A traditional Chinese medicine composition for improving cancer fatigue, and a preparation method and application thereof

Abstract

This invention relates to a traditional Chinese medicine composition for improving cancer-related fatigue, its preparation method, and its application. Belonging to the field of traditional Chinese medicine technology, it solves the technical problems of the lack of modern traditional Chinese medicine preparations for cancer-related fatigue and the lack of a systematic explanation of the pharmacological mechanism. The solution is: a traditional Chinese medicine composition for improving cancer-related fatigue, its preparation method, and its application, formulated according to the principles of principal, assistant, adjuvant, and guide herbs. The principal herbs are Astragalus membranaceus and Codonopsis pilosula; the assistant herbs are Angelica sinensis and Rehmannia glutinosa; the adjuvant herbs are Poria cocos, Citrus reticulata peel, and Ophiopogon japonicus; and the guide herb is Glycyrrhiza uralensis. By weight fraction, the principal herb is 10-18 parts, the assistant herbs are 8-14 parts, the adjuvant herbs are 8-14 parts, and the guide herb is 1-3 parts. The preparation method of the traditional Chinese medicine composition for improving cancer-related fatigue includes the following steps: 1) water extraction; 2) concentration; 3) spray drying; 4) sieving and mixing; 5) granulation; and 6) drying and packaging. Compared with the prior art, this invention has the advantages of convenient administration, stable efficacy, and a systematic explanation of the pharmacological mechanism.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for improving cancer-related fatigue, its preparation method, and its application. Background Technology

[0002] Cancer fatigue is one of the most common symptoms experienced by cancer patients during their illness and treatment. This fatigue is significant and persistent, difficult to relieve even with sufficient rest, and may be accompanied by a comprehensive decline in physical strength, mood, and cognitive function. This symptom severely impacts the quality of life, treatment adherence, and prognosis of cancer patients. While some progress has been made in the development of anti-cancer fatigue drugs in recent years, these drugs generally have significant side effects and are prone to causing dependence. Traditional Chinese medicine, as a natural therapy, is receiving increasing attention. Traditional Chinese medicinal herbs such as Codonopsis pilosula and Astragalus membranaceus, with their qi-tonifying effects, align with the core of cancer fatigue. However, there are currently no modern Chinese medicine preparations specifically targeting cancer fatigue on the market, and a systematic scientific explanation of their modern pharmacological mechanisms is lacking. Summary of the Invention

[0003] In order to overcome the shortcomings of existing technologies and solve the technical problems such as the lack of modern Chinese medicine preparations for cancer-related fatigue and the lack of systematic explanation of the pharmacological mechanism, this invention provides a Chinese medicine composition for improving cancer-related fatigue, its preparation method and application.

[0004] The present invention is achieved through the following technical solutions.

[0005] This invention provides a traditional Chinese medicine composition for improving cancer-related fatigue, formulated according to the principles of principal, assistant, adjuvant, and guide herbs. The principal herbs are Astragalus membranaceus and Codonopsis pilosula, the assistant herbs are Angelica sinensis and Rehmannia glutinosa, the adjuvant herbs are Poria cocos, Citrus reticulata peel and Ophiopogon japonicus, and the guide herb is Glycyrrhiza uralensis. By weight fraction, the principal herbs are 10-18 parts, the assistant herbs are 8-14 parts, the adjuvant herbs are 8-14 parts, and the guide herb is 1-3 parts.

[0006] Furthermore, by weight fraction, the principal herb contains 6-10 parts of Astragalus membranaceus and 4-8 parts of Codonopsis pilosula; the assistant herb contains 4-7 parts of Angelica sinensis and 4-7 parts of Rehmannia glutinosa; the adjuvant herb contains 3-5 parts of Poria cocos, 2-4 parts of Citrus reticulata peel and 3-5 parts of Ophiopogon japonicus; and the guiding herb contains 1-3 parts of Glycyrrhiza uralensis.

[0007] Furthermore, by weight fraction, the principal herb is composed of 8 parts Astragalus membranaceus and 6 parts Codonopsis pilosula; the assistant herb is composed of 5 parts Angelica sinensis and 5 parts Rehmannia glutinosa; the adjuvant herb is composed of 4 parts Poria cocos, 3 parts Citrus reticulata peel, and 4 parts Ophiopogon japonicus; and the guiding herb is composed of 2 parts Glycyrrhiza uralensis.

[0008] Water extraction: Weigh out 6-10 parts of Astragalus membranaceus, 4-8 parts of Codonopsis pilosula, 4-7 parts of Angelica sinensis, 4-7 parts of Rehmannia glutinosa, 3-5 parts of Poria cocos, 2-4 parts of Citrus reticulata peel, 3-5 parts of Ophiopogon japonicus and 1-3 parts of Glycyrrhiza uralensis according to the proportions, soak in water for 30-60 minutes, decoct 2-3 times, and extract the filtrate. concentrate: The filtrate obtained in step 1) is drawn into a concentration tank and concentrated to a relative density of 1.20-1.25 g / cm³ at 60°C. 3 The ointment; Spray drying: The ointment obtained in step 2) is dried using a spray dryer to obtain a dry ointment powder; Sieve and mix: The dry powder obtained in step 3) is passed through an 80-mesh sieve and then mixed with excipients to obtain a mixed dry powder; Granulation: The mixed dry powder obtained in step 4) is granulated by a dry granulation machine to obtain 12-40 mesh particles. Drying and Packaging: The granules obtained in step 5) are dried at 60-70℃ until the moisture content is ≤5% for granulation and quantitative packaging.

[0009] Furthermore, the 2-3 decoctions in step 1) include the first decoction with 10 times the amount of water for 2 hours, the second decoction with 8 times the amount of water for 1.5 hours, and the third decoction with 6 times the amount of water for 1 hour.

[0010] Furthermore, the excipients in step 4) include a lubricant, an adsorbent, and a filler, wherein the lubricant is magnesium stearate, the adsorbent is silicon dioxide, and the filler is maltodextrin.

[0011] Furthermore, the application of a traditional Chinese medicine composition for improving cancer-related fatigue in the preparation of a medicine for improving cancer-related fatigue.

[0012] The beneficial effects achieved by this invention are as follows: This invention selects principal, assistant, adjuvant, and guiding herbs. The principal herb plays the role of invigorating qi and nourishing yin, the assistant herb plays the role of assisting the principal herb and nourishing blood and yin, the adjuvant herb plays the role of strengthening the spleen and regulating qi and treating concurrent symptoms, and the guiding herb plays the role of harmonizing the various herbs, thereby achieving the effect of anti-fatigue for cancer patients. This invention also provides a method for preparing a traditional Chinese medicine composition that improves cancer-related fatigue. The granule form is convenient to take. In addition, this invention systematically explains the mechanism of the prepared traditional Chinese medicine composition that improves cancer-related fatigue from a pharmacological perspective.

[0013] Compared with existing technologies, this invention has the advantages of convenient administration, stable effects, and a systematic explanation of the pharmacological mechanism. Detailed Implementation

[0014] The present invention will now be described in further detail with reference to the embodiments. Example 1:

[0015] A traditional Chinese medicine composition for improving cancer-related fatigue is formulated according to the principles of principal, assistant, adjuvant, and guide herbs. The principal herbs are Astragalus membranaceus and Codonopsis pilosula; the assistant herbs are Angelica sinensis and Rehmannia glutinosa; the adjuvant herbs are Poria cocos, Citrus reticulata peel, and Ophiopogon japonicus; and the guide herb is Glycyrrhiza uralensis. By weight fraction, the principal herbs comprise 14 parts, the assistant herbs 10 parts, the adjuvant herbs 11 parts, and the guide herb 2 parts. Specifically, the principal herbs consist of 8 parts Astragalus membranaceus and 6 parts Codonopsis pilosula; the assistant herbs consist of 5 parts Angelica sinensis and 5 parts Rehmannia glutinosa; the adjuvant herbs consist of 4 parts Poria cocos, 3 parts Citrus reticulata peel, and 4 parts Ophiopogon japonicus; and the guide herb is Glycyrrhiza uralensis.

[0016] A method for preparing a traditional Chinese medicine composition for improving cancer-related fatigue includes the following steps: 1) Water extraction: Weigh out 8 parts of Astragalus membranaceus, 6 parts of Codonopsis pilosula, 5 parts of Angelica sinensis, 5 parts of Rehmannia glutinosa, 4 parts of Poria cocos, 3 parts of Citrus reticulata peel, 4 parts of Ophiopogon japonicus, and 2 parts of Glycyrrhiza uralensis according to the specified proportions. Soak the ingredients in water for 30-60 minutes, then decoct 2-3 times and extract the filtrate. The 2-3 decoctions include the first decoction with 10 times the amount of water for 2 hours, the second decoction with 8 times the amount of water for 1.5 hours, and the third decoction with 6 times the amount of water for 1 hour. The 10 times the amount of water refers to the weight of the water added being 10 times the total weight of the medicinal materials. 2) Concentration: The filtrate obtained in step 1) is drawn into a concentration tank and concentrated to a relative density of 1.20-1.25 g / cm³ at 60°C. 3 The ointment; 3) Spray drying: The ointment obtained in step 2) is dried using a spray dryer to obtain a dry ointment powder; 4) Sieve and mix: The dry paste powder obtained in step 3) is passed through an 80-mesh sieve and then mixed with excipients to obtain a mixed dry paste powder; wherein the excipients include lubricant, adsorbent and filler, the lubricant is magnesium stearate, the adsorbent is silicon dioxide and the filler is maltodextrin; 5) Granulation: The mixed dry powder obtained in step 4) is granulated by a dry granulation machine to obtain 12-40 mesh particles. 6) Drying and Packaging: The granules obtained in step 5) are dried at 60-70℃ until the moisture content is ≤5% for granulation and quantitative packaging.

[0017] Application of a traditional Chinese medicine composition for improving cancer-related fatigue in the preparation of a medicine for improving cancer-related fatigue.

[0018] Example 2: A traditional Chinese medicine composition for improving cancer-related fatigue is formulated according to the principles of principal, assistant, adjuvant, and guide herbs. The principal herbs are Astragalus membranaceus and Codonopsis pilosula; the assistant herbs are Angelica sinensis and Rehmannia glutinosa; the adjuvant herbs are Poria cocos, Citrus reticulata peel, and Ophiopogon japonicus; and the guide herb is Glycyrrhiza uralensis. By weight fraction, the principal herbs comprise 10 parts, the assistant herbs 8 parts, the adjuvant herbs 8 parts, and the guide herb 1 part. Specifically, the principal herbs consist of 6 parts Astragalus membranaceus and 4 parts Codonopsis pilosula; the assistant herbs consist of 4 parts Angelica sinensis and 4 parts Rehmannia glutinosa; the adjuvant herbs consist of 3 parts Poria cocos, 2 parts Citrus reticulata peel, and 3 parts Ophiopogon japonicus; and the guide herb is Glycyrrhiza uralensis.

[0019] A method for preparing a traditional Chinese medicine composition for improving cancer-related fatigue includes the following steps: 1) Water extraction: Weigh out 6 parts of Astragalus membranaceus, 4 parts of Codonopsis pilosula, 4 parts of Angelica sinensis, 4 parts of Rehmannia glutinosa, 3 parts of Poria cocos, 2 parts of Citrus reticulata peel, 3 parts of Ophiopogon japonicus, and 1 part of Glycyrrhiza uralensis according to the specified proportions. Soak the ingredients in water for 30-60 minutes, then decoct 2-3 times and extract the filtrate. The 2-3 decoctions include the first decoction with 10 times the amount of water for 2 hours, the second decoction with 8 times the amount of water for 1.5 hours, and the third decoction with 6 times the amount of water for 1 hour. 2) Concentration: The filtrate obtained in step 1) is drawn into a concentration tank and concentrated to a relative density of 1.20-1.25 g / cm³ at 60°C. 3 The ointment; 3) Spray drying: The ointment obtained in step 2) is dried using a spray dryer to obtain a dry ointment powder; 4) Sieve and mix: The dry paste powder obtained in step 3) is passed through an 80-mesh sieve and then mixed with excipients to obtain a mixed dry paste powder; wherein the excipients include lubricant, adsorbent and filler, the lubricant is magnesium stearate, the adsorbent is silicon dioxide and the filler is maltodextrin; 5) Granulation: The mixed dry powder obtained in step 4) is granulated by a dry granulation machine to obtain 12-40 mesh particles. 6) Drying and Packaging: The granules obtained in step 5) are dried at 60-70℃ until the moisture content is ≤5% for granulation and quantitative packaging.

[0020] Application of a traditional Chinese medicine composition for improving cancer-related fatigue in the preparation of a medicine for improving cancer-related fatigue.

[0021] Example 3: A traditional Chinese medicine composition for improving cancer-related fatigue is formulated according to the principles of principal, assistant, adjuvant, and guide herbs. The principal herbs are Astragalus membranaceus and Codonopsis pilosula; the assistant herbs are Angelica sinensis and Rehmannia glutinosa; the adjuvant herbs are Poria cocos, Citrus reticulata peel, and Ophiopogon japonicus; and the guide herb is Glycyrrhiza uralensis. By weight fraction, the principal herbs comprise 18 parts, the assistant herbs 14 parts, the adjuvant herbs 14 parts, and the guide herb 3 parts. Specifically, the principal herbs consist of 10 parts Astragalus membranaceus and 8 parts Codonopsis pilosula; the assistant herbs consist of 7 parts Angelica sinensis and 7 parts Rehmannia glutinosa; the adjuvant herbs consist of 5 parts Poria cocos, 4 parts Citrus reticulata peel, and 5 parts Ophiopogon japonicus; and the guide herb is Glycyrrhiza uralensis.

[0022] A method for preparing a traditional Chinese medicine composition for improving cancer-related fatigue includes the following steps: 1) Water extraction: Weigh out 10 parts of Astragalus membranaceus, 8 parts of Codonopsis pilosula, 7 parts of Angelica sinensis, 7 parts of Rehmannia glutinosa, 5 parts of Poria cocos, 4 parts of Citrus reticulata peel, 5 parts of Ophiopogon japonicus, and 3 parts of Glycyrrhiza uralensis according to the specified proportions. Soak the ingredients in water for 30-60 minutes, then decoct 2-3 times and extract the filtrate. The 2-3 decoctions include the first decoction with 10 times the amount of water for 2 hours, the second decoction with 8 times the amount of water for 1.5 hours, and the third decoction with 6 times the amount of water for 1 hour. 2) Concentration: The filtrate obtained in step 1) is drawn into a concentration tank and concentrated to a relative density of 1.20-1.25 g / cm³ at 60°C. 3 The ointment; 3) Spray drying: The ointment obtained in step 2) is dried using a spray dryer to obtain a dry ointment powder; 4) Sieve and mix: The dry paste powder obtained in step 3) is passed through an 80-mesh sieve and then mixed with excipients to obtain a mixed dry paste powder; wherein the excipients include lubricant, adsorbent and filler, the lubricant is magnesium stearate, the adsorbent is silicon dioxide and the filler is maltodextrin; 5) Granulation: The mixed dry powder obtained in step 4) is granulated by a dry granulation machine to obtain 12-40 mesh particles. 6) Drying and Packaging: The granules obtained in step 5) are dried at 60-70℃ until the moisture content is ≤5% for granulation and quantitative packaging.

[0023] Application of a traditional Chinese medicine composition for improving cancer-related fatigue in the preparation of a medicine for improving cancer-related fatigue.

[0024] Example 4: A traditional Chinese medicine composition for improving cancer-related fatigue is formulated according to the principles of principal, assistant, adjuvant, and guide herbs. The principal herbs are Astragalus membranaceus and Codonopsis pilosula; the assistant herbs are Angelica sinensis and Rehmannia glutinosa; the adjuvant herbs are Poria cocos, Citrus reticulata peel, and Ophiopogon japonicus; and the guide herb is Glycyrrhiza uralensis. By weight fraction, the principal herbs comprise 14 parts, the assistant herbs 10 parts, the adjuvant herbs 11 parts, and the guide herb 2 parts. Specifically, the principal herbs consist of 9 parts Astragalus membranaceus and 6 parts Codonopsis pilosula; the assistant herbs consist of 5 parts Angelica sinensis and 5 parts Rehmannia glutinosa; the adjuvant herbs consist of 4 parts Poria cocos, 3 parts Citrus reticulata peel, and 4 parts Ophiopogon japonicus; and the guide herb is Glycyrrhiza uralensis.

[0025] A method for preparing a traditional Chinese medicine composition for improving cancer-related fatigue includes the following steps: 1) Water extraction: Weigh out 9 parts of Astragalus membranaceus, 6 parts of Codonopsis pilosula, 5 parts of Angelica sinensis, 5 parts of Rehmannia glutinosa, 4 parts of Poria cocos, 3 parts of Citrus reticulata peel, 4 parts of Ophiopogon japonicus, and 2 parts of Glycyrrhiza uralensis according to the specified proportions. Soak the ingredients in water for 30-60 minutes, then decoct 2-3 times and extract the filtrate. The 2-3 decoctions include the first decoction with 10 times the amount of water for 2 hours, the second decoction with 8 times the amount of water for 1.5 hours, and the third decoction with 6 times the amount of water for 1 hour. 2) Concentration: The filtrate obtained in step 1) is drawn into a concentration tank and concentrated to a relative density of 1.20-1.25 g / cm³ at 60°C. 3 The ointment; 3) Spray drying: The ointment obtained in step 2) is dried using a spray dryer to obtain a dry ointment powder; 4) Sieve and mix: The dry paste powder obtained in step 3) is passed through an 80-mesh sieve and then mixed with excipients to obtain a mixed dry paste powder; wherein the excipients include lubricant, adsorbent and filler, the lubricant is magnesium stearate, the adsorbent is silicon dioxide and the filler is maltodextrin; 5) Granulation: The mixed dry powder obtained in step 4) is granulated by a dry granulation machine to obtain 12-40 mesh particles. 6) Drying and Packaging: The granules obtained in step 5) are dried at 60-70℃ until the moisture content is ≤5% for granulation and quantitative packaging.

[0026] Application of a traditional Chinese medicine composition for improving cancer-related fatigue in the preparation of a medicine for improving cancer-related fatigue.

[0027] Example 5: A traditional Chinese medicine composition for improving cancer-related fatigue is formulated according to the principles of principal, assistant, adjuvant, and guide herbs. The principal herbs are Astragalus membranaceus and Codonopsis pilosula; the assistant herbs are Angelica sinensis and Rehmannia glutinosa; the adjuvant herbs are Poria cocos, Citrus reticulata peel, and Ophiopogon japonicus; and the guide herb is Glycyrrhiza uralensis. By weight fraction, the principal herbs comprise 14 parts, the assistant herbs 10 parts, the adjuvant herbs 11 parts, and the guide herb 2 parts. Specifically, the principal herbs consist of 8 parts Astragalus membranaceus and 7 parts Codonopsis pilosula; the assistant herbs consist of 5 parts Angelica sinensis and 5 parts Rehmannia glutinosa; the adjuvant herbs consist of 4 parts Poria cocos, 3 parts Citrus reticulata peel, and 4 parts Ophiopogon japonicus; and the guide herb is Glycyrrhiza uralensis.

[0028] A method for preparing a traditional Chinese medicine composition for improving cancer-related fatigue includes the following steps: 1) Water extraction: Weigh out 8 parts of Astragalus membranaceus, 7 parts of Codonopsis pilosula, 5 parts of Angelica sinensis, 5 parts of Rehmannia glutinosa, 4 parts of Poria cocos, 3 parts of Citrus reticulata peel, 4 parts of Ophiopogon japonicus, and 2 parts of Glycyrrhiza uralensis according to the specified proportions. Soak the ingredients in water for 30-60 minutes, then decoct 2-3 times and extract the filtrate. The 2-3 decoctions include the first decoction with 10 times the amount of water for 2 hours, the second decoction with 8 times the amount of water for 1.5 hours, and the third decoction with 6 times the amount of water for 1 hour. 2) Concentration: The filtrate obtained in step 1) is drawn into a concentration tank and concentrated to a relative density of 1.20-1.25 g / cm³ at 60°C. 3 The ointment; 3) Spray drying: The ointment obtained in step 2) is dried using a spray dryer to obtain a dry ointment powder; 4) Sieve and mix: The dry paste powder obtained in step 3) is passed through an 80-mesh sieve and then mixed with excipients to obtain a mixed dry paste powder; wherein the excipients include lubricant, adsorbent and filler, the lubricant is magnesium stearate, the adsorbent is silicon dioxide and the filler is maltodextrin; 5) Granulation: The mixed dry powder obtained in step 4) is granulated by a dry granulation machine to obtain 12-40 mesh particles. 6) Drying and Packaging: The granules obtained in step 5) are dried at 60-70℃ until the moisture content is ≤5% for granulation and quantitative packaging.

[0029] Application of a traditional Chinese medicine composition for improving cancer-related fatigue in the preparation of a medicine for improving cancer-related fatigue.

[0030] Example 6: A traditional Chinese medicine composition for improving cancer-related fatigue is formulated according to the principles of principal, assistant, adjuvant, and guide herbs. The principal herbs are Astragalus membranaceus and Codonopsis pilosula; the assistant herbs are Angelica sinensis and Rehmannia glutinosa; the adjuvant herbs are Poria cocos, Citrus reticulata peel, and Ophiopogon japonicus; and the guide herb is Glycyrrhiza uralensis. By weight fraction, the principal herbs comprise 14 parts, the assistant herbs 10 parts, the adjuvant herbs 11 parts, and the guide herb 2 parts. Specifically, the principal herbs consist of 8 parts Astragalus membranaceus and 6 parts Codonopsis pilosula; the assistant herbs consist of 6 parts Angelica sinensis and 5 parts Rehmannia glutinosa; the adjuvant herbs consist of 4 parts Poria cocos, 3 parts Citrus reticulata peel, and 4 parts Ophiopogon japonicus; and the guide herb is Glycyrrhiza uralensis.

[0031] A method for preparing a traditional Chinese medicine composition for improving cancer-related fatigue includes the following steps: 1) Water extraction: Weigh out 8 parts of Astragalus membranaceus, 6 parts of Codonopsis pilosula, 6 parts of Angelica sinensis, 5 parts of Rehmannia glutinosa, 4 parts of Poria cocos, 3 parts of Citrus reticulata peel, 4 parts of Ophiopogon japonicus, and 2 parts of Glycyrrhiza uralensis according to the specified proportions. Soak the ingredients in water for 30-60 minutes, then decoct 2-3 times and extract the filtrate. The 2-3 decoctions include the first decoction with 10 times the amount of water for 2 hours, the second decoction with 8 times the amount of water for 1.5 hours, and the third decoction with 6 times the amount of water for 1 hour. 2) Concentration: The filtrate obtained in step 1) is drawn into a concentration tank and concentrated to a relative density of 1.20-1.25 g / cm³ at 60°C. 3 The ointment; 3) Spray drying: The ointment obtained in step 2) is dried using a spray dryer to obtain a dry ointment powder; 4) Sieve and mix: The dry paste powder obtained in step 3) is passed through an 80-mesh sieve and then mixed with excipients to obtain a mixed dry paste powder; wherein the excipients include lubricant, adsorbent and filler, the lubricant is magnesium stearate, the adsorbent is silicon dioxide and the filler is maltodextrin; 5) Granulation: The mixed dry powder obtained in step 4) is granulated by a dry granulation machine to obtain 12-40 mesh particles. 6) Drying and Packaging: The granules obtained in step 5) are dried at 60-70℃ until the moisture content is ≤5% for granulation and quantitative packaging.

[0032] Application of a traditional Chinese medicine composition for improving cancer-related fatigue in the preparation of a medicine for improving cancer-related fatigue.

[0033] Comparative Example 1: Choose the commercially available sunflower brand "Shenqi Granules", whose main ingredients are astragalus and codonopsis.

[0034] Comparative Example 2: A traditional Chinese medicine composition for improving cancer-related fatigue, comprising, by weight fraction, 8 parts Astragalus membranaceus and 6 parts Codonopsis pilosula.

[0035] Comparative Example 3: A traditional Chinese medicine composition for improving cancer-related fatigue is formulated according to the principles of principal, assistant, adjuvant, and guide herbs. The principal herbs are Astragalus membranaceus and Codonopsis pilosula, the assistant herbs are Rehmannia glutinosa, the adjuvant herbs are Poria cocos, Citrus reticulata peel, and Ophiopogon japonicus, and the guide herb is Glycyrrhiza uralensis. By weight fraction, the principal herb comprises 14 parts, the assistant herb 5 parts, the adjuvant herb 11 parts, and the guide herb 2 parts. Specifically, the principal herb contains 8 parts Astragalus membranaceus and 6 parts Codonopsis pilosula; the assistant herb contains 5 parts Rehmannia glutinosa; the adjuvant herbs contain 4 parts Poria cocos, 3 parts Citrus reticulata peel, and 4 parts Ophiopogon japonicus; and the guide herb contains 2 parts Glycyrrhiza uralensis.

[0036] Comparative Example 4: A traditional Chinese medicine composition for improving cancer-related fatigue is formulated according to the principles of principal, assistant, adjuvant, and guide herbs. The principal herbs are Astragalus membranaceus and Codonopsis pilosula; the assistant herbs are Angelica sinensis and Rehmannia glutinosa; the adjuvant herbs are Poria cocos, Citrus reticulata peel, and Ophiopogon japonicus; and the guide herb is Glycyrrhiza uralensis. By weight fraction, the principal herbs comprise 14 parts, the assistant herbs 10 parts, the adjuvant herbs 8 parts, and the guide herb 2 parts. Specifically, the principal herbs consist of 8 parts Astragalus membranaceus and 6 parts Codonopsis pilosula; the assistant herbs consist of 5 parts Angelica sinensis and 5 parts Rehmannia glutinosa; the adjuvant herbs consist of 4 parts Poria cocos and 4 parts Ophiopogon japonicus; and the guide herb is Glycyrrhiza uralensis.

[0037] Efficacy verification experiments were conducted on Examples 1-6 and Comparative Examples 1-4 using SPF (specific pathogen-free) male Kunming mice weighing 20±2g. Before the efficacy verification experiments, except for the control group, the other mice were intraperitoneally injected with cisplatin at 3 mg / kg every 3 days for 21 consecutive days to establish a mouse model of cancer fatigue. Mice with successfully established cancer fatigue models were randomly assigned to groups of 10 each, including the model group, Examples 1-6 groups, Comparative Examples 1-4 groups, and the control group. Examples 1-6 and Comparative Examples 1-4 were administered via gavage at a dose of 0.375 g / kg for 42 days, corresponding to Examples 1-6 and Comparative Examples 1-4, respectively. The model group and the control group were administered an equal volume of physiological saline via gavage for 42 days. One hour after the last administration, a weight-bearing swimming exhaustion test with a 5% body weight load at the tail base was performed, and the swimming time was recorded (see Table 1).

[0038] Table 1. Anticancer fatigue results of Examples 1-6 and Comparative Examples 1-4

[0039] In this invention, the principal ingredients, Astragalus membranaceus and Codonopsis pilosula, primarily tonify Qi and nourish Yin. Astragalus membranaceus focuses on tonifying the Qi of the spleen and lungs, while Codonopsis pilosula focuses on tonifying the Qi of the middle Jiao. The two ingredients work synergistically to tonify both Qi and Yin, precisely targeting the core pathogenesis of "Qi and Yin deficiency" in cancer-related fatigue. The combined use of these two ingredients can synergistically enhance the activation of the AMPK (adenosine monophosphate-activated protein kinase) pathway, promoting energy metabolism. Astragalus membranaceus, the principal ingredient, is warm in nature and sweet in taste, primarily treating symptoms such as poor appetite, loose stools, shortness of breath, fatigue, and sinking of Qi in the middle Jiao caused by spleen and lung Qi deficiency. Astragalus membranaceus contains active ingredients such as astragalus polysaccharides, astragaloside IV (e.g., astragaloside A), flavonoids such as verbascoside and gentianin. Astragalus polysaccharides can lower blood lactate and blood urea nitrogen levels, increase liver and muscle glycogen reserves, and enhance the body's tolerance. Astragalus polysaccharides can also activate the AMPK signaling pathway, promote mitochondrial biosynthesis, and improve ATP production efficiency. Furthermore, astragalus polysaccharides can enhance macrophage phagocytic function, regulate T cell subset balance, and improve the weakened immune function of cancer patients. In addition, flavonoids can scavenge free radicals, reduce oxidative stress damage, and delay the onset of fatigue. The principal ingredient, Codonopsis pilosula, is neutral in nature and sweet in taste. It is mainly used to treat symptoms such as poor appetite, loose stools, shortness of breath, cough, and weakness of limbs caused by spleen and stomach weakness and insufficient lung qi. Codonopsis pilosula contains active ingredients such as Codonopsis polysaccharides, Codonopsis glycosides, sterols, and alkaloids. Codonopsis polysaccharides can increase SOD (superoxide dismutase) activity, reduce MDA content, and enhance the body's antioxidant capacity. Codonopsis glycosides can promote gastrointestinal motility, improve digestive and absorptive functions, increase nutrient intake, and provide energy for the body. Codonopsis pilosula can also promote the synthesis of proteins and nucleic acids, improve basal metabolic status, and alleviate weakness.

[0040] In this invention, Angelica sinensis and Rehmannia glutinosa, as the principal and assistant herbs, nourish blood and yin. Angelica sinensis replenishes and invigorates blood, improving blood deficiency, while Rehmannia glutinosa nourishes yin, clears heat, and replenishes depleted yin fluids. Together, they achieve a balance of nourishing blood and yin, both assisting the principal herbs in enhancing their tonifying effects and preventing prolonged qi deficiency from damaging yin and blood, thus jointly treating cancer-related fatigue characterized by "deficiency of both qi and blood, and insufficiency of yin fluids." Angelica sinensis, as an assistant herb, is warm in nature and sweet and pungent in taste, used for replenishing and invigorating blood, regulating menstruation and relieving pain, and moistening the intestines to promote bowel movements. Angelica sinensis contains ferulic acid, ligustilide, angelica polysaccharide, vitamin B12, etc. Ferulic acid can dilate blood vessels, improve microcirculation, increase tissue blood and oxygen supply, and accelerate the removal of metabolic waste; ligustilide can reduce muscle inflammation associated with fatigue; and angelica polysaccharide can enhance immune function and improve tolerance to hypoxia. Rehmannia glutinosa, as an assistant herb, is cold in nature and sweet and bitter in taste, primarily used to treat bone steaming fever, dry mouth and throat, and insomnia caused by yin deficiency and internal heat. Rehmannia glutinosa contains catalpol, polysaccharides, amino acids, and trace elements. Catalpol can improve the cell's ability to withstand hypoxia and protect mitochondrial function. Polysaccharides can enhance immune function, increase SOD activity, and delay the onset of fatigue. In addition, Rehmannia glutinosa also has an adrenocortical hormone-like effect, which can regulate stress response.

[0041] In this invention, the main adjuvant herbs Poria cocos, Citrus reticulata peel, and Ophiopogon japonicus are used to invigorate the spleen and regulate qi, addressing concurrent symptoms. Poria cocos invigorates the spleen and eliminates dampness to aid digestion; Citrus reticulata peel regulates qi and harmonizes the middle jiao to prevent cloying; and Ophiopogon japonicus nourishes yin and generates fluids to moisten dryness. These three herbs, from the perspectives of invigorating the spleen, regulating qi, and generating fluids, assist the principal and assistant herbs in treating common symptoms of cancer-related fatigue such as loss of appetite, abdominal distension, and dry mouth and throat. This results in a comprehensive herbal composition that is nourishing without causing stagnation and moisturizing without being cloying. Poria cocos, as an adjuvant herb, is neutral in nature and sweet and bland in taste. It is primarily used to treat poor appetite, loose stools, edema, and scanty urine caused by spleen deficiency and dampness, as well as palpitations and insomnia caused by restlessness. Poria cocos contains polysaccharides, sterols, and triterpenoids such as pachymic acid. Poria cocos polysaccharides have significant immune-enhancing effects. Furthermore, Poria cocos can promote the secretion of digestive juices, improve loss of appetite, increase nutrient intake, and achieve the effect of invigorating the spleen and stomach. It can also reduce the excitability of the cerebral cortex, improve anxiety and insomnia associated with fatigue, and achieve a calming and soothing effect. In the auxiliary herbs, dried tangerine peel (Chenpi) is warm in nature and bitter in taste. It is mainly used to treat abdominal distension, poor appetite, vomiting and diarrhea caused by stagnation of Qi in the spleen and stomach, as well as cough with excessive phlegm caused by phlegm and dampness obstructing the lungs. Dried tangerine peel contains volatile oils such as limonene and flavonoids such as hesperidin. Hesperidin has anti-inflammatory effects and can reduce inflammatory responses. Dried tangerine peel can also regulate the movement of gastrointestinal smooth muscle, promote the secretion of digestive juices, and avoid the greasy and cloying nature of tonifying herbs that may hinder digestion. In the auxiliary herbs, Sichuan ophiopogon japonicus (Chuanmaidong) is slightly cold in nature and sweet and bitter in taste. It is mainly used to treat dry cough due to Yin deficiency, dry throat and thirst, irritability and insomnia, and constipation due to intestinal dryness. Sichuan ophiopogon japonicus contains ophiopogon saponins, ophiopogon japonicus polysaccharides, and high levels of isoflavones. Ophiopogon japonicus saponins can improve myocardial ischemia and increase cardiac output; ophiopogon japonicus polysaccharides can increase SOD activity, achieving an anti-fatigue effect; Sichuan ophiopogon japonicus can also promote saliva secretion and improve dry mouth symptoms.

[0042] This invention utilizes licorice as the dominant and guiding ingredient in the medicine. Licorice is neutral in nature and sweet in taste, benefiting the spleen and replenishing qi, clearing heat and detoxifying, resolving phlegm and relieving cough, and alleviating pain. It also harmonizes the effects of other herbs. Licorice contains flavonoids such as glycyrrhizin, glycyrrhetinic acid, and glycyrrhizin. Licorice also has adrenocorticotropic hormone-like effects, possessing anti-inflammatory, anti-allergic, and anti-stress properties. Among these, glycyrrhizin and other flavonoids have anti-fatigue and neuroprotective effects. Licorice can also mitigate the harshness of other drugs, enhance the synergistic effects of various medications, and reduce the toxic reactions of chemotherapy drugs.

[0043] Table 1 shows that the weighted swimming time of the model group was significantly lower than that of the blank control group (P < 0.01). The weighted swimming time of the Example 1-6 groups and the Comparative Examples 1-4 groups was longer than that of the model group. The weighted swimming time of the Example 1-6 groups was longer than that of the Comparative Examples 1-4 groups.

[0044] Table 1 also shows that the first group performed best in terms of weight-bearing swimming time. In the specific combination of the formulas in the first group, the "tonifying" effect of the principal herb (which nourishes Qi and Yin) and the "nourishing" effect of the assistant herb (which nourishes blood and Yin) achieved optimal balance. The 11 parts of adjuvant herbs and 2 parts of guiding herbs together created an internal environment of healthy spleen and stomach function, smooth Qi flow, and sufficient Yin fluid, allowing the principal and assistant herbs to exert their full power. In the first group, the principal herb, *Astragalus membranaceus*, was configured as 8:6 with *Codonopsis pilosula*, balancing the Qi-tonifying effects of *Astragalus membranaceus* on the spleen and lungs with the Qi-tonifying effects of *Codonopsis pilosula* on the middle Jiao; the assistant herb, *Angelica sinensis*, was configured as 5:5 with 5:5, achieving a balance between nourishing blood and Yin. In the second group, the ratio of principal to assistant herbs was 1.25:1, indicating a relative deficiency in the principal herb, resulting in an insufficient foundation for effective activation of the AMPK signaling pathway and a significant decrease in the anti-fatigue effect. In Example 3, the proportion of adjuvant herbs was too high, resulting in a stagnant effect and causing a greasy feeling that hindered stomach absorption and efficacy. The weight-bearing swimming time in Examples 2 and 3 was significantly shorter than in Example 1, indicating that the ratio of principal, adjuvant, and assistant herbs directly affects efficacy, further verifying the scientific validity and rationality of the formulations in this invention. In Examples 4 and 5, the ratio of Astragalus membranaceus and Codonopsis pilosula in the principal herbs did not reach the ratio in Example 1. In Example 6, the ratio of Angelica sinensis and Rehmannia glutinosa in the assistant herbs did not reach the ratio in Example 1. Comparative Example 3 lacked Angelica sinensis compared to Example 1. Angelica sinensis nourishes and invigorates blood, and when combined with Rehmannia glutinosa for yin nourishment, they together fulfill the function of "nourishing blood and yin" as assistant herbs. The absence of this blood-nourishing herb may lead to an overemphasis on qi while neglecting blood deficiency, significantly reducing efficacy. Comparative Example 4 lacked Citrus reticulata peel as an adjuvant, resulting in a lack of qi-regulating effect and reduced efficacy.

[0045] This invention also employed network pharmacology to analyze the main active ingredients and their targets of eight medicinal materials. Active ingredient screening involved searching the TCMSP (Traditional Chinese Medicine Systems Pharmacology) database, setting OB (oral bioavailability) ≥30% and DL (drug similarity) ≥0.18 as screening criteria. The main active ingredients of each medicinal material were obtained: * Astragalus membranaceus* mainly includes 17 active ingredients such as quercetin, gentianin, verbascoflavonoids, and kaempferol; *Codonopsis pilosula* mainly includes 9 active ingredients such as luteolin and stigmasterol; *Angelica sinensis* mainly includes β-sitosterol and stigmasterol; *Rehmannia glutinosa* mainly includes sitosterol; *Poria cocos* includes poria acid; *Citrus reticulata* includes naringenin and hesperidin; *Ophiopogon japonicus* includes ophiopogonin saponins; and *Glycyrrhiza uralensis* includes glycyrrhizic acid and glycyrrhetinic acid. A total of 312 drug targets were identified. Disease target acquisition was conducted using the Human Genome Database with "cancer-related fatigue" as the keyword, yielding 5314 disease targets and 196 intersection targets between drugs and diseases. A "active ingredient-target" network diagram was constructed, and the core active ingredients were identified as quercetin, luteolin, kaempferol, gentianin, and naringenin, sorted by degree value. The 196 intersection targets were imported into a protein-protein interaction database, and a PPI (protein-protein interaction) network was constructed to identify core targets including AKT1 (protein kinase B1), TNF (tumor necrosis factor), IL6 (interleukin-6), TP53 (tumor protein p53), CASP3 (cystase-associated protein 3), IL1B (interleukin-1β), VEGFA (vascular endothelial growth factor A), and EGFR (epidermal growth factor receptor). Molecular docking of the core active ingredients with the core targets showed that the binding energies of all components to the target proteins were ≤-5.0 kcal / mol, indicating good binding activity. This invention also conducted GO (Gene Ontology) analysis and KEGG (Kyoto Encyclopedia of Genes and Genomes) pathway enrichment analysis. GO analysis showed that the targets were mainly enriched in biological processes such as the regulation of apoptosis, the regulation of gene expression, and inflammatory responses. KEGG analysis showed that the targets were mainly involved in the TNF signaling pathway, PI3K-Akt signaling pathway, MAPK signaling pathway, IL-17 signaling pathway, and HIF-1 signaling pathway. This invention reveals, through its core active ingredients, core targets, and multiple pathways, that it systematically regulates the body's immunity, energy metabolism, and inflammatory response, thereby improving cancer-related fatigue.

[0046] This invention also included human trials in patients with cancer-related fatigue. The trials selected patients aged 18-75 years, of any gender, with pathologically confirmed malignant tumors such as lung cancer, gastric cancer, colon cancer, and breast cancer. These patients had completed radiotherapy, chemotherapy, or targeted therapy, were in a stable disease phase, and met the diagnostic criteria for cancer-related fatigue: a BFI (Brief Fatigue Index) score ≥4, a KPS (Kinetic Performance Status) score ≥60, and a projected survival of ≥6 months. Patients with severe anemia, severe heart, liver, or kidney dysfunction, thyroid dysfunction, severe depression or anxiety, those who had taken other anti-fatigue medications or health supplements within the past month, and pregnant or lactating women were excluded. The subjects were randomly divided into three groups (A, B, and C), with 30 participants in each group. Group A took the traditional Chinese medicine composition for improving cancer-related fatigue prepared in Example 1 of this invention twice daily, one sachet each time; Group B took a placebo daily, which had the same appearance and taste as the present invention, but did not contain any active ingredients; Group C took commercially available Sunflower Brand "Ginseng and Astragalus Granules" daily for 8 consecutive weeks. Evaluations were conducted at 10 weeks, before the start of the trial, at 4 weeks, 8 weeks, and 2 weeks after the end of the trial, including BFI (Brief Fatigue Index) scores, FACT-F (Functional Assessment of Cancer Treatment-Fatigue Scale) scores, KPS (Kinetic Performance Status) scores, and 6MWT (6-minute walk test) scores. There were no statistically significant differences among the three groups in terms of age, gender, tumor type, treatment history, and BFI scores, making them comparable.

[0047] Table 2 BFI (Brief Fatigue Scale) Scoring Table

[0048] Note: * indicates that the effect is effective but generally significant; ** indicates that the difference between group A and group B is statistically significant; ## indicates that the difference between group A and group C is also statistically significant.

[0049] Table 2 shows that compared with group B, *P<0.05, **P<0.01; compared with group C, #P<0.05. After 8 weeks of trial, the BFI score of subjects in group A decreased by 27.1 points, which was better than that of groups B and C, indicating that the traditional Chinese medicine composition for improving cancer fatigue of the present invention can significantly improve the fatigue level of patients with cancer fatigue.

[0050] Table 3 FACT-F (Functional Assessment of Cancer Treatment - Fatigue Scale) Scoring Sheet

[0051] Note: * indicates that the effect is effective but generally significant; ** indicates that the difference between group A and group B is statistically significant; ## indicates that the difference between group A and group C is also statistically significant.

[0052] Table 3 shows that compared with group B, *P<0.05, **P<0.01; compared with group C, #P<0.05. After 8 weeks of trial, the FACT-F score of subjects in group A improved by 14.2 points, which was better than that of groups B and C, indicating that the traditional Chinese medicine composition for improving cancer fatigue of the present invention can significantly improve the quality of life of patients with cancer fatigue.

[0053] Table 4 KPS (Kinetic Performance Status) Rating Table

[0054] Note: * indicates that the effect is effective but generally significant; ** indicates that the difference between group A and group B is statistically significant; ## indicates that the difference between group A and group C is also statistically significant.

[0055] As can be seen from Table 4, after 8 weeks of trial, the KPS score of the subjects in Group A increased by 14.1 points, which was better than that of Groups B and C, indicating that the traditional Chinese medicine composition for improving cancer fatigue of the present invention can significantly improve the physical condition of patients with cancer fatigue.

[0056] Table 5. 6MWT (6-minute walk test) scoring sheet

[0057] Note: * indicates that the effect is effective but generally significant; ** indicates that the difference between group A and group B is statistically significant; ## indicates that the difference between group A and group C is also statistically significant.

[0058] As can be seen from Table 5, after 8 weeks of trial, the 6MWT score of the subjects in Group A increased by 100.3 points, which was better than that of Groups B and C. This indicates that the traditional Chinese medicine composition for improving cancer fatigue of the present invention can significantly improve the physical condition of patients with cancer fatigue, and the 6-minute walking distance increased by 100.3 meters.

[0059] The embodiments of the present invention have been described in detail above. However, the present invention is not limited to the above embodiments. Within the knowledge of those skilled in the art, modifications can still be made to the embodiments. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for improving cancer-related fatigue, characterized in that: The formula is composed according to the principles of principal, assistant, adjuvant, and guide herbs. The principal herbs are Astragalus membranaceus and Codonopsis pilosula, the assistant herbs are Angelica sinensis and Rehmannia glutinosa, the adjuvant herbs are Poria cocos, Citrus reticulata peel and Ophiopogon japonicus, and the guide herb is Glycyrrhiza uralensis. By weight fraction, the principal herbs are 10-18 parts, the assistant herbs are 8-14 parts, the adjuvant herbs are 8-14 parts, and the guide herbs are 1-3 parts.

2. The traditional Chinese medicine composition for improving cancer-related fatigue according to claim 1, characterized in that: By weight fraction, the principal herb is composed of 6-10 parts of Astragalus membranaceus and 4-8 parts of Codonopsis pilosula; the assistant herb is composed of 4-7 parts of Angelica sinensis and 4-7 parts of Rehmannia glutinosa; the adjuvant herb is composed of 3-5 parts of Poria cocos, 2-4 parts of Citrus reticulata peel and 3-5 parts of Ophiopogon japonicus; and the guiding herb is composed of 1-3 parts of Glycyrrhiza uralensis.

3. The traditional Chinese medicine composition for improving cancer-related fatigue according to claim 1, characterized in that: By weight fraction, the principal herb is composed of 8 parts Astragalus membranaceus and 6 parts Codonopsis pilosula; the assistant herb is composed of 5 parts Angelica sinensis and 5 parts Rehmannia glutinosa; the adjuvant herb is composed of 4 parts Poria cocos, 3 parts Citrus reticulata peel, and 4 parts Ophiopogon japonicus; and the guiding herb is composed of 2 parts Glycyrrhiza uralensis.

4. A method for preparing a traditional Chinese medicine composition for improving cancer-related fatigue according to any one of claims 1-3, characterized in that: Includes the following steps: 1) Water extraction: Weigh out 6-10 parts of Astragalus membranaceus, 4-8 parts of Codonopsis pilosula, 4-7 parts of Angelica sinensis, 4-7 parts of Rehmannia glutinosa, 3-5 parts of Poria cocos, 2-4 parts of Citrus reticulata peel, 3-5 parts of Ophiopogon japonicus and 1-3 parts of Glycyrrhiza uralensis according to the proportions, soak in water for 30-60 minutes, decoct 2-3 times, and extract the filtrate. 2) Concentration: The filtrate obtained in step 1) is drawn into a concentration tank and concentrated to a relative density of 1.20-1.25 g / cm³ at 60°C. 3 The ointment; 3) Spray drying: The clear paste obtained in step 2) is dried using a spray dryer to obtain a dry paste powder; 4) Sieve and mix: The dry powder obtained in step 3) is passed through an 80-mesh sieve and then mixed with excipients to obtain a mixed dry powder; 5) Granulation: The mixed dry powder obtained in step 4) is granulated by a dry granulation machine to obtain 12-40 mesh particles. 6) Drying and Packaging: The granules obtained in step 5) are dried at 60-70℃ until the moisture content is ≤5% for granulation and quantitative packaging.

5. A method for preparing a traditional Chinese medicine composition for improving cancer-related fatigue according to claim 4, characterized in that: The 2-3 decoctions in step 1) include the first decoction with 10 times the amount of water for 2 hours, the second decoction with 8 times the amount of water for 1.5 hours, and the third decoction with 6 times the amount of water for 1 hour.

6. The method for preparing a traditional Chinese medicine composition for improving cancer-related fatigue according to claim 4, characterized in that: The excipients in step 4) include a lubricant, an adsorbent, and a filler. The lubricant is magnesium stearate, the adsorbent is silicon dioxide, and the filler is maltodextrin.

7. The use of a traditional Chinese medicine composition for improving cancer-related fatigue according to any one of claims 1-3 in the preparation of a medicine for improving cancer-related fatigue.

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