A Chinese medicine composition for treating type 2 diabetes and its preparation

Abstract

The invention discloses a traditional Chinese medicine composition for treating type 2 diabetes. The composition comprises the following medicinal materials in parts by weight: 20-40 parts of kudzu root, 10-40 parts of yam, 15-40 parts of cyathula, 10-20 parts of adenophora australis, 15-40 parts of chicken's gizzard lining, 10-30 parts of salvia miltiorrhiza, 10-20 parts of wolfberry, 5-15 parts of coptis root, 10-20 parts of dried orange peel, and 5-15 parts of dried ginger. The composition is used to treat type 2 diabetes and its complications, demonstrating excellent fasting blood sugar control effects, particularly for type 2 diabetes patients with spleen deficiency-damp-heat syndrome and combined blood stasis and kidney deficiency.

Description

Technical Field

[0001] The present invention belongs to the field of traditional Chinese medicine, and in particular relates to a traditional Chinese medicine composition and a preparation thereof for treating type 2 diabetes. Background Art

[0002] Type 2 diabetes mellitus (T2DM) is a condition characterized by elevated blood glucose levels caused by decreased insulin sensitivity in systemic cells and / or impaired pancreatic beta-cell function. The global prevalence of diabetes was estimated at 536.6 million people in 2021 and is projected to rise to 783.2 million by 2045, with T2DM accounting for 90% of these cases. Patients with T2DM are at increased risk for serious complications, including stroke, renal failure, non-traumatic lower limb amputation, blindness, and premature death. The World Health Organization estimates that by 2030, the number of diabetes-related deaths will double if greater attention is not given. The rapid and alarming rise in the prevalence of T2DM is placing a significant burden on national healthcare costs and current healthcare systems.

[0003] The pathogenesis of T2DM is mainly due to the following eight aspects, either individually or in combination: (1) pancreatic β-cell failure, resulting in decreased insulin secretion; (2) increased glucagon secretion; (3) muscle insulin resistance, impaired or reduced glucose uptake; (4) accelerated lipolysis, impaired or reduced glucose uptake; (5) liver insulin resistance, increased glucose production; (6) increased renal glucose reabsorption; (7) incretin deficiency / resistance in the gastrointestinal tract; and (8) brain insulin resistance and neurotransmitter dysfunction. Current treatment methods mainly target these key pathways using a combination of multiple drugs. Although currently clinically approved T2DM drugs, such as biguanides, sulfonylureas, and GLP-1 inhibitors, have shown good hypoglycemic effects, adverse reactions and side effects caused by them, including nausea, diarrhea, vomiting, edema, obesity, and hypoglycemia, must also be taken seriously. Traditional Chinese Medicine (TCM) has a relatively well-established theoretical framework for the intervention and treatment of T2DM. In recent years, in-depth research on TCM compounds has consistently demonstrated their effectiveness in lowering blood sugar, protecting pancreatic beta cell function, and regulating lipid metabolism. Furthermore, TCM offers advantages such as multiple targets, multiple pathways, multiple effects, and minimal toxic side effects. Therefore, there is an urgent need to develop effective, safe, and patient-acceptable TCM combinations that ensure high compliance. Summary of the Invention

[0004] To address the above-mentioned issues, the present invention provides a Chinese medicine composition and its preparation. This Chinese medicine composition is derived from the classical theories of traditional Chinese medicine and incorporates clinical, geographical, and dietary characteristics. It is primarily used to treat and prevent patients with T2DM and its complications. It is effective for treating all stages of T2DM and effectively controls blood sugar during treatment without the need for other T2DM medications.

[0005] Diabetes is also known as "xiaoke" in traditional Chinese medicine. It was first seen in "The Yellow Emperor's Classic of Internal Medicine". The records in "Suwen·Discussion on Strange Diseases" and "Lingshu·Five Changes" stated that overeating of fatty and sweet foods, emotional imbalance, and weakness of the five internal organs are the causes of diabetes. The main pathogenesis is gastrointestinal heat and loss of semen. For example, "Suwen·Discussion on Yin and Yang" states: "The knot of two yangs is called Xiao." With the continuous understanding and research of diabetes, theoretical systems have been formed in various periods. The Han Dynasty's "Golden Chamber" believed that stomach heat and kidney deficiency were the main pathogenesis of diabetes. The Sui Dynasty's "Treatise on the Origin and Symptoms of Various Diseases·Xiao Ke Bing Zhu Hou" stated that the pathogenesis of diabetes was due to the use of Wu Shi San, which caused deficiency heat in the lower burner and kidney dryness and yin deficiency. The Tang Dynasty's "Bei Ji Qian Jin Yao Fang·Xiao Ke" believed that diabetes was caused by alcoholism and the pathogenesis was dryness of the five internal organs. The Song, Jin and Yuan Dynasties formed the "Three Extinguishments and Dryness Theory", which stated that the pathogenesis of diabetes was "improper diet and feeding, dryness of the stomach and intestines, and improper balance of qi and fluid, or mental exhaustion and excessive use, or serious illness causing loss of yin qi and blood deficiency, strong yang qi and severe dryness and heat" ("Three Extinguishments Theory") as the pathogenesis of diabetes. Qing Dynasty medical scientists proposed that the pathogenesis of diabetes lies in the liver. For example, "Su Ling Wei Yun·Xiao Ke Jie" stated that "diabetes is solely responsible for the liver wood, not the lung metal." The above are the main causes and pathogenesis of diabetes in traditional knowledge. What is different is that the inventors believe that diabetes is mostly caused by congenital deficiency, or acquired dietary irregularities, improper work and rest, spleen deficiency and damp heat, phlegm coagulation, blood stasis blocking the meridians, and poor circulation of qi and blood. The core of the disease is "spleen deficiency", and "spleen deficiency and damp heat, phlegm coagulation and blood stasis" are the main pathogenesis.

[0006] In clinical practice, Qiwei Baizhu San (Seven-Ingredient White Atractylodes Powder) is commonly used to treat spleen and stomach qi deficiency in patients with T2DM. The formula's ginseng, poria, stir-fried white atractylodes, and licorice invigorate the spleen and replenish qi, while costus root and patchouli leaf promote qi and disperse fluid, and kudzu root promotes fluid production and quenches thirst. The entire formula integrates nourishment, transportation, ascending, and descending functions, tonifying without stagnation. Huangqin Huashi Tang (Scutellaria Baicalensis) is commonly used for clearing heat and dampness in patients with T2DM diagnosed with damp-heat in the middle. Scutellaria baicalensis is the main ingredient in the formula, clearing dampness and heat. Combined with umbelliferae, poria peel, talc, and tongcao, it clears heat and dampness. White cardamom seed and tangerine peel promote qi and dissipate cold, relieving stagnation and removing dampness. Combined use of these herbs eliminates dampness and heat. Jiangtang Huoxue Fang (Gantang Huoxue Fang) is commonly used to treat patients with T2DM who also present with blood stasis. Salvia miltiorrhiza, Chuanxiong, and Leonurus japonicus promote blood circulation and resolve stasis, while angelica, red and white peony root, and costus root promote blood circulation and qi, and kudzu root promotes fluid production and quenches thirst. These herbs work together to promote blood circulation and lower blood sugar. These Chinese medicine compositions are respectively effective in treating spleen and stomach qi deficiency, damp-heat obstruction and blood stasis, but there is currently a lack of Chinese medicine compositions that are effective in treating T2DM with all three syndromes combined. The present invention has a definite therapeutic effect in treating the symptoms of "spleen deficiency, damp-heat, phlegm coagulation and blood stasis".

[0007] The Neijing states that "man corresponds to heaven and earth" and that "those who treat illness must understand the laws of nature and geography." Chongqing's climate is humid, warm, and foggy, and Chongqing residents enjoy greasy, spicy foods. Therefore, influenced by the local environment and dietary characteristics, T2DM patients in Chongqing are prone to early spleen and stomach damage, poor spleen and stomach function, stagnation of Qi, and stagnation of food and water, leading to spleen deficiency, dampness (food) obstruction, and phlegm congestion. As the disease progresses, phlegm and dampness accumulate in the middle stage, generating heat, depleting Qi and damaging Yin, leading to both spleen and stomach Qi and Yin deficiency. In the later stages, the disease becomes protracted, leading to phlegm congestion and blood stasis, damaging the lungs, spleen, and kidneys. Based on this, combining the regional climate characteristics with dietary habits, treatment focuses on regulating the Qi and blood of the body's yin and yang, internal organs, and meridians, clearing away heat and dampness, tonifying the spleen and kidneys, and resolving phlegm and removing blood stasis. The Chinese medicine composition and Chinese medicine formula granules of the present invention precisely focus on regulating the Qi and blood of the body's yin and yang, internal organs, and meridians, clearing away heat and dampness, tonifying the spleen and kidneys, and resolving phlegm and removing blood stasis, making them an excellent prescription for treating T2DM in its early, mid, and late stages.

[0008] The Chinese medicine composition of the present invention comprises Rhizoma Coptidis with Wine, which clears away heat and dries dampness, and is the main drug; Pericarpium Citri Reticulatae Invigorates the Spleen and Dries Dampness, Promotes Qi and Strengthens the Spleen; Radix Puerariae and Radix Adenophorae Indicifoliae Invigorate Yin and Promotes Body Fluid; Dioscorea Rhizoma and Fructus Lycii Invigorate the Kidney and Strengthen the Spleen; and Rhizoma Zingiberis Combined with Dried Ginger Warms the Middle and Dispels Cold, Dries Dampness and Eliminates Phlegm, which can prevent the bitter and cold effects of Rhizoma Coptidis with Wine from damaging Yang and prevent the greasy effects of nourishing Yin from hindering the Stomach, and are the assistant drugs; Salvia Miltiorrhizae Invigorates Blood Circulation and Dissipates Blood Stasis, and Endothelial Gizzard Gizzard Invigorates the Stomach and Promotes Digestion, and Helps the Spleen and Stomach Restore Normal Transport and Transformation, and are the adjuvant drugs; Rhizoma Cyathulae Invigorates Blood Circulation and Unblocks Menstruation, and Leads the Deficiency Fire in the Middle and Upper Jiao to Descend, and is the guiding drug. This prescription is not restricted to traditional etiology and pathogenesis, but is based on the pathogenesis of spleen deficiency, damp-heat, phlegm coagulation and blood stasis, and has excellent effects. According to clinical observations, this prescription is safe and effective, and can significantly lower blood sugar, improve symptoms such as itchy skin, dry mouth, polydipsia, polyuria, hunger, and decreased vision. In the prescription, the spleen and kidney are harmonized, and both tonifying and purging are used, which is the characteristic of this prescription.

[0009] In one embodiment, a traditional Chinese medicine composition for treating type 2 diabetes of the present invention comprises the following medicinal materials in parts by weight: 20-40 parts of Pueraria root, 10-40 parts of Chinese yam, 15-40 parts of Cyathula, 10-20 parts of Adenophora australis, 15-40 parts of Chicken's Gizzard Stone, 10-30 parts of Salvia miltiorrhiza, 10-20 parts of Lycium barbarum, 5-15 parts of Coptis chinensis, 10-20 parts of Tangerine peel and 5-15 parts of dried ginger.

[0010] Preferably, the above-mentioned traditional Chinese medicine composition of the present invention is made of the following medicinal materials in parts by weight: 30 parts of Pueraria root, 15-30 parts of Chinese yam, 15-30 parts of Sichuan cypress, 10-20 parts of Adenophora australis, 15-30 parts of chicken's gizzard lining, 10-30 parts of Salvia miltiorrhiza, 10-15 parts of wolfberry, 5-15 parts of Coptis chinensis, 12-18 parts of dried tangerine peel and 5-10 parts of dried ginger.

[0011] In some specific embodiments, the above-mentioned traditional Chinese medicine composition of the present invention comprises 30g of Pueraria root, 30g of Chinese yam, 15g of Cyathula, 15g of Adenophora australis, 15g of Chicken Gizzard Stone, 15g of Salvia miltiorrhiza, 15g of Lycium barbarum, 10g of Coptis chinensis, 12g of dried tangerine peel, and 10g of dried ginger.

[0012] In some specific embodiments, the above-mentioned traditional Chinese medicine composition of the present invention comprises 30g of Pueraria root, 30g of Chinese yam, 30g of Cyathula, 15g of Adenophora australis, 30g of Chicken Gizzard Stone, 15g of Salvia miltiorrhiza, 15g of Lycium barbarum, 10g of Coptis chinensis, 15g of Tangerine peel, and 10g of dried ginger.

[0013] In some specific embodiments, the above-mentioned traditional Chinese medicine composition of the present invention comprises 30g of Pueraria root, 30g of Chinese yam, 30g of Cyathula, 10g of Adenophora australis, 30g of Chicken Gizzard Stone, 15g of Salvia miltiorrhiza, 15g of Lycium barbarum, 15g of Coptis chinensis, 15g of Tangerine peel, and 10g of dried ginger.

[0014] In a preferred embodiment, the Chinese medicine composition of the present invention is prepared from medicinal materials selected from the following prescription group:

[0015] Prescription 1: 30g of Pueraria root, 30g of Chinese yam, 15g of Cyathula, 15g of Adenophora australis, 15g of Chicken Gizzard Stone, 15g of Salvia miltiorrhiza, 15g of Lycium barbarum, 10g of Coptis chinensis, 12g of Tangerine peel, and 10g of Dried Ginger.

[0016] Prescription 2: 30g of Pueraria root, 30g of Chinese yam, 30g of Cyathula, 15g of Adenophora australis, 30g of Chicken Gizzard Stone, 15g of Salvia miltiorrhiza, 15g of Lycium barbarum, 10g of Coptis chinensis, 15g of Tangerine peel, and 10g of Dried Ginger.

[0017] Prescription 3: 30g of Pueraria root, 30g of Chinese yam, 30g of Cyathula, 10g of Adenophora australis, 30g of Chicken Gizzard Stone, 15g of Salvia miltiorrhiza, 15g of Lycium barbarum, 15g of Coptis chinensis, 15g of Tangerine peel, and 10g of dried ginger.

[0018] In another embodiment, the above-mentioned traditional Chinese medicine composition of the present invention is a traditional Chinese medicine formula granule, which is composed of Pueraria formula granule, Chinese yam formula granule, Sichuan cyperus rotundus formula granule, Adenophora australis formula granule, Chicken's gizzard lining formula granule, Salvia miltiorrhiza formula granule, Lycium barbarum formula granule, Coptis chinensis formula granule, Tangerine peel formula granule and Dry ginger formula granule, and its prescription amount or weight portion is the same as that of the aforementioned traditional Chinese medicine composition.

[0019] On the other hand, the Chinese medicine composition of the present invention is in the form of a decoction, mixture, oral liquid, ointment, pill, tablet, granule or capsule. The preparation is prepared by boiling and filtering the medicinal materials in the prescription amount of the Chinese medicine composition to obtain a decoction with or without the addition of pharmaceutical excipients. The pharmaceutical excipients are conventional pharmaceutically acceptable excipients or additives in the field of Chinese medicine preparations, and are also prepared by conventional processes for the corresponding preparations. For example, tablets can be prepared by concentrating the Chinese medicine composition decoction into an extract or directly adding excipients to granulate, and then pressing into tablets, all of which can be prepared according to conventional processes.

[0020] In another aspect, the present invention provides a Chinese medicine composition for use in preparing a medicament for preventing and / or treating type 2 diabetes and its complications. Preferably, the type 2 diabetes is a type of diabetes diagnosed in Traditional Chinese Medicine as having spleen deficiency and damp-heat syndrome, blood stasis, and / or concurrent kidney deficiency, particularly diabetes with three syndromes simultaneously: spleen deficiency and damp-heat syndrome, blood stasis, and concurrent kidney deficiency, as well as type 2 diabetes in early, middle, and late stages. The Traditional Chinese Medicine diagnosis of each stage of type 2 diabetes is spleen deficiency and damp-heat syndrome, blood stasis, and concurrent kidney deficiency.

[0021] In some embodiments, the Chinese medicine composition of the present invention is made from the following medicinal materials in parts by weight:

[0022] 20-40 parts of Pueraria root, 20-40 parts of Chinese yam, 20-40 parts of Cyathula, 10-20 parts of Adenophora australis, 20-40 parts of chicken's gizzard lining, 10-20 parts of Salvia miltiorrhiza, 10-20 parts of wolfberry, 5-15 parts of Coptis chinensis, 10-20 parts of dried tangerine peel, and 5-15 parts of dried ginger.

[0023] The TCM diagnosis of each stage of type 2 diabetes is spleen deficiency and damp-heat syndrome, blood stasis, and kidney deficiency.

[0024] The present invention is based on the pathogenesis of spleen deficiency, damp-heat, phlegm coagulation and blood stasis from the perspective of traditional Chinese medicine, combined with the characteristics of Chongqing area and clinical experience of type 2 diabetes. It takes clearing away heat and dampness, nourishing the spleen and kidney, and resolving phlegm and removing blood stasis as the method, and conceives, designs and develops a traditional Chinese medicine composition for the treatment of various stages of type 2 diabetes. It can significantly lower its blood sugar and improve complications such as itchy skin, dry mouth, polydipsia, polyuria, hunger, and decreased vision. In particular, it has a good therapeutic effect on type 2 diabetes patients who have spleen deficiency, damp-heat syndrome, blood stasis and kidney deficiency. DETAILED DESCRIPTION

[0025] The present invention is described in detail below with reference to the embodiments, but the scope of the invention is not limited thereto.

[0026] The following examples describe a decoction method for the composition: soak the medicinal materials in the Chinese medicine composition in 8-fold water for 30 minutes, then decoct. After a first decoction of 1 hour, filter to obtain a primary filtrate. The residue is then decocted again in 8-fold water for 1 hour, filtered to obtain a secondary filtrate, and the combined filtrates are concentrated to obtain 300-600 ml of concentrated solution. The recommended oral dosage for adults is one dose every two days, three times daily, 50-100 ml each time.

[0027] Example 1 Chinese medicine composition prescription

[0028] 30g of Pueraria root, 15g of Chinese yam, 15g of Cyathula, 15g of Adenophora australis, 20g of chicken gizzard lining, 10g of Salvia miltiorrhiza, 10g of Lycium barbarum, 5g of Coptis chinensis, 5g of dried ginger, and 15g of dried tangerine peel.

[0029] Patient Xie xx, female, visited the outpatient clinic on March 13, 2019, due to "elevated blood sugar for 6 years". The patient developed elevated blood sugar 6 years ago and was diagnosed with "type 2 diabetes" after completing relevant examinations at an external hospital. The current blood sugar-lowering regimen is: "Aspart 30 insulin, 8U in the morning and 10U in the evening, metformin, 0.5g in the morning and 0.25g in the evening". Current symptoms: dry mouth, no obvious polydipsia, good appetite, hunger, no skin itching, localized pain, especially at night, sticky and uncomfortable stools, nocturia twice a night, insomnia, dreaminess, sore waist and knees. The tongue is dark red, with a thin white greasy coating, and the pulse is deep, thin and weak. Traditional Chinese medicine diagnosis: diabetes mellitus, spleen deficiency and damp-heat syndrome, and blood stasis combined with kidney deficiency. Western medicine diagnosis: type 2 diabetes. The Chinese medicine composition of the present invention is administered to nourish yin and clear heat, and to invigorate qi and nourish yin. The above prescription was prescribed for 12 doses, one dose every two days, decocted into a decoction (using the above-mentioned decoction method) and taken three times daily. After five months of treatment, the patient's dry mouth improved, hunger improved, urine became foamy, bowel movements became normal, and sleep improved. Continued treatment with additions and subtractions to the above prescription resulted in no significant dry mouth or hunger after two weeks, and fasting blood sugar dropped to 5.7 mmol / L.

[0030] Example 2 Chinese medicine composition prescription

[0031] 30g of Pueraria root, 30g of Chinese yam, 15g of Cyathula, 15g of Adenophora australis, 15g of Chicken Gizzard Stone, 15g of Salvia miltiorrhiza, 15g of Lycium barbarum, 10g of Coptis chinensis, 10g of dried ginger, and 12g of dried tangerine peel.

[0032] Patient Zhou xx, female, 73 years old, presented to the outpatient clinic on January 8, 2020, with "elevated blood sugar for 25 years." She had a 25-year history of diabetes, with a history of hyperuricemia and hyperlipidemia; had undergone hysterectomy and oophorectomy; had cataracts in her left eye; and had undergone facial paralysis surgery. Current symptoms: dry mouth, polydipsia, and bad breath. She was easily hungry, but her appetite was strong. She slept normally, her stools varied from dry to loose, and her urine volume was high. She had itchy eyes and decreased hearing. Her tongue was dark red with a greasy yellow coating, and her pulse was firm and slightly astringent. Diagnosis: Traditional Chinese Medicine diagnosis: Xiaoke (Xiao Ke) syndrome of spleen deficiency and damp-heat. Western Medicine diagnosis: 1. Type 2 diabetes 2. Hyperuricemia 3. Hyperlipidemia. She was treated with the Chinese medicine composition of the present invention to invigorate the spleen and promote body fluid production, clear away heat and remove dampness.

[0033] The above prescription was administered in four doses, one dose every two days, decocted into a decoction (using the above-mentioned decoction method) and taken three times daily. One week later, the patient reported improved dry mouth, continued treatment with the above prescription with modifications, and another week later reported improved dry mouth, decreased hunger, improved nocturia, and a decrease in fasting blood sugar to 5.1 mmol / L.

[0034] Example 3 Chinese medicine composition prescription

[0035] 30g of Pueraria root, 30g of Chinese yam, 15g of Cyathula, 20g of Adenophora australis, 15g of Chicken Gizzard Stone, 15g of Lycium barbarum, 10g of Coptis chinensis, 10g of dried ginger, 30g of Salvia miltiorrhiza, and 12g of dried tangerine peel.

[0036] Patient Tu xx, a 56-year-old female, presented to the hospital on October 29, 2019, with "elevated blood sugar for six years, poor sleep, and a 20-day cough." A physical examination in 2013 revealed elevated blood sugar levels, with a fasting blood sugar of 8.2 mmol / L. She is currently taking long-term oral metformin and saxagliptin for glucose reduction. Her current symptoms include a mild cough without throat pain, poor sleep with difficulty falling asleep, frequent urination 3-4 times per night, and dry, rough skin. She reported recent fasting blood sugar fluctuations of 7-8 mmol / L, without noticeable dryness of mouth. She also experienced occasional hunger and poor energy after exercise. Her tongue was pale red and enlarged, with a slightly greasy white coating and a thready pulse. The Traditional Chinese Medicine (TCM) diagnosis was: diabetes mellitus, spleen deficiency with damp-heat syndrome, and combined blood stasis and kidney deficiency. The Western Medicine (WM) diagnosis was: 1. Type 2 diabetes and 2. Cough. She was treated with the TCM composition of the present invention to tonify Qi and strengthen the spleen, and clear away heat and dampness.

[0037] The above prescription was administered in seven doses, one dose every two days, decocted into a decoction (using the above-mentioned decoction method) and taken three times daily. The patient returned for a follow-up visit two weeks later, reporting improved spirits after exercise, less hunger and dry mouth, improved sleep, and improved waking times at night. Subsequently, the above prescription was continued with modifications, and fasting blood sugar dropped to 5.5 mmol / L.

[0038] Example 4 Chinese medicine composition prescription

[0039] 30g of Pueraria root, 30g of Chinese yam, 30g of Cyathula, 10g of Adenophora australis, 30g of Chicken Gizzard Stone, 15g of Salvia miltiorrhiza, 15g of Lycium barbarum, 15g of Coptis chinensis, 10g of dried ginger, and 15g of dried tangerine peel.

[0040] Patient Guo xx, male, 55 years old, visited the outpatient clinic on November 25, 2020 because of "discovery of elevated blood sugar for one year". The patient complained that he was diagnosed with "type 2 diabetes" after completing relevant examinations in an external hospital one year ago, and did not take hypoglycemic drugs. Past medical history: prostate calcification, hypercholesterolemia, and gastrointestinal polyps. Current symptoms: Recent monitoring of fasting blood sugar fluctuates between 6.2-6.5mmol / L, without dry mouth and polydipsia. Obvious sense of hunger. Stool is regular, urination is difficult and painless. The tongue is dark red, with a thin and greasy coating, and a slippery pulse. Traditional Chinese medicine diagnosis: diabetes mellitus, spleen deficiency and damp-heat syndrome; Western medicine diagnosis: type 2 diabetes. The Chinese medicine composition of the present invention is given for treatment to strengthen the spleen and replenish qi, clear away heat and remove dampness.

[0041] The above prescription was administered for a total of seven doses, one dose every two days, decocted into a decoction (using the above-mentioned decoction method) and taken three times daily. Half a month later, the patient reported improved dry mouth, but still had poor sleep. The above prescription was continued with additions and subtractions. Twenty days later, the patient reported a fasting blood sugar level of 5.7 mmol / L, good sleep, and improved skin itching.

[0042] Example 5 Chinese medicine composition prescription

[0043] 30g of Pueraria root, 30g of Chinese yam, 30g of Sichuan cypress, 30g of chicken gizzard lining, 15g of Salvia miltiorrhiza, 15g of wolfberry, 15g of Coptis chinensis, 10g of dried ginger, 20g of Adenophora australis, and 18g of dried tangerine peel.

[0044] Patient Zhao xx, a 56-year-old male, presented to the outpatient clinic on March 18, 2020, with elevated blood sugar levels for one year. One year prior, he developed elevated blood sugar levels and, after completing relevant examinations at an external hospital, was diagnosed with type 2 diabetes. He is currently taking 0.8g of metformin daily for glucose-lowering therapy. He has a history of subclinical hypothyroidism. Current symptoms: This morning's fasting blood sugar level was 7.7mmol / L, along with dry mouth, polydipsia, decreased vision, itchy skin, chills, and hair loss. He has a good appetite. His stools are loose and occur only every two to three days. His urination is normal. His tongue is red, with a greasy coating, and his pulse is thin and smooth. The Traditional Chinese Medicine diagnosis is: polydipsia, a syndrome of spleen deficiency and damp-heat; the Western Medicine diagnosis is: type 2 diabetes. Treatment is with the Chinese medicine composition of the present invention, which aims to invigorate Qi and strengthen the spleen, while clearing away heat and removing dampness.

[0045] The above prescription was administered in seven doses, one dose every two days, decocted into a decoction (using the above-mentioned decoction method) and taken three times daily. Upon follow-up two weeks later, the patient's fasting blood sugar had dropped to 6.0 mmol / L, dry mouth had lessened, and stools were formed. The above prescription was continued with modifications for conditioning.

[0046] Example 6 Chinese medicine composition prescription

[0047] 30g of Pueraria root, 30g of Chinese yam, 30g of Sichuan cypress, 30g of chicken gizzard lining, 15g of Salvia miltiorrhiza, 15g of wolfberry, 15g of Coptis chinensis, 10g of dried ginger, 20g of Adenophora australis, and 18g of dried tangerine peel.

[0048] Patient Chen xx, a 56-year-old male, presented to the outpatient clinic on January 4, 2019, with a 10-year history of dry mouth, polydipsia, fatigue, and vertigo. Ten years prior, he developed dry mouth, polydipsia, fatigue, and vertigo. After completing relevant examinations at an external hospital, he was diagnosed with type 2 diabetes and had a history of hypertension. Current symptoms included dry mouth, polydipsia, vertigo, a good appetite, abdominal distension, no acid reflux or hiccups, poor sleep, good spirits, and blurred vision. He also had facial acne with minimal pruritus. His stools were formed. He urinated 2-3 times at night. His tongue was red with a white coating and scant fluid, and his pulse was thin and smooth. The Traditional Chinese Medicine diagnosis was: diabetes mellitus, a syndrome of spleen deficiency and damp-heat; the Western Medicine diagnosis was: type 2 diabetes. Treatment with the Chinese medicine composition of the present invention aims to strengthen the spleen and replenish qi, and clear away heat and dampness.

[0049] The above prescription was administered in seven doses, one dose every two days, decocted into a decoction (using the above-mentioned decoction method) and taken three times daily. Upon follow-up two weeks later, the patient reported a recent fasting blood sugar level of 6.3 mmol / L, reduced dry mouth, and regular stools. The above prescription was continued with modifications for continued treatment.

[0050] Example 7 Chinese medicine composition prescription

[0051] 30g of Pueraria root, 30g of Chinese yam, 30g of Cyathula, 15g of Adenophora australis, 30g of Chicken Gizzard Stone, 15g of Salvia miltiorrhiza, 15g of Lycium barbarum, 15g of Coptis chinensis, 10g of dried ginger, and 15g of dried tangerine peel.

[0052] Patient Wang xx, a 67-year-old female, presented to the outpatient clinic on September 25, 2019, due to "poor blood sugar control for 10 years." Ten years ago, she discovered poor blood sugar control, with fasting blood sugar levels fluctuating between 7.5 and 8.6 mmol / L, and no post-meal checks. She now regularly takes metformin 0.25g three times a day and glimepiride 2mg daily. She has a history of gastric ulcers and urticaria. Current symptoms include poor appetite, hiccups, stomach bloating and pain, and burning sensation. She is heat-averse. She has mild dryness and a sticky mouth, but no vision loss. She is prone to sores at the corners of her mouth. She sleeps well, but has dry eyes, itchy skin, unformed stools, and no nocturia. Her tongue is red with a thin, greasy coating, and a deep, slippery pulse. The Traditional Chinese Medicine diagnosis is diabetes mellitus, a syndrome of spleen deficiency and damp-heat, and the Western Medicine diagnosis is type 2 diabetes. Treatment with the Chinese medicine composition of the present invention targets strengthening the spleen and promoting fluid production, clearing heat and removing dampness.

[0053] The above prescription was administered in seven doses, one dose every two days, decocted into a decoction (using the above-mentioned decoction method) and taken three times daily. Upon follow-up two weeks later, the patient's fasting blood sugar had dropped to 5.7 mmol / L, hiccups, abdominal distension, and dry eyes had lessened, and bowel movements were normal. The above prescription was continued with modifications for conditioning.

[0054] Example 8 Chinese medicine composition prescription

[0055] 30g of Pueraria root, 30g of Chinese yam, 30g of Cyathula, 15g of Adenophora australis, 30g of Chicken Gizzard Stone, 15g of Salvia miltiorrhiza, 15g of Lycium barbarum, 10g of Coptis chinensis, 10g of dried ginger, and 15g of dried tangerine peel.

[0056] Patient Lu xx, male, 67 years old, was admitted to the outpatient clinic on February 18, 2019 due to "elevated blood sugar for 4 years." Four years ago, the patient was found to have elevated blood sugar. After completing relevant examinations at an external hospital, he was diagnosed with "type 2 diabetes". He now takes "metformin 0.25g, Bid, Qizhijiangtang tablets 5 tablets, Tid" orally. He has a history of hypertension and cataracts. Current symptoms include dry mouth and bitter taste, good appetite, abdominal distension, dizziness, blurred vision, numbness of hands and feet, poor sleep and easy awakening, unformed stool, yellow urine, and frequent urination. The tongue is dark red, with a greasy white and slightly yellow tongue coating, and a slippery and weak pulse. Traditional Chinese medicine diagnosis: diabetes mellitus, spleen deficiency and damp-heat syndrome, and blood stasis combined with kidney deficiency and spleen deficiency syndrome; Western medicine diagnosis: type 2 diabetes. The Chinese medicine composition of the present invention is used for treatment to strengthen the spleen and promote body fluid production, clear away heat and remove dampness.

[0057] The above prescription was administered in seven doses, one dose every two days, decocted into a decoction (using the above-mentioned decoction method) and taken three times daily. Upon follow-up two weeks later, the patient reported relief from dry mouth and bitter taste, less abdominal distension and blurred vision, more firm stools, improved numbness in the hands and feet, and improved sleep. Fasting blood sugar levels were now down to 5.6-6.0 mmol / L. The above prescription was then continued with modifications for conditioning.

[0058] Example 9 Chinese medicine composition prescription

[0059] 30g of Pueraria root, 30g of Chinese yam, 30g of Cyathula, 15g of Adenophora australis, 30g of Chicken Gizzard Stone, 15g of Salvia miltiorrhiza, 15g of Lycium barbarum, 10g of Coptis chinensis, 10g of dried ginger, and 15g of dried tangerine peel.

[0060] Patient Lu xx, male, 72 years old, was admitted to the outpatient clinic on February 1, 2023 due to "elevated blood sugar for many years, accompanied by fatigue for 4 months." He is currently taking "metformin, acarbose, and glimepiride" orally to control blood sugar, and fasting blood sugar fluctuates between "8-9mmol / L". He has a history of hypertension and prostatic hyperplasia, and underwent "pulmonary nodule resection" at Chongqing Medical University on September 30, 2022. Current symptoms: slight cough, no sputum, and fatigue. Slight dryness and bitterness in the mouth, good appetite, normal sleep, and occasional dreams; constipation, requiring laxatives to defecate. The tongue is dull, the root is greasy, and the pulse is deep and slippery. Traditional Chinese medicine diagnosis: diabetes mellitus, spleen deficiency and damp-heat syndrome; Western medicine diagnosis: type 2 diabetes with multiple complications. The Chinese medicine composition of the present invention is used for treatment, and the treatment is to strengthen the spleen and replenish qi, clear away heat and remove dampness.

[0061] The above prescription was administered for a total of seven doses, one dose every two days, decocted into a decoction (using the above-mentioned decoction method) and taken three times daily. Upon follow-up two weeks later, the patient reported less dry mouth and bitter taste, better sleep, and regular bowel movements. Fasting blood sugar was controlled to 6.0 mmol / L, and the above prescription was continued with modifications.

[0062] Animal testing

[0063] The following specific test examples demonstrate the effects of the present invention.

[0064] Experimental Example 1 Effect of the present invention on blood glucose and lipid metabolism in diabetic mice

[0065] 1. Drug Preparation

[0066] Weighing: 30g of Pueraria root, 30g of Chinese yam, 30g of Sichuan cypress, 30g of chicken gizzard lining, 15g of Salvia miltiorrhiza, 15g of wolfberry, 15g of dried tangerine peel, 15g of Coptis chinensis, 10g of dried ginger, and 10g of Adenophora australis.

[0067] Add 1600 mL of distilled water to each drug, soak for 30 minutes, and boil for the first time. After boiling for 1 hour, filter to obtain the primary filtrate. Add 1600 mL of distilled water to the residue and boil for 1 hour. Filter to obtain the secondary filtrate. Combine the filtrates and concentrate to obtain 140 mL of concentrated solution, containing 1.43 g of crude drug per mL.

[0068] 2. Main instruments and reagents

[0069] Blood glucose meter (Sinocare Biosensor Co., Ltd.), 7180+ISE fully automatic biochemical analyzer (Hitachi); high-speed refrigerated microcentrifuge (SCILOGEX), multifunctional microplate reader (Tecan); free fatty acid (FFA) ELISA kit (Shanghai Zhuocai), streptozotocin (biosharp).

[0070] 3. Animal Model Establishment and Grouping

[0071] Fifty male C57BL / 6J mice were purchased from Beijing Huafukang Bioscience Co., Ltd. and housed in stainless steel cages on a 12-h light / dark cycle with free access to food and water. The air temperature was 23±2°C and the relative humidity was 50±10%. Ten mice were randomly selected to be fed a standard diet (normal group, 0.1 mL / 10 g normal saline), while 40 mice were fed a high-fat diet for 4 weeks. Subsequently, a low-dose streptozotocin (STZ, 50 mg / kg, in citrate buffer, pH 4.5) was injected intraperitoneally into the high-fat diet mice to establish a T2DM mouse model. Fasting blood glucose (FBG) was measured 3 days after STZ injection; mice with an FBG ≥11.1 mmol / L were considered T2DM mice. T2DM mice were randomly divided into four groups, 10 in each: a model group (0.1 mL / 10 g normal saline), a positive control group (0.2 g / kg metformin), and high, medium, and low drug dose groups (26.02 g crude drug / kg, 13.01 g crude drug / kg, and 6.50 g crude drug / kg). All mice in each group were gavaged once daily for four weeks.

[0072] 4. Detection indicators

[0073] 4.1 General condition, weight and blood sugar

[0074] During the whole process, the mental state, hair, urine and feces of the mice were observed every day, and the fasting blood glucose and body weight of the mice were measured by blood sampling from the tail vein regularly once a week.

[0075] 4.2 Oral glucose tolerance test

[0076] After 4 weeks of administration, the mice were fasted overnight for an oral glucose tolerance test. All mice were gavage-administered 2 g / kg glucose, and blood was collected from the tail at 0, 30, 60, and 120 min. Blood glucose levels were measured using a glucometer and the area under the blood glucose curve (AUC) was calculated.

[0077] 4.3 Serum-related biochemical index detection

[0078] After the experiment, blood samples were collected from the orbits of all mice and centrifuged at 860 g for 15 minutes to obtain serum. Plasma levels of total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-C), and high-density lipoprotein (HDL-C) were measured using an automated biochemical analyzer. Free fatty acid (FFA) content was measured using an ELISA kit.

[0079] 4.4 Immunohistochemical analysis

[0080] The mice were killed by cervical dislocation, and the pancreas was removed for insulin immunohistochemical staining and observed and images were collected under a fluorescence inverted microscope.

[0081] 4.5 Statistical methods

[0082] SPSS 26.0 statistical software was used for analysis. Data were expressed as mean ± standard deviation. The difference was determined by Tamhane's T2 or LSD test. P < 0.05 indicated that the difference was statistically significant.

[0083] 5. Experimental Results

[0084] 5.1 Effects on the general condition of T2DM mice

[0085] The daily status, diet and drinking water of each group of mice were observed. Before modeling, the mice were active and lively, with shiny fur, and normal diet, drinking water, defecation and urination. After feeding with a high-fat diet, the mice gained weight. After intraperitoneal injection of STZ, the mice lost weight, became less active, had dull and rough fur, increased urine volume, and had a distinct rotten apple smell. At week 4, the weight of the mice in the positive control group was significantly different from that in the model group (P < 0.05). After administration of the Chinese medicine composition of the present invention, the activity, diet, drinking water, and urine volume of the mice in each group improved, and there was no significant effect on the weight of the mice. The weights of the mice in each group are shown in Table 1.

[0086] Table 1 Effect of the present invention on the body weight of mice ( n=10)

[0087]

[0088] Note: Compared with the normal control group, # p<0.05, ## p<0.01, ### p<0.001; compared with the model group, * p<0.05, ** p<0.01, *** p<0.001.

[0089] 5.2 Effects on FBG in T2DM mice

[0090] The FBG of normal group mice remains at a low level all the time, and blood sugar is stable. The FBG of diabetic mice in model group is significantly higher than that in normal group (p<0.001), and shows persistent hyperglycemia, which is a typical T2DM symptom. After drug treatment, the FBG level of high-dose group obviously declines in the second week, and there is significant difference (p<0.01) with model group. The FBG level of medium-dose group obviously declines in the third week, and there is significant difference (p<0.05) with model group. The FBG level of each administration group in the fourth week is significantly different from model group (p<0.01, p<0.001). The hypoglycemic effect of high-dose group is better than medium-dose group and low-dose group. The blood sugar of positive control group is significantly different from model group in the 2nd week (p<0.05). The result shows that Chinese medicine composition of the present invention has hypoglycemic effect on T2DM mice, and hypoglycemic effect is suitable with positive control drug effect. Each group of blood sugar is shown in Table 2.

[0091] Table 2 Effect of the present invention on blood glucose in mice ( n=10)

[0092]

[0093] Note: Compared with the normal control group, # p<0.05, ## p<0.01, ### p<0.001; compared with the model group, * p<0.05, ** p<0.01, *** p<0.001.

[0094] 5.3 Effects on oral glucose tolerance in T2DM mice

[0095] After the administration, mice in each group were gavaged with 2.0 g / kg glucose. The blood glucose levels of the normal group mice remained relatively stable, while the blood glucose levels of the diabetic mice increased sharply, reaching a peak at 30 minutes, and then began to gradually decline, but still maintained a high level. Calculation of the AUC values revealed that after the administration, the AUC values of the high-dose and medium-dose groups were significantly lower than those of the model group (p < 0.05). The AUC value of the low-dose group was not significantly different from that of the model group (p > 0.05), indicating that the present invention can improve oral glucose tolerance in diabetic mice. The results are shown in Table 3.

[0096] Table 3 Effect of the present invention on oral glucose tolerance in mice ( n=10)

[0097]

[0098] Note: Compared with the normal control group, # p<0.05, ## p<0.01,### p<0.001; compared with the model group, * p<0.05, ** p<0.01, *** p<0.001.

[0099] 5.4 Effects on blood lipids in T2DM mice

[0100] Blood lipid testing showed that compared with the normal group, the model group had significant differences in TC (p < 0.001), TG (p < 0.01), LDL-C (p < 0.001), HDL-C (p < 0.01), and FFA (p < 0.05). Compared with the model group, the high-dose group had significantly reduced TC (p < 0.01), TG (p < 0.05), and LDL-C (p < 0.01) levels, while HDL-C and FFA had no significant effect (p > 0.05). The medium-dose administration had a significant effect on the TC (p < 0.05), TG (p < 0.01), LDL-C (p < 0.01), and FFA (p < 0.05) levels of the mice, but had no significant effect on HDL-C (p > 0.05). The results show that the present invention has a certain regulatory effect on lipid metabolism disorders in diabetic mice. The results are shown in Table 4.

[0101] Table 4 Effects of the present invention on blood lipids in mice ( n=10)

[0102]

[0103]

[0104] 6. Discussion

[0105] Recent studies have shown that traditional Chinese medicine compositions play an important role in the prevention and treatment of diabetes. Compared to Western medicine, they offer stable efficacy and fewer adverse reactions. The T2DM animal model induced by HFD combined with low-dose STZ is similar to human T2DM, manifesting symptoms such as hyperglycemia, obesity, hyperinsulinemia, and dyslipidemia. At various doses of the traditional Chinese medicine composition of the present invention, diabetic mice showed some improvement in blood glucose, oral glucose tolerance, and lipid metabolism, demonstrating that the traditional Chinese medicine composition of the present invention can be used to treat type 2 diabetes.

[0106] Although the embodiments of the present invention have been disclosed above, they are not limited to the applications listed in the description and implementation methods. They can be fully applied to various fields suitable for the present invention. For those familiar with the art, additional modifications can be easily implemented. Therefore, without departing from the general concept defined by the claims and the scope of equivalents, the present invention is not limited to specific details. All equivalent changes and modifications made according to the scope of the patent application of the present invention should fall within the scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating type 2 diabetes, comprising the following medicinal materials in parts by weight: 20-40 parts of Pueraria root, 10-40 parts of Chinese yam, 15-40 parts of Cyathula root, 10-20 parts of Adenophora australis, 15-40 parts of Gallus gallus domestica, 10-30 parts of Salvia miltiorrhiza, 10-20 parts of Lycium barbarum, 5-15 parts of Coptis chinensis root, 10-20 parts of dried tangerine peel, and 5-15 parts of dried ginger. The TCM diagnosis of type 2 diabetes is spleen deficiency and damp-heat syndrome.

2. The Chinese medicine composition according to claim 1 is prepared from the following medicinal materials in parts by weight: 10-30 parts of Pueraria root, 15-30 parts of Chinese yam, 15-30 parts of Cyathula, 10-20 parts of Adenophora australis, 15-30 parts of Chicken's Gizzard Stone, 10-30 parts of Salvia miltiorrhiza, 10-15 parts of Lycium barbarum, 5-15 parts of Coptis chinensis, 12-18 parts of dried tangerine peel and 5-10 parts of dried ginger.

3. The Chinese medicine composition as claimed in claim 2 is made from the following medicinal materials in parts by weight: 30g of Pueraria root, 30g of Chinese yam, 15g of Cyathula, 15g of Adenophora australis, 15g of Chicken's Gizzard Stone, 15g of Salvia miltiorrhiza, 15g of Lycium barbarum, 10g of Coptis chinensis, 12g of dried tangerine peel, and 10g of dried ginger.

4. The Chinese medicine composition as claimed in claim 2 is made from the following medicinal materials in parts by weight: 30g of Pueraria root, 30g of Chinese yam, 30g of Cyathula, 15g of Adenophora australis, 30g of Chicken's Gizzard Stone, 15g of Salvia miltiorrhiza, 15g of Lycium barbarum, 10g of Coptis chinensis, 15g of Tangerine peel, and 10g of dried ginger.

5. The Chinese medicine composition according to claim 2 is prepared from the following medicinal materials in parts by weight: 30g of Pueraria root, 30g of Chinese yam, 30g of Cyathula, 10g of Adenophora australis, 30g of Chicken's Gizzard Stone, 15g of Salvia miltiorrhiza, 15g of Lycium barbarum, 15g of Coptis chinensis, 15g of Tangerine peel, and 10g of dried ginger.

6. The Chinese medicine composition according to any one of claims 1 to 5, wherein the preparation is in the form of a decoction, oral liquid, ointment, pill, tablet, granule or capsule.

7. The Chinese medicine composition according to any one of claims 1 to 5, wherein the preparation is in the form of a mixture.

8. The Chinese medicine composition according to claim 6, wherein the preparation is prepared by boiling and filtering the medicinal materials in the prescribed amount of the Chinese medicine composition to obtain a decoction with or without adding pharmaceutical excipients.

9. The Chinese medicine composition according to claim 6, wherein the preparation is a compound Chinese medicine granule.

10. Use of the Chinese medicine composition according to any one of claims 1 to 5 in the preparation of a medicament for treating type 2 diabetes, wherein the type 2 diabetes is diagnosed as spleen deficiency and damp-heat syndrome in traditional Chinese medicine.

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