Traditional Chinese Medicine Composition, Pharmaceutical Preparation and Their Application in the Preparation of Medicines for Treating Obesity of Spleen-Kidney Yang Deficiency Type

Abstract

The present application discloses a traditional Chinese medicine composition, a pharmaceutical preparation and their application in the preparation of a medicament for treating obesity of spleen-kidney yang deficiency type. The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 10-60 parts of aconite root, 20-100 parts of amomum villosum, 50-150 parts of raw licorice root, 50-160 parts of turtle shell stir-fried with vinegar, 50-160 parts of stir-fried atractylodes macrocephala, 90-450 parts of poria with hostwood, 20-160 parts of cassia twig, 50-160 parts of turmeric, and 10-70 parts of cinnamon. The traditional Chinese medicine composition of the present application can improve the condition of spleen-kidney yang deficiency, enhance the metabolic capacity of obese people with spleen-kidney yang deficiency type, and improve the health condition of obese people with spleen-kidney yang deficiency type, so as to achieve the effect of reducing fat and increasing muscle mass.

Description

Technical Field

[0001] The present application relates to the field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition, a pharmaceutical preparation and their application in the preparation of a drug for treating obesity of spleen-kidney yang deficiency type. Background Art

[0002] Obesity is a common phenomenon in modern life and also an epidemic disease. Affected by factors such as the modern social environment, diet structure and living habits, the number of obese people is increasing year by year. Obesity not only affects the mental health of obese people, but also poses a great threat to their physical health.

[0003] Obesity of spleen-kidney yang deficiency type is the most main type of obesity in modern society. Most modern people consume yang qi due to bad living habits such as staying up late and eating raw and cold foods, resulting in the disorder of the body's qi transformation function and then leading to obesity. Therefore, the incidence rate of obesity of spleen-kidney yang deficiency type is increasing day by day. Obese people have a large body weight and more visceral fat, which are likely to cause various chronic diseases, such as diabetes, arthritis, fatty liver, high blood lipid, etc. At present, the health awareness of most obese people is gradually increasing, and they begin to seek some ways to reduce fat in order to seek the best health condition of the body.

[0004] At present, there are various ways to lose weight. Seeking a healthy and effective way to lose weight is the demand of obese people. Therefore, it is necessary to provide a traditional Chinese medicine composition that can effectively reduce weight and fat and can fundamentally improve the health condition of obese people. Summary of the Invention

[0005] In view of this, the present application provides a traditional Chinese medicine composition, a pharmaceutical preparation and their application in the preparation of a drug for treating obesity of spleen-kidney yang deficiency type.

[0006] According to the first aspect of the present application, a traditional Chinese medicine composition is provided. The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 10 parts - 60 parts of aconite lateralis preparata, 20 parts - 100 parts of fructus amomi villosi, 50 parts - 150 parts of raw licorice root, 50 parts - 160 parts of tortoise plastron stir-fried with vinegar, 50 parts - 160 parts of stir-fried atractylodes macrocephala, 90 parts - 450 parts of poria cumradix pini, 20 parts - 160 parts of cassia twig, 50 parts - 160 parts of turmeric and 10 parts - 70 parts of cassia bark.

[0007] Preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 20 parts - 60 parts of aconite lateralis preparata, 30 parts - 90 parts of fructus amomi villosi, 60 parts - 140 parts of raw licorice root, 60 parts - 150 parts of tortoise plastron stir-fried with vinegar, 60 parts - 150 parts of stir-fried atractylodes macrocephala, 120 parts - 400 parts of poria cumradix pini, 30 parts - 160 parts of cassia twig, 60 parts - 150 parts of turmeric and 20 parts - 70 parts of cassia bark.

[0008] More preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 20-50 parts of aconite root, 40-80 parts of amomum fruit, 60-130 parts of raw licorice root, 60-130 parts of tortoise shell stir-fried with vinegar, 60-130 parts of stir-fried atractylodes rhizome, 150-300 parts of poria with hostwood, 40-140 parts of cassia twig, 60-130 parts of turmeric, and 20-60 parts of cinnamon.

[0009] Even more preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 30-40 parts of aconite root, 50-70 parts of amomum fruit, 70-120 parts of raw licorice root, 70-120 parts of tortoise shell stir-fried with vinegar, 70-120 parts of stir-fried atractylodes rhizome, 170-250 parts of poria with hostwood, 50-130 parts of cassia twig, 70-120 parts of turmeric, and 30-50 parts of cinnamon.

[0010] According to the second aspect of the present application, a pharmaceutical preparation is provided, which comprises the above-mentioned traditional Chinese medicine composition and excipients. The excipients include at least one of honey, sucrose, xylitol, maltose, and starch.

[0011] Preferably, the sucrose is at least one of rock sugar, white sugar, and brown sugar.

[0012] Preferably, the dosage form of the pharmaceutical preparation includes pills, powders, ointments, granules, capsules, or decoctions.

[0013] According to the third aspect of the present application, the above-mentioned traditional Chinese medicine composition and the above-mentioned pharmaceutical preparation are used in the preparation of a drug for improving obesity of spleen-kidney yang deficiency type.

[0014] Obesity is mainly related to congenital endowment deficiency, being fond of ease and lacking labor, overeating greasy and raw and cold foods, and lack of exercise in the later days, which lead to disharmony of zang-fu functions and cause obesity. Among them, obesity of spleen-kidney yang deficiency type is the most common. Traditional Chinese medicine believes that the functions of "yang transforming qi and yin forming form" are abnormal. In terms of zang-fu organs, the deficiency of yang transforming qi is mostly attributed to the spleen and kidney. The kidney is the congenital foundation, the place where primordial yin and yang are located, and the kidney is responsible for the growth, development, and reproduction of the human body; the spleen is the acquired foundation, the spleen is responsible for transportation and transformation, and is the source of qi and blood generation. The spleen and kidney nourish each other, "the congenital nourishes the acquired, and the acquired nourishes the congenital." The spleen yang is rooted in the kidney yang, and the yang of the two complements each other, warms the whole body, and maintains the normal qi transformation function of the zang-fu organs. At the same time, the spleen is responsible for transporting and transforming body fluids, and is the hub of body fluid metabolism.

[0015] The kidney is in charge of opening and closing and is the organ that dominates water. The two function interdependently, and the qi transformation function runs through the entire process of water metabolism. Insufficient congenital endowment, acquired damage, or both will jointly lead to damage to the body's yang qi. The "transformation of yang into qi" is insufficient, and the qi transformation function is difficult to maintain. The transportation and transformation function fails, and the essence of water and grains is difficult to be transformed and distributed throughout the body, resulting in the accumulation of phlegm and fluid in the body. Moreover, yang deficiency leads to cold, and coldness is characterized by constriction and stagnation, which easily causes the formation of tangible static blood to stagnate in the body. When yang qi is insufficient, the dynamic balance between yin and yang is broken, and yin qi will be relatively excessive. Normal blood and body fluids of "yin forming form" do not nourish the body along their normal paths. Pathological products combine with each other, and then turn into phlegm and stasis, gathering into a mass, increasing body weight. Therefore, a series of symptoms accompanied by yang deficiency with phlegm and stasis, such as dizziness, fatigue, dark-colored lips, excessive phlegm, fear of cold, loose stools, etc. In the traditional Chinese medicine composition of this application, aconite, cinnamon twig, and amomum villosum are used as the monarch drugs, which have the effects of warming the kidney yang, tonifying the spleen yang, and promoting qi transformation and water circulation. Atractylodes macrocephala, poria, turmeric, and cinnamon are used as the ministerial drugs, which have the effects of strengthening the spleen, replenishing qi, promoting water circulation, warming yang, dispelling cold, promoting blood circulation to remove blood stasis, and dispelling yin stagnation. Vinegar-treated turtle shell is used as the assistant drug, which has the effect of dredging yin and assisting yang. Licorice root is used as the guiding drug. Licorice root strengthens the earth, and when the earth covers, the fire can be subdued and last for a long time without decline, and it also has the effect of coordinating various drugs. The whole formula together exerts the effects of supplementing qi and warming yang, promoting blood circulation and promoting diuresis, taking both the root cause and the symptoms into consideration, with the root cause as the main focus, thus restoring the body's qi transformation function and achieving the purpose of losing weight and reducing lipid levels.

[0016] Other features and advantages of this application will be described in detail in the subsequent specific implementation section. Specific Implementation Modes

[0017] The technical solution of this application will be described in detail below in combination with the implementation modes.

[0018] The project carrying this application has obtained the approval of the Ethics Committee of Xiyuan Hospital, China Academy of Chinese Medical Sciences (Approval No.: 2021XLA072-2).

[0019] Each traditional Chinese medicine material listed in this application can be selected with reference to the 2020 edition of the Chinese Pharmacopoeia.

[0020] According to the first aspect of this application, a traditional Chinese medicine composition is proposed. The traditional Chinese medicine composition may include the following raw materials in parts by weight: aconite 10 parts - 60 parts, amomum villosum 20 parts - 100 parts, licorice root 50 parts - 150 parts, vinegar-treated turtle shell 50 parts - 160 parts, stir-fried atractylodes macrocephala 50 parts - 160 parts, poria 90 parts - 450 parts, cinnamon twig 20 parts - 160 parts, turmeric 50 parts - 160 parts, and cinnamon 10 parts - 70 parts.

[0021] Preferably, the traditional Chinese medicine composition may comprise the following raw materials in parts by weight: 20-60 parts of aconite root, 30-90 parts of amomum villosum, 60-140 parts of raw licorice root, 60-150 parts of turtle shell stir-fried with vinegar, 60-150 parts of stir-fried atractylodes macrocephala, 120-400 parts of poria with hostwood, 30-160 parts of cassia twig, 60-150 parts of turmeric, and 20-70 parts of cinnamon.

[0022] More preferably, the traditional Chinese medicine composition may comprise the following raw materials in parts by weight: 20-50 parts of aconite root, 40-80 parts of amomum villosum, 60-130 parts of raw licorice root, 60-130 parts of turtle shell stir-fried with vinegar, 60-130 parts of stir-fried atractylodes macrocephala, 150-300 parts of poria with hostwood, 40-140 parts of cassia twig, 60-130 parts of turmeric, and 20-60 parts of cinnamon.

[0023] Even more preferably, the traditional Chinese medicine composition may comprise the following raw materials in parts by weight: 30-40 parts of aconite root, 50-70 parts of amomum villosum, 70-120 parts of raw licorice root, 70-120 parts of turtle shell stir-fried with vinegar, 70-120 parts of stir-fried atractylodes macrocephala, 170-250 parts of poria with hostwood, 50-130 parts of cassia twig, 70-120 parts of turmeric, and 30-50 parts of cinnamon.

[0024] For obese people with spleen-kidney yang deficiency, there is deficiency of both the spleen and kidney, insufficient yang qi transformation, resulting in excessive formation of yin, poor transportation of body fluids, and accumulation of phlegm turbidity, leading to obesity. Therefore, the present application creatively proposes a traditional Chinese medicine composition and pharmaceutical preparation for spleen-kidney yang deficiency type obesity. By improving the condition of spleen-kidney yang deficiency and enhancing the body's metabolic capacity, the purpose of reducing fat and increasing muscle can be achieved.

[0025] The following examples illustrate the traditional Chinese medicine composition of the present application and its application in the preparation of a drug for treating spleen-kidney yang deficiency type obesity.

[0026] 1. Subjects

[0027] All the subjects in the present application are patients who have visited Xiyuan Hospital of China Academy of Chinese Medical Sciences and suffer from spleen-kidney yang deficiency type obesity. The disclosure of the medical information of the patients involved in the present application has obtained the informed consent of the patients.

[0028] A total of 57 subjects were counted in the present application. Among the subjects randomly selected from this project, aged between 18 and 60 years old, they were randomly divided into a control group and an experimental group. Among them, the experimental group took the pharmaceutical preparation prepared from the traditional Chinese medicine composition of this application. One course of treatment was 4 weeks, and they were followed up for 4 weeks. This experiment was a randomized controlled trial, and an informed consent form was signed. The basic conditions of the subjects are shown in Table 1. 27 patients (16 males and 11 females) participated in the control group, and 30 patients (15 males and 15 females) participated in the experimental group. There were no significant differences in the number of participants and the average age between the two groups (P>0.05), and there was no previous medical history.

[0029] Table 1 Basic Information of Obese People with Spleen-Kidney Yang Deficiency

[0030]

[0031] All subjects in the control group and the experimental group were given diet, exercise, and psychological interventions during the trial period.

[0032] (1) Diet Intervention: Referring to the "Dietary Guidelines for Chinese Residents (2022)", an energy-restricted balanced diet pattern was adopted, with carbohydrates accounting for 50%-60% of the daily diet, protein accounting for 25%-30%, and fat accounting for 15%-20%. Have a balanced diet, chew slowly, and it is advisable to be 70% full.

[0033] (2) Exercise Intervention: At least 40 minutes of moderate-intensity physical activity every day. For men, activities such as tennis (moderate intensity), cycling (speed reaching 15 km / h), swimming, general jogging, skipping rope (medium speed), etc. can be selected; for women, activities such as badminton, tai chi, cycling (speed reaching 10 km / h), table tennis, fast walking (speed 1000-1200 m / 10 min), etc. can be selected; resistance strength training, 15-20 in a group, 10-20 minutes each time, at least twice a week, with interval exercise.

[0034] (3) Psychological Intervention: Health education, encourage the subjects, eliminate psychological stress, and actively guide them to adhere to the treatment.

[0035] 2. Examples

[0036] Example 1

[0037] The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 10 parts of aconite, 20 parts of amomum villosum, 50 parts of raw licorice, 50 parts of turtle shell stir-fried with vinegar, 50 parts of stir-fried atractylodes macrocephala, 90 parts of poria with hostwood, 20 parts of cinnamon twig, 50 parts of turmeric, and 10 parts of cinnamon.

[0038] It can also be by weight (1 dose): 1 g of aconite, 2 g of amomum villosum, 5 g of raw licorice, 5 g of turtle shell stir-fried with vinegar, 5 g of stir-fried atractylodes macrocephala, 9 g of poria with hostwood, 2 g of cinnamon twig, 5 g of turmeric, and 1 g of cinnamon.

[0039] Example 2

[0040] The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 60 parts of aconite, 100 parts of amomum villosum, 150 parts of raw licorice, 160 parts of turtle shell stir-fried with vinegar, 160 parts of stir-fried atractylodes macrocephala, 450 parts of poria with hostwood, 160 parts of cinnamon twig, 160 parts of turmeric, and 70 parts of cinnamon.

[0041] It can also be by weight (1 dose): 6 g of aconite, 10 g of amomum villosum, 15 g of raw licorice, 16 g of turtle shell stir-fried with vinegar, 16 g of stir-fried atractylodes macrocephala, 45 g of poria with hostwood, 16 g of cinnamon twig, 16 g of turmeric, and 7 g of cinnamon.

[0042] Example 3

[0043] The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 20 parts of aconite root, 30 parts of amomum fruit, 60 parts of raw licorice root, 60 parts of turtle shell stir-fried with vinegar, 60 parts of stir-fried atractylodes rhizome, 120 parts of poria, 30 parts of cassia twig, 60 parts of turmeric and 20 parts of cinnamon.

[0044] It can also be (1 dose) by weight: 2 g of aconite root, 3 g of amomum fruit, 6 g of raw licorice root, 6 g of turtle shell stir-fried with vinegar, 6 g of stir-fried atractylodes rhizome, 12 g of poria, 3 g of cassia twig, 6 g of turmeric and 2 g of cinnamon.

[0045] Example 4

[0046] The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 60 parts of aconite root, 90 parts of amomum fruit, 140 parts of raw licorice root, 150 parts of turtle shell stir-fried with vinegar, 150 parts of stir-fried atractylodes rhizome, 400 parts of poria, 160 parts of cassia twig, 150 parts of turmeric and 70 parts of cinnamon.

[0047] It can also be (1 dose) by weight: 6 g of aconite root, 9 g of amomum fruit, 14 g of raw licorice root, 15 g of turtle shell stir-fried with vinegar, 15 g of stir-fried atractylodes rhizome, 40 g of poria, 16 g of cassia twig, 15 g of turmeric and 7 g of cinnamon.

[0048] Example 5

[0049] The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 20 parts of aconite root, 40 parts of amomum fruit, 60 parts of raw licorice root, 60 parts of turtle shell stir-fried with vinegar, 60 parts of stir-fried atractylodes rhizome, 150 parts of poria, 40 parts of cassia twig, 60 parts of turmeric and 20 parts of cinnamon.

[0050] It can also be (1 dose) by weight: 2 g of aconite root, 4 g of amomum fruit, 6 g of raw licorice root, 6 g of turtle shell stir-fried with vinegar, 6 g of stir-fried atractylodes rhizome, 15 g of poria, 4 g of cassia twig, 6 g of turmeric and 2 g of cinnamon.

[0051] Example 6

[0052] The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 50 parts of aconite root, 80 parts of amomum fruit, 130 parts of raw licorice root, 130 parts of turtle shell stir-fried with vinegar, 130 parts of stir-fried atractylodes rhizome, 300 parts of poria, 140 parts of cassia twig, 130 parts of turmeric and 60 parts of cinnamon.

[0053] It can also be (1 dose) by weight: 5 g of aconite root, 8 g of amomum fruit, 13 g of raw licorice root, 13 g of turtle shell stir-fried with vinegar, 13 g of stir-fried atractylodes rhizome, 30 g of poria, 14 g of cassia twig, 13 g of turmeric and 6 g of cinnamon.

[0054] Example 7

[0055] The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 30 parts of aconite root, 50 parts of amomum fruit, 70 parts of raw licorice root, 70 parts of turtle shell stir-fried with vinegar, 70 parts of stir-fried atractylodes rhizome, 170 parts of poria, 50 parts of cassia twig, 70 parts of turmeric and 30 parts of cinnamon.

[0056] It can also be (1 dose) by weight: 3 g of aconite root, 5 g of amomum fruit, 7 g of raw licorice root, 7 g of turtle shell stir-fried with vinegar, 7 g of stir-fried atractylodes rhizome, 17 g of poria, 5 g of cassia twig, 7 g of turmeric and 3 g of cinnamon.

[0057] Example 8

[0058] The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 40 parts of aconite root, 70 parts of amomum fruit, 120 parts of raw licorice root, 120 parts of turtle shell stir-fried with vinegar, 120 parts of stir-fried atractylodes rhizome, 250 parts of poria, 130 parts of cassia twig, 120 parts of turmeric and 50 parts of cinnamon.

[0059] It can also be (1 dose) by weight: 4 g of aconite root, 7 g of amomum fruit, 12 g of raw licorice root, 12 g of turtle shell stir-fried with vinegar, 12 g of stir-fried atractylodes rhizome, 25 g of poria, 13 g of cassia twig, 12 g of turmeric and 5 g of cinnamon.

[0060] Example 9

[0061] The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 30 parts of aconite root, 60 parts of amomum fruit, 100 parts of raw licorice root, 110 parts of turtle shell stir-fried with vinegar, 110 parts of stir-fried atractylodes rhizome, 270 parts of poria, 90 parts of cassia twig, 100 parts of turmeric and 40 parts of cinnamon.

[0062] It can also be (1 dose) by weight: 3 g of aconite root, 6 g of amomum fruit, 10 g of raw licorice root, 11 g of turtle shell stir-fried with vinegar, 11 g of stir-fried atractylodes rhizome, 27 g of poria, 9 g of cassia twig, 10 g of turmeric and 4 g of cinnamon.

[0063] Example 10

[0064] The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 40 parts of aconite root, 60 parts of amomum fruit, 100 parts of raw licorice root, 100 parts of turtle shell stir-fried with vinegar, 100 parts of stir-fried atractylodes rhizome, 260 parts of poria, 100 parts of cassia twig, 110 parts of turmeric and 50 parts of cinnamon.

[0065] It can also be (1 dose) by weight: 4 g of aconite root, 6 g of amomum fruit, 10 g of raw licorice root, 10 g of turtle shell stir-fried with vinegar, 10 g of stir-fried atractylodes rhizome, 26 g of poria, 10 g of cassia twig, 11 g of turmeric and 5 g of cinnamon.

[0066] Example 11

[0067] The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 40 parts of aconite root, 60 parts of amomum fruit, 90 parts of raw licorice root, 90 parts of turtle shell stir-fried with vinegar, 90 parts of stir-fried atractylodes rhizome, 230 parts of poria, 80 parts of cassia twig, 90 parts of turmeric and 40 parts of cinnamon.

[0068] It can also be by weight (1 dose): 4g of Aconite Lateralis Preparata, 6g of Amomum Villosum, 9g of Raw Licorice Root, 9g of Turtle Shell Stir-Fried with Vinegar, 9g of Stir-Fried Atractylodes Macrocephala, 23g of Poria, 8g of Cinnamon Twig, 9g of Turmeric, and 4g of Cinnamon.

[0069] Example 12

[0070] The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 30 parts of Aconite Lateralis Preparata, 60 parts of Amomum Villosum, 90 parts of Raw Licorice Root, 100 parts of Turtle Shell Stir-Fried with Vinegar, 90 parts of Stir-Fried Atractylodes Macrocephala, 210 parts of Poria, 90 parts of Cinnamon Twig, 100 parts of Turmeric, and 40 parts of Cinnamon.

[0071] It can also be by weight (1 dose): 3g of Aconite Lateralis Preparata, 6g of Amomum Villosum, 9g of Raw Licorice Root, 10g of Turtle Shell Stir-Fried with Vinegar, 9g of Stir-Fried Atractylodes Macrocephala, 21g of Poria, 9g of Cinnamon Twig, 10g of Turmeric, and 4g of Cinnamon.

[0072] Control Group

[0073] Did not take medicine.

[0074] 3. Dosage Forms and Their Preparation Methods

[0075] In the second aspect of the present application, a pharmaceutical preparation is proposed, which may include the above-mentioned pharmaceutical preparation and excipients applicable in traditional Chinese medicine. The above excipients may be in an appropriate form, for example, at least one of honey, sucrose, xylitol, maltose, and starch. Preferably, the sucrose is at least one of rock sugar, white sugar, and brown sugar. Preferably, the dosage form of the pharmaceutical preparation may include pills, powders, plasters, granules, capsules, or decoctions.

[0076] The dosage form of the traditional Chinese medicine composition in the present application is prepared according to the preparation methods of conventional traditional Chinese medicine dosage forms.

[0077] For example, 1) made into a plaster, in which the traditional Chinese medicine composition of the present application accounts for 90%, and the excipients account for 10%. The excipients include honey and rock sugar; 2) made into a decoction, soak the traditional Chinese medicine pieces, add an appropriate amount of water, set the decocting time and firepower according to the nature, flavor, and efficacy of the traditional Chinese medicine composition of the present application. After decocting, cool and package.

[0078] In the examples of the present application, the dosage form taken by the subjects in the experimental group is a decoction.

[0079] 4. Prescriptions, Dosages, and Administration Methods

[0080] The prescriptions, dosages, and administration methods for obese people with spleen-kidney yang deficiency are shown in Table 2 below.

[0081] Table 2 The prescriptions, dosages, and usage methods for obese people with spleen-kidney yang deficiency are shown in Table 2.

[0082]

[0083]

[0084]

[0085]

[0086] 5. Evaluation

[0087] 5.1 Traditional Chinese Medicine Symptom Score

[0088] The Traditional Chinese Medicine symptom integral scale is shown in Table 3. The main Traditional Chinese Medicine symptoms of obese people with spleen-kidney yang deficiency are plump body build, fatigue, loss of appetite, fear of cold, deep and thready pulse, white tongue coating, and pale red tongue.

[0089] Table 3 Traditional Chinese Medicine Symptom Integral Scale

[0090]

[0091]

[0092] Using the traditional Chinese medicine composition of the present application, its influence on the Traditional Chinese Medicine symptom integral scale of obese people with spleen-kidney yang deficiency is shown in Table 4 below.

[0093] Table 4 Influence of the Traditional Chinese Medicine Composition on the Traditional Chinese Medicine Symptom Integral Scale of Obese People with Spleen-Kidney Yang Deficiency

[0094]

[0095] Note: * There was a significant difference compared with the control group, P < 0.05.

[0096] After taking the traditional Chinese medicine composition of the present application for 4 weeks, the Traditional Chinese Medicine symptom scores of the subjects in the experimental group were significantly lower than those in the control group (P < 0.05), indicating that the traditional Chinese medicine composition of the present application can significantly relieve the Traditional Chinese Medicine symptoms of obese people with spleen-kidney yang deficiency.

[0097] 5.2 Weight Loss Situation

[0098] Using the traditional Chinese medicine composition of the present application, its influence on the weight loss situation of obese people with spleen-kidney yang deficiency is shown in Table 5 below, and the weight loss situation is represented by the weight loss compliance rate.

[0099] Table 5 Influence of the Traditional Chinese Medicine Composition on the Weight Loss Situation of Obese People with Spleen-Kidney Yang Deficiency

[0100]

[0101] Note: 1. Refer to the "Expert Consensus on Weight Management for Overweight or Obese People" [1] The weight loss compliance standards are divided into two situations: compliance: weight loss percentage > 5%; non-compliance: weight loss percentage < 5%.

[0102] 2. [1] Zeng Qiang, Yang Yuexin, Jia Weiping, et al. Expert consensus and group standard on weight management for overweight or obese people [J]. Chinese Journal of Health Management, 2018, 12(03): 200-207.

[0103] As can be seen from Table 5, after taking the traditional Chinese medicine composition of the present application for 4 weeks, the weight loss compliance rate of the experimental group was significantly higher than that of the control group (P < 0.05), and the weight loss compliance rate of the experimental group was 29.66% higher than that of the control group.

[0104] 5.3 Body composition indicators

[0105] Body composition indicators include weight, waist circumference, hip circumference, waist-hip ratio, skeletal muscle, body fat, BMI, and visceral fat area; waist-hip ratio = waist circumference / hip circumference; BMI = weight (kg) / height (m 2 ). Using the traditional Chinese medicine composition of the present application, its effects on the body composition indicators of obese people with spleen-kidney yang deficiency are shown in Table 6 below.

[0106] Table 6 Effects of the traditional Chinese medicine composition on the body composition indicators of obese people with spleen-kidney yang deficiency

[0107]

[0108] Note: * There was a significant difference compared with the control group, P < 0.05.

[0109] After taking the traditional Chinese medicine composition of the present application for 4 weeks, the weight and visceral fat area of the subjects were not significantly reduced compared with the control group (P > 0.05), but the waist circumference, hip circumference, waist-hip ratio, body fat, and BMI of the subjects in the experimental group were lower than before taking, and were significantly lower than those of the control group (P < 0.05). The skeletal muscle content of the subjects increased compared with before taking, and was significantly higher than that of the control group (P < 0.05). Therefore, the traditional Chinese medicine composition of the present application can improve the body composition indicators of obese people with spleen-kidney yang deficiency.

[0110] 5.4 Blood lipid components

[0111] Blood lipid components mainly include total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C). Using the traditional Chinese medicine composition of the present application, its effects on the blood lipid components of obese people with spleen-kidney yang deficiency are shown in Table 7 below.

[0112] Table 7 Effects of the traditional Chinese medicine composition on the blood lipid components of obese people with spleen-kidney yang deficiency

[0113]

[0114] Note: *There was a significant difference compared with the control group, P < 0.05.

[0115] As can be seen from Table 7, after taking the traditional Chinese medicine composition of the present application for 4 weeks, the contents of TG and LDL-C were significantly decreased compared with the control group (P < 0.05), and the content of HDL-C was significantly increased compared with the control group (P < 0.05).

[0116] 5.5 Inflammatory indicators

[0117] The occurrence of obesity is related to the content of inflammatory factors in the body, and the inflammation caused by it is one of the processes of the development of many chronic diseases. Tumor necrosis factor-α (TNF-α) is mainly secreted by adipocytes and macrophages infiltrating into adipose tissue. The larger the adipocytes, the more TNF-α is secreted. TNF-α can cause adipocytes to release monocyte chemoattractant protein-1 and free fatty acids, promoting the progression of inflammation and obesity. The level of TNF-α in obese people is significantly higher than that in people with normal body weight. In the present application, TNF-α was taken as an example to analyze the effect of the traditional Chinese medicine composition on the inflammatory indicators of obese people with spleen-kidney yang deficiency. The effect of the traditional Chinese medicine composition of the present application on the inflammatory indicators of obese people with spleen-kidney yang deficiency is shown in Table 8 below.

[0118] Table 8 Effect of the traditional Chinese medicine composition on the inflammatory indicators of obese people with spleen-kidney yang deficiency

[0119]

[0120] Note: * There was a significant difference compared with the control group, P < 0.05.

[0121] As can be seen from Table 8, after the subjects took the traditional Chinese medicine composition for 4 weeks, the content of tumor necrosis factor-α in the body was decreased compared with that before taking, and was significantly decreased compared with the control group (P < 0.05). Therefore, the traditional Chinese medicine composition of the present application can significantly improve the inflammatory state in the body of obese people with spleen-kidney yang deficiency.

[0122] In summary, the traditional Chinese medicine composition of the present application can significantly reduce the degree of obesity of obese people with spleen-kidney yang deficiency, improve the health status of obese people with spleen-kidney yang deficiency, and has the effect of reducing fat and increasing muscle. Therefore, the traditional Chinese medicine composition of the present application has a good effect in the application of preparing drugs for treating obesity with spleen-kidney yang deficiency.

[0123] The preferred embodiments of the present application have been described in detail above. However, the present application is not limited to the specific details in the above embodiments. Within the scope of the technical concept of the present application, various simple modifications can be made to the technical solutions of the present application, and these simple modifications all belong to the protection scope of the present application.

[0124] In addition, it should be noted that, among the various specific technical features described in the above specific embodiments, without conflict, they can be combined in any suitable way. To avoid unnecessary repetition, this application will not separately describe various possible combination methods.

[0125] In addition, any combination can be made among various different embodiments of this application, as long as it does not violate the idea of this application, and it should also be regarded as the content disclosed in this invention.

Claims

1. Traditional Chinese medicine composition, characterized in that, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 10 parts - 60 parts of aconite root, 20 parts - 100 parts of amomum villosum, 50 parts - 150 parts of raw licorice root, 50 parts - 160 parts of turtle shell stir-fried with vinegar, 50 parts - 160 parts of stir-fried atractylodes macrocephala, 90 parts - 450 parts of poria with hostwood, 20 parts - 160 parts of cassia twig, 50 parts - 160 parts of turmeric, and 10 parts - 70 parts of cinnamon.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 20 parts - 60 parts of aconite root, 30 parts - 90 parts of amomum villosum, 60 parts - 140 parts of raw licorice root, 60 parts - 150 parts of turtle shell stir-fried with vinegar, 60 parts - 150 parts of stir-fried atractylodes macrocephala, 120 parts - 400 parts of poria with hostwood, 30 parts - 160 parts of cassia twig, 60 parts - 150 parts of turmeric, and 20 parts - 70 parts of cinnamon.

3. The traditional Chinese medicine composition according to claim 2, characterized in that, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 20 parts - 50 parts of aconite root, 40 parts - 80 parts of amomum villosum, 60 parts - 130 parts of raw licorice root, 60 parts - 130 parts of turtle shell stir-fried with vinegar, 60 parts - 130 parts of stir-fried atractylodes macrocephala, 150 parts - 300 parts of poria with hostwood, 40 parts - 140 parts of cassia twig, 60 parts - 130 parts of turmeric, and 20 parts - 60 parts of cinnamon.

4. The traditional Chinese medicine composition according to claim 3, characterized in that, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 30 parts - 40 parts of aconite root, 50 parts - 70 parts of amomum villosum, 70 parts - 120 parts of raw licorice root, 70 parts - 120 parts of turtle shell stir-fried with vinegar, 70 parts - 120 parts of stir-fried atractylodes macrocephala, 170 parts - 250 parts of poria with hostwood, 50 parts - 130 parts of cassia twig, 70 parts - 120 parts of turmeric, and 30 parts - 50 parts of cinnamon.

5. A pharmaceutical preparation, which is prepared from the traditional Chinese medicine composition according to any one of claims 1 - 4 and auxiliary materials.

6. The pharmaceutical preparation according to claim 5, characterized in that, the auxiliary materials comprise at least one of honey, sucrose, xylitol, maltose and starch.

7. The pharmaceutical preparation according to claim 6, characterized in that, the sucrose is at least one of rock sugar, white sugar and brown sugar.

8. The pharmaceutical preparation according to claim 5, characterized in that, the dosage form of the pharmaceutical preparation comprises pills, powders, plasters, granules, capsules or decoctions.

9. Use of the traditional Chinese medicine composition according to any one of claims 1 - 4 in the preparation of a drug for improving obesity of spleen-kidney yang deficiency type.

10. Use of the pharmaceutical preparation according to claim 5 or 6 or 7 or 8 in the preparation of a drug for improving obesity of spleen-kidney yang deficiency type.

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