Traditional Chinese medicine composition for weight loss

Abstract

The present application discloses a traditional Chinese medicine composition for weight loss, which is prepared from raw materials comprising the following parts by weight: 40-60 parts of Poria cocos, 20-40 parts of lotus leaf, 10-30 parts of hawthorn, 20-40 parts of Pueraria lobata, 40-60 parts of Alisma orientale, 20-40 parts of Cassia obtusifolia, 10-30 parts of Morinda citrifolia, 10-30 parts of Torreya grandis; optionally, the raw materials further comprise 5-15 parts of Cynara scolymus, 5-15 parts of Camellia nitidissima and 5-15 parts of Eucommia ulmoides male flower. The traditional Chinese medicine composition of the present application is used for preventing and / or treating obesity.

Description

Technical Field

[0001] This application belongs to the field of traditional Chinese medicine, and more specifically relates to a traditional Chinese medicine composition for weight loss. Technical Background

[0002] Obesity is an abnormal body state in which the body's calorie intake exceeds consumption, and the excess calories are converted into fat and excessively accumulated in the body, causing the weight to increase by more than 20% above normal. It seriously damages the body's health and is also an important risk factor for various chronic diseases such as diabetes, hypertension, cardiovascular and cerebrovascular diseases, and stroke. Obesity often causes disorders in the body's hormone levels and chronic inflammatory reactions, and can increase the incidence of cancers such as breast cancer, endometrial cancer, ovarian cancer, prostate cancer, colon cancer, and esophageal cancer. In addition, obese people are prone to psychological problems such as inferiority, sensitivity, and social phobia, which have a serious impact on personal health and society and deserve extensive attention and early prevention and treatment.

[0003] Currently, the treatment of obesity in Western medicine mainly reduces the body's calorie intake by suppressing appetite, or by inhibiting the absorption of nutrients in the intestine, or mainly reducing the synthesis of body fat. It can achieve the purpose of weight loss or weight reduction in a short time, but long-term use will cause serious adverse reactions to the body.

[0004] Traditional Chinese medicine's understanding of obesity began with "Huangdi Neijing" and has been continuously improved by medical experts of successive dynasties. The understanding of the etiology and pathogenesis of obesity is more comprehensive. It is believed that obesity is a syndrome of deficiency in origin and excess in superficiality, with deficiency and excess intermingled. The disease location is in the spleen and is related to the liver, kidney, lung, stomach, and large intestine. The deficiency in origin is mainly spleen deficiency, and the excess in superficiality is mainly phlegm-dampness, damp-heat, qi stagnation, and blood stasis. Various pathogenic mechanisms are intermingled with each other, forming multiple traditional Chinese medicine syndromes of obesity such as spleen deficiency and dampness obstruction syndrome, stomach heat and dampness obstruction syndrome, liver qi stagnation syndrome, spleen-kidney yang deficiency syndrome, and yin deficiency and internal heat syndrome. Among them, the spleen deficiency and dampness obstruction syndrome has the largest number of people and is also the basic syndrome for other traditional Chinese medicine syndromes of obesity.

[0005] The spleen is the foundation of acquired constitution and the source of qi and blood generation, and is mainly responsible for transportation and transformation. The stomach is the sea of water and grains and is mainly responsible for receiving and digesting. The spleen and stomach, one yin and one yang, one ascending and one descending, are the key points for the ascending and descending of qi movement. If the diet is irregular, the spleen is damaged by overthinking, or qi is damaged by prolonged sitting, then the spleen qi is weak, and the function of ascending, transporting, and transforming is reduced. The fatty and sweet foods cannot be transformed into fine qi and blood, but instead accumulate in the body as fat, phlegm, and stasis, forming obesity. When the spleen fails to ascend the clear qi, the clear qi fails to ascend and is injected into the lungs. The water-dampness and essence cannot be normally distributed and transformed through the hundreds of vessels in the lungs, and the internal retention of water is called phlegm-dampness. The spleen cannot transport the body fluids for the stomach, and the stomach cannot normally digest the water and grains. Instead, it combines with the internally retained water-dampness to form phlegm and stasis, which turn into obesity. In addition, the internal accumulation of phlegm-turbidity hinders the flow of qi and blood, and in turn entraps the spleen, affecting transportation and transformation, forming a vicious cycle, making obesity incurable. In severe cases, it will affect the functions of other zang-fu organs and lead to the occurrence of other diseases.

[0006] Traditional Chinese medicine's prevention and treatment of diseases embody the characteristics of people-oriented, individualized treatment, and treating both the symptoms and the root causes. The compatibility of traditional Chinese medicine compound prescriptions has the advantages of syndrome differentiation and treatment, and synergistic enhancement of efficacy. Traditional Chinese medicine has small side effects and comprehensive effects, and can be accepted by the vast majority of obese people.

[0007] The technical problem to be solved by the present invention lies in how to screen and verify effective drugs according to the etiology and pathogenesis of obesity, and develop a traditional Chinese medicine composition with definite curative effect, simple dosage form and small side effects for obesity of spleen deficiency and dampness excess type. Summary of the Invention

[0008] In view of the deficiencies in the prevention and treatment of obesity, especially obesity of spleen deficiency and dampness obstruction syndrome, based on the theory of traditional Chinese medicine syndrome differentiation for weight loss and combined with modern pharmacological research, the present application provides a traditional Chinese medicine composition for the treatment of obesity, especially obesity of spleen deficiency and dampness obstruction syndrome in traditional Chinese medicine, which has the effect of treating both the symptoms and the root causes.

[0009] In one or more embodiments, the raw materials of the traditional Chinese medicine composition of the present application include Poria cocos, lotus leaf, hawthorn, kudzu root, alisma orientale, cassia seed, noni, torreya grandis, artichoke, golden camellia, and eucommia male flower, all of which are both medicine and food, and can be applied to drugs, health foods and functional foods for the prevention and treatment of obesity and related diseases.

[0010] The traditional Chinese medicine composition of the present application embodies the traditional Chinese medicine theory of "syndrome differentiation and treatment", with a clever formula. For obese people with spleen deficiency and dampness obstruction type, it plays the role of strengthening the spleen and removing dampness, reducing lipid and weight, and reflects the unique advantage of "syndrome differentiation for weight loss" in traditional Chinese medicine.

[0011] One or more embodiments of the present application provide a traditional Chinese medicine composition for weight loss, which is prepared from raw materials comprising the following parts by weight: 40-60 parts (such as 45, 50, 55 parts) of Poria cocos, 20-40 parts (such as 25, 30, 35 parts) of lotus leaf, 10-30 parts (such as 15, 20, 25 parts) of hawthorn, 20-40 parts (such as 25, 30, 35 parts) of kudzu root, 40-60 parts (such as 45, 50, 55 parts) of alisma orientale, 20-40 parts (such as 25, 30, 35 parts) of cassia seed, 10-30 parts (such as 15, 20, 25 parts) of noni, 10-30 parts (such as 15, 20, 25 parts) of torreya grandis. In one or more embodiments, the raw materials further include 5-15 parts (such as 7, 10, 13 parts) of artichoke, 5-15 parts (such as 7, 10, 13 parts) of golden camellia, and 5-15 parts (such as 7, 10, 13 parts) of eucommia male flower.

[0012] In one or more embodiments, the traditional Chinese medicine composition is prepared from raw materials comprising the following parts by weight: 50 parts of Poria cocos, 30 parts of lotus leaf, 20 parts of hawthorn, 30 parts of kudzu root, 50 parts of alisma orientale, 30 parts of cassia seed, 20 parts of noni, and 20 parts of torreya grandis. In one or more embodiments, optionally, the raw materials further comprise 10 parts of globe artichoke, 10 parts of golden camellia, and 10 parts of eucommia male flower.

[0013] In one or more embodiments, the traditional Chinese medicine composition is extracted from raw materials comprising the following parts by weight: 40 - 60 parts of Poria cocos, 20 - 40 parts of lotus leaf, 10 - 30 parts of hawthorn, 20 - 40 parts of kudzu root, 40 - 60 parts of alisma orientale, 20 - 40 parts of cassia seed, 10 - 30 parts of noni, and 10 - 30 parts of torreya grandis. In one or more embodiments, the raw materials further comprise 5 - 15 parts of globe artichoke, 5 - 15 parts of golden camellia, and 5 - 15 parts of eucommia male flower.

[0014] In one or more embodiments, the traditional Chinese medicine composition is extracted from raw materials comprising the following parts by weight: 50 parts of Poria cocos, 30 parts of lotus leaf, 20 parts of hawthorn, 30 parts of kudzu root, 50 parts of alisma orientale, 30 parts of cassia seed, 20 parts of noni, and 20 parts of torreya grandis; optionally, the raw materials further comprise 10 parts of globe artichoke, 10 parts of golden camellia, and 10 parts of eucommia male flower.

[0015] In one or more embodiments, the traditional Chinese medicine composition is extracted with water from raw materials comprising the following parts by weight: 40 - 60 parts of Poria cocos, 20 - 40 parts of lotus leaf, 10 - 30 parts of hawthorn, 20 - 40 parts of kudzu root, 40 - 60 parts of alisma orientale, 20 - 40 parts of cassia seed, 10 - 30 parts of noni, and 10 - 30 parts of torreya grandis. In one or more embodiments, the raw materials further comprise 5 - 15 parts of globe artichoke, 5 - 15 parts of golden camellia, and 5 - 15 parts of eucommia male flower.

[0016] In one or more embodiments, the traditional Chinese medicine composition is extracted with water from raw materials comprising the following parts by weight: 50 parts of Poria cocos, 30 parts of lotus leaf, 20 parts of hawthorn, 30 parts of kudzu root, 50 parts of alisma orientale, 30 parts of cassia seed, 20 parts of noni, and 20 parts of torreya grandis. In one or more embodiments, the raw materials further comprise 10 parts of globe artichoke, 10 parts of golden camellia, and 10 parts of eucommia male flower.

[0017] In one or more embodiments, the traditional Chinese medicine composition further comprises excipients and is made into tablets, powders, granules, capsules, tea preparations, or oral liquids.

[0018] One or more embodiments provide a method for preparing the traditional Chinese medicine composition for weight loss of the present application, comprising the following steps:

[0019] (1) Weigh the following raw materials by weight parts: 40 - 60 parts (such as 45, 50, 55 parts) of Poria cocos, 20 - 40 parts (such as 25, 30, 35 parts) of lotus leaf, 10 - 30 parts (such as 15, 20, 25 parts) of hawthorn, 20 - 40 parts (such as 25, 30, 35 parts) of kudzu root, 40 - 60 parts (such as 45, 50, 55 parts) of alisma orientale, 20 - 40 parts (such as 25, 30, 35 parts) of cassia seed, 10 - 30 parts (such as 15, 20, 25 parts) of noni, 10 - 30 parts (such as 15, 20, 25 parts) of torreya grandis, and optionally 5 - 15 parts (such as 7, 10, 13 parts) of globe artichoke, 5 - 15 parts (such as 7, 10, 13 parts) of golden camellia, and 5 - 15 parts (such as 7, 10, 13 parts) of eucommia ulmoides male flower; or, 50 parts of Poria cocos, 30 parts of lotus leaf, 20 parts of hawthorn, 30 parts of kudzu root, 50 parts of alisma orientale, 30 parts of cassia seed, 20 parts of noni, 20 parts of torreya grandis, and optionally 10 parts of globe artichoke, 10 parts of golden camellia, and 10 parts of eucommia ulmoides male flower;

[0020] (2) Extract the weighed medicinal materials with water for 1 - 2 times, filter the extraction solution to obtain a filtrate, and concentrate the filtrate to obtain an extract of the traditional Chinese medicine composition;

[0021] (3) Optionally, dry the extract of the traditional Chinese medicine composition to obtain a dry extract, and crush the dry extract to obtain a dry powder of the traditional Chinese medicine composition.

[0022] In one or more embodiments, before step (2), soak the weighed medicinal materials in water for 0.5 - 1 hour.

[0023] In one or more embodiments, in step (2), extract the weighed medicinal materials with water at 12 times and 10 times the weight of the medicinal materials for 1 - 2 hours, or 1.5 hours respectively, filter to obtain a filtrate, and combine the two filtrates; concentrate the filtrate at 55°C - 60°C to obtain an extract of the traditional Chinese medicine composition.

[0024] In one or more embodiments, in step (3), carry out vacuum drying on the extract of the traditional Chinese medicine composition at 55°C - 60°C to obtain a dry extract, crush the dry extract, and pass through an 80 - mesh sieve after crushing to obtain a dry powder of the traditional Chinese medicine composition.

[0025] One or more embodiments provide the use of the traditional Chinese medicine composition of the present application for weight loss in the preparation of drugs, health foods, functional foods or health products for preventing and / or treating obesity.

[0026] In one or more embodiments, the obesity is obesity of the spleen - deficiency and damp - retention type.

[0027] One or more embodiments provide the use of the traditional Chinese medicine composition of the present application for weight loss in the preparation of a drug for strengthening the spleen and removing dampness and / or reducing lipid levels.

[0028] In one or more embodiments, the traditional Chinese medicine composition for weight loss is prepared by mixing raw materials or powders of raw materials comprising the following parts by weight: 40-60 parts of Poria cocos, 20-40 parts of lotus leaf, 10-30 parts of hawthorn, 20-40 parts of kudzu root, 40-60 parts of Alisma orientale, 20-40 parts of Cassia obtusifolia, 10-30 parts of Morinda citrifolia, 10-30 parts of Torreya grandis; optionally, the raw materials or powders of raw materials further comprise 5-15 parts of artichoke, 5-15 parts of golden camellia and 5-15 parts of powder of male Eucommia ulmoides flower.

[0029] In one or more embodiments, the traditional Chinese medicine composition for weight loss is prepared by mixing raw materials or powders of raw materials comprising the following parts by weight: 50 parts of Poria cocos, 30 parts of lotus leaf, 20 parts of hawthorn, 30 parts of kudzu root, 50 parts of Alisma orientale, 30 parts of Cassia obtusifolia, 20 parts of Morinda citrifolia, 20 parts of Torreya grandis; optionally, the raw materials or powders of raw materials further comprise 10 parts of artichoke, 10 parts of golden camellia and 10 parts of powder of male Eucommia ulmoides flower.

[0030] In one or more embodiments, after weighing each medicinal material, each medicinal material is extracted with water 1-2 times separately.

[0031] In one or more embodiments, after weighing each medicinal material, the medicinal materials are mixed and then extracted with water 1-2 times.

[0032] In one or more embodiments, after weighing each medicinal material, the medicinal materials are crushed and mixed and then extracted with water 1-2 times.

[0033] In one or more embodiments, the traditional Chinese medicine composition of the present application is prepared by the following method:

[0034] (1) Weighing: Weigh each raw material medicinal material according to the above component weight ratio and mix them;

[0035] (2) Extraction: Add 12 times the amount of pure water to the mixed medicinal materials, soak for 0.5 hour, decoct for 1.5 hours, filter to obtain the filtrate, add 10 times the amount of water for the second time, decoct for 1.5 hours, filter to obtain the filtrate, and combine the two filtrates;

[0036] (3) Concentration: Concentrate the filtrate into a thick paste at 55°C - 60°C;

[0037] (4) Drying: Dry the obtained thick paste under reduced pressure at 55°C - 60°C to obtain a dry extract, crush it and pass through an 80-mesh sieve to obtain the dry paste powder of the traditional Chinese medicine composition.

[0038] Poria cocos is the dried sclerotium of the fungus Poria cocos (Schw.) Wolf of the family Polyporaceae. It is sweet and bland in flavor, neutral in nature, and acts on the heart, lung, spleen, and kidney meridians. It can promote diuresis and percolate dampness, strengthen the spleen, and calm the heart.

[0039] Lotus leaf is the dried leaf of the plant Nelumbo nucifera Gaertn. of the family Nymphaeaceae. It is bitter in taste and neutral in nature, and acts on the liver, spleen, and stomach meridians. It can clear summer heat and transform dampness, and promote the rising of clear yang.

[0040] Hawthorn is the dried ripe fruit of the plant Crataegus pinnatifida Bge. var. major N.E.Br. or Crataegus pinnatifida Bge. of the family Rosaceae. It is sour and sweet in flavor, slightly warm in nature, and acts on the spleen, stomach, and liver meridians. It can promote digestion and strengthen the stomach, promote qi movement and disperse stasis, and reduce turbidity and lower lipid.

[0041] Kudzu root is the dried root of the plant Pueraria lobata (Willd.) Ohwi or Pueraria thomsonii Benth. of the family Leguminosae. It is sweet and pungent in flavor, cool in nature, and acts on the spleen, stomach, and lung meridians. It can relieve the muscles and reduce fever, promote the production of body fluid and quench thirst, lift yang and stop diarrhea, and dredge the channels and collaterals.

[0042] Alisma orientale is the dried rhizome of the plant Alisma orientale (Sam.) Juzep. of the family Alismataceae. It is sweet and bland in flavor, cold in nature, and acts on the kidney and bladder meridians. It can drain heat, promote diuresis and percolate dampness, and reduce turbidity and lower lipid.

[0043] Cassia seed is the dried ripe seed of the plant Cassia obtusifolia L. or Cassia tora L. of the family Leguminosae. It is sweet, bitter, and salty in flavor, slightly cold in nature, and acts on the liver and large intestine meridians. It can clear heat and improve eyesight, moisten the intestine and relieve constipation.

[0044] Noni is the dried fruit of the plant Morinda citrifolia L. (also known as Morinda officinalis) of the family Rubiaceae. It is sour and sweet in flavor, neutral in nature, and acts on the kidney, liver, and spleen meridians. It can replenish qi and nourish yin, and tonify the liver and kidney.

[0045] Chinese torreya seed is the dried ripe seed of the plant Torreya grandis Fort. of the family Taxaceae. It is sweet in flavor, neutral in nature, and acts on the lung, stomach, and large intestine meridians. It can kill parasites and eliminate accumulation, moisten dryness and relieve constipation.

[0046] Artichoke is the dried leaf of the plant Cynara scolymus L. of the family Compositae. It is bitter in taste, slightly cold in nature, and acts on the spleen, stomach, liver, and gallbladder meridians. It can eliminate accumulation and promote digestion, regulate qi and harmonize the stomach, clear away damp-heat, and reduce turbidity and lower lipid.

[0047] Chrysanthemum-flowered Camellia is the dried leaf or flower of Camellia chrysantha (Hu) Tuyama of the family Theaceae. It tastes slightly bitter and astringent, is of neutral nature, and can clear heat and detoxify, promote diuresis and relieve edema.

[0048] Male Eucommia flower is the dried flower of the male tree of Eucommia ulmoides Oliv. of the family Eucommiaceae. It can soothe the nerves, protect the liver, nourish the yin and tonify the kidney, and promote bowel movement.

[0049] In one or more embodiments, the traditional Chinese medicine composition of the present application is applicable to obesity, especially obesity with syndrome of spleen deficiency and damp obstruction. The main symptoms are obesity, especially obvious abdominal obesity and distension, soft muscles, and hypofunction of the spleen and stomach, accompanied by excessive sweating and stickiness, chest tightness and stuffiness, poor appetite, excessive phlegm, sticky or sweet taste in the mouth, loose stools, less or slightly turbid urine, greasy tongue coating, and slippery pulse. The fundamental pathogenesis of obesity is spleen deficiency as the root and phlegm-damp stasis obstruction as the branch. The spleen and stomach are the primary organs for the human body to digest and absorb food. When the diet is irregular, overeating or undereating, and excessive consumption of cold and raw foods, it is easy to damage the spleen and stomach, resulting in reduced transportation and transformation functions. When the functions of the spleen and stomach decline, the nutrients in food cannot be digested and absorbed by the body, but accumulate in the body in excess, directly forming the accumulation of phlegm, fat, and stasis in the body, leading to obesity. In addition, the spleen is responsible for ascending the clear. When the spleen is deficient, it cannot help the body fluid to be injected into the lungs and the hundred channels for distribution and transformation, and the body fluid will stagnate internally as phlegm-damp turbidity, which is heavy, turbid, and sticky, hindering the flow of qi and blood, and in turn trapping the spleen, resulting in disordered transportation and transformation, and further forming a vicious cycle, making obesity difficult to cure. In severe cases, it will affect the functions of other zang-fu organs. Starting from the etiology and pathogenesis of obesity, the present application focuses on strengthening the spleen as the root and removing dampness as the branch, taking both the root and the branch into consideration, so as to achieve the purpose of reducing fat and making the body light.

[0050] In one or more embodiments, the traditional Chinese medicine composition for weight loss of the present application closely adheres to the key pathogenesis of obesity with spleen deficiency and dampness excess. Taking strengthening the spleen, invigorating the spleen, awakening the spleen, and promoting the function of the spleen as the root, when the functions of the spleen and stomach are normal and the acquired foundation is nourished, the nutrients in the diet can be digested and absorbed, and the body fluid in the body can be normally transported, distributed, and metabolized. Removing dampness and turbidity is the branch; it can not only remove the phlegm, fat, and paste that have already accumulated in the body, but also block the formation of new phlegm, that is, promote the metabolism of body fat, reduce the formation of fat, with scientific compatibility, synergistic effect, treating both the symptoms and the root causes, and achieving the effect of reducing fat and making the body light. The raw materials all belong to the category of both medicine and food, with stable components, easy to absorb, guaranteed safety, no toxic and side effects, and can be used for a long time. Description of the Drawings

[0051] Figure 1 Showing the results of oil red staining of liver tissues of rats in each group (×200), where:

[0052] A: blank group; B: model group; C: orlistat group; D: high-dose group of the composition in Example 1; E: medium-dose group of the composition in Example 1; F: low-dose group of the composition in Example 1. Detailed Embodiments

[0053] In order to make the objectives, technical solutions and advantages of the present invention clearer, the technology of the present invention will be further described in detail through the following specific embodiments. It should be understood that the embodiments included in the present invention are not limited to the following embodiments, and all other embodiments made based on the gist of the present invention belong to the scope protected by the present invention.

[0054] Preparation Example 1

[0055] Take 50 parts of Poria cocos, 30 parts of lotus leaf, 20 parts of hawthorn, 30 parts of kudzu root, 50 parts of alisma orientale, 30 parts of cassia seed, 20 parts of noni, and 20 parts of torreya grandis. Add purified water to soak for 0.5 h. For the first time, add water with a weight 12 times that of all the medicinal materials and decoct for 1.5 h. For the second time, add water with a weight 10 times that of all the medicinal materials and decoct for 1.5 h respectively. Combine the filtrates of the two times, concentrate and dry under reduced pressure at 55°C - 60°C to obtain the dry extract powder of the traditional Chinese medicine composition. Add excipients maltodextrin, silicon dioxide, sorbitol, and sucralose, mix evenly, and make into a powder with a specification of 8 g / bag.

[0056] Preparation Example 2

[0057] Take 50 parts of Poria cocos, 30 parts of lotus leaf, 20 parts of hawthorn, 30 parts of kudzu root, 50 parts of alisma orientale, 30 parts of cassia seed, 20 parts of noni, 20 parts of torreya grandis, 10 parts of artichoke, 10 parts of golden camellia, and 10 parts of eucommia male flower. Add purified water to soak for 0.5 h. For the first time, add water with a weight 12 times that of all the medicinal materials and decoct for 1.5 h. For the second time, add water with a weight 10 times that of all the medicinal materials and decoct for 1.5 h respectively. Combine the filtrates of the two times, concentrate and dry under reduced pressure at 55°C - 60°C to obtain the dry extract powder of the traditional Chinese medicine composition. Add excipients sodium carboxymethyl starch, magnesium stearate, and microcrystalline cellulose, mix evenly, and use the wet granulation method to make into tablets with a specification of 0.8 g / tablet.

[0058] Preparation Example 3

[0059] Take 50 parts of Poria cocos, 30 parts of lotus leaf, 20 parts of hawthorn, 30 parts of kudzu root, 50 parts of alisma orientale, 30 parts of cassia seed, 20 parts of noni, 20 parts of torreya grandis, 10 parts of artichoke, 10 parts of golden camellia, and 10 parts of eucommia male flower. Add purified water to soak for 0.5 h. For the first time, add water with a weight 12 times that of all the medicinal materials and decoct for 1.5 h. For the second time, add water with a weight 10 times that of all the medicinal materials and decoct for 1.5 h respectively. Combine the filtrates of the two times, concentrate and dry under reduced pressure at 55°C - 60°C to obtain the dry extract powder of the traditional Chinese medicine composition. Add excipients stevioside, sucralose, and silicon dioxide, and make into granules with a specification of 8 g / bag by wet granulation.

[0060] Weight loss effect of Active Example 4 on obese rats

[0061] Experimental method: 70 SPF-grade male healthy SD rats with a body weight of 180 g - 200 g were selected. 10 rats were randomly selected as the blank group and fed with normal feed, while the remaining 60 rats were fed with a high-fat feed (15.0% sucrose and 15.0% lard were added to the normal feed) for 2 consecutive weeks. After excluding rats insensitive to obesity, the remaining rats were randomly divided into a model group, a positive drug orlistat group (0.048 g / kg), a low-dose group of the composition of Example 1 (1.2 g / kg), a medium-dose group of the composition of Example 1 (2.4 g / kg), and a high-dose group of the composition of Example 1 (3.6 g / kg), with 10 rats in each group. The gavage volume was 1 mL / 100 g, and gavage was performed once a day. The blank group was gavaged with normal saline. Administration was continued for 8 weeks, and the body weight of each group was recorded weekly. 1 h after the last administration, the rats were anesthetized with 1% sodium pentobarbital, the perirenal fat and peritesticular fat were dissected and weighed, the fat / body ratio was calculated, and part of the liver was fixed to prepare liver tissue sections.

[0062] Experimental results: It can be seen from Table 1 and Table 2 that compared with the blank group, there were significant differences in the body weight, epididymal and perirenal fat contents of the rats in the model group (P < 0.01), indicating that the obesity rat model was successfully established; compared with the model group, the positive drug orlistat could significantly reduce the body weight, epididymal and perirenal fat contents of the obese rats (P < 0.01); compared with the model group, each dose group of the traditional Chinese medicine composition of Example 1 could significantly reduce the body weight of the obese rats at the fourth and eighth weeks (P < 0.05, P < 0.01), and the medium-dose and high-dose groups could significantly reduce the epididymal and perirenal fat contents (P < 0.05, P < 0.01); it was shown that the traditional Chinese medicine composition of the present application could promote fat metabolism and inhibit fat formation, and had a weight loss effect.

[0063] Table 1 Statistical results of the body weight of rats in each group

[0064]

[0065] Note: Compared with the blank group, #P < 0.05, ##P < 0.01; compared with the model group, *P < 0.05, **P < 0.01 for each administration group.

[0066] Table 2 Statistical results of the body fat content and fat / body ratio of rats in each group

[0067]

[0068] Note: Compared with the blank group, #P < 0.05, ##P < 0.01; compared with the model group, *P < 0.05, **P < 0.01 for each administration group.

[0069] The fat distribution in hepatocytes and extracellular connective tissues was observed by red oil staining, as Figure 1 shown. The mean percentage of liver fat area in the blank group of rats was 52.12% ± 14.82, and the mean percentage of liver fat area in the model group of rats was 68.65% ± 15.92, which was significantly higher than that in the blank group; the percentage of fat area in the orlistat group was 53.11% ± 15.42; the mean percentages of liver fat area in the high, medium, and low dose groups of the traditional Chinese medicine composition in Example 1 were 52.75% ± 8.36, 40.02% ± 13.14, and 57.25% ± 12.46, respectively, which were significantly lower than those in the model group. This indicates that the traditional Chinese medicine composition of the present application can promote fat metabolism and inhibit fat formation.

[0070] The spleen-strengthening and dampness-removing effects of Active Example 5 on obese rats with spleen deficiency and dampness obstruction

[0071] Experimental method: Seventy SPF-grade male healthy SD rats with a body weight of 180 g - 200 g were randomly selected. Ten of them were used as the blank group and fed with normal feed, while the remaining 60 were fed with a high-fat diet (15.0% sucrose and 15.0% lard were added to the normal feed) for 2 consecutive weeks. After excluding rats insensitive to obesity, the remaining rats were randomly divided into a model group, a positive drug Shenling Baizhu San group (1.8 g / kg), a low-dose group of the composition in Example 1 (1.2 g / kg), a medium-dose group of the composition in Example 1 (2.4 g / kg), and a high-dose group of the composition in Example 1 (3.6 g / kg), with 10 rats in each group. The gavage volume was 1 mL / 100 g, and gavage was performed once a day. The blank group was gavaged with normal saline, and the administration was continued for 8 weeks. During this period, the general state of each group of rats was observed and recorded. One hour after the last administration, the rats were anesthetized with 1% sodium pentobarbital, blood was taken from the abdominal aorta, and serum and plasma were preserved. The spleen, stomach, and small intestine tissues were placed in liquid nitrogen for freezing. The levels of four blood lipid items were detected by an automatic biochemical analyzer, and the levels of serum gastrin, plasma motilin, and gastric obestatin were detected by enzyme-linked immunosorbent assay; the levels of plasma albumin and serum aldosterone were detected by radioimmunoassay.

[0072] Experimental results: Compared with the blank group, the rats in the model group showed symptoms of spleen deficiency and dampness obstruction in traditional Chinese medicine, such as reduced food intake, listlessness, sticky stools with irregular shapes, and yellow and dull hair; compared with the model group, the mental state, food intake, stool state, and hair color of the rats in each dose group of the positive Shenling Baizhu San and the traditional Chinese medicine composition in Example 1 were improved. This indicates that the traditional Chinese medicine composition of the present application can improve the symptoms of spleen deficiency and dampness obstruction and has the effect of strengthening the spleen and removing dampness.

[0073] Retention of internal dampness leads to the accumulation of phlegm-dampness, which stagnates in the blood vessels, consistent with the dyslipidemia caused by modern obesity. As can be seen from Table 3, compared with the blank group, the total cholesterol (TC), triglyceride (TG), and low-density lipoprotein (LDL-C) in the model group of rats increased, while the high-density lipoprotein (HDL-C) decreased, with statistically significant differences (P < 0.05, P < 0.01), which is in line with the characteristics of traditional Chinese medicine obesity with excessive phlegm-dampness in modern times; compared with the model group, the positive drug Shenling Baizhu Powder can significantly reduce TC and TG and increase HDL-C (P < 0.01, P < 0.05); each dose group of the traditional Chinese medicine composition in Example 1 can significantly reduce the levels of TC and TG (P < 0.01, P < 0.05), and the high-dose group can increase HDL-C (P < 0.05) and reduce LDL-C (P < 0.05), and its effect is better than that of Shenling Baizhu Powder, indicating that the traditional Chinese medicine composition of this application can improve the blood lipid elevation caused by the retention of dampness-turbidity and has the effect of removing dampness and discharging turbidity.

[0074] Table 3 Effects on the turbidity-removing effect (four blood lipid indicators)

[0075]

[0076] Note: Compared with the blank group, #P < 0.05, ##P < 0.01; compared with the model group, *P < 0.05, **P < 0.01

[0077] Retention of internal dampness accumulates into phlegm-dampness and overflows into tissues, manifested as edema, consistent with the abnormal water metabolism caused by modern obesity. As can be seen from Table 4, compared with the blank group, the plasma albumin content in the model group of rats decreased significantly, and the serum aldosterone content increased (P < 0.01, P < 0.01), with slow water metabolism, in line with the manifestation of excessive phlegm-dampness in traditional Chinese medicine. Compared with the model group, the positive drug Shenling Baizhu Powder can increase the plasma albumin content (P < 0.05) and reduce the serum aldosterone content (P < 0.01); the high-dose and medium-dose groups of the traditional Chinese medicine composition in Example 1 can significantly increase the plasma albumin content (P < 0.05) and reduce the serum aldosterone content (P < 0.01, P < 0.05), and the effect of the high-dose group is better than that of Shenling Baizhu Powder. It shows that the traditional Chinese medicine composition of this application can improve the abnormal water metabolism caused by the retention of dampness-turbidity and has the effect of resolving dampness and promoting diuresis.

[0078] Table 4 Effects on the diuretic effect (water metabolism)

[0079]

[0080] Note: Compared with the blank group, #P < 0.05, ##P < 0.01, compared with the model group, *P < 0.05, **P < 0.01

[0081] The spleen is responsible for transportation and transformation. When the spleen is weak, the digestion, absorption, and transportation of nutrients are abnormal, which is consistent with the abnormal function of the digestive system caused by modern obesity. As can be seen from Table 5, compared with the blank group, the levels of serum gastrin, plasma motilin, and ghrelin in the model group of rats were significantly decreased (P < 0.01); the digestive ability of the spleen and stomach decreased, which was in line with the characteristics of spleen deficiency in traditional Chinese medicine. Compared with the model group, the positive drug Shenling Baizhu Powder could increase the levels of motilin and ghrelin (P < 0.05). Each dose group of the traditional Chinese medicine composition in Example 1 could significantly increase the levels of serum gastrin, plasma motilin, and ghrelin (P < 0.05, P < 0.01), and the effects of the medium-dose and high-dose groups were better than those of Shenling Baizhu Powder. It was shown that the traditional Chinese medicine composition of the present application could improve the disorder of gastrointestinal hormone levels caused by spleen deficiency, enhance the digestive function, and had the effect of strengthening the spleen and promoting transportation.

[0082] Table 5 Effects on the transportation and transformation function of the spleen (gastrointestinal hormones)

[0083]

[0084] Note: Compared with the blank group in the model group, #P < 0.05, ##P < 0.01. Compared with the model group in each administration group, *P < 0.05, **P < 0.01

[0085] Clinical Example 6

[0086] Case 1: Chen, female, 32 years old, from Zhengzhou, Henan. Height 160 cm, weight 75 kg, BMI 29.3, waist circumference 110 cm. She reported that her weight had not decreased since childbirth, with obvious abdominal obesity, accompanied by hyperlipidemia. Usually, she had a poor appetite, was easy to fatigue, had a sticky mouth, excessive phlegm, irregular and formed stools, and was prone to asthma when moving more. She had tried various weight loss methods without success and was diagnosed with typical obesity of spleen deficiency and dampness obstruction type. She started taking the tablets prepared in Example 2 of the present application orally, once in the morning, noon, and evening, 2 tablets each time, in February 2021. After taking for 1 month, her weight was 70 kg, her appetite improved, the fatigue feeling decreased, and the stools were formed; after taking continuously for 3 months, her weight was 54 kg, waist circumference 82 cm, BMI 21.1, blood lipids were normal, fatty liver disappeared, diet, stools, etc. returned to normal, and her weight did not rebound after stopping taking, and various discomfort symptoms did not appear, and her life was normal.

[0087] Clinical Example 7

[0088] Case 2: Zhang, male, 45 years old, from Wuxi, Jiangsu. Height: 180 cm, weight: 93 kg, BMI: 28.7, waist circumference: 128 cm. He also suffered from hypertension, hyperlipidemia, fatty liver, etc. He reported that obesity caused inconvenience in movement. He had taken various weight-loss drugs before, but his weight rebounded after stopping taking them. He started taking the granule prepared in Example 3 of this application in September 2021, taking it with hot water once in the morning, once at noon, and once in the evening, one bag each time. After taking it for 1 month, his weight was 85 kg; after taking it continuously for 3 months, his weight was 73 kg, waist circumference was 96 cm, BMI was 22.5, blood pressure was stable, triglyceride, cholesterol and low-density lipoprotein all decreased, and his weight did not rebound after stopping taking it, blood lipid indicators were stable, and his life returned to normal.

[0089] Safety Example 8 Safety study of the traditional Chinese medicine composition of this application

[0090] Take 20 6-week-old Kunming mice, half male and half female, with a weight of 18 - 22 g. After one week of adaptive feeding, prepare the acute toxicity test drug according to Example 1 at 200 g / kg (equivalent to 100 times the human clinical dosage), with a gavage volume of 0.2 ml / 10 g, and gavage twice within 4 hours. Observe for 7 days and record the overall condition and death of each mouse.

[0091] The results showed that the overall state of each group of mice was normal and no death occurred, indicating that the traditional Chinese medicine composition of this invention patent is safe and has no toxic and side effects.

[0092] In summary, the traditional Chinese medicine composition in this invention has safe raw materials, is suitable for long-term use, has a simple preparation process and is suitable for industrial production. It has a therapeutic effect on obesity, especially for obesity with the syndrome of spleen deficiency and damp obstruction, and has a significant effect of strengthening the spleen and removing dampness, reducing fat and lightening the body.

Claims

1. A traditional Chinese medicine composition for preventing and / or treating obesity of spleen deficiency and dampness obstruction type, which is prepared by water extraction from the following raw materials in parts by weight: 40 - 60 parts of Poria cocos, 20 - 40 parts of lotus leaf, 10 - 30 parts of hawthorn, 20 - 40 parts of kudzu root, 40 - 60 parts of alisma orientale, 20 - 40 parts of cassia seed, 10 - 30 parts of noni, 10 - 30 parts of torreya grandis.

2. A traditional Chinese medicine composition for preventing and / or treating obesity of spleen deficiency and dampness obstruction type, which is prepared by water extraction from the following raw materials in parts by weight: 40 - 60 parts of Poria cocos, 20 - 40 parts of lotus leaf, 10 - 30 parts of hawthorn, 20 - 40 parts of kudzu root, 40 - 60 parts of alisma orientale, 20 - 40 parts of cassia seed, 10 - 30 parts of noni, 10 - 30 parts of torreya grandis, 5 - 15 parts of globe artichoke, 5 - 15 parts of golden camellia, and 5 - 15 parts of male eucommia flower.

3. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition is prepared by water extraction from the following raw materials in parts by weight: 50 parts of Poria cocos, 30 parts of lotus leaf, 20 parts of hawthorn, 30 parts of kudzu root, 50 parts of alisma orientale, 30 parts of cassia seed, 20 parts of noni, 20 parts of torreya grandis.

4. The traditional Chinese medicine composition according to claim 2, wherein the traditional Chinese medicine composition is prepared by water extraction from the following raw materials in parts by weight: 50 parts of Poria cocos, 30 parts of lotus leaf, 20 parts of hawthorn, 30 parts of kudzu root, 50 parts of alisma orientale, 30 parts of cassia seed, 20 parts of noni, 20 parts of torreya grandis, 10 parts of globe artichoke, 10 parts of golden camellia, and 10 parts of male eucommia flower.

5. A traditional Chinese medicine preparation, which is made into tablets, powders, granules, capsules, tea preparations, or oral liquids from the traditional Chinese medicine composition according to any one of claims 1 - 4 and excipients.

6. A preparation method of the traditional Chinese medicine composition for preventing and / or treating obesity of spleen deficiency and dampness obstruction type according to any one of claims 1 - 4, comprising the following steps: (1) Weigh the raw materials according to the parts by weight of the raw materials; (2) Extract the weighed medicinal materials with water 1 - 2 times, filter the extractive solution to obtain a filtrate, and concentrate the filtrate to obtain an extract of the traditional Chinese medicine composition.

7. The preparation method according to claim 6, wherein the extract of the traditional Chinese medicine composition is dried to obtain a dry extract, and the dry extract is pulverized to obtain a dry powder of the traditional Chinese medicine composition.

8. The preparation method according to claim 6, wherein in the step (2), the weighed medicinal materials are extracted with water at 12 times and 10 times the weight of the medicinal materials for 1 - 2 hours respectively, filtered to obtain a filtrate, and the two filtrates are combined; the filtrate is concentrated under reduced pressure at 55°C - 60°C to obtain an extract of the traditional Chinese medicine composition.

9. The preparation method according to claim 6, wherein the extract of the traditional Chinese medicine composition is dried under reduced pressure at 55°C - 60°C to obtain a dry extract, and the dry extract is pulverized and sieved through an 80 - mesh sieve to obtain a dry powder of the traditional Chinese medicine composition.

10. The preparation method according to claim 8, wherein before the step (2), the weighed medicinal materials are soaked in water for 0.5 - 1 hour.

11. The preparation method according to claim 8, wherein in the step (2), the weighed medicinal materials are extracted with water at 12 times and 10 times the weight of the medicinal materials for 1.5 hours respectively.

12. Use of the traditional Chinese medicine composition for preventing and / or treating obesity of spleen deficiency and dampness obstruction type according to any one of claims 1 to 4 or the traditional Chinese medicine preparation according to claim 5 in the preparation of a medicament for preventing and / or treating obesity of spleen deficiency and dampness obstruction type.

13. Use of the traditional Chinese medicine composition for preventing and / or treating obesity of spleen deficiency and dampness obstruction type according to any one of claims 1 to 4 or the traditional Chinese medicine preparation according to claim 5 in the preparation of a medicament for strengthening the spleen and removing dampness and / or reducing lipid.

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