A traditional Chinese medicine composition, a preparation method and application thereof

Abstract

The application relates to a traditional Chinese medicine composition and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicines. The application provides a traditional Chinese medicine composition which comprises the following components in parts by weight: atractylodes 18-30 parts, luffa retinervus 12-20 parts, black tiger 12-20 parts, incarvillea 12-20 parts, caesalpinia 12-20 parts, astragalus 12-20 parts and silkworm excrement 6-10 parts. The traditional Chinese medicine composition is prepared by matching atractylodes, luffa retinervus, black tiger, incarvillea, caesalpinia, astragalus and silkworm excrement, the efficacy of eliminating phlegm and dampness, removing stasis and toxin, dredging blood vessels, nourishing blood, relieving pain and stopping numbness is strengthened, and the excessive pungent, warm and dry heat of the whole prescription is prevented. The traditional Chinese medicine composition is suitable for relieving numbness, pain and fatigue of tumor patients in the whole process of chemotherapy, targeted therapy and immunotherapy.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition and a preparation method and application thereof. BACKGROUND

[0002] At present, there are various anti-tumor drugs in clinical application, including cytotoxic drugs, biological response modifiers, monoclonal antibody drugs, etc. Chemotherapy-induced peripheral neuropathy (CIPN) is a new disease that appears with the development of clinical treatment of tumors, and is also one of the difficult problems to be solved in the development of traditional Chinese medicine oncology. Peripheral neuropathy caused by anti-tumor drugs is mainly manifested as symmetrical sensory, motor and autonomic nervous dysfunction in the distal extremities, which can be accompanied by pain and affect functional activities, causing the decline of the quality of life of patients, and can lead to the forced interruption of drug dose reduction or treatment, which potentially affects the treatment benefit of patients, and has a high incidence and currently lacks clear and effective prevention and treatment methods.

[0003] According to the symptoms of numbness, pain and paresthesia at the end of the limbs, most doctors believe that CIPN belongs to the category of "numbness", "blood stasis", "limb paralysis" and "collateral disease" in traditional Chinese medicine. Patients widely receive traditional Chinese medicine intervention in clinic and have achieved certain curative effects.

[0004] At present, the treatment of CIPN by traditional Chinese medicine is mostly based on deficiency of qi and blood, cold coagulation of meridians and / or blood stasis and obstruction of collaterals, and the prescriptions mostly choose Huangqi Guizhi Wuwu Decoction or Danggui Sini Decoction for treatment, but the clinical curative effects are uneven. Moreover, the prescriptions of Huangqi Guizhi Wuwu Decoction and Danggui Sini Decoction are warm and dry, which can easily cause upper fire and are not suitable for long-term use; however, tumor patients often need multiple chemotherapy, and the symptoms of numbness and pain in hands and feet are more obvious in the later period of treatment, so it is necessary to find a traditional Chinese medicine prescription with neutral drug properties and convenient for long-term conditioning.

[0005] It is found in clinical observation and summary that after experiencing multiple radiotherapy and chemotherapy, the body of tumor patients is already deficient in vital energy, and deficiency of qi cannot generate blood, and deficiency of spleen qi cannot perform transportation and transformation, and phlegm-dampness is generated, and phlegm-dampness and blood stasis are combined with the toxicity of chemotherapy to cause numbness and pain in hands and feet, fatigue and dark complexion, etc.; the body cannot tolerate the traditional Chinese medicine with warm and dry properties, so the present application takes the main treatment method of eliminating dampness, removing evil and dredging collaterals, and phlegm-dampness, blood stasis and toxicity are eliminated, the qi movement is smooth, the blood is generated and transformed, the muscles and vessels are nourished by blood, and numbness and pain are eliminated. SUMMARY

[0006] The present application aims to overcome the deficiencies of the prior art and provide a traditional Chinese medicine composition and a preparation method and application thereof, which has the advantages of treating the symptoms and the root cause, remarkable and long-lasting curative effect, small side effects, low recurrence rate and no drug dependence.

[0007] To achieve the above object, the technical scheme adopted by the present application is:

[0008] In a first aspect, the present application provides a traditional Chinese medicine composition, which comprises the following components by weight: 18-30 parts of atractylodes, 12-20 parts of loofah sponge, 12-20 parts of black tiger, 12-20 parts of siegesbeckia, 12-20 parts of caesalpinia, 12-20 parts of astragalus, and 6-10 parts of silkworm excrement.

[0009] Atractylodes: bitter and pungent in taste, warm in nature. It has the effects of drying dampness, invigorating the spleen, eliminating phlegm and removing evil. It is used for symptoms such as dampness blocking the middle energizer, abdominal fullness and distension, diarrhea, and rheumatism.

[0010] Silkworm excrement: sweet and pungent in taste, warm in nature. It has the effects of dispelling wind and dampness, harmonizing the stomach and resolving turbidity, promoting blood circulation and unblocking the channels. It is used for symptoms such as rheumatism, pain in the waist and knees, and hemiplegia.

[0011] Siegesbeckia: bitter and pungent in taste, cold in nature. It has the effects of dispelling wind and dampness, benefiting the joints, and detoxifying. It is used for symptoms such as weakness of muscles and bones, soreness of the waist and knees, and paralysis of the limbs.

[0012] Loofah sponge: sweet in taste, neutral in nature. It has the effects of promoting blood circulation, unblocking the channels, and dispelling wind. It is used for symptoms such as rheumatism, muscle and tendon spasm, and numbness of the limbs.

[0013] Black tiger (Kadsura coccinea (Lem.) A.C.Smith): pungent and slightly bitter in taste, warm in nature. It has the effects of promoting qi circulation, relieving pain, removing blood stasis and unblocking the channels. It is used for symptoms such as rheumatism, soreness of the waist and knees, and injuries from falls and blows.

[0014] Caesalpinia: sweet and bitter in taste, warm in nature. It has the effects of tonifying blood, promoting blood circulation, and unblocking the channels. It is used for symptoms such as blood deficiency, numbness and paralysis, and rheumatism.

[0015] Astragalus: sweet in taste, slightly warm in nature. It has the effects of raising yang and resolving depression, reinforcing the defensive aspect and consolidating the exterior, tonifying blood and promoting blood circulation. It is used for symptoms such as qi and blood deficiency, hemiplegia, and numbness and pain.

[0016] The present application combines atractylodes, loofah sponge, black tiger, siegesbeckia, caesalpinia, astragalus and silkworm excrement into a traditional Chinese medicine composition, which not only strengthens the effects of dispelling phlegm and dampness, resolving blood stasis, promoting blood circulation, tonifying qi and blood, and relieving pain, but also prevents the excessive heat of the whole prescription. It is suitable for patients with tumors who have symptoms such as numbness, pain and fatigue during the whole process of chemotherapy, targeted therapy and immunotherapy.

[0017] The traditional Chinese medicine composition proposed in this application is based on the method of dispelling dampness, detoxifying, and unblocking the meridians. It was developed through years of clinical experience and scientific formulation. The formula uses Atractylodes lancea as the main ingredient, which has the effects of dispelling phlegm, expelling dampness, and eliminating pathogenic factors. It is good at expelling wind and dampness from the muscles, bones, and meridians to relieve pain. Silkworm excrement is sweet, pungent, and warm in nature. It can disperse and unblock, dispel wind and dampness, relax muscles and tendons to relieve pain, and assist the principal ingredient in dispelling dampness, unblocking the meridians, relieving numbness, and relieving pain. Siegesbeckia orientalis is pungent, dispersing, and cold in nature. It can dispel wind and dampness between muscles and bones, and can also unblock the meridians and joints. It also has the effect of strengthening muscles and bones. Luffa cylindrica is sweet and neutral in nature. It is good at dispelling wind and dampness, and can also promote blood circulation and relieve pain. Black tiger thorn is pungent and warm in nature. It has the effects of promoting qi, relieving pain, dispersing blood stasis, and unblocking the meridians. These four ingredients are used as assistant ingredients. They are both cold and warm, and help the principal ingredient to dispel dampness and eliminate pathogenic factors to eliminate the cause of the disease and unblock the meridians to relieve pain. Chicken blood vine (Spatholobus suberectus) is bitter, purgative, warm, and sweet, nourishing without being drying or pungent. Its mild nature makes it effective in removing blood stasis, promoting new blood circulation, and relieving pain. Astragalus membranaceus (Huangqi) is sweet and slightly warm, with the effects of nourishing and activating blood circulation. Together, they act as adjuvant herbs, removing blood stasis, promoting new blood circulation, relieving numbness, and alleviating pain. The entire formula, using both warming and cooling herbs, emphasizes both tonifying deficiency and relieving numbness, while simultaneously resolving blood stasis and eliminating dampness. This approach strengthens the body's resistance and eliminates pathogenic factors, resolving phlegm, dampness, and blood stasis, promoting the smooth flow of Qi and blood, nourishing the tendons and vessels, and eliminating numbness and pain.

[0018] As a preferred embodiment of the traditional Chinese medicine composition described in this application, the traditional Chinese medicine composition comprises the following components in parts by weight: 24 parts of Atractylodes lancea, 16 parts of Luffa cylindrica, 16 parts of Smilax china, 16 parts of Siegesbeckia orientalis, 16 parts of Spatholobus suberectus, 16 parts of Astragalus membranaceus, and 8 parts of Bombyx mori excrement.

[0019] Secondly, this application provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps:

[0020] (1) Soak Atractylodes lancea, Luffa sponge, Black Tiger, Siegesbeckia orientalis, Spatholobus suberectus, Astragalus membranaceus and silkworm excrement in water for 15-20 minutes to obtain the soaking solution;

[0021] (2) Add water to the soaking solution obtained in step (1), boil it over high heat until boiling, then simmer over low heat for 15-25 minutes, and filter to obtain the medicinal liquid and dregs.

[0022] (3) Add water to the dregs obtained in step (2), boil over high heat until boiling, then simmer over low heat for 10-15 minutes, and filter to obtain the liquid and dregs.

[0023] (4) Combine the medicinal liquids obtained in steps (2) and (3) to obtain a traditional Chinese medicine composition.

[0024] As a preferred embodiment of the preparation method described in this application, it includes at least one of the following (Ⅰ) to (Ⅲ):

[0025] (I) In step (1), the soaking time is 15 min;

[0026] (II) in step (2), the simmering time is 20 min;

[0027] (III) in step (3), the simmering time is 15 min.

[0028] As a preferred embodiment of the preparation method of the present application, at least one of the following (IV)-(VI) is included:

[0029] (IV) in step (1), the mass ratio of the traditional Chinese medicine composition to water is traditional Chinese medicine composition: water = 84: (450-500);

[0030] (V) in step (2), the amount of water is 1 / 3-1 / 4 times of the amount of water in step (1);

[0031] (VI) in step (3), the amount of water is 1 / 3-1 / 4 times of the amount of water in step (1).

[0032] In a third aspect, the present application provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicine for treating hand-foot pain.

[0033] As a preferred embodiment of the use of the present application, the medicine for treating hand-foot pain is a medicine for treating hand-foot pain caused by an anti-tumor drug.

[0034] As a preferred embodiment of the use of the present application, the dosage form of the medicine for treating hand-foot pain is at least one of a tablet, a powder, a capsule, a pill, a granule, a liquid, a granule, a drop pill, a micro-pill, an intramuscular injection, a drop infusion, and a plaster.

[0035] As a preferred embodiment of the use of the present application, the use of the medicine for treating hand-foot pain is oral and / or external.

[0036] Compared with the prior art, the present application has the following beneficial effects:

[0037] (1) The traditional Chinese medicine composition described in this application is based on the method of removing dampness, detoxifying and unblocking the meridians. It was derived through scientific formulation based on many years of clinical experience. The main ingredient is Atractylodes lancea, which has the effects of removing phlegm, expelling dampness and eliminating pathogens. It is good at expelling wind and dampness from the muscles, bones and meridians to relieve pain. Silkworm excrement is sweet, pungent and warm in nature. It can disperse and unblock, dispel wind and dampness, relax muscles and tendons and relieve pain. It assists the principal ingredient in removing dampness, unblocking the meridians and relieving numbness and pain. Siegesbeckia orientalis is pungent and cold in nature. It can remove wind and dampness between muscles and bones, and can also unblock the meridians and joints. It also has the effect of strengthening muscles and bones. Luffa sponge is sweet and neutral in nature. It is good at dispelling wind and dampness and can also promote blood circulation and relieve pain. Black tiger is pungent and warm in nature. It has the effects of promoting qi and relieving pain, dispersing blood stasis and unblocking the meridians. These four ingredients are the assistant ingredients. They are both cold and warm. They help the principal ingredient to remove dampness and eliminate pathogens to eliminate the cause of the disease and unblock the meridians to relieve pain. Chicken blood vine (Spatholobus suberectus) is bitter and warm, sweet and nourishing, bitter but not drying, warm but not pungent, with a mild nature, and excels at removing blood stasis, promoting new blood circulation, and relieving pain. Astragalus membranaceus (Huangqi) is sweet and slightly warm, with the effects of nourishing and activating blood circulation. Together, they act as adjuvant herbs, removing blood stasis, promoting new blood circulation, relieving numbness, and alleviating pain. The entire formula, using both warming and cooling herbs, emphasizes both tonifying deficiency and relieving numbness, while simultaneously resolving blood stasis and eliminating dampness. This approach strengthens the body's resistance and eliminates pathogenic factors, allowing phlegm, dampness, and blood stasis to be resolved, the flow of Qi to be smooth, the generation and circulation of blood to be facilitated, and the tendons and vessels to be nourished by Qi and blood, thus relieving numbness and pain.

[0038] (2) The formulation of the traditional Chinese medicine composition in this application not only enhances the effects of the principal, assistant, and adjuvant drugs in eliminating phlegm and dampness, resolving blood stasis and toxins, clearing blood vessels, nourishing qi and blood, and relieving pain, but also prevents the overall formula from being too pungent, warm, dry, and hot. It is suitable for cancer patients experiencing symptoms such as numbness, pain, and weakness in the limbs during chemotherapy, targeted therapy, and immunotherapy. Detailed Implementation

[0039] To better illustrate the purpose, technical solution, and advantages of this application, the following will provide further explanation of this application in conjunction with specific embodiments.

[0040] Unless otherwise specified, all other materials and reagents used in the examples, comparative examples, and experimental cases are commercially available.

[0041] Example 1

[0042] This embodiment provides a traditional Chinese medicine composition comprising the following components in parts by weight: 18 parts of Atractylodes lancea, 12 parts of Luffa cylindrica, 12 parts of Smilax china, 12 parts of Siegesbeckia orientalis, 12 parts of Spatholobus suberectus, 12 parts of Astragalus membranaceus, and 6 parts of Bombyx mori excrement.

[0043] The preparation method of the traditional Chinese medicine composition includes the following steps:

[0044] (1) Soak Atractylodes lancea, Luffa sponge, Black Tiger, Siegesbeckia orientalis, Spatholobus suberectus, Astragalus membranaceus and silkworm excrement in 450mL of water for 15min to obtain the soaking solution;

[0045] (2) Add 150 mL of water to the soaking solution obtained in step (1), and use strong fire to boil until boiling, and then use gentle fire to boil for 20 min, and filter to obtain a medicinal liquid and a residue;

[0046] (3) Add 120 mL of water to the residue obtained in step (2), and use strong fire to boil until boiling, and then use gentle fire to boil for 15 min, and filter to obtain a medicinal liquid and a residue;

[0047] (4) Combine the medicinal liquids obtained in steps (2) and (3) to obtain a traditional Chinese medicine composition.

[0048] Example 2

[0049] The present example provides a traditional Chinese medicine composition comprising the following components in parts by weight: 30 parts of atractylodes, 20 parts of silk gourd, 20 parts of black tiger, 20 parts of incised bupleurum, 20 parts of kudzuvine vine, 20 parts of milk vetch, and 10 parts of silkworm excrement, and the preparation method of the traditional Chinese medicine composition is the same as that of Example 1.

[0050] Example 3

[0051] The present example provides a traditional Chinese medicine composition comprising the following components in parts by weight: 24 parts of atractylodes, 16 parts of silk gourd, 16 parts of black tiger, 16 parts of incised bupleurum, 16 parts of kudzuvine vine, 16 parts of milk vetch, and 8 parts of silkworm excrement, and the preparation method of the traditional Chinese medicine composition is the same as that of Example 1.

[0052] Comparative Example 1

[0053] The present comparative example provides a traditional Chinese medicine composition comprising the following components in parts by weight: 20 grams of milk vetch, 20 grams of silk gourd, 20 grams of kudzuvine vine, 10 grams of cassia twig, 10 grams of white peony root, 3 pieces of Chinese date, and 5 grams of prepared licorice, and the preparation method of the traditional Chinese medicine composition is the same as that of Example 1.

[0054] Comparative Example 2

[0055] The present comparative example provides a traditional Chinese medicine composition comprising the following components in parts by weight: 10 parts of atractylodes, 6 parts of silk gourd, 6 parts of black tiger, 6 parts of incised bupleurum, 6 parts of kudzuvine vine, 6 parts of milk vetch, and 2 parts of silkworm excrement, and the preparation method of the traditional Chinese medicine composition is the same as that of Example 1.

[0056] Comparative Example 3

[0057] The present comparative example discloses a traditional Chinese medicine composition comprising the following components in parts by weight: 45 parts of atractylodes, 25 parts of silk gourd, 25 parts of black tiger, 25 parts of incised bupleurum, 25 parts of kudzuvine vine, 25 parts of milk vetch, and 20 parts of silkworm excrement, and the preparation method of the traditional Chinese medicine composition is the same as that of Example 1.

[0058] Example 1

[0059] In order to verify the effect of the traditional Chinese medicine composition in treating the hand-foot pain caused by antitumor drugs, the traditional Chinese medicine composition of Example 3 and Comparative Example 1 was subjected to clinical test, and the specific scheme was as follows.

[0060] 1. Experimental grouping: Two groups were set in the experiment, i.e. a treatment group and a control group. The patients in the treatment group were administered the traditional Chinese medicine composition of Example 3, and the patients in the control group were administered the traditional Chinese medicine composition of Comparative Example 1. There were 25 patients in each group. The patients in both groups were administered the corresponding traditional Chinese medicine composition orally and externally. The obtained traditional Chinese medicine composition was administered orally at 1 dose per day, 2 times per day, and 14 days constituted a course of treatment. The obtained residue was decocted to wash and soak the hands and feet. The soaking liquid was kept at a water temperature of about 40℃, and the soaking depth was 5 cm above the wrist and ankle joint. The soaking was performed once a night, and each time lasted for 20 minutes. 14 days constituted a course of treatment. The above administration was continuously performed for 4 courses. During the administration of the soaking liquid, the patients should avoid eating spicy, greasy, fried and pickled foods.

[0061] 2. Patient inclusion criteria: The patients were breast cancer patients who experienced hand-foot pain after oral administration of capecitabine for chemotherapy, and the chemotherapy-induced peripheral neuropathy (CIPN) was classified as grade 1-3 (see Table 1). The tongue pulse was basically in accordance with the following conditions: pale and dark tongue, white and greasy fur, and fine and slippery or rough pulse.

[0062] Table 1: CIPN classification evaluation table

[0063]

[0064] 3. Efficacy evaluation

[0065] Observation of the scores of limb numbness and limb tingling:

[0066] ① Marked effect: the limb numbness and limb tingling were obviously improved or even disappeared;

[0067] ② Effectiveness: the limb numbness and limb tingling were mostly improved;

[0068] ③ Ineffectiveness: the limb numbness and limb tingling were not improved or the improvement was very small.

[0069] Table 2: Pain symptom score

[0070]

[0071] 4. Treatment results

[0072] As shown in Table 3, by comparing the total effective rates of the patients in the two groups, it can be found that the total effective rate of the treatment group was significantly higher than that of the control group, and the effective rate of the treatment group was as high as 76%.

[0073] The counter example 1 is a commonly used prescription for treating hand-foot numbness after chemotherapy in traditional Chinese medicine, "Huangqi Guizhi Wuwu Decoction". It was found that the effect of this prescription on patients with qi and blood deficiency, phlegm and blood stasis and toxin blockage was not ideal in clinical use. After a large number of clinical practices, and in view of the characteristics that tumor patients cannot tolerate warm and dry drugs during chemotherapy and target immunotherapy, based on the pathogenesis of qi and blood deficiency, phlegm and blood stasis and toxin blockage, atractylodes, silkworm sand, black tiger and hawksbeard were added to the prescription, which were cold and warm drugs, and were combined with huangqi, jixueteng and siluoluo, which were qi and blood, blood circulation and pain relieving drugs. The prescription can not only strengthen the effects of removing phlegm and dampness, removing blood stasis and toxin, dredging blood vessels, nourishing qi and blood and relieving pain, but also prevent the overuse of warm and dry drugs. It can treat both the symptoms and the root cause of the disease, and the efficacy of the whole prescription has been greatly improved.

[0074] Table 3 treatment result statistics

[0075]

[0076] Example 2

[0077] The traditional Chinese medicine composition of example 3 was administered to a cervical cancer patient with hand-foot pain, and the specific scheme was as follows:

[0078] 1. Patient Li, female, born in 1967, visited a doctor in early April 2023 because of "vaginal bleeding for 4 months after menopause", gynecological ultrasound: abnormal cervix, possible cervical cancer invasion of the upper vagina. Pelvic MR: right posterior uterine cervical mass, consistent with cervical cancer, involving the posterior fornix of the vagina. Cervical biopsy pathology + immunohistochemistry results: moderately to poorly differentiated squamous cell carcinoma of the cervix.

[0079] On May 7, 2023, May 28, 2023, 2 courses of paclitaxel (albumin-bound) 460 mg + cisplatin 130 mg were administered intravenously, and on June 20, 2023, "laparoscopic hysterectomy + bilateral adnexectomy + pelvic lymph node dissection" was performed under general anesthesia, and postoperative pathology: the lesion was consistent with (uterine) squamous cell carcinoma after treatment, the cancer tissue was mainly scattered in the vaginal vault, the invasion depth was about 0.3 cm, and no cancer was found in the pelvic lymph nodes and left and right adnexa. On June 27, 2023, July 18, 2023, August 8, 2023, and August 28, 2023, 4 courses of paclitaxel albumin + cisplatin chemotherapy were administered.

[0080] Excluding radiotherapy contraindications, starting on September 21, 2023, 25 times of pelvic radiotherapy were performed, and the radiotherapy range was: CTV1: upper vaginal segment, vaginal side, postoperative tumor bed area, internal iliac, external iliac, common iliac, obturator, presacral lymphatic drainage area, and the radiotherapy dose was: CTV1: 45Gy / 25 times, VMAT, 9 fields. On October 8, 2023, and October 31, 2023, concurrent cisplatin chemotherapy was performed. After radiotherapy and chemotherapy, the patient felt tired and weak, numbness in the limbs, no desire to eat and drink, sweating when moving, loose stools, pale tongue, white and greasy fur, and thin pulse. CIPN classification: grade 2, and the pain symptom score: moderate.

[0081] Western medicine diagnosis: comprehensive treatment after cervical malignant tumor.

[0082] TCM diagnosis: deficiency of qi and blood, phlegm and blood stasis and toxin blockage.

[0083] Treatment plan: After taking the traditional Chinese medicine preparation of Example 3 for one course (14 days) of oral administration and external use of soaking hands and feet, the tiredness and weakness, and sweating when moving were significantly improved, and the numbness in the upper limbs was significantly relieved, but the numbness in the lower limbs was still felt. After taking another course, the numbness in the lower limbs was significantly reduced, and the spirit, appetite, and stool were normal. The treatment results show that the traditional Chinese medicine composition of the present application can treat the hand-foot pain caused by antitumor drugs.

[0084] Finally, it should be explained that the above examples are only used to illustrate the technical solutions of the present application and not to limit the protection scope of the present application. Although the present application has been described in detail with reference to the preferred embodiments, those skilled in the art should understand that the technical solutions of the present application can be modified or replaced equivalently without departing from the essence and scope of the technical solutions of the present application.

Claims

1. A traditional Chinese medicine composition for treating hand-foot pain, characterized in that, The traditional Chinese medicine composition is made of the following raw medicinal materials by weight: 18-30 parts of atractylodes, 12-20 parts of loofah sponge, 12-20 parts of black tiger, 12-20 parts of incisedleaf sage, 12-20 parts of caesalpinia, 12-20 parts of milkvetch and 6-10 parts of silkworm excrement.

2. The traditional Chinese medicine composition of claim 1, wherein, The traditional Chinese medicine composition is made of the following raw medicinal materials by weight: 24 parts of atractylodes, 16 parts of loofah sponge, 16 parts of black tiger, 16 parts of incisedleaf sage, 16 parts of caesalpinia, 16 parts of milkvetch and 8 parts of silkworm excrement.

3. The preparation method of the traditional Chinese medicine composition according to claim 1 or 2, characterized in that, The method comprises the following steps: (1) soaking atractylodes, loofah sponge, black tiger, incisedleaf sage, caesalpinia, milkvetch and silkworm excrement in water for 15-20 min to obtain a soaking liquid; (2) adding water to the soaking liquid obtained in step (1) and using strong fire to decoct until boiling, then using gentle fire to decoct for 15-25 min after boiling, and filtering to obtain a medicinal liquid and a medicinal residue; (3) adding water to the medicinal residue obtained in step (2) and using strong fire to decoct until boiling, then using gentle fire to decoct for 10-15 min after boiling, and filtering to obtain a medicinal liquid and a medicinal residue; (4) combining the medicinal liquids obtained in steps (2) and (3) to obtain a traditional Chinese medicine composition.

4. The production method according to claim 3, wherein At least one of the following (I)-(III) is included: (I) in step (1), the soaking time is 15 min; (II) in step (2), the gentle fire decocting time is 20 min; (III) in step (3), the gentle fire decocting time is 15 min.

5. The production method according to claim 3, wherein At least one of the following (IV)-(VI) is included: (IV) in step (1), the mass ratio of the traditional Chinese medicine composition to water is traditional Chinese medicine composition: water = 84: (450-500); (V) in step (2), the amount of water used is 1 / 3-1 / 4 times the amount of water used in step (1); (VI) in step (3), the amount of water used is 1 / 3-1 / 4 times the amount of water used in step (1).

6. Use of the traditional Chinese medicine composition of claim 1 or 2 in the preparation of a medicine for treating hand-foot pain.

7. Use according to claim 6, wherein the compound is ###0002### The medicine for treating hand-foot pain is a medicine for treating hand-foot pain caused by an anti-tumor drug.

8. The use according to claim 6, wherein the compound is ###0002### The dosage form of the medicine for treating hand-foot pain is at least one of a tablet, a powder, a capsule, a pill, a granule, an oral liquid, an intramuscular injection, a drip infusion and a plaster.

9. The use according to claim 6, wherein the compound is ###0003### The usage of the medicine for treating hand-foot pain is oral and / or external.

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