CN110141621A - A kind of Chinese medicine composition and its preparation method and application for treating pain - Google Patents
A kind of Chinese medicine composition and its preparation method and application for treating pain Download PDFInfo
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- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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Abstract
The invention belongs to the field of Chinese medicines, disclose a kind of Chinese medicine composition and its preparation method and application for treating the pain as caused by knee osteoarthritis, lumbar vertebrae Osteoarthritis, cervical spondylosis etc..The active constituent of the Chinese medicine composition is west safflower, the rhizome of davallia, the root of Chinese clematis, Caulis Spatholobi and safflower.For Chinese medicine composition of the invention using Chinese medicine as bulk pharmaceutical chemicals, compatibility is reasonable, preparation process is simple, good effect, quick, highly-safe, is easy to clinically promote.
Description
Technical field
The invention belongs to the field of Chinese medicines, and in particular to a kind of to treat by knee osteoarthritis, lumbar vertebrae Osteoarthritis, cervical vertebra
The Chinese medicine composition and its preparation method and application of pain caused by disease etc..
Background technique
Pain is often the main reason that patient sees a doctor, and world's pain conference is confirmed as, and " the fifth-largest life of the mankind is special
Sign " is with a kind of unhappy feeling and mental experience caused by substantive or potentiality tissue damage.By kneecap joint
Pain caused by inflammation, lumbar vertebrae Osteoarthritis, cervical spondylosis etc. is the common disease of the middle-aged and the old.Illness rate with advancing age and
Increase, clinical symptoms have the symptoms such as numbness, sciatica, Syndrome Differentiation of Chinese Medicine concurrently based on the pain in part or Substance P region
Card is that the tendon and vessel stasis of blood is stagnant, kidney deficiency and liver, and it is limited to will lead to paralysis, joint motion in severe cases, seriously affects the body of patient
Heart health.With the increasingly change of quickening and living habit of modern life rhythm, in daily life and work, youth one
In generation, does not pay attention to health care mostly, and abnormal sitting posture is true when such as bending over one's desk working for a long time, or uses computer etc. to constant posture for a long time, causes
Younger generation are mostly in sub-health state, and the patient for suffering from lumbar vertebrae Osteoarthritis, cervical spondylosis etc. is more and more.It controls at present
Treating knee osteoarthritis, lumbar vertebrae Osteoarthritis, the method for cervical spondylosis mainly has surgical therapy, drawing method and massage etc..
Although surgical therapy can obtain effect in a short time, there are risks it is big, easy to recur the disadvantages of.Drawing method and massage
Can only respite pain, the effect of healing is not achieved.Although Western medicine anodyne can be relieved pain effectively, quick, cannot control
Bitterly, it takes for a long time and is easy to make patient to generate dependence, and there is certain toxic side effect.Therefore, studying a kind of can be effectively relieved
The safety of the pain as caused by knee osteoarthritis, lumbar vertebrae Osteoarthritis, cervical spondylosis, scapulohumeral periarthritis, rheumatism, lumbar muscle strain etc. can
The drug leaned on is the current technical issues that need to address.
Chinese patent CN100496544C disclose it is a kind of with safflower, the rhizome of davallia, the root of Chinese clematis, Caulis Spatholobi composition for controlling
The Chinese medicine of pain is treated, but applicant, in practice, it has been found that pain can not be effectively relieved in the composition, action is slower, needs
Large dosage, which is used for a long time, could obtain certain effect.
Summary of the invention
Aiming at the problems existing in the prior art, the purpose of the present invention is to provide a kind of Chinese traditional medicine compositions for treating pain
Object, Chinese medicine composition of the invention is quick, good effect, compatibility are reasonable, highly-safe, suitable for clinically promoting the use of.
The present invention provides a kind of Chinese medicine compositions for treating pain, and the Chinese medicine composition is by following active ingredients group
At: 5-15% west safflower, the 35-50% rhizome of davallia, the 26-40% root of Chinese clematis and 20-32% Caulis Spatholobi.
The present invention provides a kind of Chinese medicine compositions for treating pain, and the Chinese medicine composition is by 5-15 grams of west safflower, 35-
50 grams of rhizomes of davallia, the 26-40 grams of root of Chinese clematis and 20-32 grams of Caulis Spatholobi composition.
Preferably, the dosage form of Chinese medicine composition of the invention is external preparation.
Preferably, the dosage form of Chinese medicine composition of the invention includes emplastrum, tincture, liniment, ointment, cataplasm.
Preferably, the composition further includes some auxiliary materials.
The present invention provides a kind of pharmaceutical preparation, the effective component of the pharmaceutical preparation is by mentioned-above Chinese traditional medicine composition
Object is prepared.
Preferably, the dosage form of the pharmaceutical preparation includes emplastrum, tincture, liniment, ointment, cataplasm.
The present invention provides the preparation method of above-mentioned Chinese medicine composition, the preparation method includes the following steps:
(1) rhizome of davallia, the root of Chinese clematis, Caulis Spatholobi dried and crushed are added west safflower and mixed at coarse powder；
(2) by said mixture with 75% alcohol dipping 48 hours, diacolation is carried out, collects percolate.
The present invention provides the preparation method of the pharmaceutical preparation, the preparation method includes the following steps:
(1) mentioned-above Chinese medicine composition is prepared；
(2) step (1) is prepared into resulting Chinese medicine composition according to the common process and common medicinal supplementary material system of pharmacy
For at the pharmaceutical preparation.
The present invention provides application of the Chinese medicine composition in the drug of preparation treatment pain.
The present invention provides application of the pharmaceutical preparation in the drug of preparation treatment pain.
As another object of the present invention, the present invention also provides a kind of Chinese medicine composition for treating pain, it is described in
Drug composition is made of following active ingredients: 2-10% west safflower, the 20-35% rhizome of davallia, the 15-30% root of Chinese clematis, 10-25% chicken
Blood rattan and 20-35% safflower.
The present invention provides a kind of Chinese medicine compositions for treating pain, and the Chinese medicine composition is by 2-10 grams of west safflower, 20-
35 grams of rhizomes of davallia, the 15-30 grams of root of Chinese clematis, 10-25 grams of Caulis Spatholobi and 20-35 grams of safflower composition.
Preferably, the dosage form of Chinese medicine composition of the invention is external preparation.
Preferably, the dosage form of Chinese medicine composition of the invention includes emplastrum, tincture, liniment, ointment, cataplasm.
Preferably, the composition further includes some auxiliary materials.
The present invention provides a kind of pharmaceutical preparation, the effective component of the pharmaceutical preparation is by mentioned-above Chinese traditional medicine composition
Object is prepared.
Preferably, the dosage form of the pharmaceutical preparation includes emplastrum, tincture, liniment, ointment, cataplasm.
The present invention provides the preparation method of above-mentioned Chinese medicine composition, the preparation method includes the following steps:
(1) at coarse powder west safflower is added, safflower mixes in the rhizome of davallia, the root of Chinese clematis, Caulis Spatholobi dried and crushed；
(2) by said mixture with 75% alcohol dipping 48 hours, diacolation is carried out, collects percolate.
The present invention provides the preparation method of the pharmaceutical preparation, the preparation method includes the following steps:
(1) mentioned-above Chinese medicine composition is prepared；
(2) step (1) is prepared into resulting Chinese medicine composition according to the common process and common medicinal supplementary material system of pharmacy
For at the pharmaceutical preparation.
The present invention also provides application of the Chinese medicine composition in the drug of preparation treatment pain.
The present invention also provides application of the pharmaceutical preparation in the drug of preparation treatment pain.
It is not right herein it is to be appreciated that here by the restriction that ... the closed mode that .. is formed is only to active constituent
The restriction of non-active ingredient, some auxiliary elements or auxiliary material be not within the scope of restriction, that is to say, that auxiliary material is not
Active constituent, but may be a kind of carrier of these active constituents, alternatively, due to the requirement of different expression form, such as paste,
Tincture, liniment, ointment, cataplasm need various forms of auxiliary materials to complete, but these auxiliary materials are only due to form difference
Play booster action, and itself not active ingredient the effect of.
The utility model has the advantages that
Chinese medicine composition for treating pain of the invention contains west safflower, the rhizome of davallia, the root of Chinese clematis, Caulis Spatholobi or red
Flower, wherein west safflower has relaxing tendons and activating collaterals, promoting menstruation stagnation resolvation, dissipates Yu Kaijie, removing pattogenic heat from the blood and toxic material from the body, the function improved the immunity of the human body comprehensively
Effect；Rhizome of davallia energy The strong bone of kidney tonifying, continues and hinders pain relieving；The root of Chinese clematis it is pungent it is salty wander away, dispelling wind and eliminating dampness, softening hard masses detumescence, dissipate blood stasis and smoothing collaterals；Caulis Spatholobi
It enriches blood, invigorate blood circulation, dredging collateral；The main blood circulation and promoting silt of safflower, swelling and pain relieving.Raw material in the composition is each powerful, have dredge through dredging collateral,
The advantages of activating microcirculation and removing stasis medicinal, promoting qi circulation and relieving pain and dispelling wind and eliminating dampness.The composition compatibility is reasonable, effectively prevents a variety of drug phase interactions
With the potential drug risk of bring, there is significant effect, curative effect is very fast, the higher feature of safety.
Detailed description of the invention
Fig. 1 is safflower plant aspect graph.
Fig. 2 is west safflower botanic conformation figure.
Fig. 3 is the structure of safflower part of compounds.
Fig. 4 is the chemical structure of west safflower water colo(u)r ingredient.
It is described in detail
Structure of the present invention or technical term used in these are described further below, if without spy
It is standby to indicate, understood and explained according to the general general terms of this field.
West safflower
West safflower (Crocus sativus): also known as safron, safflower, up to husband is blue, spreads French Franc, is Iridaceae safron
Belong to perennial plant bulbs, unifacial leaf.It generally picks up from the above extremely frigid zones of height above sea level 5000m, the month at florescence 10-11.It mainly contains
Water colo(u)r ingredient, such components are mainly a series of ester compounds that crocetin and sugar are formed, it is the master of west safflower
Key medicine is used and pigment composition, structure are mainly alltrans saffron glucoside, α-crocin, β-crocin, γ-crocin
And crocin-I~V, in addition there are plain -6 '-O safflower acyls of a special cis- saffron glucoside esters He Wu Mango
- 1 '-O- β of base-D-Glucose glycosides ester (structure of these compounds is as shown in figure 4, quoted from document)；Fat-soluble pigment ingredient is as recklessly
Radish element, zeaxanthin, octahydro lycopene, phytofluene, lycopene；Volatile oil precursor glycoside, volatile oil additionally contain
There are the compounds such as eucalyptus brain, firpene, multivitamin and thiamine.
Safflower
Safflower (Carthamus tinctonius): also known as red blue flower, champac, thorn safflower, safflower, it is composite family safflower category
Annual or biennial herb plant, it is dicotyledonous.There are cultivation, the month at florescence 5-7 in all parts of the country.Mainly contain quinoid chalcone glycosides
The substances such as class, flavonoids, spermidine class, alkaloids, safflower polysaccharide, organic acid.Wherein, quinoid chalcone glycoside is safflower water
The main component of extract, such as hydroxyl radical carthamin yellow carthamus A (HSYA), carthamus tinctorius yellow colour A, safflominC and dehydration carthamin yellow
B (AHSYB), with HSYA content highest；Safflower polysaccharide is that glucose, xylose, arabinose and galactolipin are more with β-key connection
Sugared body；Organic acid is palmitinic acid, cinnamic acid, lauric acid.Takahashi Y etc. mentions water-soluble Saflor yellow-A, quilt in safflower
It is considered main effects substance (Takahashi Y, Miyassaka N, Tasaka SH, the et al.constitution of safflower
of two coloring matters in the flower petals of carthamustinctorius
L.Tetrahedron Lett,1982,23(49):5163)；The discovery carthamus tinctorius yellow colour A such as Yang Zhifu can significantly extend fibrin ferment
There are preferable blood coagulation resisting function (Yang Zhifu etc., safflower effective ingredients and pharmacological action, northwest pharmacy in former time and clotting time
Magazine, 2001,16 (3): 131-132)；Huang Zhengliang reports that carthamin yellow has stronger and lasting analgesia, sedation (yellow
It is just good etc., the pharmacological research of carthamin yellow, Chinese herbal medicine, 1984:15 (8): 13-14).It can be seen that playing analgesic activity in safflower
Substance may be carthamin yellow, and the chemical structure of main component is as shown in Figure 3 (quoted from document) in safflower.
The relationship of west safflower and safflower
Group of the present invention is found surprisingly that, when existing traditional safflower is replaced with west safflower, obtains unexpected
Effect, and broken the used mode of thinking having.Although west safflower and safflower only the change of one wordThe difference lies in a single word, but two tastes it is different in
Medicine.West safflower and safflower are often erroneously interpreted as synonym in use, and same substance is taken as to obscure use.On the other hand
It is expensive because west safflower medicine source is few, it is usually alternative with safflower.However west safflower and safflower are two kinds of entirely different plants,
Its classification in botany, morphological development, contained active constituent and therapeutic effect all have very big difference.
Safflower is the flower of compositae plant safflower, the annual 5-6 month when petal from yellow to red when pick tubular flower, dry in the shade or dry
Be used as medicine, warm-natured, acrid flavour has effects that blood circulation, stasis-dispelling and pain-killing, be usually used in treat women's amenorrhoea, post partum longtime lochia,
The diseases such as extravasated blood has a pain, traumatic injury.West safflower is top and the column cap of irides safron style, generally in the 10-11 month
The middle ten days and the last ten days harvest flower, dry or low temperature drying be used as medicine, it is mild-natured, it is sweet in flavor, have relaxing tendons and activating collaterals, promoting menstruation stagnation resolvation, dissipate the stasis of blood open knot,
The effect of swelling and pain relieving, refreshing and detoxicating, is usually used in treating blood stasis stasis, irregular menstruation, post partum longtime lochia, traumatic injury and interior
The diseases such as external hemorrhage.West safflower is similar to function of the safflower in terms of activating microcirculation and removing stasis medicinal, but the efficacy of a drug of west safflower is much better than safflower.West
Safflower has the function of removing pattogenic heat from the blood and toxic material from the body not available for safflower, resolving stagnation for tranquilization, and also has effects that blood-nourishing.Therefore, safflower is not
Equal to west safflower, to guarantee drug safety, the two cannot obscure use.
On the one hand, the present invention with west safflower, the rhizome of davallia, the root of Chinese clematis, four taste drug matching of Caulis Spatholobi is prepared for one kind to have
The Chinese medicine composition of effect treatment pain.According to the literature, the principle active component that analgesic effect is played in safflower is safflower yellow
Element, and the water colo(u)r ingredient in west safflower is the primary medicinal component of west safflower, structure is mainly alltrans safflower
Glycosides, α-crocin, β-crocin, γ-crocin and crocin-I~V.Currently also about the research of west safflower
It is not deep enough, for being specifically that there are no detailed reports for which kind of ingredient performance analgesic effect in west safflower.It is free of in west safflower
There is carthamin yellow, it is seen that the ingredient of west safflower and safflower performance analgesic effect is not identical, and then leads to the effect machine of the two
Reason is different.
On the other hand, the present invention is prepared for one with west safflower, the rhizome of davallia, the root of Chinese clematis, Caulis Spatholobi, safflower traditional Chinese medicine of the five flavours compatibility
Kind can effectively treat the Chinese medicine composition of pain.The compatibility of low dosage west safflower significantly improves the therapeutic effect of the composition,
Using five kinds of compatibility of drugs for playing different efficacies, the Synergistic Mechanisms between drug are given full play to, has reached good and has controlled
Therapeutic effect.
In addition, drug component compatibility more advantages of simple of the invention, achieves good on the basis of optimizing component
Therapeutic effect.It plays the antagonism that may occur between a variety of drug components of identical function or some drugs is unsuitable
It shares, multicomponent cooperation can not only improve curative effect, and will lead to drug effect instead reduces or generate toxicity, side effect.Of the invention
Pharmaceutical composition not only has good function and effect, but also shows higher safety, at the same also reduce pharmacy at
The medication of this and patient burden.
Specific embodiment
The present invention is described in further detail with embodiment with reference to the accompanying drawing.Following embodiment is only exemplary
, only to do further detailed description to technical solution of the present invention, those skilled in the art should understand that,
In the spirit and scope without departing from technical solution of the present invention, modifying or replaceing for technical solution progress should all be covered at this
In the claims of invention.
In the present invention, if not refering in particular to, all percentage is unit of weight, and all equipment and raw material etc. can be from
Market is bought or the industry is common.If the method that embodiment uses is technology generally in the art without specializing.
Embodiment 1
The preparation of emplastrum: west safflower 5g, rhizome of davallia 45g, root of Chinese clematis 28g, Caulis Spatholobi 22g are taken, wherein the rhizome of davallia, Wheeling
Celestial, Caulis Spatholobi dried and crushed is added west safflower and mixes at coarse powder, and with 75% ethanol as solvent, dipping slowly seeps after 48 hours
It filters, percolate is collected, after adding appropriate auxiliary material, by obtained medical fluid absorption to get emplastrum on sticking material.The auxiliary material contains
Alcohol, water, Mint Essence and pigment.
Embodiment 2
The preparation of emplastrum: west safflower 10g, rhizome of davallia 40g, root of Chinese clematis 30g, Caulis Spatholobi 20g are taken, wherein the rhizome of davallia, prestige
Medicine xiaolingxian, Caulis Spatholobi dried and crushed are added west safflower and mix, with 75% ethanol as solvent, dipping slowly seeps after 48 hours at coarse powder
It filters, percolate is collected, after adding appropriate auxiliary material, by obtained medical fluid absorption to get emplastrum on sticking material.The auxiliary material contains
Alcohol, water, Mint Essence and pigment.
Embodiment 3
The preparation of emplastrum: west safflower 15g, rhizome of davallia 35g, root of Chinese clematis 30g, Caulis Spatholobi 20g are taken, wherein the rhizome of davallia, prestige
Medicine xiaolingxian, Caulis Spatholobi dried and crushed are added west safflower and mix, with 75% ethanol as solvent, dipping slowly seeps after 48 hours at coarse powder
It filters, percolate is collected, after adding appropriate auxiliary material, by obtained medical fluid absorption to get emplastrum on sticking material.The auxiliary material contains
Alcohol, water, Mint Essence and pigment.
Embodiment 4
The preparation of tincture: west safflower 10g, rhizome of davallia 40g, root of Chinese clematis 30g, Caulis Spatholobi 20g are taken, wherein the rhizome of davallia, Wheeling
Celestial, Caulis Spatholobi dried and crushed is added west safflower and mixes at coarse powder, and with 75% ethanol as solvent, dipping slowly seeps after 48 hours
It filters, collects percolate, stand 48h, add water until concentration of alcohol is 45%.Filtering, takes filtrate filling in 30mL high-density plastic
Sealed bottle, sealing cover to get tincture.
Embodiment 5
The preparation of liniment: west safflower 10g, rhizome of davallia 40g, root of Chinese clematis 30g, Caulis Spatholobi 20g are taken, wherein the rhizome of davallia, Wheeling
Celestial, Caulis Spatholobi dried and crushed is added west safflower and mixes at coarse powder, and with 75% ethanol as solvent, dipping slowly seeps after 48 hours
It filters, collects percolate, be evaporated under reduced pressure phegma and recycle ethyl alcohol, be spray-dried to get extract powder, 20g extract powder is taken to add 70%
Dimethyl sub-maple solution 1000mL dissolution, it is filling to cover in 30mL high-density plastic's bottle closure to get liniment.
Embodiment 6
The preparation of ointment: west safflower 10g, rhizome of davallia 40g, root of Chinese clematis 30g, Caulis Spatholobi 20g are taken, wherein the rhizome of davallia, prestige
Medicine xiaolingxian, Caulis Spatholobi dried and crushed are added west safflower and mix, with 75% ethanol as solvent, dipping slowly seeps after 48 hours at coarse powder
It filters, collects percolate, be evaporated under reduced pressure phegma and recycle ethyl alcohol, be spray-dried to get extract powder, by extract powder and proper amount of matrix
It grinds well to get ointment.
Embodiment 7
The preparation of cataplasm: west safflower 10g, rhizome of davallia 40g, root of Chinese clematis 30g, Caulis Spatholobi 20g are taken, wherein the rhizome of davallia, prestige
Medicine xiaolingxian, Caulis Spatholobi dried and crushed are added west safflower and mix, with 75% ethanol as solvent, dipping slowly seeps after 48 hours at coarse powder
It filters, collects percolate, recycle ethyl alcohol, and percolate is condensed into thick paste, mix, be coated with water-soluble high-molecular material matrix
Afterwards to get cataplasm.
Embodiment 8
The preparation of emplastrum: west safflower 3g, rhizome of davallia 30g, root of Chinese clematis 20g, Caulis Spatholobi 15g, safflower 32g are taken, wherein bone
West safflower, red mixing is added at coarse powder in broken benefit, the root of Chinese clematis, Caulis Spatholobi dried and crushed, with 75% ethanol as solvent, dipping 48
After hour, slowly diacolation, collects percolate, after adding appropriate auxiliary material, by obtained medical fluid absorption to get emplastrum on sticking material
Agent.The auxiliary material spirituosity, water, Mint Essence and pigment.
Embodiment 9
The preparation of emplastrum: west safflower 5g, rhizome of davallia 28g, root of Chinese clematis 20g, Caulis Spatholobi 15g, safflower 32g are taken, wherein bone
At coarse powder west safflower, safflower mixing is added, with 75% ethanol as solvent, dipping 48 in broken benefit, the root of Chinese clematis, Caulis Spatholobi dried and crushed
After hour, slowly diacolation, collects percolate, after adding appropriate auxiliary material, by obtained medical fluid absorption to get emplastrum on sticking material
Agent.The auxiliary material spirituosity, water, Mint Essence and pigment.
Embodiment 10
The preparation of emplastrum: west safflower 8g, rhizome of davallia 28g, root of Chinese clematis 20g, Caulis Spatholobi 15g, safflower 29g are taken, wherein bone
At coarse powder west safflower, safflower mixing is added, with 75% ethanol as solvent, dipping 48 in broken benefit, the root of Chinese clematis, Caulis Spatholobi dried and crushed
After hour, slowly diacolation, collects percolate, after adding appropriate auxiliary material, by obtained medical fluid absorption to get emplastrum on sticking material
Agent.The auxiliary material spirituosity, water, Mint Essence and pigment.
Embodiment 11
The preparation of tincture: west safflower 5g is taken, rhizome of davallia 28g, root of Chinese clematis 20g, Caulis Spatholobi 15g, safflower 32g, wherein bone is broken
At coarse powder west safflower, safflower mixing is added, with 75% ethanol as solvent, dipping 48 is small in benefit, the root of Chinese clematis, Caulis Spatholobi dried and crushed
Shi Hou, slowly diacolation, collects percolate, stands 48h, adds water until concentration of alcohol is 45%.Filtering, takes filtrate filling in 30mL
High-density plastic's sealed bottle, sealing cover to get tincture.
Embodiment 12
The preparation of liniment: west safflower 5g is taken, rhizome of davallia 28g, root of Chinese clematis 20g, Caulis Spatholobi 15g, safflower 32g, wherein bone is broken
At coarse powder west safflower, safflower mixing is added, with 75% ethanol as solvent, dipping 48 is small in benefit, the root of Chinese clematis, Caulis Spatholobi dried and crushed
Shi Hou, slowly diacolation, collects percolate, is evaporated under reduced pressure phegma and recycles ethyl alcohol, is spray-dried to get extract powder, 20g is taken to soak
Cream powder adds 70% dimethyl sub-maple solution 1000mL to dissolve, filling to cover in 30mL high-density plastic's bottle closure to get liniment.
Embodiment 13
The preparation of ointment: west safflower 5g, rhizome of davallia 28g, root of Chinese clematis 20g, Caulis Spatholobi 15g, safflower 32g are taken, wherein bone
At coarse powder west safflower, safflower mixing is added, with 75% ethanol as solvent, dipping 48 in broken benefit, the root of Chinese clematis, Caulis Spatholobi dried and crushed
After hour, slowly diacolation, collects percolate, is evaporated under reduced pressure phegma and recycles ethyl alcohol, is spray-dried to get extract powder, will soak
Cream powder and proper amount of matrix grind well to get ointment.
Embodiment 14
The preparation of cataplasm: west safflower 5g, rhizome of davallia 28g, root of Chinese clematis 20g, Caulis Spatholobi 15g, safflower 32g are taken, wherein bone
At coarse powder west safflower, safflower mixing is added, with 75% ethanol as solvent, dipping 48 in broken benefit, the root of Chinese clematis, Caulis Spatholobi dried and crushed
After hour, slowly diacolation, collects percolate, ethyl alcohol is recycled, and percolate is condensed into thick paste, with water-soluble high-molecular material base
To get cataplasm after matter mixing, coating.
The component compatibility of the drug of above-described embodiment as shown in the table below:
The compatibility situation of 1 embodiment 1-14 drug of table
Comparative example 1:
Safflower 10g is taken, with 75% ethanol as solvent, dipping is after 48 hours, and slowly diacolation, collects percolate, adds appropriate auxiliary
After material, by obtained medical fluid absorption to get emplastrum on sticking material.The auxiliary material spirituosity, water, Mint Essence and color
Element.
Comparative example 2:
West safflower 10g is taken, with 75% ethanol as solvent, dipping is after 48 hours, and slowly diacolation, collects percolate, and it is appropriate to add
After auxiliary material, by obtained medical fluid absorption to get emplastrum on sticking material.The auxiliary material spirituosity, water, Mint Essence and color
Element.
Comparative example 3:
Safflower 10g is taken, rhizome of davallia 40g, root of Chinese clematis 30g, Caulis Spatholobi 20g, wherein the rhizome of davallia, the root of Chinese clematis, Caulis Spatholobi are dried
It is ground into coarse powder, safflower is added and mixes, with 75% ethanol as solvent, dipping is after 48 hours, and slowly diacolation, collects percolate, add
After appropriate auxiliary material, by obtained medical fluid absorption to get emplastrum on sticking material.The auxiliary material spirituosity, water, Mint Essence
And pigment.(referring to Chinese patent CN100496544C).
Comparative example 4:
Radix Angelicae Sinensis 50g, Rhizoma Chuanxiong 50g, Rhizoma Et Radix Notopterygii 50g, polygonum cuspidate 50g, Radix Angelicae Pubescentis 50g, Radix Salviae Miltiorrhizae 50g, radix paeoniae rubra 50g are taken,The root of Chinese clematis50g,
Gentianae macrophyllae 50g,West safflower10g, radix achyranthis bidentatae 30g,Caulis Spatholobi50g, Cortex Eucommiae 30g,The rhizome of davallia30g, prevents by agkistrodon 1, kuh-seng 30g
Wind 30g, root of Dahurain angelica 50g, radix scrophulariae 50g, caulis trachelospermi 30g, turmeric 30g, root of fangji 30g, lopseed 50g, olibanum 50g, Rhizoma Gastrodiae 30g are yellow
Cypress 30g, cortex acanthopanacis 30g, ramulus mori 30g, myrrh 50g, Radix Paeoniae Alba 30g, folium artemisiae argyi 20g, cortex cinnamomi 20g, scorpio 30g, peach kernel 30g, curcuma zedoary
30g and red lead 680g, dried and crushed are added west safflower and mix at coarse powder, and with 75% ethanol as solvent, dipping delays after 48 hours
Slow diacolation, collects percolate, after adding appropriate auxiliary material, by obtained medical fluid absorption to get emplastrum on sticking material.It is described auxiliary
Expect spirituosity, water, Mint Essence and pigment.(referring to Chinese patent CN101085304B).
Comparative example 5:
Take Radix Angelicae Sinensis 9g, radix cyathulae 9g, Rhizoma Et Radix Notopterygii 10g, Radix Angelicae Pubescentis 10g, Rhizoma Chuanxiong 9g,Safflower9g, Cortex Eucommiae 12g, rhizoma dioscoreae nipponicae 12g, pig
Label grass 9g,Caulis Spatholobi9g, rhizoma homalonemae 9g, herba taxilli 10g, scythian lamb rhizome 12g, Herba Epimedii 12g, teasel root 9g, Morinda officinalis 12g, prevent
Wind 12g, olibanum 10g, myrrh 12g, green peel 12g, caulis sinomenii 12g,The root of Chinese clematis13g, root of fangji 15g, lycopodium calvatum 12g,The rhizome of davallia
12g, pawpaw 12g,West safflowerWest safflower, safflower is added at coarse powder in 10g, testiset penis phocae 13g, pilose antler 9g, Radix Glycyrrhizae 9g, dried and crushed
It mixes, with 75% ethanol as solvent, dipping is after 48 hours, and slowly diacolation, collects percolate, will be obtained after adding appropriate auxiliary material
Medical fluid absorption is on sticking material to get emplastrum.The auxiliary material spirituosity, water, Mint Essence and pigment.(specially referring to China
Sharp CN101708264B).
One, animal experiment:
Embodiment 1,2,3,8,9,10 and comparative example 1-5 are subjected to animal experiment together and carry out effect comparison.
1, hot plate method in mice analgesic test
Take percolate obtained by above-described embodiment and comparative example spare.Qualified mice 130 are taken, is randomly divided into 13 groups, respectively
Above-described embodiment and comparative example percolate (20mL/kg) are given, and negative control group (20mL/kg) is made with ethyl alcohol, with 1mg/mL
Morphine hydrochloride makees positive controls (10mL/kg).The equal gastric infusion 3d of each group, 60min measures the mouse threshold of pain after administration in the 3rd day.
Mouse is put into 55 DEG C of hot plates, the time of metapedes is licked as the pain threshold of the mouse using mouse.
2, mouse writhing method analgesic test
Qualified mice 130 are taken, is randomly divided into 13 groups, gives above-described embodiment and comparative example percolate (20mL/ respectively
Kg), and with ethyl alcohol make negative control group (20mL/kg), positive controls (10mL/kg) is made with 1mg/mL morphine hydrochloride.Each group
After administration in the 4th day after 60min, 0.6% glacial acetic acid 0.1mL/10g is injected intraperitoneally with induced pain in equal gastric infusion 4d.Record injection causes
Each mouse writhing number in pain agent 20min.Analgesia rate/%=(negative control group writhing response number-administration group writhing response
Number)/negative control group writhing response number × 100.Test result is as shown in the table:
2 analgesic test result of table
From the above it is found that the pharmaceutical composition of embodiment 1-3 and embodiment 8-10 are significant to improve the mouse threshold of pain, stop
Pain effect is apparently higher than comparative example, and analgesic effect is close to morphine hydrochloride.It can be seen that phase from the data of comparative example 1 and comparative example 2
Relieving pain with the west safflower of weight is higher than safflower, and in conjunction with the embodiments from the point of view of the data of 1-3 and embodiment 8-10,
The analgesic effect of composition increases with the increase of west safflower weight percent, it may be possible to because west safflower is to play analgesic
The main component of effect.
Two, clinical test:
By embodiment 3, embodiment 10 and comparative example 3-5 carry out clinical test together and carry out effect comparison.And comfort is set
Agent group, placebo appearance, smell, specification, packaging are as embodiment emplastrum.
1, knee osteoarthritis pain is treated
Certain hospital is chosen with knee osteoarthritis patient 240, patient age 40-65 years old, men and women met kneecap
Property arthritis diagnosis, Chinese medicine is dialectical for the tendon and vessel stasis of blood is stagnant, kidney deficiency and liver, pain scores >=4 point VAS.
Patient is randomly divided into 6 groups, every group of 40 patients take double-blind study.Embodiment 3 is used respectively, and embodiment 10 is right
Emplastrum and placebo provided by 1-3 as usual.Application method are as follows: external application, the patch of emplastrum 2/time, it spreads on pain and suffers from knee two sides,
Often stick 6 hours, once a day, the course for the treatment of 14 days.After one course for the treatment of, the therapeutic effect of each group patient is counted.
Validity Index:
Curative effect index: (1) VAS pain scores: after treatment 14 days, comparing the pretherapy and post-treatment pain scores difference of each group,
It is analyzed using FAS, weak curative effect is anisotropic between group is determined with the analysis of covariance.
Secondary efficacy index: (1) curative effect of disease scores: the 7th, 14 day at pre-treatment and after treatment, passing through symptom integral value
It scores, effectively: symptom, somatic feature score reduce >=50%, and invalid: symptom, somatic feature score are reduced less than 50%, using consideration
The CMH chucking method of central factor compares group difference.(2) Lequesne index score: the 7th, 14 day at pre-treatment and after treatment,
By researcher to knee joint rest pain, motion pain, tenderness, swelling, morning stiffness, walking ability and Lequesne in Lequesne index
The items symptom improvement rate such as combined index is made an appraisal.Compare each group to score before and after treatment situation of change, compare between two groups
The difference of Lequesne scoring and symptom improvement rate.Symptom improvement rate=(index after index-treatment before treating)/index before treating
× 100%, effectively: situation improvement rate > 60% is invalid: situation improvement rate≤60%, using the card side CMH for considering central factor
Method compares group difference.(3) the drug effect time compares group difference using log-rank inspection.(4) pain disappearing time,
Group difference is compared using log-rank inspection.
Safety indexes:
(1) variation of test front and back vital sign: body temperature, blood pressure, breathing, heart rate.
(2) variation that laboratory checks: blood, urine, feces are conventional, electrocardiogram, Liver and kidney function inspection.
(3) observation of adverse events: adverse events may be new disease, therapeutic state symptom or sign deterioration or
With the deterioration of disease, the combination of one or more factors.
Test result:
1, VAS pain scores, curative effect of disease scoring and Lequesne index score result are as shown in the table:
3 VAS pain scores of table, curative effect of disease scoring and Lequesne index score result
It can be seen from the results above that embodiment 3 and 10 drug paste of embodiment can significantly lower pain, significant effect is high
In comparative example and placebo, so that knee osteoarthritis symptom is effectively improved.By significantly analyzing, embodiment 3 and 10
All there were significant differences (P < 0.05) with comparative example 3-5.
2, drug effect time result is as shown in the table:
Play efficiency (%)=action case load/total case load.
The drug effect rate of 4 different time of table
As can be seen from the above table, it is more than 32.5% that the emplastrum medication 4h of embodiment 3 and embodiment 10, which plays efficiency, comparative example 3
Medicament medication 4h when 10% case start to work, 20% case starts when the medicament medication 4h of comparative example 4 and comparative example 5
It works, and 5% case starts to work when placebo medication 4h；The emplastrum medication 10h of embodiment 3 and embodiment 10 plays efficiency
More than 50%, the medicament of comparative example 3, which plays efficiency and reaches 50%, needs 72h, and the medicament of comparative example 4 and comparative example 5 plays efficiency and reaches
50% needs 48h.The drug effect time difference of the drug of embodiment 3 and embodiment 10 and comparative example 3-5 are significant (p < 0.05).
3, pain disappearing time
Disappearance rate (%)=pain disappearance case load/total case load, VAS pain scores drop to 0 point and are determined as pain
It disappears.
The pain disappearance rate of 5 different time of table
After treatment 14 days, 3 medicine group pain disappearance case 8 (20%) of embodiment, 10 medicine group pain of embodiment disappears
Case 9 (22.5%), 3 medicine group pain disappearance case 2 (5.0%) of comparative example, 4 medicine group pain disappearance case of comparative example
5 (12.5%), 5 medicine group pain disappearance 4 cases (10.0%) of comparative example, placebo is 1 (2.5%).It can see
Out, pharmaceutical composition of the present invention can effectively treat the pain as caused by knee osteoarthritis, embodiment 3 and embodiment 10
Drug and comparative example 3-5 drug pain disappearance rate between significant difference (p < 0.05).
4, safety evaluatio result
Serious adverse events are not found in this time clinical research.Adverse events occur for totally 25 subjects in this test, wherein
Embodiment 3 drug paste group 2 (5.0%), embodiment 10 drug paste group 3 (7.5%), comparative example 3 drug paste group 3 (7.5%), comparison
Example 4 drug paste group 6 (15.0%), comparative example 5 drug paste group 8 (20.0%), placebo 3 (7.5%).In test it is all not
Good event is patch medicine area skin allergic reaction, shows as slight itch, erythema more.Laboratory checks that safety results are shown
Obviously abnormal laboratory inspection result relevant to each group medicament is not found.All adverse events can be preferably resistant to, and symptom can
Die away.
Meanwhile pharmaceutical composition of the present invention is shown relatively by force compared to the pharmaceutical composition of comparative example 4 and comparative example 5
Safety, illustrate that pharmaceutical composition compatibility of the invention is reasonable, effectively prevent a variety of potential use of drug interaction bring
Medicine risk.
2, lumbar vertebrae relieving pain in osteoarthritis is treated
Certain hospital is chosen with lumbar vertebrae osteoarthritis patient 240, patient age 40-65 years old, men and women met waist
The diagnosis of vertebra Osteoarthritis, Chinese medicine is dialectical for the tendon and vessel stasis of blood is stagnant, kidney deficiency and liver, pain scores >=4 point VAS.
Patient is randomly divided into 6 groups, every group of 40 patients take double-blind study.Embodiment 3 is used respectively, and embodiment 10 is right
Emplastrum provided by ratio 3-5 and placebo.Application method are as follows: external application, the patch of emplastrum 1/time, lumbar pain portion is spread on, often
Stick 6 hours, once a day, the course for the treatment of 14 days.After one course for the treatment of, the therapeutic effect of each group patient is counted.
Validity Index:
Curative effect index: (1) VAS pain scores: after treatment 14 days, comparing the pretherapy and post-treatment pain scores difference of each group,
It is analyzed using FAS, weak curative effect is anisotropic between determining group using the analysis of covariance.
Secondary efficacy index: (1) curative effect of disease scores: the 7th, 14 day at pre-treatment and after treatment, passing through symptom integral value
It scores, effectively: symptom, somatic feature score reduce >=50%, and invalid: symptom, somatic feature score are reduced less than 50%, using consideration
The CMH chucking method of central factor compares group difference.(2) JOA pain in the loins therapeutic evaluation: the 7th, 14 day at pre-treatment and after treatment,
By researcher, every symptom such as, bladder function limited to subjective symptom, sign, ADL in lumbar vertebrae JOA scoring and JOA overall score changes
Kind situation is made an appraisal.Compare each group to score before and after treatment situation of change, compare lumbar vertebrae JOA scoring between two groups improve index and
The difference for treating improvement rate.Symptom improvement rate=(index after index-treatment before treating)/index × 100% before treating, effectively:
Improvement rate >=50% is treated, invalid: treatment improvement rate < 50%, using poor between the CMH chucking method comparative group for considering central factor
It is different.(3) the drug effect time compares group difference using log-rank inspection.(4) pain disappearing time, using log-rank
Group difference is compared in inspection.
Safety indexes are same as above.
Test result:
1, VAS pain scores, curative effect of disease scoring and Lequesne index score result are as shown in the table:
6 VAS pain scores of table, curative effect of disease scoring and Lequesne index score result
It can be seen from the results above that embodiment 3 and 10 drug paste of embodiment can lower pain, significant effect is higher than pair
Ratio and placebo, so that lumbar vertebra arthritic symptom is effectively improved.By significantly analyzing, embodiment 3 and 10 with
All there were significant differences by comparative example 3-5 (P < 0.05).
2, drug effect time result is as shown in the table:
Play efficiency (%)=action case load/total case load.
The drug effect rate of 7 different time of table
As can be seen from the above table, it is more than 32.5% that the emplastrum medication 4h of embodiment 3 and embodiment 10, which plays efficiency, comparative example 3
Medicament medication 4h when 20% case start to work, 22.5% case is opened when the medicament medication 4h of comparative example 4 and comparative example 5
Begin to work, and 15% case starts to work when placebo medication 4h；The emplastrum medication 8h of embodiment 3 and embodiment 10 works
Rate reaches 50%, and the medicament efficiency of comparative example 3 reaches 50% and needs 72h, and the medicament of comparative example 4 and 5 plays efficiency and reaches 50%
Need 48h.The drug of embodiment 3 and embodiment 10 and comparative example 3-5 and the drug effect time difference of placebo have statistics
It learns meaning (P < 0.05), it is clearly more rapid to illustrate that emplastrum of the present invention works.
3, pain disappearing time
Disappearance rate (%)=pain disappearance case load/total case load, VAS pain scores drop to 0 point and are determined as pain
It disappears.
The pain disappearance rate of 8 different time of table
After treatment 14 days, 3 medicine group pain disappearance case 6 (15%) of embodiment, 10 medicine group pain of embodiment disappears
Case 8 (20.0%), 3 medicine group pain disappearance case 2 (5.0%) of comparative example, 4 medicine group pain disappearance case of comparative example
4 (10.0%), 5 medicine group pain disappearance case 3 (7.5%) of comparative example, placebo is 1 (2.5%).It can see
Out, pharmaceutical composition of the present invention can effectively treat the pain as caused by knee osteoarthritis, embodiment 3 and embodiment 10
Drug and comparative example 3-5 drug pain disappearance rate between significant difference (p < 0.05).
4, safety evaluatio result
Serious adverse events are not found in this time clinical research.Adverse events occur for totally 23 subjects in this test,
It is middle embodiment 3 drug paste group 2 (5.0%), embodiment 10 drug paste group 2 (5.0%), comparative example 3 drug paste group 3 (7.5%), right
Ratio 4 drug paste group 8 (20.0%), comparative example 5 drug paste group 6 (15.0%), placebo 2 (5.0%).Own in test
Adverse events are patch medicine area skin allergic reaction, show as slight itch, erythema more.Laboratory checks that safety results are aobvious
Show and does not find obviously abnormal laboratory inspection result relevant to each group medicament.All adverse events can be preferably resistant to, symptom
It can die away.
Meanwhile pharmaceutical composition of the present invention is shown relatively by force compared to the pharmaceutical composition of comparative example 4 and comparative example 5
Safety, illustrate that pharmaceutical composition compatibility of the invention is reasonable, effectively prevent a variety of potential use of drug interaction bring
Medicine risk.
3, neck cervical spondylosis pain is treated
Certain hospital is chosen with cervical spondylosis patient 240, patient age 18-65 years old, men and women met neck type neck
The diagnosis of vertebra disease, Chinese medicine is dialectical for the tendon and vessel stasis of blood is stagnant, kidney deficiency and liver, pain scores >=4 point VAS.
Patient is randomly divided into 6 groups, every group of 40 patients take double-blind study.Embodiment 3 is used respectively, and embodiment 10 is right
Emplastrum provided by ratio 1-3 and placebo.Application method are as follows: external application, the patch of emplastrum 1/time, cervical vertebra ache portion is spread on, often
Stick 6 hours, once a day, the course for the treatment of 14 days.After one course for the treatment of, the therapeutic effect of each group patient is counted.
Validity Index:
Curative effect index: (1) VAS pain scores: after treatment 14 days, comparing the pretherapy and post-treatment pain scores difference of each group,
It is analyzed using FAS, treats otherness between determining group using the analysis of covariance.
Secondary efficacy index: (1) curative effect of disease scores: the 7th, 14 day at pre-treatment and after treatment, passing through symptom integral value
It scores, effectively: symptom, somatic feature score reduce >=50%, and invalid: symptom, somatic feature score are reduced less than 50%, using consideration
The CMH chucking method of central factor compares group difference.(2) cervical functional impairment index (NDI): at pre-treatment and after treatment the 7th,
14 days, NDI self-appraisal was carried out by sufferers themselves.Compare each group to score before and after treatment situation of change, compares cervical functional between each group
The difference of Impairment Index compares group difference using t inspection.(3) the drug effect time, using between log-rank inspection comparative group
Difference.(4) pain disappearing time compares group difference using log-rank inspection.
Safety indexes are same as above.
Test result:
1, VAS pain scores, curative effect of disease scoring and Lequesne index score result are as shown in the table:
9 VAS pain scores of table, curative effect of disease scoring and Lequesne index score result
It can be seen from the results above that embodiment 3 and 10 drug paste of embodiment can significant attenuating pain, significant effect is high
In comparative example and placebo, so that cervical vertebra disease symptoms are effectively improved.By significantly analyzing, embodiment 3 and 10 and comparison
All there were significant differences (P < 0.05) by example 3-5.
2, drug effect time result is as shown in the table:
Play efficiency (%)=action case load/total case load.
The drug effect rate of 10 different time of table
As can be seen from the above table, the emplastrum medication 4h of embodiment 3 and embodiment 10 efficiency reach 35.0%, comparative example 3
Medicament medication 4h when 15.0% case start to work, the disease when medicament medication 4h of comparative example 4 and comparative example 5 more than 20%
Example starts to work, and 5% case starts to work when placebo medication 4h；The emplastrum medication 8h of embodiment 3 and embodiment 10
Playing efficiency is more than 55%, and the medicament efficiency of comparative example 3 reaches 50% or more and needs 48h, and the medicament of comparative example 4 and 5 plays efficiency
Reach 50% and needs 12h.The drug of embodiment 3 and embodiment 10 and the drug effect time difference of comparative example and placebo have
It is clearly more rapid to illustrate that emplastrum of the present invention works for statistical significance (P < 0.05).
4, pain disappearing time
Disappearance rate (%)=pain disappearance case load/total case load, VAS pain scores drop to 0 point and are determined as pain
It disappears.
The pain disappearance rate of 11 different time of table
After treatment 14 days, 3 medicine group pain disappearance case 10 (25.0%) of embodiment, 10 medicine group pain of embodiment disappears
Case 12 (30.0%), 3 medicine group pain disappearance case 3 (7.5%) of comparative example are lost, 4 medicine group pain of comparative example disappears
Case 6 (15.0%), 5 medicine group pain disappearance case 6 (15.0%) of comparative example, placebo is 1 (2.5%).It can
To find out, pharmaceutical composition of the present invention can effectively treat the pain as caused by knee osteoarthritis, embodiment 3 and implementation
Significant difference (p < 0.05) between the drug of example 10 and the drug pain disappearance rate of comparative example 3-5.
4, safety evaluatio result
Serious adverse events are not found in this time clinical research.Adverse events occur for totally 16 subjects in this test,
It is middle embodiment 3 drug paste group 1 (2.5%), embodiment 10 drug paste group 2 (5.0%), comparative example 3 drug paste group 2 (5.0%), right
Ratio 4 drug paste group 5 (12.5%), comparative example 5 drug paste group 5 (12.5%), placebo 1 (2.5%).Own in test
Adverse events are patch medicine area skin allergic reaction, show as slight itch, erythema more.Laboratory checks that safety results are aobvious
Show and does not find obviously abnormal laboratory inspection result relevant to each group medicament.All adverse events can be preferably resistant to, symptom
It can die away.
Meanwhile pharmaceutical composition of the present invention is shown relatively by force compared to the pharmaceutical composition of comparative example 4 and comparative example 5
Safety, illustrate that pharmaceutical composition compatibility of the invention is reasonable, effectively prevent a variety of potential use of drug interaction bring
Medicine risk.
Typical case 1: patient, XXX, male, 56 years old, left gonalgia limitation of activity half a year, CCT was diagnosed as moderate joint
3 emplastrum of the embodiment of the present invention illness 2 years, is affixed on affected part by inflammation, and analgesic effect is obvious after 6h, and pain disappears after continuous use 3 days
It loses.
Typical case 2: patient, XXX, female 62 years old, suffer from cervical spondylosis 5 years, and 10 emplastrum of the embodiment of the present invention is affixed on trouble
Locate, analgesic effect is obvious after 4h, and pain symptom disappears after a course for the treatment of.
It is from above-mentioned experiment it can be confirmed that provided by the present invention for treating the Chinese medicine composition of pain, to by sclerotin
Pain caused by hyperplasia disease, the protrasion of the lumbar intervertebral disci, cervical spondylosis, scapulohumeral periarthritis, arthritis, rheumatism, lumbar muscle strain, traumatic injury etc.
Good curative effect is all had, significant effect is higher than the effect of comparative example 3, it may be possible to west safflower and the rhizome of davallia, the root of Chinese clematis and chicken
Blood rattan is combined into after composition or west safflower and the rhizome of davallia, the root of Chinese clematis, Caulis Spatholobi and safflower are combined into activating microcirculation and removing stasis medicinal after composition
Effect is more comprehensive, and shares to have and act synergistically, and substantially increases effective absorptivity in affected part.Meanwhile also illustrating west safflower
Function and effect in terms for the treatment of pain are significantly larger than safflower, it is only necessary to which low dose can reach significant lenitive mesh
's.The medicinal peace of west safflower is cooler, the function with the removing pattogenic heat from the blood and toxic material from the body that safflower does not have, and also mends with certain blood-nourishing
Blood function, so as to which pain is effectively relieved.
The effect of Chinese medicine composition provided by the present invention for treating pain is slightly higher than comparative example 4 and comparative example 5
Effect, relative to comparative example 4 and 5, drug component compatibility of the invention is simple, shows higher safety, is not easy to draw
Skin allergic symptom is played, illustrates that other drug components with similar functions of compatibility can not obtain more significant curative effect, instead
Multicomponent compatibility may will increase the toxic side effect of drug.Chinese medicine composition provided by the present invention not only effectively prevents a variety of
The potential drug risk of drug interaction bring, and significantly reduce pharmacy cost and simplify pharmaceutical preparation.
Drug component provided by the present invention for treating pain can be made into emplastrum, tincture, liniment, ointment or bar cloth
Agent.
Claims (9)
1. a kind of Chinese medicine composition for treating pain, which is characterized in that the Chinese medicine composition is made of following active ingredients: 2-
10% west safflower, the 20-35% rhizome of davallia, the 15-30% root of Chinese clematis, 10-25% Caulis Spatholobi and 20-35% safflower.
2. Chinese medicine composition according to claim 1, which is characterized in that the dosage form of the Chinese medicine composition is external preparation.
3. Chinese medicine composition according to claim 2, which is characterized in that the dosage form include emplastrum, tincture, liniment,
Ointment, cataplasm.
4. a kind of pharmaceutical preparation, which is characterized in that the effective component of the pharmaceutical preparation is by any one of claim 1-3 institute
The Chinese medicine composition stated is prepared.
5. pharmaceutical preparation according to claim 4, which is characterized in that the dosage form of the pharmaceutical preparation includes emplastrum, tincture
Agent, liniment, ointment, cataplasm.
6. a kind of preparation method of the described in any item Chinese medicine compositions of claim 1-3, which is characterized in that the preparation method
Include the following steps:
(1) at coarse powder west safflower is added, safflower mixes in the rhizome of davallia, the root of Chinese clematis, Caulis Spatholobi dried and crushed；
(2) by said mixture with 75% alcohol dipping 48 hours, diacolation is carried out, collects percolate.
7. the preparation method of pharmaceutical preparation according to claim 4 or 5, which is characterized in that the preparation method includes such as
Lower step:
(1) Chinese medicine composition of any of claims 1-3 is prepared；
(2) step (1) resulting Chinese medicine composition is prepared to be prepared into according to the common process and common medicinal supplementary material of pharmacy
The pharmaceutical preparation.
8. application of the described in any item Chinese medicine compositions of claim 1-3 in the drug of preparation treatment pain.
9. application of the pharmaceutical preparation described in claim 4 or 5 in the drug of preparation treatment pain.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1899403A (en) * | 2006-07-21 | 2007-01-24 | 黄羿 | Chinese medicine preparation for treating pains and its preparing method and use |
| WO2010010346A2 (en) * | 2008-07-24 | 2010-01-28 | Sinclair Pharmaceuticals Limited | Topical compositions for use during tooth eruption |
-
2018
- 2018-07-26 CN CN201810832551.2A patent/CN110141621B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1899403A (en) * | 2006-07-21 | 2007-01-24 | 黄羿 | Chinese medicine preparation for treating pains and its preparing method and use |
| WO2010010346A2 (en) * | 2008-07-24 | 2010-01-28 | Sinclair Pharmaceuticals Limited | Topical compositions for use during tooth eruption |
Non-Patent Citations (2)
| Title |
|---|
| 王焕华 编著: "《中华食物养生大全.典藏本》", 31 March 2013 * |
| 雷根平: "临证止痛药对举隅", 《四川中医》 * |
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