Application of traditional Chinese medicine composition in preparation of medicine for preventing and / or treating chronic fatigue syndrome

Abstract

The invention relates to the technical field of traditional Chinese medicines, relates to new application of a traditional Chinese medicine composition, and in particular relates to application of the traditional Chinese medicine composition in preparation of a medicine for preventing and / or treating chronic fatigue syndrome. The traditional Chinese medicine composition is prepared from cassia twig, white peony root, honey-fried licorice root, ginger, jujube, ginseng, Chinese angelica, salted morinda officinalis and dwarf lilyturf tuber. The traditional Chinese medicine composition provided by the invention can obviously prolong exhaustive swimming time of mice and rats with chronic fatigue syndromes, reduce serum inflammatory factor levels of fatigue mice and rats and reduce serum MDA content of rats, and has a good treatment effect on chronic fatigue syndromes.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and more particularly to a new use of a traditional Chinese medicine composition in preparing a medicine for preventing and / or treating chronic fatigue syndrome. Background Art

[0002] Chronic fatigue syndrome (CFS) is a multisystem disorder characterized by chronic, persistent fatigue. Its main symptoms are extreme fatigue, decreased exercise tolerance, and persistent fatigue after exercise. These symptoms are also accompanied by inability to sleep to relieve fatigue, memory loss, and difficulty concentrating. Its severity can cause patients to suffer from numerous physical and mental discomforts, severely impacting their quality of life. The prevalence of CFS varies from 0.4% to 2.6% in different countries worldwide. However, because its etiology and mechanisms remain unclear and diagnostic criteria remain controversial, as many as 91% of affected individuals are undiagnosed or misdiagnosed with other conditions, such as depression.

[0003] Currently recognized treatments for CFS include cognitive behavioral therapy and graded exercise therapy. However, studies have shown that these therapies can worsen patients' symptoms. Drug treatments primarily focus on symptomatic support, and a satisfactory comprehensive treatment plan remains unavailable. Traditional Chinese medicine, guided by the principle of syndrome differentiation and treatment, offers a variety of effective therapies, including Chinese medicine, acupuncture, massage, combined acupuncture and medication, and other adjunctive therapies. Therefore, providing a Chinese medicine composition for chronic fatigue syndrome is of great practical significance. Summary of the Invention

[0004] In view of this, the present invention provides use of a traditional Chinese medicine composition in preparing a medicament for preventing and / or treating chronic fatigue syndrome.

[0005] In order to achieve the above-mentioned object of the invention, the present invention provides the following technical solutions:

[0006] The present invention provides use of a traditional Chinese medicine composition in preparing a medicine for preventing and / or treating chronic fatigue syndrome. The main active ingredients of the traditional Chinese medicine composition include, by weight, 10-25 parts of cassia twig, 10-25 parts of white peony root, 5-25 parts of liquorice root, 10-30 parts of ginger, 15-30 parts of jujube, 10-30 parts of ginseng, 10-30 parts of angelica, 10-30 parts of Morinda officinalis, and 10-30 parts of ophiopogon.

[0007] This prescription utilizes Morinda officinalis (Baotian), a herb from the Foot Shaoyin Meridian, and Panax ginseng (Guangshi), a herb from the Hand Shaoyin Meridian, as the main herbs. Morinda officinalis (Baotian), a herb from the Foot Shaoyin Meridian, is sweet and warm, replenishing fire without scorching water. This combined nourishment of fire and water stimulates the primordial yang from the depths of the cauldron, strengthening essence and protecting spirit. Panax ginseng is sweet, slightly bitter, and slightly warm in nature. It enters the Hand Shaoyin Meridian, nourishing the five internal organs, calming the mind, settling the soul, calming palpitations, opening the heart and improving intelligence. It significantly replenishes vital energy, nourishes qi and blood, and nourishes the heart and calms the mind. These two herbs enter the heart and kidneys, one above and one below, one south and one north, respectively, connecting the heart and kidneys. Angelica sinensis and cinnamon twigs complement the main herbs, nourishing liver blood, invigorating liver wood, and soothing liver qi. Simultaneously, Ophiopogon japonicus and White Peony Root astringe and descend lung metal. Ophiopogon japonicus enters the lung meridian, astringing and descending lung metal and calming nighttime sleepiness, while the sourness of White Peony Root astringes heart qi and calms nighttime sleepiness. These two herbs, one left and one right, one east and one west, elevate the liver and descend the lungs. Ginger, licorice, and jujube are added to pivot the Qi in the middle burner, ensuring harmonious ascending and descending movements and a smooth, orderly rotation of the four dimensions. This formula replenishes body fluids, circulates the spleen and stomach's fluids, and harmonizes the Ying and Wei systems. In this formula, ginseng and Morinda officinalis work together to "strengthen the organs from which skill emerges," enhancing daytime energy. Angelica sinensis and white peony root, being extremely gentle, act as "the root of exhaustion," calming and calming nighttime sleep. The entire formula has the effects of warming the middle and replenishing deficiency, elevating the liver and lungs, connecting the heart and kidneys, harmonizing Qi and blood, and guiding Yang into Yin.

[0008] The sources of raw materials for this recipe are as follows:

[0009] Cinnamon twigs: Dried young twigs of Cinnamomum cassia (Cinnamomum cassia). Serves the Heart, Lung, and Bladder meridians. Pungent, sweet, and warm.

[0010] White peony root: The dried root of Paeonia lactiflora Pall. (Ranunculaceae). It enters the Liver and Spleen meridians. It has a bitter, sour, and slightly cold nature.

[0011] Licorice: The dried root of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat., or Glycyrrhiza glabra L. (all from the Leguminosae family). It enters the Heart, Lung, Spleen, and Stomach meridians. It is sweet and neutral. Roasted licorice root is a processed licorice root. Preparation: Take clean licorice slices, add refined honey and a small amount of boiling water, mix well, and briefly simmer. Stir-fry until yellow or dark yellow. Remove from heat when no longer sticky and let cool.

[0012] Ginger: Fresh rhizome of Zingiber officinale Rosc. (Zingiber officinale Rosc.). It enters the lung, spleen, and stomach meridians. It has a pungent, slightly warming effect.

[0013] Jujube: The dried mature fruit of Ziziphus jujuba Mill. var. inermis (Bunge) Reh d., a plant of the Rhamnaceae family. It enters the spleen and stomach meridians. It has a sweet and warm nature.

[0014] Ginseng: The dried root of Panax ginseng (Camey) in the Araliaceae family. Cultivated ginseng is called "garden ginseng," while sun-dried or oven-dried ginseng is called "raw sun-dried ginseng." It enters the spleen, lung, and heart meridians. It has a sweet, slightly bitter, neutral flavor.

[0015] Angelica sinensis: The dried root of Angelica sinensis (Oliv.) Diels, a plant in the Umbelliferae family. It enters the liver, heart, and spleen meridians. It has a sweet, pungent, and warming effect.

[0016] Morinda officinalis: The dried root of Morinda officinalis (Rubiaceae). It enters the kidney and liver meridians. It has a sweet, pungent, and slightly warming nature.

[0017] Ophiopogon japonicus: The dried root of Ophiopogon japonicus (Thunb.) Ker-Gaw wl., a plant of the Liliaceae family. It enters the Heart, Lung, and Stomach meridians. It has a sweet, slightly bitter, and slightly cold flavor.

[0018] In some specific embodiments of the present invention, the main active ingredients include, by mass: 15 parts of cinnamon twig, 15 parts of white peony root, 12 parts of liquorice, 18 parts of ginger, 18 parts of jujube, 10 parts of ginseng, 15 parts of angelica, 10 parts of Morinda officinalis, and 10 parts of Ophiopogon japonicus.

[0019] In some specific embodiments of the present invention, the licorice root is prepared licorice root, and the Morinda officinalis is salt Morinda officinalis. Prepared licorice root has a sweeter taste and a warmer nature, and has stronger effects of invigorating the spleen and replenishing qi, and warming the middle and tonifying deficiency. Salt Morinda officinalis is warm but not dry, has relatively less toxicity, and has a stronger medicinal effect.

[0020] In some specific embodiments of the present invention, the drug further comprises a medically acceptable excipient. Specifically, the excipient used is a carrier or excipient commonly used in the art, including but not limited to starch, lactose, glucose, sodium carboxymethyl cellulose, ethyl cellulose, methyl cellulose, malt, gelatin, polyols (such as propylene glycol, glycerol, mannitol), compressed tablets, etc., to help improve the stability or activity of the drug, or to produce an acceptable taste or smell when taken orally.

[0021] In some specific embodiments of the present invention, the dosage form of the drug is decoction, tablet, capsule, granule, oral solution or pill, so as to facilitate clinical administration.

[0022] In some specific embodiments of the present invention, the preparation method of the traditional Chinese medicine composition comprises: mixing the raw medicinal materials according to a ratio, decocting them twice with water, decocting them for 1.5 hours with 10 times the amount of water for the first time and decocting them for 1 hour with 8 times the amount of water for the second time, combining the decoctions, filtering, and concentrating the filtrate to an extract with a relative density of 1.10 to 1.20 (60°C).

[0023] In some specific embodiments of the present invention, the preparation method of the drug comprises: mixing the raw medicinal materials according to a ratio, decocting twice with water, decocting for 1.5 hours with 10 times the amount of water for the first time, and decocting for 1 hour with 8 times the amount of water for the second time, combining the decoctions, filtering, concentrating the filtrate to an extract with a relative density of 1.10 to 1.20 (60° C.), and mixing with excipients to obtain the extract;

[0024] Alternatively, the raw medicinal materials are mixed according to the ratio, 8 to 10 times the weight of water are added, and the water extraction is performed twice. The water extracts are combined and concentrated to 1 gram of crude drug / mL.

[0025] In some specific embodiments of the present invention, when the dosage form of the drug is a decoction, the preparation method thereof comprises the following steps:

[0026] Mix the raw medicinal materials according to the proportion, add 8 to 10 times the weight of water and boil for 30 to 40 minutes to obtain the product.

[0027] In some specific embodiments of the present invention, when the dosage form of the drug is tablets, capsules, granules, oral liquid or pills, the preparation method thereof comprises the following steps:

[0028] The raw medicinal materials are mixed according to the proportion, 8 to 10 times the weight of water are added, and the water extraction is performed twice. The water extracts are combined and concentrated to 1 gram of crude drug / mL, and auxiliary materials are added. The corresponding dosage form is prepared according to the conventional method in the field.

[0029] In some specific embodiments of the present invention, the prevention and / or treatment of chronic fatigue syndrome comprises:

[0030] (I) inhibiting inflammation;

[0031] (II) Reduce oxygen free radical damage;

[0032] (III) Delay the course of chronic fatigue syndrome;

[0033] (IV) Increase the body mass of fatigue mice;

[0034] (V) Prolong the time of exhaustive swimming;

[0035] (VI), reducing serum IL-6 and IL-1β levels; and / or

[0036] (VII) Reduce serum TNF-α and MDA levels.

[0037] The present invention provides the use of a traditional Chinese medicine composition in the preparation of a medicament for preventing and / or treating chronic fatigue syndrome. The composition significantly increases the body weight of fatigued mice, significantly prolongs the exhaustive swimming time, and reduces serum IL-6 and IL-1β levels. It also significantly prolongs the exhaustive swimming time and reduces serum TNF-α and MDA levels in rats with chronic fatigue syndrome. This indicates that the traditional Chinese medicine composition can significantly inhibit inflammation, reduce oxygen free radical damage, and delay the course of chronic fatigue syndrome, demonstrating its effective therapeutic effect on chronic fatigue syndrome. DETAILED DESCRIPTION

[0038] The present invention discloses the use of a Chinese medicine composition in the preparation of a medicament for preventing and / or treating chronic fatigue syndrome. Those skilled in the art can refer to the contents of this article and appropriately improve the process parameters to achieve the desired effect. It should be noted that all similar substitutions and modifications are obvious to those skilled in the art and are considered to be included in the present invention. The methods and applications of the present invention have been described through preferred embodiments, and relevant personnel can obviously modify or appropriately change and combine the methods and applications described herein without departing from the content, spirit and scope of the present invention to implement and apply the technology of the present invention.

[0039] Unless otherwise specified, the following experiments were conducted under conventional conditions or those recommended by the manufacturer. All APIs, excipients, reagents, and instruments used, unless the manufacturer is specified, are commercially available. Unless otherwise specified, all percentages, ratios, proportions, and parts are by weight.

[0040] Unless otherwise defined, all professional and scientific terms used herein have the same meaning as those familiar to those skilled in the art. In addition, any methods and materials similar or equivalent to those described herein can be applied to the present invention.

[0041] The present invention will be further described below in conjunction with the embodiments:

[0042] Example 1 Preparation of the Chinese medicine composition granules of the present invention

[0043] Take 250g of cinnamon twig, 250g of white peony root, 200g of roasted licorice root, 300g of ginger, 300g of jujube, 167g of ginseng, 250g of angelica, 167g of Morinda officinalis, and 167g of Ophiopogon japonicus, add water and boil twice, add 10 times the amount of water and boil for 1.5 hours for the first time, and add 8 times the amount of water and boil for 1 hour for the second time, combine the decoctions, filter, and concentrate the filtrate to an extract with a relative density of 1.10-1.20 (60°C) to obtain a traditional Chinese medicine composition, add maltodextrin, dry, grind into fine powder, add maltodextrin, mix, make granules, dry, and make 1000g.

[0044] Experimental Example 2 Therapeutic Effect of Chinese Medicine Composition on Mice with Chronic Fatigue Syndrome

[0045] 1. Experimental Materials

[0046] 1.1 Animals

[0047] Animals: ICR mice, purchased from Hangzhou Medical College, SPF grade, male, animal quality license number: SCXK (Zhejiang) 2019-0002

[0048] Breeding environment: room temperature 20-26℃, relative humidity controlled at 40-70%.

[0049] 1.2 Drugs and reagents

[0050] The traditional Chinese medicine composition prepared in Example 1 was purchased from Jiangsu Kangyuan Pharmaceutical Co., Ltd.; Mouse IL6 ELISA Kit and Mouse IL-1beta / IL1B ELISA Kit were purchased from Wuhan Boster Biotechnology Co., Ltd.; and physiological saline was purchased from Shanghai Beyotime Biotechnology Co., Ltd.

[0051] 1.3 Instruments

[0052] Electronic balance (METTLER TOLEDO, model ME303E); high-speed refrigerated centrifuge (Eppendorf, model BY-20); multifunctional enzyme plate reader (Perkin Elmer, model Inspire); homemade experimental swimming tank.

[0053] 2. Dosage design

[0054] The daily dosage of the Chinese herbal medicine composition was 123 g of crude drug per day. Based on the body surface area conversion method, the equivalent dose for mice was 123 g / 60 kg * 12.3 = 25.22 g of crude drug per kg. This dose was set as the medium-dose group, the low-dose group received 12.61 g of crude drug per kg, and the high-dose group received 50.44 g of crude drug per kg.

[0055] 3. Experimental Methods

[0056] Before the experiment, 50 mice were adaptively fed for 3 days and randomly divided into a blank group, a model group, and a Chinese medicine combination high, medium, and low dose group, with 10 mice in each group. A variety of stressors were used to establish the model, including exhaustion, electric shock, restraint, and cold water stimulation. Except for the blank group, the mice in the other groups were forced to swim and treadmill training every day for 21 consecutive days. One week later, the mice in each group (except the blank group) were restrained and subjected to cold water stimulation for 14 consecutive days. The operation steps are as follows: (1) Forced swimming test: The mice were placed in a homemade swimming box with warm water (23±2)℃ and a water depth that ensured that the mice could not touch the bottom, and forced to swim for 8 to 10 minutes per day. (2) Treadmill training: The mice were stimulated at a speed of 16m / min with a certain intensity of current, once a day for 20 minutes / time. (3) Restraint stress test: The mice were placed in a homemade restraint to restrict their activities for 30 minutes / time, and restrained once a day. (4) Cold water stimulation test: The mice were placed in cold water and swam for 3 to 4 minutes, once a day. The drug was administered orally twice, 0.15 mL each time, for 21 consecutive days starting from day 1. The blank group and the model group were given 0.9% normal saline by oral gavage.

[0057] Modeling evaluation criteria: Chronic fatigue is considered when the mouse's limb movement in the water decreases, the mouse stops struggling while keeping its head above water, and the "immobility period" increases with modeling time. Exhaustion is considered when the mouse's exercise capacity significantly decreases within the set running time and it takes a short break (5 minutes) after running off the treadmill, then continues exercising until it can no longer maintain the original intensity. Successful modeling is indicated by the mouse's loss of appetite, lethargy, drowsiness, and irritability, along with a significant decrease in forced swimming performance. Exhaustion is judged as follows: the mouse remains submerged in water for more than 6 seconds and is unable to perform a righting reflex when placed on a flat surface.

[0058] 4. Statistical methods

[0059] The results were statistically analyzed using t-test.

[0060] 5. Experimental Results

[0061] 5.1 Changes in body weight of mice in each group before and after modeling

[0062] The mice were weighed before and after modeling, and the results are shown in Table 1. Compared with the blank group, there was no significant difference in the body weight of the mice in the model group and the drug-treated group before modeling; after modeling, the body weight of the mice in the model group was significantly reduced compared with the blank group (P < 0.001); and compared with the model group, the body weight of the high- and medium-dose groups of the Chinese medicine composition was significantly increased (P < 0.001, P < 0.05).

[0063] Table 1 Effects on body weight of mice with chronic fatigue syndrome

[0064]

[0065] Note: Compared with the model group, *P<0.05, **P<0.01, ***P<0.001

[0066] 5.2 Changes in exhaustive swimming time of mice in each group before and after modeling

[0067] The results of the exhaustive swimming time are shown in Table 2. Compared with the blank group, the exhaustive swimming time of the mice in the model group was significantly reduced (P<0.01); compared with the model group, the exhaustive swimming time of the mice in the high-dose and medium-dose groups of the Chinese medicine composition were significantly increased (P<0.001, P<0.05).

[0068] Table 2 Effects on exhaustive swimming time in mice with chronic fatigue syndrome

[0069]

[0070] Note: Compared with the model group, *P<0.05, **P<0.01, ***P<0.001

[0071] 5.3 Effects on serum IL-1β and IL-6 in mice with chronic fatigue syndrome

[0072] The ELISA test results are shown in Table 3. Compared with the blank group, the expression of IL-1β and IL-6 in the serum of mice in the model group was significantly increased (P < 0.001). Compared with the model group, the IL-1β level in the high- and low-dose groups of the Chinese medicine composition was significantly decreased (P < 0.001, P < 0.01), and the IL-6 level in the high- and medium-dose groups of the Chinese medicine composition was significantly decreased (P < 0.001, P < 0.01). See Table 3.

[0073] Table 3 Effects on serum inflammatory factors in mice with chronic fatigue syndrome

[0074]

[0075] Note: Compared with the model group, *P<0.05, **P<0.01, ***P<0.001

[0076] 6. Experimental Conclusion

[0077] The Chinese herbal composition of 50.44 and 25.22 g / kg can significantly increase the body weight of mice, prolong the exhaustive swimming time, and reduce the serum IL-6 level. The Chinese herbal composition of 50.44 g / kg can also significantly reduce the IL-1β level, indicating that the Chinese herbal composition has a certain therapeutic effect on chronic fatigue syndrome in mice caused by complex stimulation.

[0078] Experimental Example 3 Therapeutic Effect of Chinese Medicine Composition on Rats with Chronic Fatigue Syndrome

[0079] 1. Experimental Materials

[0080] 1.1 Animals

[0081] Fifty adult male Sprague-Dawley rats, SPF grade, weighing 180–200 g. Animal quality permit number: SCXK (Zhejiang) 2019-0002.

[0082] Rearing environment: room temperature 20-26°C, relative humidity controlled at 40-60%, lighting alternating day and night (12h light / 12h dark).

[0083] 1.2 Medication

[0084] The intermediate of the Chinese medicine composition was prepared according to the method of Example 1 and provided by Jiangsu Kangyuan Pharmaceutical Co., Ltd.; chloral hydrate (purchased from Sinopharm Chemical Reagent Co., Ltd.); Rat TNF-α ELISA Kit (purchased from Wuhan Boster Bioengineering Co., Ltd.); malondialdehyde detection kit (purchased from Beyotime Biotechnology Co., Ltd.)

[0085] 1.3 Instruments

[0086] Low-temperature centrifuge (Eppendorf, model 5804R); electronic balance (METTLER TOLEDO, model ME303E); high-speed refrigerated centrifuge (Eppendorf, model BY-20); multifunctional enzyme plate reader (Perkin Elmer, model Inspire); water tank-type sleep deprivation chamber (Shanghai Yuyan Scientific Instrument Co., Ltd., model SY-3002); homemade experimental swimming tank; homemade restraint cylinder.

[0087] 2. Dosage design

[0088] The daily dose of the Chinese herbal medicine composition was 123 g of the herbal drug per day. Based on the body surface area conversion method, the equivalent dose for rats was 123 g / 60 kg * 6.2 = 12.71 g of herbal drug per kg. This dose was designated the medium-dose group. The low-dose group was 6.36 g of herbal drug per kg, and the high-dose group was 25.42 g of herbal drug per kg. The drug was prepared to a gavage volume of 10 mL / kg per rat. Both the blank and model groups were gavaged with 10 mL / kg of normal saline per day.

[0089] 3. Experimental Methods

[0090] A chronic fatigue syndrome model was established using daily exhaustive swimming, single-day sleep deprivation, and bi-day chronic restraint. Purchased SD rats were adaptively fed for 3 days with free access to feed and water. The rats were randomly divided into a blank group, a model group, a high-dose Chinese medicine composition group, a medium-dose Chinese medicine composition group, and a low-dose Chinese medicine composition group, with 10 rats in each group. Rats in the blank group did not participate in model preparation.

[0091] Perform exhaustive swimming once a day at 9 a.m. Tie a lead sheet weighing about 5% of the rat's body weight to the base of the rat's tail, and then place the rat in a swimming tank to force it to swim. The water depth of the swimming tank is 50-55 cm, ensuring that the lead weight cannot fall to the ground. The standard of exhaustion is when the rat's swimming movements are obviously uncoordinated, or the head sinks into the water for 10 seconds and cannot float to the surface, and the exhaustion time is recorded. Prevent rats from drowning during the experiment. After the rat is fished out, dry the body with a towel and put it back in the cage. Sleep deprivation treatment is performed on odd days, and chronic restraint treatment is performed on even days. Sleep deprivation treatment: The rat is placed in a water-filled box with a small cylindrical platform and deprived of sleep for 20 hours. Chronic restraint treatment: The rat is placed in a restraint cylinder with its head facing the vent, so that it is under a tension level that does not produce strong resistance, and restrained for 3 hours each time. The above-mentioned composite factor stimulation method is used to continuously establish the model for 21 days.

[0092] Drug administration began 7 days after model establishment and was continued by oral gavage for 14 days, once a day.

[0093] The rats' exhaustive swimming time on the first day (before modeling) was compared with their exhaustive swimming time on day 21. After modeling, the rats fasted for 24 hours, and blood was collected from the abdominal aorta under intraperitoneal anesthesia with 0.03% chloral hydrate. Serum levels of tumor necrosis factor-α (TNF-α) and malondialdehyde (MDA) were measured according to the corresponding kit instructions.

[0094] 4. Statistical methods

[0095] The results were statistically analyzed using t-test.

[0096] 5. Experimental Results

[0097] 5.1 Analysis of exhaustive swimming time of rats in each group

[0098] Comparison of the exhausted swimming time on the 1st day and the exhausted swimming time on the 21st day in the model group showed that the exhausted swimming time of the rats was significantly shortened after modeling (P<0.01), indicating that the modeling was successful. Compared with the model group, the exhausted swimming time of the high-dose group and the medium-dose group of the Chinese medicine composition was significantly prolonged (P<0.01). Compared with the exhausted swimming time on the 21st day (i.e., after modeling + drug administration), there was no significant difference in the exhausted swimming time of the high-dose group and the medium-dose group of the Chinese medicine composition (P>0.05). Among them, the average exhausted swimming time on the 21st day in the high-dose group was longer than the average exhausted swimming time on the 1st day. See Table 4.

[0099] Table 4: Comparison of exhaustive swimming time of rats in each group

[0100]

[0101] Note: Compared with the exhaustive swimming time on the first day of this group, #P<0.01; compared with the exhaustive swimming time of the model group on day 21, *P<0.01.

[0102] 5.2 Effects on serum TNF-α in rats with chronic fatigue syndrome

[0103] After establishing a model for chronic fatigue syndrome in rats, serum TNF-α levels were significantly increased compared to the blank group, with a statistically significant difference (P < 0.01). After treatment with the Chinese herbal composition, serum TNF-α levels in the high- and medium-dose groups were significantly decreased compared to the model group, with a statistically significant difference (P < 0.01). See Table 5.

[0104] Table 5: Effects on serum TNF-α in rats with chronic fatigue syndrome

[0105]

[0106] Note: Compared with the blank group, # P<0.01; compared with the model group, *P<0.01.

[0107] 5.3 Effects on serum MDA in rats with chronic fatigue syndrome

[0108] After establishing a model for chronic fatigue syndrome in rats, serum MDA levels were significantly increased compared to the blank group (P < 0.01). After treatment with the Chinese herbal composition, serum MDA levels in the high- and medium-dose groups were significantly decreased compared to the model group (P < 0.01). See Table 6.

[0109] Table 6: Effects on MDA in rats with chronic fatigue syndrome

[0110]

[0111] Note: Compared with the blank group, # P<0.01; compared with the model group, *P<0.01.

[0112] 6. Experimental Conclusion

[0113] The Chinese herbal composition at 25.42 and 12.71 g crude drug / kg can significantly prolong the exhaustive swimming time of rats with chronic fatigue syndrome and reduce the serum TNF-α and MDA levels, indicating that the Chinese herbal composition has a certain therapeutic effect on rats with chronic fatigue syndrome.

[0114] The above embodiments of the present invention are merely examples for the purpose of clearly illustrating the present invention, and are not intended to limit the embodiments of the present invention. Those skilled in the art will appreciate that other variations or modifications may be made based on the above description. It is not necessary and impossible to enumerate all embodiments here. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention shall be included within the scope of protection of the claims of the present invention.

Claims

1. Use of a Chinese medicine composition in the preparation of a medicament for preventing and / or treating chronic fatigue syndrome, characterized in that: In parts by weight, the Chinese medicine composition comprises:

2. The use according to claim 1, characterized in that In parts by weight, the Chinese medicine composition comprises:

3. The use according to claim 1 or 2, characterized in that The licorice is roasted licorice, and the Morinda officinalis is salt Morinda officinalis.

4. The use according to any one of claims 1 to 3, characterized in that The medicine comprises the traditional Chinese medicine composition and pharmaceutically acceptable excipients.

5. The use according to any one of claims 1 to 4, characterized in that The dosage form of the medicine is one or more of granules, decoction, tablets, capsules, oral liquid or pills.

6. The use according to any one of claims 1 to 5, characterized in that The preparation method of the traditional Chinese medicine composition comprises: mixing various raw medicinal materials according to a proportion, decocting with water twice, decocting with 10 times the amount of water for the first time for 1.5 hours, and decocting with 8 times the amount of water for the second time for 1 hour, combining the decoctions, filtering, and concentrating the filtrate to an extract with a relative density of 1.10 to 1.20 (60° C.).

7. The use according to any one of claims 1 to 6, characterized in that The preparation method of the medicine comprises: mixing the raw medicinal materials according to a proportion, decocting with water twice, decocting with 10 times the amount of water for 1.5 hours for the first time and decocting with 8 times the amount of water for 1 hour for the second time, combining the decoctions, filtering, concentrating the filtrate to an extract with a relative density of 1.10 to 1.20 (60° C.), and mixing with auxiliary materials to obtain the extract; Alternatively, the raw medicinal materials are mixed according to the ratio, 8 to 10 times the weight of water are added, and the water extraction is performed twice. The water extracts are combined and concentrated to 1 gram of crude drug / mL.

8. The use according to claim 7, characterized in that When the dosage form of the drug is a granule, the preparation method comprises: mixing the raw medicinal materials according to a proportion, decocting twice with water, decocting for 1.5 hours with 10 times the amount of water for the first time, and decocting for 1 hour with 8 times the amount of water for the second time, combining the decoctions, filtering, concentrating the filtrate to an extract with a relative density of 1.10 to 1.20 (60° C.), adding maltodextrin, drying, crushing into fine powder, adding maltodextrin, mixing, forming granules, and drying to obtain the product; When the dosage form of the drug is a decoction, tablet, capsule, oral solution or pill, the preparation method comprises: mixing the raw medicinal materials according to a proportion, adding 8 to 10 times the weight of water, extracting twice with water, combining the water extracts, concentrating to 1 gram of crude drug / mL, adding excipients, and preparing the corresponding dosage form.

9. The use according to any one of claims 1 to 8, characterized in that The prevention and / or treatment of chronic fatigue syndrome includes: (I) inhibiting inflammation; (II) Reduce oxygen free radical damage; (III) Delay the course of chronic fatigue syndrome; (IV) Increase the body mass of fatigue mice; (V) Prolong the time of exhaustive swimming; (VI), reducing serum IL-6 and IL-1β levels; and / or (VII) Reduce serum TNF-α and MDA levels.

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