Medicine for treating sarcopenia and preparation method thereof

Abstract

The invention discloses a medicine for treating sarcopenia and a preparation method of the medicine. The medicine is prepared from codonopsis pilosula, prepared rehmannia roots, poria cocos, fried rhizoma atractylodis macrocephalae, fried white hyacinth beans, lotus seeds, fried Chinese yam, fructus amomi, fried coix seeds, platycodon grandiflorum, angelica sinensis, radix paeoniae alba, ligusticum wallichii and honey-fried licorice roots. The traditional Chinese medicine composition has the effects of replenishing qi and enriching blood, tonifying spleen and excreting dampness, and tonifying kidney and replenishing essence, can be used for treating spleen and stomach disharmony and deficiency of qi and blood of patients with colorectal cancer sarcopenia and improving the sarcopenia symptom of the patients with colorectal cancer, and also can be used for resisting damage of toxicity of chemotherapeutic drugs to organisms; meanwhile, the traditional Chinese medicine composition can also treat senile sarcopenia caused by reduction of whole body muscle mass and reduction of muscle strength and activity of old people along with age increase, and is suitable for chemotherapy patients with colorectal cancer sarcopenia and senile sarcopenia patients.

Description

Field of the Invention

[0001] The present invention relates to a medicine for treating sarcopenia and a preparation method thereof, and belongs to the technical field of medicines. Background Art

[0002] Sarcopenia is a condition characterized by decreased muscle mass, strength, and physical function. It is typically caused by factors such as long-term physical inactivity, malnutrition, and chronic illness. It has been shown to be closely associated with decreased quality of life, high rates of mobility impairment, increased hospitalization rates, and high mortality rates.

[0003] Colorectal cancer (carcinoma of the colon and rectum) is a common malignant tumor of the gastrointestinal tract. Early symptoms are mild, but as the tumor grows, symptoms develop, including changes in bowel habits, blood in the stool, diarrhea, alternating diarrhea and constipation, and localized abdominal pain. In the late stages, systemic symptoms such as anemia and weight loss appear. Studies have shown that colorectal cancer patients who undergo radiotherapy and chemotherapy often develop sarcopenia, a risk factor for postoperative complications. Studies of patients who have undergone colorectal cancer surgery have shown that the risk of major postoperative complications in patients with sarcopenia is five times that of those with normal muscle mass. Other researchers have reported that sarcopenic patients who undergo radiotherapy and chemotherapy for colorectal cancer have significantly longer hospital stays, and that a significantly higher proportion of patients with sarcopenia receive postoperative radiotherapy and chemotherapy compared to those without sarcopenia.

[0004] Another cause of sarcopenia is malnutrition and insufficient protein intake in the elderly, which can lead to reduced muscle synthesis. Clinically, it is also called "sarcopenia in the elderly". It is an "elderly syndrome" characterized by a decrease in body muscle mass, muscle strength and activity with aging, also known as "sarcopenia in the elderly."

[0005] The drug formulation of the present invention has the effects of invigorating qi and blood, strengthening the spleen and eliminating dampness, and nourishing the kidneys and replenishing essence. It can not only treat spleen and stomach disharmony and qi and blood deficiency in patients with colorectal cancer sarcopenia, and improve the muscle loss symptoms of colorectal cancer patients, but also resist the damage to the body caused by the "toxicity" of chemotherapy drugs; at the same time, it can also treat elderly sarcopenia caused by the decrease in whole body muscle mass, muscle strength and activity caused by aging in the elderly. It is suitable for chemotherapy patients with colorectal cancer sarcopenia and elderly patients with sarcopenia. Summary of the Invention

[0006] The technical problem to be solved by the present invention is to provide a drug for treating sarcopenia and a method for preparing the same. The drug has the effects of replenishing qi and blood, strengthening the spleen and dispelling dampness, and tonifying the kidneys and replenishing essence. It can not only treat spleen and stomach disharmony and qi and blood deficiency in patients with colorectal cancer sarcopenia, improving the symptoms of sarcopenia in colorectal cancer patients, but also protect against the "toxic" damage to the body caused by chemotherapy drugs. It can also treat elderly sarcopenia, which is caused by the decrease in muscle mass, muscle strength, and mobility caused by aging in the elderly. The drug is suitable for chemotherapy patients with colorectal cancer sarcopenia and elderly patients with sarcopenia.

[0007] In order to solve the above technical problems, the present invention adopts the following technical solutions:

[0008] A medicine for treating sarcopenia. The medicinal active ingredients of the medicine are calculated by weight as follows: 50-200 parts of codonopsis pilosula, 50-200 parts of rehmannia root, 50-200 parts of poria, 50-200 parts of stir-fried atractylodes macrocephala, 50-200 parts of stir-fried lentils, 40-130 parts of lotus seeds, 50-200 parts of yam, 20-100 parts of amomum villosum, 50-200 parts of coix seed, 10-50 parts of platycodon, 40-130 parts of angelica sinensis, 40-130 parts of white peony root, 20-100 parts of ligusticum chuanxiong and 20-100 parts of roasted liquorice.

[0009] The aforementioned drug for treating sarcopenia, whose medicinal active ingredients are calculated by weight: 80-160 parts of Codonopsis pilosula, 80-160 parts of Rehmannia glutinosa, 80-160 parts of Poria cocos, 80-160 parts of stir-fried Atractylodes macrocephala, 80-160 parts of stir-fried Lentils, 60-120 parts of Lotus seeds, 80-160 parts of Chinese yam, 40-80 parts of Amomum villosum, 80-160 parts of Coix seed, 20-40 parts of Platycodon grandiflorum, 60-120 parts of Angelica sinensis, 60-120 parts of White Peony Root, 40-80 parts of Chuanxiong and 40-80 parts of roasted Licorice root.

[0010] Specifically, the aforementioned drug for treating sarcopenia, its medicinal active ingredients are calculated by weight: 120 parts of Codonopsis pilosula, 120 parts of Rehmannia glutinosa, 120 parts of Poria cocos, 120 parts of stir-fried Atractylodes macrocephala, 120 parts of stir-fried Lentils, 90 parts of Lotus seeds, 120 parts of Chinese yam, 60 parts of Amomum villosum, 120 parts of Coix seed, 30 parts of Platycodon grandiflorum, 90 parts of Chinese angelica, 90 parts of white peony root, 60 parts of Chuanxiong and 60 parts of roasted Licorice root.

[0011] The preparation method of the aforementioned drug for treating sarcopenia is to weigh all the medicinal materials in the prescription according to the proportion, and process them according to the conventional preparation method to prepare the corresponding drug preparation.

[0012] The aforementioned pharmaceutical preparations include decoctions, hard capsules, granules, tablets, oral preparations or pills.

[0013] The above-mentioned decoction is prepared as follows:

[0014] (1) Stir-frying sugar: Place sugar in a suitable pot, stir-fry frequently until it is completely dissolved and turns yellow. When it starts to foam and a slight bluish-white smoke is emitted, the sugar is ready for use.

[0015] (2) Weigh all the medicinal materials except Amomum villosum according to the prescription ratio, add 8 times the amount of water, soak for 1 hour, boil and reflux and extract twice, each time for 1 hour, add Amomum villosum 5-10 minutes before the last decoction is completed, combine the two extracts, mix well, concentrate to 65% of the original medicinal solution, filter while hot, and concentrate the filtrate to an extract with a relative density of 1.35-1.45 at 55°C. Take 50% of the weight of the above extract in the form of fried sugar, slowly add it to the above extract, stir well, continue to heat over low heat to reduce the paste, wait until a small amount can be pulled into a thread, or when no water marks are left when dropped on paper, put it into a sterile bottle and seal it.

[0016] The hard capsules are prepared as follows: weigh the medicinal materials according to the prescribed ratio, add 10 times the amount of water, soak for 1 hour, boil and reflux for extraction three times, each time for 0.5 hour. Add Amomum villosum 5-10 minutes before the end of the last decoction, combine the three extracts, mix well, concentrate to 65% of the original medicinal solution, filter while hot, and concentrate the filtrate to an extract with a relative density of 1.35-1.45 at 55°C. The extract is dried at 85°C to form a dry extract, pulverized into a fine powder, added with 10% of the preparation amount of starch and 1.5% of magnesium stearate, mixed evenly, granulated with 90% ethanol, dried at 75°C, granulated, and filled into capsules.

[0017] The granules are prepared as follows: weigh all the medicinal materials except Amomum villosum according to the prescription ratio, add 6 times the amount of water, soak for 1 hour, boil and reflux and extract 3 times, each time for 1 hour, add Amomum villosum 5-10 minutes before the end of the last decoction, combine the three extracts, mix well, concentrate to 65% of the original medicinal solution, filter while hot, concentrate the filtrate to an extract with a relative density of 1.35-1.45 at 55°C, dry under reduced pressure, and pulverize into a fine powder to obtain a dry extract. Take 1 part of the dry extract and 1 part of sucrose, and prepare granules by wet method using 90% ethanol. After the granules are prepared, dry them at 80-90°C, pass them through a 16-mesh sieve once, and separate the fine powder with an 80-mesh sieve.

[0018] The tablets are prepared as follows: weigh all the medicinal materials except Amomum villosum according to the prescription ratio, add 12 times the amount of water, soak for 1 hour, boil and reflux and extract twice, each time for 2 hours. Add Amomum villosum 5-10 minutes before the end of the last decoction, combine the two extracts, mix well, and concentrate to 65% of the original medicinal solution. Filter while hot, concentrate and dry the filtrate to 3% moisture, and grind into fine powder. Prepare a soft material with 10% starch slurry, granulate through a 16-mesh sieve, dry at 50°C, add 2% talc and 1% hypromellose, mix well, press into tablets, and film-coat to obtain the tablets.

[0019] The oral preparation is prepared as follows: weigh all the medicinal materials except Amomum villosum according to the prescription ratio, add 6 times the amount of water, soak for 1 hour, boil and reflux and extract twice, each time for 1 hour, add Amomum villosum 5-10 minutes before the end of the last decoction, combine the two extracts, mix well, and concentrate to 65% of the original medicinal solution. After cooling, add 2 times the amount of 95% ethanol and let it stand overnight. After the ethanol is recovered, add 20% xylitol and 0.2% sorbitol, stir well, filter, and concentrate to a relative density of 1.05-1.10 at room temperature.

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

[0021] The drug for treating colorectal cancer sarcopenia is prepared from Codonopsis pilosula, Rehmannia root, Poria cocos, stir-fried Atractylodes macrocephala, stir-fried Lentils, Lotus seeds, Chinese yam, Amomum villosum, Coix seed, Platycodon grandiflorum, Chinese angelica, White peony root, Ligusticum chuanxiong, and roasted Licorice root. The properties and efficacy of each ingredient are as follows: Codonopsis pilosula is the dried root of Codonopsis pilosula (Franch.) Nannf., Codonopsis pilosula Nannf. var. modesta (Nannf.) LTShen, or Codonopsis tangsh en Oliv. (St. Paulaceae family). It is harvested in autumn, washed, and sun-dried. It has a sweet flavor and a neutral nature. It enters the spleen and lung meridians and has the effects of strengthening the spleen and lungs, nourishing blood, and promoting the production of body fluids. It is used to treat spleen and lung qi deficiency, poor appetite, fatigue, cough, asthma, qi and blood deficiency, sallow complexion, palpitations, shortness of breath, thirst due to loss of body fluids, and internal heat and thirst. Rehmannia glutinosa (Shu Di Huang) is obtained by slowly roasting the fresh or dried root tubers of Rehmannia glutinosa Libosch. (Scrophulariaceae) until approximately 80% dry, then processing and adding to the root. It has a sweet flavor and slightly warm properties. It enters the liver and kidney meridians, nourishing blood and yin, and replenishing essence and marrow. It is used for blood deficiency and sallow complexion, palpitations, irregular menstruation, metrorrhagia, liver and kidney yin deficiency, soreness of the waist and knees, hot flashes, night sweats and spermatorrhea, internal heat and thirst, dizziness, tinnitus, and premature graying of hair. Poria cocos is the dried sclerotium of the fungus Poria cocos (Schw.) Wolf (Poria cocos) (Poria cocos) Wolf (Poria cocos) (Poria cocos) Wolf. It has a sweet, light flavor and neutral properties. It enters the heart, lung, spleen, and kidney meridians, promoting diuresis and dampness, strengthening the spleen, and calming the mind. It is used for edema and oliguria, phlegm and fluid retention, dizziness and palpitations, spleen deficiency and poor appetite, loose stools and diarrhea, restlessness, palpitations, and insomnia. Atractylodes macrocephala is the dried rhizome of Atractylodes macrocephala Koidz., a plant of the Asteraceae family. It is dug up in winter when the lower leaves turn yellow and the upper leaves become brittle, then cleared of mud and sand, dried in an oven or sun-dried, and the fibrous roots are removed. It tastes bitter and sweet and is warm in nature. It enters the spleen and stomach meridians and has the effects of nourishing the spleen and replenishing qi, drying dampness and promoting diuresis, stopping sweating, and stabilizing the fetus. It is used to treat spleen deficiency, poor appetite, abdominal distension and diarrhea, phlegm and fluid retention, dizziness and palpitations, edema, spontaneous sweating, and fetal movement disorder. White lentils are the dried mature seeds of the legume plant Dolichos lablab L. The mature fruits are harvested in autumn and winter, sun-dried, the seeds removed, and sun-dried again. They have a sweet taste and slightly warm properties. They enter the spleen and stomach meridians, strengthening the spleen and eliminating dampness, harmonizing the middle and relieving summer heat. They are used for spleen and stomach deficiency, loss of appetite, loose stools, excessive vaginal discharge, vomiting and diarrhea due to summer heat, and chest tightness and abdominal distension. Stir-fried white lentils strengthen the spleen and eliminate dampness. They are used for spleen deficiency diarrhea and excessive vaginal discharge. Stir-fried lentils are a processed version of white lentils. Lotus seeds are the dried mature seeds of the Nymphaeaceae plant Nelumbo nucifera Gaertn. The lotus pods are harvested in autumn when the fruits are ripe, the fruits are removed, the peel is removed, and dried. They have a sweet and astringent taste and are neutral in nature. They enter the spleen, kidney, and heart meridians, tonifying the spleen and stopping diarrhea, stopping vaginal discharge, benefiting the kidneys and astringing the essence, and nourishing the heart and calming the mind. They are commonly used for spleen deficiency diarrhea, vaginal discharge, spermatorrhea, palpitations, and insomnia.Chinese yam is the dried rhizome of Dioscorea opposita Thunb., a plant of the Dioscoreaceae family. It is dug up in winter after the stems and leaves wither, the root head is cut off, washed, the outer skin and fibrous roots are removed, and dried, commonly known as "hairy yam slices"; or the outer skin is removed, the yam is cut into thick slices while fresh, and dried, which is called "yam slices"; some people choose large and straight dried yams, place them in clean water, soak them until there is no dry core, steam them thoroughly, cut the ends evenly, roll them into a cylindrical shape with a wooden board, dry them, and polish them, commonly known as "glossy yam"; it tastes sweet and has a neutral nature; it enters the spleen, lung, and kidney meridians; it has the effects of nourishing the spleen and stomach, promoting fluid production and benefiting the lungs, nourishing the kidneys and astringing essence; it is used for spleen deficiency, poor appetite, chronic diarrhea, asthma and cough due to lung deficiency, spermatorrhea due to kidney deficiency, leucorrhea, frequent urination, and thirst due to deficiency heat; fried yam with bran nourishes the spleen and stomach; it is used for spleen deficiency, poor appetite, diarrhea, loose stools, and excessive leucorrhea. Amomum villosum Lour., Amomum villosum Lour. var. xanthioides TLWu et Senjen, or Amomum longiligulare TLWu, all of the Zingiberaceae family. The fruit is harvested in summer and autumn when ripe, then sun-dried or dried at low temperatures. It has a pungent flavor and warm properties, and enters the spleen, stomach, and kidneys. It has the effects of eliminating dampness and stimulating the appetite, warming the spleen and stopping diarrhea, regulating qi, and stabilizing pregnancy. It is used to treat dampness and turbidity in the middle of the body, abdominal distension without hunger, spleen and stomach deficiency and cold, vomiting and diarrhea, nausea and vomiting during pregnancy, and fetal movement disorder. Coix lachryma-jobi (Coix lachryma-jobi L. var. mayuen (Roman.) Stapf) is a plant of the Poaceae family. The plant is harvested in autumn when the fruit matures, sun-dried, the fruit is beaten, sun-dried again, the shell, yellow-brown seed coat, and impurities removed, and the kernels collected. It has a sweet, light flavor and a cooling nature. It enters the spleen, stomach, and lung meridians and has the effects of promoting diuresis and dispelling dampness, strengthening the spleen and relieving diarrhea, removing numbness, draining pus, and detoxifying and dispersing stagnation. It is used to treat edema, beriberi, dysuria, spleen deficiency diarrhea, dampness-induced stiffness and cramps, lung abscesses, intestinal abscesses, warts, and cancer. Platycodon grandiflorum (Platycodon grandiflorum) A.DC. is a plant of the Campanulaceae family. It has a bitter, pungent flavor and a neutral nature. It enters the lung meridian and has the effects of promoting lung function, relieving sore throats, removing phlegm, and draining pus. It is used to treat cough with excessive phlegm, chest tightness, sore throat, hoarseness, and lung abscesses with vomiting pus. Angelica sinensis is the dried root of Angelica sinensis (Oliv.) Diels, a plant of the Umbelliferae family. It is dug up in late autumn, and the fibrous roots and mud are removed. After the water evaporates slightly, it is tied into small bundles, hung on a shed, and slowly smoked dry with fireworks. It tastes sweet and spicy and is warm in nature. It enters the liver, heart, and spleen meridians. It has the effects of nourishing blood and activating blood circulation, regulating menstruation and relieving pain, and moistening the intestines and promoting bowel movements. It is used for blood deficiency and sallow complexion, dizziness and palpitations, irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain due to deficiency and cold, rheumatic arthralgia, injuries from falls, carbuncles, ulcers, and dry intestinal constipation. Wine-boiled angelica sinensis can promote blood circulation and regulate menstruation; it is used for amenorrhea and dysmenorrhea, rheumatic arthralgia, and injuries from falls.White peony root is the dried root of Paeonia lactiflora Pall. (Ranunculaceae). It has a bitter and sour taste and a slightly cold nature. It enters the liver and spleen meridians and nourishes blood, regulates menstruation, astringes yin and stops sweating, softens the liver and relieves pain, and calms liver yang. It is used for sallow complexion due to blood deficiency, irregular menstruation, spontaneous sweating, night sweats, flank pain, abdominal pain, cramps in the limbs, headaches, and dizziness. Chuanxiong is the dried rhizome of Ligusticum chuanxiong Hort. (Apiaceae). It is harvested in summer when the nodes on the stem are prominent and slightly purple, then desilted, sun-dried, and the fibrous roots removed. It has a pungent taste and a warm nature. It enters the liver, gallbladder, and pericardium meridians and activates blood circulation and qi, dispels wind, and relieves pain. It is used for chest pain, heart pain, stabbing pain in the chest and flanks, swelling and pain from falls, irregular menstruation, amenorrhea, dysmenorrhea, abdominal pain due to lumps, headaches, and rheumatic pain. Roasted licorice root is a processed product of the dried roots and rhizomes of Glycyrrhiza uralensis Fisch. (Glycyrrhiza inflata Bat.) or Glycyrrhiza glabra L. (Glycyrrhiza glabra). It is sweet in flavor and neutral in nature. It enters the heart, lung, spleen, and stomach meridians and has the effects of tonifying the spleen and stomach, replenishing qi and restoring pulses. It is used for spleen and stomach deficiency, fatigue, palpitations, and irregular pulse.

[0022] 1. Prescription

[0023] In this formula, Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, and Rehmannia root serve as the main ingredients, invigorating Qi, strengthening the spleen, dispelling dampness, and nourishing the kidneys, replenishing essence, and blood. Chinese yam and lotus seeds aid the main ingredients in strengthening the spleen and replenishing Qi, while also stopping diarrhea. White lentil and coix seed assist Atractylodes macrocephala and Poria cocos in strengthening the spleen and dispelling dampness, while Angelica sinensis nourishes blood and liver and assists Rehmannia root in replenishing blood and replenishing essence, serving as assistant ingredients. Amomum villosum is further used to invigorate the spleen and harmonize the stomach, promoting Qi circulation and resolving stagnation. White peony root, a yin-tonifying blood-tonifying herb (a blood-in-blood herb), nourishes blood and replenishes Yin, while Chuanxiong rhizome (a blood-in-qi herb) activates and promotes blood circulation. These two ingredients complement each other, combining both movement and stillness, replenishing blood without stagnating it, and promoting blood circulation without damaging it. Platycodon grandiflorum promotes the lungs and invigorates Qi, regulating the water channels, and transporting the herbs upward, nourishing the earth and generating essence. Stir-fried licorice root invigorates the spleen and harmonizes the middle, harmonizing the other ingredients and serving as adjuvants. The combined effects of these two ingredients invigorate Qi and blood, invigorate the spleen and dispel dampness, and nourish the kidneys and replenish essence. Patients with colorectal cancer and sarcopenia often experience spleen-stomach disharmony and qi and blood deficiency. The spleen and stomach are the source of water and grain and the biochemical production of qi and blood. Pathologically, spleen and stomach deficiency and insufficient qi and blood can lead to malnutrition of the tendons, resulting in muscle and joint weakness. When spleen function is weakened, spleen function is compromised, ascending and descending functions are abnormal, and nutrient transport is obstructed, causing the clear and turbid to mix, leading to the accumulation of turbid matter (lipids). This leads to qi and blood deficiency, stagnation in the collaterals, and a lack of warmth and nourishment. This leads to the development of paralysis, which gradually weakens muscles and weakens strength. Chemotherapy drugs are "drug toxins." After invading the body, they damage qi, blood, and essence, directly harming the spleen and kidneys. The kidneys are responsible for marrow production, while the spleen is responsible for blood transformation. With congenital and acquired deficiency, essence and blood cannot be generated. Furthermore, cancer patients already have weak vital energy and the presence of pathological products such as phlegm and blood stasis, further hindering qi and blood production, resulting in symptoms of qi and blood deficiency. In summary, the present invention has the effects of replenishing qi and blood, strengthening the spleen and eliminating dampness, and nourishing the kidney and replenishing essence. It can not only treat the spleen and stomach disharmony and qi and blood deficiency symptoms of patients with sarcopenia caused by colorectal cancer, and improve the symptoms of muscle loss in patients with colorectal cancer, but also resist the damage to the body caused by the "toxicity" of chemotherapy drugs; at the same time, it can also treat elderly sarcopenia caused by the decrease in whole body muscle mass, muscle strength and activity caused by aging in the elderly. It is suitable for chemotherapy patients with colorectal cancer sarcopenia and elderly patients with sarcopenia.

[0024] 2. The clinical research part showed that the experimental group combined Chinese medicine treatment with Ba Duan Jin, which significantly improved the patients' TCM syndrome scores, hand grip strength (HGS), relative skeletal muscle mass index (RSMI), nutritional status (PG-SGA score) and quality of life (EORTC scale score), and effectively alleviated psychological symptoms such as anxiety and depression, without any obvious adverse reactions. It can be promoted and used in clinical practice.

[0025] 3. Network pharmacology and molecular docking studies have shown that key active ingredients such as curcumin, quercetin, and luteolin, by acting on key targets such as AKT1, TNF, IL6, and IGF1, regulate multiple signaling pathways, such as PI3K-Akt, NF-κB, and AMPK. These pathways play important roles in muscle metabolism, inflammation, and cell survival. Molecular docking results further confirmed the stable binding of these active ingredients to their targets, providing new insights into their therapeutic mechanisms and laying the theoretical foundation for subsequent experimental verification and clinical application. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 : Intersection target map of the active ingredient targets of Shenling Baizhu San combined with Siwu Tang and the targets of colorectal cancer-related sarcopenia;

[0027] Figure 2 : Network diagram of active ingredients and targets of Shenling Baizhu San combined with Siwu Tang;

[0028] Figure 3 : PPI network diagram of Shenling Baizhu San combined with Siwu Tang in the treatment of colorectal cancer-related sarcopenia;

[0029] Figure 4 : Network diagram of key targets of Shenling Baizhu San combined with Siwu Tang in the treatment of colorectal cancer-related sarcopenia;

[0030] Figure 5 : GO enrichment analysis of key targets of Shenling Baizhu San combined with Siwu Tang in the treatment of colorectal cancer-related sarcopenia;

[0031] Figure 6 : KEGG enrichment analysis of key targets of Shenling Baizhu San combined with Siwu Tang in the treatment of colorectal cancer-related sarcopenia;

[0032] Figure 7 : Molecular docking model of key active ingredients and key targets of Shenling Baizhu San combined with Siwu Tang in the treatment of colorectal cancer-related sarcopenia. DETAILED DESCRIPTION

[0033] The present invention will be further described below with reference to the examples, but they are not intended to limit the present invention.

[0034] Example 1.

[0035] Prescription: Codonopsis pilosula 12g, Rehmannia root 12g, Poria 12g, stir-fried Atractylodes macrocephala 12g, stir-fried white hyacinth bean 12g, lotus seeds 9g, stir-fried Chinese yam 12g, Amomum villosum 6g, stir-fried Coix seed 12g, Platycodon grandiflorum 3g, Angelica sinensis 9g, White Peony 9g, Chuanxiong 6g, and roasted Licorice root 6g.

[0036] Preparation process:

[0037] (1) Stir-frying sugar: Place sugar in a suitable pot, stir-fry frequently until it is completely dissolved and turns yellow. When it starts to foam and a slight bluish-white smoke is emitted, the sugar is ready for use.

[0038] (2) Weigh all the medicinal materials except Amomum villosum according to the prescription ratio, add 8 times the amount of water, soak for 1 hour, boil and reflux and extract twice, each time for 1 hour, add Amomum villosum 5-10 minutes before the last decoction is completed, combine the two extracts, mix well, concentrate to 65% of the original medicinal solution, filter while hot, and concentrate the filtrate to an extract with a relative density of 1.35-1.45 at 55°C. Take 50% of the weight of the above extract in the form of fried sugar, slowly add it to the above extract, stir well, continue to heat over low heat to reduce the paste, wait until a small amount can be pulled into a thread, or when it is dropped on paper and no water marks are left, put it into a sterile bottle and seal it to obtain the decoction paste.

[0039] Dosage and administration: Take three times a day, morning, noon and evening, 20-30g each time.

[0040] Example 2.

[0041] Prescription: Codonopsis pilosula 50g, Rehmannia root 50g, Poria 200g, stir-fried Atractylodes macrocephala 200g, stir-fried lentils 50g, lotus seeds 130g, yam 200g, Amomum villosum 20g, Coix seed 50g, Platycodon grandiflorum 10g, Angelica sinensis 40g, White Peony 130g, Chuanxiong 100g and roasted Licorice root 100g.

[0042] Preparation process:

[0043] Weigh each medicinal material according to the prescription ratio, add 10 times the amount of water, soak for 1 hour, boil and reflux for extraction 3 times, each time for 0.5 hour, add Amomum villosum 5-10 minutes before the last decoction is completed, combine the three extracts, mix well, concentrate to 65% of the original medicinal solution, filter while hot, concentrate the filtrate to an extract with a relative density of 1.35-1.45 at 55°C, dry the extract at 85°C to form a dry extract, grind into fine powder, add 10% of the preparation amount of starch and 1.5% of magnesium stearate, mix evenly, granulate with 90% ethanol, dry at 75°C, granulate, and fill into capsules to obtain hard capsules.

[0044] Dosage and Administration: Take three times a day, morning, noon and evening, 4-8g each time (1g / pill).

[0045] Example 3.

[0046] Prescription: Codonopsis pilosula 200g, Rehmannia root 200g, Poria 50g, stir-fried Atractylodes macrocephala 50g, stir-fried lentils 200g, lotus seeds 40g, yam 50g, Amomum villosum 100g, Coix seed 200g, Platycodon grandiflorum 50g, Angelica sinensis 130g, White Peony Root 40g, Chuanxiong 20g and roasted Licorice root 20g.

[0047] Preparation process:

[0048] According to the prescription ratio, weigh all the medicinal materials except Amomum villosum, add 6 times the amount of water, soak for 1 hour, boil and reflux for extraction 3 times, each time for 1 hour, add Amomum villosum 5-10 minutes before the last decoction is completed, combine the three extracts, mix well, concentrate to 65% of the original medicinal solution, filter while hot, concentrate the filtrate to an extract with a relative density of 1.35-1.45 at 55℃, dry under reduced pressure, and grind into fine powder to obtain dry extract. Take 1 part of dry extract and 1 part of sucrose, prepare granules by wet method with 90% ethanol, dry at 80-90℃ after granulation, pass through a 16-mesh sieve once, and separate the fine powder with an 80-mesh sieve to obtain granules.

[0049] Dosage and administration: Take three times a day, morning, noon and evening, 10-15g each time.

[0050] Example 4.

[0051] Prescription: Codonopsis pilosula 180g, Rehmannia root 120g, Poria 80g, stir-fried Atractylodes macrocephala 200g, stir-fried lentils 110g, lotus seeds 80g, yam 70g, Amomum villosum 60g, Coix seed 180g, Platycodon grandiflorum 20g, Angelica sinensis 70g, White Peony 110g, Ligusticum chuanxiong 100g and roasted Licorice root 20g.

[0052] Preparation process:

[0053] Weigh all the medicinal materials except Amomum villosum according to the prescription ratio, add 12 times the amount of water, soak for 1 hour, boil and reflux and extract twice, each time for 2 hours, add Amomum villosum 5-10 minutes before the last decoction is completed, combine the two extracts, mix well, and concentrate to 65% of the original medicinal solution. Filter while hot, concentrate and dry the filtrate to 3% moisture, and grind it into fine powder. Use 10% starch slurry to make a soft material, pass through a 16-mesh sieve to granulate, dry at 50℃, add 2% talc powder and 1% hydropropyl methylcellulose, mix well, press into tablets, and film-coat to obtain tablets.

[0054] Dosage and Administration: Take 3-5 tablets (1g / tablet) three times a day, morning, noon and evening.

[0055] Example 5.

[0056] Prescription: Codonopsis pilosula 90g, Rehmannia root 80g, Poria 100g, stir-fried Atractylodes macrocephala 120g, stir-fried lentils 180g, lotus seeds 70g, yam 120g, Amomum villosum 70g, Coix seed 130g, Platycodon grandiflorum 40g, Angelica sinensis 50g, White Peony 80g, Ligusticum chuanxiong 90g and roasted Licorice root 80g.

[0057] Preparation process:

[0058] Weigh all the medicinal materials except Amomum villosum according to the prescription ratio, add 6 times the amount of water, soak for 1 hour, boil and reflux extraction twice, each time for 1 hour, add Amomum villosum 5-10 minutes before the last decoction is completed, combine the two extracts, mix well, and concentrate to 65% of the original medicinal solution. After cooling, add 2 times the amount of 95% ethanol and let it stand overnight. After the ethanol is recovered, add 20% xylitol and 0.2% sorbitol, stir well, filter, and concentrate to a relative density of 1.05-1.10 at room temperature to obtain an oral preparation.

[0059] Dosage and Administration: Take three times a day, morning, noon and evening, 20-30 mL each time.

[0060] Example 6.

[0061] Prescription: Codonopsis pilosula 120g, Rehmannia root 100g, Poria 50g, stir-fried Atractylodes macrocephala 60g, stir-fried lentils 100g, lotus seeds 120g, Chinese yam 140g, Amomum villosum 70g, Coix seed 90g, Platycodon grandiflorum 20g, Angelica sinensis 120g, White Peony Root 110g, Chuanxiong 70g and roasted Licorice root 30g.

[0062] Preparation process:

[0063] Weigh all the medicinal materials except Amomum villosum according to the prescription ratio, add 9 times the amount of water, soak for 1 hour, boil and reflux for extraction 3 times, each time for 1 hour, add Amomum villosum 5-10 minutes before the last decoction is completed, combine the three extracts, mix well, and concentrate to 65% of the original medicinal solution. Filter while hot, and concentrate the filtrate to an extract with a relative density of 1.35-1.45 at 55°C. Dry the extract at 80-90°C to form a dry extract, grind into fine powder, take 1 part of the extract and 2 parts of refined honey, mix evenly, let it stand for 30 minutes, roll it into strips, and make pills to obtain pills.

[0064] Dosage and Administration: Take three times a day, morning and evening, 15-30 pills at a time (0.2g / pill).

[0065] The present invention has carried out a lot of experimental research, and the following is the result of the experimental research of the present invention:

[0066] 1. Clinical Research

[0067] 1 Materials and Methods

[0068] 1.1 Case Source

[0069] This study collected 62 patients with colorectal cancer who met the inclusion criteria and visited the First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine from October 2023 to January 2025 as research subjects.

[0070] 1.2 Diagnostic criteria

[0071] 1.2.1 Western medicine diagnostic criteria

[0072] Diagnostic criteria for colorectal cancer: Refer to the diagnostic criteria of the "CSCO Guidelines for the Diagnosis and Treatment of Colorectal Cancer" (2023 edition), combined with pathological and imaging examinations, to confirm colorectal cancer. The TMN staging standards refer to the American Joint Committee on Cancer (AJCC) Colorectal Cancer TMN Staging Eighth Edition.

[0073] Diagnostic criteria for sarcopenia: The diagnostic criteria for sarcopenia formulated in the "2019 Consensus on Diagnosis and Treatment of Sarcopenia" issued by the Asian Sarcopenia Working Group (AWGS) in 2019 mainly include three related factors: skeletal muscle mass, muscle strength, and muscle function.

[0074] (1) Muscle mass index: Relative skeletal muscle mass index (RSMI): Male <7.0 kg / m 2 , female<5.7kg / m 2 (RSMI = limb skeletal muscle mass (kg) / height (m) 2 )

[0075] (2) Muscle strength index: handgrip strength (HGS), male <28kg, female <18kg.

[0076] (3) Muscle function decline index: gait speed (GS), GS < 1m / s.

[0077] Sarcopenia can be diagnosed if the first item combined with the second or third item is present.

[0078] 1.2.2 Traditional Chinese Medicine Diagnostic Criteria

[0079] There is no clear diagnosis and differentiation standard for sarcopenia in traditional Chinese medicine. This study was formulated with reference to the diagnostic criteria of "Qi and Blood Deficiency Type" of "Consumption and Fatigue" in the "Guiding Principles for Clinical Research of New Chinese Medicines" and the "Internal Medicine of Traditional Chinese Medicine" published by China Traditional Chinese Medicine Press.

[0080] Main symptoms: pale or sallow complexion, fatigue, thin body, poor appetite, dull lips and nails.

[0081] Secondary symptoms: palpitations and shortness of breath, dizziness, numbness of hands and feet, muscle cramps, or muscle twitching, persistent abdominal pain, loose stools, delayed menstruation, scanty and light-colored menstruation, or amenorrhea in women.

[0082] Tongue and pulse: thin white fur, pale tongue, pulse may be thin, weak, deficient, and powerless.

[0083] The diagnosis can be confirmed by combining the tongue and pulse if the above three main symptoms, two main symptoms plus two secondary symptoms, or two main symptoms plus two or more secondary symptoms are present.

[0084] 1.3 Inclusion criteria

[0085] (1) The colorectal cancer TMN stage is III-IV and meets the diagnostic criteria for sarcopenia developed by the Asian Sarcopenia Working Group (AWGS) in 2019.

[0086] (2) Meet the diagnostic criteria of traditional Chinese medicine for deficiency of qi and blood;

[0087] (3) Gender is not limited, age range is 18-75.

[0088] (4) The subject is in good general condition, with a KPS score greater than 60 points and an expected survival period of ≥3 months.

[0089] (5) Able to walk independently without using assistive devices.

[0090] (6) The patient is conscious and in stable condition.

[0091] (7) All of them completed the informed consent form and were willing to persist in the entire exercise process;

[0092] (8) The patient and guardian are informed and agree.

[0093] 1.4 Exclusion criteria

[0094] (1) Patients with liver and kidney dysfunction, hepatic encephalopathy, and other important organ dysfunction, failure, and infection;

[0095] (2) Having cognitive impairment, epilepsy, other neurological diseases or severe mental illness that makes it impossible to cooperate with the experiment;

[0096] (3) Accompanied by severe bone and joint diseases, severe contracture and pain;

[0097] (4) Those who are unable to cooperate with the study due to neurological or skeletal system diseases;

[0098] (5) Wearing electronic devices such as pacemakers in the body;

[0099] (6) Patients with cardiovascular and cerebrovascular diseases or other severe metabolic disorders;

[0100] (7) recent history of surgery;

[0101] (8) Those who are unable to cooperate during the trial;

[0102] (9) Those who violate the trial protocol and accept other trials during the trial;

[0103] (10) The final data are incomplete and the efficacy cannot be judged;

[0104] (11) Patients who are unwilling to continue treatment due to personal reasons;

[0105] (12) Those who do not continue to participate in training without reason;

[0106] (13) Patients who intend to use other anti-tumor treatments at the same time.

[0107] 1.5 Rejection and shedding criteria

[0108] (1) If the condition worsens during treatment and the physician assesses that treatment needs to be postponed or terminated, the patient will be excluded from the group;

[0109] (2) allergic reactions or other serious adverse events;

[0110] (3) those who met the inclusion criteria but did not receive treatment as planned after inclusion;

[0111] (4) The subject automatically withdraws.

[0112] 1.6 Termination Criteria

[0113] (1) Patients who develop severe complications or whose condition worsens during treatment;

[0114] (2) Severe allergic reactions, adverse reactions, etc. occur during treatment.

[0115] When a subject withdraws from the trial, the researcher should ask the subject why the subject withdrew and indicate the reason for withdrawal on the case report form.

[0116] 2 Research Methods

[0117] 2.1 Sample size calculation

[0118] This trial is an RCT, divided into two groups, with an equal sample size. After reviewing the literature, assuming that the effective rate of the observation group is 85% and the effective rate of the control group is 50%, assuming the test power is 0.8 and the test level (α) is 0.05, the results show that 56 subjects are required for research. Based on a 10% dropout rate, the number of cases is increased to 62. Therefore, the project will select 62 patients who meet the inclusion criteria from the First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine from October 2023 to January 2025 for research, with 31 cases in the experimental group and 31 cases in the control group.

[0119] 2.2 Grouping method

[0120] A total of 62 patients with colorectal cancer sarcopenia undergoing chemotherapy who met the inclusion criteria were randomly divided into an experimental group (n=31) and a control group (n=31) according to the random number table method.

[0121] 2.3 Treatment methods

[0122] (1) Control group: nutritional intervention + resistance exercise + standard chemotherapy combined with Ba Duan Jin exercise.

[0123] Experimental group: Based on the control group, Shenling Baizhu San and Siwu Tang were taken orally.

[0124] (2) Nutritional intervention:

[0125] Nutritional risk screening: The nutritional status of patients with colorectal cancer and sarcopenia was assessed using the Nutritional Risk Screening 2002 (NRS-2002).

[0126] Total protein intake: According to the "Guidelines for Nutritional Treatment of Sarcopenia" compiled by the Tumor Nutrition and Supportive Treatment Professional Committee of the Chinese Anti-Cancer Association, the patient's daily total protein intake is 1-1.5g / (kg·d).

[0127] Motivational interviewing (MI): Doctors explain the definition, etiology, hazards, and intervention significance of tumor sarcopenia to eliminate patients' concerns.

[0128] Dietary pattern training: Based on the "Dietary Guidelines for Chinese Residents 2022", guide patients to choose food types and intake amounts based on daily energy and nutritional needs, and use standard food models to introduce specific food intake standards.

[0129] (3) Resistance exercise

[0130] Shoulder lift and elbow flexion and extension exercises: Tie 0.5kg sandbags on both wrists and repeat each movement 15 times.

[0131] Calf lift exercise: The patient sits down, ties sandbags to the insteps of both feet, lifts the calves to a horizontal position and then slowly returns to a vertical position, doing 10-12 times on each side.

[0132] (4) Conventional chemotherapy:

[0133] XELOX is oxaliplatin 130 mg / m2, civ 2h, d1, capecitabine 1000 mg / m 2 ,po,bid,d1-14,1 course of treatment 3 weeks;

[0134] FORFIRI is irinotecan 180 mg / m2, CIV, d1, folinate 400 mg / m 2 , civ2h, d1, fluorouracil 400mg / m 2 Fluorouracil 1200 mg / m2 IV on day 1 2 CIV 24h, d1-2, 2 weeks 1 course;

[0135] FOLFOX6 (oxaliplatin 85 mg / m2) 2 , civ2h, d1, calcium folinate 400mg / m 2 , civ2h, d1, fluorouracil 400mg / m 2Fluorouracil 1200 mg / m2 IV on day 1 2 CIV 24h, d1-2, 2 weeks 1 course;

[0136] (5) Eight-Section Brocade Exercises:

[0137] Ba Duan Jin exercises must be performed under the guidance of a tumor rehabilitation team, including oncologists, rehabilitation physicians, rehabilitation therapists, and responsible nurses. All members must receive sports rehabilitation education and pass the training. Patients receive centralized training in the hospital demonstration room, where rehabilitation therapists demonstrate the movements, and nurses and therapists assist in corrections to ensure that patients master the movements. Every night at 4 p.m., patients perform 12 minutes of exercises in the hospital demonstration room. Before exercising, they check their heart rate and blood pressure for stability, wear a sports bracelet to monitor their heart rate, and ensure that the exercise intensity is between 120 and 140 beats / min. The formula for calculating exercise intensity is: 75 + (220-age-resting heart rate) x (60% + 20%). During the exercise, oncologists and rehabilitation physicians accompany the entire process. If any discomfort symptoms occur, such as dizziness, weakness in the limbs, cold sweats, etc., the exercise should be stopped immediately, and fluids and sugar should be replenished according to the doctor's instructions.

[0138] (6) Traditional Chinese Medicine Treatment: The traditional Chinese medicine treatment formula is based on Shenling Baizhu San combined with Siwu Tang. The formula is as follows: Codonopsis pilosula 12g, Rehmannia root 12g, Poria 12g, stir-fried Atractylodes macrocephala 12g, stir-fried White Lentil 12g, Lotus seed 9g, stir-fried Chinese Yam 12g, Amomum villosum 6g, stir-fried Coix seed 12g, Platycodon grandiflorum 3g, Angelica sinensis 9g, White Peony 9g, Chuanxiong 6g, and Roasted Licorice root 6g. Usage: One dose per day, decocted in water and taken once in the morning and evening according to our hospital's preparation center. If symptoms change during the treatment period, the dosage will be adjusted accordingly. If serious complications occur during treatment, the medication will be discontinued.

[0139] 3 Observation indicators and efficacy evaluation

[0140] 3.1 General indicators

[0141] Collect and record the gender, age, height, weight, and calculate the body mass index (BMI). BMI = weight (kg) / height (m) 2 , BMI was evaluated once before treatment and 2 months after treatment.

[0142] 3.2 Efficacy indicators

[0143] Evaluation was conducted once before treatment and 2 months after treatment.

[0144] (1) TCM syndrome score (see Appendix for details): Refer to the nimodipine method in the "Guidelines for Clinical Research of New Chinese Medicines". The calculation method is: efficacy index = (before treatment - after treatment) syndrome score / pre-treatment syndrome score × 100%

[0145] ① Significant effect: ≥70% reduction compared with the previous level:

[0146] ② Improvement: decreased by ≥30% and <70% compared with the previous level;

[0147] ③ Ineffective: The symptoms are reduced by less than 30% compared with the previous level, or even aggravated.

[0148] (2) Sarcopenia-related indicators: handgrip strength (HGS), relative skeletal muscle mass index (RSMI), and SPPB scale.

[0149] ①HGS

[0150] Muscle strength was assessed using an electronic handgrip dynamometer. To assess muscle strength, the dynamometer was first adjusted to an appropriate grip width. The subject sat with their forearm unsupported, their elbow bent 90°, and their wrist in a neutral position. The subject then gripped the handle with maximum force, alternating between their left and right hands twice. The maximum of these two grips was used as the muscle strength assessment result.

[0151] ②Relative skeletal muscle mass index (RSMI)

[0152] Muscle mass was assessed using a body composition analyzer using bioelectrical impedance analysis (BIA). Subjects should avoid strenuous exercise and eating for at least two hours before testing. During the test, subjects wore light clothing, stood barefoot, and held the electrode handles with their feet naturally apart. Two measurements were taken according to the instrument's prompts, and the average of the two measurements was recorded as the muscle mass assessment result.

[0153] ③SPPB scale

[0154] Muscle function was assessed using the SPPB scale, which consists of three parts: balance, gait speed, and sit-stand. The balance test assesses the subject's balance in three standing positions, the gait speed test measures the subject's walking speed over an 8-meter straight distance, and the sit-stand test assesses the subject's ability to sit and stand. Each test item is scored, and the total score is used to determine the muscle function assessment result.

[0155] (3) Nutritional status assessment: The nutritional status of patients before and after treatment was assessed using the Subjective Global Nutrition Assessment (PG-SGA) (see Appendix for details). The assessment time was before treatment and 2 months after treatment. The PG-SGA form consists of four aspects: weight change, diet, symptoms, and physical condition (filled in by the patient) and two aspects: disease and its relationship with nutritional needs, and physical examination (filled in by the doctor). Nutritional status was divided into three levels based on the score: well-nourished (SGA-A, 0-3 points), moderate or suspected malnutrition (SGA-B, 4-8 points), and severe malnutrition (SGA-C, >8 points). The efficacy assessment criteria were: markedly effective (PG-SGA score decreased compared to the previous score, such as SGA-B before treatment and SGA-A after treatment); effective (PG-SGA score decreased compared to the previous score but maintained the original level, or the score did not change, such as SGA-C before and after treatment); ineffective (PG-SGA score increased compared to the previous score).

[0156] (4) Quality of life assessment: The Chinese version of the core scale (EORTC quality of life questionnaire, QLQ-C30) jointly developed by the European Organization for the Treatment of Cancer and the QLQ-CR29, a quality of life scale specifically designed to assess colorectal cancer (see Appendix for details). The QLQ-C30 scale contains 30 items covering 15 dimensions, and the assessment content includes physical function, role function, emotional function, cognitive function, social function and overall health status, as well as the assessment of symptoms such as fatigue, nausea and vomiting, and pain. Each item is scored from 1 to 4 points, with higher scores indicating more severe symptoms; higher scores for items of overall health status and quality of life indicate better health status and quality of life. The QLQ-CR29 scale includes 4 comprehensive assessments and 19 individual assessments, covering gastrointestinal symptoms, pain, urination problems, etc. Some items are specifically for ostomy patients and sexual function problems, and the scoring criteria are the same as those of the QLQ-C30. An assessment was conducted before treatment and 2 months after treatment to record and analyze the changes in the scores of various functions and symptoms.

[0157] 3.3 Safety indicators and adverse reactions

[0158] The adverse reactions of the two groups of patients during treatment were recorded separately, mainly including nausea, vomiting, dizziness, dry mouth, fatigue, cold sweat, etc.

[0159] 4 Statistical methods

[0160] SPSS 27.0 statistical software was used for statistical analysis. For normally distributed measurement data, mean ± standard deviation was used. For data that were normally distributed and had homogeneous variance, the t-test was used to compare the means of two samples, the paired sample t-test was used to compare the differences within the groups, and the independent sample t-test was used to compare the differences between the groups. Non-parametric tests (χ2) were used to compare the data that were not normally distributed or the count data. 2 P < 0.05 indicated statistically significant differences.

[0161] 5 Results

[0162] 5.1 General Data Comparison

[0163] 5.1.1 Gender comparison

[0164] According to the inclusion and exclusion criteria, a total of 62 patients were required for observation. The gender comparison between the experimental and control groups is shown in Table 1: In the experimental group, there were 20 males (64.50%) and 11 females (35.50%); in the control group, there were 19 males (61.30%) and 12 females (38.70%). The intergroup comparisons were comparable, and the differences were not statistically significant (P>0.05).

[0165] Table 1 Comparison of gender between the two groups of patients

[0166]

[0167] Note: By x 2 The test showed that the gender comparison between the two groups was comparable, and the difference was not statistically significant (P>0.05).

[0168] 5.1.2 Age

[0169] The results of the age difference test between the experimental and control groups are shown in Table 2: the mean age of the experimental group was 61.42±4.46 years; the mean age of the control group was 62.65±4.83 years. The ages of the two groups were comparable, and the difference was not statistically significant (P>0.05).

[0170] Table 2 Comparison of age between the two groups of patients (mean ± standard deviation)

[0171]

[0172]

[0173] 5.1.3BMI

[0174] The BMI of the experimental group and the control group were compared before and after treatment. The results are shown in Table 3: an independent sample t-test was performed before treatment, and the result showed that P = 0.852> 0.05, indicating that there was no statistical difference in BMI between the two groups before treatment; a paired sample t-test was performed within the group, and the result showed that P < 0.05 in the experimental group and P = 0.037< 0.05 in the control group, indicating that the BMI of the two groups improved after treatment compared with that before treatment; an independent sample t-test was performed between the groups after treatment, and the result showed that P = 0.005< 0.05, indicating that the improvement effect of the experimental group was more significant than that of the control group.

[0175] Table 3 Comparison of BMI between the two groups of patients before and after treatment (mean ± standard deviation)

[0176]

[0177] Note: * indicates: compared with before treatment, P < 0.05.

[0178] 5.2 Efficacy indicators

[0179] 5.2.1 Traditional Chinese Medicine Symptom Scoring

[0180] The TCM symptom scores of the experimental group and the control group were compared before and after treatment, and the results are shown in Table 4: a paired sample t-test was performed within the group, and the results showed that P < 0.05 in the experimental group and P < 0.05 in the control group, indicating that the TCM symptom scores of the two groups were lower after treatment than before treatment; an independent sample t-test was performed between the groups, and before treatment, there was no significant difference in the TCM symptom scores between the experimental group and the control group P = 0.501 > 0.05; after treatment, the TCM symptom scores of the experimental group were significantly lower than those of the control group P = 0.007 < 0.05, indicating that the improvement effect of the experimental group was more significant than that of the control group.

[0181] The TCM symptom efficacy was assessed based on the TCM symptom score. The specific results are shown in Table 5. Among the 31 patients in the experimental group, 7 showed marked efficacy, 19 showed improvement, and 5 showed no efficacy, for a total effective rate of 83.87%. Among the 31 patients in the control group, 1 showed significant efficacy, 20 showed improvement, and 10 showed no efficacy, for a total effective rate of 67.74%. The difference between the two groups was statistically significant (P = 0.039, < 0.05).

[0182] Table 4 TCM symptom scores before and after treatment (mean ± standard deviation)

[0183]

[0184] Note: * indicates: compared with before treatment, P < 0.05.

[0185] Table 5 Evaluation of TCM symptoms after treatment in two groups of patients (cases)

[0186]

[0187] 5.2.2 Sarcopenia-related indicators

[0188] 5.2.2.1 Handgrip strength (HGS)

[0189] The grip strength levels of the experimental group and the control group were compared before and after treatment. The results are shown in Table 6: A paired sample t-test was performed within the group, and the results showed that P<0.05 in the experimental group and P<0.05 in the control group, indicating that the grip strength levels of the two groups were improved after treatment compared with those before treatment; an independent sample t-test was performed between the groups, and before treatment, there was no significant difference in the grip strength levels between the experimental group and the control group (P=0.142>0.05); after treatment, the grip strength level of the experimental group was significantly higher than that of the control group (P=0.006<0.05), indicating that the improvement effect of the experimental group was more significant than that of the control group.

[0190] Table 6 Comparison of grip strength before and after treatment (mean ± standard deviation)

[0191]

[0192] Note: * indicates: compared with before treatment, *P<0.05.

[0193] 5.2.2.2 Relative skeletal muscle mass index (RSMI)

[0194] The RSMI levels of the experimental group and the control group were compared before and after treatment, and the results are shown in Table 7: Paired sample t-test was performed within the group, and the results showed that P<0.05 in the experimental group and P<0.05 in the control group, indicating that the RSMI levels of the two groups were improved after treatment compared with those before treatment; independent sample t-test was performed between the groups, and before treatment, there was no significant difference in RSMI levels between the experimental group and the control group (P=0.270>0.05); after treatment, the RSMI level of the experimental group was significantly higher than that of the control group (P<0.001), indicating that the improvement effect of the experimental group was more significant than that of the control group.

[0195] Table 7 Comparison of RSMI levels before and after treatment (mean ± standard deviation)

[0196]

[0197] Note: * indicates: compared with before treatment, *P<0.05.

[0198] 5.2.2.3SPPB Scale

[0199] The SPPB levels of the experimental group and the control group were compared before and after treatment, and the results are shown in Table 8: Paired sample t-test was performed within the group, and the results showed that P<0.05 in the experimental group and P<0.05 in the control group, indicating that the SPPB levels of the two groups were improved after treatment compared with those before treatment; independent sample t-test was performed between the groups, and before treatment, there was no significant difference in SPPB levels between the experimental group and the control group P=0.206>0.05; after treatment, the SPPB level of the experimental group was significantly higher than that of the control group P<0.05, indicating that the improvement effect of the experimental group was more significant than that of the control group.

[0200] Table 8 Comparison of SPPB levels before and after treatment (mean ± standard deviation)

[0201]

[0202] Note: * indicates: compared with before treatment, *P<0.05.

[0203] 5.2.3 Nutritional Status Assessment: Subjective Global Nutrition Assessment Scale

[0204] The subjective global nutritional assessment (PG-SGA) scores of the experimental group and the control group before and after treatment were compared. The results are shown in Table 9: Paired sample t-test was performed within the group, and the results showed that P<0.05 in the experimental group and P<0.05 in the control group, indicating that the PG-SGA scores of the two groups were lower after treatment than before treatment; independent sample t-test was performed between the groups, and before treatment, there was no significant difference in PG-SGA scores between the experimental group and the control group (P=282>0.05); after treatment, the PG-SGA score of the experimental group was significantly lower than that of the control group (P<0.05), indicating that the improvement effect of the experimental group was more significant than that of the control group.

[0205] Table 9 Comparison of PG-SGA scores before and after treatment (mean ± standard deviation)

[0206]

[0207] Note: * indicates: compared with before treatment, *P<0.05.

[0208] 5.3 Occurrence of adverse reactions

[0209] During the treatment, no adverse reactions such as nausea, vomiting, dizziness, dry mouth, fatigue, or cold sweats occurred in either group of patients.

[0210] 6. Results Analysis

[0211] The Traditional Chinese Medicine (TCM) symptom score primarily encompasses symptoms such as fatigue, poor appetite, dizziness, shortness of breath, and laziness. After treatment, the TCM symptom scores of the experimental group were significantly lower than before treatment and lower than those of the control group. This suggests that Shenling Baizhu San combined with Siwu Tang and Ba Duan Jin can effectively alleviate symptoms of Qi and blood deficiency induced by colorectal cancer chemotherapy. This confirms the efficacy of the TCM compound's "Qi-tonifying and Blood-nourishing, Spleen-strengthening and Stomach-harmonizing" properties and further demonstrates the efficacy of this regimen in treating symptoms of consumptive disease.

[0212] Hand grip strength (HGS) is a commonly used indicator for assessing muscle strength. After treatment, the hand grip strength (HGS) of the patients in the experimental group was significantly improved, and the improvement was more obvious than that in the control group. The relative skeletal muscle mass index (RSMI) is an important indicator for assessing muscle mass. After treatment, the RSMI of the patients in the experimental group was significantly higher than that in the control group. The SPPB scale is an internationally recognized method for evaluating muscle function. After treatment, the SPPB scores of the patients in the experimental group were significantly higher than those in the control group, especially in the balance test, gait speed test, and sit-stand test, showing significant improvement. This shows that Shenling Baizhu San combined with Siwu Tang combined with Ba Duan Jin can not only effectively relieve the symptoms of asthenia, but also significantly improve the muscle strength and skeletal muscle mass of patients with colorectal cancer, and promote the recovery of daily activities. It further supports the clinical efficacy of Chinese medicine prescriptions combined with exercise training in improving Qi and blood deficiency type sarcopenia.

[0213] The nutritional status of patients in the experimental group improved significantly, as measured by the PG-SGA scale. By month two after treatment, the nutritional scores in the experimental group had increased compared to baseline. In contrast, the nutritional status of the control group showed little change. The Poria cocos and Chinese yam in Shenling Baizhu San strengthen the spleen and eliminate dampness, promoting nutrient absorption. Siwu Tang nourishes blood and nourishes the body, improving post-chemotherapy anemia. This approach addresses malnutrition at the level of Qi and blood metabolism, helping patients recover their physical function.

[0214] At the same time, this part of the study showed that neither group of patients experienced adverse reactions such as nausea, vomiting, dizziness, dry mouth, fatigue, and cold sweats before treatment, indicating that the treatment regimen of Shenling Baizhu San combined with Siwu Tang combined with Ba Duan Jin exercise has a certain degree of safety.

[0215] 2. Network Pharmacology Research

[0216] 1 Materials and Methods

[0217] 1.1 Collection of active ingredient targets of Shenling Baizhu San combined with Siwu Tang

[0218] The effective active ingredients of Codonopsis pilosula, Chinese yam, Chuanxiong, Angelica sinensis, Platycodon grandiflorum, Radix Glycyrrhizae Preparata, Radix Rehmanniae Preparata, Lablab dalbergiae, Atractylodes macrocephala, Amomum villosum, Paeonia lactiflora, Poria cocos, Nelumbo nucifera, and Coix lachryma-jobi were retrieved through the HERB2.0 database (http: / / 47.92.70.12 / Download / ). The typical SMILES structures corresponding to the active ingredients of traditional Chinese medicine were obtained with the help of the organic small molecule bioactivity database PubChem (https: / / pubchem.ncbi.nlm.nih.gov / ).

[0219] Next, the SMILES structural information obtained from the PubChem database was imported into the SwissADME (http: / / www.swissadme.ch / ) platform to predict the target drug structure. Based on the five drug-like screening principles (Lipinski, Ghose, Veber, Egan, and Muegge), compounds meeting any of the following criteria were screened: compounds with three or more "yes" responses for any of the five principles, as well as compounds with a "high" GIabsorptio n. Finally, the IDmapping function of the Uniport (https: / / www.uniprot.org / ) database was used to convert the active ingredient targets obtained from the screening into corresponding gene symbols, and duplicate removal was performed to obtain the final active ingredient targets.

[0220] 1.2 Target acquisition for colorectal cancer-related sarcopenia

[0221] Using "colorectal cancer" as the search term, we screened for potential target genes associated with colorectal cancer in the Drugbank (https: / / go.drugbank.com / #), OMIM (https: / / omim.org / ), and GeneCards (with a correlation score of ≥5) (https: / / www.genecards.org / ) databases. For "sarcopenia," we used "sarcopenia" as the search term and extracted its related target information from the GeneCards database. After deduplication processing and data verification and correction using the UniProt database, we finally obtained the relevant targets for the two diseases.

[0222] 1.3 Venn diagram drawing and drug component target network drawing

[0223] Using the Venny online analysis tool (https: / / bioinfogp.cnb.csic.es / tools / venny / index.html), we conducted an intersection analysis of targets associated with the active ingredients in Shenling Baizhu San and Siwu Tang, as well as targets for colorectal cancer sarcopenia, to identify potential targets for the TCM compound in treating diseases. Finally, a "drug-ingredient-intersection target-disease" network diagram was constructed using Cytoscape 3.9.1 software, and topological analysis was performed.

[0224] 1.4 PPI protein interaction network drawing

[0225] The resulting "active ingredient-disease" intersection target data was imported into the STRING database (https: / / cn.string-db.org / ), with the species restricted to "Homo sapiens" and the interaction score restricted to >0.900. Individual targets with no interactions were removed. Subsequently, topological parameters, including degree, closeness, betweenness, LAC, network, and eigenvectors, were calculated using the CytoNCA plugin in Cytoscape 3.9.1 software. Targets above the median value of these topological parameters were selected as significant targets. The data for these significant targets were also imported into the STRING database to construct a protein-protein interaction (PPI) network and visualized it. Finally, the MCC, Degree, and Betweenness algorithms in the CytoHubba plugin were used to identify hub genes by intersection analysis of the top 15 key targets in the PPI network. Furthermore, the MCODE module of the Metascape database (https: / / metascape.org / ) was used to further identify key protein clusters associated with these significant targets.

[0226] 1.5 Functional and pathway enrichment analysis of intersectional targets

[0227] The identified key targets were imported into the Metascape database, with Homo sapiens as the study species. Gene Ontology (GO) functional annotation and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway enrichment analysis were performed using default parameters. The top 10 pathways in the BP, MF, and CC categories, as well as the top 20 core pathways in the KEGG pathway enrichment analysis, were selected based on LogP value ranking. The resulting pathways were imported into the R language ggplot2 package to plot GO enrichment analysis bar charts and KEGG pathway enrichment analysis bubble plots, respectively.

[0228] 1.6 Molecular docking

[0229] To further elucidate the molecular mechanism of action of Shenling Baizhu San combined with Siwu Tang in the treatment of colorectal cancer-associated sarcopenia, we screened the top nine key targets and the most likely active ingredients, and analyzed their potential binding abilities using molecular docking. This docking was performed using AutoDock vina 2.1.6. The conformations with the best binding energy and the most repetitive binding conformations were selected as output. The results were then imported into Pymol 3.1 and Discovery Studio 2019 for visualization and analysis.

[0230] 2 Experimental results

[0231] 2.1 Screening of active ingredient targets in Shenling Baizhu San combined with Siwu Tang

[0232] After screening with the HERB2.0 database and the Swiss ADME database, 737 active ingredients in Shenling Baizhu San He Siwu Tang (after deduplication) were obtained. These included 121 active ingredients from Codonopsis pilosula, 64 from Dioscorea opposita, 159 from Ligusticum chuanxiong, 105 from Angelica sinensis, 30 from Platycodon grandiflorum, 4 from Radix Glycyrrhizae Preparata, 28 from Rehmanniae glutinosae, 23 from Lablab dahurica, 52 from Atractylodes macrocephala, 93 from Amomum villosum, 2 from Paeonia lactiflora, 24 from Poria cocos, 16 from Nelumbo nucifera seeds, and 16 from Coix lachryma-jobi. Target prediction of the resulting compounds was performed using the Swiss Target Prediction database, with a predicted target probability > 0.1 as the standard. A total of 3935 active targets were identified.

[0233] 2.2 Acquisition of target genes for colorectal cancer-related sarcopenia

[0234] After screening and removing duplicate targets using the GeneCards, OMIM, and DrugBank databases, the UniProt database was used to correct CRC-related targets, ultimately resulting in 1,313 disease-associated targets. After screening and removing duplicate entries using the GeneCards database, the UniProt database was combined for verification and correction, ultimately identifying 311 key disease targets associated with sarcopenia.

[0235] This study imported 3935 collected drug targets and 1624 colorectal cancer and sarcopenia-related targets into the Venny online analysis platform, screened for common targets through intersection analysis, and drew a Venn diagram based on the obtained data, ultimately obtaining 79 key intersection targets. Figure 1 shown.

[0236] 2.3 Construction and analysis of the ingredient-target network diagram of Shenling Baizhu San combined with Siwu Tang

[0237] A network diagram was constructed using Cytoscape 3.9.1 software to analyze the relationship between the active ingredients of Shenling Baizhu San combined with Siwu Tang and the potential targets of colorectal cancer-related sarcopenia. The relevant parameters were adjusted for visualization. The network diagram had a total of 483 nodes and 2019 relationships. The results are as follows: Figure 2 As shown in the figure, blue nodes in the network diagram represent diseases, green nodes represent targets, red nodes represent single Chinese medicines, and the remaining nodes represent the active ingredients of the drugs. The node degree values were calculated using the Analyzer Network tool. The top five active ingredients in terms of degree value are curcumin, quercetin, luteolin, capsaicin, and palmitic acid. The network diagram also shows that one active ingredient can be connected to multiple targets, and one target can act on multiple active ingredients. This demonstrates that Shenling Baizhu San combined with Siwu Tang can play a role in treating colorectal cancer-related sarcopenia by coordinating multiple ingredients and targets.

[0238] 2.4 Construction of protein-protein interaction (PPI) network

[0239] Import the obtained 79 targets into the STRING website to obtain the PPI network diagram. The results are as follows Figure 3 As shown. 79 nodes and 1045 edges together constitute the network diagram of the treatment of colorectal cancer-related sarcopenia with Shenling Baizhu San combined with Siwu Tang. The nodes in the network diagram represent the targets of the treatment of colorectal cancer-related sarcopenia with Shenling Baizhu San combined with Siwu Tang. The average node degree is 26.5, the average local clustering coefficient is 0.733, and the PPI enrichment P<1.0e-16, indicating that the interaction between targets is strong. The network data was downloaded in TSV file format and then imported into Cytoscape3.9.1 software for network topology analysis and visualization. The larger the node in the network diagram, the larger the Degree value and the more important the node. Subsequently, 15 Hub genes were obtained by screening using CytoHubba. The protein cluster with the highest MCODE score was 15 genes, and 9 core genes were obtained by intersection, namely: ALB, INS, NFKB1, IL6, IGF1, TNF, IL1B, TP53 and AKT1. The results are shown in the figure. Figure 4 shown.

[0240] 2.5GO and KEGG enrichment analysis

[0241] The Metascape data platform was used to perform GO functional enrichment analysis and KEGG pathway enrichment analysis on the 79 important targets obtained in three parts: biological process (BP), cellular component (CC) and molecular function (MF). A total of 1356 results were obtained from the GO functional enrichment analysis, of which 1210 results were related to BP, mainly involving the response of cells to nitrogen compounds, cellular response to hormone stimulation and regulation of inflammatory response, etc. CC mainly involved membrane domains, secretory granule cavities and transcriptional regulatory complexes, etc. 48 results were related to MF, mainly involving signal receptor activity regulation, ligand binding function, transcription factor binding, etc., totaling 98 results. The results were arranged from small to large according to the P value, and the top 30 were displayed as bars. Figure 5 .

[0242] KEGG pathway enrichment analysis showed that 145 pathways were finally obtained, which were arranged in descending order of enrichment scores. The top 20 pathways with the highest enrichment were selected to make a bubble diagram. The size of the bubble represents the number of genes in the pathway. The signaling pathways of Shenling Baizhu San combined with Siwu Tang acting on colorectal cancer-related sarcopenia mainly involve energy metabolism regulation, hypoxia adaptation and metabolic reprogramming, cell survival and proliferation, adipose cell factors, inflammation and immune regulation, etc. These pathways jointly involve key biological processes such as energy metabolism imbalance repair, hypoxia stress adaptation, inflammatory microenvironment regulation and maintenance of cell proliferation homeostasis, suggesting that drugs may improve the pathological progression of sarcopenia by synergistically regulating metabolic reprogramming mediated by adipose factors, inhibiting excessive activation of inflammatory signals and promoting cell survival. Results are shown in Figure 6 .

[0243] 2.6 Core active ingredient-target molecule docking

[0244] The top 9 key targets (ALB, INS, NFKB1, IL6, IGF1, TNF, IL1B, TP53, AKT1) and the top 5 effective core components (curcumin, quercetin, luteolin, capsaicin, palmitic acid) after screening were selected for molecular docking studies (Table 16). It is generally believed that a minimum binding energy of <-5kcal·mol-1 indicates good binding activity, and <-7.0kcal·mol-1 indicates significant binding affinity, and the smaller the value, the stronger the binding ability between the protein and the ligand molecule. Molecular docking showed that the five effective core components had extensive binding activity with the top 9 core targets, among which AKT1-quercetin, AKT1-luteolin, AKT1-curcumin, ALB

[0245] -Curcumin, ALB-luteolin, and ALB-quercetin showed the most significant binding activity. Figure 7 )

[0246] Table 16 Binding activity of core active ingredient-target molecule (kcal / mol)

[0247]

[0248] 3 Discussions

[0249] This study screened out 737 active ingredients in Shenling Baizhu San combined with Siwu Tang through network pharmacology analysis, including 1,313 targets for colorectal cancer and 311 targets for sarcopenia, and 79 drug-disease intersection targets. The key active ingredients were curcumin, quercetin, luteolin, capsaicin, and palmitic acid.

[0250] Colorectal cancer-related sarcopenia refers to muscle loss in colorectal cancer patients due to the tumor itself, surgical treatment, or chemotherapy. Its pathogenesis mainly includes long-term inflammatory response, metabolic disorders, and malnutrition. Colorectal cancer patients often suffer from systemic inflammatory response due to the presence of tumors. This inflammatory response promotes the breakdown of muscle protein and inhibits muscle synthesis. In addition, cancer-related malnutrition and the side effects of chemotherapy drugs can also aggravate muscle wasting, further worsening the patient's physical strength and quality of life. In summary, curcumin, quercetin, luteolin, capsaicin, and palmitic acid mainly regulate the occurrence and progression of colorectal cancer sarcopenia through multiple pathways such as anti-inflammatory, anti-tumor, regulating metabolism, and improving muscle synthesis.

[0251] This study, through PPI network analysis, identified core targets for the treatment of colorectal cancer sarcopenia with Shenling Baizhu San combined with Siwu Tang, including ALB, INS, NFKB1, IL6, IGF1, TNF, IL1B, TP53, and AKT1. INS plays an important role in multiple biological processes, including the regulation of insulin metabolism and glucose metabolism. Aberrant INS expression may increase the energy and nutrient supply to tumor cells by affecting these metabolic pathways, thereby accelerating cancer cell growth and metastasis. Dysbiosis of the gut microbiome may also exacerbate the development of colorectal cancer (CRC) and affect muscle metabolism. ALB, an important nutritional marker, is closely associated with the occurrence and progression of colorectal cancer (CRC) and sarcopenia. In colorectal cancer, aberrant activation of NFKB1 is closely associated with tumor development and progression. IL-6, a key inflammatory cytokine involved in the development of sarcopenia, promotes muscle protein breakdown by activating pathways such as K / Akt. Through inflammatory processes, it triggers muscle catabolism, disrupts protein synthesis, and alters cellular metabolism and proliferation. Chronic inflammation associated with aging and muscle fatty infiltration further exacerbates sarcopenia, with oxidative stress and signaling alterations (such as PI3K-Akt-mTOR) complicating the issue. This highlights the dual impact of inflammation and metabolism on muscle mass and function. In CRC, AKT1 activation has been linked to tumor cell proliferation and metastasis, and it is directly involved in pathways regulating cell migration, metabolism, and muscle tissue repair. TNF-α contributes to the development of muscle atrophy by promoting muscle protein degradation, inhibiting protein synthesis, and interfering with the proliferation and differentiation of muscle stem cells. It affects muscle remodeling through the Akt / mTOR pathway, which is activated by factors such as exercise and protein intake. In conditions of sarcopenia or muscle atrophy, such as cancer or aging, IGF-1 signaling may be impaired, leading to muscle loss. IGF-1's role in regulating inflammation and the tumor microenvironment also links it to cancer progression, highlighting its complex relationship with muscle mass and metabolic regulation.

[0252] According to the results of GO and KEGG enrichment analysis, Shenling Baizhu San combined with Siwu Tang showed significant multi-target effects in the treatment of colorectal cancer and sarcopenia. Through the results of GO enrichment analysis, the main targets of Shenling Baizhu San combined with Siwu Tang are in key biological processes such as hormone regulation, cell metabolism, signal transduction and cell structure. Especially in terms of hormone regulation and metabolic process regulation, it highlights the key role of this drug in maintaining cellular metabolic balance, regulating the inflammatory microenvironment and promoting cell homeostasis. In addition, the enrichment analysis of cell structure suggests that Shenling Baizhu San combined with Siwu Tang may improve muscle function and slow down the occurrence of sarcopenia by repairing cell membranes and enhancing cytoskeleton stability. KEGG pathway enrichment analysis further revealed that the signaling pathways of Shenling Baizhu San combined with Siwu Tang in the treatment of colorectal cancer sarcopenia mainly involve energy metabolism regulation, cell survival and proliferation, hypoxia adaptation and metabolic reprogramming, inflammatory response regulation, oxidative stress and apoptosis inhibition and other aspects.

[0253] Molecular docking results revealed that the key active ingredients in Shenling Baizhu San combined with Siwu Tang exhibited significant binding activity with multiple targets, suggesting a potential mechanism for the treatment of sarcopenia in colorectal cancer. In particular, the following six pairs of active molecules and targets showed the most significant binding activity: AKT1-quercetin, AKT1-luteolin, AKT1-curcumin, ALB-curcumin, ALB-luteolin, and ALB-quercetin. The AKT1-quercetin binding activity was particularly strong. Quercetin, through binding to AKT1, regulates the PI3K / Akt signaling pathway, which has important effects on the proliferation, migration, and apoptosis of colorectal cancer cells. This may have potential implications for the treatment of sarcopenia. Binding of AKT1-curcumin and AKT1-luteolin revealed that curcumin and luteolin, through binding to AKT1, may regulate cell proliferation, metabolism, and angiogenesis through the PI3K / Akt signaling pathway. Luteolin inhibits tumor cell proliferation and invasion by reducing the levels of p-Akt and p-PI3K. Furthermore, ALB-curcumin, ALB-luteolin, and ALB-quercetin also exhibited strong binding activity, suggesting that they may affect the pathological processes of colorectal cancer and sarcopenia through ALB.

[0254] 4 Summary

[0255] Based on network pharmacology and molecular docking techniques, this study screened 737 active ingredients from Shenling Baizhu San He Siwu Tang, which shared 79 targets with colorectal cancer and sarcopenia. Key active ingredients included curcumin, quercetin, luteolin, capsaicin, and palmitic acid, while core targets involved ALB, INS, NFKB1, IL6, IGF1, TNF, IL1B, TP53, and AKT1. KEGG pathway enrichment analysis showed that the drug improves sarcopenia pathology by synergistically regulating adipose factor-mediated metabolic reprogramming, inhibiting overactivation of inflammatory signals, and promoting cell survival. Molecular docking results showed that the core ingredients had significant binding activity with targets (e.g., quercetin-AKT1 binding energy -10 kcal / mol, luteolin-AKT1 binding energy -9.8 kcal / mol), suggesting that the compound can precisely regulate muscle synthesis-decomposition balance and the inflammatory-metabolic network through multiple targets. This study provides a molecular mechanism basis for the treatment of colorectal cancer chemotherapy-related sarcopenia with Shenling Baizhu San combined with Siwu Tang, and lays a theoretical foundation for subsequent experimental verification and clinical application.

Claims

1. A drug for treating sarcopenia, characterized in that: The medicinal active ingredients are calculated by weight as follows: 50-200 parts of codonopsis pilosula, 50-200 parts of rehmannia root, 50-200 parts of poria, 50-200 parts of stir-fried atractylodes macrocephala, 50-200 parts of stir-fried lentils, 40-130 parts of lotus seeds, 50-200 parts of yam, 20-100 parts of amomum villosum, 50-200 parts of coix seed, 10-50 parts of platycodon, 40-130 parts of angelica sinensis, 40-130 parts of white peony root, 20-100 parts of ligusticum chuanxiong and 20-100 parts of roasted liquorice.

2. The drug for treating sarcopenia according to claim 1, wherein: The medicinal active ingredients are calculated by weight as follows: 80-160 parts of codonopsis pilosula, 80-160 parts of rehmannia root, 80-160 parts of poria, 80-160 parts of stir-fried atractylodes macrocephala, 80-160 parts of stir-fried lentils, 60-120 parts of lotus seeds, 80-160 parts of yam, 40-80 parts of amomum villosum, 80-160 parts of coix seed, 20-40 parts of platycodon grandiflorum, 60-120 parts of angelica sinensis, 60-120 parts of white peony root, 40-80 parts of ligusticum chuanxiong and 40-80 parts of roasted liquorice.

3. The drug for treating sarcopenia according to claim 1 or 2, characterized in that: The medicinal active ingredients are calculated by weight: 120 parts of codonopsis pilosula, 120 parts of rehmannia root, 120 parts of poria, 120 parts of stir-fried atractylodes macrocephala, 120 parts of stir-fried lentils, 90 parts of lotus seeds, 120 parts of yam, 60 parts of amomum villosum, 120 parts of coix seed, 30 parts of platycodon, 90 parts of angelica sinensis, 90 parts of white peony root, 60 parts of ligusticum chuanxiong and 60 parts of roasted liquorice.

4. The method for preparing the medicament for treating sarcopenia according to any one of claims 1 to 3, characterized in that: All medicinal materials in the prescription are weighed in proportion, and processed according to conventional preparation methods to prepare corresponding pharmaceutical preparations.

5. The method for preparing the drug for treating sarcopenia according to claim 4, characterized in that: The pharmaceutical preparations include decoctions, hard capsules, granules, tablets, oral preparations or pills.

6. The method for preparing the drug for treating sarcopenia according to claim 5, wherein: The decoction is prepared as follows: (1) Stir-frying sugar: Place sugar in a suitable pot, stir-fry frequently until it is completely dissolved and turns yellow. When it starts to foam and a slight bluish-white smoke is emitted, the sugar is ready for use. (2) Weigh all the medicinal materials except Amomum villosum according to the prescription ratio, add 8 times the amount of water, soak for 1 hour, boil and reflux and extract twice, each time for 1 hour, add Amomum villosum 5-10 minutes before the last decoction is completed, combine the two extracts, mix well, concentrate to 65% of the original medicinal solution, filter while hot, and concentrate the filtrate to an extract with a relative density of 1.35-1.45 at 55°C. Take 50% of the weight of the above extract in the form of fried sugar, slowly add it to the above extract, stir well, continue to heat over low heat to reduce the paste, wait until a small amount can be pulled into a thread, or when no water marks are left when dropped on paper, put it into a sterile bottle and seal it.

7. The method for preparing the drug for treating sarcopenia according to claim 5, wherein: The hard capsule is prepared as follows: weigh each medicinal material according to the prescription ratio, add 10 times the amount of water, soak for 1 hour, boil and reflux extract 3 times, each time for 0.5 hour, add Amomum villosum 5-10 minutes before the last decoction is completed, combine the three extracts, mix well, concentrate to 65% of the original medicinal solution, filter while hot, concentrate the filtrate to an extract with a relative density of 1.35-1.45 at 55° C., dry the extract at 85° C. to obtain a dry extract, grind it into fine powder, add 10% of the preparation amount of starch and 1.5% of magnesium stearate, mix well, granulate with 90% ethanol, dry at 75° C., granulate, and fill into capsules to obtain the hard capsule.

8. The method for preparing the drug for treating sarcopenia according to claim 5, wherein: The granules are prepared as follows: weigh all medicinal materials except Amomum villosum according to the prescription ratio, add 6 times the amount of water, soak for 1 hour, boil and reflux for extraction 3 times, each time for 1 hour, add Amomum villosum 5-10 minutes before the last decoction is completed, combine the three extracts, mix well, concentrate to 65% of the original medicinal solution, filter while hot, concentrate the filtrate to an extract with a relative density of 1.35-1.45 at 55° C., dry under reduced pressure, and grind into fine powder to obtain a dry extract, take 1 part of the dry extract and 1 part of sucrose, prepare granules by wet method with 90% ethanol, dry at 80-90° C. after the granules are prepared, pass through a 16-mesh sieve once, and separate the fine powder with an 80-mesh sieve to obtain the granules.

9. The method for preparing the drug for treating sarcopenia according to claim 5, wherein: The tablets are prepared as follows: weigh all medicinal materials except Amomum villosum according to the prescription ratio, add 12 times the amount of water, soak for 1 hour, boil and reflux and extract twice, each time for 2 hours, add Amomum villosum 5-10 minutes before the last decoction is completed, combine the two extracts, mix well, concentrate to 65% of the original medicinal solution, filter while hot, concentrate and dry the filtrate to 3% moisture, and grind into fine powder, make a soft material with 10% starch slurry, granulate through a 16-mesh sieve, dry at 50°C, add 2% talc and 1% hydroxypropyl methylcellulose, mix well, press into tablets, and film-coat to obtain the tablets.

10. The method for preparing the drug for treating sarcopenia according to claim 5, wherein: The oral preparation is prepared as follows: weigh all medicinal materials except Amomum villosum according to the prescription ratio, add 6 times the amount of water, soak for 1 hour, boil and reflux and extract twice, each time for 1 hour, add Amomum villosum 5-10 minutes before the last decoction, combine the two extracts, mix well, and concentrate to 65% of the original medicinal solution, cool, add 2 times the amount of 95% ethanol, and let it stand overnight. After the ethanol is recovered, add 20% xylitol and 0.2% sorbitol, stir well, filter, and concentrate until the relative density at room temperature is 1.05-1.10.

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