A traditional Chinese medicine composition and application thereof

Abstract

The application provides a traditional Chinese medicine composition and application thereof. Animal experiments show that the traditional Chinese medicine composition can prolong the exercise distance, obviously reduce the electric shock times, increase the superoxide dismutase content in the liver, the liver glycogen content and the muscle glycogen content, reduce the lactic acid generation, thereby slowing down the exercise fatigue. The traditional Chinese medicine composition can also prolong the normal pressure anoxia time, prolong the survival time, increase the panting times, reduce the brain oxygen consumption, has a good anti-stress effect, and can effectively treat the immunodepression and cancer fatigue.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of traditional Chinese medicine products, in particular to a traditional Chinese medicine composition and application thereof. BACKGROUND

[0002] In recent years, the incidence of fatigue has shown an increasing trend year by year due to factors such as the acceleration of life rhythm, low immune function caused by diseases, side effects of anticancer drugs, etc., resulting in an increasing number of patients with immunocompromised and cancer-related fatigue and physical and mental fatigue. Immune dysfunction and cancer-related fatigue have attracted great attention from the society and medical staff. Immune dysfunction and cancer-related fatigue are mainly characterized by non-specific weakness, weakness, general decline, sleepiness, fatigue, etc. The characteristics are fast onset, severe degree, long duration, and inability to relieve through rest, etc. In particular, 90% of patients with cancer-related fatigue will experience fatigue during radiotherapy and chemotherapy, which will affect the psychological, physiological and life quality of patients, aggravate the disease, increase the economic burden, and even force patients to give up treatment. These negative effects will eventually exacerbate the symptoms of fatigue, forming a vicious cycle.

[0003] Traditional Chinese medicine believes that fatigue can be attributed to the category of "asthenia", which is caused by the imbalance of qi, blood, yin and yang in the body and the deficiency of visceral essence during the treatment of immune dysfunction and cancer-related fatigue. Syndrome differentiation and treatment is the basis of traditional Chinese medicine treatment. Studies have shown that fatigue syndrome is mostly characterized by deficiency syndrome, and the efficacy of drugs is mainly to support the body and tonify the body, which is in line with the treatment principle of deficiency syndrome. Among them, CN107136249A discloses a Dendrobium candidum tea with anti-fatigue function, which is prepared by combining Dendrobium candidum, American ginseng, Fructus Lycii, Rhizoma Polygonati and green tea. The purpose is to develop a health tea with the function of relieving physical fatigue. Among them, Dendrobium candidum is attributed to the stomach and kidney channels, and has the functions of nourishing yin and clearing heat, strengthening yin and benefiting essence, and has good anti-fatigue effect, can significantly accelerate the elimination of metabolites, and promote the rapid recovery of fatigue. American ginseng tonifies qi and nourishes yin, and the saponin components in it have the effect of eliminating fatigue. The chemical components in Rhizoma Polygonati mainly include steroidal saponins and polygonati polysaccharides, which have good effects on anti-fatigue and anti-aging. Fructus Lycii contains various nutrients and trace elements, and has the effects of anti-fatigue and immune enhancement. However, the composition contains green tea, and only mentions anti-fatigue in general, without discussing the specific fatigue or stress, such as fatigue caused by immune dysfunction, cancer-related fatigue, and various negative physiological stimuli such as brain hypoxia / ischemia. In addition, the addition of green tea may not be suitable for all populations. CN112021566A discloses a Dendrobium candidum American ginseng and Ophiopogon japonicus granule for enhancing immunity, which is mainly composed of Dendrobium candidum, American ginseng and Ophiopogon japonicus, and can also include any one or several of Astragalus membranaceus, Dioscorea, and Rhizoma Polygonati, but it does not involve cancer-related fatigue.

[0004] At present, the prior art only generally uses multiple traditional Chinese medicines to form a drug composition by simple compounding, which often cannot achieve the effect of symptomatic treatment, and the efficacy is not satisfactory. Few in-depth explorations are made on these compounded traditional Chinese medicine compositions, and the best therapeutic effect is achieved while the prescription is simplified. SUMMARY

[0005] The present application provides a traditional Chinese medicine composition and its application, aiming to make in-depth exploration and research on the therapeutic effect of fatigue caused by immunodeficiency, cancer-related fatigue and adverse hypoxia / ischemia stress, and to improve the targeting of the therapeutic effect.

[0006] To solve the above technical problems, the technical scheme of the present application is as follows:

[0007] In a first aspect, the present application provides a traditional Chinese medicine composition prepared from extracts obtained from dendrobium, polygonatum and panax quinquefolium. The weight percentage of dendrobium in the raw material composition is 20-80%.

[0008] Preferably, the weight percentage of dendrobium in the raw material composition is 40-80%, further preferably 50-80%, and more preferably 60-70%.

[0009] Preferably, in 100 parts of the raw material composition, dendrobium is 40-80 parts, polygonatum is 10-30 parts, and panax quinquefolium is 10-30 parts.

[0010] Further preferably, in 100 parts of the raw material composition, dendrobium is 50-70 parts, polygonatum is 10-30 parts, and panax quinquefolium is 10-30 parts.

[0011] More preferably, in 100 parts of the raw material composition, dendrobium is 60 parts, polygonatum is 10-30 parts, and panax quinquefolium is 10-30 parts.

[0012] Preferably, the method for obtaining extracts from dendrobium, polygonatum and panax quinquefolium is as follows: dendrobium, panax quinquefolium and polygonatum are separately or mixedly decocted with water, and the remaining decoction liquid is concentrated after filtration to obtain the extracts.

[0013] In a second aspect, the present application provides a preparation method of the traditional Chinese medicine composition. Dendrobium, panax quinquefolium and polygonatum are mixed, 8-12 times of water by weight is added, and preferably decocted for 2-5 times, each time for 60-100 minutes. The decoction liquid of each time is combined and concentrated to 10-15% of the original volume.

[0014] Preferably, dendrobium, panax quinquefolium and polygonatum are mixed, 9-10 times of water by weight is added, and preferably decocted for 2-3 times, each time for 70-80 minutes. The decoction liquid of each time is combined and concentrated to 10-15% of the original volume.

[0015] In a third aspect, the present application provides the use of the traditional Chinese medicine composition in the preparation of a traditional Chinese medicine product for resisting stimulation and / or enhancing immunity and / or resisting fatigue.

[0016] The stimulation includes hypoxic stimulation and ischemic stimulation, and the fatigue includes common fatigue, fatigue caused by low immunity, cancer fatigue, and the like.

[0017] In a fourth aspect, the present application provides a traditional Chinese medicine product comprising the traditional Chinese medicine composition and necessary excipients.

[0018] At present, most traditional Chinese medicine prescriptions still follow the ancient prescriptions to compound many components, but the components of traditional Chinese medicine are already very complex, and the more the components, the more likely to hinder the efficacy, and it is difficult to determine the components that can truly play the efficacy in the experiment. Therefore, the present application intends to find a suitable compound prescription among the components of Huangqi, Shihu, Dangshen, Xiyangshen, Huangjing and Maidong, and the components all have the effects of tonifying qi and blood, yin and yang, and viscera.

[0019] The present application provides a brand-new traditional Chinese medicine prescription with the functions of resisting common fatigue, cancer fatigue, fatigue caused by low immunity, resisting hypoxic / ischemic stress, and the like. Iron Dendrobium is used as the monarch drug in the prescription, and the components of the monarch drug mainly include polysaccharides and alkaloids. The components of the ministerial drugs Xiyangshen and Huangjing include polysaccharides, saponins and anthraquinone alkaloids, which can help the monarch drug to relieve physical fatigue. The three drugs have additive effects, and can jointly play the effects of benefiting qi, invigorating the spleen, tonifying the kidney and consolidating the root, thereby achieving the purposes of strengthening the body resistance, supplementing deficiency and balancing yin and yang, so as to reduce or eliminate fatigue caused by various diseases.

[0020] Animal experiments show that the traditional Chinese medicine composition of the present application can prolong the exercise distance, obviously reduce the number of electric shocks, increase the content of superoxide dismutase in the liver, the content of liver glycogen and muscle glycogen, and reduce the generation of lactic acid, thereby slowing down exercise fatigue. The traditional Chinese medicine composition can also prolong the time of resisting normal pressure hypoxia, prolong the survival time, increase the number of gasps, reduce the oxygen consumption of the brain, has a good anti-stress effect, and can effectively treat low immunity, cancer fatigue and hypoxic / ischemic stress. BRIEF DESCRIPTION OF DRAWINGS

[0021] Figure 1 D-anhydrous glucose standard curve. DETAILED DESCRIPTION

[0022] In the description of the present application, it should be noted that, if the specific conditions are not indicated in the examples, the conventional conditions or the conditions recommended by the manufacturers are used. If the manufacturers of the reagents or instruments are not indicated, the conventional products that can be purchased in the market are used.

[0023] The application will be further described in detail below with specific examples, which are intended to explain but not limit the application.

[0024] The information of the tested medicinal materials or reagents and instruments used in the embodiments of the application is shown in Table 1 and Table 2 respectively:

[0025] Table 1 Information of the tested medicinal materials or reagents

[0026] Medicinal materials or reagent names Purchase manufacturer Dendrobium nobile Lindl. slice Jinhua Xianyuan Mountain Dendrobium nobile Lindl. Planting Base Co., Ltd. Rhizoma Polygonati Zanthoxyli slice Jiangsu Huahong Pharmaceutical Technology Co., Ltd. Panax quinquefolium slice Yancheng Chinese Medicine Slice Co., Ltd. Radix Astragali slice Hebei Hua Chi Pharmaceutical Co., Ltd. Radix Codonopsis slice Hebei Hua Chi Pharmaceutical Co., Ltd. Radix Ophiopogonis slice Hebei Hua Chi Pharmaceutical Co., Ltd. Anhydrous ethanol Chengdu Kelong Chemical Co., Ltd. D-glucose China Institute for Food and Drug Control Phenol Solarbio Concentrated sulfuric acid Chengdu Kelong Chemical Reagent Factory Lactate dehydrogenase kit Nanjing Jiancheng Bioengineering Institute Malondialdehyde kit Nanjing Jiancheng Bioengineering Institute

[0027] Table 2 Instruments and equipment

[0028] Instrument and equipment names Manufacturer and model Electronic balance BP-211D, startorius, Sartorius, Germany Constant temperature electric heating jacket Shanghai Pinghuan Combustion Equipment Engineering Co., Ltd. Water bath HH-4 digital constant temperature water bath, Guohua Electrical Appliance Co., Ltd. Supergod wave cleaner SK6200H, Shanghai Keduo Ultrasonic Instrument Co., Ltd. Centrifuge Thermo, Sorvall ST16 Animal treadmill ZH-PT5K, ZH-PT5K animal treadmill Microplate reader TECAN, TECAN (Shanghai) Trading Co., Ltd. Full-wavelength spectrophotometer Beijing Puran General Instrument Co., Ltd.

[0029] In the embodiments of the application, the extraction and content determination method of polysaccharide is as follows:

[0030] (1) Preparation of the control solution

[0031] Accurately weigh 50.72 mg of D-anhydrous glucose control into a 10 ml solution bottle, dissolve and dilute to the mark with double distilled water, shake well, accurately take 1 ml into a 50 ml volumetric flask, and dilute to the mark with distilled water, shake well, and thus the control solution containing 0.1014 mg of glucose per milliliter is obtained.

[0032] (2) Determination of the standard curve

[0033] Accurately take 0.1, 0.2, 0.3, 0.4, 0.5, 0.6 and 0.7 ml of the D-anhydrous glucose control solution into 20 ml stoppered test tubes respectively, add distilled water to 2.0 ml, accurately add 1.0 ml of 6% phenol solution (prepared by adding 3.00 g of phenol into 50 ml of distilled water), shake well, accurately add 5.0 ml of concentrated sulfuric acid, shake well, place in a boiling water bath for 20 min, and take out. Place in an ice bath for 5 min, and determine the absorbance A at 450 nm in an enzyme marker with the corresponding reagent as blank. Take the A value as the vertical coordinate (Y), and take the glucose concentration (mg / ml) in the corresponding test tube as the horizontal coordinate. Draw the standard curve, and obtain the regression equation. y = 12.343X + 0.0366, R = 0.9991, as shown in Table 3, 2- = 0.9991, as shown in Table 3, Figure 1 The D-anhydrous glucose concentration is in the range of 0.005 mg / ml-0.035 mg / ml, and the linear relationship is good.

[0034] Table 3 Absorbance values and glucose concentrations of glucose standard solutions with different concentrations

[0035] Absorbance value (A) 0.465 0.410 0.350 0.230 0.220 0.161 Glucose concentration (mg / mL) 0.035 0.030 0.025 0.020 0.015 0.010

[0036] Example 1

[0037] Preparation of extract and polysaccharide determination:

[0038] The preparation process of the extract is as follows: add 10 times the amount of water to the traditional Chinese medicine raw material, decoct for 3 times, each time for 80 minutes, combine the decocting liquid of each time, and concentrate to 10% of the original volume for subsequent efficacy experiments (the feeding amount in the efficacy experiment is calculated according to the crude drug feeding amount). The composition of the traditional Chinese medicine raw material (total amount 100 g), polysaccharide extraction amount, and extract yield are shown in Table 4.

[0039] Table 4 Raw material composition and results

[0040]

[0041]

[0042] Among them, the comparison 1 group, the comparison 2 group, and the comparison 3 group are respectively from the examples 1-3 of CN107136249A, and the preparation method is referred to the example 2 of CN107136249A, specifically: decoct the dendrobium officinale for 1.5 hours with water, the amount of water is 9 times; add the panax quinquefolium, the medlar, and the polygonatum, continue to decoct and extract, the decocting time is 1.5 hours, filter, continue to decoct and extract for 2 times with 9 times the amount of water, the decocting time is 1.5 hours, filter; concentrate to 10% of the original volume.

[0043] Efficacy test of example 2 against ordinary fatigue

[0044] The efficacy test of verifying the anti-fatigue effect of the traditional Chinese medicine composition on the body fatigue (ordinary fatigue) of mice (determination of mouse running time) is as follows:

[0045] Purpose of the experiment: through the determination of the running time of mice in various groups, observe the influence of various traditional Chinese medicine groups on the running distance and the number of electric shocks of mice, and then determine whether these traditional Chinese medicine groups have anti-fatigue effect.

[0046] Test method for determination of mouse running time

[0047] Select pre-test qualified mice and randomly divide them into 18 groups: experimental animals: SPF healthy Kunming mice, female, body weight 18-22 g, a total of 180. Randomly allocate, 10 mice in each group, place the mice in the electric treadmill, run for 5 minutes per day on the first day, 10 m / min, electric stimulation 0.6 mA; electric shock 15 times / 15 s, run for 7 minutes per day on the second day, 10 m / min, electric stimulation 0.6 mA; electric shock 10 times / 20 s, run for 10 minutes per day on the third day, 12 m / min, electric stimulation 0.6 mA; electric shock 15 times / 20 s, eliminate mice that cannot adapt to running on the treadmill. Randomly divide the qualified mice into groups:

[0048] Blank group: normal saline 20 ml / kg (gavage volume),

[0049] Dexamethasone Western medicine positive group: 20 ml / kg (gavage volume), 2 mg / kg (dose), 0.1 mg / ml (concentration), prepared with normal saline, same below;

[0050] 0.1 mg / ml (dose), prepared with normal saline, same below;

[0051] Large strain rhodiola capsule traditional Chinese medicine positive group (remove the traditional Chinese medicine from the capsule, same below): 20 ml / kg (gavage volume), 1.52 g / kg (dose), 0.076 g / ml (concentration);

[0052] Other test groups refer to Example 1, Compound 1 group to Compound 12 group, and Comparative 1 group to Comparative 3 group: 20 ml / kg (gavage volume), 10 g / kg (dose), 0.5 g / ml (concentration).

[0053] The animals in each group were given gavage for 10 consecutive days, and trained for 10 min (12 m / min, electric stimulation 0.6 mA; 10 times of electric shock per 20 s, angle 5°) every day for 3 days before the experiment, 20 min (12 m / min, electric stimulation 0.6 mA; 10 times of electric shock per 20 s, angle 10°) for the second and third days. One hour after the last gavage, the treadmill was turned on, and the mice in each group were first warmed up at 12 m / min for 5 min; then the speed was set at 18 m / min, the time was set at 59 min, 10 times of electric shock per 20 s, and the angle was set at 10°. After the completion of the test, the mice were placed on the track of the treadmill until the treadmill stopped, and the data were printed. After the completion of the test, the liver of the mice was taken, and homogenized with normal saline (10%), centrifuged at 2500 x g for 15 min, and the supernatant was taken, and the content was measured by using an LDH kit. The results are shown in Tables 5 and 6.

[0054] Table 5 Effects of different traditional Chinese medicine extracts on the body weight and organs of mice (X ± S)

[0055]

[0056]

[0057]

[0058] Note: ΔΔP < 0.01 compared with the blank group, ΔP < 0.05 compared with the blank group, and the last two decimal places are retained.

[0059] Table 5 shows the results: The Dendrobium, American ginseng, and Polygonatum compound group, and the positive control group (Rhodiola rosea) showed no significant difference in mouse body weight before the experiment, after drug intervention, and at the end of the experiment compared to the control group. The positive control group (dexamethasone) showed no significant difference in mouse body weight before the experiment, but after drug intervention and at the end of the experiment, the mouse body weight decreased, showing a significant difference compared to the control group (P<0.01).

[0060] At the end of the experiment, there was no significant difference in the liver organ coefficient between the Dendrobium, American ginseng, and Polygonatum compound group and the positive control group (Rhodiola rosea). However, the positive control group (dexamethasone) showed a significant reduction in liver weight at the end of the experiment compared to the control group (P<0.05). Therefore, the Dendrobium, American ginseng, and Polygonatum compound group had no significant effect on mouse body weight and liver weight.

[0061] Table 6. Effects of different Chinese herbal extracts on running time and LDH in mice (X±S)

[0062]

[0063]

[0064] Note: ΔP < 0.01 is compared with the blank group, and ΔP < 0.05 is compared with the blank group, retaining two decimal places.

[0065] Table 6 shows that, in treating induced fatigue, Dendrobium, American ginseng, and Polygonatum compound groups 5, 11, and 12 significantly reduced the number of electric shocks (59 min) during running in mice, showing a significant difference compared to the control group (P<0.01). Comparison groups 1-3 showed a trend towards reducing the number of electric shocks, but the effect was weaker than compound groups 5, 11, and 12, comparable to compound group 10, and slightly better than other compound groups, indicating that the components and dosages have significantly different therapeutic effects on specific symptoms. Furthermore, the Dendrobium, American ginseng, and Polygonatum compound groups, as well as comparison groups 1-3, significantly reduced LDH concentration in the liver of mice, showing a significant difference compared to the control group (P<0.01). The Western medicine positive group and the traditional Chinese medicine positive group significantly reduced LDH concentration in the liver of mice, showing a significant difference compared to the control group (P<0.01).

[0066] Example 3: Test for resistance to hypoxic stimulation

[0067] Experimental Objective: Hypoxia is a detrimental stimulus to the body, affecting various metabolic processes, particularly oxidative energy supply, ultimately leading to death due to insufficient oxygen supply to vital organs such as the heart and brain. This experiment used respiratory arrest and death in mice under normobaric hypoxic conditions as the standard to observe the effects of different traditional Chinese medicine formulations on the hypoxia tolerance of mice.

[0068] The test method for verifying tolerance to atmospheric hypoxia time is as follows:

[0069] SPF level healthy Kunming mice, half male and half female, body weight 18-22g. 180, randomly divided into 18 groups, 10 in each group:

[0070] The blank group: normal saline 20ml / kg (gavage volume),

[0071] Dexamethasone Western medicine positive group: 20ml / kg (gavage volume), 2mg / kg (dose), 0.1mg / ml (concentration),

[0072] 0.1mg / ml (dose),

[0073] Large strain of red ginseng capsule traditional Chinese medicine positive group: 20ml / kg (gavage volume), 1.52g / kg (dose), 0.076g / ml (concentration);

[0074] Other test groups see Example 1 of compound 1 group~compound 12 group: 20ml / kg (gavage volume), 10g / kg (dose), 0.5g / ml (concentration).

[0075] SPF level healthy Kunming mice, normal feeding for 3 days, the above groups of animals were given by gavage, 10 days of intervention, 1h after the last dose, the mice were placed in a 250ml wide-mouth bottle containing 15g sodium lime, the bottle mouth was smeared with vaseline to make it not leaky, the mice were observed to breathe, the time from the mice were placed in the bottle, tightly capped bottle to respiratory arrest was recorded, that is, the survival time of mice. After the end of the hypoxia experiment, the mouse liver was taken out and weighed to calculate the organ index, 0.2g was precisely weighed with physiological saline as the extraction liquid 10% tissue homogenate, 3000xg centrifugation for 15min, the supernatant was taken, and the content was determined by malondialdehyde (MDA) kit according to the kit method. The results are shown in Tables 7 and 8.

[0076] Table 7 Effect of different traditional Chinese medicine extracts on the time of mice to resist normal pressure hypoxia and organs (X±S)

[0077]

[0078]

[0079] Note: ΔΔP<0.01 compared with the blank group, ΔP<0.05 compared with the blank group, the last two decimal places are retained.

[0080] The results of Table 7 show that the Dacemethasone group and the Rhodiola, American ginseng, and Polygonatum multiflorum compound group did not have significant differences in the body weight of the mice before the experiment, after the drug intervention, and at the end of the experiment, compared with the blank group. The Dacemethasone group had a significant difference (P<0.01, P<0.05) in the body weight of the mice after the drug intervention and at the end of the experiment, compared with the blank group.

[0081] The blank group had a significantly shorter time of tolerance to normobaric hypoxia, and the Rhodiola, American ginseng, and Polygonatum multiflorum compound groups 5, 11, and 12 and the comparison group 3 could significantly prolong the time of tolerance to normobaric hypoxia, compared with the blank group and the other experimental groups (P<0.01, P<0.05).

[0082] Table 8 shows the effect of different traditional Chinese medicine extracts on the MDA content in the liver of mice (X±S)

[0083]

[0084]

[0085] Note: ΔΔP<0.01 compared with the blank group, and ΔP<0.05 compared with the blank group, with three decimal places retained.

[0086] Table 8 shows that the MDA concentration in the liver of the blank group was significantly increased, and the Rhodiola, American ginseng, and Polygonatum multiflorum compound groups and the comparison groups 1-3 could significantly reduce the MDA concentration in the liver of the mice, compared with the blank group (P<0.01). Among them, the MDA concentration in the compound groups 5 and 11 was relatively significantly reduced. The Dacemethasone group and the Rhodiola sachet group could significantly reduce the MDA concentration in the liver of the mice, compared with the blank group (P<0.01).

[0087] The above studies show that the Rhodiola, American ginseng, and Polygonatum multiflorum compound groups can significantly reduce the lactate dehydrogenase concentration in the liver of the mice, prolong the running distance of the mice, significantly reduce the malondialdehyde concentration in the liver, and prolong the time of tolerance to normobaric hypoxia, and have a good anti-fatigue effect.

[0088] Example 4: Effect of different doses of traditional Chinese medicine compound on fatigue and hypoxic / ischemic stimulation

[0089] The purpose of the experiment is to select the compound group 5 based on the results of Example 2 and observe the effect of the group on the anti-stress ability and fatigue mechanism of normal animals. The normobaric hypoxia test, anti-fatigue test, and decapitation gasping test are used. The contents of lactic acid, superoxide dismutase, muscle glycogen, and liver glycogen are detected to clarify the anti-fatigue effect of the Rhodiola, American ginseng, and Polygonatum multiflorum compound on normal animals.

[0090] 1. Anti-fatigue test (determination of running time of mice)

[0091] Purpose of the experiment: Through the determination of running time of mice by Dendrobium, Rhizoma Polygonati, Panax quinquefolium, observe whether Dendrobium, Rhizoma Polygonati, Panax quinquefolium can prolong the running distance of mice, reduce the number of electric shocks, and judge whether it has anti-fatigue effect.

[0092] Test method of the influence of compound 5 group on the running distance of mice

[0093] Experimental animals: SPF healthy Kunming mice, female, body weight 18-22g. 96, 16 in each group, put the mice on the electric treadmill to run at 10m / min, electric stimulation 0.6mA; electric shock 10 times / 30s, eliminate mice that cannot adapt to running on the treadmill. Select qualified mice from pre-test and randomly divide them into 6 groups:

[0094] Blank group: 20ml / kg (gavage volume), 0.1mg / ml (dose concentration),

[0095] Dexamethasone Western medicine positive group: 20ml / kg (gavage volume), 2mg / kg (dose), 0.1mg / ml (dose concentration),

[0096] Large strain Rhodiola capsule traditional Chinese medicine positive group: 20ml / kg (gavage volume), 1.52g / kg (dose), 0.076g / ml (dose concentration),

[0097] High dose of compound: 20ml / kg (gavage volume), 10g / kg (dose),

[0098] Medium dose of compound: 20ml / kg (gavage volume), 5g / kg (dose),

[0099] Low dose of compound: 20ml / kg (gavage volume), 2.5g / kg (dose),

[0100] Gavage the above groups of animals, for 10 consecutive days, 3 days before the experiment every day for training;

[0101] The first day 10 min (12 m / min, electric stimulation 0.6 mA; electric shock 10 times / 20 s, angle 5°), the second day 20 min (12 m / min, electric stimulation 0.6 mA; electric shock 10 times / 20 s, angle 10°), the third day 20 min (12 m / min, electric stimulation 0.6 mA; electric shock 10 times / 20 s, angle 10°), after the last gavage administration 1 h, open the treadmill, each group of mice at a speed of 18 m / min, time 60 min, electric shock 10 times / 20 s, angle 10°, the mice were put into the runway of the treadmill until the treadmill stopped, and the data were printed. After the running experiment was finished, the mouse liver was taken, and the physiological saline was used for tissue homogenate (10%), 2500xg centrifugation for 15 min, and the supernatant was taken. The contents of lactic acid (LD), superoxide dismutase (SOD), muscle glycogen and liver glycogen were determined by using a kit. The experimental results are shown in Tables 9-12;

[0102] Table 9 Effects of D. candidum, P. quinquefolium and Polygonatum on the body weight and organs of mice

[0103]

[0104]

[0105] Note: ΔΔP<0.01 compared with the blank group, ΔP<0.05 compared with the blank group, and the last two decimal points are reserved.

[0106] Table 9 shows that, except for the dexamethasone group, there is no obvious difference in body weight during the administration period compared with the blank group, that is, the low, medium and high dose groups of D. candidum, P. quinquefolium and Polygonatum have no obvious effect on the body weight of mice (P>0.05).

[0107] The body weight of the western medicine dexamethasone group during the administration period is significantly reduced, and there is a significant difference in body weight compared with the blank group (P<0.01), and the western medicine dexamethasone group has a certain effect on the body weight of mice.

[0108] Table 10 Effects of D. candidum, P. quinquefolium and Polygonatum on the running time of mice

[0109]

[0110]

[0111] Note: ΔΔP<0.01 compared with the blank group, ΔP<0.05 compared with the blank group, the average value in each group of data is reserved to one decimal place, and the deviation is reserved to two decimal places.

[0112] ​Table 10 shows that the running distance and the number of electric shocks in the first 10 minutes after the intervention in each administration group had no significant difference compared with the blank group.

[0113] When the continuous drug intervention, the second 20 min running distance of the movement of dexamethasone group was significantly prolonged, and had significant difference compared with the blank group (P<0.01). The number of electric shocks in the running time of the high dose and the middle dose of compound group was significantly reduced, and had significant difference compared with the blank group (P<0.05).

[0114] When the continuous drug intervention, the third 20 min running distance of the movement of dexamethasone group and rhodiola group was significantly prolonged, and had significant difference compared with the blank group (P<0.05, P<0.01). The third 20 min running distance of the movement of dendrobium, American ginseng and rhizoma polygonati group was significantly prolonged, but had no significant difference compared with the blank group. The number of electric shocks in the running time of the high dose of compound group and rhodiola group was significantly reduced, and had significant difference compared with the blank group (P<0.05).

[0115] After the last administration for 1 hour, the 60 min running distance of the movement of dexamethasone group and rhodiola group was significantly prolonged, and had significant difference compared with the blank group (P<0.01). The running distance of the movement of the high dose and the middle dose of compound group was significantly prolonged, and had significant difference compared with the blank group (P<0.01), which had significant anti-fatigue effect.

[0116] Table 11 shows the effect of dendrobium, American ginseng and rhizoma polygonati group on the SOD and lactic acid content in the liver of normal mice

[0117]

[0118]

[0119]

[0120] Note: ΔΔP<0.01 compared with the blank group, retaining three decimal places.

[0121] Table 11 shows that the SOD content in the liver of mice in dexamethasone group, rhodiola group, high, middle and low dose of compound group was significantly increased, and the lactic acid content was significantly reduced, which had significant difference compared with the blank group (P<0.01). Therefore, the five groups of compound can increase the SOD content in the liver of mice and reduce the lactic acid content, which has the ability to enhance the body to remove free radicals and reduce fatigue.

[0122] Table 12 shows the effect of dendrobium, American ginseng and rhizoma polygonati group on the glycogen content in the liver and muscle of normal mice

[0123]

[0124] Note: ΔΔP <0.01 compared with the blank group, and the last three decimal places are retained.

[0125] Table 12 shows that the dexamethasone group, the Rhodiola group, and the high, medium, and low dose groups of the compound prescription significantly increased the liver glycogen content and muscle glycogen content in mice, with significant differences compared with the blank group (P <0.01). Therefore, the Compound 5 group can slow down exercise fatigue and enhance the anti-stress effect by increasing the liver glycogen and muscle glycogen content in mice.

[0126] 2. Anti-stimulation test (determination of resistance to hypoxia time)

[0127] Purpose of the experiment: Hypoxia is a poor stimulus to the body, affecting various metabolisms of the body, especially affecting the body's oxidative energy supply, ultimately leading to insufficient oxygen supply to important organs such as the heart and brain of the body and death. In this experiment, the respiratory arrest and death of mice under normal pressure hypoxia conditions were used as the standard to observe the effect of Compound 5 group on the hypoxia tolerance of mice.

[0128] The test method of Compound 5 group for determining the resistance to normal pressure hypoxia time is as follows:

[0129] Experimental animals: SPF healthy Kunming mice, half male and half female, weighing 18-22g. 60 mice, 10 mice in each group, were randomly divided into 6 groups:

[0130] Blank group: normal saline 20ml / kg (gavage volume),

[0131] Dexamethasone Western medicine positive group: 20ml / kg (gavage volume), 2mg / kg (dose), 0.1mg / ml (concentration),

[0132] Rhodiola capsule traditional Chinese medicine positive group: 20ml / kg (gavage volume), 1.52g / kg (dose), 0.076g / ml (concentration),

[0133] High dose of compound prescription: 20ml / kg (gavage volume), 10g / kg (dose),

[0134] Medium dose of compound prescription: 20ml / kg (gavage volume), 5g / kg (dose),

[0135] Low dose of compound prescription: 20ml / kg (gavage volume), 2.5g / kg (dose),

[0136] The animals of each group above were given intragastric administration continuously for 10 days. One hour after the last administration, the mice were put into 250 ml jars with 15 g sodium lime, the jar opening was smeared with vaseline to prevent air leakage, and the mice breathing was observed. The time from the mice being put into the jar to the breathing stopping was recorded, which was the survival time of the mice. The experimental results are shown in Table 13 and Table 14.

[0137] Table 13 Effects of Dendrobium, American ginseng and Polygonatum on the body weight of mice (x ± s)

[0138] Group Initial body weight (g) One-week body weight (g) Final body weight (g) Blank group 21.0±1.10 29.2±1.65 33.7±2.05 Dexamethasone group 20.8±1.02 25.9 ± 1.09 ΔΔ ]] 28.1 ± 2.24 ΔΔ ]] Rhodiola sachalinskis group 20.7±1.18 29.8±1.86 33.6±3.63 High-dose group 20.7±1.09 30.1±1.38 33.8±1.67 Medium-dose group 20.9±1.21 30.2±2.69 34.3±5.49 Low-dose group 20.8±1.20 30.1±1.90 34.3±3.83

[0139] Note: ΔΔP < 0.01, ΔP < 0.05 compared with the blank group, the average value in each group of data is kept to one decimal place, and the deviation is kept to two decimal places.

[0140] The experimental results are shown in Table 13: after one week of administration, the body weight of the dexamethasone group was significantly reduced, and there was a significant difference compared with the blank group (P < 0.01). The body weight of each dose group of the Dendrobium, American ginseng and Polygonatum formula and the Rhodiola kirilowii group during administration had no significant difference compared with the blank group. Therefore, the Dendrobium, American ginseng and Polygonatum formula had no significant effect on the body weight of mice.

[0141] Table 14 Effects of Dendrobium, American ginseng and Polygonatum formula on the normal pressure anoxia time of mice (x ± s)

[0142] Group Survival time (min) Survival time extension (%) Blank group 26.5±5.34 / Dexamethasone group 46.2 ± 7.33 ΔΔ ]] 74.3 Rhodiola sachalinskis group 32.1 ± 3.48 ΔΔ ]] 21.1 High-dose group 34.2 ± 7.07 ΔΔ ]] 29.1 Medium-dose group 38.2 ± 9.75 ΔΔ ]] 44.2 Low-dose group 30.2±5.81 13.9

[0143] Note: ΔΔP < 0.01, ΔP < 0.05 compared with the blank group, the average value in the survival time is kept to one decimal place, and the deviation is kept to two decimal places; the survival time extension is kept to one decimal place.

[0144] The experimental results are shown in Table 14: after 10 days of continuous intragastric administration, the normal pressure anoxia survival time of mice in the dexamethasone group, the Rhodiola kirilowii group, and the high and medium dose groups of the formula was significantly prolonged, and there was a significant difference compared with the blank group (P < 0.01). The normal pressure anoxia survival time of mice in the low dose group of the formula had a trend of prolongation, but there was no significant difference compared with the blank group.

[0145] The results of the normal pressure anoxia time experiment showed that the Dendrobium, American ginseng and Polygonatum formula had a good anti-fatigue effect through prolonging the normal pressure anoxia time of mice.

[0146] 3. Anti-ischemic stress test (open mouth and breathe experiment after decapitation)

[0147] Purpose of the experiment: after decapitation, the original blood and nutrients in the brain can maintain the brain function for a short time, and the mouse shows regular mouth breathing. With the breathing time as the index, the protective effect of the drug on cerebral ischemia can be observed. Through the influence of Dendrobium, American ginseng and polygonatum combination on the breathing time of mice after decapitation, whether Dendrobium, American ginseng and polygonatum combination has anti-stress effect is observed.

[0148] Dendrobium, American ginseng and polygonatum combination on the mouth breathing test method of mice after decapitation

[0149] SPF healthy Kunming mice were taken as experimental animals, half male and half female, weighing 18-22g. 60 mice, 10 mice in each group, were randomly divided into 6 groups:

[0150] Blank group: normal saline 20ml / kg (gavage volume),

[0151] Dexamethasone Western medicine positive group: 20ml / kg (gavage volume), 2mg / kg (dose), 0.1mg / ml (concentration),

[0152] Large strain of red clover capsule traditional Chinese medicine positive group: 20ml / kg (gavage volume), 1.52g / kg (dose), 0.076g / ml (concentration),

[0153] Combination (Dendrobium, American ginseng and polygonatum) high dose: 20ml / kg (gavage volume), 10g / kg (dose),

[0154] Combination (Dendrobium, American ginseng and polygonatum) medium dose: 20ml / kg (gavage volume), 5g / kg (dose),

[0155] Combination (Dendrobium, American ginseng and polygonatum) low dose: 20ml / kg (gavage volume), 2.5g / kg (dose),

[0156] The above animals were given gavage, for 10 consecutive days, 1h after the last administration, each group of mice was decapitated from the back of the ear root, and the number of mice from decapitation to mouth breathing stop was recorded, as shown in Table 15.

[0157] Table 15 Influence of Dendrobium, American ginseng and polygonatum combination on body weight and breathing time of mice (X±S)

[0158]

[0159] Note: ΔΔP<0.01, ΔP<0.05 compared with the blank group, the average value in each group of data is retained after the first decimal point, and the deviation is retained after the second decimal point.

[0160] The experimental results show that: when continuously giving the Dendrobium, American ginseng, and polygonatum group intervention, the mouse after decapitation breathing times significantly increased, compared with the blank group has significant difference (P<0.01, P<0.05). Dendrobium, American ginseng, and polygonatum low, medium, and high dose group can reduce brain oxygen consumption by increasing the mouse after decapitation breathing times, has good anti-stress effect.

[0161] In summary: Dendrobium, American ginseng, and polygonatum group can slow down the fatigue by extending the mouse movement distance, improving the mouse liver SOD content, and reducing lactic acid production, thereby reducing the fatigue, prolonging the mouse hypoxic time, and increasing the mouse after decapitation breathing times to reduce brain oxygen consumption, thereby enhancing the anti-fatigue effect.

[0162] Example 5 Effect test of cancer-related fatigue

[0163] Further investigate the effect of Example 1 compound 5 group: Dendrobium 60g, polygonatum 20g, American ginseng 20g in low, medium, and high doses on the immune function low fatigue combined with cancer-related fatigue in mice induced by cyclophosphamide:

[0164] Experimental purpose: observe the effect of compound 5 group on the anti-stress ability and fatigue mechanism of immune function low fatigue combined with cancer-related fatigue in mice induced by cyclophosphamide (anti-cancer drug). The experiment uses normal pressure hypoxia test, anti-fatigue test, and decapitation breathing test. The contents of lactic acid, superoxide dismutase, muscle glycogen, and liver glycogen are detected to clarify the effect of Dendrobium, polygonatum, and American ginseng group on cancer-related fatigue.

[0165] 1. Determination of the normal pressure hypoxia time of compound 5 group on immune function low fatigue combined with cancer-related fatigue in mice induced by cyclophosphamide

[0166] Experimental purpose:

[0167] Hypoxia is a poor stimulus to the body, affecting various metabolisms of the body, especially affecting the body's oxidative energy supply, ultimately leading to insufficient energy supply of important organs such as heart and brain, and death. In this experiment, mice were induced to produce immune function low fatigue combined with cancer-related fatigue by intraperitoneal injection of cyclophosphamide 50mg / kg, every other day for two times. The anti-hypoxia effect of different doses of Dendrobium, American ginseng, and polygonatum group on immune function low fatigue combined with cancer-related fatigue in mice was observed to clarify whether Dendrobium, polygonatum, and American ginseng group has obvious anti-fatigue effect on cancer-related fatigue in mice.

[0168] Method of Dendrobium, American ginseng, and polygonatum group on normal pressure hypoxia test of immune function low fatigue combined with cancer-related fatigue in mice induced by cyclophosphamide

[0169] Experimental animals SPF level healthy Kunming mice, half male and half female, weighing 18-22 g, were given cyclophosphamide to form immunocompromised and cancer-induced fatigue mice by the above method. A total of 60 mice, 10 mice in each group, were randomly divided into 6 groups:

[0170] Blank group: 20 ml / kg (gavage volume), physiological saline,

[0171] Dexamethasone Western medicine positive group: 20 ml / kg (gavage volume), 2 mg / kg (dose), 0.1 mg / ml (concentration),

[0172] Large strain of rhodiola capsules traditional Chinese medicine positive group: 20 ml / kg (gavage volume), 1.52 g / kg (dose), 0.076 g / ml (concentration),

[0173] High dose of group formula (dendrobium, American ginseng, polygonatum): 20 ml / kg (gavage volume), 10 g / kg (dose),

[0174] Medium dose of group formula (dendrobium, American ginseng, polygonatum): 20 ml / kg (gavage volume), 5 g / kg (dose),

[0175] Low dose of group formula (dendrobium, American ginseng, polygonatum): 20 ml / kg (gavage volume), 2.5 g / kg (dose),

[0176] The above groups of animals were given gavage, for 10 consecutive days, and each group was given intraperitoneal injection of 50 mg / kg cyclophosphamide on the 7th and 9th day of administration, respectively, to form an immunocompromised and cancer-induced fatigue animal model. One hour after the last administration, the mice were placed in a 250 ml wide-mouth bottle containing 15 g of sodium lime, the bottle opening was smeared with vaseline to prevent air leakage, and the mice were observed for breathing. The time from when the mice were placed in the bottle to when the breathing stopped was recorded, which was the survival time of the mice. After the experiment, the liver, spleen and thymus of the mice were weighed to calculate the organ index. The experimental results are shown in Tables 16 and 17.

[0177] Table 16 Effect of dendrobium, American ginseng and polygonatum formula on body weight and normal pressure hypoxia tolerance time of immunocompromised and cancer-induced fatigue mice (x ± s)

[0178]

[0179] Note: ΔΔP < 0.01, ΔP < 0.05 compared with the blank group. The average value in each group of data is retained to one decimal place, and the deviation is retained to two decimal places.

[0180] The experimental results are shown in Table 16: the body weight of the dexamethasone group was significantly reduced after one week of administration and at the end of the experiment, and there was a significant difference compared with the blank group (P<0.01). The body weight of the Dendrobium, American ginseng and polygonatum group at each dose and the Rhodiola group during administration had no significant difference compared with the blank group. Apparently, the Dendrobium, American ginseng and polygonatum group had no significant effect on the body weight of the mice with low immune function and fatigue combined with cancer-induced fatigue.

[0181] After continuous intragastric administration for 10 days, the survival time of the mice in the dexamethasone group, the Rhodiola group and the high and medium dose groups of the Dendrobium, American ginseng and polygonatum group under normobaric hypoxia was significantly prolonged, and there was a significant difference compared with the blank group (P<0.01, P<0.05). The survival time of the mice in the low dose group of the Dendrobium, American ginseng and polygonatum group under normobaric hypoxia had a tendency to be prolonged, but there was no statistical difference compared with the blank group. Therefore, the Dendrobium, American ginseng and polygonatum group had a good effect on the normobaric hypoxia of the mice with low immune function and fatigue combined with cancer-induced fatigue.

[0182] Table 17 Effect of the Dendrobium, American ginseng and polygonatum group on the organs of the mice with low immune function and fatigue combined with cancer-induced fatigue (x±s)

[0183]

[0184] Note: ΔΔP<0.01, ΔP<0.05 compared with the blank group, the average value of the last body weight is retained to one decimal place, the deviation is retained to two decimal places; the other data is retained to three decimal places.

[0185] The experimental results are shown in Table 17: after continuous intragastric administration for 10 days, the spleen and thymus of the mice were weighed to calculate the organ index. The spleen index and thymus coefficient of the mice in the dexamethasone group were significantly reduced, and there was a significant difference compared with the blank group (P<0.01); the thymus coefficient of the mice in the medium and high dose groups of the Dendrobium, American ginseng and polygonatum group was significantly increased, and there was a significant difference compared with the blank group (P<0.05); the organ index of the mice in the low dose group of the Dendrobium, American ginseng and polygonatum group and the Rhodiola group had no significant difference compared with the blank group. Therefore, the Dendrobium, American ginseng and polygonatum group can increase the thymus coefficient of the mice with low immune function and fatigue combined with cancer-induced fatigue.

[0186] 2. Determination of the running time of the mice with low immune function and fatigue combined with cancer-induced fatigue by the Dendrobium, American ginseng and polygonatum group (Example 1, Compound 5 group: Dendrobium 60g, American ginseng 20g, polygonatum 20g)

[0187] Experimental purposes: KM mice (6-8 weeks old), female, intraperitoneal injection of cyclophosphamide 50mg / kg, two consecutive days to produce low immune function in mice fatigue combined with cancer fatigue, the mouse is placed on the electric treadmill, observe the different doses of Dendrobium, American ginseng, polygonatum group on low immune function in mice fatigue combined with cancer fatigue running distance and shock times, to clarify the Dendrobium, polygonatum, American ginseng group on low immune function in mice fatigue combined with cancer fatigue whether it has anti-fatigue effect.

[0188] Dendrobium, American ginseng, polygonatum group on low immune function in mice fatigue combined with cancer fatigue running time determination method

[0189] Experimental animals SPF healthy Kunming mice, female, body weight 18-22g. 84, 14 in each group, the low immune function in mice fatigue combined with cancer fatigue is placed on the electric treadmill running 10m / min, electric stimulation 0.6mA; electric shock 30 times / 30s, eliminate the mouse can not adapt to the treadmill running. Select pre-test qualified mice randomly divided into 6 groups:

[0190] Blank group: normal saline 20ml / kg (gavage volume),

[0191] Dexamethasone western medicine positive group: 20ml / kg (gavage volume), 2mg / kg (dose), 0.1mg / ml (concentration),

[0192] Rhodiola crenula capsule traditional Chinese medicine positive group: 20ml / kg (gavage volume), 1.52g / kg (dose), 0.076g / ml (concentration),

[0193] Group (Dendrobium, American ginseng, polygonatum) high dose: 20ml / kg (gavage volume), 10g / kg (dose),

[0194] Group (Dendrobium, American ginseng, polygonatum) medium dose: 20ml / kg (gavage volume), 5g / kg (dose),

[0195] Group (Dendrobium, American ginseng, polygonatum) low dose: 20ml / kg (gavage volume), 2.5g / kg (dose),

[0196] The above animals were given gavage, after 8 days of administration, the above animals were trained, except for the blank control group, the rest of the groups were intraperitoneally injected with cyclophosphamide 50mg / kg, 2 times in a row, to cause low immune function in animals fatigue combined with cancer fatigue model, 1h after the last administration, the 8th day, open the treadmill, put the mouse into the running track of the treadmill to carry out anti-fatigue test.

[0197] Day 8 20min (16m / min, electrical stimulation 0.6mA; electric shock 30 times / 30s, angle 10°),

[0198] Day 9 20min (16m / min, electrical stimulation 0.6mA; electric shock 30 times / 30s, angle 10°),

[0199] Day 10 60min (16m / min, electrical stimulation 0.6mA; electric shock 30 times / 30s, angle 10°),

[0200] After the last gavage administration 1h, the mice were taken blood from the eye socket, and the liver, spleen, thymus were weighed to calculate the organ index. The liver and muscle tissues of the mice were homogenized with normal saline (10%), centrifuged at 3000xg for 10min, and the supernatant was taken. The lactic acid (LD), superoxide dismutase (SOD), liver glycogen content and muscle glycogen content were determined using a Nanjing Jiancheng kit. The experimental results are shown in Tables 18 to 21.

[0201] Table 18 Effect of Dendrobium, American ginseng and polygonatum combination on organ coefficient of immunocompromised and fatigue mice combined with cancer-related fatigue

[0202]

[0203] Note: ΔΔP<0.01 compared with the blank group, ΔP<0.05 compared with the blank group, the average value of the last body weight is retained to one decimal place, and the deviation is retained to two decimal places; the average value of the liver is retained to two decimal places, and the deviation is retained to three decimal places; other data are retained to three decimal places.

[0204] The results are shown in Table 18: the thymus coefficient and spleen coefficient of the dexamethasone group were significantly reduced, and the liver coefficient was increased, which had significant differences compared with the blank group (P<0.01, P<0.05). The spleen coefficient of the Rhodiola group was decreased, which had a significant difference compared with the blank group (P<0.05). The thymus coefficient of the combination group was significantly increased, which had a significant difference compared with the blank group (P<0.05). Therefore, the Dendrobium, American ginseng and polygonatum combination can enhance the thymus coefficient of immunocompromised and fatigue mice combined with cancer-related fatigue.

[0205] Table 19 Effect of Dendrobium, American ginseng and polygonatum combination on exercise distance and electric shock times of immunocompromised and fatigue mice combined with cancer-related fatigue

[0206]

[0207]

[0208] Note: ΔΔP<0.01, ΔP<0.05 compared with the blank group

[0209] Results are shown in Table 19: After continuous drug intervention, the second 20 min and third 60 min running time, the dexamethasone group, Rhodiola group, Shengmai group, and each dose of the group formula significantly reduced the number of electric shocks in the mice with immune dysfunction fatigue combined with cancer fatigue, and had a significant difference compared with the blank group (P<0.01). The exercise distance was prolonged. Therefore, the Dendrobium, American ginseng, and Polygonatum group formula has an anti-fatigue effect by reducing the number of electric shocks in the mice and prolonging the exercise distance.

[0210] Table 20 Effect of Dendrobium, American ginseng, and Polygonatum group formula on the content of liver glycogen in the liver and muscle glycogen in the muscle of the mice with immune dysfunction fatigue combined with cancer fatigue

[0211]

[0212] Note: ΔΔP<0.01, compared with the blank group, the data is kept to three decimal places.

[0213] As shown in Table 20: The dexamethasone group, Rhodiola group, Shengmai group, and high, medium, and low dose groups of the group formula significantly increased the content of liver glycogen in the liver and muscle glycogen in the muscle of the mice, and had a significant difference compared with the blank group (P<0.01). Therefore, the Dendrobium, American ginseng, and Polygonatum group formula can enhance the anti-stress effect by increasing the content of liver glycogen in the liver and muscle glycogen in the muscle of the mice with immune dysfunction fatigue combined with cancer fatigue.

[0214] Table 21 Effect of Dendrobium, American ginseng, and Polygonatum group formula on the content of SOD in the liver and the content of lactic acid in the serum of the mice with immune dysfunction fatigue combined with cancer fatigue

[0215]

[0216]

[0217] Note: ΔΔP<0.01, compared with the blank group, the data is kept to three decimal places.

[0218] As shown in Table 21: The dexamethasone group, Rhodiola group, Dendrobium, American ginseng, and Polygonatum group formula high, medium, and low dose groups significantly increased the content of SOD in the liver and significantly reduced the content of lactic acid in the serum of the mice, and had a significant difference compared with the blank group (P<0.01). It is suggested that the Dendrobium, American ginseng, and Polygonatum group formula can enhance the body's ability to scavenge free radicals and enhance the anti-stress effect by increasing the content of SOD in the mice and reducing the content of lactic acid in the serum of the mice with immune dysfunction fatigue combined with cancer fatigue.

[0219] 3. Dendrobium, American ginseng, and polygonatum combination on the open mouth and gasping test after decapitation in mice with immunocompromised fatigue combined with cancer-related fatigue

[0220] Objective: After decapitation, the original blood and nutrients in the brain can maintain brain function for a short time, and the mouse shows regular mouth breathing. The gasping time is used as an indicator to observe the protective effect of drugs on cerebral ischemia. Any drug that can reduce brain oxygen consumption can prolong the mouse's gasping time. In this experiment, 50 mg / kg of cyclophosphamide was injected intraperitoneally for two consecutive days to induce immunocompromised fatigue combined with cancer-related fatigue in mice. The gasping time of mice with immunocompromised fatigue combined with cancer-related fatigue was observed at different doses of Dendrobium, American ginseng, and polygonatum combination to determine whether the Dendrobium, American ginseng, and polygonatum combination had a protective effect on cerebral ischemia in mice with immunocompromised fatigue combined with cancer-related fatigue induced by cyclophosphamide.

[0221] Method of Dendrobium, American ginseng, and polygonatum combination on the open mouth and gasping test after decapitation in mice with immunocompromised fatigue combined with cancer-related fatigue

[0222] Experimental animals: SPF healthy Kunming mice, half male and half female, weighing 18-22 g. 60 mice, 10 mice in each group, after inducing immunocompromised fatigue combined with cancer-related fatigue, the mice were randomly divided into 6 groups:

[0223] Blank group: 20 ml / kg (gavage volume), 0.1 mg / ml (dose concentration),

[0224] Dexamethasone Western medicine positive group: 20 ml / kg (gavage volume), 2 mg / kg (dose), 0.1 mg / ml (dose concentration),

[0225] Large strain red ginseng capsule traditional Chinese medicine positive group: 20 ml / kg (gavage volume), 1.52 g / kg (dose), 0.076 g / ml (dose concentration),

[0226] High dose of combination (Dendrobium, American ginseng, and polygonatum): 20 ml / kg (gavage volume), 10 g / kg (dose),

[0227] Medium dose of combination (Dendrobium, American ginseng, and polygonatum): 20 ml / kg (gavage volume), 5 g / kg (dose),

[0228] Low dose of combination (Dendrobium, American ginseng, and polygonatum): 20 ml / kg (gavage volume), 2.5 g / kg (dose),

[0229] The animals of each group were given intragastrical administration continuously for 10 days, and the animals of each group were given intraperitoneal injection of 50 mg / kg cyclophosphamide on the 7th day and the 9th day of administration, respectively, to cause the animal model of immunocompromised fatigue combined with cancer-induced fatigue, and 1 hour after the last administration, the mice were decapitated from the back of the ear root one by one, and the breath counts of the mice after decapitation were recorded, as shown in Table 22.

[0230] Table 22 Effects of Dendrobium, American ginseng and polygonatum group on body weight and breath time of immunocompromised fatigue combined with cancer-induced fatigue mice

[0231]

[0232] Note: ΔΔP < 0.01, ΔP < 0.05 compared with the blank group, the average value is retained to one decimal place, and the deviation is retained to two decimal places.

[0233] The experimental results are shown in Table 22: the mice of each administration group were given intragastrical administration continuously for 10 days, and one week later, the body weight of the mice of the dexamethasone group was significantly reduced, and there was a significant difference (P < 0.01) compared with the blank group. 1 hour after the last administration, the animals of each group were decapitated from the back of the ear root one by one, and the breath counts of the mice of the Rhodiola crenulata group, the dexamethasone group, the Dendrobium, American ginseng and polygonatum group were significantly increased, and there was a significant difference (P < 0.01, P < 0.05) compared with the blank group. Therefore, the Dendrobium, American ginseng and polygonatum group can reduce brain oxygen consumption and has a protective effect on cerebral ischemia.

[0234] In summary: the Dendrobium, American ginseng and polygonatum group can enhance the thymus coefficient of immunocompromised fatigue combined with cancer-induced fatigue mice, prolong the shock frequency and exercise distance of mice, increase the SOD content of immunocompromised fatigue combined with cancer-induced fatigue mice and reduce the lactic acid content in serum, enhance the ability of the body to scavenge free radicals, increase the glycogen content in the liver and muscle of immunocompromised fatigue combined with cancer-induced fatigue mice, and has an anti-fatigue effect. It has a good tolerance to normal pressure hypoxia on immunocompromised fatigue combined with cancer-induced fatigue mice. It can reduce brain oxygen consumption and has a protective effect on cerebral ischemia. It has an enhanced anti-fatigue effect.

[0235] The above-described embodiments only express several embodiments of the present application, and the description is more specific and detailed, but it cannot be understood as a limitation on the scope of the patent of the present application. It should be noted that for ordinary skilled persons in the art, several modifications and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent of the present application should be subject to the appended claims.

Claims

1. The application of a traditional Chinese medicine composition in the preparation of a drug for treating cancer-related fatigue, characterized in that, The traditional Chinese medicine composition is made from extracts obtained from Dendrobium officinale, Polygonatum sibiricum, and American ginseng; and in every 100 parts of raw materials, Dendrobium officinale accounts for 60 parts, Polygonatum sibiricum accounts for 20 parts, and American ginseng accounts for 20 parts.

2. The application according to claim 1, characterized in that, The method for obtaining extracts from Dendrobium officinale, Polygonatum sibiricum, and American ginseng is as follows: Dendrobium officinale, American ginseng, and Polygonatum sibiricum are decocted separately or in combination with water, filtered, and the remaining decoction is concentrated to obtain the extract.

3. The application according to claim 2, characterized in that, The preparation of the traditional Chinese medicine composition includes: mixing Dendrobium officinale, American ginseng, and Polygonatum sibiricum, adding 8-12 times the weight volume of water, decocting 2-5 times, each time for 60-100 minutes, combining the decoctions from each decoction and concentrating to 10-15% of the original volume.

4. The application according to claim 3, characterized in that, The preparation of the traditional Chinese medicine composition includes: mixing Dendrobium officinale, American ginseng, and Polygonatum sibiricum, adding 9-10 times the weight volume of water, decocting 2-3 times, each time for 70-80 minutes, combining the decoctions from each decoction and concentrating to 10-15% of the original volume.

5. A drug for treating cancer-related fatigue, comprising the traditional Chinese medicine composition and excipients described in any one of claims 1 to 4.

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