Traditional Chinese medicine composition for treating spring and summer qi deficiency and damp-heat type hypodynamia and preparation method of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating spring and summer qi deficiency and damp-heat type hypodynamia and a preparation method thereof, and relates to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition is prepared from the following raw materials: astragalus membranaceus, rhizoma cimicifugae, ginseng slices, rhizoma alismatis, fried medicated leaven, pericarpium citri reticulatae, rhizoma atractylodis macrocephalae, radix ophiopogonis, angelica sinensis, honey-fried licorice root, pericarpium citri reticulatae viride, golden cypress, pachyrhizua angulatus, schisandra chinensis and bran-fried rhizoma atractylodis. The preparation method comprises the following steps: soaking: soaking the raw medicinal materials in water; decocting: boiling with strong fire, then decocting with slow fire, collecting the liquid medicine after the decoction is finished, adding water into the medicine residue again, decocting for the second time, and collecting the liquid medicine obtained by the second time of decoction. The traditional Chinese medicine has the effects of tonifying qi and lifting yang, clearing heat and promoting diuresis, strengthening qi and protecting yin, and tonifying middle-jiao and clearing heat, and has a remarkable treatment effect on qi deficiency and damp-heat type hypodynamia in spring and summer.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and in particular to a pharmaceutical composition related to treating spring and summer qi deficiency and damp-heat type fatigue. Background Art

[0002] Fatigue is a common clinical symptom that severely impacts patients' quality of life and daily functioning. In Traditional Chinese Medicine (TCM), fatigue falls under the category of "conjunctivitis," corresponding to fatigue syndrome in Western medicine. The concept of "conjunctivitis" can be traced back to the Han Dynasty, when Zhang Zhongjing wrote in his book "Golden Chamber Essentials" that "represents blood stasis and conjunctivitis." In TCM, it is also referred to as "deficiency," with its core clinical manifestations primarily characterized by deficiency of the five internal organs. It encompasses a broad range of chronic debilitating diseases. From a TCM perspective, conjunctivitis primarily affects the five internal organs, with its pathological manifestations focusing on deficiencies of qi, blood, yin, and yang. Due to the complex and diverse causes of conjunctivitis, each one often initially triggers a deficiency of qi, blood, yin, or yang in a specific organ. The five internal organs are interconnected and mutually restrictive, with qi, blood, yin, and yang transforming and interdependent. As the disease progresses, the various internal organs, as well as qi, blood, yin, and yang, interact, leading to a complex and varied course of symptoms.

[0003] Traditional Chinese Medicine (TCM) has a rich and in-depth understanding of the etiology and pathogenesis of fatigue. Fatigue not only falls under the category of asthenia, but is also related to depression and other conditions such as lily disease. In his Treatise on the Origin and Symptoms of Various Diseases: Various Symptoms of Asthenia, Chao Yuanfang of the Sui Dynasty explicitly identified the five emotions, six extremes, and seven injuries as key causes of asthenia, with deficiency of qi, blood, and internal organs as the root cause. The combined effects of multiple pathogenic factors can lead to a complex interplay of deficiency, excess, and depression, leading to blocked meridians and qi flow, and accumulation of phlegm, blood, and toxins in the internal organs. This in turn triggers organ dysfunction, hindering the production of qi, blood, essence, and body fluids, further exacerbating vital energy deficiency. These three factors transform and influence each other, forming a vicious cycle of deficiency leading to excess and excess leading to deficiency. As the Treatise on the Origin and Symptoms of Various Diseases states, "Individuals suffering from asthenia suffer from impairment of yin and yang, resulting in blood and qi stagnation, which prevents them from circulating freely through the meridians and thus accumulates internally." Over time, this condition can lead to both yin and yang deficiency, qi stagnation, and blood stasis, leading to accumulation and progressive disease progression.

[0004] Fatigue falls under the categories of asthenia, depression, and lily disease in Traditional Chinese Medicine. Chao Yuanfang's "Treatise on the Origin and Symptoms of Various Diseases: Various Symptoms of Asthenia" from the Sui Dynasty posits that the five emotions, six extremes, and seven injuries are the causes of asthenia, with deficiency of qi, blood, and internal organs at the root. Under the combined influence of these various pathogenic factors, the patient's body presents a state of intertwined deficiency, excess, and depression. Meridians are blocked, qi flow is sluggish, phlegm, blood stasis, and toxins accumulate in the internal organs, leading to organ dysfunction. Qi, blood, essence, and body fluids are unable to be generated, and vital energy deficiency is exacerbated. These three factors transform and influence each other, forming a vicious cycle of deficiency leading to excess and excess leading to deficiency. "Treatise on the Origin and Symptoms of Various Diseases" states, "Individuals suffering from asthenia have damaged yin and yang, resulting in blood and qi congestion, unable to circulate through the meridians, and thus accumulation within the body." Over time, this leads to deficiency of both yin and yang, qi stagnation, and blood stasis, which worsens the progression of the disease.

[0005] In clinical practice, numerous theories and treatments are currently available for fatigue. Modern physicians often approach treatment from the perspective of deficiency, focusing on tonifying the deficiency and paying relatively little attention to excess. Key therapies include tonifying the kidneys and promoting marrow production, strengthening the spleen and nourishing blood, replenishing qi and nourishing yin, and soothing and regulating the liver. In-depth basic research has been conducted on specific prescriptions and herbs. However, these treatments do not fully cover all types of asthenia.

[0006] Of particular note is the prevalence of dampness in spring and summer, particularly in southern China. During this period, dampness and turbidity trap the spleen and stomach, severely obstructing the ascending and descending of Qi, preventing the clear Yang from rising. This leads to symptoms such as heaviness in the head and body, and weakness in the limbs. Simultaneously, dampness and heat intertwine, with heat accelerating the depletion of Qi. As the Neijing states, "strong fire consumes Qi," patients often experience symptoms such as dry mouth, fever, and yellow urine. Heat, a Yang evil, is ascending and dispersing, easily depleting Qi and damaging body fluids. Dampness, a Yin evil, is heavy, turbid, and sticky. The combination of these two depletes Qi and stagnates the spleen, leading to symptoms such as fatigue, a lack of heat, and poor sweating. The intertwined dampness and heat create a lingering, persistent condition.

[0007] Given the above situation, existing treatment methods for treating spring and summer Qi deficiency, dampness-heat type fatigue have obvious limitations and cannot fully meet clinical treatment needs. Therefore, developing a traditional Chinese medicine composition with a specific therapeutic effect specifically for spring and summer Qi deficiency, dampness-heat type fatigue has important clinical significance and practical application value. Summary of the Invention

[0008] The invention provides a traditional Chinese medicine composition for treating qi deficiency and damp-heat type fatigue in spring and summer and a preparation method thereof. The traditional Chinese medicine composition has the effects of replenishing qi and raising yang, clearing away heat and removing dampness, consolidating qi and protecting yin, and replenishing the middle and clearing the body, and has a significant therapeutic effect on qi deficiency and damp-heat type fatigue in spring and summer.

[0009] In order to solve the above technical problems, one of the technical solutions adopted by the present invention is to provide a traditional Chinese medicine composition for treating fatigue caused by qi deficiency and damp-heat in spring and summer: It is made from the following raw materials: Astragalus, Cimicifuga, ginseng slices, Alisma, stir-fried Shenqu, tangerine peel, Atractylodes, Ophiopogon, Chinese Angelica, roasted licorice, Citrus aurantium, Phellodendron, Pueraria, Schisandra, stir-fried Atractylodes.

[0010] In the above technical solution, a more specific technical solution is: the weight parts of each raw material are as follows: 9-15 parts of Astragalus, 3-6 parts of Cimicifuga, 3-6 parts of Ginseng slices, 3-6 parts of Alisma, 3-6 parts of stir-fried Shenqu, 3-6 parts of dried tangerine peel, 3-6 parts of Atractylodes, 1-4 parts of Ophiopogon, 1-4 parts of Angelica, 1-4 parts of roasted Licorice, 1-3 parts of Citrus aurantium, 1-3 parts of Phellodendron, 1-3 parts of Pueraria, 3-6 parts of Schisandra, and 6-9 parts of stir-fried Atractylodes.

[0011] Furthermore, the traditional Chinese medicine composition for treating Qi deficiency and damp-heat type fatigue in spring and summer is made into an oral liquid preparation for internal use.

[0012] The second technical solution adopted by the present invention is to provide a method for preparing the above-mentioned traditional Chinese medicine composition for treating fatigue caused by qi deficiency and damp-heat in spring and summer, using the following medicinal materials as raw materials: Astragalus, Cimicifuga, Ginseng slices, Alisma, stir-fried Shenqu, Tangerine peel, Atractylodes macrocephala, Ophiopogon japonicus, Angelica sinensis, roasted Licorice root, Citrus aurantium, Phellodendron chinense, Pueraria lobata, Schisandra chinensis, stir-fried Atractylodes lancea with bran; The preparation method comprises the following steps: A. Soaking: Soak the above raw medicinal materials in water; B. Decoction: First boil over high heat, then simmer over low heat. After decoction, collect the medicinal liquid and add water to the residue for a second decoction. Collect the medicinal liquid obtained from the second decoction.

[0013] In the above technical solution, a more specific technical solution is: the weight parts of each raw material are as follows: 9-15 parts of Astragalus, 3-6 parts of Cimicifuga, 3-6 parts of Ginseng slices, 3-6 parts of Alisma, 3-6 parts of stir-fried Shenqu, 3-6 parts of dried tangerine peel, 3-6 parts of Atractylodes, 1-4 parts of Ophiopogon, 1-4 parts of Angelica, 1-4 parts of roasted Licorice, 1-3 parts of Citrus aurantium, 1-3 parts of Phellodendron, 1-3 parts of Pueraria, 3-6 parts of Schisandra, and 6-9 parts of stir-fried Atractylodes.

[0014] Furthermore, the method further includes the following steps: C. Filtration and concentration: The medicinal solutions collected from the two decoctions are combined, filtered, and then concentrated to obtain a concentrated solution; D. Preparation: Add excipients to the concentrate to make an oral liquid preparation.

[0015] Furthermore, the auxiliary materials include flavoring agents and preservatives.

[0016] Furthermore, the flavoring agent is steviol glycoside, and the preservative is one or both of sodium benzoate and ethylparaben.

[0017] The astragalus root described in this invention is the root of the plant Astragalus membranaceus, a member of the genus Astragalus in the legume family. It is sweet and slightly warm in nature, and enters the spleen and lung meridians. It is also known as Northeastern Astragalus, Astragalus membranaceus, and Astragalus membranaceus. Its effects include tonifying qi and strengthening the exterior, astringing sweat and preventing premature ejaculation, relieving sores and promoting tissue regeneration, and promoting diuresis and reducing swelling. It is primarily used to treat qi deficiency and fatigue, poor appetite and loose stools, sinking of qi in the middle, spontaneous sweating due to exterior deficiency, susceptibility to colds, qi deficiency edema, difficulty urinating, and pain due to qi deficiency and blood stasis.

[0018] The cimicifuga is the dried rhizome of Cimicifuga foetida L. of the genus Cimicifuga in the family Ranunculaceae. It is pungent, slightly sweet, and slightly cold in nature, and belongs to the lung, spleen, stomach, and large intestine meridians. Its aliases include longan root, zhouma, and holey tooth root. Efficacy: inducing sweating and promoting eruption, clearing heat and detoxifying, lifting yang qi. Indications: wind-heat headache, toothache, oral ulcers, sore throat, measles not spreading, yang toxin maculae, rectal prolapse, uterine prolapse, etc.

[0019] The ginseng is the dried root of Panax ginseng C. A. Mey. of the family Araliaceae. It is slightly warm in nature, sweet and slightly bitter in taste, and belongs to the lung and spleen meridians. Its aliases include jade essence, blood ginseng, earth essence, earth spirit, mountain ginseng, garden ginseng, ghost cover, yellow ginseng, etc. Efficacy: greatly tonifying primordial qi, invigorating the spleen and benefiting the lung, promoting fluid production, calming the mind and improving intelligence. Mainly used for qi deficiency on the verge of collapse, feeble pulse, insufficient spleen qi, sinking of middle qi, cough and asthma due to lung deficiency, shortness of breath and fatigue, thirst due to fluid impairment, consumptive thirst with deficiency heat, insomnia and forgetfulness, palpitation and anxiety, sallow complexion due to blood deficiency, impotence and cold uterus, etc.

[0020] The alisma is the dried tuber of Alisma orientale (Sam.) Juz. of the family Alismataceae. It is sweet, light, and cold in nature, and belongs to the kidney and bladder meridians. Its aliases include water alisma, wishful flower, and plantain. Efficacy: promoting diuresis and percolating dampness, clearing heat and promoting diuresis. Indications: dysuria, painful and frequent urination due to heat, edema and fullness, diarrhea, phlegm retention and dizziness, spermatorrhea, etc.

[0021] The stir-fried medicated leaven: Medicated leaven is a fermented preparation made by mixing medicinal materials such as Polygonum hydropiper L., Artemisia annua L., apricot kernel paste, adzuki bean, and fresh Xanthium sibiricum Patrin ex Widder with flour or bran. Stir-fried medicated leaven is a processed product obtained by stir-frying raw medicated leaven. It is neutral in nature, sweet in taste, and enters the spleen and stomach meridians. The alias of medicated leaven is six-ingredient medicated leaven, six-crushed medicated leaven. Efficacy: strengthening the spleen and harmonizing the stomach, promoting digestion and regulating the middle energizer. Indications: treating food stagnation, chest stuffiness and abdominal distension, vomiting, diarrhea, postpartum blood stasis pain, large abdominal mass in children, etc.

[0022] The tangerine peel is the dried ripe pericarp of Citrus reticulata Blanco and its cultivated varieties of the family Rutaceae. It is warm in nature, pungent and bitter in taste, and belongs to the spleen, stomach, and lung meridians. Its alias is orange peel. Efficacy: regulating qi and strengthening the spleen, regulating the middle energizer, drying dampness and resolving phlegm. Indications: abdominal distension or pain due to qi stagnation in the spleen and stomach, indigestion, chest and abdominal distension due to damp turbidity obstruction, poor appetite and loose stools, cough and asthma due to phlegm retention in the lung, etc.

[0023] The atractylodes is the dried rhizome of Atractylodes macrocephala Koidz. of the family Asteraceae. It is bitter, sweet, and warm in nature, and belongs to the spleen and stomach meridians. Efficacy: replenishing qi and strengthening the spleen, drying dampness and promoting diuresis, securing the exterior and stopping sweating, preventing miscarriage. Indications: qi deficiency of the spleen and stomach, weak transportation and transformation, poor appetite and loose stools, abdominal distension, weakness of limbs and spirit fatigue. It can also be used for retention of water due to spleen deficiency, resulting in phlegm retention, edema, dysuria, or for qi deficiency of the spleen with weakness, insecurity of the muscle surface and excessive sweating, etc.

[0024] The Ophiopogon japonicus is the tuberous root of a perennial herbaceous plant of the genus Ophiopogon in the family Asparagaceae. It is sweet, slightly bitter, and slightly cold in nature, and belongs to the heart, lung, and stomach meridians. Its aliases include Maidong, Ophiopogon bodinieri, Hang Maidong, Chuan Maidong, Cun Dong, Xiaomaimaidong, and Jiuye Maidong. Efficacy: Nourishing yin and promoting the production of body fluids, moistening the lungs and clearing the heart. Indications: Used for dry cough due to lung dryness, consumptive cough, thirst due to fluid impairment, restlessness and insomnia, internal heat and polydipsia, constipation due to intestinal dryness, diphtheria, etc.

[0025] The Angelica sinensis is the dried root of the plant Angelica sinensis of the genus Angelica in the family Apiaceae. It is sweet, pungent, and warm in nature, and belongs to the liver, heart, and spleen meridians. Its aliases include Ganggui, Mayidanggui, Qinggui, Mayigui, Yungui, Xidanggui, and Mingdanggui. Efficacy: Tonifying blood and promoting blood circulation, regulating menstruation and relieving pain, moistening the intestines. Indications: Various syndromes of blood deficiency, irregular menstruation, amenorrhea, dysmenorrhea, mass accumulation, metrorrhagia and metrostaxis, deficiency-cold abdominal pain, flaccidity and paralysis, numbness of the skin and muscles, difficult bowel movements due to intestinal dryness, bloody dysentery with tenesmus, carbuncles and sores, traumatic injuries, etc.

[0026] The roasted Licorice Root is the processed product of Licorice Root (the dried root and rhizome of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat., or Glycyrrhiza glabra L.) after being roasted with honey. It is sweet and slightly warm in nature, and belongs to the heart, lung, spleen, and stomach meridians. The aliases of Licorice Root include Sweet Grass Root, Red Licorice Root, Powdered Licorice Root, Licorice Root, Cortex Glycyrrhizae, and Stick Grass. Efficacy: Tonifying the spleen and replenishing qi, moistening the lungs and relieving cough, alleviating spasm and pain, and harmonizing the properties of drugs. Indications: Weakness of the spleen and stomach, deficiency of middle qi, chronic cough due to lung deficiency, dry cough with scanty sputum, spasm and pain in the epigastric or abdominal region or limbs, or insufficiency of heart qi, palpitation, and intermittent pulse, etc.

[0027] The Green Tangerine Peel is the dried immature fruit or unripe fruit peel of the tangerine of the genus Citrus in the family Rutaceae. It is bitter, pungent, and warm in nature, and belongs to the liver, gallbladder, and stomach meridians. Its aliases include Sihua Qingpi, Ge Qingpi, and Qingpi Zi. Efficacy: Soothing the liver and regulating qi, promoting digestion and resolving stagnation. Indications: Distending pain in the hypochondrium and costal region due to stagnation of liver qi, breast distending pain, breast nodules, breast abscess, hernia pain, distending pain in the epigastric region due to food retention and qi stagnation, as well as mass accumulation and malaria lump caused by qi stagnation and blood stasis, etc.

[0028] The Cortex Phellodendri Chinensis is the dried bark of the tree Phellodendron chinense Schneid. of the genus Phellodendron in the family Rutaceae. It is bitter and cold in nature, and belongs to the kidney, bladder, and large intestine meridians. Its alias is Chuan Phellodendri Cortex. Efficacy: Clearing heat and drying dampness, purging fire and detoxifying, removing fever and relieving steaming. Indications: Damp-heat diarrhea and dysentery, jaundice, leukorrhea, heat strangury, bone-steaming fever, night sweats, spermatorrhea, sores and toxic swellings, eczema and pruritus, etc.

[0029] The Radix Puerariae is the dried root of the plant Pueraria lobata (Willd.) Ohwi of the genus Pueraria in the family Leguminosae. It is cool in nature, sweet and pungent in taste, and belongs to the spleen and stomach meridians. Its aliases include Gegen, Getiao, and Gan Ge. Efficacy: Relieving muscle spasms and reducing fever, promoting the eruption of measles, promoting the production of body fluids and quenching thirst, ascending yang and stopping diarrhea. Indications: Used for exogenous fever and headache, hypertension with stiff neck pain, thirst, polydipsia, measles not erupting, heat dysentery, diarrhea, etc.

[0030] The Schisandra chinensis is the dried ripe fruit of the Schisandra chinensis plant in the Magnoliaceae family. It is warm in nature, sour and sweet in taste, and belongs to the lung, heart, and kidney meridians. Its aliases include Xuanji, Huiji, Wumeizi, Shanhuajiao, Zhuangwei, and Schisandra chinensis. Efficacy: astringing the lung, nourishing the kidney, promoting fluid production, arresting sweating, and astringing sperm. Indications: cough due to lung deficiency, dry mouth and thirst, spontaneous sweating, night sweating, emaciation due to overwork, spermatorrhea and emission, chronic diarrhea and dysentery, etc.

[0031] The stir-fried Atractylodes lancea with bran is the product of Atractylodes lancea (the dried rhizome of Atractylodes lancea Thunb. or Atractylodes chinensis (DC.) Koidz. in the Compositae family) after being stir-fried with bran. It is warm in nature, pungent and bitter in taste, and belongs to the spleen, stomach, and liver meridians. The aliases of Atractylodes lancea include Chizhu, Qiangtoucai, and Maji. Efficacy: drying dampness and strengthening the spleen, dispelling wind-dampness, and improving eyesight. Indications: dampness obstructing the spleen and stomach, lassitude and lethargy, abdominal distension and fullness, loss of appetite, vomiting and diarrhea, phlegm retention, damp swelling, exterior syndrome complicated with dampness, heavy pain in the head and body, soreness and heaviness of the limbs and joints, night blindness, etc.

[0032] Due to the adoption of the above technical solution, the beneficial effects obtained by the present invention are as follows: 1. In view of the complex pathogenesis of the coexistence of damp-heat and qi deficiency in spring and summer, the present invention combines traditional yang-ascending and qi-tonifying herbs (Astragalus membranaceus and Cimicifuga foetida) with heat-clearing and dampness-draining herbs (Phellodendron amurense and Alisma orientale), forming a dynamic balance of "clearing in tonifying and draining in ascending", breaking through the limitations of single supplementation or dampness elimination.

[0033] 2. In view of the complex pathogenesis of the coexistence of damp-heat and qi deficiency in spring and summer, through multi-target synergistic regulation of energy metabolism, water-fluid balance, and inflammatory response, the clinical effective rate of the present invention is significantly higher than that of ordinary qi-tonifying prescriptions.

[0034] 3. The common clinical fatigue of the qi deficiency and damp-heat type in spring and summer is caused by the entrapment of damp-turbidity in the spleen and stomach during the transition between spring and summer, which hinders the ascending and descending of qi movement, leading to disharmony of zang-fu functions, and is likely to cause fatigue of the qi deficiency and damp-heat type in spring and summer, affecting the quality of life. Therefore, the prescription of the present invention uses yang-ascending, heat-clearing, and dampness-draining herbs on the basis of qi supplementation to achieve the effects of consolidating qi and protecting yin, and clearing in tonifying. In the prescription, Astragalus membranaceus, Angelica sinensis, Panax ginseng, and roasted Glycyrrhiza uralensis together play the role of supplementing qi and strengthening the superficial resistance. Atractylodes lancea and Atractylodes macrocephala are used together to synergistically strengthen the spleen and eliminate dampness. Cimicifuga foetida and Pueraria lobata ascend the clear yang of the spleen and stomach. Phellodendron amurense and Alisma orientale clear heat and promote diuresis to drain dampness. In view of the sticky and stagnant damp-heat in spring and summer that hinders the spleen and damages yin, stir-fried Shenqu, Citrus reticulata Blanco, Citrus reticulata Blanco var. austera, Ophiopogon japonicus, and Schisandra chinensis are used to regulate qi, strengthen the spleen, and protect yin.

[0035] 4. The seasonal adaptability of the prescription of the present invention is reflected in the following compatibility: ① Adaptation to the core pathogenesis • Afflicted by damp-heat: The climate is humid in spring and summer, and damp-heat entraps the spleen, leading to qi stagnation. Atractylodes lancea, Phellodendron amurense, and Alisma orientale in the prescription directly clear heat and drain dampness, cutting off the cause of the disease; • Qi deficiency and non-ascending: Summer heat consumes qi, and dizziness occurs due to the non-ascending of clear yang. Astragalus membranaceus and Panax ginseng supplement qi, and Cimicifuga foetida and Pueraria lobata ascend yang, forming a "tonifying - ascending" closed loop, specifically improving fatigue and dizziness; ② Analysis of key herb pairs • Cimicifuga + Pueraria root: Improve brain oxygen supply and relieve hypoxic dizziness caused by low pressure in summer; • Schisandra chinensis + Ophiopogon japonicus: regulate excessive sweat secretion (common in summer), reduce loss of Qi and body fluid, and maintain electrolyte balance; • Stir-fried Shenqu + Atractylodes macrocephala: Enhances digestive function and improves insufficient energy supply related to loss of appetite in summer.

[0036] 5. The present invention is aimed at differentiating spring and summer Qi deficiency damp-heat type fatigue from other causes •vs Fatigue due to blood deficiency: The prescription of this invention does not contain blood-nourishing herbs such as Rehmannia glutinosa and Angelica sinensis, but focuses on replenishing Qi and raising Yang; •vs Fatigue caused by cold and dampness: The prescription of this invention does not use warming Yang drugs such as aconite root and dried ginger, but instead uses Phellodendron chinense and Alisma orientalis to clear away dampness and heat, which is more in line with the pathogenesis of spring and summer.

[0037] 6. The astragalus, ginseng, and licorice root in this prescription exhibit a synergistic effect, collectively tonifying qi and strengthening the exterior. Astragalus nourishes the lung and spleen, ginseng significantly replenishes vital energy, and licorice root harmonizes the other ingredients and enhances their tonifying effect. Furthermore, experiments have shown that astragalus polysaccharides and ginsenosides synergistically enhance immune function, improve energy metabolism, and alleviate qi deficiency-related fatigue.

[0038] 7. The Atractylodes lancea and Atractylodes macrocephala in this prescription exhibit a synergistic effect, both being key herbs for invigorating the spleen and dispelling dampness. Atractylodes lancea is more effective at dispelling dampness and invigorating the spleen, while Atractylodes macrocephala is better at tonifying the spleen and replenishing qi. Their combined use can simultaneously dispel dampness and invigorate the spleen, improving the loss of appetite and heaviness in the limbs caused by damp heat and dampness trapping the spleen in summer. Furthermore, experiments have shown that the combination of the two significantly reduces intestinal inflammatory factors and regulates water metabolism.

[0039] 8. The Cimicifuga and Puerariae Radix in the prescription of the present invention have a synergistic effect. Cimicifuga euphratica can lift the spleen and stomach and clear the yang, while Puerariae Radix can relieve muscles, promote body fluid production and promote yang. The two can work together to relieve dizziness and heaviness in the head caused by damp heat blocking the middle burner in summer, and improve the hypoxic state by increasing blood flow to the brain.

[0040] 9. The Phellodendron chinense and Alisma orientalis in this prescription exhibit a synergistic effect: Phellodendron chinense clears heat and dampness, while Alisma orientalis promotes diuresis and eliminates dampness, effectively targeting summer damp-heat. Furthermore, experiments have shown that berberine and alismatol in Phellodendron chinense synergistically inhibit the NF-κB pathway, alleviating chronic inflammatory responses caused by damp-heat.

[0041] 10. The Ophiopogon japonicus and Schisandra chinensis in the present prescription have a synergistic effect: Ophiopogon japonicus nourishes yin and promotes fluid production, while Schisandra chinensis nourishes the lungs and kidneys. Together, they protect qi and yin, preventing damage to body fluids caused by summer heat. Furthermore, experiments have shown that this combination can enhance cellular antioxidant capacity and reduce damage to qi and yin caused by excessive sweating in summer.

[0042] 11. Tangerine peel and green peel in the prescription of the present invention have a synergistic effect. Tangerine peel regulates qi and strengthens the spleen, while green peel soothes the liver and relieves qi. The two, one rising and one falling, regulate qi and promote the metabolism of dampness. In addition, clinical data show that this combination can significantly improve the chest and epigastric fullness caused by damp-heat stagnation. DETAILED DESCRIPTION

[0043] The present invention will be further described in detail below with reference to specific embodiments: Example 1 - A Chinese medicine composition for treating fatigue caused by Qi deficiency and damp-heat in spring and summer The following medicinal materials are used as raw materials: Astragalus 15g, Cimicifuga 6g, Ginseng Slices 6g, Alisma 6g, Stir-fried Shenqu 6g, Tangerine Peel 6g, Atractylodes 6g, Ophiopogon 4g, Angelica 4g, Roasted Licorice 4g, Citrus Aurantii 3g, Phellodendron 3g, Pueraria 3g, Schisandra 6g, Stir-fried Atractylodes 9g; The preparation method comprises the following steps: Step 1: Pretreatment of medicinal materials Remove impurities and moldy herbs and clean them thoroughly; Step 2: Soak All herbs in the prescription should be soaked before decoction: Place the herbs in a covered stainless steel container, add 8 to 10 times the amount of cold water (or soak the herbs 10 to 15 cm above the surface), and soak for 30 minutes; Step 3: Decoction Traditional techniques use ceramic or earthenware containers for decocting, while modern techniques mostly use stainless steel utensils and avoid using iron or copper pots. First, boil over high heat, then simmer over low heat, decocting twice, each time for 2 hours. Step 4: Filtration and concentration Filtration: Use gauze or centrifuge to remove the drug residue from the extract, then filter it through filter paper or microporous membrane. Concentrate the filtrate to a relative density of 1.02-1.03 g / mL, let it stand for 12-18 hours, take the supernatant and centrifuge. Concentration: Use an evaporator or vacuum concentration to a certain density (usually 1.08-1.10 g / mL); Step 5: Configuration Added excipients: flavoring agent: stevioside; Preservatives: sodium benzoate, ethylparaben; Mixing: Stir the concentrate and excipients evenly, and add distilled water to make up the volume if necessary; Step 6: Fine Filtering and Canning Fine filtration: ensure that the drug solution is clear and sterile; Canning: Automatic filling machine is used to pack the oral liquid into bottles (usually 10ml / tube), and sealed (with aluminum cap); Step 7: Sterilization and quality inspection Sterilization: Moist heat sterilization at 105°C for 40 minutes; Quality inspection: Microbial limit: Comply with the requirements of the Chinese Pharmacopoeia; Assay: Determine the content of the active ingredient by HPLC or UV method; Step 8: Packaging and storage Labeling: Indicate the product name, specification, batch number, and expiration date; Storage: Store in a cool and dry place.

[0044] Example 2 - A traditional Chinese medicine composition for treating fatigue of qi deficiency and damp-heat type in spring and summer The following medicinal materials are used as raw materials: Astragalus membranaceus 12g, Cimicifuga foetida 3g, Ginseng slices 5g, Alisma orientale 3g, Stir-fried medicated leaven 4g, Tangerine peel 5g, Atractylodes macrocephala 4g, Ophiopogon japonicus 3g, Angelica sinensis 3g, Honey-fried licorice root 2g, Perillae fructus 2g, Phellodendron amurense 2g, Pueraria lobata 1g, Schisandra chinensis 3g, Stir-fried Atractylodes lancea 7g.

[0045] This example uses the same preparation method as Example 1, except for the dosage ratio of each raw material.

[0046] Example 3 - A traditional Chinese medicine composition for treating fatigue of qi deficiency and damp-heat type in spring and summer The following medicinal materials are used as raw materials: Astragalus membranaceus 9g, Cimicifuga foetida 4g, Ginseng slices 3g, Alisma orientale 5g, Stir-fried medicated leaven 3g, Tangerine peel 3g, Atractylodes macrocephala 5g, Ophiopogon japonicus 1g, Angelica sinensis 2g, Honey-fried licorice root 3g, Perillae fructus 1g, Phellodendron amurense 1g, Pueraria lobata 2g, Schisandra chinensis 4g, Stir-fried Atractylodes lancea 6g.

[0047] Similarly, this example also uses the same preparation method as Example 1, except for the dosage ratio of each raw material.

[0048] Effect test part: In this research on the present invention, 80 patients who met the criteria of fatigue symptoms of qi deficiency and damp-heat type in spring and summer in Liuzhou Traditional Chinese Medicine Hospital from March 2024 to July 2024 were selected. Among them, there were 35 males and 45 females, aged 43 - 75 years old, with an average age of (48.7 ± 6.3 years). According to the treatment plan, they were divided into a control group (40 cases) and an observation group (40 cases); among them, in the control group, Sijunzi Decoction (9g of ginseng, 9g of atractylodes macrocephala, 9g of poria cocos, 6g of roasted licorice root; usage method: decocted in water for oral administration, 1 dose per day, taken warm in 2 times (preferably before meals)); in the observation group, the prescription of the present invention was taken orally (that is, 9 - 15 parts of astragalus membranaceus, 3 - 5 parts of cimicifuga foetida, 3 - 5 parts of ginseng slices, 3 - 5 parts of alisma orientale, 1 - 3 parts of stir-fried medicated leaven, 3 - 5 parts of tangerine peel, 3 - 5 parts of atractylodes macrocephala, 1 - 2 parts of ophiopogon japonicus, 3 - 5 parts of angelica sinensis, 1 - 2 parts of roasted licorice root, 1 - 2 parts of green tangerine peel, 1 - 2 parts of phellodendron amurense, 1 - 2 parts of pueraria lobata, 3 - 5 parts of schisandra chinensis, 5 - 7 parts of stir-fried atractylodes lancea, and the dosage ratio of the drugs was adjusted based on the conditions of different patients on the basis of the above prescription), usage method: three times a day, 2 vials each time, 10 ml per vial. The improvement of fatigue in the two groups of patients was compared as shown in Table 1 below.

[0049] Table 1 。

[0050] Note: 1. The total effective rate of fatigue symptoms = (number of cured cases + number of significantly improved cases + number of slightly improved cases) / total number of cases × 100%.

[0051] 2. Efficacy criteria: The efficacy evaluation criteria were drawn up with reference to "Discussion on the Efficacy Criteria for Traditional Chinese Medicine Diagnosis and Treatment of Fatigue" in "Foreign Medical Sciences · Section of Traditional Chinese Medicine and Chinese Materia Medica".

[0052] Cured: The main clinical symptoms and secondary symptoms completely disappear, and one can re - adapt to social life and the previous work rhythm. Markedly effective: The disappearance of the main symptoms and secondary symptoms that appear clinically ≥ 2 / 3. Effective: The disappearance of the main clinical symptoms and secondary symptoms is 1 / 3 - 2 / 3. Ineffective: The disappearance of the main clinical symptoms and secondary symptoms ≤ 1 / 3, with no obvious remission or aggravation.

[0053] From the above research, it can be seen that the total effective rate of fatigue symptoms after taking the prescription of the present invention is significantly higher than that after taking Sijunzi Decoction. It can be seen that the prescription of the present invention has a significant therapeutic effect on fatigue of qi deficiency and damp - heat type in spring and summer.

[0054] Among them, the present invention specifically introduces several cases among the above - mentioned numerous cases as follows: (1) Patient Qin, male, 67 years old.

[0055] Chief complaint: Repeated dizziness and fatigue for 1 month.

[0056] Present illness history: The patient gradually felt fatigued during the transition from spring to summer, accompanied by loss of appetite and chest tightness, without fever. The symptoms worsened in the recent 3 weeks. Slight activity would cause shortness of breath, which did not relieve with rest, and the weight decreased by 2 kg. Physical examination: The tongue was dark red, the tongue coating was yellow and greasy, and the pulse was string-like, slippery and weak. The patient had a history of esophageal cancer.

[0057] Western medicine diagnosis: Fatigue syndrome Traditional Chinese medicine diagnosis: Consumption - qi deficiency and damp - heat type Treatment principle: Tonify qi and promote yang - rising, clear heat and promote damp - elimination Treatment method: Oral administration of the oral liquid preparation made from the prescription of the present invention, three times a day, 2 vials each time, 10 ml per vial, for continuous treatment for 21 days. The weight parts composition of the prescription: 15 parts of Astragalus membranaceus, 4 parts of Cimicifuga foetida, 5 parts of Ginseng slices, 5 parts of Alisma orientale, 2 parts of stir - fried Shenqu, 3 parts of Tangerine peel, 4 parts of Atractylodes macrocephala, 1 part of Ophiopogon japonicus, 4 parts of Angelica sinensis, 1 part of Honey - fried Licorice root, 1 part of Pericarpium Citri Reticulatae Viride, 2 parts of Phellodendron amurense, 1 part of Pueraria lobata, 3 parts of Schisandra chinensis, 7 parts of stir - fried Atractylodes lancea.

[0058] Therapeutic effect: During the follow - up visit after 21 days, the patient reported that dizziness and fatigue had improved significantly, the appetite had improved compared with before, there was no dry mouth or bitter taste, the stools were normal, once a day.

[0059] (2) Patient Luo, female, 48 years old.

[0060] Chief complaint: Shortness of breath, weakness and excessive sweating for half a month.

[0061] Present illness history: After the Spring Equinox, the patient had shortness of breath, weakness and excessive sweating for more than 1 month without obvious inducement, especially worse after the sudden rise in temperature. Occasionally had dizziness, no aversion to cold or fever, no pharyngeal swelling and pain, no chest tightness and palpitations. Poor sleep at night, difficulty in falling asleep, loose stools with a feeling of incomplete defecation.

[0062] Physical examination: The tongue was pale, the root of the tongue coating was slightly yellow and greasy, and the pulse was slippery. The patient had a healthy past history.

[0063] Western medicine diagnosis: Fatigue syndrome Traditional Chinese medicine diagnosis: Consumption - qi deficiency and damp - heat type Treatment principle: Tonify qi and promote yang - rising, clear heat and promote damp - elimination.

[0064] Treatment method: Oral administration of the oral liquid preparation made from the prescription of the present invention, three times a day, 2 vials each time, 10 ml per vial, for continuous treatment for 21 days. The weight parts composition of the prescription: 15 parts of Astragalus membranaceus, 4 parts of Cimicifuga foetida, 3 parts of Ginseng slices, 3 parts of Alisma orientale, 2 parts of stir - fried Shenqu, 3 parts of Tangerine peel, 5 parts of Atractylodes macrocephala, 1 part of Ophiopogon japonicus, 4 parts of Angelica sinensis, 1 part of Honey - fried Licorice root, 2 parts of Pericarpium Citri Reticulatae Viride, 1 part of Phellodendron amurense, 2 parts of Pueraria lobata, 3 parts of Schisandra chinensis, 7 parts of stir - fried Atractylodes lancea.

[0065] Therapeutic effect: During the follow-up visit 7 days later, the patient reported that the shortness of breath and weakness had improved, sweating had decreased, there was no dizziness, the difficulty in falling asleep had improved compared to before, and the stools were formed and passed smoothly. Physical examination: The tongue was pale red with a thin white coating, and the pulse was slippery. 21 days later, the patient reported no symptoms of shortness of breath and fatigue, and all other symptoms had disappeared.

[0066] (3) Patient Wang, male, 61 years old, visited on July 11, 2024 (Minor Heat).

[0067] Chief complaint: Tiredness and weakness for 1 month.

[0068] Current medical history: The patient had tiredness and weakness, fear of wind, occasional dizziness, difficult-to-pass stools with a foul smell, and poor sleep 1 month ago. There was no headache, no hemoptysis, night sweats, no chest pain, no abdominal pain or diarrhea. Physical examination: The tongue was red, with a yellow and greasy coating, and the pulse was slippery. The patient had a history of left lung adenocarcinoma.

[0069] Western medicine diagnosis: Fatigue syndrome Traditional Chinese medicine diagnosis: Consumption - Qi deficiency and damp - heat type Treatment principle: Tonify qi and promote yang - rising, clear heat and promote damp - elimination Treatment method: Oral administration of the oral liquid preparation made from the prescription of the present invention, three times a day, 2 bottles each time, 10 ml per bottle, for 21 consecutive days. The weight parts composition of the prescription: 15 parts of Astragalus membranaceus, 4 parts of Rhizoma Cimicifugae, 5 parts of Ginseng slices, 5 parts of Alisma orientale, 2 parts of stir - fried Medicago sativa, 3 parts of Pericarpium Citri Reticulatae, 5 parts of Atractylodes macrocephala, 2 parts of Ophiopogon japonicus, 4 parts of Angelica sinensis, 2 parts of Radix Glycyrrhizae Preparata, 2 parts of Pericarpium Citri Reticulatae Viride, 1 part of Phellodendron amurense, 2 parts of Pueraria lobata, 3 parts of Schisandra chinensis, 7 parts of stir - fried Atractylodes lancea.

[0070] Therapeutic effect: 7 days after taking the medicine, the patient reported that the weakness had improved significantly compared to before, still had a small amount of fear of wind, the frequency of dizziness had decreased, the stools were passed smoothly, and the smell had reduced. Then, continue with the previous prescription and take it for another 14 days. The patient had no sense of weakness, no fear of wind, no dizziness, and the stools were passed smoothly.

[0071] It should be noted that: The above embodiments are only used to illustrate the technical solutions of the present invention, rather than limiting it; although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that: They can still modify the technical solutions recorded in the foregoing embodiments, or perform equivalent replacements for some of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A traditional Chinese medicine composition for treating fatigue of qi deficiency and damp-heat type in spring and summer, characterized in that Made from the following raw materials: Astragalus, Cimicifuga, ginseng slices, Alisma, stir-fried Shenqu, tangerine peel, Atractylodes, Ophiopogon, Chinese Angelica, roasted licorice, Citrus aurantium, Phellodendron, Pueraria, Schisandra, stir-fried Atractylodes.

2. The traditional Chinese medicine composition for treating fatigue of qi deficiency and damp-heat type in spring and summer according to claim 1, characterized in that The weight parts of each raw material are as follows: 9-15 parts of Astragalus, 3-6 parts of Cimicifuga, 3-6 parts of Ginseng slices, 3-6 parts of Alisma, 3-6 parts of stir-fried Shenqu, 3-6 parts of dried tangerine peel, 3-6 parts of Atractylodes, 1-4 parts of Ophiopogon, 1-4 parts of Angelica, 1-4 parts of roasted Licorice, 1-3 parts of Citrus aurantium, 1-3 parts of Phellodendron, 1-3 parts of Pueraria, 3-6 parts of Schisandra, and 6-9 parts of stir-fried Atractylodes.

3. The Chinese medicine composition for treating spring and summer Qi deficiency and damp-heat type fatigue according to claim 1 or 2, characterized in that: The traditional Chinese medicine composition for treating spring and summer qi deficiency and damp-heat type fatigue is prepared into an oral liquid preparation for oral administration.

4. A method for preparing a Chinese medicine composition for treating Qi deficiency and damp-heat type fatigue in spring and summer, characterized in that: The following medicinal materials are used as raw materials: Astragalus, Cimicifuga, Ginseng slices, Alisma, stir-fried Shenqu, Tangerine peel, Atractylodes macrocephala, Ophiopogon japonicus, Angelica sinensis, roasted Licorice root, Citrus aurantium, Phellodendron chinense, Pueraria lobata, Schisandra chinensis, stir-fried Atractylodes lancea with bran; The preparation method comprises the following steps: A. Soaking: Soak the above raw medicinal materials in water; B. Decoction: First boil over high heat, then simmer over low heat. After decoction, collect the medicinal liquid and add water to the residue for a second decoction. Collect the medicinal liquid obtained from the second decoction.

5. The method for preparing the Chinese medicine composition for treating spring and summer Qi deficiency and damp-heat type fatigue according to claim 4, characterized in that: The weight parts of each raw material are as follows: 9-15 parts of Astragalus, 3-6 parts of Cimicifuga, 3-6 parts of Ginseng slices, 3-6 parts of Alisma, 3-6 parts of stir-fried Shenqu, 3-6 parts of dried tangerine peel, 3-6 parts of Atractylodes, 1-4 parts of Ophiopogon, 1-4 parts of Angelica, 1-4 parts of roasted Licorice, 1-3 parts of Citrus aurantium, 1-3 parts of Phellodendron, 1-3 parts of Pueraria, 3-6 parts of Schisandra, and 6-9 parts of stir-fried Atractylodes.

6. The preparation method of the traditional Chinese medicine composition for treating fatigue of qi deficiency and damp-heat type in spring and summer according to claim 4 or 5, characterized in that The following steps are also included: C. Filtration and concentration: The medicinal solutions collected from the two decoctions are combined, filtered, and then concentrated to obtain a concentrated solution; D. Preparation: Add excipients to the concentrate to make an oral liquid preparation.

7. The method for preparing the Chinese medicine composition for treating spring and summer Qi deficiency and damp-heat type fatigue according to claim 6, characterized in that: The auxiliary materials include flavoring agents and preservatives.

8. The method for preparing the Chinese medicine composition for treating spring and summer Qi deficiency and damp-heat type fatigue according to claim 7, characterized in that: The flavoring agent is steviol glycoside, and the preservative is one or two of sodium benzoate and ethylparaben.