Medicine for treating myelosuppression after chemotherapy and preparation method thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicine, discloses a medicine for treating myelosuppression after chemotherapy and a preparation method thereof, and relates to the field of traditional Chinese medicine, and the key point of the technical scheme is that the medicine comprises 30-80 parts of astragalus membranaceus, 10-60 parts of angelica sinensis, 15-40 parts of fructus psoraleae, 15-40 parts of madder, 15-40 parts of polygonum cuspidatum, 10-40 parts of rhizoma curculiginis, 20-50 parts of herba epimedii, 10-30 parts of donkey-hide gelatin beads and 10-20 parts of liquorice. The traditional Chinese medicine has multiple treatment effects of replenishing qi and enriching blood, clearing heat and cooling blood, dispersing blood stasis and stopping bleeding, tonifying kidney and supporting yang, replenishing essence and blood and the like, so that a positive treatment effect on myelosuppression after chemotherapy is achieved.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and more specifically, relates to a medicine for treating post-chemotherapy bone marrow suppression and a preparation method thereof. Background Art

[0002] Bone marrow suppression is one of the common adverse reactions after chemotherapy, which is mainly manifested by "decreased peripheral blood leukocytes, or even pancytopenia", or symptoms such as anemia and bleeding, and even serious infection, which prevents patients from completing follow-up treatment. Chemotherapy is like a "double-edged sword". On the one hand, chemotherapy is one of the most effective means of treating malignant tumors in the world today. On the other hand, while it kills malignant tumor cells, it can cause bone marrow suppression. In mild cases, it affects follow-up treatment, and in severe cases, it may cause death due to the complications it brings. Therefore, preventing and treating bone marrow suppression after chemotherapy is the key to ensuring the continuation of chemotherapy and improving clinical efficacy.

[0003] Modern medicine believes that bone marrow suppression can be divided into two types: acute and chronic. Most chemotherapy drugs, such as alkylating agents, pyrimidine analogs, anthracyclines, nitrosoureas, methotrexate, etc., are highly toxic to the bone marrow, causing the attenuation of hematopoietic progenitor cells (HPCs), leading to the occurrence of acute bone marrow suppression. Acute bone marrow suppression usually occurs within a short time after chemotherapy, and our body can promote bone marrow hematopoietic recovery by applying hematopoietic growth factors (HGFs). However, if the chemotherapy regimen selects drugs that are highly selectively toxic to hematopoietic stem cells (HSCs), such as carboplatin and busulfan, it will lead to the depletion of HPCs, and at the same time cause the decrease of HSCs reserve and self-renewal ability, resulting in chronic bone marrow damage. At present, it is believed that the pathogenesis of chemotherapy-induced bone marrow suppression is mainly related to the aging and apoptosis of multipotent hematopoietic stem cells (HSCs) and the damage of the bone marrow hematopoietic microenvironment.

[0004] In western medicine, white blood cell increase, anemia correction and platelet increase are currently adopted, and blood transfusion is performed when necessary. However, patients often respond that bone or muscle pain occurs after using white blood cell increase injections, and white blood cell counts cannot be increased quickly without injections, which delays the follow-up treatment time. In the long-term treatment process of traditional Chinese medicine, rich clinical experience has been accumulated and good curative effects have been achieved. Traditional Chinese medicine believes that bone marrow suppression can be attributed to the categories of "deficiency" and "blood deficiency". "Lingshu. Jueqi" states: "The middle jiao receives qi and takes juice, which changes and turns red, which is called blood." "The Yellow Emperor's Classic of Internal Medicine" puts forward the theory that the kidney controls bone and produces marrow. "The Treatise on the Causes and Symptoms of Various Diseases" says: "Essence is formed by blood." When the kidney essence is full and the bone marrow is sufficient, qi and blood can be generated. The kidney is the foundation of the innate constitution, and the spleen and stomach are the foundation of the acquired constitution. The kidney is responsible for bone marrow production and storage of essence. The spleen and stomach are the source of Qi and blood production. The essence of water and grain transformed by the spleen and stomach is the main substance for the production of blood. The liver stores blood, essence can produce blood, and essence and blood are mutually generated. Qi and blood are the basic substances for human life activities, thus providing power for the human body.

[0005] Zhang Huahao and others systematically evaluated the efficacy of Bazhen Decoction in preventing and treating bone marrow suppression caused by tumor radiotherapy and chemotherapy, and found that Bazhen Decoction can effectively reduce the occurrence of bone marrow suppression in patients, improve the short-term treatment effect of tumors, alleviate the levels of WBC, NEU, and PLT damage caused by radiotherapy and chemotherapy, and improve the levels of CD3 and CD4 cells in patients' immune function. Wang Hongjun and others used moxibustion combined with modified Shengyang Yiwei Decoction to treat bone marrow suppression after chemotherapy in squamous cell lung cancer. The results showed that it can improve the bone marrow suppression caused by chemotherapy in squamous cell lung cancer, improve immune function, and have fewer adverse reactions.

[0006] Therefore, inventing a drug for treating post-chemotherapy bone marrow suppression and a preparation method thereof has important practical significance. Summary of the invention

[0007] In order to overcome the shortcomings of the prior art, the present invention provides a Chinese medicine composition with a short treatment cycle, high safety and few side effects, which can have multiple therapeutic effects such as invigorating qi and blood, clearing away heat and cooling blood, removing blood stasis and stopping bleeding, invigorating the kidney and assisting yang, and invigorating essence and blood, thereby producing a positive therapeutic effect on bone marrow suppression after chemotherapy.

[0008] The Chinese medicine composition of the present invention comprises the following Chinese medicine raw materials in weight proportion: 30-80 parts of astragalus, 10-60 parts of angelica, 15-40 parts of psoralea, 15-40 parts of madder, 15-40 parts of knotweed, 10-40 parts of curculigo, 20-50 parts of epimedium, 10-30 parts of donkey-hide gelatin beads and 10-20 parts of liquorice.

[0009] Preferably, the present invention is further configured as follows: including 30 parts of astragalus, 10 parts of angelica, 15 parts of psoralea corylifolia, 15 parts of madder, 15 parts of knotweed, 10 parts of curculigo, 20 parts of epimedium, 10 parts of donkey-hide gelatin beads, and 10 parts of licorice.

[0010] Preferably, the present invention is further configured as follows: including 50 parts of astragalus, 30 parts of angelica, 20 parts of psoralea corylifolia, 20 parts of madder, 20 parts of knotweed, 20 parts of curculigo, 30 parts of epimedium, 20 parts of donkey-hide gelatin beads, and 15 parts of licorice.

[0011] Preferably, the present invention is further configured as follows: including 80 parts of astragalus, 60 parts of angelica, 40 parts of psoralea corylifolia, 40 parts of madder, 40 parts of knotweed, 40 parts of curculigo, 50 parts of epimedium, 30 parts of donkey-hide gelatin beads, and 20 parts of liquorice.

[0012] For the convenience of taking, the Chinese medicine composition can be made into a preparation with pharmaceutically acceptable excipients, and the pharmaceutically acceptable excipients are one or more of fillers, lubricants, disintegrants, binders, humectants, solvents, flavoring agents, preservatives, stabilizers, thickeners, colorants, and surfactants. Fillers: used to increase the volume of the drug or change the form of the drug, such as starch, dextrin, lactose, sucrose, etc.; Lubricants: used to reduce the friction between the drug and the equipment during the preparation process, such as magnesium stearate, talc, etc.; Disintegrants: help tablets disintegrate quickly in the body, such as microcrystalline cellulose, sodium carboxymethyl starch, etc.; Binders: used to increase the adhesion of particles or tablets, such as gum arabic, gelatin, polyvinyl pyrrolidone (PVP), etc.; Humectants: used to maintain the wetness of the drug, such as glycerin, propylene glycol, etc.; Solvents: used to dissolve drugs or excipients, such as water, ethanol, propylene glycol etc.; Flavoring agents: used to improve the taste of drugs, such as sugars, flavors, etc.; Preservatives: used to prevent preparations from spoiling, such as sodium benzoate, potassium sorbate, etc.; Stabilizers: used to increase the stability of drugs, such as antioxidants (such as vitamin C, vitamin E), chelating agents (such as EDTA), etc.; Thickeners: used to increase the viscosity of liquid preparations, such as carbomer, xanthan gum, etc.; Colorants: used to improve the appearance of drugs and make them more attractive, such as food coloring, etc.; Surfactants: used to improve the solubility and dispersibility of drugs and help drug extraction, such as Tween 80, Span 20, etc.

[0013] The preparation is in the form of a decoction, capsule, granule, oral solution, tablet, pill, tea, decoction or powder.

[0014] The present invention also provides a method for preparing a drug for treating post-chemotherapy bone marrow suppression, which specifically comprises the following steps:

[0015] S1: Weigh each component and pharmaceutical excipient according to the formula of claim 1, wherein the pharmaceutical excipient is crushed and then sieved, and the remaining medicinal materials are crushed into coarse powder;

[0016] S2: mixing the medicinal materials obtained in step S1, and decocting the obtained medicinal materials for multiple times;

[0017] S3: filtering and combining the decoctions obtained after each decoction in step S2 in sequence, thereby obtaining a drug for treating bone marrow suppression after chemotherapy.

[0018] Preferably, the present invention is further configured as follows: the number of times of decocting the medicinal materials in step S2 is 3 times, the first time using 12 times the amount of water for 3 hours, the second time using 8 times the amount of water for 2 hours, and the third time using 6 times the amount of water for 0.5 hours.

[0019] The pharmacological properties of the drug of the present invention are as follows:

[0020] Astragalus: sweet, slightly warm, enters the spleen and lung meridians, replenishes qi and raises yang, strengthens the body's defense system, promotes diuresis and reduces swelling, and promotes healing and tissue regeneration;

[0021] Angelica: sweet, warm, enters the liver and spleen meridians, promotes blood circulation, regulates menstruation and relieves pain, calms the mind, and protects the liver;

[0022] Psoralea corylifolia: bitter, warm, enters the lung, spleen, and kidney meridians, nourishes bones, nourishes yin and moistens dryness, nourishes the spleen and stomach, strengthens the kidneys and yang, and has anti-inflammatory and hemostatic effects;

[0023] Rubia cordifolia: bitter, slightly cold, enters the heart, liver, and large intestine meridians, clears away heat and detoxifies, cools blood and stops bleeding, promotes blood circulation and removes blood stasis, protects and nourishes the liver, and has antioxidant and anti-tumor properties;

[0024] Polygonum cuspidatum: pungent, bitter, warm, enters the liver and spleen meridians, detoxifies and reduces swelling, clears heat and cools blood, warms the uterus and dredges the meridians, nourishes the liver and calms the mind;

[0025] Curculigo: bitter, sweet, neutral, enters the heart, liver, and kidney meridians, clears away heat and detoxifies, promotes diuresis, soothes the liver and regulates qi, nourishes the kidneys and strengthens yang;

[0026] Epimedium: sweet, pungent, warm, enters the kidney meridian, nourishes the kidney and strengthens yang, warms the kidney and helps yang, replenishes essence and qi, strengthens the kidney and consolidates essence, has anti-inflammatory, antioxidant, and anti-tumor properties;

[0027] Donkey-hide gelatin: sweet, neutral, enters the liver, lung, and stomach meridians, nourishes yin and moistens dryness, nourishes blood and replenishes deficiency, promotes blood circulation and removes blood stasis, nourishes the liver and improves eyesight;

[0028] Licorice: sweet, neutral, enters the spleen, lung, and heart meridians, warms the middle and stops vomiting, nourishes the spleen and replenishes qi, moistens the lungs and stops coughing;

[0029] The prescription of the Chinese medicine composition of the present invention is explained as follows:

[0030] Astragalus and Angelica are the main drugs, which can replenish qi and blood, while Rubia can cool blood, stop bleeding and remove blood stasis.

[0031] Astragalus and Chinese angelica are the main ingredients of this prescription, which have the effect of invigorating qi and nourishing blood. Astragalus can enhance the body's immune function, strengthen the body's resistance, and promote blood production; Chinese angelica is rich in vitamins A, B12 and iron, which can stimulate the production of red blood cells and have a significant blood-tonifying effect; this can improve the low hematopoietic function after chemotherapy, thereby reducing the degree of bone marrow suppression.

[0032] Polygonum cuspidatum disperses blood stasis, and is combined with madder to further enhance the function of removing blood stasis. As the saying goes, "If old blood is not removed, new blood will not be produced. If blood stasis is removed, new blood will be produced day by day." It is the assistant medicine.

[0033] Rubia cordifolia and Polygonum cuspidatum are the auxiliary drugs of this prescription, which have the characteristics of clearing heat, cooling blood, removing blood stasis and stopping bleeding. Rubia cordifolia is rich in flavonoids, which have the effects of clearing heat, detoxifying, cooling blood and stopping bleeding; Polygonum cuspidatum contains multiple layers of sterols, which can promote blood circulation and remove blood stasis, and is helpful for treating heat toxicity symptoms and bleeding problems that may occur after chemotherapy; this helps to improve blood circulation, reduce inflammatory reactions, and promote blood purification and platelet production;

[0034] Donkey hide gelatin beads nourish blood and stop bleeding; Psoralea corylifolia, Curculigo orchioides, and Epimedium are used as adjuvants to nourish the kidney and boost yang, and to benefit essence and blood;

[0035] Psoralea corylifolia, Curculigo orchioides and Epimedium are adjuvants in this prescription, which have the effects of tonifying the kidney and strengthening yang, and benefiting the essence and blood. Chemotherapy often leads to kidney deficiency, yang deficiency and essence deficiency. Psoralea corylifolia, Curculigo orchioides and Epimedium are all traditional Chinese medicines that have the function of tonifying the kidney. They can promote the recovery of kidney function, increase the generation of yang, and replenish essence and blood, thereby improving the body's immune function and blood production function;

[0036] Licorice is mainly used as a guiding drug, and the whole formula has the functions of strengthening the spleen and kidney, replenishing qi and nourishing blood;

[0037] Licorice is the adjuvant of this prescription and has the function of harmonizing the properties of the medicine. Licorice contains ingredients such as glycyrrhizin, which has a mild nature and can harmonize the properties of other medicinal materials and enhance the overall effect of the prescription; licorice also has the function of tonifying the spleen and replenishing qi, which can increase the synthesis and absorption of human energy and improve the body's metabolism and immune function.

[0038] The medicine of the present invention is mainly used for treating deficiency of both qi and blood; the symptoms include pale or sallow complexion, pale lips and nails, palpitations and shortness of breath, mental fatigue and limb weakness, poor appetite, dizziness, pale and fat tongue, white fur, and thready and weak pulse, and the medicine has the effects of invigorating qi and nourishing blood.

[0039] In summary, the present invention has the following beneficial effects:

[0040] 1. The drug formula of the present invention mainly comprises a combination of drugs such as Astragalus, Angelica, Rubia, Polygonum cuspidatum, donkey-hide gelatin beads, Psoralea corylifolia, Curculigo orchioides, Epimedium and Licorice, and has multiple therapeutic effects such as invigorating qi and blood, clearing away heat and cooling blood, removing blood stasis and stopping bleeding, invigorating the kidney and assisting yang, and invigorating essence and blood, thereby producing a positive therapeutic effect on bone marrow suppression after chemotherapy;

[0041] 2. The present invention adopts the method of multiple decoctions to fully extract the effective ingredients in the medicinal materials, ensure the concentration and quality of the drugs, prepare different dosage forms, such as extracts and granules, which are convenient for patients to use and take. According to the nature and taste characteristics of the medicinal materials, reasonable proportions and combinations are achieved to achieve the balance of drug compatibility and the effect of mutual promotion. DETAILED DESCRIPTION

[0042] In order to make the purpose and technical solution of the present invention clearer, the present invention is further described below in conjunction with embodiments, but the protection scope of the present invention is not limited to these embodiments, and the embodiments are only used to explain the present invention. It should be understood by those skilled in the art that any changes or equivalent substitutions that do not deviate from the concept of the present invention are included in the protection scope of the present invention.

[0043] Pharmaceutical composition (granules) in Example 1

[0044] prescription:

[0045] Dosage(g) Astragalus 50 Angelica 30 Psoralea corylifolia 20 Rubia cordifolia 20 Knotweed 20 Curculigo 20 Epimedium 30 Ejiao beads 20 Licorice 15

[0046] Preparation method:

[0047] S1: Weigh each medicinal material according to the prescription amount, crush the mother-of-pearl and pass it through a 200-mesh sieve, and crush the remaining medicinal materials into coarse powder;

[0048] S2: Mix all the above medicinal materials, boil them for 3 hours with 12 times the amount of water for the first time, boil them for 2 hours with 8 times the amount of water for the second time, and boil them for 0.5 hours with 6 times the amount of water for the third time;

[0049] S3: filtering and combining the decoction obtained in step S2;

[0050] S4: concentrating the decoction in S3 into an extract having a relative density of 1.10-1.15 at 80° C.;

[0051] S5: Add 4 times the weight of the extract in S4 to sucrose powder;

[0052] S6: Mix evenly, granulate, dry and size the particles to obtain granules.

[0053] Directions: Take with boiled water, 10g at a time, 3 times a day.

[0054] Pharmaceutical composition (granules) in Example 2

[0055] prescription:

[0056]

[0057]

[0058] Preparation method:

[0059] S1: Weigh each medicinal material according to the prescription amount, crush the mother-of-pearl and pass it through a 200-mesh sieve, and crush the remaining medicinal materials into coarse powder;

[0060] S2: Mix all the above medicinal materials, boil them for 3 hours with 12 times the amount of water for the first time, boil them for 2 hours with 8 times the amount of water for the second time, and boil them for 0.5 hours with 6 times the amount of water for the third time;

[0061] S3: filtering and combining the decoction obtained in step S2;

[0062] S4: concentrating the decoction in S3 into an extract having a relative density of 1.10-1.15 at 80° C.;

[0063] S5: Add 4 times the weight of the extract in S4 to sucrose powder;

[0064] S6: Mix evenly, granulate, dry and size the particles to obtain granules.

[0065] Directions: Take with boiled water, 10g at a time, 3 times a day.

[0066] Pharmaceutical composition (granules) in Example 3

[0067] prescription:

[0068] Dosage(g) Astragalus 80 Angelica 60 Psoralea corylifolia 40 Rubia cordifolia 40 Knotweed 40 Curculigo 40 Epimedium 50 Ejiao beads 30 Licorice 20

[0069] Preparation method:

[0070] S1: Weigh each medicinal material according to the prescription amount, crush the mother-of-pearl and pass it through a 200-mesh sieve, and crush the remaining medicinal materials into coarse powder;

[0071] S2: Mix all the above medicinal materials, boil them for 3 hours with 12 times the amount of water for the first time, boil them for 2 hours with 8 times the amount of water for the second time, and boil them for 0.5 hours with 6 times the amount of water for the third time;

[0072] S3: filtering and combining the decoction obtained in step S2;

[0073] S4: concentrating the decoction in S3 into an extract having a relative density of 1.10-1.15 at 80° C.;

[0074] S5: Add 4 times the weight of the extract in S4 to sucrose powder;

[0075] S6: Mix evenly, granulate, dry and size the particles to obtain granules.

[0076] Directions: Take with boiled water, 10g at a time, 3 times a day.

[0077] Pharmaceutical composition (decoction) in Example 4

[0078] prescription:

[0079] Dosage(g) Astragalus 50 Angelica 30 Psoralea corylifolia 20 Rubia cordifolia 20 Knotweed 20 Curculigo 20 Epimedium 30 Ejiao beads 20 Licorice 15

[0080] Preparation method:

[0081] S1: Weigh each medicinal material according to the prescription amount, crush the mother-of-pearl and pass it through a 200-mesh sieve, and crush the remaining medicinal materials into coarse powder;

[0082] S2: Mix all the above medicinal materials, boil them for 3 hours with 12 times the amount of water for the first time, boil them for 2 hours with 8 times the amount of water for the second time, and boil them for 0.5 hours with 6 times the amount of water for the third time;

[0083] S3: filtering and combining the decoction obtained in step S2;

[0084] S4: concentrating the decoction in S3 into an extract having a relative density of 1.10-1.15 at 60-65° C.;

[0085] S5: Add 100 g of honey to the extract in S4, and heat and mix well;

[0086] S6: Concentrate the extract in S5 to an extract having a relative density of 1.2-1.25 at 60-65° C., thereby obtaining a decoction.

[0087] Dosage: Orally, once in the morning and once in the evening (before or after meals), 15g each time, dissolve in hot water and take orally; can also be swallowed directly.

[0088] Pharmaceutical composition (capsule) in Example 5

[0089] prescription:

[0090] Dosage(g) Astragalus 50 Angelica 30 Psoralea corylifolia 20 Rubia cordifolia 20 Knotweed 20 Curculigo 20 Epimedium 30 Ejiao beads 20 Licorice 15

[0091] Preparation method:

[0092] S1: Weigh each medicinal material according to the prescription amount, crush the mother-of-pearl and pass it through a 200-mesh sieve, and crush the remaining medicinal materials into coarse powder;

[0093] S2: Mix all the above medicinal materials, boil them for 3 hours with 12 times the amount of water for the first time, boil them for 2 hours with 8 times the amount of water for the second time, and boil them for 0.5 hours with 6 times the amount of water for the third time;

[0094] S3: filtering and combining the decoction obtained in step S2;

[0095] S4: concentrating the decoction in S3 into an extract having a relative density of 1.10-1.15 at 80° C.;

[0096] S5: drying the extract in S4 at 70° C. under reduced pressure to obtain a dry extract, and crushing the extract;

[0097] S6: adding 10% of the amount of starch to the dry extract of S5 and mixing evenly, and making granules with 70% ethanol;

[0098] S7: Drying and granulating the granules in S6 to obtain capsules.

[0099] Dosage: Oral administration, 3 capsules at a time, 3 times a day.

[0100] Clinical trial example 1

[0101] Clinical observation of the drug of the present invention in treating chemotherapy-induced bone marrow suppression

[0102] 1. Source of cases:

[0103] The cases were patients with malignant tumors who met the inclusion criteria and received chemotherapy at the First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine from July 2015 to January 2017. Bone marrow suppression occurred after chemotherapy. A total of 60 patients were enrolled in this clinical trial, including 30 in the control group and 30 in the experimental group. There were 15 males and 15 females in the observation group. The age ranged from 38 to 71 years, with an average age of (54.52±8.26) years; there were 14 males and 16 females in the control group, with an age range of 40 to 70 years, with an average age of (55.03±7.52) years. The drug was taken 48 hours after the end of this cycle of chemotherapy, and the drug was taken continuously for 7 days in one course of treatment. There was no statistical difference in the general data of the two groups of patients (P>0.05), and they were comparable. The World Health Organization (WHO) standards (see Table 1) were used to evaluate the improvement of bone marrow suppression, symptom improvement and the incidence of adverse reactions in the two groups after the end of treatment.

[0104] Table 1 Grading of bone marrow suppression after chemotherapy

[0105]

[0106] 2. Diagnostic criteria:

[0107] (1) Malignant tumors were diagnosed by imaging and pathology, and bone marrow suppression occurred after chemotherapy, and the diagnosis was confirmed by blood-related tests;

[0108] (2) WBC <4.0×10 after chemotherapy 9 / L, hemoglobin <110g / L, platelets <100×10 9 / L or neutrophils <2×10 9 / L.

[0109] 3. Treatment methods:

[0110] Control group: According to the patient's condition, the patients were given recombinant human erythropoietin injection (CHO cells) (Harbin Pharmaceutical Group Bioengineering Co., Ltd., approval number: National Medicine Standard S20073009, specification: 6000IU); pegylated recombinant human granulocyte stimulating factor injection [Qilu Pharmaceutical Co., Ltd., approval number: National Medicine Standard S20150013, specification 1.35×10 8IU (3.0mg): 1.0mL]; recombinant human thrombopoietin injection (Shenyang Sansheng Pharmaceutical Co., Ltd., approval number: National Medicine Standard S20050048, specification: 15000U / 1mL) treatment. EPO dosage: subcutaneous injection of 150U / kg, while taking iron and vitamin B12, folic acid, etc., 3 times / week, and the basis for discontinuation of the drug is hemoglobin level>80g / L or hematocrit>40%.

[0111] Dosage and administration of PEGrhG-CSF: 100 g / kg, subcutaneous injection 48 hours after the end of each chemotherapy cycle. The basis for drug withdrawal is two consecutive tests of the absolute value of neutrophils > 10 × 10 9 / L or total white fines>10×10 9 / L.

[0112] TPO dosage: subcutaneous injection 15000U / d, 7 days as a treatment cycle, discontinuation basis is platelet count>50×10 9 / L. Observation group: patients were given a self-made Qi-invigorating and blood-nourishing prescription (30 grams of Astragalus, 10 grams of Angelica, 15 grams of Psoralea, 15 grams of Rubia, 15 grams of Polygonum cuspidatum, 15 grams of Curculigo, 20 grams of Epimedium, 10 grams of Donkey-hide Gelatin, and 10 grams of Licorice) according to their symptoms.

[0113] IV. Efficacy scoring criteria and observation indicators:

[0114] (1) TCM syndrome scores of the two groups: According to the severity of symptoms, the scores were divided into asymptomatic, mild, moderate and severe, with scores of 0 to 3 points respectively, symptom manifestations were scored from 0 to 9 points, tongue coating was scored from 0 to 3 points, and pulse was scored from 0 to 3 points. The scores were assessed once before and after treatment.

[0115] (2) Peripheral blood related indicators of the two groups: All patients had their morning fasting venous blood collected before and every 3 days after treatment to measure the number of white blood cells, neutrophils, and platelets in the blood. The Beckman Coulter IMMAGE800 specific protein analyzer was used to measure the hemoglobin level in the blood.

[0116] (3) The occurrence of adverse reactions in the two groups.

[0117] V. According to the above efficacy evaluation criteria, the clinical research results of the included cases are shown in the following table:

[0118] Table 2 Comparison of myelosuppression grades

[0119]

[0120] After treatment, the improvement of bone marrow suppression in the observation group was better than that in the control group, and the difference in efficacy between the two groups was statistically significant (P<0.05).

[0121] Table 3 Comparison of TCM symptom scores before and after treatment

[0122]

[0123] After treatment, the TCM syndrome score in the observation group was significantly lower than that in the control group, and the difference in efficacy between the two groups was statistically significant (P<0.05).

[0124] Table 4 Comparison of peripheral blood related indicators before and after treatment

[0125]

[0126] After treatment, the numbers of white blood cells, neutrophils, platelets and hemoglobin levels in the observation group were higher than those in the control group, and the difference in efficacy between the two groups was statistically significant (P<0.05).

[0127] Table 5 Comparison of adverse reactions

[0128]

[0129] After treatment, the incidence of adverse reactions in the observation group was significantly lower than that in the control group, and the difference in efficacy between the two groups was statistically significant (P<0.05).

[0130] VI. Conclusion of efficacy evaluation:

[0131] Clinical trials of the drug of the present invention for preventing and treating bone marrow suppression caused by radiotherapy and chemotherapy have shown that the drug of the present invention can effectively prevent and treat bone marrow suppression caused by radiotherapy and chemotherapy, wherein the degree of improvement of bone marrow suppression in patients is significant, with the improvement of mild bone marrow suppression cases increasing by 100% and the improvement of severe bone marrow suppression cases decreasing by 50%; the TCM syndrome score symptoms, tongue coating and pulse are significantly lower than those of the control group, wherein the symptom score is significantly decreased; the number of white blood cells, neutrophils, platelets and hemoglobin levels are higher than those of the control group, wherein the number of hemoglobin, neutrophils and platelets is significantly increased; the incidence of adverse reactions in the observation group is 30%, which is significantly lower than the incidence of adverse reactions in the control group of 56%;

[0132] It can be seen from this that the self-prescribed Qi-invigorating and blood-nourishing prescription for the treatment of bone marrow suppression after chemotherapy for malignant tumors can effectively improve the patient's bone marrow suppression level, improve the patient's traditional Chinese medicine symptoms, and increase blood cell levels. It has good safety and is worthy of further clinical promotion.

[0133] The following are cases related to the use of the drug of the present invention.

[0134] Case 1: Wang Mouhua, female, 45 years old, unemployed. Fatigue for 1 week after 2+ months of comprehensive treatment for cervical cancer. The patient was diagnosed with cervical squamous cell carcinoma in April 2023. After completing relevant examinations, it was considered stage IB3. Cisplatin synchronous chemoradiotherapy combined with brachytherapy was given. The patient completed brachytherapy 2 months ago. The patient developed fatigue 1 week ago and came to the hospital for Chinese medicine diagnosis and treatment. Symptoms: fatigue, shortness of breath and laziness, occasional insomnia and forgetfulness, no palpitations, no fever, cough, abdominal pain, diarrhea, frequent urination, dysuria, no visual rotation, etc. Appetite and bowel movements are normal. The tongue is pale red, with little fur, and a fine pulse. Auxiliary examination: routine blood test showed: WBC: 1.92×10~9 / L, Hb: 76g / l. When the patient was diagnosed with the disease, the outpatient clinic diagnosed it as "deficiency (deficiency of both qi and blood, liver and kidney yin deficiency)". After taking the granules of Example 1 orally for 2 courses, the patient felt that the symptoms of fatigue were significantly improved. Repeated blood test showed: WBC: 4.2×10~9 / L, Hb: 96g / l.

[0135] This specific embodiment is merely an explanation of the present invention and is not a limitation of the present invention. After reading this specification, those skilled in the art may make non-creative modifications to the present embodiment as needed. However, as long as they are within the scope of the claims of the present invention, they are protected by the patent law.

Claims

1. Use of a Chinese medicine composition in the preparation of a drug for preventing and / or treating post-chemotherapy bone marrow suppression, characterized in that: The Chinese medicine composition is prepared from the following Chinese medicines: astragalus, angelica, psoralea corylifolia, madder, knotweed, curculigo, epimedium, donkey-hide gelatin beads and liquorice.

2. The use according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 30 to 80 parts of astragalus, 10 to 60 parts of angelica, 15 to 40 parts of psoralea, 15 to 40 parts of madder, 15 to 40 parts of knotweed, 10 to 40 parts of curculigo, 20 to 50 parts of epimedium, 10 to 30 parts of donkey-hide gelatin beads, and 10 to 20 parts of liquorice.

3. The use according to claim 2, characterized in that: The Chinese medicine composition is prepared from the following Chinese medicines in parts by weight: 30 parts of Astragalus, 10 parts of Angelica, 15 parts of Psoralea corylifolia, 15 parts of Rubia cordifolia, 15 parts of Polygonum cuspidatum, 10 parts of Curculigo orchioides, 20 parts of Epimedium, 10 parts of Ejiao beads, and 10 parts of Licorice; Or including 50 parts of Astragalus, 30 parts of Angelica, 20 parts of Psoralea corylifolia, 20 parts of Rubia cordifolia, 20 parts of Polygonum cuspidatum, 20 parts of Curculigo orchioides, 30 parts of Epimedium, 20 parts of Ejiao beads, and 15 parts of Licorice; Or include 80 parts of astragalus, 60 parts of angelica, 40 parts of psoralea corylifolia, 40 parts of madder, 40 parts of knotweed, 40 parts of curculigo, 50 parts of epimedium, 30 parts of donkey-hide gelatin beads, and 20 parts of liquorice.

4. The use according to claim 1, characterized in that: The Chinese medicine composition can be prepared into a preparation with pharmaceutically acceptable auxiliary materials.

5. The use according to claim 4, characterized in that: The preparation is a decoction, a decoction paste, a pill, a powder, a granule, a tablet, or a capsule; preferably, the preparation is a granule.

6. The use according to claim 4, characterized in that: The pharmaceutically acceptable excipients are one or more of fillers, lubricants, disintegrants, binders, humectants, solvents, flavoring agents, preservatives, stabilizers, thickeners, colorants, and surfactants.

7. The use according to claim 4, characterized in that: The preparation method of the preparation is: S1: Weigh each component and pharmaceutical excipient according to the formula of claim 1, wherein the pharmaceutical excipient is crushed and sieved, and the remaining medicinal materials are crushed into coarse powder; S2: mixing the medicinal materials obtained in step S1, and decocting the obtained medicinal materials for multiple times; S3: filtering and combining the decoctions obtained after each decoction in step S2 in sequence, thereby obtaining a drug for treating bone marrow suppression after chemotherapy.

8. The use according to claim 7, characterized in that: In the preparation method of the preparation, the number of times of decocting the medicinal materials in step S2 is 3 times, the first time is decocted with 12 times the amount of water for 3 hours, the second time is decocted with 8 times the amount of water for 2 hours, and the third time is decocted with 6 times the amount of water for 0.5 hours.

9. The use according to claim 5, characterized in that: The preparation method of the granules is: S1: Weigh each medicinal material according to the prescription amount, crush the mother-of-pearl and pass it through a 200-mesh sieve, and crush the remaining medicinal materials into coarse powder; S2: Mix all the above medicinal materials, boil them for 3 hours with 12 times the amount of water for the first time, boil them for 2 hours with 8 times the amount of water for the second time, and boil them for 0.5 hours with 6 times the amount of water for the third time; S3: filtering and combining the decoction obtained in step S2; S4: concentrating the decoction in S3 into an extract having a relative density of 1.10-1.15 at 80° C.; S5: Add 4 times the weight of the extract in S4 to sucrose powder; S6: Mix evenly, granulate, dry and size the particles to obtain granules.

10. The use according to claim 1, characterized in that: The post-chemotherapy bone marrow suppression is caused by one or more of acute bone marrow suppression, potential bone marrow damage, tumor chemotherapy-related anemia, chemotherapy-induced neutropenia and chemotherapy-induced thrombocytopenia.

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