Traditional Chinese medicine composition for regulating glucose and lipid metabolism disorder and preparation method thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicine compositions, and particularly relates to a traditional Chinese medicine composition for regulating glucose and lipid metabolism disorder and a preparation method thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 1-6 parts of clove, 5-45 parts of semen cassiae, 3-30 parts of phyllanthus emblica, 3-15 parts of cinnamon, 5-30 parts of fingered citron, 5-45 parts of dandelion and 5-45 parts of radix puerariae. According to the invention, by controlling the specific types and proportions of the medicines, the effect of mutual cooperation of the components is improved, and the effect of preventing and treating glucose and lipid metabolism disorder is improved.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine compositions, and particularly relates to a traditional Chinese medicine composition for regulating glycolipid metabolism disorders and a preparation method thereof. Background Art

[0002] Glycolipid metabolic disease (GLMD) is a systemic metabolic disease centered on disorders of glucose metabolism and lipid metabolism, which interact and cooperate with each other to jointly cause multi-organ damage, including diseases such as diabetes, hyperlipidemia, atherosclerosis, and non-alcoholic fatty liver disease. The prevalence of glycolipid metabolic disease is increasing year by year, seriously threatening the physical and mental health of humans globally. It has become a problem that is difficult to overcome in world medicine, bringing great challenges to human health and attracting more attention. It is urgent to find suitable and effective clinical treatment methods and drugs.

[0003] In traditional Chinese medicine, glycolipid metabolic disease belongs to the categories of "consumptive thirst", "phlegm-dampness", "blood turbidity", "spleen jaundice", etc. Its onset is closely related to the failure of the spleen to transport and transform, the deficiency of the liver and kidney, and the mutual binding of phlegm and stasis. In diagnosis and treatment, overall syndrome differentiation and dynamic regulation of metabolic imbalance are emphasized. Based on in-depth research on the co-pathogenesis mechanism of glycolipid metabolism, the applicant's team innovatively proposed an overall treatment model of "regulating the liver, activating the pivot, and resolving turbidity". "Regulating the liver, activating the pivot, and resolving turbidity" is one of the core strategies for traditional Chinese medicine to prevent and treat glycolipid metabolic disease (GLMD). Through multi-level interventions such as the neuro-endocrine-immune network (NEI) and the microbiota-host metabolism axis, it precisely targets the three core pathologies of GLMD, namely insulin resistance (IR), chronic inflammation, and lipid accumulation. This theory establishes the regulation of liver system function as the core target of metabolic disorder diseases, breaking through the traditional fragmented treatment model of simply reducing blood sugar / lipid.

[0004] Some traditional Chinese medicine prescriptions are used to treat glycolipid metabolic disease and regulate glycolipid metabolism disorders. For example, Gegen Qinlian Decoction recorded in Treatise on Febrile Diseases is composed of Pueraria lobata, Scutellaria baicalensis, Coptis chinensis, and Glycyrrhiza uralensis, and has the effects of clearing heat and drying dampness, promoting the production of body fluid and quenching thirst. Jiaotai Pill recorded in General Treatise on Korean Medicine is composed of Cinnamomum cassia and Coptis chinensis, and has the effects of communicating the heart and kidney and regulating yin and yang. Liuweidingxiang Powder recorded in Tibetan Medicine Formulary is composed of Eugenia caryophyllata, Piper longum, Zingiber officinale, Terminalia chebula, Phyllanthus emblica, and Glycyrrhiza uralensis, and has the effects of warming the middle energizer to promote qi movement and resolving dampness and lowering turbidity.

[0005] For example, Chinese Patent CN119523028A discloses a preparation method of a fast hangover and liver-protecting drink, which is composed of chamomile extract and a variety of plant raw materials (dandelion, fingered citron, oriental raisin tree seed, etc.). The chamomile extract is extracted by a special process, and it is an effective hangover and liver-protecting drink, which is beneficial to preventing and treating glycolipid metabolism disorders. However, the composition of this invention is complex.

[0006] As disclosed in Chinese Patent CN110974918 A, a traditional Chinese medicine prescription for treating allergic rhinitis, chronic rhinitis and sinusitis is composed of the following raw materials in parts by weight: 3-7 g of ginseng, 6-10 g of eucommia ulmoides male flower, 15-30 g of eriobotrya japonica leaf, 6-10 g of cinnamon, 15-30 g of pueraria lobata, 15-30 g of coix seed, 10-20 g of agastache rugosa, 15-30 g of honeysuckle flower, 20-35 g of angelica dahurica, 15-20 g of elsholtzia ciliata, 15-30 g of poria cocos, 10-20 g of perilla frutescens, 12-18 g of euryale ferox, 6-10 g of tangerine peel, 12-18 g of fingered citron, 10-20 g of cassia seed, 6-10 g of clove, 15-30 g of polygonatum sibiricum, 12-18 g of phyllanthus emblica, 10-20 g of seabuckthorn, 12-18 g of alpinia oxyphylla. Although the invention has a good effect on rhinitis, its components are complex, and the effect on glucose and lipid metabolism disorders remains to be studied.

[0007] Therefore, there is an urgent need to study a traditional Chinese medicine composition with simple components and significant curative effects on glucose and lipid metabolism disorders. Summary of the Invention

[0008] Based on the deficiencies of the prior art, the present invention provides a traditional Chinese medicine composition for regulating glucose and lipid metabolism disorders and its preparation method. The traditional Chinese medicine composition provided by the present invention can regulate glucose disorder and lipid disorder at different times when glucose and lipid metabolism disorders occur through the correct compatibility and appropriate ratio of each single herb.

[0009] The explanations of each component in the formula of the present invention are as follows:

[0010] Clove is the dried flower bud (male clove) or mature fruit (female clove) of the plant Syzygium aromaticum of the Myrtaceae family. The male clove is commonly used clinically. It has a pungent taste and is warm in nature; it belongs to the spleen, stomach and kidney meridians, and has the effects of warming the middle-jiao to arrest vomiting, dispelling cold and relieving pain, and warming the kidney to assist yang. It is clinically used for stomach cold vomiting, diabetic nephropathy, toothache / bad breath, etc.

[0011] Cassia seed is the dried mature seed of the plant Cassia obtusifolia L. or Cassia tora L. of the Leguminosae family. It has a sweet, bitter and salty taste and is slightly cold in nature; it belongs to the liver and large intestine meridians and is a heat-clearing and eye-clearing herb (clearing liver fire and promoting bowel movement). It has the effects of clearing the liver and improving eyesight, moistening the intestines and promoting defecation, reducing lipid and removing turbidity. Among them, the active ingredients chrysophanol and aurantio-obtusin have lipid-lowering effects; the active ingredient cassia seed polysaccharide has the effect of regulating blood sugar.

[0012] Phyllanthus emblica L. is the dried mature fruit of the Euphorbiaceae plant. It is a traditional Tibetan medicinal material, and its Tibetan name is "Jurula". It tastes sweet, sour, astringent, and cool; it enters the lung, spleen, and stomach meridians. It has the effects of clearing heat and cooling blood, promoting body fluid and quenching thirst, and promoting digestion and strengthening the stomach. Its active ingredient, ellagic acid, has the effect of inhibiting fat production. It can treat blood heat bleeding (epistaxis, hemoptysis), sore throat; it is used for thirst caused by heat disease, thirst (diabetes), and improvement of abdominal distension caused by food accumulation.

[0013] Cinnamon bark is the dried bark of Cinnamomum cassia Presl, a plant of the Lauraceae family. It is divided into "official cinnamon" (young tree trunk bark) and "board cinnamon" (old tree thick bark) according to the parts of the tree that are harvested. It is pungent, sweet, and very hot; it enters the kidney, spleen, heart, and liver meridians. It has the effects of replenishing fire and supporting yang, guiding fire back to the origin, dispersing cold and relieving pain, and warming and unblocking the meridians. It is used to improve abdominal pain caused by cold hernia and yin carbuncle (combined with ephedra and deer horn glue); treat kidney yang deficiency (impotence, cold uterus, cold pain in waist and knees, such as Shenqi Pills in "Golden Chamber Synopsis"); relieve sore throat and mouth and tongue sores caused by floating of false yang (combined with Coptis chinensis); dysmenorrhea and chest pain caused by cold stagnation and blood stasis (such as Guixin Powder in "Hejijufang"), etc. Its active ingredients, cinnamaldehyde and polyphenols (such as proanthocyanidins), have the function of regulating glucose and lipid metabolism.

[0014] Buddha's hand is the dried fruit of the Rutaceae plant Buddha's hand (Citrus medica L.var.sarcodactylis (Noot.) Swingle). It is shaped like a Buddha's hand and is called "five-fingered tangerine" or "Fushou tangerine". It tastes pungent, bitter, sour, and warm; it enters the liver, spleen, and lung meridians. It has the effects of soothing the liver and regulating qi, harmonizing the stomach and relieving pain, and drying dampness and resolving phlegm. Clinically, it is mainly used to treat flank pain and abdominal distension caused by liver depression and qi stagnation (as described in "Compendium of Materia Medica" as "mainly treating qi stagnation"); it is used for belching and vomiting caused by stomach qi reversal (combined with costus root and amomum villosum), and relieves cough with sputum and chest tightness (combined with pinellia and dried tangerine peel).

[0015] Pueraria root is the dried root of Pueraria lobata (Willd.) Ohwi or Pueraria thomsonii Benth. of the Leguminosae family. It has the effects of relieving muscles and reducing fever, promoting fluid and quenching thirst, and clearing rashes and stopping diarrhea. It is clinically used for diseases such as diabetic peripheral neuropathy and alcoholic liver damage.

[0016] Dandelion is the dried whole herb of Asteraceae plants such as Taraxacum mongolicum Hand.-Mazz. and T. borealisinense Kitam. It has the effects of clearing away heat and detoxifying, promoting dampness and relieving stranguria, clearing the liver and improving eyesight, and is a heat-clearing and detoxifying medicine.

[0017] To achieve the above object, the present invention adopts the following technical solution:

[0018] On the one hand, the present invention provides a traditional Chinese medicine composition for regulating glycolipid metabolism disorders. The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 1-6 parts of cloves, 5-45 parts of cassia seeds, 3-30 parts of phyllanthus emblica, 3-15 parts of cinnamon, 5-30 parts of fingered citron, 5-45 parts of dandelion, and 5-45 parts of kudzu root.

[0019] As a preferred embodiment, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 3 parts of cloves, 15 parts of cassia seeds, 9 parts of phyllanthus emblica, 5 parts of cinnamon, 10 parts of fingered citron, 15 parts of dandelion, and 15 parts of kudzu root.

[0020] Preferably, the mass ratio of kudzu root to fingered citron is 1-3:1, preferably 1.5:1.

[0021] Preferably, the mass ratio of phyllanthus emblica to dandelion is 0.5-1:1-5, preferably 0.6:1.

[0022] Preferably, the mass ratio of cassia seeds, cinnamon, and cloves is 10-20:3-10:1-4, preferably 3:1:0.6.

[0023] On the other hand, the present invention also provides a preparation method of the above traditional Chinese medicine composition, including the following steps:

[0024] Soak the medicinal materials in water, mix them with water at a solid-liquid ratio of 1 g: 8-10 mL, reflux and extract for 1-2 h, filter the extract to obtain a filtrate and filter residue; mix the filter residue with water again at a solid-liquid ratio of 1 g: 8-10 mL, reflux and extract for 1-2 h, and filter the extract; combine the filtered filtrate with the filtrate obtained from the first extraction, concentrate and cool to obtain the traditional Chinese medicine composition.

[0025] Preferably, the preparation method of the traditional Chinese medicine composition includes the following steps:

[0026] Soak the medicinal materials in water, mix them with water at a solid-liquid ratio of 1 g: 10 mL, reflux and extract for 1 h, filter the extract to obtain a filtrate and filter residue; mix the filter residue with water again at a solid-liquid ratio of 1 g: 8 mL, reflux and extract for 1 h, and filter the extract; combine the filtered filtrate with the filtrate obtained from the first extraction, concentrate and cool to obtain the traditional Chinese medicine composition.

[0027] Finally, the present invention also provides the application of the above traditional Chinese medicine combination in the preparation of drugs for treating glycolipid metabolism disorders.

[0028] Specifically, the dosage forms of the drugs include pills, powders, granules, tablets, capsules, mixtures, or sprays.

[0029] Specifically, the drugs also include pharmaceutically acceptable excipients.

[0030] Preferably, the pharmaceutically acceptable excipients include one or more of a filler, a binder, a disintegrant and a lubricant.

[0031] Compared with the prior art, the present invention has the following beneficial effects:

[0032] (1) The present invention improves the synergistic effect between components by controlling the specific types and ratios of drugs, thereby improving the effect of preventing and treating glucose and lipid metabolism disorders.

[0033] (2) The present invention uses Pueraria root and Citron as the main ingredients: Pueraria root promotes fluid production and quenches thirst, promotes spleen and stomach to clear Yang; Citron soothes the liver and regulates Qi, strengthens the spleen and harmonizes the stomach. Emblica and dandelion are the subordinate ingredients: Emblica clears heat and cools blood, promotes fluid production and relieves cough; dandelion clears heat and detoxifies, and is diuretic and resolves stagnation. Cassia seed, cinnamon bark and clove are the auxiliary ingredients: Cassia seed clears the liver and improves eyesight, moistens the intestines and promotes bowel movements; cinnamon bark replenishes fire and promotes Yang, warms and unblocks the meridians; clove warms the middle and descends adverse reactions, dispels cold and relieves pain. Both cold and warm effects are used: dandelion and Emblica clear heat, cinnamon bark and clove warm Yang, and avoid cold and cold hurting the stomach. Both the symptoms and the root cause are taken into account: clearing heat and promoting fluid production treats the symptoms (symptoms), while strengthening the spleen and warming Yang treats the root cause (metabolic function). Multi-target effects regulate the functions of multiple organs such as the liver, pancreas, intestines, and blood vessels. This formula works through the linkage of the four methods of "clearing, replenishing, unblocking, and warming", and exerts its effects in multiple ways such as regulating digestion and absorption, improving insulin resistance, and promoting lipid metabolism, reflecting the advantage of "overall regulation" of traditional Chinese medicine.

[0034] (3) The Chinese medicine composition obtained by the present invention has reasonable ingredients, high activity, high drug utilization rate, good stability, and is highly effective in preventing and treating glucose and lipid metabolism diseases. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Figure 1 The oil red staining of the liver of mice in each group (microscope magnification 20×, scale bar = 100 μm). DETAILED DESCRIPTION

[0036] The technical scheme of the present invention is clearly and completely described below with specific implementation methods. Obviously, the described embodiments are only part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments in the present invention, all other embodiments obtained by ordinary technicians in the field without creative work are within the scope of protection of the present invention. The materials, reagents, etc. used, if not otherwise specified, are reagents and materials available from commercial sources.

[0037] Example 1 A Chinese medicine composition for regulating glucose and lipid metabolism disorders

[0038] It is composed of the following raw materials:

[0039] 3 parts of cloves, 15 parts of cassia seeds, 9 parts of emblica seeds, 5 parts of cinnamon bars, 10 parts of bergamots, 15 parts of dandelions and 15 parts of kudzu roots.

[0040] Example 2 A traditional Chinese medicine composition for regulating glycolipid metabolism disorders

[0041] It is composed of the following raw materials:

[0042] 1 part of clove, 5 parts of cassia seed, 3 parts of phyllanthus emblica, 3 parts of cinnamon, 5 parts of fingered citron, 5 parts of dandelion and 5 parts of kudzu root.

[0043] Example 3 A traditional Chinese medicine composition for regulating glycolipid metabolism disorders

[0044] It is composed of the following raw materials:

[0045] 6 parts of clove, 45 parts of cassia seed, 30 parts of phyllanthus emblica, 15 parts of cinnamon, 30 parts of fingered citron, 45 parts of dandelion and 45 parts of kudzu root.

[0046] Comparative Example 1 A traditional Chinese medicine composition for regulating glycolipid metabolism disorders

[0047] The difference from Example 1 is that the mass ratio of kudzu root and fingered citron is changed to 1:8, that is: 3 parts of clove, 15 parts of cassia seed, 9 parts of phyllanthus emblica, 5 parts of cinnamon, 40 parts of fingered citron, 15 parts of dandelion and 5 parts of kudzu root.

[0048] Comparative Example 2 A traditional Chinese medicine composition for regulating glycolipid metabolism disorders

[0049] The difference from Example 1 is that the mass ratio of phyllanthus emblica and dandelion is changed to 8:1, that is: 3 parts of clove, 15 parts of cassia seed, 40 parts of phyllanthus emblica, 5 parts of cinnamon, 10 parts of fingered citron, 5 parts of dandelion and 15 parts of kudzu root

[0050] Comparative Example 3 A traditional Chinese medicine composition for regulating glycolipid metabolism disorders

[0051] The difference from Example 1 is that the mass ratio of cassia seed, cinnamon and clove is changed to 1:1:5, that is: 15 parts of clove, 5 parts of cassia seed, 9 parts of phyllanthus emblica, 5 parts of cinnamon, 10 parts of fingered citron, 15 parts of dandelion and 15 parts of kudzu root

[0052] The above Examples 1 - 3 and Comparative Examples 1 - 3 are prepared according to the following method:

[0053] Weigh clove, cassia seed, phyllanthus emblica, cinnamon, fingered citron, dandelion and kudzu root according to the formula, mix them with water at a solid - liquid ratio of 1g:10mL, soak for 45min, decoct, carry out condensation reflux for 1 hour, filter while it is hot with gauze to obtain filtrate and residue; add water to the residue according to a material - liquid ratio of 1g:8mL, carry out condensation reflux for 1 hour, and filter while it is hot with gauze; combine the two filtrates and concentrate to obtain the traditional Chinese medicine composition.

[0054] Comparative Example 4 A traditional Chinese medicine composition for regulating glycolipid metabolism disorders

[0055] The difference from Example 1 is that dandelion is replaced by gardenia, and the rest is the same as in Example 1. The preparation method is as follows:

[0056] Weigh cloves, cassia seed, phyllanthus emblica, cinnamon, fingered citron, gardenia and kudzu root according to the formula, mix them with water at a solid-liquid ratio of 1 g:10 mL, soak for 45 min, decoct, carry out condensation reflux for 1 hour, filter while it is hot using gauze to obtain the filtrate and residue; add water to the residue at a material-liquid ratio of 1 g:8 mL, carry out condensation reflux for 1 hour, and filter while it is hot using gauze; combine the two filtrates and concentrate to obtain the traditional Chinese medicine composition.

[0057] Effect experiment

[0058] Setting of doses: According to the latest conversion method of drug doses between humans and animals and the results of preliminary experiments, the equivalent dose of the traditional Chinese medicine composition for large (small) mice at the normal adult daily dose is used as the medium dose, the low dose is designed by reducing it by 1 fold, and the high dose is designed by doubling it. The high, medium and low doses of the traditional Chinese medicine composition are 34.113, 17.0565, 8.52825 g / kg respectively, and the atorvastatin dose is 10 mg / kg. The administration volume for mice is 10 mL / kg.

[0059] Abbreviations of non-Chinese words: CON = blank control group, HF = model group, FAT = atorvastatin group, FL = low-dose group, FM = medium-dose group, FH = high-dose group.

[0060] 1. Experimental materials

[0061] 1.1 Experimental animals

[0062] Adult C57 mice, male, SPF grade, weighing 20 g, purchased from Zhuhai Besttone Biotechnology Co., Ltd., and the experimental animal production license number is SYXK (Guangdong) 2020-0125. After 7 days of adaptive feeding, they enter the experimental period.

[0063] 1.2 Experimental drugs

[0064] Blank control: Normal saline

[0065] Positive control: Atorvastatin tablets, provided by Qilu Pharmaceutical Co., Ltd., batch number KC1H4127 [1].

[0066] 1.3 Experimental reagents

[0067]

[0068]

[0069] 1.4 Experimental instruments

[0070] Instrument Manufacturer Blood glucose meter Roche vitality Multifunctional microplate reader Berthold

[0071] 2. Experimental methods

[0072] 2.1 Animal grouping: After 7 days of adaptive feeding, adult male SPF-grade C57 mice were randomly divided into groups of 8 - 12 mice each. They were respectively the control group (n = 8), the model group (n = 8), the positive drug group (n = 12), the high, medium, and low dose groups of Example 1 (n = 12), the medium dose groups of Examples 2 - 3 (n = 12), and the medium dose group of Comparative Example 1 (n = 12).

[0073] 2.2 Modeling method

[0074] Control group: Normal diet and water intake;

[0075] High-fat model group: Given 45% high-fat diet and normal water intake;

[0076] High-fat positive drug group: Given 45% high-fat diet and normal water intake every day, and atorvastatin at 10 mg / kg / d;

[0077] High dose group of Example 1: Given 45% high-fat diet and normal water intake every day, and the traditional Chinese medicine composition obtained in Example 1 at 3.41 g / mL;

[0078] Medium dose group of Example 1: Given 45% high-fat diet and normal water intake every day, and the traditional Chinese medicine composition obtained in Example 1 at 1.71 g / mL;

[0079] Low dose group of Example 1: Given 45% high-fat diet and normal water intake every day, and the traditional Chinese medicine composition obtained in Example 1 at 0.85 g / mL;

[0080] Medium dose groups of Examples 2 - 3 and Comparative Example 1: Given 45% high-fat diet and normal water intake every day,

[0081] The traditional Chinese medicine compositions obtained in Examples 2 - 3 and Comparative Examples 1 - 4 at 1.71 g / mL.

[0082] After 7 days of adaptive feeding, all the above mice entered the experimental period and were raised for 14 days under the above conditions.

[0083] 2.3 Oral Glucose Tolerance Test (OGTT)

[0084] At 8 pm on the 3rd day before sampling, the mice to be tested were fasted (12 hours) overnight. At the same time, ensure that the mice have access to drinking water. The weight of all mice to be tested was measured before 8 am the next day, and the weight of each mouse was recorded to within 0.1g. Calculate and record the oral injection volume of 10μL / g body weight. According to the weight of the experimental animals, 20% glucose solution was prepared according to the standard of 2g glucose / kg for oral glucose tolerance intervention. The sampling time points include the baseline time point before the injection of glucose solution (0min) and 15, 30, 60, 90, and 120min after injection, a total of 6 time points. Cut the tail with sterilized scissors to collect blood, wipe the first drop of blood with clean absorbent paper, measure the blood glucose level with a blood glucose meter and blood glucose test strips, and systematically record the blood glucose concentration value of each mouse at each time point. Draw the time-blood glucose curve, calculate the area under the OGTT curve (The Area under the Curve (AUC) of Oral Glucose Tolerance Test (OGTT), AUC-OGTT), and the results are shown in Table 4.

[0085] 2.4 Detection of fat tissue content

[0086] According to the operating instructions of the LF90Ⅱ small animal nuclear magnetic resonance instrument provided by the Bruker official website, the body fat content of all mice was tested. After the test, the body fat content of the mice was obtained and their body fat percentage was calculated. The results are shown in Table 2.

[0087] 2.5 Physical sign index detection

[0088] All mice were fasted but not watered at 9 pm the day before sampling each week. Blood samples were collected after fasting for 12 hours. The weights of the liver, pancreas, epididymal fat, and brown fat were weighed and recorded. The results are shown in Tables 1 and 2.

[0089] 2.6 Blood index detection

[0090] All mice were fasted but not watered at 9 pm the night before sampling each week. Blood was collected after fasting for 12 hours. The blood was allowed to stand for 30 minutes and then centrifuged at 3500 rpm, 4°C, for 15 minutes. The supernatant was collected for testing of blood biochemical indicators. The serum metabolic indicators were tested using the Zhongsheng Beikong kit, including:

[0091] Sugar metabolism related indicators: Fasting blood glucose (FBG)

[0092] Lipid metabolism-related indicators: Triglyceride (TG); Total Cholesterol (TC); Low-Density Lipoprotein Cholesterol (LDL-C); High density lipoprotein cholesterol (HDL-C).

[0093] Intermediate products of energy metabolism: free fatty acid (FFA).

[0094] ELISA kit for insulin to measure endocrine hormone indicators: fasting insulin (FINS).

[0095] Calculate the insulin resistance index based on the fasting blood glucose level and fasting insulin level (HOMA-IR = fasting blood glucose level (mmol / L) × fasting insulin level (mIU / L) / 22.5). Each test item strictly follows the reaction requirements of the kit instructions. Finally, the detection is carried out on an enzyme-linked immunosorbent assay (ELISA) reader. The standard product is calibrated synchronously throughout the experiment. The obtained results are shown in Table 3 and Table 4.

[0096] 2.7 Oil Red staining

[0097] (1) Place the freshly removed tissue in a fixative for fixation, then dehydrate it using the sucrose dehydration method, embed it with OTC embedding agent, and place it on a cryostat for sectioning.

[0098] (2) After restoring the frozen sections to room temperature, add Reagent A (Oil Red O staining buffer) dropwise to ensure that the tissue section is completely infiltrated. After 3 minutes, aspirate the excess solution.

[0099] (3) Without washing and transferring, immediately introduce the preheated Reagent B (Oil Red O staining solution) to create an environment for covering staining, and stain at room temperature for 15 minutes.

[0100] (4) After terminating the color development, remove the residual staining solution, and use an equal volume of Differentiation Buffer C (Oil Red O staining differentiation solution) for the differentiation process for 3 minutes until the tissue section shows a uniform color.

[0101] (5) Wash with deionized water for 1 minute to completely remove the differentiation buffer, and then apply the modified hematoxylin staining solution for precise nuclear staining for 2 minutes.

[0102] (6) After rinsing with deionized water for 1 minute, perform blueing treatment with running tap water for 7 minutes until the nucleus shows a clear blue structure.

[0103] (7) After mounting the slides with mounting medium (such as glycerol gelatin), observe and take pictures, and the obtained results are as Figure 1 shown.

[0104] 3 Experimental results

[0105] 3.1 Physical signs

[0106] Table 1

[0107]

[0108] Note: Compared with the CON group, ****P < 0.0001, ***P < 0.001, **P < 0.01, *P < 0.05; compared with the HF group,

[0109] #### P < 0.0001, ### P < 0.001, ## P < 0.01, # P < 0.05.

[0110] As shown in Table 1, after 2 weeks of high-fat diet, the pancreatic weight increased, and the groups of Examples 1 - 3 could effectively inhibit the trend of pancreatic weight gain. The wet weights of epididymal fat and brown fat in the model group mice increased significantly. The positive drug, Examples 1 and 2 could inhibit the trend of weight gain of these two kinds of fat, and Example 3 could inhibit the trend of epididymal fat weight gain. It is suggested that the traditional Chinese medicine composition prepared from Examples 1 - 3 of traditional Chinese medicine can effectively inhibit the accumulation of fat in adipose tissue and pancreas, and has a good effect on inhibiting glycolipid disorder.

[0111] Table 2

[0112]

[0113] Note: Compared with the CON group, ****P < 0.0001, ***P < 0.001, **P < 0.01, *P < 0.05; compared with the HF group,

[0114] #### P < 0.0001, ### P < 0.001, ## P < 0.01, # P < 0.05.

[0115] As shown in Table 2, after 2 weeks of high-fat diet, the pancreatic organ coefficient increased significantly. The positive drug and Example 1 could effectively inhibit the increasing trend of the pancreatic organ coefficient. The epididymal fat, brown fat organ coefficients and body fat rate of the mice in the model group increased significantly, and the epididymal fat organ coefficient, brown fat organ coefficient and body fat rate in the Example 1 group were significantly inhibited. The groups of Example 2 - 3 could all reduce the pancreatic, epididymal fat and brown fat organ coefficients to a certain extent. It is indicated that the Example groups can effectively inhibit the accumulation of fat in adipose tissue and pancreas, and have a good effect on inhibiting glycolipid disorder.

[0116] 3.2 Blood indexes

[0117] Table 3

[0118]

[0119]

[0120] Note: Compared with the CON group, ****P < 0.0001, ***P < 0.001, **P < 0.01, *P < 0.05; compared with the HF group,

[0121] #### P < 0.0001, ### P < 0.001, ## P < 0.01, # P < 0.05.

[0122] As shown in Table 3, after 2 weeks of high-fat diet, the levels of TG, FFA, and LDL-C in the mice increased significantly. Compared with the model group, the blood lipid levels in the positive drug group and the Example 1 - 3 groups decreased significantly, and the blood lipid levels in the Comparative Example 2 - 3 groups had a downward trend. It is indicated that Example 1 - 3 has a good lipid-lowering effect.

[0123] Table 4

[0124] Group FBG (mmol / L) AUC-OGTT FINS (mIU / L) HOMA-IR CON 5.59±1.00 1242.88±47.85 5.59±1.00 1.38±0.43 HF 9.26±1.53**** 1485.75±98.65** 9.26±1.53**** 3.81±0.74**** FAT <![CDATA[6.95±1.18 ## > <![CDATA[1259.56±94.58 ## > <![CDATA[6.95±1.18 #### > <![CDATA[2.15±0.38 #### > Example 1 - FH <![CDATA[7.13±0.63 # > 1421.50±137.62 <![CDATA[7.54±1.15 #### > <![CDATA[2.39±0.41 ### > Example 1 - FM <![CDATA[6.81±1.18 ## > 1403.18±133.35 <![CDATA[6.89±1.18 #### > <![CDATA[2.09±0.54 ### > Example 1 - FL <![CDATA[6.96±1.82 ## > <![CDATA[1296.80±186.11 # > <![CDATA[6.96±1.82 #### > <![CDATA[2.15±0.73 ### > Example 2 - FM <![CDATA[7.03±1.26 # > 1416.67±148.24 <![CDATA[7.55±1.23 ### > <![CDATA[2.36±0.53 ### <!-- 8 -->]]> Example 3 - FM <![CDATA[7.28±1.57 # > 1427±128.3 <![CDATA[7.79±1.56 ## > <![CDATA[2.52±0.48 # > Comparative Example 1 - FM 8.33±1.23 1458±136.7 8.53±1.48 3.21±0.62 Comparative Example 2 - FM 8.38±1.23 1469±138.3 8.62±1.56 3.02±0.65 Comparative Example 3 - FM 8.39±1.23 1460±128.3 <![CDATA[8.40±1.56 # > 3.33±0.68 Comparative Example 4 - FM 8.43±1.23 1469±128.3 8.85±1.56 3.17±0.46

[0125] Note: Compared with the CON group, ****P < 0.0001, ***P < 0.001, **P < 0.01, *P < 0.05; compared with the HF group,

[0126] #### P < 0.0001, ### P < 0.001, ## P < 0.01, # P < 0.05.

[0127] As shown in Table 4, after 2 weeks of high-fat diet, the FBG, AUC-OGTT, insulin level, and HOMA-IR of the mice all increased significantly, while the fasting blood glucose levels in the groups of Examples 1-3 decreased significantly. The glucose tolerance in the positive drug group and the group of Example 1-FL decreased significantly, and the glucose tolerance levels in the groups of Example 1-FH, FM and Examples 2-3 decreased. The fasting insulin levels in the positive drug group and the groups of Examples 1-3 decreased significantly. The HOMA-IR coefficients in the positive drug group and the groups of Examples 1-3 decreased significantly. The above results suggest that the groups of examples can better reduce blood glucose, reduce glucose tolerance, restore insulin levels to normal and relieve insulin resistance, and have a good effect on improving glucose disorders.

[0128] Figure 1 The Oil Red O staining of the livers of mice in each group was shown. There were no red lipid droplets in the CON control group, some relatively dense and small red lipid droplets appeared in the HF model group, while the red lipid droplets in the FAT positive drug group and Example 1 group were very small and sparse. It shows that under the condition of high-fat diet for 2 weeks, lipid droplets appeared in the liver, resulting in ectopic lipid deposition; while Example 1 can effectively inhibit the situation of ectopic lipid deposition, reduce the accumulation of lipid droplets in the liver, and improve glucose and lipid disorders.

[0129] In summary, the traditional Chinese medicine composition provided by the present invention interacts with each other and has a positive effect on glucose and lipid metabolism disorders.

[0130] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, rather than a limitation on the protection scope of the present invention. Any simple modification or equivalent replacement made by those of ordinary skill in the art to the technical solution of the present invention does not depart from the essence and scope of the technical solution of the present invention.

Claims

1. A traditional Chinese medicine composition for regulating glycolipid metabolism disorders, characterized in that, By weight parts, it is composed of the following raw materials: 1 - 6 parts of cloves, 5 - 45 parts of cassia seeds, 3 - 30 parts of phyllanthus emblica, 3 - 15 parts of cinnamon, 5 - 30 parts of fingered citron, 5 - 45 parts of dandelion, and 5 - 45 parts of kudzu root.

2. The traditional Chinese medicine composition according to claim 1, wherein By weight parts, it is composed of the following raw materials: 3 parts of cloves, 15 parts of cassia seeds, 9 parts of phyllanthus emblica, 5 parts of cinnamon, 10 parts of fingered citron, 15 parts of dandelion, and 15 parts of kudzu root.

3. The traditional Chinese medicine composition according to claim 1, wherein The mass ratio of the kudzu root to the fingered citron is 1 - 3:

1.

4. The traditional Chinese medicine composition according to claim 1, wherein The mass ratio of the phyllanthus emblica to the dandelion is 0.5 - 1:1 - 5.

5. The traditional Chinese medicine composition according to claim 1, wherein The mass ratio of the cassia seeds, cinnamon, and cloves is 10 - 20:3 - 10:1 - 4.

6. The preparation method of the traditional Chinese medicine composition according to any one of claims 1-5, characterized in that, It includes the following steps: Soak the medicinal materials in water, mix them with water at a solid - liquid ratio of 1g:8 - 10mL, reflux and extract for 1 - 2h, filter the extract to obtain a filtrate and residues; mix the residues with water again at a solid - liquid ratio of 1g:8 - 10mL, reflux and extract for 1 - 2h, and filter the extract; combine the filtrates after the two filtrations, concentrate and cool to obtain a traditional Chinese medicine composition.

7. Use of the traditional Chinese medicine composition according to any one of claims 1 - 5 or the traditional Chinese medicine composition prepared by the preparation method according to claim 6 in the preparation of a drug for treating glycolipid metabolism disorders.

8. The application according to claim 7, wherein The dosage form of the drug is pill, powder, granule, tablet, capsule, mixture or spray.

9. The application according to claim 7, wherein The drug further comprises pharmaceutically acceptable excipients.

10. The application according to claim 9, wherein The pharmaceutically acceptable excipients are one or several of fillers, binders, disintegrants, and lubricants.

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