Traditional Chinese medicine composition, traditional Chinese medicine acupoint patch and preparation method of traditional Chinese medicine acupoint patch

Abstract

The invention discloses a traditional Chinese medicine composition, a traditional Chinese medicine acupoint patch and a preparation method of the traditional Chinese medicine acupoint patch. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10 to 30 parts of radix astragali seu hedysari, 10 to 15 parts of fructus citri sarcodactylis, 5 to 10 parts of rhizoma curcumae, 10 to 15 parts of rhizoma curculiginis, 5 to 10 parts of herba epimedii, 5 to 10 parts of radix clematidis, 5 to 10 parts of herba ephedrae and 3 to 10 parts of herba menthae. According to the traditional Chinese medicine acupoint patch, tonifying and reducing are combined, radix astragali, rhizoma curculiginis and herba epimedii are used for tonifying, curcuma zedoary, fingered citron, radix clematidis and ephedra are used for dredging, strengthening body resistance and eliminating evil are taken into consideration, and mint is used for regulating cold and heat and preventing dryness and protecting yin; through reasonable compatibility of monarch, minister, assistant and guide, combination of external treatment and internal regulation is realized, and the flexible thought of'internal and external treatment 'in traditional Chinese medicine is embodied, so that the traditional Chinese medicine composition has the effect of improving cancer-related fatigue of lung cancer patients.

Description

Technical Field

[0001] The present application belongs to the technical field of traditional Chinese medicine, 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 one of the common complications in patients with lung cancer. It manifests as severe fatigue, which continuously affects the patient's quality of life and even leads to interruption of treatment.

[0003] According to TCM theory, the process of lung cancer development is characterized by deficiency of vital energy. If phlegm and blood stasis are not transformed for a long time, cancer toxins will be formed. Cancer toxins will damage vital energy. The five internal organs will be unable to restrain cancer toxins, and lung cancer with cancer-related fatigue (CRF) will occur. TCM classifies cancer-related fatigue as "deficiency fatigue". Based on the theoretical guidance of "Suwen·Shi Congronglun" that "liver deficiency, kidney deficiency, and spleen deficiency all make people feel heavy and upset", it is believed that the main sites of cancer-related fatigue are the liver, spleen, and kidney, and the deficiency syndrome is the main one, and spleen and kidney yang deficiency syndrome is one of them. Modern medicine has no effective means to relieve CRF, and TCM has shown unique advantages in the treatment of lung cancer-related fatigue. Through overall regulation and individualized treatment, it improves the internal environment of the body, aiming to improve the quality of life of patients and prolong their survival. At the same time, TCM can also effectively reduce or alleviate the adverse reactions caused by modern medical treatments, providing comprehensive, gentle and continuous treatment 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 the present 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 functions and improving cancer-related fatigue in lung cancer patients by stimulating the acupoints and meridians of the human body.

[0006] In order to achieve the above application purpose, the technical solution adopted in this application is as follows:

[0007] The present invention provides a Chinese medicine composition, which is composed of 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 Menthus.

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

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

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

[0012] Astragalus membranaceus 20 parts by weight, Citrus medica var. sarcodactylis 10 parts by weight, Curcuma zedoaria 10 parts by weight, Curculigo orchioides 10 parts by weight, Epimedium brevicornu 5 parts by weight, Clematis chinensis 5 parts by weight, Ephedra sinica 5 parts by weight, Mentha haplocalyx 3 parts by weight.

[0013] Optionally, take sodium polyacrylate, polyvinylpyrrolidone, glycopyrrolate aluminum, disodium ethylenediaminetetraacetate, tartaric acid and glycerol as raw materials for the cataplasm matrix.

[0014] The embodiment of the present application also provides a preparation method of a traditional Chinese medicine acupoint patch, including:

[0015] Weigh the medicinal materials according to the following ratio: Astragalus membranaceus 10 - 30 parts by weight, Citrus medica var. sarcodactylis 10 - 15 parts by weight, Curcuma zedoaria 5 - 10 parts by weight, Curculigo orchioides 10 - 15 parts by weight, Epimedium brevicornu 5 - 10 parts by weight, Clematis chinensis 5 - 10 parts by weight, Ephedra sinica 5 - 10 parts by weight, Mentha haplocalyx 3 - 10 parts by weight;

[0016] Take sodium polyacrylate, polyvinylpyrrolidone, glycopyrrolate aluminum, disodium ethylenediaminetetraacetate, tartaric acid and glycerol as raw materials for the cataplasm matrix;

[0017] S2 Prepare thick paste:

[0018] Soak and moisten the Astragalus membranaceus, Citrus medica var. sarcodactylis, Curcuma zedoaria, Curculigo orchioides, Epimedium brevicornu, Clematis chinensis, Ephedra sinica, Mentha haplocalyx with water until thoroughly soaked, then decoct and extract, collect the extract, and concentrate it under reduced pressure to obtain a thick paste;

[0019] S3 Prepare acupoint patch:

[0020] Disperse the sodium polyacrylate, disodium ethylenediaminetetraacetate and glycopyrrolate aluminum in the glycerol as phase A; separately take purified water, sequentially add the polyvinylpyrrolidone and the tartaric acid, fully dissolve them and then add the thick paste as phase B; add the phase B to the phase A in small amounts and stir evenly to form a medicinal paste, quickly coat it on the backing material, and let it stand at room temperature to dry and form, thus obtaining the traditional Chinese medicine acupoint patch.

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

[0022] A traditional Chinese medicine composition, a traditional Chinese medicine acupoint patch and a preparation method thereof provided by an embodiment of the present application. The monarch drug is Astragalus membranaceus, which replenishes qi and raises yang, benefits the defensive qi and consolidates the exterior, enhancing the body's immunity. Cancer-related fatigue is based on qi deficiency, and Astragalus membranaceus is an important drug for replenishing qi. External application can supplement the healthy qi through acupoint stimulation and improve fatigue. The ministerial drugs are Citrus medica var. sarcodactylis Swingle and Rhizoma Curcumae, and when replenishing qi, it is necessary to assist with promoting qi movement. Citrus medica var. sarcodactylis Swingle soothes the liver and regulates qi, strengthens the spleen and resolves phlegm, preventing the stagnation of Astragalus membranaceus. Lung cancer is often accompanied by stasis and toxins, and Rhizoma Curcumae promotes blood circulation and removes stasis, and is combined with Astragalus membranaceus to "combine supplementation and elimination" to improve local microcirculation. The adjuvant drugs are Curculigo orchioides Gaertn., Epimedium brevicornu Maxim., Clematis chinensis Osbeck, Ephedra sinica Stapf, and Mentha haplocalyx Briq. Curculigo orchioides Gaertn. and Epimedium brevicornu Maxim. have the effects of warming the kidney and strengthening yang, dispelling cold and dampness, and strengthening the muscles and bones. Prolonged illness of cancer tumors affects the kidney, and yang deficiency aggravates fatigue. The two warm the kidney and assist yang to strengthen the foundation and enhance the disease resistance ability. For the syndrome of kidney yang deficiency, the overall warming and dredging effect is enhanced; Clematis chinensis Osbeck dredges collaterals and relieves pain, assisting the medicinal power to penetrate into the meridians. Ephedra sinica Stapf disperses cold from the lung and penetrates the striae of the skin, promoting the percutaneous absorption of drugs, and also dispersing the lung qi to facilitate breathing; Mentha haplocalyx Briq. is pungent, cool and dispersing, clearing heat and dispelling wind, and counteracting the warm and dry medicinal properties (such as Curculigo orchioides Gaertn. and Ephedra sinica Stapf), preventing local irritation, and also guiding the drugs upward. Mentha haplocalyx Briq. also serves as the envoy drug, clearing heat and penetrating the surface, guiding all the drugs to penetrate through the skin and reach the acupoints directly. It is often used as a transdermal penetration enhancer to enhance the curative effect of acupoint application. The compatibility has the following advantages:

[0023] (1)Combining supplementation and purgation: Astragalus membranaceus mainly replenishes qi, and Rhizoma Curcumae and Citrus medica var. sarcodactylis Swingle assist in promoting qi movement and activating blood circulation, avoiding stagnation. (2)Treating both internally and externally: Ephedra sinica Stapf and Clematis chinensis Osbeck dredge collaterals and open orifices, promoting the percutaneous absorption of drugs, and Mentha haplocalyx Briq. harmonizes the medicinal properties and reduces irritation. (3)Warming yang and strengthening the foundation: Curculigo orchioides Gaertn. and Epimedium brevicornu Maxim. target the long-term yang deficiency due to prolonged illness and enhance the overall function. Through the reasonable compatibility of the monarch, ministerial, adjuvant and envoy drugs, this prescription realizes the combination of external treatment and internal regulation, reflecting the flexible thinking of "treating both internally and externally" in traditional Chinese medicine, and thus has the effect of improving cancer-related fatigue in lung cancer patients. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the following will briefly introduce the drawings required for use in the embodiments or the description of the prior art. Obviously, the following drawings are only some embodiments of the present application. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0025] Figure 1 The flowchart showing a preparation method of a traditional Chinese medicine acupoint patch provided by an embodiment of the present application is shown. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0026] In order to make the technical problems, technical solutions and beneficial effects to be solved by the present application clearer, the following further details the present application in combination with the drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present application and are not used to limit the present application.

[0027] The present application provides a Chinese medicine composition, a Chinese medicine acupuncture patch and a preparation method thereof, which can achieve a certain effect of regulating human functions and improving cancer-related fatigue in lung cancer patients by stimulating the acupuncture points and meridians of the human body. The acupuncture patch is easy to use and enables patients to have good compliance.

[0028] In order to illustrate the technical solution described in this application, a specific embodiment is provided below for illustration.

[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 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 Clematis, 5-10 parts by weight of Ephedra, and 3-10 parts by weight of Menthus.

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

[0032] Example 2

[0033] The embodiment of the present application provides a traditional Chinese medicine acupuncture point patch, which is composed of a Babu plaster base 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 Menthus.

[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 application embodiment provides a method for preparing a Chinese medicine acupuncture point patch, comprising:

[0039] S1 Prepare herbs:

[0040] Weigh the 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] Take sodium polyacrylate, polyvinylpyrrolidone, aluminum glycinate, disodium ethylenediaminetetraacetate, tartaric acid and glycerol as raw materials for the cataplasm matrix;

[0042] S2 Prepare the thick paste:

[0043] Soak the astragalus membranaceus, fingered citron, zedoary turmeric, curculigo rhizome, epimedium herb, clematis root, ephedra herb, and mint in water until thoroughly moistened, then decoct and extract. Collect the extract and concentrate it under reduced pressure to obtain a thick paste;

[0044] S3 Prepare the acupoint patch:

[0045] Disperse the sodium polyacrylate, disodium ethylenediaminetetraacetate and aluminum glycinate in the glycerol as phase A; separately take purified water, add the polyvinylpyrrolidone and tartaric acid in sequence, fully dissolve them and then add the thick paste as phase B; add the phase B to the phase A in small amounts and stir evenly to form an ointment, and quickly coat it on the backing material and let it dry at room temperature to form a shape, thus obtaining the traditional Chinese medicine acupoint patch.

[0046] The traditional Chinese medicine composition, traditional Chinese medicine acupoint patch and its preparation method provided by the above embodiments have the following

[0047] Beneficial effects:

[0048] 1. The active ingredients of the traditional Chinese medicine acupoint patch in the embodiment are composed of 8 kinds of medicinal materials including astragalus membranaceus, fingered citron, zedoary turmeric, curculigo rhizome, epimedium herb, clematis root, ephedra herb, and mint and the cataplasm matrix. Specifically:

[0049] (1) Astragalus membranaceus is sweet in taste and slightly warm in nature, belonging to the lung and spleen meridians, and has the effects of replenishing qi and raising yang, consolidating the exterior to stop sweating, promoting diuresis to alleviate edema, promoting the production of body fluid and nourishing blood, promoting qi circulation to relieve pain, expelling pus by supporting healthy qi, and promoting granulation and muscle growth.

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

[0051] (3) Zedoary turmeric is pungent, bitter and warm in nature, belonging to the liver and spleen meridians, and has the effects of promoting qi circulation and breaking blood stasis, and removing stasis and relieving pain.

[0052] (4) Epimedium herb, also known as horny goat weed, is pungent and hot in nature, belonging to the kidney, liver and spleen meridians. Epimedium herb is pungent, sweet and warm in nature, belonging to the liver and kidney meridians. Both have the effects of tonifying the kidney yang, strengthening the tendons and bones, and dispelling wind-dampness. Curculigo rhizome and horny goat weed, as a classic pair of herbs for warming and tonifying the kidney yang (Two Immortals), were first recorded in "Compendium of Materia Medica". The combination of the two herbs plays the role of warming the kidney and strengthening yang, and tonifying the kidney and strengthening the tendons.

[0053] (5) Clematis root is pungent, salty and warm in nature, belonging to the bladder meridian, and has the effects of dispelling wind-dampness and dredging the meridians.

[0054] (6) Ephedra was first recorded in "Shennong Ben Cao Jing". It is pungent, slightly bitter, and warm in nature, and belongs to the lung and bladder meridians. It has the effects of inducing sweating and dispelling cold, dispersing lung qi and relieving asthma, and promoting diuresis and reducing edema.

[0055] (7) Mentha haplocalyx Briq. 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 and eyes, relieving sore throat and promoting eruption, and soothing the liver and regulating qi.

[0056] (8) The active ingredient of Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao, astragalus polysaccharide, has the effects of anti-fatigue, enhancing immunity, antioxidant stress, and anti-tumor. By stimulating acupoints, it tonifies the vital qi and improves the cancer-related fatigue symptoms of lung cancer patients such as fatigue and spontaneous sweating; the volatile oil of Citrus medica L. var. sarcodactylis Swingle has the effects of relieving cough, reducing phlegm and relieving asthma, and anti-tumor, promotes qi and relieves depression, prevents excessive qi-tonifying by Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao, and relieves the fatigue caused by fullness and distension in the chest and hypochondrium of lung cancer patients; the zedoary oil can enhance the body's immunity and play an anti-tumor role, target the local cancer toxin aggregation in lung cancer, inhibit the tumor microenvironment, and reduce the pathological basis of cancer-related fatigue; Curculigo orchioides Gaertn. and Epimedium brevicornu Maxim. can regulate the immunity of mice by increasing the phagocytosis percentage and phagocytosis index of peritoneal macrophages in mice, improve the yang deficiency symptoms of lung cancer patients such as fear of cold and cold limbs, and weakness in the waist and knees, and relieve fatigue; the pungent and warm collaterals-dredging effect of Clematis chinensis Osbeck can dredge the meridians, relieve local pain and qi and blood stasis, thereby improving the fatigue caused by poor qi and blood circulation; the active ingredient of Ephedra, ephedrine, can dilate local blood vessels, promote blood circulation, and warm and dredge cold. On the one hand, lung cancer patients often have difficulty breathing due to tumor compression, which aggravates the feeling of fatigue. Ephedra can dilate the bronchi, relieve airway spasm, and improve ventilation function. On the other hand, the warming and dredging effect of Ephedra can promote qi and blood circulation, relieve symptoms such as weakness in the limbs and fear of cold caused by yang deficiency and cold coagulation; Mentha haplocalyx Briq. guides the medicine to act upward, reduces the skin irritation of warm and dry drugs, and harmonizes the properties of the medicine.

[0057] Therefore, all the drugs in this prescription work together to tonify the spleen and kidney, and improve the cancer-related fatigue of lung cancer patients.

[0058] 2. The traditional Chinese medicine acupoint patch prepared in this example can be applied to Zusanli (ST 36), Yongquan (KI 1), Guanyuan (CV 4), Qihai (CV 6), Tanzhong (CV 17), Sanyinjiao (SP 6), and Jiaji points. It has the functions of slow release and long-acting, can extend the action time, is convenient to use, and has high patient compliance and adherence.

[0059] Example 4

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

[0061] 1. Chemotherapy is the main treatment for advanced lung cancer. However, due to the lack of selectivity of chemotherapeutic drugs for tumors, their toxicity often far exceeds the compensatory ability of the body. The qi, blood, body fluids, and essence in the human body are rapidly depleted or even exhausted, and the healthy qi undergoes a sharp "alienation" resulting in "acute deficiency syndrome". Patients present the characteristics of "urgency, criticality, severity, and deficiency". Therefore, it is emphasized that for tonifying deficiency, prevention must come first, prevention and treatment should be combined, strongly tonify the healthy qi and strengthen the vital energy, rescue the critically ill with emergency treatment, and intervene throughout the process to cut off the rapidly deteriorating disease trend.

[0062] 2. The pathogenesis of lung cancer can generally be attributed to deficiency of healthy qi and excess of pathogenic factors. Deficiency of healthy qi is manifested as qi deficiency, yin deficiency, yang deficiency, etc., and excess of pathogenic factors is mostly pathological factors such as qi, phlegm, stasis, and fire. Lung cancer occurs due to deficiency and leads to excess due to deficiency, and it is a disease with general deficiency and local excess. After the formation of lung cancer, it continuously consumes qi and damages blood, inevitably damaging the healthy qi of the human body, further weakening the healthy qi. The weaker the healthy body, the stronger the cancer toxin. The five zang-organs and six fu-organs are deprived of nourishment and are unable to restrict the cancer toxin, resulting in cancer-related fatigue in lung cancer. "Plain Questions - Supplementary Treatise on Needling Methods" states: "If the healthy qi is stored internally, pathogenic factors cannot invade." "Plain Questions - Treatise on Febrile Diseases" states: "Where pathogenic factors gather, the qi of that place must be deficient." Traditional Chinese medicine emphasizes the holistic concept and syndrome differentiation and treatment, and pays attention to the overall function and disease resistance ability of the body. Therefore, maintaining the healthy qi is very important.

[0063] 3. Implement the clinical medication experimental plan

[0064] 3.1 Select 74 patients with cancer-related fatigue in lung cancer 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 "Diagnosis and Treatment Guidelines for Primary Lung Cancer (2022 Edition)", and the diagnostic criteria for cancer-related fatigue refer to the standards of the 10th International Classification of Diseases Conference. The traditional Chinese medicine diagnostic criteria follow the "Deficiency Consumption" in "Internal Medicine of Traditional Chinese Medicine". The main symptoms of the syndrome of spleen-kidney yang deficiency are fatigue, lassitude, shortness of breath, poor appetite, fear of cold and cold limbs, spontaneous sweating, tinnitus and deafness, soreness and weakness of the waist and knees, pale tongue, weak or deep and thready pulse; the secondary symptoms are abdominal distension, dizziness, vertigo, constipation or loose stools, and clear and long urine.

[0066] 3.3 Inclusion criteria: Patients with cancer-related fatigue in lung cancer who meet the diagnostic criteria; aged 20 - 80 years old; expected survival period greater than 3 months; KPS score ≥ 60 points; patients are willing to participate in the trial, sign the informed consent form, and have high compliance; the patient or the agent can read, understand, and fill out the questionnaire by themselves.

[0067] 3.4 Exclusion criteria: Those with severe bleeding tendency; those with diseases of important organs such as the digestive system, hematological system, urinary system, liver, and kidney; those with other malignant tumors at the same time; those with severe infectious diseases that require simultaneous treatment; pregnant, lactating women, or those with mental diseases; combined use of drugs (recombinant human granulocyte colony-stimulating factor, thymalfasin, interleukin, erythropoietin).

[0068] 3.5 Withdrawal criteria: those who seriously violate the clinical trial protocol; those whose condition deteriorates rapidly and are extremely prone to dangerous events and need to be terminated immediately; those who experience serious adverse events and it is difficult to continue; those who propose to terminate the trial; those with incomplete data; other reasons determined by the researcher that make it impossible to continue the trial.

[0069] 3.6 Treatment plan

[0070] (1) Control group: Patients only receive standard Western medicine treatment during the same period and do not receive traditional Chinese medicine treatment, including traditional Chinese medicine decoctions, ready-to-use granules, oral and injection preparations of traditional Chinese patent medicines with similar efficacy, etc.

[0071] (2) Experimental group: On the basis of the control group, traditional Chinese medicine acupoint application therapy is administered. Use the above-prepared traditional Chinese medicine acupoint patches, once a day (each patch contains 5 g of ointment and the application radius is 1.5 cm). The acupoints selected are: Zusanli, Yongquan, Guanyuan, Qihai, Tanzhong, Sanyinjiao, Jiaji points (selected according to the specific situation of the patient). The application time is more than 6 - 8 hours, generally applied before going to bed and removed in the morning, and observed for 1 week.

[0072] 3.7 Observation indicators and efficacy evaluation criteria

[0073] (1) Clinical symptoms: Before and after treatment, the changes in scores of the Cancer - related Fatigue Scale (CFS) and the Piper Fatigue Scale are used to evaluate cancer - related fatigue, and the Karnofsky Performance Status (KPS) is used to evaluate the quality of life of the patients;

[0074] (2) Clinical efficacy: According to the syndrome scores formulated in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines", the symptom degrees of fatigue, shortness of breath, fear of cold and cold limbs, poor appetite, soreness and weakness of the waist and knees, and spontaneous sweating are scored, divided into normal, mild, moderate, and severe, and given 0, 1, 2, and 3 points respectively.

[0075] Complete remission - The traditional Chinese medicine syndrome scores of the patients basically disappear, and the efficacy index is 95% and above; Partial remission - The traditional Chinese medicine syndrome scores of the patients improve, and the efficacy index is below 95% and 70% and above; Mild remission - The traditional Chinese medicine syndrome scores of the patients get better, and the efficacy index is below 70% and 30% and above; Ineffective - The efficacy index of the patients 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 period, the blood routine, liver function, and kidney function indexes of the patients are observed.

[0079] 3.9 Statistical analysis

[0080] Statistical analysis is carried out using SPSS 21.0 software. Chi - square test is used for count data; Measurement data are used... It is indicated that for those conforming to the normal distribution, t - test or paired t - test is used, while for those not conforming to the normal distribution, rank - sum test is used; all hypothesis tests adopt two - sided tests, and a difference is considered statistically significant when P < 0.05.

[0081] 4. Experimental results

[0082] 4.1 Comparison of baseline data

[0083] By chi - square test and two - independent - sample t - test for the two groups of patients, it was found that there were no statistically significant differences in the comparison between the two groups of patients in terms of gender and age (P > 0.05). See Tables 1 and 2 for details.

[0084] Table 1 Inter - group comparison of the genders of the two groups of patients

[0085]

[0086] Table 2 Inter - group comparison of the ages of the two groups of patients

[0087]

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

[0089] One week after 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 Evaluation of the clinical efficacy of the two groups of patients

[0091]

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

[0093] Before treatment, there were no statistically significant differences in the comparison of the CFS, Piper, and KPS scores between the two groups of patients (P > 0.05). Compared with before treatment, after treatment, the CFS and Piper scores of both groups of patients decreased, and the KPS score increased (P < 0.05). One week after treatment, the CFS and Piper scores of the patients in the experimental group were lower than those of the control group, and the KPS score was higher than that of the control group (P < 0.05). See Table 4 for details.

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

[0095]

[0096] Among them, a indicates the comparison within the same group after treatment and before treatment, P < 0.05.

[0097] 4.4 Safety evaluation

[0098] During the experiment, routine blood tests, liver and kidney function tests were performed on the two groups of patients before and after treatment to evaluate the safety of the drug. Before treatment, there were no statistically significant differences in the values of platelet (PLT), white blood cell (WBC), alanine aminotransferase (ALT), aspartate aminotransferase (AST) and creatinine (Cr) between the two groups of patients (P>0.05). Compared with before treatment, there were also no statistically significant differences in the values of PLT, WBC, ALT, AST and Cr in the two groups of patients after treatment (P>0.05). Test results: No results were found to be normal before treatment and abnormal after treatment, indicating the safety of the acupoint patch. See Tables 5 and 6 for details.

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

[0100]

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

[0102]

[0103] Among them, in Tables 5 and 6, b indicates comparison after treatment with before treatment 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 it; although the present application has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that they can still modify the technical solutions described in the foregoing embodiments, or perform equivalent replacements on some of the technical features; and these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the various embodiments of the present application, and should all be included within the protection scope of the present application.

Claims

1. A traditional Chinese medicine composition, characterized in that, It consists of the following raw materials in parts by weight: Astragalus membranaceus 10 - 30 parts by weight, Citrus medica var. sarcodactylis 10 - 15 parts by weight, Curcuma zedoaria 5 - 10 parts by weight, Curculigo orchioides 10 - 15 parts by weight, Epimedium brevicornu 5 - 10 parts by weight, Clematis chinensis 5 - 10 parts by weight, Ephedra sinica 5 - 10 parts by weight, Mentha haplocalyx 3 - 10 parts by weight.

2. The traditional Chinese medicine composition according to claim 1, wherein The mass ratio of the Curculigo orchioides to the Epimedium brevicornu is 2:1, and the Epimedium brevicornu is 5 - 7.5 parts by weight.

3. A traditional Chinese medicine acupoint patch for treating cancer-related fatigue in lung cancer, characterized in that, It consists of a cataplasm matrix and the traditional Chinese medicine composition described in Claim 1.

4. The traditional Chinese medicine acupoint patch according to claim 2, wherein The traditional Chinese medicine composition consists of the following raw materials in parts by weight: Astragalus membranaceus 20 parts by weight, Citrus medica var. sarcodactylis 10 parts by weight, Curcuma zedoaria 10 parts by weight, Curculigo orchioides 10 parts by weight, Epimedium brevicornu 5 parts by weight, Clematis chinensis 5 parts by weight, Ephedra sinica 5 parts by weight, Mentha haplocalyx 3 parts by weight.

5. A preparation method of a traditional Chinese medicine acupoint patch, characterized in that, It includes: S1 Prepare the medicinal materials: Weigh the medicinal materials according to the following ratio: Astragalus membranaceus 10 - 30 parts by weight, Citrus medica var. sarcodactylis 10 - 15 parts by weight, Curcuma zedoaria 5 - 10 parts by weight, Curculigo orchioides 10 - 15 parts by weight, Epimedium brevicornu 5 - 10 parts by weight, Clematis chinensis 5 - 10 parts by weight, Ephedra sinica 5 - 10 parts by weight, Mentha haplocalyx 3 - 10 parts by weight; Take sodium polyacrylate, polyvinylpyrrolidone, glycohydroxyaluminum, disodium ethylenediaminetetraacetate, tartaric acid and glycerol as the raw materials of the cataplasm matrix; S2 Prepare the thick paste: After soaking and moistening the Astragalus membranaceus, Citrus medica var. sarcodactylis, Curcuma zedoaria, Curculigo orchioides, Epimedium brevicornu, Clematis chinensis, Ephedra sinica, and Mentha haplocalyx with water until thoroughly penetrated, boil and extract, collect the extract, and concentrate it under reduced pressure to obtain a thick paste; S3 Prepare the acupoint patch: Disperse the sodium polyacrylate, disodium ethylenediaminetetraacetate and glycohydroxyaluminum in the glycerol as Phase A; separately take purified water, add the polyvinylpyrrolidone and tartaric acid in sequence, fully dissolve them and then add the thick paste as Phase B; add Phase B to Phase A in small amounts and stir evenly to form a medicinal paste, quickly coat it on the backing material, and let it stand at room temperature to dry and form, thus obtaining the traditional Chinese medicine acupoint patch.

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

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