Traditional Chinese medicine composition for treating diabetes and preparation method thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating diabetes and a preparation method thereof. The traditional Chinese medicine composition is an oral liquid preparation and comprises the following raw materials in parts by weight: 25-30 parts of prepared rehmannia root, 20-25 parts of pulp of dogwood fruit, 10-15 parts of Japanese saussurea herb, 10-15 parts of dwarf lilyturf tuber, 10-15 parts of Chinese yam, 8-10 parts of stem of falsenettleleaf pepper, 8-10 parts of Chinese magnoliavine fruit, 8-10 parts of tree peony bark and 8-10 parts of kudzuvine root. The prepared rehmannia root and the pulp of dogwood fruit in the traditional Chinese medicine composition are used as monarch drugs to nourish kidney yin, boost essence and fill marrow; the Japanese saussurea herb has the effects of dispelling wind and eliminating dampness, the dwarf lilyturf tuber has the effects of quenching thirst and clearing away heart-fire, and the Chinese yam has the effects of tonifying spleen and nourishing stomach and promoting The falsenettleleaf pepper stem has the effects of warming spleen and stomach for dispelling cold, the schisandra chinensis has the effects of tonifying qi and inducing astringency, and the moutan bark has the effects of The radix puerariae has the effects of invigorating yang and stopping diarrhea and clearing and activating the channels and collaterals. The traditional Chinese medicine composition not only can tonify the spleen and reinforce the kidney, but also can effectively tonify qi and yin, clear heat and moisten dryness, and promote blood circulation to remove meridian obstruction, and has a remarkable curative effect on the condition of diabetes mellitus.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for treating diabetes and its preparation method. Background Technology

[0002] With economic and technological development, people's dietary structure has undergone significant changes. Most people prefer high-fat and high-sugar foods, but exercise less, leading to fat accumulation and overnutrition, which in turn causes metabolic disorders and an increasing number of metabolic diseases, such as diabetes. Currently, diabetes is the third leading chronic disease threatening human health after cancer and cardiovascular disease, and its incidence continues to rise, seriously affecting human health and posing a major public health challenge.

[0003] Diabetes is classified into type 1 diabetes, type 2 diabetes, gestational diabetes, and other special types. Type 2 diabetes accounts for a relatively high proportion, and its main manifestation is obesity. Its pathogenesis is closely related to relative insulin insufficiency or insulin resistance. Current treatments for this disease mainly include insulin injections, oral hypoglycemic agents, dietary therapy, and exercise therapy. Oral hypoglycemic agents are the primary treatment method. These agents are mainly divided into insulin-secreting drugs, biguanides, and alpha-glucosidase inhibitors. However, insulin-secreting drugs carry the risk of hypoglycemia; biguanides may cause some damage to the liver and kidneys; and while alpha-glucosidase inhibitors can also lower blood sugar, they have negative effects on intestinal function.

[0004] With the development of modern medicine, people are increasingly recognizing the value and profoundness of Traditional Chinese Medicine (TCM). Diabetes, in TCM, falls under the category of "Xiao Ke Bing" (wasting and thirsting disease), and is recorded in the *Huangdi Neijing* (Yellow Emperor's Inner Classic). Its pathogenesis mainly involves pathological states such as kidney yin deficiency and lung dryness-heat. It is evident that TCM's research on diabetes has a long history. Based on the principles of syndrome differentiation and treatment in TCM, TCM herbal combinations exert synergistic effects through the "principal, assistant, adjuvant, and guide" principle, demonstrating unique advantages in the treatment of diabetes. Therefore, exploring TCM herbal combinations that can effectively treat type 2 diabetes is of great significance. Summary of the Invention

[0005] The primary objective of this invention is to provide a traditional Chinese medicine composition for treating diabetes. This composition enhances the targeted approach of "treating both the lungs and kidneys," effectively regulating glucose and lipid metabolism, improving insulin resistance, and promoting tissue repair, thus providing a scientific basis for the modernization of traditional Chinese medicine research in the prevention and treatment of diabetes.

[0006] The technical solution adopted for the first objective of this invention is: A traditional Chinese medicine composition for treating diabetes, the composition being an oral liquid preparation comprising the following raw materials in parts by weight: 25-30 parts of Rehmannia glutinosa, 20-25 parts of Cornus officinalis, 10-15 parts of Ophiopogon japonicus, 10-15 parts of Dioscorea opposita, 8-10 parts of Phragmites communis, 10-15 parts of Schisandra chinensis, 8-10 parts of Paeonia suffruticosa, and 8-10 parts of Pueraria lobata.

[0007] The above-mentioned traditional Chinese medicine composition for treating diabetes of the present invention is an oral liquid preparation comprising the following raw materials in parts by weight: 28 parts of Rehmannia glutinosa, 22 parts of Cornus officinalis, 13 parts of Ophiopogon japonicus, 12 parts of Ophiopogon japonicus, 12 parts of Dioscorea opposita, 9 parts of Phragmites communis, 14 parts of Schisandra chinensis, 9 parts of Paeonia suffruticosa, and 10 parts of Pueraria lobata.

[0008] Prescription analysis: Prepared Rehmannia Root: This is a traditional Chinese medicine made from the tuberous root of *Rehmannia glutinosa* or *Rehmannia glutinosa* (family Scrophulariaceae), after steaming. It is sweet and slightly warm in nature, and enters the liver and kidney meridians. It has the effects of nourishing blood and yin, replenishing essence and marrow. It is mainly used to treat symptoms such as blood deficiency and chlorosis, irregular menstruation, seminal emission, metrorrhagia, liver and kidney yin deficiency, bone steaming fever, frequent urination, deafness, and blurred vision. It is often used with *Cornus officinalis* and *Dioscorea opposita* to improve symptoms such as lower back and knee weakness, dizziness, and tinnitus caused by liver and kidney deficiency; it also enhances the body's hematopoietic function. *Zhenzhu Nang* states: It greatly replenishes blood deficiency, unblocks blood vessels, and strengthens qi.

[0009] Cornus officinalis: The dried, mature fruit pulp of the Cornus officinalis plant (family Cornaceae). The fruit is harvested in late autumn / early winter when the peel turns red. It is then dried over a low heat or briefly blanched in boiling water, the pits removed promptly, and then dried completely. It is acidic, astringent, and slightly warm in nature; it enters the liver and kidney meridians; it tonifies the liver and kidneys, astringes essence, and strengthens the body in cases of weakness and collapse. Functions and indications: Treats lower back and knee pain, dizziness, tinnitus, impotence, seminal emission, frequent urination, liver deficiency with chills and fever, excessive sweating, and palpitations. According to *Bielu*: Treats intestinal wind-evil, hernia with chills and fever, headache, wind-related ailments, nasal congestion, jaundice, deafness, facial acne, warms the middle jiao, lowers qi, induces sweating, strengthens yin, benefits essence, calms the five internal organs, opens the nine orifices, stops frequent urination, improves eyesight, and strengthens the body.

[0010] Eight-leaved wood: The whole herb of *Saussurea involucrata*, a plant in the genus *Saussurea* of the Asteraceae family. The whole herb is harvested around July and dried. It is neutral in nature and bitter and pungent in taste, possessing the effects of dispelling wind, activating blood circulation, dispersing blood stasis, and relieving pain. It is commonly used for rheumatic pain, lower back and leg pain, and traumatic injuries. *New Compilation of Medicinal Herbs*: Contraindicated for those with blood deficiency and qi weakness.

[0011] Ophiopogon japonicus: The tuberous root of Ophiopogon japonicus, a plant in the Liliaceae family. It is sweet, slightly bitter, and slightly cold in nature. It enters the Heart, Lung, and Stomach meridians. Ophiopogon japonicus contains various saponins and high levels of isoflavones, and has the effects of nourishing Yin and moistening the lungs, clearing the heart and relieving irritability, benefiting the stomach and promoting fluid production, protecting the cardiovascular system, enhancing immune function, and lowering blood sugar. It is mainly used to treat dry cough due to lung dryness, hemoptysis, pulmonary atrophy, lung abscess, consumptive fever, thirst, heat-related illnesses with fluid depletion, dry throat and mouth, and constipation. According to the *Shennong Bencao Jing* (Divine Farmer's Materia Medica): It treats abdominal distension, internal injury from overeating, interruption of stomach meridians, emaciation, and shortness of breath.

[0012] Yam: The dried rhizome of Dioscorea opposita, a plant in the Dioscoreaceae family. Harvested in winter after the stems and leaves wither, the root head is cut off, washed, the outer skin and fibrous roots are removed, and then dried, or sliced ​​thickly while fresh and dried. It is sweet and warm in nature. It enters the lung, spleen, and kidney meridians. It has the effects of tonifying the spleen and stomach, promoting body fluid production and benefiting the lungs, and tonifying the kidneys and astringing essence. It treats spleen deficiency diarrhea, chronic dysentery, consumptive cough, diabetes, seminal emission, leukorrhea, and frequent urination. It is used for spleen deficiency with poor appetite, chronic diarrhea, lung deficiency with wheezing and cough, kidney deficiency with seminal emission, leukorrhea, frequent urination, and thirst due to deficiency heat. Stir-fried yam with wheat bran tonifies the spleen and stomach. It is used for spleen deficiency with poor appetite, loose stools, and excessive leukorrhea. The *Shennong Bencao Jing* states: It treats internal injuries, tonifies deficiency, eliminates cold and heat pathogens, strengthens the middle jiao and boosts qi, builds muscle, and with prolonged use, improves hearing and vision.

[0013] Piper sarmentosum: The whole plant of Piper sarmentosum and Piper simaoense, belonging to the Piperaceae family. Harvested in autumn and winter. Washed, chopped, and sun-dried. The whole plant is used medicinally; it is warm in nature and pungent in taste. It enters the lung, heart, liver, spleen, and stomach meridians. It has the effects of dispelling wind and dampness, and clearing the meridians; used for colds due to wind-cold, rheumatic pain, stomachache, irregular menstruation, traumatic injuries, and fractures. According to *Yunnan Traditional Chinese Medicine*: It relaxes muscles and tendons, warms the meridians and promotes diuresis, regulates qi and relieves pain. It treats rheumatism, irregular menstruation, stomachache, and traumatic injuries.

[0014] Schisandra chinensis: The dried, mature fruit of Schisandra chinensis or Schisandra chinensis, both belonging to the Magnoliaceae family. Harvested in autumn when the fruit is ripe, it is sun-dried or steamed and then sun-dried, removing the fruit stalks and impurities. It has a sour taste and warm properties. It enters the Lung, Heart, and Kidney meridians. It is used for chronic cough and wheezing, nocturnal emission, frequent urination, chronic diarrhea, spontaneous sweating, night sweats, thirst due to fluid depletion, shortness of breath and weak pulse, internal heat and thirst, palpitations, and insomnia. *Ben Cao Jing Shu* states: It is contraindicated in cases of initial measles, stagnation of fluids, liver qi stagnation, or lung heat when using Scutellaria baicalensis to purge heat.

[0015] Peony bark: The root bark of the peony plant (Paeonia suffruticosa), a member of the Ranunculaceae family. Select peonies that have been cultivated for 3-5 years, harvest in autumn or early spring, wash away the soil, remove the fibrous roots and stems, and then cut open the root bark and sun-dry it. It tastes bitter and is slightly cold in nature. It enters the heart, liver, and kidney meridians. It has the effects of clearing heat and cooling blood, harmonizing blood and dispelling blood stasis, and antibacterial and anti-inflammatory properties. It is mainly used to treat heat entering the blood, rashes, epilepsy, vomiting, nosebleeds, hematochezia, bone steaming fever, amenorrhea, abdominal masses, carbuncles, and traumatic injuries. *Compendium of Materia Medica*: Harmonizes blood, generates blood, and cools blood. Treats latent heat in the blood and eliminates vexation and fever. *Depei Materia Medica*: Do not use if the stomach qi is weak and cold, or the ministerial fire is deficient.

[0016] Kudzu root: The dried root of *Pueraria lobata* or *Pueraria truncata*, both belonging to the legume family. It is sweet, pungent, neutral, and non-toxic, and enters the spleen, stomach, lung, and bladder meridians. It has the effects of releasing exterior pathogens and relieving muscle tension, promoting yang and relieving rashes, clearing heat and generating fluids, relieving irritability and stopping fever. It treats typhoid fever, headache and stiff neck due to febrile diseases, thirst due to fever, diarrhea, dysentery, incomplete rash eruption, hypertension, angina pectoris, and deafness. *Bielu* states: It treats headache due to typhoid fever and stroke, releases exterior pathogens, promotes sweating, and opens the pores. It treats traumatic injuries, relieves pain, and relieves hypochondriac pain. The juice of the fresh root treats thirst and high fever due to typhoid fever.

[0017] The second objective of this invention is to provide a method for preparing a traditional Chinese medicine composition for treating diabetes, which has simple preparation steps and is easy to mass-produce.

[0018] The second objective of this invention is achieved through the following technical solution: A method for preparing a traditional Chinese medicine composition for treating diabetes includes the following steps: (1) Mix the raw materials evenly according to the weight ratio, then soak them in water, decoct them after soaking, filter them to obtain a first decoction, and keep the dregs. (2) Add water to the dregs from step (1) and decoct them, then filter to obtain a secondary decoction; (3) Combine the primary drug solution in step (1) and the secondary drug solution in step (2), concentrate them to obtain a concentrated solution, add pharmaceutically acceptable excipients to the concentrated solution, and prepare the corresponding dosage form.

[0019] Furthermore, in step (1), the amount of water added is 8-15 times the total mass of the raw material; the soaking time is 2-3 hours.

[0020] Furthermore, in step (2), the amount of water added is 8-12 times the mass of the dregs.

[0021] Furthermore, the simmering time in steps (1) and (2) is 1.5-2 hours.

[0022] Furthermore, the concentrate mentioned in step (3) is an extract with a relative density of 1.1-1.2.

[0023] Compared with the prior art, the main advantages of the present invention are as follows: 1. The traditional Chinese medicine composition for treating diabetes provided by this invention comprises Rehmannia glutinosa, Cornus officinalis, Alternanthera philoxeroides, Ophiopogon japonicus, Dioscorea opposita, Phragmites communis, Schisandra chinensis, Paeonia suffruticosa, and Pueraria lobata. The principal herbs are Rehmannia glutinosa and Cornus officinalis. Rehmannia glutinosa tonifies qi and blood, and replenishes essence and marrow; Cornus officinalis tonifies kidney yin and warms and tonifies kidney yang. The assistant herbs are Alternanthera philoxeroides, Ophiopogon japonicus, and Dioscorea opposita. Alternanthera philoxeroides dispels wind and dampness; Ophiopogon japonicus nourishes yin and generates fluids, quenches thirst and clears the heart; Dioscorea opposita strengthens the spleen and stomach, generates fluids and benefits the lungs. The adjuvant herbs are Phragmites communis, Schisandra chinensis, and Paeonia suffruticosa. Phragmites communis warms the middle and dispels cold; Schisandra chinensis tonifies qi and astringes; Paeonia suffruticosa cools the blood, clears heat, and promotes blood circulation; Pueraria lobata raises yang, stops diarrhea, and unblocks meridians. The guiding herb is Pueraria lobata. The traditional Chinese medicine composition provided by this invention achieves a comprehensive effect through the scientific combination of multiple Chinese medicinal ingredients, targeting multiple points and pathways. It not only has a significant hypoglycemic effect but also effectively regulates bodily functions and improves insulin resistance. This demonstrates that the traditional Chinese medicine composition of this invention plays a certain role in improving the symptoms of diabetic patients and promoting their overall recovery.

[0024] 2. The traditional Chinese medicine composition of the present invention is an oral liquid preparation, which is convenient for patients to take orally and is conducive to digestion and absorption; and it improves the problem of drug residue precipitation that exists in traditional Chinese medicine preparations.

[0025] 3. This invention provides a method for preparing a traditional Chinese medicine composition for treating diabetes. The oral liquid preparation is obtained by soaking, controlling the heat of decoction, concentrating and adding flavoring agents. It effectively retains the effective components of the raw materials and has high safety and stable efficacy. Detailed Implementation

[0026] The technical solution of the present invention will be further described below with reference to specific embodiments. However, those skilled in the art should understand that the following embodiments are only for illustrating the present invention and should not be regarded as limiting the present invention. Specific conditions not specified in the embodiments are performed according to conventional conditions or conditions recommended by the manufacturer. Unless otherwise specified, the reagents or instruments used are all conventional products obtained through commercial channels.

[0027] Example 1 A traditional Chinese medicine composition for treating diabetes includes the following raw materials in parts by weight: 28 parts Rehmannia glutinosa, 22 parts Cornus officinalis, 13 parts Ophiopogon japonicus, 12 parts Ophiopogon japonicus, 12 parts Dioscorea opposita, 9 parts Phragmites communis, 14 parts Schisandra chinensis, 9 parts Paeonia suffruticosa, and 10 parts Pueraria lobata.

[0028] This embodiment also provides a method for preparing the above-mentioned traditional Chinese medicine composition for treating diabetes, including the following steps: (1) Mix the raw materials evenly according to the above weight ratio, then add 10 times the total weight of the raw materials in cold water and soak for 2.5 hours. After soaking, heat to boiling over high heat, then simmer over low heat for 2 hours. Filter with gauze to obtain the first decoction and keep the dregs. (2) Add 10 times the mass of hot water (at 80°C) to the dregs in step (1), simmer for 1.5 hours, and filter with gauze to obtain a secondary decoction; (3) Combine the primary solution described in step (1) and the secondary solution described in step (2), concentrate them to obtain a concentrated solution, and measure that the concentrated solution is an extract with a relative density of 1.15; add 1.5% honey by mass of the concentrated solution and mix evenly, and make an oral liquid according to conventional process.

[0029] Example 2 A traditional Chinese medicine composition for treating diabetes includes the following raw materials in parts by weight: 25 parts Rehmannia glutinosa, 20 parts Cornus officinalis, 10 parts Ophiopogon japonicus, 10 parts Dioscorea opposita, 8 parts Phragmites communis, 10 parts Schisandra chinensis, 8 parts Paeonia suffruticosa, and 8 parts Pueraria lobata.

[0030] This embodiment also provides a method for preparing the above-mentioned traditional Chinese medicine composition for treating diabetes, including the following steps: (1) Mix the raw materials evenly according to the above weight ratio, then add 8 times the total weight of the raw materials in cold water and soak for 2 hours. After soaking, heat to boiling over high heat, then simmer over low heat for 1.5 hours. Filter with gauze to obtain the first decoction and keep the dregs. (2) Add hot water (80°C) equal to the mass of the dregs in step (1) to the dregs, simmer for 1.5 hours, and filter with gauze to obtain a secondary decoction; (3) Combine the primary and secondary medicinal solutions described in steps (1) and (2), concentrate them to obtain a concentrated solution, and measure that the concentrated solution is an extract with a relative density of 1.1; add 1% honey by mass of the concentrated solution and mix evenly, and make an oral liquid according to conventional process.

[0031] Example 3 A traditional Chinese medicine composition for treating diabetes includes the following raw materials in parts by weight: 30 parts Rehmannia glutinosa, 25 parts Cornus officinalis, 15 parts Ophiopogon japonicus, 15 parts Dioscorea opposita, 10 parts Phragmites communis, 15 parts Schisandra chinensis, 10 parts Paeonia suffruticosa, and 10 parts Pueraria lobata.

[0032] This embodiment also provides a method for preparing the above-mentioned traditional Chinese medicine composition for treating diabetes, including the following steps: (1) Mix the raw materials evenly according to the above weight ratio, then add 15 times the total weight of the raw materials in cold water and soak for 3 hours. After soaking, heat to boiling over high heat, then simmer over low heat for 2 hours. Filter with gauze to obtain the first decoction and keep the dregs. (2) Add hot water (at 80°C) with a mass of 12 times the weight of the dregs to the dregs in step (1), simmer for 2 hours, and filter with gauze to obtain a secondary decoction; (3) Combine the primary solution described in step (1) and the secondary solution described in step (2), concentrate them to obtain a concentrated solution, and measure that the concentrated solution is an extract with a relative density of 1.2; add 2% honey by mass of the concentrated solution and mix evenly, and make an oral liquid according to conventional process.

[0033] Comparative Example 1 Comparative Example 1 provides a traditional Chinese medicine composition comprising the following raw materials in parts by weight: 28 parts Rehmannia glutinosa (processed), 22 parts Cornus officinalis, 12 parts Ophiopogon japonicus, 12 parts Dioscorea opposita, 9 parts Phragmites communis, 14 parts Schisandra chinensis, 9 parts Paeonia suffruticosa, and 10 parts Pueraria lobata. That is, the difference between this comparative example and Example 1 is that octagonal wood is not added to the formula.

[0034] Comparative Example 1 also provides a method for preparing the above-mentioned traditional Chinese medicine composition, which is consistent with that in Example 1.

[0035] Comparative Example 2 Comparative Example 2 provides a traditional Chinese medicine composition comprising the following raw materials in parts by weight: 28 parts Rehmannia glutinosa (processed), 22 parts Cornus officinalis, 13 parts Clematis armandii, 12 parts Ophiopogon japonicus, 12 parts Dioscorea opposita, 14 parts Schisandra chinensis, 9 parts Paeonia suffruticosa, and 10 parts Pueraria lobata. That is, the difference between this comparative example and Example 1 is that it does not contain Phragmites communis.

[0036] Comparative Example 2 also provides a method for preparing the above-mentioned traditional Chinese medicine composition, which is consistent with that in Example 1.

[0037] Experimental Example 1 Toxicological experiment: Sixty healthy male SPF-grade SD rats, weighing 180-200g, were selected and housed in an environment of 25℃ and 55% humidity, with a 12h / 12h diurnal lighting pattern. They were provided with normal water and food for one week of acclimatization. After fasting for 16 hours, the experimental SD rats (randomly divided into 4 groups of 15 rats each) were administered the compositions obtained in Examples 1, 2, and 3 by gavage at a dose of 20g / kg / d, designated as Example 1 group, Example 2 group, and Example 3 group, respectively. The blank control group received no treatment. Feeding was administered 4 hours after gavage. The presence of poisoning, death, or other adverse reactions was observed and recorded in detail. The experiment lasted for 30 days.

[0038] The above safety experiments showed that the rats in each group were similar to the blank control group, and no poisoning or death occurred, indicating that the traditional Chinese medicine composition of the present invention has good safety and is non-toxic.

[0039] Experimental Example 2 2.1 Experimental Animals and Grouping: 150 healthy male SPF-grade SD rats, weighing 180-200g, were housed in an environment of 25℃ and 55% humidity, with a 12h / 12h diurnal lighting pattern. They received normal water and food for one week of acclimatization. The SD rats were randomly divided into a normal control group and a model group (model group, positive control group, low-dose Example 1 group, medium-dose Example 1 group, high-dose Example 1 group, low-dose Example 2 group, low-dose Example 3 group, low-dose comparative example 1 group, and low-dose comparative example 2 group), with 15 rats in each group.

[0040] 2.2 Establishment of a Diabetic Model: SD rats in the model group were fed a high-sugar, high-fat diet (74wt% normal diet, 20wt% lard, 5wt% sucrose, 1wt% cholesterol), while the normal control group was fed a normal diet, for 6 weeks. Twelve hours after the last feeding, the rats in the model group were intraperitoneally injected with streptozotocin (STZ, dissolved in 0.1mmol / L citrate buffer at pH 4.0 to prepare a 1.0% (w / v) STZ solution, at a dose of 30mg / kg). Three days after the streptozotocin injection, fasting tail vein blood glucose was tested. A blood glucose concentration ≥16.7 mmol / L, accompanied by symptoms such as polydipsia, polyphagia, polyuria, sparse and dull hair, and lethargy, indicated successful model establishment.

[0041] 2.3 Administration method The gavage doses for low-dose Example 1 group, medium-dose Example 1 group, and high-dose Example 1 group were 5 g / kg / d, 10 g / kg / d, and 15 g / kg / d, respectively (all based on crude drug weight). The gavage doses for low-dose Example 2 group, low-dose Example 3 group, low-dose Comparative Example 1 group, and low-dose Comparative Example 2 group were all 5 g / kg / d. The corresponding traditional Chinese medicine compositions for each of the above groups were administered via gavage, such as the traditional Chinese medicine composition obtained in Example 1 group. The normal control group and the model group were administered the same amount of distilled water via gavage. The positive control group was administered metformin at a dose of 0.25 g / kg / d for 30 days.

[0042] 2.4 Indicator Testing Thirty days after administration, rats in each group were fasted but allowed free access to water for 12 hours. Fasting blood glucose (FBG), fasting insulin (FINS), triglyceride (TG), and total cholesterol (TC) levels were measured.

[0043] (1) Fasting blood glucose was measured according to the instructions of the enzyme-linked immunosorbent assay kit. The experimental results are shown in Table 1.

[0044] (2) The fasting insulin content was determined according to the standard instructions of the enzyme-linked immunosorbent assay kit. The experimental results are shown in Table 2.

[0045] (3) The triglyceride and total cholesterol content were determined according to the instructions of the enzyme-linked immunosorbent assay kit. The experimental results are shown in Table 3.

[0046] Table 1 As can be seen from the experimental data in Table 1, the traditional Chinese medicine composition obtained in this invention can reduce blood glucose levels in diabetic SD rats. The blood glucose levels of rats in Examples 1-3 were significantly lower than those in the model group. The reduction in blood glucose levels in low-dose comparative group 1 and low-dose comparative group 2 was not as significant as that in the low-dose group of Example 1.

[0047] Table 2 As shown in Table 2, the insulin levels in the model group rats were significantly higher than those in the normal control group, further confirming the successful establishment of the model. After drug administration, the insulin levels in the high, medium, and low dose groups (Example 1) were all lower than those in the model group rats. The insulin levels in the low dose groups (Example 2 and 3) were not as high as those in the low dose group (Example 1), but were still lower than those in the model group. Although the insulin levels in the low dose comparative groups (Example 1 and 2) were also lower than those in the model group, the effect was not as good as that in the low dose group (Example 1), indicating that their efficacy was relatively poor.

[0048] Table 3 Triglycerides (TG) and total cholesterol (TC) are frequently measured indicators in diabetic rat models. Disorders of glucose metabolism can lead to lipid metabolism disorders. As shown in Table 3, the TG and TC levels in the model group of this invention were significantly higher than those in the normal control group, indicating that the triglyceride and total cholesterol levels in the SD rats in the model group were both above the normal range. Compared with the model group, the triglyceride and total cholesterol levels in rats in the low-, medium-, and high-dose Example 1 groups, as well as the low-dose Example 2 and Low-dose Example 3 groups, all showed significant decreases. Compared with Low-dose Example 1, the effects in Low-dose Comparative Example 1 and Low-dose Comparative Example 2 groups were relatively worse.

[0049] In summary, the traditional Chinese medicine composition obtained by this invention can lower blood glucose levels in rats and improve insulin resistance; it has a significant therapeutic effect on diabetic rats.

[0050] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them. The basic principles and main features of the present invention have been described above with specific implementation schemes. Based on the present invention, some modifications or substitutions can be made, but these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of protection claimed by the present invention.

Claims

1. A traditional Chinese medicine composition for treating diabetes, characterized in that, The traditional Chinese medicine composition is an oral liquid preparation, comprising the following raw materials in parts by weight: 25-30 parts of Rehmannia glutinosa, 20-25 parts of Cornus officinalis, 10-15 parts of Ophiopogon japonicus, 10-15 parts of Dioscorea opposita, 8-10 parts of Phragmites communis, 10-15 parts of Schisandra chinensis, 8-10 parts of Paeonia suffruticosa, and 8-10 parts of Pueraria lobata.

2. The traditional Chinese medicine composition for treating diabetes according to claim 1, characterized in that, The traditional Chinese medicine composition is an oral liquid preparation, comprising the following raw materials in parts by weight: 28 parts Rehmannia glutinosa, 22 parts Cornus officinalis, 13 parts Ophiopogon japonicus, 12 parts Ophiopogon japonicus, 12 parts Dioscorea opposita, 9 parts Phragmites communis, 14 parts Schisandra chinensis, 9 parts Paeonia suffruticosa, and 10 parts Pueraria lobata.

3. The method for preparing the traditional Chinese medicine composition for treating diabetes according to claim 1 or 2, characterized in that, Includes the following steps: (1) Mix the raw materials evenly according to the weight ratio, then soak them in water, decoct them after soaking, filter them to obtain a first decoction, and keep the dregs. (2) Add water to the dregs from step (1) and decoct them, then filter to obtain a secondary decoction; (3) Combine the primary drug solution in step (1) and the secondary drug solution in step (2), concentrate them to obtain a concentrated solution, add pharmaceutically acceptable excipients to the concentrated solution, and prepare the corresponding dosage form.

4. The method for preparing the traditional Chinese medicine composition for treating diabetes according to claim 3, characterized in that, In step (1), the amount of water added is 8-15 times the total mass of the raw material; the soaking time is 2-3 hours.

5. The method for preparing the traditional Chinese medicine composition for treating diabetes according to claim 3, characterized in that, In step (2), the amount of water added is 8-12 times the mass of the dregs.

6. The method for preparing the traditional Chinese medicine composition for treating diabetes according to claim 3, characterized in that, The simmering time in steps (1) and (2) is 1.5-2 hours.

7. The method for preparing the traditional Chinese medicine composition for treating diabetes according to claim 3, characterized in that, The concentrate mentioned in step (3) is an extract with a relative density of 1.1-1.2.

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