Traditional Chinese medicine extract composition for treating diabetic complications and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine extract composition for treating diabetic complications and a preparation method thereof, and belongs to the technical field of medicines. The traditional Chinese medicine extract composition is mainly prepared from the following raw material extracts: raw radix astragali, rhizoma anemarrhenae, rhizoma atractylodis, cortex phellodendri, radix trichosanthis, fructus corni, radix puerariae and ginseng leaves. The traditional Chinese medicine composition is used for treating diabetes mellitus and various complications thereof, including diabetes mellitus complicated with coronary heart disease, diabetes mellitus complicated with hypertension, diabetes mellitus complicated with cerebrovascular lesion, diabetic nephropathy, diabetic fundus lesion, diabetic peripheral neuropathy and the like, and has the advantages of remarkable clinical curative effect, no obvious side effect, low price, good comprehensive therapeutic property and the like.

Description

Technical Field

[0001] The invention belongs to the technical field of medicine, and in particular is a traditional Chinese medicine extract composition for treating diabetic complications and a preparation method thereof. Background Art

[0002] Diabetes is a common disease caused by the interaction of genetic and environmental factors, with high blood sugar as the main clinical sign. Diabetes may cause infectious diseases represented by suppurative skin infections such as nephritis, cystitis, furuncle, carbuncle; microvascular diseases represented by nephropathy and retinopathy; nervous system diseases represented by accelerated brain aging, abnormal sensory motor function of hands and feet, and diabetic amyotrophy; acute complications represented by ketoacidosis, lactic acidosis, non-ketotic hyperosmolar coma and hypoglycemia. In addition, diabetic patients are also prone to psychological problems such as depression, anxiety and cognitive impairment. These complications seriously affect the quality of life of patients and even threaten their lives.

[0003] TCM believes that diabetes is mainly caused by the imbalance of yin and yang in the body and the dysfunction of the internal organs, and is most closely related to the lungs, spleen and kidneys. The lungs are responsible for the release and descent of qi, the spleen is responsible for transportation and transformation, and the kidneys are responsible for the body fluids. If these organs are dysfunctional, it will lead to fluid metabolism disorders, which will then cause diabetes. TCM treatment of diabetes emphasizes syndrome differentiation and treatment, and formulates personalized treatment plans based on the patient's specific condition and physical characteristics. Treatment is mainly based on clearing heat and nourishing yin, promoting blood circulation and removing blood stasis, aiming to adjust the balance of yin and yang, restore the function of internal organs, and thus improve the symptoms of diabetes. TCM treatment of diabetes includes oral Chinese medicine, acupuncture and massage and other methods. Among them, oral Chinese medicine is the most commonly used treatment method, and different Chinese medicine prescriptions are selected through syndrome differentiation to achieve the purpose of treating diabetes.

[0004] Existing Chinese patent medicines for the treatment of diabetes are represented by Xiaoke Pills and Yuquan Pills, which are mostly used to achieve the effects of nourishing yin and promoting body fluid, quenching thirst and eliminating restlessness, and invigorating qi and neutralizing. The treatment focuses on improving the symptoms of diabetes "three mores and one less". Although these Chinese patent medicines for the treatment of diabetes that have been marketed have good safety and efficacy, they lack efficacy for symptoms related to diabetes complications with high mortality and disability rates, and it is difficult to curb the comprehensive symptoms of diabetes and its complications in a timely manner. For this reason, it is necessary to propose a Chinese medicine extract composition for the treatment of diabetic complications and a preparation method thereof, which takes into account the treatment of diabetes itself and its complications, relieves the comprehensive symptoms of diabetic patients, and has significant efficacy without obvious side effects. Summary of the invention

[0005] In order to solve the above problems, the purpose of the present invention is to provide a Chinese medicine extract composition with low cost, few side effects and efficacy against diabetes and its complications.

[0006] In order to achieve the above-mentioned purpose, the technical scheme of the present invention is as follows: A Chinese medicine extract composition for treating diabetic complications, the composition is composed of the following Chinese medicine extracts in weight ratio: 5-30 parts of raw astragalus extract, 5-20 parts of Anemarrhena extract, 5-30 parts of Atractylodes extract, 5-20 parts of Phellodendron chinense extract, 5-20 parts of Trichosanthes extract, 5-20 parts of Cornus officinalis extract, 8-15 parts of Pueraria extract and 5-15 parts of ginseng leaf extract.

[0007] The principle of the basic program is: the formula is mainly composed of raw astragalus extract, Anemarrhena extract, Atractylodes extract, Phellodendron extract, Radix Trichosanthis extract, Fructus Corni extract, Radix Puerariae extract and Ginseng leaf extract. The theory of traditional Chinese medicine emphasizes the holistic concept and syndrome differentiation and treatment. The formula combines a variety of plant extracts with different pharmacological effects to regulate the body's functions in multiple targets and pathways, thereby achieving the purpose of treating diabetes and its complications. A variety of extracts contain ingredients that can lower blood sugar, improve insulin resistance, promote insulin secretion or increase insulin sensitivity, such as astragalus polysaccharides, Anemarrhena polysaccharides and Radix Trichosanthis protein. Extracts such as Phellodendron and Atractylodes are rich in antioxidants, which can scavenge free radicals and reduce oxidative stress damage; at the same time, some extracts also have anti-inflammatory effects and can relieve the inflammatory response caused by diabetes. Extracts such as Radix Trichosanthis and Fructus Corni have a protective effect on target organs such as kidneys and cardiovascular organs, and can reduce the damage of diabetes to these organs. Some extracts such as Astragalus and Ginseng leaf can regulate the body's immune function, enhance the body's resistance, and prevent the occurrence of complications such as infection.

[0008] The beneficial effects of the basic program are: 1. Lowering blood sugar levels through multiple pathways, including promoting insulin secretion, increasing insulin sensitivity and inhibiting liver gluconeogenesis.

[0009] 2. Enhance the sensitivity of cells to insulin and improve the bioavailability of insulin.

[0010] 3. Some extracts have the function of protecting pancreatic β cells, delaying their apoptosis and functional decline.

[0011] 4. Remove free radicals in the body and reduce oxidative stress damage; inhibit inflammatory response and relieve various complications caused by diabetes.

[0012] 5. It has a protective effect on target organs such as the kidneys and cardiovascular system, reducing the damage caused by diabetes to these organs.

[0013] 6. Enhance the body's immune function, improve the body's resistance, and prevent the occurrence of complications such as infection.

[0014] 7. Improve the overall health status and quality of life of diabetic patients through comprehensive conditioning effects of multiple targets and multiple pathways.

[0015] Further, it is composed of 5-30 parts of raw astragalus extract, 5-20 parts of Anemarrhena asphodeloides extract, 5-30 parts of Atractylodes lancea extract, 5-20 parts of Phellodendron chinense extract, 5-20 parts of Radix Trichosanthis extract, 5-20 parts of Cornus officinalis extract, 8-15 parts of Pueraria lobata extract, 5-15 parts of Panax ginseng leaf extract, 5-30 parts of Terminalia chebula extract and 5-15 parts of Dioscorea opposita extract.

[0016] The beneficial effects of the basic program are: 1. The antidiarrheal and astringent effects of Terminalia chebula extract combined with the laxative effect of yam extract can comprehensively regulate intestinal health, relieve diarrhea symptoms and promote intestinal detoxification.

[0017] 2. Terminalia chebula extract and yam extract also have synergistic effects in moistening the lungs and relieving coughs and strengthening the spleen and stomach, and can comprehensively improve the health of the respiratory and digestive systems.

[0018] Further, 30 parts of raw astragalus extract, 20 parts of Anemarrhena asphodeloides extract, 30 parts of Atractylodes lancea extract, 15 parts of Phellodendron chinense extract, 20 parts of Trichosanthes kirilowii extract, 20 parts of Cornus officinalis extract, 15 parts of Pueraria lobata extract and 10 parts of ginseng leaf extract.

[0019] The beneficial effects of the basic program are: Astragalus, sweet, slightly warm; enters the spleen and lung meridians. The effects are: tonifying spleen and lung qi, raising yang and lifting sunken, strengthening the body's defense system, diuresis, detoxification and muscle regeneration. Chemical composition and pharmacological effects: Astragalus mainly contains glycosides, polysaccharides, flavonoids, amino acids and trace elements, which have the effects of promoting body metabolism, resisting fatigue, eliminating urine protein, raising hypoglycemia, lowering hyperglycemia, dilating coronary arteries and peripheral blood vessels, and lowering blood pressure.

[0020] Anemarrhena, bitter, sweet, cold; enters the lung, stomach, and kidney meridians. Efficacy: clearing away heat and purging fire, nourishing yin and moistening dryness, inhibiting bacteria, anti-tumor, diuretic. Chemical composition and pharmacological effects: Anemarrhena mainly contains glycosides, polysaccharides, flavonoids, organic acids and alkaloids, which have hypoglycemic, antibacterial, anti-inflammatory, and anti-tumor effects.

[0021] Atractylodes lancea tastes bitter, pungent and warm; it enters the spleen, stomach and lung meridians. It has the functions of drying dampness and strengthening the spleen, removing rheumatism and relieving the symptoms. Chemical composition and pharmacological effects: Atractylodes lancea contains volatile oil, the main components of which are atractylol and vitamin A. Atractylodes lancea volatile oil has stomachic, sedative, hypoglycemic, potassium excretion, sodium excretion and antibacterial effects on experimental animals. It can effectively prevent night blindness and corneal softening caused by vitamin A deficiency, and can also prevent diabetic retinopathy.

[0022] Phellodendron chinense, Phellodendron chinense is bitter and cold in nature; it enters the kidney, bladder and large intestine meridians. Its main effects are clearing away heat and dampness, purging fire and removing steam, detoxifying and curing sores. Chemical composition and pharmacological effects: Phellodendron chinense contains alkaloids, bitter substances, sterols and various trace elements and volatile oil components. It has anti-inflammatory and antibacterial, immunomodulatory, antioxidant, blood pressure lowering, and inhibiting apoptosis of articular chondrocytes.

[0023] Radix Trichosanthis, sweet, slightly bitter, slightly cold. Efficacy: clearing away heat and promoting body fluid, moistening the lungs and resolving phlegm, reducing swelling and removing pus. Chemical composition: Radix Trichosanthis protein, various amino acids, ribose, xylose, arabinose, Trichosanthis root polysaccharides A, B, C, D, E; fresh roots also contain 7-stigmaster-3β-ol, brenolic acid, cucurbitacin B and D, 23,24-dihydrocucurbitacin. It has the effects of enhancing immunity, anti-cancer and anti-virus, regulating blood sugar, etc.

[0024] Cornus officinalis is sour, astringent, and slightly warm in nature. It enters the liver and kidney meridians. It has the effects of nourishing the liver and kidneys, astringing and consolidating. Chemical components: iridoid ether terpenoid glycosides, tannin polyphenol compounds, triterpenes, organic acids, flavonoids and polysaccharides. It has multiple effects such as promoting body fluid and quenching thirst, strengthening the heart, raising blood pressure, anti-oxidation, and anti-thrombosis.

[0025] Pueraria root, sweet and spicy; enters the lung and stomach meridians, and has the following effects: relieving muscles and reducing fever, relieving phlegm and clearing the throat, promoting body fluid and quenching thirst, and raising yang and stopping diarrhea. Chemical composition: Pueraria root contains daidzein, daidzein, puerarin, daidzein glycoside, genistein, formononetin, etc. Pueraria root can treat eye diseases, and has the effects of regulating endocrine, improving blood circulation, and lowering blood pressure and blood sugar.

[0026] Ginseng leaves are sweet, slightly bitter, and neutral in nature. They enter the spleen, lung, heart, and kidney meridians. The main effects include tonifying qi and lungs, dispelling heat and promoting body fluid. The chemical components mainly include various ginsenosides, volatile oils, and flavonoids. Ginseng leaves can significantly inhibit the effect of adrenaline in raising blood sugar, and have the effects of lowering blood lipids, resisting arteriosclerosis, anti-oxidation, and enhancing immune function.

[0027] A method for preparing a Chinese medicine extract composition for treating complications of diabetes, comprising mixing the components in the formula uniformly according to a weight ratio, adding the components and 50% kaoliang wine in a volume ratio of 1:1 into a blending kettle for blending and refining to prepare capsules, pills or granules;

[0028] The blending kettle comprises a kettle body and a kettle cover. The kettle cover is sealed and rotatably connected with a crank, the top of the crank is fixedly connected with a handle, the bottom of the crank passes through the kettle cover and is coaxially fixedly connected with a stirring fan blade, and the kettle cover is detachably connected to the kettle body by a buckle.

[0029] The principle of the basic solution is: add the powdered components and an equal volume of sorghum wine into the blending kettle, cover the kettle with a lid, fasten it with a buckle, and drive the stirring blades to rotate by shaking the crank handle to mix the extract powders and sorghum wine into a mud-like state. Open the lid to shape the extract components, and get the finished product after drying in the shade.

[0030] The beneficial effects of the basic scheme are: The finished product related treatment conditions are as follows:

[0031] 1. Patient profile: 97 cases in the treatment group, including 62 males and 35 females, the youngest was 32 years old and the oldest was 70 years old, 30 cases were obese, 42 cases were of medium build, 25 cases were thin, 2 cases were taller than 1.58M and weighed less than 38Kg, the longest course of disease was 15 years and the shortest was 1 month, 2 cases had fasting blood sugar >27.6mmol / L, 8 cases had fasting blood sugar >18.9mmol / L, 7 cases had fasting blood sugar >15mmol / L, 11 cases had fasting blood sugar >13.6mmol / L, and 8 cases had fasting blood sugar >8.5mmol / L 5 cases, 27 cases with fasting blood glucose >7.5mmol / L, 10 cases with urine sugar (+++), 18 cases with urine sugar (++), 12 cases with urine sugar (+), 57 cases with urine sugar (-), 45 cases with hypertension and hyperlipidemia, 39 cases with clinical manifestations of polydipsia, polyphagia and weight loss, 25 cases with polydipsia, polyuria, fatigue, poor appetite and obvious weight loss, 31 cases with polydipsia, polyuria and polyphagia without weight loss, 13 cases with diabetic retinopathy, 11 cases with peripheral neuritis, 4 cases with infection, all of which met the diagnosis of diabetes, 42 cases had been treated with Xiaoke Pills before, 25 cases had been treated with Xiaoke Pills and metformin, and 5 cases had been treated with insulin twice a day, 12u each time.

[0032] 2. Dosage and Administration: Take 6-10g each time with warm water, 3 times a day, 15 days as a course of treatment.

[0033] 3. Efficacy analysis: After 1-2 courses of treatment, the following evaluations were made: clinical symptoms of polydipsia, polyphagia and polyuria disappeared, fasting blood sugar was less than 6.3mmol / L, and urine sugar (-) was cured; clinical symptoms and signs disappeared, fasting blood sugar <7.0mmol / L, and urine sugar (-) was markedly effective; clinical symptoms and signs improved, fasting blood sugar <8.5mmol / L, and urine sugar (-) was effective; fasting blood sugar was greater than 12mmol / L, urine sugar > (+) or blood sugar increased after treatment was ineffective. The results of the efficacy on diabetes are shown in Table 1, of which 31 cases were cured, accounting for 40%, 22 cases were markedly effective, accounting for 28%, 15 cases were effective, accounting for 19%, 9 cases were ineffective, accounting for 11%, and the total effective rate was 87%. (During the treatment, except for 5 patients who were treated with insulin before taking this product and reduced their insulin dosage to once a day, 8u each time, all other patients stopped using all hypoglycemic drugs except those of the present invention.

[0034] 4. The efficacy on different complications of diabetes is shown in Table 2. It has relatively obvious efficacy on different types of complications of diabetes.

[0035] 5. Adverse reactions: The patients had no obvious adverse reactions.

[0036] Table 1 Overall efficacy of finished Chinese medicine extract composition on diabetes

[0037]

[0038] Table 2 The efficacy of finished Chinese medicine extract composition on different complications of diabetes

[0039]

[0040] Furthermore, the components in the formula are concentrated by rotary evaporation and freeze-dried to prepare powdered extracts.

[0041] The beneficial effect of the basic scheme is: through low-temperature evaporation concentration and freeze-drying, the effective ingredients of traditional Chinese medicine are prevented from being degraded or inactivated by high temperature, thereby ensuring the efficacy of the traditional Chinese medicine extract composition to the greatest extent.

[0042] Furthermore, the raw astragalus extract, kudzu root extract and ginseng leaf extract are all obtained by extracting using cellulose enzymatic hydrolysis.

[0043] Furthermore, the Atractylodes lancea extract and the Radix Trichosanthis extract were both obtained by ultrasonic extraction.

[0044] Furthermore, the Phellodendron chinense extract was obtained by decoction and infiltration method.

[0045] Furthermore, the cornus officinalis extract is obtained using a hot soaking method.

[0046] Furthermore, the Anemarrhena asphodeloides extract was obtained using a cold infusion method.

[0047] The beneficial effect of the basic scheme is that since the raw materials of each Chinese medicine component belong to different plant parts, the maximum yield of the active ingredients of each Chinese medicine component can be obtained by using different extraction methods, and the probability of inactivation or degradation of the active ingredients during the extraction process can be reduced, thereby improving the quality of the finished drug. BRIEF DESCRIPTION OF THE DRAWINGS

[0048] Figure 1 This is a schematic diagram of a method for preparing a Chinese medicine extract composition for treating diabetic complications according to an embodiment of the present invention.

[0049] Figure 2 This is an axonometric diagram of a blending kettle in the method for preparing a traditional Chinese medicine extract composition for treating diabetic complications according to an embodiment of the present invention.

[0050] Figure 3It is a cross-sectional view of a blending kettle in the method for preparing a traditional Chinese medicine extract composition for treating diabetic complications according to an embodiment of the present invention.

[0051] The figure numbers in the drawings of the specification include: 1, kettle body; 2, buckle; 3, kettle cover; 4, crank; 5, handle; 6, stirring fan blade. DETAILED DESCRIPTION

[0052] The following is further described in detail through specific implementation methods:

[0053] Example 1

[0054] Basically as attached Figure 1 , Figure 2 and Figure 3 As shown: A traditional Chinese medicine extract composition for treating diabetic complications, the composition is composed of the following traditional Chinese medicine extracts in weight ratio: 5-30 parts of raw astragalus extract, 5-20 parts of Anemarrhena extract, 5-30 parts of Atractylodes extract, 5-20 parts of Phellodendron chinense extract, 5-20 parts of Radix Trichosanthis extract, 5-20 parts of Cornus officinalis extract, 8-15 parts of Pueraria extract and 5-15 parts of ginseng leaf extract.

[0055] The components in the formula are evenly mixed in the weight ratio of 30 parts of raw astragalus extract, 20 parts of Anemarrhena extract, 30 parts of Atractylodes extract, 15 parts of Phellodendron chinense extract, 20 parts of Trichosanthes extract, 20 parts of Cornus officinalis extract, 15 parts of Pueraria extract and 10 parts of ginseng leaf extract, each part by weight.

[0056] The mixture is added to a blending kettle in a volume ratio of 1:1 with 50-proof kaoliang wine for blending and refining. The blending kettle comprises a kettle body 1 and a kettle cover 3. The kettle cover 3 is sealed and rotatably connected with a crank 4, a handle 5 is welded to the top of the crank 4, and a stirring fan 6 is coaxially welded to the bottom of the crank 4 through the kettle cover 3. The kettle cover 3 is detachably connected to the kettle body 1 by a buckle 2.

[0057] The extracts of various Chinese medicinal herbs are blended and prepared into capsules.

[0058] The specific implementation process is as follows: the staff puts the Chinese medicine extract powder or ointment in the formula into the kettle body 1 according to the weight ratio, and then adds 50-proof sorghum wine of the same volume as the extract powder, closes the kettle cover 3 and fastens the buckle 2, and shakes the crank 4 through the handle 5 to drive the stirring fan 6 to continuously mix and stir the Chinese medicine extract in the kettle body 1. After mixing evenly, the staff opens the blending kettle, adds pharmaceutically acceptable excipient starch, mixes evenly again, and puts into hard capsules to obtain the Chinese medicine extract composition capsules.

[0059] Example 2

[0060] The difference from the above embodiment is that the Chinese herbal extracts are blended and made into pills.

[0061] The specific implementation process is as follows: after blending the Chinese herbal extracts, pharmaceutically acceptable excipients such as lactose, microcrystalline cellulose, sucrose and magnesium stearate are added to prepare a soft material, granulate, dry, and granulate, and then magnesium stearate is added and pressed into pills to obtain Chinese herbal extract composition pills.

[0062] Example 3

[0063] The difference from the above embodiment is that each Chinese medicine extract is blended to form a granule

[0064] The specific implementation process is as follows: after the Chinese herbal medicine extracts are blended, pharmaceutically acceptable excipients such as starch and microcrystalline cellulose are added, soft materials are prepared, granulated, dried, granulated, and packaged to obtain Chinese herbal medicine extract composition granules.

[0065] Example 4

[0066] The difference from the above embodiment is that in a method for preparing a traditional Chinese medicine extract composition for treating diabetic complications, raw astragalus extract, kudzu root extract and ginseng leaf extract are all obtained by extraction using cellulose enzymatic hydrolysis.

[0067] The specific implementation process is as follows: Extraction of Astragalus extract by cellulose enzymatic hydrolysis: Grind the Astragalus into coarse powder, add 14 times the amount of water, adjust the pH of the mixed solution to 5.5, heat the mixed solution to 50°C and keep the temperature constant, add cellulase to the mixed solution at a ratio of 60U / g to the enzyme substrate, incubate at the constant temperature for 1.5 hours, then add 6 times the amount of 90% ethanol solution by volume, continue incubation under the same constant temperature conditions for 1 hour, filter to obtain the extract filtrate, and concentrate and dry it.

[0068] Extraction of Pueraria root extract by cellulase hydrolysis: Grind the Pueraria root into coarse powder, add 15 times the amount of water, adjust the pH of the mixed solution to 5.5, heat the mixed solution to 40°C and keep the temperature constant, add cellulase to the mixed solution at a ratio of 25U / g to the enzyme substrate, incubate at the constant temperature for 5 hours, and ultrasonicate for 1.5 hours under the conditions of 120W, 50kHz, and 30°C in an ultrasonic device. Repeat three times, filter to obtain the extract filtrate, and concentrate and dry it.

[0069] Extraction of ginseng leaf extract by cellulose enzymatic hydrolysis: Grind the ginseng leaves into coarse powder, add 20 times the amount of water, adjust the pH of the mixture to 5.5, heat the mixture to 30°C and keep the temperature constant, add cellulase to the mixture at a ratio of 30U / g to the substrate, incubate at the constant temperature for 3 hours, filter to obtain the extract filtrate, and concentrate and dry it.

[0070] Example 5

[0071] The difference from the above embodiment is that both the Atractylodes lancea extract and the Radix Trichosanthis extract were obtained by ultrasonic extraction.

[0072] The specific implementation process is as follows: Ultrasonic extraction of Atractylodes lancea extract: Grind Atractylodes lancea into 30 mesh powder, add 30 times the amount of petroleum ether, and ultrasonicate at room temperature for 4 hours under the conditions of 160W, 50kHz, repeat three times, and obtain the Atractylodes lancea extract after filtering and recovering the petroleum ether, and then concentrate and dry it.

[0073] Ultrasonic extraction of Radix Trichosanthis: Grind Radix Trichosanthis into 60 mesh powder, add 16 times the amount of water, and ultrasonicate for 2.5 hours under the conditions of 120W, 50kHz, and 50°C constant temperature. Repeat three times, filter to obtain the extract filtrate, and concentrate and dry it.

[0074] Example 6

[0075] The difference from the above embodiment is that the Phellodendron chinense extract is obtained by decoction and infiltration method.

[0076] The specific implementation process is as follows: 1. Use hydrochloric acid to adjust the pH of the extraction water to 5.5, add Phellodendron chinense raw material and decoct twice, each time using 10 times the weight of the medicinal material. After decocting for 3 hours, filter the medicine soup, combine the extract filtrate and concentrate it at 65°C to an extract with a relative density of 1.15;

[0077] 2. Add ethanol to the obtained extract to make the alcohol content reach 80%, and use calcium hydroxide to adjust the pH to 8.5. After standing for 24 hours, filter the extract, evaporate the ethanol from the extract filtrate until there is no alcohol taste, and then concentrate and dry it.

[0078] Example 7

[0079] The difference from the above embodiment is that the Cornus officinalis extract is obtained by a hot soaking method.

[0080] The specific implementation process is as follows: crush the cornus officinalis into coarse powder, add 17 times the volume fraction of 91% ethanol solution, shake and soak for 3 hours at a constant temperature of 74°C, filter to obtain the extract filtrate, and concentrate and dry it.

[0081] Example 8

[0082] The difference from the above embodiment is that the Anemarrhena asphodeloides extract is obtained by cold infusion method.

[0083] The specific implementation process is as follows: crush the Rhizoma Anemarrhenae into coarse powder, add 8 times the volume fraction of 75% ethanol solution, shake and soak for 3 hours at room temperature 25°C, filter to obtain the extract filtrate, and concentrate and dry it.

[0084] Example 9

[0085] The difference from the above embodiment is that the components in the formula are concentrated by rotary evaporation and freeze-dried to prepare powdered extracts.

[0086] The specific implementation process is as follows: Rotary evaporation concentration:

[0087] 1. Pour the filtrate of each extract into the rotary evaporation bottle, and be careful not to exceed 2 / 3 of the bottle body to prevent splashing during rotation. Install the rotary evaporation bottle on the rotary evaporator and adjust the height of the main machine so that the liquid level of the water bath is flush with or slightly higher than the liquid level in the rotary bottle.

[0088] 2. Close the vent button of the rotary evaporator, turn on the vacuum pump, and maintain the vacuum state after the vacuum degree reaches the set value of 0.05MPa. Turn on the rotary button, select a speed not higher than 6000r / min, and perform rotary evaporation at room temperature. The speed should not be too high at the beginning to prevent the sample from boiling violently. As the solvent evaporates, the speed can be gradually increased.

[0089] 3. When almost no solvent evaporates from the rotary evaporation bottle, it means that the rotary evaporation process is nearly completed. At this time, you can turn off the heating and rotation switches and stop the vacuum pump. Carefully remove the rotary evaporation bottle and collect the concentrated liquid in the bottle.

[0090] Freeze drying:

[0091] Take an appropriate volume of the concentrated solution and place it in a freezing bottle. Centrifuge it quickly in ethanol at -25°C so that the drug solution hangs thinly on the bottle wall. Then install it in a freeze dryer to make it into dry powder.

[0092] Example 10

[0093] The specific implementation process is as follows: The therapeutic effect of the core prescriptions with different ratios of the present invention on the glucose metabolism of diabetic rats induced by streptozotocin (STZ).

[0094] STZ-induced diabetic rat model was used (modeling reference: Han Xu, Wang Xuan, Yu Zhi, et al. Research progress on influencing factors of STZ-induced diabetic rat model [J]. Chinese Journal of Experimental Animals, 2020, 28(5): 716-725) as follows:

[0095] Freshly prepare 0.1mol / L, pH 4.5 citric acid buffer (prepared with citric acid and sodium citrate in a certain ratio), filter and remove impurities, and store in a refrigerator at 4°C. Prepare a 2% STZ solution with STZ before use. The model group is injected intraperitoneally at 60mg / kg, and the normal control group is injected with an equivalent amount of citric acid buffer calculated according to this dosage. Conventional iodine tincture was used to disinfect the abdominal skin of rats during the modeling process, and group experiments were performed after the modeling was successful.

[0096] The grouping, dosage and test results are shown in Tables 3 and 4. The weight ratio of each extract component is 1 gram per portion, and the composition is mixed with an equal volume of 50% kaoliang wine and concentrated to the same volume (the final concentrated volume is 25 ml).

[0097] Table 3 Core prescriptions with different ratios grouped

[0098]

[0099] Table 4 The therapeutic effects of different core prescriptions of the present invention on diabetic model rats

[0100]

[0101] Compared with the control group injected with normal saline, *P<0.05, **P<0.01.

[0102] From the results in Table 4, it can be concluded that different core prescription extract ratios have an effect on the blood sugar and glucose tolerance of model rats; at the same time, the effect on the blood sugar of normal rats was observed. The results show that each ratio group can reduce the blood sugar of diabetic rats to a certain extent and improve glucose tolerance, among which group 2 and group 3 have the most significant effect, and the difference compared with the model group is statistically significant (P < 0.05); while the effect of group 1 is poor, but compared with the normal saline group, it also has a certain improvement on the blood sugar level. The conclusion is that this prescription has a significant hypoglycemic effect.

[0103] Embodiment 11

[0104] Classic case 1: Diabetes and hypertension case

[0105] Wu, female, 33 years old, is a patient with mid-to-late stage diabetes with an 8-year history of diabetes. She took Western medicine to control her blood sugar in the first five years and injected insulin to control her blood sugar in the next three years. At that time, she injected 60 units of insulin every day, her fasting blood sugar was >12mmol / L, and her blood sugar 2 hours after a meal was >25mmol / L. She also had complications such as dry mouth, blurred vision, fatigue, edema of the limbs, loss of skin elasticity, hypertension, and hyperlipidemia.

[0106] The present invention is used in conjunction with the injection of insulin to stabilize blood sugar. 30g of raw astragalus extract, 20g of rhizoma anemarrhenae extract, 30g of atractylodes extract, 15g of phellodendron extract, 20g of root of trichosanthes extract, 20g of fructus corni extract, 15g of kudzu root extract and 10g of ginseng leaf extract are mixed with equal volumes of kaoliang wine to prepare pills, one dose per day.

[0107] Three months later, the insulin injection was stopped, and the fasting blood sugar and postprandial blood sugar were both stable within the normal range. The clinical symptoms before the use of the present invention disappeared, reaching the clinical relief standard.

[0108] Classic case 2: Diabetes combined with chest pain

[0109] Mr. Liu, male, 65 years old, is a late-stage diabetic patient with a history of diabetes for 12 years. He has been taking certain medications. His fasting blood sugar is >16mmol / L, and his blood sugar 2 hours after a meal is >25mmol / L. He also has complications such as chest pain, back pain, numbness and cramps in the feet, fear of cold, yellow face, and dry stool.

[0110] Take 30g of raw Astragalus extract, 20g of Anemarrhena extract, 30g of Atractylodes extract, 15g of Phellodendron extract, 20g of Radix Trichosanthis extract, 20g of Cornus officinalis extract, 20g of Pueraria extract and 20g of ginseng leaf extract, mix with equal volume of sorghum wine, and make into pills. Take one dose per day and stop taking other medicines.

[0111] Half a year later, the fasting blood sugar and postprandial blood sugar were both stable within the normal range, and the leg cramps, leg numbness, and bowel movements improved. All complications improved, reaching the clinical remission standard.

[0112] Classic Case 3: Diabetic Peripheral Neuropathy

[0113] Yang, male, 52 years old, is a late-stage diabetic with a 7-year history of diabetes. He injected 60 units of insulin every day, fasting blood sugar>16mmol / L, 2 hours after meal blood sugar>25mmol / L, and he also had peripheral neuritis, diabetic heart disease, and coronary heart disease. Glycated hemoglobin 7.4%.

[0114] The present invention is used in conjunction with the injection of insulin to stabilize blood sugar. 30g of raw astragalus extract, 20g of rhizoma anemarrhenae extract, 30g of atractylodes extract, 15g of phellodendron extract, 20g of root of trichosanthes extract, 20g of cornus extract, 15g of kudzu root extract, 10g of ginseng leaf extract, 20g of terminalia chebula extract and 10g of yam extract are mixed with equal volumes of kaoliang wine to make pills, one dose per day.

[0115] Two months later, both fasting blood sugar and postprandial blood sugar levels were reduced to a certain extent, fasting blood sugar>11mmol / L, blood sugar 2 hours after meal>20mmol / L, the symptoms of peripheral neuritis disappeared, and the remaining symptoms were the same as before.

[0116] Classic case 4: Diabetes combined with chest pain

[0117] Xia, female, 48 years old, is a late-stage diabetic patient with a 9-year history of diabetes. She took western medicine to control blood sugar while using the present invention. At that time, her fasting blood sugar was >11mmol / L, and her blood sugar 2 hours after a meal was >20mmol / L. She also had symptoms such as high blood pressure, palpitations, chest and back pain, frequent urination, soreness of waist and knees, insomnia, dry mouth, blurred vision, fatigue, etc.

[0118] Take 30g of raw astragalus extract, 20g of Anemarrhena extract, 30g of Atractylodes extract, 15g of Phellodendron chinense extract, 20g of Radix Trichosanthis extract, 20g of Cornus officinalis extract, 20g of Pueraria extract and 20g of ginseng leaf extract, mix with equal volume of sorghum wine, and make into pills, one dose per day.

[0119] Three months later, the patient stopped taking western medicine and used the present invention at half the original dosage. Fasting blood sugar and blood sugar 2 hours after meal were stable within the normal range, chest pain disappeared, and body weight increased, reaching the clinical relief standard.

[0120] Classic Case 5: Diabetic Nephropathy

[0121] Mr. Wang, male, 66 years old, is a late-stage diabetic patient with a 12-year history of diabetes. He is obese and has a red face. His fasting blood sugar level was >16mmol / L and his blood sugar level 2 hours after a meal was >25mmol / L. He also had symptoms such as irritability, impatience, soreness and swelling in the legs and knees, increased urine microprotein content, and high blood pressure.

[0122] Take 30g of Astragalus extract, 20g of Anemarrhena extract, 30g of Atractylodes extract, 15g of Phellodendron extract, 20g of Radix Trichosanthis extract, 20g of Cornus extract and 20g of Pueraria extract, mix with equal volume of sorghum wine and make into pills, one dose per day.

[0123] Three months later, the leg pain was relieved, the edema was significantly improved, the fasting blood sugar was >11mmol / L, and the blood sugar 2 hours after meal was >20mmol / L. The rest of the symptoms were the same as before.

[0124] It should be noted that, in this article, relational terms such as first and second, etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device.

[0125] The above is only an embodiment of the present invention. The common sense such as the known specific structure and characteristics in the scheme is not described in detail here. The ordinary technicians in the relevant field know all the common technical knowledge in the technical field of the invention before the application date or priority date, can obtain all the existing technologies in the field, and have the ability to apply the conventional experimental means before that date. The ordinary technicians in the relevant field can improve and implement this scheme in combination with their own abilities under the enlightenment given by this application. Some typical known structures or known methods should not become obstacles for ordinary technicians in the relevant field to implement this application. It should be pointed out that for those skilled in the art, without departing from the structure of the present invention, several deformations and improvements can be made, which should also be regarded as the protection scope of the present invention, which will not affect the effect of the implementation of the present invention and the practicality of the patent. The protection scope required by this application shall be based on the content of its claims, and the specific implementation methods and other records in the specification can be used to interpret the content of the claims.

Claims

1. A Chinese medicine extract composition for treating diabetic complications, characterized in that: The composition is composed of the following Chinese herbal medicine extracts in the following weight proportions: 5-30 parts of raw astragalus extract, 5-20 parts of rhizoma anemarrhenae extract, 5-30 parts of atractylodes extract, 5-20 parts of phellodendron chinense extract, 5-20 parts of trichosanthes extract, 5-20 parts of cornus officinalis extract, 8-15 parts of kudzu root extract and 5-15 parts of ginseng leaf extract.

2. A Chinese medicine extract composition for treating diabetic complications, characterized in that: It consists of 5-30 parts of raw astragalus extract, 5-20 parts of Anemarrhena asphodeloides extract, 5-30 parts of Atractylodes lancea extract, 5-20 parts of Phellodendron chinense extract, 5-20 parts of Radix Trichosanthis extract, 5-20 parts of Cornus officinalis extract, 8-15 parts of Pueraria root extract, 5-15 parts of Panax ginseng leaf extract, 5-30 parts of Terminalia chebula extract and 5-15 parts of Dioscorea opposita extract.

3. The Chinese medicine extract composition for treating diabetic complications according to claim 1, characterized in that: 30 parts of raw astragalus extract, 20 parts of Anemarrhena extract, 30 parts of Atractylodes extract, 15 parts of Phellodendron chinense extract, 20 parts of Radix Trichosanthis extract, 20 parts of Cornus officinalis extract, 15 parts of Pueraria extract and 10 parts of ginseng leaf extract.

4. A method for preparing the Chinese medicine extract composition according to any one of claims 1 to 3, characterized in that: The components in the formula are mixed evenly according to the weight ratio, and added into a blending kettle with 50% kaoliang wine in a volume ratio of 1:1 for blending and refining to prepare capsules, pills or granules; The blending kettle comprises a kettle body (1) and a kettle cover (3); a crank (4) is sealingly rotatably connected to the kettle cover (3); a handle (5) is fixedly connected to the top of the crank (4); a stirring blade (6) is coaxially fixedly connected to the bottom of the crank (4) through the kettle cover (3); and the kettle cover (3) is detachably connected to the kettle body (1) via a buckle (2).

5. The method for preparing the Chinese medicine extract composition according to claim 4, characterized in that: The components in the formula are concentrated by rotary evaporation and freeze-dried to prepare powdered extracts.

6. The method for preparing the Chinese medicine extract composition according to claim 5, characterized in that: Raw astragalus extract, kudzu root extract and ginseng leaf extract were all obtained by cellulase enzymatic extraction.

7. The method for preparing the Chinese medicine extract composition according to claim 6, characterized in that: The extracts of Atractylodes lancea and Radix Trichosanthis were both obtained by ultrasonic extraction.

8. The method for preparing the Chinese medicine extract composition according to claim 7, characterized in that: The Phellodendron chinense extract was obtained by decoction and infiltration method.

9. The method for preparing the Chinese medicine extract composition according to claim 8, characterized in that: Cornus officinalis extract was obtained using a hot-infusion method.

10. The method for preparing the Chinese medicine extract composition according to claim 9, characterized in that: The extract of Anemarrhena asphodeloides was obtained by cold infusion method.

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