Traditional Chinese medicine composition for treating metabolic syndrome

Abstract

The invention relates to a traditional Chinese medicine composition for treating metabolic syndrome. The traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 120-200 parts of liquorice, 50-150 parts of rheum officinale, 30-100 parts of bighead atractylodes rhizome, 30-100 parts of alum, 30-100 parts of radix sophorae flavescentis, 30-100 parts of curcuma zedoary, 30-100 parts of fried pericarpium citri reticulatae, 30-100 parts of compound of glauber-salt and liquorice and 3-10 parts of muskmelon pedicel. The traditional Chinese medicine preparation is easy to operate, economical, applicable, safe, reliable, few in adverse reaction, remarkable in curative effect on treating metabolic syndrome and improving obesity indexes, good in patient compliance and wide in application range.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine, and specifically to a traditional Chinese medicine composition for treating metabolic syndrome. Background Technology

[0002] Metabolic syndrome (MS) is a general term describing a group of cardiovascular diseases characterized by central obesity, hypertension, insulin resistance (IR), dyslipidemia leading to type 2 diabetes mellitus (T2DM), and atherosclerotic cardiovascular disease. Metabolic syndrome has a genetic predisposition, is associated with different types of genetic polymorphisms, and is a heterogeneous disease. It coexists with numerous risk factors, such as abdominal obesity, atherosclerotic dyslipidemia, elevated blood pressure, prethrombotic and pro-inflammatory states, IR, and hyperglycemia. These factors are associated with an increased risk of developing chronic diseases, such as T2DM and cardiovascular disease.

[0003] In recent years, metabolic syndrome has become a global problem. Although the prevalence of metabolic syndrome varies across different regions, sexes, and age groups, it is generally high and continues to rise.

[0004] Existing multi-target chemotherapy drugs carry risks associated with combined drug use. For example, combining statins with hypoglycemic agents increases the risk of liver damage, and single-target drugs struggle to address multiple pathological aspects such as insulin resistance, lipid metabolism disorders, and inflammatory responses. Furthermore, long-term use can place a heavy burden on the liver and kidneys; clinical statistics show that approximately 38% of patients discontinue treatment due to side effects from Western medicines.

[0005] Traditional Chinese medicine (TCM) lacks a complete and specific discussion of metabolic syndrome, with most practitioners categorizing it under "spleen-related diseases," "obesity," or "spleen deficiency." Based on the disease's evolution, the causes of metabolic syndrome are summarized as overeating and lack of physical activity, emotional distress, congenital deficiencies, and old age with prolonged illness. Traditional formulas often focus on single syndrome types (such as simply resolving or eliminating phlegm), while complex formulas typically contain more than ten herbs, leading to poor controllability of the effective components. Therefore, there is an urgent clinical need to develop a TCM composition that combines significant efficacy in treating metabolic syndrome with low side effects. Summary of the Invention

[0006] To solve the above-mentioned technical problems, the present invention includes the following aspects: The first aspect of the present invention provides a traditional Chinese medicine composition for treating metabolic syndrome, the traditional Chinese medicine composition being prepared from licorice, rhubarb, atractylodes macrocephala, alum, sophora flavescens, turmeric, tangerine peel, sodium sulfate, and melon stalk.

[0007] Preferably, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 120-200 parts by weight of licorice, 50-150 parts by weight of rhubarb, 30-100 parts by weight of atractylodes macrocephala, 30-100 parts by weight of alum, 30-100 parts by weight of sophora flavescens, 30-100 parts by weight of turmeric, 30-100 parts by weight of stir-fried tangerine peel, 30-100 parts by weight of sodium sulfate, and 3-10 parts by weight of melon stalk.

[0008] More preferably, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 150-190 parts by weight of licorice, 80-120 parts by weight of rhubarb, 50-90 parts by weight of atractylodes macrocephala, 50-90 parts by weight of alum, 50-90 parts by weight of sophora flavescens, 50-90 parts by weight of turmeric, 50-90 parts by weight of stir-fried tangerine peel, 50-90 parts by weight of sodium sulfate, and 5-9 parts by weight of melon stalk.

[0009] More preferably, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 160-180 parts licorice, 90-110 parts rhubarb, 60-80 parts Atractylodes macrocephala, 60-80 parts alum, 60-80 parts Sophora flavescens, 60-80 parts Curcuma zedoaria, 60-80 parts stir-fried tangerine peel, 60-80 parts sodium sulfate, and 6-8 parts melon stalk.

[0010] Most preferably, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 170 parts licorice, 100 parts rhubarb, 70 parts atractylodes macrocephala, 70 parts alum, 70 parts sophora flavescens, 70 parts turmeric, 70 parts stir-fried tangerine peel, 70 parts sodium sulfate, and 7 parts melon stalk.

[0011] Preferably, the traditional Chinese medicine composition further includes pharmaceutically acceptable excipients.

[0012] Preferably, the traditional Chinese medicine composition is an oral preparation.

[0013] Preferably, the dosage form of the traditional Chinese medicine composition is tablets, granules, pills, powders, or decoctions. More preferably, the dosage form of the traditional Chinese medicine composition is pills.

[0014] The second aspect of the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition, the method comprising the following steps: taking the prescribed amounts of licorice, rhubarb, atractylodes macrocephala, alum, sophora flavescens, turmeric, tangerine peel, sodium sulfate, and melon stalk; first, pulverizing each herb into coarse powder; then mixing the coarse powders of each herb and pulverizing them into fine powder; passing the powder through a 100-mesh sieve; adding an appropriate amount of water to make pills; and drying the pills to obtain the final product.

[0015] Preferably, each pill weighs 0.05-0.15g. More preferably, each pill weighs 0.08-0.12g. Even more preferably, each pill weighs 0.1g.

[0016] A third aspect of the present invention provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicament for treating metabolic syndrome.

[0017] A fourth aspect of the present invention provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicament that reduces the levels of glucose metabolism indicators and / or lipid metabolism indicators.

[0018] Preferably, the glucose metabolism indicators are fasting blood glucose (FBG) and fasting serum insulin (FINS).

[0019] Preferably, the lipid metabolism indicators are triglycerides (TG) and total cholesterol (TC).

[0020] The common pharmacological effects of the traditional Chinese medicine raw materials selected in this invention in this field are as follows: Licorice: It is neutral in nature and sweet in taste, and enters the heart, stomach, spleen, and lung meridians. Licorice tonifies the spleen and replenishes qi, relieves cough and eliminates phlegm, alleviates spasms and pain, and harmonizes the properties of other herbs. It is used to treat spleen and stomach weakness, insufficient qi, cough and asthma, carbuncles and boils, abdominal cramps and pain, and to moderate the harshness of other herbs. It also has anti-inflammatory, anti-ulcer, anti-cancer, antibacterial, antiviral, and immune-regulating effects.

[0021] Rhubarb: Cold in nature, bitter in taste, and enters the spleen, stomach, large intestine, liver, and pericardium meridians. Rhubarb has the effects of purging heat and relieving constipation, cooling blood and detoxifying, and removing blood stasis and promoting menstruation. Clinically, it is used to treat constipation due to excess heat, abdominal pain due to stagnation, incomplete diarrhea, jaundice due to damp heat, hematemesis due to blood heat, red eyes, sore throat, intestinal abscesses and boils, amenorrhea due to blood stasis, and traumatic injuries. Externally, it is used to treat burns and scalds, and upper gastrointestinal bleeding.

[0022] Atractylodes macrocephala: Bitter and sweet in taste, warm in nature, and enters the spleen and stomach meridians. Atractylodes macrocephala has the effects of strengthening the spleen and replenishing qi, drying dampness and promoting diuresis, stopping sweating, and calming the fetus. It is used for spleen deficiency with poor appetite, abdominal distension and diarrhea, phlegm retention with dizziness and palpitations, edema, spontaneous sweating, and threatened abortion.

[0023] Alum: It is cold in nature, sour and astringent in taste, and enters the lung, spleen, and liver meridians. Alum has the effects of drying dampness and relieving itching, detoxifying and killing insects, stopping bleeding and diarrhea, and resolving phlegm. When applied externally, it can relieve eczema, scabies, and skin ulcers by astringing and drying dampness to reduce exudation and inhibit pathogenic bacteria.

[0024] Sophora flavescens: It is cold in nature and bitter in taste, and enters the heart, liver, stomach, large intestine, and bladder meridians. Sophora flavescens has the effects of clearing heat and drying dampness, killing parasites, and promoting diuresis. Clinically, it is used to treat dysentery, hematochezia, jaundice and urinary retention, leukorrhea, vulvar swelling and itching, eczema, damp sores, pruritus, scabies, and leprosy.

[0025] Curcuma zedoaria: bitter and pungent in taste, warm in nature. Curcuma zedoaria is mainly used to treat stagnation of qi and blood, abdominal distension and pain, masses, accumulations, indigestion, amenorrhea due to blood stasis in women, and pain from falls and injuries. It has the effects of promoting qi circulation, relieving depression, breaking up blood stasis, and relieving pain.

[0026] Dried tangerine peel: bitter and pungent in taste, warm in nature, and enters the lung and spleen meridians. Dried tangerine peel regulates qi and strengthens the spleen, dries dampness and resolves phlegm, and is used to treat chest and abdominal distension, poor appetite, vomiting and diarrhea, and cough with excessive phlegm.

[0027] Glauber's salt: salty, bitter, and cold in nature. Glauber's salt can clear heat from the stomach and intestines, relieve constipation, abdominal distension and pain, and is used to treat sore throat, mouth ulcers, and red and swollen eyes caused by excessive heat and toxins.

[0028] Sweet melon stalk: bitter in taste and cold in nature, it enters the spleen, stomach, and liver meridians. Sweet melon stalk can induce vomiting of phlegm and food, remove dampness and reduce jaundice. It is used to treat stroke, epilepsy, sore throat, excessive phlegm, difficulty breathing, indigestion, chest and abdominal distension and pain, and damp-heat jaundice.

[0029] The traditional Chinese medicine composition of this invention uses licorice and atractylodes macrocephala as the principal herbs, which mainly tonify the spleen and replenish qi, and strengthen the spleen and eliminate dampness. Rhubarb and alum are used as the assistant herbs to clear the bowels and eliminate turbidity, and cleanse the intestines. Sophora flavescens and turmeric are used as the assistant herbs to clear heat, dry dampness, break up blood stasis and promote blood circulation. Tangerine peel and sodium sulfate are added as adjuvant herbs to regulate qi, soften hardness and dissipate nodules. Melon stalk is used as the guiding herb to assist in overall metabolic regulation. The combination of these herbs forms a scientific formula that combines metabolic regulation and safety.

[0030] The technical effects of this invention are as follows: Based on extensive screening experiments, this invention has obtained a traditional Chinese medicine composition with excellent therapeutic effects on metabolic syndrome by optimizing the components and proportions of the traditional Chinese medicine. The traditional Chinese medicine preparation of this invention is simple to prepare, economical, safe, reliable, and has few adverse reactions. It is significantly effective in treating metabolic syndrome and improving obesity indicators, has good patient compliance, and a wide range of applications. Detailed Implementation

[0031] Example 1 Weigh out 170g of licorice root, 100g of rhubarb, 70g of atractylodes macrocephala, 70g of alum, 70g of sophora flavescens, 70g of turmeric, 70g of stir-fried tangerine peel, 70g of sodium sulfate, and 7g of melon stalk. First, grind each herb into coarse powder. Then, mix the coarse powders of each herb together and grind them into fine powder. Pass the powder through a 100-mesh sieve, add an appropriate amount of water to make pills with a single pill weight of 0.1g, and dry them to obtain the herbal pill 1 of this invention.

[0032] Example 2 Weigh out 170g of licorice root, 70g of rhubarb, 100g of atractylodes macrocephala, 70g of alum, 70g of sophora flavescens, 70g of turmeric, 70g of stir-fried tangerine peel, 70g of sodium sulfate, and 7g of melon stalk. First, grind each herb into coarse powder. Then, mix the coarse powders of each herb together and grind them into fine powder. Pass the powder through a 100-mesh sieve, add an appropriate amount of water to make pills with a single pill weight of 0.1g, and dry them to obtain the Chinese herbal pill 2 of this invention.

[0033] Example 3 Weigh out 170g of licorice, 70g of rhubarb, 70g of atractylodes macrocephala, 100g of alum, 70g of sophora flavescens, 70g of turmeric, 70g of stir-fried tangerine peel, 70g of sodium sulfate, and 7g of melon stalk. First, grind each herb into coarse powder. Then, mix the coarse powders of each herb together and grind them into fine powder. Pass the powder through a 100-mesh sieve, add an appropriate amount of water to make pills with a single pill weight of 0.1g, and dry them to obtain the herbal pill 3 of this invention.

[0034] Example 4 Weigh out 170g of licorice, 70g of rhubarb, 70g of atractylodes macrocephala, 70g of alum, 100g of sophora flavescens, 70g of turmeric, 70g of stir-fried tangerine peel, 70g of sodium sulfate, and 7g of melon stalk. First, grind each herb into coarse powder. Then, mix the coarse powders of each herb and grind them into fine powder. Pass the powder through a 100-mesh sieve, add an appropriate amount of water to make pills with a single pill weight of 0.1g, and dry them to obtain the herbal pills of this invention 4.

[0035] Comparative Example 1 (Rhubarb replaced with Polygonum cuspidatum) Weigh out 170g of licorice root, 100g of Polygonum cuspidatum, 70g of Atractylodes macrocephala, 70g of alum, 70g of Sophora flavescens, 70g of Curcuma zedoaria, 70g of stir-fried tangerine peel, 70g of sodium sulfate, and 7g of melon stalk. First, grind each herb into coarse powder. Then, mix the coarse powders of each herb together and grind them into fine powder. Pass the powder through a 100-mesh sieve, add an appropriate amount of water to make pills with a single pill weight of 0.1g, and dry them to obtain the comparative proportion Chinese medicine pill 1.

[0036] Comparative Example 2 (Atractylodes macrocephala replaced with Coix lacryma-jobi) Weigh out 170g of licorice root, 100g of rhubarb, 70g of coix seed, 70g of alum, 70g of sophora flavescens, 70g of turmeric, 70g of stir-fried tangerine peel, 70g of sodium sulfate, and 7g of cantaloupe stalk. First, grind each herb into coarse powder. Then, mix the coarse powders of each herb together and grind them into fine powder. Pass the powder through a 100-mesh sieve, add an appropriate amount of water to make pills with a single pill weight of 0.1g, and dry them to obtain the comparative proportion Chinese medicine pill 2.

[0037] Experimental Example 1: The therapeutic effect of the traditional Chinese medicine composition of the present invention on a rat model of metabolic syndrome. 1. Test Methods Eighty male SD rats were randomly divided into a blank control group (n=10) and a model group (n=70). The blank control group was fed a normal diet, while the model group was fed a high-sugar, high-salt, and high-fat diet (47% breeding feed, 18.9% lard, 1.3% cholesterol, 0.3% bile salts, 14% sucrose, 8.7% casein, 5% salt, 1.8% premix, and 3% maltodextrin; normal diet: moisture ≤10%, crude protein ≥20.5%, crude fat ≥4%, crude fiber ≤5%, crude ash ≤8%, calcium 1.0%-1.8%, total phosphorus 0.6%-1.2%, lysine ≥1.32%, methionine + cystine ≥0.78%). The rats were fed this diet for 12 weeks to establish a rat model of metabolic syndrome.

[0038] After modeling, rats were randomly divided into 7 groups: the model group, groups 1-4 of this invention, and groups 1-2 of comparative examples, with 10 rats in each group. Rats in groups 1-4 of this invention and groups 1-2 of comparative examples were administered the pills prepared in groups 1-4 of this invention and groups 1-2 of comparative examples by gavage at a dose of 10 g / kg body weight daily (the pills were dispersed in an appropriate amount of physiological saline before gavage). The blank control group and the model group were administered the same dose of physiological saline daily. Each experimental group was administered the medication once a day for 6 consecutive weeks. During the administration period, rats in the blank control group continued to be fed a normal diet, while rats in the other experimental groups continued to be fed the above-mentioned high-sugar, high-salt, and high-fat diet.

[0039] Twelve hours after the last administration, rats in each experimental group were anesthetized by intraperitoneal injection of 10% chloral hydrate (at a dose of 0.3 ml / 100 g). Once the rats were anesthetized, the abdominal cavity was dissected, and blood samples were collected via the abdominal aorta. 5 ml of blood was collected from each rat and stored in a standard blood collection tube. After standing for 2 hours, the tube was centrifuged at 3000 rpm for 15 minutes at 4°C. Serum was then separated, and the serum from each blood collection tube was aspirated using a 200 μL pipette and placed into a 1.5 ml EP tube, which was stored at -80°C for later use.

[0040] The effects of the traditional Chinese medicine of this invention on glucose and lipid metabolism indicators in rats of different experimental groups were investigated. Fasting blood glucose (FBG) was measured using a blood glucose meter according to the operating instructions. Fasting serum insulin (FINS) was measured using an insulin ELISA kit according to the kit's instructions. Triglycerides (TG) and total cholesterol (TC) were measured according to the methods described in the respective kits' instructions.

[0041] 2. Test Results The levels of FBG and FINS in rats of each experimental group after administration of the traditional Chinese medicine composition of the present invention are shown in Table 1 below.

[0042] Table 1. Effects of the traditional Chinese medicine composition of the present invention on glucose metabolism indicators in rats with metabolic syndrome. As shown in Table 1 above, compared with the blank control group, the FBG and FINS levels of rats in the model group were significantly increased. Compared with the model group and comparative groups 1-2, the FBG and FINS levels of rats in Examples 1-4 of this invention were significantly decreased (with statistical differences). It is worth noting that, under the same total amount of traditional Chinese medicine administered, the reduction in FBG and FINS levels in rats in Example 1 of this invention was the most significant, producing an unexpectedly excellent effect.

[0043] The levels of TG and TC in rats of each experimental group after administration of the traditional Chinese medicine composition of the present invention are shown in Table 2 below.

[0044] Table 2. Effects of the herbal composition of the present invention on lipid metabolism in rats with metabolic syndrome. As shown in Table 2 above, compared with the blank control group, the levels of TG and TC in the model group rats were significantly increased. Compared with the model group and comparative groups 1-2, the levels of TG and TC in the rats of Examples 1-4 of this invention were significantly decreased (with statistical differences). The above experimental results indicate that the traditional Chinese medicine composition of this invention is expected to have good therapeutic effects on metabolic syndrome in clinical practice.

[0045] Although specific embodiments of the invention have been described, those skilled in the art will recognize that various changes and modifications can be made to the invention without departing from its scope or spirit. Therefore, the invention is intended to cover all such changes and modifications falling within the scope of the appended claims and their equivalents.

Claims

1. A traditional Chinese medicine composition for treating metabolic syndrome, characterized in that, The traditional Chinese medicine composition is prepared from licorice, rhubarb, atractylodes macrocephala, alum, sophora flavescens, turmeric, tangerine peel, sodium sulfate, and melon stalk.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 120-200 parts licorice, 50-150 parts rhubarb, 30-100 parts Atractylodes macrocephala, 30-100 parts alum, 30-100 parts Sophora flavescens, 30-100 parts Curcuma zedoaria, 30-100 parts stir-fried tangerine peel, 30-100 parts sodium sulfate, and 3-10 parts melon stalk.

3. The traditional Chinese medicine composition according to claim 2, characterized in that, The traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 150-190 parts licorice, 80-120 parts rhubarb, 50-90 parts Atractylodes macrocephala, 50-90 parts alum, 50-90 parts Sophora flavescens, 50-90 parts Curcuma zedoaria, 50-90 parts stir-fried tangerine peel, 50-90 parts sodium sulfate, and 5-9 parts melon stalk.

4. The traditional Chinese medicine composition according to claim 3, characterized in that, The traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 160-180 parts licorice, 90-110 parts rhubarb, 60-80 parts Atractylodes macrocephala, 60-80 parts alum, 60-80 parts Sophora flavescens, 60-80 parts Curcuma zedoaria, 60-80 parts stir-fried tangerine peel, 60-80 parts sodium sulfate, and 6-8 parts melon stalk.

5. The traditional Chinese medicine composition according to claim 4, characterized in that, The traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 170 parts licorice, 100 parts rhubarb, 70 parts atractylodes macrocephala, 70 parts alum, 70 parts sophora flavescens, 70 parts turmeric, 70 parts stir-fried tangerine peel, 70 parts sodium sulfate, and 7 parts melon stalk.

6. The traditional Chinese medicine composition according to any one of claims 1-5, characterized in that, The traditional Chinese medicine composition further includes pharmaceutically acceptable excipients.

7. The traditional Chinese medicine composition according to claim 6, characterized in that, The traditional Chinese medicine composition is an oral preparation.

8. The traditional Chinese medicine composition according to claim 1, characterized in that, The dosage form of the traditional Chinese medicine composition is tablets, granules, pills, powders, or decoctions.

9. A method for preparing the traditional Chinese medicine composition according to any one of claims 1-8, characterized in that, The preparation method includes the following steps: take the prescribed amounts of licorice, rhubarb, atractylodes macrocephala, alum, sophora flavescens, turmeric, tangerine peel, sodium sulfate and melon stalk, first crush each herb into coarse powder, then mix the coarse powder of each herb evenly and crush it into fine powder, pass it through a 100-mesh sieve, add an appropriate amount of water to make pills, dry them, and the product is obtained.

10. The use of the traditional Chinese medicine composition according to any one of claims 1-8 in the preparation of a medicament for treating metabolic syndrome.

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