Traditional Chinese medicine composition, traditional Chinese medicine preparation and preparation method and application thereof

Abstract

The invention belongs to the field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition, a traditional Chinese medicine preparation and a preparation method and application thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by mass: 6-15 parts of codonopsis pilosula, 15-30 parts of astragalus membranaceus, 10-15 parts of bighead atractylodes rhizome, 10-15 parts of poria cocos, 6-10 parts of honey-fried licorice root, 10-15 parts of angelica sinensis, 10-15 parts of prepared rehmannia root, 10-12 parts of radix paeoniae alba, 6-10 parts of ligusticum wallichii, 3-6 parts of cassia twig, 6-10 parts of schisandra chinensis, 6-10 parts of polygala tenuifolia, 12-15 parts of endothelium corneum gigeriae galli, 6-10 parts of pericarpium citri reticulatae, 5-10 parts of fresh ginger and 10-15 parts of jujube. And the body function and psychological state of the patient are improved through multi-target regulation.

Description

TECHNICAL FIELD

[0001] The application belongs to the field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition, a traditional Chinese medicine preparation and a preparation method and application thereof. BACKGROUND

[0002] Chronic fatigue syndrome (CFS) is one of the common symptoms in clinic, which is characterized by persistent decrease in physical and cognitive function, is not related to the amount of activity and cannot be relieved by rest, and seriously affects the quality of life of patients. At present, the treatment of western medicine mainly focuses on symptomatic intervention (such as methylphenidate and corticosteroids), but the curative effect is limited and the side effects are significant. According to the theory of traditional Chinese medicine, chronic fatigue syndrome belongs to the category of "asthenia", and the core of pathogenesis is "spleen and kidney deficiency, qi deficiency and blood deficiency", which requires to take the spleen and kidney tonification, qi and blood nourishment as the basis, and to assist the qi regulation and depression relief as the target. Although the existing traditional Chinese medicine prescriptions (such as Buzhong Yiqi Decoction and Bazhen Decoction) have certain curative effect, they have the problems of slow effect and not taking into account "qi regulation and depression relief". SUMMARY

[0003] In order to solve the above technical problems, the application provides a traditional Chinese medicine composition, a traditional Chinese medicine preparation and a preparation method and application thereof.

[0004] A traditional Chinese medicine composition is prepared from the following raw materials in parts by mass: 6-15 parts of radix codonopsis, 15-30 parts of radix astragali, 10-15 parts of atractylodes, 10-15 parts of poria cocos, 6-10 parts of prepared licorice, 10-15 parts of angelica, 10-15 parts of prepared rehmannia, 10-12 parts of white peony root, 6-10 parts of chuanxiong, 3-6 parts of cassia twig, 6-10 parts of schisandra, 6-10 parts of polygala, 12-15 parts of chicken gizzard, 6-10 parts of dried tangerine or orange peel, 5-10 parts of ginger, and 10-15 parts of jujube.

[0005] The application takes radix astragali, radix codonopsis and prepared rehmannia as monarch drugs, which can tonify blood, assist life qi, nourish kidney essence and replenish primordial qi. Atractylodes, poria cocos, prepared licorice, angelica, white peony root, chuanxiong and schisandra are used as ministerial drugs, which can strengthen the functions of spleen-tonifying, qi-tonifying and blood-tonifying, and can also consolidate and disperse qi, essence and fluid. Cassia twig, polygala and chicken gizzard are used as auxiliary drugs, in which cassia twig can warm and unblock meridians and invigorate yang qi to smooth blood circulation, polygala can calm the mind and relieve depression, and communicate heart and kidney to tranquilize the mind, and chicken gizzard can invigorate the spleen and stomach, eliminate stagnation and prevent stagnation. Dried tangerine or orange peel, ginger and jujube are used as ministerial drugs, in which dried tangerine or orange peel can regulate stagnation and regulate qi in the middle jiao, ginger can warm the middle jiao and stop vomiting to regulate the function of drugs, and jujube can regulate ying and wei and tonify qi and blood. The three drugs are combined to assist the transportation and movement of the stagnation of the tonifying drugs, and also can tonify qi and blood to maintain balance, so as to tonify the spleen and kidney, strengthen the body resistance and eliminate pathogenic factors as the core, regulate and improve the somatic function and psychological state of patients, and regulate qi and relieve depression.

[0006] A preparation method of the traditional Chinese medicine composition, comprising the following steps: The raw materials are weighed according to the proportion, washed, soaked for 20-40 minutes, then decocted, boiled for 30-50 minutes on low heat, and the medicinal liquid is filtered out; the residue is added with water and decocted for 10-30 minutes, and the medicinal liquid of the two times is combined; After the medicinal liquid is concentrated, it is spray-dried to powder to obtain the traditional Chinese medicine composition.

[0007] A traditional Chinese medicine preparation is prepared from the traditional Chinese medicine composition.

[0008] Preferably, the traditional Chinese medicine preparation is an oral preparation.

[0009] Preferably, the type of the oral preparation is granules, pills or capsules.

[0010] Preferably, the preparation method of the granules comprises the following steps: The traditional Chinese medicine composition is added with dextrin, mixed, granulated, dried, and packed. The mass ratio of the traditional Chinese medicine composition to the dextrin is 1:1-2.

[0011] Preferably, the preparation method of the pills comprises the following steps: The traditional Chinese medicine composition is added with refined honey, pan-coated, dried, and coated. The mass ratio of the traditional Chinese medicine composition to the refined honey is 1:1-2.

[0012] The traditional Chinese medicine composition or the traditional Chinese medicine preparation is used for preparing a medicine for treating chronic fatigue syndrome.

[0013] Preferably, the medicine is a medicine for treating fatigue and lazy speech, treating poor appetite, treating head heavy and limbs tired, and treating palpitation and insomnia.

[0014] Compared with the prior art, the present application has the following beneficial effects: Codonopsis root: sweet, neutral. Spleen, lung meridian. Spleen and lung, Yiqi Shengjin. As a tonic, Yiqi, special treatment of spleen and lung deficiency, fatigue, shortness of breath, lazy speech, poor appetite and diarrhea.

[0015] Radix Astragali: sweet, slightly warm. Spleen, lung meridian. Tonifying Qi and ascending Yang, consolidating the surface and stopping sweating, promoting water and swelling, and promoting toxin and generating muscle. As a tonic, it is used to treat Qi deficiency, poor appetite and diarrhea, middle Qi, and Qi and blood deficiency.

[0016] White atractylodes: bitter, sweet, warm. Spleen, stomach meridian. Spleen and Qi, dry wet and water, stop sweating, and keep the fetus. As a spleen and dryness medicine, it is good at treating spleen deficiency, poor appetite, diarrhea, phlegm, edema, and sweating.

[0017] Poria: sweet and mild in flavor, and neutral in nature. It is associated with the heart, lung, spleen, and kidney channels. It benefits water metabolism and dampness, and strengthens the spleen and calms the heart. It is good at strengthening the spleen and eliminating dampness, calming the mind and stabilizing the spirit. It is suitable for edema due to spleen deficiency and excessive dampness, diarrhea, phlegm retention, palpitation, and insomnia.

[0018] Melted licorice: sweet in flavor, and neutral in nature. It is associated with the heart, lung, spleen, and stomach channels. It supplements the spleen and qi, clears heat and detoxifies, expels phlegm and stops cough, relieves pain, and adjusts the properties of other herbs. After being melted, it enhances the nourishing effect, and can adjust the properties of other herbs and relieve pain.

[0019] Angelica: sweet and pungent in flavor, and warm in nature. It is associated with the liver, heart, and spleen channels. It supplements and activates blood, regulates menstruation and stops pain, and moistens the intestines and promotes defecation. It is a holy herb for blood, and is good at supplementing and activating blood, and stopping pain. It is suitable for blood deficiency, dizziness and palpitation, irregular menstruation, and menstrual pain.

[0020] Rehmannia: sweet in flavor, and slightly warm in nature. It is associated with the liver and kidney channels. It supplements blood and yin, and benefits essence and marrow. It is the main herb for nourishing kidney essence and liver blood. It is used to treat liver and kidney yin deficiency, blood deficiency and essence deficiency, and symptoms such as hot flashes, sweating, dizziness, tinnitus, premature graying, palpitation, and insomnia.

[0021] White peony root: bitter and sour in flavor, and slightly cold in nature. It is associated with the liver and spleen channels. It nourishes blood and regulates menstruation, calms the liver and stops pain, and astringes yin and stops sweating. It is good at nourishing blood and calming the liver, and relieving pain. It is suitable for blood deficiency, irregular menstruation, liver yang headache, rib side pain, abdominal and extremities pain, and spontaneous sweating.

[0022] Chuanxiong: pungent in flavor, and warm in nature. It is associated with the liver, gallbladder, and pericardium channels. It activates blood and moves qi, and expels wind and stops pain. It is a blood and qi herb, and is good at ascending to the head and descending to the blood sea, and is used to treat irregular menstruation, menstrual pain, chest and side pain, headache, and rheumatic pain.

[0023] Cassia twig: pungent and sweet in flavor, and warm in nature. It is associated with the heart, lung, and bladder channels. It induces perspiration and dispels pathogens from the exterior, warms and unblocks meridians, and assists yang and transforms qi. It is used to treat body pain due to cold and blood stasis, joint pain, chest pain, phlegm retention, water retention, and palpitation.

[0024] Schisandra: sour and sweet in flavor, and warm in nature. It is associated with the lung, heart, and kidney channels. It astringes and contracts, benefits qi and generates saliva, and supplements the kidney and calms the heart. It is used to treat chronic cough, dry mouth, spontaneous sweating, palpitation, and insomnia.

[0025] Polygala: bitter and pungent in flavor, and slightly warm in nature. It is associated with the heart, kidney, and lung channels. It calms the spirit, benefits wisdom, expels phlegm and opens the orifices, and dissipates abscesses. It is good at communicating between the heart and kidney, calming the heart and spirit, expelling phlegm and opening the orifices, and is used to treat palpitation, insomnia, forgetfulness, spirit confusion, and phlegm.

[0026] Chicken gizzard: sweet in flavor, and neutral in nature. It is associated with the spleen, stomach, small intestine, and bladder channels. It strengthens the stomach and promotes digestion, astringes essence and stops leakage, and dissolves stones and expels sand. It is used to strengthen the spleen and stomach, promote digestion, and dissolve various food stagnation. It can also astringe essence, shrink urine, and dissolve stones and expel sand.

[0027] Pericarpium Citri Reticulatae: bitter, pungent, warm. Spleen and lung meridians. Regulating qi and invigorating the spleen, drying dampness and reducing phlegm. Spleen and stomach qi stagnation, dryness and phlegm, eliminating distension and stopping vomiting.

[0028] Ginger: bitter, slightly warm. Lungs, spleen and stomach meridians. Resolving the exterior and dispelling cold, warming the middle to stop vomiting, reducing phlegm and relieving cough. Warm the stomach and dispel cold, stop vomiting, warm the lungs and relieve cough, and can also resolve the exterior.

[0029] Jujube: sweet, warm. Spleen and stomach meridians. Tonifying the center and replenishing qi, nourishing blood and tranquilizing the mind, regulating drug properties. Tonifying the spleen and stomach, replenishing qi and blood, and moderating drug properties, often used to regulate drug properties.

[0030] With Huangqi, Dangshen, Shudihuang as the main drug, it can supplement blood and assist life energy, nourish kidney essence and replenish vital energy. With Baizhu, Fuling, Zhigancao, Dangui, Baishao, Chuanxiong, Wweimeizi as the ministerial drug, it can strengthen the function of invigorating the spleen, replenishing qi and tonifying blood, and also can consolidate and disperse essence and fluid. With Guizhi, Yuanzhi, Jineijin as the auxiliary drug, Guizhi can warm the meridians and invigorate yang qi to promote blood circulation. Yuanzhi can calm the mind and relieve depression, and communicate between heart and kidney to calm the mind. Jineijin can invigorate the spleen and stomach, eliminate stagnation and prevent stagnation. With Chenpi, Shengjiang, Dazao as the ministerial drug, Chenpi can regulate qi and relieve stagnation in the middle jiao. Shengjiang can warm the middle to stop vomiting and promote the function of drugs. Dazao can nourish blood and regulate the ying and wei, and also can replenish qi and blood. The three drugs can not only help to promote the function of the drugs, but also can tonify qi and blood.

[0031] CFS takes "spleen and kidney deficiency, qi deficiency and blood deficiency" as the core pathogenesis, leading to the lack of source of qi and blood, and the deficiency of essence in brain marrow, and further developing into qi stagnation, dampness, blood stasis and spirit disturbance. The whole prescription closely follows the therapeutic principle of "invigorating the spleen and tonifying the kidney, replenishing qi and nourishing blood to treat the root, regulating qi and relieving depression, and smoothing the collaterals to calm the mind to treat the branch", and aims at the following symptom groups:

[0032] For persistent fatigue and limb fatigue (spleen and kidney deficiency, qi and blood deficiency), the main drug Dangshen and Huangqi can tonify the center and replenish qi, and consolidate the defensive qi and ascend yang, directly tonifying the spleen and lung qi to open the source. The ministerial drug Baizhu and Fuling can invigorate the spleen and dry dampness to assist in promoting transformation, cutting off the chain of dampness causing fatigue. Shudihuang and Dangui can nourish the kidney and replenish blood to nourish the liver, and together with Shenshi and Huangqi, they form the pattern of tonifying qi and blood, repairing the energy metabolism foundation from the first and second days.

[0033] For cognitive decline and forgetfulness (essence and blood deficiency, brain orifices lack nourishment), Shudihuang and Baishao can tonify liver blood and nourish kidney essence to nourish brain marrow. The auxiliary drug Wweimeizi can converge the heart and replenish qi and fluid, and Yuanzhi can communicate between heart and kidney to resolve the symptoms of attention wandering and thinking retardation, and restore the clear and bright mind.

[0034] For insomnia and dreaminess, and emotional depression (blood deficiency and liver depression, heart and kidney not communicating), Dangui and Baishao can tonify liver blood to suppress the hyperactive yang. Wweimeizi and Yuanzhi can calm the soul and heart, and break the difficulty of light sleep and easy wakefulness. The ministerial drug Dazao can nourish blood and regulate the ying and wei, and together with Zhigancao, it can relieve liver depression, and with Chenpi, it can regulate qi and relieve depression, resolving the stagnation of qi.

[0035] Relieving muscle soreness and joint pain (due to Yang deficiency and obstruction of the meridians, resulting in stagnation of Qi and blood), the adjuvant herb cinnamon twig warms and unblocks the twelve meridians, invigorating Yang Qi to dispel cold stagnation; the assistant herb chuanxiong ascends to the head and eyes and descends to the blood sea, combining with angelica to invigorate blood and promote Qi circulation, breaking up meridian blockages; the guiding herb ginger dispels cold and warms the middle Jiao, working synergistically with cinnamon twig to promote the flow of Qi in the limbs and joints, specifically targeting the activation of Qi. Strengthening the spleen and tonifying the kidneys: Based on the Four Gentlemen Decoction (Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, and Glycyrrhiza uralensis), it is combined with Astragalus membranaceus to enhance the replenishment of Qi, and Rehmannia glutinosa and Paeonia lactiflora to nourish Yin and blood, which is in line with the theory of "harmonizing the innate and acquired constitution".

[0036] Strengthening the middle burner: Tangerine peel, ginger, and jujube promote digestion and absorption, enhancing the efficacy of tonics; chicken gizzard aids digestion and relieves stagnation, improving appetite.

[0037] Calming the mind and relieving depression: Polygala tenuifolia and Schisandra chinensis regulate nerve function and relieve anxiety and depression, which is in line with the principle of "treating both body and mind".

[0038] Blood-nourishing and blood-activating herbs: Angelica sinensis, Ligusticum chuanxiong, and Rehmannia glutinosa work together to improve the condition of both qi and blood deficiency. This invention discloses a traditional Chinese medicine composition for treating chronic fatigue syndrome, with the core principles of invigorating the spleen and kidneys, supporting the body's resistance and eliminating pathogenic factors. It improves patients' physical function and psychological state through multi-target regulation. The efficacy is significant: clinical trials have shown that patients' fatigue scores decreased by ≥40% compared to before treatment, with a total effective rate of 92%, significantly superior to conventional tonifying formulas (P<0.01).

[0039] High safety: The whole formula is mild and no adverse reactions such as abnormal liver and kidney function have been found. Detailed Implementation

[0040] The specific embodiments of the present invention are described in detail below, but it should be understood that the scope of protection of the present invention is not limited to the specific embodiments. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention. Unless otherwise specified, the experimental methods described in the embodiments of the present invention are conventional methods.

[0041] Example 1 A traditional Chinese medicine composition is made from the following raw materials by weight: Codonopsis pilosula 12g, Astragalus membranaceus 25g, Atractylodes macrocephala 12g, Poria cocos 12g, Glycyrrhiza uralensis (processed) 8g, Angelica sinensis 12g, Rehmannia glutinosa (processed) 12g, Paeonia lactiflora 10g, Ligusticum chuanxiong 8g, Cinnamomum cassia 4g, Schisandra chinensis 8g, Polygala tenuifolia 8g, Gallus gallus domesticus (gizzard lining) 14g, Citrus reticulata 8g, Zingiber officinale 8g, and Ziziphus jujuba 12g.

[0042] Example 2 A traditional Chinese medicine composition is prepared from the following raw materials in the following amounts: Radix Codonopsis 6g, Radix Astragali 30g, Rhizoma Atractylodis Macrocephalae 15g, Poria 10g, Radix Glycyrrhizae Preparata 6g, Radix Angelicae Sinensis 10g, Radix Rehmanniae Preparata 10g, Radix Paeoniae Alba 11g, Rhizoma Chuanxiong 6g, Ramulus Cinnamomi 3g, Fructus Schisandrae Chinensis 6g, Radix Polygalae 6g, Colla Carallii 12g, Pericarpium Citri Reticulatae 6g, Rhizoma Zingiberis Recens 5g, Fructus Jujubae 10g.

[0043] Example 3 A traditional Chinese medicine composition is prepared from the following raw materials in the following amounts: Radix Codonopsis 15g, Radix Astragali 15g, Rhizoma Atractylodis Macrocephalae 10g, Poria 15g, Radix Glycyrrhizae Preparata 10g, Radix Angelicae Sinensis 15g, Radix Rehmanniae Preparata 15g, Radix Paeoniae Alba 12g, Rhizoma Chuanxiong 10g, Ramulus Cinnamomi 6g, Fructus Schisandrae Chinensis 10g, Radix Polygalae 10g, Colla Carallii 15g, Pericarpium Citri Reticulatae 10g, Rhizoma Zingiberis Recens 10g, Fructus Jujubae 15g.

[0044] Example 4 A preparation method of a traditional Chinese medicine composition comprises the following steps: The raw materials are weighed according to the ratio, washed, and then soaked in water for 30 minutes, with the water amount being 2cm higher than the medicinal materials.

[0045] After boiling, the heat is turned to low and the medicinal materials are decocted for 40 minutes, and the medicinal liquid is filtered out; the medicinal residue is added with water and decocted for 20 minutes, and the medicinal liquid obtained in the two steps is combined.

[0046] Concentration and drying: the medicinal liquid is concentrated to a relative density of 1.2-1.3, and then spray-dried to powder, and the powder is sieved through a 80-mesh sieve to obtain the traditional Chinese medicine composition, and the relative density of 1.2-1.3 is measured at 60℃.

[0047] Example 5 A preparation method of a traditional Chinese medicine preparation comprises the following steps: Dextrin is added to the traditional Chinese medicine composition, and the mixture is granulated, dried, and then granulated and packed; The mass ratio of the traditional Chinese medicine composition to the dextrin is 1:1.5.

[0048] Example 6 Refined honey is added to the traditional Chinese medicine composition, and the mixture is granulated, dried, and then coated; The mass ratio of the traditional Chinese medicine composition to the refined honey is 1:1.2.

[0049] Comparative Example 1 Comparative Example 1 differs from Example 1 in that Radix Astragali and Radix Codonopsis are excessive, and the specific amounts are as follows: A traditional Chinese medicine composition is prepared from the following raw materials in the following amounts: Radix Codonopsis 20g, Radix Astragali 40g, Rhizoma Atractylodis Macrocephalae 12g, Poria 12g, Radix Glycyrrhizae Preparata 8g, Radix Angelicae Sinensis 12g, Radix Rehmanniae Preparata 12g, Radix Paeoniae Alba 10g, Rhizoma Chuanxiong 8g, Ramulus Cinnamomi 4g, Fructus Schisandrae Chinensis 8g, Radix Polygalae 8g, Colla Carallii 14g, Pericarpium Citri Reticulatae 8g, Rhizoma Zingiberis Recens 8g, Fructus Jujubae 12g.

[0050] Comparative Example 2 Comparative Example 2 differs from Example 1 in that Angelica sinensis and Ligusticum wallichii are over-dosed, as follows: A traditional Chinese medicine composition is made from the following raw materials in the following amounts: Radix Codonopsis 12 g, Radix Astragali 25 g, Rhizoma Atractylodis Macrocephalae 12 g, Poria 12 g, Radix Glycyrrhizae Preparata 8 g, Angelica sinensis 20 g, Radix Rehmanniae Preparata 12 g, Radix Paeoniae Alba 10 g, Ligusticum wallichii 15 g, Ramulus Cinnamomi 4 g, Fructus Schisandrae 8 g, Polygala 8 g, Colla Carallidae 14 g, Pericarpium Citri Reticulatae 8 g, Zingiber officinale 8 g, Fructus Jujubae 12 g.

[0051] Comparative Example 3 Comparative Example 3 differs from Example 1 in that Ramulus Cinnamomi and Zingiber officinale are reduced in amount, as follows: A traditional Chinese medicine composition is made from the following raw materials in the following amounts: Radix Codonopsis 12 g, Radix Astragali 25 g, Rhizoma Atractylodis Macrocephalae 12 g, Poria 12 g, Radix Glycyrrhizae Preparata 8 g, Angelica sinensis 12 g, Radix Rehmanniae Preparata 12 g, Radix Paeoniae Alba 10 g, Ligusticum wallichii 8 g, Ramulus Cinnamomi 2 g, Fructus Schisandrae 8 g, Polygala 8 g, Colla Carallidae 14 g, Pericarpium Citri Reticulatae 8 g, Zingiber officinale 4 g, Fructus Jujubae 12 g.

[0052] Comparative Example 4 Comparative Example 4 differs from Example 1 in that Colla Carallidae is reduced in amount, as follows: A traditional Chinese medicine composition is made from the following raw materials in the following amounts: Radix Codonopsis 12 g, Radix Astragali 25 g, Rhizoma Atractylodis Macrocephalae 12 g, Poria 12 g, Radix Glycyrrhizae Preparata 8 g, Angelica sinensis 12 g, Radix Rehmanniae Preparata 12 g, Radix Paeoniae Alba 10 g, Ligusticum wallichii 8 g, Ramulus Cinnamomi 4 g, Fructus Schisandrae 8 g, Polygala 8 g, Colla Carallidae 6 g, Pericarpium Citri Reticulatae 8 g, Zingiber officinale 8 g, Fructus Jujubae 12 g.

[0053] Comparative Example 5 Comparative Example 5 differs from Example 1 in that Colla Carallidae and Pericarpium Citri Reticulatae are not added, as follows: A traditional Chinese medicine composition is made from the following raw materials in the following amounts: Radix Codonopsis 12 g, Radix Astragali 25 g, Rhizoma Atractylodis Macrocephalae 12 g, Poria 12 g, Radix Glycyrrhizae Preparata 8 g, Angelica sinensis 12 g, Radix Rehmanniae Preparata 12 g, Radix Paeoniae Alba 10 g, Ligusticum wallichii 8 g, Ramulus Cinnamomi 4 g, Fructus Schisandrae 8 g, Polygala 8 g, Zingiber officinale 8 g, Fructus Jujubae 12 g.

[0054] Comparative Example 6 Comparative Example 6 differs from Example 1 in that Radix Codonopsis is replaced by Panax ginseng, as follows: A traditional Chinese medicine composition is made from the following raw materials in the following amounts: Panax ginseng 12 g, Radix Astragali 25 g, Rhizoma Atractylodis Macrocephalae 12 g, Poria 12 g, Radix Glycyrrhizae Preparata 8 g, Angelica sinensis 12 g, Radix Rehmanniae Preparata 12 g, Radix Paeoniae Alba 10 g, Ligusticum wallichii 8 g, Ramulus Cinnamomi 4 g, Fructus Schisandrae 8 g, Polygala 8 g, Colla Carallidae 14 g, Pericarpium Citri Reticulatae 8 g, Zingiber officinale 8 g, Fructus Jujubae 12 g.

[0055] Comparative Example 7 Comparative Example 7 differs from Example 1 in that no Ramulus cinnamomi and Rhizoma zingiberis were added, as follows: A traditional Chinese medicine composition is made from the following raw materials in the following amounts: Radix codonopsis 12 g, Radix astragali 25 g, Rhizoma atractylodis 12 g, Poria cocos 12 g, Radix paeoniae alba 8 g, Radix angelicae sinensis 12 g, Radix rehmanniae preparata 12 g, Radix paeoniae alba 10 g, Radix notoginseng 8 g, Fructus schisandrae 8 g, Radix polygalae 8 g, Cornu biphoreae 14 g, Pericarpium citri reticulatae 8 g, Fructus jujubae 12 g.

[0056] Comparative Example 8 Comparative Example 8 differs from Example 1 in that Radix notoginseng is replaced by Radix salviae miltiorrhizae, as follows: A traditional Chinese medicine composition is made from the following raw materials in the following amounts: Radix codonopsis 12 g, Radix astragali 25 g, Rhizoma atractylodis 12 g, Poria cocos 12 g, Radix paeoniae alba 8 g, Radix angelicae sinensis 12 g, Radix rehmanniae preparata 12 g, Radix paeoniae alba 10 g, Radix notoginseng 8 g, Fructus schisandrae 8 g, Radix polygalae 8 g, Cornu biphoreae 14 g, Pericarpium citri reticulatae 8 g, Fructus jujubae 12 g.

[0057] Effect verification Inclusion criteria: 300 patients with chronic fatigue syndrome meeting the diagnostic criteria were randomly divided into a treatment group (traditional Chinese medicine formula of Examples 1 and Comparative Examples 1-8) and a control group (routine symptomatic treatment).

[0058] Diagnosis requirements for patients with chronic fatigue syndrome: Patients must meet the following three symptoms at the same time, and the symptoms must be moderate or severe, and must last at least 6 months: substantial reduction in activity: manifested as severe, not caused by overexertion, and not fully relieved after rest. Substantially reduced the level of occupational, educational, social or personal activities compared to before the disease. Post-exertional malaise: fatigue and symptoms worsen after physical or cognitive activity. Usually delayed (may occur several hours or days after the activity), and it takes an abnormally long time (several days or even weeks) to recover. Non-restorative sleep: even if you sleep enough, you still feel unwell after waking up, as if you haven't slept at all.

[0059] Patients must also meet at least one of the following: Cognitive impairment: often referred to as "brain fog", manifested as slow thinking, lack of concentration, memory loss, difficulty finding words, etc. Orthostatic intolerance: symptoms worsen when standing or sitting upright, manifested as dizziness, dizziness, blurred vision or a fainting sensation, which can be relieved by lying down.

[0060] Patients with chronic fatigue syndrome are manifested as deficiency of both qi and blood, deficiency of yang, and weakness of the spleen and stomach.

[0061] Qi and blood deficiency syndrome: fatigue, shortness of breath, lazy speech, low voice, pale or yellowish complexion, pale lips and nails, pale tongue, palpitation, insomnia, dizziness, easy sweating, dry and falling hair, less menstrual flow, pale or delayed menstruation.

[0062] Yang deficiency syndrome: fear of cold, cold limbs, listlessness, lethargy, loose stool, poor appetite, cold abdominal pain, diarrhea after eating cold food, thin and shapeless stool. Male impotence and premature ejaculation, female infertility due to palace cold, apathetic sex drive, clear and frequent urination, pale and swollen tongue with tooth marks, white and slippery fur.

[0063] Spleen and stomach weakness syndrome: poor appetite, abdominal distension, loss of appetite, abdominal distension and discomfort after meals. Loose and loose stool, aggravated by improper diet. Thin body, body edema, virtual fat. Pale complexion, body fatigue, belching, nausea, pale tongue and white fur.

[0064] Treatment group administration: one set of prescription a day, morning and evening, 7 days as a course of treatment, 3 courses of treatment.

[0065] Control group administration: diet and psychological education as the main, such as 3 times a week, 20 minutes of health lectures each time, the content covers CFS daily management, but no direct treatment intervention.

[0066] Evaluation index: MDASI scale: score range: 0-10 points, the higher the score, the more severe the symptoms or the more severe the interference. Improvement criteria: MDASI symptom score total score decreased by ≥3 points or single item decreased by ≥2 points was considered to have clinically significant improvement.

[0067] The MDASI scale usually contains two parts: symptom severity and symptom interference with life.

[0068] Symptom severity: pain, fatigue (fatigue), nausea, sleep disturbance, distress, shortness of breath, forgetfulness, poor appetite, lethargy, dry mouth, sadness, vomiting, numbness or tingling.

[0069] Patients score each symptom according to the situation in the past 24 hours: use a numerical rating scale of 0-10, 0 points: "no interference", 10 points: "complete interference".

[0070] Symptom interference with life: this part assesses the degree of interference with different aspects of daily life caused by all symptoms superimposed together in the past 24 hours. Patients need to score each item interfered by symptoms (0-10 points). General activity: daily, basic physical activity and self-care activities, mood, work, relationship with others, walking, life enjoyment.

[0071] Results Table 1: Comparison of MDASI scores and effectiveness between treatment group (Example 1) and control group Cognitive fatigue improvement: more focused attention, improved memory, clearer and more agile thinking, physical fatigue improvement: daily energy improved, daily activities easier, muscle weakness reduced, tolerance to activities improved, subjective feeling better.

[0072] As shown in Table 1, the treatment group of Example 1 had a 52.3% and 47.8% reduction in physical fatigue and cognitive fatigue scores compared to the control group, significantly better than the control group (P<0.05).

[0073] In the clinical trial of Comparative Example 1, 30 patients with qi and blood deficiency took the medicine, and the effective rate was only 70% (Example 1 was 93%). 12 patients had dry mouth and abdominal distension (incidence rate was 40%). Excessive use of qi-tonifying herbs caused stagnation of qi movement and obstruction of spleen and stomach transportation. Excessive use of Huangqi and Dangshen disrupted the balance of the prescription, resulting in decreased efficacy and significant side effects.

[0074] In the treatment group of Comparative Example 2, the effective rate of 30 patients was 76%, but 6 menstrual women had excessive menstrual flow (incidence rate was 20%). Excessive use of Dangui and Chuanxiong enhanced the blood-activating effect, but caused rapid blood flow, consumed yin blood, and violated the principle of "supplementing without being too strong". Excessive use of blood-activating herbs may lead to bleeding tendency and reduce safety.

[0075] In the treatment group of Comparative Example 3, among the 30 patients with yang deficiency, the improvement rate of aversion to cold and warm limbs was only 60% (Example 1 was 91%). Insufficient dosage of Guizhi and Shengjiang weakened the effect of warming and unblocking meridians, which could not promote the absorption of tonifying herbs, resulting in "supplementing without moving". Insufficient dosage of yang-warming herbs significantly reduced the targeting of the prescription for yang deficiency syndrome.

[0076] In the treatment group of Comparative Example 4, among the 30 patients with spleen and stomach weakness, the improvement rate of poor appetite and postprandial abdominal distension was 65% (Example 1 was 95%). Insufficient dosage of Jinejin led to weak digestion and stagnation, and tonifying herbs were greasy and hindered the stomach, resulting in decreased appetite in patients. Insufficient dosage of digestion herbs directly affected the absorption efficiency of the whole prescription, weakening the overall efficacy.

[0077] In the treatment group of Comparative Example 5, the MDASI fatigue score decreased by only 28.5% (Example 1 was ≥40%) after 4 weeks of treatment in 30 patients with chronic fatigue syndrome, and the total effective rate was 74% (Example 1 was 92%), P<0.01. The deletion of Jinejin digestion and stomach health, and Chenpi regulating qi led to greasy and stomach-hindering tonifying herbs, which increased the incidence of poor appetite and abdominal distension in patients (38% vs 8% in Example 1), affecting the absorption efficiency of the whole prescription.

[0078] In the treatment group of Comparative Example 6, the MDASI fatigue score reduction rate was 32.1% (Example 1≥40%), 16 patients had dry mouth, insomnia (occurrence rate 53%), and the ginseng nature of heat helped fire, breaking the balance of qi and yin. The party's sweet and flat gas and more compatible with chronic fatigue syndrome of qi and yin deficiency pathogenesis; Ginseng warm and heat, exacerbate the symptoms of yin deficiency and fire.

[0079] In the treatment group of Comparative Example 7, the MDASI fatigue score reduction rate was 26.7% (Example 1≥40%), and the aversion to cold and cold limbs improvement rate was 35% (Example 1 89%), because Guizhi warmed the meridians and Yang, and Shengjiang dispelled cold and stomach, and the Yang deficiency syndrome was aggravated after deletion.

[0080] In the treatment group of Comparative Example 8, the MDASI fatigue score reduction rate was 31.2% (Example 1≥40%), and the blood stasis syndrome improvement rate was only 48% (Example 1 86%) for tongue purple dark improvement rate, because Chuanxiong was a "blood gas medicine" and its blood circulation and blood circulation were stronger than Danshen; Danshen was biased to cool blood, which conflicted with the warm and tonic tone of Example 1.

[0081] It should be noted that when the present application claims involve numerical ranges, both endpoints of each numerical range and any number between the two endpoints can be selected. In order to prevent repetition, the present application describes preferred embodiments.

[0082] Although preferred embodiments of the present application have been described, those skilled in the art can make further changes and modifications to these embodiments once they know the basic inventive concept. Therefore, the appended claims are intended to include the preferred embodiments and all changes and modifications falling within the scope of the present application.

[0083] Obviously, those skilled in the art can make various modifications and variations to the present application without departing from the spirit and scope of the present application. Thus, if these modifications and variations of the present application fall within the scope of the claims of the present application and their equivalents, the present application also intends to include these modifications and variations.

Claims

1. A traditional Chinese medicine composition, characterized in that, The traditional Chinese medicine composition is prepared from the following raw materials in parts by mass: 6-15 parts of radix codonopsis, 15-30 parts of radix astragali, 10-15 parts of rhizoma atractylodis macrocephalae, 10-15 parts of poria cocos, 6-10 parts of honey-fried licorice, 10-15 parts of angelica sinensis, 10-15 parts of prepared rehmannia, 10-12 parts of radix paeoniae alba, 6-10 parts of ligusticum wallichii, 3-6 parts of cassia twig, 6-10 parts of schisandra chinensis, 6-10 parts of polygala, 12-15 parts of gigeriae, 6-10 parts of tangerine peel, 5-10 parts of ginger, and 10-15 parts of jujube.

2. A method for preparing the traditional Chinese medicine composition according to claim 1, characterized in that, The method comprises the following steps: The raw materials are weighed according to the proportion, washed, soaked for 20-40 minutes, then decocted, and boiled for 30-50 minutes on low heat, and the medicinal liquid is filtered out; the medicinal residue is added with water and decocted for 10-30 minutes, and the medicinal liquid of the two times is combined; The medicinal liquid is concentrated, and then spray-dried to prepare powder to obtain the traditional Chinese medicine composition.

3. A traditional Chinese medicine preparation, characterized in that, The traditional Chinese medicine composition is prepared from the traditional Chinese medicine composition of claim 1.

4. The traditional Chinese medicine preparation according to claim 3, characterized in that, The traditional Chinese medicine preparation is an oral preparation.

5. The traditional Chinese medicine preparation according to claim 4, characterized in that, The type of the oral preparation is granules, pills or capsules.

6. The traditional Chinese medicine preparation according to claim 5, characterized in that, The preparation method of the granules comprises the following steps: The traditional Chinese medicine composition is added with dextrin, mixed, granulated, dried, and then packed. The mass ratio of the traditional Chinese medicine composition to the dextrin is 1:1-2.

7. The traditional Chinese medicine preparation according to claim 5, characterized in that, The preparation method of the pills comprises the following steps: The traditional Chinese medicine composition is added with refined honey, pan-coated, dried, and coated. The mass ratio of the traditional Chinese medicine composition to the refined honey is 1:1-2.

8. The use of the traditional Chinese medicine composition of claim 1 or the traditional Chinese medicine preparation of claim 4 in the preparation of a medicine for treating chronic fatigue syndrome.

9. Use according to claim 8, characterized in that, The medicine is a medicine for treating fatigue, laziness, loss of appetite, dizziness, and lethargy, palpitation and insomnia.

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