Traditional Chinese medicine composition with effects of stopping vomiting and promoting blood circulation as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention belongs to the field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition with vomiting stopping and blood rising effects and a preparation method and application thereof. The traditional Chinese medicine composition is prepared from the following sixteen traditional Chinese medicines as raw materials: pinellia ternate, fingered citron, bamboo shavings, pericarpium citri reticulatae, mulberry, fried malt, endothelium corneum gigeriae galli, astragalus membranaceus, bighead atractylodes rhizome, citron, medlar, dogwood, poria cocos, lignum dalbergiae odoriferae, rhizoma polygonati and rhizoma zingiberis, and a formula system is constructed by taking the core compatibility target of calming adverse-rising energy and arresting vomiting, reinforcing qi and nourishing blood, tonifying spleen and kidney, and regulating qi and harmonizing stomach and following the compatibility theory of monarch, minister, assistant and guide in the traditional Chinese medicine. The traditional Chinese medicine composition has double effects of stopping vomiting and raising blood, is suitable for adverse reactions caused by various tumor treatment modes, can effectively improve the treatment tolerance and life quality of tumor patients, and has important clinical application value in the field of tumor adjuvant therapy.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine, specifically relating to a traditional Chinese medicine composition with antiemetic and hemostatic effects, its preparation method, and its application. Background Technology

[0002] With the global incidence of malignant tumors rising year by year, targeted therapy and chemotherapy have become one of the core methods for the clinical treatment of malignant tumors. They are widely used in the treatment of various malignant tumors such as lung cancer, breast cancer, colorectal cancer, and gastric cancer, significantly prolonging the survival of cancer patients. However, while targeted therapy and chemotherapy inhibit or kill tumor cells, they also cause non-specific damage to normal tissue cells, triggering a series of serious adverse reactions. Among these, vomiting and cytopenia are the most common and key side effects that affect patients' treatment tolerance and quality of life.

[0003] Even with existing Western medicine antiemetic regimens (such as combined use of 5-HT3 receptor antagonists, neurokinin 1 receptor antagonists, and glucocorticoids), some patients (especially those with delayed vomiting) still cannot effectively control their vomiting symptoms. Furthermore, these antiemetic regimens are often accompanied by adverse reactions such as headache, constipation, abdominal distension, and drowsiness, further increasing the burden on the patient's body. Currently, commonly used methods to improve hematopoietic function include the use of biological agents such as granulocyte colony-stimulating factor (G-CSF) and erythropoietin (EPO), or oral iron supplements and vitamin B12. However, these methods have certain limitations: biological agents may cause side effects such as bone pain, fever, and allergies, and the treatment cost is high; nutritional supplements have a slow onset of action and limited effectiveness in improving moderate to severe cytopenia, making it difficult to meet the clinical need for rapid restoration of hematopoietic function and ensuring continuity of treatment.

[0004] Traditional Chinese medicine has unique advantages in the field of adjuvant cancer treatment. Based on the "holistic view" and "syndrome differentiation and treatment", it has accumulated rich experience in alleviating the adverse reactions of radiotherapy and chemotherapy by regulating the functions of the body's internal organs and balancing qi, blood, yin and yang.

[0005] Existing traditional Chinese medicine (TCM) compositions for relieving vomiting or increasing blood volume mostly focus on a single effect (such as targeting only vomiting or only reducing blood cell count), lacking targeted formulas that simultaneously address the dual needs of "stopping vomiting" and "increasing blood volume." Furthermore, some formulas suffer from complex medicinal composition, non-standardized preparation processes, and insufficient efficacy stability, hindering their widespread clinical application. In addition, research on TCM for treating adverse reactions related to targeted therapy is relatively lagging, and the adaptability and effectiveness of existing formulas for vomiting and reducing blood cell count induced by targeted therapy need improvement.

[0006] Therefore, developing a traditional Chinese medicine composition with a reasonable formula, stable preparation process, effective relief of vomiting symptoms related to targeted therapy and chemotherapy, and improvement of erythrocyte and leukopenia, while also having high safety, is of great clinical significance for improving the treatment tolerance of cancer patients, ensuring the smooth progress of treatment, and improving the quality of life of patients. It is also a technical problem that urgently needs to be solved in the field of adjuvant cancer therapy. Summary of the Invention

[0007] To overcome the shortcomings of existing technologies, the primary objective of this invention is to provide a traditional Chinese medicine composition with dual effects of relieving vomiting and increasing blood volume. This composition addresses vomiting and the reduction of red blood cells and white blood cells caused by tumor radiotherapy, targeted therapy, chemotherapy, and immunotherapy, taking into account both the needs of "relieving vomiting" and "increasing blood volume." It also has good adaptability to adverse reactions related to targeted therapy. The formula follows the principles of "holistic concept" and "treatment based on syndrome differentiation" in traditional Chinese medicine, with rigorous formulation and high safety.

[0008] The traditional Chinese medicine composition disclosed in this invention, which has the effects of stopping vomiting and increasing blood circulation, is made from sixteen kinds of traditional Chinese medicines: Pinellia ternata, Citrus medica, Bambusa textilis, Citrus reticulata peel, Morus alba, roasted malt, chicken gizzard lining, Astragalus membranaceus, Atractylodes macrocephala, Citrus medica, Lycium barbarum, Cornus officinalis, Poria cocos, Dalbergia odorifera, Polygonatum sibiricum, and dried ginger.

[0009] The proportions of each ingredient by weight are as follows: Pinellia ternata 3-10 parts, Citrus medica 3-10 parts, Bambusa textilis 3-10 parts, Citrus reticulata peel 5-12 parts, Morus alba 10-20 parts, roasted malt 5-15 parts, chicken gizzard lining 5-12 parts, Astragalus membranaceus 15-25 parts, Atractylodes macrocephala 3-10 parts, Citronella foenum-graecum 3-10 parts, Lycium barbarum 8-16 parts, Cornus officinalis 8-16 parts, Poria cocos 5-12 parts, Dalbergia odorifera 3-10 parts, Polygonatum sibiricum 10-20 parts, and dried ginger 1-5 parts.

[0010] This invention relates to a traditional Chinese medicine composition targeting the pathogenesis of "spleen and stomach disharmony, qi and blood deficiency, and liver and kidney insufficiency" after radiotherapy and chemotherapy for tumors. Its core principles are "relieving nausea and vomiting, and nourishing qi and blood," with a rigorous combination of principal, assistant, and adjuvant herbs. The principal herbs are Astragalus membranaceus and Pinellia ternata: Astragalus membranaceus is sweet and warm, tonifying the spleen and stomach qi, generating blood and strengthening the body's resistance, treating qi and blood deficiency leading to decreased blood cell count; Pinellia ternata is pungent and warm, relieving nausea and vomiting, treating stomach disharmony leading to vomiting. Both herbs address both the root cause and the symptoms, determining the overall efficacy of the formula. The assistant herbs are divided into two categories: Citrus reticulata peel, Atractylodes macrocephala, and Poria cocos strengthen the spleen and stomach, assist Astragalus membranaceus in generating blood, and alleviate vomiting; Morus alba, Lycium barbarum, Cornus officinalis, and Polygonatum sibiricum nourish the liver and kidneys, replenish essence and blood, providing the source for hematopoiesis, and assisting the principal herbs in enhancing the blood-boosting effect, forming a synergistic effect of "spleen and stomach-liver and kidney-qi and blood." The adjuvant herbs have a triple effect: ginger, bamboo shavings, citron, and sandalwood help stop vomiting, regulate qi, and relieve abdominal distension; roasted malt and chicken gizzard aid digestion and prevent tonifying herbs from irritating the stomach; dried ginger, with its warming properties, harmonizes the cold herbs in the formula, protects the spleen yang, and ensures that tonification does not cause stagnation. The guiding herb, Buddha's Hand, directs all the herbs directly to the affected areas of the spleen, stomach, and liver, harmonizing the properties of the entire formula, regulating qi and stomach, and helping to relieve bloating. The entire formula balances qi, blood, yin, and yang by regulating the functions of the spleen, stomach, liver, and kidneys. It directly alleviates treatment-related vomiting symptoms and fundamentally improves hematopoietic function, addressing the problem of decreased red and white blood cells, aligning with the holistic conditioning concept of traditional Chinese medicine's adjuvant therapy for tumors.

[0011] The herbal composition of this invention is prepared by water decoction, and the specific steps are as follows: (1) Raw material pretreatment: Take the prescribed amount of each medicinal material, remove impurities, wash and drain the surface water; grind the chicken gizzard into coarse powder that passes through a 20-mesh sieve, and cut the sandalwood into 1-2cm small pieces; classify and process the remaining medicinal materials according to their texture, cut the root and stem materials (astragalus, polygonatum, etc.) into 2-3cm pieces, keep the fruit materials (mulberry, wolfberry, etc.) intact or cut in half, and tear the leaves / barks (bamboo shavings, tangerine peel, etc.) into small pieces to avoid excessive grinding; spread the processed medicinal materials out to dry for later use.

[0012] (2) Water decoction extraction: Mix all the pretreated medicinal materials evenly, add 8-10 times the total weight of the medicinal materials in the formula with purified water, and soak at room temperature for 30-60 minutes; first heat to boiling over high heat, then immediately reduce to low heat and simmer for 1.5-2 hours, stirring once every 20 minutes during the process; after simmering, filter while hot with a 200-mesh filter cloth, collect the first filtrate and keep it warm (around 40℃); add 6-8 times the total weight of the medicinal materials in the formula with purified water to the dregs, bring to a boil again over high heat, then reduce to low heat and simmer for 1-1.5 hours, stirring regularly; after simmering, filter while hot with a 200-mesh filter cloth and collect the second filtrate; combine the two filtrates and filter again with a 200-mesh filter cloth to obtain a clear combined filtrate.

[0013] (3) Concentration: Transfer the combined filtrate into a vacuum concentration tank, control the vacuum degree to 0.06-0.08MPa and the concentration temperature to 55-65℃, and continue to concentrate until the relative density is 1.10-1.20 (measured at 60℃). After stopping the concentration, dispense while hot or cool and seal for storage.

[0014] Furthermore, the traditional Chinese medicine composition of this invention can also be combined with pharmaceutically acceptable excipients to prepare various formulations such as decoctions, granules, tablets, capsules, oral liquids, and ointments to meet the medication needs of different patients.

[0015] The traditional Chinese medicine composition of this invention can be used to prepare drugs that alleviate and improve adverse reactions related to tumor treatment, specifically including: (1) To prepare drugs to relieve vomiting symptoms associated with radiotherapy, targeted therapy, chemotherapy, and immunotherapy; (2) To prepare drugs that improve erythrocyte and leukopenia after radiotherapy, targeted therapy, chemotherapy, and immunotherapy; (3) Prepare drugs to improve adverse symptoms such as fatigue, sallow complexion, abdominal distension, nausea and loss of appetite, soreness of the waist and knees, frequent urination at night, and loose stools during radiotherapy, targeted therapy, chemotherapy, and immunotherapy.

[0016] Compared with the prior art, the technical advantages of the present invention are as follows: (1) Dual efficacy, addressing both symptoms and root cause: This invention breaks through the limitations of existing Chinese medicine compositions that only stop vomiting or only increase blood volume, and simultaneously achieves the dual effects of "stopping vomiting" and "increasing blood volume", which can improve the gastrointestinal reaction and bone marrow suppression problems in tumor treatment.

[0017] (2) Wide applicability: The traditional Chinese medicine composition of the present invention has the effect of alleviating adverse reactions caused by radiotherapy, chemotherapy, targeted therapy and immunotherapy, and in particular makes up for the deficiency of existing traditional Chinese medicine in terms of insufficient adaptability to adverse reactions related to tumor treatment.

[0018] (3) Significant therapeutic effect: Clinical trials show that the total effective rate of the Chinese medicine composition of the present invention in stopping vomiting is 92.5%, the total effective rate of increasing red blood cells is 90.0%, and the total effective rate of increasing white blood cells is 87.5%, which is significantly better than traditional Chinese medicine formulas. Attached Figure Description

[0019] Figure 1 Statistical comparison of clinical case efficacy. Detailed Implementation

[0020] To make the objectives and technical solutions of this invention clearer, the following embodiments are provided for further explanation. However, the scope of protection of this invention is not limited to these embodiments; the embodiments are merely for illustrative purposes. Those skilled in the art should understand that any changes or equivalent substitutions that do not depart from the concept of this invention are included within the scope of protection of this invention.

[0021] Example 1: Traditional Chinese Medicine Composition formula: 5g of Pinellia ternata, 5g of Citrus medica, 5g of Zingiber officinale, 8g of Citrus reticulata peel, 15g of Morus alba, 10g of stir-fried malt, 8g of stir-fried chicken gizzard lining, 20g of Astragalus membranaceus, 6g of Atractylodes macrocephala, 5g of Citronella foenum-graecum, 12g of Lycium barbarum, 12g of Cornus officinalis (processed with wine), 8g of Poria cocos, 5g of Dalbergia odorifera, 15g of Polygonatum sibiricum (processed with wine), and 3g of dried ginger.

[0022] Preparation method: (1) Raw material pretreatment: Take the following ingredients in the formula: Pinellia ternata, Citrus medica, Bambusa textilis, Citrus reticulata peel, Morus alba, roasted malt, chicken gizzard lining, Astragalus membranaceus, Atractylodes macrocephala, Citrus medica, Lycium barbarum, Cornus officinalis, Poria cocos, Dalbergia odorifera, Polygonatum sibiricum, and dried ginger. Remove impurities, wash and drain the surface water. Grind the chicken gizzard lining into coarse powder that passes through a 20-mesh sieve. Cut Dalbergia odorifera into 1-2cm pieces. Treat the remaining medicinal materials according to their texture. Cut the root and stem materials (Astragalus membranaceus, Polygonatum sibiricum, etc.) into 2-3cm pieces. Keep the fruit materials (Morus alba, Lycium barbarum, etc.) whole or cut in half. Tear the leaves / barks (Bambusa textilis, Citrus reticulata peel, etc.) into small pieces to avoid over-grinding. Spread them out to dry after treatment and set aside.

[0023] (2) Water decoction extraction: Take all the pretreated medicinal materials and mix them evenly. Add 8-10 times the total weight of the medicinal materials in the formula with purified water and soak at room temperature for 30-60 minutes. First, heat it to boiling over high heat, then immediately turn to low heat and keep it simmering for 1.5-2 hours, stirring once every 20 minutes. After decoction, filter it while it is hot with a 200-mesh filter cloth, collect the first filtrate and keep it warm (around 40℃). Add 6-8 times the total weight of the medicinal materials in the formula with purified water to the dregs, bring it to a boil again over high heat, then turn to low heat and simmer for 1-1.5 hours, stirring regularly. After decoction, filter it while it is hot with a 200-mesh filter cloth and collect the second filtrate. Combine the two filtrates and filter them again with a 200-mesh filter cloth to obtain a clear combined filtrate.

[0024] (3) Concentration: Transfer the combined filtrate into a vacuum concentration tank, control the vacuum degree to 0.06-0.08MPa and the concentration temperature to 55-65℃, and continue to concentrate until the relative density is 1.10-1.20 (measured at 60℃). After stopping the concentration, dispense while hot or cool and seal for storage.

[0025] Example 2: Traditional Chinese Medicine Composition formula: 3g of Pinellia ternata, 3g of Citrus medica, 3g of Zingiber officinale, 5g of Citrus reticulata peel, 10g of Morus alba, 5g of stir-fried malt, 5g of stir-fried chicken gizzard lining, 15g of Astragalus membranaceus, 3g of Atractylodes macrocephala, 3g of Citronella foenum-graecum, 8g of Lycium barbarum, 8g of Cornus officinalis (processed with wine), 5g of Poria cocos, 3g of Dalbergia odorifera, 10g of Polygonatum sibiricum (processed with wine), and 1g of dried ginger.

[0026] Preparation method: (1) Raw material pretreatment: Take the following ingredients in the formula: Pinellia ternata, Citrus medica, Bambusa textilis, Citrus reticulata peel, Morus alba, roasted malt, chicken gizzard lining, Astragalus membranaceus, Atractylodes macrocephala, Citrus medica, Lycium barbarum, Cornus officinalis, Poria cocos, Dalbergia odorifera, Polygonatum sibiricum, and dried ginger. Remove impurities, wash and drain the surface water. Grind the chicken gizzard lining into coarse powder that passes through a 20-mesh sieve. Cut Dalbergia odorifera into 1-2cm pieces. Treat the remaining medicinal materials according to their texture. Cut the root and stem materials (Astragalus membranaceus, Polygonatum sibiricum, etc.) into 2-3cm pieces. Keep the fruit materials (Morus alba, Lycium barbarum, etc.) whole or cut in half. Tear the leaves / barks (Bambusa textilis, Citrus reticulata peel, etc.) into small pieces to avoid over-grinding. Spread them out to dry after treatment and set aside.

[0027] (2) Water decoction extraction: Take all the pretreated medicinal materials and mix them evenly. Add 8-10 times the total weight of the medicinal materials in the formula with purified water and soak at room temperature for 30-60 minutes. First, heat it to boiling over high heat, then immediately turn to low heat and keep it simmering for 1.5-2 hours, stirring once every 20 minutes. After decoction, filter it while it is hot with a 200-mesh filter cloth, collect the first filtrate and keep it warm (around 40℃). Add 6-8 times the total weight of the medicinal materials in the formula with purified water to the dregs, bring it to a boil again over high heat, then turn to low heat and simmer for 1-1.5 hours, stirring regularly. After decoction, filter it while it is hot with a 200-mesh filter cloth and collect the second filtrate. Combine the two filtrates and filter them again with a 200-mesh filter cloth to obtain a clear combined filtrate.

[0028] (3) Concentration: Transfer the combined filtrate into a vacuum concentration tank, control the vacuum degree to 0.06-0.08MPa and the concentration temperature to 55-65℃, and continue to concentrate until the relative density is 1.10-1.20 (measured at 60℃). After stopping the concentration, dispense while hot or cool and seal for storage.

[0029] Example 3: Traditional Chinese Medicine Composition formula: 10g of Pinellia ternata, 10g of Citrus medica, 10g of Zingiber officinale, 12g of Citrus reticulata peel, 20g of Morus alba, 15g of stir-fried malt, 12g of stir-fried chicken gizzard lining, 25g of Astragalus membranaceus, 10g of Atractylodes macrocephala, 10g of Citronella foenum-graecum, 16g of Lycium barbarum, 16g of Cornus officinalis (processed with wine), 12g of Poria cocos, 10g of Dalbergia odorifera, 20g of Polygonatum sibiricum (processed with wine), and 5g of dried ginger.

[0030] Preparation method: (1) Raw material pretreatment: Take the following ingredients in the formula: Pinellia ternata, Citrus medica, Bambusa textilis, Citrus reticulata peel, Morus alba, roasted malt, chicken gizzard lining, Astragalus membranaceus, Atractylodes macrocephala, Citrus medica, Lycium barbarum, Cornus officinalis, Poria cocos, Dalbergia odorifera, Polygonatum sibiricum, and dried ginger. Remove impurities, wash and drain the surface water. Grind the chicken gizzard lining into coarse powder that passes through a 20-mesh sieve. Cut Dalbergia odorifera into 1-2cm pieces. Treat the remaining medicinal materials according to their texture. Cut the root and stem materials (Astragalus membranaceus, Polygonatum sibiricum, etc.) into 2-3cm pieces. Keep the fruit materials (Morus alba, Lycium barbarum, etc.) whole or cut in half. Tear the leaves / barks (Bambusa textilis, Citrus reticulata peel, etc.) into small pieces to avoid over-grinding. Spread them out to dry after treatment and set aside.

[0031] (2) Water decoction extraction: Take all the pretreated medicinal materials and mix them evenly. Add 8-10 times the total weight of the medicinal materials in the formula with purified water and soak at room temperature for 30-60 minutes. First, heat it to boiling over high heat, then immediately turn to low heat and keep it simmering for 1.5-2 hours, stirring once every 20 minutes. After decoction, filter it while it is hot with a 200-mesh filter cloth, collect the first filtrate and keep it warm (around 40℃). Add 6-8 times the total weight of the medicinal materials in the formula with purified water to the dregs, bring it to a boil again over high heat, then turn to low heat and simmer for 1-1.5 hours, stirring regularly. After decoction, filter it while it is hot with a 200-mesh filter cloth and collect the second filtrate. Combine the two filtrates and filter them again with a 200-mesh filter cloth to obtain a clear combined filtrate.

[0032] (3) Concentration: Transfer the combined filtrate into a vacuum concentration tank, control the vacuum degree to 0.06-0.08MPa and the concentration temperature to 55-65℃, and continue to concentrate until the relative density is 1.10-1.20 (measured at 60℃). After stopping the concentration, dispense while hot or cool and seal for storage.

[0033] Clinical case statistics 1. Research Subjects and General Information 1.1 Research Subjects Eighty cancer patients who underwent chemotherapy / targeted therapy at Yingkou Central Hospital between May and November 2025 were selected, meeting the following criteria: Inclusion criteria: Patients were pathologically diagnosed with malignant tumors (including lung cancer, rectal cancer, breast cancer, intrahepatic cholangiocarcinoma, etc.), were undergoing chemotherapy / targeted therapy, had nausea and vomiting of WHO grade ≥1, and had mild to moderate erythrocyte and leukopenia; and provided informed consent.

[0034] Exclusion criteria: patients with severe heart, liver, or kidney failure; patients allergic to the study drug; and patients unable to take the medication.

[0035] 1.2 Grouping Method Eighty patients were randomly divided into an experimental group and a control group, with 40 patients in each group, using a random number table method.

[0036] 1.3 Baseline Data There were no statistically significant differences between the two groups of patients in terms of gender, age, tumor type, and treatment method. P >0.05), which is comparable, as shown in Table 1.

[0037] Table 1. Patient Data Statistics 2. Treatment Plan 2.1 Control Group The patient was treated with Er Chen Tang combined with Ping Wei San and E Jiao Bu Xue Ke Li: Er Chen Tang combined with Ping Wei San: Pinellia ternata 9g, Citrus reticulata peel 10g, Poria cocos 12g, Glycyrrhiza uralensis 6g, Atractylodes lancea 10g, Magnolia officinalis 9g, 1 dose per day, decocted in water and taken in 2 divided doses; E Jiao Bu Xue Ke Li: 1 sachet each time, taken orally twice a day, for a course of 7 days.

[0038] 2.2 Experimental Group The following medication was administered as described in Example 1: 5g Pinellia ternata, 5g Bambusa textilis, 6g Atractylodes macrocephala, 8g Poria cocos, 5g Citrus medica, 8g Citrus reticulata peel, 5g Citronella tamariscina, 5g Dalbergia odorifera, 10g roasted malt, 8g chicken gizzard lining, 12g Lycium barbarum, 15g Polygonatum sibiricum, 20g Astragalus membranaceus, 15g Morus alba, 12g Cornus officinalis, and 3g dried ginger. One dose was administered daily, decocted in water and taken in two divided doses. The course of treatment was 7 days.

[0039] 3. Observation indicators and efficacy evaluation criteria 3.1 Observation Indicators Antiemetic efficacy: Record WHO classification of nausea and vomiting before and after treatment (0 = no vomiting; 1 = 1 time / day; 2 = 2-5 times / day; 3 = ≥6 times / day). Efficacy of treatment: Detect the number of red blood cells and white blood cells in peripheral blood before and after treatment.

[0040] 3.2 Criteria for Evaluating Therapeutic Effect Antiemetic efficacy: Marked effect = vomiting reduced to grade 0; Effective = vomiting reduced by 1-2 grades; Ineffective = no improvement / worsening; Total effective rate = (marked effect + effective) / total number of cases × 100%.

[0041] Blood cell boosting efficacy: Marked effect = red blood cell / white blood cell increase ≥20%; Effective = increase 10%-19%; Ineffective = increase <10% / decrease; Total effective rate = (marked effect + effective) / total number of cases × 100%.

[0042] 4. Statistical Results 4.1 Comparison of antiemetic efficacy The overall effective rate of antiemetic treatment in the experimental group was significantly higher than that in the control group. P <0.05), see Table 2.

[0043] Table 2 Comparison of antiemetic efficacy 4.2 Comparison of Blood Lifting Therapy Effects 4.2.1 Erythrocyte efficacy The total effective rate of erythrocytes in the experimental group was higher than that in the control group ( P <0.05), as shown in Table 3.

[0044] Table 3 Erythrocyte efficacy 4.2.2 Leukocyte efficacy The total effective rate of leukocytes in the experimental group was higher than that in the control group ( P <0.05), as shown in Table 4.

[0045] Table 4 Leukocyte efficacy 4.3 Safety During the treatment period, no obvious drug adverse reactions occurred in both groups, and there were no abnormal fluctuations in liver and kidney functions.

[0046] 5. Conclusion In patients undergoing tumor chemotherapy / targeted therapy, the antiemetic and blood-elevating (erythrocyte and leukocyte) effects of the drug in Example 1 were significantly better than those of the combination of Erchen Decoction and Pingwei Powder + Ejiao Blood-tonifying Granules. This prescription has high clinical value in improving treatment-related digestive tract reactions and myelosuppression and can be promoted for application.

[0047] Animal experiments verified the antiemetic and leukocyte- and erythrocyte-elevating effects of the traditional Chinese medicine composition Table 5 Experimental design of the control group 1. Experimental animals SD rats (SPF grade), weighing 180 - 220 g, license number: SYXK(Shandong)20230023. Experimental environment: temperature 22 - 25°C, humidity 50% - 60%, 12-h light-dark cycle, free access to food and water, and start the experiment after 1 week of adaptive feeding.

[0048] 2. Experimental drugs Drugs for the experimental group (Examples 1 - 3): Prepare the clear paste according to the formulas and preparation methods (water decoction method) in Examples 1 - 3, and dilute it with normal saline to contain 0.22 g / mL of crude drug.

[0049] [[ID=​​​​​​Blood-boosting drug: Recombinant human granulocyte colony-stimulating factor (G-CSF), diluted to 0.5 μg / mL.

[0051] Modeling drug: cisplatin injection (20mL:20mg), diluted with physiological saline to 1mg / mL.

[0052] 3. Experimental Grouping There are 15 groups in total, with 10 rats in each group (half male and half female). The grouping is as follows: Table 6 Experimental Groups 4. Experimental Methods Model establishment: Rats were intraperitoneally injected with cisplatin 8 mg / kg once to establish a chemotherapy-induced vomiting-like reaction and bone marrow suppression model.

[0053] 5. Dosing regimen Drug administration began 24 hours after modeling and continued for 7 days: Traditional Chinese medicine group (Examples 1-3, Control groups 1-10): administered by gavage at 9:00 AM daily, dose 1 mL / 100g body weight (containing 0.22 g / mL of crude drug); Positive control group: administered ondansetron intraperitoneally at 9:00 AM daily, and G-CSF subcutaneously at the specified time; Model control group: administered an equal volume of physiological saline by gavage at 9:00 AM daily.

[0054] 6. Observation and Detection Indicators SPSS 22.0 software was used for statistical analysis of the obtained data. Quantitative data were expressed as (x̅±s). One-way ANOVA was used for comparisons among multiple groups, and independent samples t-tests were used for comparisons between two groups. A p-value < 0.05 was considered statistically significant.

[0055] Anti-nausea effect test Vomiting-like behavior scoring: Observe for 2 hours daily, record and score the following indicators: dry heaving / abdominal contraction: 0 (none), 1 (1-3 times), 2 (4-6 times), 3 (≥7 times); activity level: 0 (normal), 1 (mildly reduced), 2 (significantly reduced), 3 (drowsy and immobile); food intake: compared with before modeling, 0 (no decrease), 1 (decreased by 10%-20%), 2 (decreased by 21%-40%), 3 (decreased by ≥41%).

[0056] Table 7 Vomiting-like behavior score Compared with the model control group, p < 0.05.

[0057] Table 7 shows that vomiting-like behavior scores were similar across all groups 24 hours after modeling, indicating that the cisplatin-induced chemotherapy-related vomiting-like reaction model was successfully constructed. Comparison of vomiting-like behavior scores between the Example 1-3 groups and the positive control group shows that the herbal composition of this invention can achieve similar antiemetic effects as the positive control group. The vomiting-like behavior scores of each control group (1-10) after administration were significantly higher than those of the Example 1 group: among them, the control group without Qingbanxia (the principal drug targeting the antiemetic component) and the control group without Huangqi (the principal drug synergistic component) had scores close to the model control group, indicating that Qingbanxia and Huangqi, as principal drugs, are the core medicinal materials ensuring the antiemetic effect; other control groups (such as replacing the processed Huangjing or removing Foshou, etc.) showed some slight improvement, but the effect was far inferior to the original formula, further verifying the rigor of the original herbal composition's "principal, assistant, adjuvant, and guide" compatibility system. The absence or replacement of any core medicinal material will significantly weaken the antiemetic effect.

[0058] 2. Blood boosting effect test 0.5 mL of blood was collected from the tail vein, and the white blood cell count (WBC), red blood cell count (RBC), and hemoglobin (Hb) were measured using a fully automated blood analyzer.

[0059] Table 8 White blood cell count Compared with the model control group, p < 0.05.

[0060] Table 8 shows that the white blood cell count in the positive control group rebounded after administration, indicating that the Western medicine (ondansetron combined with G-CSF) had a certain effect on increasing white blood cell count, but the increase was limited. The white blood cell count rebound in groups 1-3 of Examples was comparable to that in the positive control group, proving that the effect of this traditional Chinese medicine composition in increasing white blood cell count can achieve the same effect as the positive control of the Western medicine. The white blood cell count rebound in each control group was much lower than that in the example groups: the control group without Pinellia ternata (the principal drug targeting the antiemetic component) and the control group without Astragalus membranaceus (the principal drug synergistic component) had white blood cell counts close to those in the model control group, indicating that these two principal drugs not only affect the antiemetic effect but are also crucial for increasing white blood cell count; other control groups (such as replacing the qi-regulating drug with Citrus aurantium, removing the digestive adjuvant drug, etc.) showed a slight tendency to increase white blood cell count, but the effect was far from comparable to the original formula, confirming that the composition and compatibility of the original formula played a key role in the effect of increasing white blood cell count, and any adjustment in any aspect would significantly reduce the efficacy of increasing white blood cell count.

[0061] Table 9 Red blood cell count Compared with the model control group, p < 0.05.

[0062] Table 9 shows that cisplatin-induced chemotherapy-related myelosuppression leads to a significant decrease in red blood cell count in rats. The traditional Chinese medicine composition of this invention (Examples 1-3) can significantly increase the red blood cell count in chemotherapy-induced rat models, with an effect comparable to that of the positive control drug. However, in each control group after adjustments such as missing or replaced medicinal materials, the red blood cell count recovery effect was significantly weaker than in the example groups. This demonstrates that the "principal, assistant, adjuvant, and guide" formulation system of this invention is key to achieving the red blood cell-increasing effect. Its qi-tonifying, blood-nourishing, spleen-strengthening, and kidney-tonifying approach can effectively improve the problem of insufficient red blood cell production caused by chemotherapy.

[0063] Table 10 Hemoglobin Compared with the model control group, p < 0.05.

[0064] Table 10 shows that the hemoglobin level in rats decreased after chemotherapy modeling. The traditional Chinese medicine composition of this invention significantly increased hemoglobin levels in the chemotherapy model rats, demonstrating a good blood-tonifying and blood-regulating effect. In each control group, due to missing medicinal materials, replacement of processed varieties, or adjustments to the formula, the hemoglobin-increasing effect was far less than that of the example group. This further confirms that the original formula, based on the principles of "relieving nausea and vomiting, invigorating qi and nourishing blood, strengthening the spleen and benefiting the kidneys," can fundamentally improve the hemoglobin reduction caused by chemotherapy by regulating qi and blood and nourishing the liver, kidneys, spleen, and stomach. The rigor and integrity of its formulation are the core guarantee for its blood-tonifying effect.

Claims

1. A traditional Chinese medicine composition with antiemetic and hemostatic effects, characterized in that, The traditional Chinese medicine composition is made of the following traditional Chinese medicines: pinellia ternata, citrus medica, bamboo shavings, dried tangerine or orange peel, mulberry, fried wheat, endod, astragalus, atractylodes, citrus medica, medlar, cornus officinalis, poria cocos, tenuilora, polygonatum, dried ginger.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is calculated by weight parts: pinellia ternata 3-10 parts, citrus medica 3-10 parts, bamboo shavings 3-10 parts, dried tangerine or orange peel 5-12 parts, mulberry 10-20 parts, fried wheat 5-15 parts, endod 5-12 parts, astragalus 15-25 parts, atractylodes 3-10 parts, citrus medica 3-10 parts, medlar 8-16 parts, cornus officinalis 8-16 parts, poria cocos 5-12 parts, tenuilora 3-10 parts, polygonatum 10-20 parts, dried ginger 1-5 parts.

3. The traditional Chinese medicine composition according to claim 2, characterized in that, The traditional Chinese medicine composition is calculated by weight parts: pinellia ternata 5 parts, citrus medica 5 parts, bamboo shavings 5 parts, dried tangerine or orange peel 8 parts, mulberry 15 parts, fried wheat 10 parts, endod 8 parts, astragalus 20 parts, atractylodes 6 parts, citrus medica 5 parts, medlar 12 parts, cornus officinalis 12 parts, poria cocos 8 parts, tenuilora 5 parts, polygonatum 15 parts, dried ginger 3 parts.

4. A method for preparing the traditional Chinese medicine composition according to claim 1, characterized in that, The preparation method is water decoction method.

5. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition can also be prepared into a preparation with a pharmaceutically acceptable adjuvant.

6. The traditional Chinese medicine composition according to claim 5, characterized in that, The preparation is decoction, granules, tablets, capsules, oral liquid, ointment.

7. Use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a medicine for relieving vomiting symptoms related to radiotherapy, targeted therapy, chemotherapy, immunotherapy.

8. Use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a medicine for improving red blood cell reduction and white blood cell reduction after radiotherapy, targeted therapy, chemotherapy, immunotherapy.

9. Use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a medicine for improving adverse symptoms during radiotherapy, targeted therapy, chemotherapy, immunotherapy.

10. Use according to claim 9, characterized in that, The adverse symptoms include at least one of the following: fatigue, sallow complexion, abdominal distension, nausea and poor appetite, soreness of waist and knees, frequent urination at night, and loose and thin stool.

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