CN113730510A

CN113730510A - Composition for treating and preventing chronic fatigue syndrome, preparation method and application thereof

Info

Publication number: CN113730510A
Application number: CN202111120401.7A
Authority: CN
Inventors: 李献华
Original assignee: Individual
Current assignee: Individual
Priority date: 2021-09-18
Filing date: 2021-09-18
Publication date: 2021-12-03

Abstract

The invention discloses a composition for treating and preventing chronic fatigue syndrome, a preparation method and application thereof, wherein the composition comprises the following raw material medicines in parts by weight: 6-24 parts of sun-dried ginseng, 10-60 parts of snakegourd fruit, 5-30 parts of radix astragali preparata, 5-30 parts of dendrobium, 5-30 parts of fried bighead atractylodes rhizome, 5-30 parts of figwort root, 5-30 parts of radix ophiopogonis, 10-60 parts of prepared rehmannia root, 5-30 parts of fringed pink, 5-30 parts of semen plantaginis, 2-10 parts of coptis chinensis, 5-30 parts of motherwort and 5-30 parts of medicinal cyathula root. The compatibility of the traditional Chinese medicine composition accords with the principle of assistant and guide of traditional Chinese medicines, and the traditional Chinese medicine composition can be used for effectively preventing and/or treating chronic fatigue syndrome of deficiency of both qi and yin, deficiency of both heart and spleen, and liver depression and spleen deficiency, particularly chronic fatigue syndrome of deficiency of both qi and yin.

Description

Composition for treating and preventing chronic fatigue syndrome, preparation method and application thereof

Technical Field

The invention relates to the technical field of traditional Chinese medicines, in particular to a composition for treating and preventing chronic fatigue syndrome, a preparation method and application thereof.

Background

Chronic Fatigue Syndrome (CFS) is a general term for a series of symptoms including subjective symptoms such as Fatigue, pain, and attentiveness reduction. The main symptoms are long-term continuous fatigue and can not be effectively relieved after rest, and some patients are accompanied with physiological and psychological dysfunction to a certain extent, and can cause depression, cognitive dysfunction and the like in serious cases, thereby greatly damaging the health of human beings. In terms of its classification, physical fatigue and mental fatigue can be classified. In addition, chronic fatigue includes psychological fatigue, mixed fatigue, etc.

According to foreign research, the incidence rate of chronic fatigue syndrome is 0.8% -3.4%; the domestic related epidemiological survey shows that the prevalence rate of the chronic fatigue syndrome is 1.95%, the prevalence rate of women is higher than that of men, the prevalence rate is the highest in the age range of 31-50 years, the prevalence rate of brain workers is higher than that of physical workers, and the life style and the working pressure are important risk factors causing the diseases.

With regard to the treatment of CFS, western medicine has no definite effective method, and many patients are treated symptomatically with drugs according to their symptoms. The medicine contains antidepressant, nutrition support, magnesium sulfate therapy, steroid medicine, dehydroepiandrosterone, antioxidant, antiviral medicine, etc., and can temporarily improve symptoms of fatigue, sleep disorder, pain, etc.; non-drug therapy includes cardiac physiotherapy and exercise therapy, etc. and has certain clinical application. Research shows that rehabilitation therapy including exercise, diet control, cognitive behavior improvement, oral medicine and the like can relieve symptoms of patients, so that the physical and mental functions of the patients are changed, and the prognosis of the patients is improved.

The chronic fatigue syndrome has no related records in ancient books of traditional Chinese medicine, and can be classified into consumptive disease, hysteria, depression and the like according to clinical manifestations. The overall thought of the traditional Chinese medicine has obvious advantages in the aspect of treating the chronic fatigue syndrome, and the traditional Chinese medicine for treating the CFS can adjust the functions of qi and blood of meridians and viscera and correct the preponderance and decline of yin and yang of the organism, and promotes the functions of tissues, organs, viscera and meridians of the human body to tend to be balanced and coordinated, so that the clinical value of the medicine for treating the chronic fatigue syndrome is obvious.

Disclosure of Invention

The first purpose of the invention is to provide a composition for treating and preventing chronic fatigue syndrome, which is found by combining the clinical practice of traditional Chinese medicine, wherein the chronic fatigue syndrome mainly comprises qi-yin deficiency syndrome, heart-spleen deficiency syndrome and liver-stagnation and spleen deficiency syndrome, particularly the most qi-yin deficiency syndrome. The second purpose of the invention is to provide a pharmaceutical preparation for treating and preventing chronic fatigue syndrome and a preparation method thereof, and the dosage forms of the pharmaceutical preparation comprise pills, capsules, tablets, powder, granules, oral liquid, enema and decoction. The third purpose of the invention is to provide the application of the composition for treating and preventing chronic fatigue syndrome.

In order to achieve the first purpose, the invention adopts the technical scheme that: the traditional Chinese medicine composition for treating and preventing chronic fatigue syndrome is composed of the following raw material medicines in parts by weight: 6-24 parts of sun-dried ginseng, 10-60 parts of snakegourd fruit, 5-30 parts of radix astragali preparata, 5-30 parts of dendrobium, 5-30 parts of fried bighead atractylodes rhizome, 5-30 parts of figwort root, 5-30 parts of radix ophiopogonis, 10-60 parts of prepared rehmannia root, 5-30 parts of fringed pink, 5-30 parts of semen plantaginis, 2-10 parts of coptis chinensis, 5-30 parts of motherwort and 5-30 parts of medicinal cyathula root.

As a preferred embodiment of the invention, the traditional Chinese medicine composition consists of the following raw material medicines in parts by weight: 9-15 parts of sun-dried ginseng, 20-40 parts of snakegourd fruit, 10-20 parts of radix astragali preparata, 10-20 parts of dendrobium, 10-20 parts of fried bighead atractylodes rhizome, 10-20 parts of figwort root, 10-20 parts of radix ophiopogonis, 20-40 parts of prepared rehmannia root, 10-20 parts of fringed pink, 10-20 parts of semen plantaginis, 6-9 parts of coptis chinensis, 10-20 parts of motherwort and 10-20 parts of medicinal cyathula root.

As a preferred embodiment of the invention, the traditional Chinese medicine composition consists of the following raw material medicines in parts by weight: 12 parts of sun-dried ginseng, 30 parts of snakegourd fruit, 15 parts of radix astragali preparata, 15 parts of dendrobium, 15 parts of fried bighead atractylodes rhizome, 15 parts of radix scrophulariae, 15 parts of radix ophiopogonis, 30 parts of prepared rhizome of rehmannia, 15 parts of fringed pink, 15 parts of semen plantaginis, 6 parts of coptis chinensis, 12 parts of motherwort and 15 parts of medicinal cyathula root.

In order to achieve the second object, the invention adopts the technical scheme that: provides a medicinal preparation for treating and preventing chronic fatigue syndrome, which is prepared from the composition.

As a preferred embodiment of the invention, the dosage form of the pharmaceutical preparation comprises tablets, capsules, granules, pills, decoction and powder.

The preparation method of the traditional Chinese medicine composition comprises the following steps:

(1) weighing the raw materials according to the weight parts, and adding water for reflux extraction;

(2) concentrating the extract in the step (1), drying, crushing, adding pharmaceutically acceptable auxiliary materials and preparing the preparation.

As a preferred embodiment of the invention, the preparation is in the form of tablets, capsules, granules, pills, decoction and powder.

As a preferred embodiment of the present invention, the water-adding reflux extraction comprises two water-adding reflux extraction processes.

As a preferred embodiment of the present invention, the preparation method of the Chinese medicinal composition comprises the following steps:

(1) weighing the raw materials according to the weight parts, adding water, refluxing and extracting for two times, wherein the water added for the first time is 12-18 times of the total weight of the raw materials, the water added for the second time is 10-12 times of the raw materials, refluxing and extracting for 2-3 hours from micro-boiling each time, and combining the extracting solutions of the two times;

(2) vacuum drying the extractive solution in (1), concentrating to obtain fluid extract with density of 1.05 + -0.1 measured at 25 deg.C, pulverizing into powder of 100 mesh or less, adding pharmaceutically acceptable adjuvants, and making into preparation.

As a preferred embodiment of the present invention, the concentration is vacuum concentration, the drying is vacuum drying, and the temperature of the concentration and the drying is below 65 ℃.

As a preferred embodiment of the invention, the medicament is prepared into any pharmaceutical dosage form by adding an acceptable carrier according to requirements. The pharmaceutically acceptable carriers include, but are not limited to: mannitol, sorbitol, sodium metabisulfite, sodium bisulfite, sodium thiosulfate, cysteine hydrochloride, thioglycolic acid, methionine, vitamin C, EDTA disodium, sodium calcium EDTA, monovalent alkali metal carbonates, acetates, phosphates or aqueous solutions thereof, hydrochloric acid, acetic acid, sulfuric acid, phosphoric acid, amino acids, sodium chloride, potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, brown sugar, mannitol, silicon derivatives, cellulose and derivatives thereof, alginates, gelatin, polyvinylpyrrolidone, glycerol, Tween 80, agar, calcium carbonate, calcium bicarbonate, surfactants, polyethylene glycol, cyclodextrin, beta-cyclodextrin, phospholipid-like materials, kaolin, talc, calcium stearate, magnesium stearate.

In order to achieve the third object, the invention adopts the technical scheme that: the traditional Chinese medicine composition is used for preparing a medicine for preventing and/or treating chronic fatigue syndrome.

The traditional Chinese medicine composition is used for preparing a medicine for preventing and/or treating chronic fatigue syndrome of deficiency of both qi and yin, deficiency of both heart and spleen or liver depression and spleen deficiency.

The traditional Chinese medicine composition is used for preparing a medicine for preventing and/or treating chronic fatigue syndrome with consumption of yin fluid and yang qi in the process of heat disease or chronic and consumptive diseases.

The traditional Chinese medicine composition is used for preparing a medicine for preventing and/or treating chronic fatigue syndrome of consumptive disease which is hyperglycemia.

In the invention, the sun-dried ginseng and the snakegourd fruit are monarch drugs in the formula of the pharmaceutical composition, and the sun-dried ginseng can greatly tonify primordial qi, promote the production of body fluid and quench thirst.

Modern pharmacological research shows that the sun-dried ginseng has the effects of resisting fatigue, enhancing the immunologic function, delaying senility, resisting anoxia, reducing blood pressure, increasing blood sugar and the like.

Gua Lou is sweet and cold in nature, and can moisten dryness, relieve chest stuffiness and promote qi circulation. Pharmacological research shows that the snakegourd fruit has the pharmacological effects of eliminating phlegm, expanding the crown, reducing blood fat, inhibiting bacteria and the like.

The astragalus root is sweet in taste and slightly warm in nature, and the syngeneic sun-dried ginseng and the bighead atractylodes rhizome have strong strength, and researches show that the astragalus root has the effects of promoting the metabolism of an organism, promoting the decomposition of protein, enhancing and regulating the immune function of the organism, improving the fatigue symptoms of a patient and the like. Bighead atractylodes rhizome, rhizoma Atractylodis Macrocephalae, bitter, sweet and warm in taste, has the effects of drying dampness and inducing diuresis, checking sweating and preventing abortion. Researches show that the bighead atractylodes rhizome can protect gastric mucosa, resist oxidation, regulate intestinal microecology, promote gastrointestinal emptying and peristalsis, and promote mouse cell activation and proliferation, so that the anti-inflammatory effect of T cells is improved, and mucosal injury is repaired to resist inflammation. Dendrobe is sweet, bland and slightly cold, has the effects of tonifying stomach and promoting fluid production, nourishing yin and removing heat, and snakegourd fruit can relieve chest stuffiness, moisten intestines, benefit qi and harmonize stomach, and researches show that dendrobe has the functions of recovering the immune function of a mouse, relieving fever and pain, resisting inflammation and the like. Studies have shown that chronic fatigue syndrome with upright intolerance patients have a smaller left ventricular volume and reduced cardiac output than healthy subjects, indicating that the disease may manifest itself as a diminished heart. The three drugs are used as ministerial drugs.

In the formula, the figwort and the dwarf lilyturf tuber nourish yin and increase the fluid, and pharmacological studies show that animal myocardial ischemia, myocardial contractility and ventricular function enhancement, pituitary adrenal cortex system function enhancement, organism social adaptability improvement and the like. The fringed pink and the plantain seed can activate blood and promote menstruation; the cerebral blood flow of CFS patients is lower than that of healthy patients, the fatigue degree of patients with high heart rate and cerebral blood flow is also lower, and the radix ophiopogonis and the semen plantaginis benefit the blood supply of heart, brain and kidney blood flow. Due to the homology of qi and blood and the deficiency of both qi and yin, the blood is also deficient, so the prepared rehmannia root is used for enriching the blood and nourishing yin, and pharmacological studies show that the prepared rehmannia root can promote the synthesis of adrenal cortical hormone, reduce the blood pressure, improve the survival rate and improve the fatigue symptoms of patients with chronic fatigue syndrome. The coptis root has the effects of relieving fever, easing pain, diminishing inflammation, inhibiting bacteria, strengthening heart and the like, and has obvious curative effects of improving tissue and organ pain, low fever and the like of patients with chronic fatigue syndrome. The above drugs are used as adjuvant drugs.

Motherwort is cold, and can promote the production of body fluid through the meridians and blood circulation; cyathula root, radix Cyathulae, as a guiding drug, promotes blood circulation, unblocks the meridians and induces blood to flow downward.

The prescription also has good curative effect on treating amenorrhea due to yin deficiency and stomach heat and infrequent menstruation, scanty menstruation, later menstruation and the like due to deficiency of both qi and yin.

Clinical tests prove that the Chinese medicine symptoms and the laboratory index level are obviously improved, and the research aspect of the laboratory index is as follows: IgA, IgG and IgM in the treated group are all higher than those in the control group, and the clinical curative effect of reducing the serum IFN-gamma and TNF-alpha contents of the patient is more advantageous.

The composition for treating and preventing chronic fatigue syndrome, the preparation method and the application thereof have the following beneficial effects:

1. the compatibility of the traditional Chinese medicine composition accords with the principle of assistant and guide of traditional Chinese medicines, and the traditional Chinese medicine composition can be used for effectively preventing and/or treating chronic fatigue syndrome of deficiency of both qi and yin, deficiency of both heart and spleen, and liver depression and spleen deficiency, particularly chronic fatigue syndrome of deficiency of both qi and yin. Obviously improves the traditional Chinese medicine symptoms and the laboratory index level, can be used as a reference for clinically treating and/or preventing the chronic fatigue syndrome of deficiency of both qi and yin, deficiency of both heart and spleen and liver-stagnation and spleen-deficiency syndrome in the future, has higher clinical application value, and is worthy of further popularization in clinic.

2. The composition, the proportion, the preparation method and the application of the traditional Chinese medicine composition are obtained by screening a large number of tests, and have the advantages of good curative effect and more obvious effect.

Detailed Description

The invention will be further illustrated with reference to specific embodiments. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention. Furthermore, it should be understood that various changes and modifications can be made by one skilled in the art after reading the description of the invention, and equivalents fall within the scope of the appended claims.

Western diagnostic standard for chronic fatigue syndrome refers to the diagnostic standard of the United states centers for disease prevention and control (CDC)1994 chronic fatigue syndrome; the Chinese medicine diagnosis and syndrome differentiation and typing standard of chronic fatigue syndrome refers to the diagnosis standards of Chinese medicine' internal medicine of traditional Chinese medicine (ninth edition) and the guidelines of clinical research on new Chinese medicines (2002 edition).

EXAMPLE 1 preparation of the Chinese medicinal composition of the present invention

Taking the following raw material medicines in parts by weight: 6 parts of sun-dried ginseng, 10 parts of snakegourd fruit, 5 parts of radix astragali preparata, 5 parts of dendrobium, 5 parts of fried bighead atractylodes rhizome, 5 parts of radix scrophulariae, 5 parts of radix ophiopogonis, 10 parts of prepared rehmannia root, 5 parts of fringed pink, 5 parts of semen plantaginis, 2 parts of coptis chinensis, 5 parts of motherwort and 5 parts of medicinal cyathula root, and decocting according to a conventional method.

Example 2 preparation of the Chinese medicinal composition of the present invention

Taking the following raw material medicines in parts by weight: 24 parts of sun-dried ginseng, 60 parts of snakegourd fruit, 30 parts of radix astragali preparata, 30 parts of dendrobium, 30 parts of fried bighead atractylodes rhizome, 30 parts of radix scrophulariae, 30 parts of radix ophiopogonis, 60 parts of prepared rehmannia root, 30 parts of fringed pink, 30 parts of semen plantaginis, 10 parts of coptis chinensis, 30 parts of motherwort and 30 parts of medicinal cyathula root by a conventional method.

Example 3 preparation of the Chinese medicinal composition of the present invention

Taking the following raw material medicines in parts by weight: 9 parts of sun-dried ginseng, 20 parts of snakegourd fruit, 10 parts of radix astragali preparata, 10 parts of dendrobium, 10 parts of fried bighead atractylodes rhizome, 10 parts of radix scrophulariae, 10 parts of radix ophiopogonis, 20 parts of prepared rehmannia root, 10 parts of fringed pink, 10 parts of semen plantaginis, 6 parts of coptis chinensis, 10 parts of motherwort and 10 parts of medicinal cyathula root by a conventional method.

Example 4 preparation of the Chinese medicinal composition of the present Invention (IV)

Taking the following raw material medicines in parts by weight: 15 parts of sun-dried ginseng, 40 parts of snakegourd fruit, 20 parts of radix astragali preparata, 20 parts of dendrobium, 20 parts of fried bighead atractylodes rhizome, 20 parts of radix scrophulariae, 20 parts of radix ophiopogonis, 40 parts of prepared rhizome of rehmannia, 20 parts of fringed pink, 20 parts of semen plantaginis, 9 parts of coptis chinensis, 20 parts of motherwort and 20 parts of medicinal cyathula root by a conventional method.

Example 5 preparation of the Chinese medicinal composition of the present invention (V)

Taking the following raw material medicines in parts by weight: 12 parts of sun-dried ginseng, 30 parts of snakegourd fruit, 15 parts of radix astragali preparata, 15 parts of dendrobium, 15 parts of fried bighead atractylodes rhizome, 15 parts of radix scrophulariae, 15 parts of radix ophiopogonis, 30 parts of prepared rehmannia root, 15 parts of fringed pink, 15 parts of semen plantaginis, 6 parts of coptis chinensis, 12 parts of motherwort and 15 parts of medicinal cyathula root by a conventional method.

Example 6 preparation of the Chinese medicinal composition of the present invention (VI)

Taking the following raw material medicines in parts by weight: 10 parts of sun-dried ginseng, 25 parts of snakegourd fruit, 10 parts of radix astragali preparata, 10 parts of dendrobium, 10 parts of fried bighead atractylodes rhizome, 20 parts of radix scrophulariae, 20 parts of radix ophiopogonis, 25 parts of prepared rehmannia root, 10 parts of fringed pink, 20 parts of semen plantaginis, 9 parts of coptis chinensis, 15 parts of motherwort and 15 parts of medicinal cyathula root, and decocting according to a conventional method.

It should be noted that the conventional method for decocting the raw materials described in examples 1 to 6 is a conventional method for preparing a decoction of Chinese herbs, that is, the raw materials are decocted into a decoction by adding water.

Example 7 preparation of tablets/capsules/granules for prevention and/or treatment of chronic fatigue syndrome:

adding 12-18 times of water into any one of the traditional Chinese medicine compositions, decocting for 2-3 hours, adding 10-12 times of water, decocting for 2-3 hours, combining the two extracting solutions, standing, filtering, vacuum drying and concentrating at 65 ℃, wherein the yield of dry paste is 39.3%, the density of the concentrated clear paste measured at 25 ℃ is 1.05 +/-0.1, crushing into 100-mesh powder, adding pharmaceutically acceptable auxiliary materials, crushing or/and granulating, and preparing into granules or pressing into tablets or filling into capsules.

Example 8 preparation of a pill for prevention and/or treatment of chronic fatigue syndrome:

adding 12-18 times of water into any one of the Chinese medicinal compositions, decocting for 2 hours, adding 10 times of water, decocting for 2 hours, combining the two extracting solutions, standing, filtering, vacuum drying at 60 ℃, concentrating, obtaining a dry extract yield of 39.5%, determining the density of the concentrated clear extract at 25 ℃ to be 1.05 +/-0.1, crushing into 80-mesh powder, adding pharmaceutically acceptable auxiliary materials, crushing, and preparing into pills.

Example 9 preparation of a powder for prevention and/or treatment of chronic fatigue syndrome:

adding 12 times of water into any one of the Chinese medicinal compositions, decocting for 2 hours, adding 10 times of water, decocting for 2 hours, combining the two extracting solutions, standing, filtering, vacuum drying and concentrating at 65 ℃, wherein the yield of the dry paste is 38.3%, the density of the concentrated clear paste measured at 25 ℃ is 1.05 +/-0.1, crushing into 100-mesh powder, adding pharmaceutically acceptable auxiliary materials, and crushing to prepare the powder.

Example 10 preparation of a decoction for preventing and/or treating chronic fatigue syndrome:

adding 12 times of water into any one of the Chinese medicinal compositions, decocting for 2 hours, adding 10 times of water, decocting for 2 hours, combining the two extracting solutions, standing, filtering, vacuum drying and concentrating at 65 ℃, wherein the yield of the dry extract is 38.5%, the density of the concentrated clear paste measured at 25 ℃ is 1.05 +/-0.1, crushing into 100-mesh powder, adding pharmaceutically acceptable auxiliary materials, and crushing to prepare the decoction.

The preparation methods of examples 7-10 were adopted, and 10 batches of each preparation were prepared according to 20 times of the prescription. By referring to the Chinese pharmacopoeia quality detection method, through statistical analysis, the dry paste yield of each type of preparation is more than 38.3%, the contrast transfer rate of monarch drug index components and raw material drugs is more than 92.3%, and the transfer rate of composite index components is more than 90.1%. The similarity of fingerprint spectra of ginsenoside Rg1 reference substance, ginsenoside Re reference substance and ginsenoside Rb1 as monarch drug index components in the same dosage form batch is more than 95.0%; compared with the standard decoction monarch drug index components of ginsenoside Rg1 reference substance, ginsenoside Re reference substance and ginsenoside Rb1, the similarity of fingerprint is more than 90.0%, and the transfer rate of the compound index component is more than 90.3%.

Experiment of drug effect

Example 11 according to the regulations of the state and the guidelines of the evaluation of clinical research and evaluation of drugs, 60 patients with chronic fatigue syndrome of deficiency of both qi and yin who were treated by outpatient service in the third department of traditional Chinese medicine were selected as the subjects to be studied, and were eligible for inclusion, signed an informed consent, and randomly divided into 30 patients each of the study group and the control group.

The experimental method comprises the following steps: the control group is treated by conventional western medicines, and intervenes in coordination with life style such as exercise and psychological adjustment; the study group takes the traditional Chinese medicine composition of the invention on the basis of a control group, takes the traditional Chinese medicine composition 2 bags of one dose and 1 bag of warm water at one time, takes the composition with 150ml of warm water (the dosage of the preparation is calculated and verified by referring to the dosage of the monarch drug index component in quantification), and takes the composition after breakfast and supper.

The treatment course is as follows: 1 course of treatment is 4 weeks, and laboratory and related changes in symptoms before and after 1 course of treatment are observed.

Statistical method

Data were analyzed using SPSS 13.0 statistical software.

The results of clinical observations and changes in laboratory indices are shown in the following table:

TABLE 1 results of changes in clinical laboratory indices

Note: (IL-6), (TNF-. alpha.) mL, (IgA), (IgM), (IgG), (ACTH), (CORT) Normal reference values were: (IL-6)0-5.900pg/mL, (TNF-alpha) 0-8.100pg/, (IgA)0.7-4g/L, (IgM)0.4-2.3g/L, (IgG)7-16g/L, (ACTH) <46.00pg/mL, (CORT)08:00AM 72.6-322.8 ng/mL.

TABLE 2 results of clinical observations and changes in laboratory indices

And (4) conclusion: the total effective rate of the treatment group is obviously higher than that of the control group, the effectiveness of the traditional Chinese medicine composition is confirmed, and meanwhile, the formula analyzes inflammatory factor indexes interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha) from the symptoms of chronic fatigue syndrome; indicators of immune cell levels immunoglobulin a (iga), immunoglobulin m (igm), immunoglobulin g (igg); the hormone level Corticotropin Releasing Hormone (CRH), Adrenocorticotropin (ACTH) and Cortisol (CORT) have obvious improvement effect.

In the aspect of improving the traditional Chinese medicine symptoms, the treatment group is obviously superior to the control group, and the traditional Chinese medicine composition has obvious curative effect on the traditional Chinese medicine symptoms of the qi-yin deficiency type chronic fatigue syndrome while effectively treating the chronic fatigue syndrome.

Example 12 according to the regulations of the state and the guidelines of the evaluation of clinical drug research, 120 patients with chronic fatigue syndrome complicated with long-term abnormal blood glucose and deficiency of both qi and yin at the clinic of the third department of traditional Chinese medicine are selected as the study subjects, meet the inclusion standard, sign informed consent, and divide into 2 experimental groups, and each group is divided into 30 study groups and control groups at random. Wherein 1 group is treated by adopting the prescription drug scheme, and 2 groups are treated by adopting the prescription drug combined with the chemical hypoglycemic drug scheme. The result shows that the total effective rate of 98.12 percent of the treatment group is obviously higher than that of 58.51 percent of the control group, and the total effective rate of 99.51 percent of the treatment group synchronously combined with the chemical hypoglycemic agent is obviously higher than that of 88.51 percent of the control group.

Example 13 according to the regulations of the state and the guidelines of evaluation of clinical research and evaluation of drugs, 60 patients with chronic fatigue syndrome of heart-spleen deficiency type who were treated by outpatient service in the third department of traditional Chinese medicine were selected as study subjects, met the inclusion criteria, signed an informed consent, and randomly divided into 30 patients each of the study group and the control group. The experimental procedure of example 11 showed an effect equivalent to 87.3% of the overall effect of the embodiment of example 11.

Example 14 according to the regulations of the state and the guidelines of the evaluation of clinical drug research, 60 patients with chronic fatigue syndrome with liver depression and spleen deficiency, who were treated by outpatient service in the third department of traditional Chinese medicine, were selected as study subjects, met the inclusion criteria, signed an informed consent, and randomly divided into 30 cases each of the study group and the control group. The experimental procedure of example 11 showed an effect equivalent to 85.6% of the overall effect of the embodiment of example 11.

In conclusion, the traditional Chinese medicine composition can effectively relieve symptoms of patients with chronic fatigue syndrome, obviously improve traditional Chinese medicine symptoms and laboratory index levels, can be used as a reference for clinically treating chronic fatigue syndrome in the future, and is worthy of further clinical popularization.

The above description is only a preferred embodiment of the present invention, and it should be noted that a person skilled in the art may make several modifications and additions without departing from the method of the present invention, and these modifications and additions should also be considered as the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating and preventing chronic fatigue syndrome is characterized by comprising the following raw material medicines in parts by weight: 6-24 parts of sun-dried ginseng, 10-60 parts of snakegourd fruit, 5-30 parts of radix astragali preparata, 5-30 parts of dendrobium, 5-30 parts of fried bighead atractylodes rhizome, 5-30 parts of figwort root, 5-30 parts of radix ophiopogonis, 10-60 parts of prepared rehmannia root, 5-30 parts of fringed pink, 5-30 parts of semen plantaginis, 2-10 parts of coptis chinensis, 5-30 parts of motherwort and 5-30 parts of medicinal cyathula root.

2. The traditional Chinese medicine composition according to claim 1, which is characterized by comprising the following raw material medicines in parts by weight: 9-15 parts of sun-dried ginseng, 20-40 parts of snakegourd fruit, 10-20 parts of radix astragali preparata, 10-20 parts of dendrobium, 10-20 parts of fried bighead atractylodes rhizome, 10-20 parts of figwort root, 10-20 parts of radix ophiopogonis, 20-40 parts of prepared rehmannia root, 10-20 parts of fringed pink, 10-20 parts of semen plantaginis, 6-9 parts of coptis chinensis, 10-20 parts of motherwort and 10-20 parts of medicinal cyathula root.

3. The traditional Chinese medicine composition according to claim 2, which is characterized by comprising the following raw material medicines in parts by weight: 12 parts of sun-dried ginseng, 30 parts of snakegourd fruit, 15 parts of radix astragali preparata, 15 parts of dendrobium, 15 parts of fried bighead atractylodes rhizome, 15 parts of radix scrophulariae, 15 parts of radix ophiopogonis, 30 parts of prepared rhizome of rehmannia, 15 parts of fringed pink, 15 parts of semen plantaginis, 6 parts of coptis chinensis, 12 parts of motherwort and 15 parts of medicinal cyathula root.

4. A pharmaceutical preparation for treating and preventing chronic fatigue syndrome, which is characterized in that: the pharmaceutical preparation is prepared from the traditional Chinese medicine composition of any one of claims 1-3.

5. The preparation method according to claim 4, wherein the dosage form of the pharmaceutical preparation comprises tablets, capsules, granules, pills, decoctions, and powders.

6. A method for preparing a Chinese medicinal composition according to any one of claims 1 to 3, comprising the steps of:

7. The method of claim 4, wherein the water reflux extraction comprises two water reflux extraction processes.

8. The method of claim 7, comprising the steps of:

9. The method according to claim 8, wherein the concentration is vacuum concentration, the drying is vacuum drying, and the temperature of concentration and drying is 65 ℃ or lower.

10. Use of a Chinese medicinal composition according to any one of claims 1 to 3 in the preparation of a medicament for the prevention and/or treatment of chronic fatigue syndrome.

11. Use of the Chinese medicinal composition of any one of claims 1 to 3 in the preparation of a medicament for preventing and/or treating chronic fatigue syndrome of deficiency of both qi and yin, deficiency of both heart and spleen, or liver-qi stagnation and spleen deficiency.

12. Use of a Chinese medicinal composition according to any one of claims 1 to 3 for the preparation of a medicament for the prevention and/or treatment of chronic fatigue syndrome with the consumption of both yin fluid and yang qi, which occurs during febrile diseases or chronic, wasting diseases.

13. Use of the Chinese medicinal composition of any one of claims 1 to 3 for the preparation of a medicament for preventing and/or treating chronic fatigue syndrome in which the wasting disease is a hyperglycemic disease.