A Chinese medicine composition with blood sugar regulating effect and its preparation method and application

Through the Chinese medicine compatibility and test design guided by traditional Chinese medicine theory, a composite oral solution including seabuckthorn plasma and a variety of Chinese medicinal materials is prepared to solve the problem of poor effects on the prevention and treatment of hypertrophic disease and diabetes. It has achieved significant prevention and treatment effects, and has good safety and synergistic treatment.

CN118286349BActive Publication Date: 2025-01-24SHANXI UNIV OF CHINESE MEDICINE +1
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Patent Information

Application Number
CN202410428141.7
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2024-04-10
Publication Date
2025-01-24
Estimated Expiration
2044-04-10

AI Technical Summary

Technical Problem

The effectiveness of existing traditional Chinese medicine prescriptions in preventing and treating hyperglycemia and diabetes still needs to be improved, and there is a lack of more effective traditional Chinese medicine compositions to provide a richer clinical drug regimen.

Method used

By using the theoretical guidance of traditional Chinese medicine, a reasonable compatible with blood glucose prescriptions, and using single -factor and response surface test design to prepare a composite oral solution, which include sea buckthorn plasma, astragalus, pueraria, yam, jade, yellow essence, wolfberry, wolfberry, wolfberry, wolfberry, wolfberry, and wolfberry Zi and mulberry leaves, explore and get the best process parameters.

Benefits of technology

The Chinese medicine composition has a significant prevention and treatment of hyperglycemia and diabetes, which can effectively prevent and delay the development of the disease. Because of the use of natural medicinal Chinese medicinal materials, it has good safety and synergistic treatment.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present invention provides a Chinese medicine composition with blood sugar regulating effect, which is prepared from the following Chinese medicines: seabuckthorn puree, astragalus, kudzu root, yam, polygonatum, polygonatum, wolfberry and mulberry leaf. The Chinese medicine composition of the present invention adopts natural Chinese medicine raw materials that are both medicinal and edible, and its preparation method is simple, the raw material medicine sources are wide, the cost is low, and it is suitable for patients to take for a long time. The compatibility of the Chinese medicine composition conforms to the principle of "monarch, minister, assistant and envoy" of Chinese medicine, the prescription is scientific and reasonable, and the raw materials and medicinal materials are used together to have the effects of strengthening the body, nourishing yin, promoting body fluid and moistening dryness. The Chinese medicine composition has a significant preventive and therapeutic effect on hyperglycemia and diabetes. Adhering to taking can effectively prevent and treat and delay the development of hyperglycemia and diabetes.
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Description

Technical Field

[0001] The present invention belongs to the field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition having the effect of regulating blood sugar, and also relates to a method for preparing the traditional Chinese medicine composition, a medicine containing the traditional Chinese medicine composition, use of the traditional Chinese medicine composition in preparing a medicine having the effect of promoting the production of body fluids and quenching thirst, and use of the traditional Chinese medicine composition in preparing a medicine for preventing and treating hyperglycemia and diabetes. Background Art

[0002] Hyperglycemia is a condition in which the sugar content in the patient's blood exceeds the normal level for a long time. Clinically, fasting blood sugar is higher than 6.1mmol / L and blood sugar is higher than 7.8mmol / L 2 hours after a meal, which can be called hyperglycemia. Symptoms may include thirst, polydipsia, polyuria, fatigue, weight loss, etc. Long-term high blood sugar can cause lesions in various tissues and organs throughout the body and should be treated early. Modern medicine believes that the main causes of hyperglycemia include insulin resistance in peripheral tissues including liver, muscle and adipose tissue, intestinal absorption, intestinal flora and intestinal effects on blood sugar control hormones leading to abnormalities, and excessive reabsorption of sugar by the kidneys. Modern clinical treatments for hyperglycemia include removing the causes of elevated blood sugar and using oral or non-oral hypoglycemic drugs.

[0003] TCM treatment of hyperglycemia is often targeted based on the pathogenesis of the disease "Xiaoke". TCM believes that this disease is the result of insufficient innate endowment, weak constitution and acquired factors, and the disease is located in the lungs, stomach and kidneys. Its mechanism can be liver qi stagnation, qi and yin deficiency, liver and kidney deficiency, etc., and the treatment methods are soothing the liver, regulating qi and relieving depression, promoting blood circulation, removing blood stasis and relieving pain, nourishing the liver and kidneys, suppressing yang and reducing fire.

[0004] Diabetes is a metabolic disease characterized by high blood sugar, which belongs to the category of diabetes in traditional Chinese medicine. Traditional Chinese medicine believes that diabetes is caused by insufficient congenital endowment, emotional disorders, and improper diet, with yin deficiency and dryness and heat as the basic pathogenesis. There are many clinical classifications, and qi and yin deficiency is one of its main syndromes. At the same time, diabetes is a disease that affects multiple internal organs, affecting the normal operation of qi and blood, and yin deficiency and internal heat, which consumes body fluids, also makes blood flow unsmooth and causes blood stasis. Therefore, blood stasis is one of the important pathogenesis of diabetes, and the occurrence of various complications of diabetes is also closely related to blood stasis. After continuous improvement by doctors of various schools in successive dynasties, it is believed that the onset of diabetes is based on yin deficiency constitution, coupled with improper diet or partiality, emotional disorders, excessive labor and desire, and exogenous six evils, with yin deficiency as the root and dryness and heat as the symptom, and the two are mutually causal.

[0005] Traditional Chinese medicine uses syndrome differentiation and treatment, and individual and holistic treatment to achieve yin-yang balance, qi and blood harmony, qi flow regulation, and organ coordination. However, the therapeutic effect of existing traditional Chinese medicine prescriptions for the prevention and treatment of hyperglycemia and diabetes still needs to be improved. Further exploration of traditional Chinese medicine compositions for the treatment of hyperglycemia and diabetes in the field of traditional Chinese medicine to provide more abundant options for clinical medication plans has become a technical problem that needs to be solved urgently. Summary of the invention

[0006] The inventors used the theory of traditional Chinese medicine to guide the rational formulation of hypoglycemic prescriptions and prepared an extract based on the formulated hypoglycemic prescriptions; they used single factor, response surface and other experimental designs to prepare a composite oral liquid for the prevention and treatment of hyperglycemia and diabetes, and explored and obtained the optimal process parameters.

[0007] The common pharmacological effects of the Chinese medicinal raw materials selected in the present invention in this field are as follows:

[0008] Astragalus has the effects of tonifying the middle and replenishing qi, strengthening the spleen and benefiting the lungs. The "Compendium of Materia Medica" calls it "the best of all qi-tonifying medicines". Modern research has found that astragalus has a wide range of pharmacological effects, especially in improving the body's sugar and lipid metabolism and regulating the body's immune function.

[0009] Pueraria root has the effects of relieving muscle pain, raising yang, promoting body fluid and quenching thirst. The foundation of traditional Chinese medicine, Shennong's Herbal Classic, states that it "can relieve thirst... raise yin energy and resolve various toxins". Modern pharmacological research has found that Pueraria root has a very significant effect of lowering blood sugar and blood pressure. It can also effectively dilate blood vessels and improve microcirculation in the body. It is often used in the prevention and treatment of various cardiovascular and cerebrovascular diseases.

[0010] Polygonatum odoratum has the effects of nourishing yin and moistening dryness, promoting body fluid and quenching thirst. The "Shen Nong's Herbal Classic" believes that Polygonatum odoratum has a mellow nature and taste, can "replenish the five internal organs, nourish qi and blood", and is a good product for food therapy and health preservation. Modern pharmacological research has shown that Polygonatum odoratum has a significant effect on lowering blood sugar, and also has medicinal value of anti-oxidation and anti-aging.

[0011] Yam has the excellent effects of nourishing the spleen and stomach, promoting fluid production and benefiting the lungs, nourishing the kidneys and astringing semen. "Shennong's Herbal Classic" describes yam as: "It is used to treat injuries, replenish deficiency, eliminate cold and heat evil spirits, replenish the middle and increase qi and strength, grow muscles, and make the ears and eyes smarter after long-term use." Modern pharmacological research has shown that yam has a significant effect in lowering blood sugar and is often praised as the "natural insulin" in the plant kingdom.

[0012] Huangjing has the effects of nourishing the kidney and spleen, strengthening tendons and bones, moistening the lungs and producing body fluids. The Compendium of Materia Medica even says that it can "replenish all deficiencies, stop cold and heat, and replenish essence and marrow". It is suitable for people with weak spleen and stomach, fatigue, internal heat and thirst, and insufficient essence and blood. Modern pharmacological research has shown that Huangjing has a clear effect of lowering blood sugar and blood pressure, and also has antioxidant, anti-fatigue, and anti-aging effects.

[0013] Lycium barbarum is mild in nature and sweet in taste. It enters the liver, kidney and lung meridians. Its main functions are to nourish the liver and kidney, improve the essence and improve eyesight. As early as the Ming Dynasty, Li Shizhen's "Compendium of Materia Medica" listed Ningxia Zhongning Lycium barbarum as a superior precious medicinal material. Lycium barbarum mainly includes polysaccharides, glycolipids, phenylpropanoids, chlorogenic acid derivatives, quinones, flavonoids, terpenes, nitrogen-containing compounds and other compounds. Modern pharmacological studies have shown that Lycium barbarum has pharmacological activities such as antioxidant, anti-aging, neuroprotective, anti-Alzheimer's disease and liver protection and eye improvement.

[0014] Mulberry leaves, also known as "magic grass", are a Chinese medicine for both medicine and food designated by the Ministry of Health. Ancient and modern books have proved that mulberry leaves are the king of plants, and have the reputation of "ginseng for heat and mulberry leaves for cooling". According to the records of classical Chinese medicine works in my country, mulberry leaves have the effects of nourishing yin and activating blood circulation, dispersing wind and heat, clearing the lungs and relieving cough. Modern pharmacological experimental studies have also shown that mulberry leaves have many pharmacological effects such as anti-aging, lowering blood lipids and blood sugar. Its chemical components are mainly polysaccharides, flavonoids, alkaloids, polyphenols, volatile oils, minerals, trace elements, dietary fiber, phytosterols, etc.

[0015] Astragalus can nourish the spleen and lungs, invigorate qi and produce body fluid; Pueraria root has the effect of clearing heat, producing body fluid and quenching thirst; Chinese yam can nourish the spleen and stomach, produce body fluid and benefit the lungs, nourish the kidney and astringe body fluid; Polygonatum odoratum nourishes stomach yin, produces body fluid and quenches thirst; Polygonatum sibiricum can nourish qi and yin, strengthen the spleen and benefit the kidney; Lycium barbarum has the effect of nourishing the liver and kidney; Mulberry leaf can dispel wind-heat, clear the lungs and moisten dryness. The inventor has found through research that the above-mentioned medicinal materials can be used together to play the effect of strengthening the body, nourishing yin, producing body fluid and moistening dryness.

[0016] The purpose of the present invention is to provide a Chinese medicine composition that can effectively prevent and treat hyperglycemia and diabetes. The Chinese medicine composition of the present invention adopts Chinese medicinal materials that are both medicinal and edible, has good safety, and the combination of medicinal materials in the whole formula of the Chinese medicine composition has the best synergistic effect in treating hyperglycemia and diabetes.

[0017] Another object of the present invention is to provide a process for preparing a hypoglycemic prescription.

[0018] In order to achieve the above-mentioned object of the invention, the present invention adopts the following technical solutions:

[0019] The first aspect of the present invention is to provide a Chinese medicine composition for promoting the production of body fluids and quenching thirst, wherein the Chinese medicine composition is prepared from the following Chinese medicines: seabuckthorn, astragalus, kudzu root, yam, polygonatum, polygonatum, wolfberry, and mulberry leaf;

[0020] The sea buckthorn described is specifically sea buckthorn puree.

[0021] The present invention provides a method for preparing seabuckthorn puree, comprising:

[0022] Preparation: Wash the sea buckthorn berries and set aside;

[0023] Crushing: roughly crush the washed seabuckthorn berries and sift out the broken kernels of the seabuckthorn berries;

[0024] Rough beating: beating the roughly crushed sea buckthorn into a pulp to obtain rough sea buckthorn pulp;

[0025] Fine grinding and filtration: Finely grind the obtained sea buckthorn pulp and filter it to obtain sea buckthorn puree.

[0026] Preferably, the weight proportions of astragalus, kudzu root, yam, polygonatum, polygonatum, wolfberry, and mulberry leaf are 25-35 parts of astragalus, 25-35 parts of kudzu root, 25-35 parts of yam, 5-15 parts of polygonatum, 5-15 parts of polygonatum, 5-15 parts of wolfberry, and 10-20 parts of mulberry leaf.

[0027] Preferably, the weight proportions of the astragalus, kudzu root, yam, polygonatum, polygonatum, wolfberry, and mulberry leaf are 27-33 parts of astragalus, 27-33 parts of kudzu root, 27-33 parts of yam, 7-13 parts of polygonatum, 7-13 parts of polygonatum, 7-13 parts of wolfberry, and 12-18 parts of mulberry leaf.

[0028] Preferably, the weight proportions of the astragalus, kudzu root, yam, polygonatum, polygonatum, wolfberry, and mulberry leaf are 30 parts of astragalus, 30 parts of kudzu root, 30 parts of yam, 10 parts of polygonatum, 10 parts of polygonatum, 10 parts of wolfberry, and 15 parts of mulberry leaf.

[0029] Preferably, the Chinese medicine composition is a decoction.

[0030] The second aspect of the present invention is to provide a method for preparing the above-mentioned Chinese medicine composition, comprising the following steps:

[0031] Mix astragalus, kudzu root, yam, polygonatum, polygonatum, wolfberry, and mulberry leaf, then decoct, and filter to obtain liquid A and residue;

[0032] The residue is decocted again to obtain liquid medicine B, and liquid medicine A and liquid medicine B are combined and concentrated to obtain liquid medicine C;

[0033] Preferably, the above-mentioned concentration adopts a low-temperature and low-pressure evaporation method, such as a rotary evaporation method, which can achieve the evaporation of solvent water at a relatively low temperature, and is more conducive to protecting the active ingredients in the drug solution.

[0034] The seabuckthorn puree and the medicinal solution C are mixed in a volume ratio of (3-5):1 to obtain the traditional Chinese medicine composition.

[0035] The third aspect of the present invention is to provide a medicine, comprising the above-mentioned Chinese medicine composition and pharmaceutically acceptable excipients.

[0036] According to conventional pharmaceutical practice, pharmaceutically acceptable carriers include diluents, fillers, disintegrants, wetting agents, lubricants, colorants, flavoring agents or other conventional additives. Typical pharmaceutically acceptable carriers include, for example, microcrystalline cellulose, starch, crosslinked polyvinylpyrrolidone, polyvinylpyrrolidone, maltitol, citric acid, sodium lauryl sulfate or magnesium stearate, etc.

[0037] The third aspect of the present invention is to provide the use of the above-mentioned Chinese medicine composition in the preparation of a drug for promoting the production of body fluids and quenching thirst.

[0038] Furthermore, the thirst-quenching effect is to prevent and treat hyperglycemia and diabetes.

[0039] The specific dosage and method of use of the Chinese medicine composition described in the present invention for different patients are determined by many factors, including the patient's age, weight, gender, natural health status, nutritional status, time of administration, metabolic rate, severity of the disease and the subjective judgment of the treating physician.

[0040] The Chinese medicine composition provided in the present application is named as the hypoglycemic prescription. In the embodiments of the present invention, the terms "Chinese medicine composition", "jin zhike oral liquid" and "hypoglycemic prescription" have the same meaning, and the three can be used interchangeably; the terms "Chinese medicine composition group", "jin zhike oral liquid group" and "kidney tonifying prescription group" have the same meaning, and the three can be used interchangeably.

[0041] Beneficial technical effects of the present invention:

[0042] 1. The Chinese medicine composition of the present invention adopts natural Chinese medicine raw materials that are both medicinal and edible, and its preparation method is simple, the raw materials are widely available, and the cost is low, and it is suitable for patients to take for a long time.

[0043] 2. The Chinese medicine composition of the present invention complies with the principle of "monarch, minister, assistant and envoy" of Chinese medicine, the prescription is scientific and reasonable, and the raw medicinal materials used together have the effects of strengthening the body, nourishing yin, promoting body fluid and moistening dryness.

[0044] 3. The Chinese medicine composition of the present invention has significant preventive and therapeutic effects on hyperglycemia and diabetes. Adherent use can effectively prevent and treat and delay the development of hyperglycemia and diabetes. BRIEF DESCRIPTION OF THE DRAWINGS

[0045] Figure 1 This is a graph showing the changing trend of water intake and food intake of mice in the blank control group in the experimental example of the present invention;

[0046] Figure 2 This is a graph showing the changing trend of water intake and food intake of mice in the model group in the experimental example of the present invention;

[0047] Figure 3 This is a graph showing the changing trend of water intake and food intake of mice in the low-dose group in the experimental example of the present invention;

[0048] Figure 4 This is a graph showing the changing trend of water intake and food intake of mice in the medium-dose group in the experimental example of the present invention;

[0049] Figure 5 This is a graph showing the changing trend of water intake and food intake of mice in the high-dose group in the experimental example of the present invention;

[0050] Figure 6 It is a trend chart of the changes in the amount of water and food consumed by mice in the positive control group in the experimental example of the present invention. The mice in the positive control group are mice that are intragastrically administered with glibenclamide as a positive drug at a dose of 5 mg / (kg·bw·d). DETAILED DESCRIPTION

[0051] The embodiments of the present invention are described in detail below. The following embodiments are implemented on the premise of the technical solution of the present invention, and detailed implementation methods and specific operation processes are given, but the protection scope of the present invention is not limited to the following embodiments.

[0052] Explanation of terms

[0053] The "medicine and food have the same origin" referred to in the present invention refers to many foods that are also medicines. Foods can prevent and treat diseases just like medicines, and there is no absolute dividing line between the two. Ancient medical scientists believed that each food has "four properties" and "five flavors". The idea of ​​"medicine and food have the same origin" was reflected in the "Huangdi Neijing Taisu" of the Tang Dynasty: "Eating it on an empty stomach is food, and eating it by patients is medicine." In the "List of Items That Are Both Food and Medicine" published by the former Ministry of Health in 2002, 87 substances were listed: cloves, fresh reed roots, sword beans, fennel, coix seeds, kelp, hawthorn, white hyacinth bean flowers, purslane, fresh white imperata roots, papaya, torreya grandis, hemp seeds, Polygonatum odoratum , Cassia seed, Licorice root, Yam , Prunus mume, Gardenia jasminoides, Nutmeg, Angelica dahurica, Thistle, Ginkgo, Almond, Black-necked snake, Plum, White lentil, Longan pulp, Cinnamon bark, Emblica officinalis, Buddha's hand, Sea buckthorn , pepper, red bean, chicken gizzard lining, malt, daidaihua, monk fruit, star anise, honeysuckle, houttuynia, euryale, ginger, peach kernel, green fruit, tangerine peel, jujube, amomum villosum, Sterculia lychnophora, Poria , citron, mulberry, Allium macrostemon, Elsholtzia ciliata, donkey-hide gelatin, mulberry leaf , orange, Wolfberry , Platycodon grandiflorum, chicory, Alpinia oxyphylla, lotus leaf, radish seed, lotus seed, bamboo leaf, chrysanthemum , lily, perilla seeds, Kudzu root , black sesame, raspberry, Sophora japonica , black pepper, light black beans, Sophora japonica, galangal, jujube kernel, Polygonatum, dandelion, perilla, honey, pit viper, orange peel, patchouli, yellow mustard, mint, etc. In 2014, 14 new substances were added: pine pollen, saffron, honeysuckle, rose, kudzu, selfheal, angelica, slag leaves, galangal, grass fruit, coriander, turmeric, ginseng, and longan. On November 17, 2023, the National Health Commission and the State Administration for Market Regulation jointly issued an announcement to add Codonopsis pilosula, Cistanche deserticola (desert), Dendrobium officinale, American ginseng, Astragalus 9 substances, including Ganoderma lucidum, Cornus officinalis, Gastrodia elata, and Eucommia ulmoides leaves, are included in the list of substances that are traditionally both food and Chinese medicinal materials.

[0054] In certain embodiments, sweeteners may also be added, which are artificially synthesized and / or naturally extracted sweeteners, including aspartame, acesulfame potassium, sodium cyclamate, saccharin, saccharin sodium, sucralose, neotame, sodium cyclamate, stevioside, licorice, disodium glycyrrhizinate, tripotassium and trisodium glycyrrhizinate, glucose, fructose, sucrose, maltose, starch sugar and lactose, sorbitol, maltitol, isomalt, xylitol, lactitol, mannitol and erythritol, any one or a combination thereof.

[0055] Example 1 Preparation of Chinese medicine composition

[0056] 1.1 Composition, source and preparation method of Chinese medicine composition

[0057] The Chinese medicine composition is prepared from the following Chinese medicine raw materials: 1200 mL of seabuckthorn stock solution, 30 g of astragalus, 30 g of kudzu root, 30 g of yam, 10 g of polygonatum, 10 g of polygonatum, 10 g of wolfberry, and 15 g of mulberry leaf.

[0058] 1.2 Preparation method of Chinese medicine composition

[0059] Take 135g of the above Chinese medicine raw materials, add 1000mL of distilled water and boil for 20min, pour out the filtrate, add 600mL of water to the residue, boil at 85℃ for 20min; combine the two liquids and concentrate to 400mL of liquid. The obtained liquid is mixed with 1200mL of seabuckthorn stock solution to obtain a Chinese medicine composition liquid.

[0060] The obtained drug solution was cooled to room temperature and then stored in a refrigerator at 4°C for later use.

[0061] Example 2

[0062] The composition of the Chinese medicine composition of Example 2 is as follows:

[0063] 1200mL seabuckthorn stock solution, 30g astragalus, 30g kudzu root, 30g yam, 10g polygonatum, 10g polygonatum, 10g wolfberry, 15g mulberry leaf, 10g chrysanthemum, 10g poria, and 10g sophora japonica seed.

[0064] The Chinese medicine composition liquid of Example 2 was prepared by referring to the method described in 1.2 of Example 1.

[0065] Example 3

[0066] The composition of the Chinese medicine composition of Example 3 is as follows:

[0067] 1200-1500mL seabuckthorn stock solution, 27-33 parts of astragalus, 27-33 parts of kudzu root, 27-33 parts of yam, 7-13 parts of polygonatum, 7-13 parts of polygonatum, 7-13 parts of wolfberry, and 12-18 parts of mulberry leaves.

[0068] The Chinese medicine composition liquid of Example 3 was prepared by referring to the method described in 1.2 of Example 1.

[0069] Experimental example

[0070] 1. Efficacy study protocol

[0071] Modeling and grouping

[0072] One of the symptoms of diabetes is high blood sugar, so this experiment used streptozotocin to create a diabetic animal model. After the model was established, the drug was gavaged daily on time and in the right amount, and the effects of different doses of the drug on the blood sugar level of the animal model were observed.

[0073] The high, medium and low doses of this product are administered by intragastric administration at 1.5 mL / (kg·bw·d), 3.0 mL / (kg·bw·d) and 6.0 mL / (kg·bw·d).

[0074] The positive drug was glibenclamide, which was administered orally at a dose of 5 mg / (kg·bw·d).

[0075] Each group was gavaged for three consecutive cycles, each cycle lasting five days.

[0076] 2. Detection Method

[0077] Record the amount of food and water you eat and drink every day.

[0078] Weigh the body weight every three days, record the weight change, and recalculate the dosage.

[0079] On the last day of the third cycle, the animals in each group were anesthetized, and the blood of the mice was collected by orbital venous plexus blood sampling method to measure the levels of glycosylated hemoglobin and glycosylated serum protein.

[0080] 3 Experimental plan and results

[0081] 3.1 Effect of Shengjin Zhike oral liquid on blood glucose levels in diabetic mice.

[0082] It can be concluded from Table 1 that among the three dosage groups of Shengjinzhike oral liquid 1.5mL / kg·bw·d, 3.0mL / kg·bw·d, and 6.0mL / kg·bw·d, the medium-dose group can reduce the blood glucose level of the diabetic mouse animal model to a level close to that of the normal control group, and has significant differences compared with the normal control group and the model group, which is similar to the effect of the positive drug glibenclamide (5mg / kg·bw·d); the high-dose group is second.

[0083] As shown in Table 1, the normal fasting blood glucose level of mice is 3.9-6.1 mmol / L.

[0084] Table 1 Effect of Shengjinzhike oral liquid on blood glucose level in diabetic mice (unit: mmol / L)

[0085] Group Before modeling Before administration First cycle Second cycle Third cycle Normal control group 4.88±0.79 6.01±0.84 5.6±0.43 5.51±0.50 5.86±0.86 Model Group 5.75±0.97 15.41±3.61* 16.08±5.86** 16.37±4.40** 16.42±3.72** Low dose group 7.88±0.53 13.54±2.38 12.52±3.82 12.46±1.65 12.36±1.85# Medium dose group 5.46±1.04 18.22±5.15 16.22±4.23 14.86±3.02# 12.3±2.48## High dose group 5.43±0.31 18.03±4.58 16.13±5.70 15.6±4.69# 13.93±3.87## Positive control group 5.53±1.09 18.85±4.27 16.02±3.35 14.11±2.99# 12.26±2.14##

[0086] Note: Compared with the normal control group, *P<0.05, **P<0.01; compared with the model group, #P<0.05, ##P<0.01, which are statistically significant.

[0087] 3.2 Effect of Shengjin Zhike oral liquid on body weight of diabetic mice.

[0088] It can be concluded from Table 2 that among the three dosage groups of Shengjinzhike oral liquid 1.5mL / kg·bw·d, 3.0mL / kg·bw·d, and 6.0mL / kg·bw·d, each dosage group can slow down the rate of weight loss in the Kunming mouse diabetic animal model, but the best slowing effect is in the medium-dose group, followed by the high-dose group, which are significantly different from the normal control group and the model group; the slowing effect of the medium-dose group is closest to that of the positive drug glibenclamide (5mg / kg·bw·d).

[0089] time Normal control group Model Group Low dose group Medium dose group High dose group Positive control group Before modeling 39.89±2.18 41.48±0.75 45.42±2.01 42.98±3.26 40.77±1.91 42.54±3.04 After modeling 45.10±2.59 38.77±3.63* 41.85±2.25 38.68±2.97 37.59±1.42 39.65±2.87 Intragastric administration for 3 days 46.07±3.26 38.87±3.51* 40.38±2.46# 38.58±3.00 37.28±1.55 38.82±2.67 6 days of intragastric administration 46.48±3.25 39.18±3.84** 41.06±1.94# 39.63±3.04 37.98±1.57 39.35±2.52 Intragastric administration for 9 days 46.89±3.48 38.08±3.59** 41.48±2.02# 40.96±3.20# 38.13±1.59 40.27±2.32# Intragastric administration for 12 days 47.88±3.25 36.23±4.85** 41.31±1.99# 41.96±3.72## 38.54±2.04# 41.04±2.41## Intragastric administration for 15 days 48.26±3.42 35.57±4.65** 41.72±1.97# 42.60±3.50## 38.94±2.00# 41.91±2.68##

[0090] Table 2 Effect of Shengjinzhike oral liquid on body weight of diabetic mice (unit: g)

[0091] Note: Compared with the normal control group, *P<0.05, **P<0.01; compared with the model group, #P<0.05, ##P<0.01, which are statistically significant.

[0092] 3.3 Effect of Shengjin Zhike oral liquid on food intake and water intake of diabetic mice.

[0093] The normal daily food intake of mice is between 5g and 9g, and the normal daily water intake is between 5.5mL and 9.5mL.

[0094] From the attached picture Figure 1-6 It can be concluded that in the three dosage groups of Shengjin Zhike oral liquid 1.5mL / kg·bw·d, 3.0mL / kg·bw·d, and 6.0mL / kg·bw·d, the water intake and food intake levels of each dosage group showed a trend of first increasing and then decreasing; the medium dose group could control the water intake and food intake of the Kunming mouse diabetic animal model at a lower level, followed by the high dose group; the degree of control in the medium dose group was most similar to the effect of the positive drug glibenclamide.

[0095] 3.4 Effect of Shengjin Zhike oral liquid on glycated serum protein and glycated hemoglobin in diabetic mice.

[0096] As can be seen from Tables 3 and 4, in the three dose groups of Shengjin Zhike oral liquid 1.5mL / kg·bw·d, 3.0mL / kg·bw·d, and 6.0mL / kg·bw·d, the glycated hemoglobin (GHb) and glycated serum protein (GSP) levels in each dose group were significantly higher than those in the blank control group, with significant differences. The GHb and GSP levels in the medium dose group were closest to the normal values, followed by the high dose group, which were significantly different from the model group; among them, the GHb and GSP levels in the medium dose group were closest to the GHb and GSP levels in the mouse animal model of the glibenclamide positive drug group.

[0097] Table 3 Effects of Shengjinzhike oral liquid on glycosylated serum protein in diabetic mice (unit: mmol / L)

[0098] Normal control group Model Group Low dose group Medium dose group High dose group Positive control group 1.73±0.16 5.41±0.55* 4.78±0.46 3.3±0.39## 4.05±0.65# 3.2±0.54##

[0099] Note: Compared with the normal control group, *P<0.05; compared with the model group, #P<0.05, ##P<0.01, which are statistically significant.

[0100] Table 4 Effect of Shengjinzhike oral liquid on glycosylated hemoglobin in diabetic mice

[0101]

[0102] Note: Compared with the normal control group, *P<0.01; compared with the model group, #P<0.05, ##P<0.01, which are statistically significant.

[0103] From the experimental data in the above tables, it can be seen that among the three dose groups, the medium dose group (3.0 mL / kg·bw·d) has the most obvious hypoglycemic effect, the body weight of the model animals is the most stable, and the levels of food intake and water intake are also the best controlled; the GHb and GSP contents in the hyperglycemic animal model are also best controlled by the medium dose group, followed by the high dose group (6.0 mL / kg·bw·d), and the worst is the low dose group (1.5 mL / kg·bw·d); and the drug effect of the medium dose group is closest to that of the positive drug glibenclamide, so it is concluded that the drug effect of the oral solution is best when the adult dose is 20 mL / d, followed by 40 mL / d.

[0104] The preferred specific embodiments of the present invention are described in detail above. It should be understood that ordinary technicians in the field can make many modifications and changes based on the concept of the present invention without creative work. Therefore, all technical solutions that can be obtained by technicians in the technical field based on the concept of the present invention through logical analysis, reasoning or limited experiments on the basis of the prior art should be within the scope of protection determined by the claims.

Claims

1. A Chinese medicine composition, characterized in that: The traditional Chinese medicine composition is prepared from the following traditional Chinese medicines: sea buckthorn puree, astragalus, kudzu root, yam, polygonatum, polygonatum, wolfberry and mulberry leaves, and the weight proportions of the astragalus, kudzu root, yam, polygonatum, polygonatum, wolfberry and mulberry leaves are 25-35 parts of astragalus, 25-35 parts of kudzu root, 25-35 parts of yam, 5-15 parts of polygonatum, 5-15 parts of polygonatum, 5-15 parts of wolfberry and 10-20 parts of mulberry leaves.

2. The Chinese medicine composition according to claim 1, characterized in that: The weight proportions of the astragalus, kudzu root, yam, polygonatum, polygonatum, wolfberry and mulberry leaf are 27-33 parts of astragalus, 27-33 parts of kudzu root, 27-33 parts of yam, 7-13 parts of polygonatum, 7-13 parts of polygonatum, 7-13 parts of wolfberry and 12-18 parts of mulberry leaf.

3. The Chinese medicine composition according to claim 2, characterized in that: The weight proportions of the astragalus, kudzu root, yam, polygonatum, polygonatum, wolfberry and mulberry leaf are 30 parts of astragalus, 30 parts of kudzu root, 30 parts of yam, 10 parts of polygonatum, 10 parts of polygonatum, 10 parts of wolfberry and 15 parts of mulberry leaf.

4. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition is a decoction.

5. The method for preparing the Chinese medicine composition according to any one of claims 1 to 4, characterized in that: include: Astragalus, kudzu root, yam, polygonatum, polygonatum, wolfberry and mulberry leaf are mixed and decocted, and the mixture is filtered to obtain liquid A and residues, which are then decocted to obtain liquid B, and liquid A and liquid B are combined and concentrated to obtain liquid C, and the seabuckthorn puree is mixed with the liquid C in a volume ratio of (3-5):1 to obtain the traditional Chinese medicine composition.

6. The method for preparing the Chinese medicine composition according to claim 5, characterized in that: The concentration is carried out by low temperature and low pressure evaporation.

7. A medicine comprising the Chinese medicine composition according to any one of claims 1 to 4 and pharmaceutically acceptable excipients.

8. Use of the Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a drug for promoting the production of body fluids and quenching thirst.

9. Use of the Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a medicament for preventing and treating hyperglycemia and elevated blood sugar symptoms of diabetes.

Citation Information

Patent Citations

  • Medicinal composition for treating diabetes and preparation method thereof

    CN102488202A