CN102935144B - Drug for treating climacteric syndrome and preparation process of drug - Google Patents
Drug for treating climacteric syndrome and preparation process of drug Download PDFInfo
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- CN102935144B CN102935144B CN201210474788.0A CN201210474788A CN102935144B CN 102935144 B CN102935144 B CN 102935144B CN 201210474788 A CN201210474788 A CN 201210474788A CN 102935144 B CN102935144 B CN 102935144B
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Abstract
The invention discloses a drug for treating climacteric syndrome and a preparation process of the drug. The drug is characterized by comprising, by weight, 10-20 parts of maca, 5-15 parts of herba epimedii, 5-15 parts of glossy privet fruits, 5-15 parts of leonurus, 5-15 parts of radix astragali, 5-15 parts of roots of kudzu vine, 5-15 parts of rehmannia, 5-15 parts of radix paeoniae alba, 3-10 parts of donkey-hide gelatin and 5-10 parts of fruits of Chinese wolfberries. The drug is good for regulating and nourishing kidney deficiencies, nourishing the blood and the liver, supplementing the energy and clearing away heat and toxic materials, is significant in improvement effect of the climacteric syndrome and is good in application prospects.
Description
technical field
The invention belongs to field of traditional Chinese, be specifically related to a kind of medicine for the treatment of climacteric syndrome and preparation method thereof.
Background technology
Climacteric is that women transits to a senile inevitable physiological process from fertility and sexual function normal period, women's ovary function disappears to the transition period disappeared completely gradually in other words conj.or perhaps, enter the old important turnover stage from the middle age, be the period with significant physiological change, its time of origin is generally between 45-55 year.Although this is an inevitable physiological process in women latter half of one's life, there is the series of symptoms that causes due to estrogen decrease and complication in the women of quite a few, comprise the disease of autonomic nervous dysfunction, these are called climacteric syndrome during this period.The traditional Chinese medical science is referred to as " before and after menopause all diseases ", and its incidence rate report differs, may be different from diagnostic criteria and investigation method relevant.The menopause syndrome incidence rate of whole nation woman in menstrual period physical constants cooperative groups investigation is 70%, and the climacteric women of nearly about 20% there will be moderate or severe symptomatic, and with a series of mental symptom, even may can produce distracting thoughts of committing suicide.In this process, kidney qi degradation, rushes conception vessel void, negative and positive disequilibrium, visceral dysfunction.Main manifestations is fertility and sexual disorder, menoxenia, is reduced to termination." Plain Questions ancient times innocence opinion " cloud: " ... seventy-seven conception vessels are empty, and taichong channel is few, exhaustion of kidney-essence with promoting reproductive function, menopause, therefore senile appearance and loss of fecundity are also." this period except change in menstrual cycle characteristics; due to impacts such as individual variation, living environment, Nervous and Mental Factors, be for the moment not suitable with these physiological changies, and usually occur series of symptoms: dizziness and tinnitus; insomnia and dreamful sleep; susceptible to lose temper due to restlessness, warm sweating, dysphoria with feverish sensation in the chest palms and soles; or cardiopalmus is had palpitation; or edema loose stool, soreness of the loins and bones, even mood disorders.If in involutional, severe symptomatic do not treated, can the disease such as secondary arrhythmia, hypertension, hyperlipemia, diabetes, atherosclerosis, osteoporosis, alzheimer disease.
The pathogeny of climacteric syndrome is mainly before and after women's nearly menopause, kidney qi degradation, and virtual loss is appointed in punching, menses will exhaust, asthenia of essence and blood, there is deficiency of kidney yin in imbalance between YIN and YANG, sun loses hiding, or kidney yang deficiency, passages through which vital energy circulates loses contains in kidney yin kidney yangs such as replenishing vital QI with drugs of warm nature the phenomenon that partially declines partially, thus causes function not normal, the particularly changes of function of kidney,liver,spleen, the heart, thus produces a series of symptomes complice in various degree.Therefore suffer from a deficiency of the kidney be pathogenic this.Due to individual variation, there is deficiency of the kidney yin again clinically, insufficiency of kidney-YANG, or deficiency in both YIN and YANG in kidney, the different manifestations such as hepatic depression and blood deficiency, deficiency of spleen-YANG and kidneyYANG, hyperactivity of hesrt-fire and liver-fire, disarmony between the heart and kidney, and the most common with deficiency of the kidney yin.In addition, climacteric syndrome belongs to psychosomatic medicine category, its morbidity not only has physiologic factor and closely related with psychologic factors, clinical when being everlasting excited or nervous symptom take place frequently, due to body constitution, the psychological characteristics of some women, more easily make negative and positive be weighed climacteric, often cause wood fire liter and send out, heart-fire is recklessly acted, and folder blood stasis expectorant heat of can holding concurrently.In recent years, along with development and the attention of country to female health of society, existing increasing women pays close attention to involutional malaise symptoms, and seeks medical advice in time and take medicine.At present, along with the quickening of social senilization's process, the number of women that Ye Shi China is about to enter into the climacteric period increases sharply.According to estimates, China in 2010 women of more than 50 years old reaches 1.9 hundred million, will reach 2.5 hundred million by 2015.What wherein have obvious menopause syndrome about has 20%, and the people of 5% then has serious symptoms.So how to make women's safety tide over climacteric, the old age having physiology and psychology is healthy, is the focus of medical circle research always.And climacteric syndrome medicine, contain the huge market space especially.
Modern medicine is treated menopausal syndrome at present and is mainly applied controversies in hormone replacement in the elderly (ERT), the history having arrived nearly 60 years so far.Clinical confirmation, ERT can prevent from even reversing climacteric women coronary heart disease, cerebrovascular, senile dementia, osteoporosis, delays the decline of ovarian function, makes women keep good physiological function and mental status, improves the quality of life of climacteric women.But its defect is, prolonged application ERT likely brings out breast carcinoma, carcinoma of endometrium, and the untoward reaction such as irregular hemorrhage, the body weight increase of vagina may be produced, and resonable touch upon clinical in still have many an open questions, as the mutual relation between various gonadal hormone (estrogen, androgen, progestogen), the effect of gonadal hormone, dosage, the problem such as ratio and SM time, drug usage individuation, so make the popularization of ERT be restricted.
Chinese medicine is then thought, the generation of primary disease, is mainly asthenia of renal qi, and punching is appointed not enough, visceral dysfunction.Kidney essense is sufficient, then kidney qi is in harmonious proportion, quiet and keep position, unlikely interior vehement rash action.And extremely over seventy-seven (namely 49 years old), essence and blood loss, then kidney qi is without institute's usage, guards dereliction, on disturb conscience, then can priming flaming up of the ministerial fire, upset gods, cause the state of mind to be lost peaceful, rise in asthenic fire, occur warming perspirations, uneasy sleeping at night, cardiopalmus of having palpitation, cry and laugh by turns, without any apparent reason, the symptom such as vertigo and tinnitus.Clinically primary disease is divided into: deficiency of the kidney yin. insufficiency of kidney-YANG, stagnation of liver-QI, deficiency of spleen-YANG and kidneyYANG. hyperactivity of hesrt-fire and liver-fire, six kinds of disease types such as disarmony between the heart and kidney.So treatment should be appointed based on the kidney invigorating gas, tune punching, Yin Yang balancing, being aided with regulating liver-QI, regulation of mental activities as the main rule for the treatment of climacteric syndrome, is also the current most widely used rule for the treatment of clinically.But the Chinese medicine of actual existing treatment climacteric syndrome, comprise brain-invigorating and kidney-tonifying pill, the peaceful ball of climacteric, the goddess in the moon add beautiful ball, female precious ball, Gengnianling Capsule, the refreshing curing capsule that relaxes, climacteric protect soft capsule, GENGNIANAN PIAN, Gengnianshu, the peaceful sheet of the kidney invigorating, norlutin, Gengnianle sheet, climacteric health, benefit be female rather etc., on curing mainly or the kidney invigorating, or regulating liver-QI, or warming YANG, or YIN nourishing, biased all to some extent.And 201010228049.4, prescription disclosed in 200810111632.X and 201110400664.3 also mainly improves the symptom of climacteric syndrome hyperactivity of fire caused by deficiency of YIN, though effective, and unsatisfactory.Though clinically primary disease is divided into deficiency of the kidney yin. insufficiency of kidney-YANG, stagnation of liver-QI, deficiency of spleen-YANG and kidneyYANG. hyperactivity of hesrt-fire and liver-fire, six kinds of disease types such as disarmony between the heart and kidney.But above disease type is not simple to be existed, or deficiency of both YIN and YANG, or folder blood stasis expectorant heat etc. of holding concurrently.Therefore, for the scarce limit of existing medicine, development awaits research and development to the medicine that multiple disease type is effectively used for the treatment of climacteric syndrome safely.
Lepidinm meyenii Walp (Lepidium meyenii, Maca), being the annual or 2 years raw herbaceous plant of Cruciferae (Cruciferae) separate row Vegetable spp (Lepidium), is have the medicine food dual purpose plant improving sexuality, endocrine regulation, fatigue-resisting function.Lepidinm meyenii Walp originates in the mountain area, Andean of Peru's height above sea level 3500 to 4500 meters, plants experimentally successfully on Yunnan Province of China, Xinjiang, Qinghai and other places now.At present, China has established normalized nursery and artificial growth system, achieves the artificial growth of scale, and annual dry product Lepidinm meyenii Walp output can reach more than 100 tons.Lijiang, yunnan, Xinjiang TAXKORGAN have become the maximum planting base of China's Lepidinm meyenii Walp.Lepidinm meyenii Walp except have improve sexuality, resisting fatigue etc. effect except, Lepidinm meyenii Walp can regulate body incretion balance, has good effect to climacteric syndrome and osteoporosis.The present invention take Lepidinm meyenii Walp as principal agent, with Traditional Chinese doctors ' theory for instructing, through years of researches, have developed the formula making us comparatively being satisfied with.
Summary of the invention
In order to overcome the above-mentioned deficiency of prior art, primary technical problem to be solved by this invention is to provide a kind of medicine for the treatment of climacteric syndrome.
Another technical problem to be solved by this invention is the preparation method providing said medicine.
The technical problem that the present invention also will solve is to provide the application of said medicine.
Treat a medicine for climacteric syndrome, comprise the raw material of following parts by weight:
Lepidinm meyenii Walp 10-20 weight portion; Herba Epimedii 5-15 weight portion; Fructus Ligustri Lucidi 5-15 weight portion; Herba Leonuri 5-15 weight portion; Radix Astragali 5-15 weight portion; Radix Puerariae 5-15 weight portion; Radix Rehmanniae 5-15 weight portion; Radix Paeoniae Alba 5-15 weight portion; Colla Corii Asini 3-10 weight portion; Fructus Lycii 5-10 weight portion.
In this side, inventor introduce nourishing the liver and kidney, adjust Gu Chong to appoint; Not only tonifying kidney-yin but also kidney-replenishing viewpoint; Think and to control simultaneously negative and positive are two, also answer regulating liver-QI, nourish blood, regulation of mental activities; Tonifying both YIN and YANG, treating both the principal and secondary aspects of a disease, can obtain special effect.When human body enters into the climacteric period, there is virtual loss in primordial essence vigour, menses day degradation few, internal organs imbalance of YIN and YANG, there will be the exception of various pathology and psychological aspects.So the party is basic with " adjust tonifying kidney-yin kidney yang " in the rule for the treatment of.Lepidinm meyenii Walp (Lepidium meyenii) energy kidney invigorating and YANG supporting, bone and muscle strengthening in side; Herba Epimedii sweet in the mouth, warm in nature, enter liver, kidney two warp, energy the kidney invigorating and essence nourishing, promotes the generation of menses; Fructus Ligustri Lucidi sweet in the mouth, hardship, cool in nature, return liver, kidney two warp, energy nourishing the liver and kidney, improving eyesight black hair; Herba Leonuri bitter in the mouth, pungent, cold nature, GUIXIN, liver, bladder three warp, can promoting blood flow to regulate menstruation, inducing diuresis to remove edema, heat-clearing and toxic substances removing; Radix Astragali sweet in the mouth, warm in nature, can strengthening QI of middle-JIAO, yang invigorating strengthening superficial resistance to stop perspiration, to grow the source of blood; Radix Puerariae sweet in the mouth, pungent, cool in nature, return spleen, stomach, lung three warp, can expelling pathogenic factors from muscles for reducing heat, promoting the production of body fluid to quench thirst, yang invigorating antidiarrheal, dredge the meridian passage; Radix Rehmanniae sweet in the mouth, cold in nature; GUIXIN, liver, lung three warp, energy clearing away heat and cooling blood, YIN nourishing and the production of body fluid promoting; Radix Paeoniae Alba bitter in the mouth, acid, cold nature, returns liver, spleen two warp, energy nourishing blood to suppress the hyperactive liver, pain relieving in slow; Colla Corii Asini sweet in the mouth, property is put down, and returns lung, liver, kidney three warp.To enrich blood YIN nourishing, to moisturize, hemostasis; Fructus Lycii sweet in the mouth, property is put down, and returns liver, kidney two warp, energy nourishing the liver and kidney, replenishing vital essence to improve eyesight.Reusing Lepidinm meyenii Walp and Herba Epimedii, Fructus Ligustri Lucidi, Fructus Lycii compatibility in side, is basic with " adjusting tonifying kidney-yin kidney yang "; In side, Colla Corii Asini closes the Radix Astragali with blood-nourishing blood-generating, plays the effect of tonifying both YIN and YANG altogether with Lepidinm meyenii Walp and excessive sheep flower bud, Fructus Ligustri Lucidi, Fructus Lycii; In side, Herba Leonuri, Radix Puerariae, Radix Rehmanniae, the Radix Paeoniae Alba share energy promoting blood flow to regulate menstruation, dredge the meridian passage, YIN nourishing and the production of body fluid promoting, nourishing blood to suppress the hyperactive liver, play the two merit controlled of specimen altogether; Full side share, and reach and adjust tonifying kidney-yin kidney yang, nourishing blood to suppress the hyperactive liver, the effect of supplementing QI and nourishing YIN, heat clearing away mind calming, can treat climacteric syndrome preferably.As " kind YANG invigorating person, must in treating YANG within YIN, then positive cloudy helping and biochemical infinite: kind nourishing YIN person, must in treating YIN within YANG, then cloudy positive liter, and source is inexhaustible.”
As a kind of preferred version, described medicine comprises the raw material of following parts by weight:
Lepidinm meyenii Walp 15-20 weight portion; Herba Epimedii 10-15 weight portion; Fructus Ligustri Lucidi 10-15 weight portion; Herba Leonuri 10-15 weight portion; Radix Astragali 10-15 weight portion; Radix Puerariae 10-15 weight portion; Radix Rehmanniae 10-15 weight portion; Radix Paeoniae Alba 10-15 weight portion; Colla Corii Asini 5-10 weight portion; Fructus Lycii 5-10 weight portion.
As one most preferably scheme, described medicine comprises the raw material of following parts by weight:
Lepidinm meyenii Walp 16 weight portion; Herba Epimedii 10 weight portion; Fructus Ligustri Lucidi 10 weight portion; Herba Leonuri 10 weight portion; The Radix Astragali 10 weight portion; Radix Puerariae 10 weight portion; Radix Rehmanniae 10 weight portion, the Radix Paeoniae Alba 10 weight portion; Colla Corii Asini 5 weight portion; Fructus Lycii 8 weight portion.
As one most preferably scheme, described Lepidinm meyenii Walp is the Lepidinm meyenii Walp of yellow Lepidinm meyenii Walp, purple Lepidinm meyenii Walp, red Lepidinm meyenii Walp, white Lepidinm meyenii Walp or other colors.
As a kind of preferred version, described Radix Rehmanniae is Radix Rehmanniae.
As a kind of preferred version, described medicine is peroral dosage form.
As one most preferably scheme, described medicine is tablet, pill, drop pill, capsule, soft capsule or granule.
The preparation method of medicine of the present invention, comprises the steps:
(1) filter after getting Lepidinm meyenii Walp and Herba Epimedii alcohol extraction, obtain filtrate;
(2) filter after getting Fructus Ligustri Lucidi and Radix Puerariae alcohol extraction, the filtrate that filtrate and step (1) obtain is merged, is then concentrated into the thick paste that relative density is 1.28-1.35;
(3) the Lepidinm meyenii Walp medicinal residues after alcohol extraction in step (1) and Herba Epimedii medicinal residues are merged with the Radix Astragali, Radix Rehmanniae, the Radix Paeoniae Alba, Herba Leonuri, Fructus Lycii, with soak by water, filtrate to relative density is the thick paste of 1.28-1.35 by filtration;
(4) get pretending of Colla Corii Asini, the thick paste obtained with step (2) and (3) is mixed homogeneously, and dry, pulverize into fine powder.
As a kind of preferred version, step (1) and the alcohol extraction described in (2) refer to that adding 6-12 60%-95% alcohol heating reflux doubly extracts 2-3 time, each 1-2 hour.6-12 times of described 60%-95% ethanol consumption refers to, the ratio of ethanol consumption and medical material consumption is 6-12L:1KG.
As a kind of preferred version, it is characterized in that the Lepidinm meyenii Walp described in step (1) and Herba Epimedii extract 2 times with 80% alcohol heating reflux, first time and second time alcohol adding amount for being respectively 10 times and 8 times, each 1.5 hours of each return time; Fructus Ligustri Lucidi described in step (2) and Radix Puerariae extract 3 times with 85% alcohol heating reflux, first time return time 2.0 hours, each 1.5 hours of second and third return time.
As a kind of preferred version, the soak by water described in step (3) refers to and adds 8-12 times of soak by water 2-3 time, each 1-2 hour.Described 8-12 doubly refers to that the consumption of water and medical material amount ratio are 8-12L:1KG.
As one most preferably scheme, the soak by water described in step (3) refers to and decocts with water 2 times, and amount of water is respectively 12 times, 10 times, each 1.5 hours of decocting time.
As one most preferably scheme, drying under reduced pressure when described drying refers to spraying dry or 60 DEG C.
As one most preferably scheme, the fine powder obtained is made oral formulations.
The extract fine powder obtained by above preparation method, can be as required, add different conventional adjuvants, as disintegrating agent, lubricant, binding agent etc., various peroral dosage form is made into the method for Chinese medicinal of routine, as tablet, pill, drop pill, capsule, soft capsule and granule etc., be preferably tablet, granule.
Compared with prior art, the present invention has following technique effect: the present invention is by the reasonable compatibility of Chinese medicine, obtain a kind of pharmaceutical composition containing Lepidinm meyenii Walp, described maca composition take Lepidinm meyenii Walp as primary raw material medicine, in conjunction with theory of Chinese medical science, with traditional Chinese Medicine and Clavicular such as nourishing YIN tonifying YANG, nourishing blood to suppress the hyperactive liver, promoting blood flow to regulate menstruation, supplementing QI and nourishing YIN, heat-clearing and toxic substances removing, through meticulous prescription, repeatedly verify, there is good tune tonifying kidney-yin kidney yang, nourishing blood to suppress the hyperactive liver, supplementing QI and nourishing YIN, heat-clearing and toxic substances removing, climacteric syndrome tool is improved significantly, there is good application prospect.
Detailed description of the invention
Explain the present invention further below in conjunction with specific embodiment, but embodiment does not limit in any form to the present invention.
Embodiment 1:
Composition of raw materials: Lepidinm meyenii Walp 160g; Herba Epimedii 100g; Fructus Ligustri Lucidi 100g; Herba Leonuri 100g; Radix Astragali 100g; Radix Puerariae 100g; Radix Rehmanniae 100g, Radix Paeoniae Alba 100g; Colla Corii Asini 50g; Fructus Lycii 80g.
Preparation method: get Lepidinm meyenii Walp and Herba Epimedii, extracts 2 times with 80% alcohol heating reflux, and each alcohol adding amount is for being respectively 10,8 times amount, and each 1.5 hours of each return time, filters, and the another device of medicinal residues is preserved, after filtrate merges, for subsequent use; Separately get Fructus Ligustri Lucidi and Radix Puerariae, 3 times are extracted with 85% alcohol heating reflux, return time 2.0 hours for the first time, each 1.5 hours of second and third return time, filter, medicinal residues discard, filtrate merges with the filtrate of above-mentioned Lepidinm meyenii Walp and Herba Epimedii after merging again, decompression recycling ethanol, and when being concentrated into 60 DEG C, relative density is the thick paste of 1.30-1.35, for subsequent use; Get the filtering residue after the Radix Astragali, Herba Leonuri, Radix Rehmanniae, the Radix Paeoniae Alba, Fructus Lycii and above-mentioned Lepidinm meyenii Walp and Herba Epimedii alcohol extraction again, decoct with water 3 times, amount of water is respectively 12,10,10 times amount, first time decocts 2.0 hours, second and third time decocts each 1.5 hours, filters, merging filtrate, when being concentrated into 60 DEG C, relative density is the thick paste of 1.30-1.35, for subsequent use; After get Colla Corii Asini again and foreignize, mix homogeneously with the thick paste after above-mentioned alcohol extraction, water boiling concentration; Finally by said mixture in 60 DEG C of drying under reduced pressure, be ground into fine powder.
Embodiment 2
Composition of raw materials: Lepidinm meyenii Walp 200g; Herba Epimedii 150g; Fructus Ligustri Lucidi 150g; Herba Leonuri 150g; Radix Astragali 150g; Radix Puerariae 150g; Radix Rehmanniae 150g; Radix Paeoniae Alba 150g; Colla Corii Asini 100g; Fructus Lycii 100g.
Preparation method: get Lepidinm meyenii Walp and Herba Epimedii, extracts 3 times with 95% alcohol heating reflux, and each alcohol adding amount is for being respectively 12,10 times amount, and each 2 hours of each return time, filters, and the another device of medicinal residues is preserved, after filtrate merges, for subsequent use; Separately get Fructus Ligustri Lucidi and Radix Puerariae, 3 times are extracted with 10 times amount 95% alcohol heating reflux, return time 2.0 hours for the first time, each 1.5 hours of second and third return time, filter, medicinal residues discard, filtrate merges with the filtrate of above-mentioned Lepidinm meyenii Walp and Herba Epimedii after merging again, decompression recycling ethanol, and when being concentrated into 60 DEG C, relative density is the thick paste of 1.30-1.35, for subsequent use; Get the filtering residue after the Radix Astragali, Herba Leonuri, Radix Rehmanniae, the Radix Paeoniae Alba, Fructus Lycii and above-mentioned Lepidinm meyenii Walp and Herba Epimedii alcohol extraction again, decoct with water 2 times, amount of water is respectively 10,8,8 times amount, first time decocts 2.0 hours, second and third time decocts each 1 hour, filters, merging filtrate, when being concentrated into 60 DEG C, relative density is the thick paste of 1.30-1.35, for subsequent use; After get Colla Corii Asini again and foreignize, mix homogeneously with the thick paste after above-mentioned alcohol extraction, water boiling concentration; Finally by said mixture in 60 DEG C of drying under reduced pressure, be ground into fine powder.
Embodiment 3
Composition of raw materials: Lepidinm meyenii Walp 100g; Herba Epimedii 50g; Fructus Ligustri Lucidi 50g; Herba Leonuri 50g; Radix Astragali 50g; Radix Puerariae 50g; Radix Rehmanniae 50g; Radix Paeoniae Alba 50g; Colla Corii Asini 30g; Fructus Lycii 50g.
Preparation method:
Get Lepidinm meyenii Walp and Herba Epimedii, extract 2 times with 60% alcohol heating reflux, each alcohol adding amount is for being respectively 10,8 times amount, and each 1.5 hours of each return time, filters, and the another device of medicinal residues is preserved, after filtrate merges, for subsequent use; Separately get Fructus Ligustri Lucidi and Radix Puerariae, 3 times are extracted with 65% alcohol heating reflux, return time 2.0 hours for the first time, each 1.5 hours of second and third return time, filter, medicinal residues discard, filtrate merges with the filtrate of above-mentioned Lepidinm meyenii Walp and Herba Epimedii after merging again, decompression recycling ethanol, and when being concentrated into 60 DEG C, relative density is the thick paste of 1.30-1.35, for subsequent use; Get the filtering residue after the Radix Astragali, Herba Leonuri, Radix Rehmanniae, the Radix Paeoniae Alba, Fructus Lycii and above-mentioned Lepidinm meyenii Walp and Herba Epimedii alcohol extraction again, decoct with water 3 times, amount of water is respectively 12,10,10 times amount, first time decocts 2.0 hours, second and third time decocts each 1.5 hours, filters, merging filtrate, when being concentrated into 60 DEG C, relative density is the thick paste of 1.30-1.35, for subsequent use; After get Colla Corii Asini again and foreignize, mix homogeneously with the thick paste after above-mentioned alcohol extraction, water boiling concentration; Finally by said mixture in 60 DEG C of drying under reduced pressure, be ground into fine powder.
Embodiment 4:
Composition of raw materials: Lepidinm meyenii Walp 4.0kg, Herba Epimedii 2.5kg, Fructus Ligustri Lucidi 2.5kg, Herba Leonuri 2.5kg, Radix Astragali 2.5kg, Radix Puerariae 2.5kg, Radix Rehmanniae 2.5kg, Radix Paeoniae Alba 2.5kg, Colla Corii Asini 1.25kg, Fructus Lycii 2.0kg.
Preparation method: get Lepidinm meyenii Walp and and Herba Epimedii, add 80% alcohol heating reflux and extract 2 times, each alcohol adding amount for being respectively 10,8 times amount, first time return time 2 hours, second time return time 1.5 hours, filters, and the another device of medicinal residues is preserved, after filtrate merges, for subsequent use; Separately get Fructus Ligustri Lucidi and Radix Puerariae, 3 times are extracted with 85% alcohol heating reflux, each alcohol adding amount for being respectively 10,8,8 times amount, first time return time 2 hours, each 1.5 hours of second and third return time, filter, medicinal residues discard, and filtrate merges with the extraction filtrate of above-mentioned Lepidinm meyenii Walp and Herba Epimedii after merging again, decompression recycling ethanol, and relative density is the thick paste of 1.30-1.35 when being concentrated into 60 DEG C, for subsequent use; The medicinal residues got again after the Radix Astragali, Herba Leonuri, Radix Rehmanniae, the Radix Paeoniae Alba, Fructus Lycii and above-mentioned Lepidinm meyenii Walp and Herba Epimedii alcohol extraction merge, decoct with water 3 times, add water as being respectively 12,10,10 times amount at every turn, first time decocts 2 hours, each 1.5 hours of second and third decocting time, filters, merging filtrate, when being concentrated into 60 DEG C, relative density is the thick paste of 1.30-1.35, for subsequent use; Get Colla Corii Asini again to foreignize, mix homogeneously with the extractum after above-mentioned alcohol extraction, water boiling concentration, in 60 DEG C of drying under reduced pressure, be ground into fine powder; Granulate, add appropriate shuttle first Starch Sodium, microcrystalline Cellulose and magnesium stearate etc., tabletted.
Embodiment 5
Composition of raw materials: Lepidinm meyenii Walp 5.0kg, Herba Epimedii 3.0kg, Fructus Ligustri Lucidi 2.5kg, Herba Leonuri 2.5kg, Radix Astragali 2.5kg, Radix Puerariae 2.5kg, Radix Rehmanniae 2.5kg, Radix Paeoniae Alba 2.5kg, Colla Corii Asini 1.5kg, Fructus Lycii 2.0kg.
Preparation method: get Lepidinm meyenii Walp and and Herba Epimedii, add 85% alcohol heating reflux and extract 2 times, each alcohol adding amount for being respectively 10,8 times amount, first time return time 2 hours, second time return time 1.5 hours, filters, and the another device of medicinal residues is preserved, after filtrate merges, for subsequent use; Separately get Fructus Ligustri Lucidi and Radix Puerariae, 3 times are extracted with 90% alcohol heating reflux, each alcohol adding amount for being respectively 9,7,7 times amount, first time return time 2 hours, each 1.5 hours of second and third return time, filter, medicinal residues discard, and filtrate merges with the extraction filtrate of above-mentioned Lepidinm meyenii Walp and Herba Epimedii after merging again, decompression recycling ethanol, and relative density is the thick paste of 1.30-1.33 when being concentrated into 60 DEG C, for subsequent use; The medicinal residues got again after the Radix Astragali, Herba Leonuri, Radix Rehmanniae, the Radix Paeoniae Alba, Fructus Lycii and above-mentioned Lepidinm meyenii Walp and Herba Epimedii alcohol extraction merge, decoct with water 2 times, add water as being respectively 12,10 times amount at every turn, first time decocts 2 hours, second time decocting time 1.5 hours, filters, merging filtrate, when being concentrated into 60 DEG C, relative density is the thick paste of 1.32-1.35, for subsequent use; Get Colla Corii Asini again to foreignize, mix homogeneously with the extractum after above-mentioned alcohol extraction, water boiling concentration, spraying dry, makes fine powder, granulates with ethanol, dries, encapsulated, makes capsule.
Embodiment 6
Composition of raw materials: Lepidinm meyenii Walp 4.5kg, Herba Epimedii 3.0kg, Fructus Ligustri Lucidi 3.0kg, Herba Leonuri 2.5kg, Radix Astragali 2.5kg, Radix Puerariae 2.5kg, Radix Rehmanniae 3.0kg, Radix Paeoniae Alba 2.5kg, Colla Corii Asini 1.3kg, Fructus Lycii 2.2kg.
Preparation method: get Lepidinm meyenii Walp and and Herba Epimedii, add 75% alcohol heating reflux and extract 2 times, each alcohol adding amount for being respectively 10,8 times amount, first time return time 2 hours, second time return time 1.5 hours, filters, and the another device of medicinal residues is preserved, after filtrate merges, for subsequent use; Separately get Fructus Ligustri Lucidi and Radix Puerariae, 3 times are extracted with 80% alcohol heating reflux, each alcohol adding amount for being respectively 10,8,8 times amount, first time return time 2 hours, each 1.5 hours of second and third return time, filter, medicinal residues discard, and filtrate merges with the extraction filtrate of above-mentioned Lepidinm meyenii Walp and Herba Epimedii after merging again, decompression recycling ethanol, and relative density is the thick paste of 1.32-1.35 when being concentrated into 60 DEG C, for subsequent use; The medicinal residues got again after the Radix Astragali, Herba Leonuri, Radix Rehmanniae, the Radix Paeoniae Alba, Fructus Lycii and above-mentioned Lepidinm meyenii Walp and Herba Epimedii alcohol extraction merge, decoct with water 3 times, add water as being respectively 10,8,8 times amount at every turn, first time decocts 2 hours, each 1.5 hours of second and third decocting time, filters, merging filtrate, when being concentrated into 60 DEG C, relative density is the thick paste of 1.32-1.35, for subsequent use; Get Colla Corii Asini again to foreignize, mix homogeneously with the extractum after above-mentioned alcohol extraction, water boiling concentration, in 60 DEG C of drying under reduced pressure, be ground into fine powder; Add appropriate soluble dextrins and 0.01% cyclamate, mixing, with alcohol granulation, less than 40 DEG C dry, makes granule.
The pharmacodynamic experiment of embodiment 7 medicine of the present invention
According to the clinical symptoms of climacteric syndrome, we adopt and adjust tonifying kidney-yin kidney yang, nourishing blood to suppress the hyperactive liver, the method for the treatment of of supplementing QI and nourishing YIN, heat clearing and blood circulation promoting and square medicine, from intending the pure plant amedica prescription of maca composition.This experiment adopts extracts the model that rat ovary causes climacteric syndrome, from estrogen level, developing womb and motion; Bone density and bone metabolism; Hemorheology three aspects, determine ten remainder indexs, observe maca composition to the curative effect of climacteric syndrome rat.
1. experiment material and reagent
1.1 animals: select cleaning grade 12 monthly age, body weight to be the Healthy female Wistar rats 72 of 290-310g, provided by Nanfang Medical Univ's animal experimental center.
1.2 medicines and reagent; Maca composition make by oneself, Lepidinm meyenii Walp purchased from Lijiang, yunnan, medical material purchased from Guangzhou medical material company; Synestrin tablets (lot number: 091011, grinds to form fine powder during use for Tianjin Lisheng Pharmaceutical Co., Ltd., 1mg/ sheet, and adding distil water is made into certain density suspension oral gavage), cod-liver oil is (containing VD
35000 units/ml), calcium gluconate tablet; Human serum estradiol (E
2) radioimmunoassay determination box, purchased from Bang Ding Tyke, Beijing Bioisystech Co., Ltd; Serum calcium, phosphorus, alkali phosphatase, Assay of acid phosphatase content test kit; Bioengineering Research Institute is built up purchased from Nanjing; 3% pentobarbital sodium Union import subpackage (Solution on Chemical Reagents in Shanghai purchasing and supply station subpackage factory; lot number: 100530); Triglyceride Reagent box provides (lot number: 100214) by Bai Ding biological engineering (Beijing) company limited; Cholesterol Kit; high density lipoprotein test kit is provided (lot number is respectively: 100922,101021) by Maike Tech Co., Ltd., Sichuan Prov..
1.3 fine drug powders embodiment 1,2 and 3 prepared, adding distil water is made into certain density suspension respectively, for rat oral gavage.
1.4 experimental apparatus: automatic clinical chemistry analyzer: Shimadzu CL8000 type; Ultraviolet-visible spectrophotometer UV-2100 type, UNICO(Shanghai) Instruments Co., Ltd.; SN-695B type intelligence is put and is exempted from γ measuring instrument (day ring instrument one factory of Shanghai nuclear research institute); Study of bone mineral density instrument-DEXA, Britain manufactures; DC-001 type isolated organ instrument, Nanjing analytical tool factory manufactures.
2. experimental technique:
The making of 2.1 climacteric syndrome animal models: after satisfied with 3% Nembutal sodium solution (45mg/kg) intraperitoneal injection of anesthesia, rat is fixed on operating-table, through lower abdomen otch, by Bilateral oophorectomy; Postoperative intramuscular injection penicillin 3 days is in case infect.
2.2 experiment grouping and administrations: randomly draw 12 rats as blank group; All the other 60 rats are cooked bilateral oophorectomy, and 3 months after operation is divided into seven groups at random, blank group: do not extract ovary, to normal saline; Model group: give normal saline after modeling; Positive controls: give diethylstilbestrol (0.02mg/kg/d), cod-liver oil (450u/kg/d) and calcium (0.5g/kg/d) after modeling; A group: give the fine drug powder (15g/kg/d) that heavy dose of embodiment 1 prepares after modeling; B group: give the fine drug powder (8g/kg/d) that middle dose delivery example 1 prepares after modeling; C group: give the fine drug powder (4g/kg/d) that low dose of embodiment 1 prepares after modeling; D group: give the fine drug powder (4g/kg/d) that low dose of embodiment 2 prepares after modeling; The fine drug powder (4g/kg/d) that low dose of embodiment 3 prepares is given after the modeling of E group.Every day to rat oral gavage once, 3 totally months.
2.3 Testing index: administration is after three months, and Rat Fast 12 hours, weighs, do vaginal smear, after Animal Anesthesia, get uterus immediately and weigh and do isolated uterine experiment; Abdominal aortic blood, anticoagulation is for doing external thrombus, and anticoagulation is for doing the hemorheology index such as packed cell volume, blood plasma and whole blood viscosity, erythrocyte sedimentation rate, fibrinogen content; Serum is for doing blood calcium, phosphorus, alkali phosphatase, acid phosphatase and estradiol Biochemical Indexes; Get femur on the right side of rat and measure bone density.
2.4 statistical dispositions: each group experimental data all checks with or without should give up value, whether meets normal distribution, variance whether together together.With means standard deviation (
± S) represent, carry out list because of rope variance analysis and multiple comparisons statistical analysis between two with SPSS1O.0 software, u=0.05.
3. experimental result and discussion
3.1 impacts on estrogen level and developing womb, motion
3.1.1 serum estradiol content (competition radio immunoassay) is improved.The results are shown in Table 1.
Note: compare with Normal group: * P<O.05, * * P<O.01;
Compare with model group: △ P<O.05, △ △ P<O.Ol;
Compare with positive group: zero P<O.05,00 P<O.01;
Compare with A group: ◇ P<O.05, ◇ ◇ P<O.01;
Compare with B group: ★ P<O.05, ★ ★ P<O.Ol;
P>0.05 will not mark, lower same.
3.1.2 developing womb, short generation in rutting period is promoted
Get rat vagina smear and examine under a microscope cell type, to judge the oestrous cycle.The results are shown in Table 2.
3.1.3 the growth in short uterus of spouting, makes uterus weight increase
After also the administration rat of 3 months is put to death after three months by excision ovary, take out uterus and weigh, calculate uterus weight index.The results are shown in Table 3.
3.1.4 improve uterus movement function
After the uterus of laboratory animal is taken out, put into 4 DEG C of tyrode's solutions, carefully cut off and be attached to
Fat on uterus, is sure not to injure uterus, and clip one cross-talk palace is fixed on L-type breather, puts into DC--001 type isolated organ instrument.Tyrode's solution constant temperature 37 ± O.5 DEG C, oxygen-supply quantity is moderate, and uterus is slightly stretching, is fixed on pressure transducing bar.Until uterus at instrument endoadaptation and when starting to shrink, open the recording equipment of instrument, chart drive speed is 50mm/s, the shrinkage curve in record uterus, according to uterine contraction curve, observes and shrinks whether rule, whether wave mode is typical, calculate and give residence contraction frequency, be converted to the pulling force born in uterus according to the amplitude of curve, finally observe uterus to after hypophysis time element (0.5u/m1) reaction.The results are shown in Table 4.
3.2 improve hemorheological property.The symptom for the treatment of climacteric cardiovascular aspect
Hemorheology is the science of research blood circulation and component flowing and distortion, is the change that " dense ", " gluing ", " gathering ", " coagulating " occur research blood.Detect dense, sticky, poly-, the solidifying index of blood a lot, we measure packed cell volume to reflect haemoconcentration; Measure plasma viscosity, whole blood viscosity to reflect the viscosity of blood; Mensuration erythrocyte sedimentation rate and ESR equation k value are to reflect erythrocyte aggregation; Measure ex vivo thrombosis, fibrinogen content to reflect the coagulability of blood.
3.2.1 haemoconcentration: packed cell volume (microdetermination).The results are shown in Table 5
3.2.2 the viscosity of blood: blood plasma and whole blood contrast viscosity (capillary tube method).The results are shown in Table 6
3.2.3 the aggregation of blood: erythrocyte sedimentation rate and ESR equation k value.The results are shown in Table 7
3.2.4 the coagulability of blood: thrombus length, weight in wet base, dry weight.The results are shown in Table 8
3.2.5 the coagulability of blood: fibrinogen content.The results are shown in Table 9
3.3 control climacteric osteoporosis
3.3.1 bone density is improved.The results are shown in Table 10
3.3.2 on blood calcium, serium inorganic phosphorus impact.The results are shown in Table 11
3.3.3 on the impact of alkali phosphatase, acid phosphatase.The results are shown in Table 12
4. experiment conclusion
4.1 impacts on estrogen level and developing womb, motion: above-mentioned experimental result shows: the rat estrogen secretion ability of extracing ovary obviously declines, serum estradiol content is starkly lower than normal group, endometrium is in resting stage, none routine rutting period, metratrophia, attenuate, diminish, weight obviously alleviates, and uterus movement is irregular.Taking estrogenic dog Mus serum estradiol level obviously to raise, there is rutting period in Some Animals, and uterus obviously becomes large, thicker, weight increases, but uterus movement function not yet recovers normal, and the hysterospasm play lobus posterior hypophyseos index is also without the solution effect of fullying recover from an illness.And take the rat of the large, medium and small dosage of fine drug powder after three months that embodiment 1 prepares, serum estradiol level obviously raises, rutting period showed increased, uterus obviously becomes large, thicker, weight increases, recover of uterus rhythmic exercise, has spasmolysis to the hysterospasm that lobus posterior hypophyseos index rises, all has statistical significance, and curative effect is better than female sharp rope, the effect of the big or middle dosage of fine drug powder that wherein embodiment 1 prepares is better than low dose.
4.2 improve hemorheological property, the symptom for the treatment of climacteric cardiovascular aspect: above-mentioned experimental result shows: the rat of extracing ovary has obvious blood stasis phenomenon, dense, sticky, poly-, the solidifying property showing as blood is all significantly increased, partly hemorheological property can be improved after using estrogen, even if the dense consistence of blood and coagulability reduce, and the viscosity of blood and coagulability are not affected.And maca composition obviously can reduce dense, sticky, poly-, the solidifying property of blood, improve the rheological characteristic of blood, its curative effect is obviously better than estrogen comprehensively.
4.3 control climacteric osteoporosis: above-mentioned experimental result shows the rat of extracing ovary, the impact of its value on blood calcium, serium inorganic phosphorus is little, this is consistent with clinical report, but the activity of alkali phosphatase and acid phosphatase obviously raises, bone density is bright to be reduced most, and the ability of the counter-bending breaking load of femur obviously reduces.Take the value impact of estrogenic rat on blood calcium, serium inorganic phosphorus little, but obviously can reduce the activity of alkali phosphatase and acid phosphatase, the ability of bone density and the counter-bending breaking load of femur is elevated to normal level.And take the rat after maca composition, the same with estrogen, on blood calcium, serium inorganic phosphorus impact not quite, but it reduces the activity of alkali phosphatase and acid phosphatase, bone density is obviously raised and the ability of the counter-bending load of femur is all obviously better than estrogen, therefore maca composition can prevention and therapy climacteric osteoporosis effectively.
Claims (10)
1. treat a medicine for climacteric syndrome, it is characterized in that being made up of the raw material of following parts by weight:
Lepidinm meyenii Walp 10-20 weight portion; Herba Epimedii 5-15 weight portion; Fructus Ligustri Lucidi 5-15 weight portion; Herba Leonuri 5-15 weight portion; Radix Astragali 5-15 weight portion; Radix Puerariae 5-15 weight portion; Radix Rehmanniae 5-15 weight portion; Radix Paeoniae Alba 5-15 weight portion; Colla Corii Asini 3-10 weight portion; Fructus Lycii 5-10 weight portion.
2. medicine according to claim 1, is characterized in that being made up of the raw material of following parts by weight:
Lepidinm meyenii Walp 15-20 weight portion; Herba Epimedii 10-15 weight portion; Fructus Ligustri Lucidi 10-15 weight portion; Herba Leonuri 10-15 weight portion; Radix Astragali 10-15 weight portion; Radix Puerariae 10-15 weight portion; Radix Rehmanniae 10-15 weight portion; Radix Paeoniae Alba 10-15 weight portion; Colla Corii Asini 5-10 weight portion; Fructus Lycii 5-10 weight portion.
3. medicine according to claim 1, is characterized in that being made up of the raw material of following parts by weight:
Lepidinm meyenii Walp 16 weight portion; Herba Epimedii 10 weight portion; Fructus Ligustri Lucidi 10 weight portion; Herba Leonuri 10 weight portion; The Radix Astragali 10 weight portion; Radix Puerariae 10 weight portion; Radix Rehmanniae 10 weight portion, the Radix Paeoniae Alba 10 weight portion; Colla Corii Asini 5 weight portion; Fructus Lycii 8 weight portion.
4. the medicine according to claim 1,2 or 3, is characterized in that, described Lepidinm meyenii Walp is the Lepidinm meyenii Walp of yellow Lepidinm meyenii Walp, purple Lepidinm meyenii Walp, red Lepidinm meyenii Walp, white Lepidinm meyenii Walp or other colors.
5. the medicine according to claim 1,2 or 3, is characterized in that, described medicine is peroral dosage form.
6. prepare a method for medicine described in claim 1, it is characterized in that, comprise the steps:
(1) filter after getting Lepidinm meyenii Walp and Herba Epimedii alcohol extraction, obtain filtrate;
(2) filter after getting Fructus Ligustri Lucidi and Radix Puerariae alcohol extraction, the filtrate that filtrate and step (1) obtain is merged, is then condensed into thick paste;
(3) the Lepidinm meyenii Walp medicinal residues after alcohol extraction in step (1) and Herba Epimedii medicinal residues are merged with the Radix Astragali, Radix Rehmanniae, the Radix Paeoniae Alba, Herba Leonuri, Fructus Lycii, with soak by water, filtration, is condensed into thick paste by filtrate;
(4) get pretending of Colla Corii Asini, the thick paste obtained with step (2) and (3) is mixed homogeneously, and dry, pulverize into fine powder.
7. preparation method according to claim 6, is characterized in that, step (1) and the alcohol extraction described in (2) refer to that adding 6-12 60%-95% alcohol heating reflux doubly extracts 2-3 time, each 1-2 hour; Step (2) and its density of the thick paste described in (3) are 1.28-1.35.
8. preparation method according to claim 7, is characterized in that the Lepidinm meyenii Walp described in step (1) and Herba Epimedii extract 2 times with 80% alcohol heating reflux, first time and second time alcohol adding amount for being respectively 10 times and 8 times, each 1.5 hours of each return time; Fructus Ligustri Lucidi described in step (2) and Radix Puerariae extract 3 times with 85% alcohol heating reflux, first time return time 2.0 hours, each 1.5 hours of second and third return time; Step (2) and its density of the thick paste described in (3) are 1.30-1.35.
9. preparation method according to claim 6, is characterized in that, the soak by water described in step (3) refers to and adds 8-12 times of soak by water 2-3 time, each 1-2 hour; Drying under reduced pressure when drying described in step (4) refers to spraying dry or 60 DEG C.
10. the application of the medicine described in any one of claim 1 ~ 3 in preparation treatment climacteric syndrome medicine.
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| CN104706704B (en) * | 2015-02-09 | 2018-01-19 | 江苏海王健康生物科技有限公司 | Maca composition, its compound preparation and its application |
| CN104886576A (en) * | 2015-06-11 | 2015-09-09 | 江苏慧博生物科技有限公司 | Female healthcare food and preparation method thereof |
| CN107441243A (en) * | 2017-08-17 | 2017-12-08 | 武汉华士特工业生物技术开发有限公司 | A kind of maca composition for preventing and treating PMO and preparation method thereof |
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