Traditional Chinese medicine composition for treating diabetes and / or diabetic complications and preparation method thereof

Abstract

The invention provides a traditional Chinese medicine composition for treating diabetes and / or diabetic complications, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition comprises calculus bovis factitius, rhizoma atractylodis, almond, radix paeoniae rubra, ligusticum wallichii, salvia miltiorrhiza, semen momordicae, elecampane, ginseng, penis et testis cervi, hippocampus, syngnathus, eucommia ulmoides, fructus psoraleae, notopterygium root, radix clematidis, sculellaria barbata, semen cassiae, curcuma zedoary, rhizoma sparganii, radix trichosanthis, felwort and astragalus membranaceus. The traditional Chinese medicine composition has the effects of promoting the production of body fluid to quench thirst, clearing away heat and toxic materials and invigorating spleen to eliminate dampness through the synergistic effect of the medicines, has a good treatment effect on type I diabetes mellitus, type II diabetes mellitus and diabetic complications (lactic acidosis, ketoacidosis and symmetric distal polyneuritis caused by ketoacidosis), has a clinical total effective rate of 91.88%, does not have toxic or side effects, and is suitable for clinical application. The preparation method is simple, and the use is convenient.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and in particular relates to a traditional Chinese medicine composition for treating diabetes and / or diabetic complications and a preparation method thereof. Background Art

[0002] Diabetes is a chronic metabolic disease characterized by hyperglycemia, caused by absolute or relative insulin deficiency and utilization disorders. The disease is mainly divided into three types: type 1 (pancreatic beta cells are destroyed, insulin secretion is absolutely insufficient), type 2 (insulin resistance and relative insulin deficiency), and gestational diabetes. The cause is mainly attributed to the combined effects of genetic and environmental factors, including decreased insulin secretion caused by pancreatic cell dysfunction, or the body's insensitivity to insulin, or both, which prevents the effective utilization and storage of glucose in the blood. The symptoms of diabetes are mainly manifested as "three mores and one less", namely, polydipsia, polyuria, polyphagia, and weight loss. In addition, patients with a long course of the disease may develop chronic progressive lesions, functional impairment, or even failure of tissues and organs such as the eyes, kidneys, nerves, heart, and blood vessels, and may also cause acute and severe metabolic disorders.

[0003] The main treatment for diabetes is to maintain blood sugar levels within a normal range through scientific and reasonable treatment methods, prevent the occurrence of acute metabolic disorders, prevent or delay the occurrence and development of complications, and improve the quality of life. The prognosis depends on whether the disease is controlled and whether complications exist. Currently, Western medicine is often used to treat diabetes clinically. Although it can have a certain or better control effect on the disease, most of them have large side effects, may cause liver and kidney damage, and have strong drug dependence, so that patients need to take medicine for life. With the continuous development of the traditional Chinese medicine industry, more and more Chinese herbal medicine formulas are disclosed, but these formulas have different efficacies and emphases, and the efficacy is also uneven. Therefore, there is an urgent need to provide a safe, effective and side-effect-free Chinese medicine composition for treating diabetes and its complications. Summary of the Invention

[0004] In order to solve the problems existing in the prior art, the purpose of the present invention is to provide a traditional Chinese medicine composition for treating diabetes and / or diabetic complications, which has a total clinical efficacy of up to 91.88%, is safe and reliable, has no toxic side effects, is simple to prepare, and is easy to use.

[0005] In order to achieve the above-mentioned object of the invention, the present invention provides the following technical solutions:

[0006] The invention provides a traditional Chinese medicine composition for treating diabetes and / or diabetic complications. The traditional Chinese medicine composition comprises the following components in parts by mass: 4-6 parts of artificial bezoar, 10-14 parts of atractylodes, 4-6 parts of apricot kernel, 8-12 parts of red peony root, 8-12 parts of ligusticum chuanxiong, 10-14 parts of salvia miltiorrhiza, 7-9 parts of momordica seeds, 10-14 parts of costus root, 1-2 parts of ginseng, 0.5-1.5 parts of deer whip, 1-2 parts of seahorse, 2-3 parts of sea dragon, 2-4 parts of eucommia bark, 6-8 parts of psoralea corylifolia, 2-4 parts of notopterygium root, 2-4 parts of clematis root, 1-2 parts of bark scutellaria, 10-12 parts of cassia seed, 8-10 parts of zedoaria, 2-4 parts of trichosanthes root, 10-14 parts of gentian and 6-8 parts of astragalus.

[0007] Preferably, the invention comprises the following components in parts by mass: 5 parts of artificial bezoar, 12 parts of atractylodes, 5 parts of apricot kernel, 10 parts of red peony root, 8 parts of chuanxiong, 12 parts of salvia miltiorrhiza, 8 parts of momordica seeds, 12 parts of costus root, 2 parts of ginseng, 1 part of deer whip, 2 parts of seahorse, 3 parts of sea dragon, 2 parts of eucommia, 6 parts of psoralea corylifolia, 4 parts of notopterygium wilfordii, 4 parts of clematis root, 1 part of barbata scabra, 12 parts of cassia seed, 9 parts of zedoaria, 3 parts of trillium, 10 parts of gentiana and 6 parts of astragalus.

[0008] The present invention also provides a preparation method of the traditional Chinese medicine composition, comprising the following steps: crushing and mixing the components and then boiling with water to form an ointment; and drying, cooling, crushing and sterilizing the ointment.

[0009] Preferably, the pulverization is performed by passing the sieve through 40-80 mesh after pulverization.

[0010] Preferably, in the boiling process, the amount of water added is 5 to 10 mL / g, and the boiling time is 3 to 5 hours.

[0011] Preferably, the ointment is placed in an oven evaporation box for drying, and the drying temperature is 30° C. to 50° C., and the drying time is 25 to 30 minutes.

[0012] Preferably, the sterilization is microwave sterilization.

[0013] Preferably, the microwave sterilization has a microwave frequency of 900-950 MHz, a temperature of 60° C.-80° C., and a time of 3-5 minutes.

[0014] The present invention also provides a medicine for treating diabetes and / or diabetic complications, which comprises the above-mentioned traditional Chinese medicine composition.

[0015] Preferably, the content of the traditional Chinese medicine composition is 60wt% to 100wt%.

[0016] Compared with the prior art, the technical solution of the present invention has the following beneficial effects:

[0017] The present invention utilizes the synergistic effects of the various drugs to promote thirst, clear away heat and detoxify, and strengthen the spleen and eliminate dampness. The composition of the present invention repairs the pancreas and eliminates toxins through intestinal absorption, thereby treating hyperglycemia. Sugar toxins are metabolized by the kidneys and excreted through urine, sweat, and feces. It has a favorable therapeutic effect on type I and type II diabetes, as well as diabetic complications (lactic acidosis, ketoacidosis, and symmetrical distal polyneuritis caused by ketoacidosis), with a total clinical efficacy of 91.88%. It is safe and reliable, has no toxic side effects, is simple to prepare, and is easy to use. DETAILED DESCRIPTION

[0018] The invention provides a traditional Chinese medicine composition for treating diabetes and / or diabetic complications. The traditional Chinese medicine composition comprises the following components in parts by mass: 4-6 parts of artificial bezoar, 10-14 parts of atractylodes, 4-6 parts of apricot kernel, 8-12 parts of red peony root, 8-12 parts of ligusticum chuanxiong, 10-14 parts of salvia miltiorrhiza, 7-9 parts of momordica seeds, 10-14 parts of costus root, 1-2 parts of ginseng, 0.5-1.5 parts of deer whip, 1-2 parts of seahorse, 2-3 parts of sea dragon, 2-4 parts of eucommia bark, 6-8 parts of psoralea corylifolia, 2-4 parts of notopterygium root, 2-4 parts of clematis root, 1-2 parts of bark scutellaria, 10-12 parts of cassia seed, 8-10 parts of zedoaria, 2-4 parts of trichosanthes root, 10-14 parts of gentian and 6-8 parts of astragalus. Preferably, the composition comprises the following components: 5 parts of artificial bezoar, 12 parts of atractylodes, 5 parts of apricot kernel, 10 parts of red peony root, 8 parts of chuanxiong, 12 parts of salvia miltiorrhiza, 8 parts of momordica seeds, 12 parts of costus root, 2 parts of ginseng, 1 part of deer whip, 2 parts of seahorse, 3 parts of sea dragon, 2 parts of eucommia, 6 parts of psoralea corylifolia, 4 parts of notopterygium wilfordii, 4 parts of clematis root, 1 part of barbata scabra, 12 parts of cassia seed, 9 parts of zedoaria, 3 parts of trillium, 10 parts of gentiana and 6 parts of astragalus.

[0019] The raw materials used in the Chinese medicine composition of the present invention are introduced as follows:

[0020] Artificial bezoar is made from ox bile powder, bile acid, hyodeoxycholic acid, taurine, bilirubin, cholesterol, and trace elements. It has a sweet flavor and cool nature, and enters the Heart and Liver meridians. It clears heat and detoxifies, resolves phlegm, and calms nerves. It is primarily used to treat phlegm-heat-induced delirium, coma, acute convulsions in children, sore throat, mouth sores, and carbuncles.

[0021] Atractylodes lancea (Thunb.) DC. or Atractylodes chinensis (DC.) Koidz., both plants of the Asteraceae family, have a pungent and bitter flavor and are warm in nature. They enter the spleen, stomach, and liver meridians. They have the effects of drying dampness and strengthening the spleen, dispelling wind and cold, and improving eyesight. They are primarily used to treat symptoms such as dampness obstructing the middle jiao, rheumatic arthralgia, wind-cold dampness with external dampness, night blindness, and blurred vision.

[0022] Apricot kernel is the seed of Armeniaca vulgaris Lam. [Prunus armeniaca L.], wild apricot A. vulgaris Lam. var. ansu (Maxim) Yu et Lu [Prunus armeniaca L. var. ansu Maxim.], mountain apricot A. sibirica (L.) Lam. [Prunus sibirica L.], and northeastern apricot A. mandshurica (Maxim.) Skv. [Prunus mandshurica (Maxim.) Koehne], all of the genus Apricot in the Rosaceae family. It has a bitter taste and slightly warm properties and enters the lung and large intestine meridians. It has the effects of relieving cough and asthma, and moistening the intestines and promoting bowel movements. It is mainly used to treat cough and asthma, chest fullness and excessive phlegm, blood deficiency and body fluid depletion, and dry bowel constipation.

[0023] Red peony root is the root of Paeonia veitchii Lynch. (Ranunculaceae). It is slightly cold in nature and bitter in taste. It enters the Liver and Spleen meridians. It belongs to the heat-clearing and blood-cooling category of heat-clearing herbs. It is used to treat fever-induced rashes, hematemesis and epistaxis, eye swelling and pain, liver depression and flank pain, amenorrhea and dysmenorrhea, abdominal pain due to lumps and masses, injuries from falls, and carbuncles and ulcers.

[0024] Chuanxiong is the dried rhizome of Ligusticum chuanxiong Hort., a plant of the genus Ligusticum in the Apiaceae family. It is pungent and warm in nature and enters the liver, gallbladder, and pericardium meridians. It has the effects of promoting blood circulation and qi, dispelling wind and relieving pain. It is primarily used to treat chest pain and heartache caused by heart meridian stagnation, flank pain and distension caused by liver qi stagnation, stabbing pain in the chest and flanks caused by liver blood stasis, injuries caused by falls, sores and swelling caused by blood stasis, irregular menstruation, amenorrhea and dysmenorrhea, postpartum pain and blood stasis, lochia retention, various headaches, and rheumatic pain.

[0025] Danshen (Salvia miltiorrhiza) is the root and rhizome of the Lamiaceae plant Salvia miltiorrhiza Bge. It is slightly cold in nature and bitter in taste. It enters the Heart and Liver meridians. It is a blood-activating and menstruation-regulating herb, classified under the category of blood-activating and stasis-removing herbs. It has the effects of removing blood stasis and relieving pain, promoting blood circulation and relieving dysmenorrhea, and clearing the heart and relieving restlessness. It is commonly used to treat irregular menstruation, amenorrhea, dysmenorrhea, accumulation of lumps and masses, stabbing pain in the chest and abdomen, pain caused by heat rheumatic arthritis, swelling and toxicity of sores, restlessness and insomnia, hepatosplenomegaly, and angina pectoris.

[0026] Momordica cochinchinensis (Lour.) Spreng., a plant of the Cucurbitaceae family, is a dried, mature seed. It has a bitter, slightly sweet, and cooling taste. It enters the Liver, Spleen, and Stomach meridians. It has the effects of dispersing stagnation, reducing swelling, and treating ulcers. It is used to treat ulcers, mastitis, scrofula, hemorrhoid fistula, psoriasis, and baldness.

[0027] Costus root is the root of Aucklandia lappa Decne., a plant of the Asteraceae family. It has a pungent and bitter flavor and a warm nature. It enters the spleen, stomach, liver, and lung meridians. It promotes qi circulation, relieves pain, and regulates the middle and relieves stagnation. It is primarily used to treat chest and flank distension, abdominal pain, vomiting, diarrhea, and heaviness after dysentery.

[0028] Ginseng is the root of Panax ginseng (Camey), a plant of the Araliaceae family. It has a sweet, slightly bitter flavor and a slightly warm nature. It enters the lung, spleen, and heart meridians. It has the effects of tonifying vital energy, tonifying the spleen and lungs, promoting fluid production, and calming the mind and improving intelligence. It is primarily used to treat qi deficiency with impatience, weak pulse, spleen deficiency, sinking of qi in the middle, wheezing and coughing due to lung deficiency, shortness of breath and fatigue, thirst due to loss of fluid, polydipsia due to deficiency-heat, insomnia and forgetfulness, palpitations, blood deficiency, chlorosis, impotence, and cold uterus.

[0029] Deer whip (Lupeng) refers to the external genitalia of the male sika deer (Cervus nippon Temminck) or red deer (C. elaphus L.), members of the Cervidae family. It has a sweet and salty flavor and a warm nature. It enters the liver, kidney, and bladder meridians. It nourishes kidney essence, strengthens kidney yang, improves vital energy, and strengthens the waist and knees. It is primarily used to treat kidney deficiency and strain, lower back and knee pain, deafness and tinnitus, impotence, spermatorrhea, premature ejaculation, uterine coldness and infertility, and clear, thin vaginal discharge.

[0030] Seahorse is the dried body of seahorses from the family Syngnathidae. It has a sweet taste and warm properties; it enters the liver and kidney meridians. It nourishes the kidneys and strengthens yang, regulates qi and activates blood circulation. It is used to treat impotence, spermatorrhea, enuresis, asthma due to kidney deficiency, accumulation of lumps and masses, injuries from falls, and boils and swellings.

[0031] Sea dragons are the whole, or the whole, excluding the membrane and internal organs, of various sea dragons, including Solenognathus hardwickii (Gray), Syngnathoides biaculeatus (Bloch), and Syngnathus acus Linnaeus, all members of the Syngnathidae family. It has a sweet and salty flavor and is warm in nature. It enters the Liver and Kidney meridians. It tonifies the kidneys and strengthens yang, dissipates stagnation, and reduces swelling. It is primarily used to treat impotence, spermatorrhea, infertility, asthma due to kidney deficiency, accumulation of lumps and masses, scrofula, goiters, injuries from falls, and carbuncles and furuncles.

[0032] Eucommia ulmoides is the bark of Eucommia ulmoides Oliv., a plant of the Eucommia family. It is sweet and warm in nature, and enters the liver and kidney meridians. It nourishes the liver and kidneys, strengthens the bones and tendons, and stabilizes pregnancy. It is primarily used to treat kidney deficiency and other low back pain, fetal restlessness, and habitual abortion.

[0033] Psoralea corylifolia L. is the mature fruit of Psoralea corylifolia L., a plant of the genus Psoralea in the Leguminosae family. It has a bitter and pungent flavor and warm nature, and enters the kidney and spleen meridians. It has the effects of tonifying the kidneys and strengthening yang, consolidating essence and reducing urination, warming the spleen and stopping diarrhea, and promoting qi and relieving asthma. It is mainly used to treat impotence due to kidney deficiency, cold pain in the waist and knees, spermatorrhea due to kidney deficiency, enuresis, frequent urination, spleen and kidney yang deficiency, diarrhea at dawn, kidney qi deficiency, and asthma and cough due to cold.

[0034] Qianghuo (Notopterygium incisum Ting ex HTChang) or Notopterygium franchetii H. de Boiss. (Umbelliferae) is a plant of the family Apiaceae. It is warm in nature, pungent and bitter in flavor, and enters the bladder and kidney meridians. It belongs to the pungent-warm antipyretic class of antipyretic drugs. It has antipyretic, analgesic, anti-inflammatory, anti-allergic, anti-myocardial ischemia, anti-arrhythmia, anti-thrombotic, anti-epileptic, antioxidant, antibacterial, sleep-promoting, and cancer-suppressing properties.

[0035] Clematis chinensis (Clematis chinensis Osbeck.), Clematis chinensis (Clematis chinensis Osbeck.), Clematis chinensis (Clematis chinensis Pall.), or Clematis manshurica Rupr. (Clematis chinensis Rupr.) are all Ranunculaceae plants. It is warm in nature, pungent and salty in flavor, and enters the bladder meridian. It is classified as a rheumatism-relieving and cold-dispelling herb under the rheumatism category. It has the effects of dispelling wind and dampness, unblocking meridians, and relieving pain. It can be used for analgesia, choleretics, inducing labor, antimicrobial effects, anti-diuresis, and blood pressure reduction.

[0036] Scutellaria barbata (Scutellaria barbata D. Don.), a plant of the Lamiaceae family, has a pungent and bitter taste and a cold nature. It enters the lung, liver, and kidney meridians. It is a heat-clearing and detoxifying herb, classified under the category of heat-clearing herbs. It has heat-clearing and detoxifying properties, promotes blood circulation and removes blood stasis, and acts as a diuretic. It is used to treat ascites caused by late-stage schistosomiasis, ascites caused by liver cirrhosis, snake bites, and sores, boils, and carbuncles.

[0037] Cassia seeds are the dried mature seeds of Cassia obtusifolia L. or Cassia tora L., a plant of the genus Cassia in the Leguminosae family. They have a sweet, bitter, and salty flavor and are slightly cold in nature. They enter the liver and large intestine meridians. They clear heat, improve eyesight, and moisten the intestines and promote bowel movements. They are primarily used to treat red, swollen, and painful eyes, photophobia, excessive tearing, blurred vision, headaches, dizziness, and constipation caused by dry intestines.

[0038] Curcuma zedoaria, the dried rhizome of the ginger family Curcuma zedoaria, Curcuma guangxiensis, or Curcuma zedoariae, is warm in nature, with a pungent and bitter taste. It enters the spleen and liver meridians. It belongs to the category of blood-activating and stasis-removing herbs, which also includes blood-clearing and stagnation-resolving herbs. It has the effects of promoting qi and dissolving blood, dissolving stagnation, and relieving pain. It is commonly used to treat lumps and masses, amenorrhea due to blood stasis, distension and pain caused by food stagnation, and early-stage cervical cancer.

[0039] Trigonella stoloniferum is the tuber of Sparganium stoloniferum Buch.-Ham. (Sparganium family). It is neutral in nature, with a pungent and bitter taste. It enters the Liver and Spleen meridians. It is classified as a blood-activating and stasis-removing herb, and is a blood-clearing and stagnation-resolving herb. It has the effects of clearing blood, promoting qi circulation, and relieving pain. It is commonly used to treat lumps and masses, amenorrhea due to blood stasis, bloating and pain caused by food stagnation, abdominal pain, dysmenorrhea, and traumatic injuries.

[0040] Radix Trichosanthis (Trichosanthes kirilovoii Maxim. or Trichosanthes rosthornii Harms), both in the Cucurbitaceae family, is sweet and slightly bitter in flavor, slightly cold in nature, and enters the Lung and Stomach meridians. It clears heat and purges fire, promotes fluid production and quenches thirst, and reduces swelling and discharges pus. It is primarily used to treat fever-induced thirst, lung-heat-induced dry cough, internal heat-induced polydipsia, and sores and swelling.

[0041] Gentiana scabra (Gentiana scabra) is the dried root and rhizome of Gentiana scabra (Gentiana scabra), Gentiana scabra (Gentiana scabra), or Gentiana triflora (Gentiana triflora), all members of the Gentianaceae family. It has a bitter taste and cold properties. It enters the Lung and Liver meridians. It clears heat and dampness, and relieves liver and gallbladder fire. It is primarily used for clearing heat and dampness, and relieving liver and gallbladder fire. It is used for damp-heat jaundice, vaginal swelling and itching, leucorrhea, eczema and itching, red eyes due to liver fire, tinnitus and deafness, flank pain and bitter taste in the mouth, dysphagia, and convulsions.

[0042] Astragalus membranaceus (Huangqi) is the root of the leguminous plants Astragalus membranaceus (Huangqi) Bge. var. mongholicus (Huangqi) Hsiao and Astragalus membranaceus (Huangqi) Bge. It is slightly warm in nature and sweet in taste. It enters the spleen and lung meridians. It is a Qi-tonifying herb, a subcategory of tonics. It has the effects of tonifying Qi and raising Yang, strengthening the exterior and stopping sweating, promoting diuresis and reducing swelling, promoting fluid production and nourishing blood, relieving stagnation and relieving numbness, expelling toxins and draining pus, and healing sores and promoting tissue regeneration. It is commonly used to treat shortness of breath, palpitations, fatigue, collapse, spontaneous sweating, night sweats, edema due to physical weakness, chronic nephritis, chronic diarrhea, rectal prolapse, uterine prolapse, difficult-to-cure carbuncles, persistent sores, pediatric bronchial asthma, chronic hepatitis B, chronic nephritis, and viral myocarditis.

[0043] In the present invention, the synergistic effect of the various drugs exerts the effects of promoting the production of body fluids and quenching thirst, clearing away heat and detoxifying, and strengthening the spleen and eliminating dampness. It can repair the pancreas and eliminate toxins through intestinal absorption to achieve the purpose of treating hyperglycemia. Sugar toxicity is metabolized by the kidneys and excreted through urine, sweat, and feces. Ginsenosides and salvia miltiorrhiza saponins in salvia miltiorrhiza and ginseng can promote glucose uptake and utilization by regulating the activity of enzymes related to sugar metabolism, such as hexokinase and glucose-6-phosphatase. Artificial bezoar inhibits liver glycogenolysis, thereby lowering blood sugar levels. The polysaccharides in ginseng and salvia miltiorrhiza are combined with apricot kernel, red peony root, seahorse, sea dragon, eucommia bark, psoralea corylifolia, notopterygium root, clematis root, Scutellaria barbata, cassia seed, zedoaria, trillium, gentian root, and astragalus to stimulate insulin secretion, enhance insulin sensitivity, and regulate blood sugar homeostasis. Astragalus root, gentian root, and artificial bezoar are rich in ingredients such as astragalus polysaccharides and flavonoids. Astragalus polysaccharides can lower blood sugar by activating the insulin signaling pathway, increasing the tyrosine phosphorylation of insulin receptor substrate-1 (IRS-1), promoting the translocation of glucose transporter 4 (GLUT4), and improving cellular glucose uptake and utilization. Psoralea corylifolia, seahorse, and sea dragon contain lignans such as lignans methyl and lignans ethyl, which have antioxidant effects. They can scavenge excess free radicals in the body, reduce oxidative stress damage to pancreatic β cells, promote the repair and regeneration of pancreatic β cells, and maintain their normal insulin secretion function. Trichosanthesin, the main component of Radix Trichosanthis and Gentiana scabra, has a protective effect on pancreatic β cells. It can inhibit the damage of inflammatory factors to pancreatic β cells, regulate intracellular signal transduction pathways, and reduce cell apoptosis, thereby maintaining the number and function of pancreatic β cells and ensuring normal insulin secretion. Artificial bezoar, ginseng, salvia miltiorrhiza, and gentian, primarily composed of bezoarin, supplemented by ginseng polysaccharides and salvia miltiorrhiza polysaccharides, can regulate fat cells. Supplemented with other prepared Chinese herbs, they can modulate the metabolism of liver and skeletal muscle cells, increase the expression and activity of insulin receptors, improve insulin sensitivity, improve insulin resistance, and lower blood sugar levels. Tanshinones and salvianolic acid, among other components in salvia miltiorrhiza, regulate lipid metabolism, lower free fatty acid levels in the blood, and reduce fat deposition in the liver and muscle tissue, thereby improving insulin resistance. They also possess antioxidant and anti-inflammatory properties, helping to mitigate the development of chronic complications of diabetes.

[0044] After the medicinal ingredients of the traditional Chinese medicine composition of the present invention reach the lesion site, they exert therapeutic effects through mechanisms such as regulating blood sugar, protecting pancreatic beta cells, and improving insulin resistance. In the liver, they inhibit gluconeogenesis and glycogenolysis, reducing glucose output; in muscle and adipose tissue, they improve glucose uptake and utilization, lowering blood sugar levels; in the pancreas, they protect pancreatic beta cells and maintain normal insulin secretion, thereby comprehensively regulating blood sugar metabolism, improving diabetic symptoms, and preventing and delaying the occurrence and development of diabetic complications. It achieves a good therapeutic effect on type I diabetes, type II diabetes, and diabetic complications (lactic acidosis, ketoacidosis, and symmetrical distal polyneuritis caused by ketoacidosis), with a total clinical efficacy of up to 91.88%.

[0045] The present invention also provides a preparation method of the traditional Chinese medicine composition, comprising the following steps: crushing and mixing the components and then boiling with water to form an ointment; and drying, cooling, crushing and sterilizing the ointment.

[0046] In the present invention, each raw material component is pulverized separately and passed through a 40-80 mesh sieve. The resulting raw material powders are mixed uniformly in proportion and boiled with water to form a paste. The amount of water added is 5-10 mL / g, preferably 6-8 mL / g, and the boiling time is 3-5 hours, preferably 4 hours. The boiled ointment is dried, preferably in an oven at a temperature of 30-50°C, preferably 32°C, for 25-30 minutes, preferably 28 minutes. After drying, the ointment is cooled to room temperature, pulverized through a 40-80 mesh sieve, and then sterilized by microwave sterilization at a microwave frequency of 900-950 MHz, preferably 915 MHz, at a temperature of 60-80°C, and for 3-5 minutes. Microwave sterilization is used in the present invention to ensure the complete elimination of various microorganisms in the raw materials, including spores, molds, yeasts, Escherichia coli, Staphylococcus aureus, and Pseudomonas aeruginosa. The invention is packaged after sterilization to obtain the traditional Chinese medicine composition preparation.

[0047] After oral administration, the Chinese medicine composition preparation of the present invention first disintegrates in the gastrointestinal tract. Since the powdered medicine has a large specific surface area, it is conducive to the dissolution of the active ingredients of the medicine. The drug ingredients enter the blood circulation through the gastrointestinal mucosa by passive diffusion, active transport, etc. For example, small molecule alkaloid components such as berberine are mainly absorbed by passive diffusion, while polysaccharide components such as ginseng polysaccharide and astragalus polysaccharide may enter the cells by active transport or endocytosis by binding to specific receptors on the surface of intestinal epithelial cells. The microvilli and villus structure in the intestine greatly increase the contact area between the drug and the intestinal mucosa, thereby promoting the absorption of the drug. The preparation of the present invention is preferably a powder capsule. As an optional embodiment, the present invention is packaged in bags of 30 capsules per bag, each 0.5g, sealed in moisture-proof bags, and stored after quality inspection.

[0048] The present invention also provides a drug for treating diabetes and / or diabetic complications, comprising the aforementioned traditional Chinese medicine composition, wherein the content of the traditional Chinese medicine composition is 60-100 wt%, preferably 85-99 wt%. The drug of the present invention may further comprise a pharmaceutically acceptable carrier, and pharmaceutically acceptable excipients may be added to the drug to ensure that the prepared drug is convenient for preparation and clinical application.

[0049] The following will be combined with the embodiments of the present invention to clearly and completely describe the technical solutions of the present invention. Obviously, the embodiments described are only some of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0050] In the following examples, unless otherwise specified, all methods are conventional.

[0051] Unless otherwise specified, the materials and reagents used in the following examples can be obtained from commercial sources.

[0052] Example 1

[0053] A traditional Chinese medicine composition for treating diabetes and / or diabetic complications comprises the following raw materials: 5g artificial bezoar, 12g atractylodes, 5g apricot kernel, 10g red peony root, 8g ligusticum, 12g salvia miltiorrhiza, 8g momordica seed, 12g costus root, 2g ginseng, 1g deer whip, 2g seahorse, 3g sea dragon, 2g eucommia bark, 6g psoralea corylifolia, 4g notopterygium root, 4g clematis root, 1g barbata, 12g cassia seed, 9g zedoaria, 3g trillium, 10g tricholoma, 10g gentiana, and 6g astragalus.

[0054] The preparation method is:

[0055] Weigh each raw material, grind it, and pass it through a 60-mesh sieve. Mix the resulting raw powders in the appropriate proportions, add 1000 mL of water, and boil for 4 hours until they become a paste. Place the resulting paste in an oven at 30°C for 30 minutes to remove excess water. After drying, cool the paste to room temperature, grind it through an 80-mesh sieve, and microwave sterilize it. Microwave sterilization is performed at a frequency of 915 MHz, a temperature of 70°C, and a time of 4 minutes. Package the resulting powder capsules. Each bag contains 30 capsules, weighing 0.5 g. Package the capsules in separate bags, seal them in moisture-proof bags, and store them after quality inspection.

[0056] Example 2

[0057] A traditional Chinese medicine composition for treating diabetes and / or diabetic complications comprises the following raw materials: artificial bezoar 4g, atractylodes 10g, apricot kernel 4g, red peony root 8g, ligusticum chuanxiong 8g, salvia miltiorrhiza 10g, momordica seed 7g, costus root 10g, ginseng 1g, deer whip 1g, seahorse 1g, sea dragon 2g, eucommia ulmoides 2g, psoralea corylifolia 6g, notopterygium root 2g, clematis root 2g, scutellaria barbata 1g, cassia seed 10g, zedoaria 8g, trillium 2g, radix trichosanthis 8g, gentiana 10g, and astragalus 6g.

[0058] The preparation method is:

[0059] Weigh each raw material, grind it, and pass it through a 70-mesh sieve. Mix the resulting raw powders in the appropriate proportions, add 1000 mL of water, and boil for 4 hours until they become a paste. Place the resulting paste in an oven at 30°C for 30 minutes to remove excess water. After drying, cool the paste to room temperature, grind it through a 40-mesh sieve, and sterilize it with a microwave. Microwave sterilization is performed at a frequency of 915 MHz, a temperature of 60°C, and a time of 5 minutes. The resulting powder capsules are packaged. Each bag contains 30 capsules, weighing 0.5 g. The capsules are then sealed in moisture-proof bags and stored after quality inspection.

[0060] Example 3

[0061] A traditional Chinese medicine composition for treating diabetes and / or diabetic complications comprises the following raw materials: artificial bezoar 6g, atractylodes 14g, apricot kernel 6g, red peony root 12g, ligusticum chuanxiong 12g, salvia miltiorrhiza 14g, momordica seed 9g, costus root 14g, ginseng 2g, deer whip 1g, seahorse 2g, sea dragon 3g, eucommia ulmoides 4g, psoralea corylifolia 8g, notopterygium incisum 4g, clematis root 4g, scutellaria barbata 2g, cassia seed 12g, zedoaria 10g, trillium 4g, radix trichosanthis 12g, gentiana 14g, and astragalus 8g.

[0062] The preparation method is:

[0063] Weigh each raw material, grind it, and pass it through an 80-mesh sieve. Mix the resulting raw powders in appropriate proportions, add 1000 mL of water, and boil for 4 hours until they become a paste. Place the resulting paste in an oven at 30°C for 30 minutes to remove excess water. After drying, cool the paste to room temperature, grind it through an 80-mesh sieve, and sterilize it with a microwave. Microwave sterilization is performed at a frequency of 915 MHz, a temperature of 80°C, and a time of 3 minutes. Package the resulting powder capsules. Each bag contains 30 capsules, weighing 0.5 g. Seal the capsules in moisture-proof bags and store them in storage after quality inspection.

[0064] Example 4

[0065] A traditional Chinese medicine composition for treating diabetes and / or diabetic complications comprises the following raw materials: artificial bezoar powder 4g, atractylodes 14g, apricot kernel 4g, red peony root 12g, ligusticum chuanxiong 8g, salvia miltiorrhiza 14g, momordica chinensis 7g, costus root 14g, ginseng 2g, deer whip 1.8g, seahorse 1.6g, sea dragon 2g, eucommia ulmoides 3g, psoralea corylifolia 7g, notopterygium incisum 2.5g, clematis root 3g, scutellaria barbata 2g, cassia seed 12g, zedoaria 9g, trillium 4g, radix trichosanthis 8g, gentiana 12g, and astragalus 7g.

[0066] The preparation method is:

[0067] Weigh each raw material, grind it, and pass it through a 70-mesh sieve. Mix the resulting raw powders in the appropriate proportions, add 1000 mL of water, and boil for 4 hours until they become a paste. Place the resulting paste in an oven at 30°C for 30 minutes to remove excess water. After drying, cool the paste to room temperature, grind it through a 50-mesh sieve, and sterilize it with a microwave. Microwave sterilization is performed at a frequency of 915 MHz, a temperature of 70°C, and a time of 4 minutes. The resulting powder capsules are packaged. Each bag contains 30 capsules, weighing 0.5 g. The capsules are then sealed in moisture-proof bags and stored after quality inspection.

[0068] Example 5

[0069] A traditional Chinese medicine composition for treating diabetes and / or diabetic complications, comprising the following raw materials: 5g artificial bezoar powder, 12g atractylodes, 5g apricot kernel, 10g red peony root, 10g ligusticum, 12g salvia miltiorrhiza, 8g momordica seed, 12g costus root, 1.8g ginseng, 1g deer whip, 1.8g seahorse, 2.4g sea dragon, 2g eucommia bark, 7g psoralea corylifolia, 3g notopterygium root, 3g clematis root, 2g barbata scutellaria, 12g cassia seed, 10g zedoaria, 3g trillium, 10g tricholoma, 12g gentian, and 7g astragalus.

[0070] The preparation method is:

[0071] Weigh each raw material, grind it, and pass it through a 60-mesh sieve. Mix the resulting raw material powders in appropriate proportions, add 1000 mL of water, and boil for 4 hours until they become a paste. Place the resulting paste in an oven at 30°C for 30 minutes to remove excess water. After drying, cool the paste to room temperature, grind it through a 60-mesh sieve, and microwave sterilize it. Microwave sterilization is performed at a frequency of 915 MHz, a temperature of 65°C, and a time of 4 minutes. Package the resulting powder capsules. Each bag contains 30 capsules, weighing 0.5 g. The capsules are packaged in separate bags, sealed in moisture-proof bags, and stored after quality inspection.

[0072] Example 6

[0073] A traditional Chinese medicine composition for treating diabetes and / or diabetic complications comprises the following raw materials: artificial bezoar 6g, atractylodes 10g, apricot kernel 6g, red peony root 8g, ligusticum chuanxiong 8g, salvia miltiorrhiza 10g, momordica seed 9g, costus root 10g, ginseng 2g, deer whip 1.2g, seahorse 1g, sea dragon 2g, eucommia ulmoides 4g, psoralea corylifolia 6g, notopterygium root 4g, clematis root 4g, scutellaria barbata 2g, cassia seed 11g, zedoaria 10g, trillium 2g, radix trichosanthis 11g, gentiana 12g, and astragalus 7g.

[0074] The preparation method is:

[0075] Weigh each raw material, grind it, and pass it through a 60-mesh sieve. Mix the resulting raw powders in the appropriate proportions, add 1000 mL of water, and boil for 4 hours until they become a paste. Place the resulting paste in an oven at 30°C for 30 minutes to remove excess water. After drying, cool the paste to room temperature, grind it through a 70-mesh sieve, and microwave sterilize it. Microwave sterilization is performed at a frequency of 915 MHz, a temperature of 70°C, and a time of 4 minutes. The resulting powder capsules are packaged. Each capsule weighs 0.5 g and is packaged in individual bags, sealed in moisture-proof bags, and stored after quality inspection.

[0076] Test example

[0077] Clinical observation was carried out using the drug prepared in Example 1:

[0078] 1. Case selection:

[0079] 320 cases were treated, including 180 males and 140 females aged from 12 to 83 years.

[0080] 2. Treatment methods:

[0081] Take the prepared medicine, open the medicine bag, and take it with an appropriate amount of warm water. Take 1 to 2 pills three times a day, once in the morning and once in the evening. Once blood sugar levels return to normal, reduce the dosage to 1 pill each time. Adjust the dosage based on blood sugar levels. The minimum dosage can be reduced to 1 / 2 pill each time.

[0082] 3. Criteria for determining efficacy

[0083] According to the "Standards for Diagnosis and Efficacy of Traditional Chinese Medicine Diseases", the degree of improvement of symptoms and physical signs is used as the standard for judging efficacy, and the categories are:

[0084] Markedly effective: all symptoms are basically eliminated or the main symptoms are eliminated; specific symptoms eliminated: diabetic nephropathy, diabetic blood sugar level, diabetic foot, diabetic ketoacidosis symptoms, hyperosmolar hyperglycemic syndrome, and lower limb edema.

[0085] Effective: Major symptoms are essentially eliminated or significantly improved. Specific effective symptoms include diabetic nephropathy, diabetic blood sugar levels, diabetic ketoacidosis symptoms, lower limb edema, and urine protein.

[0086] Ineffective: No changes in various symptoms and signs. Specific ineffective symptoms: diabetic retinopathy, heart atherosclerosis, coronary heart disease, myocardial infarction.

[0087] 4. Treatment effect

[0088] Table 1 Treatment effects of 320 patients

[0089]

[0090] The results showed that among all 320 patients who used the drug of the present invention, 116 were markedly effective, 294 were effective (including the 116 markedly effective) and 26 were ineffective, with an overall effective rate of 91.88%. No adverse reactions were observed in any of the cases.

[0091] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as within the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for treating diabetes and / or diabetic complications, characterized in that: The invention comprises the following components in parts by mass: 4-6 parts of artificial bezoar, 10-14 parts of atractylodes, 4-6 parts of apricot kernel, 8-12 parts of red peony root, 8-12 parts of ligusticum chuanxiong, 10-14 parts of salvia miltiorrhiza, 7-9 parts of momordica seeds, 10-14 parts of costus root, 1-2 parts of ginseng, 0.5-1.5 parts of deer whip, 1-2 parts of seahorse, 2-3 parts of sea dragon, 2-4 parts of eucommia bark, 6-8 parts of psoralea corylifolia, 2-4 parts of notopterygium wilfordii, 2-4 parts of clematis root, 1-2 parts of bark scutellaria, 10-12 parts of cassia seed, 8-10 parts of zedoaria, 2-4 parts of trillium, 8-12 parts of tricholoma, 10-14 parts of gentian and 6-8 parts of astragalus.

2. The Chinese medicine composition according to claim 1, characterized in that The invention comprises the following components in parts by weight: 5 parts of artificial bezoar, 12 parts of atractylodes, 5 parts of apricot kernel, 10 parts of red peony root, 8 parts of chuanxiong, 12 parts of salvia miltiorrhiza, 8 parts of momordica seeds, 12 parts of costus root, 2 parts of ginseng, 1 part of deer whip, 2 parts of seahorse, 3 parts of sea dragon, 2 parts of eucommia, 6 parts of psoralea corylifolia, 4 parts of notopterygium wilfordii, 4 parts of clematis root, 1 part of scutellaria barbata, 12 parts of cassia seed, 9 parts of zedoaria, 3 parts of trillium, 10 parts of gentiana and 6 parts of astragalus.

3. The method for preparing the Chinese medicine composition according to claim 1 or 2, characterized in that: The following steps are involved: The components are crushed and mixed, and then water is added to boil the ointment; the ointment is dried, cooled, crushed, and sterilized.

4. The preparation method according to claim 3, characterized in that The pulverization is to pass the sieve through 40-80 mesh after pulverization.

5. The preparation method according to claim 3, characterized in that In the boiling process, the amount of water added is 5 to 10 mL / g, and the boiling time is 3 to 5 hours.

6. The preparation method according to claim 3, characterized in that The ointment is placed in an oven evaporation box for drying at a temperature of 30° C. to 50° C. for 25 to 30 minutes.

7. The preparation method according to claim 3, characterized in that The sterilization is microwave sterilization.

8. The preparation method according to claim 7, characterized in that The microwave sterilization has a microwave frequency of 900-950 MHz, a temperature of 60° C.-80° C., and a time of 3-5 minutes.

9. A drug for treating diabetes and / or diabetic complications, characterized in that: The medicine comprises the traditional Chinese medicine composition according to claim 1 or 2.

10. The drug according to claim 9, characterized in that The content of the traditional Chinese medicine composition is 60wt% to 100wt%.

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