CN103736008A - Medicament composition for treating breast carcinoma concurrent uninjured side benign enclosed mass and preparation method thereof - Google Patents

Medicament composition for treating breast carcinoma concurrent uninjured side benign enclosed mass and preparation method thereof Download PDF

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CN103736008A
CN103736008A CN201310729547.0A CN201310729547A CN103736008A CN 103736008 A CN103736008 A CN 103736008A CN 201310729547 A CN201310729547 A CN 201310729547A CN 103736008 A CN103736008 A CN 103736008A
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radix
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pharmaceutical composition
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CN103736008B (en
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石彧
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LIUZHOU HOSPITAL OF TRADITIONAL CHINESE MEDICINE
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LIUZHOU HOSPITAL OF TRADITIONAL CHINESE MEDICINE
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Abstract

The invention relates to a medicament composition for treating breast carcinoma concurrent uninjured side benign enclosed mass and a preparation method thereof. The medicament composition is prepared from the following raw materials in parts by weight: astragalus membranaceus, glossy privet fruit, solomon's seal, bighead atractylodes rhizome, poria cocos, radix bupleuri, pericarpium citri reticulatae viride, dried tangerine or orange peel, thunberg fritillary bulb, rhizoma bolbostemmae, radix curcumae, dandelion, radix paeoniae alba, black nightshade, honey-fried licorice root and angelica sinensis. The medicament composition is capable of effectively treating the enclosed mass disease of benign lesions of different degrees of breast at the uninjured side of a patient suffering from breast carcinoma. The medicament composition provided by the invention is accurate in curative effect on the aspect of treating the breast carcinoma concurrent uninjured side benign enclosed mass; the effect of the medicament composition is superior to that of the prior art.

Description

Pharmaceutical composition of the concurrent strong side Benign Nodule for the treatment of breast carcinoma and preparation method thereof
Technical field
The present invention relates to drug world, be specifically related to pharmaceutical composition for the treatment of the concurrent strong side Benign Nodule of breast carcinoma and preparation method thereof.
Background technology
Breast mass is numerous women's commonly encountered diseases, according to breast molybdenum target inspection, can be divided into 0-VI, totally 6 grades.0 grade of patient is generally asymptomatic, and 0, I, II level patient be benign lesion.In III level patient, 98% is Benign Nodule, and 2% is pernicious.If I-III level pathological changes patient is without treatment, may cause classification to be increased due to the differentiation of the state of an illness, need to bear and change pernicious risk into.This risk is more remarkable on the body that itself has been patient with breast cancer.But clinically this situation do not caused to enough attention at present, and doctor trained in Western medicine aspect is without effective therapy.
My section finds in clinical position, surpasses the patient with breast cancer of half, and strong side mammary gland all exists benign lesion in various degree.Be no lack of clinically bilateral breast and all suffer from the patient of cancer, the enclosed mass disease of the strong side mammary gland of this and patient has necessarily and contacts.Therefore this class patient's strong side benign breast lesions is answered and early treatment especially.The present invention is the strong side Benign Nodule disease that the side's of plan medicine easing the affected liverization breast soup oral medication patient with breast cancer merges certainly, obtains good therapeutic effect.
Summary of the invention
The object of this invention is to provide a kind of pharmaceutical composition for the treatment of the concurrent strong side Benign Nodule of breast carcinoma;
Another object of the present invention is to provide a kind of preparation method for the treatment of the pharmaceutical composition of the concurrent strong side Benign Nodule of breast carcinoma.
The object of the invention is to realize by following technical scheme:
The pharmaceutical composition of the concurrent strong side Benign Nodule for the treatment of breast carcinoma described in patent of the present invention, it is to be prepared from by the raw material that comprises following weight portion:
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, 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, be to be prepared from by the raw material that comprises 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.
More preferably, be to be prepared from by the raw material that comprises following weight portion:
30 parts of the Radixs Astragali, 12 parts of Fructus Ligustri Lucidi, 15 parts of Rhizoma Polygonatis, 15 parts of the Rhizoma Atractylodis Macrocephalaes, 15 parts, Poria, 15 parts of Radix Bupleuri, 15 parts, Pericarpium Citri Reticulatae Viride, 10 parts of Pericarpium Citri Reticulataes, 12 parts of Bulbus Fritillariae Thunbergiis, 10 parts of Rhizoma Bolbostematiss, 10 parts of Radix Curcumaes, 15 parts of Herba Taraxacis, 12 parts of the Radix Paeoniae Albas, 10 parts of Herba Solani Nigris, 5 parts of Radix Glycyrrhizae Preparatas, 12 parts of Radix Angelicae Sinensis.
Below crude drug source and the main effect of Chinese medicine preparation of the present invention:
The Radix Astragali: be the dry root of leguminous plant Radix Astagali Astragalusmembranaceus (Fisch.) Bge. var. mongolicus (Bge.) Hsiao or Radix Astragali Astragalusmembranaceus (Fisch.) Bge..Record in one the 283rd page of < < Chinese Pharmacopoeia > > version in 2010.[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, the metrorrhagia of having blood in stool, exterior deficiency spontaneous perspiration, deficiency of vital energy edema, carbuncle is difficult bursts, and burst and do not hold back for a long time, blood deficiency dull yellowish colored skin, interior-heat is quenched one's thirst; Chronic nephritis proteinuria, diabetes.
Fructus Ligustri Lucidi: be 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, improve visual and auditory acuity, black beard and hair.Cure mainly: Light-headedness; Soreness of the waist and knees; 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: be liliaceous plant Yunnan Rhizoma Polygonati PolygonatumkingianumColl.etHemsl., Rhizoma Polygonati PolygonatumsibiricumRed. or the Polygonatum cyrtonema Hua (dry rhizome of PolygonatumcyrtonemaHua..Record in one the 288th page of < < Chinese Pharmacopoeia > > version in 2010.[nature and flavor] are sweet, flat.[return through] returns spleen, lung, kidney channel.[function cures mainly] boosting qi and nourishing yin, 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 one the 68th page of < < Chinese Pharmacopoeia > > version in 2005.[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 spleen invigorating, stomach function regulating, antiabortive.For insufficiency of the spleen lack of appetite, the loose stool of having loose bowels, frequent fetal movement.
Poria is the dry sclerotia of On Polyporaceae Poria Poriacocos (Schw.) Wolf.Record in one the 166th page of < < Chinese Pharmacopoeia > > version in 2005.[nature and flavor] are sweet, light, flat.[return through] GUIXIN, lung, spleen, kidney channel.[function cures mainly] promoting diuresis to eliminate damp pathogen, spleen invigorating mind calming.For edema oliguria, phlegm retention vertigo and palpitation, insufficiency of the spleen lack of appetite, have loose bowels in loose stool, irritability, palpitation with fear insomnia.Modern medicine study: Poria energy enhancing human body immunity function, pachyman has obvious antitumor and protects the liver dirty effect.
Radix Bupleuri: this product is the dry root of umbelliferae bupleurum BupleurumchinenseDC. or Radix Bupeuri Scorzonerfolii. Bupleurums-corzonerifoliumWilld..Different by character, practise respectively and claim " Radix Bupleuri " and " Radix Bupleuri Scorzonerifolii ".Spring, Qiu Erji excavate, and remove stem and leaf and silt, dry.[nature and flavor] hardship, is slightly cold.[return through] returns liver, gallbladder meridian.[function cures mainly] reconciling superficies and interior, soothing the liver, yang invigorating.For cold, fever, alternate attack of chill and fever, distending pain in the chest and hypochondrium, menoxenia, sub-official's prolapsus, 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 piece.
Pericarpium Citri Reticulatae: be the dry mature skin of rutaceae orange and 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, powder detoxifcation.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, careless shellfish.Source is slightly cold for cucurbitaceous plant Bolbostemma paniculatum dependent territory Bulbus Fritillariae Uninbracteatae Rhizoma Bolbostematis dry tuber [property of medicine].[flavour of a drug] hardship.[return through] returns lung, spleen channel.[function] eliminating stagnation, detumescence, removing toxic substances.[curing mainly] 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 swelling and pain, twinge, calentura coma, epilepsy is gone mad, jaundice dark coloured urine.[composition] is containing volatile oil.[pharmacology] 1, stomach invigorating 2, function of gallbladder promoting 3, diuresis 4, also has slight analgesic activity.
The Radix Paeoniae Alba: also claiming Radix Paeoniae Alba, Paeonia sterniana Fletcher in Journ., is the dry root of ranunculaceae plant Radix Paeoniae PaeonialactifloraPall..Record in one the 68th page of < < Chinese Pharmacopoeia > > version in 2005.[nature and flavor] are bitter, sour, are slightly cold.[return through] returns liver, spleen channel.The pain relieving of [function cures mainly] suppressing the hyperactive liver, nourishing blood for regulating menstruation, astringing YIN to stop sweating.Be used for having a headache dizzy, hypochondriac pain, stomachache, limb pain twin, blood deficiency and yellow complexion, menoxenia, spontaneous perspiration, night sweat.
Herba Solani Nigri: calling black seed dish, Herba Solani Surattensis, cattle Calyx seu fructus physalis, black Radix Betae, is 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 and effect]: heat clearing away, removing toxic substances, invigorates blood circulation, detumescence.Control furuncle, carbuncle, erysipelas, osteopatia sprain, chronic tracheitis, acute nephritis.For sore and toxic, skin eczema, dysuria, chronic senile tracheitis, leukorrhagia, prostatitis, dysentery, cat fever, toothache, urinary system infection, mastitis, leucorrhea, cancer; Carbuncle furuncle furuncle, pemphigus, injury from falling down, venom are controlled in external.
Radix Glycyrrhizae Preparata: the Preparation process product that this product is Radix Glycyrrhizae.Radix Glycyrrhizae is that the dry root and rhizome of glycyrrhizic legume Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat. Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L. Glycyrrhiza glabra L. records in one the 80th page of < < Chinese Pharmacopoeia > > version in 2010.
Radix Angelicae Sinensis: be 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 that all cards of blood deficiency, menoxenia, amenorrhea, dysmenorrhea, lump in the abdomen knot are poly-, weight, ulcer sores, injury from falling down after metrorrhagia, asthenia cold abdominalgia, flaccidity syndrome and arthralgia syndrome, numbness of the skin, dryness of the intestine dyschezia, bloody dysentery.
Another aspect of the present invention has been to provide the preparation method of the active component of pharmaceutical composition of the present invention, and the method is the ethanol extraction that adopts water extraction or 40-90% concentration expressed in percentage by volume.Concrete preparation method is as follows:
Scheme one: get whole medical materials, extracting in water 2-3 time, each amount of water is equivalent to 6-12 times of medical material gross weight, each extraction time is 1-3 hour, and merge extractive liquid, filters, filtrate is concentrated into the clear paste that at 70-80 ℃, relative density is 1.10-1.25, obtains active component.
Scheme two: get whole medical materials, extracting in water 2-3 time, each amount of water is equivalent to 6-12 times of medical material gross weight, each extraction time is 1-3 hour, merge extractive liquid,, filters, and filtrate is concentrated into the clear paste that at 70-80 ℃, relative density is 1.05-1.20, add ethanol, making containing alcohol amount is 40-70%, and standing 12-24 hour filters, the extractum that when filtrate is concentrated into 70-80 ℃, relative density is 1.10-1.25, obtains active component.
Scheme three: get whole medical materials, use ethanol ultrasonic extraction 3-4 time, add medical material gross weight 2-4 50-90% ethanol doubly at every turn, each supersound extraction 2-5 hour, filters merging filtrate, the extractum that while being concentrated into 70-80 ℃, relative density is 1.10-1.25, obtains active component.
Scheme four: get whole medical materials, use 40-80% alcohol reflux 2-3 time, the 4-10 that each ethanol consumption is medical material total amount doubly, extraction time is 1-4 hour, and merge extractive liquid, filters, the extractum that when filtrate is concentrated into 60-80 ℃, relative density is 1.10-1.25, obtains active component.
Scheme five: get whole medical materials, add ethanol percolate extraction 3-4 time, add amount of alcohol to be equivalent to 1~2 times of medical material gross weight at every turn, concentration of alcohol counts 40%~60% with volume ratio, and percolation speed is that effluent per minute accounts for raw material gross weight 0.2%~0.6%, collects percolate, reclaim ethanol, be evaporated to and be equivalent to 1~2 times of medical material gross weight, filter, obtain active component.
Scheme six: get whole medical materials, clean, pulverize, sieve, obtain.
 
Pharmaceutical composition of the present invention can be made various common formulations together by its effective ingredient and/or pharmaceutically acceptable carrier, as tablet, capsule, pill, drop pill, granule, medicinal tea, mixture, syrup, powder etc.
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 etc.
Binding agent: starch slurry, pregelatinized Starch, dextrin etc.
Disintegrating agent: starch, carboxymethyl starch sodium, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose, low replacement-carboxy-propyl cellulose, citric acid, polyoxyethylene sorbitan monoleate etc.
Lubricant: stearic acid, calcium stearate, magnesium stearate, Pulvis Talci, hydrogenated vegetable oil, Polyethylene Glycol, sodium lauryl sulphate, 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.
Antiseptic: benzoic acid, sodium benzoate, sorbic acid and salt thereof, propanoic acid, parabens etc.
Sugar coating material, as sucrose, Pulvis Talci, gelatin, pigment, river wax etc.; Thin film coating material, as stomach dissolution type water, alcohol coating material etc.
For example, it can be prepared as various common dosage forms by one of following method: tablet, capsule, pill, drop pill, medicinal tea, mixture, syrup, powder.
Method 1: granule
Get scheme one to one of scheme five gained active component, add granule to commonly use adjuvant, production method is prepared into the granule of pharmaceutical composition of the present invention routinely.
The conventional adjuvant of above-mentioned granule comprises one of filler, binding agent, lubricant or whole.
Method 2: syrup
Get scheme one to one of scheme five gained active component, add syrup to commonly use adjuvant, production method is prepared into the syrup of pharmaceutical composition of the present invention routinely.
The conventional adjuvant of above-mentioned syrup comprises one of correctives, antiseptic, cosolvent or whole.
Method 3: tablet
Get scheme one to one of scheme five gained active component, add tablet to commonly use adjuvant, production method is prepared into the tablet of pharmaceutical composition of the present invention routinely.
The conventional adjuvant of above-mentioned tablet comprises one of filler, binding agent, disintegrating agent, lubricant or whole.
Method 4: capsule
Get scheme one to one of scheme five gained active component, add capsule to commonly use adjuvant, production method is prepared into the capsule of pharmaceutical composition of the present invention routinely.
The conventional adjuvant of above-mentioned capsule comprises one of filler, fluidizer, disintegrating agent, lubricant or whole.
 
The applicant, on the basis of research tradition Chinese medicine, through test for many years, has found the breast carcinoma good several drugs of concurrent strong side Benign Nodule therapeutic effect has been completed to the present invention.
Mammary gland nodules is born in side, and the traditional Chinese medical science is thought Liver Channel pathological changes, does not relax with temperament and interest, and depression of liver-QI is relevant.Stagnation of liver-QI is taken advantage of spleen, and surgical injury temper, damp-retention due to hypofunction of the spleen, and turbid damp obstructing in middle-JIAO is not changed, and more easily produces enclosed mass disease, therefore this class patient belongs to liver-depression and spleen-insufficiency type more.The present invention uses kinds of traditional Chinese medicines reasonable formula, forms and has soothing liver and strengthening spleen, strengthening vital QI to eliminate pathogenic factors, the prescription of hard masses softening and resolving effect.
A kind of pharmaceutical composition for the treatment of the concurrent strong side Benign Nodule of breast carcinoma provided by the invention has the following advantages:
1, the while in hospital of patient after breast cancer operation, for the Benign Nodule situation of its strong side mammary gland, use preparation for treating of the present invention, the deliquescing of enclosed mass hardness, scope is dwindled even and is disappeared, pain relief, effect is remarkable.
2, the present invention compares with prior art Chinese patent medicine BUPIXIAO PIAN, can more effectively treat the strong side mammary gland of patient with breast cancer and have benign lesion in various degree, and both have utmost point significant difference.
 
The specific embodiment
Below by embodiment, further illustrate the present invention.It should be understood that embodiments of the invention are for the present invention rather than limitation of the present invention are described.The simple modifications that essence according to the present invention is carried out the present invention all belongs to the scope of protection of present invention.Except as otherwise noted, the percent of the amount of alcohol in the present invention is percentage by volume, and v/v represents the volume ratio of solution.
embodiment 1: the preparation of granule (scheme one)
Get 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, extracting in water 3 times, three amount of water are respectively 12 times of medical material gross weight, 8 times, 6 times, three extraction times are respectively 3 hours, 2 hours, 1 hour, merge extractive liquid, filter, filtrate is concentrated into the clear paste that at 80 ℃, relative density is 1.10, add cane sugar powder, dextrin, mix, granulate, dry, granulate, subpackage, obtain.
embodiment 2: the preparation of granule (scheme four)
Get 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, Bulbus Fritillariae Thunbergii 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, with 40% alcohol reflux 3 times, 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, merge extractive liquid, filter, the extractum that when filtrate is concentrated into 60 ℃, relative density is 1.25, obtain active component, add lactose, starch, granulate, dry, granulate, subpackage, obtain.
embodiment 3: the preparation of syrup (scheme two)
Get 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, extracting in water 3 times, three amount of water are equivalent to respectively 12 times of medical material gross weight, 8 times, 6 times, 3 hours respectively each extraction time, 2 hours, 1 hour, merge extractive liquid, filter, filtrate is concentrated into the clear paste that at 70 ℃, relative density is 1.20, add ethanol, making containing alcohol amount is 40%, standing 24 hours, filter, the extractum that when filtrate is concentrated into 80 ℃, relative density is 1.10, add sucrose, potassium sorbate, mix, subpackage, obtain.
embodiment 4: the preparation of syrup (scheme five)
Get 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, Bulbus Fritillariae Thunbergii 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 percolate extraction 4 times, add amount of alcohol to be equivalent to respectively 2 times of medical material gross weights at every turn, 2 times, 1 times, 1 times, four times percolation is respectively 60% with concentration of alcohol, 50%, 40%, 40%, four percolation speed are respectively effluent per minute and account for 0.2% of raw material gross weight, 0.3%, 0.4%, 0.6%, collect percolate, reclaim ethanol, be evaporated to and be equivalent to 1 times of medical material gross weight, filter, add glycerol, nipalgin, stevioside, mix, subpackage, obtain.
embodiment 5: the preparation of tablet (scheme three)
Get 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, with ethanol ultrasonic extraction 4 times, add respectively 4 times of medical material gross weights for four times, 3 times, 2 times, 2 times, four times ultrasonic is respectively 90% with concentration of alcohol, 80%, 60%, 50%, four supersound extraction times are respectively 5 hours, 4 hours, 3 hours, 2 hours, extracting liquid filtering, merging filtrate, the extractum that while being concentrated into 70 ℃, relative density is 1.25, add lactose, Pulvis Talci, mix, granulate, dry, tabletting, obtain.
embodiment 6: the preparation of tablet (scheme two)
Get 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, extracting in water 2 times, each amount of water is equivalent to respectively 12 times of medical material gross weight, 10 times, each extraction time is respectively 3 hours, 2 hours, merge extractive liquid, filter, filtrate is concentrated into the clear paste that at 80 ℃, relative density is 1.05, add ethanol, making containing alcohol amount is 70%, standing 12 hours, filter, the extractum that when filtrate is concentrated into 70 ℃, relative density is 1.25, add dextrin, magnesium stearate, microcrystalline Cellulose, mix, granulate, dry, tabletting, obtain.
embodiment 7: the preparation of capsule (scheme four)
Get 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, with alcohol reflux 2 times, each concentration of alcohol is respectively 80%, 60%, each ethanol consumption is respectively 10 times of medical material total amount, 8 times, extraction time is respectively 4 hours, 3 hours, merge extractive liquid, filter, the extractum that when filtrate is concentrated into 80 ℃, relative density is 1.10, add micropowder silica gel, carboxymethyl starch sodium, mix, granulate, dry, sieve, enter capsule, obtain.
embodiment 8: the preparation of capsule (scheme five)
Get 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, Bulbus Fritillariae Thunbergii 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 percolate extraction 3 times, add amount of alcohol to be equivalent to 2 times of medical material gross weights at every turn, 2 times, 1 times, three times percolation is respectively 60% with concentration of alcohol, 50%, 40%, percolation speed is that effluent per minute accounts for raw material gross weight 0.2%~0.6%, collect percolate, reclaim ethanol, be evaporated to and be equivalent to 2 times of medical material gross weight, filter, add Polyethylene Glycol, starch, Pulvis Talci, mix, granulate, dry, sieve, enter capsule, obtain.
embodiment 9: the preparation of powder
Get 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, cleans, and pulverizes, and sieves, and obtains.
?
clinical treatment is summed up
1, case selection: women, Postoperative Patient with Breast Cancer, Wo section 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 level.Patient age is not limit, and the course of disease is not limit.
2, diagnostic criteria brief introduction
The BI-RADS classification checking with reference to breast molybdenum target, this image check result shows that I-III level is optimum variation, the higher character of progression is poorer.
Symptom: patient has distending pain during strong side mammary gland, may increase the weight of at premenstrua.Clinical laying one's hand on and lump or agglomerate, has tenderness.
Molybdenum target inspection is shown as BI-RADS I-III level.
3, curative effect determinate standard:
Effective: distending pain sense disappears, palpation mammary gland nodules disappears, and molybdenum target inspection shows that BI-RADS classification reduces at least secondary, meet above wherein one be effective.
Effective: distending pain sense alleviates, the deliquescing of palpation mammary gland nodules or scope diminish, and molybdenum target inspection shows that BI-RADS classification reduces one-level, meet above wherein one be effective.
Invalid: symptom, sign or impact check unchanged.
As treat rear symptom, sign, molybdenum target inspection and improve degree have conflict in above three, according to the invalid principle of the effective > of effective >, sort out.
4, treatment grouping
Blank group: do not use medicine.
Treatment group: the embodiment of the present invention 3 syrups, each 150ml, every day 2 times.
Matched group: BUPIXIAO PIAN, oral.A 5-6 sheet, 3 times on the one.
Treat altogether 4 weeks.
5 therapeutic outcomes are in Table 1.
The comparison of table 1 clinical treatment curative effect
Figure 2013107295470100002DEST_PATH_IMAGE001
Note: compare * P<0.01 with treatment group total effective rate.
Clinical effectiveness shows: pharmaceutical composition provided by the invention is compared with prior art Chinese patent medicine BUPIXIAO PIAN, can more effectively treat the strong side mammary gland of patient with breast cancer and have benign lesion in various degree, and after treatment, patient's mammary swelling pain is alleviated completely, and enclosed mass disappears.And the present invention compares with matched group, curative effect of the present invention is better, and both have utmost point significant difference.
?
model case
Yellow X English, female, 53 years old, people from Liuzhou city, Guangxi province, in March, 2013 the row left breast cancer excision Hou Daowo section row chemotherapy of being in hospital.When medical, have distending pain more than 1 year during conscious right breast, can touch the outside upper quadrant agglomerate of right breast, border is clear, about 4*5cm, and in matter, tenderness is obvious, and skin temperature, the colour of skin are unchanged.Right newborn mixed type IV a(fibrocystic hyperplasia is shown in breast molybdenum target inspection), right newborn BI-RADS:III.Through the embodiment of the present invention 2 oral medications, after February, right mammary swelling pain is alleviated completely, and enclosed mass disappears, and right newborn BI-RADS:I is shown in the inspection of check breast molybdenum target.For effective.
Bears X is beautiful, female, and 50 years old, people from Liuzhou city, Guangxi province, after right breast cancer postoperative chemotherapy nearly 3 years, was admitted to hospital in January, 2013.Row check and immunization therapy.The patient over several years left breast of an intuition time has distending pain, and the left newborn central area of having a medical check-up touches an enclosed mass, about 3.5 * 4cm, and skin is without flushing, and enclosed mass matter is hard, and border is clear, and local skin Wen Bugao has pain, calm innervation; 1. right newborn mixed type IV b(proliferation of fibrous tissue is main), right newborn BI-RADS: II.Through the embodiment of the present invention 4 oral medications, after February, left mammary swelling pain is alleviated completely, and enclosed mass disappears, and right newborn BI-RADS:I is shown in the inspection of check breast molybdenum target.For effective.
Deep X, female, 25 years old, people from Liuzhou city, Guangxi province, after right breast cancer operation in July, the 2013 Wo section radiotherapy of being in hospital.Patient is conscious, and left breast time has distending pain more than 2 years, often in premenstrua, increases the weight of, and pain is obvious, pain and tenderness.1 distance of positions nipple 3cm of the outside upper quadrant of the left breast of having a medical check-up touches an enclosed mass, and size is 2.0 * 2.0cm approximately, and matter is tough, and border is still clear, and surface is still smooth, and mobility is general.Breast molybdenum target inspection is shown: left newborn mixed type IV a(fibrocystic hyperplasia), and left newborn BI-RADS:II.Through the embodiment of the present invention 5 oral medications, after February, left mammary swelling pain is alleviated completely, and enclosed mass disappears, and left newborn BI-RADS:I is shown in the inspection of check breast molybdenum target.For effective.
 
Although, above used general explanation, the specific embodiment and test, the present invention is described in detail, on basis of the present invention, can make some modifications or improvements it, and this will be apparent to those skilled in the art.Therefore, these modifications or improvements, all belong to the scope of protection of present invention without departing from theon the basis of the spirit of the present invention.

Claims (10)

1. treat pharmaceutical composition of the concurrent strong side Benign Nodule of breast carcinoma and preparation method thereof, it is characterized in that it is to be prepared from by the raw material that comprises following weight portion:
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, Radix Paeoniae Alba 8-18 part, Herba Solani Nigri 5-15 part, Radix Glycyrrhizae Preparata 2-9 part, Radix Angelicae Sinensis 8-18 part.
2. pharmaceutical composition according to claim 1, is characterized in that it is to be prepared from by the raw material that comprises 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.
3. pharmaceutical composition according to claim 1, is characterized in that it is to be prepared from by the raw material that comprises following weight portion:
30 parts of the Radixs Astragali, 12 parts of Fructus Ligustri Lucidi, 15 parts of Rhizoma Polygonatis, 15 parts of the Rhizoma Atractylodis Macrocephalaes, 15 parts, Poria, 15 parts of Radix Bupleuri, 15 parts, Pericarpium Citri Reticulatae Viride, 10 parts of Pericarpium Citri Reticulataes, 12 parts of Bulbus Fritillariae Thunbergiis, 10 parts of Rhizoma Bolbostematiss, 10 parts of Radix Curcumaes, 15 parts of Herba Taraxacis, 12 parts of the Radix Paeoniae Albas, 10 parts of Herba Solani Nigris, 5 parts of Radix Glycyrrhizae Preparatas, 12 parts of Radix Angelicae Sinensis.
4. as the pharmaceutical composition of claim 1-3 as described in any one, the active component that it is characterized in that it is to adopt the ethanol extraction of water extraction or 40-90% concentration expressed in percentage by volume to be prepared from.
5. the pharmaceutical composition described in any one according to claim 1-3, is characterized in that its active component is prepared from by the following method:
Get whole medical materials, extracting in water 2-3 time, each amount of water is equivalent to 6-12 times of medical material gross weight, and each extraction time is 1-3 hour, and merge extractive liquid, filters, and filtrate is concentrated into the clear paste that at 70-80 ℃, relative density is 1.10-1.25, obtains active component.
6. the pharmaceutical composition described in any one according to claim 1-3, is characterized in that its active component is prepared from by the following method:
Get whole medical materials, extracting in water 2-3 time, each amount of water is equivalent to 6-12 times of medical material gross weight, each extraction time is 1-3 hour, merge extractive liquid,, filters, and filtrate is concentrated into the clear paste that at 70-80 ℃, relative density is 1.05-1.20, add ethanol, making containing alcohol amount is 40-70%, and standing 12-24 hour filters, the extractum that when filtrate is concentrated into 70-80 ℃, relative density is 1.10-1.25, obtains active component.
7. the pharmaceutical composition described in any one according to claim 1-3, is characterized in that its active component is prepared from by the following method:
Get whole medical materials, use ethanol ultrasonic extraction 3-4 time, add medical material gross weight 2-4 50-90% ethanol doubly at every turn, each supersound extraction 2-5 hour, filters, merging filtrate, and the extractum that while being concentrated into 70-80 ℃, relative density is 1.10-1.25, obtains active component.
8. the pharmaceutical composition described in any one according to claim 1-3, is characterized in that its active component is prepared from by the following method:
Get whole medical materials, use 40-80% alcohol reflux 2-3 time, the 4-10 that each ethanol consumption is medical material total amount doubly, extraction time is 1-4 hour, and merge extractive liquid, filters, the extractum that when filtrate is concentrated into 60-80 ℃, relative density is 1.10-1.25, obtains active component.
9. the pharmaceutical composition described in any one according to claim 1-3, is characterized in that its active component is prepared from by the following method:
Get whole medical materials, add ethanol percolate extraction 3-4 time, add amount of alcohol to be equivalent to 1~2 times of medical material gross weight at every turn, concentration of alcohol counts 40%~60% with volume ratio, and percolation speed is that effluent per minute accounts for raw material gross weight 0.2%~0.6%, collects percolate, reclaim ethanol, be evaporated to and be equivalent to 1~2 times of medical material gross weight, filter, obtain active component.
10. treat a Chinese medicine preparation for the concurrent strong side Benign Nodule of breast carcinoma, comprise the pharmaceutical composition of the concurrent strong side Benign Nodule for the treatment of breast carcinoma of any one in claim 1~3 and pharmaceutically acceptable carrier.
CN201310729547.0A 2013-12-26 2013-12-26 Treatment breast carcinoma pharmaceutical composition being concurrently good for side Benign Nodule and preparation method thereof Expired - Fee Related CN103736008B (en)

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