CN114392319A

CN114392319A - Traditional Chinese medicine composition for treating early stage of diabetes and application thereof

Info

Publication number: CN114392319A
Application number: CN202210079523.4A
Authority: CN
Inventors: 陈雪琴; 沈宏平; 宋佳怡; 蔡以力; 冯定军
Original assignee: Ningbo First Hospital
Current assignee: Ningbo First Hospital
Priority date: 2022-01-24
Filing date: 2022-01-24
Publication date: 2022-04-26

Abstract

The invention provides a traditional Chinese medicine composition for treating early diabetes and application thereof, wherein the traditional Chinese medicine composition is prepared from the following raw material medicines: 10-20 parts of coptis chinensis, 20-35 parts of astragalus membranaceus, 20-30 parts of Chinese yam, 12-30 parts of rhizoma atractylodis, 10-20 parts of eupatorium fortunei, 15-30 parts of fried bighead atractylodes rhizome, 15-30 parts of poria cocos and 10-30 parts of radix ophiopogonis. The traditional Chinese medicine composition is supported by the traditional Chinese medicine classic theory, has reasonable formula and proper compatibility, can tonify spleen and qi, clear heat and dry dampness, thereby treating the early stage of diabetes, and has the advantages of definite curative effect, obvious effect, no obvious adverse reaction and good safety.

Description

Traditional Chinese medicine composition for treating early stage of diabetes and application thereof

Technical Field

The invention relates to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating early stage diabetes and application thereof.

Background

Pre-diabetes is an important step in the transition from euglycemia to type 2 diabetes. Pre-diabetes refers to an abnormal state between the normal glycometabolism and diabetes, manifested by Impaired Glucose Regulation (IGR), including Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT), or both. In recent years, the incidence rate of the early stage of diabetes is rapidly increased, and large-scale cross-sectional investigation and research show that the prevalence rate of the early stage of diabetes of Chinese adults exceeds 50 percent and becomes an important reserve army for the type 2 diabetes. Blood glucose abnormality in the pre-diabetic stage is not only a risk factor of type 2 diabetes, but also closely related to cardiovascular diseases, metabolic syndrome, cognitive dysfunction and other diseases. However, the abnormal state of sugar metabolism in the prediabetes stage is a reversible process, so that the timely discovery and active intervention in the prediabetes stage is significant for delaying or blocking the onset of diabetes.

At present, the control method of the western medicine to the early stage of diabetes mainly comprises life style intervention, blood sugar reduction, Insulin Resistance (IR) improvement and the like, and the specificity is lacked. In recent years, Chinese medicines are also researched in the aspect of treating the early stage of diabetes, and Chinese scholars achieve certain achievements in various aspects such as prevention of the early stage of diabetes from developing into diabetes, alleviation and delay of complications and the like through years of clinical practice, for example, patent CN109223902A discloses a Chinese medicinal composition for intervening in the early stage of diabetes, which is prepared from 2-10 parts of raw hawthorn, 1-6 parts of medlar, 1-6 parts of cassia seed, 1-6 parts of wild chrysanthemum flower and 1-4 parts of dark plum; patent CN102836358A discloses a traditional Chinese medicine composition for treating pre-stage diabetes, which is prepared from 1-10 parts of bighead atractylodes rhizome, 1-10 parts of dried lily bulb, 2-10 parts of dried rehmannia root, 2-10 parts of astragalus root, 1-5 parts of coptis root, 2-6 parts of coix seed, 2-6 parts of angelica regale and 2-6 parts of sophora flower bud. Compared with western medicine, the traditional Chinese medicine has the advantages of definite curative effect, less adverse reaction and the like.

Although the above patent applications describe that the traditional Chinese medicine prescription has a certain curative effect, in view of the large market demand of the medicines for treating the early stage of diabetes and the different constitutions of each patient, the existing traditional Chinese medicine prescription has the problems of uncertain curative effect and insignificant effect, so that the development of a traditional Chinese medicine preparation with definite curative effect, simple and convenient administration, safety and no toxic or side effect is urgently needed, and more medication options are provided for clinicians and patients.

Disclosure of Invention

In order to solve the defects of the prior art, the invention aims to provide the traditional Chinese medicine composition for treating the early stage of diabetes, which has a reasonable formula and a remarkable effect.

The above object of the present invention can be achieved by the following technical solutions:

a traditional Chinese medicine composition for treating pre-diabetes is prepared from the following raw material medicines in parts by weight: 10-20 parts of coptis chinensis, 20-35 parts of astragalus membranaceus, 20-30 parts of Chinese yam, 12-30 parts of rhizoma atractylodis, 10-20 parts of eupatorium fortunei, 15-30 parts of fried bighead atractylodes rhizome, 15-30 parts of poria cocos and 10-30 parts of radix ophiopogonis.

Preferably, the traditional Chinese medicine composition for treating the pre-stage diabetes is prepared from the following raw material medicines in parts by weight: 10-15 parts of coptis chinensis, 20-25 parts of astragalus membranaceus, 20-25 parts of Chinese yam, 12-20 parts of rhizoma atractylodis, 10-15 parts of eupatorium fortunei, 15-20 parts of fried bighead atractylodes rhizome, 15-20 parts of poria cocos and 10-20 parts of radix ophiopogonis.

Preferably, the traditional Chinese medicine composition for treating the pre-stage diabetes is prepared from the following raw material medicines in parts by weight: 10 parts of coptis chinensis, 20 parts of astragalus membranaceus, 20 parts of Chinese yam, 12 parts of rhizoma atractylodis, 10 parts of fortune eupatorium herb, 15 parts of fried bighead atractylodes rhizome, 15 parts of poria cocos and 10 parts of radix ophiopogonis.

Preferably, the traditional Chinese medicine composition for treating the pre-diabetes comprises a medically acceptable drug carrier.

The invention also aims to disclose the application of the traditional Chinese medicine composition in preparing a medicine for treating pre-diabetes.

Preferably, the dosage form of the medicine is granules, oral liquid, tablets, capsules, powder, pills or paste.

The invention has the following beneficial effects:

the traditional Chinese medicine composition is supported by the traditional Chinese medicine classic theory, has reasonable formula and proper compatibility, can tonify spleen and qi, clear heat and dry dampness, thereby treating the early stage of diabetes, and has the advantages of definite curative effect, obvious effect, no obvious adverse reaction and good safety.

The traditional Chinese medicine composition can be used for preparing medicines for treating the early stage of diabetes, can be selected from various dosage forms, and has the advantages of convenient treatment, long drug effect, portability of the medicines, stable curative effect, strong medicine economy and the like while ensuring the curative effect.

Detailed Description

The technical solutions of the present invention will be described clearly and completely with reference to the following embodiments, and it should be understood that the described embodiments are some, but not all, embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

The invention relates to a traditional Chinese medicine composition for treating early diabetes, which is prepared from the following raw material medicines: coptis root, astragalus root, Chinese yam, rhizoma atractylodis, fortune eupatorium herb, stir-fried bighead atractylodes rhizome, tuckahoe and dwarf lilyturf tuber.

Traditional Chinese medicine has no name of pre-diabetes, and can be classified as 'splenic fever' according to the symptoms of patients. The name of "Piyi" is first reported in Huangdi's classic on medicine. The literature of Su Wen & Qi Bin Lun (Su Wen & Qi disease): "is the disease name for those with a sweet taste? What can it be? The Qibo is given as follows: the five qi overflow is also named as splenic fever … …, and the person must eat sweet and beautiful food and have much fat, the fat person is hot, and the sweet person is full of qi, so the qi overflow turns into diabetes, which indicates that the important cause of splenic fever is overeating and fatty food, and the full of internal heat is generated and accumulated in the spleen, and the person can not intervene in time and possibly progress to diabetes. In addition, the "Huangdi's classic on medicine" also proposes the treatment principle of "splenic fever": treating the orchid and removing the old qi, namely, adopting the aromatic spleen-enlivening herbs to remove the turbid and remove the dampness. Later doctors mostly give play to theoretical understanding of "spleen fever" on the basis of "Huangdi's Nei Jing", but think that the disease is located in the spleen, and the cause of the disease is not innate endowment, overfeeding sweet and delicious, ease and move little, emotional disorder and the like. The pathogenesis is mainly qi deficiency, and qi stagnation, dryness-heat and phlegm accumulation are the symptoms. Therefore, the prescription of the invention aims at invigorating spleen and replenishing qi, clearing heat and drying dampness, thereby treating the clinical symptoms of the early stage of diabetes. The invention has the following meanings:

monarch drug: astragalus root, Chinese yam. Astragalus root: sweet in flavor, it enters spleen and lung meridians. Tonify qi, strengthen superficies, expel toxin, expel pus, induce diuresis, and promote granulation. Shen nong Ben Cao Jing (Shen nong's herbal), radix astragali is sweet in flavor and slightly warm in nature. Mainly carbuncle, cellulitis, long-term septicemia, pus discharge and pain relief, leprosy, five hemorrhoids, mouse fistula, deficiency tonifying and various diseases of children. "Chinese yam: sweet and neutral in nature, they enter spleen, lung and kidney meridians. Tonify spleen and stomach, promote the production of body fluid and nourish lung, tonify kidney and astringe essence. The book materia Medica is as follows: chinese yam can invigorate spleen, tonify deficiency, nourish essence and strengthen kidney, and treat consumptive disease and seven injuries. "(the book of materia Medica): the yam can tonify kidney and replenish essence, and the essence can strengthen yin, improve eyesight and improve hearing. The two are monarch drugs, which achieve the effects of strengthening the spleen, replenishing qi, assisting the spleen to dissipate essence.

Ministerial drugs: coptidis rhizoma, and radix Ophiopogonis. Coptis chinensis: bitter and cold in flavor, entering heart, spleen, stomach, liver, gallbladder and large intestine meridians. Clear heat and dry dampness, purge fire and remove toxicity. Compendium of materia Medica: purging liver fire, removing heart orifice and aversion to blood, stopping palpitation. "miscellaneous records of famous physicians": it is slightly cold and non-toxic. The traditional Chinese medicine composition is mainly used for treating cold and heat in five kinds of zang, chronic diarrhea and purulent blood, relieving thirst and convulsion, removing water, benefiting bones, regulating stomach, thickening intestines, benefiting gallbladder and treating aphtha. ' radix ophiopogonis: sweet, slightly bitter and slightly cold. It enters heart, lung and stomach meridians. Nourish yin, promote the production of body fluid, moisten lung and arrest cough. The miscellaneous records of famous physicians: "heaviness of the body and eyes yellow, fullness in the lower heart, consumptive disease, fever in the chest, dry and thirsty, vomiting stopping, atrophy, coldness, yin strengthening and essence benefiting, grain elimination and middle regulation, mental tranquilization, lung qi fixing, five internal organs calming, body building, skin color beautifying, son of the book" materia medica "emission-picking: "stop feverish sensation in the chest, thirst, heaviness of the body, yellow eyes, chills and fever, fatigue, stop vomiting, stimulate the appetite, and expel phlegm". The two medicines are used as ministerial medicines to achieve the effects of clearing heat, drying dampness, nourishing yin and promoting the production of body fluid.

Adjuvant drugs: atractylodis rhizoma, Poria, rhizoma Atractylodis, and herba Eupatorii. White atractylodes rhizome: bitter, sweet and warm, entering spleen and stomach meridians. Invigorate spleen, replenish qi, dry dampness, induce diuresis, stop sweating, prevent abortion. The herbal medicine Tongxian: herbs that tonify spleen and stomach do not go beyond the right. It is also indicated for food failure, food stagnation and distension and fullness because it can strengthen the body's movement with vigorous soil. When the body is too strong, it can clear dampness, so it is also used for phlegm-fluid retention, swelling and damp arthralgia. The book Ben Cao Hui Yan (treatise on materia Medica): bighead atractylodes rhizome, rhizoma Atractylodis Macrocephalae, is also the key herb for strengthening the spleen and stomach, dissipating dampness and removing arthralgia, promoting digestion and removing stuffiness. "the materia Medica: bighead atractylodes rhizome, rhizoma Atractylodis Macrocephalae, bitter and sweet in taste, can dry dampness and strengthen spleen, and can relieve spleen and promote fluid production. Moreover, it is the warmest in nature, so it can be used as the first herb for spleen qi tonify to promote digestion and to eliminate food stagnation when taken. "Poria cocos: sweet and bland, entering heart, lung, spleen and kidney meridians. Induce diuresis and drain dampness, invigorate spleen and calm heart. Compendium of materia Medica: poria cocos, Poria cocos, Poria, belongs to yang, and belongs to the yang, and also refers to the property of nature, nourishing water, promoting urination, and inducing diuresis; dongyuan means that it is the yin in yang and descending, so it is also called the action. "(materia Medica of materia Medica): poria cocos, Poria cocos wolf and Poria cocos wolf have the action of moving water, and can tonify heart and spleen, and do not reach the limit. "(materia Medica): the Chinese medicinal composition has the effects of inducing resuscitation and removing dampness, and inducing resuscitation and restoring heart and intelligence, and promoting the production of body fluid; removing dampness can expel water and dry spleen, strengthen middle-jiao and invigorate stomach; to treat epilepsy due to fright and thick intestine, it is indicated for phlegm and helps to descend. Because its taste is slightly sweet, it is said to tonify yang. But with less benefit and more profit. "rhizoma atractylodis: pungent, bitter and warm. It enters spleen, stomach and liver meridians. Dry dampness and invigorate spleen, dispel wind and cold, improve vision. Compendium of materia Medica: "Dafengbi", weak muscles and bones, dispelling wind, removing dampness and resolving stagnation ". The juice is used for brewing wine to treat all rheumatic arthralgia and myalgia. ". The herbal supplement: dryness in the stomach and strengthening the spleen. Sweating and dehumidifying. It can ascend yang qi in stomach. Stopping vomiting and diarrhea. Expelling phlegm. "Eupatorium: pungent flavor and mild property. Spleen, stomach and lung meridians. Fragrant, resolving dampness, activating spleen, stimulating appetite, relieving exterior syndrome and relieving summer-heat. Su Wen & Qi Bing Lun: body fluids are in the spleen, so it is also responsible for dry mouth and body mass. .., its qi overflows and turns into diabetes, so it is treated by orchid and removes old qi. "(Ben Cao Jing Shu): the lung governs qi, lung qi stagnation leads to upper orifice obstruction but lower orifice obstruction, the stomach mainly receives water and food, stomach qi stagnation leads to water not becoming phlegm nodule due to time-dependent change, the orchid pungent can dissipate stagnation, the fragrance can remove dirty and bad, the traditional Chinese medicines for treating various diseases are self-treatment, and most of the traditional Chinese medicines have the functions of appetizing, removing bad breath, removing phlegm and dispersing stagnation. The four medicines are used as adjuvant medicines together to achieve the effects of strengthening spleen, tonifying qi, eliminating dampness and promoting diuresis.

The whole formula is combined to play the effects of tonifying spleen and qi, clearing heat and drying dampness.

The traditional Chinese medicine composition comprises the following raw materials in parts by weight and has the pharmacological effects:

10-20 parts of coptis chinensis, 20-35 parts of astragalus membranaceus, 20-30 parts of Chinese yam, 12-30 parts of rhizoma atractylodis, 10-20 parts of eupatorium fortunei, 15-30 parts of fried bighead atractylodes rhizome, 15-30 parts of poria cocos and 10-30 parts of radix ophiopogonis.

Coptis chinensis: bitter and cold in flavor, entering heart, spleen, stomach, liver, gallbladder and large intestine meridians. Clear heat and dry dampness, purge fire and remove toxicity. Dampness-heat fullness, vomiting, acid regurgitation, dysentery, jaundice, high fever, coma, hyperactivity of heart-fire, vexation, insomnia, palpitation, hematemesis, epistaxis, conjunctival congestion, toothache, diabetes, carbuncle, swelling and sore; it can be used for treating eczema, and purulence in ear canal. Typical but non-limiting contents of coptis are: 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts, 19 parts and 20 parts.

Astragalus root: sweet and warm. It enters spleen and lung meridians. Tonify qi, strengthen superficies, expel toxin, expel pus, induce diuresis, and promote granulation. Can be used for treating deficiency of vital energy, asthenia, anorexia, loose stool, collapse of middle-warmer energy, chronic diarrhea, rectocele, hematochezia, spontaneous perspiration, qi deficiency, edema, internal heat, diabetes, blood deficiency, hemiplegia, arthralgia, numbness, carbuncle, cellulitis, and intractable ulcer. Typical but non-limiting contents of astragalus membranaceus are: 20 parts, 21 parts, 22 parts, 23 parts, 24 parts, 25 parts, 26 parts, 27 parts, 28 parts, 29 parts, 30 parts, 31 parts, 32 parts, 33 parts, 34 parts and 35 parts.

Chinese yam: sweet and neutral. It enters spleen, lung and kidney meridians. Tonify spleen and stomach, promote the production of body fluid and nourish lung, tonify kidney and astringe essence. Can be used for treating spleen deficiency, anorexia, chronic diarrhea, lung deficiency, cough, asthma, spermatorrhea, leukorrhagia, frequent micturition, asthenic fever, and diabetes. Typical but non-limiting contents of yam are: 20 parts, 21 parts, 22 parts, 23 parts, 24 parts, 25 parts, 26 parts, 27 parts, 28 parts, 29 parts and 30 parts.

Rhizoma atractylodis: pungent, bitter and warm. It enters spleen, stomach and liver meridians. Dry dampness and invigorate spleen, dispel wind and cold, improve vision. Can be used for treating damp obstruction of middle warmer, abdominal distention, diarrhea, edema, tinea pedis, atrophic debility cramped, rheumatalgia, wind-cold type common cold, night blindness, dim eyesight, and astringent taste. Typical but non-limiting contents of atractylodes rhizome are: 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts, 19 parts, 20 parts, 21 parts, 22 parts, 23 parts, 24 parts, 25 parts, 26 parts, 27 parts, 28 parts, 29 parts and 30 parts.

Herba Eupatorii: pungent flavor and mild property. Spleen, stomach and lung meridians. Fragrant, resolving dampness, activating spleen, stimulating appetite, relieving exterior syndrome and relieving summer-heat. Can be used for treating damp stagnation, abdominal distention, emesis, halitosis, sialism, summer-heat dampness syndrome, fever, listlessness, and chest distress. Typical but non-limiting amounts of eupatorium are: 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts, 19 parts and 20 parts.

Frying the bighead atractylodes rhizome: bitter, sweet and warm. It enters spleen and stomach meridians. Invigorate spleen, replenish qi, dry dampness, induce diuresis, stop sweating, prevent abortion. Can be used for treating spleen deficiency, anorexia, abdominal distention, diarrhea, phlegm retention, dizziness, palpitation, edema, spontaneous perspiration, and threatened abortion. Typical but non-limiting amounts of roasted white atractylodes rhizome are: 15 parts, 16 parts, 17 parts, 18 parts, 19 parts, 20 parts, 21 parts, 22 parts, 23 parts, 24 parts, 25 parts, 26 parts, 27 parts, 28 parts, 29 parts and 30 parts.

Tuckahoe, poria cocos: sweet and bland, entering heart, lung, spleen and kidney meridians. Can be used for treating edema, oliguria, phlegm and fluid retention, dizziness, palpitation, spleen deficiency, anorexia, loose stool, diarrhea, uneasiness, palpitation, and insomnia. Typical but non-limiting contents of poria cocos wolf are: 15 parts, 16 parts, 17 parts, 18 parts, 19 parts, 20 parts, 21 parts, 22 parts, 23 parts, 24 parts, 25 parts, 26 parts, 27 parts, 28 parts, 29 parts and 30 parts.

Radix ophiopogonis: sweet, slightly bitter and cold, entering heart, lung and stomach meridians. Nourish yin, promote the production of body fluid, moisten lung and arrest cough. Can be used for treating thirst, short breath, consumptive lung disease, cough due to dry lung, asthenia, and asthenic fever. Typical but non-limiting amounts of ophiopogon root are: 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts, 19 parts, 20 parts, 21 parts, 22 parts, 23 parts, 24 parts, 25 parts, 26 parts, 27 parts, 28 parts, 29 parts and 30 parts.

The other embodiment of the invention is a medicament for treating the pre-stage diabetes, which is prepared by processing the traditional Chinese medicine composition for treating the pre-stage diabetes and pharmaceutically acceptable auxiliary materials. The dosage form of the medicine is any one of granules, oral liquid, tablets, capsules, powder, pills and paste.

The technical solution of the present invention will be further described with reference to specific examples.

Example 1

A traditional Chinese medicine composition for treating pre-diabetes comprises the following raw material medicines by weight: 10 parts of coptis chinensis, 20 parts of astragalus membranaceus, 20 parts of Chinese yam, 12 parts of rhizoma atractylodis, 10 parts of fortune eupatorium herb, 15 parts of fried bighead atractylodes rhizome, 15 parts of poria cocos and 10 parts of radix ophiopogonis.

The preparation and administration method comprises the following steps: soaking the medicinal materials in clear water for half an hour, boiling with strong fire, decocting with slow fire for 30 min, decocting the first part, adding water, decocting for 20 min, decocting the second part, mixing the two decoctions, and taking the mixture twice in the morning and evening.

Example 2

A traditional Chinese medicine composition for treating pre-diabetes comprises the following raw material medicines by weight: 10 parts of coptis chinensis, 30 parts of astragalus membranaceus, 30 parts of Chinese yam, 15 parts of rhizoma atractylodis, 15 parts of fortune eupatorium herb, 15 parts of fried bighead atractylodes rhizome, 10 parts of poria cocos and 10 parts of radix ophiopogonis.

The preparation method comprises the following steps: weighing the above materials according to the dosage, adding water to immerse the materials, soaking for 3 hr, heating to boil, decocting for 0.5 hr, and collecting decoction. Decocting the residue by the method for 2-3 times, and mixing decoctions. Filtering, concentrating by evaporation (1:1), cooling, adding 1.5 times of ethanol, mixing, standing overnight, collecting supernatant, washing precipitate with a little 50% ethanol, mixing the washing solution with the filtrate, recovering ethanol under reduced pressure, concentrating, cooling, standing, filtering, vacuum concentrating at low temperature to obtain soft extract with specific gravity of 1.33, spray drying, sieving with 300 mesh sieve, adding appropriate amount of adjuvants, and making into granule.

Example 3

A traditional Chinese medicine composition for treating pre-diabetes comprises the following raw material medicines by weight: 10 parts of coptis chinensis, 25 parts of astragalus membranaceus, 25 parts of Chinese yam, 12 parts of rhizoma atractylodis, 10 parts of fortune eupatorium herb, 15 parts of fried bighead atractylodes rhizome, 30 parts of poria cocos and 15 parts of radix ophiopogonis.

The preparation method comprises the following steps: weighing the above medicinal materials according to the dosage, pulverizing three fifths of the medicinal materials, sieving with a 50 mesh sieve, adding water to immerse the medicinal materials, soaking for 3 hr, heating to boil, decocting for 0.5 hr, and collecting decoction. Decocting the residue by the method for 2-3 times, and mixing decoctions. Filtering, concentrating by evaporation (1:1), cooling, adding 1.5 times of ethanol, mixing, standing overnight, collecting supernatant, washing precipitate with a little 50% ethanol, mixing the washing solution with the filtrate, recovering ethanol under reduced pressure, concentrating, cooling, standing, filtering, vacuum concentrating at low temperature to obtain soft extract with specific gravity of 1.33, spray drying, grinding, sieving with 300 mesh sieve to obtain extract powder, and making into capsule.

Example 4

A traditional Chinese medicine composition for treating pre-diabetes comprises the following raw material medicines by weight: 15 parts of coptis chinensis, 30 parts of astragalus membranaceus, 30 parts of Chinese yam, 12 parts of rhizoma atractylodis, 20 parts of fortune eupatorium herb, 30 parts of fried bighead atractylodes rhizome, 30 parts of poria cocos and 10 parts of radix ophiopogonis.

The preparation method comprises the following steps: weighing the raw materials according to the weight, drying, micronizing to obtain particles above 800 meshes, adding appropriate amount of dextrin, stirring, and making into tablet.

Example 5

A traditional Chinese medicine composition for treating pre-diabetes comprises the following raw material medicines by weight: 15 parts of coptis chinensis, 30 parts of astragalus membranaceus, 30 parts of Chinese yam, 20 parts of rhizoma atractylodis, 20 parts of fortune eupatorium herb, 25 parts of fried bighead atractylodes rhizome, 25 parts of poria cocos and 25 parts of radix ophiopogonis.

The preparation method comprises the following steps: weighing the above materials according to the dosage, adding water to immerse the materials, soaking for 3 hr, heating to boil, decocting for 0.5 hr, and collecting decoction. Decocting the residue by the method for 2-3 times, and mixing decoctions. Filtering, concentrating by evaporation (1:1), cooling, adding 1.5 times of ethanol, mixing, standing overnight, collecting supernatant, washing precipitate with a small amount of 50% ethanol, mixing the washing solution with the filtrate, recovering ethanol under reduced pressure, concentrating, cooling, standing, filtering, and vacuum concentrating at low temperature to obtain fluid extract with specific gravity of 1.20-1.35; drying the second residue, pulverizing into fine powder as additive, mixing the fine powder with the fluid extract with a specific gravity of 1.20-1.35, stirring to obtain mixture, and spray drying with water vapor gas or nitrogen gas as atomizing gas to obtain medicinal powder granule.

Clinical trial

1. Study object

60 cases of diabetes mellitus early-stage patients diagnosed in the endocrinology of traditional Chinese medicine of the first hospital in Ningbo city are selected, and the patients are divided into 30 cases of traditional Chinese medicines and 30 cases of western medicines according to whether a heat-clearing and qi-tonifying prescription is adopted for treatment. The mean ages of the two groups of patients were (42.43 + -4.93), (42.83 + -4.90), respectively, and the difference was not statistically significant (P > 0.05). The two groups of patients found that the blood sugar abnormal time, BMI and waist-hip ratio were not statistically different (P is more than 0.05), and were comparable.

2. Execution standard and method

(1) Diagnostic criteria

Impaired Fasting Glucose (IFG): fasting venous plasma glucose (FBG) is more than or equal to 6.1mmol/L and less than 7.0 mmol/L; and 75g post Oral Glucose Tolerance Test (OGTT) plasma glucose < 7.8 mmol/L.

Impaired Glucose Tolerance (IGT): fasting venous plasma glucose < 7.0mmol/L (126mg/d 1); and plasma glucose (2hPG) 2 hours after 75g oral glucose tolerance test is more than or equal to 7.8mmoL/L and less than 11.1 mmoL/L.

The standards of impaired fasting glucose, impaired glucose tolerance or impaired fasting glucose combined with impaired glucose tolerance are all diabetes mellitus prophase.

(2) The treatment method comprises the following steps:

the traditional Chinese medicine comprises: 10 parts of coptis chinensis, 20 parts of astragalus membranaceus, 20 parts of Chinese yam, 12 parts of rhizoma atractylodis, 10 parts of fortune eupatorium herb, 15 parts of fried bighead atractylodes rhizome, 15 parts of poria cocos and 10 parts of radix ophiopogonis. The decoction is taken by water, one dose is taken every day, and the decoction is taken in the morning and the evening. Each menstrual cycle is 1 course, and the treatment course is 3.

Western medicine group: metformin, 250mg once, 2 times a day, is taken after meals.

(3) Observation indicator and method

1) General conditions

Demographic data: age, sex;

② the past medical history, family history and treatment history: the course of the diabetes, family history of diabetes, other diseases and their corresponding treatment history;

the living habits: history of smoking and drinking;

fourthly, physical examination: BMI (BMI <24 normal, 24-28 overweight, >28 obesity), waist circumference (female waist circumference less than or equal to 80, male waist circumference less than or equal to 90 normal, female waist circumference >80, male >90 central obesity).

2) Index of therapeutic effect

The sugar tolerance recurrence rate of the traditional Chinese medicine group and the western medicine group after 12 weeks. At the 12-week follow-up visit, an Oral Glucose Tolerance Test (OGTT) was performed at the last follow-up visit, and the glucose tolerance state of the patient was judged from the results of the test.

3) Glycolipid metabolism related indices

(ii) Fasting Plasma Glucose (FPG);

(ii) Post-prandial glucose (PPG);

③ glycated hemoglobin (HemoglobinA a1C, HbA1C) (0, 12 weeks follow-up);

fasting insulin (at 0, 12 week follow-up);

blood lipid (total Cholesterol (TC), Triglyceride (TG), low density lipoprotein Cholesterol (lowdensity lipoprotein-Cholesterol, LDL-C), high density lipoprotein Cholesterol (HDL-C)) (at follow-up for 0, 12 weeks);

sixthly, insulin resistance index (HOMA-IR).

The patients had fasting plasma glucose for more than eight hours (glucose oxidase method), HbA1C (high pressure liquid chromatography) and lipid metabolism related index (enzyme method), and the subjects had taken 75g of anhydrous glucose powder and 2 hours thereafter, postprandial plasma glucose was measured (glucose oxidase method).

(4) Statistical method

Statistical description and analysis data processing was performed using SPSS25.0 statistical software. The measured data conforms to the normal distribution

The rate, composition ratio, etc. describe the patient's general condition, BMI, waist circumference, hip circumference, etc., and M (P) is used in a non-normal distribution₂₅，P₇₅) Representing that the measurement data conforms to normal distribution and adopts t test, and does not conform to normal distribution and adopts rank sum test; counting data are described by frequency and percentage, and binary data are compared between groups by adopting a chi 2 test or a Fisher test with exact probability. P<A difference of 0.05 is statistically significant.

3. Results of the study

(1) Observation and comparison of monitoring index

As shown in Table 1, FPG, 2hPG, HbA1c and HOMA-IR indexes before and after administration of the Chinese medicinal composition and the western medicinal composition in each group have statistical significance, fasting blood sugar, postprandial blood sugar and glycosylated hemoglobin are all reduced, and insulin resistance is reduced. The differences of TC and LDL before and after the traditional Chinese medicine group is used have statistical significance (P is less than 0.05), and the differences of TG and HDL have no statistical significance (P is more than 0.05). The differences of LDL before and after the western medicine is taken have statistical significance (P is less than 0.05), and the differences of TC, TG and HDL have no statistical significance (P is more than 0.05).

TABLE 1 comparison of two groups of monitoring indicators before and after treatment

(2) Observation and comparison of two groups of post-medication monitoring indexes

After the traditional Chinese medicine group is used, the improvement degrees of FBG, 2hPG, HbA1c, HOMA-IR, TC and LDL are more obvious than those of the western medicine group, and the difference has statistical significance (P is less than 0.05). The improvement of TG and HDL is not obvious.

(3) Safety evaluation index

No obvious adverse reaction is seen in the two groups.

The research result shows that: the traditional Chinese medicine compound can reduce the blood sugar condition of a patient, improve the pancreatic islet function and clinical symptoms of the patient, has no obvious adverse reaction, and has better safety.

Typical case

Case 1: luo Shi, male, 62 years old, married. The main complaints are: blood glucose was found to be higher for 1 year. The current medical history: the physical examination in 2020 shows that the blood sugar is high, FBG: 6.4mmol/L, 2 hPG: 7.6mmol/L, which is not regarded and treated. FBG was found by physical examination in 2021: 6.8mmol/L, 2 hPG: 10.2mmol/L, the patient will be diagnosed in 2021, 9 months and 1 day, and the symptoms are shown as follows: generally, the food is fat in shape, does not have obvious symptoms of thirst, desire for drinking, weight loss, dryness and astringency of eyes, soreness and weakness of waist and knees and the like, and can be taken orally, calm and loose stool. Pale-red tongue with thin, white coating and soft pulse. The syndrome belongs to the syndrome of spleen deficiency with excessive dampness, and the main therapeutic principle is to invigorate spleen, replenish qi and dry dampness. The method comprises the following steps: 10g of coptis chinensis, 20g of astragalus membranaceus, 20g of Chinese yam, 12g of rhizoma atractylodis, 10g of fortune eupatorium herb, 15g of fried bighead atractylodes rhizome, 15g of poria cocos and 10g of radix ophiopogonis, and the decoction is decocted with water to be taken, and one dose is taken in the morning and evening. Order patients to adjust life style, enhance exercise and make discomfort for follow-up diagnosis. After 3 months of treatment, blood was rechecked, FBG: 5.4mmol/L, 2 hPG: 5.9mmol/L, HbA1 c: 5.8 percent.

Case 2: chen, woman, age 35, married. The main complaints are: blood glucose was found to be higher for 1 year. The current medical history: FBG was found in unit physical examination 1 year ago: 6.3mmol/l, which is not regarded and treated. The patients feel dry mouth and thirst before and after 1 month, and visit the clinic, go to OGTT and FBG: 6.9mmol/L, 2 hPG: 9.8mmol/l, HbA1 c: 6.1 percent. The following symptoms are shown: swollen shape, dry mouth, thirst, impatience of spleen qi, no weight loss, no soreness and weakness of waist and knees, slight appetite, late sleep, dry and thin stool, reddened tongue with white fur, thick pulse string and thready pulse. The syndrome belongs to the syndrome of liver depression and spleen deficiency, and the retention of damp-heat in the interior is the main therapeutic principle of soothing the liver, strengthening the spleen, clearing heat and drying dampness. The method comprises the following steps: 10g of coptis chinensis, 20g of astragalus membranaceus, 20g of Chinese yam, 12g of rhizoma atractylodis, 10g of fortune eupatorium herb, 15g of fried bighead atractylodes rhizome, 15g of poria cocos and 10g of radix ophiopogonis, and the decoction is decocted with water to be taken, and one dose is taken in the morning and evening. Order the patient to adjust the life style and make a diagnosis at any time. After 6 months of treatment, OGTT, FBG: 4.9mmol/L, 2 hPG: 6.5mmol/l, HbA1 c: 5.3 percent.

Although the present disclosure has been described above, the scope of the present disclosure is not limited thereto. Those skilled in the art can make various changes and modifications without departing from the spirit and scope of the present disclosure, and such changes and modifications will fall within the scope of the present invention.

Claims

1. The traditional Chinese medicine composition for treating the early stage of diabetes is characterized by being prepared from the following raw material medicines in parts by weight: 10-20 parts of coptis chinensis, 20-35 parts of astragalus membranaceus, 20-30 parts of Chinese yam, 12-30 parts of rhizoma atractylodis, 10-20 parts of eupatorium fortunei, 15-30 parts of fried bighead atractylodes rhizome, 15-30 parts of poria cocos and 10-30 parts of radix ophiopogonis.

2. The traditional Chinese medicine composition for treating pre-diabetes according to claim 1, which is prepared from the following raw material medicines in parts by weight: 10-15 parts of coptis chinensis, 20-25 parts of astragalus membranaceus, 20-25 parts of Chinese yam, 12-20 parts of rhizoma atractylodis, 10-15 parts of eupatorium fortunei, 15-20 parts of fried bighead atractylodes rhizome, 15-20 parts of poria cocos and 10-20 parts of radix ophiopogonis.

3. The traditional Chinese medicine composition for treating pre-diabetes according to claim 1, which is prepared from the following raw material medicines in parts by weight: 10 parts of coptis chinensis, 20 parts of astragalus membranaceus, 20 parts of Chinese yam, 12 parts of rhizoma atractylodis, 10 parts of fortune eupatorium herb, 15 parts of fried bighead atractylodes rhizome, 15 parts of poria cocos and 10 parts of radix ophiopogonis.

4. The Chinese medicinal composition for treating pre-diabetes according to claim 1, comprising a pharmaceutically acceptable drug carrier.

5. The use of the Chinese medicinal composition according to any one of claims 1 to 4 in the preparation of a medicament for the treatment of pre-stage diabetes.

6. The use of claim 5, wherein the medicament is in the form of granules, oral liquid, tablets, capsules, powders, pills or creams.