CN111759999B - Traditional Chinese medicine composition and application thereof in preparation of medicine for preventing and/or treating diabetes - Google Patents

Traditional Chinese medicine composition and application thereof in preparation of medicine for preventing and/or treating diabetes Download PDF

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CN111759999B
CN111759999B CN202010620498.7A CN202010620498A CN111759999B CN 111759999 B CN111759999 B CN 111759999B CN 202010620498 A CN202010620498 A CN 202010620498A CN 111759999 B CN111759999 B CN 111759999B
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rhizoma
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CN111759999A (en
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李赛美
徐越清
徐鸣
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Abstract

The invention discloses a traditional Chinese medicine composition which contains dried ginger, scutellaria baicalensis, coptis chinensis, codonopsis pilosula, poria cocos, rhizoma atractylodis, cinnamon, red paeony root, radix puerariae, rheum officinale, corn stigma, gypsum, red yeast rice and stevia rebaudiana. The invention also discloses application of the traditional Chinese medicine composition in preparing a medicine for preventing and/or treating diabetes, and the traditional Chinese medicine composition has the treatment effects of reducing the blood sugar of a diabetic patient, improving the pancreatic islet function of the patient and recovering the sensitivity of an organism to insulin through monitoring the oral glucose tolerance, the glycated hemoglobin, the insulin resistance level and the pancreatic islet beta cell function of the diabetic patient.

Description

Traditional Chinese medicine composition and application thereof in preparation of medicine for preventing and/or treating diabetes
Technical Field
The invention belongs to the technical field of medicines, and particularly relates to a traditional Chinese medicine composition and application thereof in preparing a medicine for preventing and/or treating diabetes.
Background
Diabetes is one of the common chronic non-infectious diseases, and the global diabetes overview published by the international diabetes association in 2019 shows that: by 2019, adult patients with diabetes worldwide increased 3-fold in the last 40 years, and increased to 4.22 million people in 2014, accounting for 8.5% of the global general population. Among them, the report especially indicates that the incidence of diabetes in our country has been increased explosively in the last decades, and up to now, the incidence of diabetes in adults in our country is close to 10%, which has made a great threat to national health and economic development.
Currently, drugs for the treatment of diabetes include: insulin and analogues thereof, sulfonylurea secretagogues, metformin, alpha-glucosidase inhibitors, thiazolidinedione derivative sensitizers, anisic acid derivative secretagogues, GLP-1 receptor agonists, DPP-4 enzyme inhibitors and the like, but the drugs have long treatment period and some drugs also have toxic and side effects. In addition, because the disease causes of diabetes are complex, the disease pathways are complementary, drug resistance is easy to appear, and the probability of drug resistance is greatly increased due to gene mutation caused by long-term use of a single drug. Therefore, a treatment scheme which has small toxic and side effects and is more suitable for long-term administration of patients is urgently needed to be found.
Disclosure of Invention
Based on the above, the invention aims to overcome the defects of the prior art and provide a traditional Chinese medicine composition and application thereof in preparing a medicine for preventing and/or treating diabetes. The Chinese medicinal composition has good effect of regulating and controlling blood sugar, can reduce blood sugar and blood lipid of diabetic patients, improve insulin resistance, and improve insulin secretion function, and has the advantages of safe use and low cost.
In order to achieve the purpose, the invention adopts the technical scheme that:
a Chinese medicinal composition comprises rhizoma Zingiberis, radix Scutellariae, rhizoma Coptidis, radix Codonopsis, Poria, rhizoma Atractylodis, cortex Cinnamomi, radix Paeoniae Rubra, radix Puerariae, radix Et rhizoma Rhei, stigma Maydis, Gypsum Fibrosum, Monascus purpureus went, and stevia rebaudiana.
Preferably, the traditional Chinese medicine composition comprises the following raw material medicines in parts by weight: 3-10 parts of dried ginger, 5-15 parts of scutellaria baicalensis, 5-15 parts of coptis chinensis, 5-15 parts of codonopsis pilosula, 5-15 parts of poria cocos, 5-15 parts of rhizoma atractylodis, 3-10 parts of cinnamon, 5-15 parts of red peony roots, 8-24 parts of kudzu roots, 3-10 parts of rheum officinale, 5-15 parts of corn stigma, 8-24 parts of gypsum, 3-10 parts of red yeast rice and 1-3 parts of stevia rebaudiana.
Preferably, the traditional Chinese medicine composition comprises the following raw material medicines in parts by weight: 6 parts of dried ginger, 10 parts of scutellaria baicalensis, 9 parts of coptis chinensis, 10 parts of codonopsis pilosula, 10 parts of poria cocos, 10 parts of rhizoma atractylodis, 6 parts of cinnamon, 10 parts of red paeony root, 15 parts of radix puerariae, 6 parts of rheum officinale, 10 parts of corn stigma, 15 parts of gypsum, 5 parts of red yeast rice and 1 part of stevia rebaudiana.
The raw materials in the formula are as follows:
1. the Zingiberis rhizoma is dried rhizome of Zingiber officinale Rosc (Zingiber officinale Rosc.) belonging to Zingiberaceae.
2. Scutellariae radix is dried root of Scutellaria baicalensis Georgi (Scutellaria baicalensis Ceorgi) belonging to Scutellaria of Labiatae.
3. The Coptidis rhizoma is dried rhizome of Coptidis rhizoma (Coptis chinensis Franch.) of Coptis of Ranunculaceae, Coptis deltoidea C.Y.et Hsiao, or Coptis teeta Wall.
4. The radix Codonopsis is root of radix Codonopsis (Codonopsis pilosula (Franch.) Nannf.) of Codonopsis of Campanulaceae), radix Codonopsis Lanceolatae (C.pilosula Nannf. var. (Nannf.) L.T.Shen) or radix Codonopsis (C.tangshen Oliv.).
5. Poria is dried sclerotium of Poria cocos (Schw.) Wolf) belonging to Polyporaceae, genus Poria.
6. Rhizoma Atractylodis is dried rhizome of Atractylodes lancea (Atractylodes lancea DC.) or Atractylodes chinensis (Atractylodes chinensis DC.) of Atractylodes of Compositae.
7. Cinnamon is the dried bark of cinnamon (cinnamon cassia Presl) belonging to the genus Cinnamomum of the family Lauraceae.
8. The radix Paeoniae Rubra is dried root of Paeonia lactiflora Pall or radix Paeoniae Rubra (P. veitchii Lynch) belonging to Paeonia of Paeoniaceae.
9. Pueraria lobata (Willd.) Ohwi) is dried root of Pueraria lobata (Ohwi)) belonging to Pueraria of Leguminosae.
10. The radix et rhizoma Rhei is root and rhizome of Rheum palmatum L, Rheum tanguticum Maxim. ex Balf. or Rheum officinale Baill. of Polygonaceae.
11. Stigma Maydis is stigma and stigma of semen Maydis (Zea mays L.) of Zea of Gramineae.
12. The gypsum is sulfate mineral anhydrite gypsum, and mainly contains hydrous calcium sulfate (CaSO)4·H2O), also known as gypsum.
13. The red rice is obtained by parasitizing mycelia of Monascus purpureus went (Monascus purpureus went) of Aspergillus on semen oryzae Sativae.
14. The stevia rebaudiana Bertoni is leaf of stevia rebaudiana Bertoni (stevia rebaudiana (Bertoni)) belonging to genus Eupatorium of family Compositae.
Preferably, the preparation method of the traditional Chinese medicine composition comprises the following steps: decocting Zingiberis rhizoma, Scutellariae radix, Coptidis rhizoma, radix Codonopsis, Poria, rhizoma Atractylodis, cortex Cinnamomi, radix Paeoniae Rubra, radix Puerariae, radix et rhizoma Rhei, stigma Maydis, Gypsum Fibrosum, Monascus purpureus went and sweet stevia in water.
Preferably, the preparation method of the traditional Chinese medicine extract comprises the following steps:
(1) cleaning Zingiberis rhizoma, Scutellariae radix, Coptidis rhizoma, radix Codonopsis, Poria, rhizoma Atractylodis, cortex Cinnamomi, radix Paeoniae Rubra, radix Puerariae, radix et rhizoma Rhei, stigma Maydis and Gypsum Fibrosum, removing impurities, drying, pulverizing, decocting in water, filtering, and spray drying the filtrate to obtain extract A;
(2) decocting red rice and stevia rebaudiana in water, adding the extract A, dissolving, filtering, spray drying the filtrate, pulverizing, and sieving to obtain the Chinese medicinal composition.
The invention also provides a new application of the traditional Chinese medicine composition, which comprises an application of the traditional Chinese medicine composition in preparing medicines for preventing and/or treating diabetes.
The invention also provides a medicament for preventing and/or treating diabetes, which comprises the traditional Chinese medicine composition.
Preferably, the medicament is an oral formulation.
Preferably, the oral preparation is tablet, granule, capsule, powder, pill, oral liquid, syrup, granule, drop pill or decoction.
Preferably, the weight percentage of the traditional Chinese medicine composition in the medicine is not lower than 10%.
From the perspective of traditional Chinese medicine, blood sugar belongs to the category of yang in traditional Chinese medicine, and yang hyperactivity generates heat to transform fire, so that heat evil in a body is excessive, and body fluid and qi are damaged for a long time, and the traditional Chinese medicine has the pathogenesis characteristics of cold-heat mixed, deficiency-excess mixed and phlegm-turbidity blood stasis blood blockage of channels and collaterals.
The invention starts with the multi-vitamin treatment of clearing fire, relieving depression, warming and tonifying, promoting blood circulation and eliminating turbid pathogen, and adopts the traditional Chinese medicine composition comprising coptis chinensis, scutellaria baicalensis, gypsum, prepared rhubarb, poria cocos, cinnamon, red paeony root, kudzuvine root, corn stigma, red yeast rice and stevia rebaudiana to treat diabetes. In the prescription, the coptis and the scutellaria are used as monarch drugs to clear heat and purge fire, directly transform fire evil and resolve dampness; the minister drugs use gypsum, cooked rhubarb and the like to clear yang, improve stomach and intestine heat evil, promote blood circulation and activate blood, and the tuckahoe, rhizoma atractylodis and the like to activate spleen and eliminate turbid; red peony root, radix puerariae, corn stigma, water-clearing and dampness-eliminating, red yeast rice, radix puerariae, rhizoma polygonati, radix puerariae, corn stigma, water-clearing and dampness-eliminating, red yeast rice, radix puerariae, food stagnation and blood fat regulating, and the functions of purging fire mainly and dredging vessels and dissolving turbidity mainly are achieved; radix Codonopsis is used for invigorating qi, strengthening body resistance, eliminating turbid pathogen, dredging collaterals, and removing blood stasis; cinnamon and dried ginger are used for tonifying spleen and warming kidney, so that the cinnamon and the dried ginger are used for strengthening body resistance and assisting in eliminating evil, and the dried ginger is sweet, warm, bitter and cold, so as to prevent body resistance from being damaged; stevia rebaudiana is used for preventing the medicine taste from being bitter and difficult to accept, and guiding the medicine to directly reach the disease focus due to the coordination with blood sugar. Therefore, the medicine takes the elimination of pathogenic factors as the main part, takes the effects of strengthening body resistance and cooling as the main part, and takes warm tonifying as the auxiliary part, so that the cold and warm are simultaneously applied to correct the glycolipid metabolic disorder state of the diabetes.
The invention analyzes the pharmacological action of the traditional Chinese medicine composition on treating diabetes by screening the confirmed patients with diabetes who have Fasting Blood Glucose (FBG) more than or equal to 7.0mmol/L or have blood glucose more than or equal to 11.1mmol/L for two hours after meal. After the traditional Chinese medicine composition is used for treating, the oral glucose tolerance (OGTT) and the area under the curve (AUC) of a patient and the content of glycosylated hemoglobin (HbA1c) are all remarkably reduced, which indicates that the traditional Chinese medicine composition can remarkably reduce the blood sugar level of the patient; meanwhile, the insulin resistance level (HOMA-IR) of the patient is obviously reduced, and the pancreatic islet beta cell function (HOMA-beta) is obviously recovered, which shows that the traditional Chinese medicine composition can improve the pancreatic islet function of the patient and recover the sensitivity of the body to insulin.
The invention has the beneficial effects that: the invention provides a new effective, safe and cheap medicament for treating and preventing diabetes. Clinical application proves that the traditional Chinese medicine composition provided by the invention has a good effect of regulating and controlling blood sugar, can effectively reduce the blood sugar and blood fat of a diabetic patient, improves the insulin resistance of the patient and obviously improves the insulin secretion function. Wherein, the diabetes state of part of patients is reversed, and the treatment effect of clinical medicine withdrawal is achieved. The traditional Chinese medicine composition provided by the invention is low in cost, small in side effect and suitable for long-term administration of diabetics.
Drawings
FIG. 1 is a graph showing statistics of the effect of the Chinese medicinal composition of the present invention on oral glucose tolerance (OGTT) and area under the curve (AUC) of diabetic patients;
FIG. 2 is a graph showing the effect of the Chinese medicinal composition of the present invention on the content of glycated hemoglobin (HbA1c) of a diabetic patient;
FIG. 3 is a graph showing the statistics of the effect of the Chinese medicinal composition of the present invention on the insulin resistance level (HOMA-IR) of diabetic patients;
FIG. 4 is a graph showing the statistics of the effect of the Chinese medicinal composition of the present invention on the pancreatic β -cell function (HOMA- β) of diabetic patients.
Detailed Description
In order to more concisely and clearly demonstrate technical solutions, objects and advantages of the present invention, the following detailed description of the present invention is provided with reference to specific embodiments and accompanying drawings.
Example 1
The embodiment provides a traditional Chinese medicine composition, and the prescription of each dose is as follows: 6g of dried ginger, 10g of scutellaria baicalensis, 9g of coptis chinensis, 10g of codonopsis pilosula, 10g of poria cocos, 10g of rhizoma atractylodis, 6g of cinnamon, 10g of red paeony root, 15g of radix puerariae, 6g of rheum officinale, 10g of corn stigma, 15g of gypsum, 5g of red yeast rice decoction pieces and 1g of stevia rebaudiana decoction pieces.
The preparation method of the traditional Chinese medicine composition comprises the following steps: cleaning Zingiberis rhizoma, Scutellariae radix, Coptidis rhizoma, radix Codonopsis, Poria, rhizoma Atractylodis, cortex Cinnamomi, radix Paeoniae Rubra, radix Puerariae, radix et rhizoma Rhei, stigma Maydis and Gypsum Fibrosum, removing impurities, drying at 40 deg.C, pulverizing, decocting with 10 times of water for 1 hr, filtering with 200 mesh filter screen, and spray drying the filtrate to obtain extract A; decocting red rice decoction pieces and sweet stevia decoction pieces with 500mL of water to 250mL, adding extract A, dissolving, filtering with 200 mesh filter screen, spray drying the filtrate, pulverizing, and sieving with 80 mesh sieve to obtain the Chinese medicinal composition.
The effect of the traditional Chinese medicine composition of example 1 on the oral glucose tolerance (OGTT) and its area under the curve (AUC) of diabetic patients, the glycated hemoglobin (HbA1c) content, the insulin resistance level (HOMA-IR) and the islet beta cell function (HOMA- β) were tested:
the method comprises the following steps: patients with confirmed diabetes mellitus who have been tested for multiple times and have FBG of 7.0mmol/L or more or have blood sugar of 11.1mmol/L or more for two hours after meal are treated by taking the Chinese medicinal composition of example 1 at a dose of 1 dose/time, 2 times/day and rechecked after 1 month.
As a result: significant decreases in the OGTT and its AUC occurred in patients after treatment compared to before treatment (figure 1), indicating that the patients 'islet beta cell function and body's ability to regulate blood glucose were restored; HbA1c is the gold standard for glycemic control, and the HbA1c content of the patients after treatment was also significantly reduced (fig. 2), indicating that the patients had well-controlled hyperglycemic symptoms over the past 1 month; the significant decrease in HOMA-IR levels in the patients after treatment (FIG. 3) indicates an increase in insulin sensitivity in the patients, and a significant increase in HOMA- β (FIG. 4) in the patients, indicating an improvement in pancreatic islet function in the patients, which in combination further regulates blood glucose levels in the patients.
Example 2
The embodiment provides a tablet for treating diabetes, which comprises a traditional Chinese medicine composition prepared from dried ginger, scutellaria baicalensis, coptis chinensis, codonopsis pilosula, poria cocos, rhizoma atractylodis, cinnamon, red paeony root, kudzu vine root, rheum officinale, corn stigma, gypsum, red yeast rice decoction pieces and stevia rebaudiana decoction pieces, and pharmaceutically acceptable auxiliary materials. The administration mode of the tablet is oral administration, and the administration is 1 to 3 times per day. The daily dosage is as follows according to the raw material medicine amount: 12g of dried ginger, 20g of scutellaria baicalensis, 18g of coptis chinensis, 20g of codonopsis pilosula, 20g of poria cocos, 20g of rhizoma atractylodis, 12g of cinnamon, 20g of red paeony root, 30g of radix puerariae, 12g of rheum officinale, 20g of corn stigma, 30g of gypsum, 10g of red yeast rice decoction pieces and 2g of stevia rebaudiana decoction pieces. The preparation method of the Chinese medicinal composition refers to example 1.
Example 3
The embodiment provides a capsule for treating diabetes, which contains a traditional Chinese medicine composition prepared from dried ginger, scutellaria baicalensis, coptis chinensis, codonopsis pilosula, poria cocos, rhizoma atractylodis, cinnamon, red paeony root, kudzu vine root, rheum officinale, corn stigma, gypsum, red yeast rice decoction pieces and stevia rebaudiana decoction pieces, and pharmaceutically acceptable auxiliary materials. The administration mode of the capsule is oral administration, and the administration is 1 to 3 times per day. The daily dosage is calculated according to the raw material medicaments: 12g of dried ginger, 20g of scutellaria baicalensis, 18g of coptis chinensis, 20g of codonopsis pilosula, 20g of poria cocos, 20g of rhizoma atractylodis, 12g of cinnamon, 20g of red paeony root, 30g of radix puerariae, 12g of rheum officinale, 20g of corn stigma, 30g of gypsum, 10g of red yeast rice decoction pieces and 2g of stevia rebaudiana decoction pieces. The preparation method of the Chinese medicinal composition refers to example 1.
Example 4
The embodiment provides a dripping pill for treating diabetes, which comprises a traditional Chinese medicine composition prepared from dried ginger, scutellaria baicalensis, coptis chinensis, codonopsis pilosula, poria cocos, rhizoma atractylodis, cinnamon, red paeony root, radix puerariae, rheum officinale, corn stigma, gypsum, red yeast rice decoction pieces and stevia rebaudiana decoction pieces, and pharmaceutically acceptable auxiliary materials. The administration mode of the dripping pill is oral administration, and the dripping pill is taken 1 to 3 times a day. The daily dosage is as follows according to the raw material medicine amount: 12g of dried ginger, 20g of scutellaria baicalensis, 18g of coptis chinensis, 20g of codonopsis pilosula, 20g of poria cocos, 20g of rhizoma atractylodis, 12g of cinnamon, 20g of red paeony root, 30g of radix puerariae, 12g of rheum officinale, 20g of corn stigma, 30g of gypsum, 10g of red yeast rice decoction pieces and 2g of stevia rebaudiana decoction pieces. The preparation method of the Chinese medicinal composition refers to example 1.
Example 5
The embodiment provides a granule for treating diabetes, which comprises a traditional Chinese medicine composition prepared from dried ginger, scutellaria baicalensis, coptis chinensis, codonopsis pilosula, poria cocos, rhizoma atractylodis, cinnamon, red paeony root, kudzu vine root, rheum officinale, corn stigma, gypsum, red yeast rice decoction pieces and stevia rebaudiana decoction pieces, and pharmaceutically acceptable auxiliary materials. The administration mode of the granule is oral administration, and the administration is 1 to 3 times per day. The daily dosage is as follows according to the raw material medicine amount: 12g of dried ginger, 20g of scutellaria baicalensis, 18g of coptis chinensis, 20g of codonopsis pilosula, 20g of poria cocos, 20g of rhizoma atractylodis, 12g of cinnamon, 20g of red paeony root, 30g of radix puerariae, 12g of rheum officinale, 20g of corn stigma, 30g of gypsum, 10g of red yeast rice decoction pieces and 2g of stevia rebaudiana decoction pieces. The preparation method of the Chinese medicinal composition refers to example 1.
Example 6
The embodiment provides an oral liquid for treating diabetes, which contains a traditional Chinese medicine composition prepared from dried ginger, scutellaria baicalensis, coptis chinensis, codonopsis pilosula, poria cocos, rhizoma atractylodis, cinnamon, red paeony roots, radix puerariae, rheum officinale, corn stigma, gypsum, red yeast rice decoction pieces and stevia rebaudiana decoction pieces, and pharmaceutically acceptable auxiliary materials. The dosage of the oral liquid is 1-3 times per day. The daily dosage is as follows according to the raw material medicine amount: 12g of dried ginger, 20g of scutellaria baicalensis, 18g of coptis chinensis, 20g of codonopsis pilosula, 20g of poria cocos, 20g of rhizoma atractylodis, 12g of cinnamon, 20g of red paeony root, 30g of radix puerariae, 12g of rheum officinale, 20g of corn stigma, 30g of gypsum, 10g of red yeast rice decoction pieces and 2g of stevia rebaudiana decoction pieces. The preparation of the Chinese medicinal composition is as in example 1, but finally spray drying is not required.
The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims (8)

1. The traditional Chinese medicine composition is characterized by comprising the following raw material medicines in parts by weight: 6 parts of dried ginger, 10 parts of scutellaria baicalensis, 9 parts of coptis chinensis, 10 parts of codonopsis pilosula, 10 parts of poria cocos, 10 parts of rhizoma atractylodis, 6 parts of cinnamon, 10 parts of red paeony root, 15 parts of radix puerariae, 6 parts of rheum officinale, 10 parts of corn stigma, 15 parts of gypsum, 5 parts of red yeast rice and 1 part of stevia rebaudiana.
2. The method for preparing the traditional Chinese medicine composition of claim 1, which is characterized by comprising the following steps: decocting Zingiberis rhizoma, Scutellariae radix, Coptidis rhizoma, radix Codonopsis, Poria, rhizoma Atractylodis, cortex Cinnamomi, radix Paeoniae Rubra, radix Puerariae, radix et rhizoma Rhei, stigma Maydis, Gypsum Fibrosum, Monascus purpureus went and sweet stevia with water.
3. The method for preparing a Chinese medicinal composition according to claim 1, comprising the steps of:
(1) cleaning Zingiberis rhizoma, Scutellariae radix, Coptidis rhizoma, radix Codonopsis, Poria, rhizoma Atractylodis, cortex Cinnamomi, radix Paeoniae Rubra, radix Puerariae, radix et rhizoma Rhei, stigma Maydis and Gypsum Fibrosum, removing impurities, drying, pulverizing, decocting in water, filtering, and spray drying the filtrate to obtain extract A;
(2) decocting red rice and stevia rebaudiana in water, adding the extract A, dissolving, filtering, spray drying the filtrate, pulverizing, and sieving to obtain the Chinese medicinal composition.
4. The use of the Chinese medicinal composition of claim 1 in the preparation of a medicament for the prevention and/or treatment of diabetes.
5. A medicament for preventing and/or treating diabetes, which comprises the Chinese medicinal composition of claim 1.
6. The medicament of claim 5, wherein the medicament is an oral formulation.
7. The medicament of claim 6, wherein the oral preparation is tablets, granules, capsules, powders, pills, oral liquids, syrups, granules, dripping pills or decoctions.
8. The medicament of claim 5, wherein the weight percentage of the Chinese medicinal composition in the medicament is not less than 10%.
CN202010620498.7A 2020-07-01 2020-07-01 Traditional Chinese medicine composition and application thereof in preparation of medicine for preventing and/or treating diabetes Active CN111759999B (en)

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