Traditional chinese medicine composition for controlling obesity

Abstract

The present application relates to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for controlling obesity. The traditional Chinese medicine composition comprises Pueraria pedunculata, Lantana camara, Curcuma longa, Curcuma wenyujin, Curcuma roxburghii, Angelica sinensis, Boswellia carterii, Commiphora myrrha, Semen Persicae, Radix Polygoni multiflori and Rubus corchorifolius. The traditional Chinese medicine composition can effectively regulate blood fat by external use, thereby achieving the effects of improving obesity-related metabolic disorders and controlling obesity. In addition, the traditional Chinese medicine composition has no skin irritation when used externally, and has no acute toxicity at a dosage much higher than a clinical dosage, and is safe and reliable to use, and has a wide application prospect in controlling obesity.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to a traditional Chinese medicine composition that can be used to control obesity. Background Technology

[0002] Obesity not only affects physical appearance but also triggers a series of health risks, serving as a typical contributing factor to "metabolic syndrome." Medical research shows that obese individuals are 3-7 times more likely to develop type 2 diabetes than those of normal weight. They also have a significantly increased incidence of hypertension, hyperlipidemia, and fatty liver disease. Furthermore, obesity increases the probability of cardiovascular diseases (such as coronary heart disease and stroke), bone and joint diseases (such as knee osteoarthritis), and certain malignant tumors (such as breast cancer and colorectal cancer). In addition, obesity can lead to endocrine disorders and sleep apnea syndrome, severely reducing patients' quality of life and increasing the social burden on healthcare. Therefore, controlling obesity is crucial.

[0003] Currently, most clinical weight-loss drugs are administered orally, which primarily work by suppressing appetite, reducing fat absorption, or accelerating metabolism. However, existing weight-loss drugs generally suffer from strong side effects (such as potentially causing adverse neurological reactions like palpitations, insomnia, and anxiety) and a narrow range of applications. Summary of the Invention

[0004] To solve the above-mentioned technical problems, the present invention provides a traditional Chinese medicine composition for external use to control obesity, the raw materials of which include: Eupatorium fortunei, Lycopus lucidus, Curcuma longa, Curcuma aromatica, Curcuma zedoaria, Angelica sinensis tail, Boswellia carterii, Commiphora myrrha, Prunus persica kernel, processed Polygonum multiflorum and Clematis chinensis.

[0005] In the traditional Chinese medicine composition of the present invention, Eupatorium fortunei and Lycopus lucidus strengthen the spleen, promote diuresis and reduce swelling; Curcuma longa, Curcuma aromatica, Curcuma zedoaria, Angelica sinensis tail, Prunus persica, Boswellia carterii, and Commiphora myrrha invigorate blood circulation, promote qi circulation, remove blood stasis and eliminate accumulation, and promote fat decomposition and metabolism; Polygonum multiflorum regulates metabolic function; and Clematis chinensis enhances drug penetration. All components work together to exert weight loss effects through synergistic effects.

[0006] In some implementation schemes, the raw materials include the following components by weight: 9-13 parts of Eupatorium fortunei, 9-12 parts of Lycopus lucidus, 12-15 parts of Curcuma longa, 12-15 parts of Curcuma zedoaria, 12-15 parts of Angelica sinensis (tail), 5-8 parts of Boswellia carterii, 5-8 parts of Commiphora myrrha, 9-12 parts of Prunus persica, 9-12 parts of processed Polygonum multiflorum, and 9-12 parts of Clematis chinensis.

[0007] Preferably, the raw materials include the following components by weight: 9-12 parts of Eupatorium fortunei, 9-12 parts of Lycopus lucidus, 12-15 parts of Curcuma longa, 12-15 parts of Curcuma aromatica, 12-15 parts of Curcuma zedoaria, 12-15 parts of Angelica sinensis (tail), 5-8 parts of Boswellia carterii, 5-8 parts of Commiphora myrrha, 9-12 parts of Prunus persica, 9-12 parts of processed Polygonum multiflorum, and 9-12 parts of Clematis chinensis.

[0008] In some implementations, the raw materials also include rhubarb; preferably, 9-12 parts of rhubarb are used.

[0009] The present invention also found that rhubarb in wine has the effects of purging and eliminating accumulations, removing blood stasis and promoting menstruation. It can promote intestinal peristalsis, expel excess waste and fat from the body, and at the same time enhance the overall blood-activating and meridian-clearing effects of the formula. When the above-mentioned Chinese medicine composition is further combined with rhubarb in wine, it can further improve the effect of weight control.

[0010] Preferably, the raw materials include the following components by weight: 9-10 parts of Eupatorium fortunei, 11-12 parts of Lycopus lucidus, 14-15 parts of Curcuma longa, 14-15 parts of Curcuma aromatica, 14-15 parts of Curcuma zedoaria, 12-13 parts of Angelica sinensis (tail), 5-6 parts of Boswellia carterii, 5-6 parts of Commiphora myrrha, 11-12 parts of Prunus persica, 11-12 parts of processed Polygonum multiflorum, 11-12 parts of Rheum palmatum (processed with wine), and 9-10 parts of Clematis chinensis. Preferably, the raw materials include the following components by weight: 9 parts of Eupatorium fortunei, 12 parts of Lycopus lucidus, 15 parts of Curcuma longa, 15 parts of Curcuma aromatica, 15 parts of Curcuma zedoaria, 12 parts of Angelica sinensis (tail), 5 parts of Boswellia carterii, 5 parts of Commiphora myrrha, 12 parts of Prunus persica, 12 parts of processed Polygonum multiflorum, 12 parts of Rheum palmatum (processed with wine), and 9 parts of Clematis chinensis.

[0011] When the above-mentioned proportions of raw materials are used in combination, the synergistic effect of each Chinese medicine component is the best, and the effect of controlling weight or obesity is the best.

[0012] Furthermore, the present invention provides a traditional Chinese medicine preparation, which is made from the aforementioned traditional Chinese medicine composition as raw material.

[0013] Preferably, the traditional Chinese medicine preparation uses the traditional Chinese medicine composition as its active ingredient.

[0014] In some implementations, the traditional Chinese medicine preparation is a decoction, pill, powder, ointment, elixir, medicated wine, tablet, granule, capsule, injection, aerosol, spray, gel, lozenge, syrup, mixture, or elixir.

[0015] Preferably, the traditional Chinese medicine preparation is a topical preparation.

[0016] Preferably, the traditional Chinese medicine preparation is an ointment.

[0017] In some embodiments, the traditional Chinese medicine preparation also includes pharmaceutically acceptable excipients.

[0018] Preferably, the excipients include at least one of fillers, excipients, lubricants, wetting agents, and diluents.

[0019] In some embodiments, the preparation method of the traditional Chinese medicine preparation includes: using other medicinal materials besides frankincense and myrrh as the first raw material and frankincense and myrrh as the second raw material, respectively performing alcohol extraction on the first raw material and the second raw material; and mixing the alcohol extracts of the two raw materials.

[0020] Preferably, the temperature for alcohol extraction of the first raw material is 76℃-80℃.

[0021] Preferably, the temperature for alcohol extraction of the second raw material is 70℃-75℃.

[0022] Preferably, the alcohol extraction is performed two or more times.

[0023] Preferably, the alcohol extraction uses 70% ethanol at 4 to 8 times the weight of the medicinal material.

[0024] Preferably, the alcohol extraction is performed by heating and reflux extraction.

[0025] Preferably, the alcohol extraction uses ethanol.

[0026] In some embodiments, the preparation method further includes: mixing the alcohol extracts of the two raw materials and then concentrating them to obtain a traditional Chinese medicine extract.

[0027] Preferably, the concentration is vacuum concentration.

[0028] Preferably, the concentration endpoint is a relative density of 1.20-1.25 or an effective ingredient concentration of 8-10 times that of the alcohol extract.

[0029] Preferably, the traditional Chinese medicine preparation is prepared by mixing the herbal extract with a matrix; the matrix includes petrolatum and lanolin.

[0030] Preferably, the weight ratio of petrolatum to lanolin is (2~4):1.

[0031] Preferably, the weight ratio of the herbal extract to the base is 1:(3~5).

[0032] Further research on the compounding relationship of different matrix materials and dosages revealed that when traditional Chinese medicine extract and the above-mentioned matrix are compounded into an ointment according to the above-mentioned ratio, stability and transdermal effect can be taken into account, and the efficacy of the ointment is optimal.

[0033] When using topical ointment formulations, the medication acts directly on local adipose tissue through the skin, without needing to be absorbed through the gastrointestinal tract or metabolized by the liver. This avoids the risks of gastrointestinal irritation, liver and kidney damage, and drug dependence caused by oral medications, and also avoids the trauma and potential complications of surgical weight loss.

[0034] Furthermore, the present invention provides the application of the aforementioned traditional Chinese medicine composition or the aforementioned traditional Chinese medicine preparation in the preparation of drugs for controlling weight gain, controlling obesity, or regulating blood lipids.

[0035] Preferably, the weight gain or obesity is caused by a high-fat diet.

[0036] Preferably, the obesity is diabetes mellitus combined with obesity.

[0037] Preferably, the regulation of blood lipids is manifested in reducing TC, TG or LDL-C levels, or increasing HDL-C levels.

[0038] Compared with the prior art, the beneficial effects of the present invention are as follows: This invention provides a topical traditional Chinese medicine composition for controlling obesity. Experimental verification shows that this composition effectively regulates blood lipids, thereby improving obesity-related metabolic disorders and controlling obesity. Furthermore, this composition is non-irritating to the skin when applied topically and exhibits no acute toxicity even at doses far exceeding clinically recommended levels, demonstrating safe and reliable use and broad application prospects in obesity control. Detailed Implementation

[0039] To make the objectives, technical solutions, and advantages of this invention clearer, the technical solutions of this invention will be clearly and completely described below. Obviously, the described embodiments are only some, not all, of the embodiments of this invention. Based on the embodiments of this invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this invention. In the embodiments provided in this specification, where specific techniques or conditions are not specified, they are performed according to the techniques or conditions described in the literature in this field, or according to the product instructions. Reagents or instruments whose manufacturers are not specified are all conventional products that can be purchased through legitimate channels. The weight units in the following embodiments are in grams (g).

[0040] Example 1 This embodiment provides a traditional Chinese medicine composition, the raw materials of which include the following components by weight: 9 parts of Eupatorium fortunei, 12 parts of Lycopus lucidus, 15 parts of Curcuma longa, 15 parts of Curcuma aromatica, 15 parts of Curcuma zedoaria, 12 parts of Angelica sinensis (tail), 5 parts of Boswellia carterii, 5 parts of Commiphora myrrha, 12 parts of Prunus persica, 12 parts of processed Polygonum multiflorum, 12 parts of Rheum palmatum (processed with wine), and 9 parts of Clematis chinensis.

[0041] The preparation method of the above-mentioned traditional Chinese medicine composition is as follows: Place the herbs such as Eupatorium fortunei, Lycopus lucidus, Curcuma longa, Curcuma zedoaria, Angelica sinensis (tail), Prunus persica, processed Polygonum multiflorum, and Clematis chinensis on a medicinal herb selection table and manually remove moldy, insect-infested, broken herbs, as well as stones, weeds, and other impurities. Frankincense and myrrh are selected separately, and any attached bark and debris are removed. After removing impurities, rinse the medicinal materials quickly with purified water 1-2 times, and then dry them in a 60℃ constant temperature drying oven until the moisture content of the medicinal materials is controlled at 8%-10%. Put the herbs, including Eupatorium fortunei, Lycopus lucidus, Curcuma longa, Curcuma zedoaria, Curcuma zedoaria, Angelica sinensis (tail), Prunus persica, processed Polygonum multiflorum, Rheum palmatum (processed with wine), and Clematis chinensis, into a Chinese herbal medicine pulverizer. Select a 20-mesh sieve, pulverize them, collect the coarse powder, and seal it in a clean plastic bag for later use. Cut the dried frankincense and myrrh into 1-2cm pieces, put them into a grinder, and use a 20-mesh sieve. Stop the machine for 1 minute every 5 minutes of grinding. Collect the coarse powder immediately after grinding and store it in an airtight container. Particle size inspection: Take a small amount of the crushed coarse powder and check it with a standard sieve (20 mesh). The passing rate should be above 95%. If there are any coarse particles that do not pass the test, they need to be crushed again until they meet the requirements. Extraction uses 70% ethanol as the solvent (ethanol concentration is adjusted by an alcohol meter) because it has good solubility for both fat-soluble components (such as curcumin and boswellic acid) and water-soluble components (such as alkaloids in turmeric), and can be easily removed by concentration without any risk of residue. Adding materials and solvent: Put the following herbs into a 50L multi-functional extraction tank: Eupatorium fortunei, Lycopus lucidus, Curcuma longa, Curcuma zedoaria, Angelica sinensis tail, Prunus persica kernel, processed Polygonum multiflorum, Rheum palmatum (processed with wine), and Clematis chinensis. Add 8 times the weight of 70% ethanol, stir well, and soak for 1 hour (stir once every 15 minutes during this period to ensure that the herbs are fully soaked). Close the feed inlet of the extraction tank, turn on the jacket heating, and control the extraction temperature at 76℃-80℃ (ethanol boiling point is about 78℃, this temperature can ensure the solvent boils and avoid overheating), and reflux extraction twice at a gentle boil. First extraction: Continuous reflux for 2 hours, with temperature recorded every 30 minutes to ensure the temperature is stable at 76℃-80℃; Discharge and filtration: After extraction, open the discharge valve at the bottom of the extraction tank and filter the extract through a plate and frame filter press (pre-washed and disinfected with 70% ethanol). Collect the filtrate A1 and leave the filter residue in the extraction tank. Second extraction: Add 6 times the weight of 70% ethanol to the extraction tank and repeat the above reflux extraction operation, shortening the time to 1.5 hours. After filtration, collect filtrate A2, combine filtrates A1 and A2 to obtain total filtrate A, for later use. Feeding and adding solvent: Put frankincense and myrrh into another 20L multi-functional extraction tank, add 6 times the weight of 70% ethanol, stir and soak for 30 minutes; Reflux extraction: Turn on the heating and control the temperature at 70℃-75℃ (slightly lower than the extraction temperature of non-resin-based medicinal materials to avoid excessive loss of volatile components in frankincense and myrrh), and reflux extract twice. First extraction: 1.5 hours, filter and collect filtrate B1; Second extraction: Add 4 times the weight of 70% ethanol, extract for 1 hour, filter and collect filtrate B2; Combine filtrates B1 and B2 to obtain total filtrate B, which is then set aside. Combine filtrate A and filtrate B, pour them into a clean storage tank, stir well, and then filter them again through a plate and frame filter press (replace with a new filter membrane) to remove fine medicinal residue particles, and obtain a clear combined extract for later use. Add purified water to the heating bath of the rotary evaporator and set the temperature to 60℃-70℃; Check the equipment's sealing performance to ensure that the vacuum level can stably reach 0.06-0.08 MPa; Pour the combined extracts into the evaporation flask of the rotary evaporator, ensuring the liquid volume does not exceed 2 / 3 of the evaporation flask's capacity; Turn on the rotary evaporator and adjust the rotation speed to 50-60 r / min (too fast a speed can cause liquid to splash, while too slow a speed will result in low concentration efficiency). Turn on the vacuum pump and slowly adjust the vacuum level to 0.06-0.08 MPa. At this time, the extract should slowly boil at 60℃-70℃. Continue to concentrate, taking samples every 30 minutes and measuring the relative density of the concentrate using a hydrometer (at 60℃) until the relative density reaches 1.20-1.25 (60℃). Concentration endpoint determination: Take a small amount of concentrated solution and drop it onto a glass slide. Observe at room temperature. If it is viscous and does not flow, it is qualified (when the relative density is 1.20-1.25, the concentration of effective ingredients is about 8-10 times that of the original extract). Turn off the vacuum pump, slowly release the gas, and once the vacuum level returns to normal pressure, stop heating and rotation, and remove the evaporation flask. Pour the clear extract from the evaporation flask into a clean stainless steel container and cool it to room temperature in a water bath below 40°C to obtain the clear extract of traditional Chinese medicine. The ointment should be used for ointment preparation within 24 hours. If it is not to be used immediately, it should be sealed and stored in a refrigerator at 4°C for no more than 72 hours (to prevent microbial growth or component degradation).

[0042] Furthermore, this embodiment also provides an ointment with the above-mentioned traditional Chinese medicine composition as the active ingredient, comprising the above-mentioned traditional Chinese medicine composition and a matrix in a weight ratio of 1:4, wherein the matrix is ​​a mixture of petrolatum and lanolin in a weight ratio of 3:1. Under the above ratio, the ointment can balance stability and transdermal effect (petrolatum provides good occlusive properties, reducing drug volatilization, while lanolin enhances skin permeability and promotes the absorption of active ingredients).

[0043] The preparation method of the ointment is as follows: Place the petroleum jelly and lanolin in a constant temperature mixing pot, turn on the pot, set the temperature to 60℃-65℃, and the stirring speed to 100r / min. Wait until the petroleum jelly and lanolin are completely melted and mixed evenly (without layering or particles) to form a transparent matrix solution for later use. Slowly add the cooled herbal extract to the molten matrix solution while stirring. Adjust the stirring speed to 200 rpm and maintain the temperature at 60℃-65℃. Continue stirring for 30 minutes (to ensure that the extract and matrix are fully mixed and to avoid precipitation or separation). Lower the temperature of the constant temperature mixing pot to 40℃, maintain the mixing speed at 50r / min, and slowly cool down (control the cooling rate at 1-2℃ / min to avoid the paste from cracking or becoming uneven in texture due to excessive cooling). When the temperature of the ointment drops below 35°C, stop stirring and pour the ointment into pre-sterilized medicinal ointment jars, filling each jar with a measured amount.

[0044] Example 2 This embodiment provides a traditional Chinese medicine composition and an ointment containing it, which differs from Example 1 only in that the raw materials of the traditional Chinese medicine composition include the following components by weight: 12 parts of Eupatorium fortunei, 9 parts of Lycopus lucidus, 12 parts of Curcuma longa, 12 parts of Curcuma aromatica, 12 parts of Curcuma zedoaria, 15 parts of Angelica sinensis tail, 8 parts of Boswellia carterii, 8 parts of Commiphora myrrha, 9 parts of Prunus persica, 9 parts of processed Polygonum multiflorum, 9 parts of Rheum palmatum (processed with wine), and 12 parts of Clematis chinensis.

[0045] Example 3 This embodiment provides a traditional Chinese medicine composition and an ointment containing it, the only difference from Example 1 being that it does not contain rhubarb soaked in alcohol.

[0046] Comparative Example 1 This comparative example provides an ointment containing an extract of a single herb (turmeric), prepared as follows: Take the same weight of turmeric as in Example 1 and prepare an ointment according to the preparation method in Example 1.

[0047] Comparative Example 2 This comparative example provides a traditional Chinese medicine composition and an ointment containing it, which differs from Example 1 only in that it does not contain turmeric.

[0048] Experimental Example 1 This experimental example evaluates the effectiveness of the ointments prepared in the above-described embodiments and comparative examples in controlling weight (obesity). The steps are as follows: Healthy male SD rats, weighing 200-220g, were randomly divided into groups of 10 rats each, according to the sample size and comparative sample size. Except for the control group, the rats in the other groups were fed a high-fat diet (68% basal diet, 15% lard, 10% sucrose, 5% egg yolk powder, 1.5% cholesterol, and 0.5% sodium cholate) to establish an obesity model. After 4 weeks of feeding, the obesity model was confirmed to be successfully established.

[0049] Subsequently, all experimental group rats were given the corresponding herbal ointment from the embodiment and the comparative example on the hair-removed area of ​​their backs, with an application rate of 0.5g / 100g body weight, twice daily. Control group rats were given the same amount of physiological saline on the same area for 4 consecutive weeks. During the experiment, the rats were fed a high-fat diet, and their body weight and length were measured weekly to calculate Lee's index. After the experiment, the rats were sacrificed, and the wet weight of abdominal fat (including perirenal fat and epididymal fat) was measured. The fat coefficient was calculated (fat coefficient = wet weight of abdominal fat (g) / body weight (g) × 100%). At the same time, the levels of total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) in the rat serum were detected using commercial kits.

[0050] 1. Weight changes The results of the weight change are shown in Table 1.

[0051] Table 1

[0052] As shown in Table 1, there was no significant difference in the body weight of rats in each group before the experiment (P>0.05). After 4 weeks of experimentation, the body weight of rats in Example 1 group decreased significantly; while the body weight of rats in Example 2 group, Example 3 group, each comparative group, and the control group all increased, with the control group showing the largest increase. This indicates that the optimally formulated traditional Chinese medicine composition has a significant effect on controlling body weight.

[0053] 2. Changes in Lee's Index Lee's index is an important indicator of obesity in animals; the lower the index, the lower the degree of obesity. Lee's index was measured weekly in each group of rats during the experiment, and the results are shown in Table 2 below.

[0054] Table 2

[0055] As shown in Table 2, there was no significant difference in Lee's index among the groups of rats initially (P>0.05). After 4 weeks, the Lee's index in the Example 1 group decreased significantly; the Lee's index in the other groups increased to varying degrees, with the control group showing the largest increase. This indicates that the optimally formulated traditional Chinese medicine composition can effectively improve the obesity status of rats.

[0056] 3. Changes in body fat percentage After the experiment, the wet weight of abdominal fat in each group of rats was measured and the fat coefficient was calculated. The results are shown in Table 3 below.

[0057] Table 3

[0058] As shown in Table 3, the abdominal fat wet weight and fat coefficient of rats in Example 1 group were significantly lower than those in other groups (P<0.05). The fat coefficients of all comparative groups and the control group were above 7%, with the control group having the highest coefficient. This indicates that the optimally formulated traditional Chinese medicine composition can effectively reduce abdominal fat accumulation and lower the fat coefficient in rats, and the effect is far superior to that of other groups.

[0059] 4. Changes in serum lipid levels After the experiment, the serum levels of total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) in each group of rats were measured, and the results are shown in Table 4 below.

[0060] Table 4

[0061] As shown in Table 4, the serum TC, TG, and LDL-C levels in the Example 1 group were significantly lower than those in the other groups (P<0.05), while the HDL-C level was significantly higher than that in the other groups (P<0.05). This indicates that the optimally formulated traditional Chinese medicine composition can effectively regulate lipid metabolism in rats, reduce the levels of harmful lipids (TC, TG, LDL-C) and increase the levels of beneficial lipids (HDL-C) in serum, thereby achieving the effect of assisting weight loss and improving obesity-related metabolic disorders.

[0062] Experimental Example 2 This experimental example uses the ointment from Example 1 as a representative example to conduct skin irritation and acute toxicity tests to illustrate the safety of the traditional Chinese medicine composition of the present invention.

[0063] (a) Skin irritation test Ten healthy rabbits, weighing 2.0-2.5 kg, were randomly divided into an intact skin group and a damaged skin group, with five rabbits in each group. A test area (3cm × 3cm) was prepared on the left side of the back of each rabbit, while the right side served as a blank control group (applied with an equal volume of physiological saline). The skin in the intact skin group was kept intact, while the skin in the damaged skin group was gently abraded with sandpaper (without bleeding). 0.5g of the herbal ointment prepared in Example 1 was applied to the test area daily for 7 consecutive days. The appearance of irritant reactions such as erythema, edema, papules, and vesicles was observed and recorded daily.

[0064] The experimental results showed that during the 7-day continuous application, no irritation reactions such as erythema, edema, papules, or vesicles appeared on the skin of the rabbits in both the intact skin group and the damaged skin group, and there was no significant difference compared with the blank control group. After the experiment, the application of the drug was stopped, and the skin was observed for another 7 days. No abnormal changes were observed in the test area, indicating that the topical Chinese medicine composition was non-irritating to the skin.

[0065] (ii) Acute toxicity test Forty healthy Kunming mice, weighing 18-22g, were randomly divided into four groups of ten mice each, with half males and half females. The herbal ointment prepared in Example 1 was diluted with physiological saline to form three dosage groups: high, medium, and low (20g / kg, 10g / kg, and 5g / kg, respectively). A blank control group was also included (applied with an equal volume of physiological saline). The corresponding dosage of the medication was applied to the shaved area (2cm × 2cm) on the back of each mouse. After application, the area was covered with gauze and secured to prevent the mice from licking it. The medication was removed after 24 hours. The mice were observed for 14 days, and their general condition (mental state, appetite, activity, etc.), weight changes, and mortality were recorded.

[0066] The experimental results showed that during the 14-day observation period, mice in all dosage groups were in good mental condition, had normal appetite, and moved freely. No poisoning symptoms were observed, and no mice died. The condition of mice in the blank control group was not significantly different from that of the dosage groups. This indicates that the topical Chinese medicine composition has no acute toxicity at a dose of 20g / kg (far exceeding the clinically intended dose) and is safe and reliable for use.

[0067] Experimental Example 3 This trial used the ointment from Example 1 for a clinical trial. The steps are as follows: Forty-four hospitalized patients with diabetes and obesity were selected and treated with the ointment described in Example 1. The ointment was applied topically once daily for two months. The application site was the abdominal fat accumulation area, centered on the Shenque acupoint (navel), covering the entire abdominal region from below the xiphoid process to the upper edge of the pubic symphysis, and laterally to the mid-axillary line. For adults, 5-10g of the ointment was applied per application (8g per application in the following cases), evenly and thinly applied to the application site, with a thickness of 1-2mm. After application, the abdomen was massaged clockwise for 5-10 minutes to promote transdermal absorption. The ointment was retained for 4-8 hours (preferably before bedtime). The treatment results were as follows: After treatment, patients' weight (5.64±0.38kg, P<0.01) and BMI (2.11±0.15kg, P<0.01) decreased significantly compared to before treatment.

[0068] Typical case: Ms. Shi, female, 26 years old, was 160cm tall and weighed 90kg at her first visit, with a BMI of 35.16kg / m². 2 The patient's waist circumference was 100cm. After applying the ointment in Example 1 for 2 months, the patient's weight was 78kg, a decrease of 12kg, and the waist circumference was 90.5cm, a decrease of 9.5cm.

[0069] Mr. Wang, male, 41 years old, was 185cm tall and weighed 99kg at his first visit, with a BMI of 28.93kg / m². 2The patient's waist circumference was 107cm. After applying the ointment in Example 1 for 2 months, the patient's weight decreased by 2kg to 97kg, and the waist circumference decreased by 7cm to 100cm.

[0070] Ms. Wang, female, 33 years old, was 152cm tall and weighed 89kg at her first visit, with a BMI of 38.52kg / m². 2 The patient's waist circumference was 106cm. After applying the ointment in Example 1 for 2 months, the patient's weight decreased by 4kg to 85kg, and the waist circumference decreased by 2cm to 104cm.

[0071] Ms. Zhao, female, 33 years old, was 160cm tall and weighed 70kg at her first visit, with a BMI of 27.34kg / m². 2 The patient's waist circumference was 83cm. After applying the ointment in Example 1 for 2 months, the patient's weight decreased by 5kg to 65kg, and the waist circumference decreased by 5cm to 78cm.

[0072] The above experimental results show that the traditional Chinese medicine composition of Example 1 has a significant weight loss effect, which can significantly reduce the weight, Lee's index and fat coefficient of obese rats, and effectively regulate serum lipid metabolism (reduce TC, TG and LDL-C levels, and increase HDL-C levels). At the same time, the safety evaluation experiment proved that the traditional Chinese medicine composition of the present invention is non-irritating to the skin, has no acute toxicity, and is safe and reliable to use.

[0073] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A traditional Chinese medicine composition, characterized in that, Its ingredients include: Eupatorium fortunei, Lycopus lucidus, Curcuma longa, Curcuma aromatica, Curcuma zedoaria, Angelica sinensis tail, Boswellia carterii, Commiphora myrrha, Prunus persica kernel, processed Polygonum multiflorum, and Clematis chinensis.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, Its raw materials include the following components by weight: 9-13 parts of Eupatorium fortunei, 9-12 parts of Lycopus lucidus, 12-15 parts of Curcuma longa, 12-15 parts of Curcuma zedoaria, 12-15 parts of Angelica sinensis (tail), 5-8 parts of Boswellia carterii, 5-8 parts of Commiphora myrrha, 9-12 parts of Prunus persica, 9-12 parts of processed Polygonum multiflorum, and 9-12 parts of Clematis chinensis. Preferably, the raw materials include the following components by weight: 9-12 parts of Eupatorium fortunei, 9-12 parts of Lycopus lucidus, 12-15 parts of Curcuma longa, 12-15 parts of Curcuma aromatica, 12-15 parts of Curcuma zedoaria, 12-15 parts of Angelica sinensis (tail), 5-8 parts of Boswellia carterii, 5-8 parts of Commiphora myrrha, 9-12 parts of Prunus persica, 9-12 parts of processed Polygonum multiflorum, and 9-12 parts of Clematis chinensis.

3. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that, Its raw materials also include rhubarb; preferably, 9-12 parts of rhubarb.

4. The traditional Chinese medicine composition according to claim 3, characterized in that, Its raw materials include the following components by weight: 9-10 parts of Eupatorium fortunei, 11-12 parts of Lycopus lucidus, 14-15 parts of Curcuma longa, 14-15 parts of Curcuma aromatica, 14-15 parts of Curcuma zedoaria, 12-13 parts of Angelica sinensis (tail), 5-6 parts of Boswellia carterii, 5-6 parts of Commiphora myrrha, 11-12 parts of Prunus persica, 11-12 parts of processed Polygonum multiflorum, 11-12 parts of rhubarb (processed with wine), and 9-10 parts of Clematis chinensis. Preferably, the raw materials include the following components by weight: 9 parts of Eupatorium fortunei, 12 parts of Lycopus lucidus, 15 parts of Curcuma longa, 15 parts of Curcuma aromatica, 15 parts of Curcuma zedoaria, 12 parts of Angelica sinensis (tail), 5 parts of Boswellia carterii, 5 parts of Commiphora myrrha, 12 parts of Prunus persica, 12 parts of processed Polygonum multiflorum, 12 parts of Rheum palmatum (processed with wine), and 9 parts of Clematis chinensis.

5. A traditional Chinese medicine preparation, characterized in that, It is prepared using the traditional Chinese medicine composition according to any one of claims 1 to 4 as raw material.

6. The traditional Chinese medicine preparation according to claim 5, characterized in that, The traditional Chinese medicine preparations include decoctions, pills, powders, ointments, elixirs, medicated wines, tablets, granules, capsules, injections, aerosols, sprays, gels, lozenges, syrups, mixtures, or elixirs.

7. The traditional Chinese medicine preparation according to claim 5 or 6, characterized in that, The traditional Chinese medicine preparation also includes pharmaceutically acceptable excipients; Preferably, the excipients include at least one of fillers, excipients, lubricants, wetting agents, and diluents; Preferably, the auxiliary materials include petrolatum and lanolin.

8. The traditional Chinese medicine preparation according to any one of claims 5 to 7, characterized in that, The preparation method includes: using medicinal materials other than frankincense and myrrh as the first raw material and frankincense and myrrh as the second raw material, respectively extracting the first raw material and the second raw material with alcohol; and mixing the alcohol extracts of the two raw materials. Preferably, the temperature for alcohol extraction of the first raw material is 76℃-80℃; Preferably, the temperature for alcohol extraction of the second raw material is 70℃-75℃.

9. The traditional Chinese medicine preparation according to claim 8, characterized in that, The preparation method also includes: mixing the alcohol extracts of the two raw materials and concentrating them to obtain a traditional Chinese medicine extract; Preferably, the traditional Chinese medicine preparation is prepared by mixing the herbal extract with a matrix; the matrix includes petrolatum and lanolin. Preferably, the weight ratio of petrolatum to lanolin is (2~4):1; Preferably, the weight ratio of the herbal extract to the base is 1:(3~5).

10. The use of the traditional Chinese medicine composition according to any one of claims 1 to 4, or the traditional Chinese medicine preparation according to any one of claims 4 to 7, in the preparation of a drug for controlling weight gain, controlling obesity, or regulating blood lipids; Preferably, the weight gain or obesity is caused by a high-fat diet; Preferably, the regulation of blood lipids is manifested in reducing TC, TG or LDL-C levels, or increasing HDL-C levels.

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