CN105477560A - Traditional Chinese medicine preparation for treating fibroid and preparation method and application thereof - Google Patents

Traditional Chinese medicine preparation for treating fibroid and preparation method and application thereof Download PDF

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CN105477560A
CN105477560A CN201610008128.1A CN201610008128A CN105477560A CN 105477560 A CN105477560 A CN 105477560A CN 201610008128 A CN201610008128 A CN 201610008128A CN 105477560 A CN105477560 A CN 105477560A
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radix
chinese medicine
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丁勇剑
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    • 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)
    • A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56—Materials from animals other than mammals
    • A61K35/618—Molluscs, e.g. fresh-water molluscs, oysters, clams, squids, octopus, cuttlefish, snails or slugs
    • 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)
    • A61K36/21—Amaranthaceae (Amaranth family), e.g. pigweed, rockwort or globe amaranth
    • 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)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • 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)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/483—Gleditsia (locust)
    • 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)
    • A61K36/60—Moraceae (Mulberry family), e.g. breadfruit or fig
    • 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)
    • A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • A61K36/738—Rosa (rose)
    • A—HUMAN NECESSITIES
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    • 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)
    • A61K36/75—Rutaceae (Rue family)
    • A61K36/752—Citrus, e.g. lime, orange or lemon
    • 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)
    • A61K36/88—Liliopsida (monocotyledons)
    • 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)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/906—Zingiberaceae (Ginger family)
    • A61K36/9066—Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • 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
    • A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
    • 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

Abstract

The invention discloses a traditional Chinese medicine preparation for treating fibroid and a preparation method and application thereof. The traditional Chinese medicine preparation for treating fibroid is prepared from, by weight, 20-40 parts of potentilla fragarioides L., 20-30 parts of fructus aurantii, 20-30 parts of ficus esquiroliana, 10-20 parts of radix achyranthis bidentatae, 10-20 parts of roses, 10-15 parts of Chinese honeylocust spine, 10-15 parts of silkworm shit, 10-15 parts of dipsacus asperoides, 8-12 parts of curcuma zedoary, 8-12 parts of concha arcae, 8-12 parts of clove smartweed roots, 3-5 parts of ground beeltles, 3-5 parts of caragana sinica rehd and 1-3 parts of juncus roemerianus. The dosage form of the traditional Chinese medicine preparation is capsules, tablets, granules, pills, oral liquid or powder, and auxiliary materials are dextrin, sucrose powder, starch or microcrystalline cellulose. All types of raw material medicine achieve a synergistic effect, the functions of being high in effect implementation, definite in curative effect, high in safety and simple in medicine application are achieved, the preparation process is simple, the environmental friendliness is achieved, the symptoms of colporrhagia, aching pain of the waist, hypoglycemia and the like caused by myoma of uterus can be effectively relieved, no side or side effect exists, and a new choice is clinically provided for relieving various symptoms caused by fibroid.

Description

A kind of Chinese medicine preparation for the treatment of hysteromyoma and its production and use
Technical field
The present invention relates to medical applications technical field, specifically a kind of Chinese medicine preparation for the treatment of hysteromyoma and its production and use.
Background technology
Hysteromyoma is the common a kind of illness of female sex organs, and be women's frequently-occurring disease, Women of childbearing age sickness rate is more than 30%, this illness non-evident sympton, minority performance vaginal hemorrhage, waist constriction etc.The primary disease cause of disease is not also determined, modern medicine many employings hormone expectant treatment or operative treatment.Wherein, uterectomy uses treatment means more widely at present, hysterectomy not only brings physiology and psychological injury to patient, and ovarian failure and climacteric can be caused to arrive in advance, there will be the danger of wound canceration, the sequela such as obesity, hypertension, heart disease, osteoporosis can be brought.In addition in expectant treatment, Western medicine uses hormone medicine to treat mostly, although Western medicine has certain curative effect reducing in tumor body, it can the hormonal system of grievous injury patient, occur growing the manlike features such as beard, Adam's apple is outstanding, sound is thicker, so can not life-time service.And once withdrawal, muscular tumor can recur fast again, increase.
Hysteromyoma is the commonly encountered diseases of the women of child-bearing age, and not only sickness rate is high, and is the first cause of hysterectomy.Although operation is the effective ways of this disease for the treatment of, due to the shortcoming of operation risk, damage and secondary, the trial exploring non-operative treatment comes into one's own day by day.Modern medicine non-operative treatment hysteromyoma, mainly through suppressing the growth of hysteromyoma to antiestrogenic, muscular tumor is even made to reduce, thus alleviate or alleviate muscular tumor related symptoms, but generally can not eliminate and effect a radical cure, often after drug withdrawal, in satellite dangerous hormonal readiness recovery and have muscular tumor to recur or the possibility of regrowth.And not yet solve problem that is long-term or consolidate curative effect, the safety problem of long-term treatment, the problems such as therapy mechanism.Because hysteromyoma is more common in the inharmonic women of reproduction age, the death of one's spouse and sexual life.Chronicity life is lacked of proper care and causes pelvic cavity chronic congestion also may be one of reason of bringing out hysteromyoma.In a word, the generation development of hysteromyoma may be multifactor coefficient result.
Most of patients is asymptomatic, is only occasionally found when pelvioscopy or ultrasonic examination.If any symptom then with muscular tumor growth site, speed, with or without degeneration and in close relations with or without complication, and relatively little with muscular tumor size, number how many relations.Suffer from multiple Subserous myoma person and may not have symptom, and one less eat film under muscular tumor often can cause irregular colporrhagia or menorrhagia.Symptom common clinically has:
(1) metrorrhagia is the topmost symptom of hysteromyoma, comes across patient more than half.Be wherein many with cyclic hemorrhage, hyper-menorrhea, menostaxis or cycle time can be shown as.Also the irregular colporrhagia without menstrual cycle can be shown as.Metrorrhagia is more common to eat muscular tumor and intramural myoma under film, and Subserous myoma seldom causes metrorrhagia.
(2) abdominal mass and pressure symptom muscular tumor grow gradually, when its make uterus increase above 3 months gravid uterus sizes or for being positioned at the larger Subserous myoma bottom palace time, often can be anchored to enclosed mass at abdominal part, more obvious during filling of bladder in early morning.Enclosed mass is solid, movable, without tenderness.Muscular tumor can cause peripheral organs pressure symptom when growing to a certain size, and anterior uterine wall muscular tumor presses close to wing flesh person can produce frequent micturition, urgent micturition; Huge cervical myoma compressing bladder can cause not smooth even urinary hesitancy of urinating; Uterus posterior myomas particularly isthmus or cervix uteri posterior lip muscular tumor can oppress rectum, causes that stool is smooth, sense of discomfort after defecation; Huge broad ligament myoma can oppress ureter, even causes hydronephrosis.
(3) pain generally hysteromyoma do not cause pain, but many patients can tell the sense of lower abdomen falling inflation, aching pain in waist and back.Can acute abdominal pain be produced when Subserous myoma generation torsion of pedicle or hysteromyoma generation red degeneration, muscular tumor merge endometriosis or adenomyosis person also not rare, then can have dysmenorrhea.
(4) leucorrhoea grow in quantity cavity of uterus increases, and endometrial gland increases, in addition pelvic congestion, and leucorrhea can be made to increase.The fleshy polyp generation ulcer of uterus or cervix uteri, infection, downright bad time, then produce courageous and upright or purulent leukorrhea.
(5) infertilely infertile or easy miscarriage is accompanied, on to become pregnant and the impact of pregnancy outcome may be relevant with the growth site of muscular tumor, size and number with some patients with uterine myoma of miscarriage.Giant left ventricle can cause uterine cavity to be out of shape, and hinders pregnant capsule implantation and embryo cutting; Muscular tumor compressing fallopian tube can cause tube chamber obstructed; Under Guo's film, muscular tumor can hinder pregnant capsule implantation or affect sperm and enter uterine cavity.Hysteromyoma Patients rate of spontaneous abortion is higher than normal population, and it is than about 4:1.
(6) anemia can cause hemorrhagic anemia due to long-term menorrhagia or irregular colporrhagia, and more serious anemia is more common in Hysteromyoma Patients under Guo's film.
(7) other only a few patients with uterine myoma can produce erythrocytosis, hypoglycemia, it is generally acknowledged that to produce ectopic hormone with tumor relevant.
Visible hysteromyoma, as the frequently-occurring disease of women, causes bad impact to the live and work of a lot of women, develops a kind of special effect Chinese that can effectively reduce hysteromyoma, claims extremely urgent thing.
Summary of the invention
The object of the present invention is to provide a kind of Chinese medicine preparation for the treatment of hysteromyoma and its production and use.
For achieving the above object, the invention provides following technical scheme:
Treat a Chinese medicine preparation for hysteromyoma, be made up of the raw material of following weight portion: Radix Potentillae Fragarioidis 20-40 part, Fructus Aurantii 20-30 part, Ficus fulva Reinw. 20-30 part, Radix Achyranthis Bidentatae 10-20 part, Flos Rosae Rugosae 10-20 part, sky fourth 10-15 part, late Bombyx mori L. 10-15 part, Radix Dipsaci 10-15 part, Rhizoma Curcumae 8-12 part, Concha Arcae 8-12 part, Herba Ludwigiae Prostratae root 8-12 part, Eupolyphaga Seu Steleophaga 3-5 part, Radix Caraganae Sinicae 3-5 part, Medulla Junci 1-3 part.
As the further scheme of the present invention: the Chinese medicine preparation of described treatment hysteromyoma, is made up of the raw material of following weight portion: Radix Potentillae Fragarioidis 25-35 part, Fructus Aurantii 22-28 part, Ficus fulva Reinw. 22-28 part, Radix Achyranthis Bidentatae 12-18 part, Flos Rosae Rugosae 12-18 part, sky fourth 11-14 part, late Bombyx mori L. 11-14 part, Radix Dipsaci 11-14 part, Rhizoma Curcumae 9-11 part, Concha Arcae 9-11 part, Herba Ludwigiae Prostratae root 9-11 part, Eupolyphaga Seu Steleophaga 3.5-4.5 part, Radix Caraganae Sinicae 3.5-4.5 part, Medulla Junci 1.5-2.5 part.
As the further scheme of the present invention: the Chinese medicine preparation of described treatment hysteromyoma, is made up of the raw material of following weight portion: Radix Potentillae Fragarioidis 30 parts, Fructus Aurantii 25 parts, Ficus fulva Reinw. 25 parts, Radix Achyranthis Bidentatae 15 parts, Flos Rosae Rugosae 15 part, day fourth 12 parts, late Bombyx mori L. 12 parts, Radix Dipsaci 12 parts, Rhizoma Curcumae 10 parts, Concha Arcae 10 parts, Herba Ludwigiae Prostratae root 10 parts, Eupolyphaga Seu Steleophaga 4 parts, Radix Caraganae Sinicae 4 parts, Medulla Junci 2 parts.
The preparation method of the Chinese medicine preparation of described treatment hysteromyoma, concrete steps are as follows:
(1) take each raw material according to weight portion, each raw material is cleaned rear hot blast drying respectively, is processed into fragment, with disinfection by ultraviolet light;
(2) fry after Fructus Aurantii, Radix Achyranthis Bidentatae, late Bombyx mori L. and sky fourth mix homogeneously to micro-coke yellow, and the mixture after parch is crushed into powder for subsequent use;
(3) Radix Potentillae Fragarioidis, Ficus fulva Reinw., Radix Dipsaci, Rhizoma Curcumae and Radix Caraganae Sinicae are extracted volatile oil, respectively volatile oil and medicinal residues are deposited for subsequent use;
(4) add water the medicinal residues that remaining raw material and step (3) obtain common extraction three times, first time 1-3h, second time and third time each 0.5-1.5h, the extracting solution filtrate that three times are extracted being added step (3) merges, adjust ph is 6.5-7.5, and reconcentration receives cream to during relative density d=1.32-1.35;
(5) volatile oil that powder step (2) obtained and step (3) obtain adds in the extractum that step (4) obtains, enter spray dryer, inlet temperature control 120-130 DEG C, leaving air temp 100-110 DEG C, charging rate is 3-6ml/ minute, obtains spray drying powder;
(6) in described spray drying powder, add pharmaceutic adjuvant, prepare Chinese medicine preparation finished product.
As the further scheme of the present invention: the dosage form of described Chinese medicine preparation finished product is capsule, tablet, granule, pill, oral liquid or powder.
As the further scheme of the present invention: described pharmaceutic adjuvant is dextrin, cane sugar powder, starch or microcrystalline Cellulose.
As the present invention's further scheme: the application of described Chinese medicine preparation in preparation treatment hysteromyoma medicine.
Compared with prior art, the invention has the beneficial effects as follows:
In the present invention, each crude drug synergism plays and has the high and medication of rapid-action, determined curative effect, safety and simply act on, preparation technology is simple, environmentally friendly, effectively can alleviate vaginal hemorrhage that hysteromyoma causes, the symptom such as waist is ached, hypoglycemia, do not have toxic and side effects, the various symptoms caused for clinical remission hysteromyoma provide a newly selection.
Detailed description of the invention
Be described in more detail below in conjunction with the technical scheme of detailed description of the invention to this patent.
Embodiment 1
Treat a Chinese medicine preparation for hysteromyoma, be made up of the raw material of following weight portion: Radix Potentillae Fragarioidis 20 parts, Fructus Aurantii 20 parts, Ficus fulva Reinw. 20 parts, Radix Achyranthis Bidentatae 10 parts, Flos Rosae Rugosae 10 part, day fourth 10 parts, late Bombyx mori L. 10 parts, Radix Dipsaci 10 parts, Rhizoma Curcumae 8 parts, Concha Arcae 8 parts, Herba Ludwigiae Prostratae root 8 parts, Eupolyphaga Seu Steleophaga 3 parts, Radix Caraganae Sinicae 3 parts, Medulla Junci 1 part.
The preparation method of the Chinese medicine preparation of described treatment hysteromyoma, concrete steps are as follows:
(1) take each raw material according to weight portion, each raw material is cleaned rear hot blast drying respectively, is processed into fragment, with disinfection by ultraviolet light;
(2) fry after Fructus Aurantii, Radix Achyranthis Bidentatae, late Bombyx mori L. and sky fourth mix homogeneously to micro-coke yellow, and the mixture after parch is crushed into powder for subsequent use;
(3) Radix Potentillae Fragarioidis, Ficus fulva Reinw., Radix Dipsaci, Rhizoma Curcumae and Radix Caraganae Sinicae are extracted volatile oil, respectively volatile oil and medicinal residues are deposited for subsequent use;
(4) add water the medicinal residues that remaining raw material and step (3) obtain common extraction three times, first time 1h, second time and third time each 0.5h, the extracting solution filtrate that three times are extracted being added step (3) merges, adjust ph is 6.5, and reconcentration receives cream to during relative density d=1.32;
(5) volatile oil that powder step (2) obtained and step (3) obtain adds in the extractum that step (4) obtains, enter spray dryer, inlet temperature controls 120 DEG C, leaving air temp 100 DEG C, charging rate is 3ml/ minute, obtains spray drying powder;
(6) in described spray drying powder, add dextrin, prepare capsule Chinese medicine preparation finished product.
Usage and dosage: oral.A 2-4g, 3 times on the one.
Embodiment 2
Treat a Chinese medicine preparation for hysteromyoma, be made up of the raw material of following weight portion: Radix Potentillae Fragarioidis 25 parts, Fructus Aurantii 22 parts, Ficus fulva Reinw. 22 parts, Radix Achyranthis Bidentatae 12 parts, Flos Rosae Rugosae 12 part, day fourth 11 parts, late Bombyx mori L. 11 parts, Radix Dipsaci 11 parts, Rhizoma Curcumae 9 parts, Concha Arcae 9 parts, Herba Ludwigiae Prostratae root 9 parts, Eupolyphaga Seu Steleophaga 3.5 parts, Radix Caraganae Sinicae 3.5 parts, Medulla Junci 1.5 parts.
The preparation method of the Chinese medicine preparation of described treatment hysteromyoma, concrete steps are as follows:
(1) take each raw material according to weight portion, each raw material is cleaned rear hot blast drying respectively, is processed into fragment, with disinfection by ultraviolet light;
(2) fry after Fructus Aurantii, Radix Achyranthis Bidentatae, late Bombyx mori L. and sky fourth mix homogeneously to micro-coke yellow, and the mixture after parch is crushed into powder for subsequent use;
(3) Radix Potentillae Fragarioidis, Ficus fulva Reinw., Radix Dipsaci, Rhizoma Curcumae and Radix Caraganae Sinicae are extracted volatile oil, respectively volatile oil and medicinal residues are deposited for subsequent use;
(4) add water the medicinal residues that remaining raw material and step (3) obtain common extraction three times, first time 1.5h, second time and third time each 0.8h, the extracting solution filtrate that three times are extracted being added step (3) merges, adjust ph is 6.8, and reconcentration receives cream to during relative density d=1.33;
(5) volatile oil that powder step (2) obtained and step (3) obtain adds in the extractum that step (4) obtains, enter spray dryer, inlet temperature controls 122 DEG C, leaving air temp 102 DEG C, charging rate is 4ml/ minute, obtains spray drying powder;
(6) in described spray drying powder, add cane sugar powder, prepare tablet Chinese medicine preparation finished product.
Usage and dosage: oral.A 2-4g, 3 times on the one.
Embodiment 3
Treat a Chinese medicine preparation for hysteromyoma, be made up of the raw material of following weight portion: Radix Potentillae Fragarioidis 30 parts, Fructus Aurantii 25 parts, Ficus fulva Reinw. 25 parts, Radix Achyranthis Bidentatae 15 parts, Flos Rosae Rugosae 15 part, day fourth 12 parts, late Bombyx mori L. 12 parts, Radix Dipsaci 12 parts, Rhizoma Curcumae 10 parts, Concha Arcae 10 parts, Herba Ludwigiae Prostratae root 10 parts, Eupolyphaga Seu Steleophaga 4 parts, Radix Caraganae Sinicae 4 parts, Medulla Junci 2 parts.
The preparation method of the Chinese medicine preparation of described treatment hysteromyoma, concrete steps are as follows:
(1) take each raw material according to weight portion, each raw material is cleaned rear hot blast drying respectively, is processed into fragment, with disinfection by ultraviolet light;
(2) fry after Fructus Aurantii, Radix Achyranthis Bidentatae, late Bombyx mori L. and sky fourth mix homogeneously to micro-coke yellow, and the mixture after parch is crushed into powder for subsequent use;
(3) Radix Potentillae Fragarioidis, Ficus fulva Reinw., Radix Dipsaci, Rhizoma Curcumae and Radix Caraganae Sinicae are extracted volatile oil, respectively volatile oil and medicinal residues are deposited for subsequent use;
(4) add water the medicinal residues that remaining raw material and step (3) obtain common extraction three times, first time 2h, second time and third time each 1h, the extracting solution filtrate that three times are extracted being added step (3) merges, adjust ph is 7, and reconcentration receives cream to during relative density d=1.33;
(5) volatile oil that powder step (2) obtained and step (3) obtain adds in the extractum that step (4) obtains, enter spray dryer, inlet temperature controls 125 DEG C, leaving air temp 105 DEG C, charging rate is 4ml/ minute, obtains spray drying powder;
(6) in described spray drying powder, add starch, prepare granule Chinese medicine preparation finished product.
Usage and dosage: oral.A 2-4g, 3 times on the one.
Embodiment 4
Treat a Chinese medicine preparation for hysteromyoma, be made up of the raw material of following weight portion: Radix Potentillae Fragarioidis 35 parts, Fructus Aurantii 28 parts, Ficus fulva Reinw. 28 parts, Radix Achyranthis Bidentatae 18 parts, Flos Rosae Rugosae 18 part, day fourth 14 parts, late Bombyx mori L. 14 parts, Radix Dipsaci 14 parts, Rhizoma Curcumae 11 parts, Concha Arcae 11 parts, Herba Ludwigiae Prostratae root 11 parts, Eupolyphaga Seu Steleophaga 4.5 parts, Radix Caraganae Sinicae 4.5 parts, Medulla Junci 2.5 parts.
The preparation method of the Chinese medicine preparation of described treatment hysteromyoma, concrete steps are as follows:
(1) take each raw material according to weight portion, each raw material is cleaned rear hot blast drying respectively, is processed into fragment, with disinfection by ultraviolet light;
(2) fry after Fructus Aurantii, Radix Achyranthis Bidentatae, late Bombyx mori L. and sky fourth mix homogeneously to micro-coke yellow, and the mixture after parch is crushed into powder for subsequent use;
(3) Radix Potentillae Fragarioidis, Ficus fulva Reinw., Radix Dipsaci, Rhizoma Curcumae and Radix Caraganae Sinicae are extracted volatile oil, respectively volatile oil and medicinal residues are deposited for subsequent use;
(4) add water the medicinal residues that remaining raw material and step (3) obtain common extraction three times, first time 2.5h, second time and third time each 1.2h, the extracting solution filtrate that three times are extracted being added step (3) merges, adjust ph is 7.2, and reconcentration receives cream to during relative density d=1.34;
(5) volatile oil that powder step (2) obtained and step (3) obtain adds in the extractum that step (4) obtains, enter spray dryer, inlet temperature controls 128 DEG C, leaving air temp 108 DEG C, charging rate is 5ml/ minute, obtains spray drying powder;
(6) in described spray drying powder, add microcrystalline Cellulose, prepare Chinese medical pill finished dosage form.
Usage and dosage: oral.A 2-4g, 3 times on the one.
Embodiment 5
Treat a Chinese medicine preparation for hysteromyoma, be made up of the raw material of following weight portion: Radix Potentillae Fragarioidis 40 parts, Fructus Aurantii 30 parts, Ficus fulva Reinw. 30 parts, Radix Achyranthis Bidentatae 20 parts, Flos Rosae Rugosae 20 part, day fourth 15 parts, late Bombyx mori L. 15 parts, Radix Dipsaci 15 parts, Rhizoma Curcumae 12 parts, Concha Arcae 12 parts, Herba Ludwigiae Prostratae root 12 parts, Eupolyphaga Seu Steleophaga 5 parts, Radix Caraganae Sinicae 5 parts, Medulla Junci 3 parts.
The preparation method of the Chinese medicine preparation of described treatment hysteromyoma, concrete steps are as follows:
(1) take each raw material according to weight portion, each raw material is cleaned rear hot blast drying respectively, is processed into fragment, with disinfection by ultraviolet light;
(2) fry after Fructus Aurantii, Radix Achyranthis Bidentatae, late Bombyx mori L. and sky fourth mix homogeneously to micro-coke yellow, and the mixture after parch is crushed into powder for subsequent use;
(3) Radix Potentillae Fragarioidis, Ficus fulva Reinw., Radix Dipsaci, Rhizoma Curcumae and Radix Caraganae Sinicae are extracted volatile oil, respectively volatile oil and medicinal residues are deposited for subsequent use;
(4) add water the medicinal residues that remaining raw material and step (3) obtain common extraction three times, first time 1-3h, second time and third time each 0.5-1.5h, the extracting solution filtrate that three times are extracted being added step (3) merges, adjust ph is 6.5-7.5, and reconcentration receives cream to during relative density d=1.32-1.35;
(5) volatile oil that powder step (2) obtained and step (3) obtain adds in the extractum that step (4) obtains, enter spray dryer, inlet temperature control 120-130 DEG C, leaving air temp 100-110 DEG C, charging rate is 3-6ml/ minute, obtains spray drying powder;
(6) in described spray drying powder, add dextrin, cane sugar powder, starch or microcrystalline Cellulose, prepare the agent of Chinese medicine preparation finished capsule product, tablet, granule, pill, oral liquid or powder.
Usage and dosage: oral.A 2-4g, 3 times on the one.
Comparative example 1
Treat a Chinese medicine preparation for hysteromyoma, be made up of the raw material of following weight portion: Radix Potentillae Fragarioidis 25 parts, Fructus Aurantii 22 parts, Ficus fulva Reinw. 22 parts, Radix Achyranthis Bidentatae 12 parts, Flos Rosae Rugosae 12 part, day fourth 11 parts, Radix Dipsaci 11 parts, Rhizoma Curcumae 9 parts, Concha Arcae 9 parts, Herba Ludwigiae Prostratae root 9 parts, Eupolyphaga Seu Steleophaga 3.5 parts, Radix Caraganae Sinicae 3.5 parts, Medulla Junci 1.5 parts.
The preparation method of the Chinese medicine preparation of described treatment hysteromyoma, concrete steps are as follows:
(1) take each raw material according to weight portion, each raw material is cleaned rear hot blast drying respectively, is processed into fragment, with disinfection by ultraviolet light;
(2) fry after Fructus Aurantii, Radix Achyranthis Bidentatae and sky fourth mix homogeneously to micro-coke yellow, and the mixture after parch is crushed into powder for subsequent use;
(3) Radix Potentillae Fragarioidis, Ficus fulva Reinw., Radix Dipsaci, Rhizoma Curcumae and Radix Caraganae Sinicae are extracted volatile oil, respectively volatile oil and medicinal residues are deposited for subsequent use;
(4) add water the medicinal residues that remaining raw material and step (3) obtain common extraction three times, first time 1.5h, second time and third time each 0.8h, the extracting solution filtrate that three times are extracted being added step (3) merges, adjust ph is 6.8, and reconcentration receives cream to during relative density d=1.33;
(5) volatile oil that powder step (2) obtained and step (3) obtain adds in the extractum that step (4) obtains, enter spray dryer, inlet temperature controls 122 DEG C, leaving air temp 102 DEG C, charging rate is 4ml/ minute, obtains spray drying powder;
(6) in described spray drying powder, add cane sugar powder, prepare tablet Chinese medicine preparation finished product.
Usage and dosage: oral.A 2-4g, 3 times on the one.
Comparative example 2
Treat a Chinese medicine preparation for hysteromyoma, be made up of the raw material of following weight portion: Radix Potentillae Fragarioidis 35 parts, Fructus Aurantii 28 parts, Ficus fulva Reinw. 28 parts, Radix Achyranthis Bidentatae 18 parts, Flos Rosae Rugosae 18 part, day fourth 14 parts, late Bombyx mori L. 14 parts, Radix Dipsaci 14 parts, Rhizoma Curcumae 11 parts, Concha Arcae 11 parts, Herba Ludwigiae Prostratae root 11 parts, Eupolyphaga Seu Steleophaga 4.5 parts, Medulla Junci 2.5 parts.
The preparation method of the Chinese medicine preparation of described treatment hysteromyoma, concrete steps are as follows:
(1) take each raw material according to weight portion, each raw material is cleaned rear hot blast drying respectively, is processed into fragment, with disinfection by ultraviolet light;
(2) fry after Fructus Aurantii, Radix Achyranthis Bidentatae, late Bombyx mori L. and sky fourth mix homogeneously to micro-coke yellow, and the mixture after parch is crushed into powder for subsequent use;
(3) Radix Potentillae Fragarioidis, Ficus fulva Reinw., Radix Dipsaci and Rhizoma Curcumae are extracted volatile oil, respectively volatile oil and medicinal residues are deposited for subsequent use;
(4) add water the medicinal residues that remaining raw material and step (3) obtain common extraction three times, first time 2.5h, second time and third time each 1.2h, the extracting solution filtrate that three times are extracted being added step (3) merges, adjust ph is 7.2, and reconcentration receives cream to during relative density d=1.34;
(5) volatile oil that powder step (2) obtained and step (3) obtain adds in the extractum that step (4) obtains, enter spray dryer, inlet temperature controls 128 DEG C, leaving air temp 108 DEG C, charging rate is 5ml/ minute, obtains spray drying powder;
(6) in described spray drying powder, add microcrystalline Cellulose, prepare Chinese medical pill finished dosage form.
Usage and dosage: oral.A 2-4g, 3 times on the one.
Embodiment 6
Clinical trial
(1) subjects: adopt the present invention to treat 140 routine patients altogether; The oldest person 54 years old, age reckling 36 years old;
(2) diagnostic criteria:
1) through hysteromyoma (under serous coat, muscle layer and the fleshy polyp) patient that color doppler ultrasonography confirms, tumor body minimum diameter line >=3cm, maximum gauge line is 7.3cm;
2) with or without obvious menorrhagia, menostaxis, anemia, lower abdominal pain or pressure symptom;
3) other tumors and the Leiomyoma degeneration of uterus and adnexa is got rid of;
4) hormone medicine was not used over nearly 3 months;
5) be not in the mood for, liver, lung, renal dysfunction.
(3) Therapeutic Method: 140 routine patients are equally divided into five groups, often organize 28 examples, five groups of patients the age, pregnant time, in parity, the state of an illness etc. through statistical procedures, the indifference opposite sex (P>0.05), one group, two groups and three groups are test group, one group, two groups and three components do not take the Chinese medicine preparation of the treatment hysteromyoma of the present invention that embodiment 1-embodiment 3 prepares, four groups and five groups is matched group, four groups and the five groups Chinese medicine preparation taken comparative example 1 and comparative example 2 respectively and prepare, using method is oral.A 2-4g, 3 times on the one, January is a course for the treatment of.
(5) standard is treated
Cure: muscular tumor reduces more than 80% clinical symptoms, sign disappears.
Effective: muscular tumor reduces more than 40%, clinical symptoms, sign disappear substantially.
Effective: muscular tumor reduces more than 20%, clinical symptoms and sign all take a turn for the better.
Invalid: muscular tumor reduce less than 20% and clinical symptoms all without obviously changing.
(6) therapeutic outcome: how to take effect after three weeks after taking medicine in the routine case of patient 140,1-2 the course for the treatment of cures; Wherein cure 78 examples, effective 28 examples, effective 12 examples, invalid 22 examples, total effective rate reaches 84.3%, and therapeutic outcome is as shown in table 1:
Table 1: clinical trial therapeutic outcome
As shown in Table 1, the average effectiveness level adopting the Chinese medicine preparation for the treatment of hysteromyoma of the present invention to carry out treating reaches 95.2%, the effective percentage of the pharmaceutical composition adopting comparative example to prepare only has 67.9%, therefore, between medicine of the present invention, there is synergistic function, add the effective percentage of Chinese medicine preparation.
Model case:
(1) week so-and-so, female, 52 years old, people was done in Fang An street, Fangzi District, Weifang City.Found the lump that abdominal part has volume cumulative before half a year, and with stomachache, menoxenia, leucorrhea waits disease.Recent lump more day by day increases, and about has 9cm × 8cm × 8cm size, through color ultrasound examination, is diagnosed as hysteromyoma, and gynecological's suggestion operative treatment, because of financial difficulties, patient does not agree to operation.Give Granules in Treating prepared by the present invention, every day 3 times, each 2 bags.Color ultrasound check after taking medicine one month, finds that mass reduction is to 3cm × 4cm × 5cm, and without the necessity of performing an operation, following the service one month again, lump disappears, clinical cure.
(2) Xu certain, female, 32 years old, Anhui Province Fuyang City people.Do not educate after marriage, dysmenorrhea, reaches more than 15 days menstrual period, measures medium, color exhausts, B ultrasonic shows that left uterine rear wall has the hysteromyoma of 2 × 2cm, through institute of traditional Chinese medicine's Chinese herbal medicine system oral medication four months, and hysteromyoma size does not change, do not think surgical removal, after taking two courses for the treatment of of medicine of the present invention, hysteromyoma disappears, the eumenorrhea.
(3) hole, female, 27 years old, people from Hefei City, Anhui Province, dim complexion, simple and unadorned, dysmenorrhea, the cycle is irregular, reach more than 10 days menstrual period, measure medium, color exhausts, routine blood test shows that hematochrome is low, and B ultrasonic shows that right uterine antetheca has the hysteromyoma of 3 × 4cm, is diagnosed as hysteromyoma, advise operating excision, but patient to give birth to after considering, does not agree to operative treatment, after take medicine of the present invention, adhere to having taken March, transference cure; After continue again to take four months, cure; Follow up a case by regular visits to and do not recur for 1 year.
The present invention finds that in a large amount of clinical practices it has the effect of significant treatment hysteromyoma, and existing by main effect experiment, details are as follows:
One, animal acute toxicity test:
Experimental animal: white mice, body weight is at 30-50g, and male and female Stochastic choice, is provided by Medical University Of Anhui.
Method and result: get white mice 100, be divided into 5 groups, often organize 20, hungry 15 hours, fill with medicine feed thing by every only each 20m1, fill with respectively for the 1st, 2,3,4,5 group and feed Chinese medicine preparation 1,2,3,4,5 times prepared by the present invention in 24 hours, observe 5 days, white mice is movable normal, non-toxic reaction, without dead.Wherein white mice dosage is by kg body weight medicine calculation, shows that Chinese medicine preparation of the present invention is without acute toxicity, clinical medicine dose safety.
Two, long-term toxicity test for animals:
Experimental animal: rat, body weight, at 120-130g, all selects male white rat, is provided by Medical University Of Anhui.
Method and result: get rat 100, be divided into 5 groups, often organize 20, wherein the 1st, 2, 3, 4 groups as administration group, often organize to fill with respectively and feed Chinese medicine preparation 15m1 of the present invention, 20m1, 30m1, 40m1, 5th group of diet as a control group, once a day, continuous irrigation is fed 90 days, survey body weight, 24 hours sacrificed by decapitation after last administration, survey blood, routine urinalysis, liver function, renal function, core, the internal organs such as kidney, the change of tissues observed form, observe the effect of dosage, observe diet, movable change, experiment proves that administration group compares without significant change with matched group, illustrate that Chinese medicine preparation of the present invention is a kind of safe drugs.
Three, pharmacodynamic study:
1. experimental animal: female adult unpregnancy Cavia porcellus, Wistar rat, Kun Ming mice, female, cleaning grade, is provided by Medical University Of Anhui's Experimental Animal Center.
2. positive control drug: Aspirin Enteric-coated Tablets, SmithKline pharmaceutical Co. Ltd of Tianjin Sino-U.S. produces.
3. the preparation of Experimental agents group: invention formulation is mixed with administering medical liquids with distilled water.
4. the research of anti-leiomyoma of uterus sample proliferative effect:
60 Cavia porcelluss are divided at random blank group, model group and medicine group of the present invention, often organize 20.Except blank group, all the other respectively group modelings all in the following manner: only get Cavia porcellus intramuscular injection estradiol benzoate 0.25mg/, 3 times weekly, after continuous 3 months, add a Progesterone 1.52mg/ intramuscular injection, 2 times/week, continuous 1 month.Administering mode: often organizing modeling simultaneously, model group gavage every day only takes normal saline 2ml/, and medicine group of the present invention every day, gavage took 1.1g/kg (with crude drug gauge) respectively.Blank group routine is raised, and every day, gavage only took normal saline 2ml/.After 3 months, all animals are weighed, to tap the head execution, cut open the belly and observe uterus general form, along clip uterus, uterovesical junction, weigh, calculate Uterine coefficient (weight/body weight × 100, uterus), measure more than cervix uteri and subangle uterus root transverse diameter, then under microscope, micrometer measures smooth muscle thickness, average, its result is as follows:
Table 2 is on the impact (x ± SD) of Cavia porcellus uterus weight
Group n Cavia porcellus body weight (g) Uterus heavy (g) Uterine coefficient (weight/body weight × 100, uterus)
Blank group 20 782.4±80.1 1.24±0.28 0.1586±0.002
Model group 20 395.4±66.8 ### 4.04±1.06 ###△△ 1.022±0.165 ###△△
Medicine group of the present invention 20 567.9±49.5*** 2.14±0.15*** △ 0.369±0.097*** △
Note: compare with blank group, ###p < 0.001; Compare with model group, * P < 0.05, * * P < 0.01, * * * P < 0.001.
As shown in Table 2: compare with blank group, the Cavia porcellus body weight of model group, uterus weight, Uterine coefficient numerical value all have highly significant difference, prompting modeling success; Compare with model group, medicine group of the present invention declines at the increase of Cavia porcellus body weight, uterus weight and all has significant difference in the index such as Uterine coefficient minimizing, shows that medicine group of the present invention has clear and definite curative effect.
The impact (x ± SD) that table 3 changes Cavia porcellus uterus transverse diameter
Group n Under subangle (cm) Subangle root (cm)
Blank group 20 0.54±0.09 0.27±0.05
Model group 20 1.43±0.25 ### 0.64±0.13 ###
Medicine group of the present invention 20 0.97±0.11*** △△ 0.39±0.08***
Note: compare with blank group, ###p < 0.001; Compare with model group, * P < 0.05, * * P < 0.01, * * * P < 0.001.
As shown in Table 3: compare with blank group, the uterus transverse diameter of model group changes each index all highly significant difference, prompting modeling success; Compare with model group, medicine group of the present invention has significant difference; Result is pointed out: medicine group of the present invention has preferably therapeutical effect for the change of uterus transverse diameter.
Table 4 is on the impact (x ± SD) of Cavia porcellus uterine smooth muscle thickness
Group n Thickness (mm)
Blank group 20 25.91±2.55
Model group 20 54.38±6.51 ###
Medicine group of the present invention 20 32.55±7.49***
Note: compare with blank group, ###p < 0.001; Compare with model group, * * * P < 0.001.
As shown in Table 4: compare with blank group, the uterine smooth muscle thickness of model group has significant difference, prompting modeling success; Compare with model group, medicine group of the present invention has significant difference (p < 0.001), and its uterine smooth muscle thickness obviously reduces, and shows its effect having better treatment hysteromyoma.
From table 2,3 and 4 result: medicine group of the present invention has obvious anti-leiomyoma of uterus sample proliferative effect, has good therapeutical effect to the pathological symptom of hysteromyoma.
5. analgesic activity research:
5.1 pairs of mice acetic acid cause the effect of writhing response: mice 40, be divided into 2 groups at random, every day gastric infusion once (medicine group dosage is with crude drug gauge), successive administration 5 days, after last gastric infusion 1h, lumbar injection 0.6% glacial acetic acid 0.2ml/ only, observes and records the number of times that mouse writhing in 20min reacts (abdominal part indent, stretching, extension hind leg, buttocks are raised), the results are shown in Table 5.
The analgesic activity (x ± SD) of table 5 pair mice acetic acid twisting reaction
Group N Dosage (g/kg) Writhing number of times (t=20min)
Blank group 20 -- 25.34±4.58
Medicine group of the present invention 20 1.8 12.16±2.05 ###△△
Note: compare with normal saline group, ###p < 0.001.
5.2 impacts on mice electricity irritation whipping pain threshold: mice 40, be divided into 2 groups at random, every day gastric infusion once (medicine group dosage is with crude drug gauge), successive administration 5 days, after last gastric infusion lh, one electrode is put on mice foot, another electrode stimulating afterbody, after energising, observes pain threshold during mice whipping, and calculate analgesia suppression ratio, the results are shown in Table 6.
Table 6 is on the impact (x ± SD) of mice electricity irritation whipping pain threshold
Group n Dosage (g/kg) Pain threshold (mA) Analgesia suppression ratio (%)
Saline control group 20 -- 0.35±0.12 --
Medicine group of the present invention 20 1.8 0.54±0.068 ###△△ 75.9
Note: compare with normal saline group, #p < 0.05, ###p < 0.001.
Research from above-mentioned table 5 and table 6: compare with normal saline group, medicine group of the present invention has the analgesic effect of the significance difference opposite sex, effectively can treat the Pain Complication of hysteromyoma.
6. the research of antiinflammatory action:
The impact of the mice ear that 6.1 xylol cause:
Get mice 60, be divided into 3 groups at random, often organize 20, gastric infusion 1 time every day (medicine group dosage is with crude drug gauge), continuous 5 days, after last administration 30 minutes, dimethylbenzene is only dripped by 20 μ l/ and carries on the back in mouse right ear, animal is put to death after 15 minutes, draw materials along the punching of left and right auricle same area with 5mm card punch, weigh respectively, represent swelling degree with the two auricle method of double differences, respectively organize swelling degree and obtain and press down swollen rate, the results are shown in Table 7.
Press down swollen rate=(auris dextra sheet weight-left auricle weight)/left ear weight × 100%
The impact (x ± SD) of the mice ear that table 7 xylol causes
Group Dosage (g/kg) Two auricle weight differences (mg) Press down swollen rate (%)
Saline control group -- 4.96±1.54 --
Aspirin matched group 0.2 2.24±1.28 ### 58.64
Medicine group of the present invention 1.8 2.89±1.83 ## 52.34
Note: compare with normal saline group, #p < 0.05, ##p < 0.01, ###p < 0.001.
Shown by the experimental result of table 7: compare with normal saline group, aspirin matched group and medicine group of the present invention all have the antiphlogistic effects of the significance difference opposite sex.
6.2 impacts on rat uterus inflammation:
Get mice 60, use ether light anaesthesia, hypogastric region cropping, skin degerming, pubic symphysis upper abdomen, along midline incision 2cm, exposes uterus, along work one transverse incision in 1cm place on left uterine, a plastic tube is positioned over intrauterine, fix with Uterine repair, with slip-off preventing, layering peritoneal suture and skin.Experimental rat is divided into 3 groups by next day at random, often organize 20, gastric infusion 1 time every day (medicine group dosage is with crude drug gauge), continuous 7 days, weigh after last administration 1h, put to death, from uterus subangle to uterus, oviductal junction clip both sides, get plastic tube, weigh bilateral uterine weight, calculate inflammation swelling rate and inhibitory rate of intumesce thereof, the results are shown in Table 8.
Swelling rate: (weight-right side, left side is heavy)/right side is heavy
Inhibitory rate of intumesce=(blank group average swelling rate-average swelling rate of administration the group)/average swelling rate of blank group (%)
Table 8 is on the impact (x ± SD) of rat uterus inflammation
Group Dosage (g/kg) Swelling rate (%) Press down swollen rate (%)
Saline control group -- 55.84±8.6 --
Aspirin matched group 0.2 20.53±12.9 ###△ 63.54
Medicine group of the present invention 1.2 24.62±14.63 ##△ 55.29
Note: compare with normal saline group, ##p < 0.01, ###p < 0.001.
Shown by the experimental result of table 8: compare with normal saline group, aspirin matched group and medicine group of the present invention all have the effect of Chinese People's Anti-Japanese Military and Political College's Mus inflammation of uterus swelling rate of the significance difference opposite sex.
Pointed out by the result of study of above-mentioned table 7 and table 8: medicine group of the present invention has good antiphlogistic effects.
7. mice is docked hemorrhage impact:
Get mice 40, be divided into 2 groups at random, gastric infusion 1 time every day (medicine group dosage is with crude drug gauge), for three days on end, after last administration 2 hours, respectively by cross-section for Mouse Tail-tip 0.5cm place, when blood flows out voluntarily, suck drop of blood 1 time every 15 seconds with filter paper, until blood stops naturally, the results are shown in Table 9.
The impact (x ± SD) that table 9 docks hemorrhage on mice
Note: compare with normal saline group, ###p < 0.001.
Shown by the experimental result of table 9: compare with normal saline group, medicine group of the present invention has the obviously shortening mice docking bleeding time; Because patients with uterine myoma is attended by bleeding in various degree usually, therefore medicine group of the present invention has anastalsis and will be conducive to the treatment of hysteromyoma disease, strengthens the body constitution of patient, promotes absorbing of medicine.
In the present invention, each crude drug synergism plays and has the high and medication of rapid-action, determined curative effect, safety and simply act on, preparation technology is simple, environmentally friendly, effectively can alleviate vaginal hemorrhage that hysteromyoma causes, the symptom such as waist is ached, hypoglycemia, do not have toxic and side effects, the various symptoms caused for clinical remission hysteromyoma provide a newly selection.
Above the better embodiment of this patent is explained in detail, but this patent is not limited to above-mentioned embodiment, in the ken that one skilled in the relevant art possesses, various change can also be made under the prerequisite not departing from this patent aim.

Claims (7)

1. treat the Chinese medicine preparation of hysteromyoma for one kind, it is characterized in that, be made up of the following raw material according to weight portion: Radix Potentillae Fragarioidis 20-40 part, Fructus Aurantii 20-30 part, Ficus fulva Reinw. 20-30 part, Radix Achyranthis Bidentatae 10-20 part, Flos Rosae Rugosae 10-20 part, sky fourth 10-15 part, late Bombyx mori L. 10-15 part, Radix Dipsaci 10-15 part, Rhizoma Curcumae 8-12 part, Concha Arcae 8-12 part, Herba Ludwigiae Prostratae root 8-12 part, Eupolyphaga Seu Steleophaga 3-5 part, Radix Caraganae Sinicae 3-5 part, Medulla Junci 1-3 part.
2. the Chinese medicine preparation for the treatment of hysteromyoma according to claim 1, it is characterized in that, be made up of the following raw material according to weight portion: Radix Potentillae Fragarioidis 25-35 part, Fructus Aurantii 22-28 part, Ficus fulva Reinw. 22-28 part, Radix Achyranthis Bidentatae 12-18 part, Flos Rosae Rugosae 12-18 part, sky fourth 11-14 part, late Bombyx mori L. 11-14 part, Radix Dipsaci 11-14 part, Rhizoma Curcumae 9-11 part, Concha Arcae 9-11 part, Herba Ludwigiae Prostratae root 9-11 part, Eupolyphaga Seu Steleophaga 3.5-4.5 part, Radix Caraganae Sinicae 3.5-4.5 part, Medulla Junci 1.5-2.5 part.
3. the Chinese medicine preparation for the treatment of hysteromyoma according to claim 1, it is characterized in that, be made up of the following raw material according to weight portion: Radix Potentillae Fragarioidis 30 parts, Fructus Aurantii 25 parts, Ficus fulva Reinw. 25 parts, Radix Achyranthis Bidentatae 15 parts, Flos Rosae Rugosae 15 part, day fourth 12 parts, late Bombyx mori L. 12 parts, Radix Dipsaci 12 parts, Rhizoma Curcumae 10 parts, Concha Arcae 10 parts, Herba Ludwigiae Prostratae root 10 parts, Eupolyphaga Seu Steleophaga 4 parts, Radix Caraganae Sinicae 4 parts, Medulla Junci 2 parts.
4. a preparation method for the Chinese medicine preparation of the treatment hysteromyoma as described in as arbitrary in claim 1-2, it is characterized in that, concrete steps are as follows:
(1) take each raw material according to weight portion, each raw material is cleaned rear hot blast drying respectively, is processed into fragment, with disinfection by ultraviolet light;
(2) fry after Fructus Aurantii, Radix Achyranthis Bidentatae, late Bombyx mori L. and sky fourth mix homogeneously to micro-coke yellow, and the mixture after parch is crushed into powder for subsequent use;
(3) Radix Potentillae Fragarioidis, Ficus fulva Reinw., Radix Dipsaci, Rhizoma Curcumae and Radix Caraganae Sinicae are extracted volatile oil, respectively volatile oil and medicinal residues are deposited for subsequent use;
(4) add water the medicinal residues that remaining raw material and step (3) obtain common extraction three times, first time 1-3h, second time and third time each 0.5-1.5h, the extracting solution filtrate that three times are extracted being added step (3) merges, adjust ph is 6.5-7.5, and reconcentration receives cream to during relative density d=1.32-1.35;
(5) volatile oil that powder step (2) obtained and step (3) obtain adds in the extractum that step (4) obtains, enter spray dryer, inlet temperature control 120-130 DEG C, leaving air temp 100-110 DEG C, charging rate is 3-6ml/ minute, obtains spray drying powder;
(6) in described spray drying powder, add pharmaceutic adjuvant, prepare Chinese medicine preparation finished product.
5. the preparation method of the Chinese medicine preparation for the treatment of hysteromyoma according to claim 4, is characterized in that, the dosage form of described Chinese medicine preparation finished product is capsule, tablet, granule, pill, oral liquid or powder.
6. according to the preparation method of the Chinese medicine preparation for the treatment of hysteromyoma according to claim 4, it is characterized in that, described pharmaceutic adjuvant is dextrin, cane sugar powder, starch or microcrystalline Cellulose.
7. one kind as arbitrary in claim 1-2 as described in the application of Chinese medicine preparation in preparation treatment hysteromyoma medicine.
CN201610008128.1A 2016-01-05 2016-01-05 Traditional Chinese medicine preparation for treating fibroid and preparation method and application thereof Pending CN105477560A (en)

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Citations (2)

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CN103585586A (en) * 2013-11-20 2014-02-19 潘恒晔 Traditional Chinese medicine composition for treating uterine fibroids and preparation method of same

Patent Citations (2)

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CN103585586A (en) * 2013-11-20 2014-02-19 潘恒晔 Traditional Chinese medicine composition for treating uterine fibroids and preparation method of same

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Application publication date: 20160413