats.

[0015] Attachment Figure 6 This figure shows the effect of the combined drug of the present invention on blood lipids in type 2 diabetic rats. DETAILED DESCRIPTION

[0016] A traditional Chinese medicine composition for regulating human body's appetite for fat intake and a preparation method thereof. The traditional Chinese medicine composition comprises: 20g-30g of raw rehmannia root, 15g-20g of ophiopogon japonicus, 15g-30g of pseudostellaria root, 5g-6g of rhubarb, 10g-12g of yam, 15g-30g of astragalus root, 12g-15g of safflower, and 6g-10g of peach kernel.

[0017] Astragalus: Sweet and slightly warm in nature, it enters the lung and spleen meridians, tonifying the middle qi, relieving stagnation and relieving numbness. Modern pharmacology indicates that astragaloside IV, the main active ingredient in Astragalus, has anti-inflammatory effects, treats diabetes and its complications, and regulates fat and energy metabolism, including fat deposition. Rehmannia root (Rehmannia glutinosa) is primarily composed of iridoid ether glycosides, such as catalpol (highest in fresh Rehmannia glutinosa, followed by raw Rehmannia glutinosa, and lowest in cooked Rehmannia glutinosa). These compounds possess anti-aging and anti-apoptotic properties and are widely used to cool blood, stop bleeding, and lower blood sugar.

[0018] Chinese yam: Sweet and neutral in nature, it enters the spleen, lung, and kidney meridians, tonifying the spleen and stomach, promoting fluid production and benefiting the lungs, and nourishing the kidneys and astringing semen. Modern research indicates that Chinese yam polysaccharides have a certain blood sugar-lowering effect. Ophiopogon japonicus has the benefits of nourishing qi and yin, clearing the heart, and relieving restlessness. Modern pharmacological research shows that Ophiopogon japonicus and its active ingredients have a wide range of effects. For example, its main ingredient, Ophiopogon japonicus polysaccharide, can enhance NK cell activity and improve immunity in mice. Ophiopogon japonicus polysaccharides and total saponins can also significantly reduce fasting blood sugar in mice.

[0019] Safflower: It is light and floats upward, moves outward and reaches upward, and is good at removing blood stasis in the meridians; peach kernel is heavy and sinks, enters the interior and reaches downward, and is good at removing symptoms and knots in the viscera below.

[0020] Rhubarb: bitter in taste and cold in nature, it enters the spleen, stomach, large intestine, liver, and pericardium meridians. It has the effects of purging heat and clearing the intestines, cooling blood and detoxifying, and removing blood stasis and promoting menstruation.

[0021] Based on the above, the present invention proposes a traditional Chinese medicine composition for regulating the human body's appetite for fat intake, wherein raw rehmannia and astragalus are used as the main medicines to clear away heat, invigorate qi and promote body fluid; pseudoginseng, yam and ophiopogon are used as the ministerial medicines to nourish yin and invigorate qi; peach kernel and safflower are used as the adjuvant medicines to promote blood circulation and remove blood stasis; and raw rhubarb is used as the counter-adjuvant medicine to break up blood and remove blood stasis. All the medicines work together to achieve the effects of strengthening the spleen, invigorating qi, promoting blood circulation and nourishing yin.

[0022] The Chinese medicine composition of the present invention has a simple preparation process and a stable preparation. It has a good effect of regulating fat preference, can effectively prevent excessive intake of high-fat foods, and reduce the occurrence and development of related metabolic diseases such as obesity, hyperlipidemia, and diabetes. It conforms to the traditional Chinese medicine idea of "preventing illness before it occurs and preventing complications after illness occurs" and has good and broad application prospects.

[0023] In the best embodiment of the present invention, the Chinese medicine composition comprises: 30g of Rehmannia root, 20g of Ophiopogon japonicus, 30g of Pseudostellaria baicalensis, 6g of Rhubarb, 10g of Dioscorea batatas, 30g of Astragalus membranaceus, 15g of Carthamus tinctorius and 10g of Peach Kernel.

[0024] A method for preparing a traditional Chinese medicine composition for regulating human appetite for fat intake, the method comprising the following steps: Step 1. Slice the Chinese yam and perform a pretreatment to prevent starch gelatinization. Add water to the Chinese yam, raw rehmannia root, ophiopogon japonicus, Pseudostellaria chinensis, astragalus root, Chinese yam, and safflower after starch gelatinization and decoct them three times. Combine the decoctions and filter the decoctions; concentrate under reduced pressure to obtain a thick paste, stir, and let stand to obtain a first extract. Step 2. Add 75%-80% v / v ethanol to the rhubarb and peach kernel and reflux extract to obtain a second extract; Step 3. Mixing the first extract and the second extract, recovering ethanol, and concentrating the resulting mixed extract under reduced pressure to obtain a thick paste; Step 4. granulate the thick paste, dry it, and sieve it; transfer the dried and sieved granular powder into a sealed container and let it stand, spray ethanol on the surface after standing, mix it evenly, and dry it to obtain the traditional Chinese medicine composition.

[0025] In the preparation method embodiment of the present invention: in the step 1; The yam slices are subjected to a pretreatment to prevent starch gelatinization by microwave inactivation at 650W×90s to prevent starch gelatinization; The Chinese yam, raw rehmannia root, ophiopogon japonicus, pseudoginseng, astragalus root, Chinese yam, and safflower are decocted with water three times, the first time adding 8-10 times the weight of the raw materials and soaking for 30-40 minutes, the second and third times adding 6-8 times the weight of the raw materials respectively; The decoction time for each time is 1.0-1.2 hours, and the decoction temperature is 95-100°C; The filtrate is concentrated under reduced pressure to a thick paste at 60° C. and a relative density of 1.15-1.2. 95% v / v ethanol is added to the thick paste to make its alcohol content reach 79%-81% v / v, stirred for 30-40 minutes, and allowed to stand for 12-14 hours.

[0026] In the preparation method embodiment of the present invention: in the step 2: The rhubarb and peach kernel are added with 75%-80% v / v ethanol and refluxed twice, the first time 6-7 times the weight of the raw materials are added with 75%-80% v / v ethanol and refluxed, and the second time 5-6 times the weight of the raw materials are added with 75%-80% v / v ethanol and refluxed; The reflux extraction time for each time is 1.0-1.2 hours, and the extraction temperature during the reflux is 75-85°C.

[0027] In the preparation method embodiment of the present invention: in the step 3, the obtained mixed extract is concentrated under reduced pressure to a thick paste at 60° C. with a relative density of 1.05-1.15.

[0028] In the preparation method embodiment of the present invention: the drying conditions in the step 4 are drying at 60° C.-65° C. for 2 h-3 h, the standing time is 30-40 minutes, and the sprayed alcohol concentration is 95% v / v ethanol.

[0029] The beneficial effects of the present invention are described below in combination with the specific content of the pharmacodynamics study and experimental data.

[0030] Test Example 1: 80 healthy 4-week-old SPF-grade SD male rats were selected and housed in an SPF-grade environment with constant temperature and humidity [temperature (25 ± 2) °C, humidity 55% ± 10%], 12 h light-dark cycle, and free access to food and water.

[0031] After two weeks of adaptive feeding, the model rats were continuously fed a 60% high-fat, high-calorie diet, while the normal control rats were fed a standard diet. After eight consecutive weeks of feeding, the rats were fasted for 12 hours and gavaged with 50% glucose (2g / kg) the next day. Blood glucose was collected at 0 and 120 minutes by tail puncture. Successful modeling was considered achieved when fasting blood glucose was 6.1mmol / L ≤ ≤ 7.5mmol / L or 7.8mmol / L ≤ 2-hour blood glucose ≤ 11.1mmol / L, and the body weight of the high-fat-fed rats was 10% higher than the mean body weight of the normal control rats.

[0032] After the model was successfully established, the experimental rats were divided into 5 groups (8 rats in each group).

[0033] ① Normal group: normal feed and 2 mL of normal saline by gavage.

[0034] ②Model group: 60% high-fat diet and 2 mL of normal saline administered orally.

[0035] ③ Low-dose group (Low group) of Example 1: 60% high-fat feed and gavage with 7.93 g / kg / d of the Chinese medicinal composition of the present invention.

[0036] ④ High-dose group (High group) of Example 1: 60% high-fat feed and gavage with 15.86 g / kg / d of the Chinese medicinal composition of the present invention.

[0037] ⑤Metformin group (Met group): 60% high-fat diet and oral administration of 0.158 g / kg / d metformin.

[0038] The mice were gavaged at 9:00 am every day for 12 weeks. During the whole study period, they drank normal water. Body weight, food intake and water intake were measured once a week. Figure 1 .

[0039] After the experiment, samples were taken. The data were statistically analyzed and processed using SPSS 20.0 software.

[0040] The measurement data are expressed as mean ± standard deviation ( ± s). One-way analysis of variance was used to compare the means among multiple groups. Homogeneity of variance was tested first. If the variance was equal, the F test was used for overall mean comparison and the SNK method was used for pairwise comparison. If the variance was unequal, the Welch test was used for overall mean comparison and the Dunnett T3 test was used for pairwise comparison. P < 0.05 was considered statistically significant.

[0041] Depend on Figure 1 As can be seen, compared with the normal group, the model group rats showed a significant increase in body weight, a significant decrease in food and water intake, but a significant increase in total energy intake. Compared with the model group, the low-dose and high-dose groups of the Chinese medicine composition of the present invention, as well as the metformin group, showed a significant decrease in body weight and food intake, while maintaining comparable water intake.

[0042] At the 11th week of gavage, water was fed into two bottles for pre-test training. At the end of the 12th week of gavage, a fat preference rate test was performed. During the fat preference rate test, one of the two bottles contained a solution containing 2% linoleic acid, and the other contained autoclaved pure water. The weight changes of the water bottles were accurately measured before the test, 24 hours after the test, and 48 hours after the test. The results are shown in the table. Figure 2 The appetite (preference) rate was defined as: fat intake / (fat intake + non-fat intake) × 100%.

[0043] Depend on Figure 2It can be seen that compared with the normal group, the fat preference rates of the model group rats at 24h and 48h were significantly increased; compared with the model group, the fat preference rates of the low-dose group and high-dose group of the Chinese medicine composition of the present invention and the metformin group at 24h and 48h were significantly reduced, indicating that the Chinese medicine composition of the present invention can significantly inhibit the fat preference rate.

[0044] During the experiment, blood glucose was measured once a week using a blood glucose meter (after fasting for 12 hours without water). After the treatment of each group of rats, they were fasting for 12 hours and then gavaged with 50% glucose solution (3g / kg). Blood was collected by cutting the tail at 0 hours, 0.5 hours, 1 hour, and 2 hours, and blood glucose was measured using a blood glucose meter. After the rats were paralyzed, blood was collected from the abdominal aorta of each group of rats, centrifuged, and serum was collected. Lipid metabolism indicators (TC, TG, LDL-c, HDL-c) were detected using an automatic biochemical analyzer. The results are shown in the table. Figure 3 .

[0045] As shown in the figure above, compared with the normal group, the model group rats had slightly elevated FPG, but no statistically significant difference. There were no significant differences in the OGTT test and the area under the OGTT curve (AUC). TC, TG, and LDL-C levels were significantly elevated, while HDL-C levels remained unchanged. Compared with the model group, there were no significant differences in FPG, OGTT, or AUC between the low- and high-dose groups of the traditional Chinese medicine composition for regulating fat preference prepared in Example 1 of the present invention, as well as in the metformin group. However, TC, TG, and LDL-C levels were significantly decreased in both the low- and high-dose groups of the traditional Chinese medicine composition for regulating fat preference.

[0046] After the experiment, the rats were killed and the small intestinal tissues of the rats were taken and the small intestinal epithelial tissues of each group were separated. The expression of CD36, CCK and secretin proteins was detected by WB. The results are shown in Figure 4 .

[0047] Depend on Figure 4 It can be seen that compared with the normal group, the expression levels of CD36, CKK, and secretin proteins in the small intestinal epithelial tissue of rats in the model group were significantly increased, and the difference was statistically significant ( P Compared with the model group, the low-dose and high-dose groups of the Chinese medicine composition of the present invention were able to significantly downregulate the expression levels of CD36, CKK, and secretin proteins in the rat small intestinal epithelial tissue after intervention ( P The expression levels of the two groups were similar (all < 0.05), and were comparable to those in the metformin group.

[0048] Test Example 2: Thirty-two healthy, 8-week-old, SPF-free male Sprague-Dawley rats were housed in an SPF environment with a regular 12-hour light-dark cycle (8:00 AM - 8:00 PM), an average temperature of 22-25°C, and a relative humidity of 60 ± 10%. Food and water were available ad libitum. After one week of adaptive feeding, the rats were randomly divided into a control group (8 rats) and a high-fat diet group (24 rats). The two groups received either a standard diet or a 60% high-fat, high-calorie diet, respectively. Six weeks later, the rats in the high-fat diet group were administered STZ (35 mg / kg, ip) to establish a T2DM model. Two weeks after STZ injection, blood glucose levels were measured 12 hours after fasting. Model success criteria were FBG ≥ 11.1 mmol / L.

[0049] Rats were then randomly divided into the treatment group (HJD) according to Example 1, the metformin group (MET), and the model group (MOD), with 8 rats in each group. One week after successful model establishment, rats in the CON group received a standard diet and 2 mL of normal saline by gavage; rats in the MOD group received a 60% high-fat diet and 2 mL of normal saline by gavage; rats in the HJD group received a 60% high-fat diet and 15.86 g / kg / day of the Chinese herbal composition of the present invention by gavage; and rats in the MET group received a 60% high-fat diet and 0.158 g / kg / day of metformin by gavage daily at 9:00 AM for 8 consecutive weeks. Normal drinking water was provided throughout the study.

[0050] At the 11th week of gavage, pre-test training was performed by feeding water in two bottles, and the fat preference rate test was performed on the day after the 12th week of gavage. The mice were housed in different cages and could drink water freely from two bottles within 48 hours. In the fat preference test, linoleic acid (99%, Sigma, St. Louis, MO, USA) was dissolved in a solution containing 0.3% collagen (Sigma, St. Louis, MO, USA) to prepare a solution containing 2% linoleic acid, and the solution containing 0.3% collagen was used as the culture medium for this test. For the sweet food preference test, two bottles of 10% glucose solution and glucose-free water were used. The weight changes of the two bottles were measured and accurately recorded at 0.5 hours and 48 hours, respectively. The results are shown in Figure 5 To minimize the possibility of bias, the bottles were swapped after 24 hours. After 48 hours of exposure to the linoleic acid solution, the rats underwent a washout period of approximately 48–72 hours before testing their sweet preference. Both bottles contained deionized water. Total intake of the linoleic acid solution or sugar solution was weighted, and the preference ratio was calculated as: fat (sugar) intake / (fat (sugar) intake + non-fat (sugar) intake) × 100%.

[0051] See Figure 5 ,exist Figure 5 (A and B) Fat preference levels at 0.5 and 48 h, respectively.#### P < 0.0001, vs CON; **** P<0.0001, *** P < 0.001, vs MOD. (C and D) Sugar preference levels at 0.5 and 48 h, respectively. #### P<0.0001, ### P < 0.001, vs CON; **** P<0.0001, ** P<0.01, * P<0.05, vs MOD.

[0052] Among them, # and * represent different significance levels.

[0053] Depend on Figure 5 It can be seen that diabetic rats have a stronger preference for fat and sugar. After 8 weeks of treatment, the preference ratio for fat and sugar in diabetic rats treated with the Chinese herbal composition of the present invention and metformin was significantly reduced, indicating that the Chinese herbal composition for regulating fat preference prepared in Example 1 of the present invention can significantly suppress the appetite (preference) rate for fat and sugar.

[0054] After 8 weeks of continuous gavage, the rats were paralyzed and blood was collected from the abdominal aorta of the rats in each group. The collected blood samples were centrifuged and serum was obtained. The blood lipid metabolism indicators (TC, TG, LDL-c, HDL-c) were detected using an automatic biochemical analyzer. The results are shown in Figure 6 .

[0055] Depend on Figure 6 It can be seen that the levels of TC, TG, LDL-C and FFA in the rat plasma were significantly increased after modeling. Compared with the MOD group, the treatment with the Chinese medicine composition of the present invention can significantly reverse the levels of TC, TG, LDL-C and FFA in diabetic rats.

[0056] See Figure 6 ,exist Figure 6 (A) Total cholesterol (TC) level; (B) Triglyceride (TG) level; (C) Low-density lipoprotein cholesterol (LDL-C) level; (D) Free fatty acid (FFA) level; (E) High-density lipoprotein cholesterol (HDL-C) level. #### P < 0.0001, vs CON; **** P<0.0001, vs MOD3002 Test Case 3 Experiment Forty patients with type 2 diabetes who met the TCM Qi and Yin deficiency syndrome were selected, including 21 males and 19 females, aged 30 to 60 years, with a body mass index ≥ 25 kg / m 2 The patients had diabetes mellitus duration of 1 to 5 years. They were randomly divided into 2 groups by drawing lots, with 20 cases in each group.

[0057] Example 2 Treatment Group: Basic treatment (diabetes diet and exercise therapy, abstinence from smoking and alcohol, diabetes education, and blood glucose monitoring) + sitagliptin phosphate 100 mg orally once a day (orally in the morning) + Example 2 Traditional Chinese Medicine Composition for Regulating Fat Preference (one dose per day, dissolved in 500 ml of warm water, divided into two doses, taken warm one hour after breakfast and dinner), for 8 consecutive weeks.

[0058] Control group: basic treatment (diabetes diet and exercise therapy, abstinence from smoking and alcohol, diabetes education, blood glucose monitoring) + sitagliptin phosphate 100 mg orally once a day (orally in the morning) for 8 consecutive weeks.

[0059] The treatment group included 8 males and 12 females with an average age of (45.3 ± 7.76) years, a disease course of (2.8 ± 1.16) years, and a BMI of 27.04 ± 1.78 kg / m 2 .

[0060] The control group included 13 males and 7 females with an average age of (42.7 ± 6.48) years, a disease course of (3.15 ± 1.27) years, and a BMI of 27.83 ± 2.05 kg / m 2 .

[0061] The baseline characteristics of the two groups of patients were comparable after statistical analysis (P>0.05).

[0062] The dietary preferences of the two groups of patients were tested before and after treatment. The dietary preference scores ( Results are shown in Table 1. Dietary preference was assessed using four dairy products with varying fat and carbohydrate content: A: Nestlé condensed milk [fat content (Fat) 13%; carbohydrate content (Car) 19%]; B: Yili pure milk with lactose added to a total carbohydrate content of 6% (Fat 6%, Car 6%); C: Yili pure milk (Fat 6%, Car 2%); and D: Yili skim milk (Fat 0%, Car 2%). Each drink was refrigerated to 4°C and placed in a 10ml opaque container with a lid. The drink was consumed using a straw. Patients were randomly assigned to taste each of the four drinks (rinsing their mouths with water for 5–10 minutes before tasting the next drink). After tasting each drink, they were asked to rate their preference on a scale of 0 to 10, with 0 indicating extreme dislike and 10 indicating extreme preference. Each drink was tasted three times, and the average of the three scores represented the patient's preference for that drink.

[0063] Table 1 Dietary preference scores ( ± s )

[0064] Note: Compared with before treatment, ▲P<0.05, ▲▲P<0.01; compared with the control group, △P<0.05, △△P<0.01.

[0065] As shown in Table 1, compared with before treatment, the preference scores for A (Fat14% / Car19%), B (Fat6% / Car6%), and C (Fat6% / Car2%) in both groups decreased significantly after treatment, while the preference score for D (Fat0% / Car2%) increased significantly, and the differences were statistically significant (P<0.05, P<0.01). Compared with the control group, the preference scores of the Chinese herbal composition of the present invention for B (Fat6% / Car6%) and C (Fat6% / Car2%) were significantly decreased, and the preference score for D (Fat0% / Car2%) was significantly increased after treatment, and the differences were statistically significant (P<0.01). At the same time, the difference in preference scores of B (Fat6% / Car6%), C (Fat6% / Car2%), and D (Fat0% / Car2%) were significantly increased after treatment with the Chinese herbal composition of the present invention, and the differences were statistically significant (P<0.05, P<0.01).

[0066] Free fatty acids (FFA) and soluble CD36 (sCD36) were detected in the two groups of patients before and after treatment. The results are shown in Table 2.

[0067] Table 2 FFA and sCD36 levels ( ± s )

[0068] Note: Compared with before treatment, ▲▲P<0.01, compared with the control group, △P<0.05, △△P<0.01.

[0069] As shown in Table 2, compared with pre-treatment, FFA and sCD36 levels in both groups decreased significantly after treatment, with statistically significant differences (P < 0.01). Compared with the control group, the Chinese herbal composition for regulating fat preference prepared in Example 2 of the present invention significantly decreased FFA and sCD36 levels after treatment. The difference in FFA and sCD36 levels before and after treatment also decreased significantly compared with the control group, with statistically significant differences (P < 0.05, P < 0.01).

[0070] As can be seen from Test Examples 1-3, the traditional Chinese medicine composition of the present invention can significantly inhibit the fat preference rate of prediabetic and STZ-induced diabetic rats. The traditional Chinese medicine composition of the present invention can also reverse the TC, TG, and LDL-C levels of prediabetic and STZ-induced diabetic rats, and significantly downregulate the expression of CD36 protein in the small intestinal epithelial tissue of prediabetic rats; the traditional Chinese medicine composition of the present invention significantly reduces the preference scores of B (Fat6% / Car6%) and C (Fat6% / Car2%) in patients with type 2 diabetes and who meet the syndrome of Qi and Yin deficiency in Traditional Chinese Medicine, significantly increases the preference score for D (Fat0% / Car2%), and significantly reduces the levels of FFA and sCD36.

Claims

1. A Chinese medicine composition for regulating human appetite for fat intake and a preparation method thereof, characterized in that: The traditional Chinese medicine composition comprises: raw rehmannia root: 20g-30g, ophiopogon: 15g-20g, pseudostellaria: 15-30g, rhubarb: 5g-6g, yam: 10g-12g, astragalus: 15g-30g, safflower: 12g-15g, and peach kernel 6g-10g.

2. A Chinese medicine composition for regulating human body's appetite for fat intake according to claim 1, characterized in that: The traditional Chinese medicine composition comprises: 30g of raw rehmannia root, 20g of ophiopogon japonicus, 30g of pseudoginseng, 6g of rhubarb, 10g of yam, 30g of astragalus, 15g of safflower and 10g of peach kernel.

3. The method for preparing a Chinese medicine composition for regulating human body's appetite for fat intake according to claim 1, characterized in that: The preparation method comprises the following steps: Step 1. Slice the Chinese yam and perform a pretreatment to prevent starch gelatinization. Add water to the Chinese yam, raw rehmannia root, ophiopogon japonicus, Pseudostellaria chinensis, astragalus root, Chinese yam, and safflower after starch gelatinization and decoct them three times. Combine the decoctions and filter the decoctions; concentrate under reduced pressure to obtain a thick paste, stir, and let stand to obtain a first extract. Step 2. Add 75%-80% v / v ethanol to the rhubarb and peach kernel and reflux extract to obtain a second extract; Step 3. Mixing the first extract and the second extract, recovering ethanol, and concentrating the resulting mixed extract under reduced pressure to obtain a thick paste; Step 4. granulate the thick paste, dry it, and sieve it; transfer the dried and sieved granular powder into a sealed container and let it stand, spray ethanol on the surface after standing, mix it evenly, and dry it to obtain the traditional Chinese medicine composition.

4. The method for preparing a Chinese medicine composition for regulating human body's appetite for fat intake according to claim 3, characterized in that: In the step 1; After the yam is sliced, it is subjected to a pretreatment to prevent starch gelatinization, which is to inactivate enzymes by microwave at 650W×90s to prevent starch gelatinization; The Chinese yam, raw rehmannia root, ophiopogon japonicus, pseudoginseng, astragalus root, Chinese yam, and safflower are decocted with water three times, the first time adding 8-10 times the weight of the raw materials and soaking for 30-40 minutes, the second and third times adding 6-8 times the weight of the raw materials respectively; The decoction time for each time is 1.0-1.2 hours, and the decoction temperature is 95-100°C; The filtrate is concentrated under reduced pressure to a thick paste at 60° C. and a relative density of 1.15-1.

2. 95% v / v ethanol is added to the thick paste to make its alcohol content reach 79%-81% v / v, stirred for 30-40 minutes, and allowed to stand for 12-14 hours.

5. The method for preparing a Chinese medicine composition for regulating human body's appetite for fat intake according to claim 3, characterized in that: In step 2: The rhubarb and peach kernel are added with 75%-80% v / v ethanol and refluxed twice, the first time 6-7 times the weight of the raw materials are added with 75%-80% v / v ethanol and refluxed, and the second time 5-6 times the weight of the raw materials are added with 75%-80% v / v ethanol and refluxed; The reflux extraction time for each time is 1.0-1.2 hours, and the extraction temperature during the reflux is 75-85°C.

6. The method for preparing a Chinese medicine composition for regulating human body's appetite for fat intake according to claim 3, characterized in that: In step 3, the obtained mixed extract is concentrated under reduced pressure to a thick paste at 60° C. with a relative density of 1.05-1.

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7. The method for preparing a Chinese medicine composition for regulating human appetite for fat intake according to claim 3, characterized in that: The drying conditions in step 4 are drying at 60° C.-65° C. for 2 h-3 h, the standing time is 30-40 minutes, and the concentration of the sprayed alcohol is 95% v / v ethanol.

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