A Chinese medicine composition, a Chinese medicine acupoint patch and preparation method thereof

Abstract

The present application discloses a Chinese medicine composition, a Chinese medicine acupoint patch and a preparation method thereof, wherein the Chinese medicine composition is composed of the following raw materials in parts by weight: 10-30 parts by weight of Astragalus, 10-15 parts by weight of Citron, 5-10 parts by weight of Curcuma, 10-15 parts by weight of Curculigo, 5-10 parts by weight of Epimedium, 5-10 parts by weight of Clematidis, 5-10 parts by weight of Ephedra, and 3-10 parts by weight of Menthol. The above-mentioned Chinese medicine acupoint patch is used for both tonifying and purging, with Astragalus, Curculigo, and Epimedium replenishing, while Curcuma, Citron, Clematidis, and Ephedra dredging, taking into account strengthening the body and dispelling pathogenic factors, and Menthol harmonizing cold and heat, preventing dryness and protecting yin; through the reasonable compatibility of monarch, minister, assistant, and envoy, the combination of external treatment and internal adjustment is achieved, reflecting the flexible thinking of "internal and external treatment" of traditional Chinese medicine, and therefore having the effect of improving cancer-related fatigue in patients with lung cancer.

Description

Technical Field

[0001] The present application belongs to the field of traditional Chinese medicine technology, and in particular relates to a traditional Chinese medicine composition, a traditional Chinese medicine acupuncture patch and a preparation method thereof. Background Art

[0002] Cancer-related fatigue is a common complication in lung cancer patients. It manifests as severe fatigue, which continuously affects the patient's quality of life and may even lead to interruption of treatment.

[0003] Traditional Chinese Medicine (TCM) theory posits that deficiency of vital energy permeates the progression of lung cancer. Long-term, unresolved phlegm and blood stasis can lead to cancerous toxins, which damage vital energy and render the internal organs unable to control them, leading to lung cancer-related fatigue (CRF). TCM classifies cancer-related fatigue as "consumption fatigue." Based on theoretical guidance from the Suwen (Suwen: Shi Congrong Lun), which states that "liver deficiency, kidney deficiency, and spleen deficiency all cause weight loss and discomfort," TCM believes that cancer-related fatigue primarily affects the liver, spleen, and kidneys, and is primarily characterized by deficiency syndromes, of which spleen and kidney yang deficiency is one. Modern medicine has yet to effectively alleviate CRF, but Traditional Chinese Medicine (TCM) offers unique advantages in treating lung cancer-related fatigue. Through holistic and personalized treatment, it improves the internal environment, aiming to improve patients' quality of life and prolong their survival. TCM can also effectively mitigate or alleviate the adverse effects of modern medical treatments, providing comprehensive, gentle, and sustained therapeutic support for lung cancer patients.

[0004] Therefore, developing drugs with significant clinical efficacy and few side effects has become an important research direction for current medical workers. Summary of the Invention

[0005] The purpose of this application is to provide a Chinese medicine composition, a Chinese medicine acupoint patch and a preparation method thereof, which can achieve a certain effect of regulating human body functions and improving cancer-related fatigue in lung cancer patients by stimulating the acupoints and meridians of the human body.

[0006] To achieve the above application objectives, the technical solutions adopted in this application are as follows:

[0007] The present invention provides a Chinese medicine composition comprising the following raw materials in parts by weight:

[0008] 10-30 parts by weight of Astragalus, 10-15 parts by weight of Citron, 5-10 parts by weight of Curcuma, 10-15 parts by weight of Curculigo, 5-10 parts by weight of Epimedium, 5-10 parts by weight of Clematidis, 5-10 parts by weight of Ephedra, and 3-10 parts by weight of Menthol.

[0009] Optionally, the mass ratio of Curculigo and Epimedium is 2:1, and the amount of Epimedium is 5-7.5 parts by weight.

[0010] The embodiment of the present application also provides a traditional Chinese medicine acupuncture patch, which is composed of a Babu plaster matrix and the above-mentioned traditional Chinese medicine composition.

[0011] Optionally, the Chinese medicine composition is composed of the following raw materials in parts by weight:

[0012] 20 parts by weight of Astragalus, 10 parts by weight of Citron, 10 parts by weight of Curcuma, 10 parts by weight of Curculigo, 5 parts by weight of Epimedium, 5 parts by weight of Clematidis, 5 parts by weight of Ephedra, and 3 parts by weight of Menthol.

[0013] Optionally, sodium polyacrylate, polyvinyl pyrrolidone, aluminum glycolate, disodium edetate, tartaric acid and glycerin are used as raw materials for the Babu plaster base.

[0014] The present application also provides a method for preparing a Chinese medicine acupuncture patch, comprising:

[0015] Weigh the following medicinal materials according to the following proportions: 10-30 parts by weight of Astragalus, 10-15 parts by weight of Citron, 5-10 parts by weight of Curcuma, 10-15 parts by weight of Curculigo, 5-10 parts by weight of Epimedium, 5-10 parts by weight of Clematidis, 5-10 parts by weight of Ephedra, and 3-10 parts by weight of Menthol;

[0016] Sodium polyacrylate, polyvinyl pyrrolidone, aluminum glycolate, disodium edetate, tartaric acid and glycerin are used as raw materials for the base of the babu plaster;

[0017] S2 prepares thick paste:

[0018] Soaking the astragalus root, the bergamot root, the zedoary root, the curculigo, the epimedium, the clematis root, the ephedra, and the mint in water until they are thoroughly moistened, boiling and extracting, collecting the extract, and reducing the pressure to thicken it to obtain a thick paste;

[0019] S3 preparation of acupoint patch:

[0020] The sodium polyacrylate, the disodium edetate and the aluminum glycolate are dispersed in the glycerol as phase A; purified water is taken separately, and the polyvinyl pyrrolidone and the tartaric acid are added in sequence, and after they are fully dissolved, the thick paste is added as phase B; the phase B is added to the phase A in small amounts and multiple times, and stirred evenly to form an ointment, which is quickly applied on a backing material and left to dry and form at room temperature to obtain a traditional Chinese medicine acupuncture patch.

[0021] Compared with the prior art, the beneficial effects of the embodiments of the present application are:

[0022] The present invention provides a Chinese medicine composition, a Chinese medicine acupoint patch, and a preparation method thereof. The main ingredient is Astragalus membranaceus, which replenishes Qi and raises Yang, strengthens the body's defense system, and enhances the body's immunity. Cancer-related fatigue is primarily due to Qi deficiency, and Astragalus membranaceus is a key Qi-tonifying herb. External application can replenish vital Qi through acupoint stimulation and improve fatigue. The auxiliary ingredients are Citron (Buddha's Hand) and Curcuma zedoaria. Tonifying Qi requires supplementary Qi-moving agents. Citron (Buddha's Hand) soothes the liver and regulates Qi, strengthens the spleen and resolves phlegm, and prevents Astragalus membranaceus from causing stagnation. Lung cancer is often accompanied by toxic stasis. Curcuma zedoaria promotes blood circulation and resolves stasis, and when combined with Astragalus membranaceus, it "combines tonification and elimination" to improve local microcirculation. Adjuvants include Curculigo, Epimedium, Clematidis, Ephedra, and Mentha. Curculigo and Epimedium have the effects of warming the kidney and strengthening yang, dispelling cold and removing dampness, and strengthening bones and muscles. Cancer, long-term illness and kidney, yang deficiency aggravates fatigue. The two warm the kidney and assist yang to consolidate the foundation, enhance disease resistance, and target kidney yang deficiency syndrome, enhancing the overall warming and unblocking effect; Clematidis dredges the meridians and relieves pain, helps the drug penetrate the meridians, Ephedra dispels cold and penetrates the skin, promotes drug percutaneous absorption, and promotes lung qi to facilitate breathing; Mentha is pungent and cool, clears heat and dispels wind, and counteracts warm and dry medicinal properties (such as Curculigo and Ephedra), prevents local irritation, and leads the drug upward. Mentha is also an envoy, clears heat and penetrates the surface, leads all medicines to penetrate the skin, directly to the acupuncture points, and is often used as a transdermal penetration enhancer to enhance the therapeutic effect of acupuncture point application. Compatibility has the following advantages:

[0023] (1) Both tonifying and purging: Astragalus is mainly used to tonify Qi, while Curcuma and Citron are used as supplementary ingredients to promote Qi and blood circulation, thus avoiding stagnation. (2) Treating both internal and external factors: Ephedra and Clematis chinensis open the meridians and promote drug transdermal absorption, while Peppermint harmonizes the medicinal properties and reduces irritation. (3) Warming Yang and strengthening the foundation: Curculigo and Epimedium target long-term Yang deficiency and improve overall health. This prescription combines external treatment with internal regulation through the rational combination of monarch, minister, assistant and envoy, reflecting the flexible thinking of "treating both internal and external factors" in traditional Chinese medicine, and thus has the effect of improving cancer-related fatigue in patients with lung cancer. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the following briefly introduces the drawings required for use in the embodiments or descriptions of the prior art. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without any creative work.

[0025] Figure 1 A flow chart of a method for preparing a Chinese medicine acupuncture patch provided in an embodiment of the present application is shown. DETAILED DESCRIPTION

[0026] In order to make the technical problems, technical solutions and beneficial effects to be solved by this application more clearly understood, this application is further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain this application and are not intended to limit this application.

[0027] The present invention provides a Chinese medicine composition, a Chinese medicine acupuncture patch, and a preparation method thereof. The Chinese medicine acupuncture patch can stimulate the body's acupuncture points and meridians to achieve a certain effect of regulating human body functions and improving cancer-related fatigue in lung cancer patients. The acupuncture patch is easy to use and has good patient compliance.

[0028] In order to illustrate the technical solution described in this application, specific embodiments are provided below.

[0029] Example 1

[0030] The embodiment of the present application provides a traditional Chinese medicine composition, which is composed of the following raw materials in parts by weight: 10-30 parts by weight of astragalus, 10-15 parts by weight of bergamot, 5-10 parts by weight of zedoary, 10-15 parts by weight of curculigo, 5-10 parts by weight of epimedium, 5-10 parts by weight of clematis, 5-10 parts by weight of ephedra, and 3-10 parts by weight of mint.

[0031] As an example, the mass ratio of Curculigo and Epimedium is 2:1, and the amount of Epimedium is 5-7.5 parts by weight.

[0032] Example 2

[0033] The embodiment of the present application provides a traditional Chinese medicine acupuncture patch, which is composed of a Babu plaster matrix and the above-mentioned traditional Chinese medicine composition.

[0034] As an example, the Chinese medicine composition is composed of the following raw materials in parts by weight:

[0035] 20 parts by weight of Astragalus, 10 parts by weight of Citron, 10 parts by weight of Curcuma, 10 parts by weight of Curculigo, 5 parts by weight of Epimedium, 5 parts by weight of Clematidis, 5 parts by weight of Ephedra, and 3 parts by weight of Menthol.

[0036] As an example, the poultice base is composed of sodium polyacrylate, polyvinyl pyrrolidone, aluminum glycolate, disodium edetate, tartaric acid and glycerin.

[0037] Example 3

[0038] See also Figure 1 As shown, the present embodiment provides a method for preparing a Chinese medicine acupuncture patch, comprising:

[0039] S1 Prepare herbs:

[0040] Weigh the following medicinal materials according to the following proportions: 10-30 parts by weight of Astragalus, 10-15 parts by weight of Citron, 5-10 parts by weight of Curcuma, 10-15 parts by weight of Curculigo, 5-10 parts by weight of Epimedium, 5-10 parts by weight of Clematidis, 5-10 parts by weight of Ephedra, and 3-10 parts by weight of Menthol;

[0041] Sodium polyacrylate, polyvinyl pyrrolidone, aluminum glycolate, disodium edetate, tartaric acid and glycerin are used as raw materials for the base of the babu plaster;

[0042] S2 prepares thick paste:

[0043] Soaking the astragalus root, the bergamot root, the zedoary root, the curculigo, the epimedium, the clematis root, the ephedra, and the mint in water until they are thoroughly moistened, boiling and extracting, collecting the extract, and reducing the pressure to thicken it to obtain a thick paste;

[0044] S3 preparation of acupoint patch:

[0045] The sodium polyacrylate, the disodium edetate and the aluminum glycolate are dispersed in the glycerol as phase A; purified water is taken separately, and the polyvinyl pyrrolidone and the tartaric acid are added in sequence, and after they are fully dissolved, the thick paste is added as phase B; the phase B is added to the phase A in small amounts and multiple times, and stirred evenly to form an ointment, which is quickly applied on a backing material and left to dry and form at room temperature to obtain a traditional Chinese medicine acupuncture patch.

[0046] The above embodiments provide a Chinese medicine composition, a Chinese medicine acupoint patch and a preparation method thereof, which have the following characteristics:

[0047] Beneficial effects:

[0048] 1. The medicinal ingredients of the Chinese medicine acupuncture patch of the embodiment are composed of 8 kinds of medicinal materials such as astragalus, bergamot, zedoary, curculigo, epimedium, clematis, ephedra, and mint, and a babu plaster base. Specifically:

[0049] (1) Astragalus is sweet and slightly warm in nature. It belongs to the lung and spleen meridians. It has the functions of replenishing qi and raising yang, consolidating the exterior and stopping sweating, promoting diuresis and reducing swelling, promoting fluid production and nourishing blood, relieving stagnation and relieving numbness, expelling toxins and draining pus, and healing sores and promoting tissue regeneration.

[0050] (2) Buddha’s hand is pungent, bitter, sour and warm in nature, and belongs to the liver, spleen, stomach and lung meridians. It has the effects of soothing the liver and regulating qi, harmonizing the stomach and relieving pain, and drying dampness and resolving phlegm.

[0051] (3) Curcuma zedoaria, pungent, bitter and warm in nature, belongs to the liver and spleen meridians, and has the effects of promoting qi and removing blood, eliminating accumulation and relieving pain.

[0052] (4) Epimedium, also known as Epimedium, is pungent and hot in nature and belongs to the kidney, liver and spleen meridians. Epimedium, pungent, sweet and warm in nature and belongs to the liver and kidney meridians. Both have the effects of tonifying kidney yang, strengthening tendons and bones, and removing rheumatism. Curculigo and Epimedium are a classic warming and tonifying kidney yang medicine pair (two immortals) first recorded in the Compendium of Materia Medica. The combination of the two medicines can play the role of warming the kidney, strengthening yang, tonifying the kidney and strengthening tendons.

[0053] (5) Clematis chinensis, pungent, salty and warm in nature, belongs to the bladder meridian and has the effect of removing rheumatism and unblocking meridians.

[0054] (6) Ephedra was first recorded in Shennong’s Herbal Classic. It is pungent, slightly bitter, and warm in nature. It enters the lung and bladder meridians and has the effects of inducing sweating, dispersing cold, promoting lung function, relieving asthma, and promoting diuresis and reducing swelling.

[0055] (7) Peppermint is pungent and cool in nature and belongs to the lung and liver meridians. It has the effects of dispersing wind-heat, clearing the head, relieving sore throat and rash, and soothing the liver and promoting qi.

[0056] (8) Astragalus polysaccharide, the active ingredient of Astragalus, has the effects of anti-fatigue, enhancing immunity, anti-oxidative stress, and anti-tumor. It can replenish vital energy through acupoint stimulation and improve the cancer-related fatigue symptoms of lung cancer patients such as fatigue and spontaneous sweating. Buddha's hand volatile oil has the effects of relieving cough, reducing phlegm and relieving asthma, and anti-tumor. It can promote qi circulation and relieve depression, prevent Astragalus from replenishing qi excessively, and relieve fatigue caused by chest and flank distension in lung cancer patients. Curcuma oil can enhance the body's immunity and play an anti-tumor role. It can target the local accumulation of cancer toxins in lung cancer and inhibit tumor formation. Tumor microenvironment, alleviating the pathological basis of cancer-related fatigue; Curculigo and Epimedium can regulate mouse immunity by increasing the phagocytic percentage and phagocytic index of peritoneal macrophages, improving symptoms of yang deficiency such as chills, cold limbs, and soreness of the waist and knees in lung cancer patients, and relieving fatigue; the pungent and warming effect of Clematidis can dredge the meridians, relieve local pain and blood stasis, thereby improving fatigue caused by poor blood circulation; ephedrine, the active ingredient in ephedra, can dilate local blood vessels, promote blood circulation, and warm and dispel cold. On the one hand, lung cancer patients often experience breathing difficulties due to tumor compression, which aggravates fatigue. Ephedra can dilate the bronchi, relieve airway spasms, and improve ventilation function. On the other hand, ephedra's warming and unblocking effect can promote qi and blood circulation, alleviating symptoms such as weakness and chills caused by yang deficiency and cold stagnation; peppermint can guide the upward movement of medicinal herbs, reducing the skin irritation of warm and dry herbs and harmonizing their properties.

[0057] Therefore, the various herbs in this prescription work together to nourish the spleen and kidneys, and improve cancer-related fatigue in patients with lung cancer.

[0058] 2. The Chinese medicine acupoint patch prepared in this embodiment can be applied to Zusanli, Yongquan, Guanyuan, Qihai, Tanzhong, Sanyinjiao, and Jiaji points. It has sustained-release and long-acting functions, can prolong the duration of action, is easy to use, and has high patient cooperation and compliance.

[0059] Example 4

[0060] In order to verify the beneficial effects of the above-mentioned Chinese medicine acupoint patch, this application also provides the following experimental data.

[0061] 1. Chemotherapy is the primary treatment for advanced lung cancer. However, due to the lack of selectivity for tumors, the toxicity of these drugs often far exceeds the body's ability to compensate, rapidly depleting or even exhausting the body's Qi, blood, body fluids, and fluids. This leads to a sharp "alteration" of vital Qi and the development of "acute deficiency syndrome," with patients presenting with symptoms of "acute, critical, severe, and weak." Therefore, tonifying deficiency requires prioritizing prevention, combining prevention with treatment, using strong tonification to strengthen the body, urgently addressing critical situations, and implementing comprehensive intervention to halt the rapid progression of the disease.

[0062] 2. The pathogenesis of lung cancer can be broadly attributed to deficiency of vital energy and excess of pathogenic factors. Deficiency of vital energy manifests as qi, yin, and yang deficiency, while excess pathogenic factors are primarily qi, phlegm, blood stasis, and fire. Lung cancer arises from deficiency, which in turn leads to excess. It is a systemic deficiency combined with local excess. After lung cancer develops, it continuously depletes qi and blood, inevitably damaging the body's vital energy, further depleting it. This weakens the vital energy and intensifies the cancerous toxins. The internal organs are deprived of nourishment and unable to control the cancerous toxins, leading to lung cancer and cancer-related fatigue. "Su Wen Yi Pian: On Acupuncture" states, "When vital energy is present within, pathogenic factors cannot enter." "Su Wen: On Comments on Respiratory Diseases" states, "Where pathogenic factors gather, the qi is necessarily deficient." Traditional Chinese Medicine emphasizes a holistic approach, syndrome differentiation and treatment, and focuses on the body's overall function and disease resistance. Maintaining vital energy is therefore crucial.

[0063] 3. Implement clinical drug experimental plan

[0064] 3.1 A total of 74 patients with lung cancer-related fatigue were selected from the Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine.

[0065] 3.2 Diagnostic Criteria: Western medicine diagnosis of lung cancer: Refer to the "Guidelines for the Diagnosis and Treatment of Primary Lung Cancer (2022 Edition)" and cancer-related fatigue refer to the criteria of the 10th International Classification of Diseases. Traditional Chinese Medicine diagnostic criteria follow the "deficiency and fatigue" in the "Internal Medicine of Traditional Chinese Medicine". The main symptoms of spleen and kidney yang deficiency are fatigue, shortness of breath and laziness, poor appetite, aversion to cold and cold limbs, spontaneous sweating, tinnitus and deafness, soreness of the waist and knees, pale tongue, and weak or deep pulse. Secondary symptoms include abdominal distension, dizziness, vertigo, constipation or loose stools, and clear and long urination.

[0066] 3.3 Inclusion criteria: Patients with lung cancer-related fatigue who meet the diagnostic criteria; aged 20 to 80 years; expected survival time greater than 3 months; KPS score ≥ 60 points; voluntary participation, signed informed consent, and high compliance; and the patient or his / her agent can read, understand, and complete the questionnaire.

[0067] 3.4 Exclusion criteria: patients with severe bleeding tendency; patients with diseases of the digestive system, blood system, urinary system, liver, kidney and other important organs; patients with other malignant tumors; patients with severe infectious diseases requiring concurrent treatment; patients who are pregnant, breastfeeding or have mental illness; patients taking concomitant medication (recombinant human granulocyte colony-stimulating factor, thymosin, interleukin, erythropoietin).

[0068] 3.5 Exit criteria: serious violation of the clinical trial protocol; rapid deterioration of the condition, high risk of dangerous events, requiring immediate termination of the trial; serious adverse events, making it difficult to continue the trial; request for termination of the trial; incomplete data; other reasons determined by the investigator to be unsuitable for continuing the trial.

[0069] 3.6 Treatment options

[0070] (1) Control group: Patients received only standard Western medical treatment during the same period and did not receive Chinese medicine treatment, including Chinese herbal decoctions, decoction-free granules, oral and injectable Chinese patent medicines with similar efficacy, etc.

[0071] (2) Experimental group: Based on the control group, the patients were treated with Chinese herbal acupoint patch. The above-prepared Chinese herbal acupoint patch was applied once a day (each patch weighed 5 g and had a 1.5 cm application radius). The acupoints selected were: Zusanli, Yongquan, Guanyuan, Qihai, Tanzhong, Sanyinjiao, and Jiaji (selected according to the patient's specific condition). The patch was applied for more than 6-8 hours, usually before bedtime and removed in the morning. The patients were observed for 1 week.

[0072] 3.7 Observation indicators and efficacy evaluation criteria

[0073] (1) Clinical symptoms: Cancer-related fatigue was assessed using the Cancer Fatigue Scale (CFS) score change and the Piper Fatigue Scale before and after treatment, and the KPS was used to evaluate the patient's quality of life;

[0074] (2) Clinical efficacy: According to the syndrome scoring system established in the “Guiding Principles for Clinical Research of New Chinese Medicines”, the severity of symptoms such as fatigue, shortness of breath, laziness to speak, chills and cold limbs, poor appetite, soreness of waist and knees, and spontaneous sweating were scored and divided into normal, mild, moderate, and severe, with scores of 0, 1, 2, and 3 respectively.

[0075] Complete remission - the patient's TCM symptom score basically disappears, and the efficacy index is 95% or above; partial remission - the patient's TCM symptom score improves, and the efficacy index is below 95%, 70% or above; mild remission - the patient's TCM symptom score improves, and the efficacy index is below 70%, 30% or above; ineffective - the patient's efficacy index is below 30%.

[0076] Total effective rate = complete remission rate + partial remission rate + mild remission rate.

[0077] 3.8 Safety Evaluation

[0078] During the treatment, the patients' blood routine, liver function and kidney function indicators were observed.

[0079] 3.9 Statistical analysis

[0080] SPSS 21.0 software was used for statistical analysis, and chi-square test was used for count data; If the data were in accordance with the normal distribution, the t-test or paired t-test was used; if the data were not in accordance with the normal distribution, the rank sum test was used; all hypothesis tests were two-sided, and P < 0.05 was considered to be statistically significant.

[0081] 4. Experimental Results

[0082] 4.1 Comparison of baseline data

[0083] Chi-square tests and two independent sample t-tests revealed no statistically significant differences in gender or age between the two groups (P>0.05). See Tables 1 and 2 for details.

[0084] Table 1 Comparison of gender between the two groups of patients

[0085]

[0086] Table 2 Comparison of age between the two groups of patients

[0087]

[0088] 4.2 Comparison of clinical efficacy between the two groups before and after treatment

[0089] After one week of treatment, the total effective rate of the experimental group (81.08%) was higher than that of the control group (35.14%), P < 0.01, indicating that the experimental group was effective (P < 0.05). See Table 3 for details.

[0090] Table 3 Clinical efficacy evaluation of the two groups of patients

[0091]

[0092] 4.3 Comparison of CFS, Piper, and KPS scores between the two groups before and after treatment

[0093] Before treatment, there were no statistically significant differences in CFS, Piper scores, and KPS scores between the two groups (P>0.05). After treatment, CFS and Piper scores decreased, while KPS scores increased, in both groups (P<0.05). One week after treatment, CFS and Piper scores were lower, while KPS scores were higher in the experimental group than in the control group (P<0.05). See Table 4 for details.

[0094] Table 4 Comparison of CFS, Piper and KPS scores between the two groups before and after treatment

[0095]

[0096] Wherein, a means the comparison between the treatment and pre-treatment within the same group, P < 0.05.

[0097] 4.4 Safety evaluation

[0098] During the trial, both groups underwent routine blood tests, liver and kidney function tests before and after treatment to evaluate the drug's safety. Before treatment, there were no statistically significant differences in platelet (PLT), white blood cell (WBC), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and creatinine (Cr) values ​​between the two groups (P>0.05). After treatment, there were also no statistically significant differences in PLT, WBC, ALT, AST, and Cr values ​​between the two groups compared to before treatment (P>0.05). Results: No abnormal results were found after treatment that were normal before treatment, indicating that the acupoint patch is safe. See Tables 5 and 6 for details.

[0099] Table 5 Comparison of PLT and WBC between the two groups before and after treatment

[0100]

[0101] Table 6 Comparison of ALT, AST and Cr in the two groups before and after treatment

[0102]

[0103] In Tables 5 and 6, b indicates the comparison between the post-treatment and pre-treatment results within the same group, P>0.05.

[0104] The above-described embodiments are only used to illustrate the technical solutions of the present application, rather than to limit them. Although the present application has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. These modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the various embodiments of the present application, and should all be included in the scope of protection of the present application.

Claims

1. A Chinese medicine composition for treating lung cancer-related fatigue, characterized in that: It is composed of the following raw materials in parts by weight: 10-30 parts by weight of Astragalus, 10-15 parts by weight of Citron, 5-10 parts by weight of Curcuma, 10-15 parts by weight of Curculigo, 5-10 parts by weight of Epimedium, 5-10 parts by weight of Clematidis, 5-10 parts by weight of Ephedra, and 3-10 parts by weight of Menthol.

2. The Chinese medicine composition according to claim 1, characterized in that The mass ratio of the Curculigo and Epimedium is 2:1, and the Epimedium is 5-7.5 parts by weight.

3. A Chinese medicine acupoint patch for treating lung cancer-related fatigue, characterized in that: The invention is composed of a Babu plaster matrix and the traditional Chinese medicine composition according to claim 1.

4. The Chinese medicine acupuncture point patch according to claim 3, characterized in that: The Chinese medicine composition is composed of the following raw materials in parts by weight: 20 parts by weight of Astragalus, 10 parts by weight of Citron, 10 parts by weight of Curcuma, 10 parts by weight of Curculigo, 5 parts by weight of Epimedium, 5 parts by weight of Clematidis, 5 parts by weight of Ephedra, and 3 parts by weight of Menthol.

5. A method for preparing a Chinese medicine acupoint patch for treating lung cancer-related fatigue, characterized in that: include: S1 Prepare herbs: Weigh the following medicinal materials according to the following proportions: 10-30 parts by weight of Astragalus, 10-15 parts by weight of Citron, 5-10 parts by weight of Curcuma, 10-15 parts by weight of Curculigo, 5-10 parts by weight of Epimedium, 5-10 parts by weight of Clematidis, 5-10 parts by weight of Ephedra, and 3-10 parts by weight of Menthol; Sodium polyacrylate, polyvinyl pyrrolidone, aluminum glycolate, disodium edetate, tartaric acid and glycerin are used as raw materials for the base of the babu plaster; S2 prepares thick paste: Soaking the astragalus root, the bergamot root, the zedoary root, the curculigo, the epimedium, the clematis root, the ephedra, and the mint in water until they are thoroughly moistened, boiling and extracting, collecting the extract, and reducing the pressure to thicken it to obtain a thick paste; S3 preparation of acupoint patch: The sodium polyacrylate, the disodium edetate and the aluminum glycolate are dispersed in the glycerol as phase A; purified water is taken separately, and the polyvinyl pyrrolidone and the tartaric acid are added in sequence, and after they are fully dissolved, the thick paste is added as phase B; the phase B is added to the phase A in small amounts and multiple times, and stirred evenly to form an ointment, which is quickly applied on a backing material and left to dry and form at room temperature to obtain a traditional Chinese medicine acupuncture patch.

6. The preparation method according to claim 5, characterized in that The mass ratio of the Curculigo and Epimedium is 2:1, and the Epimedium is 5-7.5 parts by weight.

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