Traditional Chinese medicine composition for treating diabetes and preparation method thereof

Abstract

The invention relates to the technical field of traditional Chinese medicine preparations, in particular to a traditional Chinese medicine composition for treating diabetes and a preparation method thereof. The invention provides a composition. The composition is prepared from the following traditional Chinese medicinal materials or raw material medicines based on the following traditional Chinese medicinal materials: poria cocos, lily, gordon euryale seeds, lotus seeds, Chinese wolfberry fruits, black dates (diospyros lotus) and ampelopsis grossedentata. The composition has the functions of tonifying middle-Jiao and Qi, invigorating spleen and kidney, nourishing Yin and soothing liver, clearing heat and activating blood, can be used for treating common diabetes symptoms such as deficiency of Qi and Yin, internal heat and dysphoria, thirst and hunger, polyphagia and polydipsia, deficiency of Qi and weakness and the like caused by deficiency syndromes of visceral systems such as liver, spleen and kidney, and can relieve insulin resistance. Therefore, absorption and metabolism of cells to glucose are increased to achieve the effect of reducing blood glucose, a certain curative effect on complications of diabetes mellitus is achieved, and the treatment effect is even remarkably superior to that of a blood glucose reducing medicine metformin which is commonly used in clinic for treating diabetes mellitus. And the method has very good practical significance.

Description

Technical Field

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

[0002] Diabetes is a common endocrine disease, often divided into type I diabetes, type II diabetes and gestational diabetes. Damage to the islets of Langerhans, which cannot produce insulin or cannot produce enough insulin for the body to use, will lead to type I diabetes, also known as insulin-dependent diabetes or juvenile diabetes, which is named because it is a congenital disease and occurs mostly in infants and teenagers. Type II diabetes results from abnormal insulin resistance or insensitivity or non-response of cells to insulin, and there is no pathological problem with the islets of Langerhans itself. It is also called non-insulin-dependent diabetes or adult-onset diabetes. Gestational diabetes refers to one of the main complications during the perinatal period of pregnant women who have no history of diabetes and whose blood sugar is higher than the normal value only during pregnancy. This disease may cause complications such as fetal developmental deformities and neonatal hypoglycemia. As of 2019, approximately 463 million adults worldwide suffered from diabetes, and type II diabetes is the most common type, accounting for more than 90% of all diabetes patients. It is estimated that by 2045, the number of diabetes patients worldwide will reach 700 million. Most of the typical symptoms of diabetes are harmless symptoms such as easy thirst, easy hunger, frequent urination, weight loss, blurred vision, and slow wound healing. However, persistent hyperglycemia can cause a series of serious complications such as cardiovascular and cerebrovascular diseases, kidney failure, retinal damage, and diabetic foot.

[0003] In recent years, with the development of diabetes towards younger ages and the continuous increase in its incidence, the prevention and treatment of diabetes have received increasing attention. The cause of diabetes is not yet very clear, and it is only known that it is related to many factors: obesity, genetic factors, eating habits, etc. Western medicine believes that diabetes is mainly related to disorders in the metabolism of sugar, lipids, and proteins in the body and endocrine disorders. Common treatments include: oral medications such as biguanide drugs (metformin), sulfonylurea drugs, thiazolidinedione drugs, repaglinide drugs, α-glucosidase inhibitors, dipeptidyl peptidase-4 inhibitors, sodium-glucose cotransporter inhibitors, etc.; injectable drugs such as insulin and insulin analogs. Currently, the treatment of diabetes in clinical practice is mainly based on Western medicine, but there are problems such as treating the symptoms rather than the root cause, having toxic and side effects, and being prone to drug tolerance, making it difficult for patients to fully recover.

[0004] Diabetes is a comprehensive chronic disease with complex etiologies and a wide range of clinical manifestations. A comprehensive and systematic study is advisable. Traditional Chinese medicine believes that diabetes is caused by deficiency syndromes of internal organs such as the liver, spleen, and kidney. Innate endowment deficiency and weakness of the five internal organs are the main causes and internal factors for the onset of diabetes. Traditional Chinese medicine has preventive and therapeutic effects on diabetes and its complications, with the characteristics of mild medicinal properties, small toxic and side effects, multiple active ingredients, and multiple action targets. Moreover, it may repair internal organs. Therefore, the hypoglycemic traditional Chinese medicine combination has great development potential and value. Giving play to the advantages of traditional Chinese medicine in the control and treatment of chronic diseases is an embodiment of the modern application of traditional Chinese medicine.

[0005] Therefore, the existing therapeutic drugs and technologies still need to be improved and developed. Summary of the Invention

[0006] In some embodiments, the present invention provides a composition, comprising the following Chinese medicinal materials or prepared from raw medicinal materials containing the following Chinese medicines: Poria cocos, Lilium brownii, Euryale ferox, Nelumbo nucifera Gaertn., Lycium barbarum, black date (scientific name "Diospyros lotus"), Ampelopsis grossedentata.

[0007] In some embodiments, the composition further comprises Cinnamomum cassia, Inonotus obliquus, and Astragalus membranaceus.

[0008] In some embodiments, the composition comprises the following components in parts by weight: Astragalus membranaceus 2 - 40 parts, Poria cocos 1 - 30 parts, Lilium brownii 1 - 30 parts, Euryale ferox 1 - 30 parts, Nelumbo nucifera Gaertn. 1 - 30 parts, Cinnamomum cassia 1 - 15 parts, Lycium barbarum 1 - 30 parts, black date 1 - 30 parts, Ampelopsis grossedentata 1 - 30 parts, and Inonotus obliquus 1 - 30 parts.

[0009] In some embodiments, the composition comprises the following components in parts by weight: Astragalus membranaceus 9 - 20 parts, Poria cocos 7 - 15 parts, Lilium brownii 7 - 15 parts, Euryale ferox 7 - 15 parts, Nelumbo nucifera Gaertn. 7 - 15 parts, Cinnamomum cassia 4 - 8 parts, Lycium barbarum 7 - 15 parts, black date 7 - 15 parts, Ampelopsis grossedentata 7 - 15 parts, and Inonotus obliquus 7 - 15 parts.

[0010] In some embodiments, the composition comprises the following components in parts by weight: Astragalus membranaceus 12 - 18 parts, Poria cocos 9 - 12 parts, Lilium brownii 9 - 12 parts, Euryale ferox 9 - 12 parts, Nelumbo nucifera Gaertn. 9 - 12 parts, Cinnamomum cassia 5 - 6 parts, Lycium barbarum 9 - 12 parts, black date 9 - 12 parts, Ampelopsis grossedentata 9 - 12 parts, and Inonotus obliquus 9 - 12 parts.

[0011] In some embodiments, the composition comprises the following components in parts by weight: Astragalus membranaceus 15 parts, Poria cocos 10 parts, Lilium brownii 10 parts, Euryale ferox 10 parts, Nelumbo nucifera Gaertn. 10 parts, Cinnamomum cassia 5 parts, Lycium barbarum 10 parts, black date 10 parts, Ampelopsis grossedentata 10 parts, and Inonotus obliquus 10 parts.

[0012] In some embodiments, the composition further comprises Dolichos lablab, Mentha haplocalyx, Zingiber officinale, Glycyrrhiza glabra, Cistanche deserticola, and Polygonatum sibiricum.

[0013] In some embodiments, the composition further comprises the following components in parts by weight: 1 - 30 parts of white hyacinth bean, 1 - 30 parts of mint, 1 - 15 parts of dried ginger, 1 - 15 parts of liquorice, 1 - 30 parts of cistanche, 1 - 30 parts of polygonatum sibiricum.

[0014] In some embodiments, the composition comprises the following components in parts by weight: 7 - 15 parts of white hyacinth bean, 7 - 15 parts of mint, 4 - 8 parts of dried ginger, 4 - 8 parts of liquorice, 7 - 15 parts of cistanche, 7 - 15 parts of polygonatum sibiricum.

[0015] In some embodiments, the composition comprises the following components in parts by weight: 9 - 12 parts of white hyacinth bean, 9 - 12 parts of mint, 5 - 6 parts of dried ginger, 5 - 6 parts of liquorice, 9 - 12 parts of cistanche, 9 - 12 parts of polygonatum sibiricum.

[0016] In some embodiments, the composition comprises the following components in parts by weight: 15 parts of astragalus membranaceus, 10 parts of poria cocos, 10 parts of lilium brownii, 10 parts of euryale ferox, 10 parts of lotus seed, 5 parts of cinnamon, 10 parts of wolfberry fruit, 10 parts of black date, 10 parts of ampelopsis grossedentata, 10 parts of inonotus obliquus, 10 parts of white hyacinth bean, 10 parts of mint, 5 parts of dried ginger, 5 parts of liquorice, 10 parts of cistanche, 10 parts of polygonatum sibiricum.

[0017] In some embodiments, the composition further contains fingered citron and male eucommia flower.

[0018] In some embodiments, the composition further comprises the following components in parts by weight: 1 - 30 parts of fingered citron, 1 - 30 parts of male eucommia flower.

[0019] In some embodiments, the composition further comprises the following components in parts by weight: 7 - 15 parts of fingered citron, 7 - 15 parts of male eucommia flower.

[0020] In some embodiments, the composition further comprises the following components in parts by weight: 9 - 12 parts of fingered citron, 9 - 12 parts of male eucommia flower.

[0021] In some embodiments, the composition comprises the following components in parts by weight: 15 parts of astragalus membranaceus, 10 parts of poria cocos, 10 parts of lilium brownii, 10 parts of euryale ferox, 10 parts of lotus seed, 5 parts of cinnamon, 10 parts of wolfberry fruit, 10 parts of black date, 10 parts of ampelopsis grossedentata, 10 parts of inonotus obliquus, 10 parts of white hyacinth bean, 10 parts of mint, 5 parts of dried ginger, 5 parts of liquorice, 10 parts of cistanche, 10 parts of polygonatum sibiricum, 10 parts of fingered citron, 10 parts of male eucommia flower.

[0022] In some embodiments, the composition further contains cinnamon, white hyacinth bean, liquorice, polygonatum sibiricum, fingered citron, male eucommia flower, raspberry and kudzu root.

[0023] In some embodiments, the composition further comprises the following components in parts by weight: 1-10 parts of cinnamon, 1-30 parts of white hyacinth bean, 1-10 parts of licorice, 1-30 parts of polygonatum, 1-30 parts of fingered citron, 1-30 parts of male eucommia flower, 1-30 parts of raspberry, and 1-30 parts of kudzu root.

[0024] In some embodiments, the composition further comprises the following components in parts by weight: 1-7 parts of cinnamon, 7-15 parts of white hyacinth bean, 1-7 parts of licorice, 7-15 parts of polygonatum, 7-15 parts of fingered citron, 7-15 parts of male eucommia flower, 7-15 parts of raspberry, and 7-15 parts of kudzu root.

[0025] In some embodiments, the composition further comprises the following components in parts by weight: 2-7 parts of cinnamon, 9-12 parts of white hyacinth bean, 2-7 parts of licorice, 9-12 parts of polygonatum, 9-12 parts of fingered citron, 9-12 parts of male eucommia flower, 9-12 parts of raspberry, and 9-12 parts of kudzu root.

[0026] In some embodiments, the composition comprises the following components in parts by weight: 15 parts of poria, 10 parts of lily, 10 parts of gorgon fruit, 10 parts of lotus seed, 5 parts of cinnamon, 10 parts of wolfberry fruit, 10 parts of black date, 10 parts of rattan tea, 10 parts of white hyacinth bean, 5 parts of licorice, 10 parts of polygonatum, 10 parts of fingered citron, 10 parts of male eucommia flower, 10 parts of raspberry, and 10 parts of kudzu root.

[0027] In some embodiments, the composition further includes astragalus root, mulberry leaf, dandelion, purslane, kudzu root, cyclocarya paliurus, fingered citron, polygonatum, cistanche, raspberry, licorice, and male eucommia flower.

[0028] In some embodiments, the composition further comprises the following components in parts by weight: 9-36 parts of astragalus root; 6-24 parts of mulberry leaf; 6-24 parts of dandelion; 6-24 parts of purslane; 6-24 parts of kudzu root; 4-18 parts of lily; 4-18 parts of gorgon fruit; 4-18 parts of poria; 4-18 parts of black date; 4-18 parts of cyclocarya paliurus; 4-18 parts of lotus seed; 4-18 parts of fingered citron; 3-12 parts of polygonatum; 3-12 parts of cistanche; 1-8 parts of raspberry; 1-8 parts of licorice; 1-8 parts of wolfberry fruit; 1-8 parts of rattan tea; and 1-6 parts of male eucommia flower.

[0029] In some embodiments, the composition further comprises the following components in parts by weight: 12-27 parts of astragalus root; 9-18 parts of mulberry leaf; 9-18 parts of dandelion; 9-18 parts of purslane; 9-18 parts of kudzu root; 6-12 parts of lily; 6-12 parts of gorgon fruit; 6-12 parts of poria; 6-12 parts of black date; 6-12 parts of cyclocarya paliurus; 6-12 parts of lotus seed; 6-12 parts of fingered citron; 4-9 parts of polygonatum; 4-9 parts of cistanche; 2-6 parts of raspberry; 2-6 parts of licorice; 2-6 parts of wolfberry fruit; 2-6 parts of rattan tea; and 2-5 parts of male eucommia flower.

[0030] In some embodiments, the composition further comprises the following components in parts by weight: 16 - 20 parts of Astragalus membranaceus; 11 - 13 parts of Morus alba leaf; 11 - 13 parts of Taraxacum mongolicum; 11 - 13 parts of Portulaca oleracea; 11 - 13 parts of Pueraria lobata; 8 - 10 parts of Lilium brownii; 8 - 10 parts of Euryale ferox; 8 - 10 parts of Poria cocos; 8 - 10 parts of black date; 8 - 10 parts of Cyclocarya paliurus; 8 - 10 parts of Nelumbo nucifera; 8 - 10 parts of Citrus medica var. sarcodactylis; 6 - 7 parts of Polygonatum sibiricum; 6 - 7 parts of Cistanche deserticola; 4 - 5 parts of Rubus idaeus; 4 - 5 parts of Glycyrrhiza glabra; 4 - 5 parts of Lycium barbarum; 4 - 5 parts of Ampelopsis grossedentata; 3 - 4 parts of male flower of Eucommia ulmoides.

[0031] In some embodiments, the present invention provides a finished product, comprising the composition and a pharmaceutically acceptable excipient.

[0032] In some embodiments, the finished product is a drug, a health food, a food, an external health product, an additive or an intermediate product. In some embodiments,

[0033] The finished product is a pharmaceutically acceptable dosage form.

[0034] In some embodiments, the finished product includes a drug, a health food, a food, an external health product, an additive or an intermediate product.

[0035] In some embodiments, the dosage form of the drug includes powder, granule, capsule, pill, oral liquid.

[0036] In some embodiments, the finished product is used for treating and improving diabetes or its complications.

[0037] In some embodiments, the mass percentage of the composition contained in the finished product is 30 - 70%.

[0038] In some embodiments, the present invention provides a pharmaceutical composition, comprising the composition and a pharmaceutically acceptable excipient.

[0039] In some embodiments, the dosage form of the drug includes powder, granule, capsule, pill, injection, but is not limited thereto.

[0040] In some embodiments, the pharmaceutical composition is a hypoglycemic or diabetes treatment drug.

[0041] In some embodiments, the mass percentage of the composition contained in the pharmaceutical composition is 30 - 70%.

[0042] In some embodiments, the present invention provides a method for preparing the composition, comprising the following steps: (1) mixing the medicinal materials in the formula according to the selected weight parts, using 5-15 times the amount of water, refluxing and extracting 2-4 times, each time for 0.5-2 hours, to obtain an extract; (2) combining the extracts obtained from each reflux extraction and concentrating; (3) adding excipients, drying into a powder, and then preparing into a dosage form.

[0043] In some embodiments, the present invention provides the application of the composition in the preparation of a product having the function of treating or improving diabetes and its complications.

[0044] In some embodiments, the product is a drug, a health food, an external health product, an additive or an intermediate.

[0045] In some embodiments, the product is a pharmaceutically acceptable dosage form.

[0046] In some embodiments, the product includes a drug, a health food, an external health product, an additive or an intermediate.

[0047] In some embodiments, the dosage forms of the drug include powder, granule, capsule, pill, injection.

[0048] In some embodiments, the diabetes includes type I diabetes and type II diabetes.

[0049] In some embodiments, the diabetes is type II diabetes. Description of the Drawings

[0050] Figure 1 Shows the effects of the traditional Chinese medicine extract combination formula A1-A6 on the glucose uptake and cell proliferation of HepG2 cells.

[0051] Figure 2 Shows the effects of the traditional Chinese medicine extract combination formula A1-A5 on the glucose uptake and cell proliferation of C2C12 cells.

[0052] Figure 3 Shows the effects of the traditional Chinese medicine extract combination formula A2-1 to A2-20 on the glucose uptake and cell proliferation of HepG2 cells.

[0053] Figure 4 Shows the effects of the traditional Chinese medicine extract combination formula A3-1 to A3-32 on the glucose uptake and cell proliferation of HepG2 cells.

[0054] Figure 5 Shows the effects of the traditional Chinese medicine extract combination formula A4-1 to A4-36 on the glucose uptake and cell proliferation of HepG2 cells.

[0055] Figure 6Effects of Formulas A5-1 to A5-30 of Traditional Chinese Medicine Extract Combinations on Glucose Uptake and Cell Proliferation of HepG2 Cells Detailed Implementation Modes

[0056] The technical solutions of the present invention are further described below through specific embodiments. The specific embodiments do not represent limitations on the protection scope of the present invention. Some non-essential modifications and adjustments made by others based on the concept of the present invention still fall within the protection scope of the present invention.

[0057] As used herein, the term "comprising" means that the compositions and methods include the recited elements, but do not exclude others. When used to define compositions and methods, "consisting essentially of" means excluding other elements essential to the combination. For example, as defined herein, a composition consisting essentially of certain elements does not exclude other elements that do not essentially affect the basic and novel features of the claimed invention. "Consisting of" means excluding other components and method steps of essential significance beyond the recited measures. Each embodiment defined by each transitional clause is within the scope of the present invention.

[0058] Unless otherwise stated, as used herein, the singular forms "a, an" and "the" include plural instances. Thus, reference to "a composition" also includes its plural "some compositions".

[0059] The term "extract" refers to an extract obtained by extracting traditional Chinese medicinal materials using water or organic solvents.

[0060] The term "traditional Chinese medicine extract combination" refers to both a mixture of extracts obtained by separately extracting each traditional Chinese medicinal material or herb, and an extract obtained by extracting a mixture of traditional Chinese medicinal materials or herbs.

[0061] The term "pharmaceutical composition" may refer to a single compound, or may refer to a combination of at least two compounds. For example, the composition may contain an active ingredient extracted from traditional Chinese medicinal materials and a pharmaceutically acceptable carrier.

[0062] "Pharmaceutically acceptable carrier" is a diluent, adjuvant, excipient or vehicle administered together with the composition. Pharmaceutical carriers include any and all physiologically compatible solvents, dispersion media, coatings, antibacterial and antifungal agents, isotonic agents and absorption delaying agents, etc. Examples of pharmaceutical carriers include, but are not limited to, sterile liquids such as water, oils and lipids such as phospholipids and glycolipids. These sterile liquids include, but are not limited to, those substances derived from petroleum, animal, vegetable or synthetic sources, such as peanut oil, soybean oil, mineral oil, sesame oil, etc.

[0063] The "treatment" of a patient's disease refers to: preventing the occurrence of the disease in patients with a predisposition or who have not yet shown symptoms of the disease; or inhibiting the disease or preventing its development; or alleviating the disease or causing its regression.

[0064] The compositions according to the present invention can be used as nutritional products or health care products, especially as drugs. The term "health food" refers to any product having nutritional and / or physiological effects, especially including food supplements, foods, diet products, etc. These products can be administered particularly via the oral, gastric or intravenous routes, but are not limited thereto.

[0065] Each traditional Chinese medicine in the disclosed compositions is a commonly used traditional Chinese medicine, which is detailedly recorded in "Chinese Pharmacopoeia" and "Compendium of Chinese Materia Medica", etc., and can be easily obtained through commercial channels. The present invention has no special restrictions on the origin of these Chinese medicinal materials, as long as they meet the relevant national standards or regulations.

[0066] Astragalus membranaceus (scientific name or official name), English name Mongolian Milkvetch Root or Membranous Milkvetch Root; Latin name is Astragali Radix.

[0067] Poria cocos (scientific name or official name), English name Indian Buead Tuckahoe; Latin name is Poria.

[0068] Lilium brownii var. viridulum (scientific name or official name), English name Greenish lily Bulb Liy Bulb, Latin name is Lilii Bulbus.

[0069] Euryale ferox (scientific name or official name), English name Gordon Euryale Seed, Latin name is Euryales Semen.

[0070] Nelumbo nucifera (scientific name or official name), English name Lotus Seed, Latin name is Nelumbinis Semen.

[0071] Cinnamomum cassia (scientific name or official name), English name Cassia Bark, Latin name is Cinnamomi Cortex.

[0072] Lycium barbarum (scientific name or official name), English name Babury Wolfberry Fruit, Latin name is Lycii Fructus.

[0073] Diospyros lotus (scientific name or official name), English name Dateplum Persimmon, Latin name is Diospyros lotus Linn.

[0074] Chaga mushroom (scientific name or official name), English name: Chaga mushroom; Latin name: Inonotus obliquus.

[0075] Vine tea (scientific name or official name), English name: vine tea; Latin name: Ampelopsis megalophylla Diels et Gilg.

[0076] White Hyacinth Bean (scientific name or official name), English name: White Hyacinth Bean, Latin name: Lablab Semen Album.

[0077] Wild Mint Herb (scientific name or official name), English name: Wild Mint Herb, Latin name: Menthae Haplocalycis Herba.

[0078] Dried Ginger (scientific name or official name), English name: Dried Ginger, Latin name: Zingiberis Rhizoma.

[0079] Liquorice Root (scientific name or official name), English name: Liquorice Root, Latin name: Glycyrrhizae Radix et Rhizoma.

[0080] Desertliving Cistanche Herb (scientific name or official name), English name: Desertliving Cistanche Herb, Latin name: Cistanches Herba.

[0081] Siberia Landpick (scientific name or official name), English name: Siberia Landpick, Latin name: Polygonatum sibiricum Delarb ex Redoute.

[0082] Finger Citron Fruit (scientific name or official name), English name: Finger Citron Fruit, Latin name: Citri Sarcodactylis Fructus.

[0083] Male flower of Eucommia ulmoides (scientific name or official name), English name: Male flower of Eucommia ulmoides, Latin name: Eucommia ulmoides Oliver.

[0084] Mulberry Leaf (scientific name or official name), English name: Mulberry Leaf, Latin name: Mori Folium.

[0085] Dandelion (scientific name or correct name), English name Mongolian Dandelion Herb, Latin name Taraxaci Herba.

[0086] Purslane (scientific name or correct name), English name Commonpurslane, Latin name Portulaca oleracea.

[0087] Kudzu Root (scientific name or correct name), English name Lobed Kudzuvine Root, Latin name Puerariae Lobatae Radix.

[0088] Cyclocarya (scientific name or correct name), English name Cyclocarya, Latin name Cyclocarya paliurus.

[0089] Raspberry (scientific name or correct name), English name Palmleaf Raspberry Fruit, Latin name Rubi Fructus.

[0090] Example 1 Formula (Formula A2) of Traditional Chinese Medicine Extract Combination and Its Preparation Method

[0091] A traditional Chinese medicine extract combination with the effect of treating diabetes, which is composed of the extraction of traditional Chinese medicinal materials in the weight parts described in Table 1; and is composed of the extraction of traditional Chinese medicinal materials in the weight parts described in Table 2, and the combination in Table 2 is the change of the concentration range of the traditional Chinese medicinal materials in Table 1.

[0092] Table 1 Composition of Formula A2

[0093] Component Mass (g) Astragalus membranaceus 15 Poria cocos 10 Lilium brownii 10 Euryale ferox 10 Nelumbo nucifera 10 Cinnamomum cassia 5 Lycium barbarum 10 Black date 10 Inonotus obliquus 10 Ampelopsis grossedentata 10 Total 100

[0094]

[0095] The steps included in the preparation method of the traditional Chinese medicine extract combination are as follows:

[0096] (1) According to the prescription amount described in Table 1 or Table 2, mix the traditional Chinese medicinal materials in the formula, use 8 times the amount of water (relative to the total weight of the traditional Chinese medicinal materials in the formula), reflux and extract twice, each time for 1 hour, to obtain an extraction solution;

[0097] (2) Combine the extraction solutions of the two times and concentrate;

[0098] (3) Add dextrin adjuvant and dry into powder or granule.

[0099] Example 2 Formula (Formula A3) of Traditional Chinese Medicine Extract Combination and Its Preparation Method

[0100] A traditional Chinese medicine extract combination with the function of treating diabetes, which is composed of the extracts of the combination of traditional Chinese medicinal materials in the parts by weight described in Table 3; or composed of the extracts of the combination of traditional Chinese medicinal materials in the parts by weight described in Table 4-1 and Table 4-2, and the combination of Table 4-1 and Table 4-2 is the change of the concentration range of the traditional Chinese medicinal materials in Table 3.

[0101] Table 3 Composition of Formula A3

[0102] Name of Chinese medicinal material Mass (g) Astragalus membranaceus 15 Poria cocos 10 Lilium brownii 10 Euryale ferox 10 Nelumbo nucifera 10 Cinnamomum cassia 5 Lycium barbarum 10 Black date 10 Inonotus obliquus 10 Ampelopsis grossedentata 10 Dolichos lablab 10 Mentha haplocalyx 10 Zingiber officinale 5 Glycyrrhiza glabra 5 Cistanche deserticola 10 Polygonatum sibiricum 10 Total 150

[0103]

[0104]

[0105] The preparation method of the traditional Chinese medicine extract combination includes the following steps:

[0106] (1) Mix the traditional Chinese medicinal materials in the formula according to the prescription amounts described in Table 3, Table 4-1 or Table 4-2, and use 8 times the amount of water (relative to the total weight of the traditional Chinese medicinal materials in the formula) for reflux extraction twice, each time for 1 hour, to obtain an extraction solution;

[0107] (2) Combine the extraction solutions of the two times and concentrate;

[0108] (3) Add dextrin adjuvant and dry into powder or granule.

[0109] Formula (Formula A4) of the traditional Chinese medicine extract combination in Example 3 and its preparation method

[0110] A traditional Chinese medicine extract combination with the function of treating diabetes, which is composed of the extracts of the combination of traditional Chinese medicinal materials in the parts by weight described in Table 5; or composed of the extracts of the combination of traditional Chinese medicinal materials in the parts by weight described in Table 6-1 and Table 6-2; the combination of Table 6-1 and Table 6-2 is the change of the concentration range of the traditional Chinese medicinal materials in Table 5.

[0111] Table 5 Composition of Formula A4

[0112] Name of Chinese medicinal material Mass (g) Astragalus membranaceus 15 Poria cocos 10 Lilium brownii 10 Euryale ferox 10 Nelumbo nucifera 10 Cinnamomum cassia 5 Lycium barbarum 10 Black date 10 Inonotus obliquus 10 Ampelopsis grossedentata 10 Dolichos lablab 10 Mentha haplocalyx 10 Zingiber officinale 5 Glycyrrhiza glabra 5 Cistanche deserticola 10 Polygonatum sibiricum 10 Citrus medica var. sarcodactylis 10 Eucommia ulmoides male flower 10 Total 170

[0113]

[0114]

[0115] The preparation method of the traditional Chinese medicine extract combination includes the following steps:

[0116] (1) Mix the traditional Chinese medicinal materials in the formula according to the prescription amounts described in Table 5, Table 6-1 or Table 6-2, and use 8 times the amount of water (relative to the total weight of the traditional Chinese medicinal materials in the formula) for reflux extraction twice, each time for 1 hour, to obtain an extraction solution;

[0117] (2) Combine the extraction solutions of the two times and concentrate;

[0118] (3) Add dextrin adjuvant and dry to form powder or granule.

[0119] Formulation (Formula A5) of the traditional Chinese medicine extract combination in Example 4 and its preparation method

[0120] A traditional Chinese medicine extract combination with the effect of treating diabetes, which is composed of the extraction of traditional Chinese medicine materials in the weight parts described in Table 7, or is composed of the extraction of traditional Chinese medicine materials in the weight parts described in Table 8-1 and Table 8-2. The combinations of Table 8, Table 8-1, and Table 8-2 are the concentration range changes of the traditional Chinese medicine materials in Table 7.

[0121] Table 7 Composition of Formula A5

[0122] Name of Chinese medicinal material Mass (g) Poria cocos 10 Lilium brownii 10 Euryale ferox 10 Nelumbo nucifera 10 Cinnamomum cassia 5 Lycium barbarum 10 Black date 10 Ampelopsis grossedentata 10 Dolichos lablab 10 Glycyrrhiza glabra 5 Polygonatum sibiricum 10 Citrus medica var. sarcodactylis 10 Eucommia ulmoides male flower 10 Rubus idaeus 10 Pueraria lobata 10 Total 140

[0123]

[0124]

[0125] The steps included in the preparation method of the traditional Chinese medicine extract combination are as follows:

[0126] (1) According to the prescription amounts described in Table 7, Table 8-1 or Table 8-2, mix the traditional Chinese medicine materials in the formula, use 8 times the amount of water (relative to the total weight of the traditional Chinese medicine materials in the formula), reflux and extract twice, each time for 1 hour, to obtain the extract solution;

[0127] (2) Combine the extract solutions of the two times and concentrate;

[0128] (3) Add dextrin adjuvant and dry to form powder or granule.

[0129] Formulation (Formula A6) of the traditional Chinese medicine extract combination in Example 5 and its preparation method

[0130] A traditional Chinese medicine extract combination with the effect of treating diabetes, which is composed of the extraction of traditional Chinese medicine materials in the weight parts described in Table 9; it is composed of the extraction of traditional Chinese medicine materials in the weight parts described in Table 10-1 and Table 10-2. The combinations of Table 10-1 and Table 10-2 are the concentration range changes of the traditional Chinese medicine materials in Table 9.

[0131] Table 9 Composition of Formula A6

[0132] Name of Chinese medicinal material Mass (g) Astragalus membranaceus 18 Mulberry leaf 12 Taraxacum mongolicum 12 Portulaca oleracea 12 Pueraria lobata 12 Lilium brownii 9 Euryale ferox 9 Poria cocos 9 Black date 9 Cyclocarya paliurus 9 Nelumbo nucifera 9 Citrus medica var. sarcodactylis 9 Polygonatum sibiricum 6 Cistanche deserticola 6 Rubus idaeus 4 Glycyrrhiza glabra 4 Lycium barbarum 4 Ampelopsis grossedentata 4 Eucommia ulmoides male flower 3 Total 160

[0133]

[0134]

[0135] The steps included in the preparation method of the traditional Chinese medicine extract combination are as follows:

[0136] (1) Mix the Chinese medicinal materials in the formula according to the prescription amounts described in Table 9, Table 10-1 or Table 10-2, and use 8 times the amount of water (relative to the total weight of the Chinese medicinal materials in the formula) to reflux and extract twice, each time for 1 hour, to obtain an extract;

[0137] (2) Combine the extracts from the two extractions and concentrate;

[0138] (3) Add dextrin adjuvant and dry to form a powder or granule.

[0139] Comparative Example 1

[0140] A combination of Chinese medicine extracts with a therapeutic effect on diabetes is composed of the extraction of a combination of Chinese medicinal materials in the weight parts described in Table 11. The preparation method of the combination of Chinese medicine extracts is the same as that of Example 1.

[0141] Table 11 Composition of Formula A1

[0142] Name of Chinese medicinal material Mass (g) Astragalus membranaceus 15 Poria cocos 10 Lilium brownii 10 Euryale ferox 10 Nelumbo nucifera 10 Cinnamomum cassia 5 Total 60

[0143] Test Example 1 Effect Test

[0144] 1. Experimental model:

[0145] Human hepatoma cell line (HepG2, American Type Culture Collection) and mouse myoblast cell line (C2C12, American Type Culture Collection)

[0146] 2. Experimental reagents:

[0147] DMEM high-glucose medium (dulbecco's modified eagle medium, Invitrogen, Carlsbad, CA), fetal bovine serum (Fetal bovine serum, Invitrogen, Carlsbad, CA), bovine serum albumin (Bovine serum albumin, USB, Cleveland, Ohio, USA), trypsin-EDTA (Trypsin-EDTA, Invitrogen, Carlsbad, CA), horse serum (Horse serum, Invitrogen, Carlsbad, CA), glucose test kit (Nanjing Jiancheng), WST-1 kit (Dojindo Molecular Technologies, Inc, Shanghai), PMS (Sigma-Aldrich, St. Louis, MO), metformin (Beijing Jingfeng Pharmaceutical), insulin (Shanghai Beyotime), palmitic acid (Sigma-Aldrich, St. Louis, MO).

[0148] 3. Experimental instruments:

[0149] Microplate Reader (Dynex Opsys MR TM ) and Chemidoc (Bio-Rad, Hercules, CA)

[0150] 4. Experimental procedures:

[0151] (1) Cell culture: After resuscitation, HepG2 cells and C2C12 cells were transferred to culture dishes with high-glucose DMEM medium containing 10% fetal bovine serum and cultured in a constant-temperature incubator at 37°C and 5% CO2. After the cells adhered and grew confluently, they were digested with trypsin. HepG2 cells were passaged once every 3 days at a ratio of 1:4, and C2C12 cells were passaged once every 3 days at a ratio of 1:10. Cells in the logarithmic growth phase were used for the experiment.

[0152] (2) Establishment of HepG2 insulin resistance model: HepG2 cells in the logarithmic growth phase were seeded into 96-well cell culture plates at a cell density of 5000 cells / well. The normal cell control group (Non-IR group, HepG2 Cells), insulin resistance model group (IR group, HepG2 Cells), insulin resistance model cells plus metformin positive control group (IR50mM metformin group), and test sample treatment group were set up, with 3 replicate wells in each group. After the cells adhered and grew for 24 h, freshly prepared cell culture medium containing 5×10 7 M insulin was added and incubated in a constant-temperature incubator at 37°C and 5% CO2 for 24 h to induce the IR-HepG2 cell model.

[0153] (3) Differentiation of C2C12 cells and establishment of insulin resistance model: After C2C12 cells adhered and grew to 80%, the original medium was replaced with high-glucose DMEM medium containing 2% heat-inactivated horse serum, and the medium was changed every two days for 5 days of induced differentiation. Differentiated C2C12 cells were seeded into 96-well cell culture plates at a cell density of 8000 cells / well. The normal cell control group (Non-IR group, C2C12cell), insulin resistance model group (IR group, C2C12cell), insulin resistance model cells plus metformin positive control group (IR50mM metformin group), and test sample treatment group were set up, with 3 replicate wells in each group. After the cells adhered and grew for 24 h, freshly prepared DMEM (serum-free) containing 0.75 mM palmitic acid and 1% BSA was added and incubated in a constant-temperature incubator at 37°C and 5% CO2 for 16 h to induce the IRC2C12 cell model.

[0154] (4) Cell viability assay: Take HepG2 cells and C2C12 cells in the logarithmic growth phase, and inoculate them into 96-well cell culture plates at cell densities of 5000 cells / well and 8000 cells / well respectively. Divide the cells into a normal cell control group, an insulin resistance model group, a positive control group of adding metformin to insulin resistance model cells, and a test sample treatment group. Each group has 3 replicate wells and is placed in a constant temperature incubator at 37°C and 5% CO2. Add an inducer to induce for 24 h (HepG2 cells) or 16 h (C2C12 cells), add the drug for 24 h, then remove the cell culture medium to measure the glucose content and calculate the glucose uptake of the cells; add 100 μl of DMEM sugar-free medium (containing 1 mM WST-1 and 0.25 mM PMS) to each well, incubate in the dark for 15 - 60 minutes, read the absorbance value of each well on an enzyme-linked immunosorbent assay (ELISA) reader (wavelength 450 nm), and calculate the cell survival rate.

[0155] Note: The drugs added to the test sample treatment group are the traditional Chinese medicine extracts of Examples 1 - 5.

[0156] (5) Glucose uptake level measurement: Take HepG2 cells and C2C12 cells in the logarithmic growth phase, and inoculate them into 96-well cell culture plates at cell densities of 5000 cells / well and 8000 cells / well respectively. Divide the cells into a blank (cell-free) group, a normal cell control group, an insulin resistance model group, a positive control group of adding metformin to insulin resistance model cells, and a test sample treatment group. Each group has 3 replicate wells and is placed in a constant temperature incubator at 37°C and 5% CO2. Add an inducer to induce for 24 h (HepG2 cells) or 16 h (C2C12 cells), add the drug for 24 h, then remove the cell culture medium to measure the glucose content and calculate the glucose uptake of the cells. Measure the glucose content in the supernatant of the cell culture medium by the glucose oxidase method (glucose test kit), and subtract the measured glucose content in the cell culture medium from the average glucose content of the blank group without inoculated cells to obtain the glucose uptake of each well of cells.

[0157] Note: The drugs added to the test sample treatment group are the traditional Chinese medicine extracts prepared in Examples 1 - 5 and Comparative Example 1.

[0158] 5. Experimental results

[0159] Calculation method of glucose uptake of cells: Subtract the glucose uptake of the insulin resistance model group from the glucose uptake of each group of cells (the absolute value of the uptake of the HepG2 cell model group is 3.2 mmol / L; the absolute value of the uptake of the C2C12 cell model group is 2.7 mmol / L, and the difference from itself is zero).

[0160] The effects of the traditional Chinese medicine composition on the glucose uptake and cell proliferation of HepG2 cells are shown in Table 12 andFigure 1 as shown

[0161] The effects of the traditional Chinese medicine composition on the glucose uptake and cell proliferation of C2C12 cells are shown in Table 12 and Figure 2 as shown

[0162] The effects of the traditional Chinese medicine compositions of groups A2-1 to A2-20 on the glucose uptake and cell proliferation of HepG2 cells are shown in Table 13-1 and Figure 3 as shown; the effects of the traditional Chinese medicine compositions of A3-1 to A3-32 on the glucose uptake and cell proliferation of HepG2 cells are shown in Table 13-2 and Figure 4 as shown; the effects of the traditional Chinese medicine compositions of A4-1 to A4-36 on the glucose uptake and cell proliferation of HepG2 cells are shown in Table 13-3 and Figure 5 as shown; the effects of the traditional Chinese medicine compositions of A5-1 to A5-30 on the glucose uptake and cell proliferation of HepG2 cells are shown in Table 13-4 and Figure 6 as shown

[0163] The experimental results show that after the action of high-concentration insulin, the glucose uptake of cells in the model control group (IR group) is significantly lower than that in the normal control group (Non IR group) (the difference is 5.9 - 3.2 = 2.7 mmol / L), indicating that the cells have insulin resistance and the modeling is successful. After treating the cells with the formulations combined with metformin and different traditional Chinese medicine extracts for 24 h, compared with the model control group, the formulations of different concentrations of the combination of traditional Chinese medicine extracts (including formulas A1 - A6) all have a certain promoting effect on the glucose uptake of HepG2 cells and show concentration dependence. Compared with the model control group, the compositions of formula A2, formula A3, formula A4, formula A5, and formula A6 can significantly improve the sugar uptake ability of HepG2 cells and improve the state of insulin resistance.

[0164] Especially for formula A4, formula A5, and formula A6, their effects on cell glucose uptake are even better than those of the commonly used anti-diabetic marketed drug metformin. Moreover, when the concentration of the formulation of the combination of traditional Chinese medicine extracts is in the range of 15 - 150 μg / mL, the cell survival rate is not significantly affected and there is no significant effect on cell proliferation, indicating that it is non-toxic to cells, which is very rare. Under the influence of 50 mM metformin, cell proliferation is affected to a certain extent.

[0165] Experimental results using different weight ratios of Chinese herbal medicine combinations showed that after 24 hours of treatment, all of the different weight ratios promoted glucose uptake in HepG2 cells in a concentration-dependent manner. The A2-A6 combination was more effective than most other weight ratios. Considering the compatibility of Chinese herbal medicines, the A2-A6 combination and ratio were chosen.

[0166] Table 12

[0167]

[0168]

[0169] Table 13-1

[0170]

[0171]

[0172]

[0173] Table 13-2

[0174]

[0175]

[0176]

[0177]

[0178] Table 13-3

[0179]

[0180]

[0181]

[0182]

[0183]

[0184] Table 13-4

[0185]

[0186]

[0187]

[0188]

[0189] Experimental Example 2 Effect of Jiangtang Prescription A4 on Blood Glucose in Diabetic Model Rats

[0190] 1. Experimental Model:

[0191] 180 SPF-grade SD rats, male, weighing 198.6 - 259.0 g, were purchased from Changsha Tianqin Biotechnology Co., Ltd. The quality certificate of experimental animals: 430726201100347262, and the production license number of experimental animals: SCXK(Xiang)2019 - 0014. They were raised in Area A of the barrier environment in Hunan Provincial Center for Drug Safety Evaluation and Research, and the experimental animal use license number: SYXK(Xiang)2015 - 0016.

[0192] 2. Experimental Materials and Instruments:

[0193] (1) Test Samples: Prescription A4, batch number: T2021011801, 20200701, property: brownish-yellow powder; low-temperature extract of Prescription A4, batch number: T20200801, property: brown granules.

[0194] The steps included in the preparation method of the traditional Chinese medicine extract combination: According to the prescription amount described in Table 5 (Prescription A4), mix the traditional Chinese medicinal materials in the formula, use 8 times the amount of water (relative to the total weight of the traditional Chinese medicinal materials in the formula), reflux and extract twice, each time for 1 hour, to obtain the extract; combine the extracts of the two times, concentrate; add dextrin auxiliary materials, and dry into powder or granule.

[0195] The steps included in the preparation method of the low-temperature extract combination of traditional Chinese medicine: According to the prescription amount described in Table 5 (Prescription A4), mix the traditional Chinese medicinal materials in the formula, and under the condition of alternating 50-degree vacuum and high pressure, extract twice with 8 times the amount of water (relative to the total weight of the traditional Chinese medicinal materials in the formula); combine the extracts of the two times, concentrate; add dextrin auxiliary materials, and dry into powder or granule.

[0196] (2) Reference Substances: Metformin Hydrochloride Tablets, batch number: ABS0260, specification: 0.3 g / tablet, product of Sino-American Shanghai Squibb Pharmaceutical Co., Ltd.; Shenqi Jiangtang Granules, batch number: 01201101, specification: 3 g / bag, product of Lunan Houpu Pharmaceutical Co., Ltd.

[0197] (3) Feeds: High-fat feed, product of Nantong Trolphy Feed Technology Co., Ltd.; complete pellet feed for rats, product of Beijing Keao Xieli Feed Co., Ltd.

[0198] (4) Main Reagents: Streptozotocin (STZ), batch number: C2019162, product of Aladdin Chemical Reagent Co., Ltd.

[0199] (5) Main instruments: Blood glucose meter, a product of Sinocare; ASP300S fully automatic tissue dehydrator, a product of Leica.

[0200] 3. Experimental methods:

[0201] (1) Establishment of rat diabetes model:

[0202] One hundred and eighty male SD rats, weighing 198.6 to 259.0 g, that had passed quarantine were selected. Twelve rats were randomly selected as the normal control group, and the rest served as the model group. The model group was fed a high-calorie, high-fat diet for four weeks before the STZ co-initiation model was established. The high-calorie, high-fat diet continued for 12 weeks. At the end of the fourth week, all rats were fasted for approximately 12 hours but not water. The model group rats were then given a single intraperitoneal injection of 30 mg / kg STZ solution, while the normal control group received an equal volume of citrate buffer. On the third day after STZ injection, venous blood was drawn from the rats to measure fasting blood glucose and fasting insulin levels. Rats with fasting blood glucose values ≥11.1 mmol / L were selected for the experiment.

[0203] (2) Grouping and administration:

[0204] Sixty SD rats with successfully established models were randomly divided into five groups based on blood glucose and body weight: a model control group, a metformin hydrochloride group (90 mg / kg), a low-dose A4 formula group (traditional Chinese medicine extract, 3 g / kg), a high-dose A4 formula group (6 g / kg), and a low-temperature A4 formula extract group (3 g / kg). Each group had 12 rats. Each treatment group was administered the corresponding drug solution at a volume of 10 mL / kg once daily for 45 consecutive days. Specific dosages are shown in Table 14.

[0205] Table 14 Trial grouping and dosage design

[0206]

[0207] (3) Detection indicators:

[0208] General: Observe changes in animal behavior, movement status, and urine.

[0209] Blood glucose detection: The fasting blood glucose levels of the rats in each group were monitored before modeling, before administration, and on days 10, 20, 30, 40, and 45 after administration.

[0210] (4) Statistical methods:

[0211] Statistical analysis was performed using SPSS 22.0. The level of statistical significance was set at P ≤ 0.05. Measurement data were expressed as mean ± standard deviation. The Leven’s test was used to test normality and homogeneity of variance. If the data met the requirements of normality and homogeneity of variance (P > 0.05), one-way analysis of variance (ANOVA) and LSD test were used for statistical analysis; if the data did not meet the requirements of normality and homogeneity of variance (P < 0.05), the Kruskal-Wallis test was used. If the Kruskal-Wallis test was statistically significant (P < 0.05), Dunnett’s Test (non-parametric method) was used for comparative analysis. Statistical differences and biological significance were considered during evaluation.

[0212] 4. Experimental results:

[0213] Effect on blood glucose: As shown in Table 15, compared with the normal control group, the blood glucose of the model control group rats increased significantly at 0 - 45 days after administration (P ≤ 0.01). Compared with the model control group, the blood glucose of the low-dose group of Formula A4 decreased significantly at 10, 30, and 40 days after administration (P ≤ 0.05 or P ≤ 0.01); the blood glucose of the high-dose group of Formula A4 decreased significantly at 30, 40, and 45 days after administration (P ≤ 0.05 or P ≤ 0.01); the blood glucose of the low-temperature extract group of Formula A4 decreased significantly at 10 - 40 days after administration (P ≤ 0.01); the blood glucose of the metformin hydrochloride group decreased significantly at 10, 30, 40, and 45 days after administration (P ≤ 0.05 or P ≤ 0.01).

[0214] Table 15 Effect of hypoglycemic formula A4 on blood glucose of diabetic model rats (x ± s)

[0215]

[0216] Note: Compared with the normal control group, ++ P ≤ 0.01; compared with the model control group, * P ≤ 0.05, ** P ≤ 0.01.

Claims

1. A composition, characterized in that, It includes the following traditional Chinese medicinal materials or products made from the raw materials containing the following traditional Chinese medicines: Poria cocos, Lilium brownii, Euryale ferox, Nelumbo nucifera Gaertn., Lycium barbarum, black jujube, Ampelopsis grossedentata W. T. Wang.

2. The composition according to claim 1, wherein, The composition further contains cinnamon, Inonotus obliquus, and Astragalus membranaceus. Preferably, the composition includes the following components in parts by weight: 2 - 40 parts of Astragalus membranaceus, 1 - 30 parts of Poria cocos, 1 - 30 parts of Lilium brownii, 1 - 30 parts of Euryale ferox, 1 - 30 parts of Nelumbo nucifera Gaertn., 1 - 15 parts of cinnamon, 1 - 30 parts of Lycium barbarum, 1 - 30 parts of black jujube, 1 - 30 parts of Ampelopsis grossedentata W. T. Wang, and 1 - 30 parts of Inonotus obliquus. Preferably, the composition includes the following components in parts by weight: 9 - 20 parts of Astragalus membranaceus, 7 - 15 parts of Poria cocos, 7 - 15 parts of Lilium brownii, 7 - 1 ​ ​ ​ ​ ​ 3. The composition according to claim 2, characterized in that, ​ 4. The composition according to claim 3, characterized in that, ​ ​ ​ 5. The composition according to claim 1, wherein ​ ​ ​ More preferably, the composition further comprises the following components in parts by weight: 2 - 7 parts of cinnamon, 9 - 12 parts of white hyacinth bean, 2 - 7 parts of liquorice, 9 - 12 parts of polygonatum sibiricum, 9 - 12 parts of fingered citron, 9 - 12 parts of male flower of eucommia ulmoides, 9 - 12 parts of raspberry, 9 - 12 parts of kudzu root.

6. The composition according to claim 1, characterized in that, The composition further includes astragalus membranaceus, mulberry leaf, dandelion, purslane, kudzu root, cyclocarya paliurus, fingered citron, polygonatum sibiricum, cistanche deserticola, raspberry, liquorice, male flower of eucommia ulmoides; Preferably, the composition further comprises the following components in parts by weight: 9 - 36 parts of astragalus membranaceus; 6 - 24 parts of mulberry leaf; 6 - 24 parts of dandelion; 6 - 24 parts of purslane; 6 - 24 parts of kudzu root; 4 - 18 parts of lily; 4 - 18 parts of gorgon fruit; 4 - 18 parts of poria cocos; 4 - 18 parts of black date; 4 - 18 parts of cyclocarya paliurus; 4 - 18 parts of lotus seed; 4 - 18 parts of fingered citron; 3 - 12 parts of polygonatum sibiricum; 3 - 12 parts of cistanche deserticola; 1 - 8 parts of raspberry; 1 - 8 parts of liquorice; 1 - 8 parts of wolfberry fruit; 1 - 8 parts of rattan tea; 1 - 6 parts of male flower of eucommia ulmoides; Preferably, the composition further comprises the following components in parts by weight: 12 - 27 parts of astragalus membranaceus; 9 - 18 parts of mulberry leaf; 9 - 18 parts of dandelion; 9 - 18 parts of purslane; 9 - 18 parts of kudzu root; 6 - 12 parts of lily; 6 - 12 parts of gorgon fruit; 6 - 12 parts of poria cocos; 6 - 12 parts of black date; 6 - 12 parts of cyclocarya paliurus; 6 - 12 parts of lotus seed; 6 - 12 parts of fingered citron; 4 - 9 parts of polygonatum sibiricum; 4 - 9 parts of cistanche deserticola; 2 - 6 parts of raspberry; 2 - 6 parts of liquorice; 2 - 6 parts of wolfberry fruit; 2 - 6 parts of rattan tea; 2 - 5 parts of male flower of eucommia ulmoides; More preferably, the composition further comprises the following components in parts by weight: 16 - 20 parts of astragalus membranaceus; 11 - 13 parts of mulberry leaf; 11 - 13 parts of dandelion; 11 - 13 parts of purslane; 11 - 13 parts of kudzu root; 8 - 10 parts of lily; 8 - 10 parts of gorgon fruit; 8 - 10 parts of poria cocos; 8 - 10 parts of black date; 8 - 10 parts of cyclocarya paliurus; 8 - 10 parts of lotus seed; 8 - 10 parts of fingered citron; 6 - 7 parts of polygonatum sibiricum; 6 - 7 parts of cistanche deserticola; 4 - 5 parts of raspberry; 4 - 5 parts of liquorice; 4 - 5 parts of wolfberry fruit; 4 - 5 parts of rattan tea; 3 - 4 parts of male flower of eucommia ulmoides.

7. A manufactured product, characterized in that, Comprising the composition according to any one of claims 1 - 6 and a pharmaceutically acceptable excipient; Preferably, the finished product is a drug, a health food, a food, an external health product, an additive or an intermediate product; Preferably, the finished product is a pharmaceutically acceptable dosage form; Preferably, the finished product includes a drug, a health food, a food, an external health product, an additive or an intermediate product; Preferably, the dosage form of the drug includes powder, granule, capsule, pill, oral liquid; Preferably, the finished product is used for treating and improving diabetes or its complications; Preferably, the mass percentage of the composition according to any one of claims 1 - 6 contained in the finished product is 30 - 70%; 8. A method for preparing the composition according to any one of claims 1-6, comprising the following steps: (1) Mix the medicinal materials in the formula according to the selected parts by weight, use 5 - 15 times the amount of water, reflux and extract 2 - 4 times, each time for 0.5 - 2 hours, to obtain an extract; (2) Combine the extracts obtained from each reflux extraction and concentrate; (3) Add excipients, dry into a powder, and then prepare into a dosage form; Preferably, the method comprises the following steps: (1) selecting the medicinal materials in one or several formulas, respectively extracting with 5-15 times the amount of water by reflux for 2-4 times, 0.5-2 hours each time, to obtain the extraction solution; (2) combining the extraction solutions obtained from each reflux extraction of each extract, and concentrating; (3) adding excipients, drying into powder, and then preparing into a dosage form; Preferably, it comprises the following steps: (1) selecting the medicinal materials in one or several formulas, respectively extracting with 5-15 times the amount of water by reflux for 2-4 times, 0.5-2 hours each time, to obtain the extraction solution; (2) combining the extraction solutions obtained from each reflux extraction, and concentrating; (3) adding excipients, drying into powder; (4) combining the powders of each extract, and then preparing into a dosage form.

9. Use of the composition according to any one of claims 1-6 or the finished product according to claim 7 in the preparation of a drug for preventing, treating or adjuvantly treating diabetes; Preferably, the diabetes is type I and type II diabetes; More preferably, the diabetes is type II diabetes.

10. Use of the composition according to any one of claims 1-6 in the preparation of a product having the effects of treating and improving diabetes and its complications; Preferably, the product is a drug, a health food, a food, an external health product, an additive or an intermediate product; Preferably, the product is a pharmaceutically acceptable dosage form; Preferably, the product further comprises a pharmaceutically acceptable carrier; Preferably, the product includes a drug, a health food, a food, an external health product, an additive or an intermediate product; Preferably, the dosage form of the drug includes powder, granule, capsule, pill, oral liquid; Preferably, the diabetes is type I and type II diabetes; More preferably, the diabetes is type II diabetes.

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