CN102028751B - Chinese medicinal composition serving as phytoestrogen and application thereof - Google Patents
Chinese medicinal composition serving as phytoestrogen and application thereof Download PDFInfo
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- CN102028751B CN102028751B CN2010105773417A CN201010577341A CN102028751B CN 102028751 B CN102028751 B CN 102028751B CN 2010105773417 A CN2010105773417 A CN 2010105773417A CN 201010577341 A CN201010577341 A CN 201010577341A CN 102028751 B CN102028751 B CN 102028751B
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Abstract
The invention relates to a Chinese medicinal composition serving as phytoestrogen and application thereof, in particular to a Chinese medicinal composition. The Chinese medicinal composition comprises malaytea scurfpea fruit, eucommia bark, root of red-rooted salvia and optional common anemarrhena rhizome or ethanol extract thereof, and optional pharmaceutically acceptable auxiliary materials. The invention also relates to application of the Chinese medicinal composition to the preparation of medicines with effect of the phytoestrogen, or application of the Chinese medicinal composition to the preparation of medicines for treating or preventing diseases related to in-vivo estrogen level imbalance of subjects, or improving symptoms of the diseases.
Description
Technical field
The invention belongs to the field of Chinese medicines, relate to a kind of Chinese medicine composition, particularly a kind of Chinese medicine composition that comprises the Cortex Eucommiae, Fructus Psoraleae, Radix Salviae Miltiorrhizae and the optional Rhizoma Anemarrhenae with phytoestrogen appearance effect.The invention still further relates to said Chinese medicine composition is used for treating or prevents the purposes in the medicine of experimenter and body inner estrogen off-leveling diseases associated or symptom in preparation.
Background technology
Phytoestrogen is one type of chemical compound with plant origin of estrogen characteristic, can be directly and estrogen receptor interact, its bonded ability a little less than, only be estrogenic 1/500～1/1000, but side effect is little in Hormone Replacement Therapy.Existing research shows, phytoestrogen demonstrates challenging result in the treatment of disease such as female climacteric syndrome and postmenopausal women's coronary heart disease, atherosclerosis, vascular endothelial injury, hypertension and osteoporosis or symptom or prevention.
Blue or green pretty young woman's ball compatibility is used head and is stated from the Song dynasty " prescription of peaceful benevolent dispensary ", is made up of Fructus Psoraleae, the Cortex Eucommiae, Semen Juglandis and Bulbus Allii.With the ancient prescription is the basis, through the blue or green pretty young woman's ball of Chinese patent medicine that modern pharmaceutical technology is processed, includes in " Chinese pharmacopoeia.Clinical report, traditional Chinese medical science syndrome of deficiency of kidney-YANG persons such as blue or green pretty young woman ball side treatment chronic lumbar muscle strain, hyperosteogeny, osteoporosis, coronary heart disease and chloasma obtain certain curative effect.The research of relevant blue or green pretty young woman's ball is more; Shenyang Pharmaceutical University's Bears will is upright to be waited in article " blue or green pretty young woman's extract of bolus is to the research of skeletonization like cell UMR106 proliferation and differentiation effect "; Prove that blue or green pretty young woman's extract of bolus has the proliferation and differentiation effect to skeletonization like cell UMR106, and filter out blue or green pretty young woman's ball ethyl acetate extraction position be the control osteoporotic effective site." blue or green pretty young woman's ball is to the bone metabolism regulating action and the study on mechanism of osteoporosis (OP) animal model " proves that the osteoporosis effect of blue or green pretty young woman's pill for curing OP animal pattern is remarkable, has strong phytoestrogen effect.Prove also in the different documents that this side's single medicinal material Fructus Psoraleae or the Cortex Eucommiae have certain estrogen activity; One Chinese patent application 200810043844.9 has compared the estrogen action of the former side of QINGEFANG and the side of tearing open; The main pharmacodynamics composition that confirms blue or green pretty young woman's ball is the use of uniting of the Fructus Psoraleae and the Cortex Eucommiae, and the effect behind adding Semen Juglandis and the Bulbus Allii is more excellent.The prior art prompting, QINGEFANG can be used to prevent and treat the climacteric syndrome that estrogen deficiency causes.
However, new safe and effective Chinese medicine preparation with the effect of phytoestrogen appearance need be provided still, to satisfy among treatment clinically or the prevention experimenter with body inner estrogen off-leveling diseases associated or to improve the demand of its symptom.
Summary of the invention
The inventor finds unexpectedly through a large amount of experiments; Be the basis with Fructus Psoraleae and the Cortex Eucommiae two flavor Chinese medicines; Increase Radix Salviae Miltiorrhizae, optionally again increase drug composition that the Rhizoma Anemarrhenae processes and can treat or prevent among the experimenter with body inner estrogen off-leveling diseases associated effectively or improve its symptom.Find Fructus Psoraleae and the Cortex Eucommiae two side effect and the risk of drug matching Radix Salviae Miltiorrhizaes can reduce Fructus Psoraleae, the Cortex Eucommiae significantly and use separately the time of distinguishing the flavor of in addition.Based on above-mentioned discovery, the inventor accomplishes the present invention.
On the one hand; The present invention provides a kind of Chinese medicine composition; It comprises among effective treatment or the prevention experimenter with body inner estrogen off-leveling diseases associated or improves Fructus Psoraleae, the Cortex Eucommiae and the Radix Salviae Miltiorrhizae of the amount of its symptom; And optional pharmaceutically acceptable auxiliary substance, wherein the weight ratio of Fructus Psoraleae, the Cortex Eucommiae and Radix Salviae Miltiorrhizae is 1: 0.2～10: 0.2～10.
In an embodiment aspect this; The present invention provides a kind of Chinese medicine composition; Its active component is by forming with body inner estrogen off-leveling diseases associated or the Fructus Psoraleae, the Cortex Eucommiae and the Radix Salviae Miltiorrhizae that improve the amount of its symptom among effective treatment or the prevention experimenter; Optional comprise pharmaceutically acceptable auxiliary substance, wherein the weight ratio of Fructus Psoraleae, the Cortex Eucommiae and Radix Salviae Miltiorrhizae is 1: 0.2～10: 0.2～10.
In another embodiment aspect this, the weight ratio of Fructus Psoraleae, the Cortex Eucommiae and Radix Salviae Miltiorrhizae is 1: 0.5～4: 0.5～4.
In a specific embodiments aspect this, the weight ratio of Fructus Psoraleae, the Cortex Eucommiae and Radix Salviae Miltiorrhizae is 1: 2: 2,1: 4: 2 or 1: 0.5: 2.
At an alternative aspect aspect this; The present invention provides a kind of Chinese medicine composition; It comprises among effective treatment or the prevention experimenter with body inner estrogen off-leveling diseases associated or improves Fructus Psoraleae ethanol extraction, Cortex Eucommiae ethanol extraction and the Radix Salviae Miltiorrhizae ethanol extraction of the amount of its symptom; And optional pharmaceutically acceptable auxiliary substance, the weight ratio of wherein said Fructus Psoraleae ethanol extraction, Cortex Eucommiae ethanol extraction and Radix Salviae Miltiorrhizae ethanol extraction is 1: 0.2～5: 1～5.
In the embodiment aspect this is alternative; The present invention provides a kind of Chinese medicine composition; Its active component is by forming with body inner estrogen off-leveling diseases associated or the Fructus Psoraleae ethanol extraction, Cortex Eucommiae ethanol extraction and the Radix Salviae Miltiorrhizae ethanol extraction that improve the amount of its symptom among effective treatment or the prevention experimenter; Optional comprise pharmaceutically acceptable auxiliary substance, the weight ratio of wherein said Fructus Psoraleae ethanol extraction, Cortex Eucommiae ethanol extraction and Radix Salviae Miltiorrhizae ethanol extraction is 1: 0.2～5: 1～5.
In another embodiment aspect this is alternative, said Fructus Psoraleae ethanol extraction, Cortex Eucommiae ethanol extraction and Radix Salviae Miltiorrhizae ethanol extraction prepare through following method respectively:
The ethanol that in the Fructus Psoraleae crude drug, adds the several times amount; Reflux, extract, to the greatest extent, is dissolved the residue that obtains from the extracting solution decompression recycling ethanol with sodium hydrate aqueous solution; In the solution that obtains, add aqueous hydrochloric acid solution then; Its pH value is adjusted to neutrality, and the collecting precipitation thing is also dry, obtains the Fructus Psoraleae ethanol extraction;
To concoct the Cortex Eucommiae and cross pulverizer, in the powder that obtains, add the ethanol of several times amount, reflux, extract,, decompression recycling ethanol is extremely most from extracting solution, and with the residue vacuum drying, obtains Cortex Eucommiae ethanol extraction;
Radix Salviae Miltiorrhizae is crossed pulverizer, in the powder that obtains, add the ethanol of several times amount, reflux, extract,, decompression recycling ethanol is extremely most from extracting solution, and with the residue vacuum drying, obtains the Radix Salviae Miltiorrhizae ethanol extraction.
In another embodiment aspect this is alternative, the weight ratio of said Fructus Psoraleae ethanol extraction, Cortex Eucommiae ethanol extraction and Radix Salviae Miltiorrhizae ethanol extraction is 1: 0.5～2: 2～4.
In the specific embodiments aspect this is alternative, the weight ratio of said Fructus Psoraleae ethanol extraction, Cortex Eucommiae ethanol extraction and Radix Salviae Miltiorrhizae ethanol extraction is 1: 1: 4,1: 0.25: 4 or 1: 2: 4.
On the other hand; The present invention provides a kind of Chinese medicine composition; It comprises among effective treatment or the prevention experimenter with body inner estrogen off-leveling diseases associated or improves Fructus Psoraleae, the Cortex Eucommiae, Radix Salviae Miltiorrhizae and the Rhizoma Anemarrhenae of the amount of its symptom, and wherein the weight ratio of Fructus Psoraleae, the Cortex Eucommiae, Radix Salviae Miltiorrhizae and the Rhizoma Anemarrhenae is 1: 0.2～10: 0.2～10: 0.2～5.
In an embodiment aspect this; The present invention provides a kind of Chinese medicine composition; Its active component is by forming with the body inner estrogen off-leveling diseases associated or the Fructus Psoraleae, the Cortex Eucommiae, Radix Salviae Miltiorrhizae and the Rhizoma Anemarrhenae that improve the amount of its symptom among effective treatment or the prevention experimenter; Optional comprise pharmaceutically acceptable auxiliary substance, wherein the weight ratio of Fructus Psoraleae, the Cortex Eucommiae, Radix Salviae Miltiorrhizae and the Rhizoma Anemarrhenae is 1: 0.2～10: 0.2～10: 0.2～5.
In an embodiment aspect this, the weight ratio of Fructus Psoraleae, the Cortex Eucommiae, Radix Salviae Miltiorrhizae and the Rhizoma Anemarrhenae is 1: 0.5～4: 0.5～4: 0.5～4.
In a specific embodiments aspect this, the weight ratio of Fructus Psoraleae, the Cortex Eucommiae, Radix Salviae Miltiorrhizae and the Rhizoma Anemarrhenae is 1: 2: 2: 1,1: 4: 2: 0.5 or 1: 0.5: 2: 2.
At an alternative aspect aspect this; The present invention provides a kind of Chinese medicine composition; It comprises among effective treatment or the prevention experimenter with body inner estrogen off-leveling diseases associated or improves Fructus Psoraleae ethanol extraction, Cortex Eucommiae ethanol extraction, Radix Salviae Miltiorrhizae ethanol extraction and the Rhizoma Anemarrhenae ethanol extraction of the amount of its symptom; And optional pharmaceutically acceptable auxiliary substance, wherein the weight ratio of Fructus Psoraleae ethanol extraction, Cortex Eucommiae ethanol extraction, Radix Salviae Miltiorrhizae ethanol extraction and Rhizoma Anemarrhenae ethanol extraction is 1: 0.2～5: 1～5: 0.5～5.
In the embodiment aspect this is alternative; The present invention provides a kind of Chinese medicine composition; Its active component is by forming with body inner estrogen off-leveling diseases associated or the Fructus Psoraleae ethanol extraction, Cortex Eucommiae ethanol extraction, Radix Salviae Miltiorrhizae ethanol extraction and the Rhizoma Anemarrhenae ethanol extraction that improve the amount of its symptom among effective treatment or the prevention experimenter; Optional comprise pharmaceutically acceptable auxiliary substance, wherein the weight ratio of Fructus Psoraleae ethanol extraction, Cortex Eucommiae ethanol extraction, Radix Salviae Miltiorrhizae ethanol extraction and Rhizoma Anemarrhenae ethanol extraction is 1: 0.2～5: 1～5: 0.5～5.
In another embodiment aspect this is alternative, said Fructus Psoraleae ethanol extraction, Cortex Eucommiae ethanol extraction, Radix Salviae Miltiorrhizae ethanol extraction and Rhizoma Anemarrhenae ethanol extraction prepare through following method respectively:
The ethanol that in the Fructus Psoraleae crude drug, adds the several times amount; Reflux, extract, to the greatest extent, is dissolved the residue that obtains from the extracting solution decompression recycling ethanol with sodium hydrate aqueous solution; In the solution that obtains, add aqueous hydrochloric acid solution then; Its pH value is adjusted to neutrality, and the collecting precipitation thing is also dry, obtains the Fructus Psoraleae ethanol extraction;
To concoct the Cortex Eucommiae and cross pulverizer, in the powder that obtains, add the ethanol of several times amount, reflux, extract,, decompression recycling ethanol is extremely most from extracting solution, and with the residue vacuum drying, obtains Cortex Eucommiae ethanol extraction;
Radix Salviae Miltiorrhizae is crossed pulverizer, in the powder that obtains, add the ethanol of several times amount, reflux, extract,, decompression recycling ethanol is extremely most from extracting solution, and with the residue vacuum drying, obtains the Radix Salviae Miltiorrhizae ethanol extraction;
The ethanol that in Rhizoma Anemarrhenae crude drug, adds the several times amount, reflux, extract,, decompression recycling ethanol with the residue vacuum drying, obtains Rhizoma Anemarrhenae ethanol extraction to the greatest extent from extracting solution.
In another embodiment aspect this is alternative, the weight ratio of said Fructus Psoraleae ethanol extraction, Cortex Eucommiae ethanol extraction, Radix Salviae Miltiorrhizae ethanol extraction and Rhizoma Anemarrhenae ethanol extraction is 1: 0.5～4: 3～5: 1～2.
In the specific embodiments aspect this is alternative, the weight ratio of said Fructus Psoraleae ethanol extraction, Cortex Eucommiae ethanol extraction, Radix Salviae Miltiorrhizae ethanol extraction and Rhizoma Anemarrhenae ethanol extraction is 1: 1: 4: 1 or 1: 0.25: 4: 2.
According to Chinese medicine composition of the present invention, wherein said Fructus Psoraleae ethanol extraction, Cortex Eucommiae ethanol extraction, Radix Salviae Miltiorrhizae ethanol extraction or Rhizoma Anemarrhenae ethanol extraction can be replaced by with they extracts of obtaining as solvent extraction of water, ethanol or water-ethanol admixture separately.Said Fructus Psoraleae ethanol extraction, Cortex Eucommiae ethanol extraction, Radix Salviae Miltiorrhizae ethanol extraction and Rhizoma Anemarrhenae ethanol extraction also can replace with the extract of Fructus Psoraleae, the Cortex Eucommiae, Radix Salviae Miltiorrhizae and Rhizoma Anemarrhenae co-extracted gained.
In Chinese medicine composition of the present invention; Said ethanol extraction is the extract that obtains through extraction as solvent with 50～98% ethanol, for example be with 55～98%, 60～98%, 65～98%, 70～98%, 70～95%, about 70%, about 75%, extract that about ethanol of 80%, about 90% or about 95% obtains through extraction as solvent.
The Fructus Psoraleae ethanol extraction that uses among the present invention contains Fructus Psoraleae glycosides and different Fructus Psoraleae glycosides, enrichment Bakuchiol and the bavachin constituents that less psoralen and isopsoralen and ability hydrolysis produce psoralen and isopsoralen.
Chinese medicine composition of the present invention has the effect of phytoestrogen appearance; Therefore can be used for treatment or prevention experimenter with body inner estrogen off-leveling diseases associated or improve its symptom, or can be used for preparing and be used for treating or prevent experimenter and body inner estrogen off-leveling diseases associated or improve the medicine of its symptom.
Again on the one hand, the present invention provides the Chinese medicine composition described in above-mentioned any embodiment to be used for treating or to prevent experimenter and body inner estrogen off-leveling diseases associated or improve the purposes in the medicine of its symptom in preparation.
At an alternative aspect aspect this, the present invention provides the purposes of the Chinese medicine composition of above-mentioned any embodiment as the medicine with the effect of phytoestrogen appearance.
At an alternative aspect aspect this; The present invention provides among a kind of treatment or the prevention experimenter with body inner estrogen off-leveling diseases associated or improves the method for its symptom, and this method comprises that the Chinese medicine composition with above-mentioned any embodiment of effective dose gives this experimenter.
In an embodiment of aspect this and alternative aspect, said and body inner estrogen off-leveling diseases associated or symptom are selected from climacteric syndrome and postmenopausal women's coronary heart disease, atherosclerosis, vascular endothelial injury, hypertension and osteoporosis.
In another embodiment of aspect this and alternative aspect, said and body inner estrogen off-leveling diseases associated or symptom are selected from climacteric syndrome (for example hectic fever, nervous etc.), cardiovascular disease and osteoporosis.
Do further to describe with embodiment to various aspects of the present invention below.
Incorporate the full content of institute's citing document in this description into this description by reference, and if any scientific and technical terminology when the expressed implication of these documents and the implication among the present invention are inconsistent, be as the criterion with the implication among the present invention.In addition; Various terms and phrase that the present invention uses have the general sense of well known to a person skilled in the art; Nonetheless; The present invention still hopes at this more detailed explanation and explanation to be done in these terms and phrase, and term of mentioning and phrase are as the criterion with the implication of being explained among the application if any inconsistent with known implication.
Term described in the present invention " Fructus Psoraleae ", " Cortex Eucommiae ", " Radix Salviae Miltiorrhizae " and " Rhizoma Anemarrhenae " should meet the regulation under the version Pharmacopoeia of the People's Republic of China corresponding entry in 2005 respectively.
Term described in the present invention " effect of phytoestrogen appearance " is meant the effect that is similar to the physiologic function that estrogen has; Said estrogen is when modifying (being phytoestrogen) with plant; Be meant a kind of derive from plant (for example from plant, extract or plant in contain and through complete synthesis or semisynthetic chemosynthesis process acquisition) chemical compound, and this chemical compound has and is similar to the physiologic function that estrogen has.
Term described in the present invention " effective dose " is meant that the pairing component of this term realizes treating, prevent, alleviate and/or alleviating the dosage of disease described in the present invention or disease in the experimenter.
Term described in the present invention " Chinese medicine composition " is meant and is used in the material of realizing treating, prevent, alleviate and/or alleviating the said disease of the application, disease, symptom among the experimenter.
Term described in the present invention " experimenter " can refer to that patient or other accept Chinese medicine composition of the present invention and extract to treat, to prevent, to alleviate and/or to alleviate the animal of the said disease of the application, disease, symptom; Particularly mammal, for example people, Canis familiaris L., monkey, cattle, horse etc.
Term described in the present invention " disease or symptom " is meant a kind of condition of said experimenter, and this condition is relevant with said disease of the application or symptom.
Symbol described in the present invention " % ", as do not specialize, when being solid, generally be meant the percentage ratio of w/w for total material; When being liquid, generally be meant the percentage ratio of weight/volume for total material.Certainly, be liquid and solute when being liquid for total material, the percentage ratio that characterizes this liquid solute generally is meant the percentage ratio of volume.
The inventor is through experiment confirm, and Chinese medicine composition of the present invention can effectively be regulated the estrogen deficiency effect of castration female rats, effectively alleviates the various symptoms of perimenopausal syndrome; Significantly reduce TC, LDL, and the HDL that can significantly raise have the lipid metabolism of adjusting function; Promote the secretion of castrated rats whole animal estradiol, uterus weight is obvious, and the uterus coefficient increases.These experimental results show that Chinese medicine composition of the present invention can be used for the protection of postmenopausal women's cardiovascular system.The inventor confirms also that through experiment Chinese medicine composition of the present invention can obviously improve bone density.Therefore, Chinese medicine composition of the present invention can be used to treat climacteric syndrome such as hectic fever, nervous etc., and is used for diseases such as cardiovascular disease risk that the climacteric women estrogen deficiency causes and osteoporosis.
The specific embodiment
Can further describe the present invention through following embodiment, yet scope of the present invention is not limited to following embodiment.One of skill in the art can understand, and under the prerequisite that does not deviate from the spirit and scope of the present invention, can carry out various variations and modification to the present invention.Though for realizing that employed many materials of the object of the invention and operational approach are well known in the art, the present invention still does to describe in detail as far as possible at this.
Hereinafter, when mentioning " QINGEFANG ", it is meant the compositions of being made up of Fructus Psoraleae and the Cortex Eucommiae two flavor Chinese medicines or its extract; Correspondingly, when mentioning " QINGEFANG adds Radix Salviae Miltiorrhizae ", it is meant the compositions of being made up of Fructus Psoraleae, the Cortex Eucommiae and Radix Salviae Miltiorrhizae three flavor Chinese medicines or its extract; When mentioning " QINGEFANG adds Radix Salviae Miltiorrhizae and adds the Rhizoma Anemarrhenae ", it is meant the compositions of being made up of Fructus Psoraleae, the Cortex Eucommiae, Radix Salviae Miltiorrhizae and the Rhizoma Anemarrhenae four flavor Chinese medicines or its extract.
The preparation of embodiment 1A, Chinese medicine composition of the present invention
Prescription:
Fructus Psoraleae 100g
Cortex Eucommiae 200g
Radix Salviae Miltiorrhizae 200g
Rhizoma Anemarrhenae 100g
With above four Chinese medicine pulverize separately, mix, every 100g powder adds an amount of water pill with refined honey 50g, and drying is processed big honeyed pills.Every ball contains and is equivalent to Fructus Psoraleae crude drug 1.0g.
The preparation of embodiment 1B, Chinese medicine composition of the present invention
Fructus Psoraleae 100g
Cortex Eucommiae 20g
Radix Salviae Miltiorrhizae 20g
Rhizoma Anemarrhenae 500g
With above four Chinese medicine pulverize separately, mix, every 100g powder adds an amount of water pill with refined honey 50g, and drying is processed big honeyed pills.Every ball contains and is equivalent to Fructus Psoraleae crude drug 1.0g.
The preparation of embodiment 1C, Chinese medicine composition of the present invention
Fructus Psoraleae 100g
Cortex Eucommiae 1000g
Radix Salviae Miltiorrhizae 20g
Rhizoma Anemarrhenae 20g
With above four Chinese medicine pulverize separately, mix, every 100g powder adds an amount of water pill with refined honey 50g, and drying is processed big honeyed pills.Every ball contains and is equivalent to Fructus Psoraleae crude drug 1.0g.
The preparation of embodiment 1D, Chinese medicine composition of the present invention
Fructus Psoraleae 100g
Cortex Eucommiae 20g
Radix Salviae Miltiorrhizae 1000g
Rhizoma Anemarrhenae 20g
With above four Chinese medicine pulverize separately, mix, every 100g powder adds an amount of water pill with refined honey 50g, and drying is processed big honeyed pills.Every ball contains and is equivalent to Fructus Psoraleae crude drug 1.0g.
The preparation of embodiment 1E, Chinese medicine composition of the present invention
Fructus Psoraleae 100g
Cortex Eucommiae 300g
Radix Salviae Miltiorrhizae 30g
Rhizoma Anemarrhenae 100g
With above four Chinese medicine pulverize separately, mix, every 100g powder adds an amount of water pill with refined honey 50g, and drying is processed big honeyed pills.Every ball contains and is equivalent to Fructus Psoraleae crude drug 1.0g.
The preparation of embodiment 2A, extract of the present invention
The preparation of step 1, Fructus Psoraleae extract:
Fructus Psoraleae 500g is with 95% alcohol reflux three times, each 10 times of amount 2h.Merge three times extracting solution, decompression recycling ethanol dissolves with 4% sodium hydrate aqueous solution to the greatest extent, adds 10% aqueous hydrochloric acid solution and regulates pH value to neutral, gets the dry Fructus Psoraleae extract 102g of getting of deposition.
The preparation of step 2, Cortex Eucommiae extract:
Concoct Cortex Eucommiae 1kg, cross pulverizer (not adding screen cloth), add 10 times of amounts (10L), 70% alcohol reflux twice, each 2h, merge extractive liquid, reclaims ethanol extremely to the greatest extent, and vacuum drying gets Cortex Eucommiae extract 104g.
The preparation of step 3, Radix Salviae Miltiorrhizae extract:
Radix Salviae Miltiorrhizae 1kg crosses pulverizer (not adding screen cloth), adds 10 times of amounts (10L), 70% alcohol reflux twice, each 2h, and merge extractive liquid, reclaims ethanol to most, and vacuum drying gets Radix Salviae Miltiorrhizae extract 421g.
The preparation of step 4, Rhizoma Anemarrhenae extract:
Rhizoma Anemarrhenae 500g adds 10 times of amounts (5L), 70% alcohol reflux and extracts twice, each 2h, and merge extractive liquid, reclaims ethanol to most, and vacuum drying gets Rhizoma Anemarrhenae extract 108g.
The preparation of step 5, Chinese medicine composition of the present invention:
The one pack system extract that above step 1-4 obtains respectively is even with the mixed of 1.02g: 1.04g: 4.21g: 1.08g, and obtaining four kinds of crude drug ratios is 1: 2: 2: the extract of 1 gained.
The preparation of embodiment 2B, Chinese medicine composition of the present invention
The one pack system extract that embodiment 2A step 1-4 obtains respectively is even with the mixed of 1.02g: 2.08g: 4.21g: 0.54g, and obtaining four kinds of crude drug ratios is 1: 4: 2: the extract of 0.5 gained.
The preparation of embodiment 2C, Chinese medicine composition of the present invention
The one pack system extract that embodiment 2A step 1-4 obtains respectively is even with the mixed of 1.02g: 1.04g: 4.21g: 0g, and obtaining four kinds of crude drug ratios is 1: 2: 2: the extract of 0 gained.
The preparation of embodiment 2D, Chinese medicine composition of the present invention
The one pack system extract that embodiment 2A step 1-4 obtains respectively is even with the mixed of 1.02g: 0.26g: 4.21g: 2.16g, and obtaining four kinds of crude drug ratios is 1: 0.5: 2: the extract of 2 gained.
Embodiment 3: the preparation of Chinese medicine composition of the present invention
The preparation of granule
Prescription is formed:
Fructus Psoraleae 50g Cortex Eucommiae 100g
Radix Salviae Miltiorrhizae 100g Rhizoma Anemarrhenae 50g
Get the extract of step 1-4 gained among the embodiment 2A respectively.Take by weighing Radix Salviae Miltiorrhizae extract 21.05g, Cortex Eucommiae extract 10.4g, Rhizoma Anemarrhenae extract 10.8g mix homogeneously, add 150g Icing Sugar mix homogeneously, it is subsequent use to cross 200 mesh sieves; Take by weighing Fructus Psoraleae extract 10.2g and be dissolved in 80% ethanol, with Fructus Psoraleae extract solution mixed powder is carried out soft material, 80 mesh sieves are granulated.20 mesh sieve granulate are crossed in dry back, the dress aluminium plastic bag, and every bag comprises the Fructus Psoraleae crude drug that is equivalent to 1g.Obtain being the Chinese medicine composition of the present invention of granule dosage form, can be called in the present invention and add the blue or green pretty young woman's granule of flavor.
The test of pesticide effectiveness of embodiment 4, Chinese medicine composition of the present invention
Observed the estrogen action of Chinese medicine composition of the present invention to estrogen deficiency rat (hysterectomy).
4.1 select laboratory animal and raising condition, random packet and reagent
Laboratory animal: select 6 monthly age multiparity female SPF Sprague-Dawley rats (SD) of 52 health, average weight 270 scholar 50g.
Raise the place: Tianjin University Of Traditional Chinese Medicine's animal center.
The raising condition: 4 in the every cage of rat, constant temperature (22 scholar 2) ℃, constant humidity (55% scholar 5%), standard are kept the Mus material and are freely drunk and purify waste water, and freely get food, claim that weekly food is heavy, calculate average every rat amount weekly.
Divide into groups: rat is familiar with environment and weighs after 2 weeks, by the body weight ordering, uses EXCELL generation random number, carries out random packet.Be divided into 6 groups, every group 8～9.The concrete grouping as follows:
Sham group: sham operated rats;
OVX group: ovariectomized group;
BDL group: removal ovary+QINGEFANG is (by Fructus Psoraleae: the Cortex Eucommiae=forms at 1: 2) 1.75 gram crude drug/kg body weight groups (promptly 0.121 restrain embodiment 2A step 1 Fructus Psoraleae extract+0.121 restrain embodiment 2A step 2 Cortex Eucommiae extract/kg body weight rat);
BDH group: removal ovary+QINGEFANG is (by Fructus Psoraleae: the Cortex Eucommiae=forms at 1: 2) 3.5 gram crude drug/kg body weight groups (promptly 0.243 restrain embodiment 2A step 1 Fructus Psoraleae extract+0.243 restrain embodiment 2A step 2 Cortex Eucommiae extract/kg body weight rat);
BDD group: removal ovary+Chinese medicine composition of the present invention (0.243 gram embodiment 2A step 1 Fructus Psoraleae extract+0.243 gram embodiment 2A step 2 Cortex Eucommiae extract+0.491 gram embodiment 2A step 3 Radix Salviae Miltiorrhizae extract/kg body weight rat);
BDDS group: removal ovary+Chinese medicine composition of the present invention (0.243 gram embodiment 2A step 1 Fructus Psoraleae extract+0.243 gram embodiment 2A step 2 Cortex Eucommiae extract+0.491 gram embodiment 2A step 3 Radix Salviae Miltiorrhizae extract+0.126 embodiment 2A step 4 Rhizoma Anemarrhenae extract/kg body weight rat).
4.2 set up animal model
The SD rat at experiment 6 monthly ages of being adopted began to carry out vaginal smear examination in 7 days behind ovarian resection.Castration operation provagina smear shows the oestrous cycle existence, and postoperative only can be observed the leukocyte of metoestrus and diestrus, and the oestrous cycle disappears, and sign OVX performs the operation successfully.
4.3 pharmaceutical intervention
4.3.1 the concrete form of pharmaceutical intervention
Table 1 pharmaceutical intervention is divided into groups
| Divide into groups | Number of animals | Crude drug consumption (gram/kg body weight) |
| The Sham group | 9 | ------ |
| The OVX group | 8 | ------ |
| The BDL group ＊ | 9 | 1.75 |
| The BDH group | 9 | 3.5 |
| The BDD group | 8 | 6 |
| The BDDS group | 9 | 8 |
4.3.2 the pharmaceutical intervention time:
The 3rd week beginning of ovary castration continued medication for 6 weeks.
4.3.3 route of administration:
Irritate stomach, every day 1 time, the set time is 11 o'clock ± 30 minutes morning.
4.3.4 general situation is observed
Sham group rat hair luster is movable good.BDD group rat hair is gloss still, and all the other removal ovary rat trichosis setosas are matt, and are movable not good enough, and the OVX group has 1 rat similar apoplexy symptom to occur, turn-takes, walks lamely.BDL group and BDD organize respectively to be had a rat front tooth to occur to come off.
4.4 Chinese medicine composition of the present invention is to the influence of body weight change
Each organizes the preceding weight ratio of rat medication than no difference of science of statistics; Respectively organizing rat body weight after the medication all increases to some extent, but more also no difference of science of statistics between group.Body weight increase not statistically significant between 6 weeks before and after the research of Sham group.OVX organizes the 5th week beginning weight increase, with the 1st all weight ratios statistical significance (P＜0.05) is arranged; BDL organizes the 4th all weight increase, with weight ratio before the medication statistical significance (P＜0.05) is arranged; BDH organizes and the 4th week began to occur weight increase, with before the medication than statistical significance (P＜0.05) is arranged; Before and after the medication of BDD group between 6 weeks weight ratio than not statistically significant (P＞0.05); BDDS organizes and the 4th week began to occur weight increase, with before the medication than statistical significance (P＜0.05) is arranged, significant difference (P＜0.01) appearred in the 6th week.
Each is organized rat and increases weight difference between 6 weeks relatively, and each organizes rat body weight before and after medication all increases to some extent, and the Sham group increases minimum, and each castration group increases more, and the weightening finish of OVX group is compared P＜0.01 with the Sham group at most
*, sharply decline is relevant with body inner estrogen level after the castration, and each treatment group is compared with the OVX group; All descend to some extent but there was no significant difference (P＞0.05); Though the treatment group is lacked than the Sham group on appetite, the health weightening finish is more than the Sham group, and the weightening finish of BDD group is minimum; BDL group, BDD group compare not statistically significant (P＞0.05) with the Sham group, and BDH group, BDDS group relatively have statistical significance P＜0.05 with the Sham group
*
The result shows, Chinese medicine composition of the present invention has and alleviates fat effect trend after the menopause, and is the most remarkable with BDD group curative effect.
Table 2 is respectively organized rat study front and rear body body weight gains situation (unit: gram)
| Divide into groups | Number of animals | Body weight before the treatment | Treatment back body weight | Weightening finish |
| The Sham group | 9 | 265.11±31.07 | 284.67±43.85 | 19.56±14.50 |
| The OVX group | 8 | 255.75±35.03 | 302.25±49.40 | 46.50±20.04 ＊＊ |
| The BDL group | 9 | 253.11±25.95 | 288.11±34.52 | 35.00±26.32 |
| The BDH group | 9 | 245.56±24.96 | 282.67±29.21 | 38.22±15.30 ＊ |
| The BDD group | 9 | 260.63±53.64 | 289.13±50.76 | 28.50±13.08 |
| The BDDS group | 8 | 250.38±29.032 | 304.63±41.08 | 41.75±20.08 ＊ |
Compare with the Sham group,
*P＜0.05,
*P＜0.01.
Result displayed proves in the last table, and BDD group can obviously can reduce the weightening finish of rat basically with respect to QINGEFANG, alleviates fat trend after the menopause
4.5 Chinese medicine composition of the present invention is to the influence of blood fat
OVX group and BDL group TG significantly raise after the rat castration, compare P＜0.01 with the Sham group, obviously descend to TG level after the traditional Chinese medicine composition for treating of the present invention; Each treatment group and OVX group has been compared significant difference (▲ ▲ P＜0.01); BDD group has been compared statistical significance (● P＜0.05) with the BDL group, the TG level of BDH group, BDD group and BDDS group is reduced to normally, and is wherein the most remarkable with BDD group effect; Explain that to add behind the Radix Salviae Miltiorrhizae effect of TG reducing more obvious, and dosage correlation is arranged.
TC all increases after the rat castration, and the OVX group increases the most remarkable, compare with the Sham group,
*P＜0.05 descends after the administration to some extent, but the administration group is compared not statistically significant (P＞0.05) with the OVX group.
Castration is respectively organized rat HDL level and is significantly raise than the Sham group
*P＜0.01, each treatment group of Chinese medicine composition of the present invention is compared not statistically significant (P＞0.05) with the OVX group.But the ratio Analysis of HDL/TC shows (seeing table 6); The ratio of BDH group, BDD group and BDDS group has been compared statistical significance (P＜0.05 or P＜0.01) with the OVX group; And BDH group and BDDS group have been compared statistical significance (● P＜0.05) with the BDL group, explain that medicine has dosage correlation on increase HDL level.
After the castration OVX group LDL compare with the Sham group remarkable rising ▲ ▲ P＜0.01, each administration group LDL level is reduced to normally, organizes with OVX and has compared significant difference (▲ ▲ P＜0.01).
The result shows that Chinese medicine composition of the present invention can reduce TC, LDL, and the level of rising HDL is having remarkable effect aspect the lipid metabolism regulating, and is the most outstanding with BDH, BDD, three groups of BDDS especially.
Table 3 is respectively organized rat fat level (unit: mg/dl)
| Divide into groups | Number of animals | TG | TC | HDL | LDL |
| The Sham group | 9 | 0.772±0.284 | 2.406±0.547 | 0.884±0.148 | 0.414±0.146 |
| The OVX group | 8 | 1.644±0.877 ＊＊ | 2.931±0.612 ＊ | 1.046±0.116 ＊＊ | 0.676±0.362 ＊＊ |
| The BDL group | 9 | 1.006±0.418▲▲ ＊＊ | 2.824±0.509 | 1.078±0.149 ＊＊ | 0.396±0.167▲▲ |
| The BDH group | 9 | 0.666±0.074▲▲ | 2.682±0.188 | 1.131±0.096 ＊＊ | 0.411±0.107▲▲ |
| The BDD group | 9 | 0.478±0.049▲▲● | 2.757±0.312 | 1.095±0.066 ＊＊ | 0.399±0.044▲▲ |
| The BDDS group | 8 | 0.596±0.087▲▲ | 2.735±0.294 | 1.138±0.085 ＊＊ | 0.408±0.047▲▲ |
Compare with the Sham group,
*P＜0.05,
*P＜0.01;
Compare with the OVX group, ▲ P＜0.05, ▲ ▲ P＜0.01;
Compare with the BDL group, ● P＜0.05, ● ● P＜0.01.Down together.
Table 4 is respectively organized the percentage ratio that HDL accounts for TC
| Divide into groups | Number of animals | HDL/TC |
| The Sbam group | 9 | 37.23±3.48 |
| The OVX group | 8 | 36.34±4.01 |
| The BDL group | 9 | 38.46±2.44 |
| The BDH group | 9 | 42.18±2.19▲▲ ＊● |
| The BDD group | 9 | 39.93±2.67▲ |
| The BDDS group | 8 | 41.72±1.81▲▲ ＊● |
Compare with the Sham group,
*P＜0.05,
*P＜0.01
Compare with the OVX group, ▲ P＜0.05, ▲ ▲ P＜0.01
Compare with the BDL group, ● P＜0.05, ● ● P＜0.01
4.6 Chinese medicine composition of the present invention is to the influence of serum gonadal hormone content
After the ovariectomized rats, OVX group serum FSH, LH significantly increase, compare with the Sham group,
* *P＜0.001; The modeling method that this institute is selected for use is described; Its mimic gonadal hormone environment meet the gonadal hormone situation of perimenopausal syndrome, Chinese medicine composition administration group of the present invention and OVX group be not statistically significant (P＞0.05) relatively, explains that medicine can not change the endocrine function of hypophysis; Behind the removal ovary, OVX group serum E
2Level significantly reduces, and compares with the Sham group
* *P＜0.001, three groups of BDL, BDH, BDD compare with the Sham group
*P＜0.05, and the BDDS group is compared not statistically significant (P＞0.05) with the Sham group, but compare E with the OVX group
2Significantly raise (▲ ▲ P＜0.01).The result shows that medicine has E in the body of promotion
2Excretory effect is especially with the effect of BDDS group significantly (seeing table 5).
Table 5 serum FSH, LH, E
2Level
| Divide into groups | Number of animals | FSH(ng/ml) | LH(ng/ml) | E 2(pg/ml) |
| The Sham group | 9 | 5.86±2.67 | 0.38±0.08 | 14.05±3.77 |
| The OVX group | 8 | 51.40±21.00 ＊＊＊ | 4.22±1.28 ＊＊＊ | 8.26±2.73 ＊＊＊ |
| The BDL group | 9 | 45.81±13.28 ＊＊＊ | 4.64±2.10 ＊＊＊ | 10.40±3.39 ＊ |
| The BDH group | 9 | 53.01±18.94 ＊＊＊ | 3.81±1.27 ＊＊＊ | 10.83±5.05 ＊ |
| The BDD group | 9 | 51.11±12.31 ＊＊＊ | 4.71±1.13 ＊＊＊ | 10.87±3.02 ＊ |
| The BDDS group | 8 | 52.18±15.91 ＊＊＊ | 3.91±0.60 ＊＊＊ | 12.18±3.87▲▲ |
Compare with the Sham group,
*P＜0.05,
*P＜0.01,
* *P＜0.001
Compare with the OVX group, ▲ P＜0.05, ▲ ▲ P＜0.01
4.7 Chinese medicine composition of the present invention is to the influence of uterus weight in wet base and uterus coefficient
Behind the removal ovary; Rat uterus weight in wet base and Sham group is compared remarkable reduction (P＜0.01), give traditional Chinese medicine composition for treating of the present invention after the uterus weight in wet base raise to some extent, the BDD group is organized with OVX with the BDDS group and is compared; Uterus weight has statistical significance (P＜0.05); All the other two treatment groups are compared with the OVX group, and not statistically significant (P＞0.05) is seen table 6.Explain that Chinese medicine composition of the present invention has uterotropic effect, the most remarkable with BDD group and BDDS group.
The result shows; Castration is respectively organized the rat uterus coefficient and is compared remarkable reduction (P＜0.01) with the Sham group; The uterus coefficient raises to some extent after traditional Chinese medicine composition for treating of the present invention, but still compares not statistically significant (P＞0.05) with the OVX group, explains that medicine has faint estrogen-like effects.
Table 6 is respectively organized rat uterus weight in wet base and uterus coefficient
| Divide into groups | Number of animals | Uterus weight in wet base (g) | Body weight (g) | The uterus coefficient |
| The Sham group | 9 | 0.566±0.132 | 284.67±43.85 | 0.2124±0.0489 |
| The OVX group | 8 | 0.176±0.025 | 302.25±49.40 | 0.0641±0.0164 |
| The BDL group | 9 | 0.193±0.032 | 288.11±34.52 | 0.0720±0.0153 |
| The BDH group | 9 | 0.204±0.030 | 282.67±29.21 | 0.0776±0.0134 |
| The BDD group | 9 | 0.211±0.028▲ | 289.13±50.76 | 0.078±0.0148 |
| The BDDS group | 8 | 0.209±0.039▲ | 304.63±41.08 | 0.0758±0.012 |
Annotate: compare ▲ P＜0.05 with the OVX group
4.8 Chinese medicine composition of the present invention is to the influence of bone density
4.8.1 drawing materials of bone
Dissect and separation right side tibia, reject muscle and the flesh key that is adhered to rapidly, soft tissue is rejected clean but is not destroyed periosteum as far as possible.Put into fixing 1 week of 70% alcoholic solution then, send the institute of materia medica, Shanghai, be used for peripheral bone QCT (pQCT) and measure.
4.8.2 bone density detects
Elder generation is to tibia sample longitudinal scanning during detection; After showing the form of proximal tibia, be that downward 3.0mm of basic point and 12.0mm place make tomography mensuration with the osteoepiphyseal line, the former is main with spongy bone; Latter's Compact bone is many, can reflect by the examination chemical compound osseous tissue different parts effect on structure.
4.8.3 testing result is expressed:
The total bone density in tested position, trabecular bone density and cortical bone density are represented with mg/cm3.
4.8.4 Chinese medicine composition of the present invention is to the influence of bone density
The test section distance of positions osteoepiphyseal line 3.0mm bone density result of place (seeing table 7) shows that bone trabecula density, total bone density reduce after the ovariectomized rats, but cortical bone density does not have obvious change.After giving traditional Chinese medicine composition for treating of the present invention, bone trabecula density and total bone density all obtain increasing, especially the BDD group; Improve significantly, compare P＜0.05 with OVX group, BDH group; Explain to add to have strengthened the effect that QINGEFANG improves bone density behind the Radix Salviae Miltiorrhizae, make estrogen effect more obvious.
Table 7 Chinese medicine composition of the present invention to right side tibial bone density influence 1
Annotate: test section distance of positions osteoepiphyseal line 3.0mm place; VS OVX,
▲P＜0.05, VS BDH,
★P＜0.05.
The test section distance of positions osteoepiphyseal line 12.0mm bone density result of place (seeing table 8) shows that bone trabecula density, total bone density reduce after the ovariectomized rats, but cortical bone density does not have obvious change.After giving traditional Chinese medicine composition for treating of the present invention, bone trabecula density and total bone density all obtain increasing, especially BDH and BDDS group; Improvement to bone trabecula density is obvious, and BDH compares P＜0.05 with the BDL group, and the BDDS group is compared with OVX group, BDL group; P＜0.05; Explain that QINGEFANG enhance bone density has dose dependent, strengthened the improvement effect of QINGEFANG after adding Radix Salviae Miltiorrhizae, make estrogen effect more obvious bone density.
Table 8 Chinese medicine composition of the present invention to right side tibial bone density influence 2
Annotate: test section distance of positions osteoepiphyseal line 12.0mm place; VS OVX,
▲P＜0.05, VS BDL,
●P＜0.05.
4.9 the influence that Chinese medicine composition of the present invention is expressed uterus C3, Clu, PCNA, IGF-1mRNA
C3: the mRNA of removal ovary rat uterus C3 expresses all and descends, compares with Sham, and P except that BDH＜0.05 or P＜0.01, each treatment group of blue or green pretty young woman's ball all has trend of rising than the OVX group; Clu: compare with Sham, the mRNA of removal ovary rat uterus Clu expresses all and raises (P＜0.05 or P＜0.01), and the trend of reduction is arranged after traditional Chinese medicine composition for treating of the present invention; PCNA: compare with the OVX group, the mRNA of BDD group PCNA expresses to reduce has statistical significance (P＜0.05); IGF-1: each mRNA that organizes rat uterus IGF-1 expresses there was no significant difference P＞0.05, after the ovariectomized rats, all has IGF-1 to express downward trend, but and not statistically significant.Explain that adding behind the Radix Salviae Miltiorrhizae apoptosis of castrated rats may accelerate, medicine does not cause endometrial proliferation.
Table 9 is respectively organized rat uterus C3, Clu, PCNA, IGF-1 mRNA expression
Compare with the Sham group,
*P＜0.05,
*P＜0.01; Compare ▲ P＜0.05 with the OVX group;
Compare with the BDL group, ● P＜0.05.
Claims (14)
1. one kind has the Chinese medicine composition that phytoestrogen appearance acts on; It consists of: effectively among treatment or the prevention experimenter with body inner estrogen off-leveling diseases associated or improve Fructus Psoraleae, the Cortex Eucommiae and the Radix Salviae Miltiorrhizae of the amount of its symptom; And optional pharmaceutically acceptable auxiliary substance, wherein the weight ratio of Fructus Psoraleae, the Cortex Eucommiae and Radix Salviae Miltiorrhizae is 1: 0.2～10: 0.2～10.
2. according to the Chinese medicine composition of claim 1, wherein the weight ratio of Fructus Psoraleae, the Cortex Eucommiae and Radix Salviae Miltiorrhizae is 1: 0.5～4: 0.5～4.
3. according to the Chinese medicine composition of claim 1, wherein the weight ratio of Fructus Psoraleae, the Cortex Eucommiae and Radix Salviae Miltiorrhizae is 1: 2: 2,1: 4: 2 or 1: 0.5: 2.
4. one kind has the Chinese medicine composition that phytoestrogen appearance acts on; It consists of: effectively among treatment or the prevention experimenter with body inner estrogen off-leveling diseases associated or improve Fructus Psoraleae ethanol extraction, Cortex Eucommiae ethanol extraction and the Radix Salviae Miltiorrhizae ethanol extraction of the amount of its symptom; And optional pharmaceutically acceptable auxiliary substance; The weight ratio of wherein said Fructus Psoraleae ethanol extraction, Cortex Eucommiae ethanol extraction and Radix Salviae Miltiorrhizae ethanol extraction is 1: 0.2～5: 1～5
Wherein said Fructus Psoraleae ethanol extraction, Cortex Eucommiae ethanol extraction and Radix Salviae Miltiorrhizae ethanol extraction prepare through following method respectively:
The ethanol that in the Fructus Psoraleae crude drug, adds the several times amount; Reflux, extract, to the greatest extent, is dissolved the residue that obtains from the extracting solution decompression recycling ethanol with sodium hydrate aqueous solution; In the solution that obtains, add aqueous hydrochloric acid solution then; Its pH value is adjusted to neutrality, and the collecting precipitation thing is also dry, obtains the Fructus Psoraleae ethanol extraction;
To concoct the Cortex Eucommiae and cross pulverizer, in the powder that obtains, add the ethanol of several times amount, reflux, extract,, decompression recycling ethanol is extremely most from extracting solution, and with the residue vacuum drying, obtains Cortex Eucommiae ethanol extraction;
Radix Salviae Miltiorrhizae is crossed pulverizer, in the powder that obtains, add the ethanol of several times amount, reflux, extract,, decompression recycling ethanol is extremely most from extracting solution, and with the residue vacuum drying, obtains the Radix Salviae Miltiorrhizae ethanol extraction.
5. according to the Chinese medicine composition of claim 4, the weight ratio of wherein said Fructus Psoraleae ethanol extraction, Cortex Eucommiae ethanol extraction and Radix Salviae Miltiorrhizae ethanol extraction is 1: 0.5～2: 2～4.
6. according to the Chinese medicine composition of claim 4, the weight ratio of wherein said Fructus Psoraleae ethanol extraction, Cortex Eucommiae ethanol extraction and Radix Salviae Miltiorrhizae ethanol extraction is 1: 1: 4,1: 0.25: 4 or 1: 2: 4.
7. one kind has the Chinese medicine composition that phytoestrogen appearance acts on; It consists of: effectively among treatment or the prevention experimenter with body inner estrogen off-leveling diseases associated or improve Fructus Psoraleae, the Cortex Eucommiae, Radix Salviae Miltiorrhizae and the Rhizoma Anemarrhenae of the amount of its symptom; And optional pharmaceutically acceptable auxiliary substance, wherein the weight ratio of Fructus Psoraleae, the Cortex Eucommiae, Radix Salviae Miltiorrhizae and the Rhizoma Anemarrhenae is 1: 0.2～10: 0.2～10: 0.2～5.
8. according to the Chinese medicine composition of claim 7, wherein the weight ratio of Fructus Psoraleae, the Cortex Eucommiae, Radix Salviae Miltiorrhizae and the Rhizoma Anemarrhenae is 1: 0.5～4: 0.5～4: 0.5～4.
9. according to the Chinese medicine composition of claim 7, wherein the weight ratio of Fructus Psoraleae, the Cortex Eucommiae, Radix Salviae Miltiorrhizae and the Rhizoma Anemarrhenae is 1: 2: 2: 1,1: 4: 2: 0.5 or 1: 0.5: 2: 2.
10. one kind has the Chinese medicine composition that phytoestrogen appearance acts on; It consists of: effectively among treatment or the prevention experimenter with body inner estrogen off-leveling diseases associated or improve the Fructus Psoraleae ethanol extraction of the amount of its symptom; Cortex Eucommiae ethanol extraction; Radix Salviae Miltiorrhizae ethanol extraction and Rhizoma Anemarrhenae ethanol extraction; And optional pharmaceutically acceptable auxiliary substance; Fructus Psoraleae ethanol extraction wherein; Cortex Eucommiae ethanol extraction; The weight ratio of Radix Salviae Miltiorrhizae ethanol extraction and Rhizoma Anemarrhenae ethanol extraction is 1: 0.2～5: 1～5: 0.5～5
Wherein said Fructus Psoraleae ethanol extraction, Cortex Eucommiae ethanol extraction, Radix Salviae Miltiorrhizae ethanol extraction and Rhizoma Anemarrhenae ethanol extraction prepare through following method respectively:
The ethanol that in the Fructus Psoraleae crude drug, adds the several times amount; Reflux, extract, to the greatest extent, is dissolved the residue that obtains from the extracting solution decompression recycling ethanol with sodium hydrate aqueous solution; In the solution that obtains, add aqueous hydrochloric acid solution then; Its pH value is adjusted to neutrality, and the collecting precipitation thing is also dry, obtains the Fructus Psoraleae ethanol extraction;
To concoct the Cortex Eucommiae and cross pulverizer, in the powder that obtains, add the ethanol of several times amount, reflux, extract,, decompression recycling ethanol is extremely most from extracting solution, and with the residue vacuum drying, obtains Cortex Eucommiae ethanol extraction;
Radix Salviae Miltiorrhizae is crossed pulverizer, in the powder that obtains, add the ethanol of several times amount, reflux, extract,, decompression recycling ethanol is extremely most from extracting solution, and with the residue vacuum drying, obtains the Radix Salviae Miltiorrhizae ethanol extraction;
The ethanol that in Rhizoma Anemarrhenae crude drug, adds the several times amount, reflux, extract,, decompression recycling ethanol with the residue vacuum drying, obtains Rhizoma Anemarrhenae ethanol extraction to the greatest extent from extracting solution.
11. according to the Chinese medicine composition of claim 10, the weight ratio of wherein said Fructus Psoraleae ethanol extraction, Cortex Eucommiae ethanol extraction, Radix Salviae Miltiorrhizae ethanol extraction and Rhizoma Anemarrhenae ethanol extraction is 1: 0.5～4: 3～5: 1～2.
12. according to the Chinese medicine composition of claim 10, the weight ratio of wherein said Fructus Psoraleae ethanol extraction, Cortex Eucommiae ethanol extraction, Radix Salviae Miltiorrhizae ethanol extraction and Rhizoma Anemarrhenae ethanol extraction is 1: 1: 4: 1 or 1: 0.25: 4: 2.
13. each Chinese medicine composition of claim 1 to 12 is used for treating or prevents experimenter and body inner estrogen off-leveling diseases associated or improve the purposes in the medicine of its symptom in preparation.
14. according to the purposes of claim 13, wherein said and body inner estrogen off-leveling diseases associated or symptom are selected from climacteric syndrome and postmenopausal women's atherosclerosis and osteoporosis.
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