CN106727776A - Pharmaceutical composition for treating fibroid - Google Patents

Pharmaceutical composition for treating fibroid Download PDF

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Publication number
CN106727776A
CN106727776A CN201611132919.1A CN201611132919A CN106727776A CN 106727776 A CN106727776 A CN 106727776A CN 201611132919 A CN201611132919 A CN 201611132919A CN 106727776 A CN106727776 A CN 106727776A
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ethanol
pharmaceutical composition
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weight portion
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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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
    • 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)
    • A61K36/20—Aceraceae (Maple 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

Abstract

Pharmaceutical composition of fibroid and preparation method thereof is treated the invention discloses a kind of, pharmaceutical composition of the present invention is with moth tree, Loxogramme chinensis ching, aurantio-obtusin, eupatilin, odoratin as bulk drug, proportioning is formed, routinely various formulations can be made by preparation process, treatment fibroid is evident in efficacy.

Description

Pharmaceutical composition for treating 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 (Uterine Fibroids) is also called leiomyoma of uterus, fibroma uteri, is because uterus is flat Sliding muscular tissue hyperplasia and formed, be also most common a kind of benign tumour in female reproductive system, be mainly in 30~50 years old Women, is gynemetrics's common disease.At present, clinically for treating the method for fibroid for operative treatment and drug therapy, Wherein based on operative treatment, but operative treatment high recurrence rate, greatly, severe patient may influence patient's reproductive function for side effect, therefore Conservative drug therapy is increasingly paid attention to by doctor and patient.Fibroid is gynecological clinic common disease, frequently-occurring disease, common It is the benign tumour formed due to uterine smooth muscle hyperblastosis in the middle age of 40~50 years old or climacteric women.And in Medical science then thinks fibroid Shu Disorder lump in the abdomen categories, and mostly palace body catches cold, and damp evil invasion, liver-spleen disharmony, qi and blood is retarded by silt, and train of thought is obstructed It is caused, need to be with warm nature medicine promoting blood circulation to remove blood stasis, warming meridians and promoting circulation of qi.
Moth tree：Pueraria lobota trailing plants maple Acer grosseri Pax var.hersii are split for Aceraceae Acer plants are long（Rehd.） Rehd. the spray and fruit of ［ A.hersii Rehd. ］.9-10 month picking fruits, dry；The 6-7 months harvest spray, dry.【Property Taste】It is bitter；It is salty；It is flat.【Indication】Cough-relieving；Sore.The new chronic cough of master is coughed；Thrush.【Original shape state】It is tall that length splits Pueraria lobota trailing plants maple fallen leaves Wood, up to 8m.Bark is filbert, smooth；Annual shoot green or purple green, perennial branch lark or taupe, leaf opposite； Petiole 2-3cm long, it is thin thin, without hair；Blade papery, avette, 7-9cm long, 5-6cm wide, edge has close and sharp heavy sawtooth, first Hold sharp point, base portion to be bordering on heart-shaped, often deeper 3 and split, central sliver is larger, and triangular shape is avette, above bottle green, without hair；Under Face light green, is then come off always in vein base portion when tender by faint yellow feathering；Base goes out 3, arteries and veins, lateral vein pinniform.Flower unisexuality, male and female are different Strain, often into thin thin sagging raceme；Sepal 5；Petal 5；Stamen 8, without hair, the agensis in female flower；Floral disc is located at stamen Inner side；Ovary purple, the agensis in male flower.Bennet 3-4mm long.Lavender, ripe rear yellowish-brown during samara children；Pyrene is micro- flat Flat, together with pyrene 2.5-2.9cm long, about 5mm wide or is bordering on level at flare up obtuse angle to wing.April at florescence, fruiting period September.Record In dictionary of medicinal plant.
Loxogramme chinensis ching：This product is the root of Loxogrammaceae sword Cyclosorus plant Loxogramme chinensis ching Loxogramme chinensis Ching Stem or herb.Whole year can harvest rhizome, the 7-9 months harvest herb, dry.【Nature and flavor】It is bitter；Cold nature.【Return through】Bladder；Kidney Through.【Indication】It is clearing heat and detoxicating；Diuresis.Main urinary tract infections；Mastitis；Lyssodexis.【Former phytomorph】Plant 8- high 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, middle part 1-1.2cm wide, 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 with middle arteries parallel, middle arteries both sides are arranged in, it is grown on more than back side middle part, bottom infertility；Without indusium.Record big in Chinese medicine Dictionary.
Eupatilin（Eupatilin）：CAS 22368-21-4, molecular formula C18H16O7, molecular weight 344.31.【It is biological Activity】Cell toxicant (KB, ED50=38 or 45 μ g/ml).【Ingredient origin】Half zigzag Herba Lycopi Eupatorium Semiserratum, red sufficient wormwood artemisia Artemisia rubripes, orange peel Citrus reticulata.
Odoratin（Odoratin）：CAS 6902-72-3, molecular formula C15H22O4, molecular weight 266.34.【Pharmacology is made With】It is antitumor（Human body nasopharyngeal carcinoma）Deng.【Ingredient origin】Feverfew film quality chrysanthemum, white Lai Shi chrysanthemums herb.
Aurantio-obtusin（Aurantio-obtusin）：CAS 67979-25-3, molecular formula C17H14O7, molecular weight 330.29.【Pharmacological action】Suppress platelet aggregation.【Ingredient origin】Cassia seed Cassia tora.
3 bulk drug chemical constitutions：
Aurantio-obtusin（Aurantio-obtusin）
Eupatilin（Homoplantaginin）Odoratin（Odoratin）.
The content of the invention
The purpose of the present invention is to overcome the shortcomings of background technology, there is provided a kind of pharmaceutical composition of effective treatment fibroid And preparation method thereof.
The present invention adopts the following technical scheme that realization：
The composition and weight portion for being made the bulk drug of the pharmaceutical composition of the treatment fibroid be：
The different Herba Lycopi of moth tree 481-487 weight portion Loxogramme chinensis ching 264-268 weight portion aurantio-obtusin 42-48 weight portions is yellow Plain 34-36 weight parts of aromatic film chrysanthemum element 8-10 weight portions.
The pharmaceutical composition for the treatment of fibroid is preferably used in, is made up of the bulk drug of following weight portion：
The weight portion of 45 weight portion eupatilin of moth tree 484 weight portion Loxogramme chinensis ching, 266 weight portion aurantio-obtusin 35 The weight portion of odoratin 9.
A kind of pharmaceutical composition for treating fibroid, it is characterised in that pharmaceutical composition can be using 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 Treatment fibroid medicine.
A kind of preparation method of the pharmaceutical composition for treating fibroid, it is characterised in that prepare as follows：
The composition and weight portion of bulk drug are the moth tree 481-487 weight portion Loxogramme chinensis ching orange Cassia of 264-268 weight portions Plain 42-48 weight portions eupatilin 34-36 weight parts of aromatic films chrysanthemum element 8-10 weight portions；
Preparation method：
（1）Moth tree, Loxogramme chinensis ching, aurantio-obtusin, eupatilin, odoratin are taken by bulk drug proportioning, is mixed, used Used as solvent, 43 DEG C of temperature extractions take the ethanol of weight percent concentration 34%, and extraction time is 11 times, and each extraction time is 47 small When, each solvent load is 37 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, dense Relative density 1.10 is reduced to, is filtered, liquid is first washed with water, then use percentage by weight by XAD-7HP large pore resin absorption columns The ethanol solution of concentration 21% elutes XAD-7HP large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 21%, reclaims Ethanol, concentrate drying obtains final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 83% as solvent, heating and refluxing extraction 14 times is carried every time The time is taken for 0.5 hour, each solvent load is 24 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 1.14 is concentrated into, filtered, liquid is first washed with water by SP825 large pore resin absorption columns, then with again Amount percent concentration 63% ethanol solution wash-out SP825 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 63% Liquid, reclaims ethanol, and concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
Preferred a kind of preparation method of the pharmaceutical composition for treating fibroid, it is characterised in that make as follows It is standby：
The composition and weight portion of bulk drug be：The weight of 484 weight portion Loxogramme chinensis ching of moth tree, 266 weight portion aurantio-obtusin 45 Part eupatilin 35 weight parts of aromatic film chrysanthemum 9 weight portions of element；
Preparation method：
（1）Moth tree, Loxogramme chinensis ching, aurantio-obtusin, eupatilin, odoratin are taken by bulk drug proportioning, is mixed, used Used as solvent, 43 DEG C of temperature extractions take the ethanol of weight percent concentration 34%, and extraction time is 11 times, and each extraction time is 47 small When, each solvent load is 37 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, dense Relative density 1.10 is reduced to, is filtered, liquid is first washed with water, then use percentage by weight by XAD-7HP large pore resin absorption columns The ethanol solution of concentration 21% elutes XAD-7HP large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 21%, reclaims Ethanol, concentrate drying obtains final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 83% as solvent, heating and refluxing extraction 14 times is carried every time The time is taken for 0.5 hour, each solvent load is 24 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 1.14 is concentrated into, filtered, liquid is first washed with water by SP825 large pore resin absorption columns, then with again Amount percent concentration 63% ethanol solution wash-out SP825 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 63% Liquid, reclaims ethanol, and concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
A kind of preparation method of 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 of 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.
Specific embodiment
Embodiment 1：Treat pharmaceutical composition of fibroid and preparation method thereof
Treat fibroid pharmaceutical composition bulk drug composition and weight portion be：Moth tree 484g Loxogramme chinensis chings 266g Aurantio-obtusin 45g eupatilin 35g odoratins 9g；
Preparation method：
（1）Moth tree, Loxogramme chinensis ching, aurantio-obtusin, eupatilin, odoratin are taken by bulk drug proportioning, is mixed, used Used as solvent, 43 DEG C of temperature extractions take the ethanol of weight percent concentration 34%, and extraction time is 11 times, and each extraction time is 47 small When, each solvent load is 37 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, dense Relative density 1.10 is reduced to, is filtered, liquid is first washed with water, then use percentage by weight by XAD-7HP large pore resin absorption columns The ethanol solution of concentration 21% elutes XAD-7HP large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 21%, reclaims Ethanol, concentrate drying obtains final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 83% as solvent, heating and refluxing extraction 14 times is carried every time The time is taken for 0.5 hour, each solvent load is 24 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 1.14 is concentrated into, filtered, liquid is first washed with water by SP825 large pore resin absorption columns, then with again Amount percent concentration 63% ethanol solution wash-out SP825 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 63% Liquid, reclaims ethanol, and concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
Embodiment 2：Treat pharmaceutical composition of fibroid and preparation method thereof
Treat fibroid pharmaceutical composition bulk drug composition and weight portion be：Moth tree 481g Loxogramme chinensis chings 268g Aurantio-obtusin 42g eupatilin 36g odoratins 8g；
Preparation method：
（1）Moth tree, Loxogramme chinensis ching, aurantio-obtusin, eupatilin, odoratin are taken by bulk drug proportioning, is mixed, used Used as solvent, 43 DEG C of temperature extractions take the ethanol of weight percent concentration 34%, and extraction time is 11 times, and each extraction time is 47 small When, each solvent load is 37 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, dense Relative density 1.10 is reduced to, is filtered, liquid is first washed with water, then use percentage by weight by XAD-7HP large pore resin absorption columns The ethanol solution of concentration 21% elutes XAD-7HP large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 21%, reclaims Ethanol, concentrate drying obtains final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 83% as solvent, heating and refluxing extraction 14 times is carried every time The time is taken for 0.5 hour, each solvent load is 24 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 1.14 is concentrated into, filtered, liquid is first washed with water by SP825 large pore resin absorption columns, then with again Amount percent concentration 63% ethanol solution wash-out SP825 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 63% Liquid, reclaims ethanol, and concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
Embodiment 3：Treat pharmaceutical composition of fibroid and preparation method thereof
Treat fibroid pharmaceutical composition bulk drug composition and weight portion be：Moth tree 487g Loxogramme chinensis chings 264g Aurantio-obtusin 48g eupatilin 34g odoratins 10g；
Preparation method：
（1）Moth tree, Loxogramme chinensis ching, aurantio-obtusin, eupatilin, odoratin are taken by bulk drug proportioning, is mixed, used Used as solvent, 43 DEG C of temperature extractions take the ethanol of weight percent concentration 34%, and extraction time is 11 times, and each extraction time is 47 small When, each solvent load is 37 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, dense Relative density 1.10 is reduced to, is filtered, liquid is first washed with water, then use percentage by weight by XAD-7HP large pore resin absorption columns The ethanol solution of concentration 21% elutes XAD-7HP large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 21%, reclaims Ethanol, concentrate drying obtains final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 83% as solvent, heating and refluxing extraction 14 times is carried every time The time is taken for 0.5 hour, each solvent load is 24 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 1.14 is concentrated into, filtered, liquid is first washed with water by SP825 large pore resin absorption columns, then with again Amount percent concentration 63% ethanol solution wash-out SP825 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 63% Liquid, reclaims ethanol, and concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
Embodiment 4：The preparation of tablet
The pharmaceutical composition 312g of Example 1, adds starch 409g, mixes, and granulation is dried, plus microcrystalline cellulose 152g, stearic Sour magnesium 10g, mixes, and is pressed into 5500, obtains final product medicinal composition tablets.
Embodiment 5：The preparation of capsule
The pharmaceutical composition 310g of Example 2, adds starch 460g, mixes, and granulation is dried, whole grain, adds appropriate stearic acid Magnesium, mixes, and encapsulated 2700, obtains final product medicament composition capsule.
Embodiment 6：The preparation of dripping pill
Weigh (80 DEG C) heating of Macrogol 6000 211g water-baths and boil molten, add the g of 3 pharmaceutical composition of embodiment 10.3, fully Stir, with atoleine as cooling agent, put glass tube（4*80cm）In, chilling temperature is -5 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 is optimum condition with every point 53 drop, and dripping pill surface is blotted with cotton Condensing agent, obtain final product medicament composition dropping pills.
Embodiment 7：Treat the pharmaceutical composition of fibroid
Treat fibroid pharmaceutical composition bulk drug composition and weight portion be：
The weight parts of aromatic film chrysanthemum of 130 weight portion eupatilin of aurantio-obtusin 2 40 weight portions of element.
Embodiment 8：Treat the pharmaceutical composition of fibroid
Treat fibroid pharmaceutical composition bulk drug composition and weight portion be：
The weight parts of aromatic film chrysanthemum of 20 weight portion eupatilin of aurantio-obtusin 120 2 weight portions of element.
Embodiment 9：Treat the pharmaceutical composition of fibroid
Treat fibroid pharmaceutical composition bulk drug composition and weight portion be：
The weight parts of aromatic film chrysanthemum of 30 weight portion eupatilin of aurantio-obtusin 120 3 weight portions of element.
Experimental example 1：Treat the experimental study of fibroid
1 clinical data
1.1 physical data
The 60 patients with uterin leiomyoma patients that selection in November, -2014 in March, 2013 this city hospital accepts for medical treatment are used as research object.By with Machine digits table will include case and be divided into observation group and control group, every group each 30.Observation group's patient age 26~58 years old, puts down Equal (45.4 ± 4.2) years；Parity 1~3 time, average 2.1 times；Course of disease March~2.1 year, average course of disease (8.0 ± 2.5) moon； Clinical manifestation with anaemia 10, dysmenorrhoea 8, menorrhalgia 6, menostaxis 3, colporrhagia 2, waist abdominal distention and pain 1；Average size of uterine fihroids is (3.65 ± 0.61) cm3.Control group patient age 27~57 years old, average (46.3 ± 4.6) Year；Parity 1~3 time, average 2.2 times；Course of disease March~2 year, average course of disease (8.0 ± 3.0) moon；Clinical manifestation is with poor Blood 10, dysmenorrhoea 8, menorrhalgia 6, menostaxis 3, colporrhagia 2, waist abdominal distention and pain 1；Fibroid is put down Equal volume is (3.89 ± 0.57) cm3.Be statistically analyzed, the physical data 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 criterias
Patient is diagnosed as fibroid and needs to receive drug therapy person through gynaecology of the court color ultrasound examination；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 standards
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 groups
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 groups
The combination of oral medication since menstruation the 1st day（The pharmaceutical composition of embodiment 1）, each 0.5g three times a day, takes medicine continuously March.
3 observation index and statistical method
3.1 observation index
2 groups of patient blood hemoglobin levels, dysmenorrhoea number of times, MBV, menstrual period, colporrhagia situation, waist are recorded after treatment end Abdominal distention and pain situation etc.；The situation that adverse reaction occurs in record therapeutic process.
3.2 statistical methods
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), checked using the t of two independent sample data.
4 criterions of therapeutical effect and treatment results
4.1 criterions 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 93.33%, hence it is evident that more than control group 76.67%, 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 30 16 12 2 93.33*
Control group 30 9 14 7 76.67
Note：Compare with control group, * P<0.05.
4.3 2 groups of each symptoms improve situation and compare
Comparing 2 groups of single symptoms of patient 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) outward, 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)
Compare with control group, * P ＜ 0.05.
4.5 adverse reactions
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 DOS are very of short duration, and do not influence successive treatment.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 Weight portion is：
The different Herba Lycopi of moth tree 481-487 weight portion Loxogramme chinensis ching 264-268 weight portion aurantio-obtusin 42-48 weight portions is yellow Plain 34-36 weight parts of aromatic film chrysanthemum element 8-10 weight portions.
2. a kind of pharmaceutical composition for treating fibroid according to claim 1, it is characterised in that be made the drug regimen The composition and weight portion of the bulk drug of thing be：
The weight portion of 45 weight portion eupatilin of moth tree 484 weight portion Loxogramme chinensis ching, 266 weight portion aurantio-obtusin 35 The weight portion of odoratin 9.
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 with change Learn the treatment fibroid medicine of medicine or Chinese medicine composition.
5. a kind of preparation method of the pharmaceutical composition for treating fibroid, it is characterised in that prepare as follows：
The composition and weight portion of bulk drug be：The moth tree 481-487 weight portion Loxogramme chinensis ching orange Cassia of 264-268 weight portions Plain 42-48 weight portions eupatilin 34-36 weight parts of aromatic films chrysanthemum element 8-10 weight portions；
Preparation method：
（1）Moth tree, Loxogramme chinensis ching, aurantio-obtusin, eupatilin, odoratin are taken by bulk drug proportioning, is mixed, used Used as solvent, 43 DEG C of temperature extractions take the ethanol of weight percent concentration 34%, and extraction time is 11 times, and each extraction time is 47 small When, each solvent load is 37 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, dense Relative density 1.10 is reduced to, is filtered, liquid is first washed with water, then use percentage by weight by XAD-7HP large pore resin absorption columns The ethanol solution of concentration 21% elutes XAD-7HP large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 21%, reclaims Ethanol, concentrate drying obtains final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 83% as solvent, heating and refluxing extraction 14 times is carried every time The time is taken for 0.5 hour, each solvent load is 24 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 1.14 is concentrated into, filtered, liquid is first washed with water by SP825 large pore resin absorption columns, then with again Amount percent concentration 63% ethanol solution wash-out SP825 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 63% Liquid, reclaims ethanol, and concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
6. a kind of preparation method of 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 weight portion of bulk drug be：The weight of 484 weight portion Loxogramme chinensis ching of moth tree, 266 weight portion aurantio-obtusin 45 Part eupatilin 35 weight parts of aromatic film chrysanthemum 9 weight portions of element；
Preparation method：
（1）Moth tree, Loxogramme chinensis ching, aurantio-obtusin, eupatilin, odoratin are taken by bulk drug proportioning, is mixed, used Used as solvent, 43 DEG C of temperature extractions take the ethanol of weight percent concentration 34%, and extraction time is 11 times, and each extraction time is 47 small When, each solvent load is 37 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, dense Relative density 1.10 is reduced to, is filtered, liquid is first washed with water, then use percentage by weight by XAD-7HP large pore resin absorption columns The ethanol solution of concentration 21% elutes XAD-7HP large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 21%, reclaims Ethanol, concentrate drying obtains final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 83% as solvent, heating and refluxing extraction 14 times is carried every time The time is taken for 0.5 hour, each solvent load is 24 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 1.14 is concentrated into, filtered, liquid is first washed with water by SP825 large pore resin absorption columns, then with again Amount percent concentration 63% ethanol solution wash-out SP825 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 63% Liquid, reclaims ethanol, and concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
7. a kind of preparation method of 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 of 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.
CN201611132919.1A 2016-12-10 2016-12-10 Pharmaceutical composition for treating fibroid Withdrawn CN106727776A (en)

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Application Number Priority Date Filing Date Title
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Application publication date: 20170531