A composition for treating tumor treatment-related thrombocytopenia and its preparation method and application

Abstract

The present invention relates to the field of medicine and food technology, and more particularly to a composition with a function of improving thrombocytopenia, a preparation method thereof, and an application thereof. The composition provided by the present invention comprises the following components in parts by weight: 20-40 parts of Chinese pine knots, 20-40 parts of herba agrimonii, 10-20 parts of raw atractylodes macrocephala, 5-20 parts of antler frost, 10-30 parts of donkey hide gelatin beads, 15-40 parts of Spatholobi vine and 5-20 parts of Leonurus japonicus; wherein, the Chinese medicine composition ... herba agrimonii; wherein, the Chinese medicine composition comprises the following components in parts by weight: 20-40 parts of Chinese pine knots, 20-40 parts of herba agrimonii, 10-20 parts of herba agrimonii; wherein, the Chinese medicine composition comprises the following components in parts by weight: 20-40 parts of Chinese pine knots, 20-40 parts of herba agrimonii, 10-20 parts of herba agrimonii; wherein, the Chinese medicine composition comprises the following components in parts by weight: 20-40 parts of Chinese pine knots, 20-40 parts of herba agrimon

Description

Technical Field

[0001] The present invention relates to the technical field of medicine and food, and relates to a composition capable of improving thrombocytopenia, a preparation method and an application thereof. Background Art

[0002] Cancer therapy-related thrombopenia (CTRT) refers to decreased platelet production or / and increased platelet destruction caused by anti-tumor therapy, with clinical manifestations of peripheral blood platelet counts below 100×10 9 / L. CTRT is one of the most common hematological toxicities associated with cancer treatment. It not only increases the risk of bleeding and prolongs hospitalization, but can also lead to death in severe cases. Based on the pathogenesis, cancer treatment-related thrombocytopenia can be divided into drug-induced non-immune thrombocytopenia and drug-induced immune thrombocytopenia. The pathogenesis of drug-induced non-immune thrombocytopenia is that bone marrow megakaryocytes are affected by the cytotoxic effect of drugs, causing megakaryocyte proliferation and differentiation disorders, leading to a decrease in platelet count. Common chemotherapy drugs include paclitaxel, capecitabine, and gemcitabine, with an incidence of 16.5%-21.8%; drug-induced immune thrombocytopenia is caused by the binding of antibodies to platelets in the body, causing platelet activation, clearance, and destruction, thereby causing a decrease in platelet count. It is often related to targeted drug therapy or immunotherapy. Long-term chemotherapy can also cause autoimmune thrombocytopenia, with an incidence of 8% (1%-28%), and grade 3-4 thrombocytopenia is 4.3%.

[0003] According to the "Guidelines for the Diagnosis and Treatment of Thrombocytopenia Induced by Cancer Therapy" (2023 edition) of the Chinese Society of Clinical Oncology, the treatment of thrombocytopenia caused by chemotherapy includes two major categories: platelet transfusion and administration of platelet-stimulating growth factors. Platelet-stimulating growth factors include recombinant human interleukin 11 (rhIL-11), recombinant human thrombopoietin (rhTPO) and thrombopoietin receptor agonists (TPO-RA), etc., with an effective rate of about 70%. 25.6% of patients have delayed chemotherapy cycles and reduced chemotherapy drug doses, which affects the anti-tumor treatment effect and shortens the patient's survival. Drug-induced immune thrombocytopenia is mainly treated by reducing the dose or stopping the drug. At present, the main clinical treatment is hormone or immunoglobulin palliative treatment, and there is still a lack of effective treatment drugs.

[0004] According to the "Expert Consensus on the Clinical Management of Cancer-Related Thrombocytopenia," Traditional Chinese Medicine (TCM) management of cancer-related thrombocytopenia is recommended for patients with grade 1-2 thrombocytopenia. For patients with grade 3-4 thrombocytopenia and a severe bleeding tendency, TCM therapy is recommended in addition to Western medicine. TCM treatment focuses on strengthening the spleen and kidneys, replenishing qi and nourishing blood, and clearing heat and cooling blood. Traditional Chinese medicine formulas include Bazhen Decoction, Guipi Decoction, Zuogui Pills, and Taohong Siwu Decoction, along with modified versions. Traditional Chinese medicines include Weixuening Granules, Fufang Zaofan Pills, Yixuesheng Capsules, Zaizaoshengxue Capsules, and Xuesusheng Granules. However, their effectiveness lacks large-scale evidence-based support.

[0005] Therefore, there is an urgent need for a composition that can effectively improve thrombocytopenia. Summary of the Invention

[0006] Based on this, the present invention aims to provide a composition that improves thrombocytopenia. This Chinese medicine composition targets CTRT and utilizes the synergistic effects of the active ingredients of multiple Chinese medicinal herbs to nourish the spleen and kidneys, replenish qi and strengthen blood, achieving the goal of treating tumor-related thrombocytopenia with significant efficacy.

[0007] To achieve the above-mentioned objectives, in a first aspect, the present invention provides a composition with the function of improving thrombocytopenia, comprising the following raw materials in the following weight ratios: 20-40 parts of Chinese pine knot, 20-40 parts of agrimony, 10-20 parts of raw Atractylodes macrocephala, 5-20 parts of antler frost, 10-30 parts of donkey-hide gelatin beads, 15-40 parts of Millettia reticulata and 5-20 parts of Leonurus japonicus.

[0008] Further, preferably, the raw materials are included in the following weight ratio: 30 grams of Chinese pine festival, 30 grams of agrimony, 15 grams of raw Atractylodes macrocephala, 10 grams of antler frost, 15 grams of donkey-hide gelatin beads, 30 grams of Millettia reticulata and 10 grams of Leonurus japonicus.

[0009] The present invention uses Chinese pine knot and agrimony as the main medicine, which is different from the existing Chinese medicine decoction and Chinese patent medicine. In this prescription, pine knot can replenish deficiency and strengthen the foundation, ventilate and harmonize blood, strengthen bones and produce marrow, and agrimony can strengthen the body and replenish deficiency, detoxify and stop bleeding. The two medicines are together the main medicines, and the compatibility can replenish deficiency and strengthen the foundation without retaining pathogenic factors, and detoxify and promote blood circulation without damaging the body. Atractylodes macrocephala can strengthen the spleen and replenish qi, and antler frost warms the kidney and supports yang. The two medicines can promote the mutual generation of fire and earth, assist the main medicines in nourishing the spleen and kidney, and strengthen the spleen and blood. Donkey-hide gelatin beads nourish blood and nourish yin, and when used together with pine knot, they can replenish without damaging its yin. Millettia reticulata can replenish and strengthen the body, promote blood circulation and stop bleeding, and enhance the effect of increasing platelets. Motherwort is good at promoting blood circulation and removing blood stasis, and enhances the power of blood consolidation. The three medicines are the main medicines for blood diseases, so as to achieve the effect of tonifying the spleen and kidney and replenishing qi and consolidating blood. The entire prescription is short and concise, with an ingenious conception. The combination of the seven medicines can promote the mutual generation of yin and yang, and replenish qi and blood to achieve the purpose of nourishing the spleen and kidneys, replenishing qi and consolidating blood, so as to treat thrombocytopenia related to tumor treatment.

[0010] The present invention is mainly applicable to various thrombocytopenias caused by tumor radiotherapy, targeted therapy and immunotherapy, and has a good clinical effect for those with drug-induced immune thrombocytopenia, which fills the gap of the current Chinese patent medicine for thrombocytopenia related to tumor treatment. Considering that tumor treatment-related thrombocytopenia is mainly caused by platelet biochemical inactivity, platelet destruction and abnormal platelet distribution, the whole prescription makes platelet biochemical active by nourishing the spleen and kidney, replenishing qi and generating blood; then protect platelets by strengthening the spleen and taking in blood to avoid platelet destruction; at the same time, Millettia reticulata and Leonurus japonicus are used to open the orifices and activate blood circulation to improve platelet distribution, thereby achieving the treatment of tumor treatment-related thrombocytopenia, especially for drug-induced immune thrombocytopenia. The effect is better. Furthermore, the prescription can improve the patient's fatigue symptoms, improve physical strength, and has a certain anti-tumor effect, and is fast-acting, less medicinal, economical and practical, non-toxic, no adverse reactions, good safety, and therefore has further transformation significance.

[0011] Specifically, Pinus tabulaeformis is warm in nature, bitter and pungent in flavor. It enters the Liver and Kidney meridians. Pinus tabulaeformis and Pinus massoniana pine primarily contain cellulose, lignin, a small amount of volatile oil (turpentine), and resin. The volatile oil contains over 90% α- and β-pinene. It also contains small amounts of camphor, dipentene, and oil. Pinus tabulaeformis pine pine also contains ursolic acid and isopimaric acid. It dispels wind and dampness, clears meridians, and relieves pain. It is classified as a rheumatic and bone-strengthening medicine, a subcategory of anti-rheumatic drugs.

[0012] Agrimony is neutral in nature, with a bitter and astringent taste. It enters the Heart and Liver meridians. It contains agrimonin, agrimolol, tannins, sterols, organic acids, phenolic compounds, saponins, flavonoid glycosides, kaempferol-7-rhamnoside, rutin, luteolin-7-glucoside, and gallic acid. It has anticoagulant and antithrombotic properties, anti-tumor effects, and a potent anti-Trichomonas vaginalis activity. Agrimonin has hemostatic, heart rate-regulating, cellular resistance-enhancing, blood sugar-lowering, and anti-inflammatory properties. The winter buds contain the phenolic compound agrimonol. The winter buds and roots have a strong tapeworm-repelling effect and exhibit inhibitory effects against Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Shigella flexneri, and Salmonella typhi.

[0013] Raw Atractylodes macrocephala is the dried rhizome of the Atractylodes macrocephala plant, a member of the Asteraceae family. It enters the spleen and stomach meridians, has a bitter, sweet flavor, and is warm in nature. It strengthens the spleen and replenishes qi, eliminates dampness and promotes diuresis, stops sweating, and stabilizes pregnancy.

[0014] Deer Antler Frost is salty and warming. It enters the Liver and Kidney Meridians. It warms the kidneys and boosts yang, astringes and stops bleeding. It is used for impotence of the spleen and kidneys, loss of appetite, vomiting and diarrhea, leucorrhea, enuresis, frequent urination, metrorrhagia, and carbuncle and phlegm nodules.

[0015] Donkey hide gelatin beads nourish yin and moisten the lungs, and are used to treat irritability, insomnia, cramps and other symptoms caused by yin deficiency and excessive fire. They can also treat cough, asthma and hemoptysis caused by lung yin deficiency.

[0016] Millettia spathiphyllum contains a variety of isoflavones, dihydroflavonoids, chalcones, pseudoestrolactones, triterpenes, sterols, epidiolecanol, darutoside, formononetin, epicatechin, and aloe-emodin. It nourishes the blood, activates blood circulation, and dredges the meridians. It is a blood-activating and menstrual-regulating herb, classified under the category of blood-activating and stasis-removing herbs. It has vasodilatory, anti-platelet aggregation, and phosphorus metabolism-promoting properties. Its decoction has a mild inhibitory effect on isolated and in vivo toad hearts. It also increases blood cell count and hemoglobin in mature rabbits and enhances uterine rhythmic contractions. It regulates blood lipids and combats atherosclerosis. Taking 10-20 ml of Millettia spathiphyllum syrup three times daily is effective in treating anemia. "Shengbai Granules" or "Jijia Shengbai Decoction," with Millettia spathiphyllum as the main ingredient, have shown good clinical efficacy in treating leukopenia. It can also treat rheumatoid arthritis, lupus erythematosus, thrombocytopenia, and acute diarrhea.

[0017] The whole herb of Leonurus contains leonurine, stachydrine, leonuridine, and motherwort diterpenes and pro-leonurine diterpenes. The aerial parts contain volatile oils. They promote blood circulation, regulate menstruation, and act as a diuretic and reduce swelling. It is classified as a blood-activating and menstruation-regulating drug under the category of blood-activating and stasis-removing drugs. It has uterine stimulation, increased coronary artery flow, improved microcirculation, dilated peripheral blood vessels, and lowered blood pressure. It also has diuretic and anti-dermatophyte effects. It contracts uterine smooth muscle and significantly increases coronary artery flow and heart rate in ischemic myocardium. It also inhibits platelet aggregation and thrombosis, enhances cellular immunity, and stimulates the respiratory center at low doses, while high doses inhibit it. Low doses can relax the tone of isolated intestinal tract and increase the amplitude of vibrations, while high doses reduce the amplitude and increase the frequency of vibrations. It is significantly effective in treating early-stage ischemic acute renal failure, with a significant increase in urine output. It exhibits a curare-like effect on neuromuscular specimens and has a limited anti-dermatophyte effect in vitro. At high concentrations, it can cause hemolysis in blood suspensions.

[0018] Those skilled in the art know that drug compatibility is different from conventional composition formulation. Even if two medicinal materials are effective in a certain aspect, their combination does not necessarily produce an additive effect or synergistic effect, and there may also be a situation where the effects are offset. At present, the interaction between hepatoprotective medicinal materials has not yet been mastered in this field, making it difficult to determine suitable medicinal materials to produce a synergistic effect after compatibility. Therefore, how to select suitable composition combinations from the numerous existing medicinal materials that nourish the spleen and kidneys and replenish qi and consolidate blood to produce a synergistic effect and avoid the antagonism of their effects is one of the technical difficulties of the present invention.

[0019] At the same time, according to existing research results, the effects of traditional Chinese medicine compositions in this field are relatively single, either solely improving anemia and other blood cell reductions through the traditional Chinese medicine mechanism, or inhibiting tumors and improving thrombocytopenia from the perspective of regulating the intestines and removing blood stasis. However, there is no traditional Chinese medicine composition that can significantly improve thrombocytopenia associated with the treatment of multiple tumors. Therefore, the traditional Chinese medicine composition described in the present invention has made a very important contribution to the treatment of thrombocytopenia associated with the treatment of multiple tumors.

[0020] In a second aspect, the present invention also protects a method for preparing the above composition. The components are mixed, soaked in cold water, and then boiled; after filtering out the first medicinal solution, water is added for decoction, and the two filtrates are combined to obtain a combined solution.

[0021] In a third aspect, the present invention also protects the use of the above composition in the preparation of medicines or health foods for improving thrombocytopenia.

[0022] Furthermore, preferably, the medicine or health product is one of capsules, tablets, granules, pills and oral liquids.

[0023] The composition for improving thrombocytopenia of the present invention, as well as its preparation method and application, has the following beneficial effects:

[0024] 1. The Chinese medicine composition of the present invention has scientific compatibility, definite efficacy, high safety and controllable quality;

[0025] 2. The Chinese medicine composition of the present invention makes platelet biochemically active by nourishing the spleen and kidneys, replenishing qi and generating blood; then protects platelets by strengthening the spleen and absorbing blood, thereby avoiding platelet destruction; at the same time, it uses Millettia reticulata and Motherwort to open the orifices and promote blood circulation to improve platelet distribution, thereby achieving the purpose of treating tumor-related thrombocytopenia, especially for drug-induced immune thrombocytopenia.

[0026] 3. The Chinese medicine composition of the present invention has multiple pathways of action, multiple drug targets, and a unique mechanism of action. The drugs target key pathological links and have significant efficacy in improving thrombocytopenia.

[0027] 4. The composition of the present invention can improve patients' fatigue symptoms, increase physical strength, and has a certain anti-tumor effect. It has a fast onset of action, less medicinal taste, is economical and practical, has no toxic taste, and has not been found to have any adverse reactions. DETAILED DESCRIPTION

[0028] The technical solutions of the present invention will be described clearly and completely below in conjunction with the embodiments of the present invention. Obviously, the embodiments described are only a part of the embodiments of the present invention, rather than all the embodiments. The following description of at least one exemplary embodiment is actually only illustrative and is in no way intended to limit the present invention and its application or use. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention. The composition with the function of improving thrombocytopenia provided by the present invention is described below in conjunction with the embodiments.

[0029] Example 1

[0030] Obtain the following raw materials in the following weight ratio: 30 grams of Chinese pine festival, 30 grams of herb Agrimoniae, 15 grams of raw Atractylodes macrocephala, 10 grams of antler frost, 15 grams of donkey-hide gelatin beads, 30 grams of Millettia reticulata and 10 grams of Leonurus japonicus.

[0031] Mix all the components, soak in cold water and boil; filter out the first medicinal solution, add water and boil, combine the two filtrates to obtain a combined solution; use the combined solution as the first medicinal solution.

[0032] Example 1

[0033] From June 2021 to June 2023, 100 patients aged 18-75 years who met the diagnostic criteria for cancer therapy-related thrombocytopenia were selected from the outpatient and inpatient departments of the Department of Integrated Traditional Chinese and Western Medicine at the China-Japan Friendship Hospital. According to the Expert Consensus on the Clinical Management of Cancer Therapy-Related Thrombocytopenia, cancer therapy-related thrombocytopenia refers to decreased platelet production or (and) increased platelet destruction caused by anti-tumor therapy, with clinical manifestations of peripheral blood platelet counts below 100 × 10 9 / L. The above patients were divided into an observation group and a control group, with 50 patients in each group. The patients in the observation group took the above-mentioned preparation examples of Medicament 1, Medicament 2, and Medicament 3, respectively; one dose per day, one bag each in the morning and evening; 21 days as a course of treatment. The control group received Western medicine treatment combined with a traditional Chinese medicine decoction; the traditional Chinese medicine decoction was made of 20g of Astragalus, 12g of Donkey-hide Gelatin, 6g of Deer Horn Glue, 15g of Pine Kernel, 10g of Agrimony Root, 15g of Millettia Reticulata, 12g of Psoralea Corylifolia, and 6g of Raw Licorice; the dosage was also one dose per day, one bag each in the morning and evening; 21 days as a course of treatment.

[0034] After using traditional Chinese medicine, blood tests were repeated, and platelet counts were monitored and compared with pre-treatment values. The number of patients who experienced bleeding events during treatment and the number of patients who required platelet transfusions were also recorded. Changes in the observation and control groups before and after treatment are shown in Tables 1-3.

[0035] Table 1 Comparison of PLT levels before and after treatment in two groups of patients with thrombocytopenia caused by tumor treatment (*10 9 / L)

[0036]

[0037] Table 2 Comparison of clinical efficacy between the two groups of patients with thrombocytopenia caused by tumor treatment

[0038]

[0039] Note: Effective rate = markedly effective + effective / total number of cases; markedly effective: the patient's PLT count increased to 100×10 within one chemotherapy cycle 9 / L or above; effective: the patient's PLT level increased by 2 times within one chemotherapy cycle but still did not reach the normal level; ineffective: the patient's PLT level did not increase significantly after one chemotherapy cycle.

[0040] Table 3 The proportion of thrombocytopenia caused by the next cycle of tumor treatment in the two groups

[0041]

[0042] As can be seen from Tables 1-3, the increase in platelet count before and after treatment in the observation group was higher than that in the control group (P < 0.05, see Table 1). The clinical efficacy rate in the observation group was 90%, higher than that in the control group (64%) (P < 0.05, see Table 2). After treatment with the Chinese herbal decoction, the incidence of thrombocytopenia in the observation group during the next cycle of tumor treatment was significantly lower than that in the control group (P < 0.05, see Table 3). Among the 50 patients observed, no toxic side effects were observed after taking the Chinese herbal composition of the first agent of the present invention.

[0043] Effect Example 1

[0044] Yan, male, 67 years old, was diagnosed with thrombocytopenia related to tumor treatment. The use of Shengxue Pills, berbamine, aminopeptidase, etc. was ineffective, so he came to seek traditional Chinese medicine treatment. The patient had intermittent low back pain without obvious cause in January 2017. CT showed a mass in the right kidney, so he underwent laparoscopic right nephrectomy in our hospital in February 2017. Postoperative pathology showed right renal clear cell carcinoma, invading the renal capsule. In May 2021, he developed cough and shortness of breath after activity. CT showed a large amount of right pleural effusion, a soft tissue mass in the right lower lung, and pleural nodules in both lungs. Puncture pathology suggested metastasis of renal clear cell carcinoma. On June 4, 2021, he started taking sunitinib malate capsules (50 mg, qd, take the medicine for 4 weeks and stop for 2 weeks). On October 13, 2022, considering that CT showed that the soft tissue mass in the right lung was larger than before, the targeted drug was adjusted to axitinib 5 mg, bid treatment. On October 20, 2022, the blood routine test showed that the platelet count was 44*10 9 / L, the rest is normal, diagnosed as tumor treatment-related thrombocytopenia grade III. Symptoms include fatigue, sallow complexion, low voice, good appetite, good sleep, normal bowel movements, pale red tongue with ecchymosis, less fur, and weak pulse. Chinese medicine diagnosed it as spleen and kidney deficiency, insufficient qi and blood. Chinese medicine treatment adopts nourishing the spleen and kidney, replenishing qi and blood. Administer the second medicine obtained in Preparation Example 2 of the present invention, and tell the patient to decoct it in water, one course of treatment for 3 weeks, one dose per day, divided into 2 parts, one part each morning and evening for treatment. The platelet count was checked on October 23, 2022 and was 46*10 9 / L. On October 26, 2022, the platelet count was 57*10 9 / L. On October 30, 2022, the platelet count was 107*10 9 / L. On November 5, 2022, the platelet count was 189*10 9 / L, returned to normal, and the patient's symptoms such as fatigue and sallow complexion improved.

[0045] Effect Example 2

[0046] Mr. Shao, a 63-year-old male, presented to the Aerospace General Hospital four months prior (May 10, 2022) due to fatigue and weight loss. An MRI examination revealed biliary obstruction, pancreatic duct dilatation, and unclear pancreatic head structure. PET-CT revealed a mass in the pancreatic head and neck, multiple metastatic lymph nodes in the peritoneum, and thickening of the soft tissue around the common bile duct. MRCP suggested the possibility of pancreatic cancer, with secondary dilatation of the intrahepatic bile duct and pancreatic duct, and enlarged lymph nodes in the portal area and retroperitoneum. Tumor markers on May 20, 2022, showed CA50 41.07 U / ml, CA199 51 U / ml, and CA125 193 U / ml. The patient was considered to have pancreatic cancer with metastasis to the portal and retroperitoneal lymph nodes. From June 10 to August 2, 2022, he was given albumin-paclitaxel 200mg d1, 100mg d8, combined with S-1a 40mg bid d1-14, for three cycles of 21-day regimen. During this period, thrombocytopenia recurred and was restored to normal after administration of recombinant human thrombopoietin. However, swelling of the right lower limb occurred, and the coagulation index D-dimer was 6.5, which was higher than before. Lower limb venous ultrasound showed lower limb thrombosis, and low molecular weight heparin anticoagulation treatment was given. On September 7, 2022, platelets reappeared after chemotherapy, with a value of 64*10 9 / L, diagnosed with tumor treatment-related thrombocytopenia grade 2. Chemotherapy was discontinued. Considering the patient had thrombosis, recombinant human thrombopoietin was not given again, and Shengxue Pills and Shengxue Platelet Capsules were given for 6 days. Platelet count was rechecked on September 13, 2022, 67*10 9 / L, platelet increase is not obvious, symptoms include: fatigue, poor appetite, sallow complexion, normal bowel movements, pale tongue with thin white fur, and deep and thin pulse. TCM diagnosis: spleen and kidney deficiency, insufficient qi and blood. TCM treatment: nourish the spleen and kidney, replenish qi and blood. The patient was given Songhe Guxue Recipe and was told to decoct it in water for 3 weeks as a course of treatment, 1 dose per day, divided into 2 parts, 1 part each morning and evening for treatment. On October 13, 2022, after taking the medicine for 1 month, the platelet count was 97*10 9 / L. Considering that the platelet count has recovered to level 1 and the symptoms such as fatigue and anorexia have improved, the original chemotherapy regimen was started on the same day, and Songhe Guxue Fang was given to prevent and treat thrombocytopenia. The platelet count was 109*10 on November 23, 2022. 9 / L, and continued chemotherapy. After that, he continued to use Chinese medicine to maintain his condition and did not experience thrombocytopenia again.

[0047] Example 2

[0048] Obtain the following raw materials in the following weight ratio: 20 parts of Chinese pine festival, 40 parts of herba agrimonii, 20 parts of raw atractylodes macrocephala, 5 parts of antler frost, 10 parts of donkey-hide gelatin beads, 15 parts of millettia reticulata and 5 parts of motherwort.

[0049] Mix all the components, soak in cold water and boil; filter out the first medicinal solution, add water and boil, combine the two filtrates to obtain a combined solution; use the combined solution as the first medicinal solution.

[0050] Example 3

[0051] Obtain the following raw materials in the following weight ratio: 40 grams of pine festival, 20 grams of herb agrimony, 10 grams of raw atractylodes, 20 grams of antler frost, 30 grams of donkey-hide gelatin beads, 40 grams of Millettia reticulata and 20 grams of motherwort.

[0052] Mix all the components, soak in cold water and boil; filter out the first medicinal solution, add water and boil, combine the two filtrates to obtain a combined solution; use the combined solution as the third medicinal agent.

[0053] Example 4

[0054] Obtain the following raw materials in the following weight ratio: 25 grams of Chinese pine festival, 35 grams of herb agrimony, 14 grams of raw Atractylodes macrocephala, 18 grams of antler frost, 15 grams of donkey-hide gelatin beads, 30 grams of Millettia reticulata and 15 grams of motherwort.

[0055] Mix all the components, soak in cold water and boil; filter out the first medicinal solution, add water and boil, combine the two filtrates to obtain a combined solution; use the combined solution as the third medicinal agent.

[0056] The efficacy test method of Example 1 was used to conduct efficacy tests on the compositions obtained in Examples 2, 3, and 4. The results showed that the efficacy of the drug combinations obtained in Examples 2, 3, and 4 in improving thrombocytopenia was slightly worse than that of Example 1, but the overall efficacy trend was the same as that of Example 1, and all showed improvement in patients' fatigue symptoms, increased physical strength, and tumor inhibition.

[0057] In specific implementations, if long-term clinical use is required, solid preparations can be formulated for easy storage and convenient patient administration, which is more adaptable to market demand. Preferred dosage forms include capsules, granules, and tablets. These preparations contain the aforementioned Chinese medicine composition and pharmaceutically acceptable excipients. The pharmaceutical excipients used may include starch, dextrin, lactose, microcrystalline cellulose, gelatin, sucrose, magnesium stearate, and the like.

[0058] The composition of the present invention can be used as a therapeutic drug and preventive drug for preventing and / or treating tumor therapy-related thrombocytopenia, especially drug-induced immune thrombocytopenia, and the dosage can be adjusted according to actual needs.

[0059] The composition of the present invention having the function of improving thrombocytopenia, and its preparation method and application, the Chinese medicine composition of the present invention has scientific compatibility, definite efficacy, high safety, and controllable quality; the Chinese medicine composition of the present invention makes platelet biochemically active by nourishing the spleen and kidney, replenishing qi and generating blood; then protects platelets by strengthening the spleen and absorbing blood, avoiding platelet destruction; at the same time, Millettia reticulata and Leonurus japonicus are used to open the orifices and promote blood circulation to improve platelet distribution, thereby achieving the treatment of tumor treatment-related thrombocytopenia, especially for drug-induced immune thrombocytopenia. The Chinese medicine composition of the present invention has multiple pathways of action, multiple drug action targets, and a unique mechanism of action. The drugs target key pathological links, and the drugs have significant efficacy in improving thrombocytopenia. The composition of the present invention has the functions of improving patients' fatigue symptoms, increasing physical strength, and having a certain anti-tumor effect, with a fast onset of action, less medicinal taste, economical and practical, non-toxic medicinal taste, and no adverse reactions.

[0060] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not limiting. Although the present invention 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 invention may be modified or replaced by equivalents without departing from the spirit and scope of the technical solutions of the present invention.

Claims

1. A composition for treating thrombocytopenia associated with tumor treatment, characterized in that: The raw material medicine is made of the following components in parts by weight: 20-40 parts of Chinese pine festival, 20-40 parts of herba agrimonii, 10-20 parts of raw atractylodes macrocephala, 5-20 parts of antler frost, 10-30 parts of donkey hide gelatin beads, 15-40 parts of millettia reticulata and 5-20 parts of motherwort.

2. The composition according to claim 1, characterized in that The raw medicine is prepared from the following components in parts by weight: 30 grams of Chinese pine knot, 30 grams of agrimony, 15 grams of raw atractylodes, 10 grams of antler frost, 15 grams of donkey-hide gelatin beads, 30 grams of Millettia reticulata and 10 grams of motherwort.

3. The method for preparing the composition according to claim 1 or 2, characterized in that: Mix all the components, soak in cold water and boil; filter out the first medicinal solution, add water and boil, combine the two filtrates to obtain a combined solution.

4. Use of the composition according to claim 1 or 2 in the preparation of a medicament for treating thrombocytopenia associated with tumor therapy.

5. The use according to claim 4, characterized in that The medicine is one of capsules, tablets, granules, pills and oral liquid.

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