CN105582471A - Traditional Chinese medicine for treating liver-qi stagnation type premenstrual tension syndrome - Google Patents

Traditional Chinese medicine for treating liver-qi stagnation type premenstrual tension syndrome Download PDF

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CN105582471A
CN105582471A CN201610045365.5A CN201610045365A CN105582471A CN 105582471 A CN105582471 A CN 105582471A CN 201610045365 A CN201610045365 A CN 201610045365A CN 105582471 A CN105582471 A CN 105582471A
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不公告发明人
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    • A61K36/88—Liliopsida (monocotyledons)
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Abstract

The invention provides a traditional Chinese medicine for treating the liver-qi stagnation type premenstrual tension syndrome. The traditional Chinese medicine is characterized by comprising raw materials as follows: Chinese thorowax roots, white paeony roots, red paeony roots, green tangerine peel, tangerine peel, nutgrass galingale rhizomes, motherwort herbs, flosmume, turmeric root-tuber, dried rehmannia roots, danshen roots, glossy privet fruits, yerbadetajo herbs, raspberries, rhizoma pinelliae preparatum, moutan bark, puncturevine caltrop fruits, catechu, lalang grass rhizomes, largehead atractylodes rhizomes, common selfheal fruit-spikes, ychee seeds, kelp, beautiful sweetgum fruits, areca seeds and liquorice. The traditional Chinese medicine is prepared according to a large quantity of clinical practices, the medicine is theoretically researched, the formula is simplified, the compatibility is optimized, experiment researches and safety evaluation can prove that the traditional Chinese medicine has a very good treatment function on the liver-qi stagnation type premenstrual tension syndrome and is safe, non-toxic and worth recommendation and use in clinic.

Description

Be used for the treatment of the Chinese medicine of liver qi stagnation type premenstrual tension syndrome
Technical field
The present invention relates to traditional Chinese medicine technical field, relate in particular to one and be used for the treatment of liver qi stagnation type premenstruum (premenstrua)The Chinese medicine of tonic symptoms.
Background technology
Premenstrual tension syndrome (PremenstrualSyndrome, PMS) refers to that women is in the menstrual cycleA series of physiology of showing of later stage (D14-D28 luteal phase) and the malaise symptoms of emotion aspect, symptomIrrelevant with spirit and internal disease, and alleviate in follicular phase, after menstrual onset, do not return to voluntarily and appointWhat symptom state. Its main manifestations has irritated irritability, insomnia, anxiety, constrain and headache, spargosisBitterly, a series of symptom such as facial edema, severe patient can affect women's normal life. Tight from premenstruum (premenstrua)Open syndromic clinical symptoms and see, this disease is one of disease that women of child-bearing age's incidence of disease is higher. Meanwhile, warpEarly stage, tonic symptoms was a kind of female diseases that the composite factors such as a kind of physiology and social mentality cause. SternlyHeavy premenstrual tension syndrome: the definition of at present serious premenstrual tension syndrome premenstrual symptom also differsCause. But in nearest research, this diagnostic criteria obtains unified substantially, and for diagnosing thisSeries has the serious premenstrual symptom (phrenoblabia of having the fidgets premenstruum (premenstrua)) of multiple performance----withAt least 5 kinds of symptoms are basis, comprise simultaneously one of 4 kinds of core mental symptoms (go out self-contained 17 kinds of physiology,The form of mental symptoms. These 17 kinds of symptoms are: depressed, helpless and sense of guilt, anxiety/pressure are large, feelingsThread shakiness, irritability/continue indignation, interest reduces, absent minded, tired, bulimia, sleepObstacle, without autocontrol force or vulnerable, assist ability, headache, pain, oedema/body weight to increase, take outJerk, swollen breasts) and increase the weight of in premenstruum (premenstrua), after menstruation, alleviate or disappear. 95% women at fertile age all goes outNow cross premenstrual tension syndrome symptom, wherein to being called as premenstrual tension syndrome, person accounts for serious symptom5%. May be inspired or hypersensitivity to progestational hormone as neuroendocrine factor by hormone and other, also canCan be caused by serotonin hyposecretion. Socio-psychological factor has necessarily premenstrual tension syndromeImpact, but correlative study deficiency.
This sick therapeutic purpose is alleviate or eliminate body, mental symptoms, reduce to personal daily life,The impact of human communication, quality of life; And make the side reaction for the treatment of minimum as far as possible, its methods for the treatment of have withWhat time lower: 1, anxiolytic/non-selective serotonin cell reabsorption inhibitor; 2, bromine is hidden stops; 3, pressThe therapy of rubbing; 4, cognitive-behavioral therapy; 5, DANAZOL; 6, diet supplements; 7, diuretics; 8, uterusIntimectomy; 10, luteinizing hormone-releasing hormone analog (GnRH analog: cloth containing Rayleigh,Dagger-axe tongue Rayleigh, Leuprorelin); 11, oophorectomy is accompanied or do not accompanied to uterectomy; 12, abdominal cavityOophorectomy under mirror; 13, low dose estrogen; 14, NSAIDs; 15, oral contraceptionMedicine; 16, progestational hormone (synthetic progesterone sample medicine): relatively the evidence of progestational hormone and placebo effect is notFoot. 17, VitB6; 18, reflexotherapy; 19, relaxation therapy; 20, selective serotonin weightAbsorption inhibitor. Although the therapeutic scheme of modern medicine is many, still can carry without any therapeutic schemeFor the extensively therapeutic scheme of accreditation of medical circle.
In ancient traditional Chinese medicine without premenstrual tension syndrome name of disease, but just like " premenstrual heating ", " premenstrualIrritated " etc. discussion. Modern Chinese medicine gynaecology is often referred to as this type of symptom " all cards before and after menstruation ". ItsClinical manifestation symptom is numerous, complicated, as headache during menstruation, generate heat, tell nosebleed, aphthous stomatitis, edema, cough breathe heavily,Emotion-thought abnormal etc. Though for another through after water pouring, tic, hiccup, lip green grass or young crops, swelling, the less generations such as disease of itching,But there is finding at ancient books and modern clinic. Be familiar with in conjunction with modern clinic reality according to ancients, think at presentWhy all cards are with menstrual cycle outbreak before and after menstruation, with menstrual period qi and blood be full of empty change and physique has close passSystem. By the epidemiology survey sick to this, in its 6 kinds of card types, with premenstrual swollen breasts, seemingly have hardTie or have piece, lower abdominal distention pain to connect and two sides of body, irritated irritability, or mental depression, kind sigh, even manicUneasiness, insomnia, or severe headache, or limb swelling, tongue is thin white, and arteries and veins string or string cunning are main manifestationsThe caused by hepatic stagnation qi stagnation premenstrual tension syndrome incidence of disease is the highest, therefore, studies a kind of in this card typeMedicine medicine is very necessary.
Chinese medicine preparation of the present invention comes from a large amount of clinical practices, through medicine is carried out to theoretical research, essenceLetter prescription, optimizes compatibility, can confirm Chinese medicine preparation of the present invention through experimental study and safety evaluatioThere is good therapeutic action for liver qi stagnation type premenstrual tension syndrome, and the secondary work of safety non-toxicWith, clinic recommendation.
Summary of the invention
Technical problem to be solved by this invention is to provide one and is used for the treatment of liver qi stagnation type premenstrual tensionSyndromic Chinese medicine, its premenstrual tension syndrome to this card type has good therapeutic action,And safe without toxic side effect, clinic recommendation.
Based on this, the invention provides a kind of Chinese medicine that is used for the treatment of perimenopausal syndrome, it is formerMaterial cartridge bag draw together radix bupleuri, the root of herbaceous peony, the radix paeoniae rubrathe, rascal, dried orange peel, rhizoma cyperi, motherwort, FLOS MUME, root tuber of aromatic turmeric,Radix rehmanniae recen, the red sage root, the fruit of glossy privet, eclipta, raspberry, rhizoma pinellinae praeparata, moutan bark, tribulus terrestris, catechu,The bighead atractylodes rhizome, cogongrass rhizome, selfheal, semen litchi, kelp, play both sides of the street, betel nut and Radix Glycyrrhizae.
Wherein, in described Chinese medicine, the weight portion of each bulk drug is respectively radix bupleuri 25 weight portion～35 weightsAmount part, the root of herbaceous peony 20 weight portion～30 weight portions, the radix paeoniae rubrathe 15 weight portion～25 weight portions, rascal 20 weightsAmount part～35 weight portions, dried orange peel 25 weight portion～45 weight portions, rhizoma cyperi 10 weight portion～15 weight portions,Motherwort 25 weight portion～35 weight portions, FLOS MUME 15 weight portion～25 weight portions, root tuber of aromatic turmeric 20 weightPart～30 weight portions, radix rehmanniae recen 25 weight portion～35 weight portions, the red sage root 15 weight portion～25 weight portions,The fruit of glossy privet 25 weight portion～35 weight portions, eclipta 25 weight portion～35 weight portions, raspberry 5 weightPart～10 weight portions, rhizoma pinellinae praeparata 10 weight portion～15 weight portions, moutan bark 10 weight portion～25 weightPart, tribulus terrestris 10 weight portion～15 weight portions, catechu 15 weight portion～20 weight portions, the bighead atractylodes rhizome 15 weightsAmount part～20 weight portions, cogongrass rhizome 15 weight portion～25 weight portions, selfheal 10 weight portion～20 weightsMeasure part, semen litchi 10 weight portion～15 weight portions, kelp 5 weight portion～10 weight portions, play both sides of the street 10Weight portion～25 weight portion, betel nut 10 weight portion～15 weight portions and Radix Glycyrrhizae 10 weight portion～20 weightPart.
Wherein, in described Chinese medicine, the weight portion of each bulk drug is respectively radix bupleuri 30 weight portion～35 weightsAmount part, the root of herbaceous peony 20 weight portion～25 weight portions, the radix paeoniae rubrathe 20 weight portion～25 weight portions, rascal 25 weightsAmount part～30 weight portions, dried orange peel 30 weight portion～35 weight portions, rhizoma cyperi 10 weight portion～15 weight portions,Motherwort 30 weight portion～35 weight portions, FLOS MUME 15 weight portion～20 weight portions, root tuber of aromatic turmeric 20 weightPart～25 weight portions, radix rehmanniae recen 30 weight portion～35 weight portions, the red sage root 15 weight portion～20 weight portions,The fruit of glossy privet 25 weight portion～30 weight portions, eclipta 30 weight portion～35 weight portions, raspberry 5 weightPart～10 weight portions, rhizoma pinellinae praeparata 10 weight portion～15 weight portions, moutan bark 15 weight portion～20 weightPart, tribulus terrestris 10 weight portion～15 weight portions, catechu 15 weight portion～20 weight portions, the bighead atractylodes rhizome 15 weightsAmount part～20 weight portions, cogongrass rhizome 15 weight portion～20 weight portions, selfheal 15 weight portion～20 weightsMeasure part, semen litchi 10 weight portion～15 weight portions, kelp 5 weight portion～10 weight portions, play both sides of the street 15Weight portion～20 weight portion, betel nut 10 weight portion～15 weight portions and Radix Glycyrrhizae 15 weight portion～20 weightPart.
Wherein, in described Chinese medicine, the weight portion of each bulk drug is respectively radix bupleuri 30 weight portions, the root of herbaceous peony25 weight portions, the radix paeoniae rubrathe 20 weight portions, rascal 25 weight portions, dried orange peel 30 weight portions, rhizoma cyperi 10 weightPart, motherwort 30 weight portions, FLOS MUME 20 weight portions, root tuber of aromatic turmeric 25 weight portions, radix rehmanniae recen 30 weightPart, the red sage root 20 weight portions, the fruit of glossy privet 30 weight portions, eclipta 30 weight portions, raspberry 5 weight portions,Rhizoma pinellinae praeparata 10 weight portions, moutan bark 20 weight portions, tribulus terrestris 10 weight portions, catechu 15 weight portions,Cogongrass rhizome 20 weight portions, the bighead atractylodes rhizome 15 weight portions, selfheal 15 weight portions, semen litchi 10 weight portions,Kelp 5 weight portions, 15 weight portions that play both sides of the street, betel nut 10 weight portions and Radix Glycyrrhizae 20 weight portions.
Wherein, described Chinese medicine routinely technique add auxiliary material make tablet, capsule, granule,Dripping pill, micropill, dispersing tablet, oral disnitegration tablet, the water-bindered pill or oral liquid.
Wherein, described Chinese medicine is prepared into the water-bindered pill.
Wherein, described auxiliary material comprise solvent, disintegrant, flavouring, anticorrisive agent, colouring agent, adhesive,One or more in lubricant and matrix.
The present invention also provides the preparation method of above-mentioned Chinese medicine, and it comprises:
The first step, takes the root of herbaceous peony, the radix paeoniae rubrathe, motherwort, FLOS MUME, the fruit of glossy privet, the China ink of above-mentioned weight portionDrought lotus, moutan bark, cogongrass rhizome, the bighead atractylodes rhizome, kelp, betel nut and licorice raw material medicine, mix powderThe broken meal that obtains, adding determining alcohol is 50%～75% ethanol water refluxing extraction three times, adds for the first time secondAlcohol amount is 8～12 times of meal weight, the 3～5h that refluxes, add for the second time amount of alcohol and be 6 of meal weight～8 times, the 2～3h that refluxes, adds amount of alcohol and is 3～5 times of meal weight for the third time, and the 1～2h that refluxes, closesAnd phegma, filter, make extract, extract is condensed into thick paste, dry, make the first extractionThing;
Second step, takes the remaining bulk drug of above-mentioned weight portion, mixes, and pulverizes to obtain meal, addsDecocting boils 2 times, for the first time amount of water be meal weight 10-15 doubly, decoct 3-5h, add water for the second timeThe 5-10 of amount meal weight doubly, decocts 1-3h; Merge decoction liquor, filter, filtrate is concentrated into temperature and is70 DEG C of clear cream that relative density is 1.10-1.12, add absolute ethyl alcohol to the concentration of ethanol in solution to be70%, leave standstill 24h, filter, make extract, extract is condensed into thick paste, dry, make theTwo extracts;
The 3rd step, mixes the first extract and the second extract, system machine for making water-bindered pills flashing pill,Then be placed in baking oven and dry to moisture content≤5wt% at 70～80 DEG C, obtain the water-bindered pill.
Useful technique effect
The Chinese medicine that is used for the treatment of liver qi stagnation type premenstrual tension syndrome provided by the invention, it is rightThe premenstrual tension syndrome of this card type has good therapeutic action, and safe without toxic side effect, valueObtain clinical recommendation.
Detailed description of the invention
The invention provides a kind of Chinese medicine that is used for the treatment of perimenopausal syndrome, its bulk drug comprisesRadix bupleuri, the root of herbaceous peony, the radix paeoniae rubrathe, rascal, dried orange peel, rhizoma cyperi, motherwort, FLOS MUME, root tuber of aromatic turmeric, radix rehmanniae recen,The red sage root, the fruit of glossy privet, eclipta, raspberry, rhizoma pinellinae praeparata, moutan bark, tribulus terrestris, catechu, cogongrass rhizome,The bighead atractylodes rhizome, selfheal, semen litchi, kelp, play both sides of the street, betel nut and Radix Glycyrrhizae.
The generation of premenstrual tension syndrome is how relevant with function disorder. Before passing through or menstrual period cloudy bloodBet punching is appointed, the cloudy blood relative deficiency of whole body, therefore be prone to, internal organs are yin or yang excess to decline partially, thereby produce one isRow syndrome. Its main interpretation of the cause, onset and process of an illness is stagnation of QI due to depression of the liver, and with the passing of time the obstruction of the circulation of vital energy changes fire, stagnation of the circulation of vital energy hematogenous blockage and blood is tired,Finally cause the generation of this disease. For above-mentioned pathogenic analysis, we support with the root of herbaceous peony, the radix paeoniae rubrathe, radix bupleuriBlood, soft liver, regulate the flow of vital energy, Xie Yu is monarch drug in a prescription. Liver is the viscus of storing blood, and body is cloudy and with sun, taking blood as, withGas is use, and irritability is adjusted freely needs to rely liver blood abundance to nourish. The root of herbaceous peony, radix paeoniae rubrathe hardship, acid, be slightly cold, and returns liver, spleenWarp, has suppressing liver-YANG, the astringe yin that nourishes blood, effect of easing the affected liver to relieve pain. Micro-pungent, the micro-hardship of radix bupleuri, property is apt to barReach irritability and separate liver depression. Three medicines coordinate, and merit is arrogated to oneself nourishing the liver blood, nourishing liver the moon, and the soft liver of astringe yin, suits liver catharsisNot as good as and the interpretation of the cause, onset and process of an illness of stagnation of liver qi, therefore be monarch drug in a prescription. The bighead atractylodes rhizome, rhizoma pinellinae praeparata, radix rehmanniae recen, the fruit of glossy privet, China ink droughtLotus, motherwort, the red sage root are ministerial drug, and the qi and blood of liver relies transporting and transforming function of the spleen and stomach essence of water and grain to support. Catharsis is too late,Stagnation of liver qi, very takes advantage of spleen soil, is the interpretation of the cause, onset and process of an illness of this disease, the bighead atractylodes rhizome, rhizoma pinellinae praeparata invigorating the spleen gas and taste source is rawGlutinous rehmannia, motherwort, the fruit of glossy privet, eclipta, the red sage root are the key medicine of nourishing liver blood, nourishing the liver menstruation regulating. All medicinesCoordinate, nourishing the liver blood, help irritability, auxiliary monarch drug in a prescription, strengthens monarch drug in a prescription nourishing the liver solution Yu Zhili, therefore be ministerial drug altogether.Rhizoma cyperi, FLOS MUME, root tuber of aromatic turmeric, dried orange peel, rascal, moutan bark, raspberry, tribulus terrestris, catechu, cogongrassRoot, selfheal, semen litchi, kelp, play both sides of the street, betel nut is adjutant. Liver dysfunction, the obstruction of the circulation of vital energy smooth andBreast is done swollen, and the obstructed and facilitation fire of obstruction of the circulation of vital energy knot, therefore some patients were has concurrently vexed, insomnia. Rhizoma cyperi taste is pungent,Micro-hardship, is good at soothing liver-qi stagnation, thus can regulating functional activities of qi and promoting qi circulation and relieving pain, be especially suitable for stagnation of liver qi and the moon that causesThrough cards such as uncomfortable, mammary swelling, stomachache, the compatibility root of herbaceous peony, radix bupleuri etc. Moutan bark is pungent in flavor and cool in property, kind purify the blood pointHot and suffocating and relieving restlessness. Root tuber of aromatic turmeric is pungent, bitterness is cold, promoting qi circulation and removing obstruction in the collateral, and clearing heat and cooling blood, be " the gas medicine in blood ",Merit is arrogated to oneself " promoting qi circulation and removing obstruction in the collateral and catharsis liver depression are invigorated blood circulation and dispelled addiction and relieve the pain pain ". Dried orange peel, rascal promoting the circulation of qi dampness elimination,Function of spleen and stomach regulating, for premenstruum (premenstrua) headache, uses selfheal, betel nut calming the liver, and the pain relieving that relieves dizziness, high fever, infantile convulsions, epilepsy, etc., with whitePuncture vine, the fruit of glossy privet, eclipta, the cooperation monarch drug in a prescription root of herbaceous peony is nourishing liver and kidney, suppressing hyperactive liver for descending adverse qi, for through fore udderDistending pain, the person that has piece, add semen litchi, kelp, the softening and resolving hard mass that plays both sides of the street, for premenstrual being irritable and getting angry easily person,Add catechu, cogongrass rhizome to coordinate moutan bark, the radix paeoniae rubrathe, the root of herbaceous peony, selfheal clearing heat and cooling blood, soothing the liver, in the hope of.All medicines share, and focus on regulating qi-flowing for relieving pain, the relieving restlessness with heat-clearing of holding concurrently, and change that can anti-depressed liver and heat transmission fire, again canThe disease of holding concurrently for the treatment of the liver failing to dredge the spleen, therefore be adjutant altogether. Radix Glycyrrhizae amount is light, and coordinating the drug actions of a prescription is thought to be made. All medicines are harmonious,Nourishing the liver blood, to help liver use, helps irritability to separate liver depression, holds concurrently with regulating qi-flowing for relieving pain, and the liver for the treatment of premenstrual syndromeObstruction of the circulation of vital energy knot, dys-splenism card.
Further preferably, described Chinese medicine is only prepared from by above-mentioned raw materials medicine.
In described Chinese medicine the weight portion of each bulk drug be respectively radix bupleuri 25 weight portion～35 weight portions,The root of herbaceous peony 20 weight portion～30 weight portions, the radix paeoniae rubrathe 15 weight portion～25 weight portions, rascal 20 weight portions～35 weight portions, dried orange peel 25 weight portion～45 weight portions, rhizoma cyperi 10 weight portion～15 weight portions, benefit motherGrass 25 weight portion～35 weight portions, FLOS MUME 15 weight portion～25 weight portions, root tuber of aromatic turmeric 20 weight portions～30 weight portions, radix rehmanniae recen 25 weight portion～35 weight portions, the red sage root 15 weight portion～25 weight portions, femaleLoyal sub 25 weight portion～35 weight portions, eclipta 25 weight portion～35 weight portions, raspberry 5 weight portions～10 weight portions, rhizoma pinellinae praeparata 10 weight portion～15 weight portions, moutan bark 10 weight portion～25 weight portions,Tribulus terrestris 10 weight portion～15 weight portions, catechu 15 weight portion～20 weight portions, cogongrass rhizome 15 weightPart～25 weight portions, the bighead atractylodes rhizome 15 weight portion～20 weight portions, selfheal 10 weight portion～20 weight portions,Semen litchi 10 weight portion～15 weight portions, kelp 5 weight portion～10 weight portions, 10 weight portions that play both sides of the street～25 weight portions, betel nut 10 weight portion～15 weight portions and Radix Glycyrrhizae 10 weight portion～20 weight portions.
Further preferably, in described Chinese medicine the weight portion of each bulk drug be respectively radix bupleuri 30 weight portions～35 weight portions, the root of herbaceous peony 20 weight portion～25 weight portions, the radix paeoniae rubrathe 20 weight portion～25 weight portions, rascal25 weight portion～30 weight portions, dried orange peel 30 weight portion～35 weight portions, rhizoma cyperi 10 weight portion～15 weightsAmount part, motherwort 30 weight portion～35 weight portions, FLOS MUME 15 weight portion～20 weight portions, root tuber of aromatic turmeric20 weight portion～25 weight portions, radix rehmanniae recen 30 weight portion～35 weight portions, the red sage root 15 weight portion～20Weight portion, the fruit of glossy privet 25 weight portion～30 weight portions, eclipta 30 weight portion～35 weight portions, cover basinSon 5 weight portion～10 weight portions, rhizoma pinellinae praeparata 10 weight portion～15 weight portions, moutan bark 15 weight portions～20 weight portions, tribulus terrestris 10 weight portion～15 weight portions, catechu 15 weight portion～20 weight portions, whiteLalang grass rhizome 15 weight portion～20 weight portions, the bighead atractylodes rhizome 15 weight portion～20 weight portions, selfheal 15 weight portions～20 weight portions, semen litchi 10 weight portion～15 weight portions, kelp 5 weight portion～10 weight portions, Lu LuLogical 15 weight portion～20 weight portions, betel nut 10 weight portion～15 weight portions and Radix Glycyrrhizae 15 weight portion～20Weight portion.
Most preferably, in described Chinese medicine, the weight portion of each bulk drug is respectively radix bupleuri 30 weight portions, the root of herbaceous peony25 weight portions, the radix paeoniae rubrathe 20 weight portions, rascal 25 weight portions, dried orange peel 30 weight portions, rhizoma cyperi 10 weightPart, motherwort 30 weight portions, FLOS MUME 20 weight portions, root tuber of aromatic turmeric 25 weight portions, radix rehmanniae recen 30 weightPart, the red sage root 20 weight portions, the fruit of glossy privet 30 weight portions, eclipta 30 weight portions, raspberry 5 weight portions,Rhizoma pinellinae praeparata 10 weight portions, moutan bark 20 weight portions, tribulus terrestris 10 weight portions, catechu 15 weight portions,Cogongrass rhizome 20 weight portions, the bighead atractylodes rhizome 15 weight portions, selfheal 15 weight portions, semen litchi 10 weight portions,Kelp 5 weight portions, 15 weight portions that play both sides of the street, betel nut 10 weight portions and Radix Glycyrrhizae 20 weight portions.
Each bulk drug pharmacology is as follows:
Radix bupleuri: latin name bupleuriradix is the dry root of umbelliferae bupleurum or radix bupleuri scorzoneraefolii,Bitter, cold nature, returns liver, gallbladder channel, has to evacuate to bring down a fever, and rises effect of the easypro liver of sun, curing mainly flu and sending outHeat, fevers and chills alternate, malaria, stagnation of QI due to depression of the liver, sternal rib pain, prolapse of the anus, uterus comes off, irregular menstruation etc.Card.
The root of herbaceous peony: latin name PaeoniaeRadixAlba, bitter, acid, cool in nature, enter liver, the spleen channel, toolThere is nourishing blood and liver, slow middle pain relieving, astringe yin is received effect of sweat, cures mainly chest abdomen pain over the hypochondriac region, rushes down dysentery stomachache,Spontaneous sweating, fever due to yin deficiency, irregular menstruation, uterine bleeding, is with inferior card, and the root of herbaceous peony has good protection liverDirty effect.
The radix paeoniae rubrathe: bitter, micro-hardship, return Liver Channel, there is purge the green, clearing heat and cooling blood, effect of stasis-dispelling and pain-killing,Cure mainly the red eye, swell pain that irascibility is vigorous, have a dizzy spell, pain in chest and hypochondrium, the hot tongue of body of warm heat disease heat invading xuefenDeep red, macula is hemorrhage, and blood stasis is through closing; The haematemesis hematuria of the burning hot absurd row of flourishing urgent blood; Women's blood-head itPass through too much; The caused various pain of blood retardance; The swollen card that waits of sore furuncle carbuncle of blood-head poison Sheng.
Rascal: bitter, pungent, warm in nature, enter liver, courage, stomach warp, there is easypro courage relieving stagnant Qi, long-pendingization that disappear is stagnantEffect, for stagnation of QI due to dyspepsia, abdominal distention, infantile malnutrition, old man's abdominal distension of stopping eating, has temperature to intestines and stomachWith spread effect, can promote digestive juice secretion and get rid of gas in body, again can diastole gastrointestinal smooth muscle,Main manifestations is the effect of adjusting gastrointestinal function.
Dried orange peel: warm in nature, taste is pungent, bitter; Return spleen, lung channel, pungent loose logical temperature, fragrant odour, is longer than reasonGas, can enter spleen lung, thus can go loose sluggishness of lung-QI, again can promoting the circulation of qi wide in, for lung qi gather around stagnant,The cards such as the full and taste stagnation of the circulation of vital energy of chest diaphragm ruffian, abdominal fullness and distention.
Rhizoma cyperi: pungent, sweet, the micro-hardship of taste, property is flat, returns liver, tri-jiao channel, has the Xie Yu of regulating the flow of vital energy, and menstruation regulating is onlyEffect of pain, cures mainly stagnation of QI due to depression of the liver, chest, the side of body, abdominal distention, and indigestion, irregular menstruation, through closingDysmenorrhoea, cold hernia stomachache, the cards such as swollen breasts.
Motherwort: latin name LeonuriHerba, bitter, pungent, cold nature, enters liver, pericardium channel, toolHave promoting blood circulation for regulating menstruation, effect of inducing diuresis to reduce edema, cures mainly irregular menstruation, dysmenorrhoea, and through closing, lochiorrhagia, waterSwollen oliguria, the cards such as acute nephritis edema.
FLOS MUME: taste acid, puckery, property is flat, returns liver, stomach, lung channel, has easypro liver, and stomach, reduces phlegmEffect, cures mainly globus hysteriocus, stomachache due to emotional depression and the hyperactive liver-qi attacking the stomach, poor appetite, dizziness, the cards such as scrofula.
Root tuber of aromatic turmeric: taste is pungent, bitter, cold in nature, returns liver, the heart, lung channel, has promoting blood circulation and stopping pain, promoting qi circulation and removing obstruction in the collateral,The cool blood that clears away heart-fire, effect of normalizing gallbladder to cure jaundice, cures mainly through closing dysmenorrhoea, chest and abdomen swelling and pain, shouting pain, pyreticosis coma, insaneEpilepsy is gone mad, the red card that waits of jaundice urine.
Radix rehmanniae recen: taste is sweet, bitter, cold in nature, the thoughts of returning home, liver, kidney channel, have clearing heat and cooling blood, eliminate blood stasis and promote tissue regeneration,Effect of nourishing Yin and promoting production of body fluid, cures mainly the Kidney-Yin cards of being robbed such as the body heat of heat as battalion point is thirsty; Or the pyreticosis later stage is lowHeat is not moved back; Chronic disease card belongs to yin asthenia generating intrinsic heat person; The thirst and drinking of lung stomach intrinsic heat, quenches one's thirst vexed, stomach-YinInjured thirsty few Tianjin; The having blood in stool of blood-heat bleeding, metrostaxis; The purple black card that waits of a spot of blood-head poison Sheng.
The red sage root: bitter, cold nature, the thoughts of returning home, Liver Channel, have promoting blood circulation for regulating menstruation, stasis-dispelling and pain-killing, cool blood disappearsCarbuncle, the relieving restlessness that clears away heart-fire, effect of nourishing blood and tranquilization, cures mainly irregular menstruation, and through closing dysmenorrhoea, a lump in the abdomen causing distension and pain, chestVentral spine pain, hot numbness pain, sore swells and ache, dysphoria and insomnia; Hepatosplenomegaly, the cards such as angina pectoris.
The fruit of glossy privet: taste is sweet, bitter, is slightly cold, enters liver, kidney channel, has strong liver kidney-nourishing, the effect of removing heat to brighten vision,Be mainly used in treating liver-kidney Yin deficiency, the head loses foster dizzy tinnitus, the symptoms such as yin asthenia generating intrinsic heat. Fruit of glossy privet energyPromote leucocyte, strengthen effect of immunologic function.
Eclipta: have another name called Eclipta prostrata, China ink grass, floods and droughts lotus, taste is sweet, sour, cold in nature, returns liver, kidney channel,Play not liver and kidney benefiting, the effect of cooling blood and hemostasis, for having a dizzy spell due to the deficiency of liver-yin and kidney-yin, blurring of vision,Soreness and weakness of waist and knees; Being suitable for the deficiency of Yin has hot person, is used for the treatment of the haematemesis of accumulated heat in stomach, the hemoptysis of heat impairing pulmonary collateralEtc. symptom, eclipta has staphylococcus aureus, typhoid bacillus, Song's Shigella flexneri, Pseudomonas aeruginosaInhibitory action, can obviously strengthen nospecific immunity and cellular immune function.
Raspberry: taste is sweet, sour, property is flat, returns liver, and kidney channel, has liver-kidney tonifying, controlling nocturnal emission with astringent drugs contracting urine,Effect of improving eyesight, cures mainly impotence and premature ejaculation, emission and spermatorrhea, and palace is cold infertile, rare clearly under band, and frequent micturition is lost and is drowned,The cards such as blurred vision is dark, poliosis.
Rhizoma pinellinae praeparata: taste is pungent, warm in nature, returns spleen, stomach, lung channel, has eliminating dampness and eliminating phlegm effect, cures mainly phlegmMany coughs, anemophlegmatic vertigo, the cards such as coma due to blocking of the respiratory system headache.
Moutan bark: bitter, pungent, cold nature, enters the heart, liver, kidney channel, has clearing heat and cooling blood, invigorates blood circulationThe effect of the loose stasis of blood, is mainly used in treating warm heat disease heat invading xuefen, sends out spot, tells nosebleed, pyreticosis later stage heatFu Yinfen heating, deficiency of Yin osteopyrexia and fever, amenorrhea due to stagnation of blood, dysmenorrhoea, carbuncle sore tumefacting virus, fall flutter the pain of injury,The cards such as rheumatic fever numbness.
Tribulus terrestris: be the fruit of zygophyllaceae Tribulus plant, taste is pungent, bitter, slightly warm in nature; Slightly poisonous, returnLiver Channel, has flat liver solution strongly fragrant, promoting blood circulation by removing wind, and improving eyesight, antipruritic effect, dizzy for having a headache, the chest side of bodyDistending pain, breast closes acute mastitis, hot eyes ocular, the cards such as rubella itch.
Catechu: bitter, puckery, cold nature, returns lung channel, has effect of hygroscopic regenerating tissue to heal wond, for burstingUlcer is not held back, eczema, and aphtha, falls cards such as flutterring the pain of injury, traumatism and bleeding.
Cogongrass rhizome: taste is sweet, cold in nature, enter lung, stomach, urinary bladder channel, there is the work of cooling blood and hemostasis, reducing fever and causing diuresisWith, being mainly used in lung stomach has haematemesis, the hemoptysis of accumulated heat; Damp invasion of lower energizer pents up the hematuria of bladder; Pyreticosis is tiredYearningly draw drink; Gastropyretic vomiting; The cards such as jaundice with damp-heat pathogen.
The bighead atractylodes rhizome: latin name atractylodismacrocephalaerhizoma, taste is sweet, bitter, warm in nature,Enter spleen, stomach warp, have tonifying spleen profit gas, eliminating dampness Li Shui, strengthening exterior and reducing sweat, the effect that fortune spleen is moisturized, mainBe used for ruffian due to the dysfunction of the spleen in transport, QI failing to transform into body fluid and have one's mind filled with and rush down, phlegm and retained fluid oedema; The heart of the deficiency of qi in middle-jiaoTired lazy speech, metrorrhagia and metrostaxis, proctoptosis with chronic dysentery; The cards such as solid in the playing of deficiency of the spleen causing weakness of QI, abnormal sweating spontaneous perspiration.
Selfheal: cold in nature, bitter, pungent, returns liver, gallbladder channel, have clear liver and improve vision, powder detoxifcationEffect, for red eye, swell pain, order pearl nyctalgia, has a headache dizzy, scrofula, goiter and tumor, swells and ache; GoitreGreatly, scrofula, the proliferation of mammary gland, the card such as hypertension, hyperglycaemia, high fat of blood and high blood are sticky.
Semen litchi: latin name SemenLitchi, warm in nature, sweet, the micro-hardship of taste, returns liver, kidney channel, hasPromoting QI to circulate and dispersing the agglomeration of the pathogens, effect of cold-dispelling pain-relieving, cures mainly cold hernia stomachache, the cards such as testiclar gall.
Kelp: latin name EckloniaeThallus, cold in nature, taste is salty, returns liver, stomach, kidney channel, toolThere is softening and resolving hard mass, dissolving phlegm, effect of Li Shui, cures mainly goiter and tumor, scrofula, testiclar gall, phlegm and retained fluid waterThe swollen card that waits.
Play both sides of the street: bitter, property is flat, returns liver, and kidney channel, has dispelling, collateral-activating, effect that Li Shui stimulates the menstrual flow,For joint pain, numbness contracture, oedema turgor, breast is few through the card such as closing.
Betel nut: bitter, pungent, warm in nature, return stomach, large intestine channel, there is desinsection, disappear long-pending, promoting the circulation of qi, Li Shui,Effect of preventing malaria, cures mainly abdominal pain due to enterositosis, stagnates and rushes down dysentery, tenesmus, oedema beriberi, and the cards such as malaria,Betel nut can promote stomach motion, the secretion that improves motilin and vasoactive intestinal peptide.
Radix Glycyrrhizae: taste is sweet, property is flat, returns 12 warps, has clearing heat and detoxicatingly, is in harmonious proportion the property of medicine, the work of expelling phlegm and arresting coughingWith, and can invigorating the spleen and in, relieving spasm to stop pain, is mainly used in weakness of the spleen and the stomach abdominal distension and anorexia, weak; Can be slowSeparate contraction pain in abdomen, relax the strong and toxicity of some drugs, alleviate medicine and do the poison of body is secondaryWith or to GI stimulation, by adding Radix Glycyrrhizae can play tonifying Qi neutralization, be in harmonious proportion the effect of each component.
Described Chinese medicine routinely technique add auxiliary material make tablet, capsule, granule, the water-bindered pill,Micropill, dispersing tablet, oral disnitegration tablet, pill or oral liquid, be preferably prepared into pill, described inAuxiliary material comprises solvent, disintegrant, flavouring, anticorrisive agent, colouring agent, adhesive, lubricant and matrixIn one or more.
The present invention also provides the preparation method of above-mentioned Chinese medicine, and it comprises:
The first step, takes the root of herbaceous peony, the radix paeoniae rubrathe, motherwort, FLOS MUME, the fruit of glossy privet, the China ink of above-mentioned weight portionDrought lotus, moutan bark, cogongrass rhizome, the bighead atractylodes rhizome, kelp, betel nut and licorice raw material medicine, mix powderThe broken meal that obtains, adding determining alcohol is 50%～75% ethanol water refluxing extraction three times, adds for the first time secondAlcohol amount is 8～12 times of meal weight, the 3～5h that refluxes, add for the second time amount of alcohol and be 6 of meal weight～8 times, the 2～3h that refluxes, adds amount of alcohol and is 3～5 times of meal weight for the third time, and the 1～2h that refluxes, closesAnd phegma, filter, make extract, extract is condensed into thick paste, dry, make the first extractionThing;
Second step, takes the remaining bulk drug of above-mentioned weight portion, mixes, and pulverizes to obtain meal, addsDecocting boils 2 times, for the first time amount of water be meal weight 10-15 doubly, decoct 3-5h, add water for the second timeThe 5-10 of amount meal weight doubly, decocts 1-3h; Merge decoction liquor, filter, filtrate is concentrated into temperature and is70 DEG C of clear cream that relative density is 1.10-1.12, add absolute ethyl alcohol to the concentration of ethanol in solution to be70%, leave standstill 24h, filter, make extract, extract is condensed into thick paste, dry, make theTwo extracts;
The 3rd step, mixes the first extract and the second extract, system machine for making water-bindered pills flashing pill,Then be placed in baking oven and dry to moisture content≤5wt% at 70～80 DEG C, obtain the water-bindered pill.
Below adopt embodiment to describe embodiments of the present invention in detail, whereby how the present invention is appliedTechnological means solves technical problem, and the implementation procedure of reaching technique effect can fully understand and real according to thisExecute.
Embodiment 1 water-bindered pill 1
Take root of herbaceous peony 25g, radix paeoniae rubrathe 20g, motherwort 30g, FLOS MUME 20g, fruit of glossy privet 30g, China ink droughtLotus 30g, moutan bark 20g, cogongrass rhizome 20g, bighead atractylodes rhizome 15g, kelp 5g, betel nut 10g and Radix Glycyrrhizae 20g,Mix, pulverize to obtain meal, adding determining alcohol is 75% ethanol water refluxing extraction three times, theOnce add amount of alcohol and be 10 times of meal weight, backflow 5h, adding for the second time amount of alcohol is 8 of meal weightDoubly, backflow 3h, adds amount of alcohol and is 5 times of meal weight for the third time, and backflow 12h, merges phegma,Filter, make extract, extract is condensed into thick paste, dry, make the first extract, take bavinRecklessly 30g, rascal 25g, dried orange peel 30g, rhizoma cyperi 10g, root tuber of aromatic turmeric 25g, radix rehmanniae recen 30g, red sage root 20g,Raspberry 5g, rhizoma pinellinae praeparata 10g, tribulus terrestris 10g, catechu 15g, selfheal 15g, semen litchi 10g,The 15g that plays both sides of the street, mixes, and pulverizes to obtain meal, boiling 2 times, and amount of water is thick for the first time12 times of grain weight amount, decoct 5h, 8 of amount of water meal weight times for the second time, decoct 2h; Merging is decoctedBoil liquid, filter, it is the clear cream that 70 DEG C of relative densities are 1.12 that filtrate is concentrated into temperature, adds absolute ethyl alcoholConcentration to ethanol in solution is 70%, leaves standstill 24h, filters, and makes extract, and extract is concentratedBecome thick paste, dry, make the second extract, the first extract and the second extract are mixed,System machine for making water-bindered pills flashing pill, is then placed in baking oven and dries to moisture content≤5wt% at 70～80 DEG C,Obtain the water-bindered pill.
Embodiment 2 water-bindered pills 2
Take root of herbaceous peony 20g, radix paeoniae rubrathe 20g, motherwort 30g, FLOS MUME 15g, fruit of glossy privet 25g, China ink droughtLotus 30g, moutan bark 15g, cogongrass rhizome 15g, bighead atractylodes rhizome 15g, kelp 5g, betel nut 10g and Radix Glycyrrhizae 15g,Mix, pulverize to obtain meal, adding determining alcohol is 75% ethanol water refluxing extraction three times, theOnce add amount of alcohol and be 10 times of meal weight, backflow 5h, adding for the second time amount of alcohol is 8 of meal weightDoubly, backflow 3h, adds amount of alcohol and is 5 times of meal weight for the third time, and backflow 12h, merges phegma,Filter, make extract, extract is condensed into thick paste, dry, make the first extract, take bavinRecklessly 30g, rascal 25g, dried orange peel 30g, rhizoma cyperi 10g, root tuber of aromatic turmeric 20g, radix rehmanniae recen 30g, red sage root 15g,Raspberry 5g, rhizoma pinellinae praeparata 10g, tribulus terrestris 10g, catechu 15g, selfheal 15g, semen litchi 10g,The 15g that plays both sides of the street, mixes, and pulverizes to obtain meal, boiling 2 times, and amount of water is thick for the first time12 times of grain weight amount, decoct 5h, 8 of amount of water meal weight times for the second time, decoct 2h; Merging is decoctedBoil liquid, filter, it is the clear cream that 70 DEG C of relative densities are 1.12 that filtrate is concentrated into temperature, adds absolute ethyl alcoholConcentration to ethanol in solution is 70%, leaves standstill 24h, filters, and makes extract, and extract is concentratedBecome thick paste, dry, make the second extract, the first extract and the second extract are mixed,System machine for making water-bindered pills flashing pill, is then placed in baking oven and dries to moisture content≤5wt% at 70～80 DEG C,Obtain the water-bindered pill.
Embodiment 3 water-bindered pills 3
Take root of herbaceous peony 25g, radix paeoniae rubrathe 25g, motherwort 35g, FLOS MUME 20g, fruit of glossy privet 30g, China ink droughtLotus 35g, moutan bark 20g, cogongrass rhizome 20g, bighead atractylodes rhizome 20g, kelp 10g, betel nut 15g and Radix Glycyrrhizae 20g,Mix, pulverize to obtain meal, adding determining alcohol is 75% ethanol water refluxing extraction three times, theOnce add amount of alcohol and be 10 times of meal weight, backflow 5h, adding for the second time amount of alcohol is 8 of meal weightDoubly, backflow 3h, adds amount of alcohol and is 5 times of meal weight for the third time, and backflow 12h, merges phegma,Filter, make extract, extract is condensed into thick paste, dry, make the first extract, take bavinRecklessly 35g, rascal 30g, dried orange peel 35g, rhizoma cyperi 15g, root tuber of aromatic turmeric 25g, radix rehmanniae recen 35g, red sage root 20g,Raspberry 10g, rhizoma pinellinae praeparata 15g, tribulus terrestris 15g, catechu 20g, selfheal 20g, semen litchi 15g,The 20g that plays both sides of the street, mixes, and pulverizes to obtain meal, boiling 2 times, and amount of water is thick for the first time12 times of grain weight amount, decoct 5h, 8 of amount of water meal weight times for the second time, decoct 2h; Merging is decoctedBoil liquid, filter, it is the clear cream that 70 DEG C of relative densities are 1.12 that filtrate is concentrated into temperature, adds absolute ethyl alcoholConcentration to ethanol in solution is 70%, leaves standstill 24h, filters, and makes extract, and extract is concentratedBecome thick paste, dry, make the second extract, the first extract and the second extract are mixed,System machine for making water-bindered pills flashing pill, is then placed in baking oven and dries to moisture content≤5wt% at 70～80 DEG C,Obtain the water-bindered pill.
Embodiment 4 drug toxicology tests
Anxious toxicity detects
Animal used as test: SPF level, kunming mice, 40,20 ± 2g, male and female half and half, by the Shandong traditional Chinese medical scienceMedicine university zoopery center provides, animal quality certification SCXK (Shandong) 2014-0140.
Tested medicine
Experimental group: the water-bindered pill 1 prepared by the embodiment of the present invention 1, be made into the solution of crude drug content 1.85g/ml,4 DEG C save backup.
Control group: gavage physiological saline, all the other conditions are with medicine group of the present invention.
Experimental technique
Grouping: get SPF level, 40 of kunming mices, male and female half and half, raise the base in Shandong Chinese medicine universityPlinth department of medial science, adaptability is raised one week. Pressing table of random numbers method, mouse is divided into 2 groups, is respectively contrastOrganize 20,20 of experimental group, male and female half and half, sub-cage rearing.
Medication
Before experiment, respectively organize mouse fasting and can't help water 12h, control group gavage distilled water 0.2ml/20g body weight,3 times/day, experimental group, the water-bindered pill 1 prepared by the gavage embodiment of the present invention 1,0.2ml/20g body weight, 3 times/Day, dosing interval 4h. Successive administration 7 days, drug withdrawal is observed 3 days.
Observation index
Ordinary circumstance: observe during administration and drug withdrawal viewing duration, respectively organize the ordinary circumstance of mouse, as sent outEducate situation (body temperature, body weight, heart rate), fur situation, the state of mind, each natural hole situation, autonomousActive situation.
Internal organs check and physics and chemistry detects: according to requirement of experiment, occur animal dead during administration, separate immediatelyCut open, observe each internal organs situation, peel off each internal organs, weigh, and calculate organ index, heart extracting blood physics and chemistryDetect; As without dead, according to requirement of experiment, after the observation period, give 10% chloral hydrate anesthesia, beatOpen abdominal cavity, observe each internal organs situation, abdominal aortic blood is put to death, and does physics and chemistry and detects, and peels off each internal organs,Weigh, and calculate organ index.
Result
Experimental session, without dead mouse, carries out coherent detection according to EE.
Ordinary circumstance: during administration and drug withdrawal viewing duration, respectively organize mouse at the basic body such as body weight, body temperatureLevy, Non Apparent Abnormality, two groups of comparisons, no difference of science of statistics, outward appearance is normal, without deformity, fur color and lusterNormally, the state of mind is good, and each natural hole is clean, and without abnormal secretion, autonomic activities is normal, is as good asChang Hangwei.
Internal organs check and physics and chemistry detects: according to requirement of experiment, after the observation period, give 10% chloraldurate fiber cropsLiquor-saturated, abdominal aortic blood is put to death, and opens abdominal cavity, observes each internal organs situation, respectively organizes mice organs and is just arrangingOften, without adhesion, without hemorrhage, the blood of getting does physics and chemistry and detects, and respectively organizes Mouse Blood conventional without abnormal, liver function,Kidney merit checks without abnormal, peels off each internal organs, weighs, and calculates organ index, and Epidemiological Analysis by statistics, without systemMeter is learned difference, and compare two groups of same periods, statistics indifference.
Conclusion
By acute toxicity test in mice, mouse dosage is 55g/kg/d, is converted into normal adult administrationAmount 55g/kg/d (mouse and 60kg health adult conversion coefficient are 10.0) is normal adult administration every day137.5 times (normal 60kg adult Chinese medicine intake is 4g/kg/d) of amount, it is generally acknowledged, animal is realIn testing, administration is behaved more than 100 times, and without obvious toxic-side effects, can think that medicine is safe.Can confirm by this experiment, Chinese kmedicine bolus of the present invention in acute toxicity test, without acute toxic reaction,Without delayed toxicity, substantially can think safe, therefore clinical use is safe.
Long term toxicity test
Experiment material
Long-term toxicological experiment carries out on acute toxicological experiment basis, identical with acute toxicity test.
Experimental drug
Experimental group: the water-bindered pill 1 prepared by the embodiment of the present invention 1, water-soluble solution be made into crude drug content 1.15g/ml,The solution of 0.85g/ml, 0.55g/ml, 4 DEG C save backup.
Control group: gavage physiological saline, all the other conditions are with medicine group of the present invention.
Experimental technique
Grouping: get SPF level, 40 of kunming mices, male and female half and half, raise in Shandong Traditional Chinese Medicine UniversityZoopery center, adaptability is raised one week. Press table of random numbers method, mouse is divided into 2 groups, be respectively10 of control groups, 10 of high dose group, 10 of middle dosage groups, 10 of low dose group, male and female half and half,Sub-cage rearing.
Medication
Before experiment, respectively organize mouse fasting and can't help water 12h, control group gavage distilled water 0.2ml/20g body weight,2 times/day, high, medium and low dosage group, the gavage embodiment of the present invention 1 is prepared into that the water-bindered pill 1 is made into respectivelyAqueous solution 1.0g/ml (crude drug concentration), 0.75g/ml (crude drug concentration), 0.5g/ml (crude drug concentration), 0.2ml/20gBody weight, 2 times/day, dosing interval 6h. Successive administration 14 days, drug withdrawal is observed 7 days.
Observation index
Observe on basis at acute toxicity test, after observation drug withdrawal, the mouse indices of 7d changes.
Result
Experimental session, without dead mouse, carries out coherent detection according to EE.
Ordinary circumstance: during administration and drug withdrawal viewing duration, respectively organize mouse at the basic body such as body weight, body temperatureLevy, Non Apparent Abnormality, two groups of comparisons, no difference of science of statistics, outward appearance is normal, without deformity, fur color and lusterNormally, the state of mind is good, and each natural hole is clean, and without abnormal secretion, autonomic activities is normal, is as good asChang Hangwei.
Internal organs check and physics and chemistry detects: according to requirement of experiment, after the observation period, give 10% chloraldurate fiber cropsLiquor-saturated, abdominal aortic blood is put to death, and opens abdominal cavity, observes each internal organs situation, respectively organizes mice organs and is just arrangingOften, without adhesion, without hemorrhage, the blood of getting does physics and chemistry and detects, and respectively organizes Mouse Blood conventional without abnormal, liver function,Kidney merit checks without abnormal, peels off each internal organs, weighs, and calculates organ index, and Epidemiological Analysis by statistics, without systemMeter is learned difference, and compare two groups of same periods, statistics indifference.
Conclusion
By mouse long term toxicity test, mouse dosage is 23g/kg/d, 17.25g/kg/d, 11.5g/kg/d,Being converted into normal adult dosage 230g/kg/d, 172.5g/kg/d, 115g/kg/d, is normal adult every day57.5 times, 43.125 times, 28.75 times of dosage, can confirm Chinese medicine of the present invention by this experimentIn long term toxicity test, without cumulative toxicity, without delayed toxicity, substantially can think safe, thereforeClinical use is safe.
Embodiment 5 clinical researches
Case selection
Diagnostic criteria
Formulate with reference to " guideline of clinical investigations of new Chinese medicine treatment premenstrual tension syndrome ".
Syndrome diagnostic criterion
Formulate with reference to People's Republic of China's traditional Chinese medical science professional standard " traditional Chinese medical science disease Standardization of diagnosis and curative effect ".
Severity Scaling standard
Formulate with reference to " new Chinese medicine treatment premenstrual tension syndrome guideline of clinical investigations ".
Slight: micro-have a headache, dizziness, breast is done swollen, or slightly feels pain, in a disturbed state of mind, and face is impractical,Work and study are as usual.
Moderate: dizziness headache, breast is done swollen, and vexed insomnia is nervous or melancholy, limb edema,Still can work and study.
Severe: severe headache is unbearably, dizzy, blurring of vision, palpitaition egersis, swollen breasts, can not touchClothing, face four limbs or whole body swelling, finger submerged while pressing, or body weight increase by 1～2kg, can not adhere to work andStudy.
Include in and exclusion standard
Meet above-mentioned disease diagnostic criteria, the age is at 18～40 years old, holds disease person under the arm and includes in without obviously merging with doubleObserve case. Meet inclusive criteria but belong to gestation or women breast-feeding their children, be associated with cardiovascular, kidney andThe serious primary disease such as hemopoietic system, mental patient get rid of.
Test method
Grouping and methods for the treatment of
Patient's 303 examples are observed in this test altogether, adopt random packet, Double-blind double-dummy contrast method, are divided intoTwo groups, wherein treatment group 152 examples (giving the water-bindered pill 1 of preparing with the embodiment of the present invention 1), control group 151Example (give and JIAWEI XIAOYAOWAN, positive contrast medicine), grouping case age, the course of disease, the state of an illness, symptom,Basal body temperature, hormonal readiness are learned processing by statistics, difference that there are no significant, tool comparativity. All casesAll start to take from premenstrual 10d, 10d is 1 course for the treatment of, takes continuously 2 menstrual cycles. To treatmentWhether rear clinical recovery, effective and effective patient, follow up a case by regular visits to 3 menstrual cycles, observe and recur.
Medicine
Treatment group: 1,30 tablet/time of the water-bindered pill (being equivalent to 9g Chinese medicine) prepared by the embodiment of the present invention 1,2Times/day, oral, warm water takes, and printed words are removed in external packing, are numbered 1.
Control group: add taste XIAOYAO WAN, 10g/ bag, 2 times/day, oral, warm water takes, purchased from TongrentangPharmacy, printed words are removed in external packing, are numbered 2.
Observation index
Curative effect observation
Before and after treatment, clinical symptoms, sign change; Period in a medicine menstrual cycle and MBV, look, qualitative changeChange; Examination of basal body temperature; Endocrine is measured; Weighing body weight.
Security observation blood, urine, feces routine: treat the forward and backward routine test inspection of carrying out; The heart, liver,Kidney function test: treat forward and backward carry out electrocardiogram, liver function (ALT), renal function (Bun, Cr) inspection.
Curative effect determinate standard
Clinical recovery: clinical symptom disappearance, normal is measured in examination of basal body temperature or endocrine, treatmentAfter finishing, observe 3 menstrual cycles without recurrence, TCM symptom score reduces more than 90%.
Effective: cardinal symptom is clearly better, basal body temperature or endocrine are measured and are approached normally, and treatment finishes3 menstrual cycles of rear observation do not increase the weight of. TCM symptom score reduces more than 60%, less than 90%. Effective:Cardinal symptom is controlled, and degree alleviates to some extent, though treatment finishes rear section symptom repeatedly, and treatmentBefore alleviate to some extent. TCM symptom score reduces more than 30%, less than 59%.
Invalid: various clinical symptoms are without taking a turn for the better or increasing the weight of. TCM symptom score reduces less than 30%.
Statistical procedures
Grade classified data is relatively applied Ridit and is analyzed; Enumeration data application X2Inspection; Measurement data shouldCheck with t.
Result
Clinical efficacy
Each group patient clinical curative effect, in table 1, is treated after 2 menstrual cycles, and treatment group and control group are clinicalCurative effect comparison, analyzes through Ridit, and, there is significant differences P < 0.05, and the clinical efficacy for the treatment of group is aobviousWork is better than control group.
Table 1 liang group patient clinical curative effect comparison
Group N Recovery from illness Effective Effectively Invalid Total effective rate %
Treatment group 152 56 57 37 2* 98.68
Control group 151 44 55 43 9 94.04
With control group comparison,*P<0.05。
Follow up a case by regular visits to curative effect
Follow up a case by regular visits to 3 menstrual cycles, treatment group and control group are followed up a case by regular visits to curative effect comparison, analyze through Ridit, and P < 0.05,There is significant differences, illustrate that the curative effect of following up a case by regular visits to for the treatment of group is obviously better than control group, in table 2.
A table 2 liang group patient follows up a case by regular visits to curative effect comparison
With control group comparison,*P<0.05。
Security detects
After each group patient treatment, security detects index all in normal range (NR), shows that curative and contrast medicine are equalSafe. Routine urinalysis, before treatment, treatment group has 10 routine mile abnormalities, the routine mile abnormality of control group 10,Mile abnormality patient all shows as urine albumen trace or has leucocyte. After treatment, treatment group and control group respectively have4 routine patients recover normal. Before ALT treatment, treatment group has 1 routine patient slightly to raise, and is 59u/L, controlsAfter treating, recover normal. Before electrocardiogram treatment, the routine patient for the treatment of group 1 is complete right bundle branch block, controlsAfter treatment without significant change. Prompting curative and contrast medicine may have certain adjustment to do to routine urinalysis mile abnormalityWith, definite situation waits to observe.
Discuss
Premenstrual tension syndrome (PMS) is concerns of doing of current medical circle, mainly because of its incidence of diseaseHeight, impact is large, without specific medicament. Recently statistics shows, external European and American developed countries PMS showsTrouble rate is the women of child-bearing age's 30%～95%. In treatment, be still symptomatic treatment, take progestational hormone, calming soporificMedicine and vitamin etc., total treatment time/most of women approximately need 2 years, even need individually to treat to climacteric.Chinese herb decoction treatment PMS has compared with clear superiority, but problem is apparent, lacks system-based research,The definite curative effect of various treatment sides medicine cannot be evaluated. Clinical test results demonstration, treatment group comprehensive therapeutic effect is excellentIn control group, but statistical analysis is without significant difference, shows that this curative effect judgment criteria has higher confidence levelAnd repeatability.
The preparation water-bindered pill of the present invention at clinical efficacy, follow up a case by regular visits to the comparison of curative effect and the course of disease and Relation With Therapeutic EfficacyIn, its effect is all better than control group, and clinical efficacy has certain directive function, is applicable to clinical expansion.
Embodiment 6 animal experiment studies
Experiment material
Medicine and reagent
The water-bindered pill 1 prepared by embodiment 1; LC/MS level acetonitrile is purchased from J.T.Bak-er company(J.T.BakerChemicalCo., USA); HPLC level methyl alcohol purchased from Merck company (Darmstadt,Germany); Formic acid is purchased from Fluka company (Buchs, Switzerland).
Instrument: U.S. WatersAcquityUPLC Ultra Performance Liquid Chromatography instrument; The U.S.WatersQ-TOFPremier mass spectrograph; VOR-TEX-5 turbine mixer (its woods Bel instrument of Haimen, JiangsuDevice Manufacturing Co., Ltd); MIKRO22R table-type high-speed refrigerated centrifuge (LAB-WAYSCIENCE,Germany); ST-A digit pulse biostimulation instrument (by Jinan air force logistics assembling head factory).
Animal used as test
The healthy unpregnancy female rats of SPF level, weight 190～200g, SD kind, purchased from Shandong traditional Chinese medicineUniversity's Experimental Animal Center, the animal quality certification number: SCXK (Shandong) 2014-0015.
Experimental technique
Modeling and administration
Rat is determined the oestrous cycle by vaginal smear method, the rat modeling of PMS reversed syndrome of mepatic qi and evaluation method ginsengAccording to " rat simulation premenstrual tension syndrome reversed syndrome of mepatic qi and behavior change " method. According to vaginal smearResult, will, in 30 of metaoestrus rats, be divided at random 3 groups, 10 every group, be respectively rightAccording to group, model group, administration group. Administration group gavage gives the water-bindered pill 1 prepared by Chinese medicine embodiment 1 of the present invention,Be dissolved in and in water, be configured to the solution that crude drug concentration is 0.15g/ml, 1ml/100g weight, administration every day1 time, successive administration 5d.
Sample collection and preparation
Model group rat continued stimulus modeling 5d, the modeling of administration group rat successive administration 5d, normal group simultaneouslyRat is normally fed after 5d, and eye socket is got blood 2ml, leaves standstill, centrifugal, gets upper serum ,-80 DEG C of refrigeratorsFreezing. After freeze thawing, get 100 μ l serum, add 400 μ l methyl alcohol, vortex 5min, 13000r/min at 4 DEG CCentrifugal 15min, gets supernatant 400 μ l, adds ultra-pure water 400 μ l, vortex 2min, 13000r/min at 4 DEG CCentrifugal 15min, is placed in the sample introduction bottle of Waters standard configuration, preserves 4 DEG C of sample introduction analyses at-20 DEG C.
Analysis condition
Chromatographic condition
The chromatographic isolation employing Ac-quityBEHC18 of Waters company analytical column (100mm × 2.1mm,1.7 μ m, Waters, MA, USA), 25 DEG C of column temperatures, volume flow 0.4ml/min. Automatic sampler4 DEG C of Temperature Settings, each sample introduction 5 μ l, each sample repeats sample introduction 3 times. Mobile phase composition: A is mutually0.2% aqueous formic acid; B is pure acetonitrile mutually, adopts gradient mode elution samples, 0～8min,70％～95％B；8～12min，95％B。
The collection of mass spectrum condition mass spectrum adopts cation V model, and detected parameters is set to: capillary voltage3.2kV, taper hole voltage 35V, 350 DEG C of desolventizing temperature degree, 120 DEG C of ion source temperatures, desolventizing gasFlow 700L/h, taper hole throughput 40L/h, acquisition time scope 0～12min, sweep limitsM/z100～1100, each sweep time 0.1s, twice sweep 0.02s interval time, lock mass calibrationPattern DRE, carries out real-time accurate mass correction ([M+H] with LEnK+＝556.2771)。
Data processing
Data acquisition carries out chromatographic peak with the Markerlynx of Waters company software (Waters, MA, USA)Automatically identification and peak match. Again by data importing SIMCA-P12.0 (Umetrics, Umea, Sweden)Carry out principal component analysis (PCA), ginsenoside (PLS-DA) and quadrature alignment partiallyLittle square law-discriminant analysis (OPLS-DA). Adopt dunett analysis, F inspection and LSD analysis and investigation generationThank to group difference and carry out conspicuousness.
Result and discussion
Serum
Sample pretreatment is investigated because the object of metabolism group is to make every effort to all metabolism in biological specimen produceThing is analyzed, and whole process should retain and reflect the information of total metabolite as much as possible. SampleProcessing method should ensure to accomplish, without partially, to retain the information of maximum metabolins as far as possible as far as possible. For blood sampleProcessing, methyl alcohol, the acetonitrile effect except albumen has been investigated in this experiment, under equal proportion, methyl alcohol is except albumenEffect be better than acetonitrile. Investigate again the methyl alcohol that has contrasted different volumes ratio except the effect of albumen, find 4 timesThe methyl alcohol of amount removes the effect of albumen except albumen effect is better than 3 times of amount methyl alcohol. So adopt in this experimentSample processing method is the heavy protein method of methyl alcohol, and to add quantity of methyl alcohol be 4 times of serum amount, medium and small point of sampleSub-compound extracts completely, and albumen removal thoroughly, is conducive to chromatographic isolation and protection chromatographic column.
The optimization of analysis condition
This experiment is that the liquid chromatogram of carrying out under UPLC separates, and what it adopted is the chromatographic column of 1.7mFiller still keeps good separative efficiency under higher linear velocity, and saves analysis time, improves and dividesAnalyse flux; Consider the tolerance of mass spectrometer system to flow, adopt the volume flow of 0.40ml/min to expireFoot separation requirement also improves analysis throughput, can efflux directly be imported to mass spectrometer system without shunting simultaneously and enterRow detects, and considers the complexity of serum sample, has taked gradient elution. Mass spectrum condition optimizing, mainInvestigate in desolventizing throughput, temperature, mobile phase and helped ionised species etc. Finally determine chromatogramCondition, applies this condition and has obtained good analytical effect.
UPLC/TOF-MS Metabolic Fingerprinting spectral method is learned and is investigated
10 peaks choosing in rat blood serum Metabolic Fingerprinting spectrum carry out methodological study. Result shows, weMethod has good precision and reappearance (peak area RSD < 10%), can meet metabolism group researchRequirement.
PMS reversed syndrome of mepatic qi rat blood serum Difference of Metabolism is analyzed
For investigating the variation of PMS reversed syndrome of mepatic qi rat blood serum metabolism, first adopt unsupervised pattern to knowOther method PCA analyzes, can draw between control group, model group and administration group, distinguish not obvious,Model explanation 38.2% initial data. For this reason, introduced and had the mode identification method of supervision numberAccording to processing. Between each group, substantially obtained separation, wherein 40.4% variable is used as for moulding modelMain component, 98.6% sample meets Model checking.
Orthogonal Signal Correction Analyze technology (OSC) can filter the variable information that judges orthogonal (uncorrelated) with classification,Only retain and judge relevant variable with classification, thereby make classification discriminant analysis can concentrate on these and classificationDifferentiate on relevant variable, improved the accuracy of differentiating. This research application OPLS-DA analyzes,Find can realize completely and separating between each group, and in each group, sample gathering ground is more compact.
The above results shows, the endogenous metabolism thing of rat blood serum and normally right after the modeling of PMS reversed syndrome of mepatic qiAccording to group, significant change has occurred, after the administration of administration group, medicine has also affected the interior generation of body of PMS reversed syndrome of mepatic qi ratThank.
The qualification of biomarker
Biomarker can characterize the difference of organism metabolism dactylogram. According to variable in multi-variate statistical analysisMagnitude of load be the common method of finding biomarker in metabolism group. In PLS-DA model,The larger contribution to grouping of VIP (VariableImportanceintheProjection) value is also larger, adoptsDunett analyzes, F checks and LSD analyzes, and examination goes out the change between group with significant difference (P < 0.05)Compound is as potential biomarker. Again in conjunction with mass spectrum isotope matching result and HMDB metabolin numberAccording to library searching, potential biomarker to be identified, result is as shown in table 3.
Quantized result is identified and respectively organized to table 3 biomarker
With model group t check analysis,*P＜0.05，**P＜0.01
The intervention effect of the water-bindered pill of the present invention to rat blood serum metabolism
As seen from Table 3, the biomarker identifying mainly comprise glucocorticoid, estrogen,Neurotransmitter, amino acid etc. When body is subject to various destructive stimuluses, as anoxic, wound, operation, famineStarve, pain, cold and nervous and anxious etc., in blood, corticotropin concentration is stoodIncrease, glucocorticoid is corresponding increasing also. Glucocorticoid can be given birth in neurosteroid hormone metabolismBecome cortisol and tetrahydro-deoxycorticosterone. Tetrahydro-deoxycorticosterone belongs to neurosteroid hormone, and with shouldSwash reaction relevant. Tetrahydrocortisol is the main metabolites of cortisol, in PMS reversed syndrome of mepatic qi rat serumIn clear, level is significantly and increases, and shows under modeling condition in rat body that glucocorticoid increases, with performanceGo out the symptom such as anxious consistent. Traditional theory think PMS be due to luteal phase progestational hormone not enough and femalely swashDue to element is too much, increasing research thinks that PMS pathogenesis and sex hormone, central neurotransmitter haveClose ties. With the related indication research of menstruation in, find that its potential source biomolecule learns mechanism and mainly concentrate onGonadal hormone, their metabolin and with the reciprocation of neurotransmitters, and nerve and Hormone system,As solid in the varies in blood, gamma aminobutyric acid (GABA), cholecystokinin and feritin-angiotensin-aldehydeKetone system etc. Research also finds that amino acid neurotransmitter focuses on as the generation development of glutamic acid and PMS hasWant associated, the eubolism of lysine depends on the adjusting of glutamic acid, at PMS reversed syndrome of mepatic qi rat blood serumMiddle discovery lysine level significantly rises, and the Glutamatergic increased activity in model group rat body is described,The activity of glutamic acid system is abnormal.
The water-bindered pill of the present invention can effectively improve the premenstruum (premenstrua)s such as premenstrual being irritable and getting angry easily, swollen breasts, headache, abdominal distensionTonic symptoms reversed syndrome of mepatic qi primary symptom. It is contrary that zoopery shows that the water-bindered pill of the present invention can obviously be adjusted PMS irritabilityThe fluctuation of estradiol and progesterone level in model of a syndrome rat, macaque behavior variation and peripheral blood, and can more thanAdjust the expression of PMS reversed syndrome of mepatic qi rat hypothalamus neurosteroid acceptor. Table 3 result also shows, thisOpen fire ball can significantly improve neurosteroid hormone tetrahydro-deoxycorticosterone and reduce monoamine neurotransmitterAdrenergic level, and raise estrogen level, show the multiple target effect feature of Chinese medicine compound prescription.
In addition, the water-bindered pill of the present invention can be lowered lysine level, reduces Glutamatergic activity. And reduction paddy ammoniaAcid can have anti-manic effect by medicine active or inhibition glutamate receptor Signal Transduction, points out thisThe regulating action of open fire ball to glutamic acid system. This research, from metabolism group angle, has been explained water of the present inventionThe therapeutic action of ball to premenstrual tension syndrome reversed syndrome of mepatic qi (rat model), has mainly reflected sugared skinThe biological cylinder metabolism-ures such as matter hormone, estrogen, neurotransmitter, amino acid regulate, for furtherExplaination pathogenesis and mechanism of drug action, clinical diagnosis and treatment provide foundation.
All above-mentioned these intellectual properties of primary enforcement, do not set the other forms of enforcement of restriction thisPlant new product and/or new method. Those skilled in the art will utilize this important information, foregoing amendment,To realize similar implementation status. But all modifications or transformation belong to reservation based on new product of the present inventionRight.
The above, be only preferred embodiment of the present invention, is not that the present invention is made to other formRestriction, any those skilled in the art may utilize the technology contents of above-mentioned announcement to be changedOr be modified as the equivalent embodiment of equivalent variations. But every technical solution of the present invention content that do not depart from, complies withAny simple modification, equivalent variations and the remodeling above embodiment done according to technical spirit of the present invention,Still belong to the protection domain of technical solution of the present invention.

Claims (8)

1. a Chinese medicine that is used for the treatment of perimenopausal syndrome, is characterized in that: bulk drug comprisesRadix bupleuri, the root of herbaceous peony, the radix paeoniae rubrathe, rascal, dried orange peel, rhizoma cyperi, motherwort, FLOS MUME, root tuber of aromatic turmeric, radix rehmanniae recen,The red sage root, the fruit of glossy privet, eclipta, raspberry, rhizoma pinellinae praeparata, moutan bark, tribulus terrestris, catechu, cogongrass rhizome,Selfheal, semen litchi, kelp, play both sides of the street, betel nut and Radix Glycyrrhizae.
2. the Chinese medicine that is used for the treatment of perimenopausal syndrome as claimed in claim 1, its feature existsIn: the weight portion of each bulk drug be respectively radix bupleuri 25 weight portion～35 weight portions, the root of herbaceous peony 20 weight portions～30 weight portions, the radix paeoniae rubrathe 15 weight portion～25 weight portions, rascal 20 weight portion～35 weight portions, dried orange peel25 weight portion～45 weight portions, rhizoma cyperi 10 weight portion～15 weight portions, motherwort 25 weight portion～35Weight portion, FLOS MUME 15 weight portion～25 weight portions, root tuber of aromatic turmeric 20 weight portion～30 weight portions, radix rehmanniae recen25 weight portion～35 weight portions, the red sage root 15 weight portion～25 weight portions, the fruit of glossy privet 25 weight portion～35Weight portion, eclipta 25 weight portion～35 weight portions, raspberry 5 weight portion～10 weight portions, method halfSummers 10 weight portion～15 weight portion, moutan bark 10 weight portion～25 weight portions, tribulus terrestris 10 weight portions～15 weight portions, catechu 15 weight portion～20 weight portions, cogongrass rhizome 15 weight portion～25 weight portions, whiteArt 15 weight portion～20 weight portions, selfheal 10 weight portion～20 weight portions, semen litchi 10 weight portions～15 weight portions, kelp 5 weight portion～10 weight portions, 10 weight portion～25 weight portions, betel nut play both sides of the street10 weight portion～15 weight portions and Radix Glycyrrhizae 10 weight portion～20 weight portions.
3. the Chinese medicine that is used for the treatment of perimenopausal syndrome as claimed in claim 1 or 2, its spyLevy and be: the weight portion of each bulk drug is respectively radix bupleuri 30 weight portion～35 weight portions, the root of herbaceous peony 20 weightPart～25 weight portions, the radix paeoniae rubrathe 20 weight portion～25 weight portions, rascal 25 weight portion～30 weight portions,Dried orange peel 30 weight portion～35 weight portions, rhizoma cyperi 10 weight portion～15 weight portions, motherwort 30 weight portions～35 weight portions, FLOS MUME 15 weight portion～20 weight portions, root tuber of aromatic turmeric 20 weight portion～25 weight portions, lifeGlutinous rehmannia 30 weight portion～35 weight portions, the red sage root 15 weight portion～20 weight portions, the fruit of glossy privet 25 weight portions～30 weight portions, eclipta 30 weight portion～35 weight portions, raspberry 5 weight portion～10 weight portions, methodThe tuber of pinellia 10 weight portion～15 weight portions, moutan bark 15 weight portion～20 weight portions, tribulus terrestris 10 weightPart～15 weight portions, catechu 15 weight portion～20 weight portions, cogongrass rhizome 15 weight portion～20 weight portions,The bighead atractylodes rhizome 15 weight portion～20 weight portions, selfheal 15 weight portion～20 weight portions, semen litchi 10 weightPart～15 weight portions, kelp 5 weight portion～10 weight portions, 15 weight portion～20 weight portions that play both sides of the street,Betel nut 10 weight portion～15 weight portions and Radix Glycyrrhizae 15 weight portion～20 weight portions.
4. the Chinese medicine that is used for the treatment of perimenopausal syndrome as described in claims 1 to 3, its spyLevy and be: the weight portion of each bulk drug is respectively radix bupleuri 30 weight portions, the root of herbaceous peony 25 weight portions, the radix paeoniae rubrathe 20Weight portion, rascal 25 weight portions, dried orange peel 30 weight portions, rhizoma cyperi 10 weight portions, motherwort 30 weightPart, FLOS MUME 20 weight portions, root tuber of aromatic turmeric 25 weight portions, radix rehmanniae recen 30 weight portions, the red sage root 20 weight portions,The fruit of glossy privet 30 weight portions, eclipta 30 weight portions, raspberry 5 weight portions, rhizoma pinellinae praeparata 10 weight portions,Moutan bark 20 weight portions, tribulus terrestris 10 weight portions, catechu 15 weight portions, cogongrass rhizome 20 weight portions,The bighead atractylodes rhizome 15 weight portions, selfheal 15 weight portions, semen litchi 10 weight portions, kelp 5 weight portions, Lu LuLogical 15 weight portions, betel nut 10 weight portions and Radix Glycyrrhizae 20 weight portions.
5. the Chinese medicine that is used for the treatment of perimenopausal syndrome as described in claim 1 to 4, its spyLevy and be: described Chinese medicine routinely technique adds auxiliary material to make tablet, capsule, granule, waterBall, micropill, dispersing tablet, oral disnitegration tablet or oral liquid.
6. the Chinese medicine that is used for the treatment of perimenopausal syndrome as described in claim 1 to 5, its spyLevy and be: described Chinese medicine is prepared into the water-bindered pill.
7. the Chinese medicine that is used for the treatment of perimenopausal syndrome as described in claim 1 to 6, its spyLevy and be: described auxiliary material comprise solvent, disintegrant, flavouring, anticorrisive agent, colouring agent, adhesive,One or more in lubricant and matrix.
8. the preparation method of Chinese medicine described in claim 1 to 7, is characterized in that, comprising:
The first step, takes the root of herbaceous peony, the radix paeoniae rubrathe, motherwort, FLOS MUME, the fruit of glossy privet, the China ink of above-mentioned weight portionDrought lotus, moutan bark, cogongrass rhizome, the bighead atractylodes rhizome, kelp, betel nut and licorice raw material medicine, mix powderThe broken meal that obtains, adding determining alcohol is 50%～75% ethanol water refluxing extraction three times, adds for the first time secondAlcohol amount is 8～12 times of meal weight, the 3～5h that refluxes, add for the second time amount of alcohol and be 6 of meal weight～8 times, the 2～3h that refluxes, adds amount of alcohol and is 3～5 times of meal weight for the third time, and the 1～2h that refluxes, closesAnd phegma, filter, make extract, extract is condensed into thick paste, dry, make the first extractionThing;
Second step, takes the remaining bulk drug of above-mentioned weight portion, mixes, and pulverizes to obtain meal, addsDecocting boils 2 times, for the first time amount of water be meal weight 10-15 doubly, decoct 3-5h, add water for the second timeThe 5-10 of amount meal weight doubly, decocts 1-3h; Merge decoction liquor, filter, filtrate is concentrated into temperature and is70 DEG C of clear cream that relative density is 1.10-1.12, add absolute ethyl alcohol to the concentration of ethanol in solution to be70%, leave standstill 24h, filter, make extract, extract is condensed into thick paste, dry, make theTwo extracts;
The 3rd step, mixes the first extract and the second extract, system machine for making water-bindered pills flashing pill,Then be placed in baking oven and dry to moisture content≤5wt% at 70～80 DEG C, obtain the water-bindered pill.
CN201610045365.5A 2016-01-22 2016-01-22 Traditional Chinese medicine for treating liver-qi stagnation type premenstrual tension syndrome Pending CN105582471A (en)

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PCT/CN2016/106720 WO2017124826A1 (en) 2016-01-22 2016-11-22 Traditional chinese medicinal product for treating liver qi stagnation type premenstrual tension and syndrome

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WO2017124826A1 (en) * 2016-01-22 2017-07-27 王平平 Traditional chinese medicinal product for treating liver qi stagnation type premenstrual tension and syndrome
CN114184704A (en) * 2021-12-13 2022-03-15 暨南大学 Construction method and application of UPLC fingerprint of Xiaoyao pills

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CN101129736A (en) * 2007-09-24 2008-02-27 北京艺信堂医药研究所 Traditional Chinese medicine composition for treating climacteric syndrome
CN103656470A (en) * 2012-09-08 2014-03-26 青岛信立德中药技术研究开发有限公司 Chinese medicinal composition for treating female climacteric syndrome

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WO2017124826A1 (en) * 2016-01-22 2017-07-27 王平平 Traditional chinese medicinal product for treating liver qi stagnation type premenstrual tension and syndrome
CN114184704A (en) * 2021-12-13 2022-03-15 暨南大学 Construction method and application of UPLC fingerprint of Xiaoyao pills
CN114184704B (en) * 2021-12-13 2023-08-29 暨南大学 Construction method and application of UPLC fingerprint of Xiaoyao pill

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