A traditional Chinese medicine preparation for improving blood glucose and blood lipid and application thereof

Abstract

The application provides a traditional Chinese medicine preparation for improving blood glucose and blood lipid and an application thereof, and relates to the technical field of traditional Chinese medicine preparation; the traditional Chinese medicine preparation is composed of fourteen kinds of traditional Chinese medicines, i.e., Eupolyphaga, Astragalus, Polygonatum, Radix Asparagi, Ophiopogon, Scrophularia, Radix Trichosanthis, Atractylodes, Anemarrhena, Pueraria, Coptis, Salvia miltiorrhiza, Radix Paeoniae Rubra and Glycyrrhiza; the traditional Chinese medicine preparation can inhibit the activities of alpha-glucosidase and pancreatic lipase; can obviously relieve the typical clinical symptoms of diabetic mice, reduce the fasting blood glucose value of the diabetic mice, enhance the glucose tolerance of the mice, increase the secretion of insulin of the mice, relieve the insulin resistance of the body, improve the influence of hyperlipidemia on the behavior of rats, inhibit the weight increase caused by high-fat diet, regulate the serum biochemical indexes of the rats, regulate the lipid metabolism, reduce the accumulation of TC and TG in the liver caused by high-fat diet, and inhibit the formation of fatty liver, so that the effect of regulating the blood glucose and blood lipid levels is achieved, and a new treatment scheme is provided for diabetes and prevention of hyperlipidemia.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine pharmaceutical technology, specifically to a traditional Chinese medicine preparation for improving blood sugar and blood lipids and its application. Background Technology

[0002] In recent years, with changes in people's lifestyles and dietary habits, the prevalence of diabetes has risen rapidly, becoming one of the most common diseases in the world. Diabetes is a metabolic disease characterized by absolute or relative insulin deficiency, leading to disorders of glucose, fat, and protein metabolism. The typical clinical features of the disease are the "three highs and one low" symptoms: polydipsia, overeating, polyuria, and weight loss. It is often accompanied by symptoms such as hyperlipidemia and insulin resistance. Hyperlipidemia is a metabolic disease caused by lipid metabolism disorder, mainly manifested by one or more lipid abnormalities, including total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C). Hyperlipidemia is a risk factor for cardiovascular disease and a leading cause of cardiovascular disease death worldwide. Currently, diabetes in my country faces a severe situation characterized by high prevalence, low awareness, low control, and high costs. Western medicine mainly treats diabetes by injecting insulin and its analogues, or by taking oral hypoglycemic drugs such as biguanides, sulfonylureas, meglitinides, alpha-glucosidase inhibitors, and thiazolidinediones. Commonly used lipid-lowering drugs include statins, ezetimibe, PCSK9 inhibitors, and bepadiasic acid. Although these drugs are fast-acting, they have a single target and require long-term use, which can easily lead to drug dependence and toxic side effects such as hypoglycemia, gastrointestinal reactions, and liver and kidney damage.

[0003] Traditional Chinese medicine (TCM) classifies diabetes under the category of "Xiao Ke Bing" (wasting and thirsting disease). Ancient physicians categorized this disease into three types: upper, middle, and lower Xiao Ke. It is often caused by external damp-heat pathogens, congenital deficiency, excessive consumption of rich and fatty foods, overexertion, and emotional imbalance, leading to simultaneous involvement of the three Jiaos (upper, middle, and lower burners) – lung dryness, stomach heat, and kidney deficiency. Ultimately, it results in a condition primarily characterized by Yin deficiency with a predominance of dryness and heat, with these two factors mutually influencing each other, leading to numerous complications. TCM treatment of Xiao Ke Bing and its complications emphasizes a holistic approach, based on syndrome differentiation and treatment, and adheres to the principle of "prevention before disease occurs and prevention of disease progression." It possesses multi-level and multi-target effects, offering unique advantages in regulating glucose and lipid metabolism, improving insulin resistance, and reducing toxic side effects. However, current research on diabetes mellitus complicated by hyperlipidemia is not in-depth. Therefore, there is an urgent need to develop a TCM preparation that can improve blood glucose and lipid levels. Summary of the Invention

[0004] (a) Technical problems to be solved

[0005] In view of the shortcomings of the prior art, the present invention provides a traditional Chinese medicine preparation for improving blood sugar and blood lipids and its application.

[0006] (II) Technical Solution

[0007] To achieve the above objectives, the present invention provides the following technical solution:

[0008] A traditional Chinese medicine preparation for improving blood sugar and blood lipids, wherein the preparation is composed of the following raw materials in parts by weight: Astragalus membranaceus 20-38 parts, Polygonatum sibiricum 15-34 parts, Pueraria lobata 22-40 parts, Ophiopogon japonicus 13-30 parts, Scrophularia ningpoensis 5-28 parts, Trichosanthes kirilowii 15-35 parts, Eupolyphaga sinensis 1-13 parts, Asparagus cochinchinensis 5-28 parts, Anemarrhena asphodeloides 5-23 parts, Coptis chinensis 1-18 parts, Salvia miltiorrhiza 10-28 parts, Paeonia lactiflora 5-24 parts, Atractylodes lancea 1-18 parts, and Glycyrrhiza uralensis 20-37 parts.

[0009] Furthermore, the traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: Astragalus membranaceus 25-35 parts, Polygonatum sibiricum 20-30 parts, Pueraria lobata 25-35 parts, Ophiopogon japonicus 15-25 parts, Scrophularia ningpoensis 10-20 parts, Trichosanthes kirilowii 20-30 parts, Eupolyphaga sinensis 5-10 parts, Asparagus cochinchinensis 10-20 parts, Anemarrhena asphodeloides 10-18 parts, Coptis chinensis 5-15 parts, Salvia miltiorrhiza 15-23 parts, Paeonia lactiflora 10-20 parts, Atractylodes lancea 5-15 parts, and Glycyrrhiza uralensis 25-32 parts.

[0010] Furthermore, the traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: Astragalus membranaceus 30 parts, Polygonatum sibiricum 25 parts, Pueraria lobata 30 parts, Ophiopogon japonicus 20 parts, Scrophularia ningpoensis 15 parts, Trichosanthes kirilowii 25 parts, Eupolyphaga sinensis 7 parts, Asparagus cochinchinensis 15 parts, Anemarrhena asphodeloides 13 parts, Coptis chinensis 10 parts, Salvia miltiorrhiza 18 parts, Paeonia lactiflora 15 parts, Atractylodes lancea 9 parts, and Glycyrrhiza uralensis 28 parts.

[0011] This invention provides a method for preparing a traditional Chinese medicine preparation that improves blood sugar and blood lipids. The traditional Chinese medicine preparation is prepared into any human-acceptable oral dosage form by conventional pharmaceutical methods and with medically acceptable excipients, including pills, powders, granules, oral liquids, decoctions, and tablets.

[0012] Furthermore, a traditional Chinese medicine tablet for improving blood sugar and blood lipids is prepared according to the following steps:

[0013] (1) Weigh each raw material according to the above weight proportions, chop them, add 1-3 times the weight of water and soak for 30-60 minutes, filter, repeat twice, combine the filtrates, and concentrate the filtrate under reduced pressure to a relative density of 1-1.2 to obtain the extract concentrate.

[0014] (2) Add 1-2 times the weight of starch to the extract concentrate, dry at 60°C and pass through a 100-mesh sieve. Then, use 85% ethanol as a wetting agent to make a soft material, granulate it through a 20-mesh sieve, and dry it in an oven at 60°C after the alcohol taste has evaporated to obtain granules.

[0015] (3) The granules are sieved through a 14-mesh sieve, 1% magnesium stearate is added and mixed evenly, and then placed in a dry, sealed container for 24 hours. The tablet weight is calculated, and the tablets are compressed using a tablet press to obtain the Chinese medicine tablets of this invention.

[0016] This invention provides the application of the aforementioned traditional Chinese medicine preparation in the preparation of drugs for the prevention and / or treatment of diabetes mellitus complicated with hyperlipidemia.

[0017] The pharmacological effects of each herbal component in the herbal preparation described in this invention are as follows:

[0018] Ground beetle: salty in taste, cold in nature, and enters the liver meridian; it has the effects of breaking up blood stasis, promoting blood circulation, and healing tendons and bones; it is used for traumatic injuries, tendon injuries and fractures, blood stasis and amenorrhea, postpartum abdominal pain due to blood stasis, and abdominal masses.

[0019] Astragalus: It has a sweet taste and slightly warm nature, and enters the lung and spleen meridians. It has the effects of tonifying qi and raising yang, consolidating the exterior and stopping sweating, promoting diuresis and reducing swelling, generating fluids and nourishing blood, promoting circulation and relieving pain, promoting detoxification and draining pus, and promoting wound healing and tissue regeneration. It is used for qi deficiency and fatigue, poor appetite and loose stools, sinking of middle qi, chronic diarrhea and rectal prolapse, hematochezia and metrorrhagia, spontaneous sweating due to exterior deficiency, edema due to qi deficiency, internal heat and thirst, blood deficiency and chlorosis, hemiplegia, numbness and pain, carbuncles and boils that are difficult to ulcerate, and chronic ulcers that do not heal.

[0020] Polygonatum: sweet in taste and neutral in nature, it enters the spleen, lung and kidney meridians; it has the effects of replenishing qi and nourishing yin, strengthening the spleen, moistening the lungs and benefiting the kidneys; it is used for spleen and stomach qi deficiency, fatigue, stomach yin deficiency, dry mouth and poor appetite, lung deficiency and dry cough, consumptive cough with hemoptysis, insufficient menstrual blood, soreness and weakness of the waist and knees, premature graying of hair, and internal heat and thirst.

[0021] Coptis chinensis: bitter in taste, cold in nature, enters the heart, spleen, stomach, liver, gallbladder and large intestine meridians; has the effects of clearing heat and drying dampness, purging fire and detoxifying; used for damp-heat fullness, vomiting and acid regurgitation, diarrhea, jaundice, high fever and delirium, excessive heart fire, restlessness and insomnia, palpitations, hematemesis due to blood heat, red eyes, toothache, thirst, carbuncles and boils; externally used for eczema, damp sores, and ear discharge.

[0022] Asparagus: It tastes sweet and bitter, is cold in nature, and enters the lung and kidney meridians; it has the effects of nourishing yin and moistening dryness, clearing the lungs and generating fluids; it is used for dry cough due to lung dryness, cough with sticky phlegm, soreness of the waist and knees, bone steaming fever, internal heat and thirst, heat-related illness with fluid depletion, dry throat and thirst, and constipation due to intestinal dryness.

[0023] Ophiopogon japonicus: It tastes sweet and slightly bitter, and is slightly cold in nature. It enters the heart, lung, and stomach meridians. It has the effects of nourishing yin and promoting body fluids, moistening the lungs and clearing the heart. It is used for dry cough due to lung dryness, consumptive cough due to yin deficiency, sore throat and pharyngitis, thirst due to fluid depletion, internal heat and thirst, irritability and insomnia, and constipation due to intestinal dryness.

[0024] Scrophularia: It tastes sweet, bitter, and salty, and is slightly cold in nature. It enters the lung, stomach, and kidney meridians. It has the effects of clearing heat and cooling blood, nourishing yin and reducing fire, and detoxifying and dispersing nodules. It is used for heat entering the blood, febrile rashes, yin deficiency due to febrile diseases, red tongue with thirst, constipation due to fluid depletion, bone steaming cough, red eyes, sore throat, diphtheria, scrofula, carbuncles and boils.

[0025] Trichosanthes kirilowii root: It tastes sweet and slightly bitter, and is slightly cold in nature. It enters the lung and stomach meridians. It has the effects of clearing heat and purging fire, promoting body fluid and quenching thirst, reducing swelling and draining pus. It is used for feverish thirst, dry cough due to lung heat, internal heat and thirst, and carbuncles and boils.

[0026] Atractylodes lancea: It is pungent and bitter in taste, warm in nature, and enters the spleen, stomach, and liver meridians. It has the effects of drying dampness and strengthening the spleen, dispelling wind and cold, and improving eyesight. It is used for dampness obstructing the middle jiao, abdominal distension, diarrhea, edema, beriberi, rheumatic pain, colds due to wind and cold, night blindness, and blurred vision.

[0027] Anemarrhena asphodeloides: bitter and sweet in taste, cold in nature, and enters the lung, stomach, and kidney meridians; it has the effects of clearing heat and purging fire, nourishing yin and moistening dryness; it is used for exogenous febrile diseases, high fever and thirst, dry cough due to lung heat, bone steaming fever, internal heat and thirst, and constipation due to intestinal dryness.

[0028] Kudzu root: sweet and pungent in taste, cool in nature, and enters the spleen, stomach, and lung meridians; it has the effects of relieving muscle tension and reducing fever, promoting body fluid production and quenching thirst, promoting rash eruption, raising yang and stopping diarrhea, clearing the meridians and activating collaterals, and detoxifying alcohol; it is used for exogenous fever and headache, stiff neck and back pain, thirst, diabetes, measles that fail to erupt, dysentery, diarrhea, dizziness and headache, hemiplegia due to stroke, chest pain and heart pain, and damage to the middle jiao from alcohol poisoning.

[0029] Salvia miltiorrhiza: bitter in taste, slightly cold in nature, enters the heart and liver meridians; it has the effects of promoting blood circulation and removing blood stasis, regulating menstruation and relieving pain, clearing the heart and relieving irritability, cooling blood and eliminating carbuncles; it is used for chest pain, abdominal pain, abdominal masses, hot arthralgia, insomnia, irregular menstruation, dysmenorrhea and amenorrhea, and sores and swelling.

[0030] Red peony root: bitter in taste and slightly cold in nature; enters the liver meridian; has the effects of clearing heat and cooling blood, dispersing blood stasis and relieving pain; used for heat entering the blood, febrile rashes, hematemesis and epistaxis, red and swollen eyes, liver stagnation and hypochondriac pain, amenorrhea and dysmenorrhea, abdominal masses and pain, traumatic injuries, carbuncles and sores.

[0031] Licorice: It has a sweet taste and neutral properties, and enters the heart, lung, spleen, and stomach meridians. It has the effects of tonifying the spleen and replenishing qi, clearing heat and detoxifying, resolving phlegm and relieving cough, relieving spasms and pain, and harmonizing various medicines. It is used for spleen and stomach weakness, fatigue, palpitations and shortness of breath, cough with excessive phlegm, abdominal and limb spasms and pain, carbuncles and boils, and to alleviate the toxicity and harshness of drugs.

[0032] (III) Beneficial Effects

[0033] This invention provides a traditional Chinese medicine preparation for improving blood sugar and blood lipids and its application. The preparation consists of fourteen herbs: Astragalus membranaceus, Polygonatum sibiricum, Pueraria lobata, Ophiopogon japonicus, Scrophularia ningpoensis, Trichosanthes kirilowii, Eupolyphaga sinensis, Asparagus cochinchinensis, Anemarrhena asphodeloides, Coptis chinensis, Salvia miltiorrhiza, Paeonia lactiflora, Atractylodes lancea, and Glycyrrhiza uralensis. Eupolyphaga sinensis is the principal herb, possessing the effect of breaking up blood stasis and removing blood stasis, improving blood circulation, and preventing metabolic abnormalities caused by blood stasis obstructing the meridians. Astragalus membranaceus, Polygonatum sibiricum, and Coptis chinensis are the assistant herbs. Astragalus membranaceus tonifies qi and raises yang, generates fluids and nourishes blood, and promotes blood circulation, making it a key herb for tonifying qi. Polygonatum sibiricum tonifies qi and nourishes yin, strengthens the spleen and moistens the lungs. Coptis chinensis clears heat and dries dampness, drains fire and detoxifies. The combined use of these three herbs assists the principal herb in enhancing the therapeutic effects of tonifying qi and nourishing yin, clearing heat and moistening dryness, promoting blood circulation, replenishing yin fluids, clearing damp heat, and improving blood sugar and blood lipids. For dyslipidemia, the treatment uses Asparagus cochinchinensis, Ophiopogon japonicus, Scrophularia ningpoensis, Trichosanthes kirilowii, Atractylodes lancea, Anemarrhena asphodeloides, Pueraria lobata, Salvia miltiorrhiza, and Paeonia lactiflora as adjuvant herbs. Asparagus cochinchinensis nourishes yin and moistens dryness, clears the lungs and generates fluids; Ophiopogon japonicus nourishes yin and generates fluids, moistens the lungs and clears the heart; Scrophularia ningpoensis clears heat and cools the blood, nourishes yin and reduces fire; Trichosanthes kirilowii clears heat and drains fire, generates fluids and quenches thirst; Atractylodes lancea dries dampness and strengthens the spleen; Anemarrhena asphodeloides clears heat and drains fire, nourishes yin and moistens dryness; Pueraria lobata relieves muscle tension and reduces fever, generates fluids and quenches thirst; Salvia miltiorrhiza invigorates blood and removes blood stasis, cools the blood and eliminates carbuncles; Paeonia lactiflora clears heat and cools the blood, disperses blood stasis and relieves pain. The combined use of these herbs can assist the principal and assistant herbs in enhancing the therapeutic effect and treat symptoms such as microcirculatory disorders and spleen and stomach weakness in diabetes. Licorice is used as the guiding herb, mainly to harmonize the herbs and guide the medicine directly to the affected area. At the same time, its spleen-tonifying and qi-boosting effects also help regulate spleen and stomach function and indirectly improve blood sugar and lipid metabolism.

[0034] The traditional Chinese medicine preparation of this invention can inhibit the activity of α-glucosidase and pancreatic lipase; significantly alleviate the typical clinical symptoms of diabetic mice, and dose-dependently reduce the fasting blood glucose level of diabetic mice, enhance glucose tolerance, and effectively increase insulin secretion in diabetic mice, alleviating insulin resistance; it can also improve the effects of hyperlipidemia on the behavior of rats, effectively inhibit the weight gain caused by a high-fat diet, regulate serum biochemical indicators in rats, regulate lipid metabolism, and reduce the accumulation of TC and TG in the liver caused by a high-fat diet, inhibiting the formation of fatty liver, thereby achieving the effect of regulating blood glucose and blood lipid levels, providing a new treatment option for diabetes and the prevention of diabetic complications. Attached Figure Description

[0035] Figure 1 This study compares the inhibitory activity of each group of drugs against α-glucosidase; compared with the positive control drug acarbose, ** P<0.01.

[0036] Figure 2 This study compares the inhibitory activity of each group of drugs on pancreatic lipase; compared with the positive control drug oseltritol,

[0037] ** P<0.01.

[0038] Figure 3This study compares the glucose tolerance of mice in different groups.

[0039] Figure 4 This section compares the serum insulin levels of mice in each group; compared with the blank control group, ## P<0.01; compared with the model control group, ** P<0.01. Detailed Implementation

[0040] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0041] Example 1

[0042] A traditional Chinese medicine preparation for improving blood sugar and blood lipids, the preparation being composed of the following raw materials in parts by weight: Astragalus membranaceus 30 parts, Polygonatum sibiricum 25 parts, Pueraria lobata 30 parts, Ophiopogon japonicus 20 parts, Scrophularia ningpoensis 15 parts, Trichosanthes kirilowii 25 parts, Eupolyphaga sinensis 7 parts, Asparagus cochinchinensis 15 parts, Anemarrhena asphodeloides 13 parts, Coptis chinensis 10 parts, Salvia miltiorrhiza 18 parts, Paeonia lactiflora 15 parts, Atractylodes lancea 9 parts, and Glycyrrhiza uralensis 28 parts.

[0043] Example 2

[0044] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: Astragalus membranaceus 20 parts, Polygonatum sibiricum 15 parts, Pueraria lobata 22 parts, Ophiopogon japonicus 13 parts, Scrophularia ningpoensis 5 parts, Trichosanthes kirilowii 15 parts, Eupolyphaga sinensis 1 part, Asparagus cochinchinensis 5 parts, Anemarrhena asphodeloides 5 parts, Coptis chinensis 1 part, Salvia miltiorrhiza 10 parts, Paeonia lactiflora 5 parts, Atractylodes lancea 1 part, Glycyrrhiza uralensis 20 parts.

[0045] Example 3

[0046] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: Astragalus membranaceus 28 parts, Polygonatum sibiricum 20 parts, Pueraria lobata 28 parts, Ophiopogon japonicus 18 parts, Scrophularia ningpoensis 10 parts, Trichosanthes kirilowii 20 parts, Eupolyphaga sinensis 5 parts, Asparagus cochinchinensis 12 parts, Anemarrhena asphodeloides 15 parts, Coptis chinensis 8 parts, Salvia miltiorrhiza 18 parts, Paeonia lactiflora 13 parts, Atractylodes lancea 9 parts, and Glycyrrhiza uralensis 28 parts.

[0047] Example 4

[0048] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: Astragalus membranaceus 38 parts, Polygonatum sibiricum 34 parts, Pueraria lobata 40 parts, Ophiopogon japonicus 30 parts, Scrophularia ningpoensis 28 parts, Trichosanthes kirilowii 35 parts, Eupolyphaga sinensis 13 parts, Asparagus cochinchinensis 28 parts, Anemarrhena asphodeloides 23 parts, Coptis chinensis 18 parts, Salvia miltiorrhiza 28 parts, Paeonia lactiflora 24 parts, Atractylodes lancea 18 parts, and Glycyrrhiza uralensis 37 parts.

[0049] Example 5

[0050] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: Astragalus membranaceus 25 parts, Polygonatum sibiricum 18 parts, Pueraria lobata 25 parts, Ophiopogon japonicus 17 parts, Scrophularia ningpoensis 8 parts, Trichosanthes kirilowii 18 parts, Eupolyphaga sinensis 5 parts, Asparagus cochinchinensis 9 parts, Anemarrhena asphodeloides 9 parts, Coptis chinensis 5 parts, Salvia miltiorrhiza 15 parts, Paeonia lactiflora 9 parts, Atractylodes lancea 5 parts, and Glycyrrhiza uralensis 25 parts.

[0051] Example 6

[0052] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: Astragalus membranaceus 35 parts, Polygonatum sibiricum 28 parts, Pueraria lobata 32 parts, Ophiopogon japonicus 26 parts, Scrophularia ningpoensis 25 parts, Trichosanthes kirilowii 32 parts, Eupolyphaga sinensis 10 parts, Asparagus cochinchinensis 25 parts, Anemarrhena asphodeloides 20 parts, Coptis chinensis 15 parts, Salvia miltiorrhiza 25 parts, Paeonia lactiflora 20 parts, Atractylodes lancea 17 parts, and Glycyrrhiza uralensis 35 parts.

[0053] Example 7

[0054] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: Astragalus membranaceus 22 parts, Polygonatum sibiricum 16 parts, Pueraria lobata 24 parts, Ophiopogon japonicus 15 parts, Scrophularia ningpoensis 7 parts, Trichosanthes kirilowii 17 parts, Eupolyphaga sinensis 3 parts, Asparagus cochinchinensis 7 parts, Anemarrhena asphodeloides 7 parts, Coptis chinensis 3 parts, Salvia miltiorrhiza 12 parts, Paeonia lactiflora 7 parts, Atractylodes lancea 3 parts, and Glycyrrhiza uralensis 22 parts.

[0055] Example 8

[0056] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: Astragalus membranaceus 32 parts, Polygonatum sibiricum 25 parts, Pueraria lobata 32 parts, Ophiopogon japonicus 24 parts, Scrophularia ningpoensis 18 parts, Trichosanthes kirilowii 28 parts, Eupolyphaga sinensis 9 parts, Asparagus cochinchinensis 18 parts, Anemarrhena asphodeloides 18 parts, Coptis chinensis 12 parts, Salvia miltiorrhiza 22 parts, Paeonia lactiflora 18 parts, Atractylodes lancea 15 parts, and Glycyrrhiza uralensis 32 parts.

[0057] Experimental Example 1

[0058] 1. Materials and Methods

[0059] 1.1 Experimental Drugs

[0060] Test substance 1: Astragalus membranaceus 30 parts, Polygonatum sibiricum 25 parts, Pueraria lobata 30 parts, Ophiopogon japonicus 20 parts, Scrophularia ningpoensis 15 parts, Trichosanthes kirilowii 25 parts, Eupolyphaga sinensis 7 parts, Asparagus cochinchinensis 15 parts, Anemarrhena asphodeloides 13 parts, Coptis chinensis 10 parts, Salvia miltiorrhiza 18 parts, Paeonia lactiflora 15 parts, Atractylodes lancea 9 parts, Glycyrrhiza uralensis 28 parts.

[0061] Test substance 2: 20 parts of Ophiopogon japonicus, 15 parts of Scrophularia ningpoensis, 25 parts of Trichosanthes kirilowii, 7 parts of Eupolyphaga sinensis, 15 parts of Asparagus cochinchinensis, 13 parts of Anemarrhena asphodeloides, 10 parts of Coptis chinensis, 18 parts of Salvia miltiorrhiza, 15 parts of Paeonia lactiflora, 9 parts of Atractylodes lancea, and 28 parts of Glycyrrhiza uralensis.

[0062] Test substance 3: Astragalus membranaceus 30 parts, Polygonatum sibiricum 25 parts, Pueraria lobata 30 parts, Eupolyphaga sinensis 7 parts, Asparagus cochinchinensis 15 parts, Anemarrhena asphodeloides 13 parts, Coptis chinensis 10 parts, Salvia miltiorrhiza 18 parts, Paeonia lactiflora 15 parts, Atractylodes lancea 9 parts, Glycyrrhiza uralensis 28 parts.

[0063] Test substance 4: Astragalus membranaceus 30 parts, Polygonatum sibiricum 25 parts, Pueraria lobata 30 parts, Ophiopogon japonicus 20 parts, Scrophularia ningpoensis 15 parts, Trichosanthes kirilowii 25 parts, Salvia miltiorrhiza 18 parts, Paeonia lactiflora 15 parts, Atractylodes lancea 9 parts, Glycyrrhiza uralensis 28 parts.

[0064] Test substance 5: Astragalus membranaceus 30 parts, Polygonatum sibiricum 25 parts, Pueraria lobata 30 parts, Ophiopogon japonicus 20 parts, Scrophularia ningpoensis 15 parts, Trichosanthes kirilowii 25 parts, Eupolyphaga sinensis 7 parts, Asparagus cochinchinensis 15 parts, Anemarrhena asphodeloides 13 parts, Coptis chinensis 10 parts.

[0065] Weigh each ingredient according to the above-mentioned weight proportions, chop and mix each ingredient, place them in a clay pot, add water and soak for 10-20 minutes, bring to a boil over high heat, then simmer over low heat for 20-30 minutes, filter the decoction while hot; repeat twice, combine the decoctions, and concentrate to a raw herb content of 1g / mL to obtain the original Chinese medicine liquid of test groups 1-5.

[0066] 1.2 Determination of α-glucosidase inhibition rate

[0067] The experiment included a blank group, a control group, a sample blank group, and sample groups (groups 1-5) and an acarbose group. Samples were added sequentially to 96-well plates according to the dosages shown in Table 1 below, with three replicates for each group. Finally, the absorbance at 405 nm was measured using a microplate reader, and the α-glucosidase inhibition rate was calculated using the following formula:

[0068] α-glucosidase inhibition rate (%) = (A 样品组 -A 样品空白组 ) / (A 对照组 -A 空白组 )×100

[0069] Table 1. Dosage and order of reactant addition (μL)

[0070]

[0071]

[0072] 1.3 Determination of pancreatic lipase inhibition rate

[0073] The experiment included a blank group, a control group, and a sample group (groups 1-5) and an oseltita group. 2.5 mL of 0.025 mol / L PBS and 1 mL of polyvinyl trioleate emulsion were mixed in an Erlenmeyer flask and incubated at 37°C for 10 min. Then, 1 mL of the sample was added, and the reaction was continued at 37°C for another 10 min. Next, 1 mL of 100 g / L porcine pancreatic lipase was added, and the reaction was continued at 37°C for 15 min. Then, 10 mL of 95% anhydrous ethanol was added, and finally, 3 drops of phenolphthalein indicator were added. The mixture was then titrated with 0.025 mol / L NaOH until a faint red color appeared. The volume of NaOH consumed in the sample group was recorded as V1. The blank group (without sample or pancreatic lipase) was recorded as V2, and the control group (without pancreatic lipase) was recorded as V3. Lipase activity and pancreatic lipase inhibition rate were calculated using the following formulas:

[0074] Pancreatic lipase activity (IU) = 1000 × (V1 - V2 - V3) × c / t × w

[0075] Pancreatic lipase inhibition rate (%) = (1 - pancreatic lipase activity in the sample group / pancreatic lipase activity in the control group) × 100

[0076] Where c is the sodium hydroxide concentration (mol / L); t is the reaction time after adding the enzyme (min); and w is the amount of pancreatic lipase added (g).

[0077] 1.4 Statistical Methods

[0078] Data processing was performed using Graphpad Prism 8.0 statistical software, and statistical graphs were drawn. The mean value was used for the measurement data. This indicates that one-way ANOVA was used for comparisons among multiple groups, and a p-value < 0.05 was considered statistically significant.

[0079] 2 Results

[0080] 2.1 α-Glucosidase Inhibition Rate

[0081] α-Glucosidase is an important member of the metabolic pathway in the body. It can regulate the chemical metabolism of sugars in the human body and participate in the metabolic pathways of starch and glycogen. It is also a key target for drugs to improve glucose metabolism. Figure 1The effects of each group of drugs on α-glucosidase activity were investigated. Among them, the positive control drug acarbose showed the strongest inhibitory effect on α-glucosidase, with an inhibition rate of (60.95±4.47)%. The inhibition rate of α-glucosidase in experimental group 1 was (55.78±3.59)%, which was comparable to the inhibitory effect of the positive control drug. However, the inhibitory effects of experimental groups 2-5 were weakened to varying degrees due to the lack of some traditional Chinese medicine components. This indicates that the components in the traditional Chinese medicine preparation of this invention have a synergistic effect and none of them can be omitted.

[0082] 2.2 Pancreatic lipase inhibition rate

[0083] Pancreatic lipase can break down fats into free fatty acids and monoacylglycerols. By inhibiting pancreatic lipase activity, the body's absorption of fat can be reduced, thereby achieving the effect of lowering blood lipids. Figure 2 The effects of each drug group on pancreatic lipase activity were investigated. Among them, the positive control drug oseltidine showed the strongest inhibitory effect on pancreatic lipase, with an inhibition rate of (67.03±3.01)%. The inhibition rate of experimental group 1 was (65.26±2.90)%, which was comparable to the inhibitory effect of the positive control drug. The inhibitory ability of experimental groups 2-5 was weakened to varying degrees due to the lack of some traditional Chinese medicine components. This indicates that the components in the traditional Chinese medicine preparation of the present invention have a synergistic effect and work together to inhibit pancreatic lipase, further verifying the scientificity and rationality of the formulation of the traditional Chinese medicine preparation of the present invention.

[0084] Experimental Example 2

[0085] 1. Materials and Methods

[0086] 1.1 Laboratory Animals

[0087] Thirty-six SPF-grade male ICR mice, weighing 22-24g, were provided by Beijing Vital River Laboratory Animal Technology Co., Ltd.

[0088] 1.2 Experimental Drugs

[0089] Weigh the following raw materials according to the above-mentioned proportions: Astragalus membranaceus 30 parts, Polygonatum sibiricum 25 parts, Pueraria lobata 30 parts, Ophiopogon japonicus 20 parts, Scrophularia ningpoensis 15 parts, Trichosanthes kirilowii 25 parts, Eupolyphaga sinensis 7 parts, Asparagus cochinchinensis 15 parts, Anemarrhena asphodeloides 13 parts, Coptis chinensis 10 parts, Salvia miltiorrhiza 18 parts, Paeonia lactiflora 15 parts, Atractylodes lancea 9 parts, and Glycyrrhiza uralensis 28 parts. Chop and mix the raw materials, place them in a clay pot, add water and soak for 10-20 minutes, bring to a boil over high heat, then simmer over low heat for 20-30 minutes. Filter the decoction while hot; repeat twice, combine the decoctions, and concentrate to a crude drug content of 1 g / mL to obtain the traditional Chinese medicine preparation described in this invention.

[0090] Metformin Hydrochloride Tablets, Tianjin Pacific Pharmaceutical Co., Ltd.

[0091] 1.3 Animal Modeling

[0092] Thirty-six healthy mice were acclimatized for three days, and six were randomly selected as the blank control group, while the rest were used as the experimental group. The blank control group was fed with normal feed, while the experimental group was fed with a high-fat, high-sugar feed. After two weeks of continuous feeding, the mice were fasted for 7 hours. The experimental group was injected intraperitoneally with streptozotocin at a dose of 100 mg / kg body weight, while the normal group was injected intraperitoneally with an equal body weight of citrate-sodium citrate buffer solution. One week later, fasting blood glucose levels were measured, and a blood glucose level >11.1 mmol / L was considered a successful model.

[0093] 1.4 Grouping and Administration

[0094] Mice that successfully developed the model were randomly divided into five groups: a model control group, a metformin group, a high-dose traditional Chinese medicine (TCM) preparation group, a medium-dose TCM preparation group, and a low-dose TCM preparation group. The blank control group and the model control group were administered physiological saline by gavage. The metformin group was administered metformin at 150 mg / kg body weight by gavage. The high-dose TCM preparation group was administered the TCM preparation of this invention at 500 mg / kg body weight by gavage. The medium-dose TCM preparation group was administered the TCM preparation of this invention at 250 mg / kg body weight by gavage. The low-dose TCM preparation group was administered the TCM preparation of this invention at 125 mg / kg body weight by gavage. Administration was once daily for 4 consecutive weeks.

[0095] 1.5 Detection Indicators

[0096] 1.5.1 Daily Indicator Observation

[0097] The activity, coat luster, and mental state of the mice in each group were observed daily. The amount of food and water consumed by the mice were recorded. The weight and fasting blood glucose of the mice were recorded weekly.

[0098] 1.5.2 Glucose Tolerance Test

[0099] Mice were fasted for 12 hours after the last administration, and their fasting blood glucose was measured. Then, after being given 2 g / kg glucose solution by gavage, blood was collected from the tail vein, and blood glucose values ​​were measured at 0, 30, 60, and 120 minutes.

[0100] 1.5.3 Serum Insulin Levels

[0101] Blood was collected from the orbital cavity of mice after the last administration, and the serum was separated by centrifugation at 4°C and 3500 rpm for 15 min. The serum insulin level was then measured according to the ELISA kit instructions.

[0102] 1.6 Statistical Methods

[0103] Data processing was performed using Graphpad Prism 8.0 statistical software, and statistical graphs were drawn. The mean value was used for the measurement data. The standard deviation (s) is expressed as ±. One-way ANOVA was used for comparisons among multiple groups. A p-value < 0.05 was considered statistically significant.

[0104] 2 Results

[0105] 2.1 Effects of various drugs on body weight and blood glucose in diabetic mice

[0106] After successful modeling, diabetic mice exhibited varying degrees of depression, dull coat color, and sluggishness, along with typical symptoms such as polyuria, polydipsia, polyphagia, and weight loss. In contrast, the control group mice displayed glossy fur, good spirits, and normal responsiveness, without exhibiting typical diabetic symptoms. After a period of drug administration, compared to the control group, mice in the metformin group and the traditional Chinese medicine preparation group showed reduced water and food intake, gradually regained their fur's luster, and showed signs of recovery in their mental state.

[0107] Table 1 shows the comparison of body weight of mice in each group before modeling and after drug administration. There was no significant difference in body weight among the groups before modeling (P>0.05). Four weeks after drug administration, the body weight of mice in the model control group was significantly lower than that in the blank control group (P<0.01). Compared with the model control group, the body weight of mice in each drug administration group was significantly higher (P<0.01). Among them, the increase in body weight was most significant in the metformin group and the high-dose group of traditional Chinese medicine preparation, indicating that the traditional Chinese medicine preparation of the present invention can alleviate the emaciation symptoms of diabetic mice and improve the typical clinical symptoms of diabetic mice.

[0108] Table 2 shows the comparison of fasting blood glucose levels in mice before and after modeling. Before modeling, there was no significant difference in fasting blood glucose levels among the groups (P>0.05). Before administration, compared with the blank control group, the blood glucose levels of mice in the model control group and each administration group were significantly increased (P<0.01), and there was no significant difference in blood glucose levels among the administration groups compared with the model control group (P>0.05). Four weeks after administration, the blood glucose levels of mice in the model control group were still significantly higher than those in the blank control group (P<0.01). Compared with the model control group, the fasting blood glucose levels of mice in each administration group were significantly decreased (P<0.01). Among them, the metformin group and the high-dose group of the traditional Chinese medicine preparation showed the most significant decreasing trend in fasting blood glucose levels, indicating that the traditional Chinese medicine preparation of this invention can effectively reduce blood glucose levels in diabetic mice and improve the clinical symptoms of diabetic mice.

[0109] Table 1 Comparison of mouse body weight in each group

[0110] Grouping Before modeling One week Two weeks Three weeks all around Blank control group 24.14±3.65 25.69±1.11 28.24±1.64 30.33±1.73 32.53±2.10 Model control group 24.25±1.84 24.20±1.24 <![CDATA[23.35±1.54 ** ]]> <![CDATA[22.32±2.23 ** ]]> <![CDATA[21.51±1.20 ** ]]> Metformin group 24.42±3.47 25.77±1.53 <![CDATA[27.20±1.51 # ]]> <![CDATA[29.33±1.04 ## ]]> <![CDATA[30.29±1.85 ## ]]> High-dose group of traditional Chinese medicine preparations 23.97±4.07 25.38±0.92 26.74±1.31 <![CDATA[28.46±0.94 ## ]]> <![CDATA[29.79±1.58 ## ]]> Medium-dose group of traditional Chinese medicine preparations 24.70±2.70 25.66±1.35 26.13±1.47 <![CDATA[27.54±1.24 ## ]]> <![CDATA[28.69±1.08 ## ]]> Low-dose group of traditional Chinese medicine preparations 24.20±3.48 25.62±1.11 25.52±1.25 <![CDATA[26.37±1.16 # ]]> <![CDATA[27.84±0.92 ## ]]>

[0111] Note: Compared with the blank control group * P<0.05, ** P<0.01; compared with the model control group, # P<0.05, ## P<0.01.

[0112] Table 2 Comparison of fasting blood glucose levels in mice of different groups

[0113] Grouping Before modeling Before administration After administration Blank control group 6.77±1.73 6.56±1.43 6.14±1.80 Model control group 6.73±1.24 <![CDATA[23.22±2.87 ** ]]> <![CDATA[23.99±2.42 ** ]]> Metformin group 6.67±2.17 <![CDATA[19.57±1.61 ** ]]> <![CDATA[7.26±0.92 ## ]]> High-dose group of traditional Chinese medicine preparations 6.02±2.30 <![CDATA[21.36±1.16 ** ]]> <![CDATA[8.31±1.21 ## ]]> Medium-dose group of traditional Chinese medicine preparations 5.95±1.81 <![CDATA[22.23±1.33 ** ]]> <![CDATA[12.43±1.11 ## ]]> Low-dose group of traditional Chinese medicine preparations 6.21±1.54 <![CDATA[22.98±1.58 ** ]]> <![CDATA[15.39±0.90 ## ]]>

[0114] Note: Compared with the blank control group * P<0.05, ** P<0.01; compared with the model control group, # P<0.05, ## P<0.01.

[0115] 2.2 Effects of various drugs on glucose tolerance in diabetic mice

[0116] Figure 3 To investigate the effects of various drugs on glucose tolerance in diabetic mice, after glucose gavage, the blood glucose levels of mice reached a peak at 30 minutes, while the blood glucose levels of mice in the blank control group returned to normal at 120 minutes. Compared with the blank control group, the blood glucose levels of mice in the model control group were significantly increased at all time points. Compared with the model control group, the blood glucose levels of mice in each treatment group were reduced. Among them, the recovery of blood glucose in the high-dose group of traditional Chinese medicine preparation and the positive drug metformin group was similar, indicating that the traditional Chinese medicine preparation of the present invention can improve the glucose tolerance of diabetic mice and improve the abnormal glucose metabolism in diabetic mice.

[0117] 2.3 Effects of various drugs on serum insulin levels in diabetic mice

[0118] Figure 4 To investigate the effects of various drugs on serum insulin levels in diabetic mice, compared with the blank control group, the serum insulin levels in the model control group were significantly decreased (P<0.01). Compared with the model control group, serum insulin levels in all drug-treated groups were increased, with the metformin group, the high-dose group of the traditional Chinese medicine preparation, and the medium-dose group of the traditional Chinese medicine preparation showing significantly increased serum insulin levels (P<0.01). Although the serum insulin levels in the low-dose group of the traditional Chinese medicine preparation did not differ significantly (P>0.05), there was still an increasing trend. This indicates that the traditional Chinese medicine preparation of this invention is beneficial in increasing insulin secretion and reducing insulin resistance in diabetic mice.

[0119] 3. Conclusion

[0120] Type 2 diabetes is a common chronic disease characterized by insulin resistance and β-cell dysfunction, and its incidence is increasing year by year. The typical clinical manifestations of diabetes are the "three highs and one low" symptoms: polydipsia, polyphagia, polyuria, and weight loss. The experimental data above show that the traditional Chinese medicine preparation of this invention can significantly alleviate the typical clinical symptoms in diabetic mice, and can dose-dependently reduce fasting blood glucose levels in diabetic mice, enhance glucose tolerance, and effectively increase insulin secretion in diabetic mice, thereby alleviating insulin resistance and achieving a hypoglycemic effect.

[0121] Experimental Example 3

[0122] 1. Materials and Methods

[0123] 1.1 Laboratory Animals

[0124] Thirty-six SPF-grade male SD rats, weighing 180-220g, were provided by Beijing Vital River Laboratory Animal Technology Co., Ltd.

[0125] 1.2 Experimental Drugs

[0126] Weigh the following raw materials according to the above-mentioned proportions: Astragalus membranaceus 30 parts, Polygonatum sibiricum 25 parts, Pueraria lobata 30 parts, Ophiopogon japonicus 20 parts, Scrophularia ningpoensis 15 parts, Trichosanthes kirilowii 25 parts, Eupolyphaga sinensis 7 parts, Asparagus cochinchinensis 15 parts, Anemarrhena asphodeloides 13 parts, Coptis chinensis 10 parts, Salvia miltiorrhiza 18 parts, Paeonia lactiflora 15 parts, Atractylodes lancea 9 parts, and Glycyrrhiza uralensis 28 parts. Chop and mix the raw materials, place them in a clay pot, add water and soak for 10-20 minutes, bring to a boil over high heat, then simmer over low heat for 20-30 minutes. Filter the decoction while hot; repeat twice, combine the decoctions, and concentrate to a crude drug content of 1 g / mL to obtain the traditional Chinese medicine preparation described in this invention.

[0127] Simvastatin tablets, Shandong Luoxin Pharmaceutical Group Co., Ltd.

[0128] 1.3 Modeling, grouping, and drug administration

[0129] After one week of acclimatization, rats were randomly divided into a control group and a high-fat model group. During the modeling period, the high-fat model group was fed a high-fat diet, while the control group was fed a basal diet. All rats had free access to water, and their weight, water and food intake, and mental status were observed daily. After five weeks of continuous feeding, blood was collected from the tail vein of the high-fat model group to measure serum total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) levels. Successful modeling was defined as follows: TC > 5.20 mmol / L; TG > 1.70 mmol / L; LDL-C > 3.40 mmol / L; HDL-C ≤ 1.00 mmol / L.

[0130] Rats in the high-fat model group were randomly divided into a model control group, a simvastatin group, a high-dose group of traditional Chinese medicine preparation, a medium-dose group of traditional Chinese medicine preparation, a low-dose group of traditional Chinese medicine preparation, a blank control group, and a model control group, and were administered physiological saline by gavage. The simvastatin group was administered simvastatin by gavage at 0.9 mg / kg body weight, the high-dose group of traditional Chinese medicine preparation was administered the traditional Chinese medicine preparation of this invention by gavage at 300 mg / kg body weight, the medium-dose group was administered the traditional Chinese medicine preparation of this invention by gavage at 150 mg / kg body weight, and the low-dose group was administered the traditional Chinese medicine preparation of this invention by gavage at 75 mg / kg body weight. The administration was once a day for 4 consecutive weeks, during which time the rats had normal diet and water intake.

[0131] 1.4 Detection Indicators

[0132] 1.4.1 Determination of rat body weight and food intake

[0133] During the feeding period, observe the rats' morphology, fur, activity, fecal changes, and weight, and record any abnormalities promptly.

[0134] 1.4.2 Serum marker detection

[0135] After the last administration, rats were fasted for 12 hours but allowed free access to water. They were then anesthetized with 7% chloral hydrate, and blood was collected from the abdominal aorta. The blood was allowed to stand at room temperature for 2 hours, and then centrifuged at 3500 rpm for 15 minutes at 4°C to separate the serum. The levels of TC, TG, LDL-C, and HDL-C in the serum were determined according to the kit instructions.

[0136] 1.4.3 Liver index and liver marker measurement

[0137] After the last administration, rats were fasted for 12 hours but allowed free access to water. The rats were then euthanized by cervical dislocation, dissected, and their livers were quickly removed, washed in pre-cooled 0.9% physiological saline, and dried with filter paper. The livers were weighed and the organ indices of each group were calculated according to the following formula. Separately, 0.2g of fresh liver was taken and homogenized in pre-cooled 0.9% physiological saline to form a 10% liver tissue homogenate. The homogenate was centrifuged at 3500rpm for 10min at 4℃, and the supernatant was collected. The TC and TG contents in the rat liver were detected according to the kit instructions.

[0138] Liver index (g / g) = Liver weight / Body weight

[0139] 1.5 Statistical Methods

[0140] Data processing was performed using Graphpad Prism 8.0 statistical software; the mean value was used for the measurement data. This indicates that one-way ANOVA was used for comparisons among multiple groups, and a p-value < 0.05 was considered statistically significant.

[0141] 2 Results

[0142] 2.1 Effects of various drugs on the behavior and body weight of hyperlipidemic rats

[0143] During the modeling period, rats in the blank control group had normal water and food intake, normal urine and feces, were agile, and had clean and shiny fur. Rats in the model group had reduced water and food intake, darker urine, coarser feces, sluggish movement, lethargy, and rough, messy, and dull fur. After drug administration, water and food intake gradually increased in each drug group, and urine and feces gradually returned to normal. Table 3 shows the effects of each drug on the body weight and Lee's index of hyperlipidemic rats. Before modeling, there was no significant difference in body weight among the groups (P>0.05). Before drug administration, compared with the blank control group, the body weight of rats in each group was significantly increased (P<0.01), and there was no significant difference in body weight among the groups. After drug administration, compared with the blank control group, the body weight of rats in the model control group was significantly increased (P<0.01). Compared with the model control group, the body weight of rats in each drug administration group was significantly decreased (P<0.01, P<0.05), indicating that the traditional Chinese medicine preparation of this invention can effectively inhibit weight gain caused by a high-fat diet and has a certain preventive effect on obesity.

[0144] Table 3 Comparison of body weight of hyperlipidemic rats in each group

[0145] Grouping Body weight before modeling (g) Body weight (g) before drug administration Body weight (g) after drug administration Blank control group 195.26±6.47 383.53±7.52 442.39±9.90 Model control group 202.10±5.94 <![CDATA[435.21±8.57 ## ]]> <![CDATA[543.34±7.11 ## ]]> Simvastatin group 201.76±6.67 <![CDATA[432.37±12.21 ## ]]> <![CDATA[472.97±8.08 ** ]]> High-dose group of traditional Chinese medicine preparations 196.15±10.83 <![CDATA[428.01±8.16 ## ]]> <![CDATA[491.34±7.99 ** ]]> Medium-dose group of traditional Chinese medicine preparations 197.35±12.42 <![CDATA[432.04±12.24 ## ]]> <![CDATA[505.67±9.22 ** ]]> Low-dose group of traditional Chinese medicine preparations 205.97±9.65 <![CDATA[425.20±11.89 ## ]]> <![CDATA[520.29±5.05 * ]]>

[0146] Note: Compared with the blank control group # P<0.05, ## P<0.01; compared with the model control group, * P<0.05, ** P<0.01.

[0147] 2.2 Effects of various drugs on serum related indicators in hyperlipidemic rats

[0148] As shown in Table 4, compared with the blank control group, the serum TC, TG, and LDL-C levels of rats in the model control group were significantly increased (P<0.01), and the HDL-C level was significantly decreased (P<0.01). Compared with the model control group, the serum TC, TG, and LDL-C levels of rats in the simvastatin group, the high-dose group of the traditional Chinese medicine preparation, and the medium-dose group of the traditional Chinese medicine preparation were significantly decreased (P<0.01, P<0.05), and the HDL-C level was significantly increased (P<0.01, P<0.05). This indicates that the traditional Chinese medicine preparation of the present invention can improve serum biochemical indicators and regulate lipid metabolism in hyperlipidemic rats.

[0149] Table 4 Comparison of relevant serum indicators in rats from different groups (mol / L)

[0150] Grouping TC TG LDL-C HDL-C Blank control group 2.54±0.08 1.65±0.11 0.46±0.11 1.53±0.11 Model control group <![CDATA[3.88±0.08 ## ]]> <![CDATA[2.85±0.08 ## ]]> <![CDATA[0.93±0.10 ## ]]> <![CDATA[0.85±0.08 ## ]]> Simvastatin group <![CDATA[2.85±0.08 ** ]]> <![CDATA[1.87±0.10 ** ]]> <![CDATA[0.54±0.07 ** ]]> <![CDATA[1.33±0.10 ** ]]> High-dose group of traditional Chinese medicine preparations <![CDATA[3.08±0.14 ** ]]> <![CDATA[2.02±0.11 ** ]]> <![CDATA[0.63±0.10 ** ]]> <![CDATA[1.14±0.10 ** ]]> Medium-dose group of traditional Chinese medicine preparations <![CDATA[3.44±0.09 ** ]]> <![CDATA[2.32±0.09 ** ]]> <![CDATA[0.70±0.06 * ]]> <![CDATA[1.06±0.08 * ]]> Low-dose group of traditional Chinese medicine preparations 3.68±0.07 2.65±0.07 0.82±0.09 0.89±0.05

[0151] Note: Compared with the blank control group # P<0.05, ## P<0.01; compared with the model control group, * P<0.05, **P<0.01.

[0152] 2.3 Effects of various drugs on liver index and liver parameters in hyperlipidemic rats

[0153] As shown in Table 5, compared with the blank control group, the liver index of rats in the model control group was significantly increased (P<0.01), and the liver TC and TG levels were significantly increased (P<0.01). Compared with the model control group, the liver index of rats in each treatment group was significantly decreased (P<0.01). The liver TC and TG levels of rats in the simvastatin group, the high-dose group of traditional Chinese medicine preparation, and the medium-dose group of traditional Chinese medicine preparation were significantly decreased (P<0.01). Although there was no significant difference in liver TC and TG levels in the low-dose group of traditional Chinese medicine preparation, there was still a decreasing trend. This indicates that the traditional Chinese medicine preparation of the present invention can improve the accumulation of liver TC and TG caused by a high-fat diet and has a certain inhibitory effect on the formation of fatty liver.

[0154] Table 5 Comparison of liver index and liver parameters among different groups of rats

[0155]

[0156]

[0157] Note: Compared with the blank control group # P<0.05, ## P<0.01; compared with the model control group, * P<0.05, ** P<0.01.

[0158] 3. Conclusion

[0159] The above experimental data show that the traditional Chinese medicine preparation of this invention can improve the effects of hyperlipidemia on rat behavior, effectively inhibit weight gain caused by a high-fat diet, regulate rat serum biochemical indicators, regulate lipid metabolism, reduce the accumulation of TC and TG in the liver caused by a high-fat diet, and inhibit the formation of fatty liver, thereby achieving the effect of lowering blood lipids.

[0160] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit it. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A traditional Chinese medicine preparation for improving blood sugar and blood lipids, characterized in that, The traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: Astragalus membranaceus 25-35 parts, Polygonatum sibiricum 20-30 parts, Pueraria lobata 25-35 parts, Ophiopogon japonicus 15-25 parts, Scrophularia ningpoensis 10-20 parts, Trichosanthes kirilowii 20-30 parts, Eupolyphaga sinensis 5-10 parts, Asparagus cochinchinensis 10-20 parts, Anemarrhena asphodeloides 10-18 parts, Coptis chinensis 5-15 parts, Salvia miltiorrhiza 15-23 parts, Paeonia lactiflora 10-20 parts, Atractylodes lancea 5-15 parts, and Glycyrrhiza uralensis 25-32 parts.

2. The traditional Chinese medicine preparation for improving blood sugar and blood lipids according to claim 1, characterized in that, The traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: Astragalus membranaceus 30 parts, Polygonatum sibiricum 25 parts, Pueraria lobata 30 parts, Ophiopogon japonicus 20 parts, Scrophularia ningpoensis 15 parts, Trichosanthes kirilowii 25 parts, Eupolyphaga sinensis 7 parts, Asparagus cochinchinensis 15 parts, Anemarrhena asphodeloides 13 parts, Coptis chinensis 10 parts, Salvia miltiorrhiza 18 parts, Paeonia lactiflora 15 parts, Atractylodes lancea 9 parts, and Glycyrrhiza uralensis 28 parts.

3. A traditional Chinese medicine preparation for improving blood sugar and blood lipids as described in any one of claims 1 to 2, characterized in that, The traditional Chinese medicine preparations are prepared into oral dosage forms, including pills, powders, granules, oral liquids, decoctions, and tablets, using conventional pharmaceutical methods and with medically acceptable excipients.

4. The use of the traditional Chinese medicine preparation according to any one of claims 1 to 2 in the preparation of a drug for treating diabetes mellitus complicated with hyperlipidemia.

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