Composition for treating leukemia as well as preparation method and application thereof

Abstract

The invention provides a composition for treating leukemia as well as a preparation method and application thereof, and relates to the technical field of biological pharmacy. The composition comprises the following raw materials in parts by weight: 12-18 parts of American ginseng, 10-15 parts of lucid ganoderma, 5-8 parts of cordyceps sinensis, 7-9 parts of pseudo-ginseng, 10-12 parts of bighead atractylodes rhizome, 11-13 parts of astragalus membranaceus, 6-8 parts of liquorice, 7-9 parts of honeysuckle, 5-7 parts of indigo naturalis, 10-13 parts of dendrobe, 3-5 parts of mint, 6-8 parts of lotus plumule and 5-7 parts of divaricate saposhnikovia root. All the raw materials are reasonable in monarch, minister, assistant and guide and compatibility, can jointly achieve the effects of tonifying liver and kidney, clearing away heat and toxic materials, enriching blood, activating blood, replenishing essence and blood, nourishing yin, promoting salivation and enhancing immunity, and has a good treatment effect on leukemia, and ginsenoside in American ginseng and cordyceps polysaccharide in cordyceps sinensis can both achieve the effect of inhibiting cancer cell proliferation. The American ginseng and the cordyceps sinensis are compounded to achieve a synergistic effect.

Description

Technical Field

[0001] The present application relates to the field of biopharmaceutical technology, and in particular, to a composition for treating leukemia and a preparation method and application thereof. Background Art

[0002] Leukemia is a type of malignant cytotoxic disease of hematopoietic stem cells. Leukemia cells stagnate at different stages of cell development due to uncontrolled proliferation, differentiation disorders, and blocked apoptosis. In the bone marrow and other hematopoietic tissues, leukemia cells proliferate and accumulate in large numbers, inhibiting normal hematopoiesis and infiltrating other organs and tissues.

[0003] The classification of leukemia is very complex. According to the severity of the disease, leukemia can be generally divided into acute leukemia and chronic leukemia. Acute leukemia develops rapidly, and the course of the disease is generally only a few months. The bone marrow and peripheral blood are mainly composed of abnormal primitive and promyelocytes. The course of chronic leukemia is generally slower, and the course of the disease generally lasts for several years. The bone marrow and peripheral blood are mainly composed of abnormal mature cells, accompanied by immature cells. According to the morphology and biochemical characteristics of white blood cells, acute leukemia can be divided into acute lymphocytic leukemia (ALL) and acute myeloid leukemia (AML), and chronic leukemia can be divided into chronic lymphocytic leukemia (CLL), chronic myeloid leukemia (CML), etc.

[0004] At present, the main treatments for leukemia are chemotherapy and bone marrow transplantation. The purpose of chemotherapy is to eliminate leukemia cell clones and reconstruct normal hematopoietic function of the bone marrow. Chemotherapy can effectively alleviate leukemia and prolong the survival time of patients, but this treatment has great side effects and a high relapse rate, especially causing great damage to the body's immune and hematopoietic systems. Bone marrow transplantation is suitable for rescuing induction failure, early relapse, or certain high-risk patients. About 60% of adult acute leukemia patients can achieve a long survival period of more than 3 years after allogeneic or syngeneic bone marrow transplantation, and some have reached more than 5 to 6 years. However, the source of bone marrow is difficult. It requires allogeneic bone marrow from siblings and sisters who match the patient's human leukocyte antigen (HLA), as well as a very small number of unrelated donors, or bone marrow transplantation between family members such as parents and children, and bone marrow from unrelated donors who are not very HLA-matched with the patient. Although non-sibling brothers and sisters have HLA matching, they are prone to graft-versus-host disease (GVHD) of varying severity.

[0005] Therefore, there continues to be an unmet need in the art to develop new drugs that are effective in treating leukemia. Summary of the invention

[0006] The purpose of the present application is to provide a composition for treating leukemia to achieve a good therapeutic effect.

[0007] Another object of the present application is to provide a method for preparing a composition for treating leukemia, which makes the preparation method simple and efficient.

[0008] Another object of the present application is to provide an application of the above-mentioned composition in the treatment of leukemia.

[0009] The present application solves the technical problem by adopting the following technical solution.

[0010] The present application provides a composition for treating leukemia, which comprises the following raw materials by weight:

[0011] 12-18 parts of American ginseng, 10-15 parts of Ganoderma lucidum, 5-8 parts of Cordyceps sinensis, 7-9 parts of Panax notoginseng, 10-12 parts of Atractylodes macrocephala, 11-13 parts of Astragalus, 6-8 parts of Licorice, 7-9 parts of Honeysuckle, 5-7 parts of Indigo naturalis, 10-13 parts of Dendrobium, 3-5 parts of Mint, 6-8 parts of Lotus seed core and 5-7 parts of Saposhnikovia divaricata.

[0012] The present application provides a method for preparing a composition for treating leukemia, comprising the following steps:

[0013] Step A: Weigh American ginseng according to the above weight, grind it into powder, extract American ginseng in ethanol, obtain extract, and set aside;

[0014] Step B: weigh the above weight portions of Ganoderma lucidum, Cordyceps sinensis, Panax notoginseng, Atractylodes macrocephala, Astragalus membranaceus, Licorice root, Honeysuckle, Indigo naturalis, Dendrobium officinale, Mint, Lotus seed core and Saposhnikovia divaricata, add them into water and boil, filter after boiling to obtain a decoction for later use;

[0015] Step C: mixing the extract and the decoction, concentrating and drying.

[0016] The present application provides an application of the above-mentioned composition in a drug for treating leukemia.

[0017] The above technical solution provided by the embodiment of the present application has at least the following advantages compared with the prior art:

[0018] 1. The present application provides a composition for treating leukemia, which can tonify the liver and kidney, clear away heat and detoxify, tonify blood, activate blood circulation, benefit essence and blood, nourish yin and promote body fluid, and enhance immunity, and has a good therapeutic effect on leukemia. American ginseng and cordyceps are monarch drugs, and ginsenosides in American ginseng and cordyceps polysaccharides in cordyceps can inhibit the proliferation of cancer cells. The combination of American ginseng and cordyceps has a synergistic effect. Ganoderma lucidum, Panax notoginseng, and Atractylodes macrocephala are ministerial drugs. Ganoderma lucidum can enhance the functions of various organs of the digestive system. Honeysuckle, mint, lotus seed core, Indigo naturalis, and Dendrobium are adjuvant drugs, which can alleviate the pain caused by leukemia complications and improve the quality of life of patients. Astragalus, licorice, and Saposhnikovia divaricata are guiding drugs, which can neutralize the coldness of other raw materials. The monarch, minister, adjuvant, and guiding roles of the raw materials are reasonable.

[0019] 2. The present application provides a method for preparing a composition for treating leukemia. The preparation method is simple, has high extraction efficiency, and has low requirements for extraction equipment. American ginseng is extracted with ethanol at a low extraction temperature, which can avoid the decomposition of the effective ingredient ginsenoside due to high temperature. The method of first distilling and then decocting is adopted. Compared with the traditional Chinese medicine decoction extraction method, the oil-soluble and water-soluble effective substances in the raw materials can be extracted, so that the composition extracted by the method of the present application has high bioavailability and better therapeutic effect.

[0020] 3. The present application provides an application of the above-mentioned composition in a drug for treating leukemia, and clinical trials have found that the effect of treating leukemia is significant. DETAILED DESCRIPTION

[0021] In order to make the purpose, technical scheme and advantages of the embodiments of the present application clearer, the technical scheme in the embodiments of the present application will be clearly and completely described below in combination with the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of this application.

[0022] Unless otherwise specified, various raw materials, reagents, instruments and equipment used in this application can be purchased from the market or prepared by existing methods.

[0023] The present application provides a composition for treating leukemia, which comprises the following raw materials by weight:

[0024] 12-18 parts of American ginseng, 10-15 parts of Ganoderma lucidum, 5-8 parts of Cordyceps sinensis, 7-9 parts of Panax notoginseng, 10-12 parts of Atractylodes macrocephala, 11-13 parts of Astragalus, 6-8 parts of Licorice, 7-9 parts of Honeysuckle, 5-7 parts of Indigo naturalis, 10-13 parts of Dendrobium, 3-5 parts of Mint, 6-8 parts of Lotus seed core and 5-7 parts of Saposhnikovia divaricata.

[0025] American ginseng, first recorded in the Zenged Compendium of Materia Medica, is bitter and cold, clearing away heat and nourishing the body. It enters the heart, lung, and kidney meridians and is a cold tonic. It is good at replenishing qi and nourishing yin, clearing away fire and promoting fluid production, and is mainly used to treat qi and yin deficiency. American ginseng can also be used to treat cardiovascular diseases, enhance immunity, and inhibit the proliferation of cancer cells. American ginseng contains a component called ginsenosides, which have multiple therapeutic effects such as antioxidant, anti-inflammatory, vasodilation, anti-allergic, and anti-diabetic. Some ginsenosides show their anti-cancer properties by reducing DNA damage, reducing the host's susceptibility to mutations, and increasing immune surveillance and cell apoptosis. In addition, ginsenosides can effectively improve the efficacy of traditional chemotherapy drugs and prevent damage to normal tissues.

[0026] Lingzhi contains ganoderic acid, a triterpenoid substance, most of which are tetracyclic triterpenes and highly oxidized lanostane. Lingzhi can inhibit the release of cellular histamine, enhance the functions of various organs of the digestive system, and also has the effects of lowering blood lipids, lowering blood pressure, protecting the liver, and regulating liver function. It is a natural organic compound with multiple functions such as analgesia, sedation, anti-cancer, and detoxification. The reason why Lingzhi can lower blood lipids and blood pressure is that Lingzhi blocks the ability of lanosterol or dioxylanosterol to synthesize cholesterol, thereby slowing down the process of atherosclerosis and slowing down the increase in blood pressure.

[0027] The main active ingredient of Cordyceps sinensis is cordyceps polysaccharide, which is a polysaccharide composed of mannose, cordycepin, adenosine, galactose, arabinose, xylose, glucose and fucose. Cordyceps sinensis can improve human immune function and increase white blood cells. It has been used clinically to treat malignant tumors. Studies have shown that Cordyceps sinensis has anti-tumor activity. Most of its anti-tumor effects are non-direct killing of cancer cells, that is, by stimulating the non-specific defense function of the human body. In the case of cancer patients whose immunity is damaged by radiotherapy and chemotherapy, combined treatment with radiotherapy and chemotherapy can achieve the purpose of curing the disease. Cordyceps sinensis inhibits tumor genes, reduces micronucleus rate and induces tumor cell differentiation.

[0028] Panax notoginseng, slightly bitter, dispersing, sweet, warming, and unblocking, has both moving and guarding properties, dispersing and nourishing, and enters the liver and stomach meridians. It has strong hemostatic and stasis-removing properties, and can replenish deficiency. It has the advantages of stopping bleeding without leaving stasis, and activating blood circulation without consuming qi. It is effective for both internal and external use. It can be used for bleeding and stasis. It is most suitable for those with cold and deficiency. Those with heat but no deficiency should be treated with heat-clearing and blood-cooling products and corresponding products. It mainly contains tetracyclic triterpenoid components such as ginsenosides, Panax notoginseng saponins, and aescin. In addition, it also contains substances such as Panax notoginseng, quercetin, and polysaccharides. It has the effects of dispersing stasis, stopping bleeding, and relieving swelling and pain.

[0029] Atractylodes macrocephala is recorded in various herbal works of all dynasties, such as Ben Jing and Ben Cao Hui Yan. Atractylodes macrocephala is a commonly used bulk Chinese herbal medicine. It has been processed and used as medicine since the Tang and Song Dynasties, and has been passed down from generation to generation and is still used today. It has the effects of replenishing qi and strengthening the spleen, drying dampness and promoting diuresis, stopping sweating, and calming the fetus. It is mainly used to treat spleen deficiency, fatigue, poor appetite and abdominal distension, loose stools, water retention, urinary incontinence, edema, phlegm and dizziness, dampness and arthralgia, spontaneous sweating due to qi deficiency, and restless fetal movement. The rhizome of Atractylodes macrocephala contains volatile oil, the main components of which are atractylodesone, atractylodes alcohol, atractylodes lactone, etc. It has certain effects on the treatment of ascites due to liver cirrhosis, primary liver cancer, Meniere's syndrome, chronic low back pain, acute enteritis, and leukopenia.

[0030] Astragalus is sweet and slightly warm in nature, and it enters the spleen and lung meridians. Astragalus is sweet and warm in nature, and it is sweet and mild in nature, and it is slightly warm when used raw, and warm in nature when roasted with honey, and it enters the spleen and lung meridians, and it is mainly used to support the positive energy and remove water evil. It is good at replenishing the middle qi and raising the clear yang, and it is also good at replenishing the lung qi, benefiting the stomach and strengthening the exterior, and it can treat spleen and lung qi deficiency, sinking of the middle qi, qi failure to hold blood, spontaneous sweating and night sweats, etc. It can also support sores and poisons, promote diuresis and reduce swelling, and treat sores and carbuncles that do not ulcerate or ulcerate for a long time due to insufficient qi and blood, as well as qi deficiency edema and urination difficulties. In addition, by replenishing qi, it can also produce blood, hold blood, produce body fluids, and promote stagnation, and treat blood deficiency, metrorrhagia and bloody stools due to qi failure to hold blood, thirst due to damage to both qi and body fluids, pain and numbness due to qi deficiency and blood stagnation, and hemiplegia.

[0031] Licorice is sweet and mild in nature, and it enters the heart, lung, spleen, and stomach meridians. Licorice is sweet, nourishing, moistening, and slowing down. It is cool in raw form, and warm in roasted form. It mainly enters the spleen and lung meridians, and also enters the stomach and heart meridians. It contains triterpenoid saponins and flavonoids, which can replenish qi and strengthen the middle, relieve pain, moderate the medicinal properties, and also eliminate phlegm, relieve cough, and detoxify. Honey roasted liquorice has strong qi-replenishing and relieving effects; raw liquorice can purge fire and detoxify.

[0032] Honeysuckle is sweet and cold in nature. It enters the lung, stomach and large intestine meridians. Honeysuckle is sweet, cold and clear, light and penetrating, clearing and dispersing, and enters the lung, stomach and large intestine meridians. It is good at clearing away heat and toxicity, and is also good at dispersing wind-heat. The medicinal power is quite strong but not bitter, and it is a good medicine for dispersing heat and toxicity, and it is not bitter and easy to take. It is mainly clearing, clearing and penetrating, and can be used for heat and toxicity and wind-heat. It contains organic acids such as chlorogenic acid and isochlorogenic acid, as well as flavonoids such as luteolin and honeysuckle. In addition, it also contains volatile oils, saponins, inositol, oleanolic acid, carrot heads and other ingredients. It has antibacterial, antiviral, antipyretic, anti-inflammatory, immune-enhancing, anti-tumor, anti-allergic, liver-protecting, bile-promoting, and blood sugar-lowering effects. The organic acids it contains can regulate blood lipids, resist platelet aggregation and thrombosis.

[0033] Indigo is a cold herb. It belongs to the liver meridian. The salty nature of this product enters the blood, clears away coldness, and is also astringent. It enters the liver and lung meridians and has a strong medicinal effect. It is good at clearing away heat and toxicity, cooling blood and removing spots, purging fire and calming the nerves when taken internally; it can clear away, disperse swelling, and heal sores when used externally. It is an important medicine for treating febrile rashes, vomiting and bleeding due to blood heat, epilepsy due to liver heat, and liver fire disturbing the lungs. It is also commonly used to treat mumps, throat paralysis, and sores. It mainly contains indole alkaloids such as indigo and indigo red, organic acids such as tryptanthone, quinazolin, and salicylic acid, glycosides such as isatis glycoside, and inorganic elements such as iron, manganese, and zinc. It has the effects of clearing away heat and toxicity, cooling blood and removing spots, purging fire and calming the nerves. It is used for fever and toxicity, vomiting and bleeding due to blood heat, chest pain and coughing up blood, mouth sores, mumps, throat paralysis, and epilepsy in children.

[0034] Dendrobium, sweet, slightly cold, enters the stomach, lung, and kidney meridians, can produce fluid and benefit the stomach, nourish yin and clear heat. It is mainly used to treat symptoms such as heat disease damaging body fluid, thirst, yin deficiency stomach pain, deficiency heat after illness, and yin damage and dark eyes.

[0035] Peppermint is pungent and cool in nature. It enters the lung and liver meridians. Peppermint is pungent and dispersing, fragrant and can dispel filth, and cool and can clear. It enters the lung and liver meridians, dispersing wind-heat and clearing the head and throat, and clearing rashes, and it can also relieve liver depression and dispel filth. It has a strong sweating power, especially good at clearing the head. It mainly contains volatile oils: menthol, menthone, isomenthone, pulegone, a-pinene, limonene and other ingredients. It has the functions of dispersing wind-heat, clearing the head, relieving throat, clearing rashes, and dispersing liver qi.

[0036] Lotus seed heart is bitter and cold in nature and enters the heart and kidney meridians. It has the functions of clearing the heart and calming the mind, connecting the heart and kidney, and stopping bleeding. On the basis of standard treatment, lotus seed heart can reduce the serum matrix metalloproteinase-9 and matrix metalloproteinase inhibitor-1 levels in patients with unstable angina pectoris, thereby improving the quality of life of patients. Protein disulfide bonds can both inhibit tumor cell apoptosis and promote tumor cell infiltration and metastasis. The main alkaloid components in lotus seed heart, neferine, methylneferine, N-methylcoclaurine, and isoliensinine, all have inhibitory effects on the activity of protein disulfide isomerase, among which N-methylcoclaurine has the strongest activity.

[0037] Saposhnikovia divaricata is pungent, sweet and slightly warm in nature. It enters the bladder, liver and spleen meridians. Saposhnikovia divaricata is pungent, slightly warm and dispersing, sweet and mild without being harsh. The properties of raw and fried charcoal are different. Raw, pungent, dispersing, sweet and mild, slightly warm and mild, enters the bladder and spleen meridians, dispersing external wind, overcoming dampness and relieving pain; enters the liver meridian, dispels internal wind and stops spasms. It is a general medicine for treating wind, dispersing external wind and calming internal wind, treating wind-cold, wind-heat and superficial symptoms with dampness, and is most suitable for treating the three evils of wind, cold and dampness. Fried charcoal is more astringent and less dispersing, astringent and ascending, dispersing, enters the spleen and liver meridians and is good at stopping bleeding and diarrhea, and is suitable for treating metrorrhagia and diarrhea.

[0038] The composition of the present application can play the effects of nourishing the liver and kidney, clearing away heat and detoxifying, nourishing blood, activating blood circulation, benefiting essence and blood, nourishing yin and promoting body fluid, and enhancing immunity, and has a good therapeutic effect on leukemia. American ginseng and cordyceps are monarch drugs, and ginsenosides in American ginseng and cordyceps polysaccharides in cordyceps can both inhibit the proliferation of cancer cells. The combination of American ginseng and cordyceps has a synergistic effect. Ganoderma lucidum, Panax notoginseng, and Atractylodes macrocephala are ministerial drugs. Ganoderma lucidum can enhance the functions of various organs of the digestive system. Honeysuckle, mint, lotus seed core, Indigo naturalis, and Dendrobium are adjuvant drugs, which can alleviate the pain caused by leukemia complications and improve the quality of life of patients. Astragalus, licorice, and Saposhnikovia divaricata are guiding drugs, which can neutralize the coldness of other raw materials. The monarch, minister, adjuvant, and guiding drugs of the raw materials are reasonably compatible.

[0039] In some embodiments of the present application, the above-mentioned composition includes the following raw materials by weight: 14-16 parts of American ginseng, 11-14 parts of Ganoderma lucidum, 6-7 parts of Cordyceps sinensis, 7-8 parts of Panax notoginseng, 10-11 parts of Atractylodes macrocephala, 11-12 parts of Astragalus, 6-7 parts of Licorice, 7-8 parts of Honeysuckle, 5-6 parts of Indigo, 11-12 parts of Dendrobium, 4-5 parts of mint, 7-8 parts of lotus seed core and 6-7 parts of Saposhnikovia divaricata.

[0040] In some embodiments of the present application, the above-mentioned composition includes the following raw materials by weight: 18 parts of American ginseng, 15 parts of Ganoderma lucidum, 8 parts of Cordyceps sinensis, 9 parts of Panax notoginseng, 12 parts of Atractylodes macrocephala, 13 parts of Astragalus, 8 parts of Licorice, 9 parts of Honeysuckle, 7 parts of Indigo, 11 parts of Dendrobium, 5 parts of Mint, 8 parts of Lotus seed core and 7 parts of Saposhnikovia divaricata.

[0041] In some embodiments of the present application, the above-mentioned composition includes the following raw materials by weight: 16 parts of American ginseng, 13 parts of Ganoderma lucidum, 6 parts of Cordyceps sinensis, 8 parts of Panax notoginseng, 11 parts of Atractylodes macrocephala, 12 parts of Astragalus, 8 parts of Licorice, 8 parts of Honeysuckle, 6 parts of Indigo naturalis, 10.5 parts of Dendrobium, 4 parts of mint, 7 parts of lotus seed core and 6 parts of Saposhnikovia divaricata.

[0042] In some embodiments of the present application, the above composition further includes the following raw materials by weight: 8-10 parts of rhubarb, 6-10 parts of isatis root, 10-15 parts of codonopsis pilosula, 8-12 parts of poria, 8-12 parts of artemisia annua, 15-20 parts of aloe, and 10-15 parts of polygonatum.

[0043] Rhubarb is bitter and cold in nature. It enters the spleen, stomach and large intestine meridians. Rhubarb is bitter and cold, and it can clear and purge. It not only enters the spleen, stomach and large intestine meridians, but also enters the heart, liver meridians and blood. When taken internally, it can clear away gastrointestinal stagnation and heat, relieve heat and relieve constipation, guide dampness and heat from the stool, promote bile secretion and reduce jaundice, "remove the firewood from the bottom of the pot" and remove heat and toxins from the blood, and relieve heat and toxins, and relieve heat and toxins from the blood, and promote blood circulation and remove blood stasis, cool blood and stop bleeding, and reduce swelling.

[0044] Isatis root is bitter and cold in nature. It enters the heart, liver and stomach meridians. Isatis root is bitter and cold, enters the heart, liver and stomach meridians, and has strong medicinal properties. It is good at clearing heat and toxins from the heart, liver and stomach, and is good at cooling blood and relieving sore throat. It is an important medicine for treating febrile diseases, macules, vomiting and bleeding, sore throat due to heat and toxins, erysipelas, and mumps. It is especially good at treating sore throat and facial erysipelas (big head plague). Isatis root contains alkaloids, amino acids, quinazolinones, and organic acids; it also contains indigo, indigo, hydroxyindigo sitosterol, adenosine, syringin, larch resin alcohol and other ingredients, which have the effects of clearing heat and detoxifying, cooling blood and relieving sore throat.

[0045] Codonopsis is sweet and neutral in nature. It enters the spleen and lung meridians and has the effects of strengthening the spleen and lungs, nourishing blood and promoting body fluid. Modern pharmacological studies have shown that Codonopsis also has a variety of pharmacological effects, such as enhancing immunity, protecting gastrointestinal mucosa and resisting ulcers, promoting hematopoiesis, regulating blood sugar, and delaying aging.

[0046] Poria cocos is sweet, mild and neutral in nature. It enters the heart, lung, spleen and kidney meridians. Poria cocos is sweet and mild in nature, and can penetrate, benefit and nourish. It is neutral in nature and enters the spleen and kidney meridians. It is good at penetrating dampness and promoting water and eliminating water, strengthening the spleen and promoting the transportation of water and dampness. It also enters the heart meridian, is good at calming the heart and soothing the mind, and is suitable for treating water qi in the heart. It is suitable for all water dampness, stagnant fluid, and spleen deficiency regardless of cold or heat or whether it is combined. It is especially good for spleen deficiency edema or excessive dampness.

[0047] Artemisia annua has bitter, pungent and cold properties. It enters the liver and gallbladder meridians. This product is bitter and cold, clearing and dispersing, and it enters the liver and gallbladder meridians. It has both clearing and penetrating properties, with clearing as the main property, and clearing with penetrating. It can not only relieve deficiency heat, but also clear excess heat and cool blood heat; it can not only clear summer heat, but also clear liver and gallbladder heat; it can not only eliminate malaria heat, but also penetrate the nutrient heat; it can not only penetrate the latent heat in the yin, but also penetrate and resolve the superficial heat. It can clear both deficiency heat and excess heat, and can also be used for both superficial and superficial heat.

[0048] Aloe, a Chinese medicine, is a concentrated dried product of the leaf juice of Aloe vera, Aloe vera, and Aloe vera. It has the effects of purgation, liver cleansing, and insecticide. It is often used for heat-induced constipation, liver-fire headache, red eyes and convulsions, abdominal pain caused by worms, scabies, hemorrhoids, and fistulas, and has anti-tumor effects.

[0049] Polygonatum sibiricum is sweet and mild in nature, and enters the spleen, lung, and kidney meridians. Polygonatum sibiricum is moist and sweet, mild and not biased, and has a mild effect. It enters the spleen, lung, and kidney meridians and is a product for tonifying qi and yin. It nourishes yin and moistens the lungs, nourishes the kidneys and replenishes essence, and also nourishes the spleen and replenishes qi. It is a good tonic medicine and is good for treating lung and kidney deficiency and qi and yin deficiency. It contains polysaccharides, saponins, flavonoids and other ingredients, and has the effects of nourishing qi and yin, strengthening the spleen, moistening the lungs, and benefiting the kidneys.

[0050] Furthermore, the dosage form of the above composition is any one of pills, powders, granules and tablets.

[0051] The present application provides a method for preparing a composition for treating leukemia, comprising the following steps:

[0052] Step A: Weigh American ginseng according to the above weight, grind it into powder, extract American ginseng in ethanol, obtain extract, and set aside;

[0053] Step B: weigh the above weight portions of Ganoderma lucidum, Cordyceps sinensis, Panax notoginseng, Atractylodes macrocephala, Astragalus membranaceus, Licorice root, Honeysuckle, Indigo naturalis, Dendrobium officinale, Menthus alba, Lotus seed core and Saposhnikovia divaricata, soak the raw materials in water and then distill them, collect volatile oil for later use, collect the residues and add them into water for repeated decoction twice, filter after decoction to obtain a decoction for later use;

[0054] Step C: the extract and the decoction are mixed, concentrated under reduced pressure, and then precipitated with alcohol, filtered, ethanol is recovered from the filtrate, concentrated, soluble dextrin is added, boiled instantly, stirred, and spray-dried to obtain a dry powder composition.

[0055] In the preparation method of the present application, American ginseng is extracted by ethanol, and the extraction temperature is low, which can avoid the decomposition of the effective ingredient ginsenoside due to high temperature. The method of first distillation and then decoction is adopted. Compared with the traditional Chinese medicine decoction extraction method, all the oil-soluble and water-soluble effective substances in the raw materials can be extracted, so that the composition extracted by the method of the present application has high bioavailability and better therapeutic effect.

[0056] Furthermore, in the above step A, the particle size of the powder is 60-80 meshes. Grinding into powder and then decocting can speed up the decoction efficiency, so that the effective ingredients in the traditional Chinese medicine are more fully dissolved in the decoction liquid, the concentration of the effective ingredients in the decoction liquid is higher, and the utilization rate of the raw materials is improved.

[0057] Furthermore, in the above step A, the extraction temperature is 60° C.-70° C. When using alcohol extraction, the extraction temperature should not be too high, as too high a temperature will cause the alcohol to volatilize, while too low a temperature will cause the effective components of American ginseng to be incompletely dissolved.

[0058] The present application provides an application of the above-mentioned composition in a drug for treating leukemia.

[0059] The present application will be further described below in conjunction with specific embodiments. It should be understood that these embodiments are intended only to illustrate the present application and are not intended to limit the scope of the present application. The experimental methods for which specific conditions are not specified in the following examples are usually measured according to national standards. If there is no corresponding national standard, then the conditions recommended by the manufacturer are followed.

[0060] Example 1

[0061] This embodiment provides a composition for treating leukemia, comprising the following raw materials:

[0062] American ginseng 15g, Ganoderma lucidum 12g, Cordyceps sinensis 6g, Panax notoginseng 8g, Atractylodes macrocephala 11g, Astragalus membranaceus 12g, Licorice root 7g, Honeysuckle 8g, Indigo naturalis 6g, Dendrobium candidum 10.5g, Peppermint 4g, Lotus seed core 7g and Saposhnikovia divaricata 6g.

[0063] The preparation method of the above composition comprises the following steps:

[0064] Step A: Weigh 15 g of American ginseng and grind it into a powder with a particle size of 65 mesh. First, extract the American ginseng in ethanol at a temperature of 66±2° C. to obtain an extract for later use;

[0065] Step B: according to the above weight, respectively weigh Ganoderma lucidum, Cordyceps sinensis, Panax notoginseng, Atractylodes macrocephala, Astragalus membranaceus, Licorice root, Honeysuckle, Indigo naturalis, Dendrobium officinale, Menthus alba, Lotus seed core and Saposhnikovia divaricata, soak the raw materials in water and then distill them, collect volatile oil for later use, collect the residues and add them into water for decoction, first decoct for 20 minutes over a low heat, then decoct for 20 minutes over a high heat, filter after decoction to obtain a decoction liquid, repeat the above operation with the residues and decoct them once more, filter to obtain a decoction liquid, mix the decoction liquids obtained twice and set aside;

[0066] Step C: the extract and the decoction are mixed, concentrated under reduced pressure, and then precipitated with alcohol, filtered, ethanol is recovered from the filtrate, concentrated, soluble dextrin is added, boiled instantly, stirred, and spray-dried to obtain a dry powder composition.

[0067] Finally, the dried product is made into pills.

[0068] Example 2

[0069] This embodiment provides a composition for treating leukemia, comprising the following raw materials:

[0070] American ginseng 14g, Ganoderma lucidum 13g, Cordyceps sinensis 7g, Panax notoginseng 8.5g, Atractylodes macrocephala 11.5g, Astragalus membranaceus 12.5g, Licorice root 7.5g, Honeysuckle 9g, Indigo naturalis 6g, Dendrobium candidum 11g, Peppermint 3g, Lotus seed heart 7g, Saposhnikovia divaricata 6.5g, Rhubarb 8g, Isatis indigotica 6g, Codonopsis pilosula 10g, Poria 8g, Artemisia annua 8g, Aloe vera 15g, Polygonatum 10g.

[0071] The preparation method of the above composition comprises the following steps:

[0072] Step A: Weigh 14 g of American ginseng and grind it into a powder with a particle size of 70 meshes. First, extract the American ginseng in ethanol at a temperature of 65±2°C to obtain an extract for later use;

[0073] Step B: according to the above weight, respectively weigh Ganoderma lucidum, Cordyceps sinensis, Panax notoginseng, Atractylodes macrocephala, Astragalus membranaceus, Licorice root, Honeysuckle, Indigo naturalis, Dendrobium, Mint, Lotus seed core, Saposhnikovia divaricata, Rhubarb, Radix Isatidis, Codonopsis pilosula, Poria cocos, Artemisia annua, Aloe vera, and Polygonatum sibiricum, soak the raw materials in water and then distill them, collect volatile oil for later use, collect the residues and add them into water for decoction, first decoct for 20 minutes over low heat, then decoct for 20 minutes over high heat, filter after decoction to obtain a decoction liquid, repeat the above operation with the residues and decoct them once more, filter to obtain a decoction liquid, mix the decoction liquids obtained twice and set aside;

[0074] Step C: the extract and the decoction are mixed and concentrated under reduced pressure, and then precipitated with alcohol, filtered, the filtrate is used to recover ethanol, concentrated, soluble dextrin is added, boiled instantly, stirred evenly, and spray-dried to obtain a dry powder composition.

[0075] Finally, the dried product is made into powder.

[0076] Example 3

[0077] This embodiment provides a composition for treating leukemia, comprising the following raw materials:

[0078] American ginseng 18g, Ganoderma lucidum 15g, Cordyceps sinensis 8g, Panax notoginseng 9g, Atractylodes macrocephala 12g, Astragalus membranaceus 13g, Licorice 8g, Honeysuckle 9g, Indigo naturalis 7g, Dendrobium 11g, Peppermint 5g, Lotus seed core 8g, Saposhnikovia divaricata 7g, Rhubarb 9g, Isatis indigotica root 8g, Codonopsis pilosula 13g, Poria 11g, Artemisia annua 9g, Aloe 19g, Polygonatum 12g.

[0079] The preparation method of the above composition comprises the following steps:

[0080] Step A: Weigh 18 g of American ginseng, grind it into a powder with a particle size of 80 mesh, extract the American ginseng in ethanol at a temperature of 68±2°C, and obtain an extract for later use;

[0081] Step B: according to the above weight, respectively weigh Ganoderma lucidum, Cordyceps sinensis, Panax notoginseng, Atractylodes macrocephala, Astragalus membranaceus, Licorice root, Honeysuckle, Indigo naturalis, Dendrobium, Mint, Lotus seed core, Saposhnikovia divaricata, Rhubarb, Radix Isatidis, Codonopsis pilosula, Poria cocos, Artemisia annua, Aloe vera, and Polygonatum sibiricum, soak the raw materials in water and then distill them, collect volatile oil for later use, collect the residues and add them into water for decoction, first decoct for 20 minutes over low heat, then decoct for 20 minutes over high heat, filter after decoction to obtain a decoction liquid, repeat the above operation with the residues and decoct them once more, filter to obtain a decoction liquid, mix the decoction liquids obtained twice and set aside;

[0082] Step C: the extract and the decoction are mixed, concentrated under reduced pressure, and then precipitated with alcohol, filtered, ethanol is recovered from the filtrate, concentrated, soluble dextrin is added, boiled instantly, stirred, and spray-dried to obtain a dry powder composition.

[0083] Finally, the dried product is made into granules.

[0084] Example 4

[0085] This embodiment provides a composition for treating leukemia, comprising the following raw materials:

[0086] American ginseng 12g, Ganoderma lucidum 10g, Cordyceps sinensis 5g, Panax notoginseng 7g, Atractylodes macrocephala 10g, Astragalus membranaceus 11g, Licorice root 6g, Honeysuckle 7g, Indigo naturalis 5g, Dendrobium candidum 10g, Peppermint 3g, Lotus seed heart 6g, Saposhnikovia divaricata 5g, Rhubarb 10g, Isatis indigotica root 10g, Codonopsis pilosula 15g, Poria 12g, Artemisia annua 12g, Aloe vera 20g, Polygonatum 15g.

[0087] The preparation method of the above composition comprises the following steps:

[0088] Step A: Weigh 12 g of American ginseng and grind it into a powder with a particle size of 60 meshes. First, extract the American ginseng in ethanol at a temperature of 63±2° C. to obtain an extract for later use;

[0089] Step B: according to the above weight, respectively weigh Ganoderma lucidum, Cordyceps sinensis, Panax notoginseng, Atractylodes macrocephala, Astragalus membranaceus, Licorice root, Honeysuckle, Indigo naturalis, Dendrobium, Mint, Lotus seed core, Saposhnikovia divaricata, Rhubarb, Radix Isatidis, Codonopsis pilosula, Poria cocos, Artemisia annua, Aloe vera, and Polygonatum sibiricum, soak the raw materials in water and then distill them, collect volatile oil for later use, collect the residues and add them into water for decoction, first decoct for 20 minutes over low heat, then decoct for 20 minutes over high heat, filter after decoction to obtain a decoction liquid, repeat the above operation with the residues and decoct them once more, filter to obtain a decoction liquid, mix the decoction liquids obtained twice and set aside;

[0090] Step C: the extract and the decoction are mixed, concentrated under reduced pressure, and then precipitated with alcohol, filtered, ethanol is recovered from the filtrate, concentrated, soluble dextrin is added, boiled instantly, stirred, and spray-dried to obtain a dry powder composition.

[0091] Finally, the dried product is made into tablets.

[0092] Comparative Example 1

[0093] The raw materials and preparation method of this comparative example are basically the same as those of Example 1, except that American ginseng is not added in this comparative example.

[0094] Comparative Example 2

[0095] The raw materials and preparation method of this comparative example are basically the same as those of Example 1, except that Cordyceps sinensis is not added in this comparative example.

[0096] Experimental Example 1

[0097] Evaluation of the inhibitory effect of the composition of the present application on the proliferation of leukemia cells:

[0098] The purpose of this experiment is to investigate the inhibitory effect of the pharmaceutical composition of the present invention on the in vitro cell proliferation of two leukemia cell lines, namely, acute myeloid leukemia cell line KG-1a and chronic myeloid leukemia cell line K562.

[0099] (1) Experimental Materials

[0100] Acute myeloid leukemia cell line KG-1a was purchased from Shanghai Kanglang Biotechnology Co., Ltd., and chronic myeloid leukemia cell line K562 was purchased from Nanjing Kebai Biotechnology Co., Ltd. Both cell lines were cultured in RPMI1640 medium containing 5% fetal bovine serum and placed in a 37°C, 5% CO2 incubator. Other reagents whose sources were not specified were commercially available.

[0101] (2) Experimental methods

[0102] KG-1a cells in exponential growth phase were cultured at 7.5×10 3 The cells were inoculated into a 96-well culture plate (each well contained 90 μL of RPMI1640 medium containing 5% fetal bovine serum) at a density of 10 cells / well, and then returned to the incubator for continued culture. After 2 hours of culture, the 96-well plate was removed from the incubator, and the drug was applied according to the following dosing schedule:

[0103] Blank control group: 10 μL of the above RPMI1640 medium was added to each well.

[0104] Positive control group: 10 μL of the above RPMI1640 medium containing 0.5 μg / mL doxorubicin was added to each well.

[0105] Example 1: 10 μL of the above RPMI1640 medium containing 0.5 μg / mL of the composition was added to each well.

[0106] Example 2: 10 μL of the above RPMI1640 medium containing 0.5 μg / mL of the composition was added to each well.

[0107] Example 3: 10 μL of the above RPMI1640 medium containing 0.5 μg / mL of the composition was added to each well.

[0108] Example 4: 10 μL of the above RPMI1640 medium containing 0.5 μg / mL of the composition was added to each well.

[0109] Comparative Example 1: 10 μL of the above RPMI1640 medium containing 0.5 μg / mL of the composition was added to each well.

[0110] Comparative Example 2: 10 μL of the above RPMI1640 medium containing 0.5 μg / mL of the composition was added to each well.

[0111] Then, the 96-well plate was returned to the incubator for further culture for 72 hours. After the culture was completed, 10 μL of MTT (PBS solution with a concentration of 5 mg / mL) was added to each well of the 96-well plate, and the plate was returned to the incubator for further culture for 3 hours, and then the culture medium was discarded, 120 μL of DMSO was added, and the plate was shaken in a 37°C water bath for 30 minutes. After the generated purple crystals were completely dissolved, the absorbance value (OD570) at a wavelength of 570 nanometers was measured with an enzyme marker, and the percentage of the OD570 value of the drug administration group to the OD570 value of the blank control group was used to reflect the survival rate of the cells. The calculation method of the inhibition rate (%) of the in vitro cell proliferation of KG-1a cells by each drug administration group is as follows:

[0112] Inhibition rate (%) = 1-[OD 570 Value / OD of blank control group 570 value] × 100%.

[0113] In addition, using the K562 cell line, the inhibition rate (%) of each administration group on the in vitro cell proliferation of K562 cells was determined by the same method as described above for the KG-1a cell line.

[0114] The final experimental results are shown in Tables 1 and 2.

[0115] Table 1. Inhibitory effect of the composition of the present application on in vitro cell proliferation of acute myeloid leukemia cell line KG-1a

[0116] Group Inhibition rate Blank control group 0 Positive control group 42.7±5.8 Example 1 76.8±2.4 Example 2 77.2±3.1 Example 3 77.3±2.9 Example 4 78.2±1.8 Comparative Example 1 42.8±3.7 Comparative Example 2 53.5±2.8

[0117] Table 2. Inhibitory effect of the composition of the present application on in vitro cell proliferation of chronic myeloid leukemia cell line K562

[0118]

[0119]

[0120] It can be seen from Table 1 and Table 2 that the composition of the present application has a good inhibitory effect on both the acute myeloid leukemia cell line KG-1a and the chronic myeloid leukemia cell line K562. At the same time, it can be seen from the experimental data of the comparative examples that the inhibitory effects of comparative examples 1 and 2 are far less than those of Examples 1-4, indicating that the combination of American ginseng and Cordyceps sinensis has a synergistic effect.

[0121] Experimental Example 2

[0122] AUC In pharmacology, the area under the blood drug concentration-time curve (AUC) is a key concept that measures the bioavailability of a drug. The larger the AUC, the more effectively the drug is absorbed by the body and enters the blood circulation; conversely, a small AUC means that the bioavailability of the drug is low.

[0123] In order to evaluate the bioavailability of the composition prepared in Example 1 (hereinafter referred to as Composition 1), groups of male beagle dogs (3 in each group) were administered an aqueous suspension of a solid dispersion of Composition 1 at a dose of 3 mg / kg (administered by oral gavage), or a dose of 3 mg / kg of Composition 1 dissolved in water: ethanol: polyethylene glycol (PEG) 400 (60:20:20) (administered by intravenous push into the cephalic vein). Blood samples were collected from the jugular vein of each animal at 0 minutes (before dosing), 5 minutes, 15 minutes and 30 minutes, and 1 hour, 2 hours, 4 hours, 8 hours, 12 hours and 24 hours after intravenous administration, and at 0 minutes (before dosing), 15 minutes and 30 minutes, and 1 hour, 2 hours, 4 hours, 8 hours, 12 hours and 24 hours after oral gavage administration. The amount of Composition 1 present in each sample was detected using a qualified LC-MS / MS method, and the lower limit of quantification was 0.5 ng / mL. The area under the curve (AUC) of the plasma concentration-time curve was determined by using the linear trapezoidal rule (up to the last measurable concentration without extrapolating the terminal elimination phase to infinity). The elimination half-life (t) was calculated by least squares regression analysis of the terminal linear portion of the logarithmic concentration-time curve. 1 / 2 The maximum plasma concentration (C max ) and reach C max The time (t max The oral bioavailability (F) was calculated by dividing the dose-normalized AUC after oral administration by the dose-normalized AUC after intravenous administration and reported as a percentage (%). The results are shown in Table 3:

[0124] Table 3. Pharmacokinetic parameters of Composition 1 after oral (PO) and intravenous (IV) administration to dogs (values ​​are the average of 3 dogs)

[0125]

[0126] As can be seen from Table 3, the average oral bioavailabilities of 25% solid dispersion of Composition 1 in PVP, 25% solid dispersion of Composition 1 in HPMCAS-M, and 50% solid dispersion of Composition 1 in HPMCAS-M are 63%, 52%, and 84%, respectively.

[0127] Experimental Example 3

[0128] Clinical therapeutic effect of the composition of this application on leukemia patients:

[0129] All the compositions obtained in Examples 1-4 were made into pills for clinical verification of drugs for treating leukemia. A total of 40 patients were selected, and each group was randomly divided into 10 patients. Considering the patient's constitution and tolerance, the experimental group was treated by gradually increasing the dosage. On the first day of treatment, 3 to 5 pills were taken once, 3 times a day. After about 10 days, 30 pills / day were taken in 3 times.

[0130] Efficacy standards (refer to the standards of the 1987 Suzhou National Leukemia Chemotherapy Symposium):

[0131] Complete remission (CR): clinically no symptoms or signs caused by leukemia cell infiltration, normal or near-normal life, blood count: Hb ≥ 100 g / L (male) or ≥ 90 g / L (female), absolute neutrophil count ≥ 1.5 × 10 9 / L, platelet ≥100×10 9 / L, no leukemic cells in peripheral blood classification, bone marrow: myeloblasts + promyelocytes ≤ 5%, red blood cells and megakaryocytes are normal;

[0132] Partial remission (PR): Myeloblasts + promyelocytes in the bone marrow >5% and ≤20% or one of the clinical or blood test results does not meet the complete remission criteria.

[0133] Complete remission rate = number of complete remission patients in each group / total number of patients in each group; partial remission rate = 1-complete remission rate.

[0134] The specific treatment results are shown in Table 3:

[0135] Table 4. Clinical effect of the composition of the present application in treating leukemia

[0136] Group Complete remission rate (%) Partial remission rate (%) Example 1 90％ 10％ Example 2 90％ 10％ Example 3 80％ 20％ Example 4 90％ 10％

[0137] It can be seen from Table 4 that the composition of the present application has a significant clinical therapeutic effect on leukemia.

[0138] In summary, the composition for treating leukemia provided by the present application can tonify the liver and kidney, clear away heat and detoxify, tonify blood, activate blood circulation, benefit essence and blood, nourish yin and promote body fluid, and enhance immunity, and has a good therapeutic effect on leukemia, wherein American ginseng and Cordyceps sinensis are monarch drugs, ginsenosides in American ginseng and cordyceps polysaccharides in Cordyceps sinensis can both inhibit the proliferation of cancer cells, and the combination of American ginseng and Cordyceps sinensis has a synergistic effect, Ganoderma lucidum, Panax notoginseng, and Atractylodes macrocephala are ministerial drugs, Ganoderma lucidum can enhance the functions of various organs of the digestive system, honeysuckle, mint, lotus seed core, Indigo naturalis, and Dendrobium can be adjuvants, which can alleviate the pain caused by leukemia complications and improve the quality of life of patients, Astragalus, Licorice, and Saposhnikovia divaricata are guiding drugs, which can neutralize the coldness of other raw materials, and the monarch, minister, adjuvant, and guiding roles of the raw materials are reasonable. The present application provides a method for preparing a composition for treating leukemia. The preparation method is simple, has high extraction efficiency, and has low requirements for extraction equipment. American ginseng is extracted by ethanol, and the extraction temperature is low, which can avoid the decomposition of the effective ingredient ginsenoside due to high temperature. The method of first distilling and then decocting is adopted. Compared with the traditional Chinese medicine decoction extraction method, the oil-soluble and water-soluble effective substances in the raw materials can be extracted, so that the composition extracted by the method of the present application has high bioavailability and better therapeutic effect. The present application provides an application of the above-mentioned composition in a drug for treating leukemia, and clinical trials have found that the effect of treating leukemia is significant.

[0139] Various embodiments of the present application may be presented in the form of a range; it should be understood that the description in the form of a range is only for convenience and brevity, and should not be understood as a rigid limitation on the scope of the present application; therefore, the range description should be considered to have specifically disclosed all possible sub-ranges and single numerical values ​​within the range. For example, the range description from 1 to 6 should be considered to have specifically disclosed sub-ranges, such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., as well as single numbers within the range, such as 1, 2, 3, 4, 5 and 6, which apply regardless of the range. In addition, whenever a numerical range is indicated herein, it is meant to include any cited number (fractional or integer) within the indicated range.

[0140] In the present application, in the absence of any contrary description, the directional words used, such as "upper" and "lower", are specifically the directions of the drawings. In addition, in the description of the present specification, the terms "include", "comprise", etc. refer to "including but not limited to". In this article, relational terms such as "first" and "second" are only used to distinguish an entity or operation from another entity or operation, and do not necessarily require or imply that there is any such actual relationship or order between these entities or operations. In this article, "and / or" describes the association relationship of the associated objects, indicating that there may be three kinds of relationships, for example, A and / or B, which can represent: A exists alone, A and B exist at the same time, and B exists alone. Wherein A, B can be singular or plural. In this article, "at least one" refers to one or more, and "multiple" refers to two or more. "At least one", "at least one of the following (individuals)" or similar expressions thereof refer to any combination of these items, including any combination of singular (individuals) or plural (individuals). For example, "at least one of a, b, or c", or "at least one of a, b and c", can both mean: a, b, c, ab (i.e. a and b), ac, bc or abc, where a, b, c can be single or plural, respectively.

[0141] The above description is only a specific implementation of the present application, so that those skilled in the art can understand or implement the present application. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein can be implemented in other embodiments without departing from the spirit or scope of the present application. Therefore, the present application will not be limited to the embodiments shown herein, but will conform to the widest range consistent with the principles and novel features applied for herein.

Claims

1. A composition for treating leukemia, characterized in that: By weight Including the following ingredients: 12-18 parts of American ginseng, 10-15 parts of Ganoderma lucidum, 5-8 parts of Cordyceps sinensis, 7-9 parts of Panax notoginseng, 10-12 parts of Atractylodes macrocephala, 11-13 parts of Astragalus, 6-8 parts of Licorice, 7-9 parts of Honeysuckle, 5-7 parts of Indigo naturalis, 10-13 parts of Dendrobium, 3-5 parts of Mint, 6-8 parts of Lotus seed core and 5-7 parts of Saposhnikovia divaricata.

2. The composition for treating leukemia according to claim 1, characterized in that: The following raw materials are included by weight: 14-16 parts of American ginseng, 11-14 parts of Ganoderma lucidum, 6-7 parts of Cordyceps sinensis, 7-8 parts of Panax notoginseng, 10-11 parts of Atractylodes macrocephala, 11-12 parts of Astragalus, 6-7 parts of Licorice, 7-8 parts of Honeysuckle, 5-6 parts of Indigo naturalis, 11-12 parts of Dendrobium, 4-5 parts of Mint, 7-8 parts of Lotus seed core and 6-7 parts of Saposhnikovia divaricata.

3. The composition for treating leukemia according to claim 1, characterized in that: By weight Including the following ingredients: 18 parts of American ginseng, 15 parts of ganoderma lucidum, 8 parts of cordyceps sinensis, 9 parts of panax notoginseng, 12 parts of atractylodes macrocephala, 13 parts of astragalus, 8 parts of liquorice, 9 parts of honeysuckle, 7 parts of indigo, 11 parts of dendrobium, 5 parts of mint, 8 parts of lotus seed core and 7 parts of siler.

4. The composition for treating leukemia according to claim 1, characterized in that: By weight Including the following ingredients: 16 parts of American ginseng, 13 parts of ganoderma lucidum, 6 parts of cordyceps sinensis, 8 parts of panax notoginseng, 11 parts of atractylodes macrocephala, 12 parts of astragalus, 8 parts of liquorice, 8 parts of honeysuckle, 6 parts of indigo, 10.5 parts of dendrobium, 4 parts of mint, 7 parts of lotus seed core and 6 parts of siler.

5. The composition for treating leukemia according to claim 1, characterized in that: The following raw materials are also included by weight: 8-10 parts of rhubarb, 6-10 parts of isatis root, 10-15 parts of codonopsis pilosula, 8-12 parts of tuckahoe, 8-12 parts of artemisia annua, 15-20 parts of aloe, and 10-15 parts of polygonatum.

6. The composition for treating leukemia according to claim 1, characterized in that: The dosage form of the composition is any one of pills, powders, granules and tablets.

7. A method for preparing a composition for treating leukemia according to any one of claims 1 to 6, characterized in that: The following steps are involved: Step A: Weigh American ginseng according to the above weight, grind it into powder, extract American ginseng in ethanol, obtain extract, and set aside; Step B: weigh the above weight portions of Ganoderma lucidum, Cordyceps sinensis, Panax notoginseng, Atractylodes macrocephala, Astragalus membranaceus, Licorice root, Honeysuckle, Indigo naturalis, Dendrobium officinale, Menthus alba, Lotus seed core and Saposhnikovia divaricata, soak the raw materials in water and then distill them, collect volatile oil for later use, collect the residues and add them into water for repeated decoction twice, filter after decoction to obtain a decoction for later use; Step C: the extract and the decoction are mixed, concentrated under reduced pressure, and then precipitated with alcohol, filtered, ethanol is recovered from the filtrate, concentrated, soluble dextrin is added, boiled instantly, stirred, and spray-dried to obtain a dry powder composition.

8. The method for preparing the composition for treating leukemia according to claim 6, characterized in that: In the step A, the particle size of the powder is 60-80 mesh.

9. The method for preparing the composition for treating leukemia according to claim 6, characterized in that: In the step A, the extraction temperature is 60°C-70°C.

10. Use of the composition according to any one of claims 1 to 6 in a drug for treating leukemia.

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