CN104306470B - A kind of pharmaceutical composition for the treatment of primary dysmenorrhea - Google Patents
A kind of pharmaceutical composition for the treatment of primary dysmenorrhea Download PDFInfo
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- CN104306470B CN104306470B CN201410625394.XA CN201410625394A CN104306470B CN 104306470 B CN104306470 B CN 104306470B CN 201410625394 A CN201410625394 A CN 201410625394A CN 104306470 B CN104306470 B CN 104306470B
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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)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
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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
- A61K36/10—Bryophyta
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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)
-
- 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)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
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- 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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
-
- 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
-
- 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
-
- 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
Abstract
The present invention relates to a kind of pharmaceutical composition for the treatment of primary dysmenorrhea, it is made up of the material of following weight portion: wild pool wormwood artemisia 10-50 part, auriculate dichrocephala herb or leaf 10-30 part, conical conocephalum herb 20-30 part, hops 10-30 part, copper arhat 20-30 part and inclined to one side wing grass of meadow rue 10-20 part. Pharmaceutical composition of the present invention interacts, synergy, and determined curative effect, with low cost, have no side effect.
Description
Technical field
The present invention relates to field of medicaments, relate in particular to a kind of medicine for the treatment of primary dysmenorrheaComposition.
Background technology
Traditional Chinese medicine claims that dysmenorrhoea is " dysmenorrhea ", " bellyache in menstrual period ", " dysmenorrhoea " etc. Menstrual period andBefore and after passing through, there is the discomforts such as obvious lower abdominal pain, falling inflation or soreness of waist pain, impact life and workDo. Dysmenorrhoea is divided into two kinds of primary and Secondary cases, and primary dysmenorrhea refers to without pelvic cavity organic disease,Mostly be functional dysmenorrhea, account for the more than 90% of dysmenorrhoea; Acquired dysmenorrhea is the organic disease of pelvic cavityThe dysmenorrhoea that disease causes, as endometriosis, pelvic infecton or cervical stenosis, Intrauterine Foreign Body etc.Due to dysmenorrhoea. At present, the method for the treatment of primary dysmenorrhea is a lot, and western medicine adopts solution moreHot antalgesic and PGSI, contraceptive etc., general analgesic effect is strong, butCurative effect is of short duration, cannot effect a radical cure.
Summary of the invention
The object of this invention is to provide a kind of pharmaceutical composition for the treatment of primary dysmenorrhea.
In order to realize object of the present invention, the invention provides a kind of medicine for the treatment of primary dysmenorrheaComposition, it is made up of the material of following weight portion: wild pool wormwood artemisia 10-50 part, auriculate dichrocephala herb or leaf 10-30Part, conical conocephalum herb 20-30 part, hops 10-30 part, copper arhat 20-30 part and Pian Chi Tang SongGrass 10-20 part.
Preferably, the pharmaceutical composition for the treatment of primary dysmenorrhea of the present invention is by following weightThe material of part is made: 30 parts of wild pool wormwood artemisias, 20 parts of auriculate dichrocephala herb or leafs, 25 parts of conical conocephalum herbs, hops15 parts of 20 parts, 22 parts of copper arhats and partially wing grass of meadow rues.
Preferably, described pharmaceutical composition can be tablet, dispersing tablet, capsule, soft capsuleAgent, decoction or powder.
The present invention also provides the purposes of composition in the medicine of preparation treatment primary dysmenorrhea, instituteStating composition is made up of the material of following weight portion: wild pool wormwood artemisia 10-50 part, auriculate dichrocephala herb or leaf 10-30Part, conical conocephalum herb 20-30 part, hops 10-30 part, copper arhat 20-30 part and Pian Chi Tang SongGrass 10-20 part.
Preferably, described composition is made up of the material of following weight portion: 30 parts of wild pool wormwood artemisias,20 parts of auriculate dichrocephala herb or leafs, 25 parts of conical conocephalum herbs, 20 parts of hops, 22 parts of copper arhats and Pian Chi Tang Song15 parts of grass.
Preferably, described medicine can be tablet, dispersing tablet, capsule, soft capsule, soupAgent or powder.
In composition of the present invention, wild pool wormwood artemisia is monarch drug in a prescription; Auriculate dichrocephala herb or leaf, conical conocephalum herb are ministerial drug;Hops, copper arhat are adjutant; Wing grass of meadow rue coordinating the drug actions of a prescription partially, for making medicine.
Pharmaceutical composition of the present invention interacts, synergy, treatment primary dysmenorrheaCan obtain more desirable result for the treatment of, be worth by promotion and application in clinical treatment.
Detailed description of the invention
Further illustrate the present invention below by embodiment. It should be understood that reality of the present inventionExecuting example is for the present invention instead of limitation of the present invention are described. According to essence pair of the present inventionThe simple modifications that the present invention carries out all belongs to the scope of protection of present invention. Unless separately hadBright, otherwise percentage in the present invention is percetage by weight.
Embodiment powder of the present invention
1) take 30 grams of wild pool wormwood artemisias, add 300 milliliters of 65 volume % ethanol waters,Under the condition refluxing, heat 2 hours, be cooled to room temperature, filter the second in recovered under reduced pressure filtrateAlcohol, is then dried to constant weight, obtains powder 1;
2) take 20 grams of auriculate dichrocephala herb or leafs, 25 grams of conical conocephalum herbs, 20 grams of hops, copper arhat 22Gram and 15 grams of wing grass of meadow rues partially, add 5000 milliliters, water, under the condition refluxing, heat 5 littleTime, be cooled to room temperature, filter, make filtrate evaporate to dryness to constant weight, obtain powder 2;
3) merge powder 1 and powder 2, mix, obtain powder of the present invention.
Toxicity test
Acute toxicity test: 60 of application NIH mouse, SPF level, male and female half and half, body weight17~24g, carries out acute toxicity test. Mouse is divided into two groups at random, 30 every group, rightAccording to group and administration group, fasting 12 hours before experiment; The powder of preparing in embodiment is added to water,Making concentration is 4.25g crude drug/ml, gavage, and gavage volume is that 5ml/kg (is single-doseDosage is 21.25g crude drug/kg), control group gives equivalent physiological saline, administration in a day 2 times,Delivery time 6 hours, Continuous Observation 14 days after administration, and it is anti-to record the toxicity of mouseAnswer and death toll. Experimental result shows: with control group comparison, after administration, mouse has no obviously poorDifferent, experiment Continuous Observation 14 days, mouse overall health of patients, diet, drinking-water, body weight gain are equalNormally. Select to put to death administration group mouse, test under microscope: in the heart, liver, lung, stomach andThe important organs such as thymus gland, no abnormality seen changes. Mouse oral administration gavage medicine LD of the present invention50>21.25g crude drug/kg, every day, maximum dosage-feeding was 42.5g crude drug/kg/ day. Medicine of the present inventionClinical application amount is 6.63g crude drug/day/people, becomes body weight for humans in 60kg, average with medicamentAmount is 0.111g crude drug/kg/ day. By batheroom scale: (average weight is in 21g) is oral for mouseThe dosis tolerata of gavage Chinese medicine of the present invention is 383 times of quantity. Therefore the present invention is taken orallyPharmaceutical composition acute toxicity is low, clinical drug safety.
Long term toxicity test: application SD rat, body weight 200g ± 10g, male and female half and half. WillThe powder of preparing in embodiment adds water to make solution to test. Prepare high, medium and low threeIndividual dosage group, is respectively 300,150,75 times of clinical application amount, with containing 2 % by weight AhDraw the physiological saline 1:1 of uncle's natural gum to mix. Adopt gastric infusion mode, continuous use 16 weeks (1.0Ml/100g body weight, every day 2 times) and drug withdrawal after 4 weeks, result shows: medicine of the present invention is to greatlyThe hair of mouse, behavior, stool and urine, body weight, organ weights, blood picture, hepatic and renal function, blood sugar,The indexs such as blood fat all have no significant effect, and internal organs naked eyes do not find that difference changes and histological examinationResult shows, medication 16 weeks and drug withdrawal are after 4 weeks, and the each internal organs of rat are all without obviously changing. SayBright the present invention pharmaceutical composition for oral administration to rat long-term prescription after toxicity little, after drug withdrawal, do not have yetDifference reaction, application safety.
Experimental example pharmaceutical composition of the present invention brings out dysmenorrhea model in mice writhing response to oxytocinImpact
1, test material: the drug powder of preparing in embodiment, pack in bag, content is3g/ bag (every bag of about 5.2g of symphysis medicine).
2, experimental animal: Kunming mouse, body weight 20 ± 2g.
3, trial drug dosage: this experiment adopts gastric infusion, and drug powder administration group is all establishedHigh, medium and low dosage group, dosage is respectively 2g/kg, 1g/kg, 0.5g/kg, according to 10ml/kgBody weight administration; Control group and model group: gavage gives isopyknic water.
4, test method: get 50 of Kunming kind female mices, be divided into 5 groups by body weight, every group10, be respectively control group, model group, the high, medium and low dosed administration group of medicine. Except rightOutside group, all the other each according to dosage 0.2mg/ hypodermic injection diethylstilbestrol 0.2mg/ that organize all only, connectContinuous 10 days, to improve uterus susceptibility. Inject diethylstilbestrol the 11st day, starting administration,For three days on end, after last administration lh, each mouse is 2U/ lumbar injection oxytocin 2U/ according to dosageOnly, record incubation period and the interior writhing number of times of 30min that mouse writhing reaction occurs.
Writhing before analgesia rate (%)=(writhing number of times after the front writhing number of times-administration of administration)/administrationNumber of times × 100%.
Observe rear 30min, put to death mouse, peeled off Mouse Uterus, taken with precision instrument0.5g, adds 1ml physiological saline, and homogenate is centrifugal, gets supernatant, to be measured. By mouse prostatitisParathyrine F2aEnzyme-linked immunologic detecting kit, mouse Prostaglandin PGE2Enzyme linked immunosorbent detection examinationPGF is carried out in the requirement of agent box2a、PGE2The detection of content.
Experimental result adopts SPSS11.0 statistical software to carry out statistical procedures, and data are usedRepresent; Between many groups, relatively, variance is used variance analysis together, and heterogeneity of variance is used non-parametric test,When P < 0.05, there is significant difference.
The impact that pharmaceutical composition brings out dysmenorrhea model in mice writhing response to oxytocin sees the following form
△ represents that control group is compared with model group, P < 0.05; * represent that each administration group is compared with model group, P <0.05; ☆ represents that high dose group compares with low dose group, middle dosage group, P < 0.05.
With control group comparison, the writhing incidence of model group gained, writhing all have aobvious incubation periodWork property difference (P < 0.05), shows this test modeling success. Each administration group compared with model group,Mouse writhing number of times reduces, writhing prolongation of latency, and each group all have significant difference (P <0.05), illustrate that each administration group brings out dysmenorrhea model in mice writhing response for oxytocin and all have betterEffect. And along with the increase of dosage, effect is also increasing.
Pharmaceutical composition brings out dysmenorrhea model in mice small mouse uterine tissue PGF to oxytocin2a、PGE2Impact see the following form
Group | Dosage (g/kg) | PGF2a(ng/ml) | PGE2(ng/ml) |
Control group | - | 41.35±2.41 | 5.53±0.41 |
Model group | - | 75.82±2.47△ | 2.63±0.35△ |
Low dose group | 0.5 | 61.37±3.16* | 3.87±0.18* |
Middle dosage group | 1 | 48.62±2.46* | 4.83±0.32* |
High dose group | 2 | 41.11±2.36*☆ | 5.23±0.42*☆ |
△ represents that control group is compared with model group, P < 0.05; * represent that each administration group is compared with model group, P <0.05; ☆ represents that high dose group compares with low dose group, middle dosage group, P < 0.05.
With control group comparison, model group is at the measured PGF of uterine tissue2aContent is higher, toolThere is significant difference (P < 0.05), measured PGE2Content reduces, and has significant difference(P < 0.05), the above results and analysis show this test modeling success.
Each administration group compared with model group, the PGF in uterine tissue2aContent is higher, has aobviousWork property difference (P < 0.05), PGE2Content reduces, and has significant difference (P < 0.05), tableBright each administration group is brought out dysmenorrhea model in mice small mouse uterine tissue PGF to oxytocin2aContentIncrease and PGE2The reduction of content all has remarkable result.
The above results shows, it is little that the each dosage group of pharmaceutical composition of the present invention is brought out for oxytocinMouse dysmenorrhea model all has good therapeutic effect, can increase PGF in uterine tissue2aContent, reducesPGE2Content.
Claims (1)
1. a powder for the treatment of primary dysmenorrhea, is characterized in that, it is by following methodMake:
1) take 30 grams of wild pool wormwood artemisias, add 300 milliliters of 65 volume % ethanol waters,Under the condition refluxing, heat 2 hours, be cooled to room temperature, filter the second in recovered under reduced pressure filtrateAlcohol, is then dried to constant weight, obtains powder 1;
2) take 20 grams of auriculate dichrocephala herb or leafs, 25 grams of conical conocephalum herbs, 20 grams of hops, copper arhat 22Gram and 15 grams of wing grass of meadow rues partially, add 5000 milliliters, water, under the condition refluxing, heat 5 littleTime, be cooled to room temperature, filter, make filtrate evaporate to dryness to constant weight, obtain powder 2;
3) merge powder 1 and powder 2, mix.
Priority Applications (1)
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CN201410625394.XA CN104306470B (en) | 2014-11-09 | 2014-11-09 | A kind of pharmaceutical composition for the treatment of primary dysmenorrhea |
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CN201410625394.XA CN104306470B (en) | 2014-11-09 | 2014-11-09 | A kind of pharmaceutical composition for the treatment of primary dysmenorrhea |
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CN104306470B true CN104306470B (en) | 2016-05-25 |
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CN105079485A (en) * | 2015-09-23 | 2015-11-25 | 谢志明 | Traditional Chinese medicine composition for treating gynecological disease and preparing method thereof |
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