A Chinese medicine composition for treating type 2 diabetes, its extract, preparation method and application

Abstract

The Chinese medicine composition for treating type 2 diabetes comprises a therapeutically effective amount of coptis root, polygonum cuspidatum, rhizoma anemarrhenae, polygonatum sibiricum, smilax glabra, centella asiatica, euphorbia pulex and cinnamon bark. The Chinese medicine composition prepared by the present invention can effectively reverse some functional disorder type, organic damage type, and even some multi-organ damage type type 2 diabetes. At the same time, for some patients with high blood sugar concentration and poor control of other drugs, it has a good hypoglycemic and sugar control effect, can not only maintain the disease of diabetes for a long time, but also can achieve the effect of curing diabetes, and has a certain auxiliary therapeutic effect on the curing of concomitant diabetic enteritis, diabetic retinopathy, hyperlipidemia and fatty liver.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and in particular relates to a traditional Chinese medicine composition, an extract thereof, a preparation method and application thereof, and a medicament containing the same. Background Art

[0002] Diabetes is a common chronic non-communicable disease and has become a serious global public health problem.

[0003] Among them, type 2 diabetes (diabetes mellitus type 2, T2DM), mostly develops after the age of 35 to 40, accounting for more than 90% of diabetic patients. Patients are characterized by high blood sugar, relative lack of insulin, insulin resistance, etc. Common symptoms include polydipsia, frequent urination, unexplained weight loss, and may also include polyphagia, fatigue or soreness. Long-term complications of high blood sugar include heart disease, stroke, and diabetic retinopathy, which may lead to blindness, kidney failure, and even poor blood flow to the limbs requiring amputation. A few may also lead to complications of diabetic ketoacidosis.

[0004] At present, the existing diabetes treatment drugs are mainly focused on controlling blood sugar indexes and delaying symptoms, and there is no drug that can reverse the disease or cure it. How to develop a drug that can cure or maintain the condition of diabetes for a long time is an important issue in the field of diabetes prevention and treatment. Summary of the invention

[0005] The technical problem to be solved by the present invention is to overcome the defects that the existing drugs for treating diabetes are mainly based on blood sugar index control and symptom delay, which cannot maintain the disease of diabetes for a long time, nor can they completely cure diabetes. As the treatment time of diabetes is prolonged, the probability of complications increases year by year, and a Chinese medicine composition, its extract, preparation method and application, and a medicament containing it are provided. The Chinese medicine composition prepared by the present invention can effectively reverse some functional disorder type (type A), organic damage type (type B), and even some multi-organ damage type (type C) type 2 diabetes; at the same time, for some patients with high blood sugar concentration and poor control of other drugs, it has a good hypoglycemic and sugar control effect, which can not only maintain the disease of diabetes for a long time, but also can achieve the effect of curing diabetes, and has a certain auxiliary therapeutic effect on the curing of concomitant diabetic enteritis, diabetic retinopathy, hyperlipidemia and fatty liver.

[0006] The present invention adopts the following technical solutions to solve the above technical problems:

[0007] The invention provides a traditional Chinese medicine composition for treating type 2 diabetes, which comprises therapeutically effective amounts of coptis root, polygonum cuspidatum, rhizoma anemarrhenae, polygonatum sibiricum, smilax glabra, centella asiatica, euphorbia pulex and cinnamon bark.

[0008] In some embodiments, the Chinese medicine composition further comprises a therapeutically effective amount of placenta.

[0009] In some embodiments, the Chinese medicine composition includes the following components in parts by weight: 12-20 parts of Coptis chinensis, 9-18 parts of Polygonum cuspidatum, 12-20 parts of Anemarrhena asphodeloides, 9-15 parts of Polygonatum sibiricum, 9-12 parts of Smilax glabra, 9-12 parts of Centella asiatica, 3-6 parts of Psoralea corylifolia and 3-6 parts of Cinnamomum cassia.

[0010] Among them, the coptis root is preferably 15-20 parts. The knotweed is preferably 12-15 parts. The anemarrhena is preferably 15-20 parts. The polygonatum is preferably 12-15 parts. The smilax is preferably 10-12 parts. The centella asiatica is preferably 10-12 parts. The euphorbia pulex is preferably 5-6 parts. The cinnamon bark is preferably 5-6 parts.

[0011] In some embodiments, the Chinese medicine composition is composed of the following components in parts by weight: 15 or 20 parts of Coptis chinensis, 15 parts of Polygonum cuspidatum, 20 parts of Anemarrhena asphodeloides, 15 parts of Polygonatum sibiricum, 10 parts of Smilax glabra, 10 parts of Centella asiatica, 5 parts of Psoralea corylifolia, and 5 parts of Cinnamon bark.

[0012] In some embodiments, the Chinese medicine composition is composed of the following components in parts by weight: 12 parts of Coptis chinensis, 12 parts of Polygonum cuspidatum, 12 parts of Anemarrhena asphodeloides, 15 parts of Polygonatum sibiricum, 10 parts of Smilax glabra, 10 parts of Centella asiatica, 5 parts of Psoralea corylifolia, and 5 parts of Cinnamon bark.

[0013] In some embodiments, the Chinese medicine composition further includes 3 to 6 portions of placenta.

[0014] In some embodiments, the Chinese medicine composition is composed of the following components in parts by weight: 15 parts of Coptis chinensis, 15 parts of Polygonum cuspidatum, 20 parts of Anemarrhena asphodeloides, 15 parts of Polygonatum sibiricum, 10 parts of Smilax glabra, 10 parts of Centella asiatica, 5 parts of Psoralea corylifolia, 5 parts of Cinnamomum cassia and 3 parts of Placenta.

[0015] In some embodiments, the Chinese medicine composition is composed of the following components in parts by weight: 20 parts of Coptis chinensis, 15 parts of Polygonum cuspidatum, 20 parts of Anemarrhena asphodeloides, 15 parts of Polygonatum sibiricum, 10 parts of Smilax glabra, 10 parts of Centella asiatica, 5 parts of Psoralea corylifolia, 5 parts of Cinnamomum cassia and 3 parts of Placenta.

[0016] In some embodiments, the Chinese medicine composition is composed of the following components in parts by weight: 12 parts of Coptis chinensis, 12 parts of Polygonum cuspidatum, 12 parts of Anemarrhena asphodeloides, 15 parts of Polygonatum sibiricum, 10 parts of Smilax glabra, 10 parts of Centella asiatica, 5 parts of Psoralea corylifolia, 5 parts of Cinnamomum cassia and 3 parts of Placenta.

[0017] The present invention also provides a method for preparing a Chinese medicine composition for treating type 2 diabetes, which comprises the following steps: mixing the components in the Chinese medicine composition as described above.

[0018] The present invention also provides a method for preparing a Chinese medicine extract for treating type 2 diabetes, which comprises method A or method B:

[0019] Method A comprises the following steps: mixing the above-mentioned Chinese medicine composition with water, decocting, filtering, and collecting the filtrate;

[0020] Method B comprises the following steps: mixing the above-mentioned traditional Chinese medicine composition with ethanol, refluxing extraction, filtering, and collecting the filtrate.

[0021] In method A, the mass ratio of the traditional Chinese medicine composition to the water can be 1:(8-10).

[0022] In method A, the decoction further includes a soaking operation, and the soaking time can be about 0.25-3 hours, preferably about 0.5 hours.

[0023] In method A, the decoction may include the following steps: first boiling with high heat, and then decocting with low heat. The high heat usually refers to a large and rapid fire in the field of traditional Chinese medicine. The low heat usually refers to a small and slow fire in the field of traditional Chinese medicine.

[0024] In method A, the decoction may be performed 1 to 3 times, preferably 2 times. According to the conventional art, the products obtained from each decoction need to be mixed before subsequent operations.

[0025] In method A, the time for completing one decoction can be conventional in the art, preferably about 30 to 60 minutes, and more preferably about 45 minutes.

[0026] In method A, the filtering operation may be followed by a concentration operation.

[0027] The concentration method may be conventional in the art, and preferably includes at least one of heating concentration, alcohol extraction concentration, ultrasonic concentration and ultrafiltration.

[0028] Wherein, during the heating and concentration, when the relative density of the concentrated liquid is ≥1.1, the concentration is stopped.

[0029] Wherein, the temperature of the heating and concentration is 70-80°C.

[0030] Wherein, the heating and concentration operation may further include a decolorization operation. The decolorization conditions and methods may be conventional in the art, generally comprising the following steps: using a decolorizer for static adsorption, and removing the decolorizer. The decolorizer may be a decolorizer conventionally used in the art, preferably activated carbon. The static adsorption time may be conventional in the art, preferably 20 to 30 hours, for example 24 hours. The method for removing the decolorizer may include centrifugation.

[0031] Among them, the alcohol extraction and concentration method can be conventional in the art, generally comprising the following steps: mixing the material to be concentrated with ethanol, placing for 20 to 30 hours, filtering, removing the solvent in the filtrate, and obtaining an extract. The alcohol content in the material mixed with the material to be concentrated and the ethanol can be 60% to 80%. The desolventizing method can be a conventional method used in the art, generally a normal pressure heating evaporation method or a reduced pressure heating evaporation method. The temperature during the desolventizing can be 55 to 65°C. When the relative density of the extract at 60°C is 1.15 to 1.2, stop desolventizing.

[0032] The alcohol extraction and concentration operation may further include drying and pulverizing operations, and the extract obtained after the alcohol extraction and concentration is used to obtain extract powder. The drying method may be conventional in the art, generally vacuum drying.

[0033] In a preferred embodiment of method A, the preparation method of the Chinese medicine extract comprises the following steps: mixing the components in the Chinese medicine composition as described above with water respectively, decocting them respectively, filtering and collecting the filtrate to obtain extracts of the components, and then mixing them.

[0034] In method B, the mass ratio of the traditional Chinese medicine composition to the ethanol can be 1:(8-20).

[0035] In method B, the reflux extraction time can be conventional in the art, preferably 45 to 60 minutes.

[0036] In method B, the number of reflux extractions can be conventional in the art, preferably 1 to 3 times, such as 2 times.

[0037] In method B, the filtering operation may further include a concentration operation to obtain an extract. When the relative density of the extract is 1.15-1.2, the concentration is stopped.

[0038] In a preferred embodiment of method B, the preparation method of the Chinese medicine extract comprises the following steps: mixing the components in the Chinese medicine composition as described above with ethanol respectively, performing reflux extraction, filtering and collecting the filtrate respectively to obtain extracts of the components, and then mixing.

[0039] The present invention also provides a traditional Chinese medicine extract for treating type 2 diabetes, which is prepared by the preparation method of the traditional Chinese medicine extract as described above.

[0040] The present invention also provides a medicament for treating type 2 diabetes, comprising the above-mentioned traditional Chinese medicine composition and / or the above-mentioned traditional Chinese medicine extract.

[0041] In some embodiments, in the medicament, the Chinese medicine composition and / or the Chinese medicine extract described above are used as active ingredients, and their mass accounts for 1% to 100% of the total mass of the medicament.

[0042] In some embodiments, the medicament may further include excipients.

[0043] Among them, the types of excipients can be excipients conventionally used in the art, and the excipients refer to conventional pharmaceutical excipients in the pharmaceutical field, which are conventional pharmaceutical materials other than active ingredients added to the prescription to solve the formability, effectiveness, stability and safety of the preparation, preferably including any one or more of diluents, binders, disintegrants, lubricants, preservatives and flavoring agents.

[0044] The diluent may include sodium starch glycolate. The binder may include povidone. The disintegrant may include microcrystalline cellulose. The lubricant may include magnesium stearate and / or micropowdered silica gel. The preservative may include sodium benzoate and / or ethylparaben. The flavoring agent may include at least one of xylitol, erythritol, thaumatin, and mint flavor.

[0045] In some embodiments, the dosage form of the medicament may be a conventional dosage form in the art, for example, oral liquid, decoction, tablet, granule, pill, powder, paste, pill, capsule or soft capsule.

[0046] The preparation methods of the oral liquid, the decoction, the tablet, the granule, the pill, the powder, the dust, the paste, the pill, the capsule or the soft capsule are all conventional preparation methods in the art.

[0047] The present invention also provides a method for preparing a decoction, which is the same as the method for preparing the filtrate described in method A.

[0048] The present invention also provides a method for preparing an oral liquid, comprising: concentrating the filtrate obtained in method A to obtain a concentrated solution A, wherein the relative density of the concentrated solution A is ≥1.02; centrifuging and re-concentrating the concentrated solution A to obtain a concentrated solution B, wherein the relative density of the concentrated solution B is ≥1.10; decolorizing the concentrated solution B, mixing it with a preservative, and mixing it with a flavoring agent after cooling.

[0049] The process of mixing with the preservative can be carried out under heating conditions according to the conventional practice in the art, so as to promote the full dissolution of the preservative and achieve a sterilization effect.

[0050] After mixing with the flavoring agent, the process may further include dilution, filtration, encapsulation and sterilization. The sterilization temperature may be 100-105° C. The sterilization time may be 25-35 minutes.

[0051] The present invention also provides a method for preparing granules, which comprises mixing the extract powder and the disintegrant, granulating, and drying.

[0052] Wherein, the disintegrant can be microcrystalline cellulose commonly used in the art.

[0053] In a preferred embodiment, the preparation method of the granules comprises the following steps: mixing the components in the Chinese medicine composition as described above with water, decocting, filtering and collecting the filtrate to obtain extracts of the components, heating and concentrating the extracts of the components, ethanol extraction and concentration, drying, crushing, mixing with a disintegrant, granulating, drying, and then mixing the components.

[0054] The present invention also provides a use of the above-mentioned traditional Chinese medicine composition and / or the above-mentioned traditional Chinese medicine extract in preparing a medicine for treating type 2 diabetes.

[0055] On the basis of being in accordance with the common sense in the art, the above-mentioned preferred conditions can be arbitrarily combined to obtain the preferred embodiments of the present invention.

[0056] The reagents and raw materials used in the present invention are commercially available.

[0057] The positive and progressive effect of the present invention is that the Chinese medicine composition prepared by the present invention can effectively reverse some dysfunctional type (type A), organic damage type (type B), and even some multi-organ damage type (type C) type 2 diabetes. At the same time, for some patients with high blood sugar concentration and poor control of other drugs, it has a good blood sugar lowering and control effect, which can not only maintain the condition of diabetes for a long time, but even achieve the effect of curing diabetes, and has a certain auxiliary therapeutic effect on the curing of concomitant diabetic enteritis, diabetic retinopathy, hyperlipidemia, fatty liver and other diseases. DETAILED DESCRIPTION

[0058] The present invention is further described below by way of examples, but the present invention is not limited to the scope of the examples. The experimental methods in the following examples without specifying specific conditions are carried out according to conventional methods and conditions, or selected according to the product specifications.

[0059] Unless otherwise specified, the experimental methods used in the following examples are conventional methods.

[0060] Example 1

[0061] Weigh 1350g of Coptis chinensis, 1350g of Polygonum cuspidatum, 1800g of Rhizoma Anemarrhenae, 1350g of Polygonatum sibiricum, 900g of Smilax glabra, 900g of Centella asiatica, 450g of Pleurotus eryngii, 450g of Cinnamomum cassia and 270g of Placenta, add appropriate amount of water and soak for 0.5h, heat to boil over high heat, then simmer for 45min, take the juice, add water to boil, then simmer for 30min, take the juice, mix the two decoctions evenly, filter to obtain the medicinal liquid, and thus prepare the decoction.

[0062] Example 2

[0063] Weigh 1350g of Coptis chinensis, 1350g of Polygonum cuspidatum, 1800g of Rhizoma Anemarrhenae, 1350g of Polygonatum sibiricum, 900g of Smilax glabra, 900g of Centella asiatica, 450g of Psoralea corylifolia, 450g of Cinnamon bark, and 270g of Placenta, add water and boil twice, add 10 times the amount of water for the first time, boil over high heat, and then simmer for 1h, add 8 times the amount of water for the second time, boil over high heat, and then simmer for 45min, filter, combine the above filtrates, concentrate, and concentrate until the concentrate is relatively dense Degree ≥1.02 (80±5℃), centrifuge, concentrate the centrifuge liquid to a relative density ≥1.10 (80±5℃), add 5g activated carbon, stir evenly, refrigerate and let stand for 24 hours, take the supernatant, centrifuge to remove the activated carbon, add 3g sodium benzoate and 0.5g ethylparaben, heat to boil, add 0.22g mint essence after cooling, add water to make it about 1000mL, stir evenly, filter, fill, heat at 100-105℃ for 30 minutes to obtain the oral solution.

[0064] Example 3

[0065] Weigh 1350g of Coptis chinensis, 1350g of Polygonum cuspidatum, 1800g of Anemarrhena asphodeloides, 1350g of Polygonatum sibiricum, 900g of Smilax glabra, 900g of Centella asiatica, 450g of Psoralea corylifolia, and 450g of Cinnamomum cassia. Add water and boil twice. For the first time, add 10 times the amount of water, boil over high heat, and then simmer for 1h. For the second time, add 8 times the amount of water, boil over high heat, and then simmer for 45 minutes. Filter the decoction, combine the above filtrates, and concentrate at 70-80℃. The relative density of the concentrate is reduced to 1.12-1.2, and ethanol is added to make the alcohol content in the material reach about 70%. The mixture is stirred evenly, left for 24 hours, filtered, and the filtrate is collected and the ethanol in the filtrate is recovered until there is no alcohol taste. An appropriate amount of microcrystalline fiber is added and mixed evenly. The above-mentioned liquid is adjusted to a relative density of about 1.15 (80±5℃) with water, and spray-dried. The powder is dry-granulated to make about 920 grams, and granules are obtained.

[0066] The following granules used to prepare the components of Examples 4 to 7 and Comparative Example 1 were purchased from domestic granule production and sales companies with production and sales qualifications, such as Jiangyin Tianjiang Pharmaceutical Co., Ltd., Guangdong Yifang Pharmaceutical Co., Ltd., Peili (Nanning) Pharmaceutical Co., Ltd., Shenzhen China Resources Sanjiu Pharmaceutical Trading Co., Ltd., Tianjin Hongri Pharmaceutical Co., Ltd., Sichuan New Green Pharmaceutical Technology Development Co., Ltd., and Beijing Kangrentang Pharmaceutical Co., Ltd.

[0067] Example 4

[0068] Compared with Example 3, the only difference is that each component is made into granules separately, and then the granules of each component are mixed to prepare mixed granules; granules corresponding to the dose of traditional Chinese medicine extracted from 1350g of Coptis chinensis, 1350g of Polygonum cuspidatum, 1800g of Anemarrhena asphodeloides, 1350g of Polygonatum sibiricum, 900g of Smilax glabra, 900g of Centella asiatica, 450g of Psoralea corylifolia and 450g of Cinnamon bark are weighed, and the granules of each component are evenly mixed to prepare mixed granules, about 920g.

[0069] Example 5

[0070] Weigh the granules corresponding to the dosage of the traditional Chinese medicine extracted from 1800g of Coptis chinensis, 1350g of Polygonum cuspidatum, 1800g of Anemarrhena asphodeloides, 1350g of Polygonatum sibiricum, 900g of Smilax glabra, 900g of Centella asiatica, 450g of Psoralea corylifolia and 450g of Cinnamomum cassia bark, mix the granules of each component evenly to prepare a mixed granule of about 1000g.

[0071] Example 6

[0072] Weigh the granules corresponding to the dosage of the traditional Chinese medicine extracted from 1350g of Coptis chinensis, 1350g of Polygonum cuspidatum, 1800g of Anemarrhena asphodeloides, 1350g of Polygonatum sibiricum, 900g of Smilax glabra, 900g of Centella asiatica, 450g of Psoralea corylifolia, 450g of Cinnamomum cassia and 270g of Placenta, mix the granules of each component evenly to prepare a mixed granule of about 1000g.

[0073] Example 7

[0074] Weigh the granules corresponding to the dosage of the Chinese medicine extracted from 1080g of Coptis chinensis, 1080g of Polygonum cuspidatum, 1080g of Anemarrhena asphodeloides, 1350g of Polygonatum sibiricum, 900g of Smilax glabra, 900g of Centella asiatica, 450g of Euphorbia obesa, 450g of Cinnamomum cassia and 270g of Placenta, mix the granules of each component evenly to prepare a mixed granule of about 900g.

[0075] Comparative Example 1

[0076] Compared with Example 4, the only difference is that the type of Chinese medicine composition is different, and the other conditions and parameters are the same as Example 4, and granules are prepared; wherein, the Chinese medicine composition formula is specifically 1000g of polygonatum, 1000g of coptis, 1000g of corn silk, 1000g of polygonatum, 1000g of trichosanthes, 1000g of lycium bark, 1000g of epimedium, 900g of polygonum cuspidatum, 1000g of ghost arrow feather, 1000g of bombyx batryticatus, 500g of cinnamon and 900g of red peony root, and the granule extract corresponding to the above doses of the drugs is about 1500g after mixing.

[0077] Effect Example 1

[0078] Healthy SPF male Wistar rats weighing about 250g were randomly divided into a normal group and a modeling group. The normal group was fed with conventional feed, and the modeling group was fed with a high-sugar and high-fat feed (clean grade, formula: 10.0wt% lard, 20.0wt% sucrose, 10.0 wt% egg yolk powder, 0.5 wt% sodium cholate and 59.5 wt% conventional feed). Each rat was fed once in the morning and evening every day, and the feeding amount was 3% of its body weight. The modeling group rats were fed with a high-sugar and high-fat feed for 6 weeks.

[0079] The rats were fasted but not watered for 12 hours and weighed. The rats in the model group were injected intraperitoneally with streptozotocin (STZ 30 mg / kg, dissolved in 0.1 mmol / L citric acid buffer, pH 4.5, final concentration of 4%, ice bath, freshly prepared and used within 20 minutes), and blood was collected from the tail vein 72 hours later to measure blood glucose ≥ 16.7 mol / l to confirm that the diabetic rat model was successful. The rats in the normal group were injected intraperitoneally with citric acid buffer (0.1 mmol / L, pH 4.5) at a dose of 0.1 mL / 100 g.

[0080] The modeling group rats were randomly divided into a model group, an experimental group 1, an experimental group 2 and a control group, with 9 rats in each group. According to the principle of diabetic diet control, rats in each group were fed with conventional feed, free drinking water, and fed continuously for 3 months, and gavage was performed before feeding. Each rat in the experimental group 1 took the granules prepared in Example 4, and the dosage was 140 mg granules / kg body weight each time (the granules were reconstituted with 1 mL of sterile water), and the dosage was 3 times a day; each rat in the experimental group 2 took the granules prepared in Example 6, and the administration method was the same as that in the experimental group 1; each rat in the control group was given the granules prepared in comparative example 1, and the dosage was 240 mg granules / kg body weight each time (the granules were reconstituted with 1 mL of sterile water), and the dosage was 3 times a day; each rat in the model group and the normal group took 1.2 mL of sterile water each time.

[0081] Blood was collected from the tail of rats at regular intervals every day to measure blood sugar. Fasting blood sugar of rats in each group was calculated after 2 weeks and 4 weeks of administration, and the average value was taken. The results are shown in Table 1.

[0082] Table 1

[0083]

[0084] Note: "*" indicates significant difference with P < 0.05 compared with the normal group; "#" indicates significant difference with P < 0.05 compared with the model group.

[0085] As can be seen from the data in Table 1, after the diabetic rats were administered the granules prepared in Example 4, Example 6 and Comparative Example 1 for 2 weeks and 4 weeks, the fasting blood glucose concentration levels of the rats decreased significantly compared with those before administration, and there were statistical differences compared with the model group.

[0086] Effect Example 2

[0087] Analyze diabetic patients who come to the outpatient clinic. They were respectively administered the granules prepared in Examples 4 to 7 above, or the traditional Chinese medicine decoction prepared in Example 1. According to the patient's weight, 20 g - 30 g / day of granule medicine or the equivalent dose of decoction medicine was given for treatment for 1 to 24 weeks. The patients' ages were from 16 to 84 years old, and patients over 36 years old were mostly accompanied by varying degrees of diabetic complications.

[0088] Observe the fasting blood glucose and glycated hemoglobin of the patients after medication. Among them, glycated hemoglobin (HBA1c) is the product of the non-enzymatic reaction binding of glucose and hemoglobin. The reaction is irreversible, the HbA1c level is stable, and it can reflect the average blood glucose level in the previous 2 months. It is the most valuable indicator for judging the blood glucose control status. Currently, the World Health Organization's diabetes diagnosis standard is that HBA1c < 6.0% is normal, 6.0% < HBA1c < 6.4% is impaired glucose tolerance, and HBA1c ≥ 6.5% is diabetes. If the HBA1c of a diabetic patient is < 6.0% after treatment, it can indicate that the diabetes has been cured.

[0089] The results show that during the period of taking the drugs prepared in Examples 1, 4 to 7 above, the blood glucose concentrations of dozens of patients decreased, and even some patients achieved the effect of cure. The overall results show that the provided drug treatment plan can well reduce the blood glucose and glycated hemoglobin indexes of diabetic patients.

[0090] Typical case:

[0091] Case 1: Yang, female, 50 years old, who had suffered from ulcerative colitis, gastric antrum gastritis, urticaria, uterine adenomyosis, atrophic gastritis. Recently, her fasting blood glucose was between 6 and 7, and she was diagnosed with type 2 diabetes and came to the outpatient clinic. Supplementary test showed that HBA1c was 7.0%. After taking the granules prepared in Example 6 for 5 weeks, the glycated hemoglobin decreased to 5.6%. Then the drug dosage was reduced for consolidation treatment. After continuous treatment for three months, HBA1c was 5.7% and the diabetes was cured.

[0092] Case 2: Wu, male, 63 years old, had suffered from prostatic hyperplasia, carcinoma, renal cyst, inflammation of the lower lobe of the lung, bullae, emphysema, erosive gastritis, and prostatitis surgery. Recently, he came to the doctor to control diabetes. After 5 weeks of treatment (taking the granules prepared in Example 6 for two weeks, and then taking the granules prepared in Example 4), HBA1c dropped from 6.6% to 6.3%. The drug was reduced for consolidation treatment, and HBA1c was 6.08% again. Diabetes was effectively controlled.

[0093] Case 3: Xu, male, 44 years old, diagnosed with type 2 diabetes, hyperlipidemia, hyperuricemia, and constipation. HBA1c was 10.0% before treatment, 8.80% after several weeks of treatment (granules prepared in Example 6), and 6.80% after three months. No data on the later treatment effect was collected, but the trend showed that the severity of diabetes decreased significantly.

[0094] Case 4: Yang, male, 49 years old, was diagnosed with type 2 diabetes, multiple gallstones, fatty liver, prostate calcification, and hypertension. Random blood sugar on the day of consultation was 16.0mmol / L, and HBA1c was 9.2% before treatment; after 4 weeks of treatment (taking the granules prepared in Example 6), HBA1c dropped to 8.4%, and after 8 weeks of treatment, HBA1c dropped to 7.4%, and blood sugar concentration was effectively controlled. No data on the later treatment effect was collected, but the trend showed that the severity of diabetes decreased significantly.

[0095] Case 5: Zhou, male, 40 years old, was diagnosed with type 2 diabetes, fatty liver, hyperuricemia, etc. Before treatment, HBA1c was 6.5%. After treatment (taking the granules prepared in Example 5 and Example 6 successively), HBA1c was 5.8% after six months, and diabetes was cured.

[0096] Case 6: Zhang, male, 45 years old, diagnosed with diabetic bladder, diabetic enteritis, and diabetic retinopathy. Before treatment, HBA1c was 10.5%, and fasting blood glucose concentration was 14.68mmol / L. After 5 months of treatment (taking the granules prepared in Example 6), HBA1c was 5.7%, and fasting blood glucose was 5.33mmol / L. Diabetes was cured, diabetic enteritis was cured, and diabetic retinopathy improved.

[0097] Case 7: Mr. Shen, male, 60 years old, was diagnosed with diabetes for 6 years when he visited the hospital. He did not take other drugs and was diagnosed with hypertension, diabetes, hyperlipidemia, femoral artery plaque, carotid artery plaque, and hyperuricemia. After 5 months of treatment (taking the granules prepared in Example 6), HBA1c decreased from 6.4% to 5.3%. Diabetes was cured.

[0098] Case 8: Yang, male, 55 years old, diagnosed with diabetes for 2 years when he was treated. He did not take other drugs. One month before the treatment, his fasting blood sugar was 9.38 mmol / L. He was diagnosed with type 2 diabetes, hyperlipidemia, and prostatic hyperplasia. After 1 month of treatment (taking the granules prepared in Example 6), his fasting blood sugar was 5.9 mmol / L and his blood sugar after breakfast was 8.9 mmol / L. The patient monitored himself and his fasting blood sugar was less than 6.0 mmol / L for three consecutive weeks. His diabetes was cured.

[0099] Case 9: Lu, male, 58 years old, diagnosed with diabetes for 8 years, HBA1c was 6.9% before the visit, taking 2 tablets of metformin and 4 tablets of repaglinide daily, diagnosed with type 2 diabetes, abnormal liver function and hyperlipidemia. After two weeks of treatment (decoction prepared in Example 1), repaglinide was discontinued, and after 3 months of treatment, fasting blood sugar was maintained at 6-7 mmol / L, and diabetes was effectively controlled.

[0100] Finally, it should be noted that in the present invention, the terms "comprises", "includes" or any other variations thereof are intended to cover non-exclusive inclusion, so that a process, method, article or apparatus that includes a series of elements includes not only those elements, but also includes other elements that are not explicitly listed, or also includes elements that are inherent to such process, method, article or apparatus.

[0101] Although the present disclosure has been disclosed above through the description of the specific embodiments of the present disclosure, it should be understood that those skilled in the art can design various modifications, improvements or equivalents to the present disclosure within the spirit and scope of the attached scheme. These modifications, improvements or equivalents should also be considered to be included in the scope of protection claimed by the present disclosure.

Claims

1. A Chinese medicine composition for treating type 2 diabetes, characterized in that: The invention comprises 12-20 parts of coptis root, 9-18 parts of polygonum cuspidatum, 12-20 parts of anemarrhena, 9-15 parts of polygonatum, 9-12 parts of smilax glabra, 9-12 parts of centella asiatica, 3-6 parts of euphorbia pulex and 3-6 parts of cinnamon bark in therapeutically effective amounts.

2. The Chinese medicine composition according to claim 1, characterized in that: 3 to 6 parts of placenta are further added to the traditional Chinese medicine composition.

3. A method for preparing a Chinese medicine composition for treating type 2 diabetes, characterized in that: The method comprises the following steps: mixing the components in the traditional Chinese medicine composition as claimed in any one of claims 1 to 2.

4. A method for preparing a Chinese medicine extract for treating type 2 diabetes, characterized in that: Including Method A or Method B: Method A comprises the following steps: mixing the Chinese medicine composition according to any one of claims 1 to 2 with water, decocting, filtering, and collecting the filtrate; Method B comprises the following steps: mixing the traditional Chinese medicine composition according to any one of claims 1 to 2 with ethanol, refluxing extraction, filtering, and collecting the filtrate.

5. The method for preparing the Chinese medicine extract according to claim 4, characterized in that: Method A meets at least one of the following conditions: The mass ratio of the Chinese medicine composition to the water is 1:(8-10); The decoction further includes a soaking operation, and the soaking time is 0.25 to 3 hours; The decoction comprises the following steps: firstly boiling with high heat, then decocting with low heat; The number of decoctions is 1 to 3 times; The time to complete the decoction is 30 to 60 minutes; The filtering operation further includes a concentration operation; the concentration method includes at least one of heating concentration, alcohol extraction concentration, ultrasonic concentration and ultrafiltration; During the heating and concentration, when the relative density of the concentrated liquid is ≥1.1, the concentration is stopped; The heating and concentrating temperature is 70-80°C; The heating and concentration operation further includes a decolorization operation, the steps of which include: using a decolorizer for static adsorption to remove the decolorizer; the decolorizer is activated carbon; the static adsorption time is 20 to 30 hours; the method for removing the decolorizer includes centrifugation; The method steps of alcohol extraction and concentration include: mixing the material to be concentrated with ethanol, placing for 20 to 30 hours, filtering, removing solvents, and obtaining an extract; the alcohol content in the material mixed with the material to be concentrated and the ethanol is 60% to 80%; the method of removing solvents is a normal pressure heating evaporation method or a reduced pressure heating evaporation method; the temperature during the solvent removal is 55 to 65° C.; when the relative density of the extract is 1.15 to 1.2, the solvent removal is stopped; and the alcohol extraction and concentration operation further includes drying and pulverizing operations, and the extract obtained after the alcohol extraction and concentration is made into extract powder.

6. The method for preparing the Chinese medicine extract according to claim 4, characterized in that: Method B meets at least one of the following conditions: The mass ratio of the Chinese medicine composition to the ethanol is 1:(8-20); The reflux extraction time is 45 to 60 minutes; The number of reflux extractions is 1 to 3 times; The filtering operation further includes a concentration operation to obtain an extract, and the concentration is stopped when the relative density of the extract is 1.15-1.

2.

7. The method for preparing the Chinese medicine extract according to claim 4, characterized in that: The preparation method satisfies any one of the following conditions: In method A, the preparation method of the Chinese medicine extract comprises the following steps: mixing the components in the Chinese medicine composition according to any one of claims 1 to 2 with water respectively, decocting them respectively, filtering and collecting the filtrate to obtain extracts of the components, and then mixing them; In method B, the preparation method of the Chinese medicine extract comprises the following steps: mixing each component in the Chinese medicine composition as described in any one of claims 1 to 2 with ethanol respectively, performing reflux extraction, filtering and collecting the filtrate respectively to obtain extracts of each component, and then mixing.

8. A Chinese medicine extract for treating type 2 diabetes, characterized in that: The extract is prepared by the method for preparing the Chinese medicine extract as described in any one of claims 4 to 7.

9. A medicament for treating type 2 diabetes, characterized in that: Comprising the Chinese medicine composition according to any one of claims 1 to 2 and / or the Chinese medicine extract according to claim 8; In the medicament, the Chinese medicine composition according to any one of claims 1 to 2 and / or the Chinese medicine extract according to claim 8 is an active ingredient, and its mass accounts for 1% to 100% of the total mass of the medicament; The medicament further includes excipients; the types of the excipients include at least one of diluents, binders, disintegrants, lubricants, preservatives and flavoring agents; the diluent includes sodium carboxymethyl starch; the binder includes povidone; the disintegrant includes microcrystalline cellulose; the lubricant includes magnesium stearate and / or micropowdered silica gel; the preservative includes sodium benzoate and / or ethylparaben; the flavoring agent includes at least one of xylitol, erythritol, thaumatin and mint flavor; The dosage form of the medicament includes oral liquid, decoction, tablet, granule, pill, powder, powder, paste, pill or capsule.

10. Use of the Chinese medicine composition according to any one of claims 1 to 2 and / or the Chinese medicine extract according to claim 8 in the preparation of a drug for treating type 2 diabetes.

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