Traditional Chinese medicine composition for treating fatigue of patients with qi deficiency and preparation method of traditional Chinese medicine composition

Abstract

The invention relates to the technical field of traditional Chinese medicine compositions, in particular to a traditional Chinese medicine composition for treating fatigue of a patient with qi deficiency and a preparation method of the traditional Chinese medicine composition. According to the theory of traditional Chinese medicine, traditional Chinese medicine components are screened by adopting the theory of treatment based on syndrome differentiation, and the provided traditional Chinese medicine composition (comprising the following raw materials in parts by weight: 6-18 parts of codonopsis pilosula, 6-18 parts of angelica sinensis, 6-18 parts of Chinese yam, 3-9 parts of astragalus membranaceus, 3-9 parts of pericarpium citri reticulatae and 3-9 parts of radix paeoniae alba) is scientific and reasonable in proportion; in clinical work, the spleen tonifying and body resistance strengthening prescription is used for intervening in patients with qi deficiency and mass accompanied with fatigue, and good curative effect feedback is obtained. In addition, a patient with qi deficiency quality is intervened by codonopsis pilosula, angelica sinensis, pericarpium citri reticulatae, radix paeoniae alba, astragalus membranaceus and Chinese yam, the curative effect is definite, and research results show that the traditional Chinese medicine composition can improve the daily living ability of the patient to a certain extent, remarkably reduce the MFI-20 score and improve the fatigue state of the patient.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine compositions, and particularly relates to a traditional Chinese medicine composition for treating fatigue in patients with qi deficiency constitution and a preparation method thereof. Background Art

[0002] Fatigue is mostly considered a multi-dimensional motor perception, emotional and cognitive experience, an early sense of exhaustion that occurs during physical or mental activities, accompanied by tiredness, lack of energy, and aversion to effort, and usually cannot be improved by rest. Pathological fatigue refers to a persistent or excessive fatigue state caused by diseases, metabolic disorders, or abnormal physiological functions, characterized by the inability to be relieved by conventional rest and often accompanied by pathophysiological changes of the primary disease. This kind of fatigue is essentially different from the temporary fatigue after normal physiological activities, and usually reflects energy metabolism disorders, endocrine disorders, or systemic inflammatory reactions in the body. A variety of diseases can cause pathological fatigue, such as cerebrovascular diseases, etc. Meta-analysis suggests that the pooled prevalence of post-stroke fatigue is estimated to be 50% (95% CI 43-57%), which is one of the common complications that seriously affect the quality of life of stroke patients. It not only affects the efficacy of the rehabilitation treatment of patients, but also has an adverse impact on the quality of life, rehabilitation, and mortality of patients. The cause of fatigue is unknown, related to multiple factors, and the current western medicine treatment of fatigue has poor effects. Therefore, studying the treatment methods of fatigue from the perspective of traditional Chinese medicine and providing a basis for traditional Chinese medicine to intervene in fatigue has great clinical value.

[0003] Fatigue belongs to the categories of "consumptive disease", "spiritual fatigue", and "lassitude" in traditional Chinese medicine. Its etiology and pathogenesis are related to the imbalance of qi, blood, yin, and yang. Excessive or insufficient work and rest, improper diet, emotional injury, external pathogen invasion, and congenital deficiency are all the causes of fatigue, involving multiple zang-fu organs, but the core pathogenesis is closely related to the spleen. The failure of the spleen to perform its transportation and transformation function is the core pathogenesis of fatigue. The "spleen" in traditional Chinese medicine is located in the middle jiao, and its functions mainly include transportation and transformation, ascending the clear, and controlling blood. The spleen has the function of transforming food into essential nutrients of water and grains and transporting the essential nutrients of water and grains to the whole body, and is known as the "source of qi and blood transformation" and the "foundation of acquired constitution". When the spleen is weak, the transportation and transformation of essential nutrients of water and grains are impaired, the generation of qi and blood is insufficient, and the limbs cannot be nourished, resulting in limb weakness. When the spleen is weak and the transportation and transformation function is disordered, the water and dampness will stagnate, and the clear yang qi will not ascend, resulting in symptoms such as a heavy head as if wrapped and limb fatigue.

[0004] Traditional Chinese medicine constitution refers to the comprehensive characteristics of an individual's morphological structure, physiological function, and mental state formed under the combined action of congenital inheritance and acquired environment, with disease susceptibility and predictability of pathological evolution rules. Research shows that qi deficiency constitution is a susceptible traditional Chinese medicine constitution for fatigue. Intervening in fatigue patients based on qi deficiency constitution not only reflects the syndrome differentiation and treatment of traditional Chinese medicine, can more effectively improve the fatigue of patients, but also can reduce the recurrence of fatigue.

[0005] Therefore, it is still crucial to provide a traditional Chinese medicine composition for treating fatigue in patients with qi deficiency constitution. Summary of the Invention

[0006] In order to solve the above problems, the object of the present invention is to provide a traditional Chinese medicine composition for treating fatigue in patients with qi deficiency constitution and its preparation method. From the perspective of traditional Chinese medicine's "treating fatigue from the spleen", the present invention combines traditional Chinese medicines that can be used both as medicine and food to condition the spleen and stomach to strengthen the spleen and support healthy qi, further improve the fatigue state of patients, and improve the quality of life. The spleen-strengthening and healthy qi formula (i.e., the "traditional Chinese medicine composition for treating fatigue in patients with qi deficiency constitution" of the present invention) is a clinical experience formula summarized by combining the classic traditional Chinese medicine formula Buzhong Yiqi Decoction and long-term clinical experience. Clinical studies have confirmed that the method of strengthening the spleen and supporting healthy qi can effectively improve the fatigue state of patients and improve the quality of life of patients.

[0007] The object of the present invention can be achieved by the following technical solutions:

[0008] The first object of the present invention is to provide a traditional Chinese medicine composition for treating fatigue in patients with qi deficiency constitution, comprising the following raw materials in parts by weight: Codonopsis pilosula 6 - 18 parts, Angelica sinensis 6 - 18 parts, Dioscorea opposita 6 - 18 parts, Astragalus membranaceus 3 - 9 parts, Citrus reticulata Blanco 3 - 9 parts, Paeonia lactiflora 3 - 9 parts.

[0009] Preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: Codonopsis pilosula 6 parts, Angelica sinensis 6 parts, Dioscorea opposita 6 parts, Astragalus membranaceus 3 parts, Citrus reticulata Blanco 3 parts, Paeonia lactiflora 3 parts.

[0010] The second object of the present invention is to provide a preparation method of a traditional Chinese medicine composition for treating fatigue in patients with qi deficiency constitution, selected from one of the following preparation methods:

[0011] The first preparation method (dosage form is decoction): Take the traditional Chinese medicine composition according to the parts by weight for soaking treatment, then decoct twice, combine the filtrates and filter through a gauze (double-layer gauze) to obtain the filtrate;

[0012] When taking, divide the filtrate into two doses and take orally twice a day, morning and evening;

[0013] The second preparation method (dosage form is oral liquid): Take the traditional Chinese medicine composition according to the parts by weight for soaking treatment, then decoct twice, combine the filtrates and filter through a gauze (double-layer gauze) to obtain the filtrate for concentration treatment, and obtain the concentrated liquid (prepared into an oral liquid dosage form of 20 mL);

[0014] When taking, take 20 mL each time and take orally twice a day, morning and evening;

[0015] The third preparation method (dosage form is granule): Take the traditional Chinese medicine composition according to the parts by weight for soaking treatment, then decoct twice, combine the filtrates and filter through a gauze (double-layer gauze) to obtain the filtrate, and successively perform concentration treatment, drying treatment, and granulation treatment to obtain the granules.

[0016] In one embodiment of the present invention, the traditional Chinese medicine composition is soaked in water for 20 - 40 min (preferably, the soaking time is 30 min);

[0017] The amount of water added is 1 - 2 times the total weight of the traditional Chinese medicine composition.

[0018] In one embodiment of the present invention, the decocting time is 20 - 40 min (preferably, the decocting time is 30 min).

[0019] The third object of the present invention is to provide a traditional Chinese medicine preparation for treating fatigue in patients with qi deficiency constitution, comprising the above-mentioned traditional Chinese medicine composition, and optionally one or more pharmaceutically acceptable carriers.

[0020] In one embodiment of the present invention, the dosage form of the traditional Chinese medicine preparation is gel, cream, tablet, capsule, powder, mixture, pill, granule, solution, syrup, decoction extract, suppository, aerosol, plaster, ointment, injection, spray, liniment, tincture, wet compress, paste or lotion.

[0021] In one embodiment of the present invention, the pharmaceutically acceptable carrier is selected from at least one of pharmaceutically acceptable solvents, solubilizers, cosolvents, emulsifiers, colorants, binders, disintegrants, fillers, lubricants, wetting agents, osmotic pressure regulators, stabilizers, glidants, flavoring agents, preservatives, suspending agents, coating materials, fragrances, antiadhesives, chelating agents, penetration enhancers, pH regulators, buffers, plasticizers, surfactants, thickeners, clathrates, humectants, absorbents, diluents, flocculants and deflocculants, filter aids, release retardants, high molecular skeleton materials and film-forming materials.

[0022] In one embodiment of the present invention, it further includes optionally one or more other drugs for treating fatigue in patients with qi deficiency constitution.

[0023] The fourth object of the present invention is to provide the use of the above-mentioned traditional Chinese medicine composition in the preparation of a drug for preventing and / or treating fatigue in patients with qi deficiency constitution.

[0024] In traditional Chinese medicine, the "spleen" is located in the middle energizer, and its functions mainly include transportation and transformation, ascending and clearing, and controlling blood. The spleen has the function of transforming food into essential nutrients of water and grains and transporting the essential nutrients of water and grains to the whole body, and is known as the "source of qi and blood generation" and the "foundation of acquired constitution". If the transportation and transformation function of the spleen fails, water, grains, body fluids will stagnate into pathological products such as dampness, phlegm, and retention of fluid, and the spleen is called the "organ that generates phlegm". Therefore, when the spleen function is impaired, there will be no source for qi and blood generation, qi and blood deficiency, and the limbs will not be nourished; at the same time, due to the failure of transportation and transformation, water and dampness stagnate, giving rise to phlegm-turbidity, resulting in heavy limbs and fatigue and drowsiness. According to the treatment principle of syndrome differentiation and treatment in traditional Chinese medicine, strengthening the spleen and supporting the healthy qi, improving the function of the spleen can make the body have sufficient qi and blood, and the trunk and limbs can be nourished.

[0025] The traditional Chinese medicine composition provided by the present invention has the following syndrome differentiation and formula composition rules: All six traditional Chinese medicines enter the spleen meridian, taking the meaning of supplementing qi and tonifying deficiency in Buzhong Yiqi Decoction. Codonopsis pilosula supplements qi and tonifies the middle-jiao, strengthens the spleen and nourishes blood; Angelica sinensis nourishes blood, strengthens the spleen and promotes blood circulation, and nourishes blood and regulates nutrient qi. Since qi and blood share the same origin, they are used as the monarch drugs together to make qi flourish and the spleen function smoothly; Dioscorea opposita supplements qi and nourishes yin, tonifies the lungs, spleen and kidneys, and Astragalus membranaceus supplements qi and raises yang, benefits the defensive qi and consolidates the exterior, and they are used as the minister drugs together to enhance the effect of the monarch drugs in strengthening the spleen, supplementing qi and promoting transportation; Citrus reticulata Blanco regulates qi and stimulates the appetite, dries dampness and resolves phlegm and promotes qi movement, so as to make the supplementation not stagnant and the movement not harmful; Paeonia lactiflora Pall. nourishes blood and astringes yin. In "Ben Cao Bei Yao", it is recorded that "Paeonia lactiflora Pall. can promote nutrient qi". They are used as the assistant drugs together to help the effect of strengthening the spleen, nourishing yin, regulating qi and promoting blood circulation, and can also prevent qi stagnation caused by excessive supplementation. They work together to strengthen the spleen and support healthy qi, and supplement qi and nourish blood.

[0026] Compared with the prior art, the present invention has the following beneficial effects:

[0027] According to the theory of traditional Chinese medicine, the present invention screens the traditional Chinese medicine formula by using the theory of syndrome differentiation and treatment. The proportion of the provided traditional Chinese medicine composition is scientific and reasonable; in clinical work, the patients with qi deficiency constitution accompanied by fatigue are intervened with the spleen-strengthening and healthy qi-supporting formula, and good curative effect feedback is obtained. In addition, Codonopsis pilosula, Angelica sinensis, Citrus reticulata Blanco, Paeonia lactiflora Pall., Astragalus membranaceus and Dioscorea opposita are used to intervene in the patients with qi deficiency constitution, and the curative effect is definite. The research results show that it can improve the daily living ability of the patients to a certain extent, significantly reduce the MFI-20 score, and improve the fatigue state of the patients. Detailed implementation manners

[0028] The present invention will be described in detail below with reference to specific embodiments.

[0029] In the following embodiments, unless otherwise specified, the reagents used are all commercially available reagents, and the detection means and methods used are all conventional detection means and methods in the art.

[0030] Embodiment 1

[0031] The present embodiment provides a preparation method of a traditional Chinese medicine composition decoction, which is specifically as follows:

[0032] Mix 6 g of Codonopsis pilosula, 6 g of Angelica sinensis, 6 g of Dioscorea opposita, 3 g of Citrus reticulata Blanco, 3 g of Astragalus membranaceus and 3 g of Paeonia lactiflora Pall., then add 2 times the amount of water and soak for 30 min, then decoct and extract twice, each time for 30 min, combine the filtrates of the two times, filter with double-layer gauze, take the filtrate, and obtain the traditional Chinese medicine composition decoction.

[0033] Embodiment 2

[0034] The present embodiment provides a preparation method of an oral liquid dosage form of a traditional Chinese medicine composition, which is specifically as follows:

[0035] Mix 6g of Codonopsis pilosula, 6g of Angelica sinensis, 6g of Chinese yam, 3g of Tangerine peel, 3g of Astragalus membranaceus, and 3g of White peony root, then add 2 times the amount of water and soak for 30 minutes, then decoct and extract 2 times, 30 minutes each time. Combine the two filtrates, filter through double-layer gauze, take the filtrate, and concentrate to obtain the oral liquid dosage form of the traditional Chinese medicine composition.

[0036] Example 3

[0037] This example provides a preparation method for granules of a traditional Chinese medicine composition, which is as follows:

[0038] Mix 6g of Codonopsis pilosula, 6g of Angelica sinensis, 6g of Chinese yam, 3g of Tangerine peel, 3g of Astragalus membranaceus, and 3g of White peony root, then add 2 times the amount of water and soak for 30 minutes, then decoct and extract 2 times, 30 minutes each time. Combine the two filtrates, filter through double-layer gauze, take the filtrate, concentrate, dry, and granulate to obtain the granules of the traditional Chinese medicine composition.

[0039] Example 4

[0040] Set up a control group: placebo; specifically, the placebo consists of 1 / 20 of Shenshao Guipi Decoction (6g of Codonopsis pilosula, 6g of Angelica sinensis, 3g of Tangerine peel, 3g of White peony root), plus an inert excipient (such as starch, etc.) without pharmacological and toxic side effects. The drug dosage form is a traditional Chinese medicine granule preparation. The finished product is completely consistent with the traditional Chinese medicine granules of the experimental group in terms of physical properties such as appearance, particle color, dissolution characteristics, taste, and smell, meeting the visual and sensory equivalence requirements of the double-blind test. Administration method: 1 dose per day, 2 times a day, orally.

[0041] Set up an experimental group: a traditional Chinese medicine composition composed of 6g of Codonopsis pilosula, 6g of Angelica sinensis, 6g of Chinese yam, 3g of Tangerine peel, 3g of Astragalus membranaceus, and 3g of White peony root. The drug dosage form is a traditional Chinese medicine granule preparation. Administration method: 1 dose per day, 2 times a day, orally.

[0042] Research result - 1: Comparison between the method of strengthening the spleen and supporting healthy qi and the traditional Chinese medicine placebo control group

[0043] (1) Comparison of the general data of the two groups of patients at the time of enrollment (as shown in Table 1). It can be found from Table 1 that there is no statistically significant difference in the general data of the two groups of patients (P > 0.05).

[0044] Table 1 General data of the two groups of patients at the time of enrollment

[0045]

[0046] (2) Comparison of the fatigue status and prognosis of the two groups of patients after 3 months and 6 months of intervention

[0047] The MFI-20 scale was used to evaluate the severity of fatigue in patients. The statistical results showed that the severity of fatigue in both groups of patients was significantly reduced after 3 months and 6 months of intervention. The BI was used to evaluate the activities of daily living ability of patients. The results showed that the Jianpi Fuzheng formula could significantly improve the activities of daily living ability of patients after intervention. At the same time, the MoCA was used to detect the cognitive function of patients. The results showed that the Jianpi Fuzheng method could significantly increase the MoCA score and improve the cognitive function after intervention (all P < 0.05) (see Tables 2 and 3).

[0048] Table 2 Comparison of fatigue status and prognosis between the two groups of patients before and after 3 months of intervention

[0049]

[0050] *Statistically significant difference, P < 0.05

[0051] Table 3 Comparison of fatigue status and prognosis between the two groups of patients before and after 6 months of intervention

[0052]

[0053] *Statistically significant difference, P < 0.05

[0054] (3) Comparison of traditional Chinese medicine syndromes between the two groups of patients after 3 months and 6 months of intervention

[0055] The traditional Chinese medicine syndrome scores, the degree of impact on life, and the traditional Chinese medicine constitution scores (Qi deficiency constitution score and peaceful constitution score) of the two groups of patients after intervention were compared. The results showed that the Jianpi Fuzheng formula could significantly improve the traditional Chinese medicine syndrome scores and the degree of impact on life, and could significantly improve the Qi deficiency constitution score and the peaceful constitution score (see Tables 4 and 5).

[0056] Table 4 Comparison of fatigue status and prognosis between the two groups of patients before and after 3 months of intervention

[0057]

[0058] *Statistically significant difference, P < 0.05

[0059] Table 5 Comparison of fatigue status and prognosis between the two groups of patients before and after 6 months of intervention

[0060]

[0061] * Statistically significant difference, P < 0.05

[0062] Research result - 2: Comparison between the Jianpi Fuzheng method and the Shenshao Guipi Decoction control group

[0063] Since the traditional Chinese medicine placebo contains 1 / 20 of Shenshao Guipi Decoction (6g Codonopsis pilosula, 6g Angelica sinensis, 3g Citrus reticulata Blanco, 3g Paeonia lactiflora Pall.), the curative effects of Jianpi Fuzheng Formula and Shenshao Guipi Decoction were further compared. The Shenshao Guipi Decoction group was treated with 6g Codonopsis pilosula, 6g Angelica sinensis, 3g Citrus reticulata Blanco, and 3g Paeonia lactiflora Pall., and the dosage form was the same as that of Jianpi Fuzheng Formula, both being traditional Chinese medicine granules. The analysis results are as follows:

[0064] (1) Comparison of fatigue and prognosis between the two groups of patients with Jianpi Fuzheng Formula and Shenshao Guipi Decoction

[0065] The fatigue and prognosis of the two groups of patients with Jianpi Fuzheng Formula and Shenshao Guipi Decoction were compared before and after treatment. The results showed that after treatment with Jianpi Fuzheng Formula, the MFI-20, BI, and MoCA scores of the patients could be significantly improved, and the fatigue and prognosis (activities of daily living ability and cognitive function) of the patients with ischemic stroke could be improved. However, there was no statistical difference in the comparison before and after treatment with Shenshao Guipi Decoction. (See Tables 6 and 7)

[0066] Table 6 Comparison of fatigue status and prognosis between the two groups of patients before and after 3 months of intervention

[0067]

[0068] * The difference was statistically significant, P < 0.05

[0069] Table 7 Comparison of fatigue status and prognosis between the two groups of patients before and after 6 months of intervention

[0070]

[0071] * The difference was statistically significant, P < 0.05

[0072] (2) Comparison of the differences between the two groups before and after treatment

[0073] To further clarify the differences in the treatment of the two groups, the differences between the two groups of patients before and after treatment were compared. The results showed that compared with the treatment with Shenshao Guipi Decoction, the treatment with Jianpi Fuzheng Method could significantly reduce the MFI-20 score of the patients and improve the fatigue status of the patients, and the difference was statistically significant (P < 0.05) (see Table 8).

[0074] Table 8 Comparison of the differences in fatigue and prognosis between the two groups of patients before and after intervention

[0075]

[0076] * The difference was statistically significant, P < 0.05

[0077] (3) Comparison of the traditional Chinese medicine syndromes between the two groups before and after treatment

[0078] The TCM syndromes of two groups of patients treated with the Spleen-Strengthening and Righteousness-Restoring Prescription and the Ginseng, Peony, Angelica and Cortex Moutan Decoction were compared before and after treatment. The results showed that after treatment with the Spleen-Strengthening and Righteousness-Restoring Prescription, the TCM syndromes and physical constitution scores (harmonious constitution and qi deficiency constitution) of patients with ischemic stroke could be significantly improved. However, there were no statistically significant differences in the TCM syndrome scores in March, the impact on life, and the TCM physical constitution scores (harmonious constitution and qi deficiency constitution) before and after treatment with the Ginseng, Peony, Angelica and Cortex Moutan Decoction (see Tables 9 and 10).

[0079] Table 9 Comparison of TCM syndromes between two groups of patients before and after 3 months of intervention

[0080]

[0081] *The difference was statistically significant, P < 0.05

[0082] Table 10 Comparison of TCM syndromes between two groups of patients before and after 6 months of intervention

[0083]

[0084] *The difference was statistically significant, P < 0.05

[0085] (4) Compare the differences in TCM syndromes between the two groups before and after treatment

[0086] To further clarify the differences in the treatment of the two groups, the differences between the two groups of patients before and after treatment were compared. The results showed that compared with the treatment with the Ginseng, Peony, Angelica and Cortex Moutan Decoction, the Spleen-Strengthening and Righteousness-Restoring Prescription could significantly improve the TCM syndromes of patients (including TCM syndrome scores, the degree of impact on life, harmonious constitution scores and qi deficiency constitution scores), and the difference was statistically significant (P < 0.05) (see Table 11).

[0087] Table 11 Comparison of differences in TCM syndromes between two groups of patients before and after intervention

[0088]

[0089] * The difference was statistically significant, P < 0.05

[0090] To sum up, the Spleen-Strengthening and Righteousness-Restoring Prescription provided by the present invention is a clinical experience prescription summarized from long-term clinical practice and has been verified by relevant clinical studies. It provides a new prevention and treatment direction for the treatment of patients with qi deficiency constitution fatigue. The research shows that there is a significant correlation between qi deficiency constitution and fatigue. The treatment for such patients can be more targeted, which can improve the fatigue state of patients with ischemic stroke, improve the quality of life, and provide economic value for reducing the social burden.

[0091] The above description of the embodiments is provided to enable those of ordinary skill in the art to understand and use the invention. It is obvious that those skilled in the art can easily make various modifications to these embodiments and apply the general principles described herein to other embodiments without creative efforts. Therefore, the present invention is not limited to the above embodiments, and all improvements and modifications made by those skilled in the art without departing from the scope of the present invention according to the interpretation of the present invention should be within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating fatigue in patients with qi deficiency constitution, characterized in that, It comprises the following crude drugs in parts by weight: Codonopsis pilosula 6 - 18 parts, Angelica sinensis 6 - 18 parts, Dioscorea opposita 6 - 18 parts, Astragalus membranaceus 3 - 9 parts, Citrus reticulata Blanco 3 - 9 parts, Paeonia lactiflora 3 - 9 parts.

2. The traditional Chinese medicine composition for treating fatigue of patients with qi deficiency constitution according to claim 1, wherein, It comprises the following crude drugs in parts by weight: Codonopsis pilosula 6 parts, Angelica sinensis 6 parts, Dioscorea opposita 6 parts, Astragalus membranaceus 3 parts, Citrus reticulata Blanco 3 parts, Paeonia lactiflora 3 parts.

3. A method for preparing a traditional Chinese medicine composition for treating fatigue in patients with qi deficiency constitution as described in any one of claims 1 to 2, characterized in that, It is selected from one of the following preparation methods: The first preparation method: Take the traditional Chinese medicine composition according to the parts by weight for soaking treatment, then decoct twice, combine the filtrates and filter through gauze, and take the filtrate. The second preparation method: Take the traditional Chinese medicine composition according to the parts by weight for soaking treatment, then decoct twice, combine the filtrates and filter through gauze, take the filtrate for concentration treatment, and take the concentrated solution. The third preparation method: Take the traditional Chinese medicine composition according to the parts by weight for soaking treatment, then decoct twice, combine the filtrates and filter through gauze, take the filtrate for concentration treatment, drying treatment, and granulation treatment in sequence, and take the granules.

4. The preparation method of a traditional Chinese medicine composition for treating fatigue of patients with qi deficiency constitution according to claim 3, characterized in that, Soak the traditional Chinese medicine composition in water for 20 - 40 min. The addition amount of water is 1 - 2 times the total weight of the traditional Chinese medicine composition.

5. The preparation method of a traditional Chinese medicine composition for treating fatigue in patients with qi deficiency constitution according to claim 3, characterized in that, The decocting time is 20 - 40 min.

6. A traditional Chinese medicine preparation for treating fatigue in patients with qi deficiency constitution, characterized in that, It comprises the traditional Chinese medicine composition as described in claim 1 or 2, and optionally one or more pharmaceutically acceptable carriers.

7. The traditional Chinese medicine preparation for treating fatigue of patients with qi deficiency constitution according to claim 6, characterized in that, The dosage form of the traditional Chinese medicine preparation is gel, cream, tablet, capsule, powder, mixture, pill, granule, solution, syrup, decoction extract, suppository, aerosol, plaster, ointment, injection, spray, liniment, tincture, wet compress, paste or lotion.

8. A traditional Chinese medicine preparation for treating fatigue of patients with qi deficiency constitution, characterized in that, The pharmaceutically acceptable carrier is selected from at least one of pharmaceutically acceptable solvents, solubilizers, cosolvents, emulsifiers, coloring agents, binders, disintegrants, fillers, lubricants, wetting agents, osmotic pressure regulators, stabilizers, glidants, flavoring agents, preservatives, suspending agents, coating materials, fragrances, anti - binders, chelating agents, penetration enhancers, pH regulators, buffers, plasticizers, surfactants, thickeners, clathrates, humectants, absorbents, diluents, flocculants and deflocculants, filter aids, release retardants, high - molecular skeleton materials and film - forming materials.

9. The traditional Chinese medicine preparation for treating the fatigue of patients with qi deficiency constitution according to claim 6, wherein, It also optionally comprises one or more other drugs for treating the fatigue of patients with qi - deficiency constitution. Application of a traditional Chinese medicine composition as described in claim 1 or 2 in the preparation of a drug for preventing and / or treating the fatigue of patients with qi - deficiency constitution.

Images