CN106728299A - It is a kind of to treat pharmaceutical composition of protrusion of lumber intervertebral disc and preparation method thereof - Google Patents

It is a kind of to treat pharmaceutical composition of protrusion of lumber intervertebral disc and preparation method thereof Download PDF

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CN106728299A
CN106728299A CN201611133017.XA CN201611133017A CN106728299A CN 106728299 A CN106728299 A CN 106728299A CN 201611133017 A CN201611133017 A CN 201611133017A CN 106728299 A CN106728299 A CN 106728299A
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ethanol
weight
pharmaceutical composition
weight portion
intervertebral disc
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不公告发明人
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Jinan Haoyu Qingtian Medicine Technology Co ltd
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Jinan Haoyu Qingtian Medicine Technology Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
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    • A61K31/7048Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/10Bryophyta (mosses)
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    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2031Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
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    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K2236/53Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
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    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/55Liquid-liquid separation; Phase separation

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Abstract

Pharmaceutical composition of protrusion of lumber intervertebral disc and preparation method thereof is treated the invention discloses a kind of, pharmaceutical composition of the present invention is with β irisones, 10000 years moss, trifid sopubia herb, protocevine, morroniside, cycloartanols as bulk drug, proportioning is formed, routinely various formulations can be made by preparation process, treatment protrusion of lumber intervertebral disc is evident in efficacy.

Description

It is a kind of to treat pharmaceutical composition of protrusion of lumber intervertebral disc and preparation method thereof
Technical field
The invention belongs to technical field of traditional Chinese medicines, more particularly to a kind of pharmaceutical composition and its system for treating protrusion of lumber intervertebral disc Preparation Method.
Background technology
Clinically, the protrasion of the lumbar intervertebral disci is a kind of common and multiple orthopaedic disease, while also causing patient to occur Pain in waist and lower extremities.Caused by major part pain in the back companion sciatica is because of protrusion of lumber intervertebral disc at present.In addition, the protrasion of the lumbar intervertebral disci is suffered from Person is also in larger pain, and Damage of cauda nerve person also has fecal and urinary functionses obstacle, so as to be made to patient's daily life quality Into severity effect.The protrasion of the lumbar intervertebral disci(Lumbar disc herniation, LDH, hereinafter referred to as waist dash forward disease)It is a kind of Common clinical, frequently-occurring disease, are one of most common causes of disease of pain in waist and lower extremities.The treatment of the current protrasion of the lumbar intervertebral disci can substantially be divided into Non-operative treatment and operative treatment.Therapeutic selection depends on age, the course of disease, pathologic stage and clinical manifestation of patient etc.. Most patients can be eased or improve through non-operative treatment, there is more research two kinds of late results of therapy of prompting Similar, its curative effect indicator difference is simultaneously not statistically signigicant.In traditional Chinese medicine, lumbar disc herniation category " pain in the back ", " numbness The categories such as card ", this disease is mainly relevant with patients blood, visceral dysfunction etc., while also occurring in the presence of tight with pain in the back Contact.Waist is the internal organs of kidney, therefore the presence of the disease and human kidney is closely connected.《Medicine Comprehended》:" pain in the back arrested anxious draw leg Foot ".《Plain Questions numbness opinions》Point out that " gas of wind, cold, wet three is miscellaneous extremely, combined into numbness."《Danxi's experiential therapy pains in the back》Then think lumbago diseases because " The understanding such as main damp and hot, kidney deficiency, hemostasis, the sudden strain of a muscle, phlegm product ".
Alpha, beta-lonone(Irisone):CAS 14901-07-6, molecular formula C13H20O, molecular weight 192.30.【Biology is living Property】Spices.【Ingredient origin】Almond Prunus armeniaca, banksia rose Saussurea lappa [Syn.Aucklandia Lappa], fruit of Chinese wolfberry Lycium chinense.
10000 years moss:This product is ten thousand Nian Xian sections, 10000 years Rhodobryum plants, 10000 years moss Climacium dendroides(Hedw.) The plant of Web.et Mohr [ Leskea dendroides Hedw. ].Spring, summer harvesting, clean, and dry.【Nature and flavor】It is bitter; It is cold.【Indication】Removing damp-heat;Stimulate the circulation of the blood and cause the muscles and joints to relax.Main rheumatism internal lesion caused by overexertion;Arthralgia and myalgia.【Chemical analysis】Containing cupreol (β- Sitosterol), stigmasterol (stigmasterol), ergosterol (ergosterol), campesterol (campesterol), Cyclolaudenol (cyclolaudenol), 31- removes first cyclolaudenol (31-norcyclolaudenol), and metal Elemental iron, manganese, zinc, copper etc..【Former phytomorph】Plant is thick in tree-like, and subterranean stem crawls to grow wild, and has rhizoid and film quality squama Shape leaflet.The aerial stem of plant is upright, multi-branched, up to 15-20cm, the densely covered green palea of branch.The leaf on stem top and branched base part Blade is in ovate triangle wide or ovum shape lanceolar, and base portion is slightly downward.Middle rib is single, and up in termination before blade tip, blade top is thin The narrow rhombus of born of the same parents, leaf corner cell is circular, semi-transparent clear.The blade on branch top is smaller, long and narrow lanceolar, leaf edge sawtooth reach in Middle part.Dioecism.Seta is elongated, 2-4cm long, red;Sporangium is upright, and cylindricality long has more;The female shape of opercule circle high;Capsule balaclava Shape, the full sporangium of clad.Record in dictionary of medicinal plant.
Trifid sopubia herb:This product is complete for the short hat grass Sopubia trfida Buch.-Ham.'s of Scrophulariaceae Sopubia plant Grass.Summer, autumn harvesting, dry.【Nature and flavor】Bitter;It is puckery;It is warm in nature.【Indication】Dispelling wind and eliminating dampness;Wet inner analgesic.Main chill is wet Numbness;Stomachache with cool feeling;Lumbago due to the kidney deficiency.【Former phytomorph】The short careless annual herb of hat, 40-90cm high.Root is carefully cylindrical.Stem list One or more numbers, uprightly, top multi-branched, branch tool corner angle and striped, by pubescence.Leaf opposite or alternate;The full shape synthesis circle of blade Taper;Luxuriant leave shape;Bennet is about 1cm, there is a pair of brill shape squamellas at nearly top;Calyx taper;Bract is lobate;Bennet is about 1cm, There are a pair of brill shape squamellas at nearly top;Calyx bracelet shape, pipe portion 10, rib of tool, calyx tooth 5 is wider than in length, triangle, internal and edge without There is wool;Corolla yellow or purple, are about 1cm, manage extremely short, sliver 5, carry out, obovate greatly, and circle is blunt, near equal;Stamen 4, The last two, filigree is born in the top of tube, and the Room of flower pesticide 1 is degenerated and narrow;Style is single, harbors.Capsule is spherical, and tip is flat And be recessed, it is shorter or isometric than calyx.Shape of the seed is uneven, the reticulate pattern for having elongated hole.The month at florescence 6-7, fruiting period September.Record big in Chinese medicine Dictionary.
Protocevine(Protocevine):CAS 5876-23-3, molecular formula C27H43NO8, molecular weight 509.64.【Composition Source】Black false hellebore Veratrum nigrum.
Cycloartanol(Cycloartanol):CAS 4657-58-3, molecular formula C30H52O, molecular weight 428.75. 【Pharmacological action】With antiinflammatory action.【Ingredient origin】Soya-bean oil, the fruit of Chinese wolfberry, Huo Yang le, the wall fern.
Morroniside(Morroniside):CAS 25406-64-8, molecular formula C17H26O11, molecular weight 406.38.【Pharmacology Effect】Stomach invigorating.【Ingredient origin】Patrinia scaniosaefolia Patrinia villosa, not Roche honeysuckle Lonicera morrowii, Fructus Corni Cornus officinalis [Syn.Macrocwpium officinale], five happinesses flower Adoxa moschatellina, Zan Shi Rough gentian Gentiana thunbergi.
4 chemical constitutions of bulk drug:
Morroniside(Morroniside)Alpha, beta-lonone(Irisone)
Protocevine(Protocevine)Cycloartanol(Cycloartanol).
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 medicine group of effective treatment protrusion of lumber intervertebral disc Compound and preparation method thereof.
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 protrusion of lumber intervertebral disc be:
10000 years moss 356-360 weight portion trifid sopubia herb 470-475 weight portion black false hellebores of alpha, beta-lonone 23.5-24.5 weight portions Cevine 18-19 weight portion morroniside 14-16 weight portion cycloartanol 1-3 weight portions.
The pharmaceutical composition for the treatment of protrusion of lumber intervertebral disc is preferably used in, is made up of the bulk drug of following weight portion:
24 weight portion of alpha, beta-lonone, 10000 years weight portions of 358 weight portion trifid sopubia herb of moss, 472 weight portion protocevine 18.5 The weight portion of 15 weight portion cycloartanol of morroniside 2.
A kind of pharmaceutical composition for treating protrusion of lumber intervertebral disc, it is characterised in that pharmaceutical composition can be using galenic pharmacy Conventional method prepares piece agent or capsule or dripping pill.
A kind of pharmaceutical composition for treating protrusion of lumber intervertebral disc, it is characterised in that pharmaceutical composition and chemical drugs or Chinese medicine group Into treatment protrusion of lumber intervertebral disc medicine.
A kind of preparation method of the pharmaceutical composition for treating protrusion of lumber intervertebral disc, it is characterised in that prepare as follows:
The composition and weight portion of bulk drug be:10000 years moss 356-360 weight portions of alpha, beta-lonone 23.5-24.5 weight portions are small to be stretched Muscle grass 470-475 weight portion protocevine 18-19 weight portion morroniside 14-16 weight portion cycloartanol 1-3 weight Part;
Preparation method:
(1)Alpha, beta-lonone, 10000 years moss, trifid sopubia herb, protocevine, morroniside, cycloartanols are taken by bulk drug proportioning, Mix, with the ethanol of weight percent concentration 33.5% as solvent, taken in 31.5 DEG C of temperature extractions, extraction time is 7 times, is carried every time The time is taken for 47 hours, each solvent load is 43 times of bulk drug gross weight, and filtration obtains dregs of a decoction A and extract solution A, extract solution A Ethanol is reclaimed, relative density 1.11 is concentrated into, filtered, liquid is first washed with water, then use by CAD-45 large pore resin absorption columns The ethanol solution of weight percent concentration 19% elutes CAD-45 large pore resin absorption columns, collects the ethanol of weight percent concentration 19% and washes De- liquid, reclaims ethanol, and concentrate drying obtains final product extract A;
(2)Take step(1)Dregs of a decoction A, with the ethanol of weight percent concentration 64% as solvent, heating and refluxing extraction 24 times is carried every time The time is taken for 0.3 hour, each solvent load is 56 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 1.03 is concentrated into, filtered, liquid is first washed with water, then use weight by H107 large pore resin absorption columns The ethanol solution of percent concentration 73% elutes H107 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 73%, Ethanol is reclaimed, 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 protrusion of lumber intervertebral disc, it is characterised in that as follows Prepare:
The composition and weight portion of bulk drug be:24 weight portion of alpha, beta-lonone, the 10000 years weight of 358 weight portion trifid sopubia herb of moss 472 The weight portion of 15 weight portion cycloartanol of part 18.5 weight portion morroniside of protocevine 2;
Preparation method:
(1)Alpha, beta-lonone, 10000 years moss, trifid sopubia herb, protocevine, morroniside, cycloartanols are taken by bulk drug proportioning, Mix, with the ethanol of weight percent concentration 33.5% as solvent, taken in 31.5 DEG C of temperature extractions, extraction time is 7 times, is carried every time The time is taken for 47 hours, each solvent load is 43 times of bulk drug gross weight, and filtration obtains dregs of a decoction A and extract solution A, extract solution A Ethanol is reclaimed, relative density 1.11 is concentrated into, filtered, liquid is first washed with water, then use by CAD-45 large pore resin absorption columns The ethanol solution of weight percent concentration 19% elutes CAD-45 large pore resin absorption columns, collects the ethanol of weight percent concentration 19% and washes De- liquid, reclaims ethanol, and concentrate drying obtains final product extract A;
(2)Take step(1)Dregs of a decoction A, with the ethanol of weight percent concentration 64% as solvent, heating and refluxing extraction 24 times is carried every time The time is taken for 0.3 hour, each solvent load is 56 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 1.03 is concentrated into, filtered, liquid is first washed with water, then use weight by H107 large pore resin absorption columns The ethanol solution of percent concentration 73% elutes H107 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 73%, 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 for treating protrusion of lumber intervertebral disc, 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.
A kind of preparation method of the pharmaceutical composition for treating protrusion of lumber intervertebral disc, it is characterised in that pharmaceutical composition and chemistry Medicine or Chinese medicine composition treatment protrusion of lumber intervertebral disc medicine.
Medicine composite for curing protrusion of lumber intervertebral disc is evident in efficacy.
Specific embodiment
Embodiment 1:Treat pharmaceutical composition of protrusion of lumber intervertebral disc and preparation method thereof
Treat protrusion of lumber intervertebral disc pharmaceutical composition bulk drug composition and weight portion be:10000 years moss of alpha, beta-lonone 24g 358g trifid sopubia herb 472g protocevine 18.5g morroniside 15g cycloartanols 2g;
Preparation method:
(1)Alpha, beta-lonone, 10000 years moss, trifid sopubia herb, protocevine, morroniside, cycloartanols are taken by bulk drug proportioning, Mix, with the ethanol of weight percent concentration 33.5% as solvent, taken in 31.5 DEG C of temperature extractions, extraction time is 7 times, is carried every time The time is taken for 47 hours, each solvent load is 43 times of bulk drug gross weight, and filtration obtains dregs of a decoction A and extract solution A, extract solution A Ethanol is reclaimed, relative density 1.11 is concentrated into, filtered, liquid is first washed with water, then use by CAD-45 large pore resin absorption columns The ethanol solution of weight percent concentration 19% elutes CAD-45 large pore resin absorption columns, collects the ethanol of weight percent concentration 19% and washes De- liquid, reclaims ethanol, and concentrate drying obtains final product extract A;
(2)Take step(1)Dregs of a decoction A, with the ethanol of weight percent concentration 64% as solvent, heating and refluxing extraction 24 times is carried every time The time is taken for 0.3 hour, each solvent load is 56 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 1.03 is concentrated into, filtered, liquid is first washed with water, then use weight by H107 large pore resin absorption columns The ethanol solution of percent concentration 73% elutes H107 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 73%, 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:Treat pharmaceutical composition of protrusion of lumber intervertebral disc and preparation method thereof
Treat protrusion of lumber intervertebral disc pharmaceutical composition bulk drug composition and weight portion be:Alpha, beta-lonone 23.5g 10000 years Moss 360g trifid sopubia herb 470g protocevine 19g morroniside 14g cycloartanols 3g;
Preparation method:
(1)Alpha, beta-lonone, 10000 years moss, trifid sopubia herb, protocevine, morroniside, cycloartanols are taken by bulk drug proportioning, Mix, with the ethanol of weight percent concentration 33.5% as solvent, taken in 31.5 DEG C of temperature extractions, extraction time is 7 times, is carried every time The time is taken for 47 hours, each solvent load is 43 times of bulk drug gross weight, and filtration obtains dregs of a decoction A and extract solution A, extract solution A Ethanol is reclaimed, relative density 1.11 is concentrated into, filtered, liquid is first washed with water, then use by CAD-45 large pore resin absorption columns The ethanol solution of weight percent concentration 19% elutes CAD-45 large pore resin absorption columns, collects the ethanol of weight percent concentration 19% and washes De- liquid, reclaims ethanol, and concentrate drying obtains final product extract A;
(2)Take step(1)Dregs of a decoction A, with the ethanol of weight percent concentration 64% as solvent, heating and refluxing extraction 24 times is carried every time The time is taken for 0.3 hour, each solvent load is 56 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 1.03 is concentrated into, filtered, liquid is first washed with water, then use weight by H107 large pore resin absorption columns The ethanol solution of percent concentration 73% elutes H107 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 73%, 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:Treat pharmaceutical composition of protrusion of lumber intervertebral disc and preparation method thereof
Treat protrusion of lumber intervertebral disc pharmaceutical composition bulk drug composition and weight portion be:Alpha, beta-lonone 24.5g 10000 years Moss 356g trifid sopubia herb 475g protocevine 18g morroniside 16g cycloartanols 1g;
Preparation method:
(1)Alpha, beta-lonone, 10000 years moss, trifid sopubia herb, protocevine, morroniside, cycloartanols are taken by bulk drug proportioning, Mix, with the ethanol of weight percent concentration 33.5% as solvent, taken in 31.5 DEG C of temperature extractions, extraction time is 7 times, is carried every time The time is taken for 47 hours, each solvent load is 43 times of bulk drug gross weight, and filtration obtains dregs of a decoction A and extract solution A, extract solution A Ethanol is reclaimed, relative density 1.11 is concentrated into, filtered, liquid is first washed with water, then use by CAD-45 large pore resin absorption columns The ethanol solution of weight percent concentration 19% elutes CAD-45 large pore resin absorption columns, collects the ethanol of weight percent concentration 19% and washes De- liquid, reclaims ethanol, and concentrate drying obtains final product extract A;
(2)Take step(1)Dregs of a decoction A, with the ethanol of weight percent concentration 64% as solvent, heating and refluxing extraction 24 times is carried every time The time is taken for 0.3 hour, each solvent load is 56 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 1.03 is concentrated into, filtered, liquid is first washed with water, then use weight by H107 large pore resin absorption columns The ethanol solution of percent concentration 73% elutes H107 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 73%, 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
The pharmaceutical composition 63g of Example 1, adds starch 77g, mixes, and granulation is dried, plus microcrystalline cellulose 50g, stearic acid Magnesium 3g, mixes, and is pressed into 500, obtains final product medicinal composition tablets.
Embodiment 5:The preparation of capsule
The pharmaceutical composition 73g of Example 2, adds starch 84g, mixes, and granulation is dried, whole grain, adds appropriate magnesium stearate, Mix, encapsulated 250, obtain final product medicament composition capsule.
Embodiment 6:The preparation of dripping pill
Weigh (80 DEG C) heating of Macrogol 6000 300g water-baths and boil molten, add the pharmaceutical composition 9.5g of embodiment 3, fully stir Mix uniform, with atoleine as cooling agent, put glass tube(4*80cm)In, chilling temperature is -4 DEG C, and drip internal-and external diameter is 7.0/ 2.0 (mm/mm), drip is 2.4cm away from liquid level, and drop speed is optimum condition with every point 49 drop, and the cold of dripping pill surface is blotted with cotton Solidifying agent, obtains final product medicament composition dropping pills.
Embodiment 7:Treat the pharmaceutical composition of protrusion of lumber intervertebral disc
Treat protrusion of lumber intervertebral disc pharmaceutical composition bulk drug composition and weight portion be:
The weight portion of 84 weight portion cycloartanol of alpha, beta-lonone 20 weight portion protocevine, 50 weight portion morroniside 15.
Embodiment 8:Treat the pharmaceutical composition of protrusion of lumber intervertebral disc
Treat protrusion of lumber intervertebral disc pharmaceutical composition bulk drug composition and weight portion be:
The weight portion of 35 weight portion cycloartanol of alpha, beta-lonone 40 weight portion protocevine, 20 weight portion morroniside 10.
Embodiment 9:Treat the pharmaceutical composition of protrusion of lumber intervertebral disc
Treat protrusion of lumber intervertebral disc pharmaceutical composition bulk drug composition and weight portion be:
The weight portion of 50 weight portion cycloartanol of alpha, beta-lonone 28 weight portion protocevine, 60 weight portion morroniside 20.
Experimental example 1:Treat the experimental study of protrusion of lumber intervertebral disc
1 data and method
1. 1 physical data
According to entering group treatment time sequencing by this city hospital 52 protrusion of lumber intervertebral disc of November -2014 years in June, 2013 Disease patient is divided into control group and seminar, every group 26.Meet People's Republic of China's traditional Chinese medicine industry standard Chinese medical disease Standardization of diagnosis and curative effect.There is chronic strain or waist wound or diseases caused by dampness history of catching cold in patient;Some patientss exist chronic in premorbid Pain in the back medical history, is apt to occur in Young crowd;Scoliosis and the disappearance of waist physiology radians;There is tenderness by diseased region vertebra, And radiated to lower limb etc..Checked through CT or magnetic resonance imaging (MRI) and made a definite diagnosis.Seminar man 13, female 13;Age 26-65 Sui, average age (52.3 ± 3.2) year;Course of disease 0.3-2.0, average course of disease (1.4 ± 0.5) year.Control group man 13 Example, female 13;Age 27-63 Sui, average age (50.2 ± 1.7) year;Course of disease 0.5-2.0, average course of disease (1.4 ± 0.2) year.Two groups of patient's physical data compare, no significant difference (P>0.05), with comparativity.
1. 2 method
Control group gives acupuncture and moxibustion therapy;In choosing Dachangshu and shen shu and Huantiao and bl, Zusanli, chengshan, committee, Yang Ling Spring, Xuanzhong acupuncture point.Dorsal position at patient, sterilizes around selected acupuncture point, and selects the acupuncture acupuncture of suitable length, so Uniform reinforcing-reducing method is used afterwards, acupuncture point is sticked a needle into until bringing about the desired sensation, and then carries slotting twisted again, let the acupuncture needle remain at a certain point 20min, every 10 minutes The hand-manipulating of needle 1 time.Seminar is treated using pharmaceutical composition (pharmaceutical composition of embodiment 1), 0.6g/ times, 3 times/d.Two groups Patient treats 20 d.
1. 3 observation index
Two groups are treated observation and treatment effect and adverse reaction after 20 d.
1. 4 the standard of curative effect evaluation
Its clinical efficacy is evaluated according to patient clinical symptom and sign.Cure:After treatment, patient's pain in waist and lower extremities is wholly absent, Straight-leg raising test>70 °, and resume work;Effectively:After treatment, patient's pain in waist and lower extremities substantially mitigates, and waist movable function is bright It is aobvious to improve;It is invalid:Patient treats pain and waist movable function without improvement, or even aggravates.Total effective rate=(cure+effectively)/ Total number of cases × 100%.
1. 5 statistical method
Statistical analysis is carried out to data using SPSS18.0 statistics softwares.Measurement data is with mean ± standard deviation (x ± s) table Show, checked using t;Enumeration data is represented with rate (%), using Chi-square Test.P<There is 0.05 expression difference statistics to anticipate Justice.
2 results
After treating 20 d, seminar cures 15, effective 9, invalid 2;Control group cures 6, effective 13 Example, invalid 7.Seminar's cure rate is 57.69% apparently higher than the 23.08% of control group, the statistically significant (P of difference< 0.05).Seminar's total effective rate is 92.31% to compare with the 73.08% of control group, the statistically significant (P of difference<0.05). During treatment, there is no adverse reaction in two groups of patients.

Claims (8)

1. a kind of pharmaceutical composition for treating protrusion of lumber intervertebral disc, it is characterised in that be made the group of the bulk drug of the pharmaceutical composition It is into weight portion:
10000 years moss 356-360 weight portion trifid sopubia herb 470-475 weight portion black false hellebores of alpha, beta-lonone 23.5-24.5 weight portions Cevine 18-19 weight portion morroniside 14-16 weight portion cycloartanol 1-3 weight portions.
2. a kind of pharmaceutical composition for treating protrusion of lumber intervertebral disc according to claim 1, it is characterised in that be made the medicine The composition and weight portion of the bulk drug of composition be:
24 weight portion of alpha, beta-lonone, 10000 years weight portions of 358 weight portion trifid sopubia herb of moss, 472 weight portion protocevine 18.5 The weight portion of 15 weight portion cycloartanol of morroniside 2.
3. a kind of pharmaceutical composition for treating protrusion of lumber intervertebral disc according to claim 1, it is characterised in that pharmaceutical composition Piece agent or capsule or dripping pill can be prepared using the conventional method of galenic pharmacy.
4. a kind of pharmaceutical composition for treating protrusion of lumber intervertebral disc according to claim 1, it is characterised in that pharmaceutical composition The treatment protrusion of lumber intervertebral disc medicine constituted with chemical drugs or Chinese medicine.
5. a kind of preparation method of the pharmaceutical composition for treating protrusion of lumber intervertebral disc, it is characterised in that prepare as follows:
The composition and weight portion of bulk drug be:10000 years moss 356-360 weight portions of alpha, beta-lonone 23.5-24.5 weight portions are small to be stretched Muscle grass 470-475 weight portion protocevine 18-19 weight portion morroniside 14-16 weight portion cycloartanol 1-3 weight Part;
Preparation method:
(1)Alpha, beta-lonone, 10000 years moss, trifid sopubia herb, protocevine, morroniside, cycloartanols are taken by bulk drug proportioning, Mix, with the ethanol of weight percent concentration 33.5% as solvent, taken in 31.5 DEG C of temperature extractions, extraction time is 7 times, is carried every time The time is taken for 47 hours, each solvent load is 43 times of bulk drug gross weight, and filtration obtains dregs of a decoction A and extract solution A, extract solution A Ethanol is reclaimed, relative density 1.11 is concentrated into, filtered, liquid is first washed with water, then use by CAD-45 large pore resin absorption columns The ethanol solution of weight percent concentration 19% elutes CAD-45 large pore resin absorption columns, collects the ethanol of weight percent concentration 19% and washes De- liquid, reclaims ethanol, and concentrate drying obtains final product extract A;
(2)Take step(1)Dregs of a decoction A, with the ethanol of weight percent concentration 64% as solvent, heating and refluxing extraction 24 times is carried every time The time is taken for 0.3 hour, each solvent load is 56 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 1.03 is concentrated into, filtered, liquid is first washed with water, then use weight by H107 large pore resin absorption columns The ethanol solution of percent concentration 73% elutes H107 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 73%, 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. a kind of preparation method of the pharmaceutical composition for treating protrusion of lumber intervertebral disc according to claim 5, it is characterised in that Prepare as follows:
The composition and weight portion of bulk drug be:24 weight portion of alpha, beta-lonone, the 10000 years weight of 358 weight portion trifid sopubia herb of moss 472 The weight portion of 15 weight portion cycloartanol of part 18.5 weight portion morroniside of protocevine 2;
Preparation method:
(1)Alpha, beta-lonone, 10000 years moss, trifid sopubia herb, protocevine, morroniside, cycloartanols are taken by bulk drug proportioning, Mix, with the ethanol of weight percent concentration 33.5% as solvent, taken in 31.5 DEG C of temperature extractions, extraction time is 7 times, is carried every time The time is taken for 47 hours, each solvent load is 43 times of bulk drug gross weight, and filtration obtains dregs of a decoction A and extract solution A, extract solution A Ethanol is reclaimed, relative density 1.11 is concentrated into, filtered, liquid is first washed with water, then use by CAD-45 large pore resin absorption columns The ethanol solution of weight percent concentration 19% elutes CAD-45 large pore resin absorption columns, collects the ethanol of weight percent concentration 19% and washes De- liquid, reclaims ethanol, and concentrate drying obtains final product extract A;
(2)Take step(1)Dregs of a decoction A, with the ethanol of weight percent concentration 64% as solvent, heating and refluxing extraction 24 times is carried every time The time is taken for 0.3 hour, each solvent load is 56 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 1.03 is concentrated into, filtered, liquid is first washed with water, then use weight by H107 large pore resin absorption columns The ethanol solution of percent concentration 73% elutes H107 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 73%, 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. a kind of preparation method of the pharmaceutical composition for treating protrusion of lumber intervertebral disc according to claim 5, it is characterised in that Pharmaceutical composition 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 protrusion of lumber intervertebral disc according to claim 5, it is characterised in that Pharmaceutical composition and chemical drugs or Chinese medicine composition treatment protrusion of lumber intervertebral disc medicine.
CN201611133017.XA 2016-12-10 2016-12-10 It is a kind of to treat pharmaceutical composition of protrusion of lumber intervertebral disc and preparation method thereof Withdrawn CN106728299A (en)

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