Traditional Chinese medicine composition as well as preparation method and application thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and relates to a traditional Chinese medicine composition and a preparation method and application thereof, in particular to a traditional Chinese medicine composition and a preparation method thereof and application in preparation of medicines for treating diabetes mellitus, especially diabetes mellitus complicated with metabolism-related fatty liver diseases. The traditional Chinese medicine composition is prepared from the following raw materials: 920 to 1200 parts of fructus crataegi, 240 to 400 parts of radix bupleuri, 580 to 700 parts of radix salviae miltiorrhizae, 240 to 400 parts of radix curcumae, 352 to 500 parts of semen cassiae, 240 to 400 parts of rhizoma pinellinae praeparata, 352 to 500 parts of rhizoma alismatis and 240 to 400 parts of pericarpium citri reticulatae. Furthermore, the mass ratio of hawthorn to radix bupleuri to salvia miltiorrhiza to radix curcumae to semen cassiae to rhizoma pinellinae praeparata to rhizoma alismatis to pericarpium citri reticulatae is (3-4): (1-2): (2-3): (1-2): (1-3): (1-2): (1-3): (1-2). The composition is prepared by the following steps: respectively removing impurities and dust from hawthorn, radix bupleuri, salvia miltiorrhiza, radix curcumae, semen cassiae, rhizoma pinellinae praeparata, rhizoma alismatis and pericarpium citri reticulatae, drying, respectively grinding, and mixing in proportion. The composition disclosed by the invention not only has an obvious effect of reducing blood sugar, but also has an effect of reducing blood fat, and is better for diabetes mellitus complicated with fatty liver.

Description

Technical field:

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and relates to a traditional Chinese medicine composition, a preparation method and application thereof, and specifically relates to a traditional Chinese medicine composition, a preparation method thereof and application thereof in preparing a drug for treating diabetes, especially diabetes combined with metabolic-related fatty liver disease. Background technology:

[0002] With the continuous improvement of living standards, the continuous changes in people's dietary structure, and the advancement and widespread application of clinical detection technology, the prevalence and detection rates of diabetes and non-alcoholic fatty liver disease are increasing. It has now become one of the chronic diseases and seriously threatens human health.

[0003] Diabetes mellitus is a group of carbohydrate, protein and fat metabolism disorders caused by absolute or relative insulin deficiency and / or insulin utilization disorder, with hyperglycemia as the main sign.

[0004] Metabolic associated fatty liver disease (MAFLD), formerly known as non-alcoholic fatty liver disease (NAFLD), originally referred to fatty degeneration of more than 5% of hepatocytes in the absence of excessive alcohol consumption and other known liver damage factors.

[0005] Diabetes and MAFLD are closely related, sharing not only common risk factors but also acting as risk factors for each other. Co-existence of the two significantly increases the risk of a poor prognosis in either condition. MAFLD not only increases the risk of diabetes but also accelerates the development of various diabetes-related complications in diabetic patients. Conversely, diabetes also increases the risk of MAFLD, promoting its progression to metabolic-related steatohepatitis and its associated cirrhosis. MAFLD in patients with diabetes has an insidious and slow onset, lacking specific clinical manifestations in the early stages. Some patients may experience loss of appetite, general fatigue, discomfort in the liver area, or dull pain in the right upper abdomen.

[0006] Diabetes mellitus falls under the categories of "xiaoke," "xiaozhong," and "xiaoshen" in Traditional Chinese Medicine (TCM). Its primary causes are congenital deficiency, weak internal organs, yin deficiency, dietary and emotional imbalances. The underlying pathogenesis is yin deficiency at the root and dryness and heat at the secondary. The disease primarily affects the lungs, stomach, and kidneys, with the kidneys being the most critical. MAFLD does not have a specific name in TCM, but because it is often clinically associated with liver discomfort, loss of appetite, nausea and vomiting, and fatigue, it is often categorized as "fat and bloating," "liver distension," "flank pain," and "accumulation." Its occurrence is often associated with excessive drinking and eating, emotional depression, advanced age, chronic illness, and the invasion of cold. This disease manifests as both underlying deficiency and superficial excess, with the liver, spleen, and kidneys as the primary sites of disease, and is closely associated with pathological products such as phlegm, dampness, turbidity, and blood stasis.

[0007] There is no name for diabetes combined with MAFLD in traditional Chinese medicine. TCM scientists classify it as "xiaoke disease" combined with "accumulation" or "side pain" based on its symptoms. TCM believes that diabetes combined with MAFLD is often caused by improper diet, especially excessive consumption of fatty and greasy foods, which produces dampness and phlegm; or abnormal hunger and satiety damages the spleen and stomach, which causes the spleen to lose its healthy function, and water and dampness cannot be transformed, which accumulates into phlegm. Phlegm enters the meridians, flows with the qi, and stagnates in the liver; or excessive emotions, such as anger and depression, damage the liver. Worrying hurts the spleen, and over time it will damage the internal organs, affecting the Qi mechanism, causing Qi stagnation and blood stasis, phlegm and blood stasis, blocking the blood vessels of the liver, and causing liver distension. Other doctors believe that the main cause of the disease is excessive work and rest, kidney deficiency in old age, emotional imbalance, irregular diet and other factors leading to Qi and Yin deficiency, liver depression and spleen deficiency, damp heat accumulation or phlegm and blood stasis, stagnation in the liver. The disease is mainly located in the liver, involving the stomach, gallbladder, spleen, etc., with spleen and kidney Yang deficiency as the root cause, and Qi stagnation, phlegm and dampness, damp heat, and blood stasis blocking the liver meridians as the symptoms.

[0008] To date, there is still a lack of effective traditional Chinese medicine for the treatment of diabetes, especially diabetes combined with MAFLD. Summary of the invention:

[0009] In order to overcome the defects of the prior art, the present invention provides a traditional Chinese medicine composition with a simple formula, a simple preparation method, and the effect of significantly improving fatty degeneration of diabetes, especially diabetes combined with MAFLD, and reducing inflammatory response, for treating diabetes or diabetes combined with fatty liver.

[0010] To achieve this purpose, the present invention is implemented through the following technical solutions:

[0011] The Chinese medicine composition of the present invention is prepared from the following raw materials:

[0012] 920-1200 parts of Hawthorn, 240-400 parts of Bupleurum, 580-700 parts of Salvia miltiorrhiza, 240-400 parts of Curcuma, 352-500 parts of Cassia seed, 240-400 parts of Pinellia, 352-500 parts of Alisma, and 240-400 parts of Tangerine peel.

[0013] Furthermore, the Chinese medicine composition of the present invention is prepared by the following raw materials:

[0014] 1000-1120 parts of Hawthorn, 300-350 parts of Bupleurum, 600-700 parts of Salvia miltiorrhiza, 300-400 parts of Curcuma, 400-500 parts of Cassia seed, 300-400 parts of Pinellia, 400-500 parts of Alisma, and 300-400 parts of Tangerine peel.

[0015] Furthermore, the Chinese medicine composition of the present invention is prepared by the following raw materials:

[0016] 1060-1120 parts of Hawthorn, 320-350 parts of Bupleurum, 600-640 parts of Salvia miltiorrhiza, 320-350 parts of Curcuma, 426-450 parts of Cassia seed, 320-350 parts of Pinellia, 426-450 parts of Alismatis, and 320-350 parts of Tangerine peel.

[0017] Furthermore, the mass ratio of hawthorn, bupleurum, salvia miltiorrhiza, curcuma, cassia seed, pinellia, oriental water chestnut and dried tangerine peel is: 3-4:1-2:2-3:1-2:1-3:1-2:1-3:1-2.

[0018] Furthermore, the mass ratio of hawthorn to tangerine peel is 3-4:1;

[0019] The mass ratio of the bupleurum root, turmeric, pinellia tuber and tangerine peel is 1:1:1:1.

[0020] The present invention also provides a preparation method of the traditional Chinese medicine composition, which comprises removing impurities and dust from hawthorn, bupleurum, salvia miltiorrhiza, turmeric, cassia seed, pinellia, oriental water chestnut and tangerine peel, drying them, grinding them respectively and mixing them according to proportion.

[0021] After grinding, the above ingredients can be passed through a 12-40 mesh sieve, preferably a 12-20 mesh sieve.

[0022] The Chinese medicine composition of the present invention can be prepared into a clinically acceptable preparation with a pharmaceutically acceptable carrier or excipient.

[0023] The preparations are tablets, capsules, granules, pills, powders and the like.

[0024] Further,

[0025] The present invention provides the use of the traditional Chinese medicine composition and the preparation thereof in preparing medicines for treating diabetes.

[0026] The present invention provides application of the traditional Chinese medicine composition and the preparation thereof in preparing medicine for treating fatty liver.

[0027] The present invention provides the use of the traditional Chinese medicine composition and the preparation thereof in preparing a medicine for treating diabetes combined with fatty liver.

[0028] The fatty liver refers to fatty liver caused by metabolic dysfunction.

[0029] The metabolic dysfunction refers to the presence of fatty liver based on liver biopsy histology or imaging, or even blood biomarker examination, while also meeting the criteria of being overweight / obese or having metabolic dysfunction.

[0030] The present invention provides the use of the traditional Chinese medicine composition and the preparation thereof in preparing a medicine for improving blood sugar, blood lipids, insulin resistance and alleviating inflammatory response in diabetes combined with MAFLD.

[0031] The beneficial effects of the present invention are derived from the synergistic effect of eight medicinal materials in the formula, including hawthorn, bupleurum, salvia miltiorrhiza, curcuma, cassia seed, pinellia ternata, oriental rhizome, and tangerine peel. Hawthorn and bupleurum are monarch herbs, salvia miltiorrhiza, curcuma, pinellia ternata, oriental rhizome, and tangerine peel are ministerial herbs, and cassia seed is an adjuvant.

[0032] hawthorn

[0033] Efficacy: Helps digestion, strengthens the stomach, promotes qi and relieves blood stasis.

[0034] Indications: Meat stagnation, epigastric distension, diarrhea and abdominal pain, blood stasis and amenorrhea, postpartum blood stasis, stabbing pain in the heart and abdomen, hernia pain, and hyperlipidemia.

[0035] Nature and flavor: sour, sweet, slightly warm. Enters the spleen, stomach, and liver meridians.

[0036] Historical origin: First recorded in "Bencao Yanyi Buyi".

[0037] Ancient books record: "Compendium of Materia Medica" says that it "digests food, eliminates meat accumulation, lumps, phlegm, fullness and acid reflux, and pain and swelling caused by blood stasis."

[0038] Modern pharmacological research indicates that hawthorn fruit is rich in lipase and maslinic acid, which promote the breakdown of fat and protein, enhance gastric juice secretion, and significantly improve digestion, aiding in the digestion of foods such as meat and oil. It also has anti-blood pressure and lipid-lowering effects, combats atherosclerosis, and enhances coronary blood flow. Studies have shown that the flavonoids in hawthorn fruit can dilate blood vessels, lower blood pressure, inhibit lipid peroxidation, and reduce the development of arteriosclerosis. Rich in flavonoids and vitamin C, hawthorn fruit possesses significant antioxidant properties, scavenging free radicals, delaying aging, and protecting cells from oxidative damage. It effectively lowers blood cholesterol and low-density lipoprotein (LDL), reduces fat deposition on blood vessels, and contributes to the prevention and treatment of atherosclerosis. Hawthorn fruit extract has inhibitory effects on various bacteria, including Escherichia coli and Staphylococcus aureus. Hawthorn fruit also exhibits anti-inflammatory properties, inhibiting the production and release of inflammatory mediators. It has been shown to inhibit tumor cell proliferation, demonstrating potential anti-cancer activity in experimental models of liver and lung cancer.

[0039] Hawthorn is good at digesting food, strengthening the stomach, promoting qi and dispersing blood stasis. In this prescription, hawthorn can not only help digestion and eliminate stagnation, soothe the stomach and relieve bloating, but also promote blood circulation and remove blood stasis, and promote blood circulation. It is quite effective for various symptoms caused by improper diet, blood stasis and qi stagnation, so it is the main medicine.

[0040] Bupleurum

[0041] Efficacy: Relieves exterior symptoms and reduces fever, soothes the liver and relieves depression, and raises Yang Qi.

[0042] Indications: cold and fever, alternating chills and fever, chest and flank pain, irregular menstruation, uterine prolapse, and rectal prolapse.

[0043] Nature and flavor: bitter, pungent, slightly cold. Enters the liver and gallbladder meridians.

[0044] Historical origin: First recorded in "Shennong Bencao Jing".

[0045] Ancient texts record that the Shennong Bencaojing (Shen Nong's Herbal Classic) lists Bupleurum as a top-grade herb, primarily treating "qi stagnation in the heart, abdomen, intestines, and stomach, cold and heat pathogenic qi, and removing the old and bringing in the new." It emphasizes Bupleurum's ability to balance internal cold and heat, soothe the liver, and relieve depression. The Ming Yi Bie Lu (Famous Doctors' Prescriptions) mentions Bupleurum as a representative herb for Shaoyang syndrome, stating that it "treats alternating cold and heat, benefits the chest and diaphragm, relieves coughs, and dissipates depression."

[0046] Modern pharmacological research indicates that its active ingredients exhibit significant antipyretic properties, inhibiting the production of fever-inducing factors and achieving a fever-reducing effect by regulating the hypothalamic temperature center. Bupleurum also exhibits certain analgesic properties and is commonly used for fever and pain symptoms caused by colds, malaria, and other conditions. It can enhance immunity, increase the activity of white blood cells and phagocytes, and help strengthen the immune system against viral and bacterial infections. Furthermore, it can exert an immunosuppressive effect when the immune system is overactive, balancing the body's immune response. The saponins in bupleurum have anti-inflammatory properties, inhibiting the release of inflammatory mediators such as interleukins and prostaglandins, and are used in inflammatory diseases such as hepatitis and arthritis. It can lower transaminases, alleviate liver cell damage, and promote liver cell regeneration, demonstrating liver protection and enzyme-lowering effects. Bupleurum extracts exhibit certain anti-tumor activity. Experimental studies have shown that it can inhibit the growth of various tumor cells, with a particularly strong inhibitory effect on liver cancer cells. It also exhibits certain anxiolytic and antidepressant properties, modulating neurotransmitter secretion to relieve stress, improve mood disorders, and help cope with anxiety, depression, and other emotional issues.

[0047] Bupleurum has the functions of relieving exterior symptoms and reducing fever, soothing the liver and relieving depression, and raising Yang Qi. In this combination, Bupleurum is mainly used to soothe the liver and relieve depression, harmonize the Qi mechanism, make the liver Qi flow smoothly, and the Qi and blood flow unimpeded, thereby relieving symptoms such as chest and flank pain caused by liver Qi stagnation. Therefore, it is used as the main medicine together with Crataegus pinnatifida.

[0048] Salvia miltiorrhiza

[0049] Efficacy: Promote blood circulation and remove blood stasis, regulate menstruation and relieve pain, clear the heart and relieve restlessness, cool blood and eliminate carbuncle.

[0050] Indications: irregular menstruation, dysmenorrhea, amenorrhea, postpartum pain due to blood stasis, chest pain, abdominal pain, flank pain, accumulation of masses, pain due to heat arthritis, swelling and pain of sores, restlessness and insomnia, hepatosplenomegaly, and angina pectoris.

[0051] Nature and flavor: bitter, slightly cold. Enters the heart and liver meridians.

[0052] Historical Origin: The name of Danshen was first seen in Shennong's Herbal Classic.

[0053] Ancient records: "Compendium of Materia Medica" states that it "treats heart and abdominal pain." "Shennong's Classic of Materia Medica" lists Salvia miltiorrhiza as a top-grade herb, noting that it "can dissolve stagnant blood, treat heart and abdominal masses, and resolve gas in the intestines. Long-term use can help with weight loss, improve eyesight, and prolong life." Li Shizhen, in "Compendium of Materia Medica," notes that Salvia miltiorrhiza "treats heart and abdominal blood and qi pain, menstrual irregularities, promotes blood circulation, eliminates sores, and promotes muscle growth." "Compendium of Materia Medica" mentions that Salvia miltiorrhiza "is effective in treating heart and abdominal blood clots, restlessness, bone steaming, and blood-wind disorders."

[0054] Modern pharmacological research has shown that Danshen can dilate coronary arteries, increase coronary blood flow, reduce myocardial oxygen consumption, and alleviate myocardial ischemia. Its active ingredients, tanshinone and salvianolic acids, have protective effects against cardiovascular diseases such as coronary heart disease and angina pectoris. They can inhibit platelet aggregation and prevent thrombosis. By improving blood circulation and reducing blood viscosity, Danshen is effective in preventing and treating thrombotic disorders such as cerebral thrombosis and deep vein thrombosis. It possesses potent antioxidant properties, scavenging free radicals, inhibiting lipid peroxidation, protecting vascular endothelial cells, slowing the onset and progression of arteriosclerosis, and delaying aging. Danshen's active ingredients inhibit inflammatory factors, effectively alleviating chronic inflammatory responses and are commonly used to treat arthritis and chronic inflammatory diseases. Danshen extracts have inhibitory effects on various tumor cells. Tanshinone I and Tanshinone II, in particular, have been shown to inhibit tumor cell proliferation and induce apoptosis, with particularly significant inhibitory effects on liver, gastric, and lung cancer cells. Danshen can dilate microvessels and improve microcirculatory disorders. Its regulatory effect on peripheral blood vessels can effectively promote blood supply to local tissues, improve ischemia and hypoxia, and is suitable for various blood stasis diseases. It has a neuroprotective effect. Studies have shown that it can improve nerve cell function and promote cerebral blood supply, which helps prevent and treat diseases such as stroke and Alzheimer's disease.

[0055] Salvia miltiorrhiza is a key herb for promoting blood circulation and removing blood stasis. It can invigorate blood circulation, dispel blood stasis, relieve menstrual pain, clear the heart and relieve restlessness, and cool the blood and eliminate carbuncle. When used with Crataegus pinnatifida and Bupleurum chinense, the effects of promoting blood circulation and removing blood stasis are doubled, so it is considered a subordinate herb.

[0056] Turmeric

[0057] Efficacy: Promotes blood circulation and relieves pain, promotes qi and relieves depression, clears the heart and cools blood, promotes bile secretion and reduces jaundice.

[0058] Indications: stabbing pain in the chest and flanks, chest pain and heart pain, amenorrhea and dysmenorrhea, breast distension and pain, coma due to fever, epilepsy and madness, vomiting and nosebleed due to blood heat, jaundice and dark urine.

[0059] Nature and flavor: Pungent, bitter, cold. Enters the liver, heart, and lung meridians.

[0060] Historical origin: The name of Curcuma was first recorded in "Materia Medica".

[0061] Ancient texts record that in the Shennong Bencaojing (Shennong's Classic of Materia Medica), turmeric is listed as a top-grade herb, stating that it "treats evil spirits in the heart and abdomen, colds and fevers, scabies, itches, scabs, and hemorrhoids; long-term use calms the mind and removes bad air." The Bencao Jingshu (Compendium of Materia Medica) states that it "treats blood and qi stagnation, heart and abdominal pain, postpartum blood stasis, suicidal thoughts, and insanity." The Mingyi Bielu (Famous Doctors' Records) mentions that turmeric "treats blood stasis and qi stagnation, chest and diaphragm tightness and pain, restlessness, and promotes bile secretion and reduces jaundice."

[0062] Modern pharmacological research indicates that turmeric has significant hepatoprotective and choleretic properties, promoting bile secretion and enhancing the excretion function of the biliary system. It is commonly used to treat conditions such as cholecystitis, cholelithiasis, and icteric hepatitis. Furthermore, turmeric can alleviate liver cell damage and protect the liver. It also has a modulating effect on the central nervous system. Experimental studies have shown that turmeric can exert antidepressant effects by regulating neurotransmitters (such as serotonin and norepinephrine), improving mood disorders and alleviating depressive symptoms. It also has significant anti-inflammatory properties, inhibiting the production and release of inflammatory mediators such as prostaglandins and interleukins, thereby reducing inflammatory responses in the body. Its analgesic properties are also prominent, and it is often used to relieve pain caused by blood stasis, such as chest pain, abdominal pain, and headaches. Curcumin, an active ingredient in turmeric, has inhibitory effects on various tumor cells. Experimental studies have shown that turmeric can inhibit tumor cell proliferation and induce apoptosis, showing particular anti-cancer activity against liver, gastric, and breast cancers. It can significantly improve blood circulation, reduce blood viscosity, prevent platelet aggregation, and reduce thrombosis. It can invigorate blood circulation, dissipate blood stasis, and prevent vascular obstruction, making it suitable for patients with blood stasis and vascular diseases. It has a protective effect on the central nervous system, improving cerebral blood supply and preventing and treating neurodegenerative diseases such as stroke and Alzheimer's disease. Studies have shown that turmeric can reduce oxidative stress in nerve cells and protect neurons from damage. Curcumin and other active ingredients in turmeric have strong antioxidant properties, scavenging free radicals and reducing cellular oxidative damage, helping to delay aging and prevent free radical-related diseases.

[0063] Curcuma Root has the effects of promoting blood circulation and relieving pain, promoting qi and relieving depression, clearing the heart and cooling blood, promoting bile secretion and relieving jaundice, and calming the mind and promoting sleep. In this prescription, Curcuma Root can not only promote qi and relieve depression, assist Bupleurum in soothing the liver, but also promote blood circulation and relieve pain. Together with Salvia miltiorrhiza and Crataegus, it plays the role of promoting blood circulation and removing blood stasis, so it is the assistant herb.

[0064] Cassia seeds

[0065] Efficacy: Clears heat and improves eyesight, moistens the intestines and promotes bowel movements.

[0066] Indications: red, swollen and painful eyes, photophobia and excessive tearing, blurred vision, headache and dizziness, dry intestines and constipation.

[0067] Nature and flavor: sweet, bitter, salty, slightly cold. Enters the liver and large intestine meridians.

[0068] Historical origin: First recorded in "Shennong Bencao Jing".

[0069] Ancient books record: "Shennong's Herbal Classic" records: "It tastes sweet and bitter, is neutral, and is used to treat amblyopia, red eyes, white film, red and painful eyes, and tearing. Long-term use improves essence and lightens the body." "Compendium of Materia Medica" records: "It clears the liver and brightens the eyes, dispels wind and opens the orifices, cools the liver and purges fire, and moistens the intestines and promotes bowel movements."

[0070] Modern pharmacological research: It has a variety of biologically active ingredients, such as emodin, chrysophanol, etc. It has the following effects: Lipid-lowering effect: The active ingredients in Cassia seed can inhibit cholesterol absorption and help lower serum total cholesterol and low-density lipoprotein (LDL) levels. Antihypertensive effect: Studies have shown that Cassia seed extract has the effect of dilating blood vessels and lowering blood pressure. Antioxidant effect: The flavonoids in Cassia seed have certain antioxidant effects, which help reduce the damage of free radicals. Antibacterial and anti-inflammatory: Cassia seed has certain antibacterial and anti-inflammatory effects, and can fight against certain pathogens. Lubricating the intestines and promoting bowel movements: Cassia seed is rich in dietary fiber and anthraquinone components, which have a laxative effect, especially for constipation in people with hot constitutions.

[0071] Cassia seed can clear the liver and improve eyesight, moisten the intestines and promote bowel movements, and can also lower blood pressure and lipids. When used in combination with the above-mentioned herbs, the liver-clearing effect is more pronounced, and it can also assist in lowering blood pressure and lipids, so it is an adjuvant.

[0072] French Pinellia

[0073] Efficacy: Drying dampness and resolving phlegm, relieving adverse symptoms and stopping vomiting, eliminating lumps and dispersing nodules.

[0074] Indications: Damp phlegm, cold phlegm, cough and asthma with excessive sputum, dizziness and palpitations due to phlegm and fluid, dizziness due to wind phlegm, headache due to phlegm, vomiting and nausea, chest and abdominal distension, plum pit qi, carbuncle and swelling.

[0075] Nature and flavor: Pungent, warm. Toxic. Enters the spleen, stomach, and lung meridians.

[0076] Historical Origin: The name Pinellia ternata was first mentioned in the Shennong's Herbal Classic. French Pinellia ternata is a processed product of Pinellia ternata. Ancient texts state that the Shennong's Herbal Classic states that it "treats cold and fever in cold-induced typhoid fever, a hardness under the heart, relieves gas, sore throat and pharynx, dizziness, chest distension, cough, intestinal rumbling, and stops sweating." In the Treatise on Febrile Diseases, Pinellia ternata is a key Chinese medicinal ingredient, appearing in numerous prescriptions such as Banxia Xiexin Decoction and Xiaobanxia Decoction, used to treat vomiting, abdominal distension, and other symptoms.

[0077] Modern pharmacological research: The specific effects are as follows: Expectorant effect: Pinellia ternata can promote the discharge of respiratory secretions, enhance ciliary movement, help dilute and expel sputum, and play an expectorant role. Antiemetic effect: Modern research shows that Pinellia ternata can effectively control vomiting by inhibiting the vomiting center in the medulla oblongata, especially for nausea and vomiting caused by chemotherapy. Anti-inflammatory effect: Pinellia ternata contains alkaloids and various chemical components, which have certain anti-inflammatory effects and can be used to treat inflammatory diseases. Antitussive effect: The ingredients in Pinellia ternata have a certain antitussive effect on the respiratory system, and are suitable for relieving coughs and asthma caused by phlegm and dampness. Anti-tumor effect: Some experimental studies have shown that extracts of Pinellia ternata have an inhibitory effect on certain tumor cells, indicating that it may have potential application value in the anti-tumor field.

[0078] Pinellia ternata has the functions of drying dampness and resolving phlegm, lowering adverse qi and stopping vomiting. In this prescription, Pinellia ternata can lower adverse qi and stop vomiting, and is combined with Bupleurum and Curcuma to regulate the Qi, so it is the assistant medicine.

[0079] Alisma orientalis

[0080] Efficacy: Diuresis, expelling dampness, relieving heat, resolving turbidity and reducing blood lipids.

[0081] Indications: Dysuria, edema, diarrhea, oliguria, phlegm and fluid retention, dizziness, painful stranguria caused by heat, and hyperlipidemia. Nature and flavor: Sweet, light, cold. Enters the kidney and bladder meridians.

[0082] Historical origin: First recorded in "Shennong Bencao Jing".

[0083] Ancient books record: "Shennong's Herbal Classic" says that it "treats wind-cold-dampness arthritis, lactation, eliminates water, nourishes the five internal organs, increases energy and strength, and makes the body fat and healthy."

[0084] Modern pharmacological research: Alisma orientalis has also shown a variety of biological activities in modern medical research. Diuretic effect: Alisma orientalis extract can significantly increase urine volume, help excrete excess water from the body, and has a good effect on water and sodium retention caused by edema and nephritis. Lipid-lowering effect: Studies have shown that the active ingredients in Alisma orientalis can lower total cholesterol and low-density lipoprotein (LDL) levels in serum, and increase high-density lipoprotein (HDL), so it has a certain therapeutic effect on hyperlipidemia. Anti-hepatic steatosis: Alisma orientalis extract can prevent and treat fatty liver, help regulate fat metabolism in the body, and protect liver health. Anti-inflammatory and antioxidant effects: The active substances in Alisma orientalis have certain anti-inflammatory and antioxidant effects, which can reduce the damage to cells caused by free radicals and help fight inflammatory diseases. Anti-hypertension: Through its diuretic and vasodilatory effects, Alisma orientalis can help lower blood pressure and is particularly suitable for auxiliary treatment of hypertension.

[0085] Alisma can promote diuresis and eliminate dampness, clear away heat and purge fire. Its diuretic and dampness-inducing power can help the body expel dampness and turbidity through urine. When used together with blood-activating and stasis-removing herbs such as hawthorn and salvia miltiorrhiza, it can accelerate the dissipation of blood stasis and dampness, so it is a ministerial drug.

[0086] Tangerine peel

[0087] Efficacy: Regulates Qi and strengthens the spleen, dries dampness and resolves phlegm.

[0088] Indications: Spleen and stomach qi stagnation syndrome, vomiting, hiccups, damp phlegm, cough due to cold phlegm, and chest pain.

[0089] Nature and flavor: Pungent, bitter, warm. Enters the spleen and lung meridians.

[0090] Historical origin: First recorded in "Shennong Bencao Jing".

[0091] Ancient books record: "Compendium of Materia Medica" says that it "treats vomiting, retching, stomach upset, occasional vomiting of clear water, phlegm, malaria, large intestine obstruction, and breast abscess in women. It can be added to food to detoxify the fishy smell."

[0092] Modern pharmacological research: Tangerine peel has the effects of regulating gastrointestinal motility, promoting gastric juice secretion, anti-ulcer, liver protection, choleretic, expectorant, anti-asthmatic, anti-inflammatory, anti-allergic, anti-platelet aggregation, lowering blood lipids, and anti-atherosclerosis.

[0093] Tangerine peel has the functions of regulating qi and strengthening the spleen, drying dampness and resolving phlegm. In this prescription, tangerine peel not only helps bupleurum and turmeric to promote qi and relieve depression, but also helps Pinellia to dry dampness and resolve phlegm, so as to regulate qi, so it is the assistant medicine.

[0094] In summary, the combined use of hawthorn, bupleurum, salvia miltiorrhiza, turmeric, cassia seed, pinellia, oriental water chestnut, and dried tangerine peel can effectively soothe the liver and relieve depression, activate blood circulation and dissipate blood stasis, promote qi circulation and relieve pain, dry dampness and resolve phlegm, promote diuresis and dampness removal, clear the liver and improve eyesight, moisten the intestines and promote bowel movements, and lower blood pressure and lipids. These herbs complement each other, harmonizing qi and blood, dissolving phlegm and dampness, unblocking stasis, and promoting smooth qi flow, thereby treating symptoms caused by liver qi stagnation, blood stasis and qi stagnation, and internal phlegm and dampness.

[0095] Advantages of the present invention:

[0096] The composition provided by the present invention has the effects of improving diabetes, especially improving blood sugar, blood lipids, insulin resistance, and reducing inflammatory response in diabetes combined with MAFLD. The pharmaceutical composition is a refined prescription determined by rationally combining Chinese medicine based on the holistic concept of traditional Chinese medicine, according to the idea of ​​TCM syndrome differentiation and treatment, combined with clinical practice, and the results of modern pharmacological research. This prescription can significantly reduce blood sugar, improve insulin resistance, and has a good hypoglycemic effect. At the same time, it has a significant therapeutic effect on diabetes combined with fatty liver, not only having a hypoglycemic effect, but also significantly improving the patient's liver function, blood lipids, blood sugar, C-peptide, OGTT, and B-ultrasound indicators when treating clinical symptoms and signs such as loss of appetite, discomfort in the liver area, and pain in the liver area. The overall clinical efficacy of the present invention is significant without obvious side effects. Description of the drawings:

[0097] Figure 1 To test the functional results of the formulated crude drugs for zebrafish experiments;

[0098] Figure 2 Western blot results of ERK, JMK, LC3B, P38 and P62 in liver tissues of mice in each group;

[0099] Figure 3 The HE staining results of the livers of mice in each group (200×). Specific implementation method:

[0100] The beneficial effects of the present invention are further illustrated by the following specific examples, but the protection scope of the present invention is not limited thereto;

[0101] Example 1: Soothing Liver and Clearing Sugar Recipe

[0102] Hawthorn 1060g, Bupleurum 320g, Salvia miltiorrhiza 640g, Curcuma 320g, Cassia seed 426g, Pinellia 320g, Alisma orientalis 426g, Tangerine peel 320g

[0103] Preparation: Grind all ingredients together to a 12-mesh fine powder. Following traditional Chinese medicine preparation methods, sieve the ground 12-mesh powder and mix thoroughly in a medicine container. Then, package and seal. Each bag contains 1.75 ± 0.25 g of Shugan Qingtang Recipe.

[0104] 64 patients were divided into a treatment group (32 cases) and a control group (32 cases). The treatment group took the prescription and the control group took Zhibitai capsules. Clinical experiments were conducted on 32 patients in each group:

[0105] The specific dosage regimen is as follows:

[0106] The treatment group was given 1 bag of Shugan Qingtang prescription each time, 1.75±0.25g per bag, orally 3 times a day;

[0107] The control group was given 2 Zhibitai capsules (0.24 g / capsule) orally twice a day.

[0108] The medicine was taken for 28 consecutive days, and the changes of alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum triglyceride (TG), total cholesterol (TC) and blood glucose (BG) in each group were detected on the 29th day.

[0109] The results showed that there was no statistical difference in alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum triglyceride (TG), total cholesterol (TC) and blood glucose (BG) between the two groups before treatment (P>0.05). However, after treatment, the ALT, AST, TG, TC and BG levels of the treatment group using the formula of Example 1 were significantly lower than those of the control group of Zhibitai Capsules (P<0.05). The results are shown in Table 1:

[0110] Table 1 Effects of Shugan Qingtang Recipe on ALT, AST, TG, TC, and BG

[0111]

[0112] The results showed that the Shugan Qingtang formula of the present invention has the effects of promoting blood circulation and removing blood stasis, soothing the liver and relieving depression, promoting qi and relieving pain, and promoting diuresis and removing dampness. It can significantly lower blood sugar, improve insulin resistance, and reduce blood lipids, significantly improving patients' symptoms such as flank pain, abdominal pain, fatigue, and poor appetite.

[0113] Example 2 predicts the function of the Soogan Qingtang recipe of Example 1 through zebrafish experiments.

[0114] Normally developed 3 dpf (days post-fertilization) zebrafish (AB line) were randomly selected and placed in a 6-well cell culture plate. The experiment set up a normal group and a Shugan Qingtang prescription group. After 3 days of intervention, the zebrafish were loaded into a microfluidic chip to analyze the effects of Shugan Qingtang prescription on the zebrafish brain nerves, behavior and heart beats. The function of Shugan Qingtang prescription was predicted by clustering analysis of the data and comparing it with the "drug comprehensive database". The experimental results showed that the crude drugs in the prescription have the potential to lower blood lipids, lower blood sugar, fight tumors, lower uric acid, lower blood pressure, and relieve depression. Among them, the effects of lowering blood lipids and relieving diabetes are more obvious ( Figure 1 ).

[0115] Example 3 Hypoglycemic Effect of the Sogan Qingtang Recipe of Example 1 on Mice with Diabetes and MAFLD

[0116] (1) Preparation of diabetic MAFLD mouse model

[0117] Currently, the commonly used methods for establishing diabetic animal models include pancreatectomy, chemical induction, spontaneous diabetic animal models, and transgenic diabetic models. Pancreatectomy requires meticulous surgical procedures and postoperative animal care, resulting in permanent β-cell loss and a low success rate. Spontaneous diabetic animal models are established using purebred inbred animals with a predisposition to spontaneous diabetes. However, purebred animal models do not conform to human genetic characteristics and are sensitive to environmental changes, primarily used for pathogenesis research. Transgenic diabetic models are established by transferring specific functional genetic genes or deleting specific endogenous genes. These methods are complex and expensive. Currently, the most commonly used chemical induction methods include streptozotocin and alloxan. However, alloxan induction has a low success rate after intravenous injection and cannot be corrected by increasing the dose. It requires fasting and has a high mortality rate. Therefore, streptozotocin-induced diabetic models were selected for this study because they selectively destroy pancreatic β cells and offer advantages such as a high success rate, good reproducibility, and affordability.

[0118] There are four main types of MAFLD animal models: malnutrition models, drug toxicity models, genetically modified models, combined gene-diet models, and combined Traditional Chinese Medicine (TCM) disease models. Drug toxicity models can easily lead to animal death and differ significantly from the pathogenesis and pathophysiological changes observed in humans. Genetically modified models are difficult to operate and expensive. Combined gene-diet models lack reproducibility and lack standardized modeling. Combined Traditional Chinese Medicine (TCM) disease models have low mouse tolerance, high mortality rates, and are difficult to establish and replicate.

[0119] This experiment used a nutritionally malnourished MAFLD animal model induced with a high-sugar, high-fat diet. This modeling method is simple, reproducible, has low mortality, and is relatively inexpensive. This diabetic MAFLD model closely resembles the natural course of human disease in terms of pathology and physiology. Reversal of the disease is very slow after modeling, making it amenable to drug intervention. It is an ideal model for studying drug treatment of diabetic MAFLD mice.

[0120] (2) Grouping and drug administration

[0121] Thirty C57BL / 6 male mice were randomly divided into a blank control group, a model group, and a Shugan Qingtang formula group, with 10 mice in each group. The blank control group was fed a normal diet; the model group and the Shugan Qingtang formula group were fed a high-sugar, high-fat diet, and after 4 weeks, streptozotocin (40 mg / kg / day) was injected intraperitoneally for 5 consecutive days. When the fasting blood glucose value was higher than 16.5 mmol / L on the 7th day, the diabetic mouse model was considered successful. The mice were then fed a high-sugar, high-fat diet for another 4 weeks to establish the MAFLD model. After successful modeling, the Shugan Qingtang formula group was gavaged with the Shugan Qingtang formula suspension, while the blank control group and the model group were gavaged with the same volume of normal saline for 4 weeks. During the gavage period, the blank control group continued to be fed a normal diet, while the model group and the Shugan Qingtang formula group continued to be fed a high-sugar, high-fat diet.

[0122] (3) Preparation of oral suspension for the Shugan Qingtang prescription group

[0123] First, you need to calculate the daily dosage required for mice based on the conversion method between adult and mouse dosages (the daily dosage of raw herbs required by humans / 70 kg × the ratio of the surface area of ​​the animal to the human body ÷ the weight of the animal). The dosage of Shugan Qingtang prescription for adults is 3 times a day, 1.75g ​​each time, so the amount of raw medicine required for an adult per day is 1.75g×3=5.25g. The body surface area of ​​a 20g mouse is about 0.0025 times the body surface area of ​​a 70kg adult, so the dosage for the mouse is converted to 5.25g×0.0025÷0.02kg=0.65625g / kg. Then, the body weight of each mouse in the Shugan Qingtang prescription group was weighed, and the dosage required for each mouse per day was calculated and weighed. Then, the gavage volume required for each mouse in the Chinese medicine group per day was calculated according to the standard of gavage volume 1ml / 100g mouse body weight, and the amount was measured with a measuring cylinder and collected into a beaker. Then, the total daily dosage of the weighed Shugan Qingtang prescription group mice was poured into the total gavage volume of water and stirred with a glass rod to fully dissolve it to prepare a suspension. The suspension was stored at 4°C and gavaged to the mice once a day.

[0124] (4) Detection indicators and methods

[0125] After 12 weeks, the serum OGTT, blood lipids, blood glucose, and liver function levels of the mice in each group were detected by automatic biochemical analyzer; the serum reactive oxygen species (ROS) levels of the mice in each group were detected by confocal microscopy; the serum C-reactive protein (CRP), C-peptide, and lipopolysaccharide (LPS) levels of the mice in each group were detected by ELISA; the expression levels of ERK, JMK, LC3B, P38, and P62 in the liver tissues of the mice in each group were detected by Western blot; and the histological morphology and lipid deposition of the livers of the mice in each group were observed by HE staining.

[0126] (5) Experimental results

[0127] ① Results of glucose tolerance test of mice in each group:

[0128] The glucose tolerance test is a laboratory test used to diagnose diabetes. Mice undergo eight weeks of modeling, and blood glucose levels are measured after four weeks of drug administration.

[0129] Testing method: Draw blood from the vein on an empty stomach in the morning to determine the blood sugar concentration, then take 75 grams of anhydrous glucose at one time, measure the blood sugar once at 1 / 2, 1, and 2 hours after taking the sugar, draw a glucose tolerance curve with the time of blood sugar measurement as the horizontal axis (0 hours when fasting) and the blood sugar concentration as the vertical axis. Normal people's blood sugar reaches a peak 1 / 2-1 hour after taking sugar, then gradually decreases, and generally returns to normal in about 2 hours, while diabetic patients have higher than normal fasting blood sugar, and their blood sugar concentration rises sharply after taking sugar, and can still be higher than normal after 2 hours.

[0130] In this study, compared with the blank control group, the blood glucose levels of the mice in the model group were significantly increased at 0, 30, 60, 90 and 120 minutes, and the inter-group comparisons showed statistical differences (P < 0.05); compared with the model group, the blood glucose levels of the mice in the Shugan Qingtang prescription group were reduced at 0, 90 and 120 minutes, and the inter-group comparisons showed statistical differences at 90 and 120 minutes (P < 0.05) (Table 2).

[0131] Table 2 Glucose tolerance test (OGTT) experimental results of mice in each group

[0132]

[0133] Conclusion: The Shugan Qingtang prescription of Example 1 has a significant effect of lowering blood sugar.

[0134] ② Results of blood lipid and liver function levels in each group of mice:

[0135] Compared with the blank control group, the levels of triglyceride (TG), total cholesterol (CHO), low-density lipoprotein (LDL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in the model group were significantly increased, and high-density lipoprotein (HDL) was significantly decreased; compared with the model group, the levels of TG, CHO, LDL, ALT and AST in the Shugan Qingtang prescription group were significantly decreased, and HDL was significantly increased; the differences between the groups were statistically significant (P < 0.05) (Table 3).

[0136] Table 3 Blood lipid and liver function levels of mice in each group

[0137]

[0138] Conclusion: The Shugan Qingtang prescription of Example 1 has obvious lipid-regulating and liver-protecting effects. It can reduce total cholesterol, low-density lipoprotein and triglycerides, which are risk factors for diabetes, through lipid-regulating effects, and increase high-density lipoprotein, which is beneficial to the human body, thereby inhibiting the progression of diabetes.

[0139] ③ ROS, LPS, CRP and C-peptide levels in mice in each group

[0140] Most patients with type 2 diabetes have elevated levels of inflammatory factors. Inflammatory markers can predict the risk of developing type 2 diabetes. Similarly, inflammation can also induce or aggravate diabetes by damaging pancreatic cell function and triggering insulin resistance. Diabetic patients who persist in a state of chronic low-grade inflammation can also develop MAFLD. Lipopolysaccharide (LPS) and C-reactive protein (CRP) are important inflammatory factors; reactive oxygen species (ROS) are normal products of cellular metabolism, primarily produced during inflammation; and C-peptide is secreted by pancreatic beta cells. It shares a common precursor, proinsulin, with insulin, so testing C-peptide can accurately reflect the function of pancreatic beta cells.

[0141] In this study, compared with the blank control group, the levels of LPS, CRP, and C-peptide in the model group mice were significantly increased, while ROS showed no significant change; compared with the model group, the levels of LPS, CRP, and C-peptide in the Shugan Qingtang prescription group mice were significantly decreased, while ROS showed no significant change; the LPS, CRP, and C-peptide levels were statistically different among the groups (P < 0.05) (Table 4).

[0142] Table 4 ROS, LPS, CRP and C-peptide levels in mice in each group

[0143]

[0144] Conclusion: The Shugan Qingtang recipe of Example 1 has the effect of reducing inflammatory factors and improving pancreatic β-cell function.

[0145] The mitogen-activated protein kinase (MAPK) signaling pathway is a classic signaling pathway involved in regulating inflammation. Extracellular signal-regulated kinase (ERK), c-Jun amino-terminal kinase (JNK), and p38 protein (P38) are the three most important branches of the MAPK pathway. JNK and p38 have similar functions and are involved in inflammation, apoptosis, and growth; ERK primarily regulates cell growth and differentiation. Studies have found that when driven by a high-fat diet, JNK can induce diabetic inflammation, activating JNK's proinflammatory cytokines or P38, while high glucose levels can also induce ERK activation.

[0146] Autophagy is a process that degrades cytoplasmic proteins and organelles, and is one of the mechanisms by which the body responds to internal and external stresses. Autophagy may influence the development and progression of diabetes through various pathways, such as affecting the function of pancreatic beta cells and participating in inflammatory responses. P62 and LC3 are two major proteins in the autophagy pathway, with LC3B being the most widely used. As an autophagy substrate protein, p62 acts as a bridge between LC3 and polyubiquitinated proteins. Therefore, when autophagy occurs, LC3B expression increases, and P62 decreases due to its continuous consumption.

[0147] In this study, compared with the blank control group, the expression levels of ERK, JNK, P38, and P62 in the liver of the model group mice were significantly increased, and the expression level of LC3B was significantly decreased; compared with the model group mice, the expression levels of ERK, JNK, P38, and P62 in the liver of the Shugan Qingtang group mice were decreased, and the expression level of LC3B was slightly increased ( Figure 2 ).

[0148] Conclusion: The Shugan Qingtang recipe in Example 1 may play the role of lowering blood sugar, lowering blood lipids, protecting the liver and alleviating inflammatory response by regulating the MAPK pathway and cellular autophagy.

[0149] ⑤ The results of HE staining of the livers of mice in the blank control group showed that the hepatocytes had regular morphology and were evenly distributed. Compared with the blank control group, a large number of fat vacuoles of varying sizes were observed in the hepatocytes of mice in the model group, the hepatic sinusoids were narrowed or disappeared, lipid deposition was obvious, and the hepatocytes showed ballooning degeneration. Compared with the model group, the fat vacuoles in the hepatocytes of mice in the Shugan Qingtang prescription group were significantly reduced, the hepatic sinusoids were alleviated, and lipid deposition was improved ( Figure 3 ).

[0150] Conclusion: The Shugan Qingtang recipe of Example 1 can improve lipid deposition in the liver of patients with diabetes combined with MAFLD.

[0151] Example 4

[0152] Hawthorn 1200g, Bupleurum 400g, Salvia miltiorrhiza 580g, Curcuma 400g, Cassia seed 500g, Pinellia 400g, Alisma orientalis 352g, Tangerine peel 400g

[0153] The preparation method is the same as that of Example 1.

[0154] This prescription has the effects of promoting blood circulation and removing blood stasis, soothing the liver and relieving depression, promoting qi and relieving pain, and promoting diuresis and removing dampness. There is no significant difference in the recovery of liver elasticity index, blood sugar reduction level, biochemistry and histology compared with Example 1.

[0155] Example 5:

[0156] Hawthorn 920g, Bupleurum 240g, Salvia miltiorrhiza 700g, Curcuma 300g, Cassia seed 400g, Pinellia 300g, Alisma orientalis 400g, Tangerine peel 240g

[0157] The preparation method is the same as that of Example 1.

[0158] Compared with Example 1, the dosage of Salvia miltiorrhiza is increased in the formula, thereby enhancing the effect of promoting blood circulation and removing blood stasis. Although the dosage of Crataegus pinellia, Curcuma aromatica, Cassia seed, Pinellia ternata and Alisma orientalis is reduced at the same time, the recovery of blood lipid and blood sugar indicators by the formula is basically consistent with that of Example 1.

[0159] Example 6:

[0160] Hawthorn 1120g, Bupleurum 350g, Salvia miltiorrhiza 600g, Curcuma 400g, Cassia seed 500g, Pinellia 240g, Alisma orientalis 500g, Tangerine peel 240g

[0161] The preparation method is the same as that of Example 1.

[0162] This prescription has the effects of promoting blood circulation and removing blood stasis, soothing the liver and relieving depression, promoting qi and relieving pain, and promoting diuresis and removing dampness. The improvement of clinical symptoms and biochemical indicators was weaker than that of other examples, but there was no significant difference.

[0163] Example 7:

[0164] Hawthorn 1200g, Bupleurum 400g, Salvia miltiorrhiza 700g, Curcuma 400g, Cassia seed 500g, Pinellia 400g, Alisma orientalis 500g, Tangerine peel 400g

[0165] Compared to Example 1, the ingredients in the formula have been increased to varying degrees, yet the formula still has the effects of promoting blood circulation and removing blood stasis, soothing the liver and relieving depression, promoting qi and relieving pain, and promoting diuresis and eliminating dampness. Furthermore, it can significantly alleviate symptoms such as flank pain, abdominal pain, and diarrhea. The results of reducing biochemical indicators such as blood lipids, blood sugar, and liver function, as well as liver elasticity and hardness test results, are comparable to those in Example 1.

[0166] Example 8 Effects of the Soothing Liver and Clearing Sugar Recipes of Examples 1, 4-7 on Blood Glucose and CAP Values

[0167] Using the Shugan Qingtang prescriptions of Examples 1 and 4-7 as treatment drugs, liver elasticity and hardness were tested on 18 patients in each group under the same administration conditions. Changes in blood glucose and CAP values ​​before and after treatment were observed in each group. The results are shown in Table 5.

[0168] Table 5 Effects of the Sogan Qingtang Recipe of Examples 1, 4-7 on blood glucose and CAP values

[0169]

[0170] Conclusion: The Shugan Qingtang prescriptions of Examples 1 and 4-7 all have a good blood sugar lowering effect and can better improve the liver elasticity and hardness of patients with diabetes and MAFLD. Among them, Example 1 is superior to other prescriptions in both improving liver elasticity and lowering blood sugar.

[0171] Example 9 Clinical Trial

[0172] A total of 399 patients with type 2 diabetes and MAFLD were randomly divided into three groups, namely the Shugan Qingtang prescription group (133 cases), the metformin group (133 cases) and the combined medication group (Shugan Qingtang prescription combined with metformin group) (133 cases). There was no statistical difference in gender and age among the three groups of patients (P>0.05) (Table 6). The patients in the Shugan Qingtang prescription group were given Shugan Qingtang prescription (Example 1) 1 bag each time, 1.75±0.25g per bag, orally three times a day; the patients in the metformin group were given metformin hydrochloride tablets 500mg, orally twice a day; the two-drug combination group was given Shugan Qingtang prescription 1 bag each time, 1.75±0.25g per bag, orally three times a day, plus metformin hydrochloride tablets 500mg, orally twice a day. All three groups of patients took the medicine for 60 consecutive days, and blood lipids, blood sugar, liver function and liver elasticity and hardness CAP values ​​were tested before and after treatment. (Table 7)

[0173] Table 6 General information of the three groups of patients with diabetes and MAFLD

[0174]

[0175] Table 7 Laboratory test results of three groups of patients with diabetes and MAFLD

[0176]

[0177] Examination results showed that blood sugar levels decreased in all three groups after treatment. The metformin and combination groups showed significantly better glucose-lowering efficacy than the Shugan Qingtang formula group, with the combination group showing the most significant glucose-lowering effect. Metformin can slightly improve blood lipids and liver elasticity and stiffness (CAP) values ​​through its glucose-lowering effect, but has no significant effect on liver function transaminases. The Shugan Qingtang formula can effectively regulate blood lipids and reduce liver function transaminases and liver elasticity and stiffness (CAP). When the Shugan Qingtang formula is used in combination with metformin, it can achieve a more effective therapeutic effect, with statistically significant differences between the groups (P < 0.05) (Table 7). Although the traditional Chinese medicine formula Shugan Qingtang Recipe is not as effective as the Western medicine metformin in lowering blood sugar in diabetic patients, it still exerts a good blood sugar-lowering effect. Moreover, while lowering blood sugar, the Shugan Qingtang Recipe of the present invention has unique advantages in regulating blood lipids, protecting the liver, and restoring the normal morphology and function of the liver. Moreover, the present invention is a new traditional Chinese medicine compound preparation for lowering blood sugar. While exerting its therapeutic effect, it does not have any toxic side effects. Compared with chemical drugs, the traditional Chinese medicine composition of the present invention can significantly reduce the damage of drugs to the liver and kidneys and improve safety.

[0178] Conclusion: The Soogan Qingtang prescription of the present invention can significantly lower blood sugar levels, effectively treat diabetes, and at the same time regulate blood lipids, protect the liver, and restore the normal morphology of the liver. It can be used to treat diabetes combined with MAFLD, thereby reducing blood lipids, blood sugar, liver function transaminases, and liver elasticity and hardness indicators in patients with diabetes combined with MAFLD, without obvious toxic and side effects.

Claims

1. A Chinese medicine composition, characterized in that: The Chinese medicine composition is prepared from the following raw materials: 920-1200 parts of hawthorn, 240-400 parts of bupleurum, 580-700 parts of salvia, 240-400 parts of curcuma, 352-500 parts of cassia seed, 240-400 parts of pinellia, 352-500 parts of oriental rhizome, and 240-400 parts of tangerine peel.

2. The Chinese medicine composition according to claim 1, characterized in that The Chinese medicine composition is prepared from the following raw materials: 1000-1120 parts of hawthorn, 300-350 parts of bupleurum, 600-700 parts of salvia, 300-400 parts of curcuma, 400-500 parts of cassia seed, 300-400 parts of pinellia, 400-500 parts of oriental rhizome, 300-400 parts of tangerine peel.

3. The Chinese medicine composition according to claim 1, characterized in that The Chinese medicine composition is prepared from the following raw materials: 1060-1120 parts of hawthorn, 320-350 parts of bupleurum, 600-640 parts of salvia, 320-350 parts of curcuma, 426-450 parts of cassia seeds, 320-350 parts of pinellia, 426-450 parts of oriental rhizome, and 320-350 parts of tangerine peel.

4. The Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The mass ratio of hawthorn, bupleurum, salvia miltiorrhiza, curcuma, cassia seed, pinellia, oriental water plantain and tangerine peel is 3-4:1-2:2-3:1-2:1-3:1-2:1-3:1-2:1-3:1-2.

5. The Chinese medicine composition according to claim 4, characterized in that: The mass ratio of hawthorn to tangerine peel is 3-4:

1.

6. The Chinese medicine composition according to claim 5, characterized in that: The mass ratio of the bupleurum root, curcuma, pinellia tuber and dried orange peel is 1:1:1:

1.

7. The Chinese medicine composition according to any one of claims 1 to 6, characterized in that: The Chinese medicine composition is prepared into a clinically acceptable preparation with a pharmaceutically acceptable carrier or excipient, and the preparation is preferably: tablets, capsules, granules, pills, and powders.

8. Use of the Chinese medicine composition according to any one of claims 1 to 7 in the preparation of a drug for treating diabetes.

9. Use of the Chinese medicine composition according to any one of claims 1 to 7 in the preparation of a drug for treating fatty liver.

10. Use of the Chinese medicine composition according to any one of claims 1 to 7 in the preparation of a drug for treating diabetes combined with fatty liver.

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