Traditional Chinese medicine granule for treating hand-foot syndrome caused by chemical drug or targeted drug treatment

Abstract

The invention discloses a traditional Chinese medicine granule for treating hand-foot syndrome caused by chemical drug or targeted drug treatment. The traditional Chinese medicine granule comprises the following raw materials by weight: 28-32 g of astragalus membranaceus, 10-15 g of angelica sinensis, 8-12 g of cassia twig, 12-17 g of caulis spatholobi, 10-15 g of tinospora sinensis merr, 12-17 g of honeysuckle, 5-7 g of radix scrophulariae and 8-12 g of fructus liquidambaris. The traditional Chinese medicine composition is scientific and reasonable in compatibility, rich in raw materials, convenient to take and stable and controllable in quality, has the effects of reinforcing qi, nourishing blood, dispersing blood stasis and clearing heat together, is a great innovation in medicines for treating hand-foot syndromes caused by treatment of chemical medicines or targeted medicines, and has remarkable economic and social benefits.

Description

Technical Field

[0001] The invention relates to the field of medicine, in particular to a traditional Chinese medicine granule for treating hand-foot syndrome caused by chemical drug or targeted drug treatment. Background Art

[0002] After cancer patients receive chemotherapy or molecular targeted therapy, about 64% of patients will experience specific skin toxicity, namely hand-foot syndrome (HFS). HFS is also known as palmo-toe sensory erythema. The main clinical manifestations are insensitivity and numbness of the palms and soles, which can progress to tingling and burning pain. Erythema and edema can be seen locally, followed by desquamation, erosion, and ulceration. It significantly reduces the quality of life and treatment compliance of patients. The exact cause and pathogenesis of HFS have not yet been determined. It is generally believed that it may be related to factors such as inflammatory response, high expression levels of drug-related metabolic enzymes in the hands and feet, mechanical pressure, and drug secretion through sweat glands that damage the skin. At present, there is no standardized treatment for hand-foot syndrome. Clinically, prevention and symptomatic treatment are the main treatments, such as local cold compresses, analgesics, or adjustment of chemotherapy regimens, but there are problems such as limited efficacy and obvious side effects. There is no relevant record of HFS in traditional Chinese medicine books, but its clinical symptoms and signs are quite similar to those of blood stasis, arthralgia, and drug toxicity rash in ancient Chinese medicine books, and most of the diseases are classified as "arthralgia, blood stasis, and poisonous sores". The cause of the disease is that the "toxic evil" of the tumor causes the patient's overall deficiency of vital energy, insufficient biochemical production of qi and blood, malnutrition of the skin, fur, and muscles, and local drug toxicity invades the meridians, causing blood stagnation and accumulation of heat. The disease is located in the hands and feet, and the nature of the disease is pathological, which is the deficiency of the root and the excess of the symptoms. The deficiency of qi and blood is the root, and blood stasis and heat are the symptoms. In recent years, traditional Chinese medicine has achieved good results in clinical practice through clinical syndrome differentiation and treatment according to the symptoms, and combined internal and external fumigation or acupuncture and moxibustion. According to traditional Chinese medicine theory, the pathogenesis of HFS is the deficiency of qi and blood as the root, and the stasis of heat as the symptoms. Chemotherapy drugs are "drug toxicity", which can easily damage the spleen and stomach, consume qi and blood, cause blood stasis, block the meridians, and turn into heat over time, forming the syndrome of deficiency of the root and excess of the symptoms. In recent years, traditional Chinese medicine has made great progress in the prevention and treatment of hand-foot syndrome. However, most of the existing Chinese medicine preparations are mainly based on single blood circulation or tonic, which makes it difficult to take into account both strengthening the body and eliminating evil, and there is a lack of special prescriptions for the pathogenesis of HFS. Although the traditional Chinese medicine Huangqi Guizhi Wuwu Decoction has the function of invigorating qi and warming the meridians, it is not strong enough to clear away heat and remove blood stasis, and cannot fully relieve the complex symptoms of HFS. Therefore, it is urgent to develop a Chinese medicine compound preparation that can both invigorate qi and nourish blood to consolidate the body, and remove blood stasis and clear heat to treat the symptoms, so as to provide a safe and effective solution for HFS patients. Summary of the invention

[0003] In view of the above situation, in order to overcome the defects of the prior art, the purpose of the present invention is to provide a Chinese medicine granule for treating hand-foot syndrome caused by chemical drugs or targeted drug treatment, which can effectively solve the problem that the existing treatment methods for hand-foot syndrome have a single efficacy and significant side effects.

[0004] To achieve the above object, the technical solution adopted by the present invention is a traditional Chinese medicine granule for treating hand-foot syndrome caused by treatment with chemical drugs or targeted drugs, which comprises the following raw materials by weight: 28-32 g of astragalus membranaceus, 10-15 g of angelica sinensis, 8-12 g of cassia twig, 12-17 g of millettia reticulata benth, 10-15 g of luffa cylindrica (l.) roem, 12-17 g of honeysuckle flower, 5-7 g of scrophularia ningpoensis hemsl and 8-12 g of clerodendrum bungei steud; wherein, the raw materials are mixed evenly and pulverized, percolated with 70% ethanol at 5 times the total weight and volume of the raw materials, concentrated under reduced pressure at 60 °C to prepare an extract with a relative density of 1.10-1.15, then the extract is dried, pulverized into fine powder, and auxiliary materials are added. The auxiliary materials are made by mixing dextrin and granulated sugar in a weight ratio of 1:1. The weight ratio of the fine powder to the auxiliary materials is 1:2. 95% ethanol is added as a wetting agent to uniformly make a soft material, and wet granules are obtained by passing through a 16-mesh sieve. The wet granules are dried at 60 °C, passed through a 14-mesh sieve and a 24-mesh sieve in sequence, and the agglomerated lumps, coarse granules and fine powder are sieved out to obtain uniformly granulated whole granules, which are then sub-packed to obtain the granule preparation.

[0005] The compatibility of the present invention is scientific and reasonable, the raw materials are abundant, the administration is convenient, the quality is stable and controllable. The whole prescription plays the role of supplementing qi and nourishing blood, removing stasis and clearing heat together, which is a major innovation in the drugs for treating hand-foot syndrome caused by treatment with chemical drugs or targeted drugs, and has significant economic and social benefits. Specific Embodiments

[0006] The following describes in detail the specific embodiments of the present invention in conjunction with the examples and specific situations.

[0007] When the present invention is specifically implemented, it is given by the following examples. Example 1

[0008] A traditional Chinese medicine granule for treating hand-foot syndrome caused by treatment with chemical drugs or targeted drugs, which comprises the following raw materials by weight: 30 g of astragalus membranaceus, 12 g of angelica sinensis, 10 g of cassia twig, 15 g of millettia reticulata benth, 12 g of luffa cylindrica (l.) roem, 15 g of honeysuckle flower, 6 g of scrophularia ningpoensis hemsl and 10 g of clerodendrum bungei steud; wherein, the raw materials are mixed evenly and pulverized, percolated with 70% ethanol at 5 times the total weight and volume of the raw materials, concentrated under reduced pressure at 60 °C to prepare an extract with a relative density of 1.10-1.15, then the extract is dried, pulverized into fine powder, and auxiliary materials are added. The auxiliary materials are made by mixing dextrin and granulated sugar in a weight ratio of 1:1. The weight ratio of the fine powder to the auxiliary materials is 1:2. 95% ethanol is added as a wetting agent to uniformly make a soft material, and wet granules are obtained by passing through a 16-mesh sieve. The wet granules are dried at 60 °C, passed through a 14-mesh sieve and a 24-mesh sieve in sequence, and the agglomerated lumps, coarse granules and fine powder are sieved out to obtain uniformly granulated whole granules, which are then sub-packed to obtain the granule preparation; the weight and volume refer to that the solid is in g and the liquid is in ml. Example 2

[0009] A traditional Chinese medicine granule for treating hand-foot syndrome caused by chemotherapy drugs or targeted drugs, comprising raw materials by weight: 28 g of Astragalus membranaceus, 10 g of Angelica sinensis, 8 g of Cinnamomum cassia, 12 g of Spatholobus suberectus, 10 g of Caulis Luffae, 12 g of Lonicera japonica, 5 g of Scrophularia ningpoensis, and 8 g of Clerodendrum fortunatum. The preparation steps are the same as those in Example 1. Example 3

[0010] A traditional Chinese medicine granule for treating hand-foot syndrome caused by chemotherapy drugs or targeted drugs, comprising raw materials by weight: 32 g of Astragalus membranaceus, 15 g of Angelica sinensis, 12 g of Cinnamomum cassia, 17 g of Spatholobus suberectus, 15 g of Caulis Luffae, 17 g of Lonicera japonica, 7 g of Scrophularia ningpoensis, and 12 g of Clerodendrum fortunatum. The preparation steps are the same as those in Example 1. Example 4

[0011] A traditional Chinese medicine granule for treating hand-foot syndrome caused by chemotherapy drugs or targeted drugs, comprising raw materials by weight: 29 g of Astragalus membranaceus, 14 g of Angelica sinensis, 9 g of Cinnamomum cassia, 16 g of Spatholobus suberectus, 12 g of Caulis Luffae, 15 g of Lonicera japonica, 5 g of Scrophularia ningpoensis, and 11 g of Clerodendrum fortunatum. The preparation steps are the same as those in Example 1. Example 5

[0012] A traditional Chinese medicine granule for treating hand-foot syndrome caused by chemotherapy drugs or targeted drugs, comprising raw materials by weight: 31 g of Astragalus membranaceus, 11 g of Angelica sinensis, 11 g of Cinnamomum cassia, 13 g of Spatholobus suberectus, 14 g of Caulis Luffae, 14 g of Lonicera japonica, 7 g of Scrophularia ningpoensis, and 9 g of Clerodendrum fortunatum. The preparation steps are the same as those in Example 1.

[0013] Among the above drugs, Astragalus membranaceus: Sweet in taste, slightly warm in nature, belonging to the spleen and lung meridians. Compendium of Materia Medica highly praises it as "the king of tonics", which can tonify the deficiency of various zang-organs, stimulate the clear yang qi of the spleen and stomach, and provide the source for the generation of qi and blood. It has the effects of boosting qi and refreshing the mind, enhancing the body surface defense, reducing sweating, eliminating edema, improving blood circulation, relieving arthralgia, expelling toxins from the body, and eliminating abscesses.

[0014] Angelica sinensis: Sweet, pungent in taste, warm in nature, belonging to the liver, heart, and spleen meridians. It is recorded in Rihua Ziben Cao that it can "treat all kinds of wind, all kinds of blood, tonify all kinds of fatigue, break up stasis, and nourish new blood". Sweet and warm in taste, it promotes blood circulation without excessive dispersion and nourishes blood while keeping it in the middle. It can regulate the delicate meridians and reverse the coldness of the limbs. It can help improve anemia and cold hands and feet, and promote blood circulation.

[0015] Cinnamomum cassia: Pungent, sweet in taste, warm. Belonging to the heart, lung, and bladder meridians. It can promote sweating, relieve muscle tension and discomfort on the body surface, warm the whole body to promote blood circulation, and improve symptoms such as cold hands and feet or menstrual pain. It can also enhance the level of yang qi in the body, help improve problems such as fear of cold and body edema, and regulate the situation of unsmooth qi and blood circulation such as palpitation, shortness of breath, nausea, and vomiting.

[0016] Caulis Spatholobi: Bitter and slightly sweet in taste, warm in nature. It mainly promotes blood circulation, nourishes blood, relaxes tendons and activates collaterals. "Newly Revised Herbal Pieces" records that it can "remove stasis, generate new blood, and smooth the meridians". It can both activate blood circulation to dredge the meridians and relieve pain, and nourish blood to relax the muscles and bones, being suitable for treating problems caused by blood stasis and cold intolerance due to blood deficiency. It is particularly effective for numbness and pain of the limbs caused by blood deficiency.

[0017] Caulis Lygodii: Cold in nature and bitter in taste, belonging to the liver, spleen and kidney meridians, with the effects of expelling wind and dampness, relaxing tendons and activating collaterals, reducing swelling and alleviating pain, etc.

[0018] Flos Lonicerae: Sweet in taste and cold in nature. Belonging to the lung and stomach meridians. It has the effects of clearing heat and detoxifying, anti-inflammatory, dispersing wind-heat, detoxifying and stopping dysentery, antibacterial, etc. It is mainly used to treat exogenous wind-heat or febrile diseases due to warm pathogens, heatstroke, dysentery due to heat-toxin, carbuncles and sores, throat obstruction, and various infectious diseases.

[0019] Radix Scrophulariae: Sweet, bitter and salty in taste, slightly cold. Belonging to the lung, stomach and kidney meridians. Through the characteristics of dispersing by bitterness, moistening by sweetness and clearing heat by coldness, Radix Scrophulariae can clear heat in blood, resolve toxins, nourish yin fluid, moisten the intestines and relieve constipation, and at the same time disperse masses. It is suitable for situations such as heat in blood causing excessive internal heat, rising of deficient fire, accumulation of toxic heat, and skin sores and boils.

[0020] Fructus Liquidambaris: Bitter in taste, flat in nature. Belonging to the liver and kidney meridians. It can not only dredge the flow of qi and blood, but also regulate body fluid metabolism, with the effects of dispelling wind-dampness, dredging meridians, eliminating edema, promoting lactation secretion and relieving skin itching. It is suitable for treating various joint pains, especially those accompanied by muscle tightness.

[0021] In the formula, Astragalus membranaceus, Angelica sinensis and Ramulus Cinnamomi are combined as the monarch drugs. When Astragalus membranaceus and Angelica sinensis are combined, one tonifies qi to generate blood, and the other nourishes blood and promotes blood circulation, jointly forming the classic formula Danggui Buxue Decoction, achieving the effect of supplementing qi and nourishing blood together. Adding Ramulus Cinnamomi can relieve the spasm of the tendons and vessels, and relieve the obstruction of the joints. Taking the monarch drug of Guizhi Huangqi Wuwu Decoction, it extends the effect of the formula in warming yang and strengthening the defense, harmonizing nutrient qi and activating collaterals. It can assist Astragalus membranaceus in warming yang and strengthening the defense, consolidating the exterior without retaining pathogens, and dispersing pathogens without harming healthy qi, increasing the power of warming and dredging. Combining with Angelica sinensis to nourish blood and harmonize blood, nourish yin and astringe nutrient qi, and regulate nutrient qi and defensive qi. Caulis Spatholobi and Caulis Lygodii are combined as the minister drugs. Working together, they can enhance the power of activating blood circulation and dredging collaterals, assisting the monarch drugs in activating blood circulation, dredging collaterals and relieving pain, nourishing blood and nourishing tendons, enabling qi and blood to flow smoothly and the meridians to be relaxed, and improving symptoms such as limb numbness and pain caused by qi and blood stagnation and meridian blockage in HFS. Flos Lonicerae and Radix Scrophulariae are used as the assistant drugs, clearing and resolving the toxic heat of the excess syndrome of hand-foot syndrome, and preventing qi and blood stagnation and meridian blockage, which may lead to heat transformation due to long-term stagnation of the meridians, and restraining the warm and dry nature of the monarch and minister drugs, so that the whole formula can achieve the effect of being warm but not dry while supplementing qi and nourishing blood, and activating blood circulation and dredging collaterals. Fructus Liquidambaris is used alone as the guiding drug. "Supplements to Compendium of Materia Medica" records that it can "circulate through the twelve meridians". Therefore, using it as the guiding drug enables all the drugs to reach the affected parts along the meridians.

[0022] As can be seen from the above, the traditional Chinese medicine granules for treating hand-foot syndrome caused by chemotherapy drugs or targeted drugs of the present invention mainly replenish qi and nourish blood, focus on promoting blood circulation and dredging collaterals, and also clear heat and cool blood. The clinical trial has shown good efficacy. Taking Example 1 as an example, the clinical data are as follows: I. Case selection: 1. Diagnostic criteria: Refer to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" issued by the State Administration of Traditional Chinese Medicine in 2002 and the "Guidelines for the Diagnosis and Treatment of Traditional Chinese Medicine for Malignant Tumors" compiled by Lin Hongsheng (People's Medical Publishing House, 2014, the first edition), and formulate the diagnostic criteria for qi and blood deficiency and mutual binding of stasis and heat syndromes regarding the diagnosis of hand-foot syndrome in the chapter on tumor complications: Main symptoms: Numbness of hands and feet, dry skin, pain.

[0023] Secondary symptoms: Fatigue; Shortness of breath and listlessness, aggravated after activity; Dry and rough skin.

[0024] Tongue manifestation: Purple and dull tongue with little coating, petechiae or ecchymoses.

[0025] Pulse condition: Thready and unsmooth pulse or deep and unsmooth pulse.

[0026] Diagnosis can be made by combining two or more of the main symptoms and secondary symptoms with tongue and pulse conditions.

[0027] 2. Case inclusion criteria: All cases meeting the following conditions can be selected as inclusion cases: ① All included cases are pathologically diagnosed with malignant tumors; ② All have received chemotherapy or targeted therapy; ③ Diagnosed with hand-foot syndrome by NCI; ④ The traditional Chinese medicine syndrome type conforms to qi and blood deficiency and mutual binding of stasis and heat type; ⑤ KPS score ≥ 60 points; ⑥ All cases have medical records; ⑦ Aged 18 - 75 years old, regardless of gender.

[0028] 3. Exclusion criteria: ① Those who do not meet the inclusion criteria; ② Those with insufficient data; ③ Those with mental illnesses; ④ Those who are participating in other drug trials; ⑤ Pregnant and lactating women; ⑥ Those with severe organ function damage (heart, brain, liver, kidney, etc.); ⑦ Those with severe gastrointestinal diseases; ⑧ Those who need to fast due to digestive tract bleeding, intestinal obstruction, etc.; ⑨ Those with hand-foot skin lesions not caused by chemotherapy drugs or drug-allergic hand-foot skin diseases.

[0029] II. Treatment plan: Take one dose daily on the basis of symptomatic supportive treatment. Take it in two divided doses, melt it with 150 - 200 ml of boiling water each time, and take it 1 hour after meals. The treatment period is 6 months, and the treatment effect is evaluated after the end of the treatment.

[0030] III. Efficacy evaluation criteria: (1) Baseline data ① Demographic characteristics: gender, age, height, weight, drinking history, family history; ② Vital signs: body temperature, heart rate, respiration, blood pressure; ③ Gastroscopy and pathological report; ④ Tongue quality, tongue coating, pulse condition.

[0031] (2) Efficacy indicators 1) Main efficacy evaluation indicator: grading score of hand - foot syndrome.

[0032] 2) Secondary evaluation indicators: ① TCM syndrome integral: including symptoms in main symptoms and secondary symptoms. Record 0 point, 2 points, 4 points, and 6 points respectively according to normal, mild, moderate, and severe. Detect it once at 0, 3, and 6 months respectively.

[0033] Calculate the efficacy index according to the Nimodipine scoring method (efficacy index (n) = (pre - treatment integral - post - treatment integral) / pre - treatment integral × 100%.): ① Marked effect: symptoms basically disappear, n≥70%; ② Effective: symptoms are relieved, 30%≤n<70%; ③ Ineffective: symptoms basically show no change, n<30%.

[0034] Total effective rate = [(marked effect + effective) / total number of cases]×100%.

[0035] (3) Safety indicators 1) Routine blood test, routine urine test, routine stool test; 2) Electrocardiogram, chest DR, liver function, kidney function; 3) Coagulation function test.

[0036] IV. Statistical analysis First, conduct a preliminary analysis of the descriptive and inferential characteristics of the baseline data. Measurement data conforming to the normal distribution are described by mean ± standard deviation (x±s) and t - test is performed. If it does not conform to the normal distribution, it is represented by the median and the rank - sum test is performed. Categorical variables are represented by frequency and constituent ratio, and the chi - square test is used for comparing the differences between groups. . After all statistical analyses of the present invention are two - sided tests, P Take α = 0.05 as the statistical standard, and take the 95% confidence interval as the confidence interval for parameter use.P <0.05 was considered to have a statistically significant difference.

[0037] V. Results According to the case selection criteria, a total of 24 patients with hand-foot syndrome caused by chemotherapy drugs or targeted drugs treated in the First Affiliated Hospital of Henan University of Chinese Medicine from May 2023 to March 2025 were included, and the statistical results of the curative effect are shown in the following table.

[0038] Table 1 Statistical results of curative effect Number of people Marked effect Effective Ineffective Total effective rate 24 6 11 7 70.83% It can be seen from the above table that there were 6 cases with marked effect, 11 cases with effective, 7 cases with ineffective, and the total effective rate was 70.83%.

[0039] No adverse reactions were found in this trial, indicating that the drug used in the present invention is safe and the curative effect is stable and reliable.

[0040] VI. Typical cases Sun XX, female, 72 years old, from Kaifeng City, Henan Province. Initial diagnosis on April 21, 2024.

[0041] Chief complaint: More than 5 months after sigmoid colon cancer surgery, accompanied by 4 cycles of chemotherapy.

[0042] Present illness history: The patient presented for medical treatment at the First Affiliated Hospital of Henan University on December 4, 2023 due to weight loss. CT examination showed: 1. Thickening of the sigmoid colon wall, suspected MT with surrounding fat infiltration and adjacent lymph node metastasis, colonoscopy was recommended for further diagnosis; 2. Solid small nodules in the anterior segment of the upper lobe of the right lung, follow-up review was recommended; 3. Calcified plaques in the aorta and coronary arteries; 4. Slight thickening of the gastric antrum wall; 5. Multiple parapelvic cysts and small renal parenchymal cysts in both kidneys; 6. Changes after uterine intrauterine device implantation. Color Doppler ultrasound examination showed anechoic in the collecting system of both kidneys (hydronephrosis of both kidneys? Cystic lesions of both kidneys? Please combine with other examinations). Pathological examination by puncture on December 6, 2023 showed: (biopsy of the rectosigmoid junction) adenocarcinoma, moderately differentiated, immunohistochemistry was recommended for guiding treatment. Supplementary report: Immunohistochemistry results of our unit: MLH1(+), MSH2(+), MSH6(+), PMS2(+), Her-2(4B5)(1+), Ki-67(70%+). Concurrent diagnosis of our unit: PD-L1(22C3)(CPS: 3). On December 12, 2023, the patient presented for medical treatment at the First Affiliated Hospital of Zhengzhou University and underwent radical resection of sigmoid colon cancer. After the operation, the patient received 4 cycles of chemotherapy with oxaliplatin + capecitabine, and then the patient has been taking "capecitabine" orally until now. Current symptoms: When taking the third cycle of capecitabine, the patient had obvious swelling of the skin color of the hands and feet, peeling and chapping, and pustules often easily appeared at the skin lesions, which were red in color. The numbness and pain were aggravated when holding objects or walking. There was also sweating, poor appetite, poor sleep, easy awakening at night, and difficulty falling asleep again after awakening. The patient slept for 1-2 hours at night, and the stools were dry, once every 2 days. The tongue was pale and dull, and the coating was yellow, greasy and less moist. The NCI-CTCAE grade of hand-foot syndrome was grade 3. The TCM syndrome score was 27 points, the pain VAS score was 6 points, and the HF-QoL score was 57 points.

[0043] After communicating with the patient and his family and signing the informed consent form, the patient began to take the traditional Chinese medicine granules prepared in Example 1 of the present invention orally. After taking the above prescription for 2 months, the skin surface of the patient was intact, and pustules were no longer seen at the skin lesions. There was mild local numbness and tingling, which did not affect normal walking and life. The NCI-CTCAE grade of hand-foot syndrome decreased from grade 3 to grade 1, the TCM syndrome score decreased from 27 points to 7 points, the pain VAS score decreased from 6 points to 3 points, and the HF-QOL score decreased from 57 points to 25 points. In addition, after the patient's pain was relieved, the diet, sleep, and sweating all improved significantly.

[0044] VII. Conclusion The traditional Chinese medicine granules (Yiqi Yangxue Tongluo Granules) for treating hand-foot syndrome caused by chemotherapy drugs or targeted drugs of the present invention are scientifically and rationally formulated, with rich raw materials and convenient administration, avoiding the cumbersome process of decocting traditional Chinese medicine, and greatly improving the medication compliance of patients. They are small in size and light in weight, convenient to carry, and extremely convenient for patients to take medicine for a long time. The quality is stable and controllable, the whole formula is properly formulated, the medication is sophisticated, and the medication is delicate. It mainly nourishes qi and blood, focuses on promoting blood circulation and dredging collaterals, and also clears heat and cools blood. The clinical efficacy is remarkable. Compared with other western medicine treatments and other common traditional Chinese medicine prescriptions, it has the characteristics of safe medication, stable and reliable efficacy, and no toxic and side effects. It is a major innovation in the drugs for treating hand-foot syndrome caused by chemotherapy drugs or targeted drugs, and has significant economic and social benefits.

[0045] It should be noted that the technical features and key of the present invention are the compatibility of traditional Chinese medicine compositions. The dosage forms given above are only partial embodiments. Any technical solutions that are essentially the same as the present invention made by using equivalent replacement means or various dosage forms suitable for taking prepared by using the traditional Chinese medicine composition of the present invention by conventional preparation methods belong to the protection scope of the present invention.

Claims

1. A traditional Chinese medicine granule for treating hand-foot syndrome caused by treatment with chemical drugs or targeted drugs, characterized in that, The raw materials include the following ingredients by weight: 28 - 32 g of Astragalus membranaceus, 10 - 15 g of Angelica sinensis, 8 - 12 g of Cinnamomum cassia, 12 - 17 g of Spatholobus suberectus, 10 - 15 g of Lycopodiella cernua, 12 - 17 g of Lonicera japonica, 5 - 7 g of Scrophularia ningpoensis, and 8 - 12 g of Liquidambar formosana; among them, the raw medicinal materials are mixed and pulverized, percolated with 70% ethanol at 5 times the total weight - volume of the raw medicinal materials, concentrated under reduced pressure at 60 °C to prepare an extract with a relative density of 1.10 - 1.15, then the extract is dried and pulverized into fine powder, and excipients are added. The excipients are made by mixing dextrin and powdered sugar in a weight ratio of 1:

1. The weight ratio of the fine powder to the excipients is 1:

2. 95% ethanol is added as a wetting agent, and a soft material is uniformly made, passed through a 16 - mesh sieve to obtain wet granules. The wet granules are dried at 60 °C, passed through a 14 - mesh sieve and a 24 - mesh sieve in sequence, and the agglomerated lumps, coarse granules, and fine powder are screened out to obtain uniformly granulated whole granules, which are then subpackaged to obtain the granule agent; the weight - volume means that the solid is in g and the liquid is in ml.

2. The traditional Chinese medicine granules for treating hand-foot syndrome caused by treatment with therapeutic chemical drugs or targeted drugs according to claim 1, wherein, The raw materials include the following ingredients by weight: 30 g of Astragalus membranaceus, 12 g of Angelica sinensis, 10 g of Cinnamomum cassia, 15 g of Spatholobus suberectus, 12 g of Lycopodiella cernua, 15 g of Lonicera japonica, 6 g of Scrophularia ningpoensis, and 10 g of Liquidambar formosana.

3. The traditional Chinese medicine granules for treating hand-foot syndrome caused by treatment with therapeutic chemical drugs or targeted drugs according to claim 1, characterized in that, The raw materials include the following ingredients by weight: 28 g of Astragalus membranaceus, 10 g of Angelica sinensis, 8 g of Cinnamomum cassia, 12 g of Spatholobus suberectus, 10 g of Lycopodiella cernua, 12 g of Lonicera japonica, 5 g of Scrophularia ningpoensis, and 8 g of Liquidambar formosana.

4. The traditional Chinese medicine granules for treating hand-foot syndrome caused by treatment with therapeutic chemical drugs or targeted drugs according to claim 1, wherein The raw materials include the following ingredients by weight: 32 g of Astragalus membranaceus, 15 g of Angelica sinensis, 12 g of Cinnamomum cassia, 17 g of Spatholobus suberectus, 15 g of Lycopodiella cernua, 17 g of Lonicera japonica, 7 g of Scrophularia ningpoensis, and 12 g of Liquidambar formosana.

5. The traditional Chinese medicine granules for treating hand-foot syndrome caused by treatment with therapeutic chemical drugs or targeted drugs according to claim 1, characterized in that, The raw materials include the following ingredients by weight: 29 g of Astragalus membranaceus, 14 g of Angelica sinensis, 9 g of Cinnamomum cassia, 16 g of Spatholobus suberectus, 12 g of Lycopodiella cernua, 15 g of Lonicera japonica, 5 g of Scrophularia ningpoensis, and 11 g of Liquidambar formosana.

6. The traditional Chinese medicine granules for treating hand-foot syndrome caused by treatment with therapeutic chemical drugs or targeted drugs according to claim 1, wherein, The raw materials include the following ingredients by weight: 31 g of Astragalus membranaceus, 11 g of Angelica sinensis, 11 g of Cinnamomum cassia, 13 g of Spatholobus suberectus, 14 g of Lycopodiella cernua, 14 g of Lonicera japonica, 7 g of Scrophularia ningpoensis, and 9 g of Liquidambar formosana.