Medicinal and edible traditional Chinese medicine composition for treating breast nodules and preparation method thereof

Abstract

The invention discloses a medicinal and edible traditional Chinese medicine composition for treating breast nodules and a preparation method thereof, and belongs to the technical field of biology and new medicine. The traditional Chinese medicine composition for treating breast nodules comprises dandelion, kelp, ginseng, mulberry, astragalus membranaceus, lucid ganoderma, brassica juncea, oyster, perilla seeds, platycodon grandiflorum, fingered citron, pericarpium citri reticulatae and the like. In addition, the invention also provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps: pouring the lucid ganoderma, the dried orange peel, the peach kernel, the Chinese angelica and the like together with soaking water into a pot, decocting, adding the soaked dandelion, kelp and the like into the pot, continuously decocting, filtering and collecting a first decoction and decoction dregs, adding a proper amount of water into the decoction dregs again, and filtering to obtain the traditional Chinese medicine composition. Continuing to boil and decoct, collecting a second decoction, and combining the first decoction and the second decoction to obtain the traditional Chinese medicine composition. The traditional Chinese medicine composition for treating breast nodules, provided by the invention, has a remarkable effect of treating breast nodules under the synergistic effect of all the components.

Description

Technical Field

[0001] The present invention relates to the field of biotechnology and new medicine technologies, and particularly relates to a medicated and edible homologous traditional Chinese medicine composition for treating breast nodules and a preparation method thereof. Background Art

[0002] Breast nodules are a common symptom of breast diseases, covering a variety of breast lesions, including benign breast hyperplasia, breast fibroids, breast cysts, and malignant breast cancer, etc. It has a relatively high incidence rate in the female population, seriously affecting the physical and mental health and quality of life of the majority of women.

[0003] From the perspective of Western medicine, the pathogenesis of breast nodules has not been fully clarified. Generally, it is considered to be closely related to the imbalance of endocrine hormone levels, such as the imbalance of estrogen and progesterone ratios, mental factors (long-term anxiety, tension, etc. leading to endocrine disorders, lifestyle factors such as long-term staying up late and overwork, and genetic factors, etc. For the treatment of breast nodules, Western medicine mainly uses surgical resection or Western medicine treatment. However, surgical treatment is traumatic, may affect the appearance and function of the breast, and has a certain risk of recurrence; although Western medicine treatment is relatively non-invasive, long-term use may cause adverse reactions such as menstrual disorders and endometrial thickening.

[0004] Traditional Chinese medicine has a long history of understanding breast nodules and classifies them into the categories of "Ru Pi" and "Ru He", etc. Traditional Chinese medicine believes that the occurrence of breast nodules is mainly related to factors such as liver qi stagnation, phlegm coagulation and blood stasis, and Chong and Ren disharmony. Emotional discomfort causes the liver qi to fail to disperse and dredge, resulting in qi stagnation and blood stasis; the spleen fails to transport and transform properly, the metabolism of water and dampness is abnormal, and phlegm is formed by the accumulation of dampness. Phlegm and stasis are mutually knotted in the breast to form nodules; Chong and Ren disharmony affects the endocrine function of women, disrupts the normal physiological function of breast tissue, and thus leads to the occurrence of nodules.

[0005] At present, traditional Chinese medicine treatment of breast nodules has unique advantages. Through overall conditioning and syndrome differentiation and treatment, it can improve the general symptoms of patients, regulate the endocrine, relieve discomfort such as breast pain, and also has a certain curative effect in controlling the growth of nodules and reducing the volume of nodules. Traditional Chinese medicine treatment is one of the important means of traditional Chinese medicine in treating breast nodules, and many traditional Chinese medicine prescriptions have been proven to have good therapeutic effects on breast nodules in clinical practice.

[0006] The existing traditional Chinese medicine compositions for treating breast nodules have achieved certain therapeutic effects, but there is still a need to propose new traditional Chinese medicine compositions that can effectively treat breast nodules. Summary of the Invention

[0007] The purpose of the present invention is to overcome the above technical deficiencies, provide a medicated and edible homologous traditional Chinese medicine composition for treating breast nodules and a preparation method thereof, and solve the technical problem of how to effectively treat breast nodules in the prior art.

[0008] In order to achieve the above technical objectives, the technical solution of the present invention provides a Chinese medicine composition for treating breast nodules. The raw materials are calculated by weight and include 15-30 parts of dandelion, 15-30 parts of kelp, 1-5 parts of ginseng, 1-5 parts of mulberry, 1-5 parts of astragalus, 1-5 parts of ganoderma lucidum, 1-5 parts of yellow mustard, 1-5 parts of oyster, 1-5 parts of perilla seeds, 1-5 parts of platycodon, 1-5 parts of bergamot, 1-5 parts of tangerine peel, 0.1-5 parts of dendrobium officinale, 1-5 parts of five-fingered peach, 1-5 parts of peach kernel, 0.1-5 parts of saffron, 1-5 parts of angelica and 1-5 parts of licorice.

[0009] In any embodiment, 2-5 portions of donkey-hide gelatin oligopeptide powder are also included.

[0010] In any embodiment, 10-50 parts of isomaltooligosaccharide are further included.

[0011] In addition, the present invention also provides a method for preparing the above-mentioned Chinese medicine composition for treating breast nodules, comprising the following steps:

[0012] Pour the soaked ganoderma lucidum, tangerine peel, peach kernel, dendrobium officinale, ginseng, oyster, perilla seed and angelica together with the soaking water into the pot, add appropriate amount of water to 5-8 times the total volume of these medicinal materials, boil, and then decoct, then add the soaked dandelion, kelp, mulberry, astragalus, yellow mustard, platycodon, bergamot, five-fingered peach and licorice, boil the water, and then continue to decoct for 1-1.5 hours, filter and collect the first decoction and the residue, add appropriate amount of water to the residue again, continue to boil and decoct for 1-1.5 hours, filter again, collect the second decoction, and combine the first decoction and the second decoction;

[0013] The soaked saffron and the soaking liquid are added into the combined decoction, and then the decoction is boiled and heated for 10-15 minutes to obtain the traditional Chinese medicine composition.

[0014] In any embodiment, Ganoderma lucidum, tangerine peel, peach kernel, Dendrobium officinale, ginseng, oyster, Perilla seed and Angelica sinensis are soaked together in water at 50-70° C. to obtain the soaked Ganoderma lucidum, tangerine peel, peach kernel, Dendrobium officinale, ginseng, oyster, Perilla seed and Angelica sinensis.

[0015] In any embodiment, dandelion, kelp, mulberry, astragalus, yellow mustard, platycodon, bergamot, quinoa oleracea and licorice are soaked together in water at 45-55° C. to obtain the soaked dandelion, kelp, mulberry, astragalus, yellow mustard, platycodon, bergamot, quinoa oleracea and licorice.

[0016] In any embodiment, it further includes adding colla corii asini oligopeptide powder to the decoction. Specifically, after adding crocus sativus, the decoction is turned to low heat and heated for 10 - 15 minutes, and then colla corii asini oligopeptide powder is added and heated until dissolved to obtain the traditional Chinese medicine composition.

[0017] In any embodiment, it further includes adding isomaltooligosaccharide to the decoction. Specifically, after adding colla corii asini oligopeptide powder and heating until dissolved, isomaltooligosaccharide is added and stirring is continued to adjust the consistency of the paste until it forms a paste to obtain the traditional Chinese medicine composition; or after adding crocus sativus, the decoction is turned to low heat and heated for 10 - 15 minutes, and then continued to be heated on low heat until the decoction is concentrated to 1 / 3 - 1 / 2 of the original volume, and then isomaltooligosaccharide is added and stirring is continued to adjust the consistency of the paste until it forms a paste to obtain the traditional Chinese medicine composition.

[0018] In any embodiment, the isomaltooligosaccharide is prepared by the following steps:

[0019] Mix maltose and glucose with a purity of more than 90% with water to obtain a syrup, ensuring that the soluble solids in the syrup are 30 - 35%, and the glucose content in the soluble solids is 70 - 75%;

[0020] Adjust the pH value of the syrup to 4 - 6, add magnesium sulfate and calcium chloride to the syrup in sequence, and then add transglucosidase. Raise the reaction temperature to 55 - 62°C, keep warm and transform for 2 - 3 hours, and then start to flow - add maltose with a purity of 90%. Flow - add 50 grams of maltose per hour at 55 - 62°C (appropriately increase the flow rate), flow - add for 10 - 12 hours, stop flow - adding, and keep warm and transform for 2 - 3 hours at 55 - 62°C to obtain isomaltooligosaccharide solution;

[0021] The obtained isomaltooligosaccharide solution is successively subjected to decolorization treatment, ion - exchange refining, and potassium - type cation resin chromatography separation and purification to obtain isomaltooligosaccharide.

[0022] In any embodiment, the addition amount of magnesium sulfate is 0.01 - 0.03% of the total mass of maltose and glucose; and / or, the addition amount of calcium chloride is 0.02 - 0.04% of the total mass of maltose and glucose; and / or, the addition amount of transglucosidase is 0.1% - 0.2% of the total mass of maltose and glucose.

[0023] Compared with the prior art, the beneficial effects of the present invention include: The medicine - food - homologous traditional Chinese medicine composition for treating breast nodules proposed by the present invention has a significant effect on treating breast nodules under the synergistic effect of each component. Specific embodiments

[0024] The "range" disclosed in the present application is defined in the form of a lower limit and an upper limit, and a given range is defined by selecting a lower limit and an upper limit, and the selected lower limit and upper limit define the boundaries of the particular range. The range defined in this way can be inclusive or exclusive of the end values, and can be arbitrarily combined, that is, any lower limit can be combined with any upper limit to form a range. For example, if a range of 60 to 120 and 80 to 110 is listed for a particular parameter, it is understood that a range of 60 to 110 and 80 to 120 is also expected. In addition, if the minimum range values ​​1 and 2 are listed, and if the maximum range values ​​3, 4 and 5 are listed, the following ranges can all be expected: 1 to 3, 1 to 4, 1 to 5, 2 to 3, 2 to 4 and 2 to 5. In the present application, unless otherwise specified, the numerical range "a to b" represents an abbreviation of any real number combination between a and b, where a and b are both real numbers. For example, the numerical range "0-5" means that all real numbers between "0-5" are listed in this document, and "0-5" is just an abbreviation of these numerical combinations. In addition, when a parameter is expressed as an integer ≥ 2, it is equivalent to disclosing that the parameter is, for example, an integer of 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, etc.

[0025] If there is no special explanation, the "include" and "comprising" mentioned in this application are open-ended or closed-ended. For example, the "include" and "comprising" may mean that other components not listed may also be included or only the listed components may be included or only the listed components may be included.

[0026] If not specifically stated, in this application, the term "or" is inclusive. For example, the phrase "A or B" means "A, B, or both A and B". More specifically, any of the following conditions satisfies the condition "A or B": A is true (or exists) and B is false (or does not exist); A is false (or does not exist) and B is true (or exists); or both A and B are true (or exist).

[0027] The present specific embodiment provides a Chinese medicine composition for treating breast nodules, which is both a medicine and an food. The raw materials are calculated by weight and include 15-30 parts of dandelion, 15-30 parts of kelp, 1-5 parts of ginseng, 1-5 parts of mulberry, 1-5 parts of astragalus, 1-5 parts of ganoderma lucidum, 1-5 parts of yellow mustard, 1-5 parts of oyster, 1-5 parts of perilla seeds, 1-5 parts of platycodon, 1-5 parts of bergamot, 1-5 parts of tangerine peel, 0.1-5 parts of dendrobium officinale, 1-5 parts of quinoa, 1-5 parts of peach kernel, 0.1-5 parts of saffron, 1-5 parts of angelica and 1-5 parts of licorice.

[0028] In some embodiments, calculated by weight parts, the raw materials further include 2 - 5 parts of donkey-hide gelatin oligopeptide powder. The donkey-hide gelatin oligopeptide powder can enhance the effect of enriching blood and replenishing qi, making qi and blood more sufficient and flowing more smoothly, thereby better improving the qi and blood disorder condition of patients with breast nodules, and then assisting the treatment effect of breast nodules.

[0029] In some embodiments, calculated by weight parts, the raw materials further include 10 - 50 parts of isomaltooligosaccharide. Isomaltooligosaccharide can regulate the taste of the traditional Chinese medicine composition, and can improve intestinal health, thereby promoting the absorption of effective components of the medicine and enhancing the treatment effect.

[0030] This specific embodiment also provides a preparation method of the above-mentioned medicated and edible homologous traditional Chinese medicine composition for treating breast nodules, including the following steps:

[0031] Wash the medicinal materials such as Ganoderma lucidum, Citrus reticulata Blanco, Prunus persica, Dendrobium officinale, Panax ginseng, Ostrea gigas, Perilla seed, and Angelica sinensis, which are relatively dense in texture and have relatively difficult-to-dissolve active ingredients, with clean water, and then soak them together in water at 50 - 70°C for 2 - 3 hours;

[0032] Soak Taraxacum mongolicum, Ecklonia kurome, Morus alba L., Astragalus membranaceus, Brassica juncea, Platycodon grandiflorum, Citrus medica L. var. sarcodactylis, Ficus hirta Vahl, and Glycyrrhiza uralensis Fisch. together in water at 45 - 55°C for 1 - 2 hours;

[0033] Pour the soaked Ganoderma lucidum, Citrus reticulata Blanco, Prunus persica, Dendrobium officinale, Panax ginseng, Ostrea gigas, Perilla seed, and Angelica sinensis together with the soaking water into a pot, add an appropriate amount of water until the water usage is 5 - 8 times the total volume of these medicinal materials, first bring the water to a boil over high heat, then turn to low heat and simmer for 20 - 40 minutes, then add the soaked Taraxacum mongolicum, Ecklonia kurome, Morus alba L., Astragalus membranaceus, Brassica juncea, Platycodon grandiflorum, Citrus medica L. var. sarcodactylis, Ficus hirta Vahl, and Glycyrrhiza uralensis Fisch. and bring the water to a boil over high heat, then continue to turn to low heat and simmer for 1 - 1.5 hours, filter to collect the first decoction and the medicinal residues, add an appropriate amount of water (about 2 / 3 of the first water addition amount) to the medicinal residues again, continue to bring to a boil and then simmer for 1 - 1.5 hours over low heat, filter again, collect the second decoction, combine the first decoction and the second decoction, add the soaked Crocus sativus together with the soaking solution into the combined decoction, then bring the decoction to a boil, and then turn to low heat and heat for 10 - 15 minutes to obtain the traditional Chinese medicine composition.

[0034] In some embodiments, it further includes adding donkey-hide gelatin oligopeptide powder to the decoction. Specifically, after adding Crocus sativus, the decoction is turned to low heat and heated for 10 - 15 minutes, and then donkey-hide gelatin oligopeptide powder is added and heated until dissolved to obtain the traditional Chinese medicine composition.

[0035] In some embodiments, it further includes adding isomaltooligosaccharide to the decoction. Specifically, after adding the donkey-hide gelatin oligopeptide powder and heating until dissolved, isomaltooligosaccharide is added and stirring continues to adjust the consistency of the paste until it forms a paste to obtain the traditional Chinese medicine composition; or after adding saffron, the decoction is heated over low heat for 10 - 15 minutes and then continues to be heated over low heat until the decoction is concentrated to 1 / 3 - 1 / 2 of the original volume, and then isomaltooligosaccharide is added and stirring continues to adjust the consistency of the paste until it forms a paste to obtain the traditional Chinese medicine composition.

[0036] In some embodiments, the isomaltooligosaccharide is prepared by the following steps:

[0037] Mix maltose and glucose with a purity of more than 90% with water to obtain a syrup, ensuring that the soluble solids in the syrup are 30 - 35%, and the glucose content in the soluble solids is 70 - 75%;

[0038] Adjust the pH value of the syrup to 4 - 6, add magnesium sulfate and calcium chloride to the syrup in sequence, stir well, add transglucosidase, raise the reaction temperature to 55 - 62°C, keep the temperature for conversion for 2 - 3 hours, and then start to flow - add maltose with a purity of 90% at 55 - 62°C, flow - add 50 grams of maltose per hour for 10 - 12 hours, stop the flow - addition, and keep the temperature for conversion at 55 - 62°C for 2 - 3 hours to obtain isomaltooligosaccharide solution; the addition amount of magnesium sulfate is 0.01 - 0.03% of the total mass of maltose and glucose, the addition amount of calcium chloride is 0.02 - 0.04% of the total mass of maltose and glucose, and the addition amount of transglucosidase is 0.1% - 0.2% of the total mass of maltose and glucose;

[0039] The obtained isomaltooligosaccharide solution is successively subjected to decolorization treatment, ion - exchange refining, and potassium - type cation resin chromatography separation and purification by the prior art to obtain isomaltooligosaccharide.

[0040] The purity of the obtained isomaltooligosaccharide is ≥98%, and the total mass content of isomaltose and isomaltotriose in the isomaltooligosaccharide is ≥90%.

[0041] The preparation method of isomaltooligosaccharide proposed by the present invention, under the combined action of magnesium sulfate and calcium chloride, shortens the preparation time of isomaltooligosaccharide on the basis of ensuring that the total mass content of isomaltose and isomaltotriose in isomaltooligosaccharide is ≥90%.

[0042] The pharmacology of each component in the medicine and food homologous traditional Chinese medicine composition proposed by the present invention is as follows:

[0043] Dandelion: It has the effects of clearing away heat and detoxifying, reducing swelling and dispersing nodules. In traditional Chinese medicine theory, heat and toxic accumulation is one of the causes of breast nodules. Dandelion can clear away heat and toxicity in the breast area and dissipate carbuncle. The ingredients it contains, such as taraxasterol and taraxacin, have been found in modern research to have anti-inflammatory effects, can reduce the inflammatory response of breast tissue, and relieve nodule symptoms.

[0044] Kelp: It is salty and cold in nature. It enters the liver, stomach and kidney meridians. It has the effects of eliminating phlegm, softening and dispersing nodules, promoting diuresis and reducing swelling. Breast nodules are often related to phlegm stagnation and qi stagnation. Kelp is rich in iodine and other minerals, which can soften and dissipate phlegm in the breast and improve the pathological state of breast tissue.

[0045] Ginseng: slightly warm in taste, sweet and slightly bitter. It enters the spleen, lung, heart and kidney meridians. It can greatly replenish vital energy, restore the pulse and consolidate the body, nourish the spleen and lungs, promote the production of body fluid and nourish blood, calm the mind and improve intelligence. It is used for physical weakness and fainting, cold limbs and weak pulse, spleen deficiency and poor appetite, lung deficiency and wheezing and coughing, thirst due to loss of body fluid, internal heat and thirst, qi and blood deficiency, long-term illness and weakness, palpitations and insomnia, impotence and cold uterus.

[0046] Mulberry: It can nourish yin and blood, promote the production of body fluids and relieve dryness. From the perspective of traditional Chinese medicine, it can replenish the body's yin and blood, regulate endocrine, improve the malnutrition of breast tissue caused by insufficient yin and blood, maintain the normal physiological function of the breast, and have a certain auxiliary effect on the recovery of breast nodules.

[0047] Astragalus: Astragalus is an important medicine for replenishing qi, and has the effects of replenishing qi and raising yang, consolidating the exterior and stopping sweating, promoting diuresis and reducing swelling, promoting body fluid and nourishing blood, and relieving stagnation and relieving numbness. When the body's positive energy is weak, it is easy to have poor circulation of qi and blood. Astragalus can strengthen the body's positive energy, promote the circulation of qi and blood, make the breast area smooth, help dissipate nodules, and at the same time improve the body's immunity.

[0048] Lingzhi: Traditional medicine believes that it has the effect of strengthening the body, regulating the human immune system and enhancing the body's resistance. Modern research shows that the polysaccharides and triterpenes in Lingzhi have immune regulation, anti-tumor and anti-inflammatory activities, and may have a certain regulatory effect on abnormal proliferation of breast tissue, helping to maintain the health of breast tissue.

[0049] Yellow mustard: warm in nature, pungent in taste, belongs to the lung meridian, has the effects of warming the lungs, dispelling phlegm and promoting qi, dispersing nodules, unblocking meridians and relieving pain. It can warm the meridians in the breast area, promote the circulation of qi and blood, dissipate phlegm, and relieve symptoms such as pain and discomfort caused by breast nodules.

[0050] Oyster: slightly cold in nature, salty in taste. Enters the liver, gallbladder, and kidney meridians. It can calm the mind, subdue yang and replenish yin, soften and disperse lumps. It is used for palpitations, insomnia, dizziness, tinnitus, scrofula, phlegm, masses, and lumps. Calcined oyster is astringent, acid-reducing and analgesic. It is used for spontaneous sweating, night sweats, spermatorrhea, metrorrhagia, leukorrhea, stomachache and acid regurgitation.

[0051] Perilla seeds: Warm in nature, pungent in taste. It belongs to the lung meridian. It can lower qi and resolve phlegm, relieve cough and asthma, moisten the intestines and promote defecation. It is used for phlegm congestion and qi reversal, cough and asthma, and intestinal dryness and constipation. Breast nodules are mostly caused by qi stagnation and blood stasis, phlegm coagulation. Perilla seeds are pungent in taste, warm in nature, and belong to the lung meridian, with the effect of regulating qi. By regulating the operation of qi mechanism, it can improve the state of poor qi and blood circulation in the breast area, make qi and blood flow smoothly, and relieve discomfort such as breast distending pain caused by qi stagnation. At the same time, it may help disperse phlegm coagulation, reduce the accumulation of phlegm turbidity in breast tissue, so as to achieve the purpose of dissipating nodules, and is helpful to reduce the size of breast nodules.

[0052] Platycodon grandiflorum: It has the functions of dispersing the lung qi, relieving sore throat, removing phlegm, and discharging pus. Platycodon grandiflorum can regulate qi mechanism, make the lung qi smooth, and help improve the state of qi stagnation and blood stasis in breast tissue caused by unsmooth qi mechanism. Its phlegm-removing effect also helps to eliminate phlegm coagulation, and is helpful for the relief of breast nodules.

[0053] Buddha's hand: It belongs to the liver, spleen, stomach, and lung meridians, and can soothe the liver and regulate qi, harmonize the middle and resolve phlegm. The occurrence of breast nodules is closely related to emotions and liver qi stagnation. Buddha's hand can regulate emotions, soothe qi mechanism, relieve the state of liver qi stagnation, make the qi and blood circulation in breast tissue return to normal, and relieve nodule symptoms.

[0054] Dried tangerine peel: Regulate qi and strengthen the spleen, dry dampness and resolve phlegm. It can regulate the function of the spleen and stomach, promote the transportation and transformation of the spleen and stomach, eliminate dampness and phlegm pathogens in the body. At the same time, its qi-regulating effect also helps to improve the qi stagnation state in the breast area, and assist in the treatment of breast nodules.

[0055] Radix Fici Hirtae: It has the effects of strengthening the spleen and tonifying the lung, promoting qi and removing dampness, relaxing muscles and activating collaterals. By strengthening the spleen and tonifying the lung, it enhances the healthy qi of the human body, promotes qi and blood circulation. And its dampness-removing effect helps to eliminate dampness pathogens in the body, improve the pathological state of breast tissue, and has a certain effect on the treatment of breast nodules.

[0056] Peach kernels: It has the functions of promoting blood circulation to remove stasis, moistening the intestines and promoting defecation. It can promote blood circulation in the breast area, eliminate blood stasis blockage, improve the blood supply of breast tissue, and help the nodules to dissipate.

[0057] Dendrobium officinale: Slightly cold in nature, sweet in taste. It belongs to the stomach and kidney meridians. It can benefit the stomach and promote the production of body fluid, nourish yin and clear heat.

[0058] Saffron: Sweet in taste, neutral in nature, it belongs to the heart and liver meridians, and has the effects of promoting blood circulation to remove stasis, cooling blood and detoxifying, relieving depression and calming the mind. It can promote blood circulation in the breast area, disperse blood stasis, and has a certain improvement effect on the nodule symptoms of breast nodule patients caused by blood stasis blockage. At the same time, its effect of relieving depression and calming the mind also helps to regulate emotions and reduce the aggravation of breast nodules caused by emotional factors.

[0059] Angelica sinensis: replenishes blood, promotes blood circulation, regulates menstruation and relieves pain, and moistens the intestines and promotes bowel movements. It can not only replenish the body's qi and blood, but also promote the circulation of qi and blood. It has a good effect on improving the symptoms of breast nodules caused by insufficient qi and blood and blood stasis. It can also regulate women's menstrual cycle and has auxiliary significance for the treatment of breast nodules.

[0060] Licorice: nourishes the spleen and replenishes Qi, moistens the lungs and relieves cough, clears away heat and detoxifies, and harmonizes various medicines. In prescriptions, licorice can not only nourish the vital energy, but also harmonize the effects of other medicines, so that the various Chinese medicines can work together to achieve better therapeutic effects. At the same time, its heat-clearing and detoxifying effects can also help reduce inflammation of breast tissue.

[0061] In order to make the purpose, technical solution and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with the embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0062] In the present invention, reference is made to “some embodiments”, “this embodiment”, examples, etc., which describe a subset of all possible embodiments, but it can be understood that “some embodiments” may be the same subset or different subsets of all possible embodiments and may be combined with each other without conflict.

[0063] If similar descriptions of "first / second" appear in the application documents, the following instructions are added. In the following description, the terms "first\second\third" are merely used to distinguish similar objects and do not represent a specific ordering of the objects. It can be understood that "first\second\third" can be interchanged in a specific order or sequence where permitted, so that the embodiments described herein can be implemented in an order other than that described herein.

[0064] In this embodiment, the term "and / or" is merely a description of the association relationship between associated objects, indicating that three relationships may exist. For example, object A and / or object B may represent three situations: object A exists alone, object A and object B exist at the same time, and object B exists alone.

[0065] Example 1

[0066] This embodiment proposes a Chinese medicine composition for treating breast nodules. The raw materials, calculated by weight, include 30g dandelion, 30g kelp, 3g ginseng, 3g mulberry, 2g astragalus, 3g ganoderma, 4g yellow mustard, 2g oyster, 4g perilla seed, 5g platycodon, 4g bergamot, 3g tangerine peel, 1g dendrobium officinale, 4g quinoa, 3g peach kernel, 1g saffron, 2g angelica and 2 licorice.

[0067] This embodiment also provides a method for preparing the above-mentioned Chinese medicine composition for treating breast nodules, comprising the following steps:

[0068] After washing the Chinese medicinal materials such as Ganoderma lucidum, dried tangerine peel, peach kernel, Dendrobium officinale, ginseng, oyster, perilla seed and angelica sinensis, which are relatively dense in texture and difficult to dissolve their active ingredients, with clean water, soak them together in water at 60°C for 2.5 hours;

[0069] Soak dandelion, kelp, mulberry, astragalus membranaceus, mustard seed, platycodon grandiflorum, fingered citron, ficus hirta and licorice together in water at 45°C for 2 hours;

[0070] Pour the soaked Ganoderma lucidum, dried tangerine peel, peach kernel, Dendrobium officinale, ginseng, oyster, perilla seed and angelica sinensis together with the soaking water into a pot, add an appropriate amount of water until the amount of water is 6 times the total volume of these Chinese medicinal materials. First, bring the water to a boil over high heat, then turn to low heat and simmer for 40 minutes. Then add the soaked dandelion, kelp, mulberry, astragalus membranaceus, mustard seed, platycodon grandiflorum, fingered citron, ficus hirta and licorice, bring the water to a boil over high heat, and then continue to turn to low heat and simmer for 1.5 hours. Filter and collect the first decoction and the medicinal residues. Add an appropriate amount of water (about 2 / 3 of the first amount of added water) to the medicinal residues again, bring to a boil and then continue to simmer over low heat for 1 hour. Filter again and collect the second decoction. Combine the first decoction and the second decoction, add the soaked saffron together with the soaking solution to the combined decoction, then bring the decoction to a boil and then turn to low heat and heat for 10 minutes to obtain the traditional Chinese medicine composition.

[0071] Example 2

[0072] This example provides a medicine and food homologous traditional Chinese medicine composition for treating breast nodules. Calculated by weight parts, the raw materials include 30 g of dandelion, 20 g of kelp, 4 g of ginseng, 2 g of mulberry, 3 g of astragalus membranaceus, 1 g of Ganoderma lucidum, 5 g of mustard seed, 5 g of oyster, 5 g of perilla seed, 4 g of platycodon grandiflorum, 5 g of fingered citron, 5 g of dried tangerine peel, 1 g of Dendrobium officinale, 5 g of ficus hirta, 4 g of peach kernel, 5 g of peony flower, 0.5 g of saffron, 5 g of angelica sinensis and 5 g of licorice.

[0073] This example also provides a preparation method of the above-mentioned medicine and food homologous traditional Chinese medicine composition for treating breast nodules, including the following steps:

[0074] After washing the Chinese medicinal materials such as Ganoderma lucidum, dried tangerine peel, peach kernel, Dendrobium officinale, ginseng, oyster, perilla seed and angelica sinensis, which are relatively dense in texture and difficult to dissolve their active ingredients, with clean water, soak them together in water at 50°C for 3 hours;

[0075] Soak dandelion, kelp, mulberry, astragalus membranaceus, mustard seed, platycodon grandiflorum, fingered citron, ficus hirta and licorice together in water at 55°C for 1 hour;

[0076] Pour the soaked ganoderma lucidum, tangerine peel, peach kernel, dendrobium officinale, ginseng, oyster, perilla seed and angelica together with the soaking water into the pot, add appropriate amount of water until the amount of water is 5 times the total volume of these medicinal materials, first boil the water over high heat, then turn to low heat and simmer for 30 minutes, then add the soaked dandelion, kelp, mulberry, astragalus, yellow mustard, platycodon, bergamot, five-fingered peach and licorice, boil the water over high heat, then continue to simmer for 1.5 hours over low heat, filter and collect the first decoction and residue, add appropriate amount of water (about 2 / 3 of the first water amount) to the residue again, continue to simmer over low heat for 1 hour after boiling, filter again, collect the second decoction, combine the first decoction and the second decoction, add the soaked saffron together with the soaking liquid to the combined decoction, then boil the decoction, then turn to low heat and heat for 15 minutes to obtain a Chinese medicine composition.

[0077] Example 3

[0078] This embodiment proposes a Chinese medicine composition for treating breast nodules. The raw materials, calculated by weight, include 20g dandelion, 30g kelp, 5g ginseng, 3g mulberry, 2g astragalus, 5g ganoderma lucidum, 5g yellow mustard, 5g oyster, 5g perilla seed, 4g platycodon, 5g bergamot, 3g tangerine peel, 0.5g dendrobium officinale, 4g quinoa, 4g peach kernel, 0.5g saffron, 4g angelica and 4g licorice.

[0079] This embodiment also provides a method for preparing the above-mentioned Chinese medicine composition for treating breast nodules, comprising the following steps:

[0080] Wash the herbs with relatively dense texture and difficult to dissolve active ingredients, such as Ganoderma lucidum, dried orange peel, peach kernel, Dendrobium officinale, ginseng, oyster, Perilla seed and Angelica sinensis, and soak them in 70℃ water for 2 hours;

[0081] Soak dandelion, kelp, mulberry, astragalus, yellow mustard, platycodon, bergamot, five-fingered peach and liquorice in 50℃ water for 1.5 hours;

[0082] Pour the soaked Ganoderma lucidum, tangerine peel, peach kernel, Dendrobium officinale, ginseng, oyster, perilla seed and angelica sinensis together with the soaking water into a pot, add an appropriate amount of water until the water volume is 8 times the total volume of these medicinal materials. First, bring the water to a boil over high heat, then turn to low heat and simmer for 20 minutes. After that, add the soaked dandelion, kelp, mulberry, astragalus membranaceus, mustard seed, platycodon grandiflorum, fingered citron, Ficus hirta and licorice, bring the water to a boil over high heat, and then continue to turn to low heat and simmer for 1.5 hours. Filter and collect the first decoction and the medicinal residues. Add an appropriate amount of water (about 2 / 3 of the first water addition) to the medicinal residues again, bring to a boil and then continue to simmer over low heat for 1.5 hours. Filter again and collect the second decoction. Combine the first decoction and the second decoction, add the soaked saffron together with the soaking solution to the combined decoction, then bring the decoction to a boil and then turn to low heat and heat for 15 minutes to obtain the traditional Chinese medicine composition.

[0083] Example 4

[0084] The difference between the homologous medicated and edible traditional Chinese medicine composition of this example and that of Example 1 is that it further includes 3 g of collagen peptide powder.

[0085] This example also provides a preparation method of the above-mentioned homologous medicated and edible traditional Chinese medicine composition for treating breast nodules, which includes the following steps:

[0086] Wash the medicinal materials with relatively dense texture and difficult-to-dissolve active ingredients, such as Ganoderma lucidum, tangerine peel, peach kernel, Dendrobium officinale, ginseng, oyster, perilla seed and angelica sinensis, with clean water, and then soak them together in water at 60 °C for 2.5 hours;

[0087] Soak dandelion, kelp, mulberry, astragalus membranaceus, mustard seed, platycodon grandiflorum, fingered citron, Ficus hirta and licorice together in water at 45 °C for 2 hours;

[0088] Pour the soaked Ganoderma lucidum, tangerine peel, peach kernel, Dendrobium officinale, ginseng, oyster, perilla seed and angelica sinensis together with the soaking water into a pot, add an appropriate amount of water until the water volume is 6 times the total volume of these medicinal materials. First, bring the water to a boil over high heat, then turn to low heat and simmer for 40 minutes. After that, add the soaked dandelion, kelp, mulberry, astragalus membranaceus, mustard seed, platycodon grandiflorum, fingered citron, Ficus hirta and licorice, bring the water to a boil over high heat, and then continue to turn to low heat and simmer for 1.5 hours. Filter and collect the first decoction and the medicinal residues. Add an appropriate amount of water (about 2 / 3 of the first water addition) to the medicinal residues again, bring to a boil and then continue to simmer over low heat for 1 hour. Filter again and collect the second decoction. Combine the first decoction and the second decoction, add the soaked saffron together with the soaking solution to the combined decoction, then bring the decoction to a boil and then turn to low heat and heat for 10 minutes, and then add the collagen peptide powder and heat until dissolved to obtain the traditional Chinese medicine composition.

[0089] Example 5

[0090] The difference between the traditional Chinese medicine composition with both medicinal and edible properties in this example and that in Example 1 is that it further includes 5 g of collagen oligopeptide powder. The preparation method of the traditional Chinese medicine composition with both medicinal and edible properties is the same as that in Example 4.

[0091] Example 6

[0092] The difference between the traditional Chinese medicine composition with both medicinal and edible properties in this example and that in Example 1 is that it further includes 2 g of collagen oligopeptide powder. The preparation method of the traditional Chinese medicine composition with both medicinal and edible properties is the same as that in Example 4.

[0093] Example 7

[0094] The difference between this example and Example 1 is that it further includes 30 g of isomaltooligosaccharide.

[0095] This example also provides a preparation method of the above-mentioned traditional Chinese medicine composition with both medicinal and edible properties for treating breast nodules, including the following steps:

[0096] Wash the medicinal materials with relatively dense texture and difficult-to-dissolve active ingredients, such as Ganoderma lucidum, Citrus reticulata Blanco, Prunus persica, Dendrobium officinale, Panax ginseng, Ostrea gigas, Perilla seed, and Angelica sinensis, with clean water and then soak them together in water at 60 °C for 2.5 hours;

[0097] Soak Taraxacum mongolicum Hand.-Mazz., Ecklonia kurome, Morus alba L., Astragalus membranaceus (Fisch.) Bunge, Brassica juncea (L.) Czern. & Coss., Platycodon grandiflorus (Jacq.) A. DC., Citrus medica L. var. sarcodactylis Swingle, Ficus hirta Vahl, and Glycyrrhiza uralensis Fisch. together in water at 45 °C for 2 hours;

[0098] Pour the soaked Ganoderma lucidum, Citrus reticulata Blanco, Prunus persica, Dendrobium officinale, Panax ginseng, Ostrea gigas, Perilla seed, and Angelica sinensis together with the soaking water into a pot, add an appropriate amount of water until the water volume is 6 times the total volume of these medicinal materials, first bring the water to a boil over high heat, then turn to low heat and simmer for 40 minutes. Then add the soaked Taraxacum mongolicum Hand.-Mazz., Ecklonia kurome, Morus alba L., Astragalus membranaceus (Fisch.) Bunge, Brassica juncea (L.) Czern. & Coss., Platycodon grandiflorus (Jacq.) A. DC., Citrus medica L. var. sarcodactylis Swingle, Ficus hirta Vahl, and Glycyrrhiza uralensis Fisch. and bring the water to a boil over high heat, then continue to turn to low heat and simmer for 1.5 hours. Filter and collect the first decoction and the medicinal residues. Add an appropriate amount of water (about 2 / 3 of the first water addition amount) to the medicinal residues again, bring to a boil and then continue to simmer over low heat for 1 hour, filter again, and collect the second decoction. Combine the first decoction and the second decoction, add the soaked Crocus sativus together with the soaking solution into the combined decoction, then bring the decoction to a boil, then turn to low heat and heat for 10 minutes. Then add isomaltooligosaccharide and continue to stir to adjust the consistency of the paste until a paste-like state is formed to obtain the traditional Chinese medicine composition.

[0099] The isomaltooligosaccharide in this example is prepared by the following steps:

[0100] Mix maltose and glucose with a purity of 95% with water to obtain a syrup, ensuring that the soluble solids in the syrup are 30%, and the glucose content in the soluble solids is 70%. Adjust the pH value of the syrup to 6. Add magnesium sulfate and calcium chloride to the syrup in sequence, stir well, add transglucosidase, raise the reaction temperature to 60°C, keep it warm for conversion for 2.5 hours, and then start to dropwise add maltose with a purity of 90%. Add 50 grams of maltose per hour at 60°C (appropriately increase the dropping rate), dropwise add for 11 hours, stop dropping, and keep it warm for conversion for 3 hours at 60°C to obtain isomaltooligosaccharide solution; the addition amount of magnesium sulfate is 0.02% of the total mass of maltose and glucose, the addition amount of calcium chloride is 0.03% of the total mass of maltose and glucose, and the addition amount of transglucosidase is 0.1% of the total mass of maltose and glucose;

[0101] The obtained isomaltooligosaccharide solution is successively subjected to decolorization treatment, ion exchange refining and potassium-type cation resin chromatography separation and purification by the prior art to obtain isomaltooligosaccharide.

[0102] Example 8

[0103] The difference between the medicated and edible homologous traditional Chinese medicine composition of this example and that of Example 1 is that it further includes 15 g of isomaltooligosaccharide.

[0104] The preparation methods of the medicated and edible homologous traditional Chinese medicine composition and isomaltooligosaccharide of this example are the same as those of Example 7.

[0105] Example 9

[0106] The difference between the medicated and edible homologous traditional Chinese medicine composition of this example and that of Example 1 is that it further includes 50 g of isomaltooligosaccharide.

[0107] The preparation methods of the medicated and edible homologous traditional Chinese medicine composition and isomaltooligosaccharide of this example are the same as those of Example 7.

[0108] Example 10

[0109] The difference between the medicated and edible homologous traditional Chinese medicine composition of this example and that of Example 4 is that it further includes 30 g of isomaltooligosaccharide.

[0110] This example also provides a preparation method of the above-mentioned medicated and edible homologous traditional Chinese medicine composition for treating breast nodules, including the following steps:

[0111] Wash the herbs with relatively dense texture and difficult-to-dissolve active ingredients, such as Ganoderma lucidum, Citrus reticulata Blanco, Prunus persica, Dendrobium officinale, Panax ginseng, Oyster, Perilla seed and Angelica sinensis, with clean water, and then soak them together in water at 60°C for 2.5 hours;

[0112] Soak Taraxacum mongolicum Hand.-Mazz., Ecklonia kurome, Morus alba L., Astragalus membranaceus (Fisch.) Bunge, Brassica juncea (L.) Czern. & Coss., Platycodon grandiflorus (Jacq.) A. DC., Citrus medica L. var. sarcodactylis Swingle, Ficus hirta Vahl and Glycyrrhiza uralensis Fisch. together in water at 45°C for 2 hours;

[0113] Pour the soaked Ganoderma lucidum, dried tangerine peel, peach kernels, Dendrobium officinale, ginseng, oysters, perilla seeds, and angelica, together with the soaking water, into a pot, add an appropriate amount of water until the water volume is 6 times the total volume of these medicinal materials. First, bring the water to a boil over high heat, then turn to low heat and simmer for 40 minutes. After that, add the soaked dandelion, kelp, mulberries, astragalus root, mustard seeds, platycodon root, fingered citron, Ficus hirta, and licorice, and bring the water to a boil over high heat. Then continue to turn to low heat and simmer for 1.5 hours. Filter to collect the first decoction and the medicinal residues. Add an appropriate amount of water (about 2 / 3 of the first water addition amount) to the medicinal residues again, bring to a boil, and then continue to simmer over low heat for 1 hour. Filter again to collect the second decoction. Combine the first decoction and the second decoction. Add the soaked saffron together with the soaking solution to the combined decoction. Then bring the decoction to a boil, and then turn to low heat and heat for 10 minutes. Add collagen peptide powder and heat until dissolved. Then continue to heat over low heat until the decoction is concentrated to 1 / 2 of the original volume. Then add isomaltooligosaccharide and continue to stir to adjust the consistency of the paste until a paste is formed to obtain the traditional Chinese medicine composition.

[0114] The preparation method of isomaltooligosaccharide in this example is the same as that in Example 7.

[0115] Animal experiment

[0116] Effect of traditional Chinese medicine composition on mammary gland nodules in rats

[0117] Select 80 female virgin Wistar rats with a body weight of 180 - 230 g and randomly divide them into multiple groups: blank group, model group, Example 1 - 4 groups, Example 7 group, Example 10 group, with 10 rats in each group. Except for the blank group, the rats in each group were intraperitoneally injected with estradiol benzoate at a dose of 0.5 mg / kg, once a day for 20 consecutive days. Then, from the 21st to the 27th day, intramuscular injection of progesterone at a dose of 5 mg / kg was given once a day. The blank group was not treated. Except for the blank group, the nipples of the rats in other groups showed redness, swelling, and enlargement, and some areolas appeared, forming a rat mammary hyperplasia model. Starting from the 28th day, the rats in the example groups were administered medicine by gavage at a dose of 1.0 mL / kg, once a day for 21 consecutive days. The nipples of the rats in the blank group were normal, the nipples of the rats in the control group continued to be red, swollen, and significantly enlarged. After continuous administration of medicine in the example groups, the enlargement of the nipples was significantly alleviated, as shown in Table 1 specifically.

[0118] Table 1

[0119]

[0120]

[0121] As can be seen from Table 1, Examples 1-4, Example 7, and Example 10 all improved the size of the nipple, but the most significant effect was shown in Example 10. This may be because isomaltooligosaccharide and colla corii asini oligopeptide powder, together with other components, significantly enhanced the therapeutic effect of the drug on nodules.

[0122] On this basis, 40 volunteers with benign breast nodules (nodule diameter ranging from 2 to 3 cm) participated in the efficacy evaluation test of the pharmaceutical compositions of Examples 1, 4, 7, and 10, with 10 people in each group. Specifically, they took it once a day at 5 mL each time for 21 consecutive days. The changes in nodule size are shown in Table 2.

[0123] Table 2

[0124]

[0125] As can be seen from Table 2, by taking the traditional Chinese medicine compositions of Example 1, Example 4, Example 7, and Example 10, different therapeutic effects on breast nodules were achieved, especially the most significant therapeutic effect was shown in Example 10.

[0126] On this basis, the other volunteers except those in Example 10 continued to take the traditional Chinese medicine composition of Example 10 continuously for 14 days. The therapeutic effect on nodules was comparable to that of Example 10 in Table 2, and when the volunteers were followed up half a year later, the nodules did not grow larger.

[0127] In addition, we unexpectedly found that the constipation problems of the patients among the volunteers with constipation problems were also significantly improved.

[0128] The traditional Chinese medicine composition for treating breast nodules provided by the present invention, based on traditional Chinese medicine theory, selects traditional Chinese medicinal materials such as dandelion, kelp, ginseng, mulberry, astragalus membranaceus, ganoderma lucidum, yellow mustard seed, oyster, perilla seed, platycodon grandiflorum, fingered citron, tangerine peel, dendrobium officinale, ficus hirta, peach kernel, saffron, angelica sinensis, and licorice, and innovatively adds colla corii asini oligopeptide powder and isomaltooligosaccharide. Each medicinal material is mutually compatible and acts synergistically, comprehensively regulating from multiple aspects such as regulating the balance of yin and yang in the human body, soothing the liver and regulating qi, promoting blood circulation to remove blood stasis, softening hard masses and dissipating nodules, and supplementing qi and blood, improving the therapeutic effect on breast nodules, and at the same time improving the physical condition and quality of life of patients, having potential clinical application value and broad market prospects.

[0129] The specific embodiments of the present invention described above do not constitute a limitation on the protection scope of the present invention. Any other corresponding changes and deformations made according to the technical concept of the present invention should be included within the protection scope of the claims of the present invention.

Claims

1. A Chinese medicinal composition for treating breast nodules, which comprises 15-30 parts of dandelion, 15-30 parts of kelp, 1-5 parts of ginseng, 1-5 parts of mulberry, 1-5 parts of astragalus, 1-5 parts of ganoderma, 1-5 parts of yellow mustard, 1-5 parts of oyster, 1-5 parts of perilla seeds, 1-5 parts of platycodon, 1-5 parts of bergamot, 1-5 parts of tangerine peel, 0.1-5 parts of dendrobium officinale, 1-5 parts of quinoa, 1-5 parts of peach kernel, 0.1-5 parts of saffron, 1-5 parts of angelica and 1-5 parts of liquorice.

2. The Chinese medicinal composition for treating breast nodules according to claim 1, characterized in that: Also included are 2-5 portions of donkey-hide gelatin oligopeptide powder.

3. The Chinese medicinal composition for treating breast nodules according to claim 1, characterized in that: Also included isomaltooligosaccharide 10-50 parts.

4. A method for preparing the Chinese medicine composition for treating breast nodules according to any one of claims 1 to 3, characterized in that: The following steps are involved: Pour the soaked ganoderma lucidum, tangerine peel, peach kernel, dendrobium officinale, ginseng, oyster, perilla seed and angelica together with the soaking water into the pot, add appropriate amount of water to 5-8 times the total volume of these medicinal materials, boil, and then decoct, then add the soaked dandelion, kelp, mulberry, astragalus, yellow mustard, platycodon, bergamot, five-fingered peach and licorice, boil the water, and then continue to decoct for 1-1.5 hours, filter and collect the first decoction and the residue, add appropriate amount of water to the residue again, continue to boil and decoct for 1-1.5 hours, filter again, collect the second decoction, and combine the first decoction and the second decoction; The soaked saffron and the soaking liquid are added into the combined decoction, and then the decoction is boiled and heated for 10-15 minutes to obtain the traditional Chinese medicine composition.

5. The method for preparing the edible and medicinal Chinese medicine composition for treating breast nodules according to claim 4, wherein the ganoderma lucidum, tangerine peel, peach kernel, dendrobium officinale, ginseng, oyster, perilla seed and angelica are soaked together in water at 50-70°C to obtain the soaked ganoderma lucidum, tangerine peel, peach kernel, dendrobium officinale, ginseng, oyster, perilla seed and angelica.

6. The method for preparing the Chinese medicine composition for treating breast nodules according to claim 4, characterized in that: The dandelion, kelp, mulberry, astragalus, yellow mustard, platycodon, bergamot, quinquefolius and liquorice are soaked together in water at 45-55° C. to obtain the soaked dandelion, kelp, mulberry, astragalus, yellow mustard, platycodon, bergamot, quinquefolius and liquorice.

7. The method for preparing the edible and medicinal Chinese medicine composition for treating breast nodules according to claim 4, characterized in that: The method further comprises adding donkey-hide gelatin oligopeptide powder to the decoction. Specifically, the decoction after adding saffron is heated on low heat for 10-15 minutes, and then the donkey-hide gelatin oligopeptide powder is added and heated until dissolved to obtain the traditional Chinese medicine composition.

8. The method for preparing the Chinese medicine composition for treating breast nodules according to claim 4, characterized in that: The method further comprises adding isomaltooligosaccharide to the decoction, specifically, adding donkey-hide gelatin oligopeptide powder and heating until dissolved, then adding isomaltooligosaccharide and continuing to stir, adjusting the consistency of the paste until a paste is formed to obtain the Chinese medicine composition; or the decoction after adding saffron is heated on low heat for 10-15 minutes and then continued to be heated on low heat until the decoction is concentrated to 1 / 3-1 / 2 of the original volume, then adding isomaltooligosaccharide and continuing to stir, adjusting the consistency of the paste until a paste is formed to obtain the Chinese medicine composition.

9. The method for preparing the Chinese medicine composition for treating breast nodules according to claim 4, characterized in that: The isomaltooligosaccharide is prepared by the following steps: Mixing maltose and glucose with a purity of more than 90% with water to obtain a syrup, ensuring that the soluble solids in the syrup are 30-35%, and the glucose content in the soluble solids is 70-75%; The pH value of the syrup is adjusted to 4-6, magnesium sulfate and calcium chloride are added to the syrup in sequence, and then transglucosidase is added, the reaction temperature is increased to 55-62° C., and then maltose with a purity of 90% is added, and 50 g of maltose is added per hour at 55-62° C. for 10-12 hours, and then the addition is stopped, and the maltose is converted at 55-62° C. for 2-3 hours to obtain an isomaltooligosaccharide solution; The obtained isomaltooligosaccharide solution is successively subjected to decolorization treatment, ion exchange refining and potassium type cationic resin chromatography separation and purification to obtain isomaltooligosaccharide.

10. The method for preparing the Chinese medicine composition for treating breast nodules according to claim 9, characterized in that: The added amount of magnesium sulfate is 0.01-0.03% of the total mass of maltose and glucose; and / or, the added amount of calcium chloride is 0.02-0.04% of the total mass of maltose and glucose; and / or, the added amount of transglucosidase is 0.1%-0.2% of the total mass of maltose and glucose.

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