Pharmaceutical composition for treating or preventing leukemia and preparation method thereof

Abstract

The invention provides a pharmaceutical composition for treating or preventing leukemia and a preparation method thereof, and relates to the technical field of biological pharmacy. The composition comprises the following raw materials in parts by weight: 10-25 parts of American ginseng, 10-20 parts of lucid ganoderma, 5-15 parts of wormwood, 5-15 parts of donkey-hide gelatin, 10-20 parts of bighead atractylodes rhizome, 10-20 parts of angelica sinensis, 5-15 parts of liquorice, 5-15 parts of fructus forsythiae, 5-15 parts of indigo naturalis, 10-20 parts of dendrobe, 1-5 parts of hawthorn, 5-15 parts of poria cocos and 3-10 parts of divaricate saposhnikovia root. The traditional Chinese medicine composition has the effects of clearing away heat and toxic materials, promoting blood circulation to remove blood stasis, tonifying spleen and kidney, promoting qi circulation and removing stasis, and has obvious effect on preventing and treating leukemia.

Description

Technical Field

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

[0002] Leukemia belongs to the category of acute labor in traditional Chinese medicine. The etiology and pathogenesis are toxic heat damaging blood, invading the bone marrow, leading to yin damage and blood consumption. Symptoms include fever, bone pain, bleeding, anemia, etc. Bone marrow tests can find an increase in immature cells, which can reach 50-90%, and the severity of the disease varies. In the field of traditional Chinese medicine, there is no name of "leukemia" in ancient literature. According to its symptoms such as fever, bleeding, anemia, hepatosplenomegaly and lymphadenopathy, it is classified into the categories of febrile disease, blood disease, consumptive tuberculosis, scrofula, etc. "Suwen Yinyang Yingxiang Dalun" says: "If you are injured by cold in winter, you will definitely get a fever in spring." "Shengji Zonglu" said: "The symptoms of heat fatigue are irritability, red face and headache, dry eyes, dry lips, high fever, constant thirst, ulcers in the mouth and tongue, loss of taste for food and drink, sore limbs, lying down more and getting up less, or occasional night sweats, and gradual weight loss." This disease, with symptoms such as retained fever, excessive sweating, progressive weight loss, and ulcers in the mouth and tongue, is very similar to the clinical manifestations of acute leukemia.

[0003] From a large number of clinical practices, early involvement of Chinese medicine and Chinese herbal medicine in the treatment of leukemia can significantly improve the patient's condition. Chinese medicine regulates the human body in a comprehensive way. The regulation of qi, blood, yin and yang, and internal organs by Chinese medicine can correspond to the regulation of immune function and immune status in Western medicine. In other words, Chinese medicine has obvious advantages in improving the quality of life of patients. Therefore, early involvement of Chinese medicine and Chinese herbal medicine is very beneficial to the recovery of the disease.

[0004] At present, there are few studies on the use of Chinese herbal medicine compositions for preventing leukemia, and we need a Chinese herbal medicine composition that can prevent leukemia. Summary of the invention

[0005] The purpose of the present application is to provide a pharmaceutical composition for treating or preventing leukemia, which can both prevent leukemia and treat leukemia.

[0006] Another object of the present application is to provide a method for preparing a pharmaceutical composition for treating or preventing leukemia, wherein the method can effectively extract effective substances from the raw materials.

[0007] The present application solves the technical problem by adopting the following technical solution.

[0008] In one aspect, the present invention provides a pharmaceutical composition for treating or preventing leukemia, comprising the following raw materials by weight:

[0009] 10-25 parts of American ginseng, 10-20 parts of Ganoderma lucidum, 5-15 parts of wormwood, 5-15 parts of donkey-hide gelatin, 10-20 parts of Atractylodes macrocephala, 10-20 parts of Angelica sinensis, 5-15 parts of Licorice, 5-15 parts of Forsythia suspensa, 5-15 parts of Indigo naturalis, 10-20 parts of Dendrobium, 1-5 parts of Hawthorn, 5-15 parts of Poria and 3-10 parts of Saposhnikovia divaricata.

[0010] On the other hand, the present invention provides a method for preparing a pharmaceutical composition for treating or preventing leukemia, comprising the following steps:

[0011] Step A: Weigh American ginseng according to the above weight, grind it into powder, extract American ginseng in ethanol, obtain extract, and set aside;

[0012] Step B: weigh the above weight portions of Ganoderma lucidum, Artemisia argyi, donkey-hide gelatin, Atractylodes macrocephala, Chinese angelica, Licorice, Forsythia suspensa, Indigo naturalis, Dendrobium officinale, Crataegus pinnatifida, Poria cocos 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;

[0013] Step C: the extract, volatile oil and 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 evenly, and spray-dried to obtain a dry powder composition.

[0014] Compared with the prior art, the embodiments of the present application have at least the following advantages or beneficial effects:

[0015] The embodiment of the present application provides a pharmaceutical composition for treating or preventing leukemia, wherein American ginseng and cordyceps are main drugs, ginsenosides in American ginseng and cordyceps polysaccharides in cordyceps can inhibit the proliferation of cancer cells, and the combination of American ginseng and cordyceps has a synergistic effect, mugwort, angelica, and atractylodes are assistant drugs, which can clear away heat and detoxify, reduce swelling and relieve pain, nourish yin and promote body fluid, and invigorate blood and promote blood circulation, forsythia, hawthorn, Poria, indigo, and dendrobium are adjuvant drugs, which can promote qi and relieve depression, harmonize blood and promote diuresis, and can alleviate the pain caused by leukemia complications and improve the quality of life of patients, and donkey-hide gelatin, liquorice, and saposhnikovia are guiding drugs, which can nourish blood and yin, invigorate the spleen and replenish qi, and invigorate the kidney and calm the mind, and the drugs are harmonized and matched to work synergistically to achieve the effects of clearing heat and detoxifying, invigorating blood and removing blood stasis, invigorating the spleen and kidney, and promoting qi and dispersing stagnation, and the drug is effective in preventing and treating leukemia.

[0016] 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. DETAILED DESCRIPTION

[0017] In order to make the purpose, technical solution and advantages of the embodiments of the present application clearer, the technical solution 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 the present application.

[0018] 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.

[0019] The present application provides a pharmaceutical composition for treating or preventing leukemia, which comprises the following raw materials by weight:

[0020] 10-25 parts of American ginseng, 10-20 parts of Ganoderma lucidum, 5-15 parts of wormwood, 5-15 parts of donkey-hide gelatin, 10-20 parts of Atractylodes macrocephala, 10-20 parts of Angelica sinensis, 5-15 parts of Licorice, 5-15 parts of Forsythia suspensa, 5-15 parts of Indigo naturalis, 10-20 parts of Dendrobium, 1-5 parts of Hawthorn, 5-15 parts of Poria and 3-10 parts of Saposhnikovia divaricata.

[0021] 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.

[0022] 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.

[0023] Mugwort, this product is the dried leaves of the mugwort plant of the Asteraceae family; it tastes pungent and bitter, and is warm in nature; it enters the liver, spleen, and kidney meridians; it dispels cold and relieves pain, warms the meridians and stops bleeding.

[0024] Donkey-hide gelatin is a tonic medicine. It is a solid gelatin made by boiling and concentrating the dried or fresh skin of the donkey, an equine animal. It has the effects of nourishing blood, stopping bleeding, nourishing yin and moistening dryness. It is often used for blood deficiency, sallow complexion, dizziness, palpitations, muscle weakness, and various bleeding syndromes: Yin deficiency syndrome and dryness syndrome. Donkey-hide gelatin tastes sweet and is neutral in nature. It enters the lung, liver, and kidney meridians. It mainly contains protein and peptide components. After hydrolysis, it can obtain a variety of amino acids, such as glycine, glutamic acid, alanine, arginine, aspartic acid, lysine, phenylalanine, serine, histidine, etc.

[0025] 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.

[0026] Angelica sinensis is sweet, pungent, warm, and enters the liver, heart, and spleen meridians. Angelica sinensis is sweet and nourishing, and pungent and warm. It mainly enters the liver and heart meridians, and also enters the spleen meridian. It is good at nourishing blood and activating blood circulation, regulating menstruation and relieving pain, moistening the intestines and relieving constipation, and can dispel cold. It is suitable for all symptoms of blood deficiency, blood stasis and cold, and is especially good for those with dry intestines and constipation. It is not only an important medicine for regulating menstruation in gynecology, but also a good product for blood tonic in internal medicine. It is also commonly used for swelling and wound treatment in surgery and trauma. It mainly contains volatile oils such as ligustilide, angelica ketone, cinnamaldehyde, n-butyl furanolide, verbenone, safrole, organic acid components such as ferulic acid, vanillic acid, niacin, succinic acid, and contains angelica polysaccharides, amino acids, vitamin A and other ingredients.

[0027] 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.

[0028] The medicinal properties of Forsythia suspensa are bitter and slightly cold. It enters the lung, heart, and small intestine meridians. The bitterness of Forsythia suspensa can dissipate, the slight cold can clear, and the light quality floats upward, entering the lung, heart, and small intestine meridians. It can not only clear away heat and toxicity, but also disperse wind and heat, and also disperse knots, promote diuresis, and reduce swelling. The medicinal power is relatively strong, mainly clearing, clearing the middle and penetrating, and can disperse knots and promote diuresis. It is suitable for heat and toxicity, wind heat, damp heat, and swelling. It is known as the "holy medicine for sores". This product contains triterpenoid saponins, and the peel contains sterols, forsythia phenol, alkaloids, saponins, oleanolic acid, coumarins, and rich vitamin P and a small amount of volatile oil. It has the functions of clearing away heat and toxicity, reducing swelling and dispersing knots, and evacuating wind and heat.

[0029] 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.

[0030] 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 stomachache, deficiency heat after illness, and yin damage and dark eyes.

[0031] The ripe fruit and flowers of hawthorn can be used as medicine. Its ripe fruit is the source of the Chinese medicinal material hawthorn, which is sour, sweet, slightly warm in nature, and enters the spleen, stomach, and liver meridians. It has the effect of eliminating food stagnation and removing stasis. It is mainly used to treat food stagnation, abdominal distension and pain, diarrhea, dysmenorrhea due to blood stasis, amenorrhea, abdominal pain and lochia after childbirth, hernia or testicular swelling and pain, and hyperlipidemia.

[0032] 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.

[0033] 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.

[0034] In the composition of the present application, American ginseng and cordyceps are the main drugs, and the ginsenosides in American ginseng and the cordyceps polysaccharides in cordyceps can both inhibit the proliferation of cancer cells. The combination of American ginseng and cordyceps has a synergistic and synergistic effect. Artemisia argyi, angelica sinensis, and Atractylodes macrocephala are the assistant drugs, which can clear away heat and detoxify, reduce swelling and relieve pain, nourish yin and promote body fluid, and invigorate blood and promote blood circulation. Forsythia suspensa, hawthorn, Poria cocos, Indigo naturalis, and Dendrobium can be used as adjuvants, which can promote qi and relieve depression, harmonize blood and promote diuresis, and can alleviate the pain caused by leukemia complications and improve the quality of life of patients. Donkey-hide gelatin, liquorice, and saposhnikovia divaricata are the guiding drugs, which can nourish blood and yin, invigorate the spleen and replenish qi, and invigorate the kidney and calm the mind. The drugs are harmonized and matched to achieve the effects of clearing away heat and detoxifying, invigorating blood and removing blood stasis, invigorating the spleen and kidney, and promoting qi and dispersing stagnation. The drug is effective in preventing and treating leukemia.

[0035] In some embodiments of the present application, the above-mentioned composition includes the following raw materials by weight: 12-18 parts of American ginseng, 12-16 parts of Ganoderma lucidum, 6-12 parts of mugwort, 8-12 parts of donkey-hide gelatin, 10-15 parts of Atractylodes macrocephala, 12-18 parts of Angelica sinensis, 6-10 parts of licorice, 7-9 parts of Forsythia suspensa, 5-7 parts of Indigo naturalis, 10-13 parts of Dendrobium, 3-5 parts of Hawthorn, 6-8 parts of Poria cocos and 5-7 parts of Saposhnikovia divaricata.

[0036] In some embodiments of the present application, the above-mentioned composition includes the following raw materials by weight: 10 parts of American ginseng, 10 parts of Ganoderma lucidum, 5 parts of mugwort, 5 parts of donkey-hide gelatin, 10 parts of Atractylodes macrocephala, 10 parts of Angelica sinensis, 5 parts of licorice, 5 parts of Forsythia suspensa, 5 parts of Indigo naturalis, 10 parts of Dendrobium, 1 part of Hawthorn, 5 parts of Poria cocos and 3 parts of Saposhnikovia divaricata.

[0037] In some embodiments of the present application, the above-mentioned composition includes the following raw materials by weight: 18 parts of American ginseng, 16 parts of Ganoderma lucidum, 12 parts of mugwort, 12 parts of donkey-hide gelatin, 15 parts of Atractylodes macrocephala, 12 parts of Angelica sinensis, 6 parts of licorice, 9 parts of Forsythia suspensa, 7 parts of Indigo naturalis, 10 parts of Dendrobium, 5 parts of Hawthorn, 8 parts of Poria cocos and 7 parts of Saposhnikovia divaricata.

[0038] 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 artemisia annua, 15-20 parts of aloe vera, and 10-15 parts of polygonatum.

[0039] 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.

[0040] 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, quinazolines, 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.

[0041] 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.

[0042] 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.

[0043] 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.

[0044] 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.

[0045] The present invention provides a method for preparing a pharmaceutical composition for treating or preventing leukemia, comprising the following steps:

[0046] Step A: Weigh American ginseng according to the above weight, grind it into powder, extract American ginseng in ethanol, obtain extract, and set aside;

[0047] Step B: weigh the above weight portions of Ganoderma lucidum, Artemisia argyi, donkey-hide gelatin, Atractylodes macrocephala, Chinese angelica, Licorice, Forsythia suspensa, Indigo naturalis, Dendrobium officinale, Crataegus pinnatifida, Poria cocos 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;

[0048] Step C: the extract, volatile oil and 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 evenly, and spray-dried to obtain a dry powder composition.

[0049] 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.

[0050] In some embodiments of the present application, the concentration of the ethanol is 80%-95%. Choosing a higher concentration of ethanol will provide better extraction effects.

[0051] In some embodiments of the present application, in the above step A, the mass ratio of American ginseng to ethanol is 1:(6-8). Under this ratio, ethanol can fully infiltrate American ginseng, and the extraction is more complete.

[0052] In some embodiments of the present application, in the above step B, 8-12 times the weight of purified water is added to the medicinal residue, refluxed and boiled for 60-100 minutes, filtered, and then 5-9 times the weight of purified water is added to the medicinal residue, boiled for 30-60 minutes, and filtered to obtain the post-decocted liquid. The reflux decoction is a fully enclosed closed-loop cycle, which can save 30%-50% of the solvent, and the secondary steam is used as a heat source, and the extraction and concentration are carried out simultaneously, saving a lot of energy. Reflux cooking can improve the extraction efficiency of the product. Due to the precise temperature control during the reflux cooking process, the material can be prevented from staying at high temperature for a long time, thereby maintaining the quality and nutritional content of the material.

[0053] In some embodiments of the present application, the dosage form of the composition is any one of pills, powders, granules, and tablets.

[0054] It should be noted that in the present application, "prevention" refers to inhibiting or delaying the occurrence of leukemia by administering a pharmaceutical composition, and "treatment" refers to improving or effectively alleviating the symptoms of leukemia by administering a pharmaceutical composition.

[0055] 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 the unrecorded specific conditions in the following examples are usually measured according to national standards. If there is no corresponding national standard, then carry out according to general international standards, normal conditions or according to the conditions recommended by the manufacturer.

[0056] Example 1

[0057] The present invention provides a pharmaceutical composition for treating or preventing leukemia, comprising the following raw materials:

[0058] 10g of American ginseng, 10g of Ganoderma lucidum, 5g of mugwort, 5g of donkey-hide gelatin, 10g of Atractylodes macrocephala, 10g of Angelica sinensis, 5g of Licorice, 5g of Forsythia suspensa, 5g of Indigo naturalis, 10g of Dendrobium, 1g of Hawthorn, 5g of Poria and 3g of Saposhnikovia divaricata.

[0059] The present invention provides a method for preparing a pharmaceutical composition for treating or preventing leukemia, comprising the following steps:

[0060] Step A: Weigh 15 g of American ginseng, grind it into a powder with a particle size of 100 mesh, extract the American ginseng in ethanol at a temperature of 70° C., and obtain an extract for later use;

[0061] Step B: weigh the above weight portions of Ganoderma lucidum, Artemisia argyi, donkey-hide gelatin, Atractylodes macrocephala, Angelica sinensis, Licorice root, Forsythia suspensa, Indigo naturalis, Dendrobium officinale, Crataegus pinnatifida, Poria cocos and Saposhnikovia divaricata, soak the raw materials in water and then distill them, collect volatile oil for later use, collect the residues, add purified water 12 times the weight of the residues to the residues, reflux and boil for 100 minutes, filter, then add purified water 9 times the weight of the residues, boil for 60 minutes, filter to obtain the decoction, and set aside;

[0062] Step C: the extract, volatile oil and 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 evenly, and spray-dried to obtain a dry powder composition.

[0063] Finally, the dry powder composition is made into pills.

[0064] Example 2

[0065] The present invention provides a pharmaceutical composition for treating or preventing leukemia, comprising the following raw materials:

[0066] 25g American ginseng, 20g Ganoderma lucidum, 15g mugwort, 15g donkey-hide gelatin, 20g Atractylodes macrocephala, 20g Angelica sinensis, 15g Licorice, 15g Forsythia suspensa, 15g Indigo naturalis, 20g Dendrobium candidum, 5g Hawthorn, 15g Poria cocos and 10g Saposhnikovia divaricata.

[0067] The present invention provides a method for preparing a pharmaceutical composition for treating or preventing leukemia, comprising the following steps:

[0068] Step A: Weigh 25 g of American ginseng, grind it into a powder with a particle size of 100 mesh, extract the American ginseng in ethanol at a temperature of 70° C., and obtain an extract for later use;

[0069] Step B: weigh the above weight portions of Ganoderma lucidum, Artemisia argyi, donkey-hide gelatin, Atractylodes macrocephala, Angelica sinensis, Licorice root, Forsythia suspensa, Indigo naturalis, Dendrobium officinale, Crataegus pinnatifida, Poria cocos and Saposhnikovia divaricata, soak the raw materials in water and then distill them, collect volatile oil for later use, collect the residues, add purified water 8 times the weight of the residues to the residues, reflux and boil for 60 minutes, filter, then add purified water 5 times the weight of the residues, boil for 30 minutes, filter to obtain the decoction, and set aside;

[0070] Step C: the extract, volatile oil and 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 evenly, and spray-dried to obtain a dry powder composition.

[0071] Finally, the dry powder composition is made into powder.

[0072] Example 3

[0073] The present invention provides a pharmaceutical composition for treating or preventing leukemia, comprising the following raw materials:

[0074] American ginseng 18g, Ganoderma lucidum 16g, mugwort 12g, donkey-hide gelatin 12g, Atractylodes macrocephala 15g, Angelica sinensis 12g, Licorice 6g, Forsythia suspensa 9g, Indigo naturalis 7g, Dendrobium candidum 10g, Hawthorn 5g, Poria cocos 8g and Saposhnikovia divaricata 7g.

[0075] The present invention provides a method for preparing a pharmaceutical composition for treating or preventing leukemia, comprising the following steps:

[0076] Step A: Weigh 18 g of American ginseng, grind it into a powder with a particle size of 100 mesh, extract the American ginseng in ethanol at a temperature of 70° C., and obtain an extract for later use;

[0077] Step B: weigh the above weight portions of Ganoderma lucidum, Artemisia argyi, donkey-hide gelatin, Atractylodes macrocephala, Angelica sinensis, Licorice root, Forsythia suspensa, Indigo naturalis, Dendrobium officinale, Crataegus pinnatifida, Poria cocos and Saposhnikovia divaricata, soak the raw materials in water and then distill them, collect volatile oil for later use, collect the residues, add purified water 10 times the weight of the residues to the residues, reflux and boil for 80 minutes, filter, then add purified water 8 times the weight of the residues, boil for 40 minutes, filter to obtain the decoction, and set aside;

[0078] Step C: the extract, volatile oil and 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 evenly, and spray-dried to obtain a dry powder composition.

[0079] Finally, the dry powder composition is made into granules.

[0080] Example 4

[0081] The present invention provides a pharmaceutical composition for treating or preventing leukemia, comprising the following raw materials:

[0082] American ginseng 18g, Ganoderma lucidum 16g, mugwort 12g, donkey-hide gelatin 12g, Atractylodes macrocephala 15g, Angelica sinensis 12g, Licorice root 6g, Forsythia suspensa 9g, Indigo naturalis 7g, Dendrobium candidum 10g, Hawthorn 5g, Poria 8g, Saposhnikovia divaricata 7g, Rhubarb 8g, Isatis indigotica 10g, Codonopsis pilosula 12g, Artemisia annua 8g, Aloe vera 16g and Polygonatum 13g.

[0083] The present invention provides a method for preparing a pharmaceutical composition for treating or preventing leukemia, comprising the following steps:

[0084] Step A: Weigh 18 g of American ginseng, grind it into a powder with a particle size of 100 mesh, extract the American ginseng in ethanol at a temperature of 70° C., and obtain an extract for later use;

[0085] Step B: weigh the above weight portions of Ganoderma lucidum, Artemisia argyi, donkey-hide gelatin, Atractylodes macrocephala, Angelica sinensis, Licorice, Forsythia suspensa, Indigo naturalis, Dendrobium officinale, Crataegus pinnatifida, Poria cocos, Saposhnikovia divaricata, Rhubarb, Radix Isatidis, Codonopsis pilosula, 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, add purified water 10 times the weight of the residues to the residues, reflux and decoct for 80 minutes, filter, then add purified water 8 times the weight of the residues, decoct for 40 minutes, filter to obtain the decoction for later use;

[0086] Step C: the extract, volatile oil and 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 evenly, and spray-dried to obtain a dry powder composition.

[0087] Finally, the dry powder composition is made into tablets.

[0088] Comparative Example 1

[0089] The present invention provides a pharmaceutical composition for treating or preventing leukemia, comprising the following raw materials:

[0090] American ginseng 18g, Ganoderma lucidum 16g, donkey-hide gelatin 12g, Atractylodes macrocephala 15g, Angelica sinensis 12g, Licorice root 6g, Forsythia suspensa 9g, Indigo naturalis 7g, Dendrobium candidum 10g, Hawthorn 5g, Poria cocos 8g and Saposhnikovia divaricata 7g.

[0091] The present invention provides a method for preparing a pharmaceutical composition for treating or preventing leukemia, comprising the following steps:

[0092] Step A: Weigh 18 g of American ginseng, grind it into a powder with a particle size of 100 mesh, extract the American ginseng in ethanol at a temperature of 70° C., and obtain an extract for later use;

[0093] Step B: weigh the above weight portions of Ganoderma lucidum, donkey-hide gelatin, Atractylodes macrocephala, Chinese angelica, liquorice, forsythia, indigo, dendrobium, hawthorn, Poria cocos and saposhnikovia divaricata, soak the raw materials in water and then distill them, collect volatile oil for later use, collect the residues, add purified water 10 times the weight of the residues to the residues, reflux and boil for 80 minutes, filter, then add purified water 8 times the weight of the residues, boil for 40 minutes, filter to obtain the decoction, and set aside;

[0094] Step C: the extract, volatile oil and 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 evenly, and spray-dried to obtain a dry powder composition.

[0095] Finally, the dry powder composition is made into granules.

[0096] Comparative Example 2

[0097] The present invention provides a pharmaceutical composition for treating or preventing leukemia, comprising the following raw materials:

[0098] American ginseng 18g, Ganoderma lucidum 16g, mugwort 12g, donkey-hide gelatin 12g, Atractylodes macrocephala 15g, Licorice 6g, Forsythia suspensa 9g, Indigo naturalis 7g, Dendrobium 10g, Hawthorn 5g, Poria 8g and Saposhnikovia divaricata 7g.

[0099] The present invention provides a method for preparing a pharmaceutical composition for treating or preventing leukemia, comprising the following steps:

[0100] Step A: Weigh 18 g of American ginseng, grind it into a powder with a particle size of 100 mesh, extract the American ginseng in ethanol at a temperature of 70° C., and obtain an extract for later use;

[0101] Step B: weigh the above weight portions of Ganoderma lucidum, Artemisia argyi, donkey-hide gelatin, Atractylodes macrocephala, Licorice root, Forsythia suspensa, Indigo naturalis, Dendrobium officinale, Hawthorn, Poria cocos and Saposhnikovia divaricata, soak the raw materials in water and then distill them, collect volatile oil for later use, collect the residues, add purified water 10 times the weight of the residues to the residues, reflux and boil for 80 minutes, filter, then add purified water 8 times the weight of the residues, boil for 40 minutes, filter to obtain the decoction, and set aside;

[0102] Step C: the extract, volatile oil and 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 evenly, and spray-dried to obtain a dry powder composition.

[0103] Finally, the dry powder composition is made into granules.

[0104] Experimental Example 1

[0105] The therapeutic effect of the Chinese medicine preparation of the present invention on leukemia K562

[0106] Materials: 80 SCID mice, half male and half female, aged 8 weeks and weighing 18-22 g, were purchased from Beijing Experimental Animal Research. Cells in the logarithmic growth phase were used for in vivo inhibition of animals.

[0107] Establishment of mouse K562 leukemia model: Each group of mice was inoculated with 0.2 mL of K562 leukemia cells (a 25% saline cell suspension was prepared under sterile conditions from K562 leukemia mice and inoculated subcutaneously in mice). The drug was administered on the third day after inoculation, and survival observation was performed on 10 animals in each group.

[0108] Trial drugs and dosing regimen:

[0109] Model control group: the same volume of normal saline was given by gavage;

[0110] Positive control group: The positive control drug was Jinxiong Capsule (Guo Shi Jian Zi G20060157, Zhejiang Yake Pharmaceutical Co., Ltd.), which was prepared with water into a 0.6 g / ml suspension. One group of mice was given the drug by gavage once a day at a dose of 2.4 g / kg for 7 consecutive days.

[0111] Group A: A group of mice was selected and marked as the medium-dose group (2.4 g / kg) of Group A. The capsules prepared in Example 1 of the present invention were mixed with water to form a suspension with a medium-dose concentration of 0.6 g / ml. The suspension was gavaged once a day according to the dose for 7 consecutive days.

[0112] Group B: The test drug is the composition prepared in Example 2 of the present invention, and the administration scheme is the same as that of Group A.

[0113] Group C: The test drug is the composition prepared in Example 3 of the present invention, and the administration scheme is the same as that of Group A.

[0114] Group D: The test drug is the composition prepared in Example 4 of the present invention, and the administration scheme is the same as that of Group A.

[0115] Group E: The test drug is the composition prepared in Comparative Example 1 of the present invention, and the administration scheme is the same as that of Group A.

[0116] Group F: The test drug is the composition prepared in Comparative Example 2 of the present invention, and the administration scheme is the same as that of Group A.

[0117] Table 1. Comparison of survival time in each experimental group

[0118] Group n Survival time (d) Model control group 10 5.32±1.03 Positive control group 10 15.92±1.89 Group A 10 34.56±1.12 Group B 10 35.08±2.74 Group C 10 37.78±2.21 Group D 10 36.31±1.67 Group E 10 21.65±1.32 Group F 10 22.76±1.43

[0119] Results analysis: Effect on survival period. The experimental results show that compared with the model control group, the survival period of the positive control group and experimental groups A, B, and C was significantly prolonged, and the difference was statistically significant (P < 0.05); compared with the positive control group, the survival period of experimental groups A, B, and C was also significantly prolonged, and the difference was statistically significant (P < 0.05), among which the survival time of mice with leukemia in group C was the longest, which shows that the granule formulation prepared in Example 3 is the best, and the results are shown in Table 1. It shows that the composition of the present application has an inhibitory effect on K562 leukemia cells and prolongs the survival time, which further shows that the composition of the present application has a therapeutic effect on leukemia. At the same time, the survival time of groups E and F is much shorter than that of experimental example 3, which can also explain the lack of synergistic enhancement of wormwood and angelica to the monarch drug, and the inhibitory effect on leukocytes is weakened.

[0120] Experimental Example 2

[0121] Preventive effect of the Chinese medicine preparation of the present invention on AML cell line HL-60

[0122] Experimental animals: SPF grade, 90 SCID mice, half male and half female, 7-8 weeks old, body weight 20-22g, animal room requires constant temperature 20-22℃, constant humidity 60%-70%, 5 mice per cage, natural light, free access to purified water, food autoclaved.

[0123] Cell culture: Take out the cryovial of frozen AML cell line HL-60 and thaw it quickly at 37℃. The cell culture incubator is vented with 5% CO2 and kept at 37℃. After thawing, HL-60 is inoculated in RPMI-1640 medium containing 100mg / L streptomycin, 100U / mL penicillin G and 10% fetal bovine serum. After routine subculture for 3 days, the cells are injected into centrifuge tubes after EDTA digestion and centrifuged at low speed of 1000r / min for 5min. The AML cell line HL-60 is collected and adjusted into a cell suspension with a cell number density of 1×107 for standby use.

[0124] Modeling and grouping: 80 mice were randomly selected from 90 mice and randomly divided into model control group, cytarabine group, group 1, group 2, group 3, group 4, group 5 and group 6, and the other 10 normal mice were set as blank control group. The SCID mice in the model group, cytarabine group and groups 1-6 were removed and placed on a clean bench. The model control group and the blank control group were gavaged with an equal volume of 0.9% sodium chloride injection, the cytarabine group was injected with cytarabine standard 100 mg / (m2·d) through the tail vein once a day, and the 1-6 groups were injected with the compositions prepared in Examples 1-4 and Comparative Examples 1-2, respectively, and pretreated with 100 mg / kg body weight of drugs by intraperitoneal injection, once a day, for 2 days, and the spare AML cell line HL-60 cell suspension was taken on the third day, and all were injected subcutaneously at a single point on the right side of the mouse abdomen (1×10^7 mice), and the blank control group was not treated. The tumor formation standard was the appearance of tumor infiltration in the liver and spleen and the peripheral blood leukocyte count reaching (4.03±1.92×10^9 / L) at the third week after injection.

[0125] In the preliminary experiment of modeling, the average tumor formation time was (14.63±2.74) days, and the average survival time was (54.36±6.97) days, indicating that this method is simple to model, has a high tumor formation rate (the tumor formation rate in this experiment was 100%), and can more realistically and intuitively observe the infiltration and metastasis of leukemia cells in internal organs such as the liver, spleen, and lungs.

[0126] Table 2. Comparison of tumor growth time in each experimental group

[0127]

[0128]

[0129] As can be seen from Table 2, the tumor formation time of groups 1 to 4 is significantly longer than that of the model control group and the cytarabine group, indicating that the combination prepared in the present application has a preventive effect on acute myeloid leukemia AML.

[0130] Experimental Example 3

[0131] Clinical therapeutic effect of the composition of this application on leukemia patients:

[0132] 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.

[0133] Efficacy standards (refer to the standards of the 1987 Suzhou National Leukemia Chemotherapy Symposium):

[0134] 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;

[0135] 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.

[0136] 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.

[0137] The specific treatment results are shown in Table 3:

[0138] Table 3. Clinical effect of the composition of the present application in treating leukemia

[0139] Group Complete remission rate (%) Partial remission rate (%) Example 1 90％ 10％ Example 2 90％ 10％ Example 3 80％ 20％ Example 4 90％ 10％

[0140] It can be seen from Table 3 that the composition of the present application has a significant clinical therapeutic effect on leukemia and has a significant alleviating effect on the disease, and it can be seen that it has an excellent therapeutic effect.

[0141] In summary, the embodiments of the present application provide a pharmaceutical composition for treating or preventing leukemia, wherein American ginseng and Cordyceps sinensis are the main 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 and synergistic effect, Artemisia argyi, Angelica sinensis, and Atractylodes macrocephala are the assistant drugs, which clear away heat and detoxify, reduce swelling and relieve pain, nourish yin and promote body fluid, and invigorate blood and promote blood circulation, Forsythia suspensa, Crataegus pinnatifida, Poria cocos, Indigo naturalis, and Dendrobium can be used as adjuvants, which promote qi and relieve depression, harmonize blood and promote diuresis, can alleviate the pain caused by leukemia complications, and improve the quality of life of patients, and donkey-hide gelatin, liquorice, and Saposhnikovia divaricata are the guiding drugs, which nourish blood and nourish yin, invigorate the spleen and replenish qi, and invigorate the kidney and calm the mind, and harmonize the various drugs, make the various drugs match, and work synergistically to achieve the effects of clearing heat and detoxifying, invigorating blood and removing blood stasis, invigorating the spleen and kidney, and promoting qi and dispersing stagnation, and are significantly effective in preventing and treating leukemia.

[0142] 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.

[0143] 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.

[0144] In the description of the specification of the present application, the terms "include", "comprise", etc. mean "including but not limited to". In this article, relational terms such as "first" and "second", etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. In this article, "and / or" describes the association relationship of associated objects, indicating that three relationships may exist. For example, A and / or B can represent: A exists alone, A and B exist at the same time, and B exists alone. Wherein A and B can be singular or plural. In this article, "at least one" means one or more, and "plurality" means two or more. "At least one", "at least one of the following" or similar expressions refer to any combination of these items, including any combination of singular or plural items. 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.

[0145] 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 pharmaceutical composition for treating or preventing leukemia, characterized in that: The following raw materials are included by weight: 10-25 parts of American ginseng, 10-20 parts of Ganoderma lucidum, 5-15 parts of wormwood, 5-15 parts of donkey-hide gelatin, 10-20 parts of Atractylodes macrocephala, 10-20 parts of Angelica sinensis, 5-15 parts of Licorice, 5-15 parts of Forsythia suspensa, 5-15 parts of Indigo naturalis, 10-20 parts of Dendrobium, 1-5 parts of Hawthorn, 5-15 parts of Poria and 3-10 parts of Saposhnikovia divaricata.

2. The pharmaceutical composition for treating or preventing leukemia according to claim 1, characterized in that: The following raw materials are included by weight: 12-18 parts of American ginseng, 12-16 parts of Ganoderma lucidum, 6-12 parts of wormwood, 8-12 parts of donkey-hide gelatin, 10-15 parts of Atractylodes macrocephala, 12-18 parts of Angelica sinensis, 6-10 parts of Licorice, 7-9 parts of Forsythia suspensa, 5-7 parts of Indigo naturalis, 10-13 parts of Dendrobium, 3-5 parts of Hawthorn, 6-8 parts of Poria and 5-7 parts of Saposhnikovia divaricata.

3. The pharmaceutical composition for treating or preventing leukemia according to claim 1, characterized in that: The following raw materials are included by weight: 10 parts of American ginseng, 10 parts of Ganoderma lucidum, 5 parts of Artemisia argyi, 5 parts of donkey-hide gelatin, 10 parts of Atractylodes macrocephala, 10 parts of Angelica sinensis, 5 parts of Licorice, 5 parts of Forsythia suspensa, 5 parts of Indigo naturalis, 10 parts of Dendrobium, 1 part of Hawthorn, 5 parts of Poria and 3 parts of Saposhnikovia divaricata.

4. The pharmaceutical composition for treating or preventing leukemia according to claim 1, characterized in that: The following raw materials are included by weight: 18 parts of American ginseng, 16 parts of ganoderma lucidum, 12 parts of wormwood, 12 parts of donkey-hide gelatin, 15 parts of atractylodes macrocephala, 12 parts of angelica sinensis, 6 parts of liquorice, 9 parts of forsythia, 7 parts of indigo, 10 parts of dendrobium, 5 parts of hawthorn, 8 parts of poria and 7 parts of siler.

5. The pharmaceutical composition for treating or preventing 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 artemisia annua, 15-20 parts of aloe, and 10-15 parts of polygonatum.

6. A method for preparing a pharmaceutical composition for treating or preventing leukemia according to any one of claims 1 to 5, 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, Artemisia argyi, donkey-hide gelatin, Atractylodes macrocephala, Chinese angelica, Licorice, Forsythia suspensa, Indigo naturalis, Dendrobium officinale, Crataegus pinnatifida, Poria cocos 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, volatile oil and 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 evenly, and spray-dried to obtain a dry powder composition.

7. The method for preparing the pharmaceutical composition for treating or preventing leukemia according to claim 6, characterized in that: The concentration of the ethanol is 80%-95%.

8. The method for preparing the pharmaceutical composition for treating or preventing leukemia according to claim 6, characterized in that: In step A, the mass ratio of the ginseng to the ethanol is 1:(6-8).

9. The method for preparing the pharmaceutical composition for treating or preventing leukemia according to claim 6, characterized in that: In the step B, 8-12 times the weight of purified water is added to the medicinal residue, refluxed and boiled for 60-100 minutes, filtered, and then 5-9 times the weight of purified water is added to the medicinal residue, boiled for 30-60 minutes, and filtered to obtain the post-decoction liquid.

10. The method for preparing the pharmaceutical composition for treating or preventing leukemia according to claim 6, characterized in that: The dosage form of the composition is any one of pills, powders, granules and tablets.

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