A composition, preparation and method of preparation thereof for breast cancer hydrothorax / ascites

Abstract

The present invention discloses a composition, preparation, and preparation method for treating pleural effusion / ascites caused by breast cancer, belonging to the technical field of traditional Chinese medicine. The composition is composed of roasted licorice root, codonopsis pilosula, bupleurum root, vinegared corydalis, curcuma aromatica, thunbergia thunbergii, roasted malt, hedyotis diffusa, julibrissin bark, bergamot, parsnip, toosendan fruit, lycopodiella catechu, duchesnea, and pinellia tuber. The composition principle of the formula is based on the liver depression transforming into fire syndrome. The formula is mainly used to treat pleural effusion / ascites caused by breast cancer, liver depression transforming into fire syndrome, and damp-heat accumulation in the spleen syndrome. The formula's mechanism is as follows: Hedyotis diffusa (Houttuynia cordata) clears heat and dampness, serving as the main herb; Duchesnea oleracea (Duchesnea indica), Catechu (Catechu), Bletilla striata (Bai Ying), and Paris polyphylla (Paridis parviflora) clear dampness and heat, serving as the assistant herb; Toosendan fruit, Albizia julibrissin (Albizia julibrissin), Bupleurum chinense (Bupleurum chinense), Curcuma aromatica (Curcuma zedoaria), and Citron (Buddha's hand) soothe the liver and regulate qi; Corydalis yanhusuo (Rhizoma Corydalis) relieves stagnant qi in the blood, promoting blood circulation and alleviating pain; Pinellia ternata (Zingiber officinale) eliminates dampness and resolves phlegm; Codonopsis pilosula (Dong Shen) tonifies the middle and replenishes qi; Fritillaria thunbergii (Thunbergia thunbergii) clears heat and resolves stagnation, serving as the adjuvant; and Roasted Licorice root (Glycyrrhiza uralensis) harmonizes the other herbs, serving as the guiding herb. This formula's efficacy: soothes the liver and relieves heat, promotes blood circulation and relieves pain, and eliminates dampness and heat.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of traditional Chinese medicine, and particularly relates to a composition for breast cancer hydrothorax / ascites, a preparation and a preparation method thereof. BACKGROUND

[0002] Breast cancer is one of the common malignant tumors in women, and the incidence rate increases with age. Genetic, infertility, unhealthy lifestyle and excessive mental stress are several common factors causing breast cancer. Generally, most breast cancer patients in China are concentrated in the age group of 45-55. The causes of female breast cancer are as follows: 1. genetic reason. Generally, if a woman's mother has breast cancer, the woman's incidence rate will be higher than that of ordinary people, and the incidence time may be earlier than that of people who are not cancer second-generation. 2. Menarche and menopause. Women who have menstruation before the age of 12 and menopause after the age of 55 have a higher risk of the disease. 3. Unmarried and infertile. 4. Unhealthy lifestyle. 5. Excessive mental stress. 6. Affected by chemical substances. Some inferior and unqualified skin care products and cosmetics may contain chemical substances that are easy to cause cancer, and if they are used frequently, they may induce breast cell carcinogenesis. In addition, the components in chemical products such as pesticide residues on fruits and vegetables, air fragrances, and clothes dry cleaning agents need to be paid attention to. Symptoms of breast cancer: 1. Lumps in the breast, which is one of the most significant symptoms of breast cell carcinogenesis. 2. A series of changes in the breast, including unilateral or bilateral nipple discharge, itching, erosion, depression, areola abnormalities, etc. Generally, nipple discharge indicates that breast cell tumors may be benign, but it does not rule out the possibility of malignant carcinogenesis. In addition, the hair follicles on the surface of the breast skin of breast cancer patients may appear small depressions, showing a morphology similar to orange peel, and may also appear winegoblet-like collapse, or breast swelling and congestion, etc. 3. Lymph node enlargement, lymph is a defense line of the immune system in the body, and the lymph cells close to the breast are located in the axillary. If the breast cells of one side of the breast are carcinogenic, the lymph node cells in the same side of the axillary may become swollen and enlarged.

[0003] Traditional Chinese Medicine believes that the causes of breast cancer involve both internal and external factors, with internal factors being the primary. 1. Internal cold qi, leading to blood clots and blood deficiency. "The Treatise on the Origin and Symptoms of Various Diseases, Volume 40, on the Symptoms of Stone Carbuncle" states: "In cases of breast cancer, the meridians are weak, and wind and cold qi invade them, causing blood to stagnate and clot... There is no fever, but only tuberculosis-like lumps." This suggests that breast cancer can also be caused by external factors, "internal cold qi." 2. Internal damage caused by the seven emotions, leading to liver and spleen disharmony. "Danxi's Heart Method, Volume 5, on Breast Cancer" states: "Worry, anger, and depression accumulate day and night, stagnate the spleen qi, and cause liver qi to revolt, resulting in hidden nodules, like large chess pieces, painless and itchy. Decades later, they become sunken ulcers, known as breast cancer." "The Authentic Surgery, Treatise on Breast Cancer, Chapter 26," explains the cause of breast cancer: "Furthermore, worry and depression damage the liver, anxiety damages the spleen, and accumulated thoughts and unfulfilled wishes lead to stagnation in the meridians, which then form nodules." "Collection of Experiences in the Department of Surgery" contains similar accounts. The book "Medical Mirror: Essentials of Surgery: Breast Cancer" states that "Breast cancer is initially caused by tuberculosis and dull pain, and liver and spleen are damaged and qi is stagnant." The above shows that breast cancer is caused by seven emotional injuries, such as liver qi disharmony, liver qi stagnation, spleen damage due to stagnation, and liver and spleen deficiency.

[0004] Breast cancer symptoms are often accompanied by pleural or peritoneal effusions. Currently, advanced breast cancer metastasizes to the pleura or peritoneum, causing pleural or peritoneal effusions. Current treatments for this condition primarily involve chemotherapy, endocrine therapy, immunotherapy, and intrathoracic or peritoneal drug injections. Because the breast is a relatively minor organ and not life-threatening, surgical resection is currently the primary treatment for breast cancer, particularly for patients in the early stages and those without metastatic disease. Radiotherapy is primarily a localized procedure to address postoperative recurrence, while chemotherapy is a systemic adjuvant therapy. Endocrine therapy is reserved for patients who are not suitable for surgery. Summary of the Invention

[0005] Given the various shortcomings of current traditional treatments, the present invention aims to provide a composition for treating breast cancer pleural and ascites effusions. The composition is formulated based on the principle of liver depression transforming into fire syndrome. This composition is primarily indicated for breast cancer pleural and ascites effusions, liver depression transforming into fire syndrome, and damp-heat accumulation in the spleen.

[0006] The present invention is achieved through the following technical solutions:

[0007] A composition for treating pleural effusion / ascites of breast cancer, wherein the composition is mainly prepared from the following raw materials in parts by weight:

[0008] 3-10 parts of roasted liquorice root, 10-30 parts of codonopsis pilosula, 3-10 parts of bupleurum root, 3-10 parts of vinegar corydalis, 6-12 parts of turmeric, 3-10 parts of thunbergia bulb, 10-12 parts of roasted malt, 15-60 parts of oldenlandia diffusa, 10-15 parts of julibrissin bark, 3-10 parts of bergamot, 3-9 parts of parsley, 5-10 parts of toosendan fruit, 15-25 parts of white peony root, 3-6 parts of catechu, 15-25 parts of duchesnea and 3-10 parts of pinellia.

[0009] The mechanism of this formula is as follows: Hedyotis diffusa (Houttuynia cordata) clears heat and dampness, serving as the main herb; Duchesnea oleracea, Catechu, Bletilla striata, and Paris polyphylla clear dampness and heat, serving as the assistant herb; Toosendan fruit, Albizia julibrissin bark, Bupleurum chinense, Curcuma aromatica, and Citron stalk soothe the liver and regulate qi; Corydalis yanhusuo (Rhizoma Corydalis) relieves qi stagnation in the blood, promoting blood circulation and alleviating pain; Pinellia ternata (Rhizoma Zingiberis) eliminates dampness and resolves phlegm; Codonopsis pilosula replenishes qi; Fritillaria thunbergii (Rhizoma Zingiberis) clears heat and resolves stagnation, serving as the adjuvant; and Radix Glycyrrhizae (Rhizoma Licorice) harmonizes the other herbs, serving as the guiding herb. This formula's efficacy: soothes the liver and relieves heat, promotes blood circulation and relieves pain, and eliminates dampness and heat. This formula is primarily indicated for breast cancer, ascites and pleural effusion, liver depression transforming into fire, and damp-heat accumulation in the spleen.

[0010] Preferably, the composition is mainly prepared from the following raw materials in parts by weight:

[0011] 5-8 parts of roasted liquorice root, 15-24 parts of codonopsis pilosula, 5-8 parts of bupleurum root, 5-8 parts of vinegar corydalis, 8-10 parts of turmeric, 5-8 parts of thunbergia bulb, 10.5-11.5 parts of roasted malt, 25-50 parts of oldenlandia diffusa, 11-14 parts of julibrissin bark, 5-8 parts of bergamot, 4-8 parts of parsnip, 7-9 parts of toosendan fruit, 18-23 parts of gentiana chinensis, 4-5 parts of catechu, 18-23 parts of duchesnea and 5-8 parts of pinellia.

[0012] Preferably, the composition is mainly prepared from the following raw materials in parts by weight:

[0013] 10 parts of roasted liquorice root, 30 parts of codonopsis pilosula, 10 parts of bupleurum root, 10 parts of vinegar corydalis, 12 parts of turmeric, 10 parts of thunbergia bulbs, 12 parts of roasted malt, 60 parts of oldenlandia diffusa, 15 parts of julibrissin bark, 10 parts of bergamot, 9 parts of parsley, 10 parts of toosendan fruit, 25 parts of white peony root, 6 parts of catechu, 25 parts of duchesnea and 10 parts of pinellia.

[0014] Preferably, the composition is mainly prepared from the following raw materials in parts by weight:

[0015] 6 parts of roasted liquorice root, 18 parts of codonopsis pilosula, 6 parts of bupleurum root, 6 parts of vinegar corydalis, 9 parts of turmeric, 6 parts of thunbergia bulbs, 11 parts of roasted malt, 40 parts of oldenlandia diffusa, 12 parts of julibrissin bark, 6 parts of bergamot, 5.5 parts of parsnip, 8 parts of toosendan fruit, 20 parts of lycopodiella vulgaris, 4.5 parts of catechu, 20 parts of duchesnea and 6 parts of pinellia.

[0016] Licorice root, a Chinese medicinal name. Latin name: Glycyrrhizae Radix Et Rhizoma. It is a processed product of licorice. It has the effects of replenishing qi and tonifying the middle, moistening the lungs and relieving cough, clearing away heat and detoxifying, relieving pain, and harmonizing the properties of medicines. It is mainly used to treat spleen deficiency and fatigue, heart deficiency and palpitations, cough and asthma, carbuncle and throat paralysis, drug and food poisoning, abdominal and limb cramps and pain, etc. Nature and flavor: sweet, neutral. It enters the heart, lung, spleen, and stomach meridians. Licorice also has certain antioxidant, anti-diuretic, anti-tumor, auditory function improvement, pancreatic secretion promotion, and anti-allergic effects.

[0017] Codonopsis, Chinese medicine name. For Codonopsis pilosula (Franch.) Nannf., party party Codonopsis pilosula Nannf. var. (Nannf.) L. T. Shen or Suhua Codonopsis tangshen Oliv. root. Has the effect of spleen and lung, and can also be used to treat spleen deficiency, lung deficiency, cough, thirst, blood deficiency, and other symptoms. Nature and taste: sweet, nature; spleen, lung. Effects on the immune system: Codonopsis and its polysaccharides can increase the number of macrophages, increase cell volume, and increase phagocytic function, and have the effect of enhancing immune function. Codonopsis also has the effects of lowering blood sugar, improving learning and memory function, enhancing SOD activity, anti-hypoxia, anti-radiation, anti-cancer, anti-inflammatory and analgesic effects.

[0018] Chaihu, Chinese medicine name. For Umbelliferae Chaihu Bupleurum chinense DC. or Bupleurum scorzonerifolium Willd. dry root. Has the effect of relieving fever, soothing liver and depression, and lifting Yang. It is used to treat fever, less yang syndrome, liver depression, qi stagnation, qi deficiency, organ prolapse, and fever. Nature and taste: bitter, pungent, cold; liver, gallbladder. Chaihu also has the effects of anti-cold virus, increasing protein biosynthesis, anti-tumor, anti-radiation and enhancing immune function.

[0019] Vinegar Corydalis is a traditional Chinese medicine, which is used for blood stasis and pain. It has the effects of promoting blood circulation, unblocking qi, and relieving pain. Nature and taste: pungent, bitter, warm, non-toxic. Meridians: into the liver, stomach, heart. Promote blood circulation; unblock qi; relieve pain. It is used for blood stasis and pain. The product is pungent and warm, and can unblock qi and blood stasis, so it is used to treat all kinds of pain. It is often used for chest pain, stomach pain, liver depression and rib pain, dysmenorrhea, postpartum abdominal pain, cold abdominal pain, sprains, rheumatism and other pains.

[0020] Curcuma jin (Chinese medicinal herb) is the dried root of Curcuma wenyujin (YHChen et C. Ling), Curcuma longa L., Curcuma kwangsiensis (SG Lee et C. F. Liang), or Curcuma phaeocaulis Val., all of the Zingiberaceae family. It has the effects of promoting blood circulation and relieving pain, promoting qi and relieving depression, clearing the heart and cooling blood, and promoting bile secretion and relieving jaundice. It is mainly used to treat symptoms of qi stagnation and blood stasis, coma due to febrile illness, epilepsy and phlegm retention, hematemesis, epistaxis, retrograde menstruation, hematuria, hematuria, jaundice caused by damp-heat in the liver and gallbladder, and cholelithiasis. Its nature and meridians are pungent and bitter, with a cold nature; it enters the liver, gallbladder, and heart meridians. Curcuma jin protects hepatocytes, promotes hepatocyte regeneration, removes fat, and inhibits hepatocyte fibrosis, combating toxic liver diseases. Curcumin and volatile oils promote bile secretion and excretion, reducing urinary urobilinogen. Its decoction can stimulate gastric acid and duodenal fluid secretion.

[0021] Fritillaria thunbergii, a traditional Chinese medicine, is the bulb of Fritillaria thunbergii Miq., a plant of the genus Fritillaria in the Liliaceae family. It has the effects of clearing heat and resolving phlegm, dispersing nodules and eliminating carbuncles. It is mainly used to treat wind-heat, phlegm-heat cough, scrofula, goiter, mastitis, and lung abscess. Its nature and meridians are bitter and cold; it enters the lung and heart meridians. Fritillaria thunbergii alkaloids have a significant dilating effect on bronchial smooth muscle at low concentrations. Fritillaria thunbergii alkaloids and dehydrothunbergii alkaloids have significant antitussive effects and also have central nervous system depressant effects, providing sedative and analgesic effects.

[0022] Roasted barley malt is sweet and soothing, helps aid digestion, strengthens the spleen and stimulates appetite, and reduces lactation and bloating. It can be used to treat indigestion, abdominal distension and pain, spleen deficiency and poor appetite, milk and sweat stagnation, and breast tenderness. It promotes qi circulation, aids digestion, strengthens the spleen and stimulates appetite, and reduces lactation and bloating. Roasted barley malt contains a variety of vitamins and minerals, such as vitamin E and zinc, which nourish yin and moisten dryness, relieve symptoms like dry mouth and cough, and enhance immunity and prevent disease.

[0023] Oldenlandia diffusa (Willd.) Roxb., a traditional Chinese medicine, is the whole herb of the Rubiaceae family. It has the effects of clearing heat and detoxifying, promoting dampness and relieving stranguria. It is mainly used to treat carbuncles, sores, sore throat, snake bites, and painful stranguria caused by heat. Its nature and meridians are bitter and sweet, with a cold nature; it enters the stomach, large intestine, and small intestine meridians. In vitro, it has a weak inhibitory effect on Staphylococcus aureus and Shigella dysenteriae. In vivo, it stimulates the proliferation of the reticuloendothelial system, promotes antibody formation, and enhances the phagocytic capacity of reticular cells and leukocytes, thereby achieving antibacterial and anti-inflammatory effects.

[0024] Hehuanpi, a Chinese herb. It is the bark of Albizia julibrissin Durazz. of the family Leguminosae. It has the functions of relieving depression and soothing the nerves, promoting blood circulation and removing swelling. It is used for restlessness of the heart, depression, insomnia, convulsion, injury, fracture, blood stasis and swelling, and carbuncle and sores. It has the function of enhancing immune function and anti-tumor effect.

[0025] Foshou, a Chinese herb. It is the dried fruit of Citrus medica L. var. sarcodactylis Swingle of the Rutaceae family. It has the functions of soothing the liver, relieving depression, regulating qi and reducing phlegm. It is used for chest and hypochondrium distending pain due to liver depression and disharmony between the liver and stomach, abdominal fullness due to spleen and stomach qi stagnation, abdominal distending pain, vomiting, poor appetite, chronic cough and excessive phlegm. It contains volatile oil, flavonoids, polysaccharides, and coumarin compounds.

[0026] Chonglou, a Chinese herb. It is the dried rhizome of Paris polyphylla Smith var. Yunnanensis (Franch.) Hand.-Mazz. or P. polyphylla Smith var. Chinensis (F.) Hara of the Liliaceae family. It has the functions of clearing heat and resolving toxins, removing swelling and relieving pain, and cooling the liver and calming the nerves. It is used for carbuncle and sores, sore throat, snake bite, convulsion, and injury. It has the function of clearing heat and resolving toxins, removing swelling and relieving pain, and cooling the liver and calming the nerves.

[0027] Chuanlianzi, a Chinese herb. It is the dried mature fruit of Melia toosendan Sieb. et Zucc. of the Meliaceae family. It has the functions of dispersing the liver, removing heat, regulating qi and relieving pain, and killing insects. It is used for abdominal and hypochondriac pain, hernia pain, abdominal pain due to insect accumulation, and tinea capitis. It contains the anthelmintic effective component meliatosendanin, as well as a variety of bitter triterpenoid components, such as meliatoxiketone and lipomeliatoxiketol.

[0028] White night, Chinese medicinal material name. For Solanaceae Solanum lyrate Thunb. [S. dulcamara L. var. lyrate (Thunb.) Sieb. et Zucc., S. dulcamara L. var. pubescens Blume, S. dulcamara L. var. chinense Dunal] plant, with whole grass or root into medicine. Has heat-clearing and detoxifying, diuresis and swelling, anti-cancer effect. Whole grass for colds and fever, jaundice hepatitis, cholecystitis, gallstones, cancer, cervical erosion, leukorrhea, nephritis edema; external use for carbuncle abscess. Root for rheumatoid arthritis. Nature and flavor: bitter, slightly cold. Liver, stomach meridian. Pharmacological action: the product has anti-cancer effect on human lung cancer.

[0029] Catechu, Chinese medicine name. For the skin of Acacia catechu (L. f.) Willd. of Mimosaceae plant branches, dry decoction paste. Has the effect of promoting blood circulation to remove stasis, hemostasis, muscle, wet and sore, clear lung and phlegm. Mainly for sprains and pain, bleeding, sore, wet, dental caries, chancroid, hemorrhoids, lung heat cough. Nature and flavor: bitter, astringent, cool; heart, lung meridian. Pharmacological action: has the effect of astringent, antidiarrheal, antihypertensive; dextromethamphetamine on isolated heart first inhibition and then excitation; can inhibit the activity of tyrosine decarboxylase, inhibit hyaluronidase, choline acetylase, can inhibit the dissolution of fibrin by streptokinase; in vitro test on a variety of skin fungi and staphylococcus aureus, a variety of bacillus and so on has certain inhibitory effect; decoction can damage ascites cells in vitro.

[0030] Duchesne indica (Andr.) Focke. It has the functions of clearing heat and detoxifying, cooling blood and stopping bleeding, and dissipating blood stasis and swelling. It is used for treating heat disease, convulsion, common cold, dysentery, jaundice, red eye, mouth sore, sore throat, mumps, furuncle, snake bite, hemoptysis, metrorrhagia, irregular menstruation, scald, and contusion and swelling. It is sweet and bitter in taste and cold in nature. Pharmacological effects: 1. Anti-cancer effect: 5 mg / ml and 10 mg / ml of water extract of Duchesne indica can inhibit the division index of human esophageal cancer Eca-109 cell line in vitro; 10 mg / ml and 15 mg / ml can reduce the cell density and make the structure fuzzy; after 48 hours of action, the cell colony formation is significantly inhibited, and 15 mg / ml can completely lose the ability of cell reproduction; 10 mg / ml and 15 mg / ml have a slight inhibitory effect on DNA synthesis (3H-TdR labeling) of Eca-109 cells, indicating that the effect of Duchesne indica on esophageal cancer cells may be mainly through the inhibition of cell division and DNA synthesis. The polysaccharide part of Duchesne indica shows obvious anti-tumor activity in transplanted S180 sarcoma mice at 100 mg / kg and 200 mg / kg. 2. Enhancing immune function: Duchesne indica flow extract (2 g / ml) can significantly increase the phagocytic function of mouse peritoneal macrophages, with each cell phagocytizing 7-8 chicken red blood cells, but there is no significant difference in the digestion state of each level compared with the control group.

[0031] Pinellia ternata, warm in nature, dries dampness, resolves phlegm, stops cough, and reduces adverse flow and vomiting.

[0032] A preparation for breast cancer chest / abdominal fluid, which is prepared from the composition.

[0033] A preparation method of a preparation for breast cancer chest / abdominal fluid, comprising the following steps:

[0034] After selecting Rhizoma Glycyrrhizae, Radix Codonopsis, Radix Bupleuri, Rhizoma Corydalis, Radix Curcumae, Fritillariae Thunbergii, Fructus Immaturus Arecae, Herba Belamcandae, Cortex Albiziae, Citrus medica, Yunnan Rhizoma, Fructus Aurantii, Radix Angelicae Pubescentis, Radix Pseudolaricis, and Pinellia ternata in corresponding mass fractions, mixing them, and then soaking and decocting them in a container, the residue is filtered to obtain the preparation.

[0035] As a preference, the soaking time is 25-30 min.

[0036] As a preference, the decocting temperature is 95-100 ℃.

[0037] As a preference, the decocting time is 35-45 min.

[0038] As a preference, the preparation is an oral decoction.

[0039] Compared with the prior art, the present application has at least the following technical effects:

[0040] The present application provides a composition for breast cancer chest / ascites, which is composed of prepared licorice, radix codonopsis, radix bupleuri, vinegar rhizoma Corydalis, radix curcumae, Zhebei, roasted barley, oldenlandia diffusa, Albizia julibrissin, bergamot, yunnan bletilla, melia toosendan, herba, catechu, snakeberry and pinellia ternata. The composition principle is based on the liver stagnation and fire. The composition is used for treating breast cancer chest / ascites, liver stagnation and fire, and damp-heat accumulation in the spleen.

[0041] The mechanism of the composition is as follows: oldenlandia diffusa is the monarch herb for clearing heat and dampness; snakeberry, catechu, herba, and yunnan bletilla are the ministerial herbs for clearing damp-heat; melia toosendan, Albizia julibrissin, radix bupleuri, radix curcumae, and bergamot are used for soothing the liver and regulating qi; vinegar rhizoma Corydalis can remove blood stasis and qi stagnation to achieve the effect of activating blood and relieving pain; pinellia ternata can dry dampness and reduce phlegm; radix codonopsis can tonify the center and benefit qi; Zhebei can clear heat and resolve masses; prepared licorice can harmonize all herbs. The composition has the effects of soothing the liver and clearing heat, activating blood and relieving pain, and removing damp-heat. DETAILED DESCRIPTION

[0042] The embodiments of the present application will be described in detail below with reference to the examples, but those skilled in the art will understand that the following examples are only used to illustrate the present application and should not be regarded as limiting the scope of the present application. The specific conditions not mentioned in the examples are carried out according to the conventional conditions or the conditions recommended by the manufacturer. The reagents or instruments not mentioned by the manufacturer are conventional products that can be purchased on the market.

[0043] Example 1

[0044] A composition for breast cancer chest / ascites is composed of the following raw materials in mass fraction:

[0045] Prepared licorice 3g, radix codonopsis 10g, radix bupleuri 3g, vinegar rhizoma Corydalis 3g, radix curcumae 6g, Zhebei 3g, roasted barley 10g, oldenlandia diffusa 15g, Albizia julibrissin 10g, bergamot 3g, yunnan bletilla 3g, melia toosendan 5g, herba 15g, catechu 3g, snakeberry 15g, and pinellia ternata 3g.

[0046] A preparation method of a decoction for breast cancer chest / ascites is prepared from the above composition, which comprises the following steps:

[0047] The prepared licorice, radix codonopsis, radix bupleuri, vinegar rhizoma Corydalis, radix curcumae, Zhebei, roasted barley, oldenlandia diffusa, Albizia julibrissin, bergamot, yunnan bletilla, melia toosendan, herba, catechu, snakeberry, and pinellia ternata are mixed according to the corresponding mass fraction, then soaked and decocted in a container, and the residue is filtered to obtain the preparation.

[0048] The soaking time is 25 min.

[0049] The decocting temperature is 100℃.

[0050] The decocting duration is 35 min.

[0051] The preparation is an oral decoction.

[0052] Example 2:

[0053] A composition for breast cancer hydrothorax / ascites is prepared from the following raw materials in mass parts:

[0054] Radix glycyrrhizae praeparata 3g, radix codonopsis 10g, radix bupleuri 3g, acorus calamus 3g, radix curcumae 6g, fritillaria thunbergii 3g, farfarae praeparata 10g, oldenlandia diffusa 15g, albizia julibrissin 10g, bergamot 3g, yucca 3g, melia toosendan 5g, herba solani 15g, catechu 3g, rubus chingii 15g, and pinellia ternata 3g.

[0055] A preparation method of a decoction for breast cancer hydrothorax / ascites is prepared from the above composition, comprising the following steps:

[0056] Radix glycyrrhizae praeparata, radix codonopsis, radix bupleuri, acorus calamus, radix curcumae, fritillaria thunbergii, farfarae praeparata, oldenlandia diffusa, albizia julibrissin, bergamot, yucca, melia toosendan, herba solani, catechu, rubus chingii, and pinellia ternata are selected according to the corresponding mass parts, mixed, placed in a container for soaking and decocting, and the residue is filtered to obtain the preparation.

[0057] The soaking duration is 30 min.

[0058] The decocting temperature is 95℃.

[0059] The decocting duration is 35 min.

[0060] The preparation is an oral decoction.

[0061] Example 3:

[0062] A composition for breast cancer hydrothorax / ascites is prepared from the following raw materials in mass parts:

[0063] Radix glycyrrhizae praeparata 10g, radix codonopsis 30g, radix bupleuri 10g, acorus calamus 10g, radix curcumae 12g, fritillaria thunbergii 10g, farfarae praeparata 12g, oldenlandia diffusa 60g, albizia julibrissin 15g, bergamot 10g, yucca 9g, melia toosendan 10g, herba solani 25g, catechu 6g, rubus chingii 25g, and pinellia ternata 10g.

[0064] A preparation method of a decoction for breast cancer hydrothorax / ascites is prepared from the above composition, comprising the following steps:

[0065] The licorice, codonopsis, bupleurum, vinegar Corydalis, goldthread, Zhebeimu, roasted wheat, oldenlandia, Chinese albizia, bergamot, yucca, melia, bittersweet, catechu, snakeberry and pinellia are selected according to the corresponding mass fraction, mixed, placed in a container for soaking and decocting, and the residue is filtered to obtain a preparation.

[0066] The soaking time is 25 min.

[0067] The decocting temperature is 100 DEG C.

[0068] The decocting time is 35 min.

[0069] The preparation is an oral decoction.

[0070] Example 4:

[0071] A composition for breast cancer chest / ascites is composed of the following mass fraction of raw materials:

[0072] The licorice, codonopsis, bupleurum, vinegar Corydalis, goldthread, Zhebeimu, roasted wheat, oldenlandia, Chinese albizia, bergamot, yucca, melia, bittersweet, catechu, snakeberry and pinellia are selected according to the corresponding mass fraction, mixed, placed in a container for soaking and decocting, and the residue is filtered to obtain a preparation.

[0073] A preparation method of a decoction for breast cancer chest / ascites is prepared from the above composition, comprising the following steps:

[0074] The licorice, codonopsis, bupleurum, vinegar Corydalis, goldthread, Zhebeimu, roasted wheat, oldenlandia, Chinese albizia, bergamot, yucca, melia, bittersweet, catechu, snakeberry and pinellia are selected according to the corresponding mass fraction, mixed, placed in a container for soaking and decocting, and the residue is filtered to obtain a preparation.

[0075] The soaking time is 30 min.

[0076] The decocting temperature is 95 DEG C.

[0077] The decocting time is 35 min.

[0078] The preparation is an oral decoction.

[0079] Example 5:

[0080] A composition for breast cancer chest / ascites is composed of the following mass fraction of raw materials:

[0081] Radix Glycyrrhizae Praeparata cum Melle 5g, Radix Codonopsis 15g, Radix Bupleuri 5g, Rhizoma Corydalis 5g, Radix Curcumae 8g, Bulbus Fritillariae Thunbergii 5g, Fructus Hordei Germinatus 10.5g, Herba Sarcandrae 25g, Cortex Albiziae 11g, Fructus Citri Sarcodactylis 5g, Rhizoma Typhonii 4g, Fructus Xanthii 7g, Folium Phyllostachyse Angustissimae 4g, Radix Paeoniae Alba 18g, Herba Serpylli 18g, and Rhizoma Pinelliae 5g.

[0082] A preparation method of a decoction for breast cancer hydrothorax / ascites is prepared from the above composition, comprising the following steps:

[0083] Radix Glycyrrhizae Praeparata cum Melle, Radix Codonopsis, Radix Bupleuri, Rhizoma Corydalis, Radix Curcumae, Bulbus Fritillariae Thunbergii, Fructus Hordei Germinatus, Herba Sarcandrae, Cortex Albiziae, Fructus Citri Sarcodactylis, Rhizoma Typhonii, Fructus Xanthii, Folium Phyllostachyse Angustissimae, Radix Paeoniae Alba, Herba Serpylli, and Rhizoma Pinelliae are selected according to the corresponding mass fraction, mixed, soaked and decocted in a container, and the residue is filtered to obtain the preparation.

[0084] The soaking time is 25 min.

[0085] The decocting temperature is 100℃.

[0086] The decocting time is 35 min.

[0087] The preparation is an oral decoction.

[0088] Example 6:

[0089] A composition for breast cancer hydrothorax / ascites is composed of the following raw materials in mass fraction:

[0090] Radix Glycyrrhizae Praeparata cum Melle 5g, Radix Codonopsis 15g, Radix Bupleuri 5g, Rhizoma Corydalis 5g, Radix Curcumae 8g, Bulbus Fritillariae Thunbergii 5g, Fructus Hordei Germinatus 10.5g, Herba Sarcandrae 25g, Cortex Albiziae 11g, Fructus Citri Sarcodactylis 5g, Rhizoma Typhonii 4g, Fructus Xanthii 7g, Folium Phyllostachyse Angustissimae 4g, Radix Paeoniae Alba 18g, Herba Serpylli 18g, and Rhizoma Pinelliae 5g.

[0091] A preparation method of a decoction for breast cancer hydrothorax / ascites is prepared from the above composition, comprising the following steps:

[0092] Radix Glycyrrhizae Praeparata cum Melle, Radix Codonopsis, Radix Bupleuri, Rhizoma Corydalis, Radix Curcumae, Bulbus Fritillariae Thunbergii, Fructus Hordei Germinatus, Herba Sarcandrae, Cortex Albiziae, Fructus Citri Sarcodactylis, Rhizoma Typhonii, Fructus Xanthii, Folium Phyllostachyse Angustissimae, Radix Paeoniae Alba, Herba Serpylli, and Rhizoma Pinelliae are selected according to the corresponding mass fraction, mixed, soaked and decocted in a container, and the residue is filtered to obtain the preparation.

[0093] The soaking time is 30 min.

[0094] The decocting temperature is 95℃.

[0095] The decocting time is 35 min.

[0096] The preparation is an oral decoction.

[0097] Example 7:

[0098] A composition for breast cancer chest / ascites is composed of the following mass parts of raw materials:

[0099] Radix glycyrrhizae praeparata 8g, radix codonopsis 24g, radix bupleuri 8g, rhizoma corydalis 8g, radix notoginseng 10g, fritillariae thunbergii 8g, farina granulorum 11.5g, oldenlandia 50g, albizia 14g, bergamot 8g, yucca 8g, melia 9g, herba solani 23g, catechu 5g, serissa 23g and pinellia 8g.

[0100] A preparation method of a decoction for breast cancer chest / ascites is prepared from the above composition, comprising the following steps:

[0101] Radix glycyrrhizae praeparata, radix codonopsis, radix bupleuri, rhizoma corydalis, radix notoginseng, fritillariae thunbergii, farina granulorum, oldenlandia, albizia, bergamot, yucca, melia, herba solani, catechu, serissa and pinellia are mixed according to the corresponding mass parts, then soaked and decocted in a container, and the residue is filtered out to obtain the preparation.

[0102] The soaking time is 25 min.

[0103] The decoction temperature is 100℃.

[0104] The decoction time is 35 min.

[0105] The preparation is an oral decoction.

[0106] Example 8:

[0107] A composition for breast cancer chest / ascites is composed of the following mass parts of raw materials:

[0108] Radix glycyrrhizae praeparata 8g, radix codonopsis 24g, radix bupleuri 8g, rhizoma corydalis 8g, radix notoginseng 10g, fritillariae thunbergii 8g, farina granulorum 11.5g, oldenlandia 50g, albizia 14g, bergamot 8g, yucca 8g, melia 9g, herba solani 23g, catechu 5g, serissa 23g and pinellia 8g.

[0109] A preparation method of a decoction for breast cancer chest / ascites is prepared from the above composition, comprising the following steps:

[0110] Radix glycyrrhizae praeparata, radix codonopsis, radix bupleuri, rhizoma corydalis, radix notoginseng, fritillariae thunbergii, farina granulorum, oldenlandia, albizia, bergamot, yucca, melia, herba solani, catechu, serissa and pinellia are mixed according to the corresponding mass parts, then soaked and decocted in a container, and the residue is filtered out to obtain the preparation.

[0111] The soaking time is 30 min.

[0112] The decoction temperature is 95℃.

[0113] The decocting duration is 35 min.

[0114] The preparation is an oral decoction.

[0115] Example 9:

[0116] A composition for breast cancer hydrothorax / ascites is prepared from the following raw materials in mass parts:

[0117] Gancao 6g, Dangshen 18g, Chaihu 6g, Yuxinhu 6g, Yujin 9g, Zhebeimu 6g, Chaoma 11g, Baishashexue 40g, Huhuapi 12g, Foshou 6g, Chonglou 5.5g, Chuanjizi 8g, Baiying 20g, Echa 4.5g, Shehe 20g, and Banxia 6g.

[0118] A preparation method of a decoction for breast cancer hydrothorax / ascites is prepared from the above composition, comprising the following steps:

[0119] Gancao, Dangshen, Chaihu, Yuxinhu, Yujin, Zhebeimu, Chaoma, Baishashexue, Huhuapi, Foshou, Chonglou, Chuanjizi, Baiying, Echa, Shehe, and Banxia are selected according to the corresponding mass parts, mixed, placed in a container for soaking and decocting, and the residue is filtered to obtain the preparation.

[0120] The soaking duration is 25 min.

[0121] The decocting temperature is 100°C.

[0122] The decocting duration is 35 min.

[0123] The preparation is an oral decoction.

[0124] Usage method: oral administration, 100ml / time, 2 times / day.

[0125] Example 10:

[0126] A composition for breast cancer hydrothorax / ascites is prepared from the following raw materials in mass parts:

[0127] Gancao 10g, Dangshen 30g, Chaihu 10g, Yuxinhu 10g, Yujin 12g, Zhebeimu 10g, Chaoma 12g, Baishashexue 60g, Huhuapi 15g, Foshou 10g, Chonglou 9g, Chuanjizi 10g, Baiying 25g, Echa 6g, Shehe 25g, and Banxia 10g.

[0128] A preparation method of a decoction for breast cancer hydrothorax / ascites is prepared from the above composition, comprising the following steps:

[0129] According to the corresponding mass fraction, select Zhi Gan Cao, Dang Shen, Chai Hu, vinegar Yansu, Ju Jin, Zhe Bei Mu, Fried Mai Ya, Bai Hua She Che Cai, He Huan Pi, Fo Shou, Chong Lou, Chuan Jie Zi, Bai Ying, Er Cha, She He and Ban Xia are mixed and placed in a container for soaking and decoction. Remove the residue after filtering to obtain the preparation.

[0130] The soaking time is 25 min.

[0131] The decoction temperature is 100°C.

[0132] The decoction time is 35 min.

[0133] The preparation is an oral decoction.

[0134] Method of use: oral, 100ml / time, 2 times / day.

[0135] Contraindications: jaundice, difficulty eating, diarrhea, survival time not more than 1 month, gastrointestinal bleeding, pancreatitis.

[0136] Clinical cases:

[0137] Criteria:

[0138] I. Cure: complete absorption of pleural and abdominal effusion, no recurrence within 4 weeks;

[0139] Marked effect: pleural and abdominal fluid reduction by more than 50%, abdominal circumference reduction by more than 20cm, no recurrence within 4 weeks;

[0140] Effective: pleural and abdominal fluid reduction by 25%-50%, abdominal circumference reduction by less than 20cm, no recurrence within 4 weeks;

[0141] No effect: pleural and abdominal fluid reduction less than 25%, and increased within 4 weeks.

[0142] Source of standard: Efficacy analysis of malignant pleural and abdominal fluid in the combination of traditional Chinese and Western medicine

J

[0143] II. Clinical symptom score table of traditional Chinese medicine: damp-heat spleen syndrome

[0144] Main symptoms: abdominal distension, thirst, poor appetite, loose stool, red tongue, yellow and greasy tongue coating.

[0145] Secondary symptoms: heavy limbs, body heat, abdominal distension, nausea, yellowish bright eyes, soft and rapid pulse.

[0146] Damp-heat spleen syndrome 3 main symptoms (tongue appearance required); or 2 main symptoms (tongue appearance required), plus 2 secondary symptoms.

[0147] Symptom grading table of damp-heat spleen syndrome

[0148]

[0149] TCM: According to the Guiding Principle of Clinical Research for New Drugs of Traditional Chinese Medicine in 2003, the symptoms and signs of the subjects are formulated into an efficacy scale, and the integral reduction rate (pre-treatment integral - post-treatment integral) / pre-treatment integral) is used as the standard to determine the efficacy, which is divided into clinical cure, significant effect, effectiveness, and ineffectiveness.

[0150] Clinical cure: the clinical symptoms and signs of damp-heat accumulation in the spleen syndrome disappear or basically disappear, and the syndrome integral reduction is ≥95%.

[0151] Significant effect: the clinical symptoms and signs of damp-heat accumulation in the spleen syndrome are significantly improved, and the syndrome integral reduction is ≥70%.

[0152] Effective: the clinical symptoms and signs of damp-heat accumulation in the spleen syndrome are improved, and 30% ≤ syndrome integral reduction ≤ 70%.

[0153] Ineffective: the clinical symptoms and signs of damp-heat accumulation in the spleen syndrome are not significantly improved, or even aggravated, and the syndrome integral reduction is less than 30%.

[0154] III. Liver and kidney function: measure and record ALT, TBil, DBil, CR, and UA.

[0155] IV. Quality of life (QOL) reference karnosky score change, KPS increase ≥10 points after treatment as QOL improvement, change <10 points as QOL stable, and reduction ≥10 as QOL reduction.

[0156] V. Toxicity and side effects are divided into 0-4 grades according to WHO anti-cancer drug toxicity reaction standard.

[0157] Specific case:

[0158] Take the product of Example 10.

[0159] Case 1: Cao, female, 44 years old. Suffering from breast cancer with pleural effusion and ascites. First perform thoracentesis and drainage, then take the product of Example 10, effective for 1 year, then change to endocrine therapy.

[0160] Case 2: Wang, female, 60 years old. Suffering from breast cancer with pleural effusion and ascites. First perform thoracentesis and drainage, then take the product of Example 10, and improve.

[0161] Case 3: Guo, female, 58 years old. Suffering from breast cancer with pleural effusion and ascites. First perform thoracentesis and drainage, then take the product of Example 10, effective for 1 year, then change to endocrine therapy.

[0162] Case 4: Gao Moumou, female, 60 years old. Suffering from: breast cancer, accompanied by pleural effusion, ascites. First pleural puncture and drainage treatment, then take the product of Example 10, 13 days in hospital, improved.

[0163] Case 5: He Moumou, female, 77 years old. Suffering from: breast cancer, accompanied by pleural effusion, ascites. First pleural puncture and drainage treatment, then take the product of Example 10, effective for 1 year, and continue to take it now.

[0164] Case 6: Zhang Moumou, female, 60 years old. Suffering from: breast cancer, accompanied by pleural effusion, ascites. First pleural puncture and drainage treatment, then take the product of Example 10, began to take effect in half a month, and pleural effusion was reduced in 1 month. Discharged after taking orally for 4 months.

[0165] Case 7: Wang Moumou, female, 60 years old. Suffering from: breast cancer, accompanied by pleural effusion, ascites. First pleural puncture and drainage treatment, then take the product of Example 10, 9 days in hospital, improved and discharged.

[0166] Case 8: Ma Moumou, female, 68 years old. Suffering from: breast cancer, accompanied by pleural effusion, ascites. First pleural puncture and drainage treatment, then take the product of Example 10, 1 year, and continue to take it.

[0167] Case 9: Zhang Moumou, female, 68 years old. Suffering from: breast cancer, accompanied by pleural effusion, ascites. First pleural puncture and drainage treatment, then take the product of Example 10, took effect in half a month, and continued to take it.

[0168] Case 10: Duan Moumou, female, 57 years old. Suffering from: breast cancer, accompanied by pleural effusion, ascites. First pleural puncture and drainage treatment, then take the product of Example 10, took effect in half a month, and continued to take it.

[0169] Finally, it should be noted that: the above only for the preferred embodiments of the present application, and not for limiting the scope of protection of the present application. Any modification, equivalent replacement, improvement, etc. made within the spirit and principles of the present application shall be included in the scope of protection of the present application.

Claims

1. A composition for treating breast cancer pleural effusion / ascites, characterized in that: The composition is prepared from the following raw materials in parts by weight: 3-10 parts of roasted liquorice root, 10-30 parts of codonopsis pilosula, 3-10 parts of bupleurum root, 3-10 parts of vinegar corydalis, 6-12 parts of turmeric, 3-10 parts of thunbergia bulb, 10-12 parts of roasted malt, 15-60 parts of oldenlandia diffusa, 10-15 parts of julibrissin bark, 3-10 parts of bergamot, 3-9 parts of parsley, 5-10 parts of toosendan fruit, 15-25 parts of white peony root, 3-6 parts of catechu, 15-25 parts of duchesnea and 3-10 parts of pinellia.

2. A composition for treating breast cancer pleural effusion / ascites according to claim 1, characterized in that: The composition is prepared from the following raw materials in parts by weight: 5-8 parts of roasted liquorice root, 15-24 parts of codonopsis pilosula, 5-8 parts of bupleurum root, 5-8 parts of vinegar corydalis, 8-10 parts of turmeric, 5-8 parts of thunbergia bulb, 10.5-11.5 parts of roasted malt, 25-50 parts of oldenlandia diffusa, 11-14 parts of julibrissin bark, 5-8 parts of bergamot, 4-8 parts of parsnip, 7-9 parts of toosendan fruit, 18-23 parts of gentiana chinensis, 4-5 parts of catechu, 18-23 parts of duchesnea and 5-8 parts of pinellia.

3. The composition for treating breast cancer pleural effusion / ascites according to claim 1, wherein The composition is prepared from the following raw materials in parts by weight: 10 parts of roasted liquorice root, 30 parts of codonopsis pilosula, 10 parts of bupleurum root, 10 parts of vinegar corydalis, 12 parts of turmeric, 10 parts of thunbergia bulbs, 12 parts of roasted malt, 60 parts of oldenlandia diffusa, 15 parts of julibrissin bark, 10 parts of bergamot, 9 parts of parsley, 10 parts of toosendan fruit, 25 parts of white peony root, 6 parts of catechu, 25 parts of duchesnea and 10 parts of pinellia.

4. The composition for treating breast cancer pleural effusion / ascites according to claim 2, wherein: The composition is prepared from the following raw materials in parts by weight: 6 parts of roasted liquorice root, 18 parts of codonopsis pilosula, 6 parts of bupleurum root, 6 parts of vinegar corydalis, 9 parts of turmeric, 6 parts of thunbergia bulbs, 11 parts of roasted malt, 40 parts of oldenlandia diffusa, 12 parts of julibrissin bark, 6 parts of bergamot, 5.5 parts of parsnip, 8 parts of toosendan fruit, 20 parts of lycopodiella vulgaris, 4.5 parts of catechu, 20 parts of duchesnea and 6 parts of pinellia.

5. A preparation for treating breast cancer pleural effusion / ascites, characterized in that: The preparation is prepared from the composition according to any one of claims 1 to 4.

6. A method for preparing a preparation for treating breast cancer pleural effusion / ascites according to claim 5, characterized in that: The steps include: Roasted licorice root, codonopsis pilosula, bupleurum root, vinegar corydalis, turmeric, thunbergia thunbergii, stir-fried malt, oldenlandia diffusa, julibrissin bark, bergamot, parsley, toosendan fruit, lycopodiella vulgaris, catechu, duchesnea and pinellia tuber are selected according to corresponding parts by mass, mixed, placed in a container for soaking and decocting, and the residue is filtered out to obtain a preparation.

7. The method for preparing a preparation for breast cancer pleural effusion / ascites according to claim 6, characterized in that: The soaking time is 25-30 minutes.

8. The method for preparing a preparation for breast cancer pleural effusion / ascites according to claim 6, characterized in that: The decoction temperature is 95-100°C.

9. The method for preparing a preparation for breast cancer pleural effusion / ascites according to claim 7, characterized in that: The decocting time is 35-45 minutes.

10. The method for preparing a preparation for treating breast cancer pleural effusion / ascites according to claim 6, characterized in that: The preparation is a decoction for internal use.

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