Traditional Chinese medicine composition for treating cancer-related fatigue of intestinal cancer as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention provides a traditional Chinese medicine composition for treating cancer-related fatigue of intestinal cancer as well as a preparation method and application thereof, and belongs to the technical field of medicines. The traditional Chinese medicine composition comprises the following components in parts by weight: 3-30 parts of radix bupleuri, 5-30 parts of radix paeoniae alba, 5-30 parts of angelica sinensis, 3-20 parts of albizia flowers, 10-60 parts of hairyvein agrimony, 5-40 parts of coix seeds, 5-30 parts of roasted rhizoma atractylodis macrocephalae, 5-30 parts of poria cocos, 5-60 parts of astragalus membranaceus, 5-30 parts of codonopsis pilosula or 3-15 parts of ginseng, 5-30 parts of dahurian patrinia herb, 3-20 parts of sargentgloryvine stem, 5-20 parts of fiveleaf akebia fruit and 1-10 parts of cooked rhubarb. The traditional Chinese medicine composition is designed aiming at the pathogenesis of colorectal cancer caused fatigue, is composed of traditional Chinese medicines for soothing liver, invigorating spleen, replenishing qi, clearing heat, eliminating dampness and detoxifying, can strengthen body resistance, eliminate pathogenic factors and treat both symptoms and root causes, and can soothe liver, invigorating spleen, eliminating dampness, detoxifying, harmonizing qi and blood and giving consideration to internal organs by combining the medicines; the traditional Chinese medicine composition has a good effect of preventing and treating cancer-related fatigue, can quickly, remarkably and durably relieve fatigue of cancer-related fatigue patients, and has no side effect or addiction to human bodies.

Description

Technical Field

[0001] The present invention belongs to the field of medical technology, and more specifically, relates to a traditional Chinese medicine composition for treating cancer-related fatigue of intestinal cancer, and a preparation method and application thereof. Background Art

[0002] Malignant tumors seriously threaten people's lives and health. Cancer accounts for 23.9% of all causes of death among Chinese residents. With the continuous advancement of medical technology, the cure rate of cancer is also increasing year by year, and the quality of life of cancer patients has gradually received more attention. The incidence of cancer-related fatigue during tumor treatment is 65%-100%. NCCN included cancer-related fatigue in 2000, defining it as a painful, persistent subjective fatigue related to tumors or tumor treatment, including physiological, emotional and cognitive levels. It can be seen that cancer-related fatigue is a typical physical and psychological disease. It is not only a lack of physical sensory strength, but also affects the patient's inner emotional world and cognitive response to the outside world, seriously reducing the patient's quality of life, increasing the fear of tumors and treatment, weakening compliance, and even forcing patients to refuse treatment without reason.

[0003] The pathogenesis of cancer-related fatigue is relatively complex and is still unclear. Most studies believe that there are mainly the following mechanisms: (1) Neurotransmitter imbalance: 5-HT is an inhibitory neurotransmitter that is mainly distributed in the cerebral cortex and nerve synapses and is involved in the regulation of pain, sleep, mood and other functions. (2) Mitochondrial and skeletal muscle dysfunction: When cancer or its treatment damages mitochondria, it will lead to impaired adenosine triphosphate (ATP) synthesis and reduced cellular energy supply. ATP is the main energy source for skeletal muscle contraction. Its deficiency or depletion will affect muscle function, leading to fatigue and decreased exercise capacity, which will affect the quality of life. (3) Cytokine abnormalities: Cytokines are small molecule proteins with biological activity synthesized and secreted by immune cells or non-immune cells. They are closely related to the occurrence and development of various physiological and pathological processes in the human body. (4) Immune dysfunction: Studies have found that the changes in fatigue in patients with cancer-related fatigue are consistent with the changes in immune function. Strengthening immune function can help improve symptoms such as fatigue. (5) The patient's own condition: Most cancer patients do not have a correct understanding of their own disease and often experience fear, anxiety, and depression, which can induce or aggravate cancer-related fatigue.

[0004] For the treatment of cancer-related fatigue, according to NCCN and domestic treatment guidelines, current clinical treatment measures are mainly divided into two categories: one is drug intervention, including central nervous system stimulants (such as methylphenidate), corticosteroids, etc. Studies have found that the central nervous system stimulant methylphenidate has improved mental fatigue, depression and anxiety, but withdrawal will significantly worsen mental fatigue, depression and anxiety. Ferro Matteo and other scholars found that if corticosteroids are used for a long time, the patient's fatigue level is twice that of the control group. The second is non-drug intervention, including physical activity, massage therapy, psychosocial intervention, nutritional counseling, sleep cognitive behavioral therapy, and bright white light therapy. Analysis results show that non-drug intervention, especially exercise intervention and psychological intervention, can effectively improve cancer-related fatigue, but the disadvantages are also obvious. Professional personnel are needed to assist and guide, and it is difficult for patients to persist.

[0005] In general, the following problems exist in the current clinical treatment of cancer-related fatigue: (1) Non-drug therapies usually take effect slowly and require long-term persistence and cooperation from patients, and are more suitable as adjuvant treatments; (2) Psychostimulants such as methylphenidate and modafinil can improve patients' fatigue levels, but studies have shown that they are ineffective for patients with mild or moderate fatigue, and long-term use is addictive; (3) Corticosteroids such as dexamethasone are more suitable for use before chemotherapy, which can improve fatigue and alleviate the adverse reactions of chemotherapy, but long-term use of corticosteroids has a variety of adverse reactions and may aggravate fatigue; (4) Hematopoietic drugs, analgesics, etc. are only suitable for cancer-related fatigue caused by certain reasons and are not universally applicable.

[0006] Colorectal cancer is one of the most common clinical tumors. According to statistics from some scholars, the incidence of colorectal cancer-related fatigue is 89.1%, of which 50% suffer from moderate to severe fatigue. The occurrence of cancer-related fatigue is related to many factors, such as the progression of the tumor itself, tumor-related treatments, the condition of the tumor patient himself, and other social and psychological factors. The occurrence of cancer-related fatigue will also affect the patient's physical, emotional, cognitive and other functions, which not only reduces the patient's quality of life, but also affects the treatment of cancer. It is a major problem that needs to be solved. However, there is currently no effective drug for colorectal cancer-related fatigue that is fast-acting, has few side effects, is non-addictive, and has a wide range of applications. Summary of the invention

[0007] The purpose of the present invention is to provide a Chinese medicine composition for treating cancer-related fatigue of colorectal cancer, as well as a preparation method and application thereof. The Chinese medicine composition is a Chinese medicine composition for fatigue after cancer surgery, chemoradiotherapy, targeted therapy and immunotherapy of colorectal cancer. The Chinese medicine composition has good effect in preventing and treating cancer-related fatigue, high efficiency, no side effects to the human body, and no addiction.

[0008] To achieve the above objectives, in a first aspect, the present invention provides a traditional Chinese medicine composition for treating cancer-related fatigue in intestinal cancer, comprising the following ingredients in parts by weight: 3-30 parts of bupleurum, 5-30 parts of white peony root, 5-30 parts of angelica root, 3-20 parts of julibrissin, 10-60 parts of agrimony, 5-40 parts of coix seeds, 5-30 parts of stir-fried atractylodes, 5-30 parts of poria, 5-60 parts of astragalus, 5-30 parts of codonopsis pilosula or 3-15 parts of ginseng, 5-30 parts of patrinia herb, 3-20 parts of clary vine, 5-20 parts of aconite, and 1-10 parts of cooked rhubarb.

[0009] Furthermore, it contains the following ingredients in parts by weight: 9-24 parts of bupleurum, 10-15 parts of white peony root, 10-15 parts of angelica, 10-15 parts of julibrissin, 15-30 parts of agrimony, 10-30 parts of coix seed, 10-20 parts of stir-fried atractylodes, 10-20 parts of poria, 10-30 parts of astragalus, 10-20 parts of codonopsis pilosula or 5-12 parts of ginseng, 10-20 parts of patrinia herb, 5-15 parts of scutellaria baicalensis, 10-15 parts of amaranth, and 3-6 parts of cooked rhubarb.

[0010] Furthermore, it contains the following ingredients in parts by weight: 12 parts of bupleurum, 10 parts of white peony root, 10 parts of angelica, 10 parts of julibrissin, 15 parts of agrimony, 12 parts of coix seed, 12 parts of stir-fried atractylodes, 12 parts of poria, 15 parts of astragalus, 10 parts of codonopsis pilosula or 10 parts of ginseng, 12 parts of patrinia herb, 10 parts of scutellaria baicalensis, 10 parts of amaranth, and 3 parts of cooked rhubarb.

[0011] The second aspect of the present invention provides a traditional Chinese medicine preparation for treating colorectal cancer-related fatigue, comprising any one of the above-mentioned traditional Chinese medicine compositions.

[0012] Furthermore, the Chinese medicine preparation is a decoction or granules.

[0013] The third aspect of the present invention provides a method for preparing a Chinese medicine preparation for treating cancer-related fatigue in intestinal cancer, comprising the following steps:

[0014] Mix the formulated amounts of bupleurum, white peony root, angelica, julibrissin, agrimony, coix seed, stir-fried atractylodes, tuckahoe, astragalus, codonopsis or ginseng, patrinia herb, scutellaria baicalensis, amaranth, and cooked rhubarb, soak in water, then boil, filter the boiled medicinal liquid, and retain the filtrate.

[0015] Furthermore, the decoction is performed twice, and the ratio of the total weight of the Chinese medicinal materials to the weight of water during the first decoction can be (1-2): (10-15), and the ratio of the total weight of the Chinese medicinal materials to the weight of water during the second decoction is (1-2): (5-10).

[0016] Furthermore, the decoction is performed three times, and the ratio of the total weight of the Chinese medicinal materials to the weight of water during the first decoction is (1-2): (5-20), and the ratio of the total weight of the Chinese medicinal materials to the weight of water during the second decoction is (1-2): (5-10); the ratio of the total weight of the Chinese medicinal materials to the weight of water during the third decoction is (1-2): (5-10); the filtrates after the three decoctions are combined and concentrated under reduced pressure to a relative density of 1.1-1.15 at 60°C, and after filtering again, water is added to the filtrate to obtain a water decoction; or the filtrates after the three decoctions are combined and concentrated under reduced pressure to a clear paste with a relative density of 1.2-1.25 at 50°C, and a one-step granulation method is adopted, with dextrin and mannitol at a ratio of 8:1 as the base material, and the clear paste is sprayed to obtain granules.

[0017] Further, the following steps are included:

[0018] The granules are directly mixed with the formulated amounts of bupleurum, white peony root, angelica root, julibrissin flower, agrimony herb, coix seed, stir-fried atractylodes, tuckahoe, astragalus, codonopsis pilosula or ginseng, patrinia herb, scutellaria baicalensis, aconite root and cooked rhubarb.

[0019] The fourth aspect of the present invention provides the use of the above-mentioned Chinese medicine composition in the preparation of a medicament for treating cancer-related fatigue caused by intestinal cancer.

[0020] Compared with the prior art, the present invention has the following technical effects:

[0021] The Chinese medicine composition for treating cancer-related fatigue of intestinal cancer of the present invention is designed for the pathogenesis of cancer-related fatigue of large intestine cancer, and is composed of Chinese medicines for soothing liver, strengthening spleen and replenishing qi and clearing away heat, removing dampness and detoxifying. The Chinese medicine composition can strengthen the body and eliminate evil, and treat both the symptoms and the root causes. The combination of the medicines can soothe the liver, strengthen spleen, remove dampness and detoxify, harmonize qi and blood, and take care of the internal organs. The Chinese medicine composition has good effects on preventing and treating cancer-related fatigue, can quickly, significantly and lastingly relieve fatigue in patients with cancer-related fatigue, and has no side effects and is non-addictive to the human body. Clinical research and practice show that the Chinese medicine composition can also improve traditional Chinese medicine symptoms, relieve emotions, and improve sleep, thereby improving the clinical treatment effect of patients with cancer-related fatigue and improving the quality of life.

[0022] The Chinese medicine preparation for treating cancer-related fatigue of intestinal cancer of the present invention comprises the Chinese medicine composition of the present invention, and it also has the above advantages, which will not be described in detail here.

[0023] The preparation method of the traditional Chinese medicine preparation for treating cancer-related fatigue of intestinal cancer of the present invention is simple, can be prepared by batch production, and is suitable for popularization and application.

[0024] The Chinese medicine composition for treating colorectal cancer-related fatigue of the present invention has a significant therapeutic effect in preventing and treating colorectal cancer-related fatigue, and has broad application prospects in preparing drugs for treating colorectal cancer-related fatigue. DETAILED DESCRIPTION

[0025] In order to make the technical problems, technical solutions and beneficial effects to be solved by the present invention more clearly understood, the present invention is further described in detail below in conjunction with the embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0026] The terms used in the embodiments of the present invention are only for the purpose of describing specific embodiments, and are not intended to limit the present invention. The singular forms "a", "said" and "the" used in the embodiments of the present invention and the appended claims are also intended to include plural forms, unless the context clearly indicates other meanings.

[0027] Compared with cancer-related fatigue caused by other cancers, the diagnosis and treatment of colorectal cancer-related fatigue in traditional Chinese medicine is special. At present, the academic community unanimously believes that the pathogenesis of colorectal cancer is spleen deficiency, damp-heat and toxic accumulation. In view of this pathogenesis, the inventors of the present invention proposed a Chinese medicine composition for treating colorectal cancer-related fatigue by adding and subtracting medicinal ingredients based on the original anti-cancer prescription after repeated clinical verification.

[0028] Based on this, the first aspect of the embodiments of the present invention provides a traditional Chinese medicine composition for treating cancer-related fatigue in colorectal cancer, comprising the following ingredients in parts by weight: 3-30 parts of bupleurum, 5-30 parts of white peony root, 5-30 parts of angelica root, 3-20 parts of julibrissin, 10-60 parts of agrimony, 5-40 parts of coix seed, 5-30 parts of stir-fried atractylodes, 5-30 parts of poria, 5-60 parts of astragalus, 5-30 parts of codonopsis pilosula or 3-15 parts of ginseng, 5-30 parts of patrinia herb, 3-20 parts of scutellaria baicalensis, 5-20 parts of ajulibrissin, and 1-10 parts of cooked rhubarb.

[0029] The Chinese medicine composition of the embodiment of the present invention is designed for the pathogenesis of colorectal cancer-related fatigue, and is composed of Chinese medicines for soothing the liver, strengthening the spleen and replenishing qi, and clearing away heat, removing dampness and detoxifying. In the Chinese medicine composition: Bupleurum is used to harmonize the Shaoyang meridian, relieve the stagnation of qi, and Codonopsis or ginseng is used to strengthen the spleen, replenish qi and remove dampness. The two medicines are used together to soothe the liver, strengthen the spleen and replenish qi, and are the main medicine; White peony root helps Bupleurum to soothe the liver, nourish the blood and restrain the yin, and can also prevent Bupleurum from ascending and dispersing the yin; Atractylodes macrocephala strengthens the spleen and removes dampness, and helps Codonopsis or ginseng to strengthen the effect, so Atractylodes macrocephala and White peony root are used as the ministerial medicine; Angelica sinensis and Albizzia julibrissin nourish blood and harmonize blood, soothe the liver, relieve depression and calm the mind, open the heart and improve intelligence, and Poria cocos can also help Bupleurum to soothe the liver and nourish the liver, nourish blood and restrain yin, and can also prevent Bupleurum from ascending and dispersing yin and robbing yin; White atractylodes macrocephala strengthens the spleen and removes dampness, and helps Codonopsis or ginseng to strengthen the effect, so White atractylodes macrocephala and White peony root are used as the ministerial medicine; Angelica sinensis and Albizzia julibrissin nourish blood and harmonize blood, soothe the liver, relieve depression and calm the mind, and open the heart and improve intelligence; Poria and Coix seed can strengthen the spleen, eliminate dampness and aid digestion, increase appetite, Astragalus is sweet and warm and invigorates Qi, Herba Agrimoniae can nourish the deficiency and strengthen the weak, both of them can nourish the deficiency and strengthen the weak, Patrinia herb and Scutellaria baicalensis can clear away dampness and heat in the intestines and viscera, so they can soothe the liver and strengthen the spleen, replenish Qi and blood, clear away heat and eliminate dampness, and eliminate cancer toxins, all of which are adjuvants; August zelkova can soothe the liver and regulate Qi, promote blood circulation, disperse blood stasis and relieve pain, eliminate restlessness and promote diuresis, a small amount of cooked rhubarb can clear the intestines and viscera, settle the medicinal potential, and lead the medicine into the intestines, so it is a guiding drug.

[0030] The Chinese medicine composition of the embodiment of the present invention has the functions of soothing the liver and strengthening the spleen, replenishing qi and blood, and removing dampness and detoxifying. It is mainly used to treat: cancer-related fatigue including fatigue after cancer and related treatments, such as postoperative, radiotherapy, chemotherapy, targeted and immunotherapy, accompanied by mental fatigue, depression, insomnia, loss of appetite, loose stools, pale tongue, and weak and stringy pulse.

[0031] The Chinese medicine composition of the embodiment of the present invention can strengthen the body's resistance and eliminate evil, treat both the symptoms and the root causes, and the combination of the medicines can soothe the liver and strengthen the spleen, eliminate dampness and detoxify, harmonize qi and blood, and take care of the internal organs. It has a good effect in preventing and treating cancer-related fatigue, has a high efficiency, has no side effects on the human body, and is not addictive.

[0032] The Chinese medicine composition of the embodiment of the present invention has the following advantages:

[0033] (1) Fatigue can be prevented: Traditional Chinese medicine classifies cancer-related fatigue as a disease of "depression" and "deficiency". It is said that "Yang Qi nourishes the spirit when it is refined and nourishes the tendons when it is soft". It is believed that deficiency of Qi and blood is the beginning of Yang deficiency, which runs through the occurrence and development of cancer-related fatigue. Drugs that replenish Qi and blood and strengthen the body and restore the spirit can cure deficiency. Therefore, when cancer patients do not experience fatigue, taking the Chinese medicine composition of the embodiment of the present invention first can help "prevent fatigue before it occurs", which is also in line with the idea of ​​"preventing disease before it occurs" in traditional Chinese medicine.

[0034] (2) Significant and lasting therapeutic effect: Clinical practice shows that oral administration of the Chinese medicine composition can improve the symptoms of patients with cancer-related fatigue due to intestinal cancer. It has a rapid onset of effect, a lasting effect, and no side effects.

[0035] (3) Improving the patient's mood and mental state: Cancer-related fatigue itself is a psychosomatic disease. In addition to the main symptoms of fatigue and weakness, most patients are accompanied by obvious adverse psychological states such as anxiety and depression. The Chinese medicine composition of the embodiment of the present invention contains Chinese medicine varieties that soothe the liver and relieve depression. After taking it, it can effectively improve anxiety and depression, improve the patient's sleep, and play a role in improving the patient's quality of life and prognosis.

[0036] (4) Combined with Western medicine treatment: The Chinese medicine composition of the embodiment of the present invention has the effect of strengthening the body and fighting cancer. Clinically, it has been shown that when combined with surgical treatment, radiotherapy, chemotherapy, targeted therapy, and immunotherapy, it can prevent and relieve patients' fatigue, enhance patients' body immunity, improve patients' physical strength, and reduce the adverse reactions of Western medicine-related treatments, thereby enhancing the clinical treatment effect and improving patients' quality of life and prognosis.

[0037] (5) No side effects: Commonly used drugs currently have certain adverse reactions, such as methylphenidate may cause severe anorexia, modafinil may cause insomnia, gastrointestinal reactions, etc., and long-term use is addictive and prone to drug dependence. Long-term use of corticosteroids such as dexamethasone may cause Cushing's syndrome, or mental symptoms, causing sleep and mood disorders, and aggravating fatigue. The Chinese medicine composition of the embodiment of the present invention is not addictive after long-term use and has no other adverse reactions.

[0038] The Chinese medicine composition of the embodiment of the present invention is designed for advanced colorectal cancer and cancer-related fatigue. On the basis of retaining the original Chinese medicine for the pathogenesis of colorectal cancer and the treatment of colorectal cancer, combined with the fact that most colorectal cancer patients have depression, depression, liver qi stagnation and liver failure caused by depression, the medicinal flavor of soothing and nourishing the liver is added. The Chinese medicine composition of the embodiment of the present invention is used together to soothe the liver and spleen, clear away dampness and heat, and remove cancer toxins. It has the effects of regulating qi and blood, replacing supplements with regulation, and taking into account both internal organs. The Chinese medicine composition of the embodiment of the present invention takes the liver and spleen as the pivot, which not only strengthens the body but also eliminates evil, not only replenishes qi and nourishes blood, but also detoxifies, removes blood stasis and fights cancer, so that the whole prescription can supplement without stagnating evil, and expel evil without hurting the body. The Chinese medicine composition of the embodiment of the present invention not only relieves the fatigue of patients and relieves emotions, but also treats cancer itself, and has good clinical efficacy.

[0039] The Chinese medicine composition of the embodiment of the present invention can quickly, significantly and lastingly relieve fatigue in patients with cancer-related fatigue. Clinical studies and practices show that it can also improve TCM symptoms, relieve emotions, and improve sleep, thereby improving the clinical treatment effect of patients with cancer-related fatigue and improving the quality of life. The Chinese medicine composition of the embodiment of the present invention can prevent and relieve cancer-related fatigue in patients, improve the patient's physical strength, improve sleep, relieve emotions, and reduce the adverse reactions of Western medicine treatment when combined with Western medicine treatment, such as surgery, radiotherapy, chemotherapy, targeted therapy or immunotherapy, and has a synergistic enhancement effect.

[0040] The Chinese medicine composition implemented in the present invention can be used to prevent and treat patients with cancer-related fatigue, including patients with fatigue after cancer and related treatments (such as after surgery, chemoradiotherapy, targeted and immunotherapy). The Chinese medicine composition implemented in the present invention has a definite therapeutic effect and a synergistic and enhancing effect with Western medicine treatment. It can improve symptoms, relieve emotions, improve the quality of life, and improve the prognosis of patients without obvious adverse reactions. It is worthy of development and clinical promotion.

[0041] Preferably, the Chinese medicine composition implemented by the present invention contains the following ingredients in parts by weight: 9-24 parts of bupleurum, 10-15 parts of white peony root, 10-15 parts of angelica, 10-15 parts of julibrissin, 15-30 parts of agrimony, 10-30 parts of coix seed, 10-20 parts of stir-fried atractylodes, 10-20 parts of poria, 10-30 parts of astragalus, 10-20 parts of codonopsis pilosula or 5-12 parts of ginseng, 10-20 parts of patrinia herb, 5-15 parts of clary vine, 10-15 parts of amaranth, and 3-6 parts of cooked rhubarb.

[0042] More preferably, the Chinese medicine composition implemented by the present invention contains the following ingredients in parts by weight: 12 parts of bupleurum, 10 parts of white peony root, 10 parts of angelica, 10 parts of julibrissin, 15 parts of agrimony, 12 parts of coix seed, 12 parts of stir-fried atractylodes, 12 parts of Poria, 15 parts of astragalus, 10 parts of Codonopsis pilosula or 10 parts of ginseng, 12 parts of Patrinia scabra, 10 parts of Sargentodoxa chinensis, 10 parts of Atractylodes macrocephala, and 3 parts of cooked rhubarb.

[0043] The second aspect of the embodiment of the present invention provides a Chinese medicine preparation for treating cancer-related fatigue of intestinal cancer, wherein the Chinese medicine preparation comprises the Chinese medicine composition described above. Preferably, the Chinese medicine preparation is a decoction or a granule.

[0044] A third aspect of the embodiments of the present invention provides a method for preparing a Chinese medicine preparation for treating cancer-related fatigue in intestinal cancer, comprising the following steps:

[0045] Mix the formulated amounts of bupleurum, white peony root, angelica, julibrissin, agrimony, coix seed, stir-fried atractylodes, tuckahoe, astragalus, codonopsis pilosula or ginseng, patrinia herb, scutellaria baicalensis, amaranth, and cooked rhubarb and soak in water for 10-60 minutes, then boil, filter the boiled medicinal liquid and retain the filtrate.

[0046] In one embodiment, the decoction can be performed twice. In the first decoction, the ratio of the total weight of the Chinese medicinal materials to the weight of water can be (1-2): (10-15), and the decoction time can be 10-30 minutes; in the second decoction, the ratio of the total weight of the Chinese medicinal materials to the weight of water can be (1-2): (5-10), and the decoction time can be 10-30 minutes. The specific amount of water added can be determined according to the weight of the medicinal materials. The filtrates after the two decoctions are mixed to obtain a water decoction.

[0047] In one embodiment, the decoction can be performed three times. During the first decoction, the ratio of the total weight of the Chinese medicinal materials to the weight of water can be (1-2): (5-20), and the decoction time can be 10-60 minutes; during the second decoction, the ratio of the total weight of the Chinese medicinal materials to the weight of water can be (1-2): (5-10), and the decoction time can be 10-60 minutes; during the third decoction, the ratio of the total weight of the Chinese medicinal materials to the weight of water can be (1-2): (5-10), and the decoction time can be 10-30 minutes; the filtrates after the three decoctions are combined and concentrated under reduced pressure to a relative density of 1.1-1.15 at 60°C, and after filtering again, water is added to the filtrate to obtain a water decoction.

[0048] In one embodiment, decoction can be performed three times. During the first decoction, the ratio of the total weight of the Chinese medicinal materials to the weight of water can be (1-2): (5-20), and the decoction time can be 10-90 minutes; during the second decoction, the ratio of the total weight of the Chinese medicinal materials to the weight of water can be (1-2): (5-10), and the decoction time can be 10-90 minutes; during the third decoction, the ratio of the total weight of the Chinese medicinal materials to the weight of water can be (1-2): (5-10), and the decoction time can be 10-90 minutes; the filtrates after the three decoctions are combined and concentrated under reduced pressure to a clear paste with a relative density of 1.2-1.25 at 50°C, and a one-step granulation method is adopted, with dextrin and mannitol as the base material in a ratio of 8:1, and the clear paste is sprayed to obtain the whole-formula granules.

[0049] In one embodiment, the method for preparing the Chinese medicine preparation of the embodiment of the present invention comprises the following steps:

[0050] Directly mix the formula amounts of bupleurum, white peony root, angelica, julibrissin, agrimony, coix seed, stir-fried atractylodes, tuckahoe, astragalus, codonopsis or ginseng, patrinia, scutellaria, aconite, and cooked rhubarb to obtain the formula granules.

[0051] A fourth aspect of the embodiments of the present invention provides use of the above-mentioned Chinese medicine composition in the preparation of a medicament for treating cancer-related fatigue caused by intestinal cancer.

[0052] The following is a description of a Chinese medicine preparation for treating colorectal cancer-related fatigue and a preparation method thereof according to an embodiment of the present invention through a plurality of specific embodiments.

[0053] Example 1

[0054] Embodiment 1 of the present invention provides a Chinese medicine composition decoction for treating cancer-related fatigue and a preparation method thereof, comprising the following steps:

[0055] (1) Take 12 parts of bupleurum, 10 parts of white peony root, 10 parts of angelica, 10 parts of julibrissin, 15 parts of agrimony, 12 parts of coix seed, 12 parts of stir-fried atractylodes, 12 parts of tuckahoe, 15 parts of astragalus, 10 parts of codonopsis, 12 parts of patrinia, 10 parts of scutellaria, 10 parts of aconite, 10 parts of rhubarb, 3 parts of cooked rhubarb, mix them, add them to a decoction vessel, add water and soak for half an hour, and the ratio of the total weight of the Chinese medicinal materials to the weight of the water is 1:10.

[0056] (2) After boiling over high heat, simmer over low heat for 30 minutes. Filter the decoction to obtain a filtrate and a filter residue, and the first decoction is completed.

[0057] (3) Remove the filtrate and add water again, with the ratio of the total weight of the Chinese medicinal materials to the weight of water being 1:8. Boil over high heat and then simmer over low heat for 25 minutes.

[0058] (4) Filter the decoction to obtain a filtrate and a filter residue, and the second decoction is completed.

[0059] (5) The filtrate obtained from the first decoction is mixed with the filtrate obtained from the second decoction to obtain a water decoction of the Chinese medicine composition.

[0060] This preparation method is suitable for individuals to decoct at home and take immediately after it is obtained.

[0061] Example 2

[0062] Embodiment 2 of the present invention provides a Chinese medicine composition decoction for treating cancer-related fatigue and a preparation method thereof, comprising the following steps:

[0063] (1) Take 12 parts of bupleurum, 10 parts of white peony root, 10 parts of angelica, 10 parts of julibrissin, 15 parts of agrimony, 12 parts of coix seed, 12 parts of stir-fried atractylodes, 12 parts of tuckahoe, 15 parts of astragalus, 10 parts of ginseng, 12 parts of patrinia, 10 parts of scutellaria, 10 parts of aconite, and 3 parts of cooked rhubarb, mix them, add them to a decoction vessel, add water and soak for half an hour, and the ratio of the total weight of the Chinese medicinal materials to the weight of the water is 1:10.

[0064] (2) After boiling over high heat, simmer over low heat for 60 minutes. Filter the decoction to obtain a filtrate and a filter residue, and the first decoction is completed.

[0065] (3) Take out the filter residue, add water again, the ratio of the total weight of the Chinese medicinal materials to the weight of water is 1:8, boil over high heat and then simmer over low heat for 60 minutes. Filter the decoction to obtain the filtrate and filter residue, and the second decoction is completed.

[0066] (4) Take out the filter residue, add water again, the ratio of the total weight of the Chinese medicinal materials to the weight of water is 1:8, boil over high heat and then simmer over low heat for 30 minutes. Filter the decoction to obtain the filtrate and filter residue, and the third decoction is completed.

[0067] (5) The filtrates obtained from the three decoctions were mixed, and then concentrated under reduced pressure to a relative density of 1.1-1.15 at 60° C., refrigerated, and allowed to stand for 24 hours.

[0068] (6) Filter through 200 mesh to obtain the filtrate, add water to 500 ml, fill and sterilize to obtain a water decoction of the Chinese medicine composition.

[0069] The preparation method is suitable for decoction preparation in pharmacies, pharmaceutical factories, institutions, etc. and has a long shelf life.

[0070] Example 3

[0071] Embodiment 3 of the present invention provides a Chinese medicine composition granule for treating cancer-related fatigue and a preparation method thereof, comprising the following steps:

[0072] Take 12g of Bupleurum, 10g of White Peony, 10g of Angelica, 10g of Albizzia julibrissin, 15g of Herba Agrimoniae, 12g of Coix Seed, 12g of Stir-fried Atractylodes, 12g of Poria, 15g of Astragalus, 10g of Codonopsis pilosula, 12g of Patrinia herb, 10g of Scutellaria baicalensis, 10g of Fructus Aconiti Lateralis, and 3g of Rhubarb, and mix them directly to obtain the Chinese medicine composition granules, which can be taken with hot water when used.

[0073] Example 4

[0074] Embodiment 4 of the present invention provides a Chinese medicine composition for treating cancer-related fatigue, a whole-formula granule and a preparation method thereof, comprising the following steps:

[0075] (1) Take 12 parts of bupleurum, 10 parts of white peony root, 10 parts of angelica, 10 parts of julibrissin, 15 parts of agrimony, 12 parts of coix seed, 12 parts of stir-fried atractylodes, 12 parts of tuckahoe, 15 parts of astragalus, 10 parts of ginseng, 12 parts of patrinia, 10 parts of scutellaria, 10 parts of aconite, and 3 parts of cooked rhubarb, mix them, add them to a decoction vessel, add water and soak for half an hour, and the ratio of the total weight of the Chinese medicinal materials to the weight of the water is 1:10.

[0076] (2) After boiling over high heat, simmer over low heat for 90 minutes. Filter the decoction to obtain a filtrate and a filter residue, and the first decoction is completed.

[0077] (3) Take out the filter residue, add water again, the ratio of the total weight of the Chinese medicinal materials to the weight of water is 1:8, boil over high heat and then simmer over low heat for 90 minutes. Filter the decoction to obtain the filtrate and filter residue, and the second decoction is completed.

[0078] (4) Take out the filter residue, add water again, the ratio of the total weight of the Chinese medicinal materials to the weight of water is 1:8, boil over high heat and then simmer over low heat for 90 minutes. Filter the decoction to obtain the filtrate and filter residue, and the third decoction is completed.

[0079] (5) The filtrates obtained from the three decoctions were mixed and filtered through 200 mesh to obtain a filtrate.

[0080] (6) Concentrating at a vacuum degree of -0.06 to -0.08 MPa and a temperature of 70-80°C to a relative density of 1.20-1.25 (50°C) to obtain a clear paste.

[0081] (7) A one-step granulation method is used, with dextrin and mannitol in a ratio of 8:1 as the base material, and the clear paste is sprayed in to obtain granules. After packaging, the whole formula granules of the Chinese medicine composition are obtained.

[0082] The preparation method is suitable for decocting and preparing granules in pharmacies, pharmaceutical factories, institutions, etc., has a long shelf life, is simple to use, and is easy to transport and carry.

[0083] Typical cases of application

[0084] Lou, male, 79 years old, 1 year after chemotherapy for colon cancer surgery. Current symptoms include fatigue, depression, insomnia, dizziness, abdominal distension, dull pain in the liver area, loose and sticky stools, thin white greasy tongue coating, and stringy pulse. Piper fatigue score is 6 points, and KPS score is 70 points.

[0085] Take the decoction of Example 1, 1 dose per day (400 mL per dose), twice a day, 200 mL each time, half an hour after meals, for 1 month. Consciously, the patient's spirits improved significantly, fatigue and sleep improved, discomfort in the abdomen and liver area disappeared, and the stool was formed, once a day. The Piper fatigue score was 4 points, and the KPS score was 90 points.

[0086] The patient underwent chemotherapy after colon cancer surgery, which damaged the vital energy, damaged the spleen and stomach, and had internal dampness and heat. In addition, due to the inner troubles, the liver qi was stagnant and the emotions were uncomfortable, so there were symptoms such as fatigue, depression, liver and flank discomfort, sticky and uncomfortable stools, thin white greasy tongue coating, and stringy pulse. This prescription was given with Bupleurum, White Peony Root, Albizzia julibrissin to soothe the liver and nourish the liver, Codonopsis pilosula, Astragalus membranaceus, and Angelica sinensis to nourish qi and blood, Coix seeds, stir-fried Atractylodes macrocephala, and Poria to strengthen the spleen and eliminate dampness, Patrinia scabra, Red vine, August stalk, and cooked rhubarb to clear heat and dampness, and eliminate the remaining evil. This method of attacking and supplementing, treating the liver and spleen, and regulating qi and blood, is very consistent with the pathogenesis of carcinogenic fatigue caused by colon cancer, so it has achieved good results.

[0087] Application example Animal experiment

[0088] 1. Animal Experimental Protocol

[0089] (1) Model construction: Colon cancer CT26 cells in the logarithmic growth phase were cultured in serum-free 1640 medium at a density of 1×10 7 / ml single cell suspension. Take 20 BALB / c mice aged 4-6 weeks and weighing 20g±2g, shave the back of the right forelimb, disinfect routinely, use a 1ml syringe to extract 0.2ml of the single cell suspension and inject it subcutaneously into the shaved area, and then return to the cage for breeding. Observe the tumor formation at the injection site day by day. Generally, 7-10 days after inoculation, the tumor diameter reaches about 0.5cm 3 When the rats were large, fluorouracil was injected intraperitoneally to establish the model.

[0090] (2) The drugs were divided into groups and administered according to the following regimen: a control group (fluorouracil 20 mg / kg, 0.2 ml / time, intraperitoneal injection, once every other day) and a Chinese medicine intervention group (granules prepared in Example 3 of the present invention). The drugs were administered once a day, 0.5 g each time, dissolved into 0.5 ml for intragastric administration, and administered continuously for 14 days.

[0091] (3) Result test: The fatigue degree of each group of animals was mainly understood through the exhaustive swimming test and the tail suspension test. Exhaustive swimming test: Prepare a weight equivalent to 7% of the mouse's body weight, preferably a lead sinker. If there is no lead sinker, use a ball of tin foil of the same weight instead. Use medical tape to stick the weight to the mouse's tail, and put the mouse in a swimming box (30 cm high × 30 cm long × 30 cm wide) with a water temperature of 25℃±1℃ for swimming test until its strength is exhausted and it cannot sink. The time elapsed is recorded by a stopwatch. The standard of exhaustion is that the tip of the mouse's nose sinks below the water surface and cannot float up for 10 seconds. After the experiment, wipe off the water stuck on the mouse with a towel and return it to the cage. Tail suspension test: Take the mouse to be tested in the experiment, and use medical tape to stick the mouse's tail to the tail suspension tester. The sticking point is 2 cm away from the tip of the tail, and stick it tightly to prevent it from falling off in the middle. The height is that the head of the mouse is 50 cm from the ground when it is hanging upside down. The time the mouse does not move within 6 minutes is recorded. After the experiment, return it to the cage for feeding. Determination of liver glycogen and muscle glycogen: refer to the instructions of the glycogen test kit of Nanjing Jiancheng Bioengineering Institute.

[0092] 2. Animal Experiment Results

[0093] Table 1 Comparison of exhaustive swimming time between the control group and the Chinese medicine intervention group (unit: seconds)

[0094]

[0095] Table 2 Comparison of tail suspension immobility time between the control group and the Chinese medicine intervention group (unit: seconds)

[0096]

[0097] Table 3 Comparison of liver glycogen and muscle glycogen between the control group and the Chinese medicine intervention group

[0098]

[0099] In Tables 1-3 above, each group of test data is expressed as mean ± standard deviation. For example, the test data of the control group before the experiment in Table 1 is 383.2 ± 28.41s, where 383.2 is the mean value of the test data of this group, and 28.41 is the standard deviation of the test data of this group.

[0100] It can be seen from the above animal experimental results that the Chinese medicine composition of the embodiment of the present invention can significantly prolong the exhaustive swimming time of the animal model, shorten the tail suspension immobility time, and increase the liver glycogen and muscle glycogen content of the animal model, providing a material basis for relieving fatigue, and providing an experimental basis for the Chinese medicine composition formula of the embodiment of the present invention to relieve fatigue.

[0101] The above embodiments only express several implementation methods of the present invention, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the present invention. It should be pointed out that, for a person of ordinary skill in the art, several modifications and improvements can be made without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the present invention patent shall be subject to the attached claims.

Claims

1. A Chinese medicine composition for treating cancer-related fatigue, characterized in that: It contains the following ingredients in parts by weight: 3-30 parts of bupleurum, 5-30 parts of white peony root, 5-30 parts of angelica, 3-20 parts of julibrissin, 10-60 parts of agrimony, 5-40 parts of coix seeds, 5-30 parts of stir-fried atractylodes, 5-30 parts of tuckahoe, 5-60 parts of astragalus, 5-30 parts of codonopsis or 3-15 parts of ginseng, 5-30 parts of patrinia herb, 3-20 parts of scutellaria baicalensis, 5-20 parts of ajulibrissin, and 1-10 parts of cooked rhubarb.

2. A Chinese medicine composition for treating cancer-related fatigue according to claim 1, characterized in that: The invention contains the following ingredients in parts by weight: 9-24 parts of bupleurum, 10-15 parts of white peony root, 10-15 parts of angelica root, 10-15 parts of julibrissin flower, 15-30 parts of agrimony, 10-30 parts of coix seed, 10-20 parts of stir-fried atractylodes, 10-20 parts of tuckahoe, 10-30 parts of astragalus, 10-20 parts of codonopsis pilosula or 5-12 parts of ginseng, 10-20 parts of patrinia herb, 5-15 parts of scutellaria baicalensis, 10-15 parts of amaranth, and 3-6 parts of cooked rhubarb.

3. A Chinese medicine composition for treating cancer-related fatigue according to claim 2, characterized in that: It contains the following ingredients in parts by weight: 12 parts of bupleurum, 10 parts of white peony root, 10 parts of angelica, 10 parts of julibrissin, 15 parts of agrimony, 12 parts of coix seeds, 12 parts of stir-fried atractylodes, 12 parts of poria, 15 parts of astragalus, 10 parts of codonopsis pilosula or 10 parts of ginseng, 12 parts of patrinia herb, 10 parts of scutellaria baicalensis, 10 parts of atractylodes, and 3 parts of cooked rhubarb.

4. A Chinese medicine preparation for treating cancer-related fatigue, characterized in that: A Chinese medicine composition comprising any one of claims 1 to 3.

5. A Chinese medicine preparation for treating cancer-related fatigue according to claim 4, characterized in that: The Chinese medicine preparation is a decoction or a granule.

6. The method for preparing a traditional Chinese medicine preparation for treating cancer-related fatigue according to claim 5, characterized in that: The following steps are involved: Mix the formulated amounts of bupleurum, white peony root, angelica, julibrissin, agrimony, coix seed, stir-fried atractylodes, tuckahoe, astragalus, codonopsis or ginseng, patrinia herb, scutellaria baicalensis, amaranth, and cooked rhubarb, soak in water, then boil, filter the boiled medicinal liquid, and retain the filtrate.

7. The method for preparing a traditional Chinese medicine preparation for treating cancer-related fatigue according to claim 6, characterized in that: The decoction is performed twice. During the first decoction, the ratio of the total weight of the Chinese medicinal materials to the weight of water is (1-2): (10-15). During the second decoction, the ratio of the total weight of the Chinese medicinal materials to the weight of water is (1-2): (5-10).

8. The method for preparing a traditional Chinese medicine preparation for treating cancer-related fatigue of intestinal cancer according to claim 6, characterized in that: The decoction is performed three times, the ratio of the total weight of the Chinese medicinal materials to the weight of water in the first decoction is (1-2): (5-20), the ratio of the total weight of the Chinese medicinal materials to the weight of water in the second decoction is (1-2): (5-10); the ratio of the total weight of the Chinese medicinal materials to the weight of water in the third decoction is (1-2): (5-10); the filtrates after the three decoctions are combined and concentrated under reduced pressure to a relative density of 1.1-1.15 at 60°C, filtered again, and water is added to the filtrate to obtain a water decoction; or the filtrates after the three decoctions are combined and concentrated under reduced pressure to a clear paste with a relative density of 1.2-1.25 at 50°C, and a one-step granulation method is adopted, dextrin and mannitol are used as a base material in a ratio of 8:1, and the clear paste is sprayed into the base to obtain granules.

9. The method for preparing a traditional Chinese medicine preparation for treating cancer-related fatigue according to claim 5, characterized in that: The following steps are involved: The granules are directly mixed with the formulated amounts of bupleurum, white peony root, angelica root, julibrissin flower, agrimony herb, coix seed, stir-fried atractylodes, tuckahoe, astragalus, codonopsis pilosula or ginseng, patrinia herb, scutellaria baicalensis, aconite root and cooked rhubarb.

10. Use of the Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a medicament for treating cancer-related fatigue caused by intestinal cancer.

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