Traditional Chinese medicine composition for treating diabetes mellitus with hyperlipemia and preparation method thereof

Abstract

The invention belongs to the technical field of diabetes medicines, and particularly relates to a traditional Chinese medicine composition for treating diabetes with hyperlipemia and a preparation method thereof.The composition is prepared from, by weight, 20-40 parts of astragalus membranaceus, 10-20 parts of coptis chinensis, 20-40 parts of Chinese yam, 9-15 parts of lotus leaves, 3-9 parts of red yeast rice, 12-18 parts of scorched hawthorn fruit, 12-18 parts of winged euonymus twig and 15-25 parts of fiveleaf gynostemma herb. According to the traditional Chinese medicine composition, the spleen-tonifying and qi-replenishing medicine is matched with the heat-clearing and turbidity-transforming medicine, and the traditional Chinese medicine composition has the effects of activating blood circulation, tonifying without nourishing greasy feeling and eliminating evil without hurting vital energy, has the effects of replenishing qi, tonifying spleen, removing turbidity and dispersing blood stasis together, and has remarkable curative effects in the aspects of improving symptoms and signs of diabetes accompanied by hyperlipidemia, improving the living quality of patients and the like.

Description

Technical Field

[0001] The invention belongs to the technical field of diabetes medicines, and particularly relates to a traditional Chinese medicine composition for treating diabetes with hyperlipidemia and a preparation method thereof. Background Art

[0002] Diabetes mellitus (DM) is a chronic progressive metabolic disease characterized by elevated blood sugar. The main physiological and pathological causes are the relative lack of insulin secretion accompanied by varying degrees of insulin resistance (IR). Long-term IR and poor blood sugar control cause the patient's body to be in a state of metabolic disorder for a long time. At present, the incidence and mortality of diabetes are increasing worldwide. According to the International Diabetes Federation, the global prevalence of diabetes will reach more than 700 million in 2045, and it is gradually showing a trend of younger age.

[0003] Hyperlipemia (HLP) usually refers to elevated levels of total cholesterol (TC), triglyceride (TG), and low-density lipoprotein cholesterol (LDL-C) in serum, and decreased levels of high-density lipoprotein cholesterol (HDL-C). A study on monitoring chronic diseases and their risk factors in Chinese adults published in 2018 showed that 26.3% of adults had LDL-C levels ≥3.4mmol / L, which was elevated or abnormal. The percentage of adults whose LDL-C levels reached the ideal level recommended by the guidelines was only 39.3%. In addition, 25.8% of adults had TG ≥1.7mmol / L and 20.4% of adults had HDL-C <1.0mmol / L.

[0004] Diabetes with hyperlipidemia refers to a state in which diabetes is accompanied by increased plasma TG and decreased HDL-C, or increased LDL-C, or IR. According to statistics, the incidence of hyperlipidemia in patients with type 2 diabetes (T2DM) in my country exceeds 60%, and the combined disease will increase the risk of cardiovascular disease by more than 8 times. At present, the main treatment for DM in clinical practice is oral hypoglycemic drugs, such as biguanides, sulfonylureas, α-glucosidase inhibitors and thiazolidinediones. These oral drugs mainly focus on the regulation of blood sugar in the treatment of DM, and there are certain limitations. Especially for elderly DM patients who are often accompanied by multiple complications, a single hypoglycemic drug is not enough to improve the symptoms. Therefore, more effective and safer therapeutic drugs are urgently needed to be developed. Traditional Chinese medicine has the advantages of mild and lasting effects, few side effects, and low cost. Studies have confirmed that traditional Chinese medicine and its natural bioactive ingredients have a variety of anti-hyperglycemic effects, such as scavenging oxygen free radicals, preventing blood hypercoagulation, inhibiting protein non-enzymatic glycosylation, inhibiting aldose reductase, regulating fat and protein metabolism, and effectively controlling or delaying the occurrence of DM and its complications. The "National Primary Diabetes Prevention and Management Guidelines" (2022 edition) clearly states that in the diagnosis and treatment of T2DM, attention should be paid to prevention before illness. For common intervenible risk factors such as dyslipidemia, comprehensive intervention treatments such as TCM syndrome differentiation should be combined as soon as possible to help prevent and delay complications. It is of great significance to reduce the prevalence of cardiovascular disease and improve the quality of life.

[0005] Blood lipid management, mainly adjusting cholesterol levels, is an important measure for the prevention and treatment of atherosclerotic cardiovascular disease (ASCVD). At present, the awareness, treatment and control rates of hyperlipidemia in adults are still at a low level, and the lipid-lowering treatment rate and compliance rate of high-risk / extremely high-risk groups for ASCVD are worrying. After primary and secondary prevention (statin treatment) or combined treatment with fenofibrate drugs, the cholesterol levels of many patients are still difficult to reach the target. In addition, problems such as reduced tolerance to statins have led to new bottlenecks in the prevention and treatment of ASCVD. Therefore, in order to reduce the increasing burden of cardiovascular diseases, it is of great significance to explore the prevention and treatment strategies of diabetes with hyperlipidemia from the perspective of traditional Chinese medicine. Exploring effective Chinese medicine compositions to prevent and treat diabetes with hyperlipidemia is the research direction of Chinese medicine practitioners in my country. Summary of the invention

[0006] In view of the current situation that there is still a lack of unified and effective treatment plans for the prevention and treatment of diabetes with hyperlipidemia by traditional Chinese medicine, the present invention provides a traditional Chinese medicine composition for treating diabetes with hyperlipidemia and a preparation method thereof. The composition is composed of drugs such as astragalus, coptis root, yam, lotus leaf, red yeast rice, charred hawthorn, euphorbia pulex, and gynostemma pentaphyllum, and spleen-tonifying and qi-invigorating drugs are matched with heat-clearing and turbidity-removing drugs, and blood circulation promoting drugs are used to nourish without being greasy, and to remove pathogens without hurting the body, and the effects of invigorating qi and strengthening the spleen, clearing turbidity and removing blood stasis are achieved together, and the composition has remarkable curative effect in improving the symptoms and signs of diabetes with hyperlipidemia, improving the quality of life of patients, etc.

[0007] Diabetes belongs to the category of "Xiao Ke" in traditional Chinese medicine. Its name was first seen in "Su Wen·Qi Bing Lun". Its cause is related to insufficient congenital endowment, improper diet, emotional disorder, and excessive labor and desire. The pathogenesis is Yin fluid deficiency and excessive dryness and heat. "Yi Xue Zhong Can Xi Lu" has a discussion on the pathogenesis of Xiao Ke, which is "Xiao Ke's symptoms are mostly caused by the failure of Yuan Qi to rise" and the symptoms of Xiao Ke start from the middle jiao. Ancient doctors did not have a good understanding of the concept of "hyperlipidemia", so they did not record it in ancient books, but the descriptions of "cream", "fat turbidity" and "blood turbidity" can be seen, which are roughly consistent with its symptoms. "Su Wen·Tong Ping Xu Shi Lun Pian": "Sweet and fat noble people, then it is the disease of sorghum." Improper diet and excessive consumption of fat, sweet and greasy food will make the spleen's transportation and transformation function insufficient and lipids accumulate. "Suwen Zhizhen Yaoda Lun Pian" states: "All swellings and fullness due to dampness belong to the spleen." Obese people have more phlegm and dampness, and their innate endowment is insufficient, and their spleen and stomach are weak, so the spleen's transportation and transformation are unfavorable, and dampness gathers to produce phlegm; the transformation of water and grain essence is abnormal, so the dregs are mixed into the blood, and turbidity and blood stasis are produced. Diabetes is caused by yin deficiency as the root and dryness and heat as the symptom, so yin deficiency produces internal heat, consumes semen, causes poor blood circulation and blood stasis, and burns body fluids, refining fluids into phlegm, forming a pathological product of turbidity and blood stasis. Diabetes can cause the production of tangible evils such as phlegm turbidity and blood stasis, which can induce lipid turbidity, and can also serve as a pathogenic factor to further aggravate diabetes, making the combined diseases stick together and difficult to cure. In the end, a disease with spleen deficiency as the root and turbidity and blood stasis as the symptom is formed, with the root deficiency and the symptom as the real, and the deficiency and real mixed, so the treatment is mainly to replenish the deficiency and eliminate the evil.

[0008] In summary, the inventors finally found that the treatment of diabetes with hyperlipidemia should focus on the main links and main contradictions. The inventors believe that strengthening the spleen and stomach is the key. By strengthening the spleen and replenishing qi, clearing away heat and removing turbidity, and promoting blood circulation, the functions of raising clearness and lowering turbidity are restored, and the qi and blood are sufficient, and the qi movement is unobstructed, which is conducive to the removal of dampness, blood stasis, and heat toxins, thereby improving the patient's sugar and lipid levels and blocking the progression of the disease. The above is the treatment mechanism proposed by the inventors, and it is applied to the specific treatment process:

[0009] On the basis of the above treatment mechanism, combined with the action mechanism of related drugs, the specific technical solutions provided by the present invention are as follows:

[0010] A Chinese medicine composition for treating diabetes with hyperlipidemia, the main components of which are calculated by weight:

[0011] 20-40 parts of Astragalus, 10-20 parts of Coptis, 20-40 parts of Dioscorea, 9-15 parts of Lotus Leaf, 3-9 parts of Red Yeast, 12-18 parts of Crataegus pinnatifida, 12-18 parts of Euphorbia obesa, 15-25 parts of Gynostemma pentaphyllum;

[0012] The best therapeutic effect can be obtained within the above dosage range. Too much or too little drug dosage will lead to changes in the primary and secondary pathogenesis of the prescription.

[0013] Preferably, the main components of the Chinese medicine composition are as follows by weight:

[0014] 21-39 parts of astragalus, 11-19 parts of coptis root, 21-39 parts of yam, 10-14 parts of lotus leaf, 4-8 parts of red yeast rice, 13-17 parts of charred hawthorn, 13-17 parts of euphorbia obesa, and 16-24 parts of gynostemma pentaphyllum.

[0015] The prescription of the present invention uses Astragalus as the main ingredient, which is sweet and slightly warm. It has the functions of nourishing the spleen and lungs, replenishing blood and activating blood circulation, as well as the effects of raising yang and lifting the sunken. It can nourish the vital energy of the spleen and stomach, and targets the root cause of the pathogenesis of weak spleen in diabetes with hyperlipidemia.

[0016] With coptis chinensis, yam, lotus leaf, clematis fasciata and gynostemma pentaphyllum as ministers. coptis chinensis is very bitter and cold, clears and dries, drains and descends pure yin, and is good at clearing heat from the middle burner; yam is sweet and neutral, can strengthen the spleen and replenish deficiency, nourish the kidney and benefit the essence, and benefit the stomach yin; lotus leaf is bitter and neutral, can clear away heat and dampness, promote the clear yang, cool blood and stop bleeding; clematis fasciata is bitter, pungent and cold, and has the functions of breaking up blood, removing blood stasis, dredging menstruation, dispelling wind and killing insects; gynostemma pentaphyllum is bitter, slightly sweet and cool, can strengthen the spleen and benefit qi, clear away heat and remove phlegm.

[0017] Red yeast rice and charred hawthorn are used as adjuvants. Red yeast rice is sweet and slightly warm, and can invigorate the spleen and digestion, promote blood circulation and remove blood stasis; charred hawthorn is sour, sweet and slightly warm, and can invigorate digestion and invigorate the stomach, promote qi and disperse blood stasis, remove turbidity and reduce fat. The two herbs assist astragalus in invigorating the spleen and stomach. The combination of all the herbs can play the role of invigorating the spleen and replenishing qi, and removing turbidity and removing blood stasis.

[0018] The more specific Chinese and Western medicine mechanisms for each medicine are as follows:

[0019] Astragalus: first seen in "Wu Er Bing Fang", it is slightly warm in nature, sweet in taste, and belongs to the lung and spleen meridians. It has many functions such as replenishing qi and raising yang, consolidating the exterior and stopping sweating, promoting diuresis and reducing swelling. Astragalus contains chemical components such as polysaccharides, saponins, flavonoids, and amino acids. Astragalus is particularly effective in replenishing qi. "Ben Cao Qiu Zhen" records: "Astragalus is sweet in taste and warm in nature, light in quality, yellow in skin and white in flesh, so it can enter the lungs to replenish qi, enter the exterior and strengthen the defense, and is the best of all qi-replenishing medicines, so it is called astragalus." Astragalus polysaccharide achieves insulin sensitization and hypoglycemic activity by reducing the expression and activity of protein tyrosine phosphatase 1B (PTP1B) in skeletal muscle of streptozotocin-induced T2DM rats. Astragalus polysaccharide can regulate some insulin signals in insulin-resistant skeletal muscle and may become a potential insulin sensitizer for the treatment of T2DM. In addition, studies have found that astragalus polysaccharide can reduce the appetite of db rats, which may be through improving leptin sensitivity to improve lipid metabolism in fat rats. By testing the active ingredient astragaloside I in Qige Decoction, the researchers found that it can reduce lipid accumulation in rat liver cells.

[0020] Coptis chinensis: bitter, cold, enters the heart, spleen, stomach, liver, gallbladder, and large intestine meridians, clears away heat and dampness, and purges fire and detoxifies. Studies have shown that quercetin, palmitine, berberine, and other components of Coptis chinensis have the effects of regulating glucose and lipid metabolism, reducing proinflammatory factors, anti-oxidation, upregulating the expression of glucose transporter 4, and increasing the level of insulin, thereby promoting the cell's uptake of glucose to achieve the purpose of lowering blood sugar. Quercetin can effectively improve IR, inhibit adipocyte differentiation, and reduce adipocyte inflammatory response. High-dose administration of berberine can improve blood lipid indicators TC, TG, HDL-C and LDL-C, regulate glucose tolerance, fasting blood glucose (FBG), fasting insulin (FIns) and insulin resistance index (homeostasismodel assessment of insulin resistance, HOMA-IR).

[0021] Chinese Yam: From the Tang Dynasty Hou Ningji's "Pharmacopoeia", it is sweet, flat, and can strengthen the spleen and replenish deficiency, nourish the kidney and benefit the essence, and benefit the stomach yin. Chinese Yam polysaccharides have the effect of lowering blood sugar, and can also increase insulin sensitivity and improve the insulin signal transduction pathway. Experiments have shown that Chinese Yam polysaccharides can reduce the levels of TC, TG, LDL-C and HDL-C in the plasma of obese mice induced by a high-fat diet, and reduce the expression of MMP-3 and NF-κB / p65, indicating that Chinese Yam polysaccharides can improve insulin sensitivity and have a protective effect on hyperlipidemia. Resistant starch (RS) in Chinese Yam tubers regulates lipid metabolism by producing short-chain fatty acids (SCFAs). SCFAs can bind to free fatty acid receptor 2 (FFAR2), enhance the activity of adenylate-activated protein kinase (AMPK), and promote the expression of peroxisome proliferator-activated receptor α (PPARα), thereby improving lipid metabolism disorders.

[0022] Lotus leaf: cool in nature, bitter, pungent, slightly astringent, and enters the heart, liver, and spleen meridians. It has the effects of relieving heat and dampness, strengthening the spleen and raising yang, and dispersing blood stasis and stopping bleeding. Studies have found that lotus leaf water extract can reduce the body weight and serum triglyceride levels of HLP rats. The results show that lotus leaf extract can improve liver function and reduce blood lipid levels. Its main bioactive substance, lotus leaf alkaloid compounds, are related to lipid-lowering effects. First, the overexpression of dopamine receptors can lead to obesity, and lotus leaf alkaloids can inhibit dopamine receptors D1 and D2, thereby achieving the purpose of lipid-lowering; second, lotus leaf alkaloids are involved in bile secretion and glyceride metabolism, and are also involved in the expression of key genes in the peroxisome proliferator-activated receptor (PPAR) signaling pathway. In addition, in the high-fat diet and streptozotocin-induced diabetic mouse model, nuciferol can significantly improve the glucose tolerance of DM mice, relieve insulin resistance, increase insulin sensitivity, activate the PPARα / PGC1α pathway, and upregulate the expression of IR, IRS1, Glut2 and Glut4 mRNA in the liver tissue of the model animals. In the cell model, nuciferol can increase the expression of glucose translocator 4 (GLUT4) and its translocation to the cell membrane by activating the AMPK pathway and the G protein-PLC-PKC pathway, thereby promoting the cell's uptake of glucose; on the other hand, nuciferol can directly promote the secretion of insulin, and its mechanism of action is similar to shutting down the ATP-dependent K + Channel related.

[0023] Herba Astragali: bitter, pungent, cold in nature, enters the liver and spleen meridians, has the functions of breaking blood and dredging menstruation, detoxifying and reducing swelling, and killing insects. According to modern research, Herba Astragali mainly contains ingredients such as Astragali alkaloids, tripterygium wilfordii, dasyphylline, citronellin, and dasyphylline. While effectively lowering blood sugar, it has a certain protective effect on pancreatic β cells, thereby improving the ability to synthesize insulin and enhancing insulin secretion to regulate abnormal metabolism. In addition to reducing the patient's FBG and FIns, Herba Astragali can also correct the lipid metabolism disorder in the patient's body and increase the activity of superoxide dismutase in the patient's body, thereby improving DM symptoms.

[0024] Gynostemma pentaphyllum: bitter, sweet, cool in nature, belongs to the lung, spleen, and kidney meridians, sweet tonic and bitter to relieve, cold can be cleared, and has the effects of strengthening the spleen and replenishing qi, removing phlegm and relieving cough, clearing away heat and detoxifying. The active ingredients such as saponins and polysaccharides of Gynostemma pentaphyllum have hypoglycemic effects, can significantly reduce HOMA-IR, and improve DM complications. A large number of studies have reported that the total saponins extracted from Gynostemma pentaphyllum can significantly reduce serum cholesterol, triglycerides and blood sugar levels, can significantly improve the IR in T2DM rats, can significantly improve the glucose and lipid metabolism level of T2DM mice, and reduce the degree of liver lipid degeneration, and no serious adverse reactions have been found. Studies have shown that the lipid-regulating effect of total saponins of Gynostemma pentaphyllum is related to the inhibition of free fatty acid production and synthesis of neutral fat in adipocytes. Gynostemma pentaphyllum saponins and their derivatives regulate the insulin pathway by inhibiting PTP1B. Gynostemma pentaphyllum polysaccharide has a significant lipid-lowering effect on DM rats. In addition, studies have found that Gynostemma pentaphyllum polysaccharide can inhibit the absorption of glucose by DM mice and affect the expression of GLUT2 protein, but does not affect the expression of sodium / glucose co-transporter 1, indicating that Gynostemma pentaphyllum polysaccharide can be used as an effective ingredient for the prevention and treatment of diabetes.

[0025] Red yeast rice: sweet in taste, slightly warm in nature, enters the spleen, large intestine, and liver meridians, and has the effects of strengthening the spleen and digestion, promoting blood circulation and removing blood stasis. Monacolin compounds are the main lipid-regulating active substances in red yeast rice. They are the rate-limiting enzymes in the cholesterol synthesis process, and can competitively inhibit HMG-Co A reductase to reduce the synthesis of endogenous cholesterol, thereby achieving the purpose of regulating blood lipids. Some studies have shown that stigmasterol isolated from red yeast rice also has the effect of regulating blood lipids. Stigmasterol can competitively inhibit the body's absorption of cholesterol and effectively reduce serum cholesterol levels. It is an important active ingredient for regulating blood lipid balance and preventing cardiovascular and cerebrovascular diseases. In addition, animal experiments have shown that red yeast rice can reduce blood sugar concentration, improve insulin resistance and hyperinsulinemia, and increase insulin sensitivity, indicating that the hypoglycemic effect of red yeast rice is achieved by increasing insulin secretion and improving insulin resistance. Clinical data also show that red yeast rice extract preparations have a definite lipid-lowering effect, and also have a definite effect on patients with non-insulin-dependent diabetes.

[0026] Scorched Hawthorn: First recorded in the New Compendium of Materia Medica, it is sour, sweet, slightly warm, and enters the spleen, stomach, and liver meridians. It has the functions of digesting food, strengthening the stomach, promoting qi and dispersing blood stasis, removing turbidity and reducing fat. It is widely used in the treatment of erosion of meat accumulation, stomach distension, abdominal pain and diarrhea, blood stasis and amenorrhea, hypertension, and hyperlipidemia. The main active ingredient of scorched hawthorn, total flavonoids, can lower blood lipids; ursolic acid is the main component of hawthorn triterpenoids, which also has antioxidant and blood lipid-lowering effects. Experiments have shown that scorched hawthorn can significantly reduce fat accumulation in rats, reduce liver and spleen index, and significantly reduce the levels of TG, TC and LDL-C in rat serum. In addition, studies have shown that the combined use of hawthorn leaf and hawthorn fruit extracts can improve blood sugar and lipid metabolism disorders in rats with glucose and lipid metabolism disorders, significantly increase the expression of cholesterol regulatory element binding protein-1 (SREBP-1) and aminocyclopropane-l-carboxylic acid (ACC) proteins in the liver tissue of model rats, and regulate the content of SREBP-1 and ACC proteins.

[0027] Furthermore, the inventors have rationally optimized the above-mentioned drug components and finally obtained the following technical solution: The main components of the drug are calculated by weight:

[0028] 30 parts of Radix Astragali, 15 parts of Rhizoma Coptidis, 30 parts of Rhizoma Dioscoreae, 12 parts of Lotus Leaves, 6 parts of Red Yeast, 15 parts of Fructus Crataegi, 15 parts of Radix Psoraleae, 20 parts of Gynostemma Pentaphyllum.

[0029] On the basis of the above-mentioned drug composition, the inventor further provides a method for preparing the above-mentioned Chinese medicine decoction, which is as follows:

[0030] First, weigh out each Chinese medicine according to the ratio of the raw materials, then add water until the surface of the medicine is covered by 3-5 cm, soak for 1.5 hours, boil over high heat, then simmer for 40-50 minutes, filter out the juice for later use, add water to the residue again, until the surface of the residue is covered by 1-2 cm, boil over high heat, then simmer for 20-30 minutes, filter out the juice and combine it with the previous juice to get the Chinese medicine decoction.

[0031] The method of taking the above-mentioned liquid medicine is as follows: 1 dose per day, divided into two doses in the morning and evening, taken warm 1-2 hours after meals.

[0032] The drug obtained by the prescription and preparation method of the present invention is very effective in clinical application. The inventor has proved through a large number of experiments that compared with the currently commonly used clinical drugs for treating diabetes with hyperlipidemia, metformin and atorvastatin calcium, the pharmaceutical composition of the present invention has significant efficacy and has significant advantages in reducing blood sugar, reducing blood lipids, improving clinical symptoms and signs, and improving the quality of life of patients. Therefore, the technical scheme of the present invention has obvious advantages from theory to clinical effect. In actual conditions, the combination of the present invention can be selected and used together with Western medicine (metformin, atorvastatin calcium).

[0033] In summary, the present invention combines traditional Chinese medicine theory with the theory of disease-symptom combination to obtain a Chinese medicine composition specifically for treating diabetes with hyperlipidemia. The spleen-tonifying and qi-invigorating drugs are matched with heat-clearing and turbid-removing drugs, and blood circulation is promoted to achieve the effects of invigorating qi and strengthening the spleen, removing heat and clearing turbidity, and removing evil without damaging the body, and achieving the effects of invigorating qi and strengthening the spleen, clearing turbidity and removing blood stasis. The Chinese medicine composition has remarkable therapeutic effects in improving the symptoms and signs of diabetes with hyperlipidemia and improving the quality of life of patients. DETAILED DESCRIPTION

[0034] The present invention is not limited by the following embodiments. The following embodiments and descriptions are only for illustrating the principles of the present invention. Without departing from the spirit and scope of the present invention, the present invention may be subject to various changes and improvements, and these changes and improvements all fall within the scope of the present invention to be protected.

[0035] Example 1

[0036] A Chinese medicine composition for treating diabetes with hyperlipidemia, prepared from the following drugs:

[0037] Astragalus 30g, Coptis chinensis 15g, Chinese yam 30g, lotus leaf 12g, red yeast rice 6g, charred hawthorn 15g, Psoralea corylifolia 15g, Gynostemma pentaphyllum 20g.

[0038] The method for preparing Chinese medicine decoction using the above Chinese medicine composition is as follows:

[0039] (1) First, weigh out each Chinese medicine according to the ratio of raw materials, mix evenly, add 1200 ml of cold water, covering the surface of the medicine by 3-5 cm, and soak for 1.5 hours;

[0040] (2) Boil the mixed raw materials over high heat, simmer over low heat for 45 minutes, and filter through gauze to obtain the filtrate and residue;

[0041] (3) mixing the residue obtained in step (2) with 550 ml of hot water to cover the residue by 1-2 cm, and boiling the mixture. The hot water is purified water at a temperature of 80° C., boiling the mixture over high heat, and then boiling the mixture over low heat for 25 minutes. After that, filtering the mixture again with gauze to obtain the filtrate and the residue.

[0042] (4) The filtrate obtained in step (2) and the filtrate obtained in step (3) are mixed to obtain a Chinese medicine decoction for treating diabetes with hyperlipidemia.

[0043] Example 2

[0044] A Chinese medicine composition for treating diabetes with hyperlipidemia, prepared from the following drugs:

[0045] 20g of Astragalus, 10g of Coptis chinensis, 20g of Chinese yam, 9g of lotus leaf, 3g of red yeast rice, 12g of charred hawthorn, 12g of Psoralea corylifolia, and 15g of Gynostemma pentaphyllum.

[0046] The method for preparing a Chinese medicine decoction using the above Chinese medicine composition is as follows:

[0047] (1) First, weigh out each Chinese medicine according to the ratio of raw materials, mix evenly, add 900 ml of cold water, covering the surface of the medicine by 3-5 cm, and soak for 1.5 hours;

[0048] (2) Boil the mixed raw materials over high heat, simmer over low heat for 40 minutes, and filter through gauze to obtain the filtrate and residue;

[0049] (3) mixing the residue obtained in step (2) with 400 ml of hot water to cover the residue by 1-2 cm, and boiling the mixture. The hot water is purified water at a temperature of 80° C., boiling the mixture over high heat, and then boiling the mixture over low heat for 20 minutes. After that, filtering the mixture again with gauze to obtain the filtrate and the residue.

[0050] (4) The filtrate obtained in step (2) and the filtrate obtained in step (3) are mixed to obtain a Chinese medicine decoction for treating diabetes with hyperlipidemia.

[0051] Example 3

[0052] A Chinese medicine composition for treating diabetes with hyperlipidemia, prepared from the following drugs:

[0053] 40g of Astragalus, 20g of Coptis chinensis, 40g of Dioscorea batatas, 15g of Lotus leaf, 9g of Red Yeast, 18g of Charred Crataegus pinnatifida, 18g of Psoralea corylifolia, and 25g of Gynostemma pentaphyllum.

[0054] The method for preparing a Chinese medicine decoction using the above Chinese medicine composition is as follows:

[0055] (1) First, weigh out each Chinese medicine according to the ratio of raw materials, mix evenly, add 1500 ml of cold water, covering the surface of the medicine by 3-5 cm, and soak for 1.5 hours;

[0056] (2) Boil the mixed raw materials over high heat, simmer over low heat for 50 minutes, and filter through gauze to obtain the filtrate and residue;

[0057] (3) mixing the residue obtained in step (2) with 600 ml of hot water to cover the residue by 1-2 cm, and boiling the mixture. The hot water is purified water at a temperature of 80° C., boiling the mixture over high heat, and then boiling the mixture over low heat for 30 minutes. After that, filtering the mixture again with gauze to obtain the filtrate and the residue.

[0058] (4) The filtrate obtained in step (2) and the filtrate obtained in step (3) are mixed to obtain a Chinese medicine decoction for treating diabetes with hyperlipidemia.

[0059] Experimental example

[0060] 1. Clinical data

[0061] 1.1 Source of research subjects and sample size:

[0062] Research subjects: A total of 60 patients who have been diagnosed with diabetes mellitus and hyperlipidemia, who meet the diagnosis of TCM syndrome and require drug intervention were selected in this case. The case data came from outpatient and inpatient patients of the Endocrinology Department of the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine from January 2022 to December 2023.

[0063] 1.2 Diagnostic criteria:

[0064] 1.2.1 Western medicine diagnostic criteria:

[0065] 1.2.1.1 Diagnostic criteria for diabetes:

[0066] According to the diagnostic criteria for diabetes in the "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2020 Edition)", patients have typical symptoms of diabetes (polydipsia, polyphagia, polyuria, unexplained weight loss) and any of the following:

[0067] (1) Random venous plasma glucose ≥11.1 mmol / L;

[0068] (2) or fasting venous plasma glucose ≥7.0 mmol / L;

[0069] (3) Or oral glucose tolerance test 2h (OGTT2h) plasma glucose ≥11.1mmol / L;

[0070] (4) Or glycated hemoglobin HbA1c ≥ 6.5%.

[0071] Note: Random blood sugar refers to blood sugar at any time of the day without considering the last meal time. It cannot be used to diagnose impaired fasting glucose or impaired glucose tolerance. Fasting state refers to no caloric intake for at least 8 hours. If typical symptoms of diabetes do not appear, recheck and confirm on another day.

[0072] 1.2.1.2 Diagnostic criteria for hyperlipidemia:

[0073] Refer to the diagnosis of hyperlipidemia in the "Guidelines for the Prevention and Treatment of Dyslipidemia in Chinese Adults 2016" as the standard:

[0074] (1) Total cholesterol ≥5.2mmol / L;

[0075] (2) triglyceride ≥1.7mmol / L;

[0076] (3) low-density lipoprotein cholesterol ≥ 3.4 mmol / L;

[0077] (4) high-density lipoprotein cholesterol ≤ 1.0 mmol / L;

[0078] Under normal dietary conditions, blood lipids are tested after fasting for 12 hours or more, and those who meet one or more criteria can be diagnosed with hyperlipidemia.

[0079] 1.2.2 TCM syndrome diagnostic criteria

[0080] It is formulated based on the Guiding Principles for Clinical Research of New Chinese Medicines.

[0081] Main symptoms: nausea and vomiting, poor appetite, heaviness in limbs, and abdominal distension;

[0082] Secondary symptoms: fatigue, dull complexion, shortness of breath, laziness in speech, tasteless or sticky mouth;

[0083] Tongue and pulse: pale tongue with tooth marks or petechiae, greasy coating, and thready and wiry pulse.

[0084] If the patient has three main symptoms or two main symptoms and three or more secondary symptoms, combined with tongue and pulse, it can be diagnosed as spleen deficiency, turbidity and blood stasis syndrome.

[0085] 1.3 Case selection criteria

[0086] 1.3.1 Inclusion criteria

[0087] (1) Patients with type 2 diabetes or hyperlipidemia who meet the diagnostic criteria of Western medicine;

[0088] (2) Patients who meet the TCM diagnosis and syndrome differentiation of spleen deficiency, turbidity and blood stasis;

[0089] (3) fasting venous blood glucose between 7.5-13.8mmol / L;

[0090] (4) Aged between 30 and 70 years old, regardless of gender;

[0091] (5) Those with good compliance and able to take medication at the prescribed time and dosage;

[0092] (6) Those who expressed informed consent and were willing to participate in this study.

[0093] 1.3.2 Exclusion criteria

[0094] (1) Those who do not meet the diagnostic criteria and inclusion criteria;

[0095] (2) Patients with type 1 diabetes or other types of diabetes;

[0096] (3) Pregnant or lactating women and those who are intolerant or allergic to the drugs in this prescription;

[0097] (4) Patients with severe acute or chronic complications of diabetes;

[0098] (5) Patients with abnormal blood sugar and blood lipids due to other diseases;

[0099] (6) Patients with serious diseases of important organs such as heart, liver, kidney, brain, and mental illness;

[0100] (7) Patients who are participating in clinical studies of other drugs;

[0101] (8) Those who are unable to use medications as prescribed and fail to cooperate with the researchers of this project.

[0102] 1.3.3 Suspension and elimination criteria

[0103] (1) Patients who experience drug allergy and severe adverse reactions during treatment;

[0104] (2) Patients with severe cardiovascular or cerebrovascular diseases during treatment;

[0105] (3) Patients who use medication irregularly or stop taking medication on their own during treatment, or are unwilling to cooperate with treatment, fail to have regular follow-up visits, or have ineffective responses to active communication;

[0106] (4) Patients who wish to become pregnant or have become pregnant during treatment;

[0107] (5) Patients who want to join other clinical studies during treatment;

[0108] (6) Patients who take drugs that may affect this study during treatment.

[0109] 1.3.4 Shedding Standard

[0110] (1) Those who voluntarily withdraw from treatment;

[0111] (2) Those who cannot continue to participate due to other emergencies;

[0112] (3) Incomplete clinical data collection makes it impossible to conduct clinical efficacy and safety evaluation;

[0113] (4) Patients who have lost contact and cannot be tracked or followed up.

[0114] 2. Research Methods

[0115] 2.1 Study design

[0116] 60 patients diagnosed with spleen deficiency and turbidity and stasis syndrome among patients with diabetes and hyperlipidemia who met the diagnostic criteria of Western medicine were selected, and they were randomly divided into a test group and a control group using a random number table method, with 30 cases in each group. The clinical efficacy was observed by comparing the pharmaceutical composition of Example 1 (the process and dosage of Example 1 were used to decoct 200ml of Chinese medicine decoction, which was taken warm twice in the morning and evening, 100ml each time) and metformin hydrochloride tablets and atorvastatin calcium tablets. The treatment course was 8 weeks, and the changes in the quantitative score of the TCM syndrome of diabetes with hyperlipidemia (spleen deficiency and turbidity and stasis syndrome) diagnostic scale and the changes in the experimental value index were observed before and after the two groups of patients were treated. After the end of the course of treatment, all data were statistically analyzed using the statistical software SPSS27.0, and the differences before and after treatment of the test group and the control group and between the two groups were compared.

[0117] 2.2 Treatment methods

[0118] 2.2.1 Basic treatment

[0119] (1) Health education: All patients included in the study were educated on relevant health knowledge and were provided with relevant medical knowledge on diabetes and hyperlipidemia so that they would have sufficient knowledge and attention on the disease. At the same time, psychological counseling was provided to the patients, who were advised to keep their mood happy and avoid psychological factors from interfering with the research results.

[0120] (2) Control diet: Advise patients to follow a healthy diet and strictly control it during the observation period. On the one hand, the dietary structure can be improved by appropriately increasing the dietary fiber content in each meal; on the other hand, the intake of fat and salt can be controlled.

[0121] (3) Exercise therapy: Patients are advised to engage in scientific and reasonable exercise, and moderate exercise intensity is recommended, such as Tai Chi, jogging, etc., and they should be able to persist in doing so for a long time.

[0122] 2.2.2 Group treatment

[0123] (1) Experimental group: treated with the pharmaceutical composition of Example 1 (200 ml of the medicinal solution was obtained by decoction using the process and dosage of Example 1, and taken twice a day, morning and evening, 1-2 hours after meals, 100 ml each time).

[0124] (2) Control group: Blood sugar lowering: Metformin hydrochloride tablets (Glucophage, specification: 0.5 g / tablet, national medicine standard number H20023370, produced by Shanghai Bristol-Myers Squibb Pharmaceuticals Co., Ltd.), 0.5 g each time, 3 times a day, orally before meals; lipid-regulating: Atorvastatin calcium tablets (Lipitor, specification: 20 mg / tablet, produced by Pfizer Pharmaceuticals Co., Ltd., national medicine standard number H20051408), 20 mg each time, once a day, before bedtime.

[0125] The observation period for both the experimental group and the control group was 8 weeks, followed by regular follow-up to understand the improvement of patients' subjective symptoms and laboratory tests before and after treatment and record their adverse reactions.

[0126] 2.3 Observation indicators

[0127] 2.3.1 Safety indicators

[0128] (1) Vital signs: respiration, pulse, heart rate, and blood pressure. Evaluation was performed twice before and after treatment.

[0129] (2) Laboratory examinations: three routine tests, electrocardiogram, liver and kidney function (ALT, AST, BUN, SCr), evaluated once before and after treatment, for a total of 2 times.

[0130] (3) Adverse reactions: including drug allergy symptoms, hypoglycemia symptoms and other uncomfortable reactions, and observing its safety indicators to determine whether the drug is safe.

[0131] 2.3.2 Efficacy observation indicators

[0132] (1) Blood glucose indicators: fasting blood glucose (FBG) and 2-hour postprandial blood glucose (2hPG) were evaluated once a week for a total of 8 times; glycosylated hemoglobin (HbA1c) was evaluated once before and after treatment for a total of 2 times.

[0133] (2) Blood lipid indexes: serum total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C). Evaluation was performed once before and after treatment, for a total of 2 times.

[0134] (3) TCM syndrome indicators: evaluated once before and after treatment, for a total of 2 times.

[0135] 2.4 Efficacy evaluation criteria

[0136] 2.4.1 Criteria for determining efficacy of TCM syndromes

[0137] With reference to the "Guidelines for Clinical Research of New Chinese Medicines", the following standards are formulated based on changes in clinical symptoms and signs:

[0138] The efficacy index formula (nimodipine method) is: [(pre-treatment score-post-treatment score) ÷ pre-treatment score] X 100%.

[0139] (1) Significantly effective: clinical symptoms and signs of TCM were significantly improved, and the syndrome score was reduced by ≥70%;

[0140] (2) Effective: clinical symptoms and signs of TCM have improved, and the syndrome score has decreased by ≥30%;

[0141] (3) Ineffective: There is no significant improvement in TCM clinical symptoms and signs, or they may even worsen, and the symptom score decreases by less than 30%.

[0142] 2.4.2 Criteria for determining blood sugar efficacy

[0143] (1) Significant effect: FPG and 2hPG decreased to the normal range, or decreased by more than 40% before treatment; HbA1c value decreased to normal, or decreased by more than 30% before treatment;

[0144] (2) Effective: FPG and 2hPG decreased by more than 20% before treatment, but did not meet the standard of marked effect; HbA1c value decreased by more than 10% before treatment, but did not meet the standard of marked effect;

[0145] (3) Ineffective: FPG and 2hPG did not decrease, or the decrease did not meet the effective criteria; HbA1c did not decrease, or the decrease did not meet the effective criteria.

[0146] 2.4.3 Criteria for determining the efficacy of hyperlipidemia:

[0147] (1) Significant effect: TC decreases by ≥40%, or TG decreases by ≥20%, or HDL-C increases by ≥0.26 mmol / L (10 mg / dl).

[0148] (2) Effective: TC decreased by 20%-40%, or TG decreased by 10%-20%, or HDL-C increased by 0.104-0.26mmol / L (4mg / dl-10mg / dl).

[0149] (3) Invalid: The above TG, TC, and HDL-C indicators did not meet the effective standards.

[0150] 2.5 Statistical methods

[0151] Statistical analysis: An Excel database was established and SPSS 27.0 statistical software was used for data analysis. The data followed a normal distribution and the measurement data were expressed as mean ± standard deviation. The data were described by t test if the variance was equal, and by approximate t test if the variance was not equal; the count data were described by rate (%) and chi-square (χ2) test; the rank data and data that did not conform to normal distribution were described by median and interquartile range, and nonparametric rank sum test was used. All statistical methods were two-sided, and the differences were statistically significant when P < 0.05.

[0152] 3. Results and Analysis

[0153] 3.1 General Information

[0154] All patients were from the outpatient and inpatient departments of the Department of Endocrinology of the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine from January 2022 to December 2023, with a total of 60 cases (n), 30 cases in the experimental group and 30 cases in the control group. No cases dropped out during the treatment in both groups. Among them, there were 12 males and 18 females in the experimental group, with an average age of (52.44±9.23) years old; there were 16 males and 14 females in the control group, with an average age of (50.64±8.99) years old; there was no statistical difference (P>0.05) in gender (P=0.300), age (P=0.124), and BMI (P=0.052) between the two groups before treatment, and they were comparable (see Tables 1, 2, and 3).

[0155] Table 1 Comparison of gender between the two groups of patients

[0156]

[0157] Note: After χ2 test, P=0.300>0.05, there is no statistically significant difference between genders, and comparison can be made.

[0158] Table 2 Comparison of age between the two groups of patients

[0159]

[0160] Note: According to the independent sample t-test, P=0.124>0.05, there is no statistically significant difference in age, so comparison can be made.

[0161] Table 3 Comparison of BMI between the two groups of patients

[0162]

[0163] Note: According to the independent sample t test, P = 0.052> 0.05, there is no statistically significant difference in the course of disease, and comparison can be made. 3.2 Comparison of efficacy indicators before and after treatment between the two groups

[0164] 3.2.1 Comparison of blood sugar levels before and after treatment between the two groups of patients (Table 4)

[0165] Table 4 Comparison of blood sugar indexes before and after treatment between the two groups of patients

[0166]

[0167] After testing, before treatment, the two groups had no significant difference in FPG, 2hPG, and HbA1c, P>0.05, and the difference was comparable. After treatment, the two groups had a decrease in FPG, 2hPG, and HbA1c, P<0.01, and the difference was statistically significant, indicating that both the experimental group and the control group could significantly reduce FPG, 2hPG, and HbA1c. After treatment, the two groups had a significant difference in 2hPG (P<0.001<0.01), and FPG (P=0.019<0.05), indicating that the experimental group had a more obvious effect in reducing 2hPG and FPG; there was no statistically significant difference in HbA1c (P=0.083>0.05).

[0168] 3.2.2 Comparison of blood lipids between the two groups of patients before and after treatment (Table 5)

[0169] Table 5 Comparison of blood lipid indexes between the two groups of patients before and after treatment

[0170]

[0171] After testing, before treatment, the TC, TG, HDL-C, and LDL-C between the two groups were compared, P>0.05, and there was no statistically significant difference, which was comparable. After treatment, the TC, TG, HDL-C, and LDL-C in the two groups decreased compared with those before treatment, and P<0.01, with significant statistical differences, indicating that both the experimental group and the control group could reduce TC, TG, HDL-C, and LDL-C. After treatment, the inter-group comparison showed that the difference in TC (P=0.006<0.01) was statistically significant, and the difference in LDL-C (P=0.038<0.05) was statistically significant, indicating that the experimental group had a more obvious effect in reducing TC and LDL-C; there was no statistically significant difference in TG (P=0.489>0.05) and HDL-C (P=0.720>0.05).

[0172] 3.2.3 Comparison of TCM syndrome scores between the two groups of patients before and after treatment (Table 6)

[0173] Table 6 Comparison of TCM syndrome scores between the two groups of patients before and after treatment

[0174]

[0175] After testing, the TCM syndrome scores of the two groups before treatment were compared, P>0.05, the difference was not statistically significant, and they were comparable. After treatment, the TCM syndrome scores of the two groups were improved, P<0.01, and the difference was statistically significant, indicating that both the experimental group and the control group could significantly improve the TCM clinical symptoms. After treatment, the inter-group comparison was P<0.01, and the difference was statistically significant, indicating that the experimental group had a more obvious effect in improving the TCM clinical symptoms.

[0176] 3.2.4 Comparison of the efficacy of diabetes mellitus between the two groups before and after treatment (Table 7)

[0177] Table 7 Comparison of the efficacy of diabetes mellitus in the two groups before and after treatment

[0178]

[0179] Note: According to the rank sum test, Z=-2.316, P=0.021<0.05, the difference is statistically significant.

[0180] 3.2.5 Comparison of the efficacy of hyperlipidemia in the two groups before and after treatment (Table 8)

[0181] Table 8 Comparison of the efficacy of hyperlipidemia in the two groups of patients before and after treatment

[0182]

[0183] Note: According to the rank sum test, Z=-2.560, P=0.010<0.05, the difference is statistically significant.

[0184] 3.2.6 Comparison of TCM symptom efficacy between the two groups of patients (Table 9)

[0185] Table 9 Comparison of TCM syndrome efficacy between the two groups of patients

[0186]

[0187] Note: According to the rank sum test, Z=-2.421, P=0.015<0.05, the difference is statistically significant.

[0188] 3.3 Comparison of clinical recurrence rates between the two groups of patients (Table 10)

[0189] Table 10 Comparison of clinical recurrence rate

[0190]

[0191] Note: 4 weeks after the end of treatment, 3 people in the experimental group relapsed, with a relapse rate of 10%, and 12 people in the control group relapsed, with a relapse rate of 40%. The difference was statistically significant (P<0.01).

[0192] 3.4 Security Analysis

[0193] No serious adverse reactions were reported in both groups during the trial, and all indicators showed no obvious abnormalities, indicating that the drug safety of this trial was good.

[0194] Specific cases

[0195] Case 1

[0196] Liu, female, 56 years old, height 161cm, weight 71kg, BMI27.4, first visit on January 7, 2023. Chief complaint: elevated blood sugar for 2 years and elevated blood lipids for 2 years. The patient was found to have elevated blood sugar and blood lipids in a local hospital 2 years ago. She took metformin and glimepiride regularly to control blood sugar, and atorvastatin calcium to lower blood lipids, but the effect was not good. The patient did not strictly control diet and increase exercise. Current symptoms: fatigue, heavy limbs, poor appetite, abdominal distension after meals, good sleep, regular bowel movements, pale tongue, tooth marks on the edges, yellow and greasy fur, and thin and astringent pulse. Check: FPG10.9mmol / L, 2hPG14.2mmol / L, HbA1c9.2%, TC6.82mmol / L, TG3.44mmol / L, HDL-C0.91mmol / L, LDL-C3.81mmol / L. Western medicine diagnosis: diabetes combined with hyperlipidemia; Chinese medicine diagnosis: thirst, spleen deficiency and turbidity and blood stasis. Treatment: invigorate the spleen and replenish qi, clear turbidity and remove blood stasis. Prescription: 30g of Astragalus, 15g of Coptis chinensis, 30g of Chinese yam, 12g of lotus leaf, 6g of red yeast rice, 15g of charred hawthorn, 15g of Radix Gynostemma, 20g of Chinese medicine decoction obtained according to the preparation method of Example 1, 1 dose of 200ml per day, warm twice a day in the morning and evening, 100ml each time, 14 packs;

[0197] Follow-up on January 21, 2023: The patient complained of fatigue and heaviness in the limbs, but other symptoms did not change significantly. The tongue was pale with teeth marks on the edges, the tongue coating was white and greasy, and the pulse was thin and wiry. Examination showed that FPG was 9.7mmol / L. The above prescription was continued for 28 packs;

[0198] Follow-up visit on February 18, 2023: The patient felt that his fatigue and heaviness were significantly reduced, his appetite improved, his abdominal distension after meals was relieved, his tongue was pale red, his fur was thin and white, and his pulse was fine and wiry. Examination: FPG8.1mmol / L. Continue to take the above prescription, 14 packs;

[0199] Follow-up visit on March 4, 2023: The patient’s symptoms disappeared or were significantly relieved, the tongue was pale red, the coating was thin white, the pulse was fine, and the examination results were: FPG7.2mmol / L, 2hPG8.8mmol / L, HbA1c6.9%, TC4.79mmol / L, TG2.01mmol / L, HDL-C1.77mmol / L, LDL-C1.96mmol / L.

[0200] Case 2

[0201] Wang, male, 52 years old, height 172cm, weight 78kg, BMI26.4, first visit on May 13, 2023. Chief complaint: elevated blood sugar for 2 years and elevated blood lipids for 4 years. The patient was found to have elevated blood lipids during a physical examination 4 years ago, and elevated blood sugar during a physical examination 2 years ago. The patient did not control his diet or exercise actively. He had taken metformin and other Western medicines for treatment, but the effect was not obvious. His fasting blood sugar fluctuated between 11 and 12 mmol / L. For further treatment, he went to Professor Xu's outpatient clinic for medical treatment. Current symptoms: general fatigue, especially in the limbs, shortness of breath and laziness, bland mouth, poor appetite, good sleep at night, regular bowel movements, dark tongue, petechiae on the tongue, white and greasy tongue coating, and fine and astringent pulse. Check: FPG11.2mmol / L, 2hPG15.1mmol / L, HbA1c10.4%, TC6.46mmol / L, TG2.98mmol / L, HDL-C0.85mmol / L, LDL-C3.02mmol / L. Western medicine diagnosis: diabetes combined with hyperlipidemia; Chinese medicine diagnosis: thirst, spleen deficiency and turbidity and blood stasis. Treatment: invigorate the spleen and replenish qi, clear turbidity and remove blood stasis. Prescription: 30g of Astragalus, 15g of Coptis chinensis, 30g of Chinese yam, 12g of lotus leaf, 6g of red yeast rice, 15g of charred hawthorn, 15g of Euphorbia obesa, 20g of Gynostemma pentaphyllum, the Chinese medicine decoction obtained according to the preparation method of Example 1, 1 dose of 200ml per day, warm and take twice a day in the morning and evening, 100ml each time, 14 packs;

[0202] Follow-up visit on May 27, 2023: The patient felt that his shortness of breath and fatigue had been alleviated, but he still felt a bland mouth, poor appetite, dark tongue, greasy white fur, and a thready pulse. Examination showed that FPG was 9.8mmol / L. He continued to take the above medicine for 28 doses;

[0203] Follow-up on June 24, 2023: The patient reported that his shortness of breath and fatigue were significantly relieved, his taste in the mouth improved, his appetite improved, his tongue was pale, his fur was thin and white, and his pulse was thin. Examination: FPG8.4mmol / L. He continued to take the above medicine, 14 packs;

[0204] Follow-up on July 8, 2023: The patient's complaints were alleviated or disappeared, appetite and sleep were good, bowel movements were normal, tongue was pale red, thin white fur, and pulse was fine. Examination: FPG7.8mmol / L, 2hPG9.2mmol / L, HbA1c8.1%, TC4.11mmol / L, TG1.24mmol / L, HDL-C1.56mmol / L, LDL-C1.44mmol / L.

[0205] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any equivalent substitutions, modifications, etc. made by technicians in this field without any creative work within the spirit and principles of the present invention should be included in the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating diabetes with hyperlipidemia, characterized in that: The main components are calculated by weight as follows: 20-40 parts of astragalus, 10-20 parts of coptis root, 20-40 parts of yam, 9-15 parts of lotus leaf, 3-9 parts of red yeast rice, 12-18 parts of charred hawthorn, 12-18 parts of euphorbia obesa and 15-25 parts of gynostemma pentaphyllum.

2. The Chinese medicine composition for treating diabetes with hyperlipidemia according to claim 1, characterized in that: The main components are calculated by weight as follows: 21-39 parts of astragalus, 11-19 parts of coptis root, 21-39 parts of yam, 10-14 parts of lotus leaf, 4-8 parts of red yeast rice, 13-17 parts of charred hawthorn, 13-17 parts of euphorbia obesa and 16-24 parts of gynostemma pentaphyllum.

3. The Chinese medicine composition for treating diabetes with hyperlipidemia according to claim 2, characterized in that: The main components are calculated by weight as follows: 30 parts of astragalus, 15 parts of coptis root, 30 parts of yam, 12 parts of lotus leaf, 6 parts of red yeast rice, 15 parts of charred hawthorn, 15 parts of euphorbia obesa and 20 parts of gynostemma pentaphyllum.

4. A method for preparing a Chinese medicine composition for treating diabetes with hyperlipidemia using any one of claims 1 to 3, characterized in that: The specific steps are as follows: first weigh each Chinese medicine according to the ratio of the raw materials, then add water until the surface of the medicine is 3-5 cm high, soak for 1.5 hours, boil over high heat, then simmer for 40-50 minutes, filter out the juice for later use, add water to the residue again, until the surface of the residue is 1-2 cm high, boil over high heat, then simmer for 20-30 minutes, filter out the juice and combine it with the above juice.

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