Traditional Chinese medicine composition for treating simple obesity

Abstract

The invention relates to the technical field of traditional Chinese medicine compositions, and discloses a traditional Chinese medicine composition for treating simple obesity, which is prepared from the following components in parts by weight: 8 to 12 parts of lotus leaf, 25 to 32 parts of exocarpium benincasae, 25 to 32 parts of radix astragali seu hedysari, 58 to 63 parts of gypsum, 8 to 12 parts of rhizoma zingiberis, 25 to 32 parts of radix polygonati officinalis, 25 to 32 parts of concha arcae, 25 to 32 parts of pericarpium arecae, 12 to 17 parts of pericarpium trichosanthis and 8 to 12 parts of cassia twig. 25-32 parts of salvia miltiorrhiza and 8-12 parts of gynostemma pentaphylla. According to the traditional Chinese medicine composition provided by the invention, all the components are coordinated and compatible to regulate qi and blood, yin and yang, cold and heat, deficiency and excess, jointly achieve the effects of strengthening the spleen, inhibiting the stomach, resolving dampness and promoting the circulation of qi, have a remarkable curative effect on the simple obesity, and particularly explore a treatment thought of strengthening the spleen and inhibiting the stomach for the simple obesity; and a new progress of treating simple obesity by traditional Chinese medicine is achieved.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating simple obesity. Background Art

[0002] Simple Obesity is a chronic metabolic disease characterized by excessive accumulation of body fat without obvious endocrine and metabolic disease etiologies. Obesity is often closely related to insulin resistance, chronic low-grade inflammatory state, polycystic ovary syndrome, etc., and is a risk factor for diseases such as diabetes, cardiovascular and cerebrovascular diseases, and non-alcoholic fatty liver disease. For the management of simple obesity, lifestyle intervention, drug treatment, and surgical treatment are currently the main methods.

[0003] Lifestyle intervention is the first-line treatment plan. Weight loss is achieved through personalized diet plans such as energy-restricted balanced diets, regular exercise combining aerobic and resistance training, and behavior modification, thereby improving metabolic indicators and reducing the risk of complications. In terms of drug treatment, according to the mechanism of action, it can be divided into central appetite suppressants, gastrointestinal lipase inhibitors, and hypoglycemic drugs with weight loss effects, such as GLP-1 receptor agonists, orlistat, etc. However, most current Western anti-obesity drugs have problems such as side effects and high prices. Surgical treatments such as sleeve gastrectomy are invasive treatment methods, which are costly and have risks such as bile reflux and nutritional deficiency. Currently, the guidelines recommend that this method be used only in cases where lifestyle and weight loss drug interventions are not satisfactory and the patient can tolerate the surgery itself. In addition, when treating obesity, the patient's age, comorbidities, and fertility needs need to be taken into account, and its systematic prevention and control is of great significance for improving the overall health outcome. Summary of the Invention

[0004] To improve the above technical problems, the present invention provides a traditional Chinese medicine composition for treating simple obesity. The traditional Chinese medicine composition comprises the following components in parts by weight:

[0005] 8 - 12 parts of lotus leaf, 25 - 32 parts of wax gourd peel, 25 - 32 parts of astragalus membranaceus, 58 - 63 parts of gypsum, 8 - 12 parts of dried ginger, 25 - 32 parts of polygonatum odoratum, 25 - 32 parts of arcae concha, 25 - 32 parts of areca peel, 12 - 17 parts of trichosanthis peel, 8 - 12 parts of cinnamon twig, 25 - 32 parts of salvia miltiorrhiza, and 8 - 12 parts of gynostemma pentaphyllum.

[0006] According to an embodiment of the present invention, the traditional Chinese medicine composition comprises the following components in parts by weight:

[0007] 8 - 10 parts of lotus leaf, 28 - 30 parts of wax gourd peel, 28 - 30 parts of astragalus root, 58 - 60 parts of gypsum, 8 - 10 parts of dried ginger, 27 - 30 parts of polygonatum odoratum, 27 - 30 parts of armoured concha, 28 - 30 parts of areca peel, 12 - 15 parts of trichosanthes peel, 8 - 10 parts of cassia twig, 28 - 30 parts of salvia miltiorrhiza and 8 - 10 parts of gynostemma pentaphyllum.

[0008] According to an embodiment of the present invention, the traditional Chinese medicine composition comprises the following components in parts by weight:

[0009] 10 parts of lotus leaf, 30 parts of wax gourd peel, 30 parts of astragalus root, 60 parts of gypsum, 10 parts of dried ginger, 30 parts of polygonatum odoratum, 30 parts of armoured concha, 30 parts of areca peel, 15 parts of trichosanthes peel, 10 parts of cassia twig, 30 parts of salvia miltiorrhiza and 10 parts of gynostemma pentaphyllum.

[0010] According to an embodiment of the present invention, the traditional Chinese medicine composition comprises the following components in parts by weight:

[0011] 8 - 12 g of lotus leaf, 25 - 32 g of wax gourd peel, 25 - 32 g of astragalus root, 58 - 63 g of gypsum, 8 - 12 g of dried ginger, 25 - 32 g of polygonatum odoratum, 25 - 32 g of armoured concha, 25 - 32 g of areca peel, 12 - 17 g of trichosanthes peel, 8 - 12 g of cassia twig, 25 - 32 g of salvia miltiorrhiza and 8 - 12 g of gynostemma pentaphyllum.

[0012] According to an embodiment of the present invention, the traditional Chinese medicine composition comprises the following components in parts by weight:

[0013] 8 - 10 g of lotus leaf, 28 - 30 g of wax gourd peel, 28 - 30 g of astragalus root, 58 - 60 g of gypsum, 8 - 10 g of dried ginger, 27 - 30 g of polygonatum odoratum, 27 - 30 g of armoured concha, 28 - 30 g of areca peel, 12 - 15 g of trichosanthes peel, 8 - 10 g of cassia twig, 28 - 30 g of salvia miltiorrhiza and 8 - 10 g of gynostemma pentaphyllum.

[0014] According to an embodiment of the present invention, the traditional Chinese medicine composition comprises the following components in parts by weight:

[0015] 10 g of lotus leaf, 30 g of wax gourd peel, 30 g of astragalus root, 60 g of gypsum, 10 g of dried ginger, 30 g of polygonatum odoratum, 30 g of armoured concha, 30 g of areca peel, 15 g of trichosanthes peel, 10 g of cassia twig, 30 g of salvia miltiorrhiza, 10 g of gynostemma pentaphyllum.

[0016] According to an embodiment of the present invention, the traditional Chinese medicine composition further comprises a pharmaceutically acceptable excipient or carrier.

[0017] According to an embodiment of the present invention, the excipient or carrier includes one or several of diluents, excipients, fillers, binders, disintegrants, surfactants and lubricants.

[0018] According to an embodiment of the present invention, the dosage forms of the traditional Chinese medicine composition include: injection, oral preparation, and external preparation.

[0019] According to an embodiment of the present invention, the oral preparation is a granule, powder, pill or solution.

[0020] According to an embodiment of the present invention, the dosage of the traditional Chinese medicine composition is one dose per day, each dose being 300 mL - 500 mL (for example, 150 mL), and taken in 2 - 3 divided doses.

[0021] Explanation of the formula: In the formula, gypsum clears and purges stomach fire; trichosanthes peel clears heat and resolves phlegm, widens the chest and disperses binds, and its bitter and cold nature helps gypsum clear and drain stomach heat. Astragalus membranaceus invigorates the spleen and benefits qi; gynostemma pentaphyllum clears heat, strengthens the spleen and tonifies deficiency, and the two enhance the transportation and transformation function of the spleen, promoting the transformation and distribution of water and grain essence. Lotus leaf and wax gourd peel promote diuresis and reduce swelling, enhancing the power of promoting diuresis and percolating dampness; areca peel promotes qi movement in the middle energizer and promotes diuresis and reduces swelling, assisting in the excretion of water and dampness. Cinnamon twig warms and dredges the meridians, helps yang transform qi; salvia miltiorrhiza promotes blood circulation and removes stasis; the two are used together with warming and dredging and promoting blood circulation. Polygonatum odoratum nourishes yin and moistens dryness, preventing the damage of yin fluid by heat-clearing and purging fire and warming and dredging drugs. Dry ginger warms the middle-jiao and dispels cold, preventing the damage of the yang qi of the spleen and stomach by the cold drugs in the formula. Concha arcae suppresses acid and relieves pain, preventing excessive gastric acid secretion caused by gypsum and protecting the stomach qi. The whole formula together exerts the effects of strengthening the spleen qi, suppressing the stomach qi, resolving phlegm turbidity, promoting blood circulation, removing water and dampness, and lightening the body.

[0022] The present invention also provides a preparation method of the above traditional Chinese medicine composition, which includes the following steps:

[0023] Prepare each traditional Chinese medicine according to parts by weight, mix, and decoct with water to obtain the traditional Chinese medicine composition.

[0024] According to an embodiment of the present invention, each dose is decocted with water to 300 mL - 500 mL.

[0025] The present invention also provides the use of the above traditional Chinese medicine composition in the preparation of a drug for treating simple obesity.

[0026] Beneficial effects

[0027] The present invention provides a traditional Chinese medicine composition, which can significantly reduce the body mass index of patients with simple obesity, decrease the leptin level, increase the adiponectin level, and have no obvious adverse reactions.

[0028] The traditional Chinese medicine composition provided by the present invention coordinates and combines various components to regulate qi, blood, yin, yang, cold, heat, deficiency and excess, and together exerts the effects of strengthening the spleen and suppressing the stomach, resolving dampness and promoting qi movement, and has a significant curative effect on the treatment of simple obesity. In particular, a treatment idea for strengthening the spleen and suppressing the stomach for simple obesity has been explored, achieving new progress in the traditional Chinese medicine treatment of simple obesity. Specific embodiments

[0029] The technical solution of the present invention will be further described in detail below in conjunction with specific embodiments. It should be understood that the following embodiments are only for illustrative and explanatory purposes of the present invention, and should not be construed as limiting the protection scope of the present invention. All technologies implemented based on the above content of the present invention are covered within the scope of protection intended by the present invention.

[0030] Unless otherwise specified, the raw materials and reagents used in the following examples are all commercially available products, or can be prepared by known methods.

[0031] Example 1

[0032] A decoction of a traditional Chinese medicine composition (Spleen-Strengthening and Stomach-Regulating Decoction), weigh the following weights of each traditional Chinese medicine raw material: 10 g of lotus leaf, 30 g of wax gourd peel, 30 g of astragalus membranaceus, 60 g of gypsum, 10 g of dried ginger, 30 g of polygonatum odoratum, 30 g of armoured concha, 30 g of greater abdominal skin, 15 g of trichosanthes peel, 10 g of cassia twig, 30 g of salvia miltiorrhiza, 10 g of gynostemma pentaphyllum; after mixing the above components of the traditional Chinese medicine raw materials, soak them in normal water for half an hour, boil them over high heat and then simmer for 30 minutes, and warm and take 150 mL before breakfast, lunch and dinner.

[0033] Example 2 Clinical Trial Example

[0034] 1. Clinical Data

[0035] 1.1 Case Source

[0036] Adult simple obesity patients who visited the outpatient and inpatient departments of the Endocrinology Department of Wuhan Traditional Chinese Medicine Hospital from July 2022 to June 2023.

[0037] 1.2 Diagnostic Criteria

[0038] The diagnostic criteria for obesity are as follows: Obesity BMI ≥ 28 kg / m 2 , and the waist circumference is waist circumference ≥ 90 cm for men and waist circumference ≥ 85 cm for women. And exclude obesity caused by endocrine and metabolic diseases.

[0039] 1.3 Inclusion Criteria

[0040] Meet the above diagnostic criteria for simple obesity;

[0041] Gender is not limited, age ≥ 18 years old and ≤ 60 years old;

[0042] Can accept exercise and diet therapy;

[0043] Voluntarily accept and cooperate with this trial, and those who give informed consent.

[0044] Complete at least 2 / 3 of the medication course, and the medication amount is at least 80%.

[0045] 1.4 Exclusion Criteria

[0046] Those who are in a severe stress state, or combined with severe infection, severe liver and kidney function impairment, or combined with severe heart and lung diseases and malignant tumors; those who do not cooperate with the experiment.

[0047] 1.5 Criteria for excluding cases

[0048] Those found not to meet the inclusion criteria after inclusion; those treated with surgery; those who did not receive treatment according to the research protocol after inclusion; those who interrupted treatment on their own without the permission of the researcher.

[0049] 1.6 Criteria for drop - out cases

[0050] Those who have serious adverse events, develop complications and are not suitable to continue the trial; those who withdraw on their own or do not complete the whole course of treatment, affecting the judgment of efficacy or safety; those who meet the inclusion criteria but do not complete the study for some reason; those who become pregnant during treatment.

[0051] 2. Research design method

[0052] Trial design: Using a random number table, the experimental subjects were randomly and equally divided into 2 groups. Both groups were given basic treatment, that is, diet control and appropriate exercise. The control group was given subcutaneous injection of liraglutide on this basis; the experimental group was given the oral administration of the traditional Chinese medicine of the present invention on this basis, and the treatment time was 12 weeks.

[0053] Sample size: According to the actual situation of this study, a small - sample clinical study was planned. Finally, 42 patients were included in the experimental group and 43 patients were included in the control group.

[0054] 3. Treatment method

[0055] Experimental group: Treated for 12 weeks. On the basis of diet control and appropriate exercise, the traditional Chinese medicine decoction was taken warm three times a day. The water - decocted preparation of the traditional Chinese medicine composition in Example 1 was taken orally.

[0056] Control group: Treated for 12 weeks. On the basis of diet control and appropriate exercise, subcutaneous injection of liraglutide was given (that is, Victoza (liraglutide injection, Novo Nordisk A / S, Denmark, registration number S20110046)). Treatment started at a dose of 0.6 mg per day for 1 week, and then the dose was increased weekly until the maximum tolerated dose or 3.0 mg dose (the highest allowed dose) was reached.

[0057] 4. Observation indicators

[0058] Course of treatment and follow - up:

[0059] General physical examinations and detection of glycolipid metabolism indexes were carried out on the two groups of patients before treatment and 12 weeks after treatment, and the observation indicators were recorded. According to the detection of the incidence of adverse reactions, none of the patients withdrew from the trial due to adverse reactions.

[0060] 5. Clinical trial results

[0061] The clinical trial results of the two groups of patients are shown in Table 1.

[0062] Table 1 Clinical trial results

[0063]

[0064] 5.1 Experimental group VS control group

[0065] Before treatment, there were no statistically significant differences in body mass index (experimental group: 31.07 ± 2.25 kg / m 2 and control group: 30.96 ± 2.21 kg / m 2 , P = 0.821), leptin level (experimental group: 6.36 ± 1.17 ng / mL and control group: 6.51 ± 1.25 ng / mL, P = 0.570), and adiponectin level (experimental group: 4.01 ± 0.46 mg / L and control group: 3.87 ± 0.42 mg / L, p = 0.146) between the two groups of patients.

[0066] After treatment, the body mass index of the experimental group was lower than that of the control group (experimental group: 26.85 ± 1.71 kg / m 2 and control group: 28.03 ± 1.96 kg / m 2 , P = 0.004); the leptin level of the experimental group was lower than that of the control group (experimental group: 2.87 ± 0.61 ng / mL and control group: 3.79 ± 0.84 ng / mL, P < 0.001); the adiponectin level of the experimental group was higher than that of the control group (experimental group: 6.53 ± 0.74 mg / L and control group: 5.49 ± 0.67 mg / L, P < 0.001).

[0067] 5.2 Conclusion

[0068] By comparing the experimental group with the control group, it can be seen that the traditional Chinese medicine composition Jianpi Yiwei Decoction of the present invention can significantly reduce the body mass index of patients, lower the leptin level, increase the adiponectin level, and have no obvious adverse reactions.

[0069] The above describes the embodiments of the present invention. However, the present invention is not limited to the above embodiments. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principle of the present invention shall be included within the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating simple obesity, comprising the following components in parts by weight: 8-12 parts of lotus leaves, 25-32 parts of wax gourd peels, 25-32 parts of astragalus, 58-63 parts of gypsum, 8-12 parts of dried ginger, 25-32 parts of polygonatum, 25-32 parts of corrugated seeds, 25-32 parts of tangerine peels, 12-17 parts of trichosanthes peels, 8-12 parts of cassia twigs, 25-32 parts of salvia miltiorrhiza and 8-12 parts of gynostemma pentaphyllum.

2. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition comprises the following components in parts by weight: 8-10 parts of lotus leaf, 28-30 parts of wax gourd peel, 28-30 parts of astragalus, 58-60 parts of gypsum, 8-10 parts of dried ginger, 27-30 parts of polygonatum, 27-30 parts of corrugated seeds, 28-30 parts of tangerine peel, 12-15 parts of trichosanthes peel, 8-10 parts of cassia twig, 28-30 parts of salvia miltiorrhiza and 8-10 parts of gynostemma pentaphyllum; Preferably, the Chinese medicine composition comprises the following components in parts by weight: 10 parts of lotus leaves, 30 parts of wax gourd peels, 30 parts of astragalus, 60 parts of gypsum, 10 parts of dried ginger, 30 parts of polygonatum, 30 parts of corrugated seeds, 30 parts of tangerine peels, 15 parts of trichosanthes peels, 10 parts of cassia twigs, 30 parts of salvia miltiorrhiza and 10 parts of gynostemma pentaphyllum.

3. The Chinese medicine composition according to claim 1, characterized in that The Chinese medicine composition comprises the following components in parts by weight: Lotus leaf 8-12g, wax gourd peel 25-32g, astragalus 25-32g, gypsum 58-63g, dried ginger 8-12g, polygonatum 25-32g, corrugated fruit 25-32g, tangerine peel 25-32g, trichosanthes peel 12-17g, cinnamon twig 8-12g, salvia miltiorrhiza 25-32g and gynostemma pentaphyllum 8-12g.

4. The Chinese medicine composition according to claim 3, characterized in that: The Chinese medicine composition comprises the following components in parts by weight: Lotus leaf 8-10g, wax gourd peel 28-30g, astragalus 28-30g, gypsum 58-60g, dried ginger 8-10g, polygonatum 27-30g, corrugated seeds 27-30g, tangerine peel 28-30g, trichosanthes peel 12-15g, cassia twig 8-10g, salvia miltiorrhiza 28-30g and gynostemma pentaphyllum 8-10g; Preferably, the Chinese medicine composition comprises the following components in parts by weight: Lotus leaf 10g, wax gourd peel 30g, astragalus 30g, gypsum 60g, dried ginger 10g, polygonatum 30g, corrugated fruit 30g, tangerine peel 30g, trichosanthes peel 15g, cinnamon twig 10g, salvia miltiorrhiza 30g, and Gynostemma pentaphyllum 10g.

5. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition further includes pharmaceutically acceptable excipients or carriers.

6. The Chinese medicine composition according to claim 5, characterized in that: The auxiliary materials or carriers include one or more of diluents, excipients, fillers, binders, disintegrants, surfactants and lubricants.

7. The Chinese medicine composition according to claim 1, characterized in that: The dosage forms of the Chinese medicine composition include: injection, oral preparation, and external preparation; Preferably, the oral preparation is granules, powders, pills or solutions.

8. The Chinese medicine composition according to claim 1, characterized in that: The dosage of the Chinese medicine composition is one dose per day, each dose is 300mL-500mL, and is taken in 2-3 times.

9. A method for preparing the Chinese medicine composition according to any one of claims 1 to 8, comprising the following steps: Prepare the Chinese medicines according to weight, mix them, add water and boil them to obtain the Chinese medicine composition.

10. Use of the Chinese medicine composition according to any one of claims 1 to 8 in preparing a medicament for treating simple obesity.

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