CN105582473A - Medicine preparation for treating hyperplasia of mammary glands and application thereof - Google Patents

Medicine preparation for treating hyperplasia of mammary glands and application thereof Download PDF

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Publication number
CN105582473A
CN105582473A CN201610066053.2A CN201610066053A CN105582473A CN 105582473 A CN105582473 A CN 105582473A CN 201610066053 A CN201610066053 A CN 201610066053A CN 105582473 A CN105582473 A CN 105582473A
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parts
grams
pharmaceutical preparation
chinese
golden
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王传秀
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Qingdao Yuntian Biotechnology Co Ltd
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Qingdao Yuntian Biotechnology Co Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/906—Zingiberaceae (Ginger family)
    • A61K36/9066—Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/24—Mucus; Mucous glands; Bursa; Synovial fluid; Arthral fluid; Excreta; Spinal fluid
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/36—Skin; Hair; Nails; Sebaceous glands; Cerumen; Epidermis; Epithelial cells; Keratinocytes; Langerhans cells; Ectodermal cells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56—Materials from animals other than mammals
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Abstract

The invention relates to a medicine preparation for treating hyperplasia of mammary glands and application thereof. The medicine preparation is prepared from the following traditional Chinese medicinal materials: radix bupleuri, fructus citri, aloe, rhizoma atractylodis macrocephalae, cortex phellodendri, dandelion, herba houttuyniae, rhizoma sparganii, curcuma zedoary, licorice root, cornus officinalis, Chinese yam, semen cuscutae, selfheal, cynomorium songaricum, fructus forsythiae, fructus aurantii immaturus, pangolin scales, golden silkworm, trogopterus dung, costus root, gentiana macrophylla, laportea cuspidata, sedum sarmentosum and herba ecliptae. The medicine preparation is reasonable in combination, has the effects of softening hard lumps, dispelling nodes, diminishing swelling and relieving pains, and has an excellent treatment effect on female breast nodules and breast distending pains. Clinical tests and pharmacodynamic tests prove that the medicine preparation has the characteristics of symptoms and root cause treatment, no toxic or side effect, relapse prevention after healing and the like.

Description

A kind of pharmaceutical preparation that is used for the treatment of the proliferation of mammary gland and uses thereof
Technical field
The invention belongs to tcm field, especially relate to a kind of pharmaceutical preparation for the treatment of the proliferation of mammary gland and uses thereof.
Background technology
Society women's status is more and more important, but the puzzlement of long-term disease is hindering its development, women to a certain degreeAlso have women's worry, the proliferation of mammary gland, breast cancer, near the disease in uterus etc. perplex women's development, the proliferation of mammary gland always(hyperplasticdiseaseofbreast, HDBA), taking breast portion lump and pain as two large primary symptoms, is that breast structure is in quantityWith modal abnormal breast disease, belong to mammary dysplasia pathology, mainly comprise Simple proliferation of mammary gland and mammary gland capsuleTwo kinds of property hyperplasia diseases. In China, Cystic changes is rare, is main mainly with glandular hyperplasia, claims " cyclomastopathy " therefore more. ThisDisease is due to the essence of the mammary gland that in body, multiple hormonal action imbalance and other factors cause and interstitial generation increasing in various degreeRaw, and it is caused in the time returing to the past, to fail to return to the past completely, therefore claim again mammary dysplasia. Cyclomastopathy accounts for whole breastsThe more than 70% of gland disease, the peak age of its morbidity is 25～45 years old, the women's incidence of disease more than 30 years old reach 90% withOn. This disease is commonly encountered disease, frequently-occurring disease in worldwide, and has certain canceration rate, is about 10%-20%,Compared with healthy women, the high 1.4-2.5 of dangerous probability of Patients of Mammary Gland Hyperplasia generation breast cancer doubly. In modern society, lifeRhythm is accelerated gradually, and women's social status improves constantly, and the change of various factors causes the incidence of disease of the proliferation of mammary gland to be risingTrend, in numerous mammary gland diseases, the incidence of disease of cyclomastopathy is in first place, therefore for this disease timely and effectivelyControl has very important clinical meaning and realistic meaning. Modern medicine is thought various hormones and acceptor thereof in this patient bodyExpression and effect abnormal, relevant with dyssecretosis.
Because this course of disease is long, be easy to recurrence, serious harm women's physical and mental health, current pure Western medicine there is no desirable controllingTreatment method, traditional Chinese medicine is the Main Means of the clinical treatment proliferation of mammary gland. In theory of traditional Chinese medical science, cyclomastopathy belongs to " newborn addiction " category.Motherland's traditional medicine thinks that the proliferation of mammary gland and liver,spleen,kidney, punching occur appoints relevantly, has mechanism of qi obstructed more, and blood stasis, phlegm coagulate, and makeThe strongly fragrant resistance of meridian qi and blood is agglomerated into due to core. Ancients think " married woman's disease, a lot of in strongly fragrant ", the heart easily changing for feelings will due to womenReason feature and suffer from liver depression. Meanwhile, motherland's medical science thinks that gas and blood are closely bound up, qi as the commander of blood, the capable blood of gas, the stagnation of the circulation of vital energyBlood stasis, hematogenous blockage mammary gland changes thereupon, thereby very easily forms liver energy stagnation type cyclomastopathy.
At present, to want the mechanism of action be to utilize androgen or progestational hormone to resist the estrogen increasing to drug main; Female pregnant with in control agentThe balance of hormonal readiness, eases the pain, softening tubercle; But oneself uses as the routine of this disease for the treatment of by little this type of medicine of application at presentMedicine, although because hormone therapy initial stage effect is pretty good, during due to treatment, the amount of the hormone that drops into and Applicative time are difficult to just like itDivide ground to be applicable to the needs of this disease, often have the fraud of exceeding the proper limits in righting a wrong; Misapplication, will certainly more increase the weight of this unbalance state.The effect of TCM Therapy treatment cyclomastopathy is to be worth sure, and safe and reliable, payes attention to examining in time of cyclomastopathyDisconnected and effectively treatment, can contribute to improve patient quality of life, alleviate the financial burden of society and family, the more important thing is and fallThe incidence of low breast cancer, this has very important significance, and definite prescriptions of traditional Chinese medicine is also of no curative effect at present.
Summary of the invention
For the defect of prior art, the present invention is in conjunction with dialectical to the proliferation of mammary gland of the traditional Chinese medical science, and consideration Chinese prescription, has allocatedA kind of kidney tonifying nourshing kidney, Yin Yang balancing, is aided with soothing the liver dissipating bind, dissipating phlegm and removing blood stasis, the clearing heat and detoxicating proliferation of mammary gland of effectively treatingPharmaceutical preparation.
Particularly, technical scheme of the present invention is achieved in that
Treat a pharmaceutical preparation for the proliferation of mammary gland, comprise following composition: radix bupleuri, citron, aloe, the bighead atractylodes rhizome, golden cypress, PuPublic English, cordate houttuynia, Rhizoma Sparganii, curcuma zedoary, Radix Glycyrrhizae, Fructus Corni, Chinese yam, the seed of Chinese dodder, selfheal, cynomorium songaricum, the capsule of weeping forsythia, the dried immature fruit of citron orange,First pearl, golden silkworm, excrementum pteropi, costus root, bark of ash, largespike woodnettle root, stringy stonecrop, eclipta.
Treat a pharmaceutical preparation for the proliferation of mammary gland, comprise according to weight fraction ratio: radix bupleuri 10-20 part, citron 3-10 part,Aloe 15-20 part, bighead atractylodes rhizome 10-15 part, golden cypress 5-10 part, dandelion 10-15 part, cordate houttuynia 10-25 part, Rhizoma Sparganii 6-9Part, curcuma zedoary 6-9 part, Radix Glycyrrhizae 6-9 part, Fructus Corni 10-20 part, Chinese yam 10-20 part, seed of Chinese dodder 5-12 part, selfheal8-12 part, cynomorium songaricum 5-17 part, capsule of weeping forsythia 7-23 part, dried immature fruit of citron orange 5-16 part, first pearl 4-10 part, golden silkworm 10-20 part, excrementum pteropi8-12 part, costus root 5-20 part, bark of ash 8-15 part, largespike woodnettle root 5-10 part, stringy stonecrop 5-15 part, eclipta 5-11 part.
In order further to obtain good technique effect, a kind of pharmaceutical preparation for the treatment of the proliferation of mammary gland, above each composition is according to heavyAmount is than being: 15 parts of radix bupleuri, 8 parts of citrons, 17 parts of aloes, 13 parts of the bighead atractylodes rhizomes, 9 parts of golden cypresses, 13 parts of dandelions, fish raw meat22 parts of grass, 8 parts of Rhizoma Sparganiis, 7.5 parts of curcuma zedoarys, 8 parts, Radix Glycyrrhizae, 15 parts of Fructus Cornis, 15 parts of Chinese yams, 8 parts of the seed of Chinese dodders, summer11 parts of withered grass, 12 parts of cynomorium songaricums, 15 parts of the capsules of weeping forsythia, 10 parts of the dried immature fruit of citron oranges, 8 parts, first pearl, 15 parts of golden silkworms, 10 parts of excrementum pteropis,17 parts of costus root, 12 parts of bark of ash, 8 parts of largespike woodnettle roots, 10 parts of stringy stonecrops, 8 parts of ecliptas.
In order further to obtain good technique effect, a kind of pharmaceutical preparation for the treatment of the proliferation of mammary gland, above each composition is according to heavyAmount is than being: 14 parts of radix bupleuri, 7 parts of citrons, 15 parts of aloes, 12 parts of the bighead atractylodes rhizomes, 8 parts of golden cypresses, 12 parts of dandelions, fish raw meat20 parts of grass, 7 parts of Rhizoma Sparganiis, 7.5 parts of curcuma zedoarys, 8 parts, Radix Glycyrrhizae, 14 parts of Fructus Cornis, 14 parts of Chinese yams, 9 parts of the seed of Chinese dodders, summer12 parts of withered grass, 10 parts of cynomorium songaricums, 14 parts of the capsules of weeping forsythia, 8 parts of the dried immature fruit of citron oranges, 7.5 parts, first pearl, 14 parts of golden silkworms, 9 parts of excrementum pteropis, wide16 parts of the banksia rose, 11 parts of bark of ash, 7.5 parts of largespike woodnettle roots, 9 parts of stringy stonecrops, 7 parts of ecliptas.
Treat a pharmaceutical preparation for the proliferation of mammary gland, the application of described pharmaceutical preparation in preparation treatment proliferation of mammary gland medicine.
Treat a pharmaceutical preparation for the proliferation of mammary gland, described pharmaceutical preparation is prepared into granule, powder, and capsule, pill,Tablet and clinically acceptable formulation.
The present invention also puies forward a kind of preparation method of pharmaceutical preparation for the treatment of the proliferation of mammary gland, and it comprises the steps:
(1) get radix bupleuri, dandelion, cordate houttuynia, Radix Glycyrrhizae, Fructus Corni, the seed of Chinese dodder, Chinese yam, selfheal, costus root, largespike woodnettle root,Stringy stonecrop and eclipta are soaked 1.5 hours, the boiled 10min of intense fire, and slow fire 1.5 hours, decocts twice, reduced pressure concentrationTo 80 DEG C, the medicinal extract that density is 1.05, dry rear for subsequent use; Get filtrate for subsequent use;
(2) get Rhizoma Sparganii, curcuma zedoary, cynomorium songaricum, golden silkworm and excrementum pteropi and grind to form meal and add 70% alcohol extract 2 times, each 2 hours,Merge liquid, leave standstill 24 hours, for subsequent use;
(3) getting citron, aloe, the bighead atractylodes rhizome, golden cypress, the capsule of weeping forsythia, the dried immature fruit of citron orange, first pearl and bark of ash is ground into appropriate 70% ethanol of fine powder and carriesGet 2 times, each 1.5 hours, collect extract, merge liquid, leave standstill 24 hours, for subsequent use;
(4) get (2) and (3) step in the supernatant that makes, decompression recycling ethanol, is concentrated into 70 DEG C, what density was 1.03 soaksCream, dry rear for subsequent use;
(5) medicinal extract of step (1) and (4) is mixed, be prepared into pharmaceutical preparation with pharmaceutically acceptable auxiliary material.
Pharmaceutical preparation in above-mentioned preparation method, described pharmaceutical preparation is prepared into granule, powder, capsule, pill, sheetAgent and clinically acceptable formulation. Wherein being prepared as of capsule adds the sweet mellow wine of extract powder weight 9% and mixing of dextrinCompound, wherein in the mixture of sweet mellow wine and dextrin, the weight ratio of sweet mellow wine and dextrin is 1:1; Stir and be heated to 75 DEG C,Cross 80 mesh sieves, granulate, be dried and incapsulate, obtain capsule; The auxiliary material of granule can be multitudinous Icing Sugar, methylol fiberIn element sodium, dextrin and flavouring etc., select; Powder can select from starch, white bole, calcium phosphate, precipitated calcium carbonate etc.Select; The auxiliary material of pill can be selected from starch, microcrystalline cellulose, pregelatinized starch etc.; The auxiliary material of tablet can from starch,In dextrin, microcrystalline cellulose, pregelatinized starch, dolomol, lactose, Icing Sugar, carboxyrnethyl starch sodium etc., select.
Compared with prior art, major advantage of the present invention is:
(1) prescriptions of traditional Chinese medicine of the treatment proliferation of mammary gland of the present invention, all medicine drug combinations, compatibility is reasonable, and softening and resolving hard mass, detumescence are onlyBitterly, there is good result for the treatment of for women's breast core tubercle, swollen breasts, by clinical testing of the present invention and pharmacodynamics examinationTesting can be formal, and the present invention's prescription has treats both principal and secondary aspect of disease, has no side effect, and is difficult for the features such as recurrence more afterwards.
(2) treatment is also provided is the formulation method of the prescriptions of traditional Chinese medicine of the proliferation of mammary gland in the present invention, Chinese drug preparation can be become capsule,The pharmaceutical dosage form such as tablet, granule, facilitates administration, and patient's compliance is higher, and its production method is simple, cost is low, is applicable toIndustrialized production.
Detailed description of the invention
Further describe the present invention by specific embodiment below, the present invention is not limited only to following examples. Of the present inventionIn scope or not departing from content of the present invention, spirit and scope, change, combination or replacement that the present invention is carried out,Be apparent for a person skilled in the art, and be included within the scope of the present invention.
Embodiment 1: a kind of capsule for the treatment of the proliferation of mammary gland, the Chinese medicine that contains following weight portion:
10 grams of radix bupleuri, 3 grams of citrons, 15 grams of aloes, 10 grams of the bighead atractylodes rhizomes, 5 grams of golden cypresses, 10 grams of dandelions, cordate houttuynia 10Gram, 6 grams of Rhizoma Sparganiis, 6 grams of curcuma zedoarys, 6 grams, Radix Glycyrrhizae, 10 grams of Fructus Cornis, 10 grams of Chinese yams, 5 grams of the seed of Chinese dodders, selfheal 8Gram, 5 grams of cynomorium songaricums, 7 grams of the capsules of weeping forsythia, 5 grams of the dried immature fruit of citron oranges, 4 grams, first pearl, 10 grams of golden silkworms, 8 grams of excrementum pteropis, 5 grams of costus root,8 grams of bark of ash, 5 grams of largespike woodnettle roots, 5 grams of stringy stonecrops, 5 grams of ecliptas.
Concrete preparation method is:
(1) get radix bupleuri, dandelion, cordate houttuynia, Radix Glycyrrhizae, Fructus Corni, the seed of Chinese dodder, Chinese yam, selfheal, costus root, largespike woodnettle root,Stringy stonecrop and eclipta are soaked 1.5 hours, the boiled 10min of intense fire, and slow fire 1.5 hours, decocts twice, reduced pressure concentrationTo 80 DEG C, the medicinal extract that density is 1.05, dry rear for subsequent use; Get filtrate for subsequent use;
(2) get Rhizoma Sparganii, curcuma zedoary, cynomorium songaricum, golden silkworm and excrementum pteropi and grind to form meal and add 70% alcohol extract 2 times, each 2 hours,Merge liquid, leave standstill 24 hours, for subsequent use;
(3) getting citron, aloe, the bighead atractylodes rhizome, golden cypress, the capsule of weeping forsythia, the dried immature fruit of citron orange, first pearl and bark of ash is ground into appropriate 70% ethanol of fine powder and carriesGet 2 times, each 1.5 hours, collect extract, merge liquid, leave standstill 24 hours, for subsequent use;
(4) get (2) and (3) step in the supernatant that makes, decompression recycling ethanol, is concentrated into 70 DEG C, what density was 1.03 soaksCream, dry rear for subsequent use;
(5) medicinal extract of step (1) and (4) is mixed to obtain to medicinal extract powder, add sweet mellow wine and the paste of medicinal extract powder weight 9%The mixture of essence, wherein in the mixture of sweet mellow wine and dextrin, the weight ratio of sweet mellow wine and dextrin is 1:1; Stir and be heated to75 DEG C, cross 80 mesh sieves, granulate, be dried and incapsulate, obtain capsule.
Embodiment 2: a kind of capsule for the treatment of the proliferation of mammary gland, the Chinese medicine that contains following weight portion:
20 grams of radix bupleuri, 10 grams of citrons, 20 grams of aloes, 15 grams of the bighead atractylodes rhizomes, 10 grams of golden cypresses, 15 grams of dandelions, cordate houttuynia25 grams, 9 grams of Rhizoma Sparganiis, 9 grams of curcuma zedoarys, 9 grams, Radix Glycyrrhizae, 20 grams of Fructus Cornis, 20 grams of Chinese yams, 12 grams of the seed of Chinese dodders, selfheal12 grams, 17 grams of cynomorium songaricums, 23 grams of the capsules of weeping forsythia, 16 grams of the dried immature fruit of citron oranges, 10 grams, first pearl, 20 grams of golden silkworms, 12 grams of excrementum pteropis, wide wood20 grams of perfume, 15 grams of bark of ash, 10 grams of largespike woodnettle roots, 15 grams of stringy stonecrops, 11 grams of ecliptas.
Preparation method is with embodiment 1.
Embodiment 3: a kind of capsule for the treatment of the proliferation of mammary gland, the Chinese medicine that contains following weight portion:
15 grams of radix bupleuri, 8 grams of citrons, 17 grams of aloes, 13 grams of the bighead atractylodes rhizomes, 9 grams of golden cypresses, 13 grams of dandelions, cordate houttuynia 22Gram, 8 grams of Rhizoma Sparganiis, 7.5 grams of curcuma zedoarys, 8 grams, Radix Glycyrrhizae, 15 grams of Fructus Cornis, 15 grams of Chinese yams, 8 grams of the seed of Chinese dodders, selfheal11 grams, 12 grams of cynomorium songaricums, 15 grams of the capsules of weeping forsythia, 10 grams of the dried immature fruit of citron oranges, 8 grams, first pearl, 15 grams of golden silkworms, 10 grams of excrementum pteropis, costus root17 grams, 12 grams of bark of ash, 8 grams of largespike woodnettle roots, 10 grams of stringy stonecrops, 8 grams of ecliptas.
Preparation method is with embodiment 1.
Embodiment 4: a kind of capsule for the treatment of the proliferation of mammary gland, the Chinese medicine that contains following weight portion:
14 grams of radix bupleuri, 7 grams of citrons, 15 grams of aloes, 12 grams of the bighead atractylodes rhizomes, 8 grams of golden cypresses, 12 grams of dandelions, cordate houttuynia 20Gram, 7 grams of Rhizoma Sparganiis, 7.5 grams of curcuma zedoarys, 8 grams, Radix Glycyrrhizae, 14 grams of Fructus Cornis, 14 grams of Chinese yams, 9 grams of the seed of Chinese dodders, selfheal12 grams, 10 grams of cynomorium songaricums, 14 grams of the capsules of weeping forsythia, 8 grams of the dried immature fruit of citron oranges, 7.5 grams, first pearl, 14 grams of golden silkworms, 9 grams of excrementum pteropis, costus root16 grams, 11 grams of bark of ash, 7.5 grams of largespike woodnettle roots, 9 grams of stringy stonecrops, 7 grams of ecliptas.
Preparation method is with embodiment 1.
Embodiment 5: a kind of tablet for the treatment of the proliferation of mammary gland, the Chinese medicine that contains following weight portion:
15 grams of radix bupleuri, 8 grams of citrons, 17 grams of aloes, 13 grams of the bighead atractylodes rhizomes, 9 grams of golden cypresses, 13 grams of dandelions, cordate houttuynia 22Gram, 8 grams of Rhizoma Sparganiis, 7.5 grams of curcuma zedoarys, 8 grams, Radix Glycyrrhizae, 15 grams of Fructus Cornis, 15 grams of Chinese yams, 8 grams of the seed of Chinese dodders, selfheal11 grams, 12 grams of cynomorium songaricums, 15 grams of the capsules of weeping forsythia, 10 grams of the dried immature fruit of citron oranges, 8 grams, first pearl, 15 grams of golden silkworms, 10 grams of excrementum pteropis, costus root17 grams, 12 grams of bark of ash, 8 grams of largespike woodnettle roots, 10 grams of stringy stonecrops, 8 grams of ecliptas.
Concrete preparation method is:
(1) get radix bupleuri, dandelion, cordate houttuynia, Radix Glycyrrhizae, Fructus Corni, the seed of Chinese dodder, Chinese yam, selfheal, costus root, largespike woodnettle root,Stringy stonecrop and eclipta are soaked 1.5 hours, the boiled 10min of intense fire, and slow fire 1.5 hours, decocts twice, reduced pressure concentrationTo 80 DEG C, the medicinal extract that density is 1.05, dry rear for subsequent use; Get filtrate for subsequent use;
(2) get Rhizoma Sparganii, curcuma zedoary, cynomorium songaricum, golden silkworm and excrementum pteropi and grind to form meal and add 70% alcohol extract 2 times, each 2 hours,Merge liquid, leave standstill 24 hours, for subsequent use;
(3) getting citron, aloe, the bighead atractylodes rhizome, golden cypress, the capsule of weeping forsythia, the dried immature fruit of citron orange, first pearl and bark of ash is ground into appropriate 70% ethanol of fine powder and carriesGet 2 times, each 1.5 hours, collect extract, merge liquid, leave standstill 24 hours, for subsequent use;
(4) get (2) and (3) step in the supernatant that makes, decompression recycling ethanol, is concentrated into 70 DEG C, what density was 1.03 soaksCream, dry rear for subsequent use;
(5) medicinal extract of step (1) and (4) is mixed to obtain to medicinal extract powder, adds the beta-schardinger dextrin-of 0.1 times of medicinal extract powder weight,Add the 50% ethanolic solution softwood processed of 3% appropriate Hydroxypropyl methylcellulose, 16-20 order is granulated, dry, obtains granule, everyBag 10g.
Embodiment 6: a kind of granule for the treatment of the proliferation of mammary gland, the Chinese medicine that contains following weight portion:
14 grams of radix bupleuri, 7 grams of citrons, 15 grams of aloes, 12 grams of the bighead atractylodes rhizomes, 8 grams of golden cypresses, 12 grams of dandelions, cordate houttuynia 20Gram, 7 grams of Rhizoma Sparganiis, 7.5 grams of curcuma zedoarys, 8 grams, Radix Glycyrrhizae, 14 grams of Fructus Cornis, 14 grams of Chinese yams, 9 grams of the seed of Chinese dodders, selfheal12 grams, 10 grams of cynomorium songaricums, 14 grams of the capsules of weeping forsythia, 8 grams of the dried immature fruit of citron oranges, 7.5 grams, first pearl, 14 grams of golden silkworms, 9 grams of excrementum pteropis, costus root16 grams, 11 grams of bark of ash, 7.5 grams of largespike woodnettle roots, 9 grams of stringy stonecrops, 7 grams of ecliptas.
Preparation method is with embodiment 5.
Embodiment 7: animal model test
Diethylstilbestrol and progesterone diethylstilbestrol (stilbestrol) are artificial synthetic non steroidal estrogen materials, can produce andAll pharmacology and therapeutic action that natural estradiol is identical. Progesterone is a kind of natural progestogen of being secreted by corpus luteum,The endometrium in body, estrogen being excited has remarkable Morphology Effects, and the present invention carries out modeling experiment with both.
TAM, as 1. group of positive control medicine of the present invention, is mainly used in treating breast cancer, also for oophoroma, sonThe treatment of endometrial carcinoma and endometriosis etc., for the non-steroidal antiestrogenic kind anti-cancer drugs of chemical synthesis, at twoIn isomers, transconfiguration has therapeutic activity, and cis-structure has faint estrogen action. Its antineoplastic precise mechanism is not stillClear, may be and estradiol competition born of the same parents inner estrogen acceptor, form stable compound and transport in core with acceptor, makeBorn of the same parents' inner estrogen acceptor is exhausted, in blocking-up estradiol body, absorbs, thus the growth of breast cancers of inhibition estrogen-dependent.
What the newborn dissipating bind capsule that disappears was main become radix bupleuri (vinegar is processed), to fry white peony root, prepared RHIZOMA CYPERI with vinegar, radix scrophulariae, kelp, Snakegourd Fruit, summer witheredGrass, oyster, radix ranunculi ternati, the root of large-flowered skullcap, the red sage root, the rhizoma bolbostemmae, edible tulip, moutan bark, Radix Angelicae Sinensis, scorpio. Primary treatment liver phlegm,Tie strongly fragrant looseization and discongest, promoting blood circulation and stopping pain. For stagnation of QI due to depression of the liver, the proliferation of mammary gland due to the cohesion of the phlegm stasis of blood, swollen breasts. This experimentSelect it as 2. group of positive control medicine.
7.1, animal modeling
Select 70 of the female unpregnancy healthy rats of clean level SD, body weight 220-240 gram, in 3 months ages of mouse, is numbered,Choose at random 10 for blank group, all the other carry out animal modeling: rat femoribus internus intramuscular injection diethylstilbestrol injection0.5mg/kg, once a day, continuous 25 days, then use intramuscular injection progesterone 4mg/kg instead, once a day, continuous 5 days, itLaggard line correlation experiment.
7.2, grouping and administration
Proliferation of mammary gland rat is divided into 6 groups at random, 10 every group, is respectively model group, 1. group of positive control medicine, the positiveControl drug is group 2., Chinese medicine high dose group, and middle dosage group and low dose group, the methods for the treatment of of every group is:
Blank group and model group are filled with isopyknic physiological saline;
Chinese medicine high dose group, the capsule of embodiment 3, according to 2g.kg-1Dosage gavage every day once;
Dosage group in Chinese medicine, the capsule of embodiment 3, according to 1g.kg-1Dosage gavage every day once;
Chinese medicine low dose group, the capsule of embodiment 3, according to 0.5g.kg-1Dosage gavage every day once;
1. group of positive control medicine, TAM, according to 0.5mg.kg-1, every day gavage once.
2. group of positive control medicine, the newborn dissipating bind capsule that disappears, according to 65mg.kg-1, every day gavage once.
7.3, index observing
7.3.1 breast height is measured: measure and treat the 2nd pair of breast height of front and back rat with accurate oil ga(u)ge slide calliper rule.
7.3.2 tectology: finish rear execution animal in experiment, get the 2nd pair of mammary gland sample of rat, use 10% formalinFixing.
Breast tissue FFPE, section, HE dyeing.
1. the conventional dewaxing of paraffin organization section secondary, each 10 and n;
2. 100%, 95%, 85%, 75% gradient alcohol aquation;
3. distilled water is developed a film 2 times, and each 5 and n;
4. haematoxylin dyeing 5 and n, distilled water develop a film 1 and; n
5. acidic alcohol differentiation 255, flowing water rinse 30 and; n
6. put Zn five n in the liquid of Yihong, distilled water develops a film 25, flowing water punching 3 and; n
7. alcohol gradient dehydration from low to high, dimethylbenzene is transparent, dry rear resinene mounting.
Tissues observed performance under light microscopic, and measure mammary gland alveolus number, alveolar lumen diameter and conduit diameter.
7.4, experimental result
7.4.1 height of nipples
As can be seen from Table 1, blank group is compared with model group, and after treatment, height of nipples has significant difference (P < 0.01),Rat modeling success of the present invention is described, respectively organizing rat height of nipples after experiment finishes all has growth in various degree, whereinModel group increases obviously, relatively has highly significant difference (P < 0.01) with normal group; And treatment by Chinese herbs group and positive control medicine1. the growth of, 2. organizing height of nipples is starkly lower than model group (P < 0.05), wherein the middle and high dosage group of Chinese medicine and positive control drugThing 2. group has significant difference (P < 0.05) (in table 1).
The impact of the each medicine group of table 1. on rat height of nipples
Group Before treatment-height of nipples (cm) After treatment-height of nipples (cm)
Blank group 0.14±0.023 0.14±0.033
Model group 0.15±0.025 0.27±0.030**
1. group of positive control medicine 0.14±0.033 0.18±0.032#
2. group of positive control medicine 0.13±0.021 0.22±0.025#
Chinese medicine low dose group 0.15±0.022 0.21±0.039#
Dosage group in Chinese medicine 0.14±0.018 0.17±0.044##％
Chinese medicine high dose group 0.14±0.022 0.16±0.031##％
Note:
With the comparison of blank group, * p < 0.05, * * p < 0.01;
With model group comparison,#p<0.05，##p<0.01；
With 1. group of positive control medicine,&p<0.05，&&p<0.01；
With 2. group of positive control medicine,％p<0.05，％％p<0.01。
7.4.2 the each group of impact on rat mammary gland tissue
Each group lobule of mammary gland acinus number, alveolar lumen diameter and catheter lumen diameter are in table 2.
The each group of table 2 rat mammary gland leaflet acinus number, alveolar lumen diameter and conduit diameter
Group Acinus number (μ m) for acinus diameter (μ m) for conduit diameter
Blank group ---- ---- ----
Model group 22.7±5.9 20.1±2.7 18.6±2.8
1. group of positive control medicine 16.2±1.9## 10.3±1.8## 8.5±1.6##
2. group of positive control medicine 18.3±1.7# 12.3±1.7## 10.6±2.8##
Chinese medicine low dose group 16.0±1.3## 11.2±3.3## 9.5±2.4#
Dosage group in Chinese medicine 15.3±2.2##％ 9.3±2.3## 8.1±1.9##％
Chinese medicine high dose group 13.4±1.2##&％％ 7.2±1.9##&％％ 6.9±1.8##&％％
Note:
With model group comparison,#p<0.05，##p<0.01；
With 1. group of positive control medicine,&p<0.05，&&p<0.01；
With 2. group of positive control medicine,％p<0.05，％％p<0.01。
As can be seen from Table 2; Normal group compared with model group, model group breast duct epithelial cell arrangement disorder, epithelium increaseObviously raw, part is irregular projection, and conduit cavity, alveolar lumen are obviously expanded, and inside have the epithelial cell and the secretion that come off,Leaflet showed increased, acinus number increases obviously, and the obvious hyperplasia of interstitial fibers connective tissue, illustrates that the present invention tests modeling and is intoMerit; Treatment by Chinese herbs group and positive control medicine are 1., 2. the breast duct epithelium of group is arranged primitive rule, and model group comparison:Tube chamber expansion obviously alleviates; Leaflet volume and leaflet acinus number obviously reduce, wherein the middle and high dosage group for the treatment of by Chinese herbs with respect toPositive control medicine group difference is very significant (P < 0.01 or p < 0.05).
7.5, the mensuration of VEGF, bFGF content in rat mammary gland tissue:
VEGF and bFGF are considered to two kinds of Angiogenesis that specificity is the strongest, can more intuitively reflect rat mammary gland tissueVariation, after last administration, rat fasting water supply 12h, extract eyeball get blood, static separation of serum, 4 DEG C of storages. In mammary glandFixed position, gets after the weighed quality of breast tissue, puts into physiological saline after ice bath with the 10% mammary gland homogenate of Potter-Elvehjem Tissue Grinders system,Taking centrifugal radius as 13.5cm, the centrifugal 15min of 3000r/min, all separation processes are carried out at 0-4 DEG C. Get supernatant, put-20 DEG C of storages, to be measured. Press the operation of kit description, ELISA method is measured VEGF, bFGF content in breast tissue.
The each group of table 3 rat mammary gland leaflet acinus number, alveolar lumen diameter and conduit diameter
Group VEGF，pg/ml bFGF，pg/ml
Blank group 17.235±3.697 243.128±63.785
Model group 28.546±5.235** 601.369±61.362**
1. group of positive control medicine 18.012±2.365## 261.235±59.231##
2. group of positive control medicine 21.333±3.215## 287.697±59.231##
Chinese medicine low dose group 17.552±2.124## 365.014±54.159##
Dosage group in Chinese medicine 16.357±3.258## 282.147±62.314##
Chinese medicine high dose group 15.798±2.234##％ 245.129±54.982##&％
Note:
With the comparison of blank group,*p<0.05，**p<0.01；
With model group comparison,#p<0.05，##p<0.01；
With 1. group of positive control medicine,&p<0.05，&&p<0.01；
With 2. group of positive control medicine,％p<0.05，％％p<0.01。
As can be seen from Table 3, respectively organizing rat is not identical at VEGF, bFGF content, and wherein model group increases obviously, and justNormal group relatively has highly significant difference (P < 0.01); And 1., 2. treatment by Chinese herbs group and positive control medicine organize VEGF, bFGF containsAmount is starkly lower than model group (P < 0.01), wherein the middle and high dosage group of Chinese medicine and positive control medicine 1., 2. group to have conspicuousness poorDifferent (P < 0.05), has further confirmed that technique effect of the present invention is better.
Embodiment 8: clinical data
8.1, physical data
During year September in August, 2013 to 2015, accept patient 202 examples medical because of the proliferation of mammary gland for medical treatment, patient age 25-55 year, average48.3 years old age; The course of disease 6 months-10 years, average 3.9 years; One-sided breast 88 examples of falling ill, bilateral breast 114 examples of falling ill; Breast pain journeyDegree: slight 51 examples, moderate 135 examples, severe 18 examples, patient is divided into treatment group and control group at random, age between two groups, the course of disease,The factor there was no significant differences such as diet (P > 0.05), there is comparativity.
8.2, grouping and treatment
Treatment group: 101 examples, one-sided breast 44 examples of falling ill, bilateral breast 57 examples of falling ill; Breast pain degree: slight 25 examples, moderate 68Example, severe 9 examples. Take the capsule 3-4 grain of the embodiment of the present invention 3, every day three times, 45 days courses for the treatment of.
Control group: 101 examples, one-sided breast 44 examples of falling ill, bilateral breast 57 examples of falling ill; Breast pain degree: slight 26 examples, inSpend 67 examples, severe 9 examples, Rupi Sanjie Tablets, one time 4,3 times on the one, 45 days courses for the treatment of.
8.3, diagnosis and exclusion standard
8.3.1 " traditional Chinese medical science disease Standardization of diagnosis and curative effect ", within 1994, issued with reference to State Administration of Traditional Chinese Medicine drafted.
(1) periodicity swollen breasts, mostly occurring or adding overweights premenstrua.
Differing in size appears in (2) one sides or bilateral breast, streak or diffusivity sheet bulk, and matter is tough, and border owes clearly, have pressurePain tubercle, with surrounding tissue without adhesion.
(3) local skin is without redness, and axillary lymph is tied without enlargement.
(4) mammary gland infrared link scanning, molybdenum target photo, color Doppler ultrasound examination or pin are inhaled cytoscopy and are diagnosed as mammary gland increasingSick.
8.3.2, exclusion standard:
(1) get rid of other mammary gland diseases such as breast cancer, fibroadenoma of breast.
(2) get rid of and merge the serious illness such as cardiovascular, liver kidney and hemopoietic system and mental patient.
(3) gestation, women breast-feeding their children.
(4) not treatment in accordance with regulations, cannot judge curative effect, or the not congruent judgement person that affects the treatment of data.
8.4, curative effect determinate standard
Observe two groups for the treatment of front and back clinical symptoms, sign variation, infrared ray breast scanning, breast molybdenum target photo, color doppler sonographyUltrasonic examination, a situation arises for blood, routine urinalysis, liver, kidney function test and bad reaction.
Cure: lump in breast and breast pain disappear, and within after drug withdrawal 3 months, do not recur;
Effective; Lump in breast dwindles more than 1/2, and breast pain disappears;
Effective: lump in breast maximum gauge dwindles less than 1/2, breast pain alleviates;
Invalid: lump in breast does not dwindle, increase, hardening on the contrary, or simple breast pain is alleviated.
8.5, result and analysis
After 3 courses for the treatment of, the treatment situation for the treatment of group and control group is as follows:
The treatment situation of table 4 treatment group and control group
Cure Effective Effectively Invalid Efficient (%)
Treatment group 63 32 5 1 99.0
Control group 17 34 38 12 88.1
As can be seen from Table 4: the Chinese medicine that oral the present invention provides, continuous use is added up curative effect after 3 menstrual cycles, to clinical trueExamine patient's 101 examples of suffering from the proliferation of mammary gland and treat, clinical cure 63 people, effective 32 people, effective 5 people, invalid 1 people, always hasEfficiency 99%, control group 101 examples, clinical cure 17 people, effective 34 people, effective 38 people, invalid 12 people, total effective rate 88.1%,In therapeutic process, treatment group and control group occur without obvious toxicity, blood, routine urinalysis, liver, renal function ratio before and after treatmentBe showed no ANOMALOUS VARIATIONS, treatment group, compared with control group, has significant technique effect, treatment group treatment proliferation of mammary gland effectSignificantly, reach clinical treatment object, be adapted in clinical further applying.
8.6, classical case
Case 1: wish certain, female 42 years old, Yancheng, Jiangsu Province people, the people's teacher, patient's private prosecution goes out a left side in Physical examination in 2013In side breast, can touch 1 scleroma, gradually increase, hurt like hell afterwards, especially menstrual period mastodynia very. Take the present inventionThe Chinese medicinal capsule of embodiment 3, after 1 course for the treatment of of medication, symptom alleviates, scleroma diminishes, pain relief, continual cure schemeTo 3 courses for the treatment of, pain disappears, and scleroma disappears, and not recurrence is followed up a case by regular visits in drug withdrawal then for 3 months.
Case 2: fourth, female 51 years old, people from Handan, Hebei, pharmaceutical factory workman, patient's private prosecution has been climacteric, in unit bodiesIn inspection, find induration of breast, when districts and cities' hospital admission, through color ultrasound, left side 2 tubercles of breaking forth, right side 1 tubercle of breaking forth,Regular throe, take 2 courses for the treatment of of 'rukuaixiao ' tablet treatment, and poor effect is taken the embodiment of the present invention 5 upon somebody's introductionAfter 2 courses for the treatment of of tablet in treatment, symptom alleviates, and breast rhabdion disappears, and 2 courses for the treatment of of continual cure, the symptom when medical all disappearsLose, through color ultrasound examination, induration of breast disappears, and cures completely, within 3 months, follows up a case by regular visits to not recurrence.
Case 3: Jin, female 48 years old, people from Yantai, Shandong, civil servant, patient's private prosecution proliferation of mammary gland hurt like hell, impact is justNormal work, 3 courses for the treatment of of Rupi Sanjie Tablets treatment, poor effect, takes the capsule of the embodiment of the present invention 4 upon somebody's introduction, controlsTreat 2 the course for the treatment of symptom alleviate, breast rhabdion disappears substantially, 2 courses for the treatment of of continual cure, the symptom when medical all disappears, warpCross color ultrasound examination, induration of breast disappears, and cures completely, within 3 months, follows up a case by regular visits to not recurrence.

Claims (7)

1. a pharmaceutical preparation that is used for the treatment of the proliferation of mammary gland, is characterized in that, described pharmaceutical preparation comprises following Chinese medicine: bavinCitron, aloe, the bighead atractylodes rhizome, golden cypress, dandelion, cordate houttuynia, Rhizoma Sparganii, curcuma zedoary, Radix Glycyrrhizae, Fructus Corni, Chinese yam, Tu recklessly,Silk, selfheal, cynomorium songaricum, the capsule of weeping forsythia, the dried immature fruit of citron orange, first pearl, golden silkworm, excrementum pteropi, costus root, bark of ash, largespike woodnettle root, vertical basinGrass, eclipta.
2. pharmaceutical preparation according to claim 1, is characterized in that, described pharmaceutical preparation comprises the Chinese medicine of following weight portionMaterial: radix bupleuri 10-20 part, citron 3-10 part, aloe 15-20 part, bighead atractylodes rhizome 10-15 part, golden cypress 5-10 part, dandelion 10-15Part, cordate houttuynia 10-25 part, Rhizoma Sparganii 6-9 part, curcuma zedoary 6-9 part, Radix Glycyrrhizae 6-9 part, Fructus Corni 10-20 part, Chinese yam 10-20Part, seed of Chinese dodder 5-12 part, selfheal 8-12 part, cynomorium songaricum 5-17 part, capsule of weeping forsythia 7-23 part, dried immature fruit of citron orange 5-16 part, first pearl 4-10Part, golden silkworm 10-20 part, excrementum pteropi 8-12 part, costus root 5-20 part, bark of ash 8-15 part, largespike woodnettle root 5-10 part, vertical basinGrass 5-15 part, eclipta 5-11 part.
3. pharmaceutical preparation according to claim 2, is characterized in that, described pharmaceutical preparation comprises the Chinese medicine of following weight portionMaterial: 15 parts of radix bupleuri, 8 parts of citrons, 17 parts of aloes, 13 parts of the bighead atractylodes rhizomes, 9 parts of golden cypresses, 13 parts of dandelions, cordate houttuynia 22Part, 8 parts of Rhizoma Sparganiis, 7.5 parts of curcuma zedoarys, 8 parts, Radix Glycyrrhizae, 15 parts of Fructus Cornis, 15 parts of Chinese yams, 8 parts of the seed of Chinese dodders, selfheal11 parts, 12 parts of cynomorium songaricums, 15 parts of the capsules of weeping forsythia, 10 parts of the dried immature fruit of citron oranges, 8 parts, first pearl, 15 parts of golden silkworms, 10 parts of excrementum pteropis, costus root17 parts, 12 parts of bark of ash, 8 parts of largespike woodnettle roots, 10 parts of stringy stonecrops, 8 parts of ecliptas.
4. pharmaceutical preparation according to claim 2, is characterized in that, described pharmaceutical preparation comprises the Chinese medicine of following weight portionMaterial: 14 parts of radix bupleuri, 7 parts of citrons, 15 parts of aloes, 12 parts of the bighead atractylodes rhizomes, 8 parts of golden cypresses, 12 parts of dandelions, cordate houttuynia 20Part, 7 parts of Rhizoma Sparganiis, 7.5 parts of curcuma zedoarys, 8 parts, Radix Glycyrrhizae, 14 parts of Fructus Cornis, 14 parts of Chinese yams, 9 parts of the seed of Chinese dodders, selfheal12 parts, 10 parts of cynomorium songaricums, 14 parts of the capsules of weeping forsythia, 8 parts of the dried immature fruit of citron oranges, 7.5 parts, first pearl, 14 parts of golden silkworms, 9 parts of excrementum pteropis, costus root16 parts, 11 parts of bark of ash, 7.5 parts of largespike woodnettle roots, 9 parts of stringy stonecrops, 7 parts of ecliptas.
5. a preparation method for the pharmaceutical preparation of the treatment proliferation of mammary gland claimed in claim 1, comprises the following steps:
(1) get radix bupleuri, dandelion, cordate houttuynia, Radix Glycyrrhizae, Fructus Corni, the seed of Chinese dodder, Chinese yam, selfheal, costus root, largespike woodnettle root,Stringy stonecrop and eclipta are soaked 1.5 hours, the boiled 10min of intense fire, and slow fire 1.5 hours, decocts twice, reduced pressure concentrationTo 80 DEG C, the medicinal extract that density is 1.05, dry rear for subsequent use; Get filtrate for subsequent use;
(2) get Rhizoma Sparganii, curcuma zedoary, cynomorium songaricum, golden silkworm and excrementum pteropi and grind to form meal and add 70% alcohol extract 2 times, each 2 hours,Merge liquid, leave standstill 24 hours, for subsequent use;
(3) getting citron, aloe, the bighead atractylodes rhizome, golden cypress, the capsule of weeping forsythia, the dried immature fruit of citron orange, first pearl and bark of ash is ground into appropriate 70% ethanol of fine powder and carriesGet 2 times, each 1.5 hours, collect extract, merge liquid, leave standstill 24 hours, for subsequent use;
(4) get (2) and (3) step in the supernatant that makes, decompression recycling ethanol, is concentrated into 70 DEG C, what density was 1.03 soaksCream, dry rear for subsequent use;
(5) medicinal extract of step (1) and (4) is mixed, be prepared into pharmaceutical preparation with pharmaceutically acceptable auxiliary material.
6. preparation method according to claim 5, is characterized in that, the described pharmaceutical preparation of step (5) comprises granule,Powder, capsule, pill, tablet and clinically acceptable formulation.
7. according to the pharmaceutical preparation described in any one in claim 1-5, it is characterized in that, described pharmaceutical preparation is at preparation treatment breastApplication in gland hyperplasia medicine.
CN201610066053.2A 2016-01-29 2016-01-29 Medicine preparation for treating hyperplasia of mammary glands and application thereof Withdrawn CN105582473A (en)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106822353A (en) * 2017-03-22 2017-06-13 李妮 A kind of Chinese medicine composition for treating the proliferation of mammary gland

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102935209A (en) * 2012-12-04 2013-02-20 白恩忠 Traditional Chinese medicinal preparation for treating hyperplasia of mammary glands

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102935209A (en) * 2012-12-04 2013-02-20 白恩忠 Traditional Chinese medicinal preparation for treating hyperplasia of mammary glands

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106822353A (en) * 2017-03-22 2017-06-13 李妮 A kind of Chinese medicine composition for treating the proliferation of mammary gland

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Application publication date: 20160518