CN107029006A - A kind of pharmaceutical composition for being used to treat fibroid - Google Patents

A kind of pharmaceutical composition for being used to treat fibroid Download PDF

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CN107029006A
CN107029006A CN201611132918.7A CN201611132918A CN107029006A CN 107029006 A CN107029006 A CN 107029006A CN 201611132918 A CN201611132918 A CN 201611132918A CN 107029006 A CN107029006 A CN 107029006A
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weight
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ethanol
pharmaceutical composition
decoction
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不公告发明人
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Jinan Haoyu Qingtian Medicine Technology Co ltd
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Jinan Haoyu Qingtian Medicine Technology Co ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/12—Ketones
    • A61K31/122—Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
    • 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
    • A61K36/11—Pteridophyta or Filicophyta (ferns)
    • 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)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • 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)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/35—Caprifoliaceae (Honeysuckle family)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/55—Liquid-liquid separation; Phase separation

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  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
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Abstract

The invention discloses a kind of pharmaceutical composition for treating fibroid and preparation method thereof, pharmaceutical composition of the present invention is using Chinese viburnum stem, streamwort, dryocrassin, Loxogramme chinensis ching, close flowers and plants as bulk drug, proportioning is formed, routinely various formulations can be made by preparation process, treatment fibroid is evident in efficacy.

Description

A kind of pharmaceutical composition for being used to treat fibroid
Technical field
The invention belongs to technical field of traditional Chinese medicines, more particularly to a kind of pharmaceutical composition for treating fibroid and its preparation side Method.
Background technology
Fibroid refers mainly to involve one group of disease of bone, joint and its surrounding soft tissue, and most of fibroids There is systemic manifestation, and may occur in which multiple organ injuries, once there is " collagen disease ", the title such as " CTD ".The general table of patient It is now self immune system dysfunction, it can detect that a variety of autoantibodies in vivo, and these antibody are examined rheumatic disease There is important value in disconnected.The generation of fibroid mainly with it is weakened body resistance relevant, QI-blood circulation is not smooth, hinders train of thought, strongly fragrant and heat With the passing of time red and swollen distending pain is not cured, muscle stiff atrophy short of provisions and numb, deformity, tends to be maimed, even involves the heart, lungs internal organs work( Can, threat to life.《Plain Questions》Point out:" go to garden to remove Zuo ", that is, dispel extravasated blood to attack relieve oedema or abdominal distension through diuresis or purgation wet therapy, suitable for bi Zheng with the passing of time, addiction Blood and wet turbid deadlocked to suffer from, the touching refractory person of painful swelling of joints.《The all numbness source streams of the turbid of miscellaneous diseases source stream rhinoceros》Say:" numbness person closes ", " three Gas is miscellaneous extremely, stops up amenorrhoea network, and qi and blood is not all right, can not dispel at any time scattered, therefore is numbness long ".QI-blood circulation is not smooth, and extravasated blood resistance network is rheumatism Main pathology link.《Danxi's experiential therapy》Meaning:" this is extravasated blood by oncotic arthralgia of limbs, the puckery person of rapid pulse " Tang Rongchuan is also said:" every pain, All addiction blood stagnation therefore ".Rheumatoid swelling pain, is the event of rheumatism blood clotting resistance network accordingly.Fibroid is treated to mend from promoting blood circulation Blood correct blood, body fluid firewood it is thick, cohesion set about, make train of thought is unimpeded just can dissipate without heat, flow and be stale-proof, lead to without pain, surely Obtain good effect.
Loxogramme chinensis ching：This product is Loxogrammaceae sword Cyclosorus plant Loxogramme chinensis ching Loxogramme chinensis Ching root Stem or herb.Whole year can harvest rhizome, the 7-9 months harvest herb, dry.【Nature and flavor】It is bitter；Cold nature.【Channel tropism】Bladder；Kidney Through.【Major function】It is clearing heat and detoxicating；Diuresis.Main urinary tract infections；Mastitis；Lyssodexis.【Former phytomorph】The high 8- of plant 18cm.Rhizome is elongated, grows wild, close by brown brown, lanceolar scale.Ye Jinsheng, has short handle；Blade meat, wire lanceolar is long 5-17cm, the wide 1-1.2cm in middle part, the sharp point of tip, base portion wedge shape and under be extended down to petiole bottom, full edge or wavy, do after remove from office Matter, there is wrinkle above；Slightly swell on middle arteries two sides.Sporangiorus Long Circle, is separated from each other by usual 5-8 pairs, pole obliquely, sometimes It is several parallel with middle arteries, middle arteries both sides are arranged in, are grown on more than back side middle part, bottom infertility；Without indusium.Record big in Chinese medicine Dictionary.
Chinese viburnum stem：For Caprifoliaceae Viburnum plant silk ball Jia Opulus Viburnum macrocephalum Fort. stem. Whole year can be harvested, and segment is dried.【Nature and flavor】Bitter；It is cool in nature.【Major function】Eliminating dampness is antipruritic.Main scabies is fresh；Wet rotten pain of itching.【Medicine Reason is acted on】The V. macrocephalum that European and American countries were once produced with it in one's early years（Europe V. macrocephalum Viburnumopulus or U.S. V. macrocephalums V.prunifolium）Preparation controls irregular menstruation, uterine hemorrhage, antenatal pain etc. as uterus sedative, records in America and Europe one In the pharmacopeia of a little countries.V. macrocephalum contained glucoside in Europe has contraction to uterus, blood vessel；In addition, also containing inhibition composition; 50% alcohol extracting thing effect is preferable.Fruit energy cardiac stimulant, diuresis.【Former phytomorph】Silk ball Jia Opulus fall leaves or semi-evergreen shrubs, high Up to 4m.Sprout is considered to be worth doing by dirt closes stellate hair, old branch grey black, and hibernaculum is without scale.Leaf is to life；The long 10-15mm of petiole；Blade papery； Leaf is avette, oval circular to ovate square, and long 5-11cm, wide 2.5-4.5cm, tip are blunt or slightly sharp, base portion circle or sometimes micro- heart Table, edge serration, below sparsely grow stellate hair, 5-6 pairs of lateral vein nets knot before nearly leaf margin, fallen into together with slightly concave above middle arteries, lower convexity. Cancel umbrella inflorescence diameter 8-15cm, be all made up of large-scale sterile flower；Total bennet is obvious, the 1st grade of 5 articles of radiation branch, and peanut is in the 3rd In level radiation branch；Calyx tube tubular, is about 2.5mm, and limb has 5 micro- teeth；Corolla white, spoke shape, diameter 1.5-4cm, sliver round shape Obovate, corolla tube is short；Stamen 5, is about 3mm；Gynoecium infertility.The month at florescence 4-5.Record in dictionary of medicinal plant.
Streamwort:Haloragaceae seaberry streamwort Haloragis micrantha (Thunb.) R.Br.ex Sidb. Et Zucc. [Goniocarpus micranthus Thunb.] herb.Summer harvests Herb, cleans, dries.【Nature and flavor】Bitter；It is puckery；It is cool in nature.【Channel tropism】Return lung；Large intestine；Bladder；It is nontoxic.【Major function】Cough-relieving is put down Breathe heavily；Clearing heat and promoting diuresis；Regulating menstruation and activating blood.Main cough；Asthma；Heat gonorrhea；Constipation；Dysentery；Irregular menstruation；Fall damage fracture；Furunculosis；Acute mastitis； Scald；Venomous snake bite.【Former phytomorph】Perennial slim and frahile draft, grows thickly, high 20-40cm.The prismatic of stem four, band russet, directly Vertical, base portion is crawled branch.Leaf is small, has short handle, to life, and stem upper leaf is alternate sometimes；The usual egg shape or circular shape of blade, long 6- 10cm, wide 4-8mm, tip is short sharp or blunt, and there is small tooth at edge, and basal circular, two sides is bald net, light green or puce.Circular cone Inflorescence basidixed, is made up of thin raceme；Spend small, both sexes；Calyx pipe has rib, and sliver 4, triangle is harbored；Petal 4, it is red； Stamen 8, flower pesticide aubergine；Gynoecium 1；Ovary is the next, has ratio rib, and style 4, the pink hair of the close life of column cap, drupe is subsphaeroidal, Be about 1mm, it is bald will and it is bright, have 8 ribs.The month at florescence 6-7, the fruiting period 9-10 months.Record in dictionary of medicinal plant.
Close flowers and plants：This product is Elatinaceae field chickweed platymiscium field chickweed Bergia ammannioides Roxb. Ex Roth herb.Whole year can adopt；Clean；Dry.【Nature and flavor】It is sweet；It is cool in nature.【Major function】It is clearing heat and detoxicating.Main urinary tract infections； Carbuncle furuncle；Stomatitis.【Original shape state】Annual herb, high 7-30cm.Near upright or edge up, branch is more, pale red, has open and flat Glandular hairs.Leaf is to life, several stockless；Slotting leaf is about 2mm, and 2 drastic cracks, sliver lanceolar has the tear small tooth of shape；The narrow ellipse of blade falls There is sharp small sawtooth at lanceolar, long 0.4-2cm, wide 2-8mm, edge, there is undercoat below.Spend small, majority is fasciating in axil；Flower Obstruct long 1-2mm；Sepal 5, it is narrow avette, 1.2mm is about, tip is tapering；Petal 5, pale red is narrow avette, about isometric with sepal；It is male Stamen 5；Style 5, it is short.Capsule is subsphaeroidal, long 1.2-2mm, splits for 5 valves.I counts seed, minimum.Florescence is almost annual.Record in Medicine voluminous dictionary.
Dryocrassin（Dryocrassin）：CAS 12777-70-7, molecular formula C43H48O16, molecular weight 820.84. 【Physical property】Yellow crystal (acetone), 209-214 DEG C of fusing point；UVλEtOHmax nm(ε):222,306,351.It is light yellow Powdered crystallization, 210~214 ° of fusing point；IRνKClmax cm-1:3200 (hydroxyl association absworption peaks), 1625,1610 (carbonyls Base association absworption peak), 1480 (alkane absworption peaks), 1200,1160,1030；NMR (CDCl3) δ:0.92 (6H, three companies Peak), 1.43 and 1.55 (12H, two are unimodal), 2.76 (6H, unimodal), 3.17 (4H, Duo Lianfeng), 3.56 (4H, it is single Peak), 3.85 (2H, unimodal)；MS m/e:820 (M+), 612,417,404,268,196,193,153,70,55,43. 【Pharmacological action】Through pharmacological screening, it was demonstrated that there is Schistosonia Japonicum.【Purposes】Anti-schistosome.【Ingredient origin】Shield-fern Section plant dryopteris crassirhizoma (dryopteris crassirhizoma Nakai) Dryopteris crassirhizoma Nakai.
1 bulk drug chemical constitution：
Dryocrassin（Dryocrassin）.
The content of the invention
The purpose of the present invention be overcome the shortcomings of background technology there is provided it is a kind of it is effective treatment fibroid pharmaceutical composition And preparation method thereof.
The present invention adopts the following technical scheme that realization：
The composition and parts by weight that the bulk drug of the pharmaceutical composition of the treatment fibroid is made be：
Chinese viburnum stem 922-928 parts by weight streamwort 582-590 parts by weight dryocrassin 15-17 parts by weight China sword The close flowers and plants 65-70 parts by weight of fern 162-168 parts by weight.
The pharmaceutical composition for the treatment of fibroid is preferably used in, is made up of the bulk drug of following parts by weight：
The parts by weight of 16 parts by weight Loxogramme chinensis ching of Chinese viburnum stem 925 parts by weight streamwort, 586 parts by weight dryocrassin 165 The close parts by weight of flowers and plants 68.
A kind of pharmaceutical composition for treating fibroid, it is characterised in that pharmaceutical composition can use the routine of galenic pharmacy Method prepares piece agent or capsule or dripping pill.
A kind of pharmaceutical composition for treating fibroid, it is characterised in that pharmaceutical composition is constituted with chemical drugs or Chinese medicine Treat fibroid medicine.
A kind of preparation method for the pharmaceutical composition for treating fibroid, it is characterised in that prepare as follows：
The composition and parts by weight of bulk drug be：Chinese viburnum stem 922-928 parts by weight streamwort 582-590 parts by weight northeast is passed through The close flowers and plants 65-70 parts by weight of many element 15-17 parts by weight Loxogramme chinensis ching 162-168 parts by weight；
Preparation method：
（1）Chinese viburnum stem, streamwort, dryocrassin, Loxogramme chinensis ching, close flowers and plants are taken by bulk drug proportioning, mixes, uses weight The ethanol of percent concentration 38.5% takes, extraction time is 25 times, each extraction time is 33 as solvent in 37.5 DEG C of temperature extractions Hour, each solvent load is 42 times of bulk drug gross weight, and filtration obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, Relative density 1.03 is concentrated into, is filtered, decoction is first eluted with water by HC-ADS-4 large pore resin absorption columns, then with weight hundred Divide the ethanol solution of specific concentration 22% elution HC-ADS-4 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 22% Liquid, reclaims ethanol, is concentrated and dried, produces extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 51% as solvent, heating and refluxing extraction 24 times is carried every time It is 0.4 hour to take the time, and each solvent load is 50 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned Ethanol is received, relative density 1.12 is concentrated into, filtered, decoction is first eluted with water by XAD-4 large pore resin absorption columns, then with again The ethanol solution of percent concentration 81% elution XAD-4 large pore resin absorption columns are measured, the ethanol elution of weight percent concentration 81% is collected Liquid, reclaims ethanol, is concentrated and dried, produces extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is produced.
It is preferred that a kind of pharmaceutical composition for treating fibroid preparation method, it is characterised in that make as follows It is standby：
The composition and parts by weight of bulk drug be：The weight of 925 parts by weight streamwort of Chinese viburnum stem, 586 parts by weight dryocrassin 16 Measure the close parts by weight of flowers and plants 68 of parts by weight of part Loxogramme chinensis ching 165；
Preparation method：
（1）Chinese viburnum stem, streamwort, dryocrassin, Loxogramme chinensis ching, close flowers and plants are taken by bulk drug proportioning, mixes, uses weight The ethanol of percent concentration 38.5% takes, extraction time is 25 times, each extraction time is 33 as solvent in 37.5 DEG C of temperature extractions Hour, each solvent load is 42 times of bulk drug gross weight, and filtration obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, Relative density 1.03 is concentrated into, is filtered, decoction is first eluted with water by HC-ADS-4 large pore resin absorption columns, then with weight hundred Divide the ethanol solution of specific concentration 22% elution HC-ADS-4 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 22% Liquid, reclaims ethanol, is concentrated and dried, produces extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 51% as solvent, heating and refluxing extraction 24 times is carried every time It is 0.4 hour to take the time, and each solvent load is 50 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned Ethanol is received, relative density 1.12 is concentrated into, filtered, decoction is first eluted with water by XAD-4 large pore resin absorption columns, then with again The ethanol solution of percent concentration 81% elution XAD-4 large pore resin absorption columns are measured, the ethanol elution of weight percent concentration 81% is collected Liquid, reclaims ethanol, is concentrated and dried, produces extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is produced.
A kind of preparation method for the pharmaceutical composition for treating fibroid, it is characterised in that pharmaceutical composition can be using system The conventional method of agent prepares piece agent or capsule or dripping pill.
A kind of preparation method for the pharmaceutical composition for treating fibroid, it is characterised in that pharmaceutical composition and chemical drugs or Chinese medicine composition treatment fibroid medicine.
Medicine composite for curing fibroid is evident in efficacy.
Embodiment
Embodiment 1：Treat pharmaceutical composition of fibroid and preparation method thereof
Treat fibroid pharmaceutical composition bulk drug composition and parts by weight be：Chinese viburnum stem 925g streamworts The close flowers and plants 68g of 586g dryocrassin 16g Loxogramme chinensis chings 165g；
Preparation method：
（1）Chinese viburnum stem, streamwort, dryocrassin, Loxogramme chinensis ching, close flowers and plants are taken by bulk drug proportioning, mixes, uses weight The ethanol of percent concentration 38.5% takes, extraction time is 25 times, each extraction time is 33 as solvent in 37.5 DEG C of temperature extractions Hour, each solvent load is 42 times of bulk drug gross weight, and filtration obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, Relative density 1.03 is concentrated into, is filtered, decoction is first eluted with water by HC-ADS-4 large pore resin absorption columns, then with weight hundred Divide the ethanol solution of specific concentration 22% elution HC-ADS-4 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 22% Liquid, reclaims ethanol, is concentrated and dried, produces extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 51% as solvent, heating and refluxing extraction 24 times is carried every time It is 0.4 hour to take the time, and each solvent load is 50 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned Ethanol is received, relative density 1.12 is concentrated into, filtered, decoction is first eluted with water by XAD-4 large pore resin absorption columns, then with again The ethanol solution of percent concentration 81% elution XAD-4 large pore resin absorption columns are measured, the ethanol elution of weight percent concentration 81% is collected Liquid, reclaims ethanol, is concentrated and dried, produces extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is produced.
Embodiment 2：Treat pharmaceutical composition of fibroid and preparation method thereof
Treat fibroid pharmaceutical composition bulk drug composition and parts by weight be：Chinese viburnum stem 922g streamworts The close flowers and plants 65g of 590g dryocrassin 15g Loxogramme chinensis chings 168g；
Preparation method：
（1）Chinese viburnum stem, streamwort, dryocrassin, Loxogramme chinensis ching, close flowers and plants are taken by bulk drug proportioning, mixes, uses weight The ethanol of percent concentration 38.5% takes, extraction time is 25 times, each extraction time is 33 as solvent in 37.5 DEG C of temperature extractions Hour, each solvent load is 42 times of bulk drug gross weight, and filtration obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, Relative density 1.03 is concentrated into, is filtered, decoction is first eluted with water by HC-ADS-4 large pore resin absorption columns, then with weight hundred Divide the ethanol solution of specific concentration 22% elution HC-ADS-4 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 22% Liquid, reclaims ethanol, is concentrated and dried, produces extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 51% as solvent, heating and refluxing extraction 24 times is carried every time It is 0.4 hour to take the time, and each solvent load is 50 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned Ethanol is received, relative density 1.12 is concentrated into, filtered, decoction is first eluted with water by XAD-4 large pore resin absorption columns, then with again The ethanol solution of percent concentration 81% elution XAD-4 large pore resin absorption columns are measured, the ethanol elution of weight percent concentration 81% is collected Liquid, reclaims ethanol, is concentrated and dried, produces extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is produced.
Embodiment 3：Treat pharmaceutical composition of fibroid and preparation method thereof
Treat fibroid pharmaceutical composition bulk drug composition and parts by weight be：Chinese viburnum stem 928g streamworts The close flowers and plants 70g of 582g dryocrassin 17g Loxogramme chinensis chings 162g；
Preparation method：
（1）Chinese viburnum stem, streamwort, dryocrassin, Loxogramme chinensis ching, close flowers and plants are taken by bulk drug proportioning, mixes, uses weight The ethanol of percent concentration 38.5% takes, extraction time is 25 times, each extraction time is 33 as solvent in 37.5 DEG C of temperature extractions Hour, each solvent load is 42 times of bulk drug gross weight, and filtration obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, Relative density 1.03 is concentrated into, is filtered, decoction is first eluted with water by HC-ADS-4 large pore resin absorption columns, then with weight hundred Divide the ethanol solution of specific concentration 22% elution HC-ADS-4 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 22% Liquid, reclaims ethanol, is concentrated and dried, produces extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 51% as solvent, heating and refluxing extraction 24 times is carried every time It is 0.4 hour to take the time, and each solvent load is 50 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned Ethanol is received, relative density 1.12 is concentrated into, filtered, decoction is first eluted with water by XAD-4 large pore resin absorption columns, then with again The ethanol solution of percent concentration 81% elution XAD-4 large pore resin absorption columns are measured, the ethanol elution of weight percent concentration 81% is collected Liquid, reclaims ethanol, is concentrated and dried, produces extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is produced.
Embodiment 4：The preparation of tablet
The pharmaceutical composition 630g of Example 1, adds starch 520g, mixes, and pelletizes, and dries, plus microcrystalline cellulose 130g, stearic Sour magnesium 15g, mixes, is pressed into 6000, produces medicinal composition tablets.
Embodiment 5：The preparation of capsule
The pharmaceutical composition 420g of Example 2, adds starch 600g, mixes, and pelletizes, and dries, whole grain, adds appropriate stearic acid Magnesium, mixes, encapsulated 2400, produces medicament composition capsule.
Embodiment 6：The preparation of dripping pill
Weigh (80 DEG C) heating of Macrogol 6000 820g water-baths and boil molten, add the pharmaceutical composition 30g of embodiment 3, fully stir Mix uniform, using atoleine as cooling agent, put glass tube（4*80cm）In, chilling temperature is 7 DEG C, and drip internal-and external diameter is 7.0/ 2.0 (mm/mm), drip is 2.3cm away from liquid level, and drop speed, for optimum condition, the cold of dripping pill surface is blotted with cotton with every point 46 drop Solidifying agent, produces medicament composition dropping pills.
Experimental example 1：Treat the experimental study of fibroid
1 clinical data
1.1 general information
62 patients with uterin leiomyoma patients that this city hospital accepts for medical treatment in December, -2014 in April, 2013 are chosen as research object.By with Machine digits table will include case and be divided into observation group and control group, every group each 31.Observation group's patient age 26~58 years old, puts down Equal (45.3 ± 4.3) years；Parity 1~3 time, it is average 2.3 times；Course of disease March~2.3 year, average course of disease (8.3 ± 2.3) moon； Clinical manifestation with anaemia 10, dysmenorrhoea 8, menorrhalgia 6, menostaxis 4, colporrhagia 2, waist abdominal distention and pain 1；Average size of uterine fihroids is (3.63 ± 0.60) cm3.Control group patient age 27~56 years old, average (46.1 ± 4.4) Year；Parity 1~3 time, it is average 2.2 times；Course of disease March~2 year, average course of disease (8.1 ± 3.0) moon；Clinical manifestation is with poor Blood 10, dysmenorrhoea 8, menorrhalgia 6, menostaxis 3, colporrhagia 2, waist abdominal distention and pain 2；Fibroid is put down Equal volume is (3.85 ± 0.53) cm3.Be statistically analyzed, the general information difference such as basic document and the state of an illness of 2 groups of patients without Statistical significance (P ＞ 0.05), with comparativity.
1.2 inclusive criteria
Patient is diagnosed as fibroid through gynaecology of the court color ultrasound examination and needs to receive drug therapy person；My husband is removed through gynecologial examination Other malignant tumor patients of palace；March does not receive to treat medicine or the operation of fibroid before being admitted to hospital；More or less occur together poor Blood, dysmenorrhoea, excessive menstruation, menostaxis, colporrhagia, waist abdominal distension pain symptom, but symptom does not seriously influence medication；It is clinical Complete data, patient's signature informed consent form and cooperation doctor's advice medication.
1.3 exclusion standard
The gestational period, women breast-feeding their children；Serious hepatic and kidney function obstacle person；Complicated with diabetes, cardiovascular and cerebrovascular and disease in the blood system with And insane；To Chinese medicine allergy sufferers used.
2 treatment methods
2.1 control group
Oral GUIZHI FULING JIAONANG (the medicine source since menstruation the 1st day：Kangyuan Pharmaceutical Co., Ltd., Jiangsu Prov), continuously Take March, medication dose：3 every time, daily 3 times.
2.2 observation group
The combination of oral medication since menstruation the 1st day（The pharmaceutical composition of embodiment 1）, each 0.6g 3 times a day, even served March.
3 observation index and statistical method
3.1 observation index
2 groups of patient blood hemoglobin levels, dysmenorrhoea number of times, menstrual flow, menstrual period, colporrhagia situation, waist are recorded after treatment end Abdominal distention and pain situation etc.；Record the situation that adverse reaction occurs in therapeutic process.
3.2 statistical method
Statistical analysis is carried out to the data obtained using SPSS18.0 statistical softwares, qualitative data uses Chi-square Test；Quantitative money Material is represented with (x ± s), is examined using the t of two independent sample data.
4 criterions of therapeutical effect and treatment results
4.1 criterion of therapeutical effect
According to《Traditional Chinese obstetrics and gynecology》.
It is effective：Clinical symptoms disappear substantially, and B is super, and display fibroid reduces more than 1/2；
Effectively：Clinical symptoms make moderate progress, and B is super, and display fibroid reduces 1/3~1/2；
It is invalid：Clinical symptoms do not improve, and B is super, and display fibroid has no diminution.
4.2 2 groups of Clinical efficacy comparisons
It is shown in Table 1.Observation group's total effective rate is 93.55%, hence it is evident that more than control group 77.42%, the statistically significant (P of difference ＜ 0.05).
12 groups of Clinical efficacy comparison examples of table
Group n It is effective Effectively It is invalid Total effective rate (%)
Observation group 31 15 14 2 93.55*
Control group 31 9 15 7 77.42
Note：Compared with control group, * P<0.05.
4.3 2 groups of each symptoms improve situation and compared
Comparing the single symptom of 2 groups of patients improves situation discovery, and observation group is except the improvement rate that menostaxis with control group without bright Different (the P of significant difference>0.05) outside, the improvement rate of the symptom such as anaemia, dysmenorrhoea, menorrhalgia, colporrhagia, waist abdominal distention and pain obviously higher than Control group, the statistically significant (P of difference<0.05).
4.4 2 groups of fibroid volume ratios compared with
It is shown in Table 2.2 groups of average size of uterine fihroids compare after treatment, and difference is statistically significant (P ＜ 0.05).
22 groups of fibroid volume ratios of table are compared with (x ± s)
Compared with control group, * P ＜ 0.05.
4.5 adverse reaction
Observation group once had 1 patient to occur slight anorexia and belly distending pain during treating, and control group has 3 also to go out Existing above-mentioned symptom, but 2 groups of symptom durations are very of short duration, and successive treatment is not influenceed.2 groups of adverse reaction rate ratios Compared with difference is not statistically significant (P ＞ 0.05).

Claims (8)

1. a kind of pharmaceutical composition for treating fibroid, it is characterised in that be made the bulk drug of the pharmaceutical composition composition and Parts by weight are：
Chinese viburnum stem 922-928 parts by weight streamwort 582-590 parts by weight dryocrassin 15-17 parts by weight China sword The close flowers and plants 65-70 parts by weight of fern 162-168 parts by weight.
2. a kind of pharmaceutical composition for treating fibroid according to claim 1, it is characterised in that the drug regimen is made The composition and parts by weight of the bulk drug of thing be：
The parts by weight of 16 parts by weight Loxogramme chinensis ching of Chinese viburnum stem 925 parts by weight streamwort, 586 parts by weight dryocrassin 165 The close parts by weight of flowers and plants 68.
3. a kind of pharmaceutical composition for treating fibroid according to claim 1, it is characterised in that pharmaceutical composition can be with Piece agent or capsule or dripping pill are prepared using the conventional method of galenic pharmacy.
4. a kind of pharmaceutical composition for treating fibroid according to claim 1, it is characterised in that pharmaceutical composition is with changing Learn the treatment fibroid medicine of medicine or Chinese medicine composition.
5. a kind of preparation method for the pharmaceutical composition for treating fibroid, it is characterised in that prepare as follows：
The composition and parts by weight of bulk drug be：Chinese viburnum stem 922-928 parts by weight streamwort 582-590 parts by weight northeast is passed through The close flowers and plants 65-70 parts by weight of many element 15-17 parts by weight Loxogramme chinensis ching 162-168 parts by weight；
Preparation method：
（1）Chinese viburnum stem, streamwort, dryocrassin, Loxogramme chinensis ching, close flowers and plants are taken by bulk drug proportioning, mixes, uses weight The ethanol of percent concentration 38.5% takes, extraction time is 25 times, each extraction time is 33 as solvent in 37.5 DEG C of temperature extractions Hour, each solvent load is 42 times of bulk drug gross weight, and filtration obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, Relative density 1.03 is concentrated into, is filtered, decoction is first eluted with water by HC-ADS-4 large pore resin absorption columns, then with weight hundred Divide the ethanol solution of specific concentration 22% elution HC-ADS-4 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 22% Liquid, reclaims ethanol, is concentrated and dried, produces extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 51% as solvent, heating and refluxing extraction 24 times is carried every time It is 0.4 hour to take the time, and each solvent load is 50 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned Ethanol is received, relative density 1.12 is concentrated into, filtered, decoction is first eluted with water by XAD-4 large pore resin absorption columns, then with again The ethanol solution of percent concentration 81% elution XAD-4 large pore resin absorption columns are measured, the ethanol elution of weight percent concentration 81% is collected Liquid, reclaims ethanol, is concentrated and dried, produces extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is produced.
6. a kind of preparation method for the pharmaceutical composition for treating fibroid according to claim 5, it is characterised in that by such as It is prepared by lower step：
The composition and parts by weight of bulk drug be：The weight of 925 parts by weight streamwort of Chinese viburnum stem, 586 parts by weight dryocrassin 16 Measure the close parts by weight of flowers and plants 68 of parts by weight of part Loxogramme chinensis ching 165；
Preparation method：
（1）Chinese viburnum stem, streamwort, dryocrassin, Loxogramme chinensis ching, close flowers and plants are taken by bulk drug proportioning, mixes, uses weight The ethanol of percent concentration 38.5% takes, extraction time is 25 times, each extraction time is 33 as solvent in 37.5 DEG C of temperature extractions Hour, each solvent load is 42 times of bulk drug gross weight, and filtration obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, Relative density 1.03 is concentrated into, is filtered, decoction is first eluted with water by HC-ADS-4 large pore resin absorption columns, then with weight hundred Divide the ethanol solution of specific concentration 22% elution HC-ADS-4 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 22% Liquid, reclaims ethanol, is concentrated and dried, produces extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 51% as solvent, heating and refluxing extraction 24 times is carried every time It is 0.4 hour to take the time, and each solvent load is 50 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned Ethanol is received, relative density 1.12 is concentrated into, filtered, decoction is first eluted with water by XAD-4 large pore resin absorption columns, then with again The ethanol solution of percent concentration 81% elution XAD-4 large pore resin absorption columns are measured, the ethanol elution of weight percent concentration 81% is collected Liquid, reclaims ethanol, is concentrated and dried, produces extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is produced.
7. a kind of preparation method for the pharmaceutical composition for treating fibroid according to claim 5, it is characterised in that medicine Composition can prepare piece agent or capsule or dripping pill using the conventional method of galenic pharmacy.
8. a kind of preparation method for the pharmaceutical composition for treating fibroid according to claim 5, it is characterised in that medicine Composition and chemical drugs or Chinese medicine composition treatment fibroid medicine.
CN201611132918.7A 2016-12-10 2016-12-10 A kind of pharmaceutical composition for being used to treat fibroid Withdrawn CN107029006A (en)

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