CN106581102A - Pharmaceutical composition for treatment of uterine myoma - Google Patents

Pharmaceutical composition for treatment of uterine myoma Download PDF

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Publication number
CN106581102A
CN106581102A CN201611132924.2A CN201611132924A CN106581102A CN 106581102 A CN106581102 A CN 106581102A CN 201611132924 A CN201611132924 A CN 201611132924A CN 106581102 A CN106581102 A CN 106581102A
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ethanol
pharmaceutical composition
weight portion
weight
weight percent
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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
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • 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
    • 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)
    • A61K36/12—Filicopsida or Pteridopsida
    • 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)
    • A61K36/24—Apocynaceae (Dogbane family), e.g. plumeria or periwinkle
    • 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

The invention discloses a pharmaceutical composition for treatment of uterine myoma and a preparing method thereof. The pharmaceutical composition is prepared by proportioning loxogramme chinensis, root or stem of hairyleaf chonemorpha, eupatilin and tagitinin F as raw material medicines, can be made into various dosage forms according to a conventional preparation process, and has remarkable curative effect on treatment of uterine myoma.

Description

A kind of pharmaceutical composition for treating hysteromyoma
Technical field
The invention belongs to technical field of Chinese medicines, more particularly to a kind of pharmaceutical composition for treating hysteromyoma and its preparation side Method.
Background technology
Hysteromyoma is the modal benign tumor of female sex organ, and its sickness rate is about 25%～30%.General feelings Under condition, women after 30 years old its sickness rate it is very high, reached 20%.Traditional treatment way mostly is hysterectomy treatment, so Then in premenopausal excision uterus, osteoporosises, coronary heart disease etc. is set to occur ahead of time very much easily.Climacteric syndrome can also be caused, made There is the puzzlement such as endocrine disturbance in woman.Traditional excision uterus is cured hysteromyoma and can not obtain good curative effect, instead And can also be to bring many worries on minimal invasive treatment.So, on the premise of can be with Reservations uterus, patients with uterine myoma row be protected Stay to be cured and control, mitigate ailing suffering in life after patient cures, reputation more and more higher in patients.Hysteromyoma is often at present A kind of gynaecopathia seen, in recent years sickness rate sharp increase can generally cause woman in menstrual period excessive, menostaxis, more than the first quarter moon that is continuous It is unnet, the physical and mental health of women is had a strong impact on, doctor trained in Western medicine typically adopts operative therapy, but a part of patient to be reluctant to perform an operation, and Postoperative relapse rate is still higher.
Traditional Chinese medical science hysteromyoma is called " stony mass of uterus " or " abdominal mass is gathered ", " mass in the abdomen ", belongs to " lump in the abdomen " category." lump in the abdomen " just refers to women Underbelly enclosed mass, and with symptoms such as pain, distension and bleedings.From the viewpoint of with the traditional Chinese medical science, " disease " category disorders of blood, " abdominal mass " category gas Disease, the formation of hysteromyoma is exactly that, by deficiency of vital QI, vim and vigour imbalance causes, and both are closely related.
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 Jing.【Indication】Heat-clearing and toxic substances removing；Diuresis.Main urinary tract infection；Mastitis；Lyssodexiss.【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, middle part width 1-1.2cm, 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 above wrinkle；Slightly swell on middle arteries two sides.Sporangioruses Long Circle, is separated from each other by usual 5-8 pair, 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.
Radix seu caulis chonemorphae valvatae：For Apocynaceae Chonemorpha eriostylis platymiscium hair leaf Radix seu caulis chonemorphae valvatae：Root, the stem of Chonemorpha valvata Chatt And peel of stem.Whole year can adopt, and clean, and dry.【Nature and flavor】It is sweet；Slight bitter；Slightly warm in nature；Mild toxicity.【Indication】Dispelling, collateral-activating；Only Blood.Main rheumatic arthritis；Fracture；Traumatic hemorrhage.【Former phytomorph】Sturdy woody climber.Sprout is by yellow pubescence, Quan Lin Has abundant milk.Leaf opposite, width egg shape or subcircular, long 15-30cm, wide 10-20cm, tip is suddenly sharp or perfectly round, base portion circle Shape, blade back is by pubescence；Vein is obvious.Basidixed cyme, flower pale red；Calyx 5 is split to base portion, and splinter forceps closes shape arrangement, Inner face base portion has dentation body of gland；The nearly high foot disk like of corolla, tube inner face is covered to the right by close pubescence, sliver；Stamen is born in Tube middle part, flower pesticide arrow shaped, filigree is by micro- pubescence；Floral disc ring-type, tip is shallow to be split；Constituted from raw carpel by 2 pieces in room, flower Post is thread, and tip is by microtriche.Follicle radish is twin parallel.Seed is flat, and tip has long thin,tough silk matter kind hair.Spring at florescence, summer, the fruiting period autumn, Winter.Record in dictionary of medicinal plant.
Tagitinin F（Tagitinin F ）：CAS 59979-57-6, molecular formula C19H24O6, molecular weight 348.40.【Pharmacological action】There is antitumaous effect.To mouse lymphocyte leukemia P388, the life in 1.25mg/kg dosage Rate elongation is 61%.It is the A of gained, B, C, D, E, F, the six kinds of compositions person that uniquely has antitumaous effect from roundleaf Radix Tithoniae diversifoliae.【Into Divide source】Feverfew roundleaf Radix Tithoniae diversifoliae Tithonia tagiliflora Desf. (T.rotundifolia) herbs.
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 Artemisia Artemisia rubripes, Pericarpium Citri tangerinae Citrus reticulata.
2 crude drug chemical constitutions：
Eupatilin（Eupatilin）Tagitinin F（Tagitinin F ）.
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 effectively treatment hysteromyoma And preparation method thereof.
The present invention adopts the following technical scheme that realization：
The composition and weight portion for making the crude drug of the pharmaceutical composition of the treatment hysteromyoma be：
Loxogramme chinensis ching. 562-568 weight portion Radix seu caulis chonemorphae valvatae 436-440 weight portion eupatilin 42-48 weight portion roundleaf Radix Tithoniae diversifoliaes Plain F 32-38 weight portions.
The pharmaceutical composition for the treatment of hysteromyoma is preferably used in, is made up of the crude drug of following weight portion：
The weight of 46 weight portion tagitinin F of Loxogramme chinensis ching. 565 weight portion Radix seu caulis chonemorphae valvatae, 438 weight portion eupatilin 35 Part.
A kind of pharmaceutical composition for treating hysteromyoma, it is characterised in that pharmaceutical composition can adopt the routine of galenic pharmacy Method prepares piece agent or capsule or drop pill.
A kind of pharmaceutical composition for treating hysteromyoma, it is characterised in that pharmaceutical composition is constituted with chemical drugs or Chinese medicine Treatment hysteromyoma medicine.
A kind of preparation method of the pharmaceutical composition for treating hysteromyoma, it is characterised in that prepare as follows：
The composition and weight portion of crude drug be：Loxogramme chinensis ching. 562-568 weight portion Radix seu caulis chonemorphae valvatae 436-440 weight portion eupatilins 42-48 weight portion tagitinin F 32-38 weight portions；
Preparation method：
（1）Loxogramme chinensis ching., Radix seu caulis chonemorphae valvatae, eupatilin, tagitinin F are taken by crude drug proportioning, is mixed, use weight percent The ethanol of specific concentration 32% is extracted as solvent in 37 DEG C of warm macerating, and extraction time is 26 times, and each extraction time is 0.3 hour, often Secondary solvent load is 32 times of crude drug gross weight, filters, and obtains medicinal residues A and extracting solution A, and extracting solution A reclaims ethanol, is concentrated into phase To density 1.07, filtration, medicinal liquid is first washed with water by LD605 macroporous adsorptive resins, then with weight percent concentration 41% Ethanol solution eluting LD605 macroporous adsorptive resins, collect the ethanol elution of weight percent concentration 41%, reclaim ethanol, concentration It is dried, obtains final product extract A；
（2）Take step（1）Medicinal residues A, with the ethanol of weight percent concentration 71% as solvent, heating and refluxing extraction 13 times, carries every time The time is taken for 0.2 hour, each solvent load is 30 times of medicinal residues A weight, filters, obtain medicinal residues B and extracting solution B, extracting solution B is returned Ethanol is received, relative density 1.15 is concentrated into, is filtered, medicinal liquid is first washed with water by HC-ADS-7 macroporous adsorptive resins, then is used The ethanol solution eluting HC-ADS-7 macroporous adsorptive resins of weight percent concentration 87%, collect the ethanol of weight percent concentration 87% Eluent, 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 hysteromyoma, it is characterised in that make as follows It is standby：
The composition and weight portion of crude drug be：The weight portion of 565 weight portion Radix seu caulis chonemorphae valvatae of Loxogramme chinensis ching., 438 weight portion eupatilin 46 The weight portion of tagitinin F 35；
Preparation method：
（1）Loxogramme chinensis ching., Radix seu caulis chonemorphae valvatae, eupatilin, tagitinin F are taken by crude drug proportioning, is mixed, use weight percent The ethanol of specific concentration 32% is extracted as solvent in 37 DEG C of warm macerating, and extraction time is 26 times, and each extraction time is 0.3 hour, often Secondary solvent load is 32 times of crude drug gross weight, filters, and obtains medicinal residues A and extracting solution A, and extracting solution A reclaims ethanol, is concentrated into phase To density 1.07, filtration, medicinal liquid is first washed with water by LD605 macroporous adsorptive resins, then with weight percent concentration 41% Ethanol solution eluting LD605 macroporous adsorptive resins, collect the ethanol elution of weight percent concentration 41%, reclaim ethanol, concentration It is dried, obtains final product extract A；
（2）Take step（1）Medicinal residues A, with the ethanol of weight percent concentration 71% as solvent, heating and refluxing extraction 13 times, carries every time The time is taken for 0.2 hour, each solvent load is 30 times of medicinal residues A weight, filters, obtain medicinal residues B and extracting solution B, extracting solution B is returned Ethanol is received, relative density 1.15 is concentrated into, is filtered, medicinal liquid is first washed with water by HC-ADS-7 macroporous adsorptive resins, then is used The ethanol solution eluting HC-ADS-7 macroporous adsorptive resins of weight percent concentration 87%, collect the ethanol of weight percent concentration 87% Eluent, 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 hysteromyoma, it is characterised in that pharmaceutical composition can be using system The conventional method of agent prepares piece agent or capsule or drop pill.
A kind of preparation method of the pharmaceutical composition for treating hysteromyoma, it is characterised in that pharmaceutical composition and chemical drugs or Chinese medicine composition treatment hysteromyoma medicine.
Medicine composite for curing hysteromyoma is evident in efficacy.
Specific embodiment
Embodiment 1：Pharmaceutical composition for the treatment of hysteromyoma and preparation method thereof
Treatment hysteromyoma pharmaceutical composition crude drug composition and weight portion be：565g Radix seu caulis chonemorphae valvatae 438g are different for Loxogramme chinensis ching. Eupatorin 46g tagitinin F 35g；
Preparation method：
（1）Loxogramme chinensis ching., Radix seu caulis chonemorphae valvatae, eupatilin, tagitinin F are taken by crude drug proportioning, is mixed, use weight percent The ethanol of specific concentration 32% is extracted as solvent in 37 DEG C of warm macerating, and extraction time is 26 times, and each extraction time is 0.3 hour, often Secondary solvent load is 32 times of crude drug gross weight, filters, and obtains medicinal residues A and extracting solution A, and extracting solution A reclaims ethanol, is concentrated into phase To density 1.07, filtration, medicinal liquid is first washed with water by LD605 macroporous adsorptive resins, then with weight percent concentration 41% Ethanol solution eluting LD605 macroporous adsorptive resins, collect the ethanol elution of weight percent concentration 41%, reclaim ethanol, concentration It is dried, obtains final product extract A；
（2）Take step（1）Medicinal residues A, with the ethanol of weight percent concentration 71% as solvent, heating and refluxing extraction 13 times, carries every time The time is taken for 0.2 hour, each solvent load is 30 times of medicinal residues A weight, filters, obtain medicinal residues B and extracting solution B, extracting solution B is returned Ethanol is received, relative density 1.15 is concentrated into, is filtered, medicinal liquid is first washed with water by HC-ADS-7 macroporous adsorptive resins, then is used The ethanol solution eluting HC-ADS-7 macroporous adsorptive resins of weight percent concentration 87%, collect the ethanol of weight percent concentration 87% Eluent, 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：Pharmaceutical composition for the treatment of hysteromyoma and preparation method thereof
Treatment hysteromyoma pharmaceutical composition crude drug composition and weight portion be：562g Radix seu caulis chonemorphae valvatae 440g are different for Loxogramme chinensis ching. Eupatorin 42g tagitinin F 38g；
Preparation method：
（1）Loxogramme chinensis ching., Radix seu caulis chonemorphae valvatae, eupatilin, tagitinin F are taken by crude drug proportioning, is mixed, use weight percent The ethanol of specific concentration 32% is extracted as solvent in 37 DEG C of warm macerating, and extraction time is 26 times, and each extraction time is 0.3 hour, often Secondary solvent load is 32 times of crude drug gross weight, filters, and obtains medicinal residues A and extracting solution A, and extracting solution A reclaims ethanol, is concentrated into phase To density 1.07, filtration, medicinal liquid is first washed with water by LD605 macroporous adsorptive resins, then with weight percent concentration 41% Ethanol solution eluting LD605 macroporous adsorptive resins, collect the ethanol elution of weight percent concentration 41%, reclaim ethanol, concentration It is dried, obtains final product extract A；
（2）Take step（1）Medicinal residues A, with the ethanol of weight percent concentration 71% as solvent, heating and refluxing extraction 13 times, carries every time The time is taken for 0.2 hour, each solvent load is 30 times of medicinal residues A weight, filters, obtain medicinal residues B and extracting solution B, extracting solution B is returned Ethanol is received, relative density 1.15 is concentrated into, is filtered, medicinal liquid is first washed with water by HC-ADS-7 macroporous adsorptive resins, then is used The ethanol solution eluting HC-ADS-7 macroporous adsorptive resins of weight percent concentration 87%, collect the ethanol of weight percent concentration 87% Eluent, 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：Pharmaceutical composition for the treatment of hysteromyoma and preparation method thereof
Treatment hysteromyoma pharmaceutical composition crude drug composition and weight portion be：568g Radix seu caulis chonemorphae valvatae 436g are different for Loxogramme chinensis ching. Eupatorin 48g tagitinin F 32g；
Preparation method：
（1）Loxogramme chinensis ching., Radix seu caulis chonemorphae valvatae, eupatilin, tagitinin F are taken by crude drug proportioning, is mixed, use weight percent The ethanol of specific concentration 32% is extracted as solvent in 37 DEG C of warm macerating, and extraction time is 26 times, and each extraction time is 0.3 hour, often Secondary solvent load is 32 times of crude drug gross weight, filters, and obtains medicinal residues A and extracting solution A, and extracting solution A reclaims ethanol, is concentrated into phase To density 1.07, filtration, medicinal liquid is first washed with water by LD605 macroporous adsorptive resins, then with weight percent concentration 41% Ethanol solution eluting LD605 macroporous adsorptive resins, collect the ethanol elution of weight percent concentration 41%, reclaim ethanol, concentration It is dried, obtains final product extract A；
（2）Take step（1）Medicinal residues A, with the ethanol of weight percent concentration 71% as solvent, heating and refluxing extraction 13 times, carries every time The time is taken for 0.2 hour, each solvent load is 30 times of medicinal residues A weight, filters, obtain medicinal residues B and extracting solution B, extracting solution B is returned Ethanol is received, relative density 1.15 is concentrated into, is filtered, medicinal liquid is first washed with water by HC-ADS-7 macroporous adsorptive resins, then is used The ethanol solution eluting HC-ADS-7 macroporous adsorptive resins of weight percent concentration 87%, collect the ethanol of weight percent concentration 87% Eluent, 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 466g of Example 1, adds starch 321g, mixes, and granulation is dried, plus Microcrystalline Cellulose 73g, Hard Fat Sour magnesium 8g, mixes, and is pressed into 3300, obtains final product medicinal composition tablets.
Embodiment 5：The preparation of capsule
The pharmaceutical composition 160g of Example 2, adds starch 221g, mixes, and granulation is dried, granulate, adds appropriate stearic acid Magnesium, mixes, and encapsulated 1150, obtains final product medicament composition capsule.
Embodiment 6：The preparation of drop pill
Weigh (80 DEG C) heating of polyethylene glycol 6000 235g water-baths and boil molten, add the pharmaceutical composition 11.4g of embodiment 3, fully Stir, with liquid paraffin as coolant, put glass tubing（4*80cm）In, chilling temperature is 4 DEG C, and drip internal-and external diameter is 7.0/ 1.5 (mm/mm), drip is 1.8cm away from liquid level, and drop speed, as optimum condition, with cotton the cold of drop pill surface is blotted with per point 56 drops Solidifying agent, obtains final product medicament composition dropping pills.
Experimental example 1：The Experiment on Function research for the treatment of hysteromyoma
1 clinical data
1.1 physical data
34 are city hospital outpatient patient, are randomly divided into two groups.Treatment group's (pharmaceutical composition group) 17, age 18-57 Year, average 40 years old.The course of disease 3 months ~ 3.5 years, average 2.6 years.Matched group (GONGLIUQING group) 17,18 ~ 58 years old age, average 40 Year.The course of disease 3 months ~ 3.5 years, average 2.7 years.Two groups of Genders, age, courses of disease are without significant difference (P>0.05), having can Compare property.
1.2 diagnostic criteria
Tcm diagnosis standard reference《New Chinese medicine guideline of clinical investigations》(the 1st volume)/new Chinese medicine treat hysteromyoma and Guideline of clinical investigations, all possess following 5 persons and be classified as the object of observation：The course of disease is within 4 years；Jing B ultrasonic is detected more than 2 times； Gynecologial examination is defined as hysteromyoma；Age was at 18 ~ 60 years old；Person's clinical manifestation that Chinese medical discrimination has syndrome of qi stagnation and blood stasis:Menoxenia Amount is more irregular, less abdomen and flank pain, falling inflation, leucorrhoea grow in quantity, chest distending pain of the breast, and body of the tongue is dim stagnant or has petechia, pulse condition Heavy string is thin puckery.
2 Therapeutic Method
2.1 treatment group
Pharmaceutical composition is the pharmaceutical composition of embodiment 1.Orally, each 0.9g, 3 times a day, and 1 menstrual cycle is 1 course for the treatment of, even With judging curative effect after 6 months.
2.2 matched group
GONGLIUQING capsule (Zhong Hui drugmakers of China Academy of TCM produce, and lot number (98) defends the quasi- word of medicine Z-158), 3/ Secondary, 3 times/d, the effective prescription is derived from《Medical Treasures of the Golden Chamber》Radix Et Rhizoma Rhei et Eupolyphaga Seu Steleophaga Pilulae is added and subtracted, and Main Ingredients and Appearance is Radix Et Rhizoma Rhei, Hirudo, Eupolyphaga Seu Steleophaga Deng, also take medicine 6 months after judge curative effect.
3 observation of curative effect
3.1 curative effect determinate standard
Reference《New Chinese medicine treats the clinical research principle of hysteromyoma》, recovery from illness:Muscular tumor disappears, clinical symptoms, sign and inspection Look into recovery normal, the main symptom of tcm syndrome, secondary card disappear fire；It is effective:Symptom disappears, and muscular tumor reduces, and sign and gynecologial examination have bright Aobvious to change, muscular tumor reduces more than 1/2 person；Effectively:Symptom mitigation or disappearance, sign and gynecologial examination take a favorable turn, and muscular tumor reduces 1/3 Above person；It is invalid:Without improvement, muscular tumor has no diminution person to indices.
3.2 therapeutic outcome
3.2.1 the Clinical efficacy comparison of two groups of hysteromyoma
Treatment group 17, fully recovers 8, effective 5, effective 3, invalid 1, total effective rate 94.12%；Matched group 17, recovery from illness 4, effective 4, effective 5, invalid 4, total effective rate 76.47% is checked using t, and two groups of total effective rates compare P<0.01, With pole significant.
3.2.2 two groups of menoxenias, leucorrhea abnormal comparitive study
Treatment group 17, recovery from illness (menstruation, leucorrhea recover normal) 9, effective 4, effective 4, invalid 0, total effective rate 100%；Matched group 17, fully recovers 3, effective 4, effective 5, invalid 5, total effective rate 70.59%.Two groups of total effective rate ratios Compared with P<0.01, with pole significant.
3.2.3 two groups of distending pain of the breast, lack abdomen pendant pain comparitive study
Treatment group 17, recovery from illness (distending pain of the breast, hypogastralgia are wholly absent) 7, effective 6, effective 2, invalid 2, always Effective percentage is 88.24%；Matched group 17, fully recovers 5, and effective 4, effective 4, invalid 4, total effective rate is 76.47%.Two Group total effective rate compares P<0.05, there is significant difference.
3.2.4 two groups of dimly red tongue, petechia ecchymosis, deep and stringy pulse, thin puckery comparitive study
Treatment group 17, recovery from illness (tongue arteries and veins recovers completely normal) 9, effective 5, effective 3, invalid 0, total effective rate is 100%；Matched group 17, fully recovers 6, and effective 6, effective 3, invalid 2, total effective rate is 88.24%.Two groups of total effective rates Relatively P<0.05, there is significant difference.

Claims (8)

1. a kind of pharmaceutical composition for treating hysteromyoma, it is characterised in that make the crude drug of the pharmaceutical composition composition and Weight portion is：
Loxogramme chinensis ching. 562-568 weight portion Radix seu caulis chonemorphae valvatae 436-440 weight portion eupatilin 42-48 weight portion roundleaf Radix Tithoniae diversifoliaes Plain F 32-38 weight portions.
2. a kind of pharmaceutical composition for treating hysteromyoma according to claim 1, it is characterised in that make the drug regimen The composition and weight portion of the crude drug of thing be：
The weight of 46 weight portion tagitinin F of Loxogramme chinensis ching. 565 weight portion Radix seu caulis chonemorphae valvatae, 438 weight portion eupatilin 35 Part.
3. a kind of pharmaceutical composition for treating hysteromyoma according to claim 1, it is characterised in that pharmaceutical composition can be with Piece agent or capsule or drop pill are prepared using the conventional method of galenic pharmacy.
4. a kind of pharmaceutical composition for treating hysteromyoma according to claim 1, it is characterised in that pharmaceutical composition with change Learn the treatment hysteromyoma medicine of medicine or Chinese medicine composition.
5. a kind of preparation method of the pharmaceutical composition for treating hysteromyoma, it is characterised in that prepare as follows：
The composition and weight portion of crude drug be：Loxogramme chinensis ching. 562-568 weight portion Radix seu caulis chonemorphae valvatae 436-440 weight portion eupatilins 42-48 weight portion tagitinin F 32-38 weight portions；
Preparation method：
（1）Loxogramme chinensis ching., Radix seu caulis chonemorphae valvatae, eupatilin, tagitinin F are taken by crude drug proportioning, is mixed, use weight percent The ethanol of specific concentration 32% is extracted as solvent in 37 DEG C of warm macerating, and extraction time is 26 times, and each extraction time is 0.3 hour, often Secondary solvent load is 32 times of crude drug gross weight, filters, and obtains medicinal residues A and extracting solution A, and extracting solution A reclaims ethanol, is concentrated into phase To density 1.07, filtration, medicinal liquid is first washed with water by LD605 macroporous adsorptive resins, then with weight percent concentration 41% Ethanol solution eluting LD605 macroporous adsorptive resins, collect the ethanol elution of weight percent concentration 41%, reclaim ethanol, concentration It is dried, obtains final product extract A；
（2）Take step（1）Medicinal residues A, with the ethanol of weight percent concentration 71% as solvent, heating and refluxing extraction 13 times, carries every time The time is taken for 0.2 hour, each solvent load is 30 times of medicinal residues A weight, filters, obtain medicinal residues B and extracting solution B, extracting solution B is returned Ethanol is received, relative density 1.15 is concentrated into, is filtered, medicinal liquid is first washed with water by HC-ADS-7 macroporous adsorptive resins, then is used The ethanol solution eluting HC-ADS-7 macroporous adsorptive resins of weight percent concentration 87%, collect the ethanol of weight percent concentration 87% Eluent, 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 hysteromyoma according to claim 5, it is characterised in that by such as It is prepared by lower step：
The composition and weight portion of crude drug be：The weight portion of 565 weight portion Radix seu caulis chonemorphae valvatae of Loxogramme chinensis ching., 438 weight portion eupatilin 46 The weight portion of tagitinin F 35；
Preparation method：
（1）Loxogramme chinensis ching., Radix seu caulis chonemorphae valvatae, eupatilin, tagitinin F are taken by crude drug proportioning, is mixed, use weight percent The ethanol of specific concentration 32% is extracted as solvent in 37 DEG C of warm macerating, and extraction time is 26 times, and each extraction time is 0.3 hour, often Secondary solvent load is 32 times of crude drug gross weight, filters, and obtains medicinal residues A and extracting solution A, and extracting solution A reclaims ethanol, is concentrated into phase To density 1.07, filtration, medicinal liquid is first washed with water by LD605 macroporous adsorptive resins, then with weight percent concentration 41% Ethanol solution eluting LD605 macroporous adsorptive resins, collect the ethanol elution of weight percent concentration 41%, reclaim ethanol, concentration It is dried, obtains final product extract A；
（2）Take step（1）Medicinal residues A, with the ethanol of weight percent concentration 71% as solvent, heating and refluxing extraction 13 times, carries every time The time is taken for 0.2 hour, each solvent load is 30 times of medicinal residues A weight, filters, obtain medicinal residues B and extracting solution B, extracting solution B is returned Ethanol is received, relative density 1.15 is concentrated into, is filtered, medicinal liquid is first washed with water by HC-ADS-7 macroporous adsorptive resins, then is used The ethanol solution eluting HC-ADS-7 macroporous adsorptive resins of weight percent concentration 87%, collect the ethanol of weight percent concentration 87% Eluent, 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 hysteromyoma according to claim 5, it is characterised in that medicine Compositionss can adopt the conventional method of galenic pharmacy to prepare piece agent or capsule or drop pill.
8. a kind of preparation method of the pharmaceutical composition for treating hysteromyoma according to claim 5, it is characterised in that medicine Compositionss and chemical drugs or Chinese medicine composition treatment hysteromyoma medicine.
CN201611132924.2A 2016-12-10 2016-12-10 Pharmaceutical composition for treatment of uterine myoma Withdrawn CN106581102A (en)

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Application publication date: 20170426