CN116459311A

CN116459311A - Traditional Chinese medicine composition for treating type 2 diabetes and extract, preparation method and application thereof

Info

Publication number: CN116459311A
Application number: CN202211415128.5A
Authority: CN
Inventors: 田海宏; 胡文亮; 范东升; 田胜利; 田海涛
Original assignee: Shanghai Tcmcares Technology Co ltd
Current assignee: Shanghai Tcmcares Technology Co ltd
Priority date: 2022-01-12
Filing date: 2022-11-11
Publication date: 2023-07-21

Abstract

The traditional Chinese medicine composition for treating type 2 diabetes comprises coptis chinensis, polygonum cuspidatum, rhizoma anemarrhenae, rhizoma polygonati, rhizoma smilacis glabrae, centella asiatica, euonymus alatus and cinnamon in a therapeutically effective amount. The traditional Chinese medicine composition prepared by the invention can effectively reverse partial dysfunction type, organ injury type and even partial multi-organ injury type 2 diabetes. Meanwhile, for patients with partial high blood sugar concentration and poor control of other medicines, the traditional Chinese medicine composition has better blood sugar reducing and controlling effects, can not only maintain the disease condition of diabetes for a long time, but also achieve the efficacy of curing diabetes, and has certain auxiliary treatment effects on diseases such as curing complicated diabetic enteritis, diabetic retinopathy, hyperlipidemia, fatty liver and the like.

Description

Traditional Chinese medicine composition for treating type 2 diabetes and extract, preparation method and application thereof

Technical Field

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition, an extract thereof, a preparation method and application thereof, and a medicament containing the same.

Background

Diabetes is a common chronic non-infectious disease that has become a serious worldwide public health problem. The international diabetes union (IDF) data shows that the 20-79 year old diabetes population in 2019 is 1.164 billion, and the world is first, with more than 95% of them being type 2 diabetes. In 2020, recent national epidemiological investigation results of Chinese diabetes mellitus have been published in BMJ, and the overall prevalence of Chinese diabetes mellitus is 12.8% and the pre-diabetes prevalence is 35.2%. That is, on average, there are 1 diabetic patient per 10 adults, and more than one third of the adults are pre-diabetic. In recent 30 years, the prevalence of diabetes mellitus in China is obviously increased. The incidence of type 2 diabetes (T2 DM) in the diabetic population is 93.7%. The data published by the international diabetes union (IDF) shows that the total number of diabetics worldwide is expected to increase to 6.29 billion by 2045 years.

Among them, type 2 diabetes (diabetes mellitus type, T2 DM) usually occurs after the age of 35-40 years, accounting for more than 90% of diabetics. Patients are characterized by hyperglycemia, relative lack of insulin, insulin resistance, etc. Common symptoms are Polydipsia, frequent urination, weight loss of unknown origin, and may also include overeating, tiredness or soreness. Long-term complications from hyperglycemia include heart disease, stroke, diabetic retinopathy, which can lead to blindness, renal failure, even poor blood flow to the extremities, requiring amputation, and a few can also lead to complications of diabetic ketoacidosis.

Currently, the existing diabetes treatment drugs mainly take blood glucose index control and symptom delay as main, and no reversion of disease or cure drugs exist yet. How to develop a medicine for curing or long-term maintaining diabetes mellitus is an important subject in the field of preventing and treating diabetes mellitus at present.

Disclosure of Invention

The invention aims to overcome the defects that the existing medicine for treating diabetes mainly controls blood sugar indexes and delays symptoms, cannot maintain the disease condition of diabetes for a long time, cannot thoroughly cure diabetes, increases the occurrence probability of complications year by year along with the prolonged treatment time of diabetes, and the like, and provides a traditional Chinese medicine composition, an extract thereof, a preparation method and application thereof, and a medicament containing the traditional Chinese medicine composition. The traditional Chinese medicine composition prepared by the invention can effectively reverse partial dysfunction type (A type), organ injury type (B type) and even partial multi-organ injury type (C type) type 2 diabetes; meanwhile, for patients with partial high blood sugar concentration and poor control of other medicines, the traditional Chinese medicine composition has better blood sugar reducing and controlling effects, can not only maintain the disease condition of diabetes for a long time, but also achieve the efficacy of curing diabetes, and has certain auxiliary treatment effects on diseases such as curing complicated diabetic enteritis, diabetic retinopathy, hyperlipidemia, fatty liver and the like.

The invention adopts the following technical scheme to solve the technical problems:

the invention provides a traditional Chinese medicine composition for treating type 2 diabetes, which comprises coptis chinensis, polygonum cuspidatum, rhizoma anemarrhenae, rhizoma polygonati, rhizoma smilacis glabrae, centella asiatica, winged euonymus twig and cinnamon with effective treatment amounts.

In some embodiments, the traditional Chinese medicine composition further comprises a therapeutically effective amount of human placenta.

In some embodiments, the traditional Chinese medicine composition comprises the following components in parts by weight: 12-20 parts of coptis chinensis, 9-18 parts of polygonum cuspidatum, 12-20 parts of rhizoma anemarrhenae, 9-15 parts of rhizoma polygonati, 9-12 parts of rhizoma smilacis glabrae, 9-12 parts of centella asiatica, 3-6 parts of winged euonymus twig and 3-6 parts of cinnamon.

Wherein, the coptis is preferably 15-20 parts. The polygonum cuspidatum is preferably 12-15 parts. The rhizoma anemarrhenae is preferably 15-20 parts. Preferably 12-15 parts of rhizoma polygonati. Preferably, the glabrous greenbrier rhizome is 10-12 parts. The centella is preferably 10-12 parts. The euonymus alatus is preferably 5-6 parts. The cinnamon is preferably 5-6 parts.

In some embodiments, the traditional Chinese medicine composition comprises the following components in parts by weight: 15 parts or 20 parts of coptis chinensis, 15 parts of polygonum cuspidatum, 20 parts of rhizoma anemarrhenae, 15 parts of rhizoma polygonati, 10 parts of rhizoma smilacis glabrae, 10 parts of centella asiatica, 5 parts of winged euonymus twig and 5 parts of cinnamon.

In some embodiments, the traditional Chinese medicine composition comprises the following components in parts by weight: 12 parts of coptis chinensis, 12 parts of polygonum cuspidatum, 12 parts of rhizoma anemarrhenae, 15 parts of rhizoma polygonati, 10 parts of rhizoma smilacis glabrae, 10 parts of centella asiatica, 5 parts of euonymus alatus and 5 parts of cinnamon.

In some embodiments, the traditional Chinese medicine composition further comprises 3-6 parts of placenta hominis.

In some embodiments, the traditional Chinese medicine composition comprises the following components in parts by weight: 15 parts of coptis chinensis, 15 parts of polygonum cuspidatum, 20 parts of rhizoma anemarrhenae, 15 parts of rhizoma polygonati, 10 parts of rhizoma smilacis glabrae, 10 parts of centella asiatica, 5 parts of winged euonymus twig, 5 parts of cinnamon and 3 parts of placenta hominis.

In some embodiments, the traditional Chinese medicine composition comprises the following components in parts by weight: 20 parts of coptis chinensis, 15 parts of polygonum cuspidatum, 20 parts of rhizoma anemarrhenae, 15 parts of rhizoma polygonati, 10 parts of rhizoma smilacis glabrae, 10 parts of centella asiatica, 5 parts of winged euonymus twig, 5 parts of cinnamon and 3 parts of placenta hominis.

In some embodiments, the traditional Chinese medicine composition comprises the following components in parts by weight: 12 parts of coptis chinensis, 12 parts of polygonum cuspidatum, 12 parts of rhizoma anemarrhenae, 15 parts of rhizoma polygonati, 10 parts of rhizoma smilacis glabrae, 10 parts of centella asiatica, 5 parts of winged euonymus twig, 5 parts of cinnamon and 3 parts of placenta hominis.

The invention also provides a preparation method of the traditional Chinese medicine composition for treating type 2 diabetes, which comprises the following steps: mixing the above Chinese medicinal composition.

The invention also provides a preparation method of the traditional Chinese medicine extract for treating type 2 diabetes, which comprises a method A or a method B:

the method A comprises the following steps: mixing the above Chinese medicinal composition with water, decocting, filtering, and collecting filtrate;

the method B comprises the following steps: mixing the above Chinese medicinal composition with ethanol, reflux extracting, filtering, and collecting filtrate.

In the method a, the mass ratio of the traditional Chinese medicine composition to the water may be 1: (8-10).

In the method a, the soaking operation is further included before the decocting, and the soaking time may be about 0.25-3 h, preferably about 0.5h.

In method a, the decocting may comprise the steps of: boiling with strong fire, and decocting with slow fire. Wherein, the strong fire refers to big and urgent fire in the traditional Chinese medicine field. The slow fire is usually referred to as small and slow fire in the field of traditional Chinese medicine.

In method A, the number of times of the decoction is 1 to 3, preferably 2. The products obtained by each decoction are mixed and then subjected to subsequent operations according to the conventional method in the art.

In method A, the time for completing one time of the decoction may be conventional in the art, preferably about 30 to 60min, more preferably about 45min.

In the method a, the filtering operation may further include a concentrating operation.

Wherein the concentration method may be conventional in the art, and preferably includes at least one of heat concentration, alcohol concentration, ultrasonic concentration and ultrafiltration.

Wherein, when the relative density of the concentrated solution is more than or equal to 1.1, the concentration is stopped when the heating concentration is performed.

Wherein the temperature of the heating concentration is 70-80 ℃.

Wherein, the heating concentration operation can be further followed by a decoloring operation. The conditions and methods of decolorization can be conventional in the art and generally include the steps of: and (3) adopting a decoloring agent for standing adsorption, and removing the decoloring agent. The decolorizing agent may be one conventionally used in the art, preferably activated carbon. The time for the stationary adsorption may be conventional in the art, preferably 20 to 30 hours, for example 24 hours. The method of removing the decolorizing agent can include centrifugation.

Wherein, the method of alcohol extraction concentration can be conventional in the art, and generally comprises the following steps: mixing the concentrated material with ethanol, standing for 20-30 h, filtering, and removing the solvent in the filtrate to obtain the extract. The alcohol content in the material to be concentrated and the material mixed with the ethanol can be 60% -80%. The solvent removal method may be a method conventionally used in the art, and may be generally an atmospheric pressure heating evaporation method or a reduced pressure heating evaporation method. The temperature during solvent removal can be 55-65 ℃. And stopping removing the solvent when the relative density of the extract at 60 ℃ is 1.15-1.2.

Wherein the operation of alcohol extraction and concentration can be further followed by drying and crushing, and the extract obtained after the alcohol extraction and concentration is prepared into extract powder. The drying method may be conventional in the art, and may be generally vacuum drying.

In a preferred embodiment of the method a, the preparation method of the traditional Chinese medicine extract comprises the following steps: mixing the above Chinese medicinal materials with water, decocting, filtering, collecting filtrate to obtain extract, and mixing.

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

In the method B, the time for the reflux extraction may be conventional in the art, preferably 45-60 min.

In method B, the number of reflux extractions may be conventional in the art, preferably 1 to 3, such as 2.

In the method B, the filtering operation can be further followed by concentrating to obtain extract. And stopping concentrating when the relative density of the extract is 1.15-1.2.

In a preferred embodiment of the method B, the preparation method of the traditional Chinese medicine extract comprises the following steps: mixing the above Chinese medicinal materials with ethanol, reflux extracting, filtering, collecting filtrate to obtain extract, and mixing.

The 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.

The invention also provides a medicament for treating type 2 diabetes, which comprises the traditional Chinese medicine composition and/or the traditional Chinese medicine extract.

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

In some embodiments, the medicament may further comprise an auxiliary material.

The auxiliary materials can be auxiliary materials conventionally used in the field, and refer to medicinal auxiliary materials conventionally used in the field of pharmacy, and are conventional medicinal materials except active ingredients in a prescription for solving the problems of formability, effectiveness, stability and safety of the preparation, and preferably comprise any one or more of diluents, adhesives, disintegrants, lubricants, preservatives and flavoring agents.

The diluent may include sodium carboxymethyl starch. The binder may include povidone. The disintegrant may comprise microcrystalline cellulose. The lubricant may include magnesium stearate and/or fumed silica. The preservative may comprise sodium benzoate and/or ethyl hydroxy benzoate. The flavoring agent may include at least one of xylitol, erythritol, thaumatin, and peppermint essence.

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

The preparation methods of the oral liquid, the decoction, the tablet, the granule, the pill, the powder, the paste, the pellet, the capsule or the soft capsule are all conventional preparation methods in the field.

The invention also provides a preparation method of the decoction, and the preparation method of the filtrate in the method A.

The invention also provides a preparation method of the oral liquid, the filtrate obtained in the method A is concentrated to obtain concentrated solution A, the relative density of the concentrated solution A is more than or equal to 1.02, the concentrated solution A is centrifuged and secondarily concentrated to obtain concentrated solution B, the relative density of the concentrated solution B is more than or equal to 1.10, the concentrated solution B is decolorized, mixed with a preservative, cooled and mixed with a flavoring agent.

Wherein, the mixing process with the preservative can be carried out under the condition of heating according to the conventional method in the field, so as to promote the sufficient dissolution of the preservative and play a role in sterilization.

Wherein, the method further comprises the operations of dilution, filtration, encapsulation and sterilization after being mixed with the flavoring agent. The sterilization temperature can be 100-105 ℃. The sterilization time can be 25-35 min.

The invention also provides a preparation method of the granule, which comprises the steps of mixing the extract powder with the disintegrating agent, granulating and drying.

Wherein the disintegrant may be microcrystalline cellulose as conventionally used in the art.

In a preferred embodiment, the preparation method of the granule comprises the following steps: mixing the above Chinese medicinal materials with water, decocting, filtering, collecting filtrate to obtain extracts, heating and concentrating, concentrating with ethanol, drying, pulverizing, mixing with disintegrating agent, granulating, drying, and mixing the above materials.

The invention also provides a traditional Chinese medicine composition and/or application of the traditional Chinese medicine extract in preparation of a medicine for treating type 2 diabetes.

On the basis of conforming to the common knowledge in the field, the above preferred conditions can be arbitrarily combined to obtain the preferred examples of the invention.

The reagents and materials used in the present invention are commercially available.

The invention has the positive progress effects that: the traditional Chinese medicine composition prepared by the invention can effectively reverse partial dysfunction type (A type), organ injury type (B type) and even partial multi-organ injury type (C type) type 2 diabetes. Meanwhile, for patients with partial high blood sugar concentration and poor control of other medicines, the traditional Chinese medicine composition has better blood sugar reducing and controlling effects, can not only maintain the disease condition of diabetes for a long time, but also achieve the efficacy of curing diabetes, and has certain auxiliary treatment effects on diseases such as curing complicated diabetic enteritis, diabetic retinopathy, hyperlipidemia, fatty liver and the like.

Detailed Description

The invention is further illustrated by means of the following examples, which are not intended to limit the scope of the invention. The experimental methods, in which specific conditions are not noted in the following examples, were selected according to conventional methods and conditions, or according to the commercial specifications.

The experimental methods used in the following examples are conventional methods unless otherwise specified.

Example 1

Weighing 1350g of coptis chinensis, 1350g of polygonum cuspidatum, 1800g of rhizoma anemarrhenae, 1350g of rhizoma polygonati, 900g of rhizoma smilacis glabrae, 900g of centella asiatica, 450g of winged euonymus twig, 450g of cinnamon and 270g of human placenta, adding a proper amount of water, soaking for 0.5h, heating and boiling with strong fire, decocting with slow fire for 45min, taking the decoction, adding water and boiling, decocting with slow fire for 30min, taking the decoction, mixing the two decoctions uniformly, and filtering to obtain the liquid medicine, thus obtaining the decoction.

Example 2

Weighing 1350g of coptis chinensis, 1350g of polygonum cuspidatum, 1800g of rhizoma anemarrhenae, 1350g of rhizoma polygonati, 900g of rhizoma smilacis glabrae, 900g of centella asiatica, 450g of winged euonymus twig, 450g of cinnamon and 270g of human placenta, adding water for decocting twice, adding 10 times of water for the first time, adding water for decocting with slow fire for 1h after heating and boiling with big fire, adding 8 times of water for the second time, decocting with slow fire for 45min after heating and boiling with big fire, filtering, mixing the filtrates, concentrating until the relative density of the concentrated solution is more than or equal to 1.02 (80+/-5 ℃), centrifuging, concentrating the centrifugate until the relative density is more than or equal to 1.10 (80+/-5 ℃), adding 5g of active carbon, stirring uniformly, refrigerating and standing for 24 hours, taking supernatant, centrifuging to remove active carbon, adding 3g of sodium benzoate and 0.5g of ethylparaben, heating and boiling, cooling, adding 0.22g of peppermint essence, adding water to about 1000mL, stirring, filtering, encapsulating, and heating for 30min at 100-105 ℃ to obtain the oral liquid.

Example 3

Weighing 1350g of coptis chinensis, 1350g of polygonum cuspidatum, 1800g of rhizoma anemarrhenae, 1350g of rhizoma polygonati, 900g of rhizoma smilacis glabrae, 900g of centella asiatica, 450g of winged euonymus twig and 450g of cinnamon, adding water for decocting twice, adding 10 times of water for the first time, heating and boiling with strong fire, then decocting with slow fire for 1h, adding 8 times of water for the second time, heating and boiling with strong fire, then decocting with slow fire for 45min, filtering decoction, mixing the filtrate, concentrating at 70-80 ℃ until the relative density of concentrated solution is 1.12-1.2, adding ethanol, enabling the alcohol content in the material to be about 70%, uniformly stirring, standing for 24 hours, filtering, collecting the filtrate, recovering ethanol in the filtrate until no alcohol taste exists, adding a proper amount of microcrystalline fiber and the like, uniformly mixing, adjusting the liquid medicine to be about 1.15 (80+/-5 ℃) with water, performing spray drying, granulating the medicinal powder by a dry method, and preparing about 920g of granules.

The following granules for preparing the components of examples 4 to 7 and comparative example 1 were purchased from domestic granule production and sales enterprises having production and sales qualifications such as Jiang Yintian Jiang pharmaceutical Co., guangdong party pharmaceutical Co., ltd, jiuzhen pharmaceutical Co., shenzhen Huarun Sanjiu pharmaceutical trade Co., tianjin Red daily pharmaceutical Co., ltd, sichuan New Green pharmaceutical technology development Co., beijing Kang Rentang pharmaceutical Co., ltd.

Example 4

Compared with the embodiment 3, the preparation method is only different in that each component is respectively prepared into granules, and the granules of each component are mixed to prepare mixed granules; weighing granules of corresponding doses of traditional Chinese medicines extracted from 1350g of coptis chinensis, 1350g of polygonum cuspidatum, 1800g of rhizoma anemarrhenae, 1350g of rhizoma polygonati, 900g of rhizoma smilacis glabrae, 900g of centella asiatica, 450g of winged euonymus twig and 450g of cinnamon, uniformly mixing the granules of all the components, and preparing mixed granules of about 920g.

Example 5

Weighing granules of corresponding doses of traditional Chinese medicines extracted from 1800g of coptis chinensis, 1350g of polygonum cuspidatum, 1800g of rhizoma anemarrhenae, 1350g of rhizoma polygonati, 900g of rhizoma smilacis glabrae, 900g of centella asiatica, 450g of winged euonymus twig and 450g of cinnamon, uniformly mixing the granules of all the components, and preparing mixed granules of about 1000g.

Example 6

Weighing granules with the dosage corresponding to the traditional Chinese medicines extracted from 1350g of coptis chinensis, 1350g of polygonum cuspidatum, 1800g of rhizoma anemarrhenae, 1350g of rhizoma polygonati, 900g of rhizoma smilacis glabrae, 900g of centella asiatica, 450g of winged euonymus twig, 450g of cinnamon and 270g of human placenta, uniformly mixing the granules of all the components, and preparing mixed granules of about 1000g.

Example 7

Weighing the granules with the dosages corresponding to the traditional Chinese medicines extracted from 1080g of coptis chinensis, 1080g of polygonum cuspidatum, 1080g of rhizoma anemarrhenae, 1350g of rhizoma polygonati, 900g of rhizoma smilacis glabrae, 900g of centella asiatica, 450g of winged euonymus twig, 450g of cinnamon and 270g of human placenta, uniformly mixing the granules of all the components, and preparing mixed granules of about 900g. .

Comparative example 1

Compared with the embodiment 4, the method is different in the types of the traditional Chinese medicine composition, and other condition parameters are the same as the embodiment 4, so that the granules are prepared; the traditional Chinese medicine composition comprises 1000g of rhizoma polygonati, 1000g of coptis chinensis, 1000g of corn silk, 1000g of polygonatum odoratum, 1000g of radix trichosanthis, 1000g of cortex lycii radicis, 1000g of herba epimedii, 900g of polygonum cuspidatum, 1000g of winged euonymus twig, 1000g of stiff silkworm, 500g of cinnamon and 900g of radix paeoniae rubra, and the granule extracts corresponding to the medicines with the dosages are evenly mixed to be about 1500g.

Effect example 1

Healthy SPF-grade male Wistar rats weighing about 250g were randomly divided into normal groups and model groups. Wherein normal group of conventional feed is fed, and model group rats are fed with high sugar and high fat feed (clean grade, formula: 10.0wt% lard, 20.0 wt% sucrose, 10.0wt% egg yolk powder, 0.5 wt% sodium cholate and 59.5 wt% conventional feed). Each rat was fed once daily in the morning and evening with a feed intake of 3% of its body weight. The modular rats were fed with high sugar and high fat feed for 6 weeks.

Rats were fasted without water for 12h and weighed. The model group rat is injected with streptozotocin (STZ 30mg/kg, dissolved in 0.1mmol/L citric acid buffer solution, pH4.5, final concentration 4%, ice bath, and used up in 20 min) once, and after 72 hours, tail vein blood is taken to measure blood sugar not less than 16.7mol/L, and the diabetic rat model is determined to be successful. Normal rats were injected intraperitoneally with citric acid buffer (0.l mmol/L, pH 4.5) at a dose of 0.1mL/100 g.

Model rats were randomly divided into model, experimental 1, experimental 2, and control groups of 9 animals each. According to the diet control principle of diabetes, each group of rats is fed with conventional feed, is free to drink water, is continuously fed for 3 months, and is subjected to stomach irrigation before feeding. Each rat in experiment 1 group took the granules prepared in example 4 at an amount of 140mg granules per kg body weight (granules reconstituted with 1mL sterile water) 3 times per day; each rat in experiment 2 was dosed with the granules prepared in example 6 in the same manner as in experiment 1; each rat in the control group was given the granules prepared in comparative example 1 at an amount of 240mg granules per kg body weight (granules reconstituted with 1mL of sterile water) 3 times per day; each rat in the model and normal groups received 1.2mL of sterile water per time.

Blood is collected from the rat tail at regular time every day, and blood sugar is measured. And the fasting blood glucose of each group of rats was counted for 2 weeks and 4 weeks after administration, and the average value was taken, and the results are shown in Table 1.

TABLE 1

Note that: ". Times." represents that P <0.05 has significant differences compared to the normal group; # represents that P <0.05 has significant differences compared to the model group.

As can be seen from the data in table 1, when the granules prepared in example 4, example 6 and comparative example 1 were used to treat diabetic rats for 2 weeks and 4 weeks, the fasting blood glucose levels of the rats were significantly reduced compared to those before administration, and there was a statistical difference compared to the model group.

Effect example 2

The granules prepared in the examples 4-7 or the traditional Chinese medicine decoction prepared in the example 1 are respectively taken by diabetics who come out of clinic for treatment, 20g-30 g/day of granule medicines or equivalent dose of decoction medicines are taken according to the weight condition of the patients, the patients are treated for 1-24 weeks, and the patients with the ages of 16-84 years and over 36 years are accompanied with diabetes complications of different degrees.

The patients were observed for fasting blood glucose and glycosylated hemoglobin after administration. Among them, glycosylated hemoglobin (HBA 1 c) is a product of non-enzymatic reaction binding of glucose and hemoglobin, the reaction is irreversible, HBA1c level is stable, and it can reflect average blood glucose level 2 months before blood sampling. Is the most valuable index for judging the blood sugar control state. At present, the world health organization diabetes diagnosis standard is that HBA1c <6.0% is normal, HBA1c <6.4% is impaired glucose tolerance, and HBA1c is more than or equal to 6.5% is diabetes. If the diabetes patient has HBA1c <6.0% after treatment, it can be said that the diabetes has healed.

The results show that the blood glucose concentration of tens of patients is reduced and even some patients are cured during the period of taking the medicines prepared in examples 1 and 4-7. Overall results show that the provided medication regimen can well reduce the blood glucose and glycosylated hemoglobin index of diabetics.

Typical cases:

case 1: yang Mou women, 50 years old, had ulcerative colitis, antral gastritis, urticaria, myometrial gland, atrophic gastritis and a daily fasting blood glucose of between 6 and 7, and were diagnosed with type 2 diabetes for outpatient service. The additional test shows that HBA1c is 7.0%, and after taking the granule prepared in example 6 for 5 weeks, glycosylated hemoglobin is reduced to 5.6%, and then the granule is subjected to drug-reducing consolidation treatment, and after three months of continuous treatment, HBA1c is 5.7%, and diabetes is cured.

Case 2: wu Mou A, 63 years old, had been suffering from prostatic hyperplasia, elevated carcinoembryonic, renal cyst, lower lung half-lobe inflammation, lung bulla, emphysema, erosive gastritis, after prostatitis, diabetes mellitus is controlled in recent days for diagnosis. HBA1c was treated for 5 weeks (after taking the granule prepared in example 6 for two weeks, the granule prepared in example 4) from 6.6% down to 6.3%, drug-reducing consolidation treatment, and HBA1c was detected as 6.08%. Diabetes is effectively controlled.

Case 3: xu Mou A, 44 years old, diagnosed with type 2 diabetes, hyperlipidemia, hyperuricemia, 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. Post-treatment effect data were not received, but the severity of diabetes was significantly reduced from the trend.

Case 4: yang Mou it is used for men, 49 years old, to diagnose type 2 diabetes, multiple gall bladder stones, fatty liver, prostate calcification, and hypertension. The random blood sugar at the same day of treatment is 16.0mmol/L, and the HBA1c is 9.2% before treatment; after 4 weeks of treatment (taking the granules prepared in example 6), HBA1c was reduced to 8.4%, and after 8 weeks of treatment, HBA1c was reduced to 7.4%, and blood glucose concentration was also effectively controlled. Post-treatment effect data were not received, but the severity of diabetes was significantly reduced from the trend.

Case 5: zhou Mou it is used for men, and is used for treating type 2 diabetes, fatty liver, and hyperuricemia at 40 years old. The HBA1c before treatment is 6.5%, and after six months of treatment (taking the granules prepared in example 5 and example 6 in sequence), the HBA1c is 5.8%, and diabetes is cured.

Case 6: zhang Mou A, 45 years old, diagnosed with diabetic bladder, diabetic enteritis, diabetic retinopathy. The HBA1c before treatment is 10.5%, the fasting blood glucose concentration is 14.68mmol/L, and after 5 months treatment (taking the granules prepared in example 6), the HBA1c is 5.7%, the fasting blood glucose is 5.33mmol/L, the diabetes is cured, the diabetic enteritis is cured, and the diabetic retinopathy is improved.

Case 7: shen Mou when a man is 60 years old, he is diagnosed with diabetes for 6 years at the time of taking a doctor, and is diagnosed with hypertension, diabetes, hyperlipidemia, femoral artery plaque, carotid artery plaque and hyperuricemia without taking other medicines. After 5 months of treatment (taking the granules prepared in example 6), HBA1c was reduced from 6.4% to 5.3%. Diabetes mellitus is cured.

Case 8: yang Mou A, 55 years old, is diagnosed with diabetes for 2 years at the time of the visit, takes no other medicines, measures fasting blood glucose 9.38 mmol/L one month before the visit, and is diagnosed with type 2 diabetes, hyperlipidemia and prostatic hyperplasia. After 1 month of treatment (taking the granules prepared in example 6), fasting blood glucose was 5.9 mmol/L, blood glucose after breakfast was 8.9 mmol/L, and patients were self-monitored, and fasting blood glucose was lower than 6.0mmol/L for three consecutive weeks, so that diabetes was cured.

Case 9: liu Mou A, 58 years old, diagnosed with diabetes for 8 years, HBA1c was 6.9% before the visit, 2 granules of metformin, 4 granules of repaglinide were taken daily, and type 2 diabetes, liver dysfunction and hyperlipidemia were diagnosed. Repaglinide is deactivated after two weeks of treatment (decoction prepared in example 1), and fasting blood glucose is maintained at 6-7 mmol/L after 3 months of treatment, so that diabetes is effectively controlled.

Finally, it is also noted that the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus.

While the disclosure has been disclosed by the foregoing description of specific embodiments thereof, it will be understood that various modifications, improvements, or equivalents may be devised by those skilled in the art that will fall within the spirit and scope of the appended claims. Such modifications, improvements, or equivalents are intended to be included within the scope of this disclosure.

Claims

1. A Chinese medicinal composition for treating type 2 diabetes is characterized by comprising coptis chinensis, polygonum cuspidatum, rhizoma anemarrhenae, rhizoma polygonati, rhizoma smilacis glabrae, centella asiatica, euonymus alatus and cinnamon in effective treatment amounts.

2. The traditional Chinese medicine composition according to claim 1, further comprising a therapeutically effective amount of human placenta.

3. The traditional Chinese medicine composition according to claim 1, which is characterized by comprising the following components in parts by weight: 12-20 parts of coptis chinensis, 9-18 parts of polygonum cuspidatum, 12-20 parts of rhizoma anemarrhenae, 9-15 parts of rhizoma polygonati, 9-12 parts of rhizoma smilacis glabrae, 9-12 parts of centella asiatica, 3-6 parts of winged euonymus twig and 3-6 parts of cinnamon;

preferably, the traditional Chinese medicine composition further comprises 3-6 parts of placenta hominis.

4. The traditional Chinese medicine composition according to claim 2 or 3, wherein the traditional Chinese medicine composition satisfies at least one of the following conditions:

15-20 parts of coptis chinensis;

12-15 parts of polygonum cuspidatum;

the weight parts of the rhizoma anemarrhenae are 15-20 parts;

12-15 parts of rhizoma polygonati;

the weight parts of the glabrous greenbrier rhizome are 9-12 parts;

9-12 parts of centella asiatica;

3-6 parts of winged euonymus twig;

the cinnamon comprises 3-6 parts by weight of cinnamon; and

the traditional Chinese medicine composition further comprises 3-6 parts of human placenta.

5. The preparation method of the traditional Chinese medicine composition for treating type 2 diabetes is characterized by comprising the following steps: the method of any one of claims 1 to 4, wherein the components are mixed.

6. A preparation method of a traditional Chinese medicine extract for treating type 2 diabetes, which is characterized by comprising a method A or a method B:

the method A comprises the following steps: mixing the Chinese medicinal composition according to any one of claims 1 to 4 with water, decocting, filtering, and collecting filtrate;

the method B comprises the following steps: mixing the Chinese medicinal composition according to any one of claims 1 to 4 with ethanol, reflux-extracting, filtering, and collecting filtrate.

7. The method of preparing a herbal extract according to claim 6, wherein method a satisfies at least one of the following conditions:

the mass ratio of the traditional Chinese medicine composition to the water is 1: (8-10);

the method further comprises soaking operation before decoction, wherein the soaking time is about 0.25-3 h, preferably about 0.5h;

the decoction comprises the following steps: boiling with strong fire, and decocting with slow fire;

the times of the decoction are 1-3 times, preferably 2 times;

the time for completing one time of the decoction is 30-60 min, preferably about 45min;

the filtering operation further comprises a concentration operation; the concentration method preferably comprises at least one of heat concentration, alcohol extraction concentration, ultrasonic concentration and ultrafiltration;

preferably, when the relative density of the concentrated solution is more than or equal to 1.1, stopping concentrating;

preferably, the temperature of the heating concentration is 70-80 ℃;

preferably, the heating and concentrating operation further comprises a decoloring operation; more preferably, the decoloring comprises the steps of: standing and adsorbing by using a decoloring agent, and removing the decoloring agent; even more preferably, the decolorizing agent is activated carbon; still more preferably, the standing adsorption time is 20-30 hours; even more preferably, the method of removing a decolorizing agent includes centrifugation;

preferably, the alcohol extraction and concentration method comprises the following steps: mixing the concentrated material with ethanol, standing for 20-30 h, filtering, and removing solvent to obtain extract; more preferably, the alcohol content in the material to be concentrated and the material mixed by the ethanol is 60% -80%; more preferably, the solvent removing method is an atmospheric pressure heating evaporation method or a reduced pressure heating evaporation method; more preferably, the temperature of the solvent is 55-65 ℃; more preferably, stopping removing the solvent when the relative density of the extract is 1.15-1.2; more preferably, the alcohol extraction and concentration operation further comprises drying and crushing operations, and the extractum prepared after the alcohol extraction and concentration operation is prepared into extractum powder.

8. The method for preparing a Chinese medicinal extract according to claim 6, wherein the method B satisfies at least one of the following conditions:

the mass ratio of the traditional Chinese medicine composition to the ethanol is 1: (8-20);

the reflux extraction time is 45-60 min;

the number of times of the reflux extraction is 1-3, preferably 2;

the filtering operation further comprises the operation of concentrating to prepare extract; preferably, when the relative density of the extract is 1.15-1.2, stopping concentrating.

9. The method for preparing a Chinese medicinal extract according to claim 6, wherein the method satisfies any one of the following conditions:

in the method A, the preparation method of the traditional Chinese medicine extract comprises the following steps: mixing the components in the Chinese medicinal composition according to any one of claims 1 to 4 with water, decocting, filtering, and collecting filtrate to obtain extract, and mixing;

in the method B, the preparation method of the traditional Chinese medicine extract comprises the following steps: the method for preparing the Chinese medicinal composition according to any one of claims 1 to 4 comprises mixing the above components with ethanol, reflux-extracting, filtering, and collecting filtrate to obtain extract, and mixing.

10. A traditional Chinese medicine extract for treating type 2 diabetes mellitus, characterized by being prepared by a preparation method of the traditional Chinese medicine extract according to any one of claims 6 to 9.

11. A medicament for the treatment of type 2 diabetes comprising a Chinese medicinal composition according to any one of claims 1 to 4 and/or a Chinese medicinal extract according to claim 10;

preferably, in the medicament, the Chinese medicinal composition according to any one of claims 1 to 4 and/or the Chinese medicinal extract according to claim 10 is an active ingredient, and the mass of the Chinese medicinal composition is 1% -100% of the total mass of the medicament;

preferably, the medicament further comprises auxiliary materials; more preferably, the auxiliary materials comprise at least one of diluents, binders, disintegrants, lubricants, preservatives and flavoring agents; more preferably, the diluent comprises sodium carboxymethyl starch; more preferably, the binder comprises povidone; more preferably, the disintegrant comprises microcrystalline cellulose; more preferably, the lubricant comprises magnesium stearate and/or aerosil; more preferably, the preservative comprises sodium benzoate and/or ethyl hydroxy benzoate; more preferably, the flavoring agent comprises at least one of xylitol, erythritol, thaumatin and peppermint essence;

preferably, the dosage form of the medicament comprises oral liquid, decoction, tablets, granules, pills, powder, paste, pellets, capsules or soft capsules.

12. Use of a traditional Chinese medicine composition according to any one of claims 1 to 4 and/or a traditional Chinese medicine extract according to claim 10 for the preparation of a medicament for the treatment of type 2 diabetes.