CN103330837A

CN103330837A - Traditional Chinese medicine composition for curing osteoporosis of menopausal women

Info

Publication number: CN103330837A
Application number: CN2013102995626A
Authority: CN
Inventors: 王磊; 刘海春; 王霞
Original assignee: 王磊
Current assignee: Qilu Hospital of Shandong University
Priority date: 2013-07-17
Filing date: 2013-07-17
Publication date: 2013-10-02
Anticipated expiration: 2033-07-17
Also published as: CN103330837B

Abstract

The invention aims to provide a traditional Chinese medicine composition for curing osteoporosis of menopausal women. The traditional Chinese medicine composition is a new medicine simple in formula, simple and convenient in manufacture process, low in toxic or/and side effects, convenient to dose, easy to manufacture and low in cost. According to the compatibility of a composite Chinese medicine theory, the medicines of the traditional Chinese medicine composition perform a synergistic effect, so that the traditional Chinese medicine composition serves the functions of replenishing liver, tonifying kidney, and strengthening bones and muscles, and can effectively cure postmenopausal osteoporosis. The traditional Chinese medicine composition adopts Chinese medicinal plants of different properties according to scientific compatibility, can achieve an ideal curative effect, is safe, low in toxic or/and side effects and simple to prepare, can reach a nidus directly, and is short in curing time and fast in prevention and cure effects.

Description

A kind of Chinese medicine composition for the treatment of the menopausal women osteoporosis

Technical field

The present invention relates to the field of Chinese medicines, specifically a kind of Chinese medicine composition for the treatment of the menopausal women osteoporosis.

Background technology

Osteoporosis (osteoporosis) is a kind of with the minimizing of bone amount, and the fine structure of bone destroys and is feature, and the fragility that causes bone increases a kind of general osteopathia that is easy to fracture.Osteoporosis can be divided into three major types: primary osteoporosis, secondary osteoporosis and idiopathic osteoporosis disease.

First kind primary osteoporosis can be divided into osteoporosis (I type) and the senile osteoporosis (II type) of menopausal women again;

Second class is secondary osteoporosis, and it is by other diseases (as renal failure, excessive thyroid hormone or leukemia), or medicine (as the steroid) osteoporosis that waits some factors to bring out;

The 3rd class is idiopathic osteoporosis disease, is more common in 8 ~ 14 years old teenager or adult, and hereditary family history is arranged mostly, and the women is more than the male, and the osteoporosis that takes place women's gestation and age of sucking also can be listed idiopathic osteoporosis in.

Modern medicine is thought postmenopausal osteoporosis (postmenopausal osteoporosis, POP) refer to the postmenopausal women because hypo-ovaria, estrogen descends, cause body internal skeleton amount to reduce and bone structure is changed to feature, clinical manifestation is a kind of metabolic disease that bone fragility and fracture susceptibility increase.

Osteoporosis is a kind of commonly encountered diseases of postmenopausal women, and frequently-occurring disease endangers seriously day by day, is called as " silent epidemic diseases ", has caused global concern.Clinical disease shows: have a back ache the earliest, vertebral body compression thereupon also can be with deformity of spine, and bow-backed change is short etc., and severe patient can cause chest deformity, influences the lung merit

Can, concurrent fracture, and along with the increase at age, the danger of fracture increases.At present this disease western medical treatment method is adopted complementing estrogen, calcium preparation and vitamin more, but take estrogen for a long time in a large number and might cause side effect such as carcinoma of endometrium and mastocarcinoma, and replenishing of calcium preparation and vitamin is difficult to control again on the dosage, and Chinese medicine has been obtained many achievements at the drug treatment of postmenopausal osteoporosis.

Though China's Chinese medicine does not have the disease name of postmenopausal osteoporosis, its clinical manifestation, pathogenesis should belong to " asthenia ", " category of the atrophic debility of bones, " rheumatism involving the bone ", " bone is withered ".

The traditional Chinese medical science think suffer from a deficiency of the kidney be osteoporosis main diseases because of, can divide the deficiency of YIN, yang deficiency clinical according to the rise and fall of yin and yang difference; Normal hold concurrently that the many internal organs of folder are deficient, blood stasis, the stagnation of QI, cold-damp disease etc.Clinical treatment is reason with " kidney storing essence master bone is given birth to marrow ", is method with " the kidney invigorating ".

Summary of the invention

Technical problem to be solved by this invention is, provides that a kind of prescription is simple, processing technology is easy, the little and convenient drug administration of toxic and side effects, and medicament is easy to make new drug with low cost.Chinese medicine composition of the present invention, the compound theory of Chinese medical science of compatibility, each efficacy of drugs produces synergism, makes it to have liver-kidney tonifying, the effect of the solid bone of strong muscle, thus can effectively treat postmenopausal osteoporosis.The present invention adopts the Chinese crude drug of the different property of medicine, has carried out the science compatibility, can reach desirable therapeutic effect, and safety, and toxic and side effects is little, and preparation is simple, the cause of disease of going directly, and healing time is short, the control instant effect.

For solving the problems of the technologies described above, the invention provides a kind of Chinese medicine composition for the treatment of the menopausal women osteoporosis, the ratio of weight and number of various crude drug is in the described Chinese medicine composition:

Rhizoma Xylanches Himalaicae 1-10 part, Fructus Rubi 1-10 part, Semen Cuscutae 5-15 part, Semen Castaneae 1-5 part, Fructus Lycii 5-15 part, Fructus Ligustri Lucidi 0.5-0.9 part, Rhizoma Polygonati 1-15 part, Herba Epimedii 1-15 part, Herba Saussureae Involueratae 0.1-0.8 part, Radix Morindae Officinalis 0.01-0.09 part, Rhizoma Curculiginis 0.01-0.09 part, Herba Erodii 0.01-0.09 part, Folium Linderae strychnifoliae 1-15 part, Lignum Aquilariae Resinatum 1-10 part, Fructus Liquidambaris 1-15 part, Gekko Swinhonis 1-5 part, Carapax Trionycis 1-15 part Herba Siegesbeckiae 0.01-0.09 part, Radix Salviae Miltiorrhizae 1-15 part, Semen Sesami 1-10 part Cacumen Securinegae Suffruticosae 0.01-0.09 part, Herba Epimedii 0.01-0.09 part, Lycopodium sieboldii Miq. 1-10 part, Radix Viburni Cordifolii 1-10 part, Radix Ainsliaeae Bonatii 0.01-0.09 part, Semen Persicae 1-15 part, Fructus Jujubae 1-15 part, Herba Taxilli 1-5 part, Fructus Mori 10-15 part, Lac regis apis 10-15 part, Cordyceps 1-5 part, Fructus Chaenomelis 1-15 part.

The invention provides a kind of Chinese medicine composition for the treatment of the menopausal women osteoporosis, the ratio of weight and number of various crude drug is in the described Chinese medicine composition:

Rhizoma Xylanches Himalaicae 2-8 part, Fructus Rubi 2-8 part, Semen Cuscutae 6-14 part, Semen Castaneae 2-4 part, Fructus Lycii 6-14 part, Fructus Ligustri Lucidi 0.6-0.8 part, Rhizoma Polygonati 2-14 part, Herba Epimedii 2-14 part, Herba Saussureae Involueratae 0.2-0.7 part, Radix Morindae Officinalis 0.02-0.08 part, Rhizoma Curculiginis 0.02-0.08 part, Herba Erodii 0.02-0.08 part, Folium Linderae strychnifoliae 2-14 part, Lignum Aquilariae Resinatum 2-9 part, Fructus Liquidambaris 2-14 part, Gekko Swinhonis 2-4 part, Carapax Trionycis 2-14 part Herba Siegesbeckiae 0.02-0.08 part, Radix Salviae Miltiorrhizae 2-14 part, Semen Sesami 2-8 part Cacumen Securinegae Suffruticosae 0.02-0.08 part, Herba Epimedii 0.02-0.08 part, Lycopodium sieboldii Miq. 2-8 part, Radix Viburni Cordifolii 2-8 part, Radix Ainsliaeae Bonatii 0.02-0.08 part, Semen Persicae 2-14 part, Fructus Jujubae 2-14 part, Herba Taxilli 2-4 part, Fructus Mori 11-14 part, Lac regis apis 11-14 part, Cordyceps 2-4 part, Fructus Chaenomelis 2-14 part.

5 parts of Rhizoma Xylanches Himalaicaes, 5 parts of Fructus Rubies, 10 parts of Semen Cuscutae, 3 parts in Semen Castaneae, 10 parts of Fructus Lycii, 0.7 part of Fructus Ligustri Lucidi, 10 parts of Rhizoma Polygonatis, 10 parts of Herba Epimedii, 0.5 part of Herba Saussureae Involueratae, 0.05 part of Radix Morindae Officinalis, 0.05 part of Rhizoma Curculiginis, 0.05 part of Herba Erodii, 10 parts of Folium Linderae strychnifoliaes, 8 parts of Lignum Aquilariae Resinatum, 10 parts of Fructus Liquidambaris, 3 parts of Gekko Swinhonis, 0.05 part of 10 parts of Herba Siegesbeckiae of Carapax Trionycis, 12 parts of Radix Salviae Miltiorrhizaes, 0.05 part of 5 parts of Cacumen Securinegae Suffruticosae of Semen Sesami, 0.05 part of Herba Epimedii, 5 parts of Lycopodium sieboldii Miq.s, 5 parts of Radix Viburni Cordifolii, 0.05 part of Radix Ainsliaeae Bonatii, 12 parts in Semen Persicae, 12 parts in Fructus Jujubae, 3 parts of Herba Taxillis, 12 parts in Fructus Mori, 12 parts of Lac regis apis, 3 parts of Cordyceps, 10 parts of Fructus Chaenomeliss.

For solving the problems of the technologies described above, the present invention also provides a kind of preparation method for the treatment of the Chinese medicine composition of menopausal women osteoporosis, and the dosage form of described Chinese medicine composition comprises for the preparation method of honey refining pill:

A, the crude drug except Lac regis apis is put into soak with ethanol, heat is extracted 1 time, becomes the extractum shape, is component 1;

B, medicinal residues extracting in water 2 times, thickening filtration are the extractum shape, are component 2;

C, above-mentioned two kinds of extractum are condensed into pasty state, add Lac regis apis and be twisted into pill.

Among the described step a, the crude drug except Lac regis apis is added 60-90% soak with ethanol 1-2 hour that 5-10 doubly measures, heating extraction 1-2 hour, remove supernatant, mass continues heating and is concentrated into the extractum shape, and stand for standby use becomes component 1.

Among the described step b, medicinal residues can be soaked 1-2 hour, extract twice, each 1-1.5 hour, merge extractive liquid,, the 80-120 order filters, and is the ultrafiltration post ultrafiltration of 5000-10000 again through the molecular weight that dams, 1.36 extractum when ultrafiltrate concentrating under reduced pressure relative density is 80 ℃, heating concentrates, and 30 minutes～45 minutes, extracts active ingredient, concentrated solution is settled into the extractum shape, as component 2.

For solving the problems of the technologies described above, the present invention also provides a kind of preparation method for the treatment of the Chinese medicine composition of menopausal women osteoporosis, and the dosage form of described Chinese medicine composition is that the preparation method of capsule comprises:

A, Radix Salviae Miltiorrhizae is put into the ethanol heating and refluxing extraction;

B, get surplus stock among the above-mentioned side except Carapax Trionycis again, add the water heating and refluxing extraction;

C, above-mentioned two kinds of extracting solution are merged, decompression recycling ethanol also concentrates sucking filtration absorption, obtains crude drug; Add the finely disintegrated Carapax Trionycis, canned.

Among the described step a, Radix Salviae Miltiorrhizae can be put into 10 times of amount ethanol, heating and refluxing extraction 2 times, each 1～2 hour, extract active ingredient, 2 extracting solution are merged leave standstill;

Among the described step b, surplus stock is put into 10 times of water gagings except Carapax Trionycis, heating and refluxing extraction 3 times each 45 minutes～1 hour, leaves standstill 3 extracting solution merging.

Among the described step c, can be with the merging of above-mentioned two kinds of filtrates, decompression recycling ethanol and to be concentrated into liquor strength be 0.4g crude drug/mL is behind the sucking filtration, when the relative density of filtrate is about 20 ℃ 1.06; Above-mentioned filtrate is the macroporous adsorptive resins of 10L through volume, earlier with deionized water or the distilled water eluting of 10 times of resin column volumes, uses 95% ethanol elution of 5 times of resin column volumes again, collects ethanol elution, removes solvent, obtains raw material medicated powder; Again Carapax Trionycis is worn into fine powder, incapsulate with the raw material medicated powder that obtains.

For solving the problems of the technologies described above, the present invention also provides a kind of preparation method for the treatment of the Chinese medicine composition of menopausal women osteoporosis, and the dosage form of described Chinese medicine composition is that the preparation method of tablet comprises:

Radix Salviae Miltiorrhizae is put into 10 times of amount ethanol, heating and refluxing extraction 2 times, each 1～2 hour, extract active ingredient, 2 extracting solution are merged leave standstill; The surplus stock of getting again among the above-mentioned side is put into 10 times of water gagings, and heating and refluxing extraction 3 times each 30 minutes～1 hour, leaves standstill 3 extracting solution merging; Above-mentioned two kinds of extracting solution are merged, decompression recycling ethanol and to be concentrated into liquor strength be 0.5g crude drug/mL, behind the sucking filtration, the relative density of filtrate is about 1.08 (20 ℃); Above-mentioned filtrate is the macroporous adsorptive resins of 10L through volume, earlier with deionized water or the distilled water eluting of 10 times of resin column volumes, uses 95% ethanol elution of 5 times of resin column volumes again, collects ethanol elution, removes solvent, obtains crude drug; Add starch or dextrin tabletting.

For solving the problems of the technologies described above, the present invention also provides a kind of dosage form for the treatment of the Chinese medicine composition of menopausal women osteoporosis, pharmaceutical dosage form can for: sugar coated tablet, film coated tablet, enteric coated tablet, hard capsule, soft capsule, oral liquid, suck agent, granule, electuary, honey pill agent, powder, sublimed preparation, injection, suppository, plaster, syrup, pin powder or slow releasing capsule.

The pharmacology and the property of medicine that the present invention relates to Chinese medicine preparation are as follows:

Rhizoma Xylanches Himalaicae

[nature and flavor] " Shaanxi Chinese herbal medicine ": " puckery little hardship, temperature, slightly poisonous."

[function cures mainly] the kidney warming, relieving distension, pain relieving.Control abdominal distention, stomachache, hernia, epersalgia cough, schistosomicide.1. " Shaanxi Chinese herbal medicine ": " regulating QI to relieve pain, relieving cough and resolving phlegm, relieving distension stomach invigorating.Control abdominal distention, stomachache, hernia, epersalgia cough." 2. " Chinese herbal medicine is used in Tibet always ": " reinforcing the kidney and supporting YANG, bone and muscle strengthening.Control pain in the low back and legs, sexual impotence."

Fructus Rubi:

[nature and flavor] temperature; Sweet, sour; Return kidney, urinary bladder channel.

[function cures mainly] kidney tonifying, controlling nocturnal emission with astringent drugs, reducing urination.Be used for enuresis due to deficiency of the kidney, frequent micturition, impotence and premature ejaculation, emission and spermatorrhea.

Semen Cuscutae:

[nature and flavor] Gan Xinping goes into liver, kidney channel.

[function cures mainly] the kidney invigorating and essence nourishing, nourishing the liver to improve visual acuity, antiabortive.Be used for caused by liver and kidney deficiency, soreness of waist and knee joint, impotence and seminal emission, frequent urination and enuresis, two blurred visions are dark, diseases such as frequent fetal movement.

Semen Castaneae:

[meridian distribution of property and flavor] is warm in nature, and sweet in the mouth is flat; Go into spleen, stomach, kidney channel.

[effect cures mainly] nourishing stomach and spleen, the strong muscle of the kidney invigorating; Cure mainly regurgitation and do not eat, dysentery is spitted blood, and epistaxis is had blood in stool, injury of tendon and muscle fracture congestive edema, pain, diseases such as scrofula toxic swelling." food book on Chinese herbal medicine ": " the kidney invigorating gas makes us anti-famine for main QI invigorating, thick the intestines and stomach.”

Fructus Lycii:

[nature and flavor] are sweet, and are flat, go into liver, stomach two warps, doublely go into lung meridian;

[function cures mainly] the kidney invigorating and essence nourishing, nourishing the liver to improve visual acuity, blood-enriching tranquillizing, promoting the production of body fluid to quench thirst, nourishing the lung to arrest cough.Cure mainly: it is dizzy to control apoplexy, and asthenia is allly seen blood disorder, cough blood, flaccidity, faint, contraction, the miasma that disappears is hindered dryly, passes out semen reddish and whitish turbid urine, beriberi, the arthroncus of knee.

Fructus Ligustri Lucidi:

[meridian distribution of property and flavor] bitter in the mouth, sweet, property is flat, goes into liver, kidney channel;

[effect] enriching yin and nourishing kidney.

Rhizoma Polygonati:

[nature and flavor] are sweet, and are flat; Return lung, spleen, kidney channel.

[function cures mainly] nourishing kidney profit spleen, invigorating the spleen and replenishing QI.Deficiency of YIN chronic cough; The xeropulmonary cough; Insufficiency of the spleen weak; The lack of appetite xerostomia; Quench one's thirst; The deficiency of the kidney soreness of the waist and knees; Impotence and seminal emission; The tinnitus order is dark; Early whitening of beard and hair; The empty win of body is thin; Wind favus disease.

Herba Epimedii:

[flavor property return through] is hot, sweet, temperature.Return liver, kidney channel;

[curing mainly function] kidney-replenishing, bone and muscle strengthening, wind-damp dispelling.

The Herba Epimedii stem and leaf contains icariine and volatile oil.Verified, Herba Epimedii has the effect of androgen sample, and its effect is better than Gecko and Hippocampus.Clinical demonstration, it is by promoting gonepoiesis, make seminal vesicle be full of seminal fluid after, conversely again can the sensation nerve, thus excite libido and cause erection.Simultaneously, Herba Epimedii can also suppress vasomotor center, and the expansion peripheral vessels makes blood pressure drops, and can antitussive, eliminate the phlegm, relieving asthma, poliovirus, Staphylococcus albus, staphylococcus aureus etc. are also had significant inhibitory effect.

Herba Epimedii is mainly used in treating reproduction, osteoarthrosis, respiratory system disease clinically.Herba Epimedii compatibility Radix Rehmanniae Preparata, Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, Fructus Lycii, the Cortex Eucommiae, Rhizoma Curculiginis, Radix Morindae Officinalis, Fructus Corni, Fructus Cnidii, Semen Allii Tuberosi, Herba Cistanches, Radix Aconiti Lateralis Preparata, Cortex Cinnamomi are called " praise and educate pellet ", can control sexual impotence, premature ejaculation.Herba Epimedii compatibility Radix Clematidis, Fructus Xanthii, Rhizoma Chuanxiong can be controlled arthralgia.How many Herba Epimedii is regardless of, and fries in shallow oil soup and gargles, and can control toothache.Get Herba Epimedii and add Herba Ardisiae Japonicae and fry in shallow oil soup and take, can control chronic bronchitis, its eliminating phlegm and relieving cough plays a role clearly.Get Herba Epimedii and the Radix Astragali, Radix Codonopsis, Radix Aconiti Lateralis Preparata, Herba Asari, Herba Ephedrae etc. and decoct same usefulness, the attitude of can curing the disease sinus syndrome and atrioventricular block.

Herba Saussureae Involueratae:

[nature and flavor] Uygur medicine: character, secondary is damp and hot.The traditional Chinese medical science: little hardship, temperature.　　

[function with cure mainly] Uygur medicine: invigorating kidney, promoting blood circulation, bone and muscle strengthening, trophic nerve, dysregulation body fluid.Be used for rheumatic arthritis, arthralgia, lung cold cough, kidney and cold and pain in the lower abdomen, leukorrhagia etc.The traditional Chinese medical science: warming the kidney to activate YANG, expelling wind and dampness restores menstrual flow and invigorates blood circulation.Be used for wind plug pain of dampness syndrome, rheumatoid arthritis, lower abdomen pain, menoxenia.

Various places are among the people with the Herba Saussureae Involueratae all herbal medicine, cure mainly snow the region between the heart and the diaphragm, toothache, rheumatic arthritis, sexual impotence, menoxenia, redly collapse, disease such as leucorrhea.India's Herba Saussureae Involueratae of going back among the people is treated many chronics.As diseases such as gastric ulcer, hemorrhoid, bronchitis, heart disease, epistaxis and venom.Herba Saussureae Involueratae is as the existing long history of medicine on Tibetan medicine.All on the books on Tibetanmedicine document " month king's medicine treasure " and the Four-Volume Medical Code.The wet arthritis that dispels the wind is except functions such as cold transformation expectorant, tonifying yang and enriching blood, warm uterus.Cure mainly snow the region between the heart and the diaphragm, toothache, rheumatic arthritis, sexual impotence, menoxenia, redly collapse, disease such as leucorrhea.India is among the people also treats many chronics with Herba Saussureae Involueratae.As diseases such as gastric ulcer, hemorrhoid, bronchitis, heart disease, epistaxis and venom.Herba Saussureae Involueratae is as the existing long history of medicine on Tibetan medicine.Existing record to Herba Saussureae Involueratae in Qing Dynasty's supplementary Amplifications of the Compendium of Materia Medica claims Herba Saussureae Involueratae " extremely hot in nature, can mend the lean sun ".Through modernized chemical composition analysis, the Herba Saussureae Involueratae flowers and plants contain alkaloid, flavone, alcohol, volatile oil now, contain raw sugar and 16 seed amino acids etc., its major function has dispelling cold and removing dampness, pain relieving, promoting blood circulation to restore menstrual flow, the diffusing silt in warm palace, strong muscle is supporing yang, and medical rheumatism is had special efficacy.In addition prove that through the clinical pharmacy research practice Herba Saussureae Involueratae flowers and plants are used as medicine, have and restore menstrual flow and invigorate blood circulation, dim palace loose silt, dispelling cold and removing dampness, strong muscle is supporing yang, stop blooding, the function of detumescence.To treating the diseases such as pain, lung cold cough, cold womb stomachache, amenorrhea, placenta retention, sexual impotence and measles without adequate eruption that acute and chronic rheumatic arthritis causes.

Radix Morindae Officinalis:

[nature and flavor] acrid in the mouth, sweet; Slightly warm in nature; Return kidney, Liver Channel.

[function] reinforcing the kidney and supporting YANG, expelling wind and removing dampness, strengthening the tendons and bones.Cure mainly that impotence and seminal emission, cold womb are infertile, menoxenia, few abdomen cold type of pain, rheumatic arthralgia, muscles and bones flaccidity be soft.

Rhizoma Curculiginis:

[nature and flavor] suffering, temperature, poisonous.Go into kidney, Liver Channel.

[function cures mainly] the kidney warming sun, strengthening bone and muscle.Control the sexual impotence cold sperm, urinary incontinence, metrorrhagia, trusted subordinate's cold type of pain, cold arthralgia of loins and legs, carbuncle, scrofula, yang deficiency cold diarrhea.Sexual impotence is smart cold, and the waist knee joint is air-cooled, diseases such as muscles and bones flaccidity syndrome and arthralgia syndrome.

Herba Erodii:

[nature and flavor] are hot, bitter, and are flat.　　

[return through] returns the liver,kidney,spleen warp.　　

[function cures mainly] wind-damp dispelling, the meridian dredging, antidiarrheal profit.Be used for rheumatic arthralgia, numbness contracture, muscles and bones is ached, dysentery.

Folium Linderae strychnifoliae:

[meridian distribution of property and flavor] is hot, temperature is gone into lung, spleen, kidney three warps;

[effect cures mainly] warming middle-JIAO is regulated the flow of vital energy pain relieving.Control the pathogenic cold in abdomen pain, the sliding number of urine, food stagnation, rheumatic arthritis.

Radix Linderae compatibility effectiveness: Radix Linderae compatibility Lignum Aquilariae Resinatum Radix Linderae warming kidney for dispelling cold, promoting the circulation of QI to relieve pain; Lignum Aquilariae Resinatum be amusing appetizing, turbid, the promoting the circulation of QI to relieve pain of damp eliminatingization. two medicines share, and walk edema caused by disorder of QI, reach the part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels, and the effect of the cold expelling of being amusing, promoting the circulation of QI to relieve pain is arranged, with uncomfortable in chest, the abdominal distention of what treatment stagnation of liver-QI with deficiency of the spleen, breathe hard, disease such as weak, vomiting.

Radix Linderae compatibility Radix Angelicae Sinensis Radix Linderae Xin Kaiwentong, promoting QI circulation for relieving depression, dispersing cold for relieving pain are walked edema caused by disorder of QI partially; The hot Wen Yun that looses of Radix Angelicae Sinensis, nourshing blood and promoting blood circulation, menstruction regulating and pain relieving are walked blood system partially. and the two 5 usefulness, the effect of playing promoting flow of QI and blood, cold expelling antalgic altogether is with the diseases such as dysmenorrhea, puerperal abdonimal pain and colic of cold type of what treatment QI stagnated by cold blood stasis.

Radix Linderae compatibility Radix Aucklandiae Radix Linderae promoting the circulation of QI to relieve pain cold expelling, the long what temperature part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels cold-damp of loosing; Radix Aucklandiae promoting the circulation of QI to relieve pain, merit are arrogated to oneself capable stagnation of QI in spleen and stomach. and two medicine mutual reinforcements between are usefulness, and the effect of its cold expelling, circulation of qi promoting, pain relieving is more outstanding, belong to the obstructed person of the stagnation of QI with abdominal distention and gastrointestinal neurosis due to the what treatment QI stagnated by cold.

Radix Linderae compatibility Bulbus Allii Macrostemonis Radix Linderae promoting the circulation of QI to relieve pain cold expelling; The circulation of qi promoting of Bulbus Allii Macrostemonis activating YANG and eliminating stagnation. the two 5 usefulness, have that circulation of qi promoting activates yang, the effect of pain relieving cold expelling, disease is seen uncomfortable in chest, pain person with the thoracic obstruction due to turbid the stagnating of what treatment YIN-cold expectorant.

Radix Linderae compatibility Fructus Alpiniae Oxyphyllae Radix Linderae warming kidney for dispelling cold; Fructus Alpiniae Oxyphyllae the kidney invigorating reducing urination. the two 5 usefulness has the effect of warming and recuperating the kidney-YANG, cold expelling reducing urination, with the frequent micturition of what treatment kidney yang deficiency, the enuresis etc.

Lignum Aquilariae Resinatum:

[meridian distribution of property and flavor] is hot, bitter, temperature.Return spleen, stomach, kidney, lung meridian

[effect] sending down the abnormal ascending QI warming middle-JIAO, the warming the kidney improving inspiration by invigorating kidney-QI.　　

[curing mainly] controlled QI rising in reverse order and panted, vomiting singultus, abdominal distention, waist knee joint cold caused by deficiency, large intestine constipation due to insufficiency, urine qi stranguria, man's cold sperm.1. " not Lu ": " it be swollen to treat the edema due to wind pathogen poison, removes bad odor.”

Fructus Liquidambaris:

[meridian distribution of property and flavor] hardship, flat.Return liver, kidney channel.

[function cures mainly] dispelling, collateral-activating, diuretic stimulates the menstrual flow.Be used for arthralgia, numbness contracture, edema distension, the few amenorrhea of breast.

Gekko Swinhonis:

[meridian distribution of property and flavor] is salty, and be cold.Slightly poisonous.

[function cures mainly] dispels the wind, and be active, eliminating stagnation.Be used for paralysis due to windstroke, rheumatic arthritis, osteomyelitis, tuberculous lymphadenitis, tumor.

Carapax Trionycis:

[nature and flavor] are salty, cold.　　

[function] nourishing kidney YANG hyperactivity suppressing, hard masses softening and resolving.　　

[curing mainly] nourishing YIN for suppressing the hyperactive YANG, hard masses softening and resolving is brought down a fever except steaming.Be used for fever due to yin deficiency, consumptive fever hectic fever due to YIN-deficiency, stirring-up of pathogenic wind in the interior resulting from deficiency, amenorrhea ， WEIJIA, chronic malaria malaria with splenomegaly." not Lu ": treat pyrexial malaria, abdominal mass due to blood stasis, lumbago, children's coerces down heavily fortified point." property of medicine opinion ": main dyspepsia, disease piece, mass beside the umbilicus gas, cold abdominal mass, labor are thin, the therapeutic method to keep the adverse QI flowing downwards, and except bone heat, consumptive fever between joint, solid being jammed.Control married woman's five colors that leak down and win thin person." Japan hanako materia medica ": the gas of dehematizing, broken sense knot, stagnant blood, induced abortion, the skin ulcer that disappears swells and pounces on and decrease remorse blood, malaria, acute appendicitis." Amplification on Materia Medica addendum ": nourishing YIN QI invigorating." Elementary Medicine ": main malaria with general debility, old malaria, woman's amenorrhea, children's's epilepsy disease." detailed outline ": except old malaria malaria with splenomegaly, insidious stomachache, recurrence caused by overexertion, relapse due to improper diet, speckle pox restlessness and dyspnea, married woman's difficult labour, puerperal prolapse of the uterus, husband's erosion of vulva, stranguria caused by urinary stone; Hold back routed carbuncle." Jiangxi Chinese medicine ": control osteomalacia.

Herba Siegesbeckiae:

[function] wind-damp dispelling, sharp joint, detoxifcation.　　

[curing mainly] is used for that rheumatic arthralgia, muscles and bones are unable, soreness of the waist and knees, quadriplegia, hemiplegia, rubella eczema.

Radix Salviae Miltiorrhizae:

[meridian distribution of property and flavor] hardship is slightly cold.GUIXIN, Liver Channel.

[function cures mainly] stasis-dispelling and pain-killing, promoting blood circulation to restore menstrual flow, relieving restlessness clears away heart-fire.Be used for menoxenia, the amenorrhea dysmenorrhea, lump in the abdomen, breast ventral spine pain, pyretic arthralgia pain, skin infection swells and ache, dysphoria and insomnia; Hepatosplenomegaly, angina pectoris." book on Chinese herbal medicine justice ": Radix Salviae Miltiorrhizae, what " herbal classic " called is slightly cold, and TAO Hong-Jing has been doubted its mistake, and Miao's secondary alcohol is also doubted it, and stupid to a stone is to transform tepor into." herbal classic ": main trusted subordinate's pathogen, borborygmus are faint as leaking water, and cold and heat gather; Broken disease is ended stuffy sensation with restlessness, QI invigorating except abdominal mass." WU Pu Bencao ": control cardiac and abdominal pain." not Lu ": nourish blood, remove trusted subordinate's obstinate disease stagnation of QI, stiffness along the spinal column, foot numbness; Except wind Xing stays heat, obey sharp people for a long time.TAO Hong-Jing: the stain beverage it, treat migratory arthralgia." property of medicine opinion ": control flaccidity of the lower limbs, painful numbness, main attacked by pestiferous factors; Control stomachache, gas is done the sound ring and is shouted." Japan hanako materia medica ": the sedate of reposing, tonneau GUAN-pulse.Control cold and hot labor, arthralgia, extremity are unsuccessful; The evacuation of pus pain relieving, granulation promoting is put on flesh; Broken stagnated blood is mended new hemopoietic; Peaceful tire, stillborn fetus falls; Under the hemostasis metrorrhagia and leukorrhagia, transfer married woman's passages through which vital energy circulates irregular, the blood evil thought is tired; Malignant boil scabies, the wart toxic swelling of going to live in the household of one's in-laws on getting married, erysipelas; Headache, acute conjunctivitis, the heat temperature is mad vexed." the southern regions of the Yunnan Province book on Chinese herbal medicine ": reinforcing the heart sedate, calming heart and tranquilizing mind.Control forgetful palpitation with a distress feeling, palpitation with fear is insomnia." detailed outline ": invigorate blood circulation logical percardium.Control colic." choosing of Yunnan Chinese herbal medicine ": promoting blood circulation to remove blood stasis, sedation-analgesia.Control menoxenia, dysmenorrhea, rheumatic arthralgia, metrorrhagia is spitted blood mastitis, carbuncle.

Semen Sesami:

Medicine is through record

Shennong's Herbal says, Semen Sesami cures mainly that " damaging the spleen and stomach is empty wins, and mends in five, physical strength profiting, longue meat, life essence-filling, marrow-benefitting.”

" the Master of Preserving Simplicity ": anti-rheumatism, mend old and feeble.

Compendium of Material Medica: linum is got oil, wins with Bai Zhewei, and it serves as good taking with black person.

" Bencao Congxin ": the intestinal that makes us of linum clothes is slided, and vital essence is not consolidated the person and also should do not eaten.

" book on Chinese herbal medicine is looked for the truth ": instability of kidney-QI and see the loose stool, sexual impotence, smart sliding, leucorrhea is all avoided usefulness.

Health preserving in ancient times scholar TAO Hong-Jing was once said: among eight paddy, only this be good, celestial family do the meal bait it, the paddy of breaking is long-living.

In Ancient Chinese generation, Semen Sesami always is regarded as life lengthening food, and Song dynasty famous poet Soviet Union and Eastern Europe also thinks on the slope, and Semen Sesami can be kept fit body, and defying age steams linum with nine, and with the peeling Poria, going into whitish honey less is wheaten food, and with the passing of time strength does not wane, and all kinds of diseases and ailments are from going, and this is long-living gist.

Dietary function

Semen Sesami sweet in the mouth, property are put down, and go into liver, kidney, lung, spleen channel.

Enrich blood make eye bright, dispel the wind intestine moistening, the lactogenesis that promotes the production of body fluid, the liver benefiting hair care, keep fit body, the effect of defying age.

Can be used for treating that physical weakness, dizziness and tinnitus, hypertension, hyperlipidemia, cough, physical weakness, early whitening of hair, anemia are sallow, deficiency of body fluid, constipation due to dry stool, breast less, disease such as hematuria.

It is deficient that [purposes] is used for Liver and kidney, asthenia of essence and blood, early whitening of beard and hair, vertigo and tinnitus, soreness of the waist and knees, myasthenia of limbs; Puerperal blood deficiency, hypogalactia; Blood deficiency and depleted fluid, dryness of the intestine constipation etc.

Cacumen Securinegae Suffruticosae:

[effect]: relaxing muscles and tendons to promote blood circulation, tonifying speen and tonifying kidney.　　

[meridian distribution of property and flavor]: arduous, temperature, poisonous." Hunan medicine will " " Gan Weixin, temperature." go into liver,kidney,spleen three warps

[usage and dosage]: for oral administration: as to fry in shallow oil soup, 3～5 money.　　

[compatibility of drugs]: join Radix Angelicae Pubescentis, expelling wind and dampness; Join Radix Angelicae Sinensis, warm in nature and diffusing; Join Herba Epimedii, kidney invigorating and YANG supporting.

Herba Epimedii:

[nature and flavor] are hot, cold, nontoxic.

Expelling wind and removing dampness is invigorated blood circulation in [function] tonifying YANG.

[curing mainly] be caused by liver and kidney deficiency 1., can not replenishing vital QI with drugs of warm nature, and QI-blood circulation is obstructed, and wet three heresies of wind and cold are taken advantage of the limbs joint pain due to attacking, migratory pain, joint joint stuffiness.2. the waist that thanks to causes of insufficiency of kidney-YANG is ached the lower limb weakness.3. the extremity of apoplexy sequela appearance are unsuccessful, skin numbness.

Lycopodium sieboldii Miq.:

[meridian distribution of property and flavor]: suffering, temperature.Go into liver, kidney two warps.

[effect]: expelling wind and removing dampness, reducing swelling and alleviating pain.　　

[curing mainly]: traumatic injury; Muscle spasm; Bones and muscles pain; Rheumatic arthritis; Loose rachitis; Rheumatoid arthritis.

Radix Viburni Cordifolii:

[nature and flavor] are wet, temperature.　　

[return through] goes into Liver Channel.　　

[function cures mainly] dispelling the wind and dampness pathogens numbness, bones and muscles pain is fallen and is decreased the stasis of blood with fixed attention, waist side of body flatulence.　　

[usage and consumption] is for oral administration: fry in shallow oil soup, 5～7 money; Or infusing drugs in wine.　　

[choosing side] dispelling the wind and dampness pathogens bones and muscles pain: Xin Ye Caulis Viburni Dilatati is joined Cortex Acanthopancis; Herba Epimedii, Lignum Pini Nodi, Radix Gentianae Macrophyllae, the clothes of steeping in wine.

Radix Ainsliaeae Bonatii:

[nature and flavor] bitter little suffering is puckery, temperature.　　

[function cures mainly] wind-damp dispelling, the Shujin network.The dispelling the wind and dampness pathogens bones and muscles pain, traumatic injury: Radix Ainsliaeae Bonatii three to five money, be decocted in water for oral dose, or the outsourcing sore place.

Semen Persicae:

Sweet flat, the bitter in the mouth of [meridian distribution of property and flavor] property is gone into lung, liver, large intestine channel;

[function cures mainly] has blood stasis removing and clots absorbing, moisturizes the effect of laxation; Control amenorrhea, dysmenorrhea, abdominal mass abdominal mass mass in the abdomen, traumatic injury, dryness of the intestine constipation.

Fructus Jujubae:

[meridian distribution of property and flavor] is sweet, and temperature is returned spleen, stomach warp;

[function cures mainly] invigorating the spleen and replenishing QI, nourishing blood to tranquillize the mind.Be used for insufficiency of the spleen lack of appetite, weak loose stool, woman hysteria.

Herba Taxilli:

[nature and flavor] are bitter, sweet, and are flat.

[return through] returns liver, kidney channel.

[function cures mainly] invigorating the liver and kidney, bone and muscle strengthening, wind-damp dispelling, antiabortive unit.Be used for rheumatic arthralgia, soreness of the waist and knees, muscles and bones is unable, and the metrorrhagia warp is many, blood leaking in gestation, frequent fetal movement; Hypertension.

Fructus Mori:

[nature and flavor] are sweet, are slightly cold; GUIXIN, liver, kidney channel.

[function cures mainly] treating the liver kidney yin is lost, and send and take off, constipation, order is dark, tinnitus, former infections, articular instability.It has the skin of improvement (comprising scalp) blood supply, the nutrition skin, makes effect such as the delicate and black hair of skin, and can slow down aging.Fructus Mori is be healthy and strong U.S. face, antidotal good fruit and good medicine of middle-aged and elderly people.Normal food Fructus Mori can make eye bright, the tired dry and astringent symptom of easing eyes.Fructus Mori has immunologic enhancement.Fructus Mori has effect of gain to spleen, and reaction has potentiation to hemolytic, can prevent human body artery sclerosis, skeleton arthrosclerosis, enhances metabolism; Fructus Mori can promote the growth of erythrocyte, prevents leukopenia, and diseases such as treatment diabetes, anemia, hypertension, hyperlipidemia, coronary heart disease, neurasthenia are had auxiliary curative effect.Fructus Mori has effects such as promoting the production of body fluid to quench thirst, facilitating digestion, help defecation, and proper amount of edible can promote gastric secretion, stimulates enterokinesia and removes scorching.The traditional Chinese medical science thinks that Fructus Mori is sweet in flavor and cold in property, has the liver and the kidney tonifying, an effect such as the intestine moistening of promoting the production of body fluid, black hair make eye bright.

Lac regis apis:

[nature and flavor] sweet acid, flat.

[function cures mainly] nourishing, strong, the liver benefiting, spleen invigorating.Weak after curing the disease, infantile malnutrition, old asthenia, infectious hepatitis, hypertension, rheumatic arthritis, duodenal ulcer.

Cordyceps:

[nature and flavor] sweet in the mouth, property is flat.

[function] has the effect of nourishing YIN and moistening the lung, kidney invigorating and YANG supporting, so can be used as nourishing the lung and kidney, hemostasis and phlegm, guarantor's lung, change dysentery, end that consumptive disease is coughed etc. and transfer the food of mending.Cordycep includes cordycepic acid.Vitamin B12, fat, albumen etc.Cordyceps property is sweet, Wen Ping, nontoxic, is famous strengthening by means of tonics medicine, meat boiled dinner commonly used, the effect that has tonify deficiency to be healthy and strong.Be applicable to spitting of blood due to treatment insufficiency of lung-QI and deficiency of both the lung and kidney, the pulmonary tuberculosis etc. or sputum mixed with blood, cough.Breathe hard, night sweat etc., impotence due to deficiency of the kidney, waist knee joint ache etc. is also had good curative effect, the person's that also is the oldaged physically weak excellent tonic product.

Fructus Chaenomelis:

[return through] returns liver, spleen channel.

[function cures mainly] suppressing the hyperactive liver Shujin, the stomach function regulating removing dampness cures mainly diseases such as weakness of the spleen and stomach, inappetence, hypogalactia, joint pain, numb limbs and tense tendons.

The specific embodiment:

Embodiment 1, prescription:

Rhizoma Xylanches Himalaicae 1g, Fructus Rubi 1g, Semen Cuscutae 5g, Semen Castaneae 1g, Fructus Lycii 5g, Fructus Ligustri Lucidi 0.5g, Rhizoma Polygonati 1g, Herba Epimedii 1g, Herba Saussureae Involueratae 0.1g, Radix Morindae Officinalis 0.01g, Rhizoma Curculiginis 0.01g, Herba Erodii 0.01g, Folium Linderae strychnifoliae 1g, Lignum Aquilariae Resinatum 1g, Fructus Liquidambaris 1g, Gekko Swinhonis 1g, Carapax Trionycis 1g Herba Siegesbeckiae 0.01g, Radix Salviae Miltiorrhizae 1g, Semen Sesami 1g Cacumen Securinegae Suffruticosae 0.01g, Herba Epimedii 0.01g, Lycopodium sieboldii Miq. 1g, Radix Viburni Cordifolii 1g, Radix Ainsliaeae Bonatii 0.01g, Semen Persicae 1g, Fructus Jujubae 1g, Herba Taxilli 1g, Fructus Mori 10g, Lac regis apis 10g, Cordyceps 1g, Fructus Chaenomelis 1g;

The dosage form of Chinese medicine composition comprises for the preparation method of honey refining pill:

Animal local excitation test:

The guinea pig skin hypersensitive test of tablet of the present invention.The result shows: skin anaphylactic test, and high dose group 0.8g (medicated powder)/kg, low dose group 0.1g (medicated powder)/kg is equivalent to intend 20 times, 2.5 times of clinical people's consumption [0.04g (medicated powder)/kg] respectively, through the skin administration, there is no animal and produces allergy; Rectal application irritation test high dose group 5.0g (medicated powder)/kg, low dose group 3.2g (medicated powder)/kg, be equivalent to intend 125,80 times of clinical people's consumption respectively, in official hour, observe mucous membrane of rectum and all do not have phenomenons such as hyperemia, edema, histopathologic examination and blank group be no significant difference relatively, do not see and tangible irritative response occurs, every group of its overall health of patients of part animal of retaining, body weight, breathing, circulation, central nervous system and extremity activity etc., all Non Apparent Abnormality reactions.

Acute toxicity test

The application mice carries out acute toxicity testing and shows: the tablet of mice oral administration gavage Chinese medicine composition of the present invention, under 488.8g crude drug/kg dosage, the light activity minimizing appears in mice after the administration, recover normal about 1 hour, observed 7 days continuously after the administration, none animal dead, its overall health of patients, diet, to take the photograph water, urine and body weight gain all normal, and experimental result shows: the maximum dosage-feeding of mice oral administration gavage Chinese medicine preparation tablet of the present invention is 488.8g crude drug/kg/d (LD 50＞488.8g crude drug/kg).Chinese medicine preparation clinical application every day total amount of the present invention is 0.1g crude drug/kg/d; Press weighing machine, the dosis tolerata of mouse stomach Chinese medicine preparation of the present invention is 4888 times of clinical patient.Point out this medicine acute toxicity low, clinical drug safety.

Model case and curative effect:

The Qin, the woman, at 56 years old age, menopause is by normal lumbar and back pain, physically-draining.CT diagnosis prolapse of lumbar intervertebral disc in 2011, CT cervical spondylosis in 2012, tired back double knee joint swelled and ache the nuclear-magnetism inspection in 2013: hyperosteogeny, meniscus injury.Patient's readme foot pain and with swelling sense when morning, both feet landed sometimes plays the both hands arthralgia in the recent period, but can alleviate a little after the activity morning.Go the examination in hospital bone density June 5 this year: lumbar vertebra: L1-2.6, L2-2.3, L3-3.0, L4-3.0.The patient takes medicine of the present invention after two courses for the treatment of, and arthralgia, swelling alleviate, and movable function takes a turn for the better.

Embodiment 2, prescription:

Rhizoma Xylanches Himalaicae 2g, Fructus Rubi 2g, Semen Cuscutae 6g, Semen Castaneae 2g, Fructus Lycii 6g, Fructus Ligustri Lucidi 0.6g, Rhizoma Polygonati 2g, Herba Epimedii 2g, Herba Saussureae Involueratae 0.2g, Radix Morindae Officinalis 0.02g, Rhizoma Curculiginis 0.02g, Herba Erodii 0.02g, Folium Linderae strychnifoliae 2g, Lignum Aquilariae Resinatum 2g, Fructus Liquidambaris 2g, Gekko Swinhonis 2g, Carapax Trionycis 2g Herba Siegesbeckiae 0.02g, Radix Salviae Miltiorrhizae 2g, Semen Sesami 2g Cacumen Securinegae Suffruticosae 0.02g, Herba Epimedii 0.02g, Lycopodium sieboldii Miq. 2g, Radix Viburni Cordifolii 2g, Radix Ainsliaeae Bonatii 0.02g, Semen Persicae 2g, Fructus Jujubae 2g, Herba Taxilli 2g, Fructus Mori 11g, Lac regis apis 11g, Cordyceps 2g, Fructus Chaenomelis 2g;

The dosage form of Chinese medicine composition is that the preparation method of tablet comprises:

Acute toxicity test

The application mice carries out acute toxicity testing and shows: the capsule of mice oral administration gavage Chinese medicine composition of the present invention, under 488.8g crude drug/kg dosage, the light activity minimizing appears in mice after the administration, recover normal about 1 hour, observed 7 days continuously after the administration, none animal dead, its overall health of patients, diet, to take the photograph water, urine and body weight gain all normal, and experimental result shows: the maximum dosage-feeding of mice oral administration gavage Chinese medicine preparation capsule of the present invention is 488.8g crude drug/kg/d (LD 50＞488.8g crude drug/kg).Chinese medicine preparation clinical application every day total amount of the present invention is 0.1g crude drug/kg/d; Press weighing machine, the dosis tolerata of mouse stomach Chinese medicine preparation of the present invention is 4888 times of clinical patient.Point out this medicine acute toxicity low, clinical drug safety.

Embodiment 3, prescription:

Rhizoma Xylanches Himalaicae 5g, Fructus Rubi 5g, Semen Cuscutae 10g, Semen Castaneae 3g, Fructus Lycii 10g, Fructus Ligustri Lucidi 0.7g, Rhizoma Polygonati 10g, Herba Epimedii 10g, Herba Saussureae Involueratae 0.5g, Radix Morindae Officinalis 0.05g, Rhizoma Curculiginis 0.05g, Herba Erodii 0.05g, Folium Linderae strychnifoliae 10g, Lignum Aquilariae Resinatum 8g, Fructus Liquidambaris 10g, Gekko Swinhonis 3g, Carapax Trionycis 10g Herba Siegesbeckiae 0.05g, Radix Salviae Miltiorrhizae 12g, Semen Sesami 5g Cacumen Securinegae Suffruticosae 0.05g, Herba Epimedii 0.05g, Lycopodium sieboldii Miq. 5g, Radix Viburni Cordifolii 5g, Radix Ainsliaeae Bonatii 0.05g, Semen Persicae 12g, Fructus Jujubae 12g, Herba Taxilli 3g, Fructus Mori 12g, Lac regis apis 12g, Cordyceps 3g, Fructus Chaenomelis 10g;

Long term toxicity test:

Select the SD rat for use, give variable concentrations (18.0,6.0, the Chinese medicine preparation honey pill agent of the present invention of 2.0g crude drug/kg), irritate stomach every day once, continuous 90 days, respectively organized 1/2 animal (male and female half and half) extremely that lives in 24 hours after the last administration, all the other 1/2 animals continuation observation, 2 all backs are extremely alive.Duration of test is observed outward appearance, general behavior, food ration, the body weight change of animal, after the administration 90 days and carry out hematology's (RBC, HB, reticulocyte, PLT, CT, WBC and classification) in 2 weeks of drug withdrawal and index inspections such as blood biochemical (AST, ALT, ALP, Glu, BUN, Crea, TP, T.BIL, ALB, CHOL), urine biochemistry, organ coefficient, histopathology.Result of the test shows: preparation of the present invention is good at high, medium and low dosage treated animal general state, and outward appearance sign, behavioral activity, food-intake and body weight gain be no abnormal variation all; Three dosage groups and matched group hematological examination, blood biochemical are learned, the urine biochemical analysis is all in normal range, do not have significant difference between group; Each is organized the main organs histopathological examination and shows no obvious abnormalities.The These parameters drug withdrawal is not seen change after 2 weeks yet.This test dosage is respectively 180,60,20 times of clinical medicine dose, according to result of the test Chinese medicine preparation of the present invention high, medium and low three dosage (18.0,6.0, the 2.0g crude drug/kg) administration in continuous 90 days does not have obvious influence to rat, no clear and definite toxicity target organ and sensitive indicator, the retardance toxic reaction is not seen in the convalescent period observation yet, points out the dosage safety of Chinese medicine preparation clinical practice of the present invention higher.

Model case and curative effect:

Chapter XX, the woman, menopause in 50 years old checked that bone density-2.25,56 years old checked bone density-3.45 in 54 years old, and joint and waist have the sense of rising bitterly, and nothing decays tooth but the power of gritting one's teeth reduces.The patient takes medicine of the present invention after course for the treatment of, transference cure, and lab testing bone density 0.80 is cured.

Embodiment 4, prescription:

Rhizoma Xylanches Himalaicae 8g, Fructus Rubi 8g, Semen Cuscutae 14g, Semen Castaneae 4g, Fructus Lycii 14g, Fructus Ligustri Lucidi 0.8g, Rhizoma Polygonati 14g, Herba Epimedii 14g, Herba Saussureae Involueratae 0.7g, Radix Morindae Officinalis 0.08g, Rhizoma Curculiginis 0.08g, Herba Erodii 0.08g, Folium Linderae strychnifoliae 14g, Lignum Aquilariae Resinatum 9g, Fructus Liquidambaris 14g, Gekko Swinhonis 4g, Carapax Trionycis 14g Herba Siegesbeckiae 0.08g, Radix Salviae Miltiorrhizae 14g, Semen Sesami 8g Cacumen Securinegae Suffruticosae 0.08g, Herba Epimedii 0.08g, Lycopodium sieboldii Miq. 8g, Radix Viburni Cordifolii 8g, Radix Ainsliaeae Bonatii 0.08g, Semen Persicae 14g, Fructus Jujubae 14g, Herba Taxilli 4g, Fructus Mori 14g, Lac regis apis 14g, Cordyceps 4g, Fructus Chaenomelis 14g;

The dosage form of described Chinese medicine composition comprises for the preparation method of honey refining pill:

Step a adds 60-90% soak with ethanol 1-2 hour that 5-10 doubly measures with the crude drug except Lac regis apis, and heating extraction 1-2 hour, remove supernatant, mass continues heating and is concentrated into the extractum shape, and stand for standby use becomes component 1.

Step b can soak medicinal residues 1-2 hour, extracted twice, each 1-1.5 hour, merge extractive liquid,, the 80-120 order filters, and is the ultrafiltration post ultrafiltration of 5000-10000 again through the molecular weight that dams, 1.36 extractum when ultrafiltrate concentrating under reduced pressure relative density is 80 ℃, heating concentrates, and 30 minutes～45 minutes, extracts active ingredient, concentrated solution is settled into the extractum shape, as component 2.

Step c is condensed into pasty state with above-mentioned two kinds of extractum, adds Lac regis apis and is twisted into pill.

Long term toxicity test:

Model case and curative effect:

Once XX, 60 years old, retirement, the main suit: be interrupted lumbago and backache 5 years and treat in 3 moon gate diagnosis and treatment in 2012, age of meuopause 55 years old, menopause is 5 years; Physical examination: height 165CM, body weight 58KG, BMI:21.3kg/m2, fracture wound: 11-10-27 causes right ulnar fracture because falling down, and orthopaedics is handled, and 12-1-9 falls down again, and to left fracture of the carpal bone, orthopaedics is handled; Go the examination in hospital bone density March 5 this year: lumbar vertebra: L1-2.7, L2-2.2, L3-3.1, L4-3.0.The patient takes medicine of the present invention after two courses for the treatment of, and arthralgia, swelling alleviate, and movable function takes a turn for the better.

Embodiment 5, prescription:

Rhizoma Xylanches Himalaicae 10g, Fructus Rubi 10g, Semen Cuscutae 15g, Semen Castaneae 5g, Fructus Lycii 15g, Fructus Ligustri Lucidi 0.9g, Rhizoma Polygonati 15g, Herba Epimedii 15g, Herba Saussureae Involueratae 0.8g, Radix Morindae Officinalis 0.09g, Rhizoma Curculiginis 0.09g, Herba Erodii 0.09g, Folium Linderae strychnifoliae 15g, Lignum Aquilariae Resinatum 10g, Fructus Liquidambaris 15g, Gekko Swinhonis 5g, Carapax Trionycis 15g Herba Siegesbeckiae 0.09g, Radix Salviae Miltiorrhizae 15g, Semen Sesami 10g Cacumen Securinegae Suffruticosae 0.09g, Herba Epimedii 0.09g, Lycopodium sieboldii Miq. 10g, Radix Viburni Cordifolii 10g, Radix Ainsliaeae Bonatii 0.09g, Semen Persicae 15g, Fructus Jujubae 15g, Herba Taxilli 5g, Fructus Mori 15g, Lac regis apis 15g, Cordyceps 5g, Fructus Chaenomelis 15g;

Long term toxicity test:

Model case and curative effect:

Liu XX, the woman, 55 years old age, because of osteoporosis, hip joint degeneration and sclerosis, the thigh pain of how having walked.The patient takes medicine of the present invention after two courses for the treatment of, the thigh pain relief, and movable function takes a turn for the better.

" kidney governing bones ", " the kidney being the origin of congenital constitution ", after the middle age, kidney essense is depleted gradually, superintends and directs wantonly two arteries and veins and damages, and deficiency of the kidney is the marrow sky then, and bone is not supplemented nutrition and thin and weak.Waist is house of kidney, so lumbago; So the muscles and bones flaccidity is weak unable.Suffer from a deficiency of the kidney in following, it is warm that the five internal organs can not get, and yang-energy is on the decline, cloudy insufficiency of essence, thus the deficiency-heat contact, the timidness due to deficiency of QI spontaneous perspiration.

According to the theory of the traditional Chinese medical science " kidney governing bones ", " element ask-the most pure virginity will discuss greatly " said: " salty taste entering the kidney first ", life-time service salty food will cause internal organs function prosperity correspondingly.Body potential is transferred in use by medicated diet, obtains preventing and treating osteoporotic purpose.Wherein the Carapax Trionycis replenishing kidney-YIN is treated soreness of the waist and knees; The Fructus Lycii the kidney invigorating and essence nourishing.Assistant is with Fructus Jujubae, the Radix Salviae Miltiorrhizae QI invigorating that nourishes blood, the effect that invigorating function of kidney and strengthening bone is played in the nutrition of medicated diet food altogether.The kidney of the traditional Chinese medical science has comprised genitourinary system, hormonal system and the neural function of doctor trained in Western medicine, as one group of functional unit.Nephrasthenia syndrome is that to go down with the dysfunction of a plurality of target origin system of hypothalamus hypophysis, whole body physiological function be a kind of body reaction state of feature, and suffering from a deficiency of the kidney to have influence on the phosphorus calcium metabolism, is reflected in the decline that bone density has just appearred in bone mineral metabolism aspect.The main tonifying liver spleen of Chinese medicine kidney as kidney-nourishing tcm drug (medical herbs) compound recipe with " multicomponent, many target spots, collaborative potentiation, the moderate safety of compatibility of promoting " feature, has been carried out a large amount of infrastests and clinical application research, has obtained the achievement that attracts people's attention.Suffering from a deficiency of the kidney is the osteoporosis basis, it is low that the kidney invigorating method can be corrected the body functions of immune system, recover the functional activity of hypothalamus-hypophysis-target gland organ, promote bone calcium deposition, suppress bone resorption, accelerate bone formation, delay bone loss, rising bone mineral content and bone density reach the purpose for the treatment of osteoporosis.

Clinical manifestation:

1, bone pantalgia, based on spinal column and pelvis and fracture, when changing position or upper and lower stair more very.

2, stature becomes short.

3, easily fracture.

Experimental study of the present invention:

Menopausal osteoporosis disease women 200 examples that 1 object and method 1.1 objects are being seen and treated patients year June in January, 2012 to 2013.

Inclusion criteria: 1. the women 2. the age at 55 years old to 65 years old 3. menopausal osteoporosis disease 4. bone density unusually 5. ALP is unusual.

Exclusion standard: 1. the male 2. the age less than 55 years old greater than 65 years old 3. acatalepsia really 4. bone density or the no abnormal 5. allergic constitution of ALP or to test medication allergy sufferers 6. suspect or truly have ethanol, drug dependence medical history person 7. participated in 3 months other clinical trial person 8. researcher think and get rid of.1.2 method 1.2.1 includes 1. menopausal women (age was at 55 years old to 65 years old) of standard in.2. the patient includes diagnosis in by international standard, and namely dual intensity X line absorption method is measured 2. 5 standard deviations (bone density＜0. 861 g/cm2), can be diagnosed as osteoporosis that lumbar spine bmd is lower than normal young women meansigma methods.1.2.2 exclusion standard does not have endocrine metabolism or other influences the chronic disease of alcium and phosphor metabolization, also not having the hepatorenal disease history and taking influences the pharmacohistory of alcium and phosphor metabolization 1.2.3 and originally studies to use Chinese medicine composition composition formula of the present invention, do not adopt the osteoporosis base therapy, by consulting with the patient, after obtaining patient's agreement, signature Informed Consent Form and hand-in-glove.1.2.4 the menopausal osteoporosis disease women that 120 examples are in hospital, quantitative Analysis machine plane scan method (QCT) is surveyed lumbar vertebra spongy bone density, dual intensity X line absorption method (DEXA) is surveyed lumbar vertebra (L2-L4) and neck of femur (Neck) bone density and ALP and measured with measuring before the Chinese medicine composition of the present invention.1.2.5 in the time of by clinical treatment, take Chinese medicine of the present invention, 3 doses of the branches of whenever taking medicine, 3 doses/day, 15 days is a course for the treatment of, take January after same procedure measure bone density, ALP.1.2.6 adopt SPSS13.0 statistics software to carry out data analysis bone density, ALP.1.3 two groups of patients of observation index respectively at before taking medicine, take medicine after January, measure that quantitative Analysis machine plane scan method (QCT) is surveyed lumbar vertebra spongy bone density, dual intensity X line absorption method (DEXA) is surveyed lumbar vertebra (L2-L4) and neck of femur (Neck) bone density and ALP mensuration.1.4 statistical analysis adopts SPSS13.0 statistics software, carries out data analysis bone density, ALP.Before 2 results, 2.1 ordinary circumstances were taken medicine, each is organized, and the patient measured quantitative Analysis machine plane scan method (QCT) survey lumbar vertebra spongy bone density, dual intensity X line absorption method (DEXA) is surveyed lumbar vertebra (L2-L4) and neck of femur (Neck) bone density and ALP and measured.Not statistically significant.2.2 bone density, ALP index situation of change are taken medicine after January, each is organized, and the patient measures quantitative Analysis machine plane scan method (QCT) survey lumbar vertebra spongy bone density respectively, dual intensity X line absorption method (DEXA) is surveyed lumbar vertebra (L2-L4) and neck of femur (Neck) bone density and ALP and measured.2.3 the clinical final result matched group 100 routine patient's osteodynia of short-term do not have obvious improvement, dysfunction does not have obvious improvement; Taking medicine group 100 routine patients has osteodynia obviously to improve respectively after January, recovery from dysfunction is normal.

Efficacy assessment standard

1, cure: disappear, it is normal that movable function recovers, and lab testing is normal.

2, take a turn for the better: arthralgia, swelling alleviate, and movable function takes a turn for the better.

3, do not heal: arthralgia and swelling no change.

The group of taking medicine therapeutic outcome statistics:

Cure rate 78%, improvement rate 19%, rate 3% does not heal

Wherein: total effective rate=cure rate+improvement rate

Total effective rate is 97%

To treat the Chinese medicine composition of menopausal women osteoporosis effective so the present invention is a kind of.

Claims

1. Chinese medicine composition for the treatment of the menopausal women osteoporosis, it is characterized in that: the ratio of weight and number of various crude drug is in the Chinese medicine composition:

2. a kind of Chinese medicine composition for the treatment of the menopausal women osteoporosis according to claim 1, it is characterized in that: the ratio of weight and number of various crude drug is in the Chinese medicine composition:

3. a kind of Chinese medicine composition for the treatment of the menopausal women osteoporosis according to claim 1, it is characterized in that: the ratio of weight and number of various crude drug is in the Chinese medicine composition:

4. according to any described a kind of Chinese medicine composition for the treatment of the menopausal women osteoporosis of claim 1-3, it is characterized in that: the dosage form of Chinese medicine composition comprises for the preparation method of honey refining pill:

5. according to any described a kind of preparation method for the treatment of the Chinese medicine composition of menopausal women osteoporosis of claim 1-3, it is characterized in that: the dosage form of Chinese medicine composition is that the preparation method of capsule comprises:

6. according to any described a kind of preparation method for the treatment of the Chinese medicine composition of menopausal women osteoporosis of claim 1-3, it is characterized in that: the dosage form of Chinese medicine composition is that the preparation method of tablet comprises:

7. according to any described a kind of preparation method for the treatment of the Chinese medicine composition of menopausal women osteoporosis of claim 1-3, it is characterized in that: pharmaceutical dosage form can for: sugar coated tablet, film coated tablet, enteric coated tablet, hard capsule, soft capsule, oral liquid, suck agent, granule, electuary, honey pill agent, powder, sublimed preparation, injection, suppository, plaster, syrup, pin powder or slow releasing capsule.