A traditional Chinese medicine composition with weight-reducing effect and a preparation method and application thereof

Abstract

The application belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition with a weight-reducing effect and a preparation method and application thereof. The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: lotus leaves 2-10 parts, raw hawthorn 5-15 parts, tuckahoe 5-10 parts, rosette flower 5-15 parts, dried orange peel 5-10 parts, gynostemma pentaphyllum 1-5 parts, pearl powder 1-5 parts, and tea leaves 2-10 parts. The green tea is any one of Longjing, Biluochun, Xianhao, Maofeng, Cuiya, and Huangjinya. The traditional Chinese medicine composition is prepared from lotus leaves, raw hawthorn, tuckahoe, rosette flower, dried orange peel, gynostemma pentaphyllum, pearl powder, and tea leaves. The traditional Chinese medicine composition can effectively relieve the body weight, fat index, and serum biochemical indexes of obese rats, has excellent weight-reducing effect, high safety, and no toxic side effects.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition with weight loss effect, its preparation method and application. Background Technology

[0002] Obesity refers to a physiological state characterized by a significantly elevated body weight, a substantial increase in body fat, particularly the excessive accumulation of triglycerides. With the gradual improvement of living standards in modern society, people consume far more nutrients than their bodies require for normal development. Coupled with a lack of sufficient exercise, the number of obese individuals is constantly increasing. Currently, the proportion of obese people in the total population continues to rise, impacting not only their work, life, and appearance, but also significantly increasing the risk of hypertension, coronary heart disease, fatty liver, diabetes, hyperlipidemia, gout, and gallstones. The causes of obesity can be broadly categorized into the following five types.

[0003] First, genetic factors are a significant contributing factor to obesity, primarily affecting the body's susceptibility to obesity; obese individuals often have a strong family history of obesity. Second, endocrine factors are also crucial, including abnormalities in adrenal glucocorticoids, hypothalamic and pituitary diseases, Cushing's syndrome, hypothyroidism, hypogonadism, and polycystic ovary syndrome. Third, unhealthy lifestyle habits also lead to obesity, such as overeating, irregular eating habits (e.g., frequency of meals, type and fat content of food, meal timing), lack of exercise, and excessive alcohol consumption. Furthermore, medication factors cannot be ignored; long-term use of drugs such as glucocorticoids, chlorpromazine, and insulin may induce iatrogenic obesity. Finally, research on adipokines has provided new perspectives on the pathogenesis of obesity; for example, abnormalities in adiponectin and resistin are closely related to obesity.

[0004] Currently, Western medicines for treating obesity are mainly divided into two categories. One category acts on the central norepinephrine and serotonin pathways, achieving weight loss by suppressing appetite and increasing satiety, such as amphetamine and benzodiazepine. The other category acts on the peripheral system, reducing weight by decreasing the absorption of nutrients. Although Western medicine treatments for obesity have the advantages of short treatment courses and rapid effects, their side effects are also quite significant. The former (category one) may cause problems such as insomnia, dry mouth, constipation, and mild increases in heart rate and blood pressure, while the latter (category two) may affect the absorption of fat-soluble vitamins with long-term use. Therefore, although a single compound can be effective for weight loss, its side effects may also cause certain harm to health.

[0005] Existing research indicates that traditional Chinese medicine (TCM) therapies for obesity have fewer toxic side effects. By regulating the internal organs, they help patients lose weight and improve their quality of life, and have gradually become a commonly used clinical treatment for obesity. Therefore, finding a convenient, safe, effective, and suitable TCM weight loss method for long-term use is of significant practical importance.

[0006] Chinese patent CN201610073460.6 discloses a composition with weight-loss effects, its preparation method, and its uses. The composition consists of: epicatechin gallate 3-30 parts by weight, Poria cocos peel extract 8-35 parts by weight, cinnamon extract 5-35 parts by weight, Plantago asiatica extract 1-22 parts by weight, Atractylodes macrocephala extract 1-25 parts by weight, and Taxillus chinensis extract 4-23 parts by weight. This composition exhibits significant weight-loss and lipid-lowering effects with minimal side effects and high safety. However, it does not cause the intestinal discomfort associated with Poria cocos or cinnamon.

[0007] Chinese patent CN110755562A discloses a traditional Chinese medicine composition for weight loss, comprising the following components by weight: 20-40 parts roasted Job's tears; 5-15 parts lotus leaf; 5-15 parts chrysanthemum; 5-15 parts red adzuki bean; 10-20 parts hawthorn; 5-15 parts radish seed; 2-8 parts cassia seed; 5-15 parts chicken gizzard lining; and 5-15 parts astragalus. The preparation method of this traditional Chinese medicine composition is as follows: grind the above raw materials into powder and mix them. This traditional Chinese medicine composition has the effects of promoting diuresis and reducing swelling, lowering blood lipids, reducing cholesterol, and aiding weight loss.

[0008] Chinese patent CN110694039A discloses a traditional Chinese medicine composition for weight loss and its preparation method. The raw materials used in the composition include fennel fruit, rhubarb, senna leaf extract, alisma, kudzu flower, polygonatum, ginger, mulberry leaf extract, notoginseng, borneol, and camphor. The composition is applied via a hot compress, allowing the medicine to be absorbed into the bloodstream through abdominal hair follicles, sebaceous glands, sweat glands, keratinocytes, and intercellular spaces, bypassing liver metabolism and avoiding the burden of liver detoxification. This aligns with modern medical principles advocating for transdermal, mucosal, or rectal absorption for health.

[0009] The compositions disclosed in the aforementioned patent applications all contain multiple traditional Chinese medicine ingredients, but they still have shortcomings such as unclear weight loss effects and easy to produce side effects. Summary of the Invention

[0010] To address the shortcomings of existing compositions, which contain multiple traditional Chinese medicine ingredients and suffer from unclear weight-loss effects and a tendency to produce side effects, this invention provides a traditional Chinese medicine composition with weight-loss effects, its preparation method, and its application. This composition offers advantages such as low cost, minimal toxicity and side effects, and low risk of rebound weight gain. To achieve the above objectives, this invention adopts the following technical solution:

[0011] This invention provides a traditional Chinese medicine composition with weight loss effect, which is composed of the following raw materials in parts by weight: 2-10 parts lotus leaf, 5-15 parts hawthorn, 5-10 parts poria cocos, 5-15 parts roselle, 5-10 parts dried tangerine peel, 1-5 parts gynostemma pentaphyllum, 1-5 parts pearl powder, and 2-10 parts tea leaves.

[0012] The tea mentioned is green tea. Green tea, as one of the main raw materials of this traditional Chinese medicine composition, is rich in catechins and flavonols, which have been proven to effectively reduce the levels of total cholesterol and triglycerides in blood plasma, thereby promoting fat metabolism and consumption. At the same time, the polyphenols in green tea have powerful antioxidant functions, which can activate lipase, accelerate the decomposition and consumption of body fat, increase the metabolic rate, and reduce fat accumulation in the body, thus having a significant auxiliary effect on weight loss.

[0013] This traditional Chinese medicine composition uses lotus leaf, hawthorn, poria cocos, hibiscus, tangerine peel, gynostemma pentaphyllum, pearl powder, and tea as raw materials, and has been scientifically and rationally formulated based on their unique pharmacological effects and properties. Lotus leaf has the effects of clearing heat and relieving summer heat, promoting diuresis and weight loss, effectively promoting the excretion of excess water and reducing edema. Hawthorn is rich in various organic acids and vitamins, aiding digestion and eliminating stagnation, thus having a good auxiliary effect on weight loss. Poria cocos, as a diuretic, can enhance metabolism and help eliminate excess body fat. Hibiscus is rich in vitamin C and various natural acids, which not only promote digestion but also have lipid-lowering and weight-loss effects. Tangerine peel can regulate qi and strengthen the spleen, helping to improve digestive function and prevent fat accumulation. Gynostemma pentaphyllum has the effects of lowering lipids and blood pressure, clearing heat and detoxifying, effectively assisting weight loss and improving physical condition. Pearl powder is rich in various amino acids and trace elements, which can enhance the body's immunity and improve skin condition, offering multiple benefits for those pursuing healthy weight loss. Tea, especially green tea, is widely recognized for its weight-loss effects. Its rich content of polyphenols and other components accelerates fat metabolism and increases the metabolic rate. This formula aims to comprehensively improve the body's metabolic state through the synergistic effect of its ingredients, promoting the breakdown and consumption of fat, while simultaneously regulating the body's overall health to achieve healthy and effective weight loss goals.

[0014] Preferably, the ingredients are composed of the following raw materials in parts by weight: 1-5 parts lotus leaf, 5-7 parts hawthorn, 5-10 parts poria cocos, 5-8 parts roselle, 5-10 parts dried tangerine peel, 1-3 parts gynostemma pentaphyllum, 1-5 parts pearl powder, and 4-8 parts green tea.

[0015] Preferably, the green tea includes any one of Longjing, Biluochun, Xianhao, Maofeng, Cuiya, and Huangjinya.

[0016] The selection of several green tea varieties—Longjing, Biluochun, Xianhao, Maofeng, Cuiya, and Huangjinya—in this traditional Chinese medicine composition is based on their unique qualities and characteristics, as well as their potential contribution to weight loss. Longjing tea, as a representative of traditional Chinese green tea, has a good auxiliary effect in promoting fat metabolism and reducing weight. Biluochun tea is renowned for its unique curled shape and fragrant aroma; it is rich in tea polyphenols and other beneficial components, which can effectively accelerate the decomposition and consumption of fat. Xianhao tea contains various alkaloids and flavonoids, which have a significant effect on improving metabolism and reducing fat absorption. Furthermore, Maofeng tea is rich in amino acids and various vitamins, which have a positive effect on promoting metabolism and burning fat. Finally, Huangjinya tea's buds and leaves are rich in tea polyphenols and amino acids, not only offering a refreshing taste but also effectively inhibiting fat synthesis, significantly enhancing the weight loss effect. In conclusion, the selection of these green tea varieties as raw materials for this traditional Chinese medicine composition aims to leverage their unique qualities and characteristics to work together to achieve a weight loss effect.

[0017] This invention also provides a method for preparing a traditional Chinese medicine composition with weight-loss effect, comprising the following steps:

[0018] After washing the raw hawthorn, poria cocos, roselle, dried tangerine peel, gynostemma pentaphyllum, pearl powder, and green tea, they are dried at 70-80℃. This step removes excess moisture from the Chinese herbs, thus fixing their quality, inhibiting enzymatic oxidation, enhancing their storage resistance, and facilitating subsequent processing.

[0019] Weigh out the dried lotus leaves, hawthorn, poria cocos, roselle, dried tangerine peel, gynostemma pentaphyllum, and green tea according to their weight proportions. Add the lotus leaves and decoct with 2-6 times the amount of water for 1-3 hours. After filtering, add 2-6 times the amount of water to the dregs and continue decocting for 1-2 hours. Filter again, combine the two filtrates, and concentrate to a paste to obtain a paste. The decoction method can fully dissolve and extract the effective components of traditional Chinese medicine, such as alkaloids, flavonoids, and polysaccharides, ensuring that these components can enter the decoction and provide sufficient therapeutic efficacy.

[0020] Weigh the pearl powder according to its weight, add 1-5 times its volume of 50-70% ethanol solution, soak for 2-6 hours, filter, and concentrate the filtrate to obtain a concentrated liquid. Ethanol has excellent organic solvent properties and can extract the effective components from pearls, such as amino acids, trace elements, and polypeptides.

[0021] Add the concentrated liquid to the paste, add 1-10g of erythritol, mix well, bottle and sterilize to obtain the Chinese herbal composition with weight loss effect.

[0022] The mass ratio of concentrated liquid to paste is 1 mL: 30-60 g; the amount of erythritol added is 0.1-0.5 times the weight of the paste. Erythritol, as a low-calorie sweetener, not only provides a sweetness close to sucrose, improving the taste of traditional Chinese medicine extracts, but its low-calorie properties also help reduce total energy intake and promote weight loss.

[0023] The sterilization conditions are 140-160℃ for 1-2 hours. High-temperature sterilization can effectively kill microorganisms such as bacteria, viruses, and fungi in traditional Chinese medicine extracts, thereby ensuring the safety of the product during use.

[0024] The present invention also provides the application of a traditional Chinese medicine composition with weight loss effect in the preparation of a weight loss drug, wherein the weight loss drug includes any one of ointment, solution, granule or capsule.

[0025] The weight-loss drug is made from the traditional Chinese medicine composition together with a pharmaceutically acceptable carrier according to conventional pharmaceutical techniques.

[0026] The weight-loss drug contains 50-90% of the effective content of the traditional Chinese medicine composition.

[0027] When the weight-loss drug is in the form of a paste, it is prepared using the traditional Chinese medicine composition as the active ingredient, supplemented with honey, sugar, and donkey-hide gelatin, through conventional methods for preparing pastes.

[0028] When the weight-loss drug is a solution, it is prepared using the traditional Chinese medicine composition as the active ingredient, supplemented with ultrapure water, polyethylene glycol, and potassium sorbate, through conventional methods for solution preparation.

[0029] When the weight-loss drug is in granule form, it is prepared using the traditional Chinese medicine composition as the active ingredient, supplemented with lactose, starch, and dextrin, through conventional methods for granule preparation.

[0030] When the weight-loss drug is in capsule form, it is prepared using the traditional Chinese medicine composition as the active ingredient, supplemented with any one or more of glycerin, agar, and sodium carboxymethyl cellulose, through conventional capsule preparation methods.

[0031] Compared with the prior art, the present invention has the following beneficial effects:

[0032] 1. This invention provides a traditional Chinese medicine composition with weight loss effect. The composition, through Poria cocos which has diuretic and swelling-reducing activity, helps to expel excess water and toxins from the body, while also controlling appetite and helping to reduce calorie intake.

[0033] 2. The traditional Chinese medicine composition with weight loss effect provided by the present invention uses pharmacologically active ingredients such as lotus leaf, roselle, and gynostemma pentaphyllum as raw materials, which enables the traditional Chinese medicine composition with weight loss effect to reduce the occurrence of diseases such as fatty liver, hyperlipidemia, hyperglycemia, coronary heart disease, and gout, and helps users reduce the risk of diseases caused by obesity.

[0034] 3. Through extensive experimentation, this invention has revealed unexpected effectiveness of the traditional Chinese medicine composition with weight-loss properties in treating or preventing obesity. Animal experiments show that the traditional Chinese medicine composition prepared in this invention can significantly reduce weight in obese rats, lowering their fat index, blood glucose, and blood lipid levels. It is characterized by rapid onset of action, no adverse reactions, short treatment time, no rebound effect, convenient use, and low treatment cost.

[0035] 4. This invention uses lotus leaf, hawthorn, poria cocos, roselle, tangerine peel, gynostemma pentaphyllum, and pearl powder as raw materials. Through the synergistic effect of these raw materials, the weight loss effect is achieved.

[0036] Lotus leaf: Lotus leaf is bitter in taste and neutral in nature; it enters the liver, spleen, and stomach meridians; it has the functions of clearing summer heat and dampness, promoting the upward movement of clear yang, cooling blood and stopping bleeding. Its chemical components are mainly alkaloids, flavonoids, volatile oils, and various trace components. Lotus leaf exerts its weight loss effect in multiple ways: ① It can inhibit the activity of pancreatic lipase and regulate lipid metabolism, thereby inhibiting the absorption of carbohydrates and lipids; ② It can significantly reduce the content of triglycerides and total cholesterol in serum, thereby reducing fat deposition; ③ It can also inhibit the proliferation and differentiation of adipocytes, thereby playing a role in weight loss; ④ By increasing the level of glucose transporter proteins, it can improve the uptake and utilization of glucose by adipose tissue.

[0037] Raw hawthorn: Raw hawthorn is sour, sweet, and warm in nature, and enters the spleen, stomach, and liver meridians. It has the effects of promoting digestion, resolving food stagnation, and invigorating blood circulation. The medicinal part is mostly its fruit, which has the functions of strengthening the stomach and promoting digestion, invigorating blood circulation and removing blood stasis, and stopping diarrhea. Hawthorn can effectively inhibit hyperinsulinemia and insulin resistance, reducing cardiovascular and digestive system diseases induced by obesity. At the same time, raw hawthorn effectively blocks the activation of pancreatic lipase, thereby blocking the conversion of large molecule triglycerides into small molecule fatty acids and glycerol, thus reducing fat accumulation and playing a certain role in combating obesity.

[0038] Poria cocos: Poria cocos is the dried sclerotium of the fungus Poria cocos, a type of health-promoting edible fungus. It is sweet, bland, and neutral in nature, and enters the heart, lung, spleen, and kidney meridians. It can calm the mind and strengthen the spleen, and has wide applications in strengthening the spleen, removing dampness, resolving phlegm, and reducing swelling. The *Ben Cao Zheng* states: "Poria cocos can clear the orifices and remove dampness; clearing the orifices opens the heart and improves intelligence, guides turbidity and generates fluids; removing dampness expels water and dries the spleen, tonifies the middle and strengthens the stomach; it dispels fright and carbuncles, thickens the intestines, treats the root cause of phlegm, and assists the downward movement of other medicines." It can improve obesity symptoms in the body by improving intestinal flora, promoting adipocyte degradation, and regulating the AMPK pathway.

[0039] Roselle: Roselle is rich in nutrients, containing 0.93% vitamin C, 0.21% vitamin B, 2.55% polysaccharides, and 1.76% starch. It is rich in malic acid, anthocyanins, and other nutrients. Consuming roselle can improve pancreatic function, promote bile and gastric acid secretion, accelerate metabolism, and enhance gastrointestinal function, thus having good effects in lowering blood lipids and promoting fat breakdown.

[0040] Dried tangerine peel (Chenpi): According to the *Compendium of Materia Medica*, dried tangerine peel has a bitter taste and can regulate qi and dry dampness. The flavonoids in dried tangerine peel include hesperidin, tangeretin, hesperidin, neohesperidin, naringin, and polymethoxyflavonoids. Dried tangerine peel promotes digestion and the secretion of digestive juices, stimulates gastric smooth muscle, promotes intestinal peristalsis and gas expulsion, increases appetite, and accelerates digestion. The pectin in dried tangerine peel has in vitro intestinal immunomodulatory activity; it can also improve gastrointestinal motility disorders by regulating gastrointestinal hormone levels, repair damaged intestinal mucosa, enhance intestinal defense capabilities, and thus aid in weight loss.

[0041] Gynostemma pentaphyllum: It is bitter, sweet and cold in nature, and non-toxic. It has the effects of clearing heat and detoxifying, replenishing qi and promoting body fluid, resolving phlegm and relieving cough, calming the mind and consolidating essence. It can reduce the content of total cholesterol and triglycerides in the blood, significantly reduce the content of low-density lipoprotein and very low-density lipoprotein, and promote the metabolism of cholesterol and B lipoprotein; at the same time, it exerts the effects of lowering blood lipids and weight loss by absorbing glucose into fat cells to synthesize neutral fats.

[0042] Pearl powder: Pearl powder is made from the powder of pearls formed by bivalves such as *Pteria martensii* (Dunker), *Hyriopsis cumingii* (Lea), or *Cristaria plicata* (Leach), when stimulated. It has calming, vision-improving, detoxifying, and tissue-regenerating effects. It is commonly used for palpitations, insomnia, infantile convulsions, epilepsy, corneal opacity, and slow-healing sores.

[0043] When used together, these herbs work synergistically to clear heat, purge fire, detoxify, promote diuresis, and reduce swelling. The components of each herb complement each other and enhance their effects, reducing the weight and fat index of rats, while also lowering the levels of total cholesterol and triglycerides in the serum. This effectively inhibits the weight, fat index, and serum biochemical indicators in obese rats, demonstrating a very significant effect on weight loss. Furthermore, the preparation method is simple, and the use is safe and convenient, making it an effective traditional Chinese medicine formula for weight loss. Detailed Implementation

[0044] The present invention will be described in detail below with reference to specific embodiments, but should not be construed as limiting the present invention. Unless otherwise specified, the technical means used in the following embodiments are conventional means well known to those skilled in the art, and the materials, reagents, etc. used in the following embodiments can be obtained commercially unless otherwise specified.

[0045] Example 1

[0046] A traditional Chinese medicine composition with weight loss effect is composed of the following raw materials in parts by weight: 2 parts lotus leaf, 5 parts hawthorn, 5 parts poria cocos, 5 parts roselle, 5 parts dried tangerine peel, 1 part gynostemma pentaphyllum, 1 part pearl powder, and 4 parts tea leaves.

[0047] The tea is Biluochun green tea, sourced from Tangmingyuan Tea Industry Co., Ltd.

[0048] The lotus leaf, raw hawthorn, poria cocos, roselle, dried tangerine peel, gynostemma pentaphyllum, and pearl powder are sourced from Bozhou Kangbida Pharmaceutical Co., Ltd.

[0049] The preparation method of the above-mentioned traditional Chinese medicine composition with weight loss effect includes the following steps:

[0050] S1. Weigh out the washed and dried lotus leaves, hawthorn, poria cocos, roselle, tangerine peel, gynostemma pentaphyllum, and Biluochun green tea according to the weight proportions. Add 6 times the amount of water and decoct for 1-3 hours. After filtering, add 6 times the amount of water to the dregs and continue to decoct for 2 hours. Filter again, combine the two filtrates, concentrate for 60 minutes, and concentrate to a paste to obtain a paste for later use.

[0051] S2. Weigh the pearl powder according to the weight parts, add twice the volume of 70% ethanol solution, soak for 2 hours, stir once every 0.5 hours, filter, concentrate the filtrate to 100mL, and obtain concentrated liquid for later use.

[0052] S3. Add 5 mL of concentrated liquid obtained in S2 to 200 g of paste obtained in S1, add 20 g of erythritol, stir well, bottle and sterilize to obtain a traditional Chinese medicine composition with weight loss effect.

[0053] The sterilization conditions are 160℃ for 2 hours.

[0054] Example 2

[0055] A traditional Chinese medicine composition with weight loss effect is composed of the following raw materials in parts by weight: 6 parts lotus leaf, 10 parts hawthorn, 7 parts poria cocos, 10 parts roselle, 7 parts dried tangerine peel, 3 parts gynostemma pentaphyllum, 3 parts pearl powder, and 6 parts tea leaves.

[0056] The tea is Biluochun green tea, sourced from Tangmingyuan Tea Industry Co., Ltd.

[0057] The lotus leaf, raw hawthorn, poria cocos, roselle, dried tangerine peel, gynostemma pentaphyllum, and pearl powder are sourced from Bozhou Kangbida Pharmaceutical Co., Ltd.

[0058] The preparation method of the above-mentioned traditional Chinese medicine composition with weight loss effect includes the following steps: the same as in Example 1.

[0059] Example 3

[0060] A traditional Chinese medicine composition with weight loss effect is composed of the following raw materials in parts by weight: 10 parts lotus leaf, 15 parts hawthorn, 10 parts poria cocos, 15 parts roselle, 10 parts dried tangerine peel, 5 parts gynostemma pentaphyllum, 5 parts pearl powder, and 10 parts tea leaves.

[0061] The tea is Biluochun green tea, sourced from Tangmingyuan Tea Industry Co., Ltd.

[0062] The lotus leaf, raw hawthorn, poria cocos, roselle, dried tangerine peel, gynostemma pentaphyllum, and pearl powder are sourced from Bozhou Kangbida Pharmaceutical Co., Ltd.

[0063] The preparation method of the above-mentioned traditional Chinese medicine composition with weight loss effect includes the following steps: the same as in Example 1.

[0064] Example 4

[0065] A traditional Chinese medicine composition with weight loss effect is composed of the following raw materials in parts by weight: 1 part lotus leaf, 5 parts hawthorn, 5 parts poria cocos, 5 parts roselle, 5 parts dried tangerine peel, 1 part gynostemma pentaphyllum, 1 part pearl powder, and 4 parts tea leaves.

[0066] The tea is Biluochun green tea, sourced from Tangmingyuan Tea Industry Co., Ltd.

[0067] The lotus leaf, raw hawthorn, poria cocos, roselle, dried tangerine peel, gynostemma pentaphyllum, and pearl powder are sourced from Bozhou Kangbida Pharmaceutical Co., Ltd.

[0068] The preparation method of the above-mentioned traditional Chinese medicine composition with weight loss effect includes the following steps: the same as in Example 1.

[0069] Example 5

[0070] A traditional Chinese medicine composition with weight loss effect is composed of the following raw materials in parts by weight: 3 parts lotus leaf, 6 parts hawthorn, 7 parts poria cocos, 6 parts roselle, 7 parts dried tangerine peel, 2 parts gynostemma pentaphyllum, 3 parts pearl powder, and 6 parts tea leaves.

[0071] The tea is Biluochun green tea, sourced from Tangmingyuan Tea Industry Co., Ltd.

[0072] The lotus leaf, raw hawthorn, poria cocos, roselle, dried tangerine peel, gynostemma pentaphyllum, and pearl powder are sourced from Bozhou Kangbida Pharmaceutical Co., Ltd.

[0073] The preparation method of the above-mentioned traditional Chinese medicine composition with weight loss effect includes the following steps: the same as in Example 1.

[0074] Example 6

[0075] A traditional Chinese medicine composition with weight loss effect is composed of the following raw materials in parts by weight: 5 parts lotus leaf, 7 parts hawthorn, 10 parts poria cocos, 8 parts roselle, 10 parts dried tangerine peel, 3 parts gynostemma pentaphyllum, 5 parts pearl powder, and 8 parts tea leaves.

[0076] The tea is Biluochun green tea, sourced from Tangmingyuan Tea Industry Co., Ltd.

[0077] The lotus leaf, raw hawthorn, poria cocos, roselle, dried tangerine peel, gynostemma pentaphyllum, and pearl powder are sourced from Bozhou Kangbida Pharmaceutical Co., Ltd.

[0078] The preparation method of the above-mentioned traditional Chinese medicine composition with weight loss effect includes the following steps: the same as in Example 1.

[0079] Example 7

[0080] A traditional Chinese medicine composition with weight loss effect is composed of the following raw materials in parts by weight: 5 parts lotus leaf, 8 parts hawthorn, 5 parts poria cocos, 8 parts roselle, 5 parts dried tangerine peel, 3 parts gynostemma pentaphyllum, 2 parts pearl powder, and 8 parts tea leaves.

[0081] The tea is Longjing green tea, sourced from Hubei Aidafu Ecological Tea Industry Co., Ltd.

[0082] The lotus leaf, raw hawthorn, poria cocos, roselle, dried tangerine peel, gynostemma pentaphyllum, and pearl powder are sourced from Bozhou Kangbida Pharmaceutical Co., Ltd.

[0083] The preparation method of the above-mentioned traditional Chinese medicine composition with weight loss effect includes the following steps: the same as in Example 1.

[0084] Example 8

[0085] A traditional Chinese medicine composition with weight loss effect is composed of the following raw materials in parts by weight: 5 parts lotus leaf, 8 parts hawthorn, 5 parts poria cocos, 8 parts roselle, 5 parts dried tangerine peel, 3 parts gynostemma pentaphyllum, 2 parts pearl powder, and 8 parts tea leaves.

[0086] The tea is Xianhao green tea, sourced from Hubei Aidafu Ecological Tea Industry Co., Ltd.

[0087] The lotus leaf, raw hawthorn, poria cocos, roselle, dried tangerine peel, gynostemma pentaphyllum, and pearl powder are sourced from Bozhou Kangbida Pharmaceutical Co., Ltd.

[0088] The preparation method of the above-mentioned traditional Chinese medicine composition with weight loss effect includes the following steps: the same as in Example 1.

[0089] Example 9

[0090] A traditional Chinese medicine composition with weight loss effect is composed of the following raw materials in parts by weight: 5 parts lotus leaf, 8 parts hawthorn, 5 parts poria cocos, 8 parts roselle, 5 parts dried tangerine peel, 3 parts gynostemma pentaphyllum, 2 parts pearl powder, and 8 parts tea leaves.

[0091] The tea leaves are green bud tea, sourced from Hubei Aidafu Ecological Tea Industry Co., Ltd.

[0092] The lotus leaf, raw hawthorn, poria cocos, roselle, dried tangerine peel, gynostemma pentaphyllum, and pearl powder are sourced from Bozhou Kangbida Pharmaceutical Co., Ltd.

[0093] The preparation method of the above-mentioned traditional Chinese medicine composition with weight loss effect includes the following steps: the same as in Example 1.

[0094] Example 10

[0095] A traditional Chinese medicine composition with weight loss effect is composed of the following raw materials in parts by weight: 5 parts lotus leaf, 8 parts hawthorn, 5 parts poria cocos, 8 parts roselle, 5 parts dried tangerine peel, 3 parts gynostemma pentaphyllum, 2 parts pearl powder, and 8 parts tea leaves.

[0096] Among them, the tea leaves are Golden Buds, which come from Hubei Aidafu Ecological Tea Industry Co., Ltd.

[0097] The lotus leaf, raw hawthorn, poria cocos, roselle, dried tangerine peel, gynostemma pentaphyllum, and pearl powder are sourced from Bozhou Kangbida Pharmaceutical Co., Ltd.

[0098] The preparation method of the above-mentioned traditional Chinese medicine composition with weight loss effect includes the following steps: the same as in Example 1.

[0099] Example 11

[0100] A traditional Chinese medicine composition with weight loss effect is composed of the following raw materials in parts by weight: 6 parts lotus leaf, 10 parts hawthorn, 7 parts poria cocos, 10 parts roselle, 7 parts dried tangerine peel, 3 parts gynostemma pentaphyllum, 3 parts pearl powder, and 6 parts tea leaves.

[0101] Among them, the tea leaves are Golden Buds, which come from Hubei Aidafu Ecological Tea Industry Co., Ltd.

[0102] The lotus leaf, raw hawthorn, poria cocos, roselle, dried tangerine peel, gynostemma pentaphyllum, and pearl powder are sourced from Bozhou Kangbida Pharmaceutical Co., Ltd.

[0103] The preparation method of the above-mentioned traditional Chinese medicine composition with weight loss effect includes the following steps: the same as in Example 1.

[0104] Example 12

[0105] A traditional Chinese medicine composition with weight loss effect is composed of the following raw materials in parts by weight: 10 parts lotus leaf, 15 parts hawthorn, 10 parts poria cocos, 15 parts roselle, 10 parts dried tangerine peel, 5 parts gynostemma pentaphyllum, 5 parts pearl powder, and 10 parts tea leaves.

[0106] Among them, the tea leaves are Golden Buds, which come from Hubei Aidafu Ecological Tea Industry Co., Ltd.

[0107] The lotus leaf, raw hawthorn, poria cocos, roselle, dried tangerine peel, gynostemma pentaphyllum, and pearl powder are sourced from Bozhou Kangbida Pharmaceutical Co., Ltd.

[0108] The preparation method of the above-mentioned traditional Chinese medicine composition with weight loss effect includes the following steps: the same as in Example 1.

[0109] Comparative Example 1

[0110] A traditional Chinese medicine composition with weight-loss effects comprises the following raw materials in parts by weight: 20-40 parts roasted Job's tears; 5-15 parts lotus leaf; 5-15 parts chrysanthemum; 5-15 parts red adzuki bean; 10-20 parts hawthorn; 5-15 parts radish seed; 2-8 parts cassia seed; 5-15 parts chicken gizzard lining; and 5-15 parts astragalus. The preparation method of this traditional Chinese medicine composition is as follows: grind the above raw materials into powder and mix them.

[0111] Comparative Example 2

[0112] A composition with weight-loss effect, its preparation method and uses. The raw material composition of the composition is: epicatechin gallate ester 3-30 parts by weight, Poria cocos peel extract 8-35 parts by weight, cinnamon extract 5-35 parts by weight, Plantago asiatica extract 1-22 parts by weight, Atractylodes macrocephala extract 1-25 parts by weight, and Taxillus chinensis extract 4-23 parts by weight.

[0113] Comparative Example 3

[0114] A traditional Chinese medicine composition for weight loss and its preparation method are disclosed. The raw materials used in the composition include fennel fruit, rhubarb, senna leaf extract, alisma, kudzu flower, polygonatum, ginger, mulberry leaf extract, notoginseng, borneol, and camphor. The composition is applied via a hot compress to promote blood circulation.

[0115] Extraction method is one of the key factors affecting the retention of active ingredients and extraction efficiency of drugs. The composition provided in Comparative Example 1 is prepared by grinding into powder. However, water extraction or ethanol extraction has significant advantages over the traditional grinding into powder method in terms of extraction efficiency, retention of active ingredients and drug activity.

[0116] The composition provided in Comparative Example 2 lacks flavoring agents such as erythritol, sucrose, and aspartame. Due to the diversity of medicinal materials, traditional Chinese medicine often has unpleasant tastes such as bitterness and astringency, which can affect patient compliance. The addition of flavoring agents can reduce or eliminate these unpleasant tastes, thereby improving patient compliance and weight loss efficacy.

[0117] The composition provided in Comparative Example 3 was prepared using a film-forming process, which limits its drug loading capacity. Furthermore, for some patients requiring long-term, continuous treatment, frequent changes to the film or adjustments to the dosage may be necessary, and the film may not meet their needs.

[0118] Compared with Comparative Examples 1-3, the traditional Chinese medicine composition with weight-loss effect provided in this embodiment of the invention employs water extraction and alcohol extraction processes, which have significant advantages in terms of extraction efficiency, retention of active ingredients, and drug activity. Simultaneously, erythritol is added as a flavoring agent to enhance the taste of this composition. Furthermore, this traditional Chinese medicine composition can be applied in ointments, solutions, granules, or capsules, making it convenient to use and suitable for repeated applications.

[0119] To illustrate the efficacy of the traditional Chinese medicine composition with weight-loss effect provided by this invention, the following studies were conducted:

[0120] The weight loss effect of the traditional Chinese medicine composition with weight loss effect provided by the present invention will be explained by taking the traditional Chinese medicine composition with weight loss effect prepared in Embodiment 1 as an example.

[0121] (1) Establishment of an animal model of obesity:

[0122] Forty-eight newly weaned rats were randomly divided into a normal control group (n=6) and a model group (n=42). The rats were fed a normal diet and a high-sugar, high-fat diet, respectively, for six consecutive weeks. The standard for screening obese rats was that the weight of rats fed the high-sugar, high-fat diet exceeded that of rats fed the normal diet by 20%.

[0123] Thirty obese rats that successfully developed the model were selected from the model group and randomly divided into five groups: the model group, the orlistat group (positive control group), and the low, medium, and high dose groups of the combination, with six rats in each group. There were also six normal control rats.

[0124] The rats were sourced from Chengdu Dashuo Experimental Animal Co., Ltd.

[0125] (2) Sample preparation for low, medium, and high dose groups of the composition:

[0126] The traditional Chinese medicine composition with weight-loss effect prepared in Example 1 was administered to rats in each group by gavage at doses of 2, 4, and 8 g / kg, respectively. Different treatment methods corresponded to low, medium, and high doses of the composition, respectively. After weighing the rats in the low, medium, and high dose groups, the required dosage of the traditional Chinese medicine composition with weight-loss effect was calculated. Then, the composition was prepared into a liquid using sterile water at a dosage volume of 5 mL / kg, which were the sample solutions for the low, medium, and high dose groups.

[0127] The method for preparing sample solutions of the low, medium and high dose groups of the composition is to weigh 8, 16 and 32 g of the traditional Chinese medicine composition respectively, dissolve it fully in 20 mL of ultrapure water, and store it at 4 °C.

[0128] (3) Sample preparation for the orlistat group (positive control group):

[0129] The dosage of orlistat in the group was 5 mg / kg. After weighing each mouse, the required amount of orlistat was calculated. Then, orlistat was prepared into a solution with sterile water at a dosage volume of 5 mL / kg to obtain the sample solution of orlistat group.

[0130] (4) Processing:

[0131] Rats in the model group, orlistat group, low-, medium-, and high-dose groups of the composition, and normal control group were administered the drug by gavage once daily in the morning for 4 consecutive weeks. The model group and normal control group were administered 5 mL / kg of sterile water by gavage. The low-, medium-, and high-dose groups of the composition were administered the prepared sample solutions of the low-, medium-, and high-dose groups of the composition, and the orlistat group was administered the prepared sample solution of the orlistat group.

[0132] (5) Effects of the composition on body weight and fat index in obese rat models

[0133] Rats in the above model group, orlistat group, low-, medium-, and high-dose combination groups, and normal control group were weighed once a week. After the last administration and fasting for 24 hours, blood was collected from the abdominal aorta under sodium barbital anesthesia. The blood was allowed to stand for 30 minutes, centrifuged at 3000 rpm for 10 minutes, and the serum was separated and stored at -80℃ for later use. Abdominal genital tissue and perirenal adipose tissue were collected, weighed, and the adipose tissue index was calculated.

[0134] The calculation method for the body fat index is disclosed as follows:

[0135] Fat index = (fat weight / body weight) × 100%. The results are shown in Table 1.

[0136] Table 1. Effects of the composition on body weight and adipose tissue index in an obese rat model (mean ± standard deviation)

[0137]

[0138] Note: Compared with the normal group, *P<0.05, **P<0.01; compared with the model group, #P<0.05, ##P<0.01 (the same applies below).

[0139] As shown in Table 1, compared with the normal control group, the body weight and fat index of the model group rats were significantly increased; while the body weight and fat index of the obese rats at medium and high doses of the composition were significantly decreased compared with the model group. These results indicate that the traditional Chinese medicine composition can effectively reduce the body weight and fat index of rats, demonstrating good weight-loss activity.

[0140] (6) Effects of the composition on blood glucose and total cholesterol in an obese rat model

[0141] Serum samples stored at -80℃ were used to detect total cholesterol and blood glucose levels in rats using glucose and total cholesterol assay kits produced by Nanjing Jiancheng Bioengineering Research Institute Co., Ltd. The results are shown in Table 2.

[0142] Table 2. Effects of the composition on blood glucose and total cholesterol in an obese rat model (mean ± standard deviation)

[0143]

[0144] As shown in Table 2, compared with the normal control group, the blood glucose and total cholesterol levels of the model group rats were significantly increased; while compared with the model group, the blood glucose and total cholesterol levels in the serum of obese rats were significantly decreased at high doses of the composition, indicating that the traditional Chinese medicine composition can effectively regulate the blood lipid levels of obese rats.

[0145] (6) Effects of the composition on insulin and leptin in obese rat models

[0146] Serum samples stored at -80℃ were used to detect insulin and leptin levels in rat serum using insulin and leptin assay kits produced by Nanjing Jiancheng Bioengineering Research Institute Co., Ltd. The results are shown in Table 3.

[0147] Table 3. Effects of the composition on insulin and leptin in an obese rat model (mean ± standard deviation)

[0148]

[0149] As shown in Table 3, compared with the normal control group, the insulin and leptin levels in the model group rats were significantly increased; while the high-dose composition showed a significant decrease in serum insulin and leptin levels in obese rats compared with the model group. This indicates that the traditional Chinese medicine composition can effectively regulate insulin and leptin metabolism in the body and exert a weight-loss effect.

[0150] (7) Effects of the composition on liver biochemical parameters in an obese rat model

[0151] Serum samples stored at -80℃ were used to detect the levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in rats using a kit produced by Nanjing Jiancheng Bioengineering Research Institute Co., Ltd. The results are shown in Table 4.

[0152] Table 4. Effects of the composition on ALT and AST in an obese rat model (mean ± standard deviation)

[0153]

[0154] As shown in Table 4, compared with the model group, the ALT and AST levels in rats in the high-dose group of the composition were significantly reduced, and no abnormalities were found in any organs after dissection. This indicates that the traditional Chinese medicine composition has high safety.

[0155] In summary, the experimental results show that this traditional Chinese medicine composition can effectively reduce the body weight and fat index of rats, lower serum blood glucose and total cholesterol levels in obese rats, regulate insulin and leptin metabolism, and thus exert a weight-loss effect. Furthermore, this traditional Chinese medicine composition did not cause any damage to the rat organs, demonstrating high safety.

[0156] Compared with existing weight-loss compositions, the traditional Chinese medicine composition for weight loss provided by this invention has good weight-loss activity, can effectively regulate blood lipid levels in obese rats, exert weight-loss effects by regulating insulin and leptin metabolism in the body, and has high safety and can alleviate liver damage caused by obesity.

[0157] This invention provides a traditional Chinese medicine composition with weight loss effect, which uses pharmacologically active ingredients such as lotus leaf, roselle, and gynostemma pentaphyllum as raw materials. This composition can reduce the occurrence of diseases such as fatty liver, hyperlipidemia, hyperglycemia, coronary heart disease, and gout, thus helping users reduce the risk of diseases caused by obesity.

[0158] Meanwhile, the traditional Chinese medicine composition with weight loss effect provided by the present invention can be used to prepare a weight loss drug, which includes any one of ointment, solution, granule or capsule; the weight loss drug is made by the traditional Chinese medicine composition together with a pharmaceutically acceptable carrier according to conventional pharmaceutical techniques.

[0159] The weight-loss drug contains 50-90% of the effective content of the traditional Chinese medicine composition.

[0160] When the weight-loss drug is in the form of a paste, it is prepared using the traditional Chinese medicine composition as the active ingredient, supplemented with conventional excipients such as honey, sugar, and donkey-hide gelatin, through conventional methods for paste preparation.

[0161] When the weight-loss drug is a solution, it is prepared using the traditional Chinese medicine composition as the active ingredient, supplemented with conventional excipients such as ultrapure water, polyethylene glycol, and potassium sorbate, through conventional methods for preparing solutions.

[0162] When the weight-loss drug is in granule form, it is prepared using the traditional Chinese medicine composition as the active ingredient, supplemented with conventional excipients such as lactose, starch, and dextrin, through conventional methods for granule preparation.

[0163] When the weight-loss drug is in capsule form, it is prepared using the traditional Chinese medicine composition as the active ingredient, supplemented with conventional excipients such as glycerin, agar, and sodium carboxymethyl cellulose, and prepared using conventional capsule preparation methods.

[0164] Through experimental studies on the same effects as the aforementioned traditional Chinese medicine composition with weight loss effects, it has been proven that the weight loss drug provided by the present invention also has the same effects as the aforementioned traditional Chinese medicine composition with weight loss effects.

[0165] It should be noted that when numerical ranges are mentioned in the claims of this invention, it should be understood that the two endpoints of each numerical range and any value between the two endpoints can be selected. To avoid redundancy, the present invention describes preferred embodiments.

[0166] Although preferred embodiments of the invention have been described, those skilled in the art, upon learning the basic inventive concept, can make other changes and modifications to these embodiments. Therefore, the appended claims are intended to be interpreted as including both the preferred embodiments and all changes and modifications falling within the scope of the invention.

[0167] Obviously, those skilled in the art can make various modifications and variations to this invention without departing from its spirit and scope. Therefore, if these modifications and variations fall within the scope of the claims of this invention and their equivalents, this invention also intends to include these modifications and variations.

Claims

1. A traditional Chinese medicine composition with weight-loss effect, characterized in that, The ingredients are composed of the following ingredients by weight: 2-10 parts lotus leaf, 5-15 parts hawthorn, 5-10 parts poria cocos, 5-15 parts roselle, 5-10 parts dried tangerine peel, 1-5 parts gynostemma pentaphyllum, 1-5 parts pearl powder, and 2-10 parts tea leaves.

2. The method for preparing the traditional Chinese medicine composition according to claim 1, characterized in that, Includes the following steps: Weigh out lotus leaves, hawthorn, poria cocos, roselle, tangerine peel, gynostemma pentaphyllum, and green tea according to the weight ratio. Add 2-6 times the amount of water and decoct for 1-3 hours. After filtering, add 2-6 times the amount of water to the dregs and continue to decoct for 1-2 hours. Filter again, combine the two filtrates, and concentrate to a paste to obtain a paste. Weigh the pearl powder according to the weight parts, add 1-5 times the amount of ethanol solution, soak, filter, and concentrate the filtrate to obtain concentrated liquid; Add the concentrated liquid to the paste, add 1-10g of erythritol, mix well, bottle and sterilize to obtain the Chinese herbal composition with weight loss effect.

3. The method for preparing the traditional Chinese medicine composition according to claim 2, characterized in that, The mass ratio of concentrated liquid to paste is 1 mL: 30-60 g; the amount of erythritol added is 0.1-0.5 times the weight of the paste.

4. The method for preparing the traditional Chinese medicine composition according to claim 2, characterized in that, The ethanol solution is a 50-70% ethanol solution by volume.

5. The method for preparing the traditional Chinese medicine composition according to claim 2, characterized in that, Soaking time is 2-6 hours.

6. The method for preparing the traditional Chinese medicine composition according to claim 2, characterized in that, The sterilization conditions are 140-160℃ for 1-2 hours.

7. The method for preparing the traditional Chinese medicine composition according to claim 2, characterized in that, Lotus leaves, raw hawthorn, poria cocos, roselle, dried tangerine peel, gynostemma pentaphyllum, pearl powder, and green tea are all used after being washed and dried.

8. The application of the traditional Chinese medicine composition according to claim 1 in the preparation of a weight-loss drug, characterized in that, The weight-loss drug is any one of the following: ointment, solution, granules, or capsules; The weight-loss drug is prepared by the traditional Chinese medicine composition together with a pharmaceutically acceptable carrier according to conventional pharmaceutical techniques.

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