CN106727752A - Treat pharmaceutical composition of synovitis and preparation method thereof - Google Patents

Treat pharmaceutical composition of synovitis and preparation method thereof Download PDF

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CN106727752A
CN106727752A CN201611132989.7A CN201611132989A CN106727752A CN 106727752 A CN106727752 A CN 106727752A CN 201611132989 A CN201611132989 A CN 201611132989A CN 106727752 A CN106727752 A CN 106727752A
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ethanol
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pharmaceutical composition
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weight portion
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Jinan Haoyu Qingtian Medicine Technology Co ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404—Indoles, e.g. pindolol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/11—Pteridophyta or Filicophyta (ferns)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/55—Liquid-liquid separation; Phase separation

Abstract

Pharmaceutical composition of synovitis and preparation method thereof is treated the invention discloses a kind of, pharmaceutical composition of the present invention is with poly- algae, bowl fern, betulic acid, small purpleflower stonecrop herb, mesembranone as bulk drug, proportioning is formed, and routinely can be made various formulations by preparation process, and treatment synovitis is evident in efficacy.

Description

Treat pharmaceutical composition of synovitis and preparation method thereof
Technical field
The invention belongs to technical field of traditional Chinese medicines, more particularly to a kind of pharmaceutical composition for treating synovitis and its preparation side Method.
Background technology
Causes of Acute Traumatic gonarthromeningitis is the synovial membrane aseptic inflammation due to causing after injury of knee joint, is clinically Orthopedics and traumatology is common, frequently-occurring disease, and its general clinical manifestation is gonalgia, swelling, local pyrexia, the floating patella test positive etc.. Traditional Chinese medicine thinks that Treatment of knee joint acute traumatic synovitis belongs to " numbness disease ", " injury of the tissues disease " category, and because of traumatic injury, qi and blood is disorderly, hemostasis In knee, so that new blood is not given birth to, wind-cold damp pathogen is taken advantage of the occasion and people, is harmonious with hemostasis for internal resistance, and numbness is hindered in knee, the retardance of knee qi and blood it is obstructed and Send out as this disease.Day protracted blood stasis condensation, it is wet to be polymerized to phlegm, aggravate disease, it is touching refractory, therefore with warming and activating meridian, dispelling cold in treatment Based on dehumidifying.The earliest record on " bi Zheng ", " injury of tendon and muscle " sees in traditional Chinese medicine history《Interior warp》" wet three gas of chill is miscellaneous extremely, close and It is numbness ".《Miscellaneous diseases source stream rhinoceros is lit up》Day, " sudden strain of a muscle suddenly, must be the shake of gas, and shake then swashs, sharp then harmony, the circumfluence of Yong Ze gas, all over the body Person, one of gathers place because of institute's harmony suddenly, and wherein, then blood also becomes silted up where gas harmony ".《Plain Questions numbness opinions》To being discussed as of bi Zheng " or Bitterly, or not bitterly, it is or meciless or cold, or heat, or dry or wet ".This disease is outer because wound, wind-cold damp pathogen, and overstrain is damaged；It is interior because Not smooth, the phlegm-blood stasis internal resistance of kidney deficiency and liver, the dysfunction of the spleen in transport, channels and collaterals.Its interpretation of the cause, onset and process of an illness is mainly：Wound or strain cause qi depression to blood stasis, and wind is felt again Cold-dampness is evil, obstruction of meridians and collaterals, and in entering long, liver spleen kidney deficiency, water humidity hysteresis is stayed, and general rule is not bitterly.Modern medicine thinks, knee joint trauma Synovitis is that the synovial membrane non-infectious inflammation caused after wound due to the liner synovial membrane of capsula articularis genus fiber is reacted, main pathology Intra-articular pressure rising is shown as, synovial membrane blood vessel dilatation, hyperemia, blood plasma and haemocyte exosmose, and blood and Lymphatic Circulation are obstructed, together When synovial cell also because active with the generation of a large amount of mucoitins, joint adhesion is occurred so that patient articular freely bends and stretches work It is dynamic limited.Therefore arthralgia and inflammatory conditions is eased, repaired involvement cartilage, it is the pass for treating this disease Key.At present, the therapy of Chinese medicine traumatic synovitis of knee joint mainly include oral medicinal herb, the external application of Chinese medicine, Chinese herbal fumigation and washing, The perfusion of Chinese medicine joint, acupuncture composite treatment etc., western medicine therapy are mainly Western medicine oral administration and externally, joint puncture and rinse injection treatment Method, surgical operation therapy, physical therapy is mainly based on ultrashort wave, microwave.
Small purpleflower stonecrop herb：It is complete for the small purpleflower stonecrop herb Petrocosmea minor Hemsl. of Gesneriaceae Petrocosmea plant Grass.The 7-9 months harvest, and clean, and dry.Seed is small, oval, smooth.【Nature and flavor】Taste micro-pungent；It is mild-natured.【Indication】Dissipate wind-heat; Invigorating the spleen disperse accumulations.Main cold, fever；Infantile malnutrition.【Former phytomorph】The small perennial small grass of purpleflower stonecrop herb acaulescence.Rhizome is short and thick, to Under close raw fibrous fibrous root.Phyllopodium gives birth to, 15-40 pieces;Leaf tool short handle or the stockless of inner face, outside leaf tool handle, up to 4cm, close quilt The pubescence of shape swallowtail;Blade ellipticity whip shape, oval or subcircular, 1-2.5cm long, 8-15mm wide, the micro- point of tip, base portion Wide wedge shape or wedge shape, ellipse, full edge or have unconspicuous wavy small knuckle-tooth, green above leaf, below light green, the close quilt in two sides The pubescence of development.Flower 1-5 bars, there is 1 (- 2) flower per inflorescence;Peduncle 3.5-7.5cm long, by development pubescence;Bract is narrow linear, 3mm is about, it is close by pubescence;Calyx 5 is split up to base portion, sliver wire lanceolar, and outside is by pubescence;Corolla purple, outside is by short soft Hair, corolla tube is short, 2.5-3.5cm long, is preced with the lip of mast two, upper lip ovate triangle, tip fine fisssure or nearly full edge, and lower lip 3 splits, sliver Near to wait big, tip is circular;Can educate stamen 2, filigree suede shape wide, close by brown undercoat, flower pesticide is about 5mm, staminodium 2;Ovary Close to lie prostrate pubescence by patch, style is about 7mm, and, by short volt hair, column cap is small, point-like for usual base portion.Capsule Long Circle, up to 10mm, By pubescence, room antiform is 2 valves.Seed is small, oval, smooth.The month at florescence 8-9, the fruiting period 10-11 months.Record in the big diction of Chinese medicine Allusion quotation.
Poly- algae：This product is Haloragaceae Myriophyllum plant spike watermifoil Ntruiogtkkyn soucatyn L.'s Herb.From April to October, harvested 1 time every 2 months, in pond 1/2 poly- algae is harvested every time, dried or dry.【Nature and flavor】Taste It is sweet；It is light；It is cold in nature.【Indication】Heat-clearing；Cool blood, removing toxic substances.Main pyreticosis polydipsia；Dysentery；Erysipelas；Boil；Scald.【Chemistry into Part】Containing substantial amounts of chlorophyllide (chlorophyllide).【Original shape state】The perennial heavy pasture and water sheet of spike watermifoil. Root-like stock is crawled, raw fibrous root on section.Stem cylinder, elongation, normal branch, according to the depth difference of water, length differs, internode length 3- 4cm.4 pieces of leaf is verticillate；Stockless；Bottle green, to lanceolar, 2-3cm long, pinniform drastic crack, sliver is linear, fine and closely woven, 13- for oblong More than 20 is right, alternate and nearly opposite.Spike basidixed, 5-10cm long stands upright in the water surface, fruiting period submerged in the water；Flower unisexuality, 4 to Most verticillate, male and female flowering homophyletics；Male flower occupies top, and bract green, edge is red, and Long Circle, squamella is avette, calyx pipe mitriform, Calyx 4, ovate triangle, petal 4, red greening, navicular cochlear is caducous, stamen 8, light green or yellow green, 2mm long；Female flower Portion is given birth to, calyx pipe is several truncate or has shallow tooth, petal 4, and oval, tip is blunt, pink, caducous, and ovary is the next, Room 4, column cap 4, Pinniform, outwards reversion.Really spherical, diameter 1.5-3mm is divided into 4 mericarps.The month at florescence 4-10.Record in dictionary of medicinal plant.
Bowl fern：It is bowl Pteridiaceae bowl Cyclosorus plant bowl fern Dennstaedtia scabra (Wall.) Moore [Dicksonia Scabra Wall.] herb.【Nature and flavor】It is pungent；It is cool.【Return through】Bladder warp.【Indication】Wind-dispelling；Relieving superficies by cooling.Main flu head Bitterly；Arthralgia pain due to rheumatism.【Chemical analysis】Aerial part contains pterosin（pterosin）A, F, K, V, onychium japonicum Kunze are pungent（onitisin）That is 4- Hydroxyl pterosin（4-hydroxypterosin）A, Europe fern Yi Lu glucosides（ptaquiloside）, bowl fern glucoside（dennstoside）A. 【Proterties】Root-like stock cylinder, thick long, surface rufous, the close nodular hair by brown, it descends the fibrous root for giving birth to numerous grey blacks. Petiole 20-35cm long, slightly rufous, gloss；Blade 20-35cm long, 15-20cm wide, 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 becomes mildewed；End time sliver is short, blunt Point, full edge has scun 1 per sliver, and tip enlarges into water pocket, not up to limb；Sporangiorus is born in scun tip, sorus teabowl with a cover Shape, slightly celadon, hair.Matter is crisp, and gas is micro-, lightly seasoned.Record in dictionary of medicinal plant.
Betulic acid（Betulinic acid）：CAS 472-15-1, molecular formula C30H48O3, molecular weight 456.71.【It is raw Thing activity】It is antitumor（W256）.【Ingredient origin】Date Ziziphus jujuba, tree-like cuckoo Rhododendron Arboreum, camplotheca acuminata Camptotheca acuminata.
Mesembranone（Mesembrine）：CAS 24880-43-1, molecular formula C17H23NO3, molecular weight 289.37.【Medicine Reason is acted on】Anesthetic；Central stimulant.【Ingredient origin】Expansion mesembrianthemum Mesembryanthemum expansum, bright pine needle Chrysanthemum Mesembryanthemum anatomtcum, distortion mesembrianthemum Mesembryanthemum tortuosum.
2 structures of bulk drug：
Mesembranone（Mesembrine）Betulic acid（Betulinic acid）.
The content of the invention
The purpose of the present invention is to overcome the shortcomings of background technology, there is provided it is a kind of it is effective treatment synovitis pharmaceutical composition and Its preparation method.
The present invention adopts the following technical scheme that realization：
The composition and weight portion for being made the bulk drug of the pharmaceutical composition of the treatment synovitis be：
The poly- small purpleflower stonecrop herb 50-60 weights of algae 562-568 weight portions bowl fern 500-506 weight portion betulic acid 204-208 weight portions Amount part mesembranone 12-14 weight portions.
The pharmaceutical composition for the treatment of synovitis is preferably used in, is made up of the bulk drug of following weight portion：
The small weight portion mesembranone 13 of purpleflower stonecrop herb 55 of weight portion of 503 weight portion betulic acid of the weight portion of poly- algae 565 bowl fern 206 Weight portion.
A kind of pharmaceutical composition for treating synovitis, it is characterised in that pharmaceutical composition can be using the routine side of galenic pharmacy Method prepares piece agent or capsule or dripping pill.
A kind of pharmaceutical composition for treating synovitis, it is characterised in that pharmaceutical composition and controlling that chemical drugs or Chinese medicine are constituted Treat synovitis medicine.
A kind of preparation method of the pharmaceutical composition for treating synovitis, it is characterised in that prepare as follows：
The composition and weight portion of bulk drug be：Poly- algae 562-568 weight portions bowl fern 500-506 weight portion betulic acids 204- The small purpleflower stonecrop herb 50-60 weight portions mesembranone 12-14 weight portions of 208 weight portions；
Preparation method：
（1）Poly- algae, bowl fern, betulic acid, small purpleflower stonecrop herb, mesembranone are taken by bulk drug proportioning, is mixed, it is dense with percentage by weight 34% ethanol being spent as solvent, being taken in 37.5 DEG C of temperature extractions, extraction time is 11 times, 66 hours each extraction times, each solvent Consumption is 64.5 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, is concentrated into relatively close Degree 1.13, filtration, liquid is first washed with water by NKA-9 large pore resin absorption columns, then with the ethanol of weight percent concentration 14% Eluant solution NKA-9 large pore resin absorption columns, collect the ethanol eluate of weight percent concentration 14%, reclaim ethanol, and concentration is dry It is dry, obtain final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 44% as solvent, heating and refluxing extraction 8 times is carried every time The time is taken for 0.1 hour, each solvent load is 39 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned Ethanol is received, relative density 1.16 is concentrated into, filtered, liquid is first washed with water by LSD280 large pore resin absorption columns, then with again Amount percent concentration 82% ethanol solution wash-out LSD280 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 82% Liquid, reclaims ethanol, and concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
Preferred a kind of preparation method of the pharmaceutical composition for treating synovitis, it is characterised in that prepare as follows：
The composition and weight portion of bulk drug be：The weight portion gravelstone of 503 weight portion betulic acid of the weight portion of poly- algae 565 bowl fern 206 The weight portion of 55 weight portion mesembranone of butterfly 13；
Preparation method：
（1）Poly- algae, bowl fern, betulic acid, small purpleflower stonecrop herb, mesembranone are taken by bulk drug proportioning, is mixed, it is dense with percentage by weight 34% ethanol being spent as solvent, being taken in 37.5 DEG C of temperature extractions, extraction time is 11 times, 66 hours each extraction times, each solvent Consumption is 64.5 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, is concentrated into relatively close Degree 1.13, filtration, liquid is first washed with water by NKA-9 large pore resin absorption columns, then with the ethanol of weight percent concentration 14% Eluant solution NKA-9 large pore resin absorption columns, collect the ethanol eluate of weight percent concentration 14%, reclaim ethanol, and concentration is dry It is dry, obtain final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 44% as solvent, heating and refluxing extraction 8 times is carried every time The time is taken for 0.1 hour, each solvent load is 39 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned Ethanol is received, relative density 1.16 is concentrated into, filtered, liquid is first washed with water by LSD280 large pore resin absorption columns, then with again Amount percent concentration 82% ethanol solution wash-out LSD280 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 82% Liquid, reclaims ethanol, and 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 for treating synovitis, it is characterised in that pharmaceutical composition can use preparation Conventional method prepares piece agent or capsule or dripping pill.
A kind of preparation method of the pharmaceutical composition for treating synovitis, it is characterised in that pharmaceutical composition and chemical drugs or in Medicine composition treatment synovitis medicine.
Medicine composite for curing synovitis is evident in efficacy.
Specific embodiment
Embodiment 1：Treat pharmaceutical composition of synovitis and preparation method thereof
Treat synovitis pharmaceutical composition bulk drug composition and weight portion be：Poly- algae 565g bowls of fern 503g betulic acids The small purpleflower stonecrop herb 55g mesembranones 13g of 206g；
Preparation method：
（1）Poly- algae, bowl fern, betulic acid, small purpleflower stonecrop herb, mesembranone are taken by bulk drug proportioning, is mixed, it is dense with percentage by weight 34% ethanol being spent as solvent, being taken in 37.5 DEG C of temperature extractions, extraction time is 11 times, 66 hours each extraction times, each solvent Consumption is 64.5 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, is concentrated into relatively close Degree 1.13, filtration, liquid is first washed with water by NKA-9 large pore resin absorption columns, then with the ethanol of weight percent concentration 14% Eluant solution NKA-9 large pore resin absorption columns, collect the ethanol eluate of weight percent concentration 14%, reclaim ethanol, and concentration is dry It is dry, obtain final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 44% as solvent, heating and refluxing extraction 8 times is carried every time The time is taken for 0.1 hour, each solvent load is 39 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned Ethanol is received, relative density 1.16 is concentrated into, filtered, liquid is first washed with water by LSD280 large pore resin absorption columns, then with again Amount percent concentration 82% ethanol solution wash-out LSD280 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 82% Liquid, reclaims ethanol, and concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
Embodiment 2：Treat pharmaceutical composition of synovitis and preparation method thereof
Treat synovitis pharmaceutical composition bulk drug composition and weight portion be：Poly- algae 562g bowls of fern 506g betulic acids The small purpleflower stonecrop herb 60g mesembranones 12g of 204g；
Preparation method：
（1）Poly- algae, bowl fern, betulic acid, small purpleflower stonecrop herb, mesembranone are taken by bulk drug proportioning, is mixed, it is dense with percentage by weight 34% ethanol being spent as solvent, being taken in 37.5 DEG C of temperature extractions, extraction time is 11 times, 66 hours each extraction times, each solvent Consumption is 64.5 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, is concentrated into relatively close Degree 1.13, filtration, liquid is first washed with water by NKA-9 large pore resin absorption columns, then with the ethanol of weight percent concentration 14% Eluant solution NKA-9 large pore resin absorption columns, collect the ethanol eluate of weight percent concentration 14%, reclaim ethanol, and concentration is dry It is dry, obtain final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 44% as solvent, heating and refluxing extraction 8 times is carried every time The time is taken for 0.1 hour, each solvent load is 39 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned Ethanol is received, relative density 1.16 is concentrated into, filtered, liquid is first washed with water by LSD280 large pore resin absorption columns, then with again Amount percent concentration 82% ethanol solution wash-out LSD280 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 82% Liquid, reclaims ethanol, and concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
Embodiment 3：Treat pharmaceutical composition of synovitis and preparation method thereof
Treat synovitis pharmaceutical composition bulk drug composition and weight portion be：Poly- algae 568g bowls of fern 500g betulic acids The small purpleflower stonecrop herb 50g mesembranones 14g of 208g；
Preparation method：
（1）Poly- algae, bowl fern, betulic acid, small purpleflower stonecrop herb, mesembranone are taken by bulk drug proportioning, is mixed, it is dense with percentage by weight 34% ethanol being spent as solvent, being taken in 37.5 DEG C of temperature extractions, extraction time is 11 times, 66 hours each extraction times, each solvent Consumption is 64.5 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, is concentrated into relatively close Degree 1.13, filtration, liquid is first washed with water by NKA-9 large pore resin absorption columns, then with the ethanol of weight percent concentration 14% Eluant solution NKA-9 large pore resin absorption columns, collect the ethanol eluate of weight percent concentration 14%, reclaim ethanol, and concentration is dry It is dry, obtain final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 44% as solvent, heating and refluxing extraction 8 times is carried every time The time is taken for 0.1 hour, each solvent load is 39 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned Ethanol is received, relative density 1.16 is concentrated into, filtered, liquid is first washed with water by LSD280 large pore resin absorption columns, then with again Amount percent concentration 82% ethanol solution wash-out LSD280 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 82% Liquid, reclaims ethanol, and 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
The pharmaceutical composition 144g of Example 1, adds starch 257g, mixes, and granulation is dried, plus microcrystalline cellulose 144g, stearic Sour magnesium 12g, mixes, and is pressed into 1500, obtains final product medicinal composition tablets.
Embodiment 5：The preparation of capsule
The pharmaceutical composition 240.5g of Example 2, adds starch 331.5g, mixes, and granulation is dried, whole grain, adds appropriate stearic Sour magnesium, mixes, and encapsulated 1400, obtains final product medicament composition capsule.
Embodiment 6：The preparation of dripping pill
Weigh (80 DEG C) heating of Macrogol 6000 235.5g water-baths and boil molten, add the pharmaceutical composition 12.6g of embodiment 3, fill Divide and stir, with atoleine as cooling agent, put glass tube（4*80cm）In, chilling temperature is 5 DEG C, and drip internal-and external diameter is 7.0/2.0 (mm/mm), drip is 2.3cm away from liquid level, and drop speed is optimum condition with every point 52 drop, and dripping pill surface is blotted with cotton Condensing agent, obtain final product medicament composition dropping pills.
Experimental example 1：Treat the experimental study of synovitis
1 data and method
1.1 case selections
Western medicine diagnostic criteria is referred to《Surgery》In about Causes of Acute Traumatic synovitis diagnostic criteria, tcm diagnosis standard reference 《Chinese medical disease Standardization of diagnosis and curative effect》In the relevant diagnostic criteria corner of the eyes].Exclusion standard：(1) x-ray inspection has disease in other joints Person；(2) it is associated with open wound person；(3) pain caused, the red and swollen, struttuer of inflammatory infection；(4) because taking other medicines Thing and influence this experiment curative effect person；(5) gestational period or women breast-feeding their children；(6) due to a variety of causes midway abandoner, or observation period Between receive other therapies and cannot judge curative effect person.
1.2 clinical datas
This object for studying selection is in April, 2011 in April, 2012 in Jinan City's hospital admission and is diagnosed as acute injury The patient 60 of property gonarthromeningitis, all patients are unilateral damage, there is arthroncus, pain and different degrees of Function limitation.It is randomly divided into control group and each 30 of observation group.Wherein control group male 15, women 15；Age 25~71 Year, average (55.56 ± 3.52) year；12~55d of the course of disease.Treatment group male 15, women 15；25~70 years old age, averagely (55.23 ± 4.77) year；12~52d of the course of disease.The physical data comparing differences such as two groups of conditions of patients, age, sex, courses of disease are without system Meter learns meaning (P>0.05).
1.3 treatment methods
The oral synovitis electuary of control group patient, 1 bag every time, 3 times a day, and 7 d are 1 course for the treatment of, according to disease in therapeutic process Feelings give knee joint and bend fixed outside the plaster slab of side, and the time is generally 2~4 weeks；Not fixing person answers suffering limb to brake, and lies up, together When suitably carry out quadriceps muscle of thigh contraction movement, daily 3~5 times, every time 10~20 min；It is fixed except swelling is removable after disappearing, Practise joint active flexion-extension motion, can lifting affected limb stay aloft the several seconds.Observation group on the basis of control group, combination medicine Composition（The pharmaceutical composition of embodiment 1）External application for curing.During external application, first pharmaceutical composition is crushed, mixed, hot tune is boiled with honey Into pasty state, then covered with sterile gauze by knee area.The pasty ointment that will be mixed up is uniformly coated on about 2 mm thickness on Gao pads, uses Bandage by cotton pad be fixed on trouble it is above-knee, one time a day, 7 d be 1 course for the treatment of.Can be according to knee recovery situation to carrying out during external application Local frequency spectrum heating irradiation.Two groups are treated 4 courses for the treatment of.
1.4 criterions of therapeutical effect
Reference《New Chinese medicine guideline of clinical investigations》In the evaluation criterion on curative effect of disease and therapeutic effect of syndrome.(1) it is clinical Control：The symptom of patient, sign disappear or basic disappearance after treatment, and total mark is not less than 90% before and after treatment.(2) it is effective：Face Bed symptom, sign are clearly better, syndrome integral reduction by 70%~90%.(3) effectively：Clinical symptoms, sign take a favorable turn, syndrome Integration is reduced 30%~70%.(4) it is invalid：Clinical symptoms, sign are not improved, or even have aggravated, syndrome integral drop It is low to be less than 30%.C reactive protein (CRP), erythrocyte sedimentation rate (ESR) before and after patient's treatment are checked simultaneously.
1.5 statistical procedures
Using SPSSl6.0 statistical softwares.Measurement data is represented with mean, and is checked using f, is compared between the group of ranked data and is adopted Checked with Mann-Whitnev U, compare between the group of enumeration data and use Chi-square Test.P<O.05 for difference is statistically significant.
2 results
2.1 two groups of patient clinical comparitive studies
It is shown in Table 1.Result shows that observation group patient total effective rate and control show rate apparently higher than control group (P<0.05).
1 two groups of Treatment of knee joint acute traumatic synovitis patient clinical comparitive study (n) of table
Group n Clinic control It is effective Effectively It is invalid Total effective rate (%)
Observation group 30 12 10 6 2 93.33*
Control group 30 6 7 9 8 73.33
Compare with control group, * P<O.05.
Cardinal symptom average integral compares before and after 2.2 two groups of treatments
Compare with before treatment, the symptom average integral such as Hao groups patient pain, swelling, mobility significantly reduces (P after treatment< 0.05)；Compare between group after treatment, observation group is better than control group (P<O.05).
ESR, CRP enter to compare before and after 2.3 two groups of patient's treatments
Compare with before treatment, two groups of patients ESR, CRP are obviously improved (P after treatment<0.05)；Compare between group after treatment, observation group Better than control group (P<0.05).

Claims (8)

1. a kind of pharmaceutical composition for treating synovitis, it is characterised in that be made the composition and weight of the bulk drug of the pharmaceutical composition Measuring part is：
The poly- small purpleflower stonecrop herb 50-60 weights of algae 562-568 weight portions bowl fern 500-506 weight portion betulic acid 204-208 weight portions Amount part mesembranone 12-14 weight portions.
2. a kind of pharmaceutical composition for treating synovitis according to claim 1, it is characterised in that be made the pharmaceutical composition Bulk drug composition and weight portion be：
The small weight portion mesembranone 13 of purpleflower stonecrop herb 55 of weight portion of 503 weight portion betulic acid of the weight portion of poly- algae 565 bowl fern 206 Weight portion.
3. a kind of pharmaceutical composition for treating synovitis according to claim 1, it is characterised in that pharmaceutical composition can be adopted Piece agent or capsule or dripping pill are prepared with the conventional method of galenic pharmacy.
4. a kind of pharmaceutical composition for treating synovitis according to claim 1, it is characterised in that pharmaceutical composition and chemistry The treatment synovitis medicine of medicine or Chinese medicine composition.
5. a kind of preparation method of the pharmaceutical composition for treating synovitis, it is characterised in that prepare as follows：
The composition and weight portion of bulk drug be：Poly- algae 562-568 weight portions bowl fern 500-506 weight portion betulic acids 204- The small purpleflower stonecrop herb 50-60 weight portions mesembranone 12-14 weight portions of 208 weight portions；
Preparation method：
（1）Poly- algae, bowl fern, betulic acid, small purpleflower stonecrop herb, mesembranone are taken by bulk drug proportioning, is mixed, it is dense with percentage by weight 34% ethanol being spent as solvent, being taken in 37.5 DEG C of temperature extractions, extraction time is 11 times, 66 hours each extraction times, each solvent Consumption is 64.5 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, is concentrated into relatively close Degree 1.13, filtration, liquid is first washed with water by NKA-9 large pore resin absorption columns, then with the ethanol of weight percent concentration 14% Eluant solution NKA-9 large pore resin absorption columns, collect the ethanol eluate of weight percent concentration 14%, reclaim ethanol, and concentration is dry It is dry, obtain final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 44% as solvent, heating and refluxing extraction 8 times is carried every time The time is taken for 0.1 hour, each solvent load is 39 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned Ethanol is received, relative density 1.16 is concentrated into, filtered, liquid is first washed with water by LSD280 large pore resin absorption columns, then with again Amount percent concentration 82% ethanol solution wash-out LSD280 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 82% Liquid, reclaims ethanol, and concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
6. a kind of preparation method of the pharmaceutical composition for treating synovitis according to claim 5, it is characterised in that by as follows It is prepared by step：
The composition and weight portion of bulk drug be：The weight portion gravelstone of 503 weight portion betulic acid of the weight portion of poly- algae 565 bowl fern 206 The weight portion of 55 weight portion mesembranone of butterfly 13；
Preparation method：
（1）Poly- algae, bowl fern, betulic acid, small purpleflower stonecrop herb, mesembranone are taken by bulk drug proportioning, is mixed, it is dense with percentage by weight 34% ethanol being spent as solvent, being taken in 37.5 DEG C of temperature extractions, extraction time is 11 times, 66 hours each extraction times, each solvent Consumption is 64.5 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, is concentrated into relatively close Degree 1.13, filtration, liquid is first washed with water by NKA-9 large pore resin absorption columns, then with the ethanol of weight percent concentration 14% Eluant solution NKA-9 large pore resin absorption columns, collect the ethanol eluate of weight percent concentration 14%, reclaim ethanol, and concentration is dry It is dry, obtain final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 44% as solvent, heating and refluxing extraction 8 times is carried every time The time is taken for 0.1 hour, each solvent load is 39 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned Ethanol is received, relative density 1.16 is concentrated into, filtered, liquid is first washed with water by LSD280 large pore resin absorption columns, then with again Amount percent concentration 82% ethanol solution wash-out LSD280 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 82% Liquid, reclaims ethanol, and concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
7. a kind of preparation method of the pharmaceutical composition for treating synovitis according to claim 5, it is characterised in that medicine group Compound can prepare piece agent or capsule or dripping pill using the conventional method of galenic pharmacy.
8. a kind of preparation method of the pharmaceutical composition for treating synovitis according to claim 5, it is characterised in that medicine group Compound and chemical drugs or Chinese medicine composition treatment synovitis medicine.
CN201611132989.7A 2016-12-10 2016-12-10 Treat pharmaceutical composition of synovitis and preparation method thereof Withdrawn CN106727752A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023076533A1 (en) * 2021-10-29 2023-05-04 Sensorium Therapeutics, Inc. Solid forms of mesembrine and therapeutic uses thereof

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023076533A1 (en) * 2021-10-29 2023-05-04 Sensorium Therapeutics, Inc. Solid forms of mesembrine and therapeutic uses thereof

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