CN104324149A - Medicament for dysmenorrhea and preparation method thereof - Google Patents
Medicament for dysmenorrhea and preparation method thereof Download PDFInfo
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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)
- A61K36/66—Papaveraceae (Poppy family), e.g. bloodroot
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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)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
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- 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)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/232—Angelica
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- 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)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/236—Ligusticum (licorice-root)
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- 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
- A61K36/282—Artemisia, e.g. wormwood or sagebrush
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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)
- A61K36/54—Lauraceae (Laurel family), e.g. cinnamon or sassafras
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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)
- A61K36/83—Thymelaeaceae (Mezereum family), e.g. leatherwood or false ohelo
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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
- A61K9/14—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
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- 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
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- 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
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- 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
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- 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
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
Abstract
The invention relates to the technical field of Kazakh medicaments, and discloses a medicament for dysmenorrhea and a preparation method thereof. The medicament for dysmenorrhea comprises the following raw materials: rhizoma corydalis, Chinese angelica, szechuan lovage rhizome, argy wormwood leaf, combined spicebush root, fennel and daphne altaica. The preparation method of the medicament for dysmenorrhea comprises the following steps: step I, mixing Chinese angelica, szechuan lovage rhizome, argy wormwood leaf, combined spicebush root, fennel and daphne altaica with required amounts together to form a mixed medicinal material, adding water into the mixed medicinal material, then performing steam distillation, and finally respectively preparing a water solution and extracted volatile oil after steam distillation. The medicament for dysmenorrhea, which is disclosed by the invention, is prepared from Kazakh medicinal materials, and is simple in preparation method; all adopted medicaments are warm, and have the effects of warming channel and nourishing blood, and regulating menstruation and relieving pain without causing toxic or side effects; and the medicament for dysmenorrhea, which is obtained according to an embodiment disclosed by the invention, is short in curative effect in treating dysmenorrhea, can be used for significantly improving dysmenorrhea symptoms, is high in effective treatment rate, cannot cause toxic or side effects, does not have drug resistance, is not easy to relapse after treatment, and can be used for effectively relieving diseases and pains for patients.
Description
Technical field
The present invention relates to Kazak medicine technical field, is a kind of dysmenorrhea medicine and preparation method thereof.
Background technology
Dysmenorrhea, or be called pain in menstrual period, be one of modal symptom of gynecological patient.Refer on the occasion of menstrual period or through row front and back, women occurs that periodicity lower abdomen pain or pain draw waist sacrum, the even severe pain person of fainting, also known as " abdominal pain during menstruation ".Clinically dysmenorrhea is divided into primary dysmenorrhea and secondary dysmenorrhea.Primary dysmenorrhea refers to primary dysmenorrhea, and secondary dysmenorrhea is caused by pelvic cavity organic disease.Many women have slight discomfort in menstrual period, but dysmenorrhea refers to the normal activity of the ache influence in menstrual period, and need Drug therapy.Pain was common and betided most of menstrual cycle periodic menstrual period.Dysmenorrhea is often angor and with back pain, Nausea and vomiting, headache or diarrhoea.26% adolescence women can not go to school or go to work due to dysmenorrhea.Typically, pain occurs in the first day of menstruation, usually in the time that menstruation starts, but also has people until menstruation second talent starts pain.Pain is spastic, paroxysmal.Time serious complexion turn white, be in a cold sweat, general weakness, extreme cold of the limbs.Nausea,vomiting,diarrhea is also more common with headache.Patients ' psychological and physiology are affected greatly, easily brings out the other diseases of self.Western medical treatment dysmenorrhea commonly uses the analgesic drug products such as ibuprofen, but side effect is large.Often cause symptom of digestive tract to comprise dyspepsia, stomach burn feeling, stomachache, Nausea and vomiting etc., there is gastric ulcer and digestive tract hemorrhage in small number of patients, also has because of perforated ulcer person.Can occur that neurological symptom is as headache, drowsiness, dizzy etc.Life-time service ibuprofen can cause renal function injury, ibuprofen has inhibitory action to platelet aggregation, prolonged bleeding time can be made, caused bleeding hepatic disfunction, vitamin K deficiency, hemophilia and other blood coagulation disorder, or take ibuprofen again because the disease such as gastric and duodenal ulcers, ulcerative colitis uses after anticoagulant, digestive tract occult bleeding can be caused, severe one can be had blood in stool, hematuria, wound blood oozing from the wound surface or ecchymosis., after taking ibuprofen, easily there is delayed bronchial asthma in the person of suffering with chronic bronchitis.Also allergic rash can be caused.Although can alleviating pain after use ibuprofen, can not cure, easily recur.The pain relieving of life-time service ibuprofen can cause drug resistance.
Doctor trained in Western medicine also treats dysmenorrhea with hormone medicine, and side effect is comparatively large, can have Nausea and vomiting, giddy, class morning sickness and the irregular bleeding such as weak, drowsiness; Occasionally there are mammary swelling, erythra, acne, body weight increase etc.Can not miss, miss and can occur heavy vaginal bleeding, therefore patient can be pretty troublesome during taking.There is liver, nephropathy avoids use.Hysteromyoma, hyperpietic and have liver, nephropathy history person is cautious use of.Central obesity, moon face, purple striae, thinning of skin, myasthenia, amyotrophy, hypokalemia, edema, Nausea and vomiting, hypertension, glycosuria, acne, hirsutism, infection, pancreatitis, poor wound healing, osteoporosis can be there is, bring out or increase the weight of the side effect such as digestive tract ulcer.Prolonged application easily causes infection, and more common infection is infection and the tuberculosis etc. such as respiratory tract, skin, urinary tract.Heavy dose of hormone can cause blood leukocytes to increase, and sometimes can reach 20 × 109/L.Heavy dose of hormone can cause diuresis.But when head begins treatment, hormone still fails to play diuresis, can cause water, sodium retention on the contrary, increase the weight of edema, now if necessary, should use diuretic, and carry out low salt diet simultaneously.Hormone increases the weight of sometimes or causes hypertension, should give Treatment of Hypertension.After there is diuresis, the possibility having hypokalemia should be noted, patient should being advised suitably to take food containing the abundant food of potassium, or share isokalaemic diuretic, as still there is hypokalemia, suitably can supplement potassium salt.Hormone can increase calcium, phosphorus excretion, reduces the absorption of calcium, widely applies for a long time, can cause osteoporosis, spontaneous fracture and aseptic necrosis of femoral head.Easily can cause excitement, insomnia, can not bring out psychosis, suitably can use stable grade for tranquilizer.Hormone can promote breaks down proteins and suppress its synthesis to cause negative nitrogen balance, therefore should give high protein diet, and some patient originally had slight azotemia, in hormone therapy postemphasis, even occurs renal failure.Hormone can promote gluconeogenesis, and reduce the utilization of tissue to glucose, severe patient blood glucose can occur and increases and glycosuria.Prolonged application hormone can bring out cataract, poor wound healing, thrombosis and thromboembolism disease, hyperhidrosis and night sweat, and menoxenia etc.Therefore application hormone medicine treatment dysmenorrhea should be prudent.
Traditional Chinese medical science application oral medicinal herb and herbal enema, the external treatment treatment dysmenorrhea such as to stick and have and be much short of part, the external treatment Comprehensive Treatments such as herbal retention enema, patient can not Self-operating, Implementing Hospital treatment must be arrived, make troubles to patient, make patient can not adhere to the treatment of specification, and affect therapeutic effect.Long-time application Chinese medicine external patient compliance can decline, and multipath administration is effective, but Therapeutic Method is more loaded down with trivial details, and patient not easily adheres to.Application Chinese medicine long-term taking is for severe pain through patient, and therapeutic effect owes desirable sometimes.Continuous medicine for a long time, the compliance of patient can decline gradually.The course of disease of Chinese medicine dysmenorrhea is long, the course for the treatment of is long, improves slowly.Dysmenorrhea Patients on Recurrence rate is high, and treatment late result owes satisfied, and curative effect can not be consolidated, and even becomes chronic disease, so prevention and minimizing recurrence are the keys for the treatment of.To be in a bad way altauna caused through or the patient of persistence pelvic pain, Chinese medicine still effectively or pain relieving completely, can not need to coordinate Western medicine analgesics, even adopts operative treatment.
Summary of the invention
The invention provides a kind of dysmenorrhea medicine and preparation method thereof, overcome the deficiency of above-mentioned prior art, it effectively can solve current Chinese medicine dysmenorrhea and there is the problem that the course for the treatment of is long, improvement is slow, side effect is large, Therapeutic Method is more loaded down with trivial details.
One of technical scheme of the present invention is realized by following measures: a kind of dysmenorrhea medicine, and its raw materials by weight portion meter comprises Rhizoma Corydalis 3 parts to 10 parts, Radix Angelicae Sinensis 6 parts to 12 parts, Rhizoma Chuanxiong 3 parts to 10 parts, Folium Artemisiae Argyi 3 parts to 9 parts, the Radix Linderae 6 parts to 10 parts, Fructus Foeniculi 3 parts to 6 parts and Radix Daphnes altaicae 0.5 part to 1 part.
Here is the further optimization and/or improvements to one of foregoing invention technical scheme:
Above-mentioned dysmenorrhea medicine obtains as follows: the first step, the Radix Angelicae Sinensis of aequum, Rhizoma Chuanxiong, Folium Artemisiae Argyi, the Radix Linderae, Fructus Foeniculi and Radix Daphnes altaicae are mixed and forms mixing medical material, vapor distillation is carried out add the water of mixing quality of medicinal material 6 doubly to 9 times in mixing medical material after, the temperature of vapor distillation is 100 DEG C to 200 DEG C, the time is 4 little of 6 hours, obtains the volatile oil of aqueous solution and extraction after vapor distillation respectively, second step, reflux, extract, is carried out 1 time to 3 times to the Rhizoma Corydalis of aequum, the volumetric concentration that each reflux, extract, adds Rhizoma Corydalis quality 4 doubly to 10 times in Rhizoma Corydalis is the ethanol water of 30% to 95%, the temperature of each reflux, extract, is 60 DEG C to 100 DEG C, time is 0.5 little of 3.5 hours, filter after each reflux, extract, and obtain filtrate, obtain after merging filtrate mixing filtrate, reclaim the ethanol in mixing filtrate, the aqueous solution that mixing filtrate after recovery ethanol and first step reflux, extract, obtain carries out merging and obtains mixed solution, mixed solution is concentrated, the dry extract that mass water content is 1% to 10% is obtained after vacuum drying, dry extract is broken into 100 order to 200 object fine powders, 3rd step, in fine powder, add the dextrin of fine powder quality 1 doubly to 3 times, the sweetener of fine powder quality 0.1% to 5% obtains mixing fine powders, the volumetric concentration adding volatile oil quality 0.5 doubly to 2 times in the volatile oil that the first step obtains be 80% to 95% ethanol water carry out dilution and obtain diluting volatile oil, make granule by after mixing fine powders and dilution volatile oil mix homogeneously, after drying, granulate, obtain dysmenorrhea medicine.
In above-mentioned second step, the number of times of reflux, extract, is 2 times; Or/and in second step, the ethanol reclaimed in mixing filtrate is less than 10% to the mass content of ethanol in mixing filtrate.
Simmer down to concentrating under reduced pressure in above-mentioned second step, the temperature of concentrating under reduced pressure is 50 DEG C to 80 DEG C, pressure is-0.05MPa to-0.09MPa; Or/and in second step, vacuum drying temperature is 50 DEG C to 80 DEG C, pressure is-0.05MPa to-0.09MPa.
In above-mentioned 3rd step, will make by 10 mesh sieves, not by the granule of 80 mesh sieves after mixing fine powders and dilution volatile oil mix homogeneously; Or/and, in the 3rd step, be 0.5% to 5% by particle drying to granular mass water content; Or/and dried granule is not with by 10 mesh sieves, carry out granulate by 80 mesh sieves in the 3rd step.
Two of technical scheme of the present invention is realized by following measures: a kind of dysmenorrhea medicine and preparation method thereof, it carries out in the steps below: the first step, the Radix Angelicae Sinensis of aequum, Rhizoma Chuanxiong, Folium Artemisiae Argyi, the Radix Linderae, Fructus Foeniculi and Radix Daphnes altaicae are mixed and forms mixing medical material, vapor distillation is carried out add the water of mixing quality of medicinal material 6 doubly to 9 times in mixing medical material after, the temperature of vapor distillation is 100 DEG C to 200 DEG C, the time is 4 little of 6 hours, obtains the volatile oil of aqueous solution and extraction after vapor distillation respectively, second step, reflux, extract, is carried out 1 time to 3 times to the Rhizoma Corydalis of aequum, the volumetric concentration that each reflux, extract, adds Rhizoma Corydalis quality 4 doubly to 10 times in Rhizoma Corydalis is the ethanol water of 30% to 95%, the temperature of each reflux, extract, is 60 DEG C to 100 DEG C, time is 0.5 little of 3.5 hours, filter after each reflux, extract, and obtain filtrate, obtain after merging filtrate mixing filtrate, reclaim the ethanol in mixing filtrate, the aqueous solution that mixing filtrate after recovery ethanol and first step reflux, extract, obtain carries out merging and obtains mixed solution, mixed solution is concentrated, the dry extract that mass water content is 1% to 10% is obtained after vacuum drying, dry extract is broken into 100 order to 200 object fine powders, 3rd step, in fine powder, add the dextrin of fine powder quality 1 doubly to 3 times, the sweetener of fine powder quality 0.1% to 5% obtains mixing fine powders, the volumetric concentration adding volatile oil quality 0.5 doubly to 2 times in the volatile oil that the first step obtains be 80% to 95% ethanol water carry out dilution and obtain diluting volatile oil, make granule by after mixing fine powders and dilution volatile oil mix homogeneously, after drying, granulate, obtain dysmenorrhea medicine, wherein, the raw materials by weight portion meter of dysmenorrhea medicine comprises Rhizoma Corydalis 3 parts to 10 parts, Radix Angelicae Sinensis 6 parts to 12 parts, Rhizoma Chuanxiong 3 parts to 10 parts, Folium Artemisiae Argyi 3 parts to 9 parts, the Radix Linderae 6 parts to 10 parts, Fructus Foeniculi 3 parts to 6 parts and Radix Daphnes altaicae 0.5 part to 1 part.
Here is the further optimization and/or improvements to foregoing invention technical scheme two:
In above-mentioned second step, the number of times of reflux, extract, is 2 times; Or/and in second step, the ethanol reclaimed in mixing filtrate is less than 10% to the mass content of ethanol in mixing filtrate.
Simmer down to concentrating under reduced pressure in above-mentioned second step, the temperature of concentrating under reduced pressure is 50 DEG C to 80 DEG C, pressure is-0.05MPa to-0.09MPa; Or/and in second step, vacuum drying temperature is 50 DEG C to 80 DEG C, pressure is-0.05MPa to-0.09MPa.
In above-mentioned 3rd step, will make by 10 mesh sieves, not by the granule of 80 mesh sieves after mixing fine powders and dilution volatile oil mix homogeneously; Or/and, in the 3rd step, be 0.5% to 5% by particle drying to granular mass water content; Or/and dried granule is not with by 10 mesh sieves, carry out granulate by 80 mesh sieves in the 3rd step.
Dysmenorrhea drug utilization Kazak of the present invention medical material obtains, preparation method is simple, medicine used is all warm nature medicine, has the effect of channel warming and blood nourishing, menstruction regulating and pain relieving, nontoxic pair, adopts the dysmenorrhea medicine curative effect when treating dysmenorrhea obtained according to the above embodiment of the present invention short, improve dysmenorrhea symptom obvious, treated effect is high, has no side effect, without drug resistance phenomenon, not easily recur after treatment, can effectively for patient removes slight illness.
Detailed description of the invention
The present invention by the restriction of following embodiment, can not determine concrete embodiment according to technical scheme of the present invention and practical situation.Unless stated otherwise, the % in the present invention is mass percent; Unless stated otherwise, preparation process is carried out under room temperature, atmospheric pressure state; Unless stated otherwise, the reagent adopted in the present invention, method and apparatus are the art conventional reagent, method and apparatus; Unless stated otherwise, in the present invention, agents useful for same is commercial; Unless stated otherwise, the water in the present invention is deionized water; Unless stated otherwise, the solution in the present invention is the aqueous solution that solvent is water, and such as, if illustrate, hydrochloric acid solution is aqueous hydrochloric acid solution.
Below in conjunction with embodiment, the invention will be further described:
Embodiment 1, the raw materials by weight portion meter of this dysmenorrhea medicine comprises Rhizoma Corydalis 3 parts to 10 parts, Radix Angelicae Sinensis 6 parts to 12 parts, Rhizoma Chuanxiong 3 parts to 10 parts, Folium Artemisiae Argyi 3 parts to 9 parts, the Radix Linderae 6 parts to 10 parts, Fructus Foeniculi 3 parts to 6 parts and Radix Daphnes altaicae 0.5 part to 1 part.The present embodiment also can obtain dysmenorrhea medicine according to pharmacopeia or this area conventional phamaceutical techniques means.Unit of the present invention acts like a bully the dry tuber of papaveraceae plant corydalis Corydalis yanhusuo W.T.Wang.When being classified as samphire Angelica sinensis(Oliv.) dry root of Diels.Rhizoma Chuanxiong is the dry rhizome of samphire Rhizoma Chuanxiong Ligusticum chuanxiong Hort..Folium Artemisiae Argyi is the dried leaves of feverfew Chinese mugwort Artemisia argyi Levl.et Vant.Radix Linderae canella Radix Linderae Lindera aggregata(Sims) the fast drying root of Kosterm..Fructus Foeniculi is the dry mature fruit of samphire Fructus Foeniculi Foeniculum vulgare Mill..Winter daphne is dry skin and the leaf of Isolated From Thymelaeaceae Species Altay winter daphne Daphne altaica Pall.Wherein Rhizoma Corydalis is pungent, bitter, and temperature, has effect of regulating QI to relieve pain, is clinically used for the treatment of all kinds of pain, particularly dysmenorrhea; Described Radix Angelicae Sinensis sweet, acrid, warm, has expelling wind and removing dampness, dispersing cold for relieving pain, tonifying blood and regulating menstruation, the function of intestine moistening, is clinically used for the treatment of dysmenorrhea, menoxenia, blood deficiency amenorrhea, anemia, constipation, the diseases such as rheumatism; Described Rhizoma Chuanxiong is pungent, and temperature, has blood-activating and qi-promoting, the function of wind-expelling pain-stopping, is clinically used for the treatment of dysmenorrhea, menoxenia, the stagnant stomachache of the stasis of blood in puerperal, headache, the diseases such as rheumatism; Described Folium Artemisiae Argyi is bitter, tepor, has dispelling cold and removing dampness, the function of warming the meridian for stopping bleeding, clinical in menoxenia, dysmenorrhea, dysfunctional uterine hemorrhage, the diseases such as amenorrhea; The described Radix Linderae is pungent, and temperature, has and have a respite, warming middle-JIAO, cold expelling, the function of pain relieving, is clinically used for the treatment of multiple pain; Described Fructus Foeniculi is pungent, and temperature, has and regulate the flow of vital energy, cold expelling, the function of appetizing, is clinically used for the treatment of dysmenorrhea, abdominal distention, the diseases such as lack of appetite and vomiting; Described Altay daphneticin, temperature, poisonous.There is relieving the exterior syndrome by diaphoresis, eliminating phlegm and stopping cough, the function of pain relieving, be clinically used for the treatment of dysmenorrhea, tracheitis, anemofrigid cold, rheumatism, the diseases such as lumbago and skelalgia.
Embodiment 2, the raw materials by weight portion meter of this dysmenorrhea medicine comprises Rhizoma Corydalis 3 parts or 10 parts, Radix Angelicae Sinensis 6 parts or 12 parts, Rhizoma Chuanxiong 3 parts or 10 parts, Folium Artemisiae Argyi 3 parts or 9 parts, the Radix Linderae 6 parts or 10 parts, Fructus Foeniculi 3 parts or 6 parts and Radix Daphnes altaicae 0.5 part or 1 part.The present embodiment also can obtain dysmenorrhea medicine according to pharmacopeia or this area conventional phamaceutical techniques means.
Embodiment 3, preferred as above-described embodiment, this dysmenorrhea medicine is pressed and is stated preparation method and obtain: the first step, the Radix Angelicae Sinensis of aequum, Rhizoma Chuanxiong, Folium Artemisiae Argyi, the Radix Linderae, Fructus Foeniculi and Radix Daphnes altaicae are mixed and forms mixing medical material, vapor distillation is carried out add the water of mixing quality of medicinal material 6 doubly to 9 times in mixing medical material after, the temperature of vapor distillation is 100 DEG C to 200 DEG C, the time is 4 little of 6 hours, obtains the volatile oil of aqueous solution and extraction after vapor distillation respectively, second step, reflux, extract, is carried out 1 time to 3 times to the Rhizoma Corydalis of aequum, the volumetric concentration that each reflux, extract, adds Rhizoma Corydalis quality 4 doubly to 10 times in Rhizoma Corydalis is the ethanol water of 30% to 95%, the temperature of each reflux, extract, is 60 DEG C to 100 DEG C, time is 0.5 little of 3.5 hours, filter after each reflux, extract, and obtain filtrate, obtain after merging filtrate mixing filtrate, reclaim the ethanol in mixing filtrate, the aqueous solution that mixing filtrate after recovery ethanol and first step reflux, extract, obtain carries out merging and obtains mixed solution, mixed solution is concentrated, the dry extract that mass water content is 1% to 10% is obtained after vacuum drying, dry extract is broken into 100 order to 200 object fine powders, 3rd step, in fine powder, add the dextrin of fine powder quality 1 doubly to 3 times, the sweetener of fine powder quality 0.1% to 5% obtains mixing fine powders, the volumetric concentration adding volatile oil quality 0.5 doubly to 2 times in the volatile oil that the first step obtains be 80% to 95% ethanol water carry out dilution and obtain diluting volatile oil, make granule by after mixing fine powders and dilution volatile oil mix homogeneously, after drying, granulate, obtain dysmenorrhea medicine.
Embodiment 4, preferred as above-described embodiment, this dysmenorrhea medicine is pressed and is stated preparation method and obtain: the first step, the Radix Angelicae Sinensis of aequum, Rhizoma Chuanxiong, Folium Artemisiae Argyi, the Radix Linderae, Fructus Foeniculi and Radix Daphnes altaicae are mixed and forms mixing medical material, vapor distillation is carried out add the water mixing quality of medicinal material 6 times or 9 times in mixing medical material after, the temperature of vapor distillation is 100 DEG C or 200 DEG C, the time is 4 hours or 6 hours, obtains the volatile oil of aqueous solution and extraction after vapor distillation respectively, second step, reflux, extract, is carried out 1 time or 3 times to the Rhizoma Corydalis of aequum, the volumetric concentration that each reflux, extract, adds Rhizoma Corydalis quality 4 times or 10 times in Rhizoma Corydalis is the ethanol water of 30% or 95%, the temperature of each reflux, extract, is 60 DEG C or 100 DEG C, time is 0.5 hour or 3.5 hours, filter after each reflux, extract, and obtain filtrate, obtain after merging filtrate mixing filtrate, reclaim the ethanol in mixing filtrate, the aqueous solution that mixing filtrate after recovery ethanol and first step reflux, extract, obtain carries out merging and obtains mixed solution, mixed solution is concentrated, the dry extract that mass water content is 1% or 10% is obtained after vacuum drying, dry extract is broken into 100 orders or 200 object fine powders, 3rd step, in fine powder, add fine powder quality 1 times or the dextrin of 3 times, the sweetener of fine powder quality 0.1% or 5% obtains mixing fine powders, the volumetric concentration adding volatile oil quality 0.5 times or 2 times in the volatile oil that the first step obtains be 80% or 95% ethanol water carry out dilution and obtain diluting volatile oil, make granule by after mixing fine powders and dilution volatile oil mix homogeneously, after drying, granulate, obtain dysmenorrhea medicine.
Embodiment 5, preferred as embodiment 3 and embodiment 4, in second step, the number of times of reflux, extract, is 2 times; Or/and in second step, the ethanol reclaimed in mixing filtrate is less than 10% to the mass content of ethanol in mixing filtrate.
Embodiment 6, preferred as embodiment 3, embodiment 4 and embodiment 5, simmer down to concentrating under reduced pressure in second step, the temperature of concentrating under reduced pressure is 50 DEG C to 80 DEG C, pressure is-0.05MPa to-0.09MPa; Or/and in second step, vacuum drying temperature is 50 DEG C to 80 DEG C, pressure is-0.05MPa to-0.09MPa.
Embodiment 7, preferred as embodiment 3, embodiment 4, embodiment 5 and embodiment 6, in the 3rd step, will make by 10 mesh sieves, not by the granule of 80 mesh sieves after mixing fine powders and dilution volatile oil mix homogeneously; Or/and, in the 3rd step, be 0.5% to 5% by particle drying to granular mass water content; Or/and dried granule is not with by 10 mesh sieves, carry out granulate by 80 mesh sieves in the 3rd step.
The clinical observation of the dysmenorrhea Drug therapy dysmenorrhea one, obtained according to the above embodiment of the present invention
1, clinical therapeutic efficacy evaluation:
1.1 case selections: extract patient's random packet that 197 examples meet primary dysmenorrhea (sympotoms caused by cold factors) diagnostic criteria, clinical eliminating cardiovascular and cerebrovascular vessel, liver, kidney and disease in the blood system, confirm without organic disease through gynecologial examination and B ultrasonic, wherein oral dysmenorrhea medicine 147 example obtained according to the above embodiment of the present invention, for of the present invention group, year mean age (17.0 ± 5), average course of disease (2 ± 0.24) year; Oral ibuprofen capsule 50 example is matched group, the mean age (18.0 ± 6) year, average course of disease (1.6 ± 0.37) year.Two groups of ages and the course of disease are checked through t, P>0.05, no significant difference.
Treat front two groups of menstruations to compare, average (22.0 ± 6.0) sky of matched group menstrual cycle, menstrual phase 3 ~ 7 days, medium through measuring, of the present invention group of menstrual cycle, menstrual period, through amount roughly the same with matched group (P>0.05), two groups of menstrual onsets are all more than 3 years.
1.2 methods:
1.2.1 of the present invention group: the oral dysmenorrhea medicine obtained according to the above embodiment of the present invention, oral 3 times of every day, each 10g, premenstrual 3 days of the moon started medication, and use 5 days continuously, two weeks is a course for the treatment of, is used in conjunction 3 courses for the treatment of.
1.2.2 matched group: oral ibuprofen capsule, 1 time 1, every day 3 times, the daystart before menstrual onset is taken, and serve on 3 days.
Treat 3 cycle post-evaluation therapeutic outcomes for two groups.And do not take other drug during advising patient treatment, menstrual period avoid cold and uncooked food, smooth feelings will.
1.3 results:
Cure: abdominal pain in menstruation transference cure;
Effective: abdominal pain in menstruation symptom disappears substantially;
Effective: abdominal pain in menstruation symptom does not disappear, but comparatively before alleviates;
Invalid: abdominal pain in menstruation symptom does not disappear, unchanged comparatively.
1, of the present invention group of therapeutic outcome (see table 1 and table 2)
2, treatment of control group result (see table 3 and table 4)
As can be seen from table 1, table 2 and table 3 and table 4, of the present invention group for the treatment of 147 example, after the treatment, cures 76 examples, effective 58 examples, invalid 13 examples, cure rate 51.70%, obvious effective rate 39.46%, total effective rate 91.16%; Treatment of control group 50 example, after the treatment, cure 24 examples, effective 9 examples, invalid 17 examples, cure rate 48%, obvious effective rate 18%, total effective rate 66%, this shows, the dysmenorrhea medicine obtained according to the above embodiment of the present invention is compared current common drug ibuprofen capsule and had better therapeutic effect in treatment primary dysmenorrhea.
Two, acute toxicity test
1, object
Detect emmenagogue raw material powder to 1 to 3 gavage in animal (mice, rat) 1 day, observe the toxic reaction symptom that it occurs, measure LD
50or maximum dosage-feeding, for the dose design of long term toxication, the test of pesticide effectiveness and the safety of clinical practice provide foundation.
Because the toxicity of the dysmenorrhea medicine obtained according to the above embodiment of the present invention is lower, do not measure LD
50, can only survey maximum dosage-feeding, with the raw material not adding adjuvant, be the relevant guideline regulation of national Bureau of Drugs Supervision.
Emmenagogue raw material powder/raw material powder alleged is below worn into fine powder mix homogeneously and is obtained after choosing raw material according to the proportioning raw materials of the above embodiment of the present invention 1 or embodiment 2.
Emmenagogue alleged is below the dysmenorrhea medicine obtained according to the above embodiment of the present invention.
Life alleged below will for mix according to the raw material of the above embodiment of the present invention 1 or embodiment 2.
2, medication
The female mice of fasting after 16 hours is divided equally 2 groups by 2.1: negative control group, emmenagogue raw material powder group, with maximum gavage concentration 0.5g/ml, maximum gavage volume 40ml/kg, mouse stomach 2 emmenagogue raw material powder solution are given in 24h, negative control group gives isometric distilled water, observe and record acute toxicity test in mice body weight change, toxic reaction and death condition, acute toxicity test in mice body weight change the results are shown in Table 5;
The female rats of fasting after 16 hours is divided equally 2 groups by 2.2: negative control group, emmenagogue raw material powder group, with maximum gavage concentration 0.5g/ml, maximum gavage volume 20ml/kg, rat oral gavage 3 emmenagogue raw material powder solution are given in 24h, negative control group gives isometric distilled water, observe and record rat acute toxicity test body weight change, toxic reaction and death condition, rat acute toxicity test body weight change the results are shown in Table 6.
3, result
3.1 emmenagogue raw material powders fail to measure mice LD
50, under maximum dosage-feeding 40g raw material powder/kg dosage, in mice 2 weeks figure, extremity activity, breathing, hair color, two just, the Non Apparent Abnormality more equal to matched group such as body weight growth.By mice gross anatomy during off-test, the perusal heart, liver, spleen, lung, the equal Non Apparent Abnormality of kidney; As can be seen from data in table 5, mice is after taking emmenagogue raw material powder solution, and the bodyweight difference of negative control group and emmenagogue raw material powder group is little.Illustrate that the dysmenorrhea medicine obtained according to the above embodiment of the present invention is safety by acute toxicity test.
3.2 emmenagogue raw material powders fail to measure rat LD
50, under maximum dosage-feeding 30g raw material powder/kg dosage, in rat 2 weeks figure, extremity activity, breathing, hair color, two just, the Non Apparent Abnormality more equal to matched group such as body weight growth.By rat gross anatomy during off-test, the perusal heart, liver, spleen, lung, the equal Non Apparent Abnormality of kidney; As can be seen from data in table 6, rat is after taking emmenagogue raw material powder solution, and the bodyweight difference of negative control group and emmenagogue raw material powder group is little.Illustrate that the dysmenorrhea medicine obtained according to the above embodiment of the present invention is safety by acute toxicity test.
3.3 emmenagogue recipe quantity every day 51g crude drugs, 2 times on the 1st; Emmenagogue raw material powder is 8.7% relative to the yield of raw material, the dysmenorrhea medicine obtained according to the above embodiment of the present invention containing 37% raw material, namely granule clinical plan dosage is 12g/ people/day (suitable emmenagogue raw material powder 4.44g/ people/day), namely raw material powder 0.074g/kg(women per capita body weight by 60kg), this dosage is only equivalent to 1/540 of acute toxicity test in mice maximum dosage-feeding 40g/kg, this dosage is only equivalent to 1/405 of rat acute toxicity test maximum dosage-feeding 30g/kg, so clinical odd-numbered day drug safety scope is larger.
Three, pharmacodynamics test
1, the impact that the dysmenorrhea medicine obtained according to the above embodiment of the present invention reacts mice acetic acid twisting
1.1 methods: divide 6 groups by 80 female 28g to 30g mices: matched group (14), tramadol sheet 15mg/kg group (13), emmenagogue 3.8675g crude drug/kg group (13), emmenagogue 7.735g crude drug/kg group (13), emmenagogue 15.47g crude drug/kg group (13), emmenagogue 30.94g crude drug/kg group (14), by tramadol sheet 15mg/kg, emmenagogue 3.8675g crude drug/kg, emmenagogue 7.735g crude drug/kg, emmenagogue 15.47g crude drug/kg, the dosage of emmenagogue 30.94g crude drug/kg gives the dysmenorrhea obtained according to the above embodiment of the present invention medicine to mouse stomach, gavage volume 20ml/kg, matched group gives isometric distilled water, after last administration, each Mus of 1h only distinguishes the acetum 0.27ml/ of 0.6% of the above-mentioned preparation of lumbar injection, observe the writhing number of times of each mice in 15min from injection acetic acid, measurement result is in table 7.
The dysmenorrhea medicine that result obtains according to the above embodiment of the present invention has obvious inhibitory action to the writhing response caused by acetic acid, and dose gradient selects 3.8675g crude drug/kg, 7.735g crude drug/kg, 15.47g crude drug/kg better, in table 7.
Tramadol, English name: Tramadol(INN), be a kind of non-opium central analgesics, be mainly used as analgesic, can alleviate common to serious pain.This medicine is synthetic, acts on μ-opioid recdptor and norepinephrine and serum tension force prime system and unites.Tramadol can be used for treating medium extremely serious pain.Tramadol mainly acts on central nervous system, and over administration can produce dependence, to the similar morphine of the effect of human body and heroin.2008, tramadol hydrochloride was carried out control as psychotropic substances by China.Therefore, although it is good that tramadol compares the dysmenorrhea medicine analgesic effect obtained according to the above embodiment of the present invention, its side effect is comparatively large, and, data according to table 1 can be found out, also have certain analgesic effect according to the dysmenorrhea medicine that the above embodiment of the present invention obtains.
2, the dysmenorrhea medicine obtained according to the above embodiment of the present invention is on the impact of dysmenorrhea model in mice
The 2.1 dysmenorrhea medicines obtained according to the above embodiment of the present invention are on the impact of oxytocin induced mice dysmenorrhea model
Method: 60 mices (female) are divided equally 5 groups: model group, TONGJINGBAO KELI 3.0g/kg group, emmenagogue 3.8675g crude drug/kg group, emmenagogue 7.735g crude drug/kg group, emmenagogue 15.47g crude drug/kg group.Each Mus presses 0.05ml/ subcutaneous injection estradiol benzoate (0.1mg/ only), only (0.05mg) within 2nd day, start subcutaneous injection estradiol benzoate 0.025ml/, continuous 9d, from the 7th day, while every day subcutaneous injection estradiol benzoate, by TONGJINGBAO KELI 3.0g/kg, emmenagogue 3.8675g crude drug/kg, emmenagogue 7.735g crude drug/kg, the dosage of emmenagogue 15.47g crude drug/kg gives the dysmenorrhea obtained according to the above embodiment of the present invention medicine to mouse stomach, gavage volume 20ml/kg, matched group gives isometric distilled water, continuous 4d, within 10th day, each Mus presses 0.05ml/ subcutaneous injection estradiol benzoate (0.1mg/ only), after 24h, last gives test medicine, 60min after administration, lumbar injection oxytocin 0.2ml/ only (10U/ml), writhing number of times in rear mouse writhing incubation period and 15min injected in record, calculate writhing response suppression ratio, record the results are shown in Table 8.
Date processing: indices is used (
± S) represent, adopt statistic software SPSS (17.0), one factor analysis of variance (oneway ANOVA) between organizing.
Result: as can be seen from data in table 8, the dysmenorrhea medicine obtained according to the above embodiment of the present invention has obvious prolongation effect to oxytocin induced mice dysmenorrhea writhing response incubation period, obvious reducing effect is had and effect is better than at present conventional TONGJINGBAO KELI to writhing response number of times, illustrate, the dysmenorrhea medicine obtained according to the above embodiment of the present invention has good effect to treatment dysmenorrhea.
The 2.2 dysmenorrhea medicines obtained according to the above embodiment of the present invention are to prostaglandin E
1the impact of induced mice dysmenorrhea model
Method: 60 mices (female) are divided equally 5 groups: model group, TONGJINGBAO KELI 3.0g/kg group, emmenagogue 3.8675g crude drug/kg group, emmenagogue 7.735g crude drug/kg group, emmenagogue 15.47g crude drug/kg group.Each Mus presses 0.05ml/ subcutaneous injection estradiol benzoate (0.1mg/ only), only (0.05mg) within 2nd day, start subcutaneous injection estradiol benzoate 0.025ml/, continuous 9d, from the 7th day, while every day subcutaneous injection estradiol benzoate, by TONGJINGBAO KELI 3.0g/kg, emmenagogue 3.8675g crude drug/kg, emmenagogue 7.735g crude drug/kg, the dosage of emmenagogue 15.47g crude drug/kg gives the dysmenorrhea obtained according to the above embodiment of the present invention medicine to mouse stomach, gavage volume 20ml/kg, matched group gives isometric distilled water, continuous 4d, within 10th day, each Mus presses 0.05ml/ subcutaneous injection estradiol benzoate (0.1mg/ only), after 24h, last gives test medicine, 60min after administration, lumbar injection alprostadil injection 0.2ml/ only (2ml:10 μ g), writhing number of times in rear mouse writhing incubation period and 15min injected in record, calculate writhing response suppression ratio, measurement result is in table 9.
Date processing: indices is used (
± S) represent, adopt statistic software SPSS (17.0), one factor analysis of variance (oneway ANOVA) between organizing.
Result: as shown in Table 9, emmenagogue is to prostaglandin E
1induced mice dysmenorrhea writhing response has obvious prolongation effect incubation period, obvious reducing effect is had and effect is better than at present conventional TONGJINGBAO KELI to writhing response number of times, illustrate, the dysmenorrhea medicine obtained according to the above embodiment of the present invention has good effect to treatment dysmenorrhea.
3, the dysmenorrhea medicine obtained according to the above embodiment of the present invention is on the microcirculatory impact of rat uterus
Grouping: divide 6 groups by the female rats of body weight 180g to 200g: Normal group, model group, TONGJINGBAO KELI 2.2g/kg group, emmenagogue 2.8475g crude drug/kg group, emmenagogue 5.695g crude drug/kg group, emmenagogue 11.39g crude drug/kg group.The dysmenorrhea obtained according to the above embodiment of the present invention medicine is given to rat oral gavage by the dosage of TONGJINGBAO KELI 2.2g/kg, emmenagogue 2.8475g crude drug/kg, emmenagogue 5.695g crude drug/kg group, emmenagogue 11.39g crude drug/kg, gavage volume 10ml/kg, matched group gives isometric distilled water, every day 1 time, administration 7 days altogether, while the 3rd day after gastric infusion starts gavage, intramuscular injection diethylstilbestrol 1mg/kg(makes its unification enter rutting period), every day 1 time, inject 4 times altogether.
Microcirculation detects: after last administration, by rat with 3% pentobarbital sodium anesthetized rat (45mg/kg, lumbar injection 1.5ml/kg), back of the body position is fixed, row abdomen median line otch 2-3cm, left uterine angle is gently pulled out abdominal cavity, be placed on the convex observation platform of the lucite constant temperature water bath central authorities of the 37 DEG C of HW-2000 microcirculation numeral thermostats being full of Krebs liquid, Multi Position (Fiber Optic llluminator System) cold light source is utilized to irradiate, video image under the dynamic Microcirculation observation assay surface collection microscope of employing BI-2O00 image analysis system, select ring-type small artery branch as the object of observation, stable about 30min, after gastric infusion 1 hour, the arteriole caliber of record selection area, point of intersect of the capillary network counts, blood flow state score value, Blood cell accumulation state score values etc. are as observation index.
Modeling method: sublingual vein injection oxytocin 2U/ (0.2ml/ only), then 1min, 3min, 5min, 10min, 15min, 20min These parameters after record injection oxytocin.
Blood flow state is divided into 4 grades:
1. linear flow: blood flow is fast, in smooth rope strip, without granular sensation---0 grade;
2. line grain stream: blood flow is very fast, in streak, has obvious granular sensation---1 grade;
3. grain stream: blood flow is slow, becomes silt shape, flows slowly or swing---and 2 grades;
4. stagnate: blood flow cessation is motionless or blood flow is invisible---3 grades
Erythrocyte aggregation state is divided into 4 grades:
5. without gathering---0 grade;
6. slightly assemble---1 grade;
7. moderate is assembled---and 2 grades;
8. moderate is assembled---and 3 grades
Data statistics
Before and after arteriole caliber, point of intersect of the capillary network number adopt and calculate administration, change percentage in arid represents, such as, after administration certain moment microvascular diameter change percentage in arid=[before (before modeling after diameter-modeling certain moment diameter) ÷ modeling diameter] × 100%, and then to t inspection between change percentage in arid group; T inspection between blood flow state score value, Blood cell accumulation state score value are directly organized.
The results are shown in Table 10, table 11, table 12, table 13.
By table 10 finding, emmenagogue 2.8475g crude drug/kg, emmenagogue 5.695g crude drug/kg, the reduction of emmenagogue 11.39g crude drug/kg to the uterus microvascular diameter caused by oxytocin improve significantly, and effect is better than TONGJINGBAO KELI group.
Seen by table 11, emmenagogue 2.8475g crude drug/kg, emmenagogue 5.695g crude drug/kg, the emmenagogue 11.39g crude drug/kg reduction to the uterus point of intersect of the capillary network number caused by oxytocin has obvious inhibitory action, and effect is better than TONGJINGBAO KELI group.
Seen by table 12, emmenagogue 2.8475g crude drug/kg, emmenagogue 5.695g crude drug/kg, emmenagogue 11.39g crude drug/kg improve significantly to the uterus microvascular blood flow state caused by oxytocin, and effect is better than TONGJINGBAO KELI group.
Seen by table 13, emmenagogue 2.8475g crude drug/kg, emmenagogue 5.695g crude drug/kg, emmenagogue 11.39g crude drug/kg improve significantly to the uterus blood capillary Blood cell accumulation state caused by oxytocin, and effect is better than TONGJINGBAO KELI group.
In sum, the dysmenorrhea medicine obtained according to the above embodiment of the present invention improves significantly to the uterus microcirculation disturbance index of correlation caused by oxytocin.
Known in sum, Kazak medicine according to the above embodiment of the present invention obtains: dysmenorrhea drug utilization Kazak medical material obtains, preparation method is simple, and medicine used is all warm nature medicine, there is the effect of channel warming and blood nourishing, menstruction regulating and pain relieving, nontoxic pair, adopt the dysmenorrhea medicine curative effect when treating dysmenorrhea obtained according to the above embodiment of the present invention short, improve dysmenorrhea symptom obvious, treated effect is high, have no side effect, without drug resistance phenomenon, not easily recur after treatment, can effectively for patient removes slight illness.
Claims (9)
1. a dysmenorrhea medicine, is characterized in that raw materials by weight portion meter comprises Rhizoma Corydalis 3 parts to 10 parts, Radix Angelicae Sinensis 6 parts to 12 parts, Rhizoma Chuanxiong 3 parts to 10 parts, Folium Artemisiae Argyi 3 parts to 9 parts, the Radix Linderae 6 parts to 10 parts, Fructus Foeniculi 3 parts to 6 parts and Radix Daphnes altaicae 0.5 part to 1 part.
2. dysmenorrhea medicine according to claim 1, it is characterized in that obtaining as follows: the first step, the Radix Angelicae Sinensis of aequum, Rhizoma Chuanxiong, Folium Artemisiae Argyi, the Radix Linderae, Fructus Foeniculi and Radix Daphnes altaicae are mixed and forms mixing medical material, vapor distillation is carried out add the water of mixing quality of medicinal material 6 doubly to 9 times in mixing medical material after, the temperature of vapor distillation is 100 DEG C to 200 DEG C, the time is 4 little of 6 hours, obtains the volatile oil of aqueous solution and extraction after vapor distillation respectively, second step, reflux, extract, is carried out 1 time to 3 times to the Rhizoma Corydalis of aequum, the volumetric concentration that each reflux, extract, adds Rhizoma Corydalis quality 4 doubly to 10 times in Rhizoma Corydalis is the ethanol water of 30% to 95%, the temperature of each reflux, extract, is 60 DEG C to 100 DEG C, time is 0.5 little of 3.5 hours, filter after each reflux, extract, and obtain filtrate, obtain after merging filtrate mixing filtrate, reclaim the ethanol in mixing filtrate, the aqueous solution that mixing filtrate after recovery ethanol and first step reflux, extract, obtain carries out merging and obtains mixed solution, mixed solution is concentrated, the dry extract that mass water content is 1% to 10% is obtained after vacuum drying, dry extract is broken into 100 order to 200 object fine powders, 3rd step, in fine powder, add the dextrin of fine powder quality 1 doubly to 3 times, the sweetener of fine powder quality 0.1% to 5% obtains mixing fine powders, the volumetric concentration adding volatile oil quality 0.5 doubly to 2 times in the volatile oil that the first step obtains be 80% to 95% ethanol water carry out dilution and obtain diluting volatile oil, make granule by after mixing fine powders and dilution volatile oil mix homogeneously, after drying, granulate, obtain dysmenorrhea medicine.
3. dysmenorrhea medicine according to claim 2, is characterized in that the number of times of reflux, extract, in second step is 2 times; Or/and in second step, the ethanol reclaimed in mixing filtrate is less than 10% to the mass content of ethanol in mixing filtrate.
4. the dysmenorrhea medicine according to Claims 2 or 3, is characterized in that simmer down to concentrating under reduced pressure in second step, and the temperature of concentrating under reduced pressure is 50 DEG C to 80 DEG C, pressure is-0.05MPa to-0.09MPa; Or/and in second step, vacuum drying temperature is 50 DEG C to 80 DEG C, pressure is-0.05MPa to-0.09MPa.
5. the dysmenorrhea medicine according to Claims 2 or 3 or 4, is characterized in that in the 3rd step, will make by 10 mesh sieves, not by the granule of 80 mesh sieves after mixing fine powders and dilution volatile oil mix homogeneously; Or/and, in the 3rd step, be 0.5% to 5% by particle drying to granular mass water content; Or/and dried granule is not with by 10 mesh sieves, carry out granulate by 80 mesh sieves in the 3rd step.
6. dysmenorrhea medicine according to claim 1 and preparation method thereof, it is characterized in that carrying out in the steps below: the first step, the Radix Angelicae Sinensis of aequum, Rhizoma Chuanxiong, Folium Artemisiae Argyi, the Radix Linderae, Fructus Foeniculi and Radix Daphnes altaicae are mixed and forms mixing medical material, vapor distillation is carried out add the water of mixing quality of medicinal material 6 doubly to 9 times in mixing medical material after, the temperature of vapor distillation is 100 DEG C to 200 DEG C, the time is 4 little of 6 hours, obtains the volatile oil of aqueous solution and extraction after vapor distillation respectively, second step, reflux, extract, is carried out 1 time to 3 times to the Rhizoma Corydalis of aequum, the volumetric concentration that each reflux, extract, adds Rhizoma Corydalis quality 4 doubly to 10 times in Rhizoma Corydalis is the ethanol water of 30% to 95%, the temperature of each reflux, extract, is 60 DEG C to 100 DEG C, time is 0.5 little of 3.5 hours, filter after each reflux, extract, and obtain filtrate, obtain after merging filtrate mixing filtrate, reclaim the ethanol in mixing filtrate, the aqueous solution that mixing filtrate after recovery ethanol and first step reflux, extract, obtain carries out merging and obtains mixed solution, mixed solution is concentrated, the dry extract that mass water content is 1% to 10% is obtained after vacuum drying, dry extract is broken into 100 order to 200 object fine powders, 3rd step, in fine powder, add the dextrin of fine powder quality 1 doubly to 3 times, the sweetener of fine powder quality 0.1% to 5% obtains mixing fine powders, the volumetric concentration adding volatile oil quality 0.5 doubly to 2 times in the volatile oil that the first step obtains be 80% to 95% ethanol water carry out dilution and obtain diluting volatile oil, make granule by after mixing fine powders and dilution volatile oil mix homogeneously, after drying, granulate, obtain dysmenorrhea medicine.
7. dysmenorrhea medicine according to claim 6 and preparation method thereof, is characterized in that the number of times of reflux, extract, in second step is 2 times; Or/and in second step, the ethanol reclaimed in mixing filtrate is less than 10% to the mass content of ethanol in mixing filtrate.
8. dysmenorrhea medicine according to claim 6 or 7 and preparation method thereof, is characterized in that simmer down to concentrating under reduced pressure in second step, and the temperature of concentrating under reduced pressure is 50 DEG C to 80 DEG C, pressure is-0.05MPa to-0.09MPa; Or/and in second step, vacuum drying temperature is 50 DEG C to 80 DEG C, pressure is-0.05MPa to-0.09MPa.
9. dysmenorrhea medicine according to claim 6 or 7 or 8 and preparation method thereof, is characterized in that in the 3rd step, will make by 10 mesh sieves, not by the granule of 80 mesh sieves after mixing fine powders and dilution volatile oil mix homogeneously; Or/and, in the 3rd step, be 0.5% to 5% by particle drying to granular mass water content; Or/and dried granule is not with by 10 mesh sieves, carry out granulate by 80 mesh sieves in the 3rd step.
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|---|---|---|---|---|
| CN104688941A (en) * | 2015-03-17 | 2015-06-10 | 苏州市天灵中药饮片有限公司 | Traditional Chinese medicine decoction for relieving dysmenorrhea and preparation method thereof |
| CN107335046A (en) * | 2017-08-29 | 2017-11-10 | 南京多宝生物科技有限公司 | A kind of medicine moxa roll for treating dysmenorrhoea and preparation method thereof |
| CN117695371A (en) * | 2024-02-06 | 2024-03-15 | 中科创导(山东)生物科技有限公司 | Traditional Chinese medicine fermentation preparation for treating dysmenorrhea and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103239702A (en) * | 2013-05-24 | 2013-08-14 | 温美珍 | Medicament for treating dysmenorrhea |
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- 2014-11-09 CN CN201410623311.3A patent/CN104324149B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103239702A (en) * | 2013-05-24 | 2013-08-14 | 温美珍 | Medicament for treating dysmenorrhea |
Non-Patent Citations (1)
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| 徐汝德主编: "《常见病效验方荟萃》", 28 February 2013 * |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104688941A (en) * | 2015-03-17 | 2015-06-10 | 苏州市天灵中药饮片有限公司 | Traditional Chinese medicine decoction for relieving dysmenorrhea and preparation method thereof |
| CN107335046A (en) * | 2017-08-29 | 2017-11-10 | 南京多宝生物科技有限公司 | A kind of medicine moxa roll for treating dysmenorrhoea and preparation method thereof |
| CN117695371A (en) * | 2024-02-06 | 2024-03-15 | 中科创导(山东)生物科技有限公司 | Traditional Chinese medicine fermentation preparation for treating dysmenorrhea and preparation method thereof |
| CN117695371B (en) * | 2024-02-06 | 2024-04-19 | 中科创导(山东)生物科技有限公司 | Traditional Chinese medicine fermentation preparation for treating dysmenorrhea and preparation method thereof |
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|---|---|
| CN104324149B (en) | 2018-12-07 |
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