CN103736008B - Treatment breast carcinoma pharmaceutical composition being concurrently good for side Benign Nodule and preparation method thereof - Google Patents

Abstract

The present invention relates to a kind of treat breast carcinoma pharmaceutical composition being concurrently good for side Benign Nodule and preparation method thereof.This Chinese medicine is to be prepared from by the raw material including following weight portion: the Radix Astragali, Fructus Ligustri Lucidi, Rhizoma Polygonati, the Rhizoma Atractylodis Macrocephalae, Poria, Radix Bupleuri, Pericarpium Citri Reticulatae Viride, Pericarpium Citri Reticulatae, Bulbus Fritillariae Thunbergii, Rhizoma Bolbostematis, Radix Curcumae, Herba Taraxaci, the Radix Paeoniae Alba, Herba Solani Nigri, Radix Glycyrrhizae Preparata, Radix Angelicae Sinensis.Can effectively treat patient with breast cancer and be good for the enclosed mass disease of side mammary gland existence benign lesion in various degree.The pharmaceutical composition that the present invention provides is in terms for the treatment of breast carcinoma is concurrently good for side Benign Nodule, and determined curative effect, effect is better than prior art.

Description

Treatment breast carcinoma pharmaceutical composition being concurrently good for side Benign Nodule and preparation method thereof

Technical field

The present invention relates to drug world, be specifically related to treat breast carcinoma be concurrently good for side Benign Nodule pharmaceutical composition and Preparation method.

Background technology

Breast mass is the commonly encountered diseases of numerous women, can be divided into 0-VI according to breast molybdenum target inspection, totally 6 grades.0 grade of patient The most asymptomatic, 0, I, II grade of patient is benign lesion.In III grade of patient, 98% is Benign Nodule, and 2% is pernicious.Such as I III Pathological changes patient is without treatment for level, then be likely to be due to the differentiation of the state of an illness, cause classification to be increased, and needs to undertake to be changed into pernicious wind Danger.This risk itself be on the body of patient with breast cancer the most notable.But clinically to this situation the most also Do not cause enough attention, and doctor trained in Western medicine aspect is without effective therapy.

My section finds in clinical position, exceedes the patient with breast cancer of half, and it is good that strong side mammary gland all exists in various degree Sexually transmitted disease (STD) becomes.Being no lack of bilateral breast clinically and all suffer from the patient of cancer, this enclosed mass disease being good for side mammary gland with patient has and necessarily contacts. Therefore the strong side benign breast lesions of this kind of patient especially should and early treatment.The present invention is with from plan side's medicine easing the affected liver breast soup oral medication The strong side Benign Nodule disease that patient with breast cancer is merged, obtains good therapeutic effect.

Summary of the invention

It is an object of the invention to provide a kind of breast carcinoma for the treatment of and be concurrently good for the pharmaceutical composition of side Benign Nodule；

It is a further object of the present invention to provide and a kind of treat the system that breast carcinoma is concurrently good for the pharmaceutical composition of side Benign Nodule Preparation Method.

It is an object of the invention to by following technical scheme realization:

Treatment breast carcinoma described in patent of the present invention is concurrently good for the pharmaceutical composition of side Benign Nodule, and it is as follows by including The raw material of weight portion is prepared from:

Radix Astragali 20-40 part, Fructus Ligustri Lucidi 8-18 part, Rhizoma Polygonati 10-20 part, Rhizoma Atractylodis Macrocephalae 10-20 part, Poria 10-20 part, Radix Bupleuri 10- 20 parts, Pericarpium Citri Reticulatae Viride 10-20 part, Pericarpium Citri Reticulatae 5-15 part, Bulbus Fritillariae Thunbergii 8-18 part, Rhizoma Bolbostematis 5-15 part, Radix Curcumae 5-15 part, Herba Taraxaci 10-20 Part, Radix Paeoniae Alba 8-18 part, Herba Solani Nigri 5-15 part, Radix Glycyrrhizae Preparata 2-9 part, Radix Angelicae Sinensis 8-18 part.

Preferably, it is to be prepared from by the raw material including following weight portion:

Radix Astragali 25-35 part, Fructus Ligustri Lucidi 10-15 part, Rhizoma Polygonati 12-18 part, Rhizoma Atractylodis Macrocephalae 12-18 part, Poria 12-18 part, Radix Bupleuri 12- 18 parts, Pericarpium Citri Reticulatae Viride 12-18 part, Pericarpium Citri Reticulatae 8-12 part, Bulbus Fritillariae Thunbergii 10-15 part, Rhizoma Bolbostematis 8-12 part, Radix Curcumae 8-12 part, Herba Taraxaci 12-18 Part, Radix Paeoniae Alba 10-15 part, Herba Solani Nigri 8-12 part, Radix Glycyrrhizae Preparata 3-7 part, Radix Angelicae Sinensis 10-15 part.

It is highly preferred that be to be prepared from by the raw material including following weight portion:

The Radix Astragali 30 parts, Fructus Ligustri Lucidi 12 parts, Rhizoma Polygonati 15 parts, the Rhizoma Atractylodis Macrocephalae 15 parts, 15 parts of Poria, Radix Bupleuri 15 parts, 15 parts of Pericarpium Citri Reticulatae Viride, Pericarpium Citri Reticulatae 10 parts, Bulbus Fritillariae Thunbergii 12 parts, Rhizoma Bolbostematis 10 parts, Radix Curcumae 10 parts, Herba Taraxaci 15 parts, the Radix Paeoniae Alba 12 parts, Herba Solani Nigri 10 parts, Radix Glycyrrhizae Preparata 5 parts, when Return 12 parts.

The following is crude drug source and the primary efficacy of Chinese medicine preparation of the present invention:

The Radix Astragali: for leguminous plant Radix Astagali Astragalusmembranaceus (Fisch.) Bge. var. Mongolicus (Bge.) Hsiao or Radix Astragali Astragalusmembranaceus (Fisch.) Bge. is dried Root.Record in " Chinese Pharmacopoeia " version in 2010 page 283.[nature and flavor] are sweet, temperature.[return through] returns lung, spleen channel.[function cures mainly] Invigorating QI to consolidate the body surface resistance, diuresis poison holding, evacuation of pus, expelling pus and promoting granulation.Weak for the deficiency of vital energy, anorexia and loose stool, sinking of QI of middle-JIAO, chronic diarrhea proctoptosis, have blood in stool Metrorrhagia, exterior deficiency spontaneous perspiration, deficiency of vital energy edema, carbuncle difficulty is burst, and bursts for a long time and does not holds back, and blood deficiency dull yellowish colored skin, interior-heat is quenched one's thirst；Chronic nephritis proteinuria, sugar Urine disease.

Fructus Ligustri Lucidi: for the dry mature fruit of Oleaceae plants Fructus Ligustri Lucidi Ligustrum lucidum Ait..Nature and flavor: sweet, Hardship, flat.Gui Jing: liver；Kidney channel.Effect: liver and kidney tonifying, clearind deficient heat, strong waist knee joint, bright knowledge, crow beard and hair.Cure mainly: Light-headedness；Waist Knees soreness；Seminal emission；Tinnitus；Early whitening of beard and hair, osteopyrexia and fever.For the poor vision of the hepatic and renal YIN deficiency, visual deterioration, early whitening of beard and hair, Soreness of waist tinnitus and fever due to yin deficiency etc..

Rhizoma Polygonati: for liliaceous plant P. kingianum PolygonatumkingianumColl.etHemsl., Rhizoma Polygonati Or the Polygonatum cyrtonema Hua (dry rhizome of PolygonatumcyrtonemaHua. PolygonatumsibiricumRed..Record in " Chinese Pharmacopoeia " version in 2010 one page 288.[nature and flavor] are sweet, flat.[return through] returns spleen, lung, kidney channel.[function cures mainly] QI invigorating is supported The moon, spleen invigorating, lung moistening, kidney tonifying.For weakness of the spleen and stomach, fatigue and asthenia, xerostomia lack of appetite, deficiency of the lung cough caused by dryness, asthenia of essence and blood, interior-heat is quenched one's thirst.

The Rhizoma Atractylodis Macrocephalae is the dry rhizome of feverfew Rhizoma Atractylodis Macrocephalae AtractylodesmacrocephalaKoidz..Record in " in State's pharmacopeia " 2005 years versions one page 68.[nature and flavor] are bitter, sweet, temperature.[return through] returns spleen, stomach warp.[function cures mainly] invigorating the spleen and benefiting QI, Dampness diuretic, hidroschesis, antiabortive.For insufficiency of the spleen lack of appetite, abdominal distention is had loose bowels, phlegm retention vertigo and palpitation, edema, spontaneous perspiration, frequent fetal movement.Rhizoma Atractylodis Macrocephalae is good for Spleen, stomach function regulating, antiabortive.For insufficiency of the spleen lack of appetite, loose stool of having loose bowels, frequent fetal movement.

Poria is the dry sclerotia of On Polyporaceae Poria Poriacocos (Schw.) Wolf.Record in " middle traditional Chinese medicines Allusion quotation " 2005 years versions one page 166.[nature and flavor] are sweet, light, flat.[return through] GUIXIN, lung, spleen, kidney channel.[function cures mainly] diuretic oozes Wet, spleen invigorating mind calming.For edema oliguria, phlegm retention vertigo and palpitation, insufficiency of the spleen lack of appetite, loose stool has loose bowels, irritability, palpitation with fear insomnia.Modern doctor Learn research: Poria energy enhancing human body immunity function, pachyman has obvious antitumor and protects the liver dirty effect.

Radix Bupleuri: this product is umbelliferae bupleurum BupleurumchinenseDC. or Radix Bupeuri Scorzonerfolii. Bupleurums- CorzonerifoliumWilld. dry root.Different by character, practise title " Radix Bupleuri " and " Radix Bupleuri Scorzonerifolii " respectively.Spring, Qiu Erji Excavate, remove stem and leaf and silt, be dried.[nature and flavor] are bitter, are slightly cold.[return through] returns liver, gallbladder meridian.[function cures mainly] reconciling superficies and interior, dredges Liver, yang invigorating.For cold, fever, alternate attack of chill and fever, distending pain in the chest and hypochondrium, menoxenia, sub-official prolapses, proctoptosis.

Pericarpium Citri Reticulatae Viride: Dipterocarpaceae Armeniaca mume Sieb. belongs to Pericarpium Citri Reticulatae Viride Vatica mangachapoi Blanco.[function cures mainly] is soothing the liver dispelling the stagnated QI； Removing food stagnancyization is stagnant.The distending pain over the hypochondrium of main stagnation of QI due to depression of the liver；Distending pain of the breast；Nodule in the breast；Acute mastitis；Hernia pain；The epigastric distending pain of stagnation of QI due to dyspepsia； And qi depression to blood stasis lump in the abdomen extremely；Chronic malaria addiction block.

Pericarpium Citri Reticulatae: for rutaceae orange and the dry mature skin of variety thereof.[nature and flavor] are bitter, pungent, temperature.[return through] returns Lung, spleen channel.[function cures mainly] regulating qi-flowing for strengthening spleen, drying dampness to eliminate phlegm.For fullness in the epigastrium and chest, lack of appetite and vomiting, cough with copious phlegm.

Bulbus Fritillariae Thunbergii: Liliaceae Fritillaria Bulbus Fritillariae Thunbergii Fritillaria thunbergii Miq..Removing heat-phlegm, eliminating stagnation solution Poison.Control cough due to pathogenic wind-heat, lung abscess sore throat, scrofula, sore swollen toxin.

Rhizoma Bolbostematis: another name Rhizoma Bolbostematis, Bulbus Fritillariae Thunbergii, Herba Elephantopi scaberis, grass shellfish.Source is cucurbitaceous plant Bolbostemma paniculatum dependent territory Bulbus Fritillariae Uninbracteatae Rhizoma Bolbostematis dry tuber [property of medicine] is slightly cold.[flavour of a drug] are bitter.[return through] returns lung, spleen channel.[function] dissipates Knot, detumescence, removing toxic substances.[curing mainly] is used for acute mastitis, scrofula；Mastitis, lymphoid tuberculosis, chronic lymphadenitis, hypertrophic rhinitis.

Radix Curcumae: the tuber of Zingiberaceae Curcuma Radix Curcumae Curcuma aromatica Salisb..[meridian distribution of property and flavor] is pungent, bitter, Temperature.Return liver, spleen channel.[function] promoting blood circulation and stopping pain, promoting QI circulation for relieving depression, removing heat from blood clears away heart-fire, promoting the function of the gallbladder to alleviate jaundice.[curing mainly] amenorrhea dysmenorrhea, chest and abdomen are swollen Bitterly, twinge, calentura coma, epilepsy goes mad, jaundice dark coloured urine.[composition] contains volatile oil.[pharmacology] 1, stomach invigorating 2, function of gallbladder promoting 3, diuresis 4, Also has slight analgesic activity.

The Radix Paeoniae Alba: also referred to as Radix Paeoniae Alba, Paeonia sterniana Fletcher in Journ., being dried for ranunculaceae plant Radix Paeoniae PaeonialactifloraPall. Root.Record in " Chinese Pharmacopoeia 2005 version one page 68.[nature and flavor] are bitter, sour, are slightly cold.[return through] returns liver, spleen channel.[function Cure mainly] suppressing the hyperactive liver pain relieving, nourishing blood for regulating menstruation, astringing YIN to stop sweating.For dizziness of having a headache, hypochondriac pain, stomachache, limb pain twin, blood deficiency and yellow complexion, menstruation Uncomfortable, spontaneous perspiration, night sweat.

Herba Solani Nigri: another name crow seed dish, Herba Solani Surattensis, cattle Calyx seu fructus physalis, crow Radix Betae, be Solanaceae nightshade Herba Solani Nigri Solanum nigrum.[nature and flavor with return through]: cold in nature, bitter in the mouth, micro-sweet；Slightly poisonous.[function cures mainly]: heat-clearing and toxic substances removing, promoting blood circulation and detumescence.[effect With effect]: heat clearing away, removing toxic substances, invigorate blood circulation, detumescence.Control furuncle, carbuncle, erysipelas, osteopatia sprain, chronic tracheitis, acute nephritis.With Send out in sore and toxic, skin eczema, dysuria, chronic senile tracheitis, leukorrhagia, prostatitis, dysentery, flu Burn, toothache, urinary system infection, mastitis, leucorrhea, cancer；Carbuncle furuncle furuncle, pemphigus, injury from falling down, venom are controlled in external.

Radix Glycyrrhizae Preparata: this product is the Preparation process product of Radix Glycyrrhizae.Radix Glycyrrhizae is glycyrrhizic legume Glycyrrhiza Uralensis Fisch., Glycyrrhiza inflata Bat. Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L. Glycyrrhiza The dry root and rhizome of glabra L. records in " Chinese Pharmacopoeia " version in 2010 page 80.

Radix Angelicae Sinensis: for the dry root of umbelliferae angelica Angelica sinensis (Oliv.) Diels.Sweet in the mouth, Pungent, bitter, warm in nature.Return liver, the heart, spleen channel.Enrich blood；Invigorate blood circulation；Menstruction regulating and pain relieving；Moisturize laxation.Cure mainly all cards of blood deficiency, menoxenia, warp Close, dysmenorrhea, lump in the abdomen knot is poly-, metrorrhagia, asthenia cold abdominalgia, flaccidity syndrome and arthralgia syndrome, numbness of the skin, dryness of the intestine dyschezia, weight, ulcer sores after bloody dysentery, fall and flutter Damage.

Another aspect of the present invention there is provided the preparation method of the active component of pharmaceutical composition of the present invention, and the method is Water is used to carry or the ethanol extraction of 40 90% concentration expressed in percentage by volumes.Concrete preparation method is as follows:

Scheme one: take whole medical material, extracting in water 2-3 time, each amount of water is equivalent to 6-12 times of medical material gross weight, often Secondary extraction time is 1-3 hour, united extraction liquid, filters, and at filtrate is concentrated into 70-80 DEG C, relative density is 1.10-1.25's Clear paste, obtains active component.

Scheme two: take whole medical material, extracting in water 2-3 time, each amount of water is equivalent to 6-12 times of medical material gross weight, often Secondary extraction time is 1-3 hour, united extraction liquid, filters, and at filtrate is concentrated into 70-80 DEG C, relative density is 1.05-1.20's Clear paste, adds ethanol, and making alcohol content is 40-70%, stands 12-24 hour, filters, and filtrate is concentrated into when 70-80 DEG C the closeest Degree is the extractum of 1.10-1.25, obtains active component.

Scheme three: take whole medical material, with ethanol ultrasonic extraction 3-4 time, adds the 50-90% of medical material gross weight 2-4 times every time Ethanol, each supersound extraction 2-5 hour, filter, merging filtrate, when being concentrated into 70-80 DEG C, relative density is 1.10-1.25's Extractum, obtains active component.

Scheme four: take whole medical material, with 40-80% alcohol reflux 2-3 time, each ethanol consumption is medical material total amount 4-10 times, extraction time is 1-4 hour, united extraction liquid, filters, and when filtrate is concentrated into 60-80 DEG C, relative density is 1.10- The extractum of 1.25, obtains active component.

Scheme five: take whole medical material, adds ethanol percolate extraction 3-4 time, adds amount of alcohol every time and is equivalent to medical material gross weight Measuring 1～2 times, concentration of alcohol is 40%～60% with volume basis, and percolation speed is that effluent per minute accounts for raw material gross weight 0.2%～0.6%, collect percolate, reclaim ethanol, be evaporated to be equivalent to 1～2 times of medical material gross weight, filter, to obtain final product Active component.

Scheme six: take whole medical material, clean, pulverizes, sieves, to obtain final product.

Its effective ingredient and/or pharmaceutically acceptable carrier can be made various by the pharmaceutical composition of the present invention together Common formulations, such as tablet, capsule, pill, drop pill, granule, medicinal tea, mixture, syrup, powder etc..

The pharmaceutically acceptable carrier of the present invention includes but not limited to following:

Filler: lactose, dextrin, Icing Sugar, calcium sulfate, sucrose, mannitol, microcrystalline Cellulose, glucose, corn starch Deng.

Binding agent: starch slurry, pregelatinized Starch, dextrin etc..

Disintegrating agent: starch, carboxymethyl starch sodium, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose, low replacement-carboxylic propyl group Cellulose, citric acid, polyoxyethylene sorbitan monoleate etc..

Lubricant: stearic acid, calcium stearate, magnesium stearate, Pulvis Talci, hydrogenated vegetable oil, Polyethylene Glycol, dodecyl sulfur Acid sodium, glyceryl monostearate etc..

Wetting agent: distilled water, ethanol etc..

Correctives: sucrose, stevioside, aspartame etc..

Cosolvent: the polyhydric alcohol such as glycerol, sorbitol.

Fluidizer: micropowder silica gel, Pulvis Talci etc..

Preservative: benzoic acid, sodium benzoate, sorbic acid and salt thereof, propanoic acid, parabens etc..

Sugar coating material, such as sucrose, Pulvis Talci, gelatin, pigment, river wax etc.；Thin film coating material, such as stomach dissolution type water, alcohol Coating material etc..

Such as, it can be prepared as various common dosage forms by one of following method: tablet, capsule, pill, drop pill Agent, medicinal tea, mixture, syrup, powder.

Method 1: granule

Take one of scheme one to scheme five gained active component, add granule and commonly use adjuvant, producer legal system routinely The standby granule obtaining pharmaceutical composition of the present invention.

Above-mentioned granule is commonly used adjuvant and is included one of filler, binding agent, lubricant or whole.

Method 2: syrup

Take one of scheme one to scheme five gained active component, add syrup and commonly use adjuvant, producer legal system routinely The standby syrup obtaining pharmaceutical composition of the present invention.

Above-mentioned syrup is commonly used adjuvant and is included one of correctives, preservative, cosolvent or whole.

Method 3: tablet

Taking one of scheme one to scheme five gained active component, add tablet and commonly use adjuvant, routinely prepared by production method Obtain the tablet of pharmaceutical composition of the present invention.

Above-mentioned tablet is commonly used adjuvant and is included one of filler, binding agent, disintegrating agent, lubricant or whole.

Method 4: capsule

Take one of scheme one to scheme five gained active component, add capsule and commonly use adjuvant, producer legal system routinely The standby capsule obtaining pharmaceutical composition of the present invention.

Above-mentioned capsule is commonly used adjuvant and is included one of filler, fluidizer, disintegrating agent, lubricant or whole.

The applicant, on the basis of research tradition Chinese medicine, through test for many years, have found and is concurrently good for breast carcinoma Several drugs that side Benign Nodule therapeutic effect is good and complete the present invention.

Mammary gland nodules is born in side, and the traditional Chinese medical science is considered Liver Channel pathological changes, does not relaxes with temperament and interest, and depression of liver-QI is relevant.Stagnation of liver-QI takes advantage of spleen, And surgical injury temper, damp-retention due to hypofunction of the spleen, turbid damp obstructing in middle-JIAO is not changed, and is more easily generated enclosed mass disease, therefore this kind of patient belongs to stagnation of liver-QI more Spleen-deficient.The present invention is to use kinds of traditional Chinese medicines reasonable formula, is formed and has soothing liver and strengthening spleen, strengthening vital QI to eliminate pathogenic factors, hard masses softening and resolving effect Prescription.

A kind of breast carcinoma for the treatment of that the present invention provides concurrently is good for the pharmaceutical composition of side Benign Nodule and is had the advantage that

1, patient is in the while in hospital of Mammary cancer, and the Benign Nodule situation for its strong side mammary gland uses system of the present invention Agent is treated, and enclosed mass hardness deliquescing, range shorter even disappears, pain relief, and effect is notable.

2, the present invention is compared with prior art Chinese patent medicine BUPIXIAO PIAN, can more effectively treat patient with breast cancer and be good for side mammary gland and deposit At benign lesion in various degree, both have pole significant difference.

Detailed description of the invention

The present invention is further illustrated below by embodiment.It should be understood that embodiments of the invention are for illustrating The present invention rather than limitation of the present invention.The simple modifications that the present invention is carried out by the essence according to the present invention broadly falls into the present invention Claimed scope.Except as otherwise noted, the percent of the amount of alcohol in the present invention is percentage by volume, and v/v represents solution Volume ratio.

Embodiment 1: the preparation (scheme one) of granule

Take Radix Astragali 35g, Fructus Ligustri Lucidi 15g, Rhizoma Polygonati 18g, Rhizoma Atractylodis Macrocephalae 18g, Poria 18g, Radix Bupleuri 18g, Pericarpium Citri Reticulatae Viride 18g, Pericarpium Citri Reticulatae 12g, Bulbus Fritillariae Thunbergii 15g, Rhizoma Bolbostematis 12g, Radix Curcumae 12g, Herba Taraxaci 18g, Radix Paeoniae Alba 15g, Herba Solani Nigri 12g, Radix Glycyrrhizae Preparata 7g, Radix Angelicae Sinensis 15g, add water and carry Taking 3 times, three times amount of water is respectively 12 times of medical material gross weight, 8 times, 6 times, three extraction times be respectively 3 hours, 2 hours, 1 hour, united extraction liquid, filter, it is the clear paste of 1.10 that filtrate is concentrated into relative density at 80 DEG C, adds cane sugar powder, dextrin, mixed Even, pelletize, be dried, granulate, subpackage, to obtain final product.

Embodiment 2: the preparation (scheme four) of granule

Take Radix Astragali 25g, Fructus Ligustri Lucidi 10g, Rhizoma Polygonati 12g, Rhizoma Atractylodis Macrocephalae 12g, Poria 12g, Radix Bupleuri 12g, Pericarpium Citri Reticulatae Viride 12g, Pericarpium Citri Reticulatae 8g, Zhejiang Bulbus Fritillariae Uninbracteatae 10g, Rhizoma Bolbostematis 8g, Radix Curcumae 8g, Herba Taraxaci 12g, Radix Paeoniae Alba 10g, Herba Solani Nigri 8g, Radix Glycyrrhizae Preparata 3g, Radix Angelicae Sinensis 10g, return with 40% ethanol Stream extracts 3 times, and each ethanol consumption is respectively 10 times of medical material total amount, 8 times, 4 times, 4 hours respectively extraction time, 2 hours, 1 Hour, united extraction liquid, to filter, when filtrate is concentrated into 60 DEG C, relative density is the extractum of 1.25, obtains active component, adds breast Sugar, starch, pelletize, be dried, granulate, subpackage, to obtain final product.

Embodiment 3: the preparation (scheme two) of syrup

Take Radix Astragali 30g, Fructus Ligustri Lucidi 12g, Rhizoma Polygonati 15g, Rhizoma Atractylodis Macrocephalae 15g, Poria 15g, Radix Bupleuri 15g, Pericarpium Citri Reticulatae Viride 15g, Pericarpium Citri Reticulatae 10g, Bulbus Fritillariae Thunbergii 12g, Rhizoma Bolbostematis 10g, Radix Curcumae 10g, Herba Taraxaci 15g, Radix Paeoniae Alba 12g, Herba Solani Nigri 10g, Radix Glycyrrhizae Preparata 5g, Radix Angelicae Sinensis 12g, add water and carry Taking 3 times, three times amount of water is respectively equivalent to 12 times of medical material gross weight, 8 times, 6 times, 3 hours respectively each extraction time, 2 little Time, 1 hour, united extraction liquid, filter, it is the clear paste of 1.20 that filtrate is concentrated into relative density at 70 DEG C, add ethanol, make containing alcohol Amount is 40%, stands 24 hours, filters, and when filtrate is concentrated into 80 DEG C, relative density is the extractum of 1.10, adds sucrose, sorbic acid Potassium, mixing, subpackage, to obtain final product.

Embodiment 4: the preparation (scheme five) of syrup

Take Radix Astragali 20g, Fructus Ligustri Lucidi 8g, Rhizoma Polygonati 10g, Rhizoma Atractylodis Macrocephalae 10g, Poria 10g, Radix Bupleuri 10g, Pericarpium Citri Reticulatae Viride 10g, Pericarpium Citri Reticulatae 5g, Zhejiang Bulbus Fritillariae Uninbracteatae 8g, Rhizoma Bolbostematis 5g, Radix Curcumae 5g, Herba Taraxaci 10g, Radix Paeoniae Alba 8g, Herba Solani Nigri 5g, Radix Glycyrrhizae Preparata 2g, Radix Angelicae Sinensis 8g, add ethanol percolation and carry Take 4 times, add every time amount of alcohol be respectively equivalent to medical material gross weight 2 times, 2 times, 1 times, 1 times, four times percolation concentration of alcohol divides Be not 60%, 50%, 40%, 40%, four percolation speed be respectively effluent per minute account for the 0.2% of raw material gross weight, 0.3%, 0.4%, 0.6%, collect percolate, reclaim ethanol, be evaporated to be equivalent to 1 times of medical material gross weight, filter, addition glycerol, Nipalgin, stevioside, mixing, subpackage, to obtain final product.

Embodiment 5: the preparation (scheme three) of tablet

Take Radix Astragali 40g, Fructus Ligustri Lucidi 18g, Rhizoma Polygonati 20g, Rhizoma Atractylodis Macrocephalae 20g, Poria 20g, Radix Bupleuri 20g, Pericarpium Citri Reticulatae Viride 20g, Pericarpium Citri Reticulatae 15g, Bulbus Fritillariae Thunbergii 18g, Rhizoma Bolbostematis 15g, Radix Curcumae 15g, Herba Taraxaci 20g, Radix Paeoniae Alba 18g, Herba Solani Nigri 15g, Radix Glycyrrhizae Preparata 9g, Radix Angelicae Sinensis 18g, use ethanol Supersound extraction 4 times, be separately added into for four times medical material gross weight 4 times, 3 times, 2 times, 2 times, four times ultrasonic concentration of alcohol is respectively 90%, 80%, 60%, 50%, four supersound extraction times are respectively 5 hours, 4 hours, 3 hours, 2 hours, and extracting solution filters, and merge Filtrate, when being concentrated into 70 DEG C, relative density is the extractum of 1.25, adds lactose, Pulvis Talci, mixing, pelletizes, is dried, tabletting, i.e. ?.

Embodiment 6: the preparation (scheme two) of tablet

Take Radix Astragali 20g, Fructus Ligustri Lucidi 10g, Rhizoma Polygonati 15g, Rhizoma Atractylodis Macrocephalae 20g, Poria 18g, Radix Bupleuri 15g, Pericarpium Citri Reticulatae Viride 10g, Pericarpium Citri Reticulatae 12g, Bulbus Fritillariae Thunbergii 12g, Rhizoma Bolbostematis 15g, Radix Curcumae 12g, Herba Taraxaci 15g, Radix Paeoniae Alba 8g, Herba Solani Nigri 12g, Radix Glycyrrhizae Preparata 5g, Radix Angelicae Sinensis 18g, add water and carry Taking 2 times, each amount of water is respectively equivalent to 12 times of medical material gross weight, 10 times, each extraction time be respectively 3 hours, 2 little Time, united extraction liquid, filter, it is the clear paste of 1.05 that filtrate is concentrated into relative density at 80 DEG C, adds ethanol, makes the alcohol content be 70%, stand 12 hours, filter, when filtrate is concentrated into 70 DEG C, relative density is the extractum of 1.25, adds dextrin, magnesium stearate, micro- Crystalline cellulose, mixing, pelletize, be dried, tabletting, to obtain final product.

Embodiment 7: the preparation (scheme four) of capsule

Take Radix Astragali 25g, Fructus Ligustri Lucidi 12g, Rhizoma Polygonati 20g, Rhizoma Atractylodis Macrocephalae 12g, Poria 15g, Radix Bupleuri 20g, Pericarpium Citri Reticulatae Viride 12g, Pericarpium Citri Reticulatae 10g, Bulbus Fritillariae Thunbergii 15g, Rhizoma Bolbostematis 8g, Radix Curcumae 10g, Herba Taraxaci 10g, Radix Paeoniae Alba 10g, Herba Solani Nigri 10g, Radix Glycyrrhizae Preparata 3g, Radix Angelicae Sinensis 8g, return with ethanol Stream extracts 2 times, and each concentration of alcohol is respectively 80%, 60%, and each ethanol consumption is respectively 10 times of medical material total amount, 8 times, extracts Time is respectively 4 hours, 3 hours, united extraction liquid, filters, and when filtrate is concentrated into 80 DEG C, relative density is the extractum of 1.10, adds Enter micropowder silica gel, carboxymethyl starch sodium, mix, pelletize, be dried, sieve, enter capsule, to obtain final product.

Embodiment 8: the preparation (scheme five) of capsule

Take Radix Astragali 30g, Fructus Ligustri Lucidi 10g, Rhizoma Polygonati 20g, Rhizoma Atractylodis Macrocephalae 15g, Poria 12g, Radix Bupleuri 10g, Pericarpium Citri Reticulatae Viride 15g, Pericarpium Citri Reticulatae 8g, Zhejiang Bulbus Fritillariae Uninbracteatae 8g, Rhizoma Bolbostematis 10g, Radix Curcumae 8g, Herba Taraxaci 5g, Radix Paeoniae Alba 12g, Herba Solani Nigri 8g, Radix Glycyrrhizae Preparata 7g, Radix Angelicae Sinensis 15g, add ethanol percolation Extract 3 times, add every time amount of alcohol be equivalent to medical material gross weight 2 times, 2 times, 1 times, three times percolation concentration of alcohol is respectively 60%, 50%, 40%, percolation speed is that effluent per minute accounts for raw material gross weight 0.2%～0.6%, collects percolate, reclaims Ethanol, is evaporated to be equivalent to 2 times of medical material gross weight, filters, and adds Polyethylene Glycol, starch, Pulvis Talci, mix, pelletize, It is dried, sieves, enter capsule, to obtain final product.

Embodiment 9: the preparation of powder

Take Radix Astragali 30g, Fructus Ligustri Lucidi 12g, Rhizoma Polygonati 15g, Rhizoma Atractylodis Macrocephalae 15g, Poria 15g, Radix Bupleuri 15g, Pericarpium Citri Reticulatae Viride 15g, Pericarpium Citri Reticulatae 10g, Bulbus Fritillariae Thunbergii 12g, Rhizoma Bolbostematis 10g, Radix Curcumae 10g, Herba Taraxaci 15g, Radix Paeoniae Alba 12g, Herba Solani Nigri 10g, Radix Glycyrrhizae Preparata 5g, Radix Angelicae Sinensis 12g, clean, Pulverize, sieve, to obtain final product.

Clinical treatment is summed up

1, case selection: women, Postoperative Patient with Breast Cancer, me section's hospitalization (chemicotherapy, check, immunization therapy person All include in), strong side mammary gland has distending pain sense, and strong side Galactophore Dept. is laid one's hand on and agglomerate, and molybdenum target inspection is shown as BI-RADS I III grades.Patient Age does not limits, and the course of disease does not limits.

2, diagnostic criteria brief introduction

The BI-RADS classification checked with reference to breast molybdenum target, this image check result shows I III grades for optimum change, level The highest character of number is the poorest.

Symptom: patient has distending pain when being good for side mammary gland, may increase the weight of at premenstrua.Clinic is laid one's hand on and lump or agglomerate, has pressure Bitterly.

Molybdenum target inspection is shown as BI-RADS I III grades.

3, curative effect determinate standard:

Effective: distending pain sense disappears, palpation mammary gland nodules disappears, and molybdenum target inspection display BI-RADS classification reduces at least two grades, Meet above wherein one be effective.

Effective: distending pain sense alleviates, palpation mammary gland nodules deliquescing or scope diminish, molybdenum target inspection display BI-RADS classification fall Low one-level, meet above wherein one be effective.

Invalid: symptom, sign or impact check unchanged.

As after treatment, symptom, sign, molybdenum target inspection improvement degree have conflict, according to the effective ＞ of effective ＞ in above three Invalid principle is sorted out.

4, treatment packet

Blank group: do not use medicine.

Treatment group: the embodiment of the present invention 3 syrup, each 150ml, every day 2 times.

Matched group: BUPIXIAO PIAN, oral.5-6 sheet, 3 times on the one.

Treatment 4 weeks altogether.

5 therapeutic outcomes are shown in Table 1.

Table 1 clinical treatment comparitive study

Note: compared with treatment group total effective rate, * P < 0.01.

Clinical effectiveness shows: the pharmaceutical composition that the present invention provides, can be more compared with prior art Chinese patent medicine BUPIXIAO PIAN Effectively treatment patient with breast cancer is good for side mammary gland existence benign lesion in various degree, patient's mammary swelling pain complete incidence graph, bag after treatment Block disappears.And the present invention is compared with matched group, curative effect of the present invention is more preferable, and both have pole significant difference.

Model case

Yellow X English, female, 53 years old, people from Liuzhou city, Guangxi province, arrives my section's rowization in hospital in March, 2013 after row left breast cancer excision Treat.Having distending pain more than 1 year during conscious right breast time medical, accessible right breast outside upper quadrant agglomerate, border is clear, about 4*5cm, matter In, tenderness is obvious, and skin temperature, the colour of skin are unchanged.Right breast mixed type IV a(fibrocystic hyperplasia is shown in breast molybdenum target inspection), right breast BI- RADS:III.After the embodiment of the present invention 2 oral medication February, right mammary swelling pain complete incidence graph, enclosed mass disappears, and checks breast molybdenum target Right breast BI-RADS:I is shown in inspection.For effective.

Bears X is beautiful, female, 50 years old, people from Liuzhou city, Guangxi province, after right breast cancer postoperative chemotherapy nearly 3 years, is admitted to hospital in January, 2013.OK Check and immunization therapy.Having distending pain during the left breast of patient's intuition over several years, left breast central area of having a medical check-up touches an enclosed mass, about 3.5 × 4cm, skin is without flushing, and enclosed mass matter is hard, and border is clear, locally skin Wen Bugao, has pain, without fluctuation；The rightest breast mixed type IV b(is fine Dimensional tissue hypertrophy is main), right breast BI-RADS: II.After the embodiment of the present invention 4 oral medication February, left mammary swelling pain complete incidence graph, Enclosed mass disappears, and right breast BI-RADS:I is shown in check breast molybdenum target inspection.For effective.

Deep X, female, 25 years old, people from Liuzhou city, Guangxi province, right Mammary cancer was in hospital radiotherapy in my section in July, 2013.Patient is certainly Feel left breast time have distending pain more than 2 years, often increase the weight of in premenstrua, pain is obvious, pain and tenderness.Have a medical check-up 1 position of the outside upper quadrant of left breast Touching an enclosed mass away from nipple 3cm, size about 2.0 × 2.0cm, matter is tough, and border is still clear, and surface is the most smooth, and mobility is general.Mammary gland Molybdenum target inspection is shown: left breast mixed type IV a(fibrocystic hyperplasia), left breast BI-RADS:II.Through the embodiment of the present invention 5 oral medication After February, left mammary swelling pain complete incidence graph, enclosed mass disappears, and left breast BI-RADS:I is shown in check breast molybdenum target inspection.For effective.

Although, used general explanation, detailed description of the invention and test, the present invention made detailed retouching Stating, but on the basis of the present invention, can make some modifications or improvements it, this is apparent to those skilled in the art 's.Therefore, these modifications or improvements without departing from theon the basis of the spirit of the present invention, belong to claimed Scope.

Claims (10)

1. treatment breast carcinoma is concurrently good for the pharmaceutical composition of side Benign Nodule, it is characterised in that it is by the raw material of following weight portion It is prepared from:

Radix Astragali 20-40 part, Fructus Ligustri Lucidi 8-18 part, Rhizoma Polygonati 10-20 part, Rhizoma Atractylodis Macrocephalae 10-20 part, Poria 10-20 part, Radix Bupleuri 10-20 part, Pericarpium Citri Reticulatae Viride 10-20 part, Pericarpium Citri Reticulatae 5-15 part, Bulbus Fritillariae Thunbergii 8-18 part, Rhizoma Bolbostematis 5-15 part, Radix Curcumae 5-15 part, Herba Taraxaci 10-20 part, in vain Chinese herbaceous peony 8-18 part, Herba Solani Nigri 5-15 part, Radix Glycyrrhizae Preparata 2-9 part, Radix Angelicae Sinensis 8-18 part.

Pharmaceutical composition the most according to claim 1, it is characterised in that it is to be prepared from by the raw material of following weight portion :

Radix Astragali 25-35 part, Fructus Ligustri Lucidi 10-15 part, Rhizoma Polygonati 12-18 part, Rhizoma Atractylodis Macrocephalae 12-18 part, Poria 12-18 part, Radix Bupleuri 12-18 Part, Pericarpium Citri Reticulatae Viride 12-18 part, Pericarpium Citri Reticulatae 8-12 part, Bulbus Fritillariae Thunbergii 10-15 part, Rhizoma Bolbostematis 8-12 part, Radix Curcumae 8-12 part, Herba Taraxaci 12-18 Part, Radix Paeoniae Alba 10-15 part, Herba Solani Nigri 8-12 part, Radix Glycyrrhizae Preparata 3-7 part, Radix Angelicae Sinensis 10-15 part.

Pharmaceutical composition the most according to claim 1, it is characterised in that it is to be prepared from by the raw material of following weight portion :

The Radix Astragali 30 parts, Fructus Ligustri Lucidi 12 parts, Rhizoma Polygonati 15 parts, the Rhizoma Atractylodis Macrocephalae 15 parts, 15 parts of Poria, Radix Bupleuri 15 parts, 15 parts of Pericarpium Citri Reticulatae Viride, Pericarpium Citri Reticulatae 10 Part, Bulbus Fritillariae Thunbergii 12 parts, Rhizoma Bolbostematis 10 parts, Radix Curcumae 10 parts, Herba Taraxaci 15 parts, the Radix Paeoniae Alba 12 parts, Herba Solani Nigri 10 parts, Radix Glycyrrhizae Preparata 5 parts, Radix Angelicae Sinensis 12 parts.

4. the pharmaceutical composition as described in one of claim 1-3, it is characterised in that its active component be use water carry or The ethanol extraction of 40-90% concentration expressed in percentage by volume is prepared from.

5. according to the pharmaceutical composition described in claim 1-3 any one, it is characterised in that its active component be by with Lower section method is prepared from:

Taking whole medical material, extracting in water 2-3 time, each amount of water is equivalent to 6-12 times of medical material gross weight, each extraction time For 1-3 hour, united extraction liquid, filter, at filtrate is concentrated into 70-80 DEG C, relative density is the clear paste of 1.10-1.25, to obtain final product Active component.

6. according to the pharmaceutical composition described in claim 1-3 any one, it is characterised in that its active component be by with Lower section method is prepared from:

Taking whole medical material, extracting in water 2-3 time, each amount of water is equivalent to 6-12 times of medical material gross weight, each extraction time For 1-3 hour, united extraction liquid, filter, at filtrate is concentrated into 70-80 DEG C, relative density is the clear paste of 1.05-1.20, adds Ethanol, making alcohol content is 40-70%, stands 12-24 hour, filters, and when filtrate is concentrated into 70-80 DEG C, relative density is 1.10- The extractum of 1.25, obtains active component.

7. according to the pharmaceutical composition described in claim 1-3 any one, it is characterised in that its active component be by with Lower section method is prepared from:

Take whole medical material, with ethanol ultrasonic extraction 3-4 time, add the 50-90% ethanol of medical material gross weight 2-4 times every time, surpass every time Sound extracts 2-5 hour, filters, and merging filtrate, when being concentrated into 70-80 DEG C, relative density is the extractum of 1.10-1.25, obtains work Property composition.

8. according to the pharmaceutical composition described in claim 1-3 any one, it is characterised in that its active component be by with Lower section method is prepared from:

Taking whole medical material, with 40-80% alcohol reflux 2-3 time, each ethanol consumption is 4-10 times of medical material total amount, extracts Time is 1-4 hour, united extraction liquid, filters, and when filtrate is concentrated into 60-80 DEG C, relative density is the extractum of 1.10-1.25, i.e. Obtain active component.

9. according to the pharmaceutical composition described in claim 1-3 any one, it is characterised in that its active component be by with Lower section method is prepared from:

Taking whole medical material, add ethanol percolate extraction 3-4 time, addition amount of alcohol is equivalent to medical material gross weight 1～2 times, second every time Determining alcohol is 40%～60% with volume basis, and percolation speed is that effluent per minute accounts for raw material gross weight 0.2%～0.6%, Collect percolate, reclaim ethanol, be evaporated to be equivalent to 1～2 times of medical material gross weight, filter, obtain active component.

10. treat breast carcinoma and be concurrently good for a Chinese medicine preparation for side Benign Nodule, by the treatment any one of claims 1 to 3 Breast carcinoma is concurrently good for the pharmaceutical composition of side Benign Nodule and is prepared from pharmaceutically acceptable carrier combination.