Composition capable of eliminating dampness, inducing diuresis and losing weight as well as preparation method and application of composition

Abstract

The invention discloses a traditional Chinese medicine composition for eliminating dampness, inducing diuresis and losing weight and application thereof, and relates to the technical field of traditional Chinese medicines. The composition comprises codonopsis pilosula, Chinese yam, poria cocos, lotus seeds, gordon euryale seeds, coix seeds, white hyacinth beans, liquorice, phaseolus calcaratus, radix fici simplicissimae, lotus leaves and corn stigma, and through combination of specific medicinal materials, the effects of obviously reducing body weight, improving dyslipidemia and serum water metabolism indexes, clearing damp and inducing diuresis are achieved.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a composition for removing dampness, promoting diuresis and reducing weight, and a preparation method and application thereof. Background Art

[0002] In recent years, with the accelerated pace of life and the popularity of fast food culture, some office workers and college students have a life state of unregulated diet and excessive fatigue, which leads to spleen and stomach weakness, dysfunction of water and moisture transportation, and then leads to the occurrence of obesity, which poses a huge threat to people's physical and mental health. At present, the only drugs approved for marketing in my country for weight loss are orlistat, liraglutide, semaglutide, etc., but these drugs have adverse reactions reported in clinical applications. According to the theory of traditional Chinese medicine, spleen deficiency and dampness obstruction are one of the main syndromes of obesity. The spleen is responsible for transportation and transformation. Spleen deficiency and excessive consumption of fat and sweet food lead to poor transportation and transformation, stagnation of water and moisture, and the occurrence of symptoms such as obesity. The etiology and pathogenesis are spleen deficiency, phlegm and dampness, and water and dampness obstruction, and the disease is mainly in the spleen and stomach. "Dampness" is most likely to damage the spleen and hinder spleen transportation, while spleen deficiency is prone to "dampness", which leads to water and moisture metabolism disorders and obstruction of qi. Therefore, the method of removing dampness and strengthening the spleen can be used to treat body obesity caused by dampness obstruction.

[0003] In TCM theory, obesity due to spleen deficiency and dampness is a common type of obesity, with the main manifestations of obesity and edema, fatigue, heaviness of limbs, oliguria, poor appetite, abdominal distension, pale, convex, thin and greasy tongue, and deep and thin pulse. TCM treatment of obesity focuses on qi deficiency, with the spleen as the source of phlegm, and the general principle of spleen transformation of phlegm, dampness-clearing and bowel-clearing. For example: (1) Dampness-clearing method is used for patients with spleen deficiency and dampness obstruction, with fatigue, poor appetite, and chest congestion as the main manifestations. The representative prescription is Ershu Pu Si Tang; (2) Diuretic method is used for patients with dampness stagnation, with swelling of the limbs, or oliguria and edema, abdominal distension and loose stools as the main manifestations. The representative prescriptions are Wupi Yin and Daoshui Fuling Tang.

[0004] The use of TCM's syndrome differentiation and treatment to treat obesity has the advantages of strong targeting, no complications, little toxicity and side effects, flexible formulation, rapid onset and good results.

[0005] Chinese patent application CN106692532A discloses a Chinese medicine composition for burning fat and losing weight, a patch thereof, and a weight loss kit. The Chinese medicine composition comprises the following ingredients in parts by weight: 28-32 parts of lotus leaf, 15-20 parts of Polygonum multiflorum, 18-24 parts of safflower, 16-25 parts of peach kernel, 18-23 parts of oriental rhizome, 27-31 parts of angelica sinensis, 15-20 parts of immature bitter orange, and 18-24 parts of Shenqu; the patch is prepared from the Chinese medicine composition and auxiliary materials, and the weight ratio of the Chinese medicine composition to the auxiliary materials is 1:2-5; the weight loss kit comprises a patch and food, and the food is mainly prepared from the following ingredients in parts by weight: 25-35 parts of Euryale ferox, 28-32 parts of konjac, 18-22 parts of lotus leaf, 25-30 parts of hawthorn, and 15-25 parts of Poria. The invention effectively promotes the decomposition of body fat, not only improves the body's metabolic circulation, but also increases the efficiency of fat decomposition and prevents fat accumulation, thereby achieving the effect of reducing weight.

[0006] At present, there is still a lack of a Chinese medicine composition that can both remove dampness and promote diuresis and achieve a good weight loss effect. Summary of the invention

[0007] In view of this, the present invention provides a composition for removing dampness, promoting diuresis and reducing weight, and a preparation method and application thereof, which can achieve the effects of significantly reducing body weight, improving dyslipidemia, serum water metabolism indicators, and removing dampness and promoting diuresis through a combination of specific medicinal materials.

[0008] Terms and Claims of the Present Invention:

[0009] 1. As used herein, the articles "a", "an" and "the" include plural referents unless expressly limited to one or more referents otherwise.

[0010] 2. As used herein, numerical range: Unless otherwise expressly indicated, all ranges or ratios disclosed herein will be understood to include any and all sub-ranges or sub-ratios contained therein. For example, a range or ratio of 1 to 30 stated should be considered to be included between a minimum value of 1 and a maximum value of 30, and any sub-range or sub-ratio, integer, decimal, or sub-range or sub-ratio consisting of integers or decimals including the end points.

[0011] 3. As used herein, the terms "comprises," "including," "have," "have," "may," "contain" and variations thereof mean open-ended conjunctions or terms that do not exclude the possibility of additional compositions or structures.

[0012] To achieve the above-mentioned object of the invention, the technical solution of the present invention is as follows:

[0013] On the one hand, the present invention provides a composition for removing dampness, promoting diuresis and reducing weight, comprising: codonopsis pilosula, yam, poria, lotus seed, euryale ferox, coix seed, white hyacinth bean, licorice, red bean, quinoa strychnos nux vomica, lotus leaf and corn silk.

[0014] The prescription of the present invention is explained as follows: the present invention provides a composition for removing dampness and promoting diuresis and reducing weight, wherein Codonopsis pilosula and Poria cocos are matched to enhance the power of tonifying spleen qi, and can penetrate dampness and promote water metabolism, and are the main medicines; Euryale ferox, Chinese yam, and lotus seeds can replenish qi and have the function of consolidating the intestines to prevent diarrhea caused by excessive water metabolism, and are the ministerial medicines; Coix seeds and white hyacinth beans can help Poria cocos strengthen the spleen, remove dampness and stop diarrhea, and are the ministerial medicines; lotus leaves and corn silk can be used to enhance the effects of clearing heat and removing dampness, and promoting diuresis and reducing swelling; Licorice can invigorate qi, detoxify, and warm the spleen to coordinate various medicines, and is the guiding medicine. Through the combination of the above specific medicinal materials, weight loss can be achieved, and the effects of improving dyslipidemia, serum water metabolism indicators, and removing dampness and promoting diuresis can be achieved.

[0015] Preferably, the composition comprises, by weight: 3-7 parts of Codonopsis pilosula, 6-10 parts of yam, 15-20 parts of Poria cocos, 3-7 parts of lotus seeds, 3-7 parts of Euryale ferox, 8-12 parts of Coix seeds, 10-14 parts of white hyacinth bean, 3-7 parts of licorice, 3-7 parts of adzuki bean, 1-4 parts of ginseng, 2-5 parts of lotus leaves and 40-50 parts of corn silk.

[0016] Further preferably, the composition comprises, by weight: 5 parts of Codonopsis pilosula, 8 parts of yam, 18 parts of Poria cocos, 5 parts of lotus seeds, 5 parts of Euryale ferox, 10 parts of Coix seeds, 12 parts of white hyacinth bean, 5 parts of licorice, 5 parts of adzuki bean, 2 parts of ginseng, 3 parts of lotus leaves and 45 parts of corn silk.

[0017] On the other hand, the present invention provides a method for preparing the above-mentioned composition for removing dampness, promoting diuresis and reducing weight, comprising the following steps: extracting a formulated amount of medicinal materials with water to obtain an extract.

[0018] Preferably, the method comprises the following steps: adding water, heating and refluxing for extraction 2-4 times, adding 10-15 times the weight of the medicinal material of water each time, and extracting for 1-3 hours each time to obtain an extract.

[0019] More preferably, the method comprises the following steps: adding water, heating and refluxing for extraction twice, adding 12 times the weight of water of the medicinal material each time, and extracting for 2 hours each time to obtain an extract.

[0020] More preferably, the preparation method further comprises the following steps: concentrating the extract under reduced pressure to form a thick paste, drying under reduced pressure, and crushing into powder to obtain an extract.

[0021] More preferably, the preparation method further comprises the following steps: concentrating the extract under reduced pressure to a thick paste with a specific gravity of 1.1-1.3 (thermal measurement at 50-60°C), drying under reduced pressure at 60-70°C, and crushing into powder to obtain an extract.

[0022] The term "specific gravity" refers to the weight ratio of the medicinal material to the extract.

[0023] In another aspect, the present invention provides a medicine, the effective ingredient of which includes the above-mentioned Chinese medicine composition, or the extract prepared according to the above-mentioned preparation method.

[0024] The drug can be prepared into dosage forms such as pills, capsules, granules, oral liquids, powders, tablets, lozenges, ointments, etc., and suitable drug carriers in the art can be selected for different dosage forms.

[0025] The pharmaceutical carrier used can be solid, liquid or gas. Examples of solid carriers include lactose, kaolin, sucrose, talc, gelatin, agar, pectin, gum arabic, magnesium stearate and stearic acid. Examples of liquid carriers include syrup, peanut oil, olive oil and water. Examples of gaseous carriers include carbon dioxide and nitrogen.

[0026] When preparing the composition for oral dosage form, any convenient pharmaceutical medium can be used. For example, water, ethanol, oil, alcohol, flavoring agent, preservative, coloring agent, etc. can be used to form oral liquid preparations, such as suspensions and solutions; while carriers, such as starch, sugars, microcrystalline cellulose, diluents, granulating agents, emulsifiers, lubricants, binders, disintegrants can be used to form oral solid preparations, such as powders, capsules and tablets. Tablets and capsules are the preferred oral dosage units using solid pharmaceutical carriers due to their ease of administration. Tablets can be coated using standard aqueous or non-aqueous techniques.

[0027] Tablets containing the Chinese medicine composition or extract of the present invention can be prepared by tableting or molding, and one or more auxiliary ingredients or adjuvants can be used. The active ingredient can be tableted in a free-flowing form (such as powder or granules) in a suitable machine, and can be mixed with a binder, a lubricant, an inert diluent, a surfactant or a dispersant to prepare a tablet. Molded tablets can be molded in a suitable machine, i.e., a powdered compound mixture moistened with an inert liquid diluent. Each tablet preferably contains about 0.05 mg to about 5 g of active ingredient, and each sachet or capsule preferably contains about 0.05 mg to about 5 g of active ingredient. For example, a preparation intended for oral administration to humans may contain about 0.5 mg to about 5 g of active drug, mixed with an appropriate and convenient carrier material, which may account for about 5% to 95% of the total composition. The unit dosage form usually contains about 1 mg to about 2 g of active ingredient, usually 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600 mg, 800 mg or 1000 mg.

[0028] The pharmaceutical composition suitable for parenteral administration of the present invention can be prepared as an aqueous solution or suspension of the active compound. Suitable surfactants such as hydroxypropylcellulose can be included. Dispersions can also be prepared in glycerol, liquid polyethylene glycol and oil mixtures thereof. In addition, preservatives can be added to prevent the harmful growth of microorganisms.

[0029] Medicine of the present invention can be in the form suitable for topical use, for example aerosol, cream, ointment, lotion, powder or the like. In addition, composition can be in the form suitable for transdermal administration device. Can use Chinese medicine composition of the present invention, prepare these prescriptions by conventional processing method. For example, by mixing hydrophilic material and water, and about 5wt% to about 10wt% of compound, prepare cream or ointment with required consistency.

[0030] The medicine of the present invention can be in a form suitable for rectal administration, wherein the carrier is a solid. Preferably, the mixture is made into a unit dose suppository. Suitable carriers include cocoa butter and other materials commonly used in the art. Suppositories can be prepared by first forming a composition containing a softened or melted carrier, followed by cooling and shaping in a mold.

[0031] In addition to the above-mentioned carrier components, the above-mentioned pharmaceutical preparations may include (if applicable) one or more additional carrier components, such as diluents, buffers, flavoring agents, adhesives, surfactants, thickeners, lubricants, preservatives (including antioxidants), etc. In addition, other excipients, such as lactose, starch, cellulose derivatives, magnesium stearate, stearic acid, etc., colorants and flavoring agents, etc., may be added. The preparation is made isotonic with the blood of the intended recipient. The components containing the Chinese medicine composition of the present invention can also be prepared in the form of powder or concentrate.

[0032] Preferably, the pharmaceutical preparation is an oral pharmaceutical preparation.

[0033] More preferably, the oral pharmaceutical preparation is any one of a decoction, a pill, a tablet, a capsule, a powder, a granule, an oral liquid, and an ointment, preferably an ointment.

[0034] Finally, the present invention provides the use of the above-mentioned Chinese medicine composition, or the extract prepared according to the above-mentioned preparation method in the preparation of dampness-removing, diuretic and / or weight-loss products.

[0035] The beneficial effects of the present invention include:

[0036] The present invention uses a combination of specific medicinal materials, including twelve Chinese medicinal materials: Codonopsis pilosula, yam, Poria cocos, lotus seed, Euryale ferox, coix seed, white hyacinth bean, licorice, red bean, quinquefolius, lotus leaf, and corn silk. The Chinese medicine in this prescription is mainly diuretic and dampness-invigorating drugs and spleen-tonifying drugs, and is matched with heat-clearing and summer-heat relieving drugs. Multiple drugs are used together to exert the effects of removing dampness and strengthening the spleen, promoting diuresis and reducing swelling, lowering blood lipids and reducing weight, and achieve the effect of significantly reducing weight, improving dyslipidemia, serum water metabolism indicators, and removing dampness and promoting diuresis. DETAILED DESCRIPTION

[0037] In order to make the technical means, creative features, purpose and efficacy of the present invention easy to understand, the present invention is further explained in conjunction with specific embodiments below, but the following embodiments are only preferred embodiments of the present invention, not all. Based on the embodiments in the implementation mode, other embodiments obtained by those skilled in the art without creative work all belong to the protection scope of the present invention. In the following embodiments, unless otherwise specified, the operating methods used are conventional operating methods, the equipment used are conventional equipment, and the equipment materials used in each embodiment are the same.

[0038] Example 1

[0039] The recipe is as follows: 5 parts of Codonopsis pilosula, 8 parts of yam, 18 parts of Poria cocos, 5 parts of lotus seeds, 5 parts of Euryale ferox, 10 parts of Coix seeds, 12 parts of white hyacinth bean, 5 parts of licorice, 5 parts of adzuki bean, 2 parts of ginseng, 3 parts of lotus leaves, and 45 parts of corn silk.

[0040] Preparation method: Take the prescribed amount of medicinal materials, add pure water, heat and reflux to extract twice, add 12 times the amount each time, each time for 2 hours, filter the extract, reduce the pressure of the filtrate and concentrate it to a thick paste with a relative density of 1.2 (50-60℃ thermal measurement), dry it under reduced pressure at 60-70℃, crush it into powder, and make 1000 portions.

[0041] Example 2

[0042] The recipe is as follows: 3 parts of Codonopsis pilosula, 6 parts of yam, 15 parts of Poria cocos, 3 parts of lotus seeds, 3 parts of Euryale ferox, 8 parts of Coix seeds, 10 parts of white hyacinth bean, 7 parts of licorice, 7 parts of adzuki bean, 4 parts of ginseng, 5 parts of lotus leaves, and 50 parts of corn silk.

[0043] The preparation method is the same as that of Example 1.

[0044] Example 3

[0045] The recipe is as follows: 7 parts of Codonopsis pilosula, 10 parts of yam, 20 parts of Poria cocos, 7 parts of lotus seeds, 7 parts of Euryale ferox, 12 parts of Coix seeds, 14 parts of white hyacinth bean, 3 parts of licorice, 3 parts of adzuki bean, 1 part of ginseng, 2 parts of lotus leaves, and 40 parts of corn silk.

[0046] The preparation method is the same as that of Example 1.

[0047] Comparative Example 1

[0048] The recipe is as follows: 2 parts of Codonopsis pilosula, 4 parts of yam, 12 parts of Poria cocos, 1 part of lotus seeds, 1 part of Euryale ferox, 6 parts of Coix seeds, 8 parts of white hyacinth bean, 9 parts of licorice, 9 parts of adzuki beans, 6 parts of ginseng, 6 parts of lotus leaves, and 52 parts of corn silk.

[0049] The preparation method is the same as that of Example 1.

[0050] Comparative Example 2

[0051] The recipe is as follows: 9 parts of Codonopsis pilosula, 12 parts of yam, 22 parts of Poria cocos, 9 parts of lotus seeds, 9 parts of Euryale ferox, 14 parts of Coix seeds, 16 parts of white hyacinth bean, 1 part of licorice, 1 part of adzuki bean, 1 part of ginseng, 1 part of lotus leaf, and 35 parts of corn silk.

[0052] The preparation method is the same as that of Example 1.

[0053] Comparative Example 3

[0054] The recipe is as follows: 5 parts of Codonopsis pilosula, 8 parts of yam, 18 parts of Poria cocos, 5 parts of lotus seeds, 10 parts of Coix seeds, 12 parts of white hyacinth bean, and 5 parts of licorice.

[0055] The preparation method is the same as that of Example 1.

[0056] Comparative Example 4

[0057] The recipe is as follows: 8 parts of yam, 18 parts of Poria cocos, 5 parts of lotus seeds, 5 parts of Euryale ferox, and 10 parts of Coix seeds.

[0058] The preparation method is the same as that of Example 1.

[0059] Comparative Example 5

[0060] The recipe is as follows: 5 parts of red beans, 2 parts of ginseng, 3 parts of lotus leaves, and 45 parts of corn silk.

[0061] The preparation method is the same as that of Example 1.

[0062] Results

[0063] 1. Weight loss effect

[0064] 1.1 Experimental animals

[0065] SPF male SD rats, 180–200 g, were purchased from Jiangsu Jicui Pharmaceutical Biotechnology Co., Ltd. with license number SCXK(Su)2023-0009.

[0066] 1.2 Experimental methods

[0067] 1.2.1 Modeling and drug administration of obese rats with spleen deficiency and dampness obstruction

[0068] Male SPF SD rats weighing 180-200 g were randomly selected as blank group, and the rest were randomly divided into model group, orlistat group, low-dose group of Example 1, high-dose group of Example 1, Example 2 group, Example 3 group, comparative example 1 group, comparative example 2 group, comparative example 3 group, comparative example 4 group, comparative example 5 group, 10 rats in each group.

[0069] After 1 week of adaptive feeding, the feeding environment of the normal group was strictly controlled at a temperature of (25±2)℃ and a relative humidity of (50±5)%, and the rats were fed with ordinary feed. The model group and the experimental group were fed with a high-fat feed + high-humidity environment modeling method, that is, the temperature and humidity of the feeding environment were (25±2)℃, (95±5)%, and the rats were fed with a high-calorie feed (15.0% sucrose and 15.0% lard were added to the maintenance feed). The food intake and water intake were recorded every week, and the body weight was weighed once. After 2 weeks of feeding, the rats fed with high-calorie feed were sorted according to the weight gain, and 10 obese-resistant rats with low weight gain were eliminated. Obese-sensitive rats were screened to establish a wet-resistance obesity model. After that, the experimental group was gavaged with the corresponding composition, and the blank group and the model group were gavaged with the same volume of normal saline for 28 consecutive days. The blank group was given a maintenance feed, and the other groups were fed with a high-calorie feed. The rats were anesthetized by intraperitoneal injection of 20 mg / kg of sodium pentobarbital, and blood was collected from the abdominal aorta to collect serum samples, which were stored in a -80℃ refrigerator. The rats were killed by cervical dislocation, and the body fat (testis and perirenal adipose tissue) of the rats were weighed.

[0070] 1.2.2 Drug preparation and daily dosage

[0071] The drug preparations for each group are as follows:

[0072] (1) Blank control group: normal saline.

[0073] (2) Model control group: normal saline.

[0074] (3) Orlistat group (positive control): Orlistat capsules, purchased from Zhien Biotechnology Co., Ltd., approval number: National Medicine Standard H20123131; specification: 0.12 g; dosage: 21.6 mg kg -1 ·d -1 (twice the clinical equivalent amount), dissolved in normal saline.

[0075] (4) Low-dose group of Example 1: product prepared in Example 1, dosage: 300 mg·kg -1 ·d -1 , dissolved in saline.

[0076] (5) High-dose group of Example 1: product prepared in Example 1, dosage 600 mg·kg -1 ·d -1, dissolved in saline.

[0077] (6) Example 2 group: product prepared in Example 2, dosage: 600 mg·kg -1 ·d -1 , dissolved in saline.

[0078] (7) Example 3 group: product prepared in Example 3, dosage: 600 mg·kg -1 ·d -1 , dissolved in saline.

[0079] (8) Comparative Example 1: The product prepared in Comparative Example 1, dosage: 600 mg kg -1 ·d -1 , dissolved in saline.

[0080] (9) Comparative Example 2: The product prepared in Comparative Example 2, dosage: 600 mg kg -1 ·d -1 , dissolved in saline.

[0081] (10) Comparative Example 3: The product prepared in Comparative Example 3, dosage: 600 mg kg -1 ·d -1 , dissolved in saline.

[0082] (11) Comparative Example 4: The product prepared in Comparative Example 4, dosage: 600 mg kg -1 ·d -1 , dissolved in saline.

[0083] (12) Comparative Example 5: The product prepared in Comparative Example 5, dosage: 600 mg kg -1 ·d -1 , dissolved in saline.

[0084] 1.2.3 Index determination

[0085] 1.2.3.1 General indicator status observation

[0086] The mental state and hair condition of each group of rats were observed and recorded, and the body weight, diet and water intake were recorded every week. 1.2.3.2 Body fat content and body fat ratio

[0087] After the experiment, the body fat (testicular and perirenal fat tissue) of the rats was weighed and the fat coefficient was calculated. Fat body ratio (%) = fat mass / body mass × 100%

[0088] 1.2.3.3 Rat serum analysis

[0089] The kit was used to determine the levels of albumin (ALB), aldosterone (ALD), total cholesterol (TC) and triglyceride (TG) in rat serum. The operating steps were in accordance with the kit instructions. The specific operations of the ELISA kit include: standard dilution, sample addition, solution preparation, washing, color development, termination, using an automatic microplate reader to measure the absorbance (OD value) of each well, drawing a standard curve, and obtaining the ALB and ALD concentrations on the standard curve according to the OD value. The specific operations of the TC and TG detection kits include: sample processing, solution preparation, incubation, color development, using an automatic microplate reader to measure the absorbance of samples and standards, and calculating the TC and TG contents according to the formula.

[0090] 1.2.4 Statistical analysis

[0091] The experimental results were statistically analyzed using GraphPad Prism 9.0 software and expressed as Mean±SD. One-way ANOVA was performed for each component, and p<0.05 was considered statistically significant.

[0092] 1.3 Results

[0093] 1.3.1 General Status Changes

[0094] Compared with the blank group, the modeling groups showed decreased activity, dry and yellow fur, poor mental state, etc. Compared with the model control group, the above conditions in each drug-treated group were improved to a certain extent.

[0095] 1.3.2 Changes in rat body weight

[0096] As can be seen from Table 1, before administration, there was no significant difference in body weight between the administration groups compared with the model group, while there was a significant difference in the normal control group (P < 0.0001), indicating that the weight of the rats increased after modeling. After the first week of administration, there was a significant difference in the normal control group compared with the model control group, indicating that after the successful modeling, the model rats remained obese and no natural recovery occurred. However, compared with the model control group, there was no significant difference in each administration group. After the second week of administration, compared with the model control group, except for the obvious difference in the normal control group, the positive drug group, the high-dose combination group, the combination group 1, and the combination group 2 had significant differences (all P < 0.01), among which the positive drug group and the high-dose combination group had the most obvious effects (all P < 0.001). After the third week of administration, compared with the model control group, all the administration groups had significant differences (all P < 0.05), and the effects of the positive drug group, high-dose combination group, combination group 1, and combination group 2 were more significant (all P < 0.0001); after the fourth week of administration, compared with the model control group, all the administration groups had significant differences (all P < 0.05), and the effects of the positive drug group, high-dose combination group, combination group 1, and combination group 2 were more significant (all P < 0.0001). It is worth noting that compared with the positive drug group, there were no significant differences in the high-dose combination group, combination group 1, and combination group 2, while compared with the high-dose combination group, the weight reduction effect of combination groups 3-7 on rats was significantly reduced, indicating that the weight control effect of the composition within the range on obese rats with spleen deficiency and dampness obstruction is equivalent to that of the positive drug.

[0097] Table 1. Results of rat body weight changes ( n=10,g)

[0098]

[0099] Note: Compared with the model group, * p<0.05, ** p<0.01, *** p<0.001, **** p<0.0001;

[0100] Compared with the positive drug group, ◆ p<0.05, ◆◆ p<0.01, ◆◆◆ p<0.001, ◆◆◆◆ p<0.0001;

[0101] Compared with the high-dose group of the combination, # p<0.05, ## p<0.01, ### p<0.001, #### p<0.0001. 1.3.3 Perirenal and epididymal fat weight and fat body ratio in rats

[0102] The statistical results of the perirenal fat, epididymal fat weight and fat / body ratio of rats in each group are shown in Table 2. The results showed that the epididymal fat, perirenal fat and corresponding fat / body ratio of rats in the model control group were significantly higher than those in the empty control group (P<0.01), among which the perirenal and epididymal fat / body ratios of the positive drug group, the high-dose combination group, the combination group 1 and the combination group 2 were significantly lower than those in the model control group, among which the effect of reducing the epididymal fat / body ratio was more significant (P<0.0001); compared with the positive drug, there was no significant difference in the effect of reducing the epididymal fat weight and fat / body ratio in the high-dose combination group, the combination group 1 and the combination group 2, indicating that the combination and the positive drug have a comparable effect of reducing epididymal fat accumulation in obese rats with dampness resistance.

[0103] Table 2. Epididymal and perirenal fat weights (g) and corresponding fat / body ratios (%) of rats in each group n=10)

[0104]

[0105]

[0106] Note: Compared with the model group, * p<0.05, ** p<0.01, *** p<0.001, **** p<0.0001;

[0107] Compared with the positive drug group, ◆ p<0.05, ◆◆ p<0.01, ◆◆◆ p<0.001, ◆◆◆◆ p<0.0001;

[0108] Compared with the high-dose group of the combination, # p<0.05, ## p<0.01, ### p<0.001, #### p<0.0001. 1.3.4 ALB and ALD levels in rat serum

[0109] Albumin is the most abundant protein in plasma. It has the function of maintaining blood colloidal osmotic pressure and is an important indicator for judging water metabolism and edema status. Aldosterone is an important hormone involved in water metabolism. It can retain sodium and excrete potassium. It is related to water reabsorption and also reflects human water metabolism. The statistical results of serum ALB and ALD content of rats in each group are shown in Table 3. The results showed that the ALB content of rats in the model control group was significantly lower than that in the blank control group (P<0.0001), indicating that the model group rats had abnormal body fluid metabolism. Compared with the model group, the ALB content of the positive drug group, the low-dose group of the combination, the high-dose group of the combination, the combination group 1, and the combination group 2 was significantly reduced (P<0.05); compared with the positive drug group, the ALB content of the high-dose group of the combination was significantly reduced (P<0.05), indicating that the high-dose group of the combination was superior to the positive drug group in regulating ALB; compared with the high-dose group of the combination, there was no significant difference in the ALB content of the combination 1-2 group, indicating that the effects of the three were equivalent. Compared with the normal control group, the ALD level of the model control group increased significantly, indicating that the model group rats had abnormal water metabolism. Compared with the model group, the ALD content of each drug administration group decreased significantly (P < 0.0001), indicating that each group of drugs had a certain regulatory effect on the abnormal water metabolism of rats, among which the high-dose group of the combination had the best correction effect. Compared with the positive drug group, the ALD content of the high-dose group of the combination and the combination 1-2 group decreased significantly (P < 0.0001). The above results indicate that the combination has a good effect on improving the abnormal water metabolism of obese rats with dampness resistance.

[0110] Table 3. Serum ALB and ALD levels of rats in each group ( n=10)

[0111]

[0112]

[0113] Note: Compared with the model group, * p<0.05, ** p<0.01, *** p<0.001, **** p<0.0001;

[0114] Compared with the positive drug group, ◆ p<0.05, ◆◆ p<0.01, ◆◆◆ p<0.001, ◆◆◆◆ p<0.0001;

[0115] Compared with the high-dose group of the combination, # p<0.05, ## p<0.01, ### p<0.001,#### p<0.0001. 1.3.5 TC and TG levels in rat serum

[0116] Blood lipid metabolism is closely related to the occurrence and development of spleen deficiency and dampness obstruction syndrome and obesity. Studies have shown that obese people have high visceral fat content, increased TG synthesis, and excessive fat deposition leads to lipoprotein lipase activity, which further leads to increased TC. The statistical results of serum TC and TG content of rats in each group are shown in Table 4. The results showed that the TC and TG content of rats in the model control group were significantly higher than those in the empty control group (P<0.0001), indicating that the model group rats had dyslipidemia. Compared with the model group, the TC and TG content of each drug administration group was significantly reduced (P<0.01), indicating that each drug administration group can effectively regulate dyslipidemia in rats, among which the positive drug group and the high-dose group of the combination had the best effect. Compared with the positive drug group, there was no significant difference in ALB content in the high-dose group of the combination, group 1 of the combination, and group 2 of the combination. The above results indicate that the combination and the positive drug have a comparable effect in improving dyslipidemia in obese rats with dampness obstruction.

[0117] Table 4. Serum ALB and ALD levels of rats in each group ( n=10,mmol / L)

[0118]

[0119]

[0120] Note: Compared with the model group, * p<0.05, ** p<0.01, *** p<0.001, **** p<0.0001;

[0121] Compared with the positive drug group, ◆ p<0.05, ◆◆ p<0.01, ◆◆◆ p<0.001, ◆◆◆◆ p<0.0001;

[0122] Compared with the high-dose group of the combination, # p<0.05, ## p<0.01, ### p<0.001, #### p<0.0001.

[0123] 2. Effect of removing dampness and promoting diuresis

[0124] 2.1 Experimental Materials

[0125] 2.1.1 Experimental animals

[0126] SPF male SD rats, 180–200 g, were purchased from Jiangsu Jicui Pharmaceutical Biotechnology Co., Ltd. with license number SCXK(Su)2023-0009.

[0127] 2.2 Experimental methods

[0128] 2.2.1 Screening of experimental animals

[0129] Male SPF SD rats weighing 180-200g were adapted to feeding (temperature (25±2)℃, relative humidity (50±5)%) for 1 week and then fasted but not watered for 12h. The abdomen of the rats was gently pressed to empty the remaining urine, and then 2.5mL / 100g of normal saline was gavaged orally. The urine volume of each rat within 2h was collected in a metabolic cage, and 110 qualified rats whose urine volume exceeded 40% of the gavage volume were selected.

[0130] 2.2.2 Animal grouping and drug administration

[0131] Rats were randomly divided into a blank control group, a hydrochlorothiazide group, a low-dose group of Example 1, a high-dose group of Example 1, an Example 2 group, an Example 3 group, a comparative example 1 group, a comparative example 2 group, a comparative example 3 group, a comparative example 4 group, and a comparative example 5 group.

[0132] The experimental group was gavaged with the corresponding composition, and the blank control group was gavaged with the same volume of normal saline for 14 consecutive days.

[0133] 2.2.3 Drug preparation and daily dosage

[0134] The drug preparations for each group are as follows:

[0135] (1) Negative control group: normal saline.

[0136] (2) Hydrochlorothiazide group (positive control): Hydrochlorothiazide tablets, purchased from Shanghai SPH Pharmaceuticals Co., Ltd., approval number: National Medicine Standard H31020778; specification: 25 mg; dosage: 21.6 mg kg -1 ·d -1 (twice the clinical equivalent amount), dissolved in normal saline.

[0137] (3) The drug configurations of the low-dose group of Example 1, the high-dose group of Example 1, the group of Example 2, the group of Example 3, the group of Comparative Example 1, the group of Comparative Example 2, the group of Comparative Example 3, the group of Comparative Example 4, and the group of Comparative Example 5 were the same as those in Item 1.2.2.

[0138] 2.2.4 Index determination

[0139] 2.2.4.1 Urine of water-loaded rats at different time periods

[0140] Before the last administration, the rats were fasted but not water-free. After 12 hours, the abdomen of the rats was pressed to empty the remaining urine. The rats in each group were gavaged with 20 mL / kg of normal saline to cause water and sodium retention. The rats were placed in metabolic cages, and urine was collected in the time periods of 0-1h, 1-2h, 2-4h, 4-6h, and 6-24h and stored at -80°C for later use.

[0141] 2.2.4.2 Determination of electrolyte content in urine of rats in each group

[0142] Monitor the electrolyte content in urine within 6 hours according to the kit instructions. Use colorimetry to monitor and calculate Na + The content of Cl was determined by microplate reader - and K + The content.

[0143] 2.2.5 Statistical analysis

[0144] The experimental results were statistically analyzed using GraphPad Prism 9.0 software and expressed as Mean±SD. One-way ANOVA was performed for each component, and p<0.05 was considered statistically significant.

[0145] 2.3 Results

[0146] 2.3.1 Changes in urine volume in rats

[0147] As can be seen from Table 5, compared with the negative control group, the urine volume of each medication group in different time periods showed an upward trend, and the positive drug effect was the most significant. Among them, within 0-1, 1-2, 2-4, and 6-24h, the rising degrees of the positive control group, the high-dose group of the composition, and the composition 1-2 group had significant differences. Compared with the positive control group, the high-dose group of the composition and the composition 1-2 group had no significant differences in each time period, indicating that the diuretic effect of the composition on water-loaded rats within the range is equivalent to that of the positive drug. Compared with the high-dose group of the composition, the urine output of rats in the composition 3-7 group was significantly lower. The above results suggest that the composition has a comparable diuretic effect to the positive drug hydrochlorothiazide.

[0148] Table 5 Changes in urine volume of rats in each group at different times ( n=10,mL / 100g)

[0149]

[0150]

[0151] Note: Compared with the negative control group, * p<0.05, ** p<0.01, *** p<0.001,**** p<0.0001;

[0152] Compared with the positive drug group, ◆ p<0.05, ◆◆ p<0.01, ◆◆◆ p<0.001, ◆◆◆◆ p<0.0001;

[0153] Compared with the high-dose group of the combination, # p<0.05, ## p<0.01, ### p<0.001, #### p<0.0001. 2.3.2 Electrolyte content in rat urine

[0154] The Na content in urine of water-loaded rats in each group + , K + and Cl - The statistical results are shown in Table 6. Compared with the negative control group, each group showed a certain degree of promotion of the excretion of Na+ and Cl-, among which the positive drug and high-dose combination groups and combination 1-2 groups had significant effects. Compared with the positive drug group, the high-dose combination and combination 1-2 groups had no significant difference in the excretion of Na+ and Cl-, but in K + Compared with the high-dose group of the composition, the electrolyte excretion effect of the composition 3-7 group was poor. The above results prove that the composition can effectively regulate electrolyte disorders, and its diuretic effect is related to promoting the excretion of Na+ and Cl-.

[0155] Table 6 The contents of Na+, K+ and Cl- in urine of rats in each group ( n=10,mmol / L)

[0156]

[0157]

[0158] Note: Compared with the model group, * p<0.05, ** p<0.01, *** p<0.001, **** p<0.0001;

[0159] Compared with the positive drug group, ◆ p<0.05, ◆◆ p<0.01, ◆◆◆ p<0.001, ◆◆◆◆ p<0.0001;

[0160] Compared with the high-dose group of the combination, #p<0.05, ## p<0.01, ### p<0.001, #### p<0.0001.

[0161] In summary, the present invention simulates the clinical etiology and pathogenesis of obesity, adopts a two-factor modeling method, establishes an improper diet + long-term residence in wetlands to induce obesity, and the rats in the model group show mental depression, fatigue and less activity, dry and yellow hair, and weight gain, which is consistent with literature reports, indicating that the model has been successfully replicated. After 4 weeks of continuous administration, compared with the model group, the body weight of each administration group decreased significantly (all P < 0.01), and the groups of Examples 1-3 had significant differences in indicators such as fat / body ratio, serum aldosterone, albumin, total triglycerides, and total cholesterol, indicating that the composition has a certain degree of improvement on moisture-blocking obesity. Among them, ALB has a hypertonic effect, maintains the water balance between tissues and blood vessels, and increasing ALB can improve abnormal water metabolism, which is an important indicator for judging water metabolism and edema status. ALD retains sodium and excretes potassium, promotes the reabsorption of water by kidney tissue, and its numerical difference can also reflect changes in human body water metabolism. According to the experimental results, compared with the positive drug, the Example 1-3 group has a more significant effect on the water metabolism index, indicating that the Chinese medicine composition can promote the body's water discharge, regulate water and moisture metabolism disorders, and play a role in removing dampness and promoting diuresis on the basis of fat reduction comparable to the positive drug. Within the scope of protection of this patent, the Chinese medicine composition has the best effect on dampness-obstructed obesity.

[0162] The pathological basis of dampness syndrome is the body's water metabolism disorder, among which diuresis and dehumidification are one of the main methods to alleviate dampness syndrome. Diuretics are drugs that increase urine volume by excreting electrolytes and water from the body, while electrolytes in the body are freely filtered out from the kidneys, and most of them are reabsorbed. Electrolytes play a central role in maintaining normal water distribution and osmotic pressure. The excretion of electrolytes in the body is positively correlated with the efficacy of diuretics, which is one of the mechanisms of action that reflects diuresis. This study explored the diuretic effect of the Chinese medicine composition using a rat water load model. The results showed that the urine volume and Na in the urine of the group receiving the composition were significantly lower than those of the group receiving the composition. + , K + , Cl - The ion content was significantly higher than that of the negative control group rats, which was consistent with the above experimental results, indicating that the composition had a good water metabolism effect.

[0163] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, rather than to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions of the technical solution of the present invention by ordinary technicians in this field do not deviate from the essence and scope of the technical solution of the present invention.

Claims

1. A composition for removing dampness, promoting diuresis and reducing weight, characterized in that: The composition comprises: codonopsis pilosula, yam, tuckahoe, lotus seed, euryale ferox, coix seed, white hyacinth bean, liquorice, red bean, quinquefolius chinensis, lotus leaf and corn silk.

2. The composition according to claim 1, characterized in that The composition comprises, by weight, 3-7 parts of codonopsis pilosula, 6-10 parts of yam, 15-20 parts of poria, 3-7 parts of lotus seeds, 3-7 parts of euryale seeds, 8-12 parts of coix seeds, 10-14 parts of white hyacinth bean, 3-7 parts of liquorice, 3-7 parts of adzuki beans, 1-4 parts of quinquefolius, 2-5 parts of lotus leaves and 40-50 parts of corn silk.

3. The composition according to claim 2, characterized in that The composition comprises, by weight, 5 parts of codonopsis pilosula, 8 parts of yam, 18 parts of poria, 5 parts of lotus seeds, 5 parts of euryale, 10 parts of coix seeds, 12 parts of white hyacinth bean, 5 parts of liquorice, 5 parts of red bean, 2 parts of quinquefolius, 3 parts of lotus leaves and 45 parts of corn silk.

4. A method for preparing the composition according to any one of claims 1 to 3, characterized in that: The method comprises the following steps: adding water to a prescribed amount of medicinal materials to extract the extract.

5. The preparation method according to claim 4, characterized in that: The specific steps include: Add water, heat and reflux to extract 2-4 times, add 10-15 times the weight of the medicinal material of water each time, extract for 1-3 hours each time, and obtain the extract.

6. The preparation method according to claim 5, characterized in that: The specific steps include: Add water and heat under reflux for extraction twice, adding 12 times the weight of the medicinal material of water each time, and extract for 2 hours each time to obtain the extract.

7. The preparation method according to claim 4, characterized in that: The preparation method further comprises the following steps: concentrating the extract under reduced pressure into a thick paste, drying under reduced pressure, and crushing into powder to obtain the extract.

8. The preparation method according to claim 7, characterized in that: The preparation method further comprises the following steps: concentrating the extract under reduced pressure to a specific gravity of 1.1-1.3, drying under reduced pressure at 60-70° C., and crushing into powder to obtain an extract.

9. A medicine, the active ingredient of which comprises the composition according to any one of claims 1 to 3, or the extract prepared by the preparation method according to any one of claims 4 to 8.

10. Use of the composition according to any one of claims 1 to 3, or the extract prepared according to any one of claims 4 to 8, in the preparation of a product for removing dampness, promoting diuresis and / or reducing weight.

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