Traditional Chinese medicine composition for treating glycolipid metabolic disease and preparation method thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating glycolipid metabolic diseases and a preparation method thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15-19 parts of coptis chinensis, 10-15 parts of rhodiola rosea, 10-20 parts of gynostemma pentaphylla, 9-12 parts of kapok, 10-15 parts of soapberry, 9-15 parts of salvia miltiorrhiza, 10-15 parts of rhizoma alismatis, 9-12 parts of oriental wormwood, 9-12 parts of radix bupleuri, 5-10 parts of semen cassiae, 10-15 parts of rhizoma anemarrhenae, 10-15 parts of hawthorn, 6-9 parts of polygonum cuspidatum and 5-10 parts of fructus aurantii. The traditional Chinese medicine composition disclosed by the invention has the effects of inhibiting hyperlipidemia, hyperglycemia and hepatic lipid accumulation and relieving insulin resistance, and has a remarkable curative effect on relieving and treating glycolipid metabolic diseases.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and in particular, relates to a traditional Chinese medicine composition for treating glucose and lipid metabolism diseases and a preparation method thereof. Background Art

[0002] Glucolipid metabolic disease (GLMD) is a disease characterized by disordered sugar and lipid metabolism. It is affected by multiple factors such as genetics, environment, and mental health. Its main clinical manifestations are single or combined hyperglycemia, dyslipidemia, fatty liver, overweight, hypertension, and atherosclerosis. With the improvement of people's quality of life and excessive intake of high-fat and high-sugar diets, its incidence rate has been increasing year by year, and the age of onset has also begun to become younger. Glucolipid metabolic disease often exists in patients with metabolic syndrome. Metabolic syndrome is a group of clinical syndromes that are characterized by obesity, hyperglycemia (diabetes or impaired glucose regulation), dyslipidemia (referring to hypertriglyceridemia and / or low HDL-C blood), and hypertension, which seriously affect the health of the body. It is a combination of metabolically interrelated risk factors. These factors directly promote the occurrence of atherosclerotic cardiovascular disease and increase the risk of type 2 diabetes.

[0003] Currently, the drugs on the market for the treatment of GLMD, such as insulin, glinides, metformin, statins, etc., focus on lowering blood sugar and blood lipid levels, and there is no ideal solution to the fundamental problem of excess calories accumulated in the patient's body. Therefore, it is urgent and necessary to find safe and effective drugs for the prevention and treatment of GLMD. Summary of the invention

[0004] The purpose of the present invention is to provide a Chinese medicine composition for treating glucose and lipid metabolism diseases and a preparation method thereof, so as to achieve effective treatment of glucose and lipid metabolism diseases.

[0005] To this end, the present invention provides the following technical solutions.

[0006] One aspect of the present invention provides a traditional Chinese medicine composition for treating glucose and lipid metabolism diseases. The raw materials for preparing the traditional Chinese medicine composition include, by weight, 15-19 parts of coptis chinensis, 10-15 parts of rhodiola rosea, 10-20 parts of gynostemma pentaphyllum, 9-12 parts of kapok, 10-15 parts of soapberry, 9-15 parts of salvia miltiorrhiza, 10-15 parts of oriental water plantain, 9-12 parts of capillaris, 9-12 parts of bupleurum, 5-10 parts of cassia seed, 10-15 parts of anemarrhena, 10-15 parts of hawthorn, 6-9 parts of polygonum cuspidatum, and 5-10 parts of fructus aurantii.

[0007] In a preferred embodiment of the present invention, the raw materials for preparing the traditional Chinese medicine composition include, by weight: 17 parts of Coptis chinensis, 10 parts of Rhodiola rosea, 15 parts of Gynostemma pentaphyllum, 10 parts of Kapok flower, 12 parts of Sapindus mukorossi, 12 parts of Salvia miltiorrhiza, 13 parts of Alisma orientalis, 10 parts of Artemisia capillaris, 9 parts of Bupleurum chinense, 8 parts of Cassia seed, 13 parts of Anemarrhena asphodeloides, 10 parts of Crataegus pinnatifida, 7 parts of Polygonum cuspidatum, and 5 parts of Citrus aurantium.

[0008] The second aspect of the present invention provides a medicine for treating glucose and lipid metabolism diseases, comprising the above-mentioned traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0009] In a preferred embodiment of the present invention, the auxiliary material is selected from one or more of fillers, emulsifiers, disintegrants, preservatives, bases, lubricants, suspending agents, binders, sweeteners, and flavoring agents.

[0010] In a preferred embodiment of the present invention, the dosage form of the drug is decoction, granules, pills, powders, tablets, capsules, drops, suspensions, syrups, mixtures, tinctures, ointments, inhalants or injections.

[0011] In a preferred embodiment of the present invention, the preparation method of the decoction is: S1: taking each raw material according to weight, soaking it in water, and obtaining a mixture; S2: boiling the obtained mixture for the first time, and then filtering it to obtain a first medicinal solution and a first filter residue; S3: adding water to the obtained first filter residue for a second decoction, and then filtering to obtain a second medicinal solution and a second filter residue; S4: combining the first medicinal liquid and the second medicinal liquid to obtain the decoction.

[0012] In a preferred embodiment of the present invention, in step S1, The amount of water added is 4 to 6 times the total mass of each raw material; The soaking time is 15 to 20 minutes.

[0013] In a preferred embodiment of the present invention, in step S2, the first decoction method is: first use high heat 220-230° C. to boil, and then use low heat 160-170° C. to continue boiling for 20-30 minutes.

[0014] In a preferred embodiment of the present invention, in step S3, The amount of water added should be 2~3cm above the medicine surface; The second decoction method is: first use high heat 220-230° C. to boil, and then use low heat 160-170° C. to continue boiling for 15-25 minutes.

[0015] The third aspect of the present invention provides an application of the traditional Chinese medicine composition as described above or the medicine as described above in the preparation of a medicine for treating glycolipid metabolism diseases.

[0016] Usage and dosage: Taking the decoction prepared by the above method as an example, it is taken twice a day, 200 ml each time.

[0017] Explanation of the formula: In the present invention, Cordyceps sinensis and Astragalus membranaceus are used as the monarch drugs; Polygonatum sibiricum Red. var. kingianum (Coll. et Hemsl.) Hoo & Tsai, Rhodiola rosea, Ephedra sinica Stapf honey-fried, Armeniaca vulgaris Lam. var. ansu (Maxim.) Yü & Lu bitter almond stir-fried, Lepidium apetalum Willd., Aster tataricus L. f. honey-fried, Perilla frutescens (L.) Britt. var. acuta (Thunb.) Kudo stir-fried are used as the minister drugs; Ginkgo biloba L. seeds and Pheretima aspergillum (E. Perrier) are used as the assistant drugs; Glycyrrhiza uralensis Fisch. is used as the guiding drug.

[0018] Monarch drugs Coptis chinensis Franch.: Scientific name: Coptis chinensis (plants of the genus Coptis), medicinal part: rhizome, nature and flavor and meridian tropism: bitter, cold; attributing to the heart, spleen, stomach, liver, gallbladder, and large intestine meridians. Main components: berberine (berberine), coptisine, methylcoptisine and other alkaloids. It has the effects of lowering blood sugar and regulating blood lipids. At the same time, it also has the effects of clearing the excess fire of the heart and stomach, treating high fever, restlessness, mouth sores, gum swelling and pain, etc.

[0019] Rhodiola rosea L.: Scientific name: Rhodiola rosea (Rhodiola of the family Crassulaceae). Medicinal part: root and rhizome. Nature and flavor and meridian tropism: sweet, astringent, cold; attributing to the lung and heart meridians. Main active components: salidroside, tyrosol, flavonoids, polysaccharides, etc. It has the effects of improving the tolerance of the body to hypoxia, scavenging free radicals, protecting cells, and delaying aging. At the same time, it also has the effects of regulating blood pressure, improving myocardial blood supply, preventing high altitude heart disease, and helping to improve glucose metabolism and lipid abnormalities.

[0020] Gynostemma pentaphyllum (Thunb.) Makino: Scientific name: Gynostemma pentaphyllum (Gynostemma of the family Cucurbitaceae). Medicinal part: whole herb (leaves, stems). Nature and flavor and meridian tropism: sweet, slightly bitter, cool; attributing to the lung, spleen, and kidney meridians. Main active components: gypenosides (similar to ginsenosides), polysaccharides, flavonoids. It has the effects of enhancing immunity, antioxidant, anti-aging, protecting the liver and reducing enzymes. At the same time, it also has the effects of regulating blood lipids, protecting the cardiovascular system, and regulating blood sugar.

[0021] Minister drugs Bombax ceiba L.: Scientific name: Bombax ceiba (Bombax of the family Malvaceae). Medicinal part: flower (most commonly used), bark, root. Nature and flavor and meridian tropism: flower - sweet, light, cool; attributing to the large intestine meridian. Main components: the flower contains flavonoids, polysaccharides; the bark contains tannins, alkaloids. It has the effects of clearing heat and promoting diuresis, detoxifying and stopping bleeding. At the same time, it also has the effects of antibacterial and anti-inflammatory. There is currently no report on its use in the treatment of glycolipid metabolism diseases.

[0022] Sapindus mukorossi: Scientific name: Sapindus mukorossi (Sapindus, Sapindaceae). Medicinal parts: pericarp, seeds, roots. Nature and flavor, and meridian tropism: bitter, pungent, slightly cold; attributing to the lung, stomach, and large intestine meridians. Main components: Pericarp: sapindus saponins (natural surfactants); Seeds: oils (for making soap or lubricating oil); Roots and leaves: flavonoids, tannins. It has the effects of clearing heat and detoxifying, resolving phlegm and relieving cough, etc. There is currently no report on its use in the treatment of glycolipid metabolism diseases.

[0023] Salvia miltiorrhiza: Scientific name: Salvia miltiorrhiza (Salvia, Lamiaceae). Medicinal part: dried roots and rhizomes. Nature and flavor, and meridian tropism: bitter, slightly cold; attributing to the heart and liver meridians. Main active components: Lipid-soluble components: tanshinone IIA, cryptotanshinone (antibacterial and anti-inflammatory); Water-soluble components: salvianolic acid B (antioxidant, protecting blood vessels). It has the effects of promoting blood circulation to remove blood stasis, dissipating swelling and relieving pain, etc. It also has the effects of cardiovascular protection, antioxidant, and anti-tumor.

[0024] Alisma plantago-aquatica: Scientific name: Alisma plantago-aquatica (Alisma, Alismataceae). Medicinal part: rhizomes (dug in autumn, removing fibrous roots and dried in the sun). Nature and flavor, and meridian tropism: sweet, light, cold; attributing to the kidney and bladder meridians. Main components: alisol, polysaccharides, volatile oils, choline, etc. It has the effects of promoting diuresis and percolating dampness, clearing away damp-heat, etc. It also has the effects of reducing blood lipid: reducing serum cholesterol and triglycerides, reducing blood sugar: improving insulin resistance, and protecting the kidneys.

[0025] Artemisia capillaris: Scientific name: Artemisia capillaris (Artemisia, Asteraceae). Medicinal part: seedlings (harvested in spring) or whole plants. Nature and flavor, and meridian tropism: bitter, pungent, slightly cold; attributing to the spleen, stomach, liver, and gallbladder meridians. Main components: volatile oils (β-pinene, capillene), flavonoids (capillarisin), coumarins (6,7-dimethoxycoumarin). It has the effects of promoting diuresis to reduce jaundice, clearing heat and detoxifying. It also has the effects of promoting bile secretion, protecting the liver, and anti-fibrosis.

[0026] Bupleurum chinense: Scientific name: Bupleurum chinense (Bupleurum, Apiaceae). Medicinal part: dried roots (Bupleurum chinense DC.) or whole plants (Bupleurum scorzonerifolium Willd.). Nature and flavor, and meridian tropism: bitter, pungent, slightly cold; attributing to the liver, gallbladder, and lung meridians. Main components: bupleurum saponins (a, b, c, d, etc.), volatile oils (saikohol), and flavonoids. It has the effects of reconciling shaoyang, soothing the liver and relieving depression, lifting yang qi, etc. It also has the effects of antiviral, anti-inflammatory, regulating immunity, protecting the liver and promoting bile secretion, etc.

[0027] Adjuvant drug Cassia Seed: Scientific name: Cassia obtusifolia (Cassia genus, Leguminosae). Medicinal part: Mature seeds. Flavor and Meridian Tropism: Sweet, bitter, salty, slightly cold; attributing to the Liver and Large Intestine Meridians. Main components: Anthraquinones (chrysophanol, emodin), naphthopyranones (cassiaside), fatty acids (palmitic acid, linoleic acid). It has the effects of clearing the liver and improving eyesight, moistening the intestines and promoting defecation, etc. It also has the functions of lowering blood pressure, reducing blood lipid and antioxidant.

[0028] Anemarrhena Rhizome: Scientific name: Anemarrhena asphodeloides (Anemarrhena genus, Liliaceae). Medicinal part: Rhizome (dug in spring and autumn). Flavor and Meridian Tropism: Bitter, sweet, cold; attributing to the Lung, Stomach and Kidney Meridians. Main components: Saponins (anemarrhena saponins), flavonoids (mangiferin), polysaccharides. It has the effects of clearing heat and purging fire, nourishing yin and moistening dryness, etc. It also has the functions of lowering blood sugar (increasing insulin sensitivity), anti-inflammatory (inhibiting NF-κB pathway), etc.

[0029] Hawthorn Fruit: Scientific name: Crataegus pinnatifida (Crataegus genus, Rosaceae). Medicinal part: Mature fruit (preferably the northern hawthorn). Flavor and Meridian Tropism: Sour, sweet, slightly warm; attributing to the Spleen, Stomach and Liver Meridians. Main components: Organic acids (citric acid, malic acid), flavonoids (hyperoside, quercetin), triterpenoids (ursolic acid). It has the effects of promoting digestion and resolving food stagnation, promoting blood circulation and removing blood stasis. It also has the functions of reducing blood lipid, lowering blood pressure, strengthening the heart and antioxidant.

[0030] Adjuvant Drug Japanese Knotweed Rhizome: Scientific name: Reynoutria japonica (Reynoutria genus, Polygonaceae, former genus name Polygonum). Medicinal part: Rhizome and root. Flavor and Meridian Tropism: Slightly bitter, slightly cold; attributing to the Liver, Gallbladder and Lung Meridians. Main components: Anthraquinones (emodin, chrysophanol) → laxative and antibacterial, stilbenes (resveratrol) → antioxidant, flavonoids (polydatin) → protecting cardiovascular. It has the effects of promoting diuresis and reducing jaundice, detumescence and pain relief, promoting blood circulation and removing blood stasis, etc. It also has the functions of antiviral, reducing blood lipid and anti-tumor, etc.

[0031] Fructus Aurantii Immaturus: Flavor and Meridian Tropism: Bitter, pungent, sour, slightly cold; attributing to the Spleen and Stomach Meridians. Main components: Volatile oils (limonene, linalool), flavonoids (hesperidin, naringin) and alkaloids (synephrine). It has the effects of regulating qi and widening the middle, promoting qi movement and relieving distension, resolving phlegm and relieving stuffiness, etc.

[0032] By the above technical solutions, the present invention has at least the following advantages: In the traditional Chinese medicine composition of the present invention, the combined effects of each component far exceed the effects of single drugs. In the present invention, Coptis chinensis, Rhodiola rosea, and Gynostemma pentaphyllum are used as the monarch drugs, Bombax ceiba, Sapindus mukorossi, Salvia miltiorrhiza, Alisma orientale, Artemisia capillaris, and Bupleurum chinense are used as the minister drugs, Cassia obtusifolia, Anemarrhena asphodeloides, and Crataegus pinnatifida are used as the assistant drugs, and Polygonum cuspidatum and Aurantii Fructus Immaturus are used as the messenger drugs to harmonize all the drugs, so that the obtained traditional Chinese medicine preparation has the effects of rapid onset, high cure rate, and low recurrence rate. At the same time, it can inhibit hyperlipidemia, hyperglycemia, hepatic lipid accumulation, and relieve insulin resistance, and has a significant effect on relieving and treating glycolipid metabolic diseases.

[0033] Through the scientific compatibility of traditional Chinese medicine raw materials, the present invention can effectively relieve the clinical symptoms of patients with abnormal glycolipid metabolism, including but not limited to symptoms such as inhibiting hyperlipidemia, hyperglycemia, hepatic lipid accumulation, and relieving insulin resistance. The traditional Chinese medicine composition of the present invention has no toxic and side effects and has many advantages such as good curative effect, rapid onset, strong drug effect, and low recurrence rate in the treatment of glycolipid metabolic diseases.

[0034] The above description is only an overview of the technical solution of the present invention. In order to understand the technical means of the present invention more clearly and implement it according to the content of the specification, the following describes the preferred embodiments of the present invention in detail. Detailed Description of the Invention

[0035] In order to make the technical means, creative features, achieved purposes, and effects of the present invention easy to understand, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

[0036] Unless otherwise specified, the experimental methods used in the following embodiments are all conventional methods.

[0037] Unless otherwise specified, the materials, reagents, etc. used in the following embodiments can all be obtained from commercial channels.

[0038] Unless otherwise specified, the strong fire mentioned in the following embodiments refers to the fire with a temperature between 220 and 230 °C, and the slow fire refers to the fire with a temperature between 160 and 170 °C.

[0039] The traditional Chinese medicine composition for treating glycolipid metabolism diseases provided by the present invention mainly targets the clinical symptoms of patients with glycolipid metabolism diseases, such as abnormal glucose tolerance, hyperglycemia, insulin level, insulin resistance index, etc. The traditional Chinese medicine composition is prepared by combining drugs such as Coptis chinensis, Rhodiola rosea, Gynostemma pentaphyllum, Bombax ceiba, Sapindus mukorossi, Salvia miltiorrhiza, Alisma orientale, Artemisia capillaris, Bupleurum chinense, Cassia obtusifolia, Anemarrhena asphodeloides, Crataegus pinnatifida, Polygonum cuspidatum, and Fructus Aurantii. The prescription is formulated from the perspective of syndrome differentiation and treatment, that is, diagnosing and treating from multiple dimensions such as zang-fu organs, exterior-interior, cold-heat, deficiency-excess, etc., and combining traditional Chinese medicine thinking, paying attention to treating both the exterior and interior simultaneously and regulating qi movement. In the prescription, Coptis chinensis, Rhodiola rosea, and Gynostemma pentaphyllum are used as the monarch drugs to regulate blood sugar and blood lipids and relieve insulin resistance. Bombax ceiba, Sapindus mukorossi, Salvia miltiorrhiza, Alisma orientale, Artemisia capillaris, and Bupleurum chinense are used as the minister drugs to further enhance the power of replenishing qi and nourishing yin and strengthening the healthy qi; Cassia obtusifolia and Anemarrhena asphodeloides are used as the assistant drugs to regulate qi and relieve distension and improve immunity.

[0040] Example 1: Preparation of Traditional Chinese Medicine Decoction I Raw material composition of the traditional Chinese medicine composition: 17 g of Coptis chinensis, 10 g of Rhodiola rosea, 15 g of Gynostemma pentaphyllum, 10 g of Bombax ceiba, 12 g of Sapindus mukorossi, 12 g of Salvia miltiorrhiza, 13 g of Alisma orientale, 10 g of Artemisia capillaris, 9 g of Bupleurum chinense, 8 g of Cassia obtusifolia, 13 g of Anemarrhena asphodeloides, 10 g of Crataegus pinnatifida, 7 g of Polygonum cuspidatum, and 5 g of Fructus Aurantii.

[0041] Accurately weigh the above raw material components and put them into a casserole. Add water to the casserole and soak for 30 minutes to obtain a mixture. Conduct the first decoction on the obtained mixture, that is: first bring to a boil with strong fire and then heat with gentle fire for 30 minutes. After the temperature drops slightly, filter to obtain the first medicinal liquid and the first residue. Add water to the obtained first residue until it is 2 - 3 cm higher than the drug surface for the second decoction, that is: first bring to a boil with strong fire and then heat with gentle fire for 20 minutes. After the temperature drops slightly, filter to obtain the second medicinal liquid. Put the first medicinal liquid and the second medicinal liquid obtained from the above two decoctions into the same container to obtain about 400 ml of traditional Chinese medicine decoction in total. Finally, sterilize the prepared traditional Chinese medicine decoction, fill it into a container and seal it, and store it in the refrigerator. It should be noted that the above-prepared traditional Chinese medicine decoction is the daily dosage for one patient, and more traditional Chinese medicine decoctions can be prepared in multiple pots and / or multiple times according to the number of patients and the number of days of taking.

[0042] Example 2: Preparation of Traditional Chinese Medicine Decoction II Raw material composition of the traditional Chinese medicine composition: 15 g of Coptis chinensis, 15 g of Rhodiola rosea, 10 g of Gynostemma pentaphyllum, 9 g of Bombax ceiba, 10 g of Sapindus mukorossi, 15 g of Salvia miltiorrhiza, 10 g of Alisma orientale, 12 g of Artemisia capillaris, 10 g of Bupleurum chinense, 5 g of Cassia obtusifolia, 15 g of Anemarrhena asphodeloides, 13 g of Crataegus pinnatifida, 6 g of Polygonum cuspidatum, and 8 g of Fructus Aurantii.

[0043] The preparation method is the same as that in Example 1 and will not be elaborated here.

[0044] Example 3: Preparation of Traditional Chinese Medicine Decoction III Raw material composition of the traditional Chinese medicine composition: 19 g of Coptis chinensis, 10 g of Rhodiola rosea, 20 g of Gynostemma pentaphyllum, 12 g of Bombax ceiba, 15 g of Sapindus mukorossi, 9 g of Salvia miltiorrhiza, 15 g of Alisma orientale, 9 g of Artemisia capillaris, 12 g of Bupleurum chinense, 10 g of Cassia obtusifolia, 10 g of Anemarrhena asphodeloides, 15 g of Crataegus pinnatifida, 9 g of Polygonum cuspidatum, 10 g of Aurantii Fructus Immaturus.

[0045] The preparation method is the same as that of Example 1 and will not be elaborated here.

[0046] Example 4: Preparation of traditional Chinese medicine decoction IV Raw material composition of the traditional Chinese medicine composition: 16 g of Coptis chinensis, 14 g of Rhodiola rosea, 12 g of Gynostemma pentaphyllum, 9 g of Bombax ceiba, 11 g of Sapindus mukorossi, 9 g of Salvia miltiorrhiza, 10 g of Alisma orientale, 10 g of Artemisia capillaris, 9 g of Bupleurum chinense, 5 g of Cassia obtusifolia, 15 g of Anemarrhena asphodeloides, 10 g of Crataegus pinnatifida, 9 g of Polygonum cuspidatum, 10 g of Aurantii Fructus Immaturus.

[0047] The preparation method is the same as that of Example 1 and will not be elaborated here.

[0048] Example 5: Preparation of traditional Chinese medicine decoction V Raw material composition of the traditional Chinese medicine composition: 18 g of Coptis chinensis, 12 g of Rhodiola rosea, 18 g of Gynostemma pentaphyllum, 10 g of Bombax ceiba, 14 g of Sapindus mukorossi, 10 g of Salvia miltiorrhiza, 11 g of Alisma orientale, 12 g of Artemisia capillaris, 11 g of Bupleurum chinense, 9 g of Cassia obtusifolia, 13 g of Anemarrhena asphodeloides, 13 g of Crataegus pinnatifida, 7 g of Polygonum cuspidatum, 6 g of Aurantii Fructus Immaturus.

[0049] The preparation method is the same as that of Example 1 and will not be elaborated here.

[0050] Example 6: Preparation of traditional Chinese medicine decoction VI Raw material composition of the traditional Chinese medicine composition: 17 g of Coptis chinensis, 10 g of Rhodiola rosea, 15 g of Gynostemma pentaphyllum, 10 g of Bombax ceiba, 12 g of Sapindus mukorossi, 12 g of Salvia miltiorrhiza, 13 g of Alisma orientale, 10 g of Artemisia capillaris, 9 g of Bupleurum chinense, 8 g of Cassia obtusifolia, 13 g of Anemarrhena asphodeloides, 10 g of Crataegus pinnatifida, 7 g of Polygonum cuspidatum, 5 g of Aurantii Fructus Immaturus.

[0051] Accurately weigh the above raw material components and put them into a casserole. Add 1000 mL of water to the casserole, soak for 20 minutes to obtain a mixture. Conduct the first decoction on the obtained mixture, that is: first bring to a boil with strong fire and then heat with gentle fire for 25 minutes. After the temperature drops slightly, filter to obtain the first medicinal liquid and the first residue. Add water to the obtained first residue to a height 2 - 3 cm above the drug surface for the second decoction, that is: first bring to a boil with strong fire and then heat with gentle fire for 15 minutes. After the temperature drops slightly, filter to obtain the second medicinal liquid. Put the first medicinal liquid and the second medicinal liquid obtained from the above two decoctions into the same container to obtain approximately 400 milliliters of traditional Chinese medicine decoction in total. Finally, sterilize the prepared traditional Chinese medicine decoction, fill it and seal it, and store it in the refrigerator. It should be noted that the above-prepared traditional Chinese medicine decoction is the dosage for one patient in a day, and more traditional Chinese medicine decoctions can be prepared in multiple pots and / or multiple times according to the number of patients and the number of days of taking.

[0052] Add 5 g of oat β-glucan and 1 g of astragalus polysaccharide to the obtained 400 mL of traditional Chinese medicine decoction, stir evenly to obtain traditional Chinese medicine decoction VI.

[0053] Comparative Example 1: Preparation of Traditional Chinese Medicine Decoction 1 The only difference between this comparative example and Example 1 is that: rhodiola rosea is not added, and the rest is the same as in Example 1.

[0054] Comparative Example 2: Preparation of Traditional Chinese Medicine Decoction 2 The only difference between this comparative example and Example 1 is that: kapok is not added, and the rest is the same as in Example 1.

[0055] Comparative Example 3: Preparation of Traditional Chinese Medicine Decoction 3 The only difference between this comparative example and Example 1 is that: sapindus mukorossi is not added, and the rest is the same as in Example 1.

[0056] Comparative Example 4: Preparation of Traditional Chinese Medicine Decoction 4 The only difference between this comparative example and Example 1 is that: kapok and sapindus mukorossi are not added, and the rest is the same as in Example 1.

[0057] Comparative Example 5: Preparation of Traditional Chinese Medicine Decoction 5 The only difference between this comparative example and Example 1 is that: rhodiola rosea, kapok and sapindus mukorossi are not added, and the rest is the same as in Example 1.

[0058] Comparative Example 6: Preparation of Traditional Chinese Medicine Decoction 6 The only difference between this comparative example and Example 6 is that: oat β-glucan is not added, and the rest is the same as in Example 1.

[0059] Comparative Example 7: Preparation of Traditional Chinese Medicine Decoction 7 The only difference between this comparative example and Example 6 is that Astragalus polysaccharide was not added, and the rest was the same as in Example 1.

[0060] Experiment 1: Effects of Different Traditional Chinese Medicine Decoctions on Glucose and Lipid Metabolism in Diet-Induced Model Mice C57 / BJ6 male mice were induced to develop glucose and lipid metabolism disorders by a high-sugar and high-fat diet. At the same time, the above-mentioned traditional Chinese medicine decoctions prepared in the examples were fed to the mice, and TG, TC, LDL-C, HDL-C in the mouse serum, TG and TC in the liver tissue, fasting blood glucose, and oral glucose tolerance (OGTT) were detected to evaluate the effects of different traditional Chinese medicine decoctions on mouse blood lipids, liver lipids, blood glucose, and insulin resistance. The specific steps are as follows: 1.1 Construction of Model Mice Animal source: 8-week-old C57 / BJ6 male mice, from Shandong University of Traditional Chinese Medicine. Animal culture conditions: Raised in a SPF-level animal house; temperature: 22 - 24 °C; humidity: 45 - 80%; illumination: 150 - 300 Lx, 12-hour day-night alternation. Their feeding, administration, and euthanasia were all strictly carried out in accordance with the guidance of animal experiments and welfare (referring to the Shandong Regulations on the Administration of Laboratory Animals).

[0061] First, C57BL / 6J mice were raised in a SPF-level animal house. After one week of adaptive domestication, they were randomly divided into two groups - a normal group (control, 10 mice) and a model group (160 mice). At the same time, the following treatments were carried out on each group: Normal group: Fed with normal common feed; Model group: Fed with a high-sugar and high-fat diet (the high-fat diet was 60 kcal% Fat, and the high sugar was given in the form of drinking water, and the sugar water formula was: 5% glucose, 17% fructose).

[0062] After 8 weeks of feeding, the mice were fasted for 12 h. The normal group mice were intraperitoneally injected with the same dose of citric acid - sodium citrate buffer (pH = 4.2 - 4.5), and the model group mice were intraperitoneally injected with 30 mg / kg STZ (citric acid - sodium citrate buffer) for three consecutive days. After 7 days, the blood glucose value was measured. When the blood glucose value of the model group mice was ≥ 11.1 mmol / L, it was considered that the model was successfully established.

[0063] 1.2 Experimental Method The successfully modeled mice were randomly divided into 15 groups, with 10 animals in each group, namely 15 groups: a model group, a metformin hydrochloride tablet + simvastatin group (positive group), Traditional Chinese Medicine Decoction I - VI groups, and Traditional Chinese Medicine Decoction 1 - 7 groups; and the following treatments were carried out on each group of mice: Normal group (control) and model group: Given an equal volume of normal saline; Positive group: Given metformin hydrochloride (300 mg / kg) + simvastatin (6 mg / kg); Traditional Chinese medicine decoction groups I - VI: Given traditional Chinese medicine decoctions I - VI in Examples 1 - 6 respectively; Traditional Chinese medicine decoction groups 1 - 7: Given traditional Chinese medicine decoctions 1 - 7 in Comparative Examples 1 - 7 respectively; Each group of mice was administered by gavage, and the administration volume was 1 mL / 100 g. During the treatment period, the normal group was given normal feed, and the remaining groups were given high - sugar and high - fat feed. The treatment lasted for 8 weeks. Then, the relevant indicators of each group of mice were measured, including TG, TC, LDL - C, HDL - C in mouse serum, TG, TC in liver tissue, fasting blood glucose, and oral glucose tolerance (OGTT).

[0064] 1.3 Detection methods The serum sample indicators LDL - C (low - density lipoprotein cholesterol), HDL - C (high - density lipoprotein cholesterol), TC (total cholesterol), and TG (triglyceride) of all mice were detected by a biochemical analyzer (Roche, Cobas C501).

[0065] TG (triglyceride) and TC (total cholesterol) in the livers of all mice were detected using TG and TC detection kits purchased from Shanghai Enzyme - linked Biotechnology Co., Ltd.

[0066] The fasting blood glucose (fasting for 6 hours) of all mice was detected by a portable blood glucose meter from Roche.

[0067] OGTT detection method for all mice: The mice were starved overnight, and 1.5 g / kg glucose was given to the mice by gavage. The blood glucose concentration of the mouse tail vein was detected at 0, 15, 30, 45, 60, 90, and 120 minutes respectively.

[0068] 1.4 Results and analysis The results are shown in Tables 1 - 3.

[0069] Table 1 Contents of serum sample indicators LDL - C, HDL - C, TC, and TG Table 2 Contents of TG and TC in the liver Table 3 Determination of mouse blood glucose concentration As can be seen from the results of Table 1 and Table 2, the LDL-C, HDL-C, TC, and TG in the sera of mice in each group showed different results with different treatments. Among them, compared with the model group, the LDL-C, HDL-C, TC, and TG in the sera of mice in the positive drug group and the treatment groups of Examples 1-6 and Comparative Examples 1-7 all showed a downward trend, and the decline was relatively obvious. However, compared with the treatment groups of Comparative Examples 1-7, the values of LDL-C, HDL-C, TC, and TG in the treatment groups of Examples 1-6 of the present invention were closer to those of the positive drug group and the control group. Thus, it can be seen that the traditional Chinese medicine composition of the present invention has a more obvious effect. The contents of liver TG and TC in Table 2 also showed the same change trend as that in Table 1. As can be seen from the results of Table 3, in the glucose tolerance tests of fasting, 15 min, 30 min, 60 min, 90 min, and 120 min of each group of mice, compared with the model group and the groups of Comparative Examples 1-7, after 120 min of glucose tolerance test of the mice in the groups of Examples 1-6 of the present invention, the final blood glucose concentration had no obvious difference from the fasting state. The above experimental results indicate that the traditional Chinese medicine composition with a specific formula of the present invention can improve the blood glucose and blood lipid levels of glycolipid metabolic diseases and can effectively treat glycolipid metabolic diseases through multiple targets, multiple pathways, and multiple components.

[0070] Specifically, after the traditional Chinese medicine composition of Comparative Example 1 without adding Rhodiola rosea acted on mice, the contents of LDL-C, HDL-C, TC, TG in the serum and the blood glucose concentration at each time all showed an obvious increasing trend, indicating that Rhodiola rosea as the monarch drug plays a relatively important role in glycolipid metabolism. After the traditional Chinese medicine compositions of Comparative Examples 2 and 3 with Bombax malabaricum and Sapindus mukorossi acted on mice, the changes in the contents of LDL-C, HDL-C, TC, TG in the serum and the blood glucose concentration at each time of the mice were not obvious. However, when both Bombax malabaricum and Sapindus mukorossi were not added (Comparative Examples 4 and 5), the contents of LDL-C, HDL-C, TC, TG in the serum and the blood glucose concentration at each time of the mice decreased significantly. The above results show that in the traditional Chinese medicine composition of the present invention, Rhodiola rosea, Sapindus mukorossi, and Bombax malabaricum act synergistically to improve the therapeutic effect of the composition on glycolipid metabolism. Compared with Example 6, Comparative Example 6 was the composition without adding oat β-glucan, Comparative Example 7 was the composition without adding astragalus polysaccharide, and Example 1 was the composition without adding oat β-glucan and astragalus polysaccharide simultaneously. From the changes in the contents of LDL-C, HDL-C, TC, TG in the serum of mice and the blood glucose concentration at each time of each composition, the influence of astragalus polysaccharide was not obvious. However, when oat β-glucan and astragalus polysaccharide acted together (Example 6), the most obvious therapeutic effect was achieved. The above results indicate that although astragalus polysaccharide itself has no regulatory effect on glycolipid metabolism, when it coexists with oat β-glucan, it has the effect of promoting the regulation of LDL-C, HDL-C, TC, TG in the serum of mice and the blood glucose concentration at each time by oat β-glucan, thus achieving an ideal therapeutic effect.

[0071] The above are only the preferred embodiments of the present invention, and do not impose any form of limitation on the present invention. Although the present invention has been disclosed above with the preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make some changes or modifications within the scope of the technical solution of the present invention to equivalent embodiments of equivalent changes. However, as long as it does not depart from the content of the technical solution of the present invention, any simple modification, equivalent change and modification made to the above embodiments according to the technical essence of the present invention still fall within the scope of the technical solution of the present invention.

Claims

1. A traditional Chinese medicine composition for treating glycolipid metabolism diseases, characterized in that, Calculated by weight parts, the raw materials for preparing the traditional Chinese medicine composition include: 15-19 parts of Coptis chinensis, 10-15 parts of Rhodiola rosea, 10-20 parts of Gynostemma pentaphyllum, 9-12 parts of kapok, 10-15 parts of Sapindus mukorossi, 9-15 parts of Salvia miltiorrhiza, 10-15 parts of Alisma orientale, 9-12 parts of Artemisia capillaris, 9-12 parts of Bupleurum chinense, 5-10 parts of Cassia obtusifolia, 10-15 parts of Anemarrhena asphodeloides, 10-15 parts of Hawthorn, 6-9 parts of Polygonum cuspidatum, 5-10 parts of Aurantii Fructus Immaturus.

2. The traditional Chinese medicine composition according to claim 1, characterized in that Calculated by weight parts, the raw materials for preparing the traditional Chinese medicine composition include: 17 parts of Coptis chinensis, 10 parts of Rhodiola rosea, 15 parts of Gynostemma pentaphyllum, 10 parts of kapok, 12 parts of Sapindus mukorossi, 12 parts of Salvia miltiorrhiza, 13 parts of Alisma orientale, 10 parts of Artemisia capillaris, 9 parts of Bupleurum chinense, 8 parts of Cassia obtusifolia, 13 parts of Anemarrhena asphodeloides, 10 parts of Hawthorn, 7 parts of Polygonum cuspidatum, 5 parts of Aurantii Fructus Immaturus.

3. A drug for treating glycolipid metabolism diseases, characterized in that, It includes the traditional Chinese medicine composition described in claim 1 or 2, and a pharmaceutically acceptable excipient.

4. The drug according to claim 3, characterized in that, The excipient is selected from one or more of a filler, an emulsifier, a disintegrant, a preservative, a matrix, a lubricant, a suspending agent, a binder, a sweetening agent, and a flavoring agent.

5. The drug according to claim 3, characterized in that, The dosage form of the drug is a decoction, a granule, a pill, a powder, a tablet, a capsule, a drop, a suspension, a syrup, a mixture, a tincture, a plaster, an inhalant, or an injection.

6. The medicament according to claim 5, characterized in that, The preparation method of the decoction is as follows: S1: Weigh each raw material according to weight parts, soak it in water to obtain a mixture. S2: Boil the obtained mixture for the first time, and then filter it to obtain a first medicinal liquid and a first filter residue. S3: Add water to the obtained first filter residue for a second decoction, and then filter it to obtain a second medicinal liquid and a second filter residue. S4: Combine the obtained first medicinal liquid and the second medicinal liquid to obtain the decoction.

7. The medicament according to claim 6, characterized in that, In step S1, The addition amount of water is 4-6 times the total mass of each raw material. The soaking time is 15-20 min.

8. The drug according to claim 6, characterized in that, In step S2, the first decoction method is: first use strong fire to boil at 220-230 °C until boiling, and then use slow fire to continue boiling at 160-170 °C for 20-30 min.

9. The medicament according to claim 6, wherein In step S3, The addition amount of water is 2-3 cm higher than the drug surface. The second decoction method is: first use strong fire to boil at 220-230 °C until boiling, and then use slow fire to continue boiling at 160-170 °C for 15-25 min.

10. Use of the traditional Chinese medicine composition described in claim 1 or 2 or the drug described in any one of claims 3-9 in the preparation of a drug for treating glycolipid metabolism diseases.

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