Traditional Chinese medicine composition for reducing blood sugar and blood fat as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of traditional Chinese medicine and application, and relates to a traditional Chinese medicine composition for reducing blood sugar and blood fat as well as a preparation method and application thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 20-40 parts of raspberry, 3-17 parts of cinnamon, 30-40 parts of hawthorn, 20-40 parts of radix polygonati officinalis, 35-50 parts of radix puerariae and 17-33 parts of folium mori. The traditional Chinese medicine composition provided by the invention has the activity of reducing blood sugar and blood fat on the cellular level, and has the effect of reducing blood sugar and blood fat on a type II diabetes model constructed by combining high-sugar and high-fat feed with streptozotocin (STZ) on the animal level.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicine and its application, and relates to a Chinese medicine composition for lowering blood sugar and blood lipids, and a preparation method and application thereof. Background Art

[0002] The information disclosed in this background technology section is only intended to enhance the understanding of the overall background of the invention, and should not necessarily be regarded as an admission or any form of suggestion that the information constitutes the prior art already known to a person skilled in the art.

[0003] Diabetes is a disease caused by insufficient insulin secretion or reduced insulin sensitivity, which leads to insulin resistance and metabolic disorders. The main feature is high blood sugar, which is often manifested clinically as three more (food, water, urine volume) and one less (weight) and increased blood sugar. Diabetes is one of the fastest growing global health emergencies in the 21st century. The global incidence of diabetes is 10%, of which type 2 diabetes accounts for as high as 90%, posing a threat to the life and health of all mankind.

[0004] Hyperlipidemia is a disease caused by excessive fat intake, abnormal lipoprotein synthesis and metabolism. The main characteristics are the increase of total cholesterol (TC), triglycerides (TG) and low-density lipoprotein cholesterol (LDL-C). The high prevalence of hyperlipidemia is the main cause of human cardiovascular and cerebrovascular diseases, type 2 diabetes and non-alcoholic fatty liver diseases. The increasing prevalence of hyperlipidemia has become a public health issue that threatens human health.

[0005] At the same time, high blood lipids and high blood sugar are often comorbid with obesity, hypertension, fatty liver, etc., and a single Western medicine is often difficult to take into account multiple metabolic disorders. Therefore, there is a need for a food that can regulate blood lipids and blood sugar at the same time, as well as a medicine that can lower blood lipids and blood sugar at the same time. Summary of the invention

[0006] In order to solve the shortcomings of the prior art, the purpose of the present invention is to provide a Chinese medicine composition for lowering blood sugar and blood lipids, and its preparation method and application. After research, it was found that the Chinese medicine composition provided by the present invention has blood sugar and blood lipid lowering activities at the cellular level, and has blood sugar and blood lipid lowering effects on the type 2 diabetes model constructed by high-sugar and high-fat feed combined with streptozotocin (STZ) at the animal level.

[0007] In order to achieve the above object, the present invention provides the following technical solutions:

[0008] In the first aspect, a Chinese medicine composition for lowering blood sugar and blood lipids is composed of the following raw materials in parts by weight:

[0009] 20-40 parts of raspberries, 3-17 parts of cinnamon, 30-40 parts of hawthorn, 20-40 parts of polygonatum, 35-50 parts of kudzu roots, and 17-33 parts of mulberry leaves.

[0010] Rubus idaeus, nourishes the kidney, consolidates essence, reduces urination, nourishes the liver and improves eyesight, and is used for spermatorrhea, enuresis, frequent urination, impotence, premature ejaculation, and blurred vision; it has pharmacological activities such as improving sugar and lipid metabolism, anti-oxidation, anti-inflammatory and anti-tumor. It is the dried fruit of Rubuschingii Hu, a plant of the Rosaceae family.

[0011] Cinnamon bark, replenishes fire and boosts yang, guides fire back to the origin, dispels cold and relieves pain, warms and dredges the meridians, and is used for impotence, cold uterus, cold pain in the waist and knees, asthma due to kidney deficiency, cold pain in the heart and abdomen, vomiting and diarrhea due to deficiency and cold, abdominal pain due to cold hernia, dysmenorrhea and amenorrhea; it has pharmacological activities such as improving sugar and lipid metabolism, anti-inflammatory, antibacterial and anti-tumor. It is the dried bark of Cinnamomum cassia Presl, a plant of the Lauraceae family.

[0012] Hawthorn can help digestion and invigorate the stomach, promote qi and dissipate blood stasis, remove turbidity and reduce fat. It is used for meat stagnation, diarrhea, blood stasis, amenorrhea, chest pain, hernia pain, and hyperlipidemia. It has pharmacological activities such as lipid regulation, anti-myocardial injury, antibacterial and gastrointestinal function regulation. It is the dried mature fruit of Crataegus pinnatifida Bge.var.major NEBr. or Crataeguspinnatifida Bge., a plant of the Rosaceae family.

[0013] Polygonatum odoratum, nourishing yin and moistening dryness, promoting fluid and quenching thirst, used for lung and stomach yin injury, dry heat cough, dry throat and thirst, internal heat and thirst. Pharmacological activities such as lowering blood sugar, enhancing immunity and anti-aging. The dried rhizome of Polygonatum odoratum (Mill.) Druce, belonging to the Liliaceae family. Pueraria root, relieves muscles and reduces fever, promotes fluid and quenches thirst, clears rashes, raises yang and stops diarrhea, promotes blood circulation and activates collaterals, and detoxifies alcohol. It is used for exogenous fever and headache, stiff neck and back pain, thirst, measles that does not break out, heat dysentery, diarrhea, hemiplegia caused by stroke, chest pain and heart pain, and alcohol poisoning. It has pharmacological activities such as lowering blood sugar, lowering blood lipids, anti-inflammatory, protecting the liver, protecting cardiovascular and cerebrovascular and kidney functions. The dried root of Pueraria lobata (Willd.) Ohwi, belonging to the Leguminosae family. Mulberry leaf, evacuates wind-heat, clears the lungs and moisturizes dryness, clears the liver and improves eyesight, and is used for wind-heat cold, lung heat and dry cough, dizziness and headache, and red and blurred eyes. It has hypoglycemic, lipid-lowering, antioxidant and anti-tumor pharmacological activities. The dried leaves of Morus alba L., a plant of the Moraceae family.

[0014] In the present invention, raspberry nourishes liver and kidney, reduces blood lipid and blood sugar, and is the main drug. Mulberry leaf clears liver; hawthorn helps digestion and strengthens stomach, removes turbidity and reduces blood lipid; kudzu root produces body fluid and quenches thirst, promotes blood circulation and activates collaterals, and is the ministerial drug, which enhances the blood lipid and blood sugar reducing effect of raspberry. Polygonatum odoratum nourishes yin and moistens dryness, produces body fluid and harmonizes stomach, and helps hawthorn to strengthen stomach; cinnamon warms and dredges meridians, and helps kudzu root to promote blood circulation and activate collaterals, and is the adjuvant drug. The six drugs are used together to strengthen stomach, nourish liver and kidney, and reduce blood lipid and blood sugar.

[0015] In a second aspect, a method for preparing the above-mentioned Chinese medicine composition comprises the following steps:

[0016] (1) Weigh raspberry, cinnamon bark, hawthorn, polygonatum odoratum, kudzu root and mulberry leaf according to a ratio, and soak them in a solvent;

[0017] (2) heating and refluxing the material soaked in step (1) for at least two times;

[0018] (3) The extracts extracted in step (2) are combined and concentrated to obtain the product.

[0019] A third aspect is the use of the above-mentioned Chinese medicine composition in the preparation of products for preventing and treating hyperglycemia and / or hyperlipidemia.

[0020] Since the raspberry, cinnamon, hawthorn, polygonatum, kudzu root and mulberry leaf used in the Chinese medicine composition provided by the present invention are all Chinese medicinal materials that are both medicinal and edible, the product of the present invention can be a functional food for maintaining blood sugar and blood lipids at normal levels, that is, a health product, and can also be a medicine for treating hyperglycemia and hyperlipidemia. Different purposes can be achieved by controlling the amount of the Chinese medicine composition used, for example, using 1 mass part of the Chinese medicine composition can achieve the purpose of treatment, and using 0.01-0.5 mass parts of the Chinese medicine composition can achieve the purpose of health care.

[0021] A fourth aspect provides a pharmaceutical composition, comprising the above-mentioned Chinese medicine composition and pharmaceutical excipients.

[0022] A fifth aspect is the use of the above-mentioned pharmaceutical composition in the preparation of a product for simultaneously lowering blood sugar and blood lipids.

[0023] According to the inventors' further understanding, mutations in ASGR1 can reduce serum cholesterol levels, reduce liver cholesterol synthesis and increase liver low-density lipoprotein uptake to reduce blood lipid levels, and the risk of coronary heart disease in people with ASGR1 deficiency can be reduced by 34%. The above shows that ASGR1 still has great research prospects in lowering blood lipids and cardiovascular diseases. The Chinese medicine composition of the present invention has a therapeutic effect of lowering blood sugar and blood lipids on type 2 diabetic mice fed with high-sugar and high-fat feed combined with streptozotocin (STZ) induction, and also has a good therapeutic effect on liver and kidney damage caused by diabetes, and it is found that its blood lipid-lowering effect is achieved by inhibiting the ASGR1 pathway. It is further speculated that the Chinese medicine composition provided by the present invention has potential cardiovascular protective effects. That is, the sixth aspect provides the use of the above-mentioned Chinese medicine composition or pharmaceutical composition in the preparation of cardiovascular protection products.

[0024] The beneficial effects of the present invention are:

[0025] 1. The Chinese medicine composition provided by the present invention has both α-glucosidase inhibitory activity and bile salt binding ability, indicating that the Chinese medicine composition provided by the present invention has the effects of lowering blood lipids and blood sugar.

[0026] 2. The Chinese medicine composition provided by the present invention can reduce the blood lipid level of mixed hyperlipidemia rats fed with a hyperlipidemia feed. The Chinese medicine composition can reduce the levels of triglycerides, low-density lipoprotein and total cholesterol in the serum of rats, so the Chinese medicine composition provided by the present invention has the function of lowering blood lipids.

[0027] 3. The Chinese medicine composition provided by the present invention can reduce the blood sugar level of hyperglycemic mice with pancreatic islet damage induced by streptozotocin (STZ). The Chinese medicine composition can significantly improve the fasting blood sugar reduction rate of hyperglycemic mice with pancreatic islet damage. At the same time, there is no difference in fasting blood sugar between the high-dose control group and the blank control group. Therefore, the Chinese medicine composition provided by the present invention has the function of lowering blood sugar and has no effect on the blood sugar of normal animals. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] The accompanying drawings in the specification, which constitute a part of the present invention, are used to provide a further understanding of the present invention. The exemplary embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute improper limitations on the present invention.

[0029] Figure 1 This is a graph showing the effect of the Chinese medicine composition granules prepared in Example 3 of Example 6 of the present invention on the serum triglyceride, cholesterol, low-density lipoprotein and high-density lipoprotein levels in rats with combined hyperlipidemia.

[0030] Figure 2This is a graph showing the effect of the Chinese medicine composition granules prepared in Example 3 of Example 7 of the present invention on the body weight and blood sugar of insulin-damaged hyperglycemic mice. DETAILED DESCRIPTION

[0031] It should be noted that the following detailed descriptions are exemplary and are intended to provide further explanation of the present invention. Unless otherwise specified, all technical and scientific terms used herein have the same meanings as those commonly understood by those skilled in the art to which the present invention belongs.

[0032] It should be noted that the terms used herein are only for describing specific embodiments and are not intended to limit exemplary embodiments according to the present invention. As used herein, unless the context clearly indicates otherwise, the singular form is also intended to include the plural form. In addition, it should be understood that when the terms "comprising" and / or "including" are used in this specification, it indicates the presence of features, steps, operations, devices, components and / or combinations thereof.

[0033] In order to provide a Chinese medicine composition that can lower blood lipids and blood sugar at the same time and is both a medicine and a food, the present invention provides a Chinese medicine composition for lowering blood sugar and blood lipids, and a preparation method and application thereof.

[0034] A typical embodiment of the present invention provides a Chinese medicine composition for lowering blood sugar and blood lipids, which is composed of the following raw materials in parts by weight:

[0035] 20-40 parts of raspberries, 3-17 parts of cinnamon, 30-40 parts of hawthorn, 20-40 parts of polygonatum, 35-50 parts of kudzu roots, and 17-33 parts of mulberry leaves.

[0036] The raw materials of the traditional Chinese medicine composition provided by the present invention include 20-40 parts of raspberries, wherein the number of raspberries can be 20 parts, 25 parts, 30 parts, 35 parts, 40 parts, or any value between 20-40 parts.

[0037] The raw materials of the Chinese medicine composition provided by the present invention include 3-17 parts of cinnamon, wherein the parts of cinnamon can be 3 parts, 5 parts, 7 parts, 9 parts, 11 parts, 13 parts, 15 parts, 17 parts, or any value between 3-17 parts.

[0038] The raw materials of the Chinese medicine composition provided by the present invention include 30-40 parts of hawthorn, wherein the amount of hawthorn can be 30 parts, 32 parts, 34 parts, 36 parts, 38 parts, 40 parts, or any value between 30-40 parts.

[0039] The raw materials of the Chinese medicinal composition provided by the present invention include 20-40 parts of Polygonatum odoratum, wherein the amount of Polygonatum odoratum can be 20 parts, 25 parts, 30 parts, 35 parts, 40 parts, or any value between 20 and 40 parts.

[0040] The raw materials of the Chinese medicine composition provided by the present invention include 35-50 parts of Pueraria root, wherein the number of Pueraria root can be 35 parts, 38 parts, 41 parts, 44 parts, 47 parts, 50 parts, or any value between 35 and 50 parts.

[0041] The raw materials of the traditional Chinese medicine composition provided by the present invention include 17-33 parts of mulberry leaves, wherein the number of mulberry leaves can be 17 parts, 19 parts, 21 parts, 23 parts, 25 parts, 27 parts, 29 parts, 31 parts, 33 parts, or any value between 17-33 parts.

[0042] In some embodiments, 30-40 parts of raspberry, 10-17 parts of cinnamon, 32-38 parts of hawthorn, 20-30 parts of polygonatum, 35-45 parts of kudzu root, and 20-30 parts of mulberry leaf.

[0043] In some embodiments, 33-37 parts of raspberry, 13-17 parts of cinnamon, 34-36 parts of hawthorn, 25-30 parts of polygonatum, 38-42 parts of kudzu root, and 24-28 parts of mulberry leaf.

[0044] In some embodiments, 34-36 parts of raspberry, 15-17 parts of cinnamon, 34-36 parts of hawthorn, 27-29 parts of polygonatum, 39-41 parts of kudzu root, and 25-27 parts of mulberry leaf.

[0045] In some embodiments, 35 parts of raspberries, 16 parts of cinnamon, 35 parts of hawthorn, 28 parts of polygonatum, 40 parts of kudzu root, and 26 parts of mulberry leaves.

[0046] A second embodiment of the present invention provides a method for preparing the above-mentioned Chinese medicine composition, comprising the following steps:

[0047] (1) Weigh raspberry, cinnamon bark, hawthorn, polygonatum odoratum, kudzu root and mulberry leaf according to a ratio, and soak them in a solvent;

[0048] (2) heating and refluxing the material soaked in step (1) for at least two times;

[0049] (3) The extracts extracted in step (2) are combined and concentrated to obtain the product.

[0050] In some embodiments, the solvent in step (1) is water, ethanol or a mixture of the two. Water can be mixed with ethanol in any proportion. Studies have shown that when the solvent is an aqueous solution with a volume fraction of ethanol of 0-75%, the prepared Chinese medicine composition has higher α-glucosidase inhibitory activity and sodium cholate binding activity.

[0051] In some embodiments, the volume of the solvent in step (1) is 5-18 times the mass of the raw material.

[0052] In some embodiments, the temperature of the heated reflux extraction is 50-100°C.

[0053] In some embodiments, the concentration method is a reduced pressure concentration method.

[0054] A third embodiment of the present invention provides a use of the above-mentioned Chinese medicine composition in the preparation of a product for preventing and treating hyperglycemia and / or hyperlipidemia.

[0055] In some embodiments, the product is a health product or a medicine.

[0056] A fourth embodiment of the present invention provides a pharmaceutical composition, comprising the above-mentioned traditional Chinese medicine composition and pharmaceutical excipients.

[0057] In some embodiments, the pharmaceutical excipients may be dextrin, starch, microcrystalline cellulose, talc, magnesium stearate, and the like.

[0058] In some embodiments, the dosage form of the pharmaceutical composition can be capsules, tablets, powders, granules, oral liquids, alcoholic preparations, pills, micropills, mixtures or tinctures, etc.

[0059] A fifth embodiment of the present invention provides a use of the above-mentioned pharmaceutical composition in the preparation of a product for simultaneously lowering blood sugar and blood lipids.

[0060] In some embodiments, the product is a health product or a medicine.

[0061] A sixth embodiment of the present invention provides a use of the above-mentioned traditional Chinese medicine composition or pharmaceutical composition in the preparation of a cardiovascular protection product.

[0062] In some embodiments, the product is a health product or a medicine.

[0063] In order to enable those skilled in the art to more clearly understand the technical solution of the present invention, the technical solution of the present invention will be described in detail below in conjunction with specific embodiments.

[0064] Embodiment 1:

[0065] The raw material composition is as follows by weight: 35 parts of raspberries, 16 parts of cinnamon, 35 parts of hawthorn, 28 parts of polygonatum, 40 parts of kudzu root and 26 parts of mulberry leaves.

[0066] Crush raspberry, cinnamon, polygonatum and kudzu root with a grinder, cut hawthorn into slices. Add 15 times the mass of distilled water, soak at 25℃ for 1.5 hours, heat and reflux to extract for 2 hours, filter and add the same volume of distilled water to the residue, extract for 2 hours, filter, and combine the filtrate. Concentrate under reduced pressure to a paste.

[0067] Embodiment 2:

[0068] The raw material composition is as follows by weight: 35 parts of raspberries, 16 parts of cinnamon, 35 parts of hawthorn, 28 parts of polygonatum, 40 parts of kudzu root and 26 parts of mulberry leaves.

[0069] Crush raspberry, cinnamon, polygonatum and kudzu root with a grinder, cut hawthorn into slices. Add 75% (volume fraction) ethanol 15 times the mass of the raw materials, soak at 25℃ for 1.5 hours, heat and reflux to extract for 2 hours, filter and add the same volume of 75% ethanol to the residue again, extract for 2 hours, filter, and combine the filtrate. Concentrate under reduced pressure to a paste.

[0070] Embodiment 3:

[0071] The raw material composition is as follows by weight: 35 parts of raspberries, 16 parts of cinnamon, 35 parts of hawthorn, 28 parts of polygonatum, 40 parts of kudzu root and 26 parts of mulberry leaves.

[0072] Crush raspberry, cinnamon, polygonatum and kudzu root with a grinder, cut hawthorn into slices. Add 90% (volume fraction) ethanol 15 times the mass of the raw materials, soak at 25°C for 1.5 hours, heat and reflux to extract for 2 hours, filter and add the same volume of 90% ethanol to the residue again, extract for 2 hours, filter, and combine the filtrate. Concentrate under reduced pressure to a paste.

[0073] Example 4: Preparation of Chinese medicine composition granules

[0074] The extract of the Chinese medicine composition prepared in Example 1 was selected for the preparation of granules. 100 g of the extract of the Chinese medicine composition obtained in Example 1 was taken, heated at 45°C to a viscous flowable state, 100 g of dextrin and extract were added in batches and stirred evenly, pressed into thin sheets, vacuum dried at 70°C for 6 hours, taken out and crushed into powder, passed through a 60-mesh sieve, added with anhydrous ethanol and mixed to prepare a soft material, granulated with a 20-mesh sieve in the soft material, and granulated again after drying through a 20-mesh sieve, and after granulation, passed through an 80-mesh sieve again to remove fine powder to obtain the granules of the Chinese medicine composition.

[0075] Example 5: In vitro hypoglycemic and hypolipidemic activities of Chinese medicine compositions

[0076] Method: The α-glucosidase inhibitory activity of the Chinese medicine composition prepared in Examples 1-3 was detected. The experiment was divided into a drug reaction group, a drug control group, a blank reaction group, and a blank control group. Each group had 3 replicate wells. The contents were added in sequence as shown in Table 1. First, phosphate buffer, drug solution, and PNPG solution were added. After being placed in a microplate reader and vibrated for 1 minute to mix evenly, they were incubated at 37°C for 10 minutes. After being taken out, the enzyme solution that had been pre-bathed at 37°C was added (the enzyme solution should be liquidized at 4°C after being taken out at -20°C, and then in a water bath at 37°C), the plate was vibrated to mix evenly, and then reacted at 37°C for 20 minutes. After the reaction, 100 μL Na 2 CO3 The solution was added to terminate the reaction. The absorbance of the solution was measured at 400 nm in a 96-well plate. The results after the measurement were calculated according to the following formula:

[0077] Inhibition rate = [(A blank - A sample) / A blank] × 100% (A blank = A blank reaction group - A blank control group, A sample = A drug reaction group - A drug control group)

[0078] After calculating the inhibition rate of each drug, GraphPad Prism 8.0 software was used for processing and analysis, and the results were expressed as mean ± SD.

[0079] Table 1 Grouping and solution addition amount

[0080]

[0081]

[0082] The Chinese medicine composition prepared in Examples 1-3 was subjected to bile salt binding capacity determination. The experiment was divided into a drug blank control group, a drug binding bile salt experimental group, a bile salt blank reaction group, and a bile salt blank control group. A certain mass of drug and the same mass of cholestyramine were accurately weighed in a glass test tube, 1 mL of 0.1 mol / L hydrochloric acid solution was added, and the mixture was shaken at 37 ° C for 1 h in a constant temperature shaking box, and a 0.1 mol / L sodium hydroxide solution was added, and the pH of the solution was adjusted to 6.8, and 4 mL of phosphate buffer was added, and the mixture was shaken again under the same conditions for 1 h and then taken out to simulate the effect of the in vivo environment on the drug. Then add 3mL of 0.3mmol / L corresponding bile salt solution to each group, shake at 37℃ for 1h, centrifuge at 7500rpm for 30min, take 2.5mL of supernatant in a test tube, add 7.5mL of 60% sulfuric acid solution to the test tube, seal the test tube mouth with sealing film, heat the test tube in a water bath at 70℃ for 20min, take out and cool to room temperature, take 250μL of solution in a 96-well plate, set three replicates for each group, and detect the absorbance of the solution at 387nm. The drug bile salt binding rate is determined according to the following formula:

[0083] Binding rate = [(A 空 -A 样 ) / A 空 ]×100%(A 空 =A 空白反应组 -A 空白对照组 , A 样 =A 药物实验组 -A 药物对照组 )

[0084] After calculating the inhibition rate of each drug, GraphPad Prism 8.0 software was used to analyze the data, and the one-way analysis of variance (ANOVA) method was used to analyze the significance of the difference between the two groups. The results were expressed as mean ± SD.

[0085] The results are shown in Table 2. The Chinese medicine compositions of Examples 1-3 all have α-glucosidase inhibitory activity and sodium cholate binding activity, indicating that they have in vitro hypoglycemic and hypolipidemic activities at the cellular level, among which the Chinese medicine compositions of Examples 1 and 2 are more active. Among them, the cost of water preparation used in Example 1 is lower, so the method of Example 1 is selected to prepare the ingredients with lower cost.

[0086] Table 2 Comparison of the activity of the Chinese medicine composition of Examples 1-3

[0087]

[0088]

[0089] Example 6: Therapeutic effect of Chinese medicine composition granules on mixed hyperlipidemia rats fed with hyperlipidemia diet

[0090] Method: The in vivo activity of the Chinese medicine composition granules provided in Example 4 was verified. This example uses 40 SD rats (3-8 weeks, 180-200g, purchased from Beijing Weitong Lihua Company). The rats were raised in a growth environment with a 12-h day and night cycle, ensuring free drinking water and regular food. All in vivo experiments were in accordance with the regulations of the Ethics Committee of the School of Pharmacy of Shandong University. Adaptive feeding for one week.

[0091] The experimental animals were divided into three dosing groups, a blank control group and a model control group, with 8 animals in each group. Combined with the extraction rate of the health food compound, the groups and dosing were finally determined as follows: (1) Control group; (2) Model group; (3) Low-dose group (WF-L): Model + 0.96 g / kg granules; (4) Medium-dose group (WF-M): Model + 1.92 g / kg granules; (5) High-dose group (WF-H): Model + 2.88 g / kg granules.

[0092] Eight rats continued to be fed with maintenance feed as the blank control group, and the remaining 32 rats were fed with model feed as the model group. After the model group was fed with the model feed for 2 weeks, blood was collected from all rats without fasting, and the serum was separated to measure the four levels of serum blood lipids. The model group was randomly divided into 4 groups according to the TC level. Three dose groups were given the corresponding dose of granule aqueous solution by oral gavage every day, and the remaining groups were given the same volume of distilled water for 30 days. At the end of the experiment, blood was collected from the rats without fasting, and the serum was separated to measure the four levels of serum blood lipids. All rats were weighed once a week.

[0093] Rat serum analysis: After administration, blood was collected from the mouse eyeballs, and the blood samples were allowed to stand at room temperature for 4 hours, centrifuged at 2500 rpm for 20 minutes at 4°C, and the supernatant was used to detect the levels of blood creatinine and urea nitrogen using an automatic biochemical analyzer and calculate the ratio; the levels of four blood lipids in serum were detected.

[0094] The results are as follows Figure 1 As shown, compared with the blank control group, the model group, serum TC, TG and LDL-C were significantly increased, while the serum TG and LDL levels of rats in the three dose groups of the granules were significantly decreased compared with those in the model group, and the TC level of rats in the high dose group (WF-H) was also significantly decreased compared with the model group. At the same time, there was no significant difference in the serum HDL-C level between the dose groups and the model group. Therefore, it can be determined that the results of the health food compound auxiliary lipid-lowering function experiment are positive, and further determine that the granule health food has the auxiliary lipid-lowering function.

[0095] Example 7: Therapeutic effect of Chinese medicine granules on hyperglycemic mice with pancreatic islet damage induced by streptozotocin (STZ)

[0096] Method: The in vivo activity of the Chinese medicine composition granules provided in Example 4 was verified. This study used 60 male C57BL / 6J mice (6-8 weeks, 22g-25g, purchased from Beijing Weitong Lihua Company). The mice were raised in a growth environment with a 12-h day and night cycle, ensuring free drinking water and regular food. All in vivo experiments were in accordance with the regulations of the Ethics Committee of the School of Pharmacy of Shandong University. Adaptive feeding for one week.

[0097] The experimental animals were divided into three dosing groups, a blank control group, a model group and a high-dose normal control group, with 10 animals in each group. Combined with the extraction rate of the health food compound, the groups and dosing were finally determined as follows: (1) Control group; (2) Model group; (3) Low-dose group (WF-L): Model + 1.92 g / kg granules; (4) Medium-dose group (WF-M): Model + 2.88 g / kg granules; (5) High-dose group (WF-H): Model + 3.84 g / kg granules; (6) High-dose normal control group (WF-HC): Control + 3.84 g / kg granules.

[0098] The purchased adult mice were adapted for 7 days, fasted for 24 hours, and freely drank water. Then, 130 mg / kg of streptozotocin (freshly prepared in sodium citrate buffer) was injected intraperitoneally to establish the model. After 5-7 days, the animals were fasted for 3-5 hours, and the fasting blood glucose of the mice was measured. The blood glucose value was 10-25 mmol / L, which was a successful hyperglycemia model animal. The hyperglycemia model animals with successful modeling were randomly divided into groups, and the dose group was given the corresponding concentration of the test sample, and the model group was given the solvent. After 35 consecutive days, the fasting blood glucose values ​​of the mice were measured, and the percentage of blood glucose reduction of each group of animals was calculated.

[0099] like Figure 2 As shown in the figure, the weight change results of mice showed that the mice were in a normal state and the model was successfully established. The blood glucose results of mice showed that the fasting blood glucose reduction rates of mice in the three dose groups were higher than those in the model group, and the difference in the high dose group was significant. There was no significant difference in the blood glucose of mice in the high dose normal control group compared with the blank control group. Therefore, it is believed that the granules have the function of assisting in lowering blood glucose and have no effect on the blood glucose of normal animals.

[0100] Example 8: Preparation of Chinese medicine composition tablets

[0101] 30 g of the Chinese medicine composition extract (provided in Example 1) is added with 40 g of corn starch and 20 g of dextrin, and the mixture is fully mixed to prepare granules. The granules are dried and granulated, and an appropriate amount of talcum powder is added and tablets are obtained.

[0102] Example 9: Preparation of Chinese medicine composition capsules

[0103] 30 g of the Chinese medicine composition extract (provided in Example 1) is added with 30 g of starch, 15 g of dextrin, and 10 g of microcrystalline cellulose, and the mixture is thoroughly mixed to obtain granules. The granules are dried and granulated, and an appropriate amount of magnesium stearate is added to the granules. The granules are then filled into capsules to obtain the product.

[0104] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A Chinese medicine composition for lowering blood sugar and blood lipids, characterized in that: According to weight parts, it is composed of the following raw materials: 20-40 parts of raspberries, 3-17 parts of cinnamon, 30-40 parts of hawthorn, 20-40 parts of polygonatum, 35-50 parts of kudzu root, and 17-33 parts of mulberry leaves.

2. The Chinese medicine composition according to claim 1, characterized in that: 30-40 parts of raspberries, 10-17 parts of cinnamon, 32-38 parts of hawthorn, 20-30 parts of polygonatum, 35-45 parts of kudzu root, and 20-30 parts of mulberry leaves; Or, 33-37 parts of raspberries, 13-17 parts of cinnamon, 34-36 parts of hawthorn, 25-30 parts of polygonatum, 38-42 parts of kudzu root, and 24-28 parts of mulberry leaves; Or, 34-36 parts of raspberries, 15-17 parts of cinnamon, 34-36 parts of hawthorn, 27-29 parts of polygonatum, 39-41 parts of kudzu root, and 25-27 parts of mulberry leaves; Or, 35 parts of raspberries, 16 parts of cinnamon bars, 35 parts of hawthorns, 28 parts of polygonatum odoratum, 40 parts of kudzu roots, and 26 parts of mulberry leaves.

3. A method for preparing the Chinese medicine composition according to claim 1, characterized in that: The steps include: (1) Weigh raspberry, cinnamon bark, hawthorn, polygonatum odoratum, kudzu root and mulberry leaf according to a ratio, and soak them in a solvent; (2) heating and refluxing the material soaked in step (1) for at least two times; (3) The extracts extracted in step (2) are combined and concentrated to obtain the product.

4. The preparation method according to claim 3, characterized in that: The solvent in step (1) is water, ethanol or a mixture of the two; preferably an aqueous solution with a volume fraction of ethanol of 0-75%; Or, the volume of the solvent in step (1) is 5-18 times the mass of the raw material; Or, the temperature of heating reflux extraction is 50-100°C; Alternatively, the concentration method is a reduced pressure concentration method.

5. Use of the Chinese medicine composition according to claim 1 or 2 in the preparation of products for preventing and treating hyperglycemia and / or hyperlipidemia.

6. A pharmaceutical composition, characterized in that: The invention comprises the Chinese medicine composition according to claim 1 or 2, and pharmaceutical excipients.

7. The pharmaceutical composition according to claim 6, characterized in that: The pharmaceutical excipient is one or more of dextrin, starch, microcrystalline cellulose, talc, and magnesium stearate; Alternatively, the pharmaceutical composition is in the form of capsules, tablets, powders, granules, oral liquids, alcoholic beverages, pills, micropills, mixtures or tinctures.

8. Use of the pharmaceutical composition according to claim 6 or 7 in preparing a product for simultaneously lowering blood sugar and blood lipids.

9. Use of the traditional Chinese medicine composition according to claim 1 or 2 or the pharmaceutical composition according to claim 6 or 7 in the preparation of a cardiovascular protection product.

10. The use according to any one of claims 5, 8 and 9, characterized in that: The product is a health product or a medicine.

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