A Chinese medicine composition and its application

Abstract

The present application relates to the technical field, in particular to the technical field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition and its application. Among them, a traditional Chinese medicine composition includes: psoralea corylifolia, astragalus, orientalis, millet spatholobus, silkworm cocoon, yam, capillaris, ligusticum chuanxiong, ginseng, phellodendron, angelica, agrimony and mistletoe, and the components of the traditional Chinese medicine composition are compatible with each other, and can jointly play the effects of tonifying the kidney and spleen, benefiting the marrow and producing blood, removing dampness and jaundice, and promoting blood circulation and removing blood stasis.

Description

Technical Field

[0001] The present application belongs to the technical field of traditional Chinese medicine, and specifically relates to a traditional Chinese medicine composition and its application. Background Art

[0002] Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, chronic, progressive, life-threatening blood disease characterized by complement-mediated hemolysis (destruction of red blood cells), anemia (manifested by pale complexion, shortness of breath, fatigue, palpitations and dizziness), jaundice, soy sauce-colored urine, and clinical manifestations such as thrombosis and hematopoietic failure. PNH can occur at any age, and the disease is more common in young and middle-aged people. The most devastating consequence of PNH hemolysis is the formation of thrombi, which damages organs and leads to death.

[0003] At present, there is no radical cure for this disease except bone marrow transplantation. Clinically, maintenance treatments such as glucocorticoids, androgens, and intermittent blood transfusions are usually given. Bone marrow transplantation has many shortcomings such as difficulty in finding a suitable fully matched donor, acute and chronic rejection reactions after transplantation, and poor quality of life; long-term use of glucocorticoids will not only fail to cure PNH, but also cause various side effects such as diabetes, hypertension, hyperlipidemia, edema, and low immunity; long-term use of androgens will cause adverse reactions such as liver damage, amenorrhea in women, hoarse voice, prostate hyperplasia in men, edema, etc.; long-term blood transfusions will lead to complications such as iron deposition in the patient's body, liver damage, diabetes, heart disease, etc. Although the new drug monoclonal antibody drug that inhibits complement activation can control hemolytic attacks, it cannot cure it. The condition recurs or worsens after stopping the drug, and the annual medical expenses are expensive. Moreover, these drugs have great side effects, poor efficacy, and patients are prone to recurrent attacks. Summary of the invention

[0004] In view of the technical problems existing in the prior art, the purpose of the present application is to provide a Chinese medicine composition, which has a better effect on treating paroxysmal nocturnal hemoglobinuria.

[0005] In the first aspect, the present application provides a Chinese medicine composition, which adopts the following technical solution:

[0006] A Chinese medicine composition comprises: psoralea corylifolia, astragalus, oriental rhizome, millet spatholobi, silkworm cocoon, yam, capillaris, ligusticum chuanxiong, ginseng, phellodendron, angelica, agrimony and mistletoe.

[0007] Furthermore, the Chinese medicine composition includes the following components in parts by weight: 15 to 20 parts of Psoralea corylifolia, 20 to 30 parts of Astragalus membranaceus, 15 to 20 parts of Alisma orientalis, 20 to 40 parts of Millettia spatholobi, 10 to 20 parts of Silkworm Codonopsis pilosula, 15 to 20 parts of Dioscorea opposita, 15 to 25 parts of Artemisia capillaris, 10 to 25 parts of Ligusticum chuanxiong, 8 to 16 parts of Ginseng, 10 to 16 parts of Phellodendron amurense, 20 to 25 parts of Angelica sinensis, 20 to 25 parts of Agrimoniae and 16 to 25 parts of Viscum album.

[0008] Furthermore, the Chinese medicine composition includes the following components in parts by weight: 17 to 19 parts of Psoralea corylifolia, 23 to 27 parts of Astragalus membranaceus, 17 to 19 parts of Alisma orientalis, 25 to 35 parts of Millettia spatholobi, 12 to 18 parts of Silkworm Codonopsis pilosula, 17 to 19 parts of Dioscorea opposita, 17 to 19 parts of Artemisia capillaris, 15 to 20 parts of Ligusticum chuanxiong, 11 to 13 parts of Ginseng, 12 to 14 parts of Phellodendron amurense, 17 to 19 parts of Angelica sinensis, 22 to 24 parts of Agrimoniae and 18 to 22 parts of Viscum album.

[0009] Furthermore, the Chinese medicine composition includes the following components in parts by weight: 18 parts of Psoralea corylifolia, 25 parts of Astragalus membranaceus, 18 parts of Alisma orientalis, 30 parts of Millettia spatholobi, 19 parts of Silkworm Codonopsis pilosula, 18 parts of Dioscorea opposita, 18 parts of Artemisia capillaris, 18 parts of Ligusticum chuanxiong, 12 parts of Ginseng, 15 parts of Phellodendron amurense, 18 parts of Angelica sinensis, 23 parts of Agrimoniae and 20 parts of Viscum album.

[0010] In a second aspect, the present application provides a use of a Chinese medicine composition in the treatment of paroxysmal nocturnal hemoglobinuria.

[0011] In summary, the present application includes at least one of the following beneficial technical effects:

[0012] (1) The present invention selects Psoralea corylifolia, Astragalus membranaceus, Alisma orientalis, Millettia spatholobi as the main drugs, Silkworm Corydalis, Dioscorea opposita, Artemisia capillaris, Ligusticum chuanxiong as the ministerial drugs, Ginseng, Phellodendron chinense, Angelica sinensis, Agrimoniae scabra as the adjuvant drugs, and Viscum album as the guiding drug. The main, ministerial, adjuvant and guiding component drugs are mutually compatible and used together to jointly exert the effects of tonifying the kidney and spleen, benefiting the marrow and producing blood, removing dampness and relieving jaundice, and promoting blood circulation and removing blood stasis.

[0013] (2) The Chinese medicine composition of the present application is used to treat paroxysmal nocturnal hemoglobinuria, promote hematopoiesis, and prevent hemolysis, and has good clinical efficacy.

[0014] (3) The Chinese medicine composition of the present application has the effect of reducing the risk of thrombosis caused by paroxysmal nocturnal hemoglobinuria.

[0015] (4) The Chinese medicine composition of the present application has the effect of preventing and treating hematopoietic failure caused by paroxysmal nocturnal hemoglobinuria. DETAILED DESCRIPTION

[0016] The present application is further described in detail below in conjunction with specific embodiments.

[0017] The following raw materials in this application are all commercially available products, and are intended to fully disclose the raw materials of this application, and should not be construed as limiting the sources of the raw materials.

[0018] First of all, Chinese medicine believes that the spleen is the foundation of the acquired constitution, responsible for transportation and transformation. If the transportation and transformation are not functioning properly, water and dampness will stagnate inside the body. The kidney is the foundation of the innate constitution, responsible for storing essence, and essence produces blood. The kidney is responsible for bone production and marrow production, and marrow produces blood. If the kidney is deficient in essence, blood cannot be produced. The root cause of paroxysmal nocturnal hemoglobinuria (PNH) is insufficient innate endowment (genetic or physical defects), as well as improper conditioning of acquired living habits, diet, environment and other factors, which lead to spleen and kidney deficiency, internal accumulation of dampness, and blood stasis blocking the collaterals. The spleen is responsible for transportation and transformation. If the spleen is weak, transportation and transformation will be impaired. Water cannot be transported and transformed, and becomes dampness. Dampness accumulates inside the body, and the qi is not flowing smoothly. It overflows into the skin, causing pale complexion and jaundice. Dampness flows into the lower part of the body, causing urine to be like soy sauce. Dampness tends to go down, sticking to qi and blood. Qi and blood are not flowing smoothly, causing the legs to feel heavy. The waist is the home of the kidneys. If the kidneys are weak, there will be back pain. The kidneys store essence, and essence produces blood. The kidneys are responsible for bone marrow production, and marrow produces blood. Kidney deficiency prevents blood from being produced, so there is blood deficiency. Blood deficiency causes the face to lose blood nourishment, so the face is pale; limbs lose blood nourishment, so fatigue and weakness occur easily; dampness blocks the qi, qi is not smooth, blood stasis occurs over time, blood stasis blocks the meridians, and different meridians can cause abdominal pain, back pain, limb pain, and even hemiplegia; dampness accumulates for a long time, injures qi and blood, and can also cause qi and blood deficiency, so there is pale or dark complexion, dizziness, palpitations, shortness of breath, fatigue, yellow face, and deep and thin pulse. This disease presents a pathological state of mixed deficiency and excess of spleen and kidney deficiency, internal accumulation of dampness, and blood stasis in the meridians, so the patient shows symptoms such as dull or dark complexion, or pale complexion, dizziness, palpitations, forgetfulness, shortness of breath, fatigue, heavy legs, back pain, occasional jaundice, and soy sauce-colored urine. The nature of dampness is sticky. If it is not removed for a long time, it will damage the spleen and kidney, making the spleen and kidney weaker. Dampness accumulates and turns into blood stasis, forming a vicious cycle that is difficult to cure. Therefore, PNH patients often have a long course of disease, ranging from a few years to decades. In short, the TCM syndrome differentiation of paroxysmal nocturnal hemoglobinuria is a syndrome of spleen and kidney deficiency and dampness and blood stasis.

[0019] Based on this, the applicant has provided a Chinese medicine composition that can effectively treat paroxysmal nocturnal hemoglobinuria (PNH) after years of clinical practice and exploration. The Chinese medicine composition includes: psoralea corylifolia, astragalus, oriental rhizome, millet spatholobi, silkworm cocoon, yam, capillaris, ligusticum chuanxiong, ginseng, phellodendron, angelica, agrimony and mistletoe.

[0020] Psoralea corylifolia is warm in nature and pungent in taste. It warms and tonifies kidney qi, consolidates kidney essence, and improves related symptoms such as dull complexion, cold body and limbs, cold pain in waist and knees, and frequent urination caused by kidney yang deficiency by warming and tonifying kidney qi. The kidney is responsible for bone and marrow production, and the marrow produces blood. Psoralea corylifolia nourishes the kidney, thereby benefiting the marrow and producing blood, thereby treating kidney deficiency and blood deficiency. Modern pharmacological research shows that Psoralea corylifolia contains coumarin components and flavonoid components such as psoralen and isopsoralen. These components have multiple biological activities such as antioxidant and anti-inflammatory, and can also regulate hormone levels in the body, which can improve the bone marrow hematopoietic function of PNH patients and alleviate PNH hemolytic attacks.

[0021] Astragalus is sweet and slightly warm in nature. It enters the spleen and lung meridians. Entering the spleen meridian means that Astragalus has a special effect on the spleen. The spleen is the foundation of acquired constitution, responsible for transporting and transforming the essence of water and grain, and is the source of qi and blood biochemical transformation. Astragalus can strengthen the spleen and replenish qi, enhance the spleen's transportation and transformation function, and promote the body's absorption and utilization of nutrients, thereby improving the symptoms of loss of appetite, fatigue, abdominal distension, loose stools, etc. caused by spleen deficiency in PNH patients. Modern research has found that the active ingredients of Astragalus have a bidirectional immunomodulatory effect, anti-infection, anti-tumor, and anti-inflammatory effects, which are beneficial to improving the immune status of PNH patients, reducing red blood cell destruction, and preventing the occurrence of hemolysis.

[0022] Alisma orientalis is cold in nature, sweet and light in taste, and has the function of penetrating and removing dampness. It enters the kidney and bladder meridians, and clears the dampness in the kidney and bladder meridians through penetrating and removing dampness, avoiding the accumulation of dampness in the body and causing illness, thereby treating the internal dampness of PNH; the cold nature of Alisma orientalis can also alleviate the warmth of Psoralea corylifolia, making it not too hot; modern pharmacological studies have shown that the active ingredients of Alisma orientalis affect the activity of immune cells and the secretion of cytokines by regulating the NF-κB signaling pathway, and maintain the balance of pro-inflammatory and anti-inflammatory factors by regulating the secretion of these cytokines, thereby preventing and treating over-activation of the immune response or immune dysfunction, and then playing a positive role in restoring the hematopoietic function and reducing red blood cell destruction in PNH patients.

[0023] Millettia reticulata is bitter, sweet, and warm in nature. It enters the liver and kidney meridians. Its main function is to invigorate blood circulation and replenish blood, thereby treating the blood deficiency and blood stasis symptoms of PNH. Modern pharmacological studies have found that the active ingredients in Millettia reticulata upregulate the expression of GM-CSF mRNA and IL-6 mRNA, which are positive regulatory factors for hematopoiesis, promote cells to enter the cell proliferation cycle, accelerate the proliferation and differentiation of hematopoietic stem / progenitor cells, increase the colony yield of hematopoietic progenitor cells, effectively improve the function of the hematopoietic system, and increase the number of red blood cells and hemoglobin. It can improve the hematopoietic microenvironment, including the regulation and repair of bone marrow stromal cells, extracellular matrix, and vascular endothelial cells, and provide a good place and conditions for the survival, proliferation, and differentiation of hematopoietic stem cells. It can resist platelet aggregation, reduce blood viscosity, and reduce the risk of thrombosis. These effects of Millettia reticulata can improve the hematopoietic function of PNH patients, promote normal hematopoiesis, and prevent thrombosis in PNH patients.

[0024] Therefore, the Chinese medicine composition of the present application selects Psoralea corylifolia, Astragalus membranaceus, Alisma orientalis, and Millettia spatholobi as the main medicines. These four medicines work together to achieve the effects of tonifying the kidney and spleen, nourishing the marrow and producing blood, removing dampness, and promoting blood circulation and removing blood stasis, so as to treat PNH patients with spleen and kidney deficiency and dampness and blood stasis.

[0025] The silkworm cocoon is sweet and mild in nature. It can nourish the kidney and consolidate the essence. It can prevent and treat the kidney essence loss caused by hemoglobinuria in PNH patients. Modern pharmacological research has found that the silkworm cocoon regulates the body's immune function by affecting macrophage function, cytokine secretion and complement function, and can inhibit cell damage caused by complement activation and other immune abnormalities in PNH patients.

[0026] Chinese yam is sweet in taste, neutral in nature, and is good for the spleen and kidney essence. It has the effect of strengthening the spleen and kidney, and can treat the spleen and kidney deficiency syndrome of PNH. Modern research has found that Chinese yam is rich in polysaccharides, saponins, flavonoids, polyphenols and other ingredients, which have the pharmacological effects of regulating immunity, improving metabolism, scavenging oxygen free radicals and resisting oxidative damage, which can improve fatigue, weakness, loss of appetite and cell damage in PNH patients.

[0027] Artemisia capillaris tastes bitter and pungent, and is slightly cold in nature. Bitterness and pungentness can dry dampness, and coldness can clear heat. Therefore, Artemisia capillaris has the effects of clearing dampness and heat and relieving jaundice, and is used to treat internal dampness and heat and jaundice in PNH. In the study of the traditional Chinese medicine Artemisia capillaris, it was found that its main active ingredients are coumarins, flavonoids, organic acids, volatile oils and other ingredients, which can regulate signal pathways, affect the expression of related genes, proteins or cytokines, and exert antibacterial, anti-inflammatory, antioxidant and other pharmacological activities, which have a therapeutic effect on PNH patients with low immune function and oxidative damage.

[0028] Chuanxiong is warm in nature and pungent in taste. Its pungent taste can disperse the qi and promote blood circulation. Its warm nature can warm the meridians, dispel cold and relieve pain, and treat the symptoms of heavy legs and pain in PNH patients caused by dampness and blood stasis. Chuanxiong extract can improve microcirculation, increase superoxide dismutase, increase the activity of antioxidant enzymes, and reduce the accumulation of reactive oxygen. These effects are beneficial to protecting the cells of PNH patients and reducing damage.

[0029] Therefore, mulberry silkworm cocoon, Chinese yam, Artemisia capillaris and Chuanxiong are selected as ministerial drugs, among which Chinese yam can help mulberry silkworm cocoon to nourish the kidney and prevent Artemisia capillaris from damaging the spleen due to its bitter and cold nature. The mulberry silkworm cocoon, Chinese yam, Artemisia capillaris and Chuanxiong work together, mulberry silkworm cocoon nourishes the kidney and consolidates the essence, Chinese yam strengthens the spleen and nourishes the kidney, Artemisia capillaris clears away dampness, and Chuanxiong activates blood circulation and dredges the meridians. The four drugs are ministerial drugs in total, so as to achieve the functions of strengthening the spleen, nourishing the kidney, producing blood, removing dampness and relieving jaundice, activating blood circulation and dredges the meridians, and together help the monarch drug to nourish the kidney qi, remove dampness, nourish blood and activate blood circulation, and strengthen the monarch drug to achieve the effects of nourishing the kidney and strengthening the spleen, benefiting the marrow and producing blood, activating blood circulation and removing blood stasis, and removing dampness and relieving jaundice.

[0030] Ginseng is slightly warm in nature, sweet and slightly bitter in taste. It enters the kidney, spleen and liver meridians, and can not only greatly replenish the kidney's vitality, replenish kidney qi, benefit the marrow and produce blood, but also replenish the spleen and lungs, and replenish the acquired qi, thereby treating the symptoms of PNH patients caused by spleen and kidney deficiency and marrow blood deficiency, such as dull or dark complexion, fatigue, weakness, forgetfulness, shortness of breath and laziness, dizziness, and weakness in the waist and knees. Modern pharmacological research shows that the ingredients in ginseng have antioxidant effects, can scavenge free radicals, reduce oxidative damage, and have anti-apoptosis effects, which can directly inhibit the excessive destruction of red blood cells in PNH patients; the active ingredients in ginseng can regulate the immune system, enhance the body's resistance, increase the production of immunoglobulins, and improve the body's immunity. By enhancing the body's immunity, it can prevent the onset of PNH hemoglobinuria induced by infection.

[0031] Phellodendron chinense is bitter and cold in nature. It enters the kidney and bladder meridians and has the effect of clearing away heat and dampness. It can remove dampness in the lower kidney and bladder, thereby treating PNH patients with damp-heat flowing into the lower part of the body. Phellodendron chinense contains effective ingredients such as alkaloids, flavonoids, phenols and terpenes, which can exert anti-inflammatory, antioxidant and free radical scavenging effects, which is beneficial to reduce cell damage in PNH patients.

[0032] Angelica sinensis is sweet and pungent, warm in nature, and has the effect of nourishing blood and activating blood circulation. It is an essential medicine for nourishing blood, and can treat the pale complexion, fatigue, palpitation and pain caused by blood stasis meridians caused by blood deficiency in PNH patients. Angelica sinensis contains ingredients such as ligusticum lactone, ferulic acid, and polysaccharides, and has multiple pharmacological effects such as promoting hematopoiesis, regulating immunity, anti-oxidation, and anti-thrombosis, which are beneficial to improving the hematopoietic function of PNH patients and preventing thrombosis. In this group of adjuvants, ginseng is warm in nature, which can prevent Phellodendron from being too bitter and cold to injure the spleen and kidney, and Phellodendron is cold in nature, which can prevent ginseng from being too warm and damaging yin blood.

[0033] Therefore, selecting ginseng, phellodendron and angelica as the first adjuvant, ginseng, phellodendron and angelica together assist the main medicine, can make the Chinese medicine composition reach the effects of tonifying the kidney and spleen, benefiting the marrow and producing blood, removing dampness and jaundice, and promoting blood circulation and removing blood stasis.

[0034] At the same time, the Chinese medicine composition of the present application contains three Chinese medicines with blood-activating effects, namely, Millettia reticulata, Angelica sinensis, and Chuanxiong, which have the meaning of removing blood stasis and promoting new blood. However, some PNH patients are prone to bleeding due to thrombocytopenia. In order to eliminate this concern, Herba Agrimoniae is selected as the second adjuvant. Herba Agrimoniae is flat in nature and bitter in taste. It has the effects of astringent hemostasis, treatment of fatigue and tonification, and is suitable for the treatment of PNH bleeding and deficiency syndrome; Herba Agrimoniae astringent hemostasis can also assist Millettia reticulata, Angelica sinensis, and Chuanxiong in the treatment of the disadvantages of bleeding caused by drugs with blood-activating functions; modern pharmacological studies have revealed that Herba Agrimoniae can astringe blood vessels, promote blood coagulation, increase platelet aggregation, and thus reduce bleeding. Therefore, the addition of Herba Agrimoniae and Chuanxiong, Millettia reticulata, and Angelica sinensis can effectively prevent the occurrence of bleeding caused by excessive blood-activating effects, and assist the above-mentioned monarch and ministerial medicines to achieve the effects of tonifying the kidney, replenishing essence, treating slowness, removing blood stasis, promoting new blood, and preventing bleeding.

[0035] Mulberry parasite is mild in nature, bitter and sweet in taste, enters the kidney meridian, and has the effects of nourishing kidney qi and strengthening tendons and bones. The Qing Dynasty herbal medicine "Bencao Qiuzhen" lists it as an important medicine for nourishing the kidney and blood. The drug combination in this application selects mistletoe as a guiding drug. Mulberry parasite is used not only to enhance the effects of various kidney-tonifying and blood-tonifying drugs on nourishing the kidney and producing blood, but also to guide other drugs to better enter the kidney meridian, so that each drug in the traditional Chinese medicine composition can fully exert its efficacy, thereby enhancing the overall efficacy of the traditional Chinese medicine composition.

[0036] In summary, through the mutual compatibility of the above-mentioned component drugs, they can jointly exert the effects of nourishing the kidney and spleen, benefiting the marrow and producing blood, removing dampness and jaundice, and promoting blood circulation and removing blood stasis.

[0037] In some embodiments, the Chinese medicine composition includes the following components in parts by weight: 15 to 20 parts of Psoralea corylifolia, 20 to 30 parts of Astragalus membranaceus, 15 to 20 parts of Alisma orientalis, 20 to 40 parts of Millettia spatholobi, 10 to 20 parts of Silkworm Codonopsis pilosula, 15 to 20 parts of Dioscorea opposita, 15 to 25 parts of Artemisia capillaris, 10 to 25 parts of Ligusticum chuanxiong, 8 to 16 parts of Ginseng, 10 to 16 parts of Phellodendron amurense, 20 to 25 parts of Angelica sinensis, 20 to 25 parts of Agrimoniae and 16 to 25 parts of Viscum album.

[0038] Exemplarily, the amount of Psoralea corylifolia may be 15 parts, 16 parts, 17 parts, 18 parts, 19 parts or 20 parts, etc., and is not limited thereto.

[0039] Illustratively, the amount of Astragalus membranaceus may be 20 parts, 22 parts, 24 parts, 26 parts, 28 parts or 30 parts, etc., but is not limited thereto.

[0040] Illustratively, the amount of Alisma orientalis can be 15 parts, 16 parts, 17 parts, 18 parts, 19 parts or 20 parts, etc., which is not limited here.

[0041] Exemplarily, the amount of Millettia spatholobi may be 20 parts, 25 parts, 30 parts, 35 parts or 40 parts, etc., and is not limited thereto.

[0042] Exemplarily, the silkworm cocoons may be 10 parts, 12 parts, 15 parts, 17 parts or 20 parts, etc., and are not limited thereto.

[0043] Exemplarily, the yam can be 15 portions, 16 portions, 17 portions, 18 portions, 19 portions or 20 portions, etc., which is not limited here.

[0044] Exemplarily, the amount of Artemisia capillaris can be 15 parts, 17 parts, 19 parts, 21 parts, 23 parts or 25 parts, etc., which is not limited here.

[0045] For example, the amount of Rhizoma Chuanxiong can be 10 parts, 13 parts, 16 parts, 19 parts, 22 parts or 25 parts, etc., which is not limited here.

[0046] Exemplarily, the ginseng may be 8 parts, 10 parts, 12 parts, 14 parts or 16 parts, etc., but is not limited thereto.

[0047] Exemplarily, the amount of Phellodendron chinense may be 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts or 16 parts, etc., but it is not limited here.

[0048] Exemplarily, the amount of angelica sinensis may be 20 parts, 21 parts, 22 parts, 23 parts, 24 parts or 25 parts, etc., but is not limited thereto.

[0049] Exemplarily, the amount of Agrimony graally may be 20 parts, 21 parts, 22 parts, 23 parts, 24 parts or 25 parts, etc., and is not limited thereto.

[0050] Exemplarily, the amount of mistletoe can be 16 parts, 18 parts, 20 parts, 22 parts, 24 parts or 25 parts, etc., but there is no limitation thereto.

[0051] By setting the component drugs of the above-mentioned traditional Chinese medicine composition within the range of 15-20 parts of psoralea corylifolia, 20-30 parts of astragalus, 15-20 parts of oriental rhizome, 20-40 parts of millettia spatholobi, 10-30 parts of silkworm cocoons, 15-20 parts of yam, 15-25 parts of capillaris, 10-25 parts of ligusticum chuanxiong, 8-16 parts of ginseng, 10-16 parts of phellodendron, 20-25 parts of angelica, 20-25 parts of agrimony and 16-25 parts of parasitic plant, the traditional Chinese medicine composition can better exert its medicinal effect and further improve the effects of tonifying the kidney and spleen, benefiting the marrow and producing blood, removing dampness and jaundice, and promoting blood circulation and removing blood stasis.

[0052] In some embodiments, the Chinese medicine composition includes the following components in parts by weight: 17 to 19 parts of Psoralea corylifolia, 23 to 27 parts of Astragalus membranaceus, 17 to 19 parts of Alisma orientalis, 25 to 35 parts of Millettia spatholobi, 12 to 18 parts of Silkworm Codonopsis pilosula, 17 to 19 parts of Dioscorea opposita, 17 to 19 parts of Artemisia capillaris, 15 to 20 parts of Ligusticum chuanxiong, 11 to 13 parts of Ginseng, 12 to 14 parts of Phellodendron amurense, 17 to 19 parts of Angelica sinensis, 22 to 24 parts of Agrimoniae and 18 to 22 parts of Viscum album.

[0053] By setting the component drugs of the above-mentioned traditional Chinese medicine composition within the range of 17 to 19 parts of psoralea corylifolia, 23 to 27 parts of astragalus, 17 to 19 parts of oriental rhizome, 25 to 35 parts of millettia spatholobi, 12 to 18 parts of silkworm cocoons, 17 to 19 parts of yam, 17 to 19 parts of capillaris, 15 to 20 parts of ligusticum chuanxiong, 11 to 13 parts of ginseng, 12 to 14 parts of phellodendron, 17 to 19 parts of angelica, 22 to 24 parts of agrimony and 18 to 22 parts of mistletoe, the traditional Chinese medicine composition can better exert its medicinal effect and further improve the effects of tonifying the kidney and spleen, benefiting the marrow and producing blood, removing dampness and jaundice, and promoting blood circulation and removing blood stasis.

[0054] In some embodiments, the Chinese medicine composition includes the following components in parts by weight: 18 parts of Psoralea corylifolia, 25 parts of Astragalus membranaceus, 18 parts of Alisma orientalis, 30 parts of Millettia spatholobi, 19 parts of Silkworm Codonopsis pilosula, 18 parts of Dioscorea opposita, 18 parts of Artemisia capillaris, 18 parts of Ligusticum chuanxiong, 12 parts of Ginseng, 15 parts of Phellodendron amurense, 18 parts of Angelica sinensis, 23 parts of Agrimoniae and 20 parts of Viscum album.

[0055] By setting the component drugs of the above-mentioned traditional Chinese medicine composition in 18 parts of psoralea corylifolia, 25 parts of astragalus, 18 parts of oriental rhizome, 30 parts of millettia spatholobi, 19 parts of silkworm cocoons, 18 parts of yam, 18 parts of capillaris, 18 parts of ligusticum chuanxiong, 12 parts of ginseng, 15 parts of phellodendron, 18 parts of angelica, 23 parts of agrimony and 20 parts of mistletoe, the traditional Chinese medicine composition can better exert its medicinal effect and further improve the effects of tonifying the kidney and spleen, benefiting the marrow and producing blood, removing dampness and jaundice, and promoting blood circulation and removing blood stasis.

[0056] In a second aspect, the present application provides a use of a Chinese medicine composition in the treatment of paroxysmal nocturnal hemoglobinuria.

[0057] The Chinese medicine compositions provided in the above embodiments of the present application are used in the treatment of paroxysmal nocturnal hemoglobinuria, and can play the role of nourishing the kidney and activating blood circulation, strengthening the spleen and removing dampness, promoting normal hematopoiesis, reducing hemolytic attacks, and may have a preventive effect on the occurrence of thrombotic events.

[0058] Illustratively, the Chinese medicine composition in the above embodiment is taken once a day, divided into two doses and washed down with boiled water, and taken for more than 6 months to determine the efficacy.

[0059] The Chinese medicine composition in the above embodiment of the present application was used to treat PNH. A total of 20 patients were treated, including 9 males and 11 females, aged 28 to 63 years old, with a median age of 50 years old. The course of disease ranged from 8 months to 3 years, with a median course of 16 months.

[0060] PNH is classified as follows:

[0061] 1. Anemia classification: Hb ≤ 30g / L is extremely severe, Hb 31g / L ~ 60g / L is severe, Hb 61g / L ~ 90g / L is moderate, and Hb > 90g / L is mild.

[0062] 2. Hemoglobinuria grading: frequent occurrence if the disease occurs once every 2 months or less, occasional occurrence if the disease occurs once every 2 months or more, and no occurrence if the disease does not occur after 2 years of observation (temporary no occurrence if the disease does not occur after less than 2 years of observation).

[0063] 3. Bone marrow hyperplasia degree: In addition to the four-level classification based on the number of nucleated cells, attention should also be paid to the granulocyte-red blood cell ratio. If it is low, it is necessary to indicate whether it is a single site or multiple sites.

[0064] The method for judging the efficacy is as follows:

[0065] 1. Diagnostic criteria: According to the diagnostic criteria for paroxysmal nocturnal hemoglobinuria (PNH) in the third edition of the Diagnostic and Response Criteria for Hematological Disorders.

[0066] 2. Efficacy criteria: According to the efficacy criteria for paroxysmal nocturnal hemoglobinuria (PNH) in the third edition of the Diagnosis and Efficacy Criteria for Hematological Diseases, they are as follows:

[0067] (1) Recent clinical recovery, i.e., no episode of hemoglobinuria for 1 year, no need for blood transfusion, and blood count (including reticulocytes) returning to normal.

[0068] (2) Recent clinical remission, i.e., no hemoglobinuria, no need for blood transfusion, and hemoglobin returns to normal within 1 year.

[0069] (3) Recent significant improvement, that is, according to the classification of the condition before and after the observation period. Any improvement of two levels in any of the following items, including the frequency of hemoglobinuria, the severity of anemia, and the bone marrow hyperplasia, is considered significant improvement.

[0070] (4) Recent improvement, that is, improvement in any of the examinations in the disease classification.

[0071] (5) Ineffective, i.e., the condition remains unchanged or worsens.

[0072] Treatment results: The observation indicators were to observe the efficacy, adverse drug reactions, and whether there were statistically significant differences in the changes in PNH clones, lactate dehydrogenase, and bilirubin before and after treatment, as well as the adverse reactions.

[0073] 1. Efficacy analysis: Among the 20 cases treated with the Chinese medicine combination, 4 cases were clinically cured in the near future, 2 cases were clinically relieved in the near future, and 10 cases were significantly improved in the near future, with an overall effective rate of 80%.

[0074] 2. Changes of hemoglobin, indirect bilirubin (IBIL), lactate dehydrogenase (LDH), and red blood cell CD59 before and after treatment. The quantitative data were expressed as x±s and tested by t test. The counting data were tested by χ test. 2 Test. P < 0.05 was considered statistically significant. The results are shown in the following table.

[0075]

[0076]

[0077] It should be noted that CD59 + Red blood cells represent normal red blood cell clones, and the cause of PNH hemolysis is CD59 + Decreased red blood cells (i.e., CD59- The red blood cells increase), causing the red blood cells to be attacked by complement and hemolysis to occur. Lactate dehydrogenase (LDH) and indirect bilirubin (IBIL) are positively correlated with the degree of hemolysis.

[0078] The above Chinese medicine composition achieved a clinical efficacy of 80%, and after treatment, CD59 + The red blood cell ratio increased significantly, LDH and IBIL decreased significantly, and there was a good clinical effect, indicating that the Chinese medicine composition of the present application can promote the generation of normal red blood cell clones, thereby reducing hemolysis. Safety observations found that the Chinese medicine composition had no serious adverse reactions. PNH patients are prone to thrombosis, and no thrombotic events occurred in patients during the treatment of the Chinese medicine composition, indicating that the application of the Chinese medicine composition has the effect of reducing the risk of PNH thrombosis.

[0079] Example 1

[0080] Patient Zhang, male, 25 years old, first visited the hospital on June 19, 2018 because of pale complexion, fatigue, and occasional urine color like soy sauce for 3 years. In June 2015, the patient had fatigue and yellow complexion without obvious cause, and dark urine color like soy sauce in the morning, without fever. Blood and bone marrow examinations in hospitals in Hengshui and Tianjin diagnosed paroxysmal nocturnal hemoglobinuria, and intermittent use of methylprednisolone and red blood cell transfusion treatment, the condition was sometimes mild and sometimes severe, often felt fatigue, heavy legs, poor appetite, unable to work.

[0081] Physical examination: pale complexion, icteric sclera, no bleeding spots on the skin and mucous membranes, normal lung abnormalities, regular heart rhythm, and a grade 3 systolic murmur in the aortic valve auscultation area. The liver and spleen were not palpable, there was no percussion pain in the liver area, mild edema of the lateral malleolus, pale tongue, thin white fur, and a deep and weak pulse.

[0082] Blood routine test showed: white blood cell count: 2.55×10 9 / L, hemoglobin 56g / L, platelets 34×10 9 / L, alanine aminotransferase 68U / L, aspartate aminotransferase 139U / L, total bilirubin 53.2μmol / L, indirect bilirubin 41.6μmol / L, lactate dehydrogenase 13691U / L.

[0083] PNH clone examination: red blood cell CD59 was 63%.

[0084] FLAER (Fluorescent AERolysin) detection: monocyte CD59 was 86%.

[0085] Urine occult blood 3+, microscopic examination: 8 red blood cells / high-power field of view.

[0086] The bone marrow proliferation was obviously active, with significant erythroid hyperplasia, and there were 7 to 10 megakaryocytes in the whole piece.

[0087] Diagnosis: paroxysmal nocturnal hemoglobinuria.

[0088] Syndrome analysis: The patient's face is yellow and the sclera is yellow, which is a sign of internal dampness and jaundice; fatigue, palpitation and shortness of breath after activities, and loss of appetite are signs of spleen deficiency; the waist is the home of the kidney, and kidney deficiency causes waist pain and discomfort; spleen and kidney deficiency, water and moisture are not transported well, dampness is internal, and stagnation blocks the lower part of the body, which becomes blood stasis over time. Dampness and blood stasis are combined and flow into the kidney and bladder, so soy sauce-colored urine is seen; the tongue is pale, the tongue is fat, there are many tooth marks, white greasy fur, and the pulse is slippery and large, all of which are signs of spleen and kidney deficiency. Dampness is sticky and combined with blood stasis, which is more difficult to remove, so it does not heal for a long time and the course of the disease is long. Chinese medicine syndrome differentiation believes that it is spleen and kidney deficiency, internal dampness, and dampness and blood stasis. The treatment is to strengthen the spleen and kidney, eliminate dampness and reduce jaundice, and replenish blood and promote blood circulation.

[0089] Administration: On June 19, 2018, 15g of Psoralea corylifolia, 30g of Astragalus, 15g of Alisma orientalis, 40g of Millettia reticulata, 18g of Silkworm Corydalis, 15g of Dioscorea opposita, 15g of Artemisia capillaris, 15g of Ligusticum chuanxiong, 8g of Ginseng, 10g of Phellodendron chinense, 20g of Angelica sinensis, 20g of Agrimoniae, and 20g of Viscum album. Take the granules, one dose per day, divided into two doses, for 2 months.

[0090] On August 28, 2018, he came to the clinic for the second time and complained that his fatigue and palpitations had improved, but he felt that his appetite was poor. His tongue was pale, with a thin white coating, and his pulse was deep and weak. The white blood cell count was 4.2×10 9 / L, hemoglobin 95g / L, platelets 57×109 / L, urine occult blood negative. Change the above prescription to 20 grams of Chinese yam, and keep the rest of the medicine unchanged, 30 doses.

[0091] The patient came to the clinic on September 30, 2018 and reported that his fatigue and palpitations had disappeared, his appetite had improved, and he had gone back to work. His condition had improved, and he continued the previous consolidation treatment for one year.

[0092] On September 11, 2019, he came to the clinic without any complaints, with thin white fur and deep pulse. The white blood cell count was 3.61×10 9 / L, neutrophils 45.7%, hemoglobin 129g / L, platelets 71×10 9 / L. Urine occult blood 1+, no red blood cells. Red blood cell CD59 + The condition was stable and improved, and the consolidation treatment was continued for 2 months.

[0093] November 16, 2019, blood white blood cell count: 4.23×10 9 / L, neutrophil 46.9%, hemoglobin 126g / L, platelet 131×10 9 / L. Urine occult blood was negative, and no red blood cells were found. The dosage of Chinese medicine was reduced, once every two days, to consolidate the treatment.

[0094] Routine blood test on March 1, 2020: White blood cell count 3.72×10 9 / L, neutrophils 45.8%, hemoglobin 125g / L, platelets 127×10 9 / L, stop taking the medication.

[0095] Follow-up: On March 21, 2023, blood test showed leukocyte count of 4.15×10 9 / L, neutrophil 47.2%, hemoglobin 129g / L, platelet 133×109 / L, serum alanine aminotransferase 18.1U / L / L, aspartate aminotransferase 15.8, U / L, total bilirubin 8.0mol / L, indirect bilirubin 5.9mol / L, lactate dehydrogenase 362U / L, γ-glutamyl transpeptidase 13U / L. White blood cells, hemoglobin, and platelets remained normal, the patient worked normally, the condition did not recur, and the patient was clinically cured in the near future.

[0096] Example 2

[0097] The patient, Wang, female, 26 years old, first visited the hospital on October 19, 2016, mainly because of pale complexion, fatigue, and occasional urine color like soy sauce for 5 months. On May 14, 2011, the patient went to Zhengzhou, Henan, Shijiazhuang, Hebei and other hospitals for fatigue, yellow complexion, and dark urine color like soy sauce in the morning. After blood and bone marrow diagnosis of paroxysmal nocturnal hemoglobinuria, and was treated with androgens, glucocorticoids and intermittent blood transfusions, the condition did not improve significantly, and there was intermittent soy sauce urine. Every time she caught a cold, the fever worsened, she often felt weak, had less food and bloating, felt short of breath after activities, had poor sleep, back pain and weak legs, and her menstrual period was 7-9 days, light and thin with blood clots.

[0098] Blood routine test showed: white blood cell count: 4.6×10 9 / L, neutrophil percentage 56%, hemoglobin 57g / L, red blood cell count 1.63×10 12 / L, platelets 138×10 9 / L.

[0099] PNH clone examination: erythrocyte CD59 was 52%, granulocyte CD59 was 64%, monocyte CD59 was 71%. Serum alanine aminotransferase was 56U / L, aspartate aminotransferase was 127U / L, total bilirubin was 47.6μmol / L, indirect bilirubin was 31.6μmol / L, and lactate dehydrogenase was 15681U / L.

[0100] Urine occult blood 3+, microscopic examination: 5 red blood cells / high-power field of view.

[0101] Bone marrow hyperplasia was obviously active, with significant erythroid hyperplasia, mainly composed of middle and late immature erythrocytes, with no abnormal morphology. There was no abnormality in the proportion of granulocyte and lymphocyte morphology. There were 36 megakaryocytes in the whole film, with no abnormal morphology.

[0102] Clinical diagnosis: Diagnosis of paroxysmal nocturnal hemoglobinuria.

[0103] Chinese medicine diagnosis believes that it is spleen and kidney deficiency, internal dampness, and dampness and blood stasis. Internal dampness can be seen in yellow complexion and yellow sclera; the spleen governs muscles and limbs, and the spleen governs transportation and transformation. The spleen is deficient, so there is fatigue, palpitations and shortness of breath after activities, poor appetite, and abdominal distension; the waist is the home of the kidneys, and kidney deficiency can cause soreness in the waist and back, and back pain and discomfort after bending over. Qi deficiency, qi cannot hold blood, and menstruation is prolonged; blood deficiency causes light and thin menstrual blood; there is blood stasis inside, so menstruation is mixed with blood clots; dampness and blood stasis are intertwined, and dampness tends to flow downward and into the lower part of the body, so there is soy sauce-colored urine; the tongue is pale, the tongue is fat, the tongue coating is thin and yellow, and the pulse is weak and slippery, which are signs of spleen and kidney deficiency.

[0104] Treatment principle: Strengthen the spleen and kidney, eliminate dampness and reduce jaundice, promote blood circulation and replenish blood.

[0105] Dosage: On October 19, 2016, 15g of Psoralea corylifolia, 30g of Astragalus membranaceus, 20g of Alisma orientalis, 40g of Millettia reticulata, 18g of Silkworm Codonopsis pilosula, 20g of Dioscorea batatas, 25g of Artemisia capillaris, 25g of Ligusticum chuanxiong, 12g of Ginseng, 18g of Phellodendron amurense, 20g of Angelica sinensis, 20g of Agrimoniae herb, and 25g of Viscum album. Take the granules, one dose per day, divided into two doses, for 3 months of treatment.

[0106] On January 27, 2017, he came to the clinic for the second time and complained that his fatigue and palpitations had improved, his appetite had improved, his back pain had eased, he had no soy sauce-colored urine, his tongue was light red, his tongue coating was thin and white, and his pulse was weak and slippery. His white blood cell count was 3.6×10 9 / L, hemoglobin 70g / L, platelets 153×109 / L, urine occult blood 2+. The condition improved. Change the above prescription to Psoralea corylifolia 20, and keep the rest of the medicine unchanged, 60 doses.

[0107] The patient came to the clinic on March 31, 2017 and complained that his fatigue and palpitations had disappeared, and there was no soy sauce-colored urine. His condition had improved, and he continued the previous consolidation treatment for 6 months.

[0108] On September 29, 2017, he came to the clinic with occasional fatigue and back pain, thin white fur, deep pulse, and blood white blood cell count of 3.8×10 9 / L, neutrophil 47.5%, hemoglobin 92g / L, platelet 141×10 9 / L. Urine occult blood 1+, no red blood cells, serum total bilirubin 37.1μmol / L, indirect bilirubin 21.2μmol / L, lactate dehydrogenase 961U / L, the condition was stable and improved, and consolidation treatment was continued for 3 months.

[0109] On December 26, 2017, the white blood cell count was 4.43×109 / L, neutrophils 51.3%, hemoglobin 106g / L, platelets 173×10 9 / L. Urine occult blood was negative, and no red blood cells were found. The condition improved, and the prescription remained unchanged and the consolidation treatment continued for 6 months.

[0110] Routine blood test on June 1, 2018: White blood cell count 4.71×10 9 / L, neutrophil 54.8%, hemoglobin 115g / L, platelet 157×109 / L, serum total bilirubin 27.1μmol / L, indirect bilirubin 31.6μmol / L, lactate dehydrogenase 612U / L, red blood cell CD59+88.2%. Stop medication.

[0111] Follow-up: Blood test on March 21, 2022 showed a white blood cell count of 4.15×10 9 / L, neutrophils 47.2%, hemoglobin 129g / L, platelets 133×10 9 / L, total bilirubin 18.0mol / L, indirect bilirubin 10.2mol / L, lactate dehydrogenase 303U / L. White blood cells, hemoglobin, and platelets remained normal, achieving clinical cure in the near future and working normally.

[0112] Example 3

[0113] The patient, Ma Moumou, male, 53 years old, first visited the hospital on January 12, 2018 because of yellow complexion and fatigue for 2 months. The patient had unexplained fatigue, yellow complexion, heavy legs, palpitations after activities, sore waist and back, and anemia 2 months ago.

[0114] Physical examination: yellow complexion, jaundice sclera, liver and spleen not palpable, pale tongue, thin yellow coating, weak and slippery pulse.

[0115] Blood routine showed: white blood cell count 2.9×10 9 / L, absolute value of neutrophils 0.81×10 9 / L, the absolute value of lymphocytes was 1.69×10 9 / L, red blood cell count 1.84×10 12 / L, hemoglobin 68g / L, mean corpuscular volume 116.5fL, mean hemoglobin 37.3PG, platelet count 61×10 9 / L; serum aspartate aminotransferase 77.5U / L, lactate dehydrogenase 1872.0U / L, and hydroxybutyrate dehydrogenase 1533.0U / L.

[0116] PNH clone examination: erythrocyte CD55 was 75.01%, erythrocyte CD59 was 75.74%, leukocyte CD55 was 73.80%, and leukocyte CD59 was 90.51%.

[0117] FLAER (Fluorescent AERolysin) test: monocyte negative rate 80.98%, granulocyte negative rate 19.37%; urine routine: occult blood 3+, protein 2+ (1.0) g / L.

[0118] Microscopic examination: 4 red blood cells / high-power field, bone marrow cytology showed obvious active proliferation of nucleated cells, and hemolytic anemia was considered.

[0119] Clinical diagnosis: paroxysmal nocturnal hemoglobinuria.

[0120] TCM diagnosis of spleen and kidney deficiency, dampness and blood stasis

[0121] Treatment principle: Strengthen the spleen and kidney, eliminate dampness and reduce jaundice, promote blood circulation and replenish blood.

[0122] Administration: On January 12, 2018, 20g of Psoralea corylifolia, 18g of Rhizoma Alismatis, 20g of Ophiopogonis, 20g of Phellodendron, 30g of Millettia reticulata, 20g of Rhizoma Chuanxiong, 20g of Artemisia capillaris, 18g of Angelica sinensis, 12g of Ginseng, 20g of Astragalus, 20g of Dioscorea opposita, 25g of Agrimoniae, and 20g of Herba Viscume. Take the granules, one dose per day, divided into two doses, for 6 months.

[0123] On July 20, 2018, he came to the clinic for the second time and complained that his fatigue and palpitations had improved, his appetite had improved, his back pain had eased, his tongue was pale red, his tongue coating was thin and white, and his pulse was weak and slippery. The white blood cell count was 3.6×10 9 / L, hemoglobin 70g / L, platelets 153×10 9 / L. Urine occult blood 2+. The patient did not need blood transfusion after 6 months of treatment. White blood cell and platelet count returned to normal and the condition improved. The above prescription was changed to Psoralea corylifolia 20, and the other medicines remained unchanged. The patient continued to take the medicine for 90 doses and stopped it on his own after feeling well.

[0124] On October 17, 2019, the white blood cell count was 5.3×10 9 / L, neutrophils 59.8%, hemoglobin 81g / L, platelets 286×10 9 / L. On July 25, 2020, I felt more fatigued, woke up easily during sleep, and had occasional nocturnal emission. I came to the hospital for a follow-up visit. The white blood cell count was 3.4×10 9 / L, neutrophil 35.6%, hemoglobin 63g / L, platelet 230×10 9 / L, reticulocyte 2.66%; erythrocyte CD55 62.65%, erythrocyte CD59 66.50%; monocyte flare positive rate 43.89%, neutrophil flare positive rate 51.72%; direct anti-human globulin test negative; urine occult blood 3+, urine protein 3+. Microscopic examination of erythrocytes 5 / high-power field; serum total bilirubin 58.3μmol / L, indirect bilirubin 31.4μmol / L, lactate dehydrogenase 1109.0U / L.

[0125] Later, the condition recurred, and the medication was continued: Psoralea corylifolia 18g, Alisma orientalis 18g, Silkworm cocoon 30g, Phellodendron chinense 10g, Artemisia capillaris 15g, Millettia reticulata 30g, Ligusticum chuanxiong 20g, Ginseng 12g, Astragalus 20g, Dioscorea opposita 20g, Angelica 18g, Agrimoniae 25g, Viscum album 20g, granules, one dose per day, taken in two doses, for 1 month.

[0126] On August 27, 2020, he came to the clinic and reported that his fatigue had improved. His white blood cell count was 8.4×10 9 / L, neutrophils 54.7%, hemoglobin 83g / L, platelets 158×10 9 / L, the condition improved, then continue taking the above for 3 months.

[0127] Follow-up visit on December 10, 2020: fatigue improved, tongue pale, cracked, thin white fur, weak pulse. Blood test: WBC 6.6×10 9 / L, neutrophil 58.1%, hemoglobin 103g / L, platelet 220×10 9 / L. Comprehensive analysis shows that anemia has improved, but there is still spleen and kidney deficiency, so the tongue is pale, with many cracks, thin white fur, and weak pulse. Although the condition has improved, the symptoms of dampness and blood stasis are not easy to go away, so continue to use the above consolidation treatment.

[0128] On June 24, 2021, the patient felt well and blood test showed that the white blood cell count was 3.9×10 9 / L, neutrophils 1.6×10 9 / L, hemoglobin 118g / L, platelets 199×10 9 / L. White blood cells, hemoglobin, and platelets basically returned to normal, and the condition was relieved.

[0129] It should be noted that the FLAER test is a specific method for detecting paroxysmal nocturnal hemoglobinuria (PNH).

[0130] The above are only specific implementations of the present application, but the protection scope of the present application is not limited thereto. Any technician familiar with the technical field can easily think of changes or substitutions within the technical scope disclosed in the present application, which should be included in the protection scope of the present application. Therefore, the protection scope of the present application should be based on the protection scope of the claims.

Claims

1. A Chinese medicine composition, characterized in that: include: Psoralea corylifolia, Astragalus membranaceus, Alisma orientalis, Millettia reticulata, Silkworm cocoon, Dioscorea batatas, Capillaris ternata, Ligusticum chuanxiong, Ginseng, Phellodendron amurense, Angelica sinensis, Agrimoniae and Viscum album.

2. The Chinese medicine composition according to claim 1, characterized in that: The invention comprises the following components in parts by weight: 15 to 20 parts of psoralea corylifolia, 20 to 30 parts of astragalus, 15 to 20 parts of orientalis, 20 to 40 parts of millettia reticulata, 10 to 20 parts of silkworm cocoons, 15 to 20 parts of yam, 15 to 25 parts of capillaris, 10 to 25 parts of ligusticum chuanxiong, 8 to 16 parts of ginseng, 10 to 16 parts of phellodendron, 20 to 25 parts of angelica sinensis, 20 to 25 parts of agrimony and 16 to 25 parts of mistletoe.

3. The Chinese medicine composition according to claim 2, characterized in that: The invention comprises the following components in parts by weight: 17 to 19 parts of psoralea corylifolia, 23 to 27 parts of astragalus, 17 to 19 parts of oriental rhizome, 25 to 35 parts of millettia reticulata, 12 to 18 parts of silkworm cocoons, 17 to 19 parts of yam, 17 to 19 parts of capillaris, 15 to 20 parts of ligusticum chuanxiong, 11 to 13 parts of ginseng, 12 to 14 parts of phellodendron, 17 to 19 parts of angelica sinensis, 22 to 24 parts of agrimony and 18 to 22 parts of mistletoe.

4. The Chinese medicine composition according to claim 3, characterized in that: The invention comprises the following components in parts by weight: 18 parts of psoralea corylifolia, 25 parts of astragalus, 18 parts of oriental rhizome, 30 parts of millettia spatholobi, 19 parts of silkworm cocoons, 18 parts of yam, 18 parts of capillaris, 18 parts of ligusticum chuanxiong, 12 parts of ginseng, 15 parts of phellodendron, 18 parts of angelica sinensis, 23 parts of agrimony and 20 parts of mistletoe.

5. Use of the traditional Chinese medicine composition according to any one of claims 1 to 4 in treating paroxysmal nocturnal hemoglobinuria.

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