CN105267543A

CN105267543A - Chinese medical preparation for treating qi-stagnation and blood stasis type primary dysmenorrheal and chloasma

Info

Publication number: CN105267543A
Application number: CN201510821684.6A
Authority: CN
Inventors: 吴兴连
Original assignee: Qingdao Mairuite Medicine Technology Co Ltd
Current assignee: Qingdao Mairuite Medicine Technology Co Ltd
Priority date: 2015-11-23
Filing date: 2015-11-23
Publication date: 2016-01-27

Abstract

The invention belongs to the field of traditional Chinese medicine and discloses a Chinese medical preparation for treating qi-stagnation and blood stasis type primary dysmenorrheal and chloasma. The Chinese medical preparation is prepared from rhizoma cyperi, ligusticum wallichii, salviae miltiorrhizae, herba lycopi, caulis spatholobi, codonopsis convolvulacea, fructus lycii, rhizoma atractylodis macrocephalae, radix paeoniae alba, radix caulophylli, vervain and cortex albiziae. Through combination of the medicinal materials, aiming at the etiology and pathogenesis of qi-stagnation and blood stasis type primary dysmenorrheal and chloasma, the functions of soothing liver and regulating qi, promoting blood circulation to remove blood stasis, removing chloasma, regulating the chong and ren meridians, and relieving pains are realized through comprehensive communication, the multi-target, multi-link and multi-level comprehensive regulating effect is realized, side effect is mild, patient compliance is high, the medicine is easy to take, and recurrence rate is low.

Description

A kind of Chinese medicine preparation for the treatment of qi stagnation and blood stasis type primary dysmenorrhea companion chloasma

Technical field

The invention belongs to the field of Chinese medicines, be specifically related to a kind of qi stagnation and blood stasis type primary dysmenorrhea for the treatment of and accompany Chinese medicine preparation of chloasma and preparation method thereof.

Background technology

Before and after passing through or menstrual phase there is lower abdominal pain, falling inflation, with the soreness of waist or companion's pale complexion, dripping cold sweat, symptoms such as brothers are ice-cold, nausea and vomiting, so that affect orthobiosis and the symptom that works is called dysmenorrhea.Wherein genitals is called primary dysmenorrhea without organic disease person, does not produce women common with youth.Primary disease belongs to the traditional Chinese medical science " abdominal pain during menstruation " category.Dysmenorrhoea disease, because of multiterminal, is broadly divided into qi depression to blood stasis, dampness and heat stasis, deficient qi and blood, caused by liver and kidney deficiency, the pattern of syndrome such as cold blood stasis,

And chloasma is the pigmented dermatosis of common pigments betiding face, be common near eye socket, around volume Jia portion, muzzle, can join together, motherland's medical science is referred to as " dark class ", " liver class ", " dusty face ", the multiple women being born in anemia of pregnant woman or irregular menstruation of this disease, some patients can with other chronic diseases, say in a sense, chloasma is a kind of outward manifestation of inherent visceral dysfunction, some primary dysmenorrhea patient, simultaneously with facial area chloasma, has a strong impact on women and normally works and quality of life.Western medicine gives pain relieving, calmness, contraceptive and prostaglandin antagonists to the many employings of primary disease and gives the Western medicine such as vitamin C and vitamin E soft capsule Comprehensive Treatment simultaneously and alleviate, and side effect is comparatively large, and repeatability is comparatively large, treats thorny.

Chinese medicine is thought, the generation of menstruation be kidney-menses-punching appoint-uterine axis under the coordinative role of whole body internal organs, meridians, QI and blood, the result of letting out regularly is hidden in uterus.No matter be qi depression to blood stasis, cold coagulation, or deficient qi and blood, deficiency of both the liver and kidney, all can produce QI-blood circulation not smooth, Chong and Ren channel disorder, cause " stagnation of QI and blood may bring about pain " or " not Rong Ze pain ", wherein the stasis of blood is the key of primary disease pathogenesis.Formation and the dirty functional disorder of liver,spleen,kidney three of chloasma are in close relations, and feelings will is smooth clinically, causes stagnation of QI due to depression of the liver, heat resulting from stagnation of QI, fumigates in face, the cloudy blood and giving birth to of burning; Or Chong and Ren channel disorder, deficiency of the liver and kindey, discordance between water(the kidney)and fire(the heart), caused by hyperactivity of deficient fire; Or chronic disease, battalion defends and becomes estranged, and QI-blood circulation is not smooth, qi depression to blood stasis, becomes homeless to support and form in face; Or eating and drinking without temperance, be worried excessively, impairing the spleen and stomach, dysfunction of the spleen in transportation, damp and hot interior life, fumigate and cause a disease.Therefore many Traditional Chinese Medicine experts think that internal organs discord, feelings will, QI and blood, woman's Chong and Ren channel disorder are the basic reasons producing chloasma.

The Etiological pathogenesis that chloasma produces and dysmenorrhea have a lot of similarity, mainly deficiency of the liver and kindey and qi depression to blood stasis, theory of Chinese medical science thinks that complexion all has close relationship with internal organs qi and blood prosperity and decline from holding the withered change of profit, positive what is called " has Zhu Neibi shape in outer ", and Chinese medicine primary disease has unique advantage.

Summary of the invention

Inventor is based on theory of Chinese medical science, in conjunction with the cause of disease causing qi stagnation and blood stasis type primary dysmenorrhea to accompany chloasma, hammer away, meticulous compatibility, adopt modern crafts, provide a kind of Chinese medicine preparation for the treatment of qi stagnation and blood stasis type primary dysmenorrhea companion chloasma, it has the double effects of depressed liver-energy dispersing and QI regulating, blood circulation promoting and blood stasis dispelling speckle removing, Chong and Ren Meridians regulating pain relieving.

For achieving the above object, the present invention adopts following technical scheme: a kind of Chinese medicine preparation for the treatment of qi stagnation and blood stasis type primary dysmenorrhea companion chloasma, it is that medicinal raw material is made by Rhizoma Cyperi, Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Herba Lycopi, Caulis Spatholobi, Radix Codonopsis Convolvulaceae, Fructus Lycii, the Rhizoma Atractylodis Macrocephalae, the Radix Paeoniae Alba, Radix Caulophylli, Herba Verbenae, Cortex Albiziae.

In order to increase the coordinated effect between each raw material further, inventor is from raising curative effect of medication, the angle reducing side effect is set out, through screening Chinese medicine ingredients, optimize following technical scheme: a kind of Chinese medicine preparation for the treatment of qi stagnation and blood stasis type primary dysmenorrhea companion chloasma, it is by the medicinal raw material elaborate of following weight: Rhizoma Cyperi 10-18 part, Rhizoma Chuanxiong 5-15 part, Radix Salviae Miltiorrhizae 8-18 part, Herba Lycopi 10-15 part, Caulis Spatholobi 15-20 part, Radix Codonopsis Convolvulaceae 10-20 part, Fructus Lycii 10-20 part, Rhizoma Atractylodis Macrocephalae 10-15 part, Radix Paeoniae Alba 8-13 part, Radix Caulophylli 5-9 part, Herba Verbenae 3-10 part, Cortex Albiziae 6-16 part.

Further preferably, treat a Chinese medicine preparation for qi stagnation and blood stasis type primary dysmenorrhea companion chloasma, it is by the medicinal raw material elaborate of following weight: Rhizoma Cyperi 12-15 part, Rhizoma Chuanxiong 7-12 part, Radix Salviae Miltiorrhizae 10-15 part, Herba Lycopi 10-15 part, Caulis Spatholobi 15-20 part, Radix Codonopsis Convolvulaceae 15-20 part, Fructus Lycii 15-20 part, Rhizoma Atractylodis Macrocephalae 10-15 part, Radix Paeoniae Alba 9-13 part, Radix Caulophylli 5-8 part, Herba Verbenae 4-7 part, Cortex Albiziae 9-13 part.

Further preferably, treat a Chinese medicine preparation for qi stagnation and blood stasis type primary dysmenorrhea companion chloasma, it is by the medicinal raw material elaborate of following weight: Rhizoma Cyperi 13 parts, Rhizoma Chuanxiong 10 parts, Radix Salviae Miltiorrhizae 13 parts, Herba Lycopi 12 parts, Caulis Spatholobi 17 parts, Radix Codonopsis Convolvulaceae 15 parts, Fructus Lycii 20 parts, the Rhizoma Atractylodis Macrocephalae 12 parts, the Radix Paeoniae Alba 10 parts, Radix Caulophylli 6 parts, Herba Verbenae 5 parts, Cortex Albiziae 10 parts.

Inventor sums up and thinks that qi stagnation and blood stasis type primary dysmenorrhea companion chloasma and Liver and kidney relation are the closest, liver-blood deficiency, and irritability stasis all can cause blood not allow face-beautifying noodle and raw speckle, and The liver and the kidney have a common source, kidney water virtual loss, and face is lost and supported and a speckle; Sea of blood disorder of QI movement, uterus QI-blood circulation is not smooth, and menses run retardance, " stagnation of QI and blood may bring about pain ", and sore warp.Therefore inventor is according to the physiological characteristics of women, adopts depressed liver-energy dispersing and QI regulating, blood circulation promoting and blood stasis dispelling speckle removing, Chong and Ren Meridians regulating for ruling by law.Fang Zhong: the gas of Rhizoma Cyperi is flat and do not tremble with fear, and acrid in the mouth can fall apart, and micro-hardship can be fallen, micro-sweet energy and, promoting QI circulation for relieving depression, menstruction regulating and pain relieving, and skin can be reached outward; The pungent temperature of Rhizoma Chuanxiong, kind blood-activating and qi-promoting, wind-expelling pain-stopping, can on reach head top, the descending sea of blood, two medicine 5 dispersing liver and promoting blood circulations, promoting the circulation of QI to relieve pain power is by force monarch drug.Radix Salviae Miltiorrhizae bitter cold, is apt to into blood system, blood circulation promoting and blood stasis dispelling, inducing menstruation to relieve menalgia, and clear away heart-fire relieving restlessness, blood cooling and ecchymoses removing; Herba Lycopi's toil tepor, is also apt to away blood system, energy blood circulation promoting and blood stasis dispelling, the bitter sweet temperature of Caulis Spatholobi, and kind enriching blood is invigorated blood circulation, dredging collateral, and three medicine compatibilities can stimulate the menstrual flow in promoting the circulation of blood, and repercussive is by stagnant, and logical nine orifices, sharp GUAN-pulse, tune punching is appointed, and eliminating blood stasis to promote regeneration of blood is ministerial drug.Radix Codonopsis Convolvulaceae invigorating QI and blood, spleen invigorating, clearing away heat and promoting production of body fluid; Fructus Lycii profit and nourishing, doublely can bring down a fever, and specially in the kidney invigorating, lung moistening, promote the production of body fluid, QI invigorating, be Liver and kidney kidney-YIN being deficient; Two medicine 5 invigorating QI and bloods, moistening five ZANG-organs, anti-monarch drug pungent temperature consumption impairment of QI is cloudy; Rhizoma Atractylodis Macrocephalae invigorating the spleen and benefiting QI, dampness diuretic, spleen invigorating helps fortune essence of water and grain; Radix Paeoniae Alba picric acid is slightly cold, and being apt to hold back liver-yin is liver use, nourishing blood for regulating menstruation, pain relieving in slow, helps the clear and coherent blood vessels of monarch-minister drug; The arduous temperature of Radix Caulophylli, kind promoting blood circulation to remove blood stasis, menstruction regulating and pain relieving, Herba Verbenae hardship is cool, promoting blood circulation to remove blood stasis, promoting diuresis to remove toxic substance; Cortex Albiziae resolving stagnation for tranquilization, and blood detumescence, tool is adjuvant drug.All medicines close 5, can link up up and down, depressed liver-energy dispersing and QI regulating, blood circulation promoting and blood stasis dispelling speckle removing, Chong and Ren Meridians regulating pain relieving, play Mutiple Targets, too many levels, multi-level comprehensive regulation effect.

The pharmaceutical research present situation of the present invention's each medicinal raw material used is as follows:

Rhizoma Cyperi: [nature and flavor] pungent, micro-hardship, micro-sweet, flat.[return through] returns liver, spleen, tri-jiao channel.[function cures mainly] promoting QI circulation for relieving depression, menstruction regulating and pain relieving.For stagnation of QI due to depression of the liver, breast, the side of body, abdominal distention, dyspepsia, breast gastral cavity painful abdominal mass is vexed, and colic of cold type is suffered from abdominal pain, distending pain of the breast, menoxenia, amenorrhea dysmenorrhea.

Caulis Spatholobi: [nature and flavor] property is bitter, sweet, temperature.[return through] returns liver, kidney channel.[function cures mainly] enriches blood, and invigorates blood circulation, dredging collateral.For menoxenia, blood deficiency and yellow complexion, paralysis and numbness, rheumatic arthralgia relaxing muscles and tendons to promote blood circulation; Nourishing blood for regulating menstruation, supplementary Amplifications of the Compendium of Materia Medica carries it can cure numb hand and foot; Quadriplegia; Rheumatic arthralgia; Women has through uncomfortable; Dysmenorrhea.

Radix Salviae Miltiorrhizae: [nature and flavor] are bitter, are slightly cold.[return through] GUIXIN, Liver Channel.[function cures mainly] stasis-dispelling and pain-killing, promoting blood circulation to restore menstrual flow, clear away heart-fire relieving restlessness.For menoxenia, amenorrhea dysmenorrhea, lump in the abdomen, breast ventral spine pain, pyretic arthralgia pain, skin infection swells and ache, dysphoria and insomnia; Hepatosplenomegaly, angina pectoris.

Rhizoma Chuanxiong: [nature and flavor] are pungent, temperature.[return through] returns liver, gallbladder, pericardium channel.[function cures mainly] blood-activating and qi-promoting, wind-expelling pain-stopping.For menoxenia, amenorrhea dysmenorrhea, lump in the abdomen is suffered from abdominal pain, the twinge of the breast side of body, tumbling and swelling, headache, rheumatic arthralgia.

Radix Caulophylli: [nature and flavor] are pungent; Bitter; Warm in nature.[return through] liver; Stomach warp.[function cures mainly] promoting blood circulation to remove blood stasis; Expelling wind and removing dampness; Promoting the circulation of QI to relieve pain.Main menoxenia; Dysmenorrhea; Puerperal abdominal pain due to blood stasis; The cold pain of gastral cavity abdomen; Traumatic injury, rheumatic arthralgia.

Herba Verbenae: [nature and flavor] are bitter, cool.[return through] returns liver, spleen channel.[function cures mainly] promoting blood circulation to remove blood stasis, preventing the attack (or recurrence) of malaria, removing toxic substances, inducing diuresis to remove edema.For lump in the abdomen, amenorrhea dysmenorrhea, malaria, sore throat, carbuncle, edema, pyretic stranguria.

Herba Lycopi: [nature and flavor] are bitter, pungent, tepor.[return through] returns liver, spleen channel.[function cures mainly] blood circulation promoting and blood stasis dispelling, line water detumescence.For menoxenia, amenorrhea, dysmenorrhea, postnatal blood stasis is suffered from abdominal pain, edema." Japan hanako materia medica ": logical nine orifices, sharp GUAN-pulse, nourish blood gas, broken stagnated blood, eliminating mass abdominal mass, antenatal puerperal all kinds of diseases and ailments, logical small intestinal, granulation promoting of putting on flesh, disappears and flutters damage blood stasis, and control serious epistaxis and spit blood, wind syndrome of head ophthalmalgia, married woman's labor is thin, husband's yellowish complexion.

Radix Codonopsis Convolvulaceae: [nature and flavor] sweet, micro-hardship, puckery, micro-cool.[function cures mainly] invigorating QI and blood, spleen invigorating, replenishing body fluid and clearing away heat pathogen.For flu, cough, tonsillitis, chest pain, inappetence, malnutrition.

Fructus Lycii: [nature and flavor] are sweet is flat.[return through] returns liver, kidney channel.[function cures mainly] nourishing the liver and kidney, replenishing vital essence to improve eyesight.For asthenia damage of essence, soreness of waist and knee joint, vertigo and tinnitus, interior-heat is quenched one's thirst, blood deficiency and yellow complexion, and blurred vision is failed to understand.

The Rhizoma Atractylodis Macrocephalae: [nature and flavor] are bitter, sweet, temperature.[return through] returns spleen, stomach warp.[function cures mainly] invigorating the spleen and benefiting QI, dampness diuretic, hidroschesis, antiabortive.For insufficiency of the spleen lack of appetite, abdominal distention is had loose bowels, phlegm retention vertigo and palpitation, edema, spontaneous perspiration, frequent fetal movement.Rhizoma Atractylodis Macrocephalae spleen invigorating, stomach function regulating, antiabortive.For insufficiency of the spleen lack of appetite, loose stool of having loose bowels, frequent fetal movement.

The Radix Paeoniae Alba: [nature and flavor] are bitter, sour, are slightly cold.[return through] returns liver, spleen channel.The pain relieving of [function cures mainly] suppressing the hyperactive liver, nourishing blood for regulating menstruation, astringing YIN to stop sweating.Dizzy for having a headache, hypochondriac pain, stomachache, limb pain twin, blood deficiency and yellow complexion, menoxenia, spontaneous perspiration, night sweat.

Cortex Albiziae: [nature and flavor] are sweet, flat.[return through] GUIXIN, liver, lung meridian.[function cures mainly] resolving stagnation for tranquilization, promoting blood circulation and detumescence.For irritability, melancholy insomnia, lung abscess skin ulcer swells, and falls and flutters the pain of injury.

In order to express Chinese medicine preparation of the present invention better, Chinese medicine preparation of the present invention is active component by Rhizoma Cyperi, Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Radix Caulophylli, Herba Lycopi, Caulis Spatholobi, Radix Codonopsis Convolvulaceae, Fructus Lycii, the Rhizoma Atractylodis Macrocephalae, the Radix Paeoniae Alba, Herba Verbenae, Cortex Albiziae or its water or its extractive with organic solvent, adds medicine acceptable carrier and be prepared from.

Chinese medicine preparation of the present invention can be any pharmaceutically useful dosage form, and these dosage forms comprise: tablet, sugar coated tablet, film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, suck agent, granule, electuary, pill, powder, unguentum, sublimed preparation, suspensoid, powder, solution, injection, suppository, ointment, plaster, cream, spray, drop, patch.Preparation of the present invention, preferably peroral dosage form, as: soft capsule, capsule, tablet, oral liquid, granule, pill, powder, sublimed preparation, unguentum, most preferably Chinese medicine preparation preparation of the present invention is preferably tablet, capsule or granule.

Chinese medicine preparation of the present invention, applicable medicine acceptable carrier is optionally added when being prepared into medicament, described medicine acceptable carrier is selected from: mannitol, sorbitol, sodium pyrosulfite, sodium sulfite, sodium thiosulfate, cysteine hydrochloride, TGA, methionine, vitamin C, EDETATE SODIUM, Ethylenediaminetetraacetic Acid Calcium Salt, the alkali-metal carbonate of monovalence, acetate, phosphate or its aqueous solution, hydrochloric acid, acetic acid, sulphuric acid, phosphoric acid, aminoacid, sodium chloride, potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, mannitol, silicon derivative, cellulose and its derivates, alginate, gelatin, polyvinylpyrrolidone, glycerol, POLYSORBATE 80, agar, calcium carbonate, calcium bicarbonate, surfactant, Polyethylene Glycol, cyclodextrin, beta-schardinger dextrin-, phospholipid material, Kaolin, Pulvis Talci, calcium stearate, magnesium stearate etc.

The present inventor also finds under study for action, by optimized fabrication method, and can when remaining valid medicine, remove impurity or the part without drug effect, reduce impurity to the interference of therapeutic effect, make this Chinese medicine preparation more effective, and reduce the consumption of medicine thus.Therefore, present invention also offers a kind of method preparing the Chinese medicine preparation for the treatment of qi stagnation and blood stasis type primary dysmenorrhea companion chloasma, the method comprises the following steps:

(1) Rhizoma Cyperi, Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Radix Caulophylli, Herba Lycopi, adds 2-10 times amount 70-95% ethanol, reflux, extract, twice, each 1-3 hour, filters, merges twice filtrate, and decompression recycling ethanol, to without alcohol taste, makes clear paste for subsequent use;

(2) filtering residue after Rhizoma Cyperi, Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Radix Caulophylli, Herba Lycopi's ethanol extraction and Caulis Spatholobi, Radix Codonopsis Convolvulaceae, Fructus Lycii, the Rhizoma Atractylodis Macrocephalae, the Radix Paeoniae Alba, Herba Verbenae, Cortex Albiziae are merged, add 2-10 times of water gaging, decoct extraction 3 times, each 1-3 hour, merging filtrate, filters, is concentrated into relative density 1.20 (60 DEG C of surveys), be placed to room temperature, adding ethanol makes alcohol content reach 65%, stirs evenly ,-5-0 DEG C of cold preservation 12 hours, filter, decompression filtrate recycling ethanol, to without alcohol taste, merges with above-mentioned clear paste, mix homogeneously, drying under reduced pressure, to dry, obtains active constituents of medicine; This composition is independent or mix with medicine acceptable carrier, makes Chinese medicine preparation of the present invention according to galenic pharmacy routine techniques.

Preparation of the present invention is in use according to the situation determination usage and dosage of patient.Preparation of the present invention according to the situation determination usage and dosage of patient, can take 1-3 time in use every day, each 1-20 agent, as: 1-20 bag or grain or sheet.

Catch Disease Essence to carry out for treatment, so-called " have is that card is with being medicine ", thus ensure that good clinical efficacy.The feature of menstruation when inventor passes through according to time of pain, character combining, the Syndrome Differentiation of Constitution of patient treats, and further illustrates beneficial effect of the present invention by clinical observation test, and details are as follows:

1 data and method

1.1 physical data: carry out qi stagnation and blood stasis type primary dysmenorrhea companion patient with chloasma 124 example that my institute accepts for medical treatment during being chosen in March ,-2014 in January, 2013, the course of disease 3 months ~ 12 years, pain time continues 2h ~ 5d, dysmenorrhea with premenstrual 1 ~ 2d and menstrual period common compared with severe one.Patient is divided into two groups at random, treatment group 64 example, 16 years old ~ 35 years old age, 16 years old ~ 25 years old 37 example, 26 years old ~ 30 years old 17 example, more than 31 years old 10 example, wherein, unmarried 42 example, the married 22 example; The course of disease 3 months ~ 12 years.Matched group 60 example, 16 years old ~ 34 years old age, 16 years old ~ 25 years old 36 example, 26 years old ~ 30 years old 16 example, more than 31 years old 8 example, wherein, unmarried 41 example, the married 19 example; The course of disease 5 months ~ 10 years.Two groups of patients there was no significant difference (P > 0.05) in the physical data such as size and color intensity of age, the course of disease, pain time, pain degree and mottle, has comparability.

1.2 diagnostic criterias: " diagnosis basis of disease of tcm Standardization of diagnosis and curative effect-dysmenorrhea " that " clinical diagnosis of chloasma and criterion of therapeutical effect " (2003 revised draft) formulated with reference to Dermatology Professional Committee of CAIM (Chinese Association Of Integrative Medicine) pigment disease group and State Administration of Traditional Chinese Medicine promulgate.

Inclusion criteria: meet chloasma Western medicine diagnose, primary dysmenorrhea qi stagnation and blood stasis type tcm diagnosis, age at 16 years old ~ 35 years old.Exclusion standard: get rid of gestation, the chloasma that hysteromyoma, freckle, Addison's disease, all kinds of hepatitis, thyroid disease, malignant tumor, contraceptive cause and can not adhering to is taken medicine.

1.3 Therapeutic Method:

Treatment group: capsule prepared by the embodiment of the present invention 1, starts to take at premenstrual 6-7 days, until after menstrual onset the 3rd day, once take 2-4 grain, one day 2 times, continuous use 3 menstrual cycle are a course for the treatment of.2 courses for the treatment of judge curative effect.

Matched group: oral Rhizoma Corydalis relieves the pain sheet, starts to take at premenstrual 6-7 days, until after menstrual onset the 3rd day, once takes 4-6 sheet, within one day, takes 3 times; Add VITAMIN C TABLET 200mg, vitamin E soft capsule 100mg equal every day three times, 3 menstrual cycle were 1 course for the treatment of simultaneously.2 courses for the treatment of judge curative effect.

1.4 curative effect determinate standards: about the criterion of therapeutical effect of dysmenorrhea and with reference to the criterion of therapeutical effect about chloasma in " clinical diagnosis of chloasma and criterion of therapeutical effect " (2003 revised draft) of Dermatology Professional Committee of CAIM (Chinese Association Of Integrative Medicine) pigment disease group formulation in " Chinese medical disease Standardization of diagnosis and curative effect " that reference State Administration of Traditional Chinese Medicine promulgates.Cure: pain disappearance, the improvement and chloasma disappears that continuous 3 menstrual cycle have no recurrence: pain relief or disappearance, chloasma disappears or area minimizing is greater than 50%, but can not maintain more than 3 months.Do not heal: pain has no improvement, and chloasma has no and goes down or increase the weight of on the contrary.

1.5 statistical methods: adopt SPSS16.0 statistical software to calculate.Each numerical value with represent, measurement data adopts t inspection, and enumeration data adopts χ ²inspection, with P < 0.05 for difference has statistical significance.

2 results

2.1 liang of group therapeutic effect compare: after two courses for the treatment of, and treatment group cures 45 examples, effective 17 examples, invalid 2 examples, total effective rate 96.88%; Matched group cures 18 examples, effective 23 examples, invalid 19 examples, total effective rate 68.33%, and treatment group total effective rate is higher than matched group, and difference has statistical significance (P < 0.05); More also there were significant differences (P < 0.05) for two groups of cure rates.Concrete outcome is in table 1.

A table 1 liang group therapeutic effect compares

Group	Number	Cure	Effective	Invalid	Total effective rate
						Treatment group	64	45(70.31％)	17(26.56％)	2	96.88％
Matched group	60	18(30.00％)	23(38.33％)	19	68.33％

2.2 liang of group Patients on Recurrence situations compare: follow the tracks of and follow up a case by regular visits to 1 year, and treatment group follows up a case by regular visits to 61 examples, and matched group follows up a case by regular visits to 56 examples, and two groups of relapse rates compare that there were significant differences (P < 0.01), and each group recurrence is in table 2.

A table 2 liang group Patients on Recurrence situation compares

Group	Follow up a case by regular visits to number	Recurrence number	Relapse rate
				Treatment group	61	4	6.56％
Matched group	56	31	55.36％

Model case:

In so-and-so, female, 28 years old, worker.In December, 2013 is gone to a doctor.Patient's readme has dysmenorrhea history 3 to 5 years, lower abdominal distention pain before each menstrual onset, time light time heavy, dol urg cannot be stood, extreme cold of the limbs, not dim for feed, hypomenorrhea, color purple, have clot, uncomfortable in chest swollen, there is chloasma etc. at volume, nose place.Indagation finds that patient's body of the tongue purple is dim, there are petechia, white and thin fur, deep and stringy pulse in limit.Be diagnosed as dysmenorrheal caused by qi stagnation and blood stasis companion chloasma, adopt capsule of the present invention, from before passing through the 7th day, each 3, every day 2 times, pain obviously slowed down.When second time is passed through, all transference cures of dysmenorrhea, when third time passes through, volume, nose place chloasma disappear, and be consolidate curative effect, patient takes 3 menstrual cycle continuously.Visit after 12 months, have no recurrence.

Compared with prior art beneficial effect of the present invention is: the present invention is based on theory of Chinese medical science, compatibility is rigorous, employing modern technologies are made, have that replenishing essence is nourished blood, the kidney invigorating nourishing the liver, promoting blood circulation to restore menstrual flow, relieving spasm to stop pain effect, by regulating human-body viscera function, for affecting the principal element of stimulating the menstrual flow, run QI and blood, link up up and down, play Mutiple Targets, too many levels, multi-level comprehensive regulation effect, hit pathogenesis; Adopt to be implemented on by menstrual cycle simultaneously and premenstrually start treatment, stop using menstrual period as principle, clinical efficacy is definite, and side effect is less, and patient compliance is better, and taking convenience, relapse rate is lower.

Detailed description of the invention

Further describe the present invention below by way of specific embodiment, the present invention is not limited only to following examples.Within the scope of the invention or not departing from content of the present invention, spirit and scope, the change carried out the present invention, combination or replacement, be apparent for a person skilled in the art, and be included within the scope of the present invention.

Embodiment 1

Prescription: Rhizoma Cyperi 13 parts, Rhizoma Chuanxiong 10 parts, Radix Salviae Miltiorrhizae 13 parts, Herba Lycopi 12 parts, Caulis Spatholobi 17 parts, Radix Codonopsis Convolvulaceae 15 parts, Fructus Lycii 20 parts, the Rhizoma Atractylodis Macrocephalae 12 parts, the Radix Paeoniae Alba 10 parts, Radix Caulophylli 6 parts, Herba Verbenae 5 parts, Cortex Albiziae 10 parts.

Preparation method: (1) Rhizoma Cyperi, Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Radix Caulophylli, Herba Lycopi, adds 2-10 times amount 70-95% ethanol, reflux, extract, twice, each 1-3 hour, filters, merges twice filtrate, and decompression recycling ethanol is to without alcohol taste, for subsequent use;

(2) by Rhizoma Cyperi, Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Radix Caulophylli, filtering residue and Caulis Spatholobi after Herba Lycopi's ethanol extraction, Radix Codonopsis Convolvulaceae, Fructus Lycii, the Rhizoma Atractylodis Macrocephalae, the Radix Paeoniae Alba, Herba Verbenae, Cortex Albiziae merges, add 2-10 times of water gaging, decoct extraction 3 times, each 1-3 hour, merging filtrate, filter, be concentrated into relative density 1.20 (60 DEG C of surveys), be placed to room temperature, adding ethanol makes alcohol content reach 65%, stir evenly,-5-0 DEG C of cold preservation 12 hours, filter, decompression filtrate recycling ethanol is extremely without alcohol taste, merge with above-mentioned clear paste, mix homogeneously, drying under reduced pressure is to dry, be ground into fine powder, granulate, dress up 100 capsules.

Embodiment 2

Prescription: Rhizoma Cyperi 12 parts, Rhizoma Chuanxiong 8 parts, Radix Salviae Miltiorrhizae 12 parts, Herba Lycopi 15 parts, Caulis Spatholobi 20 parts, Radix Codonopsis Convolvulaceae 15 parts, Fructus Lycii 15 parts, the Rhizoma Atractylodis Macrocephalae 10 parts, the Radix Paeoniae Alba 12 parts, Radix Caulophylli 5 parts, Herba Verbenae 5 parts, Cortex Albiziae 10 parts.

Preparation method: the operation with reference to embodiment 1 is carried out.

Embodiment 3

Prescription: Rhizoma Cyperi 15 parts, Rhizoma Chuanxiong 7 parts, Radix Salviae Miltiorrhizae 10 parts, Herba Lycopi 12 parts, Caulis Spatholobi 15 parts, Radix Codonopsis Convolvulaceae 20 parts, Fructus Lycii 10 parts, the Rhizoma Atractylodis Macrocephalae 10 parts, the Radix Paeoniae Alba 10 parts, Radix Caulophylli 8 parts, Herba Verbenae 4 parts, Cortex Albiziae 9 parts.

Embodiment 4

Prescription: Rhizoma Cyperi 15 parts, Rhizoma Chuanxiong 10 parts, Radix Salviae Miltiorrhizae 15 parts, Herba Lycopi 15 parts, Caulis Spatholobi 15 parts, Radix Codonopsis Convolvulaceae 20 parts, Fructus Lycii 15 parts, the Rhizoma Atractylodis Macrocephalae 10 parts, the Radix Paeoniae Alba 12 parts, Radix Caulophylli 5 parts, Herba Verbenae 7 parts, Cortex Albiziae 12 parts.

Embodiment 5

Prescription: Rhizoma Cyperi 15 parts, Rhizoma Chuanxiong 5 parts, Radix Salviae Miltiorrhizae 15 parts, Herba Lycopi 10 parts, Caulis Spatholobi 15 parts, Radix Codonopsis Convolvulaceae 10 parts, Fructus Lycii 20 parts, the Rhizoma Atractylodis Macrocephalae 12 parts, the Radix Paeoniae Alba 12 parts, Radix Caulophylli 7 parts, Herba Verbenae 3 parts, Cortex Albiziae 9 parts.

Embodiment 6

Prescription: Rhizoma Cyperi 12 parts, Rhizoma Chuanxiong 7 parts, Radix Salviae Miltiorrhizae 15 parts, Herba Lycopi 10 parts, Caulis Spatholobi 15 parts, Radix Codonopsis Convolvulaceae 15 parts, Fructus Lycii 10 parts, the Rhizoma Atractylodis Macrocephalae 10 parts, the Radix Paeoniae Alba 10 parts, Radix Caulophylli 6 parts, Herba Verbenae 5 parts, Cortex Albiziae 6 parts.

Embodiment 7

(2) by Rhizoma Cyperi, Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Radix Caulophylli, filtering residue and Caulis Spatholobi after Herba Lycopi's ethanol extraction, Radix Codonopsis Convolvulaceae, Fructus Lycii, the Rhizoma Atractylodis Macrocephalae, the Radix Paeoniae Alba, Herba Verbenae, Cortex Albiziae merges, add 2-10 times of water gaging, decoct extraction 3 times, each 1-3 hour, merging filtrate, filter, be concentrated into relative density 1.20 (60 DEG C of surveys), be placed to room temperature, adding ethanol makes alcohol content reach 65%, stir evenly,-5-0 DEG C of cold preservation 12 hours, filter, decompression filtrate recycling ethanol is extremely without alcohol taste, merge with above-mentioned clear paste, mix homogeneously, drying under reduced pressure is to dry, be ground into fine powder, granulate, tabletting, obtain 100, tablet.

Embodiment 8

Preparation method: the operation with reference to embodiment 7 is carried out.

Embodiment 9

Prescription: Rhizoma Cyperi 12 parts, Rhizoma Chuanxiong 10 parts, Radix Salviae Miltiorrhizae 13 parts, Herba Lycopi 12 parts, Caulis Spatholobi 17 parts, Radix Codonopsis Convolvulaceae 15 parts, Fructus Lycii 20 parts, the Rhizoma Atractylodis Macrocephalae 12 parts, the Radix Paeoniae Alba 10 parts, Radix Caulophylli 6 parts, Herba Verbenae 5 parts, Cortex Albiziae 8 parts.

(2) by Rhizoma Cyperi, Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Radix Caulophylli, filtering residue and Caulis Spatholobi after Herba Lycopi's ethanol extraction, Radix Codonopsis Convolvulaceae, Fructus Lycii, the Rhizoma Atractylodis Macrocephalae, the Radix Paeoniae Alba, Herba Verbenae, Cortex Albiziae merges, add 2-10 times of water gaging, decoct extraction 3 times, each 1-3 hour, merging filtrate, filter, be concentrated into relative density 1.20 (60 DEG C of surveys), be placed to room temperature, adding ethanol makes alcohol content reach 65%, stir evenly,-5-0 DEG C of cold preservation 12 hours, filter, decompression filtrate recycling ethanol is extremely without alcohol taste, merge with above-mentioned clear paste, mix homogeneously, drying under reduced pressure is to dry, be ground into fine powder, dress up 100 bags of granules.

Embodiment 10

(2) filtering residue after Rhizoma Cyperi, Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Radix Caulophylli, Herba Lycopi's ethanol extraction and Caulis Spatholobi, Radix Codonopsis Convolvulaceae, Fructus Lycii, the Rhizoma Atractylodis Macrocephalae, the Radix Paeoniae Alba, Herba Verbenae, Cortex Albiziae are merged, add 2-10 times of water gaging, decoct extraction 3 times, each 1-3 hour, merging filtrate, filters, is concentrated into relative density 1.20 (60 DEG C of surveys), be placed to room temperature, adding ethanol makes alcohol content reach 65%, stirs evenly ,-5-0 DEG C of cold preservation 12 hours, filter, decompression filtrate recycling ethanol, to without alcohol taste, merges with above-mentioned clear paste, mix homogeneously, concentrating under reduced pressure, preparation oral liquid.

Embodiment 11 animal experiment is reported

One, Chinese medicine preparation animal acute toxicity test of the present invention

1. trial drug: Chinese medicine preparation of the present invention.

2. experimental animal: regular grade NIH mice 12, body weight 19g ± 3g, male and female half and half.

3. method and result: be divided into blank group at random, fasting was tested after 16 hours, administration group gives the embodiment of the present invention 1 capsule suspension (capsule 's content and water 1:1 are in harmonious proportion and form) by the dosage gavage of 0.2g/10g, the dosage gastric infusion of 0.2g/10g is pressed again once, twice totally after 6 hours.Meanwhile blank group gavage gives consubstantiality hydrops, raises seven days to observation post administration, the reaction of record mouse toxicity and death condition, and observes the change of its main organs and tissue.

After seven days, mice is without death in administration, and behavior is active, and food ration is as usual, and hair color light is without loose dirty, and without fainting from fear addicted to saliva, eye, mouth, nose, ear and crissum secretions without exception, without the rotten toe of docking.Put to death mice, dissect, observe the main organs such as its heart, liver, lung, kidney and organize no abnormality seen, showing the oral safety of this medicine.

Two, Chinese medicine composition long-term toxicity test for animals of the present invention

1. trial drug: pharmaceutical composition of the present invention.

2. experimental animal: regular grade SD rat 30, body weight 175g ± 16g, male and female half and half, are divided into 3 groups at random.

3. method and result:

Pharmaceutical formulations: point high and low, blank three dosage groups, are respectively 100,50,0 times of clinical application amount.

Experiment adopts gastric infusion mode, all by the capacity gastric infusion of 1ml/100g, successive administration 90 days: blank group gives the distilled water of the capacity of grade every day, then every treated animal puts to death 4, become celestial and perusal is carried out to each organs and tissues of animal, and pathologic finding is done to organs such as the heart, liver, spleen, lung, kidney, adrenal gland, thymus

4. conclusion:

1, each treated animal tested period feed, drinking-water, defecation are all normal, and sport health is active, by hair gloss, do not find death and other ANOMALOUS VARIATIONS.

2, each treated animal body weight increases normal, and administration group compares there was no significant difference (P>0.05) with matched group.

3, after experiment, each treated animal hepatic and renal function and serum biochemistry measurement result compare there was no significant difference with matched group.

4, after experiment, each treated animal hemogram checking compares there was no significant difference with matched group.

5, each treated animal heart, liver, spleen, lung, kidney, adrenal gland, thymus outward appearance and its organ index there are no significant difference.

6, each treated animal is the same with matched group, the size and form of the organs such as the heart, liver, spleen, lung, kidney is normal, smooth surface, without hemorrhage, adhesion or necrosis, histological examination is respectively organized internal organs and is showed no organic disease, cardiac muscle fiber is without degeneration or necrosis, and structure is normal, and lung tissue and spleen organize also no abnormality seen to change, hepatocyte and the change all without exception of the structure such as glomerule, renal tubules, namely relevant with drug metabolism important organ is all without obviously changing.

Claims

1. treat a Chinese medicine preparation for qi stagnation and blood stasis type primary dysmenorrhea companion chloasma, it is characterized in that by Rhizoma Cyperi, Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Herba Lycopi, Caulis Spatholobi, Radix Codonopsis Convolvulaceae, Fructus Lycii, the Rhizoma Atractylodis Macrocephalae, the Radix Paeoniae Alba, Radix Caulophylli, Herba Verbenae, Cortex Albiziae be that medicinal raw material is made.

2. Chinese medicine preparation as claimed in claim 1, is characterized in that being made up of the medicinal raw material of following weight: Rhizoma Cyperi 10-18 part, Rhizoma Chuanxiong 5-15 part, Radix Salviae Miltiorrhizae 8-18 part, Herba Lycopi 10-15 part, Caulis Spatholobi 15-20 part, Radix Codonopsis Convolvulaceae 10-20 part, Fructus Lycii 10-20 part, Rhizoma Atractylodis Macrocephalae 10-15 part, Radix Paeoniae Alba 8-13 part, Radix Caulophylli 5-9 part, Herba Verbenae 3-10 part, Cortex Albiziae 6-16 part.

3. Chinese medicine preparation as claimed in claim 2, is characterized in that being made up of the medicinal raw material of following preferred weight part proportioning: Rhizoma Cyperi 12-15 part, Rhizoma Chuanxiong 7-12 part, Radix Salviae Miltiorrhizae 10-15 part, Herba Lycopi 10-15 part, Caulis Spatholobi 15-20 part, Radix Codonopsis Convolvulaceae 15-20 part, Fructus Lycii 15-20 part, Rhizoma Atractylodis Macrocephalae 10-15 part, Radix Paeoniae Alba 9-13 part, Radix Caulophylli 5-8 part, Herba Verbenae 4-7 part, Cortex Albiziae 9-13 part.

4. Chinese medicine preparation as claimed in claim 3, is characterized in that being made up of the medicinal raw material of following weight: Rhizoma Cyperi 13 parts, Rhizoma Chuanxiong 10 parts, Radix Salviae Miltiorrhizae 13 parts, Herba Lycopi 12 parts, Caulis Spatholobi 17 parts, Radix Codonopsis Convolvulaceae 15 parts, Fructus Lycii 20 parts, the Rhizoma Atractylodis Macrocephalae 12 parts, the Radix Paeoniae Alba 10 parts, Radix Caulophylli 6 parts, Herba Verbenae 5 parts, Cortex Albiziae 10 parts.

5. the Chinese medicine preparation as described in claim 1-4, is characterized in that described Chinese medicine preparation is peroral dosage form.

6. Chinese medicine preparation as claimed in claim 5, is characterized in that described peroral dosage form is preferably soft capsule, capsule, tablet, oral liquid, granule, pill, powder, sublimed preparation, unguentum.

7. Chinese medicine preparation as claimed in claim 6, is characterized in that described peroral dosage form is preferably capsule, tablet, granule.

8. Chinese medicine preparation as claimed in claim 7, is characterized in that described peroral dosage form is preferably capsule.

9. the Chinese medicine preparation as described in as arbitrary in claim 1-4, it is characterized in that described Chinese medicine preparation is is active component by Rhizoma Cyperi, Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Radix Caulophylli, Herba Lycopi, Caulis Spatholobi, Radix Codonopsis Convolvulaceae, Fructus Lycii, the Rhizoma Atractylodis Macrocephalae, the Radix Paeoniae Alba, Herba Verbenae, Cortex Albiziae or its water or its extractive with organic solvent, adds medicine acceptable carrier and is prepared from.

10. the Chinese medicine preparation as described in as arbitrary in claim 1-4, is characterized in that the preparation method of described Chinese medicine preparation comprises the following steps: