CN105943700A - Traditional Chinese medicine composition capable of tonifying kidney and relieving paralysis and preparation method and application thereof - Google Patents
Traditional Chinese medicine composition capable of tonifying kidney and relieving paralysis and preparation method and application thereof Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/80—Scrophulariaceae (Figwort family)
- A61K36/804—Rehmannia
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- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/62—Leeches; Worms, e.g. cestodes, tapeworms, nematodes, roundworms, earth worms, ascarids, filarias, hookworms, trichinella or taenia
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/11—Pteridophyta or Filicophyta (ferns)
- A61K36/12—Filicopsida or Pteridopsida
- A61K36/126—Drynaria
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/21—Amaranthaceae (Amaranth family), e.g. pigweed, rockwort or globe amaranth
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/232—Angelica
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/236—Ligusticum (licorice-root)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/238—Saposhnikovia
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/286—Carthamus (distaff thistle)
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/46—Eucommiaceae (Eucommia family), e.g. hardy rubber tree
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/481—Astragalus (milkvetch)
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/486—Millettia
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- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
Abstract
The invention provides a traditional Chinese medicine composition capable of tonifying the kidney and relieving paralysis. The traditional Chinese medicine composition is prepared from, by mass, 15 parts of radix rehmanniae preparata, 15 parts of rhizoma drynariae, 30 parts of milkvetch roots, 15 parts of radix angelica sinensis, 15 parts of radix achyranthis bidentatae, 15 parts of bark of eucommia, 12 parts of rhizoma chuanxiong, 12 parts of radix saposhnikoviae, 12 parts of radix angelicae pubescentis, 9 parts of lumbricus, 15 parts of caulis spatholobi and 12 parts of flos carthami. The invention further provides a preparation method and application of the traditional Chinese medicine composition. Trough testing, the traditional Chinese medicine composition has the significant clinical treatment effect on osteoarthritis.
Description
Technical field
The present invention relates to Chinese medicine composition of a kind of the kidney invigorating blood stasis dispelling and its preparation method and application.
Background technology
Osteoarthritis (Ostcoarthriti OA) is a kind of common Chronic Progressive arthritis, and its pathological characteristic is
Articular cartilage degeneration, destruction, osteosclerosis under bone, joint margins and subchondral bone reactive hyperplasia, hyperosteogeny is formed.OA is more common in always
Year people, Epidemiological study shows that its sickness rate in 55~64 years old crowd is 40%, the sickness rate in over-65s crowd
Reach 60%.Along with the increase of the world aged, OA sickness rate is also in ascendant trend year by year, and OA patient occurs that pain, joint become
Shape, severe patient causes physical disabilities, makes life of elderly person Quality Down, brings the human body and the most dual misery;These harm
Cause extensive concern.At present its definite pathogenic factor is the most unclear, on western medical treatment many to suit the medicine to the illness, alleviating pain,
Minority even needs replacement joint, causes the most painful and the decline of quality of life to patient.And osteoarthritis
Treatment time longer, nonsteroidal antiinflammatory drug, act on antirheumatic slowly, the use etc. of hormone can make patient occur being difficult to take precautions against
Untoward reaction and paradox problem.Use nonsteroidal antiinflammatory drug can cause gastrointestinal upset, dizziness, headache, alopecia, oral cavity
Ulcer, hepatic disfunction, bone marrow depression etc., make patient be difficult to whole therapeutic scheme;The use of hormone can make patient occur
Hormone dependant phenomenon, and during Hormone Withdrawal subtracts, disease relapse occurs and touching difficulty more.All these toxic and side effects all pole
Limit greatly the clinical treatment of osteoarthritis, have a strong impact on the life quality of patient.
Chinese medicine osteoarthritis plays its comprehensive function from too many levels, Mutiple Targets, can not only promoting bone growing, also
Bone loss can be suppressed, and toxicity is little, be suitable to long-term taking, the most increasingly by common concern, its application prospect
The most wide.
Summary of the invention
The invention provides the Chinese medicine composition of a kind of the kidney invigorating blood stasis dispelling, to this end, the present invention also provides for its preparation method and answers
With.
In order to solve problems of the prior art, the technical scheme that the present invention provides is:
The Chinese medicine composition of a kind of the kidney invigorating blood stasis dispelling, described Chinese medicine composition is made up of each crude drug of following mass fraction: Radix Rehmanniae Preparata
Yellow 15 parts, Rhizoma Drynariae 15 parts, the Radix Astragali 30 parts, Radix Angelicae Sinensis 15 parts, Radix Achyranthis Bidentatae 15 parts, the Cortex Eucommiae 15 parts, Rhizoma Chuanxiong 12 parts, Radix Saposhnikoviae 12 parts, Radix Angelicae Pubescentis
12 parts, Pheretima 9 parts, Caulis Spatholobi 15 parts, 12 parts of Flos Carthami.
The present invention also provides for the preparation method of above-mentioned Chinese medicine composition, and step is as follows:
(1) Radix Astragali of formula ratio, Rhizoma Chuanxiong are ground into fine powder;
(2) by remaining 10 taste water extraction 2 times, collecting decoction, after filtration, filtrate is condensed into thick paste;
(3) add the fine powder mixing in step (1), make pill.
As preferably, it is the water extraction of addition 10 times in crude drug mixture that water described in step (2) carries.
As preferably, extracting described in step (2) is for 2 times to extract 2h for the first time, and second time extracts 1h.
As preferably, filtrate is condensed into relative density by step (2) and is 1.30 ~ 1.35(60 DEG C) thick paste.
The present invention also provides for the application in the medicine of preparation treatment the kidney invigorating blood stasis dispelling disease of the above-mentioned Chinese medicine composition.
The present invention also provides for the application in the medicine of preparation treatment osteoarthritis of the above-mentioned Chinese medicine composition.
The present invention also provides for a kind of medicine, and its effective ingredient is the Chinese medicine composition described in claim 1.
As preferably, the dosage form of described medicine is pill.
As preferably, described medicine also includes medically acceptable adjuvant.
With any means of the prior art, the Chinese medicine composition of the present invention is prepared as medicine.Because containing effectively
Composition, so all can effectively treat the kidney invigorating blood stasis dispelling disease, has good therapeutic effect to osteoarthritis.In the preparation, also may be used
The adjuvant medically accepted with addition.
Professor Meng Qingcai always works on the Chinese medicine prevention research work of orthopaedics difficult and complicated illness for many years, in clinical studies
First pass through and a large amount of Osteoarthritis are carried out clinical observation and efficacy evaluation;Zoopery is passed through in the middle of infrastest
Come the mechanism of action of research and discussion side's medicine and possible action pathway, thus for we effectiveness, safety, can apply and
Replicability provides theoretical foundation and the guarantee of science.Secondly, superintending and directing stagnant according to suffering from a deficiency of the kidney, poison is evil to be retarded by silt, and inside and outside combined pathogens falls ill it
Etiology and pathogenesis, establishes the Clinical symptoms of above two disease based on deficiency in origin and excess in superficiality, and deficiency of both the liver and kidney occupies in its pathogenesis lapses to
In hinge status.Specifically, deficiency of the liver and kindey is this, and blockage of meridian, poison evil stasis are marks, the weakened body resistance and domination of pathogen, and in treatment, evidence " is controlled
Disease must first be asked in this " propose strengthening vital QI to eliminate pathogenic factors, the Therapeutic Principle for the treatment of both the principal and secondary aspects of a disease.Righting is i.e. liver and kidney tonifying;Eliminating evil is i.e. dredging DU Meridian
Eliminating evil dredging collateral, by dispeling the wind, cold expelling, dampness removing, heat clearing away, reduce phlegm, removing blood stasis etc. makes heresy go then venation to lead to.Both complement each other, healthy energy
Filling and contain, expectorant, wet, the stasis of blood, turbid all heresies are from going out;Pathogen is dispelled, then essence, Tianjin, gas, blood fill.According to above-mentioned Therapeutic Principle, draft benefit
Kidney nourshing blood and promoting blood circulation, the method for the treatment of of active numbness relieving and pain relieving, side medicine composition Radix Rehmanniae Preparata, Rhizoma Drynariae, the Radix Astragali, Radix Angelicae Sinensis, Radix Achyranthis Bidentatae, the Cortex Eucommiae, Rhizoma Chuanxiong,
Radix Angelicae Pubescentis, Radix Saposhnikoviae, Pheretima, Caulis Spatholobi, Flos Carthami.
Radix Rehmanniae Preparata in side: enter Liver and kidney and have nourishing YIN and benefiting blood, the effect of life essence-filling, marrow-benefitting, " pearl sac " carries its " main replenishing blood and vital energy, nourishing kidney
Water, benefit Kidney-Yin, tibia is ached after being ill ", Compendium of Material Medica cloud its " fill out bone marrow, long muscle, promoting generation of vital essence and blood, tonifying five ZANG-organs ", " book on Chinese herbal medicine from
Newly " record " tonification is Kidney-Yin for kidney nourishing water, packing bone marrow ".It is agent on the essence of big nourishing YIN blood Tianjin, enriching yin and nourishing kidney principal agent;Conjunction Rhizoma Drynariae:
Bitter temperature, enters Liver and kidney warp, has continuous muscle of invigorating blood circulation, effect of invigorating the kidney and strengthening the bones, " book on Chinese herbal medicine is stated ": " control lumbago migratory arthralgia apoplexy arthroncus of knee contraction gas
Card ".This product energy promoting blood circulation to remove blood stasis, reducing swelling and alleviating pain, reunion of fractured tendons and bones, for the key medicine of traumatology.Two medicine kidney tonifying fill superintends and directs, temperature and the driest, negative and positive
Giving young employees remedial-courses in general knowledge and vocational skills, is monarch drug altogether.
Radix Achyranthis Bidentatae blood circulation promoting and blood stasis dispelling, invigorating the liver and kidney, bone and muscle strengthening, profit joint, to walk and can mend, it is descending that property is apt to draw all medicines, enters part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels blood system;
Cortex Eucommiae invigorating the liver and kidney, strong governor vessel, strengthening bone and muscle, mend and the driest, and " book on Chinese herbal medicine converge with speech ": " the non-Cortex Eucommiae of pain of waist knee joint is not removed ", go directly part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels gas
Point;Two medicines share reinforcement invigorating the liver and kidney, the merit of strong logical muscles and bones.Radix Astragali, Radix Angelicae Sinensis are strongly invigorating QI and blood, join that Rhizoma Chuanxiong is existing " to be controlled wind first to manage
Blood, blood wind is from going out " meaning, have again the merit indirectly reaching the kidney invigorating with spleen invigorating.The most all medicines, play invigorating the liver and kidney, bone and muscle strengthening altogether, and QI invigorating is supported
Blood, blood circulation promoting and blood stasis dispelling reaches strengthening vital QI to eliminate pathogenic factors, assists monarch drug to be ministerial drug altogether.
Radix Saposhnikoviae, pungent, sweet, tepor.Enter bladder, liver, spleen channel.Expelling pathogenic wind from the body surface, wins wet spasmolytic, and antidiarrheal is stopped blooding.For rheumatism numbness
Bitterly." book on Chinese herbal medicine converges and says ": " Radix Saposhnikoviae, the medicine of dispersing wind and cold arthralgia chiefly caused by damp pathogen is also.Therefore master's all wind whole body is the most unsuccessful, pain all over the joints, extremity contraction is anxious, fistula
Epilepsy convulsions etc. are demonstrate,proved "." book on Chinese herbal medicine is just ": " Radix Saposhnikoviae dissipates wind, though bladder stomach is through medicine, so with the medicine of all warps, respectively through all with this person with its gas is flat
To ";Radix Angelicae Pubescentis, pungent scattered hardship is dry, and tepor can be led to, function expelling wind and dampness, numbness relieving and pain relieving, all anemofrigid-damp arthralgia, arthralgia, newly
For a long time, all can apply, be suitable with diseases such as the arthralgia pain of bottom, soreness of waist and knee joint, two foot painful abdominal mass numbness, joint stuffiness especially, be often equal to Radix Achyranthis Bidentatae
With." wood grass converges and says ": " benefaction blood system, the medicine of the wet cold expelling of row that dispels the wind is also.The card of all sick wind, as head term can not pitching, waist knee joint can not
Bend and stretch, or arthralgia pain be difficult to walk, numbness need not, all wind is caused with cold, and summer-heat is with wet institute wound also;Must be warm by the toil of Radix Angelicae Pubescentis, live
Taking offence blood, cold expelling of dispelling is evil "." wood grass justice ": " abnormal smells from the patient hero is strong, and sweet perfumes are diffused all around, therefore can declare logical hundred arteries and veins, mediation meridians, lead to muscles and bones and
Profit office, the numbness of all cold-damp, in muscle, in joint person, the taste that this gas hero taste of non-used is strong, it is impossible to go directly in passages through which vital energy circulates joint it
Between, therefore be the medicine that the soft all big cards of migratory arthralgia painful abdominal mass are essential;Pheretima, salty-cold, return liver, spleen, bladder warp.Relieving spasm by subduing liver-wind, dredge the meridian passage,
Dispel the stasis of blood of meridians, be longer than and alter removing obstruction in the collateral to relieve pain, therefore be used for treating blood stagnancy due to deficiency of QI hemiplegia and arthromyodynia podomere is unfavorable.It is equipped with again chicken
Caulis seu Radix Schisandrae Henryi nourishing blood and promoting blood circulation, activating muscle and blood, can invigorate blood circulation, can nourish blood again, and have the merit of relaxing muscles and tendons and activating QI and blood in the collateral, to numb limbs and tense tendons, rheumatic arthralgia
Deng disease, no matter blood deficiency, the stasis of blood is stagnant all can apply;Flos Carthami, blood circulation promoting and blood stasis dispelling, reducing swelling and alleviating pain." medicineization justice ": " Flos Carthami, kind promoting blood circulation,
For gas medicine in blood, can rush down and can mend, being respectively arranged with wonderful justice ".This product kind energy promoting blood circulation, energy blood circulation promoting and blood stasis dispelling, reducing swelling and alleviating pain.Play altogether and dispel
The all heresies of wind, cold, wet, heat, expectorant, the stasis of blood, the meridian dredging numbness hinders, and heresy is gone beniol, all cards to be naturally readily solved, is adjuvant drug altogether.
Function cures mainly: invigorating kidney, promoting blood circulation, numbness relieving and pain relieving.For deficiency of kidney-essence, the joint dull pain caused by obstruction of collaterals by blood stasis or twinge,
Localized pain, very, spinal column is unable for hypnalgia, joint joint stuffiness.Osteoarthritis is shown in above-mentioned patient.
In sum, the Chinese medicine composition prescription of the kidney invigorating blood stasis dispelling of the present invention is according to the osteoarthritis course of disease many delay days
For a long time, and the touching difficulty of the state of an illness is more, the feature of deficiency in origin and excess in superficiality, employing reinforcement and elimination in combination, and residence leads to the rule for the treatment of in benefit, has eliminating evil and does not just hinder
Prescription feature.All medicines share, and play " kidney-replenishing blood-nourishing is invigorated blood circulation, the method for the treatment of of active numbness relieving and pain relieving " invigorating kidney, promoting blood circulation altogether, numbness relieving and pain relieving it
Merit.
Through test, the traditional Chinese medicine composition for treating osteoarthritis clinical efficacy of the present invention is notable.
Detailed description of the invention
Below example facilitates a better understanding of the present invention, but does not limit the present invention.Experiment in following embodiment
Method, if no special instructions, is conventional method.Test material used in following embodiment, if no special instructions, is city
Sell.
Embodiment 1
The Chinese medicine composition of the kidney invigorating blood stasis dispelling of the present invention is made up of following crude drug:
Radix Rehmanniae Preparata 15g Rhizoma Drynariae 15g Radix Astragali 30g Radix Angelicae Sinensis 15g
Radix Achyranthis Bidentatae 15g Cortex Eucommiae 15g Rhizoma Chuanxiong 12g Radix Saposhnikoviae 12g
Radix Angelicae Pubescentis 12g Pheretima 9g Caulis Spatholobi 15g Flos Carthami 12g.
The preparation method of the Chinese medicine composition of the kidney invigorating blood stasis dispelling of the present invention is:
The Radix Astragali, Rhizoma Chuanxiong power are broken into fine powder.10 tastes such as remaining Radix Rehmanniae Preparata, the Cortex Eucommiae, Pheretima, Caulis Spatholobi add 10 times of weight water and extract 2 times,
2h for the first time, for the second time 1h, collecting decoction, filter, filtrate is condensed into relative density and is 1.30 ~ 1.35(60 DEG C) thick paste, with
Above-mentioned fine medicinal material powder (1:1.5) mixes, and makes 1000 balls, is dried, polishing, to obtain final product.
Discrimination method:
(1) this product 5g is taken, finely ground, add methanol 30ml, be heated to reflux 1 hour, let cool, filter, filtrate is evaporated, and residue adds methanol
1ml makes dissolving, as need testing solution.Separately take naringin reference substance, add methanol and make every 1ml solution containing 0.5mg, as right
According to product solution.Test according to thin layer chromatography (annex VI B), draw each 4 μ l of above two solution, put in same silica gel G thin respectively
On laminate, with the upper solution of toluene-ethyl acetate-formic acid-water (1: 12: 2.5: 3) as developing solvent, launch, take out, dry in the air
Dry, spray, with aluminum chloride test solution, is put and is inspected under ultra-violet lamp (365nm).In test sample chromatograph, corresponding with reference substance chromatograph
On position, the fluorescence speckle of aobvious same color.
(2) this product 6g is taken, finely ground, add methanol 30ml, supersound process 40 minutes, filter, filtrate is concentrated near dry, and residue adds
Water 10ml, slight fever makes dissolving, extracts 2 times with the shaking of water saturated n-butyl alcohol, each 20ml, merges n-butyl alcohol liquid;Use ammonia solution
Wash 2 times, each 20ml, discard ammonia solution;It is washed with water and washs 2 times, each 20ml, discard water liquid;N-butyl alcohol liquid is evaporated, residue
Add water 5ml, and slight fever makes dissolving, by D101 type macroporous adsorptive resins (internal diameter is 1.5cm, a height of 12cm of post) after cooling, uses
Water 50ml eluting, discards water liquid, then with 40% ethanol 30ml eluting, discards eluent, continues, with 70% ethanol 80ml eluting, to collect
Eluent, is evaporated, and residue adds methanol 1ml makes dissolving, as need testing solution.Separately taking Radix Astragali control medicinal material 1g, it is right to be made in the same way of
According to medical material solution.Take astragaloside reference substance again, add methanol and make every 1ml solution containing 1mg, as reference substance solution.According to thin
Layer chromatography (one annex VI B of " Chinese Pharmacopoeia " version in 2010) is tested, and draws need testing solution and control medicinal material solution each 5
μ l, reference substance solution 2 μ l, put respectively on same silica gel g thin-layer plate, with [the upper strata of n-butyl alcohol-ethyl acetate-water (4: 1: 5)
Solution]-methanol (10: 1) is developing solvent, launches, and takes out, dries, spray, with 10% ethanol solution of sulfuric acid, is heated to speckle at 105 DEG C
Colour developing is clear.In test sample chromatograph, with on control medicinal material and the corresponding position of reference substance chromatograph, show identical brown mottle
Point.
(3) taking this product powder lg, add diethyl ether 20ml, is heated to reflux l hour, filters, and filtrate volatilizes, and residue adds ethyl acetate
2ml makes dissolving, as need testing solution.Separately take Rhizoma Chuanxiong control medicinal material lg, be made in the same way of control medicinal material solution.Take again in Radix Levistici Officinalis
Ester A reference substance, adds ethyl acetate and makes every 1ml solution (putting in brown measuring bottle) containing 0.1mg, as reference substance solution.According to thin
Layer chromatography (annex VI B) is tested, and draws above-mentioned three kinds of solution each l0 μ l, puts respectively in same silica gel G F254On lamellae, with
N-hexane-ethyl acetate (3: 1) is developing solvent, launches, and takes out, dries, put and inspect under ultra-violet lamp (254nm).Test sample color
In spectrum, with in control medicinal material chromatograph and the corresponding position of reference substance chromatograph, show the speckle of same color.
The test of pesticide effectiveness of the Chinese medicine composition of embodiment 2 present invention
One, clinical experiment process
1. physical data is originally organized 70 example patients and is all from January, 2013 in January, 2015 Hospital of TCM, Xinjiang Uygur Autonomous Region
Orthopaedics Clinic is gone to a doctor patient, is randomly divided into two groups.Treatment group 35 example, the maleest 16 examples, female 19 example, 59 years old mean age.Comparison
Organize 35 examples, male 13 examples, female 22 example, 60 years old mean age.Two groups of cases all meet diagnostic criteria.Through statistical procedures, difference without
Significant, has comparability (P > 0.05).
Include in and exclusion standard
(1) in the knee osteoarthritis diagnostic criteria that inclusive criteria Western medicine diagnose standard proposes with reference to rheumatism association of the U.S. (ACR)
Clinic adds two set standards of radiological examination, i.e. must have knee-joint pain, 1 in hyperosteogeny 2, and the most following 3
In 1: the age>40 years old, morning is stiff, and<30min and bony crepitus, tenderness bone increases and joint is without obvious temperature.All meet it
In 1 set standard can make a definite diagnosis.
TCM syndrome diagnostic criteria is with reference to " Chinese medical disease Standardization of diagnosis and curative effect ", " Diagnostics of Chinese Medicine ", kidney deficiency blood stasis type: close
Joint dull pain or twinge, sore spot is fixed or joint deformity, movable unfavorable, accompanies soreness of the waist and knees, dizzy, tinnitus, dim complexion, pale tongue
Dark or the stasis of blood purple, white and thin fur, deep-thready pulse.
(2) exclusion standard age person more than 75 years old;Hypertension blood pressure is higher than 140/90mmHg person;Gestation or suckling
Phase women;Allergic constitution person.
Therapeutic Method:
Treatment group: give the embodiment of the present invention 1 preparation the kidney invigorating numbness lead to ball (side medicine composition Radix Rehmanniae Preparata, Rhizoma Drynariae, the Radix Astragali, Radix Angelicae Sinensis,
Radix Achyranthis Bidentatae, the Cortex Eucommiae, Rhizoma Chuanxiong, Radix Angelicae Pubescentis, Radix Saposhnikoviae, Pheretima, Caulis Spatholobi, Flos Carthami.), by Hospital of TCM, Xinjiang Uygur Autonomous Region's Chinese medicine system
Agent room provides.10g every time, three times a day, ante cibum is administered orally.
Matched group: took celecoxib capsule (pfizer inc produces, traditional Chinese medicines quasi-word J20030098), every day 1
Secondary, each 200mg, swells and ache and disables after alleviating;(Shanghai Pharmaceutical's letter friendship pharmacy head factory is raw for methotrexate
Produce, traditional Chinese medicines quasi-word H31020644) oral, 1 times a week, each 10mg.Two groups of courses for the treatment of are 3 months.
Observation index and method
(1) arthralgia index, articular pain number (individual), joint swelling index, joint before and after sings and symptoms comparison therapy
The diseases such as swelling number (individual), function of joint classification, deadlock time in morning (min), the average grip of both hands (mmHg) and 15m walking time (s)
Shape and sign.
(2) erythrocyte sedimentation rate (ESR), RF and c reactive protein (CRF) etc. are measured before and after lab index treatment.
Efficacy assessment standard: formulate with reference to " new Chinese medicine guideline of clinical investigations ".Effective: cardinal symptom, sign are whole
Body improvement rate >=75%;ESR and CRP is normal or is obviously improved or close to normal.Progressive: cardinal symptom, sign entirety improvement rate >=
50%;ESR and CRP has improvement.Effective: cardinal symptom, sign entirety improvement rate >=30%;ESR and CRP has improvement or without improving.
Invalid: cardinal symptom, sign entirety improvement rate < 30%;ESR and CRP is without improving.
Statistical method
Using SPSS 16.0 statistical software to carry out statistical analysis, continuous data represents with mean ± standard deviation (x ± s), compares between group
Relatively using t inspection, remaining detection uses one factor analysis of variance, and P < 0.05 is that difference is statistically significant.
Two, interpretation of result
1. liang group patient clinical comparitive study
By comparing discovery treatment group total effective rate apparently higher than matched group (P < 0.05).
1 liang of table group patient clinical comparitive study (example/%)
Note: compare with matched group, * P < 0.05.
2. before and after liang group patient treatment, the change of major laboratories index is compared
As shown in table 2, after two groups of treatments, ESR, CRP, RF all have clear improvement (P < 0.05), compare after treatment group and treatment of control group
Relatively, ESR difference statistically significant (P < 0.05).
2 liang of table group patient treatment before and after ESR, RF and CRP compare ()
Note: with this group before treatment, * P < 0.05;Compare with after treatment of control group, △ P < 0.05.
3. liang group patient's cardinal symptom compares with sign change: articular pain number, swelling number, arthritis before and after two groups of treatments
Bitterly, tenderness, swelling index, function of joint grade, deadlock time in morning, the two average grips of hands, 15m walking time, difference has statistics
Meaning (P < 0.05), after treatment, treatment group compares with matched group, above-mentioned each indicator difference the most statistically significant (P < 0.05).
4. a liang group patient safety compares: treatment group has 2 example generation untoward reaction, and incidence rate is 4%;Matched group has 3 examples to send out
Raw untoward reaction, incidence rate is 6%, and two groups are compared no difference of science of statistics (P > 0.05).Treatment group untoward reaction show as erythra or
Gastrointestinal upset, its degree is slight;Matched group untoward reaction mainly shows as leukopenia, alanine aminotransferase raises
Deng, its degree is slight.Two groups of untoward reaction all disappear after symptomatic treatment.
Research conclusion: treatment group total effective rate is apparently higher than matched group (P < 0.05), arthralgia before and after two groups of treatments, swollen
Swollen, function of joint grade, deadlock time in morning, the two average grips of hands, 15m walking time difference statistically significant (P < 0.05), control
After the treatment for the treatment of group, These parameters compares with matched group, difference statistically significant (P < 0.05).ESR, CRP, RF after two groups of treatments
The most relatively improving (P < 0.05) before treatment, wherein ESR improves treatment group and is better than matched group (P < 0.05);Treatment group and matched group are bad
Reaction incidence rate is respectively 4%, 6%, two groups of comparing difference not statistically significants (P > 0.05).
To sum up, to lead to pill for curing osteoarthritis clinical efficacy notable for the kidney invigorating numbness of the present invention.
Finally it is noted that the foregoing is only the preferred embodiments of the present invention, it is not limited to the present invention,
Although being described in detail the present invention with reference to previous embodiment, for a person skilled in the art, it still may be used
So that the technical scheme described in foregoing embodiments to be modified, or wherein portion of techniques feature is carried out equivalent.
All within the spirit and principles in the present invention, any modification, equivalent substitution and improvement etc. made, should be included in the present invention's
Within protection domain.
Claims (10)
1. the Chinese medicine composition of a kidney invigorating blood stasis dispelling, it is characterised in that: each former by following mass fraction of described Chinese medicine composition
Material medicine composition: Radix Rehmanniae Preparata 15 parts, Rhizoma Drynariae 15 parts, the Radix Astragali 30 parts, Radix Angelicae Sinensis 15 parts, Radix Achyranthis Bidentatae 15 parts, the Cortex Eucommiae 15 parts, Rhizoma Chuanxiong 12 parts,
Radix Saposhnikoviae 12 parts, Radix Angelicae Pubescentis 12 parts, Pheretima 9 parts, Caulis Spatholobi 15 parts, 12 parts of Flos Carthami.
2. the preparation method of the Chinese medicine composition described in claim 1, it is characterised in that: step is as follows:
(1) Radix Astragali of formula ratio, Rhizoma Chuanxiong are ground into fine powder;
(2) by remaining 10 taste water extraction 2 times, collecting decoction, after filtration, filtrate is condensed into thick paste;
(3) add the fine powder mixing in step (1), make pill.
Method the most according to claim 2, it is characterised in that: it is in crude drug mixture that water described in step (2) carries
Add the water extraction of 10 times.
Method the most according to claim 2, it is characterised in that: extracting described in step (2) is for 2 times to extract 2h for the first time,
Second time extracts 1h.
Method the most according to claim 2, it is characterised in that: filtrate is condensed into by step (2) relative density be 1.30 ~
1.35(60 DEG C) thick paste.
6. the application in the medicine of preparation treatment the kidney invigorating blood stasis dispelling disease of the Chinese medicine composition described in claim 1.
7. the application in the medicine of preparation treatment osteoarthritis of the Chinese medicine composition described in claim 1.
8. a medicine, its effective ingredient is the Chinese medicine composition described in claim 1.
A kind of medicine the most according to claim 8, it is characterised in that: the dosage form of described medicine is pill.
A kind of medicine the most according to claim 8, it is characterised in that: described medicine also include medically acceptable
Adjuvant.
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