Traditional Chinese medicine composition for relieving chemotherapy vomiting and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for relieving chemotherapy vomiting and a preparation method thereof.The traditional Chinese medicine composition is prepared from pinellia ternate, pericarpium citri reticulatae, poria cocos, honey-fried licorice roots, caulis bambusae in taeniam, immature bitter oranges, scorched medicated leaven and endothelium corneum gigeriae galli. Good clinical application prospects and important transformation significance are realized in the technical field of development of chemotherapy vomiting relieving medicines.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and in particular, relates to a traditional Chinese medicine composition for relieving chemotherapy vomiting and a preparation method thereof. Background Art

[0002] Chemotherapy is an important means of comprehensive treatment for advanced malignant tumors. Chemotherapy-induced nausea and vomiting (CINV) is the most common gastrointestinal toxic reaction to tumor chemotherapy, with an incidence as high as 70%-80%. In particular, highly emetogenic drugs such as cisplatin and cyclophosphamide can cause acute vomiting in over 90% of cases and delayed vomiting in over 50%. There are various types of vomiting, including acute (within 24 hours of chemotherapy), delayed (after 24 hours of chemotherapy), and anticipatory (induced by psychological factors). Frequent vomiting not only causes physiological complications such as dehydration, electrolyte imbalance, and malnutrition, but also aggravates patients' anxiety and depression, and may even interrupt treatment due to fear of chemotherapy, seriously affecting the continuity and effectiveness of tumor treatment. According to statistics, approximately 30% of patients reduce chemotherapy doses or refuse subsequent treatment due to poor vomiting control, which has become one of the key bottlenecks restricting the efficacy of chemotherapy.

[0003] At present, the mainstream antiemetic regimen in clinical practice is mainly based on Western medicine, including the combined use of 5-HT3 receptor antagonists (such as ondansetron), NK-1 receptor antagonists (such as aprepitant) and glucocorticoids (such as dexamethasone). Although the triple regimen can control 70%-80% of acute vomiting of highly emetogenic chemotherapy, the effect on delayed vomiting, expected vomiting and refractory vomiting is still not ideal, and about 20%-30% of patients have breakthrough vomiting. In addition, Western medicine antiemetic drugs are often accompanied by side effects such as headache, constipation, and dizziness, and long-term use may affect liver and kidney function. More importantly, the use of glucocorticoids may interfere with the effect of immunotherapy (such as PD-1 inhibitors). At present, with the diversification of tumor treatment modes, the problem of limited use is becoming increasingly prominent. Therefore, the development of antiemetic drugs that are not hormone-dependent, have few side effects, and have novel mechanisms of action has become an urgent clinical need.

[0004] The high incidence of chemotherapy-induced vomiting and the limitations of existing Western medicines highlight the urgency of developing traditional Chinese medicine. With its multi-target, individualized, low-toxic and safe characteristics, traditional Chinese medicine can not only make up for the shortcomings of Western medicine, but also improve the overall control level of CINV through an integrated medical model, providing cancer patients with better supportive treatment options. It has important clinical value and social significance, and traditional Chinese medicine is expected to bring new breakthroughs in the relief or control of CINV. Summary of the Invention

[0005] In view of this, the object of the present invention is to provide a Chinese medicine composition for relieving chemotherapy vomiting and a preparation method thereof in the art.

[0006] The present invention adopts the following technical solutions to achieve the above-mentioned invention objectives:

[0007] A first aspect of the present invention provides a traditional Chinese medicine composition for relieving chemotherapy-induced vomiting.

[0008] Furthermore, the Chinese medicine composition is composed of the following raw materials in parts by weight: 5-15 grams of Pinellia, 5-15 grams of dried tangerine peel, 25-35 grams of Poria, 1-11 grams of roasted licorice, 5-15 grams of Rhizoma Anemarrhenae, 5-15 grams of Citrus aurantium, 5-15 grams of scorched Shenqu, and 5-15 grams of chicken's gizzard lining.

[0009] Furthermore, the Chinese medicine composition is composed of the following raw materials in parts by weight: 10 grams of Pinellia ternata, 10 grams of dried tangerine peel, 30 grams of Poria cocos, 6 grams of roasted licorice root, 10 grams of Rhizoma Anemarrhenae, 10 grams of Citrus aurantium, 10 grams of scorched Shenqu, and 10 grams of chicken's gizzard lining.

[0010] In the composition of the pharmaceutical composition described above, the weight of the medicinal material is calculated based on the raw material, and the proportions are calculated in parts by weight. This proportion can be increased or decreased during production. For example, large-scale production can use kilograms or tons as the unit, while small-scale production can use grams or milligrams as the unit. While the weight can be increased or decreased, the weight ratios of the raw materials in each component remain unchanged. The above weight ratios are determined through scientific screening. For special patient needs, such as those with severe or mild illnesses, or those who are obese or thin, the proportions of the components can be adjusted accordingly, with increases or decreases not exceeding 100% without changing the efficacy.

[0011] In some embodiments, Jiao Shenqu (Scored Shenqu) is a traditional Chinese medicine (TCM) preparation made by frying Shenqu (Shenqu) until it turns a burnt brown. It is primarily used to help digestion, relieve stagnation, and strengthen the spleen and stomach. Its efficacy is enhanced through fermentation and frying, and it is suitable for treating indigestion symptoms such as food stagnation and abdominal distension. Jiao Shenqu is based on Shenqu, which is fermented with flour and bran mixed with traditional Chinese medicines such as Polygonum hydropiper and Artemisia annua. Frying over medium heat until the surface is burnt brown and the interior is slightly yellow, it imparts a milder medicinal property and enhances its digestive properties.

[0012] In some embodiments, the chicken's gizzard lining is a Chinese medicinal material made from the dried inner wall of the gizzard of a chicken. It is sweet and mild in nature, and enters the spleen, stomach, small intestine, and bladder meridians. It has the effects of invigorating the stomach and promoting digestion, astringing spermatorrhea, stopping nocturnal emission, and relieving stranguria and dispelling urinary stones. It is widely used for indigestion, infantile malnutrition, nocturnal emission, and urinary calculi. Chicken's gizzard lining is taken from the inner wall of the stomach (gizzard) of a chicken, washed and dried after peeling. According to different processing methods, it is divided into raw chicken's gizzard lining and fried chicken's gizzard lining. The raw product is better than the raw product in relieving stranguria and dispelling urinary stones. After frying, it has better digestion and stomach-strengthening effects, and can reduce fishy smell, making it easy to take. In a specific embodiment of the present invention, the chicken's gizzard lining is fried chicken's gizzard lining.

[0013] In the present invention, the present invention proves through Jin's method that the traditional Chinese medicine composition described in the first aspect of the present invention, which is composed of the original formula Wen Dan Tang and additives (scorched Shen Qu, chicken gizzard lining), has a synergistic therapeutic effect (CI>1.15) on relieving chemotherapy vomiting, that is, the traditional Chinese medicine composition provided by the present invention has achieved unexpected technical effects.

[0014] Among them, the King's method is a method that is widely used to calculate the combined efficacy of drugs. Taking drug A and drug B as an example, the drug effects of drug A and drug B are regarded as independent events, and the probability formula P is used. AB =P A +P B -P A *P B , and use this formula as the calculation formula E for the expected additive effect of combined drug use AB =E A +E B -E A *E B The ratio of the actual efficacy value to the calculated value of the formula is CI. The CI value between 0.85-1.15 is simple addition; between 1.15-20 is synergy, and >20 is significant synergy; the CI value between 0.85-0.55 is antagonism, and <0.55 is obvious antagonism.

[0015] A second aspect of the present invention provides a pharmaceutical preparation for alleviating chemotherapy-induced emesis.

[0016] Furthermore, the active ingredient of the pharmaceutical preparation is the traditional Chinese medicine composition described in the first aspect of the present invention.

[0017] Furthermore, the pharmaceutical preparation comprises a pharmaceutically acceptable excipient.

[0018] Furthermore, the pharmaceutically acceptable excipient is a filler, a binder, a surfactant and / or a lubricant.

[0019] Furthermore, the dosage form of the pharmaceutical preparation is an oral dosage form or an injection dosage form.

[0020] Furthermore, the oral dosage form is decoction, pills, powders, granules, tablets, capsules or pills.

[0021] In some embodiments, when preparing the preparation unit of the present invention, the active ingredients extracted by the present invention are added to pharmaceutically acceptable excipients, and conventional preparation techniques well known to those skilled in the art are used to prepare the drug dosage forms routinely required in clinical practice.

[0022] In some embodiments, the pharmaceutically acceptable excipients include, but are not limited to, fillers, binders, surfactants, humectants, adsorbent carriers, lubricants, and / or disintegrants.

[0023] In some embodiments, the pharmaceutically acceptable excipients are described in detail in Remington's Pharmaceutical Sciences (19th ed, 1995). These substances are used to help the stability of the drug or to help improve the activity of the active ingredient (i.e., the Chinese medicine composition of the present invention as described above) as needed. The substances include but are not limited to: surfactants, wetting agents, adhesives, fillers, disintegrants, adsorption carriers, lubricants, stabilizers, bactericides, buffers, isotonic agents, chelating agents, pH control agents. The pharmaceutical preparations thus prepared can be administered by any appropriate administration method known to those skilled in the art as needed.

[0024] In some embodiments, the filler includes, but is not limited to, lactose, dextrin, microcrystalline cellulose, starch, sorbitol, mannitol, pregelatinized starch, and the like.

[0025] In some embodiments, the binder includes but is not limited to starch slurry, sodium starch slurry, hypromellose, povidone, and the like.

[0026] In some embodiments, the surfactant includes but is not limited to sodium lauryl sulfate, sodium hexadecyl sulfate, stearic acid, oleic acid, lauric acid, and the like.

[0027] In some embodiments, the humectant includes but is not limited to: water, ethanol, glycerol, polysorbate-80, poloxamer, sodium lauryl sulfate, etc.;

[0028] In some embodiments, the adsorption carrier includes but is not limited to starch, dextrin, microcrystalline cellulose, sodium carboxymethyl cellulose, powdered sugar, lactose, calcium hydrogen phosphate, silica gel, cyclodextrin, polyethylene glycol, and the like.

[0029] In some embodiments, the lubricant includes but is not limited to magnesium stearate, talc, polyethylene glycol, and the like.

[0030] In some embodiments, the disintegrant includes but is not limited to: cross-linked polyvinylpyrrolidone, cross-linked sodium carboxymethyl cellulose, sodium carboxymethyl starch, hydroxypropyl cellulose, and the like.

[0031] In some embodiments, pharmaceutically acceptable suspending agents, solubilizing agents, flavoring agents, preservatives, antioxidants, stabilizers, and the like may also be added to the pharmaceutical preparation.

[0032] In some embodiments, the suspending agent includes but is not limited to gum arabic, sodium carboxymethyl cellulose, gum tragacanth, peach gum, methyl cellulose, hydroxypropyl cellulose, silica bentonite, etc.

[0033] In some embodiments, the cosolvent includes but is not limited to: hydrochloric acid, phosphoric acid, propionic acid, acetic acid, lactic acid, citric acid, tartaric acid, glucuronic acid, gluconic acid, lactobionic acid, boric acid, malic acid, threonic acid, glucoheptonic acid, 2,5-dihydroxybenzoic acid, acidic amino acids, etc.

[0034] In some embodiments, the flavoring agents include but are not limited to aspartame, acesulfame-K, glycerin, saccharin sodium, cyclamate, sorbitol, mannitol, sucrose, simple syrup, aromatic syrup, and the like.

[0035] In some embodiments, the preservatives include but are not limited to phenol, thymol, benzoic acid and its salts, cresol, chlorocresol, sorbic acid and its salts, boric acid and its salts, propionic acid, formaldehyde, glutaraldehyde, benzyl alcohol, phenylethyl alcohol, chlorobutanol, chloroform, chlorhexidine, etc.

[0036] In some embodiments, the antioxidants and stabilizers include but are not limited to glutathione, dimercaprol, thioglycolic acid and salts, thiolactic acid and salts, sulfurous acid, sulfites, bisulfites, pyrosulfites, dithionites, thiosulfates, thiourea, thiodipropionic acid and salts, gallic acid and salts, caffeic acid or pharmaceutically acceptable salts thereof, di-tert-butylparaphenol, ferulic acid or pharmaceutically acceptable salts thereof, 2,5-dihydroxybenzoic acid or salts thereof, ascorbic acid and ascorbic acid salts, isoascorbic acid and isoascorbic acid salts, nicotinamide, tartaric acid, salicylic acid or salts thereof, phosphates, pharmaceutically acceptable acetic acid salts, citrates, EDTA and EDTA salts, etc.

[0037] In a specific embodiment, the specific excipients, suspending agents, solubilizers, flavoring agents, preservatives, antioxidants and stabilizers selected for combination with the Chinese medicine composition are determined according to the preparation to be made. When making ordinary preparations, the excipients, suspending agents, solubilizers, flavoring agents, preservatives, antioxidants and stabilizers selected are well known to those skilled in the art.

[0038] In some embodiments, the pharmaceutically acceptable excipient may additionally contain liquids such as water, saline, glycerol, and ethanol.

[0039] Those skilled in the art will understand that although the pharmaceutical preparations mentioned above in the present invention may further contain pharmaceutically acceptable excipients, when the Chinese medicine composition is used as a medicine for humans or animals, it can also be administered in its own form, that is, the present invention can be achieved without adding any of the above-mentioned pharmaceutically acceptable excipients.

[0040] The third aspect of the present invention provides a method for preparing the traditional Chinese medicine composition described in the first aspect of the present invention.

[0041] Furthermore, the method comprises the following steps: weighing the raw materials according to the ratio of the Chinese medicinal materials, decocting them in water for extraction, filtering, and combining the extracts to prepare the Chinese medicinal composition.

[0042] The fourth aspect of the present invention provides use of the traditional Chinese medicine composition described in the first aspect of the present invention in the preparation of a medicament for alleviating chemotherapy-induced vomiting.

[0043] The fifth aspect of the present invention provides use of the pharmaceutical preparation described in the second aspect of the present invention in the preparation of a medicament for alleviating chemotherapy vomiting.

[0044] In addition, the present invention also provides a method for relieving chemotherapy vomiting, which comprises the following steps: administering a therapeutically and / or prophylactically effective amount of the Chinese medicine composition of the first aspect of the present invention or the pharmaceutical preparation of the second aspect of the present invention to a subject in need.

[0045] In some embodiments, the subject includes humans and non-human animals. Non-human animals include all vertebrates (e.g., mammals and non-mammals) such as non-human primates (e.g., cynomolgus monkeys), sheep, dogs, cattle, chickens, amphibians, and reptiles. In certain embodiments, the subject is preferably a human. In a specific embodiment of the present invention, the subject is a human, specifically, a chemotherapy patient or a patient in need of chemotherapy.

[0046] In some embodiments, the treatment and / or prevention refers to the complete or partial improvement or alleviation of a disease or condition or disorder, or symptoms, adverse effects or consequences, or phenotypes associated therewith. This includes, but is not limited to, preventing the occurrence or recurrence of a disease, alleviating symptoms, reducing any direct or indirect pathological consequences of a disease, reducing the rate of progression of a disease or disorder, improving or alleviating the disease condition, and alleviating or improving the prognosis. The term does not imply a complete cure of the disease or complete elimination of any symptoms or an effect on all symptoms or consequences.

[0047] In some embodiments, the specific dosage and frequency (single or multiple doses) of the Chinese medicine composition or pharmaceutical preparation administered to the subject in need thereof may vary according to a variety of factors, such as whether the subject suffers from another disease and its route of administration; the subject's age, sex, health status, weight, body mass index, and diet; the nature and extent of the symptoms of the disease being treated, the type of simultaneous treatment, complications caused by the disease being treated, or other health-related problems. Other treatment regimens or medicaments can be used in combination with the Chinese medicine composition or pharmaceutical preparation and treatment methods described above in this application. Adjustment and manipulation of dosage (e.g., frequency and duration) are fully within the capabilities of those skilled in the art.

[0048] Compared with the prior art, the present invention has the following advantages and beneficial effects:

[0049] The present invention discovers for the first time that the combination of the original Wen Dan Tang formula and its additives (scorched Shen Qu and chicken's gizzard lining) has a synergistic therapeutic effect on relieving chemotherapy-induced vomiting. This indicates that the traditional Chinese medicine formula provided by the present invention achieves unexpected technical benefits compared to the prior art. The combination of the original Wen Dan Tang formula and its additives (scorched Shen Qu and chicken's gizzard lining) achieved an efficacy of 86.67% in relieving chemotherapy-induced vomiting, significantly superior to the combination of the original Wen Dan Tang formula and the additives. This present invention provides an effective therapeutic strategy for relieving chemotherapy-induced vomiting and has promising clinical application prospects and significant translational significance in the technical field of developing drugs to alleviate chemotherapy-induced vomiting. DETAILED DESCRIPTION

[0050] The present invention will be further described below with reference to specific embodiments. The following specific embodiments are intended only to illustrate the present invention and are not to be construed as limiting the present invention. Those skilled in the art will appreciate that various changes, modifications, substitutions, and variations may be made to these embodiments without departing from the principles and spirit of the present invention. The scope of the present invention is defined by the claims and their equivalents.

[0051] The drugs, reagents, raw materials, and experimental consumables used in the present invention are readily available to those of ordinary skill in the art and, unless otherwise specified, can be obtained commercially. Experimental methods for which specific conditions are not specified in the present invention are generally tested under conventional conditions or under conditions recommended by the manufacturer. In particular, the following examples are intended only to illustrate the present invention and should not limit the scope of the present invention in any way. It should be noted that the experimental conditions and results described in the following examples are intended only to illustrate the present invention and should not, and will not, limit the present invention described in detail in the claims.

[0052] Example Preparation of a Chinese medicine composition for relieving chemotherapy vomiting and study of its pharmacological effects

[0053] 1. Experimental Grouping

[0054] (1) Negative control group (no treatment).

[0055] (2) The original formula of Wen Dan Tang (Pinellia tuber, dried tangerine peel, Poria cocos, roasted licorice root, bamboo shavings, and immature bitter orange) group.

[0056] (3) Additives (scorched Shenqu, chicken gizzard lining) group.

[0057] (4) Improved formula (all components, i.e., Pinellia ternata, Tangerine peel, Poria cocos, Roasted Licorice root, Rhizoma Anemarrhenae, Citrus aurantium, Scorched Shenqu, Chicken Gizzard Stone, a total of 8 kinds) group.

[0058] The original recipe for Wen Dan Tang (Wendan Decoction) contains the following ingredients by weight: 10 grams of Pinellia ternata, 10 grams of dried tangerine peel, 30 grams of Poria cocos, 6 grams of roasted licorice root, 10 grams of bamboo shavings, and 10 grams of immature bitter orange. The preparation method is as follows: First, soak the herbs for 30 minutes, using enough water to cover the surface of the herbs. Then, boil the herbs for 20 minutes and pour out the decoction. Then, add more water and boil for 20 minutes. Pour out the decoction. Remove the residue from the two decoctions, filter them thoroughly, and combine them. Then, take the decoction twice, once in the morning and once in the evening, half an hour after meals.

[0059] The additive comprises the following raw materials in parts by weight: 10 grams of scorched Shenqu (Scorched Shenqu) and 10 grams of chicken gizzard lining. The preparation method is as follows: first, soak the herbs for 30 minutes, using enough water to cover the surface of the herbs. Then, boil the herbs for 20 minutes and pour out the decoction. Then, add more water and boil for 20 minutes. Pour out the decoction. Remove the residue from the two decoctions, filter them thoroughly, and mix them. Then, take the decoction twice, once in the morning and once in the evening, half an hour after meals.

[0060] The improved recipe comprises the following ingredients by weight: 10 grams of Pinellia ternata, 10 grams of dried tangerine peel, 30 grams of Poria cocos, 6 grams of roasted Licorice root, 10 grams of Rhizoma Anemarrhenae, 10 grams of Immature Citrus aurantium, 10 grams of Scorched Shenqu, and 10 grams of Chicken's Gizzard Stone. The preparation method is as follows: first, soak the herbs for 30 minutes, using enough water to cover the surface of the herbs, then boil for 20 minutes, and pour out the decoction; then, add more water and boil for 20 minutes, pour out the decoction, remove the residue from the two decoctions, filter them thoroughly, and mix them before taking them twice, one in the morning and one in the evening, half an hour after meals.

[0061] 2. Source of cases

[0062] This study included 30 patients with gastric cancer, 22 with colorectal cancer, 29 with lung cancer, and 40 with breast cancer. All patients provided written informed consent. The cancer patients in each group are shown in Table 1 below. The interventions for each group were as follows:

[0063] (1) Negative control group: no treatment.

[0064] (2) Original Wen Dan Tang group: The patients were treated with the above-mentioned original Wen Dan Tang Chinese herbal decoction (oral) for 2 weeks.

[0065] (3) Additive group: The patients were treated with the above-mentioned Chinese herbal decoction with additives (oral administration) for 2 weeks.

[0066] (4) Improved prescription group: The patients were treated with the above improved prescription (10g of Pinellia ternata, 10g of dried tangerine peel, 30g of Poria cocos, 6g of roasted licorice root, 10g of bamboo shavings, 10g of Citrus aurantium, 10g of scorched Shenqu, and 10g of chicken gizzard lining) Chinese herbal decoction (oral administration) for 2 weeks.

[0067] Table 1 Tumor types and groups

[0068] Tumor type / group Negative control group Original prescription Wen Dan Tang group Additive Group Improved group Gastric cancer 7 8 6 8 Bowel cancer 6 5 6 5 lung cancer 7 6 8 8 Breast cancer 10 11 10 9

[0069] 3. Patient's general information

[0070] The gender of the patients in each group is shown in Table 2 below, and the age of the patients in each group is shown in Table 3 below.

[0071] Table 2 Gender of patients in each group

[0072] Gender / Group Negative control group Original prescription Wen Dan Tang group Additive Group Improved group male 17 15 14 16 female 13 15 16 14

[0073] Table 3 Age of patients in each group

[0074]

[0075]

[0076]

[0077] 4. Diagnostic criteria

[0078] Western medicine diagnostic standards: The diagnostic standards for malignant tumors are based on the NCCN 2022 Guidelines for the Diagnosis and Treatment of Malignant Tumors. The clinical diagnosis and pathological examination of traditional Chinese medicine are consistent with malignant tumors and meet the indications for chemotherapy.

[0079] Traditional Chinese Medicine diagnostic criteria: formulated with reference to the relevant content of spleen and stomach damp-heat syndrome in the "Guiding Principles for Clinical Research of New Chinese Medicines".

[0080] 5. Inclusion and exclusion standards

[0081] (1) Inclusion criteria: ① Patients diagnosed with malignant tumors by pathological biopsy and receiving chemotherapy for the first time; ② Expected survival time > 3 months; ③ Age 18 ≤ ≤ 75 years; ④ Blood routine, liver and kidney function, and electrocardiogram examinations before treatment indicated no contraindications to chemotherapy; ⑤ Systemic Karnofsky Health Status Score (KPS) ≥ 70 points; ⑥ No history of central nervous system disease (such as coma, epilepsy, etc.); ⑦ Subjects agreed to participate in this trial and signed the informed consent form, with good compliance and voluntary adherence to the treatment plan during the study.

[0082] (2) Exclusion criteria: ① Patients with nausea and vomiting symptoms within 24 hours before chemotherapy, or those who used sedatives or other antiemetic drugs within 24 hours before chemotherapy that affected the efficacy of chemotherapy; ② Patients with severe dysfunction of the heart, liver, kidney, or hematopoietic system, or a history of uncontrolled diabetes and hypertension; ③ Patients with mental illness, communication difficulties, or uncooperativeness; ④ Patients with intestinal obstruction, vestibular dysfunction, brain metastasis with increased intracranial pressure, and / or other diseases that may cause or aggravate nausea and vomiting symptoms; ⑤ Pregnant and lactating women; ⑥ Patients who have difficulty taking oral medications or have oral medication absorption disorders.

[0083] 6. Nausea and vomiting grading evaluation criteria

[0084] The nausea and vomiting grading evaluation criteria are shown in Table 4 below.

[0085] Table 4 Nausea and vomiting grading evaluation criteria

[0086]

[0087]

[0088] 7. Evaluation criteria for nausea and vomiting

[0089] The evaluation criteria for nausea and vomiting are shown in Table 5 below.

[0090] Table 5 Evaluation criteria for nausea and vomiting

[0091]

[0092] 8. Experimental Results

[0093] The therapeutic efficacy results of each group are shown in Table 6 below. The results show that the efficacy of the improved prescription group prepared by the present invention in relieving chemotherapy vomiting is as high as 86.67%, which is significantly better than the original prescription Wen Dan Tang group (66.67%) and the additive group (23.33%). The CI value calculated using King's formula is 86.67% / [66.67%+23.33%-(66.67%*23.33%)]=1.1642>1.15, indicating that the combination of the original prescription Wen Dan Tang and the additive has a synergistic therapeutic effect on relieving chemotherapy vomiting. This result is a technical effect that is unexpected by those skilled in the art based on the content disclosed in the prior art.

[0094] Table 6 Treatment efficacy results of each group

[0095]

[0096]

Claims

1. A Chinese medicine composition for relieving chemotherapy-induced vomiting, characterized in that: The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 5-15 grams of pinellia, 5-15 grams of dried tangerine peel, 25-35 grams of poria, 1-11 grams of roasted liquorice, 5-15 grams of bamboo shavings, 5-15 grams of immature bitter orange, 5-15 grams of scorched Shenqu, and 5-15 grams of chicken's gizzard lining.

2. The Chinese medicine composition according to claim 1, characterized in that The Chinese medicine composition is composed of the following raw materials in parts by weight: 10 grams of pinellia, 10 grams of dried tangerine peel, 30 grams of poria, 6 grams of roasted liquorice, 10 grams of bamboo shavings, 10 grams of immature bitter orange, 10 grams of scorched Shenqu, and 10 grams of chicken's gizzard lining.

3. A pharmaceutical preparation for relieving chemotherapy vomiting, characterized in that: The active ingredient of the pharmaceutical preparation is the traditional Chinese medicine composition according to claim 1 or 2.

4. The pharmaceutical preparation according to claim 3, characterized in that The pharmaceutical preparation comprises a pharmaceutically acceptable excipient.

5. The pharmaceutical preparation according to claim 4, characterized in that The pharmaceutically acceptable excipients are fillers, binders, surfactants and / or lubricants.

6. The pharmaceutical preparation according to claim 3, characterized in that The dosage form of the pharmaceutical preparation is an oral dosage form or an injection dosage form.

7. The pharmaceutical preparation according to claim 6, characterized in that The oral dosage form is decoction, pill, powder, granule, tablet, capsule or pill.

8. A method for preparing the Chinese medicine composition according to claim 1 or 2, characterized in that: The method comprises the following steps: weighing the raw materials according to the ratio of the Chinese medicinal materials, decocting them in water for extraction, filtering, and combining the extracts to prepare the Chinese medicinal composition.

9. Use of the traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a medicament for alleviating chemotherapy-induced vomiting.

10. Use of the pharmaceutical preparation according to any one of claims 3 to 7 in the preparation of a medicament for alleviating chemotherapy emesis.

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