CN106539854A - A kind of pharmaceutical composition of preventing and treating knee osteoarthritis and preparation method thereof - Google Patents

A kind of pharmaceutical composition of preventing and treating knee osteoarthritis and preparation method thereof Download PDF

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CN106539854A
CN106539854A CN201611133072.9A CN201611133072A CN106539854A CN 106539854 A CN106539854 A CN 106539854A CN 201611133072 A CN201611133072 A CN 201611133072A CN 106539854 A CN106539854 A CN 106539854A
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Jinan Haoyu Qingtian Medicine Technology Co ltd
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Abstract

The invention discloses a kind of pharmaceutical composition of preventing and treating knee osteoarthritis and preparation method thereof, pharmaceutical composition of the present invention is with Herba Haloragidis Micranthae, plateau sandwort, pseudojervine, rattan wingceltis, Dennstaedtia scabra (Wall.) Moore. as crude drug, proportioning is formed, routinely various dosage forms can be made by preparation process, preventing and treating knee osteoarthritis are evident in efficacy.

Description

A kind of pharmaceutical composition of preventing and treating knee osteoarthritis and preparation method thereof
Technical field
The invention belongs to technical field of Chinese medicines, more particularly to a kind of pharmaceutical composition and its preparation of preventing and treating knee osteoarthritis Method.
Background technology
Knee osteoarthritis (knee osteoarthritis, KOA) be with knee cartilage non-inflammation degenerative change, With a kind of disease with the characteristics of knee joint surface and its edge response new bone formation, its sickness rate is high, it has also become cause residual The second largest reason of disease.KOA is a kind of due to articular cartilage, the degeneration of articulation structure, and is secondary to degeneration A series of diseases caused by cartilage destruction or hypertrophy, the basic reason of disease is the degeneration and damage of articular cartilage.With people The aging of mouth structure, its sickness rate more and more higher endanger also increasing.The disease belongs to Chinese medical ' arthralgia syndrome ' category.《Plain Questions. numbness A card piece》Say:" wet three gas of wind and cold is miscellaneous extremely, combined into numbness.”《Plain Questions. lunge section discusses a piece》Say:" disease in bone, unable to raise the limbs due to heaviness of the bones, Aching pain in the bone marrow, extremely, name says rheumatism involving the bone to cold." Chinese medicine thinks that Liver and kidney is the closest with the relation of bone, and liver governing tendonses, the QI and blood of liver fill Contain, fascia obtains which is supported, then biceps is strong, move flexibly；Kidney governing bones, kidney essense are sufficient, and bone marrow biochemistry is active, and skeleton obtains bone marrow Nourishing and it is firm strong.
Plateau sandwort：This product is pinkwort plateau sandwort Arenaria przewalskii Maxim. and its belongs to together Various plants are dried herb.7～August gathers herb, cleans soil, dries.【Nature and flavor】Sweet, bitter, cold.【Function with cure mainly】Clearly Diarrhea of heat type lung.For diseases such as pneumonia, pulmonary tuberculosis, lung heat cough and asthmas.【Character】This product is often crimped to bulk.Root pitchy, yellowish-brown are main Root woody part white.Stem foot harbors the withered sheath of threadiness, and close by filbert glandular hair.Blade is linear to lanceolar, and base portion is wider, Into sheath, middle rib is obvious for Colaesce.Flower basidixed, crushes more, launches visible bract green, ovate-elliptic, by glandular hair；Sepal is pale purple Color；Petal fallow (being white when fresh).Feeble QI, taste micro-sweet, hardship.Record Tibetan medicine standard is issued in Ministry of Public Health（First）, mark Quasi- numbering：WS3-BC-0084-95.
Herba Haloragidis Micranthae:Haloragaceae seaberry Herba Haloragidis Micranthae Haloragis micrantha (Thunb.) herb of R.Br.ex Sidb. Et Zucc. [Goniocarpus micranthus Thunb.].Summer harvests Herb, cleans, dries.【Nature and flavor】Bitter in the mouth；It is puckery；It is cool in nature.【Return through】Return lung；Large intestine；Bladder；It is nontoxic.【Indication】Cough-relieving is put down Breathe heavily；Clearing away heat-damp and promoting diuresis；Regulating menstruation and activating blood.Main cough；Asthma；Pyretic stranguria；Constipation；Dysentery；Menoxenia；Fall damage fracture；Furuncle；Acute mastitis； Scald；Venom.【Former phytomorph】Perennial slim and frahile draft, grows thickly, high 20-40cm.Four prismatic of stem, band russet, directly Vertical, base portion is crawled branch.Leaf is little, has short handle, opposite, and stem upper leaf is alternate sometimes；The usual egg shape or circular shape of blade, long 6- 10cm, wide 4-8mm, tip are short sharp or blunt, and there is a little tooth at edge, basal circular, and two sides is bald net, light green or puce.Circular cone Inflorescence basidixed, is made up of thin raceme；Spend little, both sexes；Calyx pipe has rib, and sliver 4, triangle are harbored；Petal 4, it is red； Stamen 8, flower pesticide aubergine；Gynoecium 1；Ovary is the next, has ratio rib, and style 4, the pink hair of the close life of stigma, drupe are subsphaeroidal, Be about 1mm, it is bald will and it is bright, have 8 ribs.The month at florescence 6-7, the fruiting period 9-10 month.Record in dictionary of medicinal plant.
Rattan wingceltis：Rattan of this product for pulse family Dalbergia rattan of plant yellow wingceltis Dalbergia hancei Benth..Whole year can Adopt, be washed and chopped, dry.【Nature and flavor】It is pungent, temperature.【Indication】Regulating QI to relieve pain.Cure mainly costa sternaless to lead to, gastric abscess, stomachache, impairment caused by overstrain pain Bitterly.【Former phytomorph】Liana.Branch is very thin, and slightly by pubescence, sprig has time-varying hook-shaped or turn-knob to sprout.Winglike compound leaf is long 5-8 li Rice;Stipule film quality, lanceolar are caducous;3-6 pair, lobule, less long and narrow circle or the Long Circle of falling ovate, long 10-20 millimeters, wide 5-10 Millimeter, tip is blunt or circle, micro- to lack, base portion circle or wealthy wedge shape, when tender two sides by submissive thin pubescence, during growth above without hair.Total shape Inflorescence is short far beyond compound leaf, contains in navicular, imbricate arrangement, caducous bract, several racemes normal axil integrated again when young The short panicle of life;The long 1-2 millimeters of bennet, with calyx and squamella with by brown short down;The raw squamella of base is avette, calycule shape Squamella lanceolar, it is caducous;The wealthy mitriform of calyx, is about 3 millimeters, and calyx tooth is short, wealthy triangle, in addition to the anxious point of most lower 1 piece of tip, Remaining blunt or circle, has echinid;The green white of corolla, fragrance, is about 6 millimeters, and each lobe has long handle, and vexil is oval, base portion Both sides are slightly in section shape, have an ear, middle gradually narrow downward to form a lobe handle, ala and fossil fragments Long Circle;Stamen 9, monomer, sometimes 10 Piece, wherein 1 piece against vexil;Ovary is linear, and in addition to abdomen stitches somewhat echinid, remaining has short ovary handle without hair, and style is slightly long, Stigma is little.Pod is flat, Long Circle or banding, and without hair, long 3-7 centimetre, wide 8-14 millimeters, base portion are punctured into a thin fruit neck, leads to Often there are 1 seed, dilute 2-4 grains;Seed kidney shape, it is extremely flat, 8 millimeters are about, it is wide about 5 millimeters.The month at florescence 4-5.Record in Chinese medicine Voluminous dictionary.
Dennstaedtia scabra (Wall.) Moore.：For Dennstaedtia scabra (Wall.) Moore. section Dennstaedtia scabra (Wall.) Moore. platymiscium Dennstaedtia scabra (Wall.) Moore. Dennstaedtia scabra (Wall.) Moore [Dicksonia Scabra Wall.] herb.【Nature and flavor】It is pungent；It is cool.【Return through】Bladder warp.【Indication】Wind-dispelling；Clearing away heat and expelling pathogen in the exterior.Main flu head Bitterly；Rheumatic arthralgia.【Chemical analysis】Aerial partss contain pterosin（pterosin）A, F, K, V, onychium japonicum Kunze are pungent（onitisin）That is 4- Hydroxyl pterosin（4-hydroxypterosin）A, Europe Herba pteridii latiusculi Yi Lu glycosides（ptaquiloside）, Dennstaedtia scabra (Wall.) Moore. glycoside（dennstoside）A. 【Character】Root stock cylinder, thick long, surface rufous, the close nodular hair by brown, which descends the fibrous root for giving birth to numerous grey blacks. The long 20-35cm of petiole, slightly rufous, gloss；The long 20-35cm of blade, wide 15-20cm, three to quadripinnate drastic crack；Triangular shape Lanceolar or square are circular, and papery, brown-green, the nodular that leaf two sides, pinna rachis and vein have brown become mildewed；End time sliver is short, blunt Point, full edge have scun 1 per sliver, and tip enlarges into water pocket, not up to limb；Sporangioruses are born in scun tip, sorus teabowl with a cover Shape, slightly celadon, hair.Matter is crisp, feeble QI, lightly seasoned.Record in dictionary of medicinal plant.
Pseudojervine（Pseudojervine）：CAS 36069-05-3, molecular formula C33H49NO8, molecular weight 587.75. 【Ingredient origin】Rhizoma et radix veratri (Radix Rhizoma Veratri) Veratrum nigrum.
Pseudojervine（Pseudojervine）.
The content of the invention
The purpose of the present invention is to overcome the shortcomings of background technology, there is provided a kind of drug regimen of effective preventing and treating knee osteoarthritis Thing and preparation method thereof.
The present invention adopts the following technical scheme that realization：
The composition and weight portion for making the crude drug of the pharmaceutical composition of the preventing and treating knee osteoarthritis be：
Herba Haloragidis Micranthae 356-358 weight portions plateau sandwort 360-364 weight portion pseudojervine 12-14 weight portion rattan wingceltises 350-352 weight portion Dennstaedtia scabra (Wall.) Moore. 330-336 weight portions.
The pharmaceutical composition of preventing and treating knee osteoarthritis is preferably used in, is made up of the crude drug of following weight portion：
357 13 weight portion rattan wingceltis of weight portion plateau 362 weight portion pseudojervine of sandwort of Herba Haloragidis Micranthae, 351 weight portion Dennstaedtia scabra (Wall.) Moore. 333 weight portions.
A kind of pharmaceutical composition of preventing and treating knee osteoarthritis, it is characterised in that pharmaceutical composition can adopt the normal of galenic pharmacy Rule method prepares piece agent or capsule or drop pill.
A kind of pharmaceutical composition of preventing and treating knee osteoarthritis, it is characterised in that pharmaceutical composition is constituted with chemical drugs or Chinese medicine Preventing and treating knee osteoarthritis medicine.
A kind of preparation method of the pharmaceutical composition of preventing and treating knee osteoarthritis, it is characterised in that prepare as follows：
The composition and weight portion of crude drug be：The false white Herba chenopodii of Herba Haloragidis Micranthae 356-358 weight portions plateau sandwort 360-364 weight portions Reed alkali 12-14 weight portion rattan wingceltis 350-352 weight portion Dennstaedtia scabra (Wall.) Moore. 330-336 weight portions；
Preparation method：
（1）Herba Haloragidis Micranthae, plateau sandwort, pseudojervine, rattan wingceltis, Dennstaedtia scabra (Wall.) Moore. are taken by crude drug proportioning, is mixed, is used percentage by weight 29% ethanol of concentration is extracted in 37 DEG C of warm macerating as solvent, and extraction time is 20 times, and each extraction time is 17 hours, molten every time 46 times for crude drug gross weight of agent consumption, filtration obtain medicinal residues A and extracting solution A, and extracting solution A reclaims ethanol, is concentrated into relatively close Degree 1.16, filtration, medicinal liquid are first washed with water by DM20 macroporous adsorptive resins, then molten with 17% ethanol of weight percent concentration Liquid eluting DM20 macroporous adsorptive resins, collection 17% ethanol elution of weight percent concentration, recovery ethanol, concentrate drying, i.e., Obtain extract A；
（2）Take step（1）Medicinal residues A, with 67% ethanol of weight percent concentration as solvent, heating and refluxing extraction 15 times, is carried every time The time is taken for 0.3 hour, 56 times for medicinal residues A weight of each solvent load, filtration obtain medicinal residues B and extracting solution B, and extracting solution B is returned Ethanol is received, relative density 1.03 is concentrated into, is filtered, medicinal liquid is first washed with water, then uses weight by LK06 macroporous adsorptive resins 76% ethanol solution eluting LK06 macroporous adsorptive resins of percent concentration, collect 76% ethanol elution of weight percent concentration, Ethanol is reclaimed, concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
The preparation method of the pharmaceutical composition of preferred a kind of preventing and treating knee osteoarthritis, it is characterised in that make as follows It is standby：
The composition and weight portion of crude drug be：357 362 weight portion pseudojervine of weight portion plateau sandwort of Herba Haloragidis Micranthae, 13 weight 351 weight portion Dennstaedtia scabra (Wall.) Moore. of amount part rattan wingceltis, 333 weight portion；
Preparation method：
（1）Herba Haloragidis Micranthae, plateau sandwort, pseudojervine, rattan wingceltis, Dennstaedtia scabra (Wall.) Moore. are taken by crude drug proportioning, is mixed, is used percentage by weight 29% ethanol of concentration is extracted in 37 DEG C of warm macerating as solvent, and extraction time is 20 times, and each extraction time is 17 hours, molten every time 46 times for crude drug gross weight of agent consumption, filtration obtain medicinal residues A and extracting solution A, and extracting solution A reclaims ethanol, is concentrated into relatively close Degree 1.16, filtration, medicinal liquid are first washed with water by DM20 macroporous adsorptive resins, then molten with 17% ethanol of weight percent concentration Liquid eluting DM20 macroporous adsorptive resins, collection 17% ethanol elution of weight percent concentration, recovery ethanol, concentrate drying, i.e., Obtain extract A；
（2）Take step（1）Medicinal residues A, with 67% ethanol of weight percent concentration as solvent, heating and refluxing extraction 15 times, is carried every time The time is taken for 0.3 hour, 56 times for medicinal residues A weight of each solvent load, filtration obtain medicinal residues B and extracting solution B, and extracting solution B is returned Ethanol is received, relative density 1.03 is concentrated into, is filtered, medicinal liquid is first washed with water, then uses weight by LK06 macroporous adsorptive resins 76% ethanol solution eluting LK06 macroporous adsorptive resins of percent concentration, collect 76% ethanol elution of weight percent concentration, Ethanol is reclaimed, concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
A kind of preparation method of the pharmaceutical composition of preventing and treating knee osteoarthritis, it is characterised in that pharmaceutical composition can be adopted The conventional method of galenic pharmacy prepares piece agent or capsule or drop pill.
A kind of preparation method of the pharmaceutical composition of preventing and treating knee osteoarthritis, it is characterised in that pharmaceutical composition and chemical drugs Or Chinese medicine composition preventing and treating knee osteoarthritis medicine.
Pharmaceutical composition preventing and treating knee osteoarthritis are evident in efficacy.
Specific embodiment
Embodiment 1：Pharmaceutical composition of preventing and treating knee osteoarthritis and preparation method thereof
Preventing and treating knee osteoarthritis pharmaceutical composition crude drug composition and weight portion be：Herba Haloragidis Micranthae 357g plateaus sandwort 362g pseudojervine 13g rattan wingceltis 351g Dennstaedtia scabra (Wall.) Moore. 333g；
Preparation method：
（1）Herba Haloragidis Micranthae, plateau sandwort, pseudojervine, rattan wingceltis, Dennstaedtia scabra (Wall.) Moore. are taken by crude drug proportioning, is mixed, is used percentage by weight 29% ethanol of concentration is extracted in 37 DEG C of warm macerating as solvent, and extraction time is 20 times, and each extraction time is 17 hours, molten every time 46 times for crude drug gross weight of agent consumption, filtration obtain medicinal residues A and extracting solution A, and extracting solution A reclaims ethanol, is concentrated into relatively close Degree 1.16, filtration, medicinal liquid are first washed with water by DM20 macroporous adsorptive resins, then molten with 17% ethanol of weight percent concentration Liquid eluting DM20 macroporous adsorptive resins, collection 17% ethanol elution of weight percent concentration, recovery ethanol, concentrate drying, i.e., Obtain extract A；
（2）Take step（1）Medicinal residues A, with 67% ethanol of weight percent concentration as solvent, heating and refluxing extraction 15 times, is carried every time The time is taken for 0.3 hour, 56 times for medicinal residues A weight of each solvent load, filtration obtain medicinal residues B and extracting solution B, and extracting solution B is returned Ethanol is received, relative density 1.03 is concentrated into, is filtered, medicinal liquid is first washed with water, then uses weight by LK06 macroporous adsorptive resins 76% ethanol solution eluting LK06 macroporous adsorptive resins of percent concentration, collect 76% ethanol elution of weight percent concentration, Ethanol is reclaimed, concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
Embodiment 2：Pharmaceutical composition of preventing and treating knee osteoarthritis and preparation method thereof
Preventing and treating knee osteoarthritis pharmaceutical composition crude drug composition and weight portion be：Herba Haloragidis Micranthae 356g plateaus sandwort 364g pseudojervine 12g rattan wingceltis 352g Dennstaedtia scabra (Wall.) Moore. 330g；
Preparation method：
（1）Herba Haloragidis Micranthae, plateau sandwort, pseudojervine, rattan wingceltis, Dennstaedtia scabra (Wall.) Moore. are taken by crude drug proportioning, is mixed, is used percentage by weight 29% ethanol of concentration is extracted in 37 DEG C of warm macerating as solvent, and extraction time is 20 times, and each extraction time is 17 hours, molten every time 46 times for crude drug gross weight of agent consumption, filtration obtain medicinal residues A and extracting solution A, and extracting solution A reclaims ethanol, is concentrated into relatively close Degree 1.16, filtration, medicinal liquid are first washed with water by DM20 macroporous adsorptive resins, then molten with 17% ethanol of weight percent concentration Liquid eluting DM20 macroporous adsorptive resins, collection 17% ethanol elution of weight percent concentration, recovery ethanol, concentrate drying, i.e., Obtain extract A；
（2）Take step（1）Medicinal residues A, with 67% ethanol of weight percent concentration as solvent, heating and refluxing extraction 15 times, is carried every time The time is taken for 0.3 hour, 56 times for medicinal residues A weight of each solvent load, filtration obtain medicinal residues B and extracting solution B, and extracting solution B is returned Ethanol is received, relative density 1.03 is concentrated into, is filtered, medicinal liquid is first washed with water, then uses weight by LK06 macroporous adsorptive resins 76% ethanol solution eluting LK06 macroporous adsorptive resins of percent concentration, collect 76% ethanol elution of weight percent concentration, Ethanol is reclaimed, concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
Embodiment 3：Pharmaceutical composition of preventing and treating knee osteoarthritis and preparation method thereof
Preventing and treating knee osteoarthritis pharmaceutical composition crude drug composition and weight portion be：Herba Haloragidis Micranthae 358g plateaus sandwort 360g pseudojervine 14g rattan wingceltis 350g Dennstaedtia scabra (Wall.) Moore. 336g；
Preparation method：
（1）Herba Haloragidis Micranthae, plateau sandwort, pseudojervine, rattan wingceltis, Dennstaedtia scabra (Wall.) Moore. are taken by crude drug proportioning, is mixed, is used percentage by weight 29% ethanol of concentration is extracted in 37 DEG C of warm macerating as solvent, and extraction time is 20 times, and each extraction time is 17 hours, molten every time 46 times for crude drug gross weight of agent consumption, filtration obtain medicinal residues A and extracting solution A, and extracting solution A reclaims ethanol, is concentrated into relatively close Degree 1.16, filtration, medicinal liquid are first washed with water by DM20 macroporous adsorptive resins, then molten with 17% ethanol of weight percent concentration Liquid eluting DM20 macroporous adsorptive resins, collection 17% ethanol elution of weight percent concentration, recovery ethanol, concentrate drying, i.e., Obtain extract A；
（2）Take step（1）Medicinal residues A, with 67% ethanol of weight percent concentration as solvent, heating and refluxing extraction 15 times, is carried every time The time is taken for 0.3 hour, 56 times for medicinal residues A weight of each solvent load, filtration obtain medicinal residues B and extracting solution B, and extracting solution B is returned Ethanol is received, relative density 1.03 is concentrated into, is filtered, medicinal liquid is first washed with water, then uses weight by LK06 macroporous adsorptive resins 76% ethanol solution eluting LK06 macroporous adsorptive resins of percent concentration, collect 76% ethanol elution of weight percent concentration, Ethanol is reclaimed, concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
Embodiment 4：The preparation of tablet
1 pharmaceutical composition 706g of Example, adds starch 1230g, mixes, and granulation is dried, plus Microcrystalline Cellulose 350g, firmly Fatty acid magnesium 4g, mixes, is pressed into 7000, obtains final product medicinal composition tablets.
Embodiment 5：The preparation of capsule
2 pharmaceutical composition 640g of Example, adds starch 886g, mixes, and granulation is dried, granulate, adds appropriate stearic acid Magnesium, mixes, encapsulated 5000, obtains final product medicament composition capsule.
Embodiment 6：The preparation of drop pill
Weigh (80 DEG C) heating of polyethylene glycol 6000 303g water-baths and boil molten, add 3 pharmaceutical composition 23g of embodiment, fully stir Mix uniform, with liquid paraffin as coolant, put glass tubing（4*80cm）In, chilling temperature is -5 DEG C, and drip internal-and external diameter is 7.0/ 2.0 (mm/mm), drip are 2.5cm away from liquid level, and drop speed is per dividing 49 drops as optimum condition, to blot the cold of drop pill surface with cotton Solidifying agent, obtains final product medicament composition dropping pills.
Embodiment 7：The pharmaceutical composition of preventing and treating knee osteoarthritis
Preventing and treating knee osteoarthritis pharmaceutical composition crude drug composition and weight portion be：
383 365 weight portion Dennstaedtia scabra (Wall.) Moore. of weight portion rattan wingceltis of Herba Haloragidis Micranthae, 340 weight portion.
Embodiment 8：The pharmaceutical composition of preventing and treating knee osteoarthritis
Preventing and treating knee osteoarthritis pharmaceutical composition crude drug composition and weight portion be：
12 136 weight portion Dennstaedtia scabra (Wall.) Moore. of weight portion rattan wingceltis of pseudojervine, 250 weight portion.
Embodiment 9：The pharmaceutical composition of preventing and treating knee osteoarthritis
Preventing and treating knee osteoarthritis pharmaceutical composition crude drug composition and weight portion be：
14 350 weight portion Dennstaedtia scabra (Wall.) Moore. of weight portion rattan wingceltis of pseudojervine, 345 weight portion.
Experimental example 1：The experimental study of preventing and treating knee osteoarthritis
1 clinical data
1.1 physical data
Include the KOA patient 48 of research, man 24, female 24.45～70 years old age, median 55 years old.The course of disease 0.5 ～14 years, median 5.5 years.
1.2 diagnostic criteria
1.2.1 Western medicine diagnostic criteria
Using《Osteoarthritis diagnosis and treatment guide (version in 2007)》The KOA diagnostic criterias of middle formulation.
1.2.2 tcm diagnosis standard
Reference《New Chinese medicine guideline of clinical investigations》Middle deficiency of the liver and kindey, tendon and vessel numbness type KOA diagnostic criterias formulate following Standard:Knee pain, soreness of the waist and knees, activity are unfavorable, and action is forced, light red tongue or partially red, thin fur or thin white, rolling pulse or string.
1.3 inclusive criteria
1. meet above-mentioned diagnostic criteria；2. age 40～75 years old；3. agree to participate in present study and sign Informed Consent Form.
1.4 exclusion standard
1. the primary disease persons such as more serious cardiovascular, Liver and kidney and hemopoietic system are merged；2. long-term taking treats its of KOA He is medicine person；3. take additive method therapist；4. rheumatoid arthritis, rheumatic arthritis, gouty arthritises person are merged； 5. there is drug allergy history person；6. gestation or women breast-feeding their children；7. psychotic.
1.5 the standard of curative effect evaluation
Reference《New Chinese medicine guideline of clinical investigations》The curative effect determinate standard of middle osteoarthritis formulates following standard.1. face Bed recovery from illness:Clinical symptoms, sign disappear, and joint motion is normal, therapeutic index >=90%；2. it is effective:Clinical symptoms, sign are bright Aobvious to improve, joint motion is unrestricted, 70%≤therapeutic index ＜ 90%；3. it is effective:Clinical symptoms, sign take a favorable turn, and joint is lived It is dynamic slight limited, 30%≤therapeutic index ＜ 70%；4. it is invalid:Clinical symptoms, sign are not improved, even increasing, curative effect refers to Number ＜ 30%.Therapeutic index is calculated using nimodipine method, before therapeutic index=(integrating after integration-treatment before treatment)/treatment Integration × 100%.
2 methods
2.1 group technology
The patient for including research is randomly divided into into 2 groups using table of random number, treatment group 24, matched group 24.
2.2 Therapeutic Method
2.2.1 treatment group
Combination of oral medication (1 pharmaceutical composition of embodiment) is treated.Orally, each 1.5g, daily 2 times, continuous oral 4 Week is 1 course for the treatment of, totally 1 course for the treatment of.
2.2.2 matched group
Oral Anti-coronavirus Antibody (Kangyuan Pharmaceutical Co., Ltd., Jiangsu Prov, Chinese medicines quasi-word Z10980006).Every time 5 Grain, daily 3 times, continuous oral 4 weeks is 1 course for the treatment of, totally 1 course for the treatment of.
2.3 method for estimating curative effect
Before treatment, after treating 4 weeks, 3 months after treatment end, using visual analogue scale scale (visual Ana-logue score, VAS) evaluate 2 groups of patients suffer from knee joint pain, stiff, swelling situation and ADL.And in controlling After treating 4 weeks, general curative effect and the safety of 2 groups of patients are evaluated.
2.4 statistical method
Statistical procedures are carried out to the data obtained using SPSS17.0 statistical softwares.Compare between 2 groups of patient ages, groups of the course of disease Relatively checked using t；Compare between sex, the group of the state of an illness and adopt X 2 test；Suffer from knee joint pain, stiff, swelling and daily routines Compare the variance analyses using Repeated Measurement Data between the group of ability VAS scoring；The comparison of general curative effect is examined using sum of ranks Test；Inspection level α=0.05.
3 results
3.1 group result
2 groups of patient ages, sex, the state of an illness and courses of disease compare, and group difference is not statistically significant, has comparability.
3.2 suffer from knee joint pain, stiff, swelling and ADL VAS scoring
The difference for suffering from the scoring of knee joint pain VAS between different time points is statistically significant.
Treatment suffer within front 2 weeks knee joint pain VAS scoring compare, no significant difference, treat 4 weeks after and treat 3 months after end, suffer from the scoring of knee joint pain VAS for 2 groups and compare, the statistically significant (P of difference<0.05).
The difference for suffering from the stiff VAS scorings of knee joint between different time points is statistically significant.2 groups of patients suffer from the stiff VAS of knee joint The group difference of scoring is generally not statistically significant.Further compare display, before treatment, after treating 4 weeks and after treatment end 3 months, suffer from the stiff VAS scorings of knee joint for 2 groups and compare, the not statistically significant (P of group difference>0.05).
The difference for suffering from knee joint swelling VAS scorings between different time points is statistically significant.2 groups of patients suffer from knee joint swelling VAS The group difference of scoring is generally not statistically significant.Further compare display, before treatment, after treating 4 weeks and after treatment end 3 months, suffer from knee joint swelling VAS scorings for 2 groups and compare, the not statistically significant (P of group difference>0.05).
The difference for suffering from knee joint ADL VAS scorings between different time points is statistically significant.2 groups of patients suffer from knee joint The group difference of ADL VAS scorings is generally statistically significant.Further compare display, treat first 2 groups Suffer from knee joint ADL VAS scorings to compare, no significant difference (P>0.05)；After treating 4 weeks and treatment end 3 months afterwards, suffer from knee joint ADL VAS scorings for 2 groups and compare, the statistically significant (P of group difference<0.05).
3.3 general curative effect
The results are shown in Table 1.
12 groups of KOA overall patient's comparitive study examples of table
Group Clinical recovery It is effective Effectively It is invalid It is total
Treatment group 9 10 4 1 24
Matched group 9 10 3 2 24
After treating 4 weeks, the general curative effect for the treatment of group is compared with matched group, no significant difference.
3.4 untoward reaction
After treating 4 weeks, there is not hepatic and renal function exception and gastrointestinal reaction in 2 groups of patients.

Claims (8)

1. it is a kind of preventing and treating knee osteoarthritis pharmaceutical composition, it is characterised in that make the composition of the crude drug of the pharmaceutical composition With weight portion it is：
Herba Haloragidis Micranthae 356-358 weight portions plateau sandwort 360-364 weight portion pseudojervine 12-14 weight portion rattan wingceltises 350-352 weight portion Dennstaedtia scabra (Wall.) Moore. 330-336 weight portions.
2. according to claim 1 it is a kind of preventing and treating knee osteoarthritis pharmaceutical composition, it is characterised in that make the medicine group The composition and weight portion of the crude drug of compound be：
357 13 weight portion rattan wingceltis of weight portion plateau 362 weight portion pseudojervine of sandwort of Herba Haloragidis Micranthae, 351 weight portion Dennstaedtia scabra (Wall.) Moore. 333 weight portions.
3. according to claim 1 it is a kind of preventing and treating knee osteoarthritis pharmaceutical composition, it is characterised in that pharmaceutical composition can Piece agent or capsule or drop pill are prepared with the conventional method using galenic pharmacy.
4. according to claim 1 it is a kind of preventing and treating knee osteoarthritis pharmaceutical composition, it is characterised in that pharmaceutical composition with The preventing and treating knee osteoarthritis medicine of chemical drugs or Chinese medicine composition.
5. it is a kind of preventing and treating knee osteoarthritis pharmaceutical composition preparation method, it is characterised in that prepare as follows：
The composition and weight portion of crude drug be：The false white Herba chenopodii of Herba Haloragidis Micranthae 356-358 weight portions plateau sandwort 360-364 weight portions Reed alkali 12-14 weight portion rattan wingceltis 350-352 weight portion Dennstaedtia scabra (Wall.) Moore. 330-336 weight portions；
Preparation method：
（1）Herba Haloragidis Micranthae, plateau sandwort, pseudojervine, rattan wingceltis, Dennstaedtia scabra (Wall.) Moore. are taken by crude drug proportioning, is mixed, is used percentage by weight 29% ethanol of concentration is extracted in 37 DEG C of warm macerating as solvent, and extraction time is 20 times, and each extraction time is 17 hours, molten every time 46 times for crude drug gross weight of agent consumption, filtration obtain medicinal residues A and extracting solution A, and extracting solution A reclaims ethanol, is concentrated into relatively close Degree 1.16, filtration, medicinal liquid are first washed with water by DM20 macroporous adsorptive resins, then molten with 17% ethanol of weight percent concentration Liquid eluting DM20 macroporous adsorptive resins, collection 17% ethanol elution of weight percent concentration, recovery ethanol, concentrate drying, i.e., Obtain extract A；
（2）Take step（1）Medicinal residues A, with 67% ethanol of weight percent concentration as solvent, heating and refluxing extraction 15 times, is carried every time The time is taken for 0.3 hour, 56 times for medicinal residues A weight of each solvent load, filtration obtain medicinal residues B and extracting solution B, and extracting solution B is returned Ethanol is received, relative density 1.03 is concentrated into, is filtered, medicinal liquid is first washed with water, then uses weight by LK06 macroporous adsorptive resins 76% ethanol solution eluting LK06 macroporous adsorptive resins of percent concentration, collect 76% ethanol elution of weight percent concentration, Ethanol is reclaimed, concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
6. according to claim 5 it is a kind of preventing and treating knee osteoarthritis pharmaceutical composition preparation method, it is characterised in that press It is prepared by following steps：
The composition and weight portion of crude drug be：357 362 weight portion pseudojervine of weight portion plateau sandwort of Herba Haloragidis Micranthae, 13 weight 351 weight portion Dennstaedtia scabra (Wall.) Moore. of amount part rattan wingceltis, 333 weight portion；
Preparation method：
（1）Herba Haloragidis Micranthae, plateau sandwort, pseudojervine, rattan wingceltis, Dennstaedtia scabra (Wall.) Moore. are taken by crude drug proportioning, is mixed, is used percentage by weight 29% ethanol of concentration is extracted in 37 DEG C of warm macerating as solvent, and extraction time is 20 times, and each extraction time is 17 hours, molten every time 46 times for crude drug gross weight of agent consumption, filtration obtain medicinal residues A and extracting solution A, and extracting solution A reclaims ethanol, is concentrated into relatively close Degree 1.16, filtration, medicinal liquid are first washed with water by DM20 macroporous adsorptive resins, then molten with 17% ethanol of weight percent concentration Liquid eluting DM20 macroporous adsorptive resins, collection 17% ethanol elution of weight percent concentration, recovery ethanol, concentrate drying, i.e., Obtain extract A；
（2）Take step（1）Medicinal residues A, with 67% ethanol of weight percent concentration as solvent, heating and refluxing extraction 15 times, is carried every time The time is taken for 0.3 hour, 56 times for medicinal residues A weight of each solvent load, filtration obtain medicinal residues B and extracting solution B, and extracting solution B is returned Ethanol is received, relative density 1.03 is concentrated into, is filtered, medicinal liquid is first washed with water, then uses weight by LK06 macroporous adsorptive resins 76% ethanol solution eluting LK06 macroporous adsorptive resins of percent concentration, collect 76% ethanol elution of weight percent concentration, Ethanol is reclaimed, concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
7. according to claim 5 it is a kind of preventing and treating knee osteoarthritis pharmaceutical composition preparation method, it is characterised in that medicine Compositions can adopt the conventional method of galenic pharmacy to prepare piece agent or capsule or drop pill.
8. according to claim 5 it is a kind of preventing and treating knee osteoarthritis pharmaceutical composition preparation method, it is characterised in that medicine Compositions and chemical drugs or Chinese medicine composition preventing and treating knee osteoarthritis medicine.
CN201611133072.9A 2016-12-10 2016-12-10 A kind of pharmaceutical composition of preventing and treating knee osteoarthritis and preparation method thereof Withdrawn CN106539854A (en)

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