CN101940585B - Composition with orientin-2' -O-beta-L-galactoside as main component and application thereof - Google Patents
Composition with orientin-2' -O-beta-L-galactoside as main component and application thereof Download PDFInfo
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- CN101940585B CN101940585B CN201010262115XA CN201010262115A CN101940585B CN 101940585 B CN101940585 B CN 101940585B CN 201010262115X A CN201010262115X A CN 201010262115XA CN 201010262115 A CN201010262115 A CN 201010262115A CN 101940585 B CN101940585 B CN 101940585B
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- orientin
- galactoside
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Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
The invention discloses a composition with orientin-2' -O-beta-L-galactoside as a main component, which is extracted and prepared from dried flowers of globeflower (Trolilus chinensis Bunge), trollflower (Trolilus ledebour Reichb.) and trollflower (Trolilus macrophyllus Fr.Schmidt) of globeflower plants of Ranunculaceae, and pharmacological tests prove that the composition has the effects of preventing and treating prostatitis, prostatic hyperplasia and the like. The composition has new application in preparing medicine for preventing and treating prostate diseases. The pharmaceutical preparation of the composition is described, and can be any one of tablets, capsules, pills, granules, suspensions, dripping pills, ointments and rectal administration preparations of suppositories.
Description
Technical field
The invention relates to orientin-2 application of " O-β-L-galactoside is the new medical use of the compositions of main component; mainly contain orientin-2 specifically " compositions of O-β-L-galactoside in preparation prostatosis medicine; Also relate to the pharmaceutical preparation of this medicine, the invention belongs to medical technical field.
Background technology
In recent years, prostatosis is rising and rejuvenation trend, and prostatic hyperplasia and prostatitis are the common diseases of male prostate.Prostatic hyperplasia is one of common disease of male elderly patients.Along with the increase at age, the menfolk more or less has the phenomenon of prostatic hyperplasia to take place.After there are some researches show that prostatic hyperplasia started from 40 years old, see but the old people more than 60 years old more more.The cardinal symptom of prostatic hyperplasia has dysuria, and the lighter's urine increased frequency of getting up at night has urine retention or urinated the back to also have a small amount of phenomenon of discharging; It is thin that the urine rheology appears in severe patient, even the phenomenon of can not arranging; Together often with symptoms such as soreness of waist lumbago, myasthenia of limbs, seminal emissions.The necessary surgical removal of prostatic hyperplasia severe patient, general conservative treatment comprises hand massage, effect is all not too satisfied.Prostatitis divides acute and chronic two kinds.Acute prostatitis is a cardinal symptom with irritation sign of bladder and terminal hematuria, perineal position pain, but clinical more rare.Chronic prostatitis is dripped urine with delayed urination, urine back, or oozes white prostatic fluid, or causes that seminal emission, sexual impotence, premature ejaculation etc. are cardinal symptom.Chronic prostatitis is a kind of common and multiple urology department illness, and according to statistics, male 30-40% suffers from various degree chronic prostatitis (the Jiangsu traditional Chinese medical science, 2000 more than 35 years old; (2): 43), the primary disease reason is complicated, and symptom is various; Course of disease delay, obstinate difficult healing has a strong impact on the physical and mental health of adult male; Therefore, treat medicine for prostate disease safely and effectively for one, the chronic prostate patient is needed just.
Flos Trollii is claimed " nasturtium ", " golden Hibisci Mutabilis ", " globe-flower ", " golden pimple " etc. again, is the dried floral of ranunculaceae plant Flos Trollii (Trollius chinensis Bunge).Totally 25 kinds of Flos Trollii platymisciums, medicinal gold Flos Nelumbinis have Flos Trollii asiatici (Trollius asiaticusL.) and short lobe Flos Trollii (Trollius ledebouri Reichb.) and longpetal globeflower flower (TroUius macropetalus Fr.Schmidt).The Flos Trollii beginning is stated from Qing Dynasty's supplementary Amplifications of the Compendium of Materia Medica that ZHAO Xue-Min is shown.In addition, all on the books in the books such as " groupoid side's spectrum ", " Zhiwu Mingshi Tukao ".Call its " bitter in the mouth, cold in nature, nontoxic " in the supplementary Amplifications of the Compendium of Materia Medica, can " it is swollen to control aphtha, larynx, the superficial heat gingival atrophy, ear is painful, ophthalmalgia ", the effect of " make eye bright, separate the haze miasma " had.The aboundresources of Flos Trollii has antibiotic, antivirus action, is widely used in treatment respiratory tract and intestinal infection etc. (contemporary Chinese Chinese medicine, 2007 9 volume 3 phase 29-32 pages or leaves).It is a big characteristic that Flos Trollii mainly contains carbon glycosides flavone, at the existing report of research in the past.Reports such as Zhao Yimin extract chromocor compound with organic reagent and are used for diseases (CN1872084) such as rheumatic arthritis or rheumatoid arthritis; High spring equality report, Flos Trollii prepares Chinese globe flower injection (CN1876031) with water decoction-alcohol sedimentation, the isolating method of macroporous resin; Cai Jinna etc. have reported the method for preparing (CN101234147) of total flavones of tropaeolum for injections, are with water extraction or ethanol extraction, concentrate, and separate through macroporous resin, polyamide then; Reports such as Fan Guorong will be lacked the lobe Flos Trollii and used ethanol extraction, concentrate, and concentrated solution is crossed macroporous adsorbent resin, uses ethanol elution, with high-speed countercurrent chromatography (HSCCC) and preparative liquid chromatography purification, obtains highly purified orientin, apigenin-8-C-glucoside (CN1660864); Yang Yaxin etc. have reported that Flos Trollii uses 70% ethanol extraction, use n-butanol extraction, then with SephadexLH one 20 posts separate orientin-2 " (Heilungkiang medicine; 2006; 19 (2) 93-94), but does not have clear and definite pharmacodynamics report for O-β-L-galactoside, orientin.The application (CN 1230160C) of report such as Zhang Ying Folium Bambusae total flavones in preparation prostatosis control medicine; Wherein the general flavone content of report counts 50% with rutin; Wherein do not contain orientin-2 in the total flavones " O-β-L-galactoside; and our experimentation proves, " O-β-L-galactoside is the effect that the compositions of main component has control row gland disease, has the difference of very big progress and essence with orientin-2.Up to the present also there be not the research and the application of bibliographical information with orientin-2 " O-β-L-galactoside 30%～65%, orientin 5%～30%, apigenin-8-C-glucoside 2%～10% and orientin-2 "-composition for preventing and controlling prostatosis that O-β-galactoside 1%～6% is formed.We are on the basis of searching document and patent, to orientin-2 " O-β-L-galactoside be main component compositions carried out antibiotic, antiinflammatory, resistance prostatitis, anti-prostatic hyperplasia experiment, prove to have good pharmacological action.
Had report can treat prostatosis be mainly compound Chinese medicinal preparation and chemical drugs.Antibiotic is the most frequently used in the chemical drugs, and administration time is long, and chronic prostatitis is stopped using, and the back is easy recurs, and many clinically at present have certain curative effect with antibiotic and topical therapeutic way of combining, but can not effect a radical cure, and toxic and side effects is big; Alpha-blocking agent also is the main medicine of treatment prostatosis.The compound of Chinese medicine prostatosis mainly contains pills for prostate disease, shenqi pill, YEJUHUA SHUAN, prostatitis return of spring capsule and QIANLIEKANG PIAN etc.Be not used to treat the report of prostatosis so see carbon glycoside flavone component.
Before accomplishing, the present invention finds " O-β-L-galactoside is the report of the compositions of main component as control prostatosis medicine, also finds mainly to contain that " compositions of O-β-L-galactoside is used to prevent and treat the clinicing aspect application of prostatosis to orientin-2 relevant with orientin-2.
Characteristics of the present invention are mainly to contain orientin-2 " compositions of O-β-L-galactoside is to obtain from from the dried floral of Ranunculaceae Flos Trollii platymiscium Flos Trollii (Trollius chinensis Bunge), short lobe Flos Trollii (Trollius ledebouri Reichb.) and longpetal globeflower flower (Trollius macropetalus Fr.Schmidt), extracting; relate in the former inventor's patent of invention of its production technology (patent publication No. is CN101559066); it is to be noted; this patent indication " O-β-L-galactoside is that the compositions of main component can be the product that the above-mentioned patent technology of employing obtains, and also can be further to use technology such as absorption, desorbing, column chromatography, recrystallization and combined method thereof to make with extra care the goods that obtain on this basis with orientin-2.
Orientin-2 " O-β-L-galactoside structural formula
Summary of the invention
" compositions of O-β-L-galactoside, said composition are from Ranunculaceae Flos Trollii platymiscium, to obtain to the purpose of this invention is to provide a kind of orientin-2 that mainly contains; Proved that through further animal experiment research said composition has the effect of control prostatosis.Said composition has the new purposes in the medicine of preparation prostatosis.
Another object of the present invention and characteristics are: provide a kind of plant resources abundant; Containing orientin-2 but industrialization is produced " compositions of O-β-L-galactoside; said composition is characterised in that: orientin-2 " O-β-L-galactoside is 30%～65%, orientin is 5%～30%, apigenin-8-C-glucoside is 2%～10%, orientin-2 "-O-β-galactoside is 1%～6% by weight; have the effect of significantly antibiotic, antiinflammatory, anti-prostatic hyperplasia through evidence, and do not have obvious toxic-side effects; Stable performance can be processed various dosage form; The compositions main component is a carbon glycosides flavone, and carbon glycosides flavone Stability Analysis of Structures is difficult for being degraded; Can go deep into diseased region, directly bring into play drug effect; Hydrophilic strengthens, and dissolution is high, helps the exploitation of medicine." O-β-L-galactoside is the research report of the compositions of main component to prostatic physiology and pharmacologically active, and the application in the control prostatosis also is a main innovate point of the present invention with orientin-2 the carbon glycosides flavone of not finding about from Flos Trollii, extracting before the present invention accomplishes.
The invention also discloses this compositions except that mainly containing orientin-2 " O-β-L-galactoside; also contain orientin-2 " O-β-arabinose, orientin, apigenin-8-C-glucoside etc.; With total flavones of tropaeolum, the Folium Bambusae total flavones of bibliographical information preparation the difference and the tangible technological progress of essence, orientin-2 in the compositions of our preparation are arranged " O-β-L-galactoside be main active its contain 30%～50% in compositions.
" the pharmaceutical preparation of O-β-L-galactoside compositions that another object of the present invention provides and mainly contains orientin-2.Main drug form is tablet, capsule, pill, granule, suspensoid, drop pill, any in injection, ointment, the suppository rectally preparation.
For realizing above-mentioned purpose, the present invention provides following technical solution.
The content of compositions is measured through following method:
1, orientin-2 " O-β-L-galactoside, orientin-2 "-O-β-arabinose, orientin, apigenin-8-C-glucoside utilize high effective liquid chromatography for measuring: be filler with the octadecylsilane chemically bonded silica; With acetonitrile-0.35% phosphate aqueous solution (13: 87) is mobile phase; The detection wavelength is 345nm.Number of theoretical plate is by orientin-2, and " O-β-L-galactoside peak calculates and is not less than 3000.
The preparation of reference substance solution precision respectively takes by weighing orientin-2, and " O-β-arabinose, orientin, apigenin-8-C-glucoside reference substance; put in the volumetric flask are processed the reference substance solution that 1ml contains orientin-2 " O-β-arabinose 0.005mg, orientin-2 "-O-β-L-galactoside 0.04mg, orientin 0.02mg, apigenin-8-C-glucoside 0.01mg with 60% dissolve with methanol.
Compositions 5mg is got in the preparation of need testing solution, and accurate the title decides, and puts in the 50ml measuring bottle, adds 60% methanol 40ml, and ultrasonic 30min is placed to room temperature, and 60% methanol constant volume shakes up to scale, as need testing solution.
Accurate respectively reference substance solution and each the 10 μ l of need testing solution of drawing of assay method inject chromatograph of liquid, measure, and promptly get.
2, total flavones utilizes the ultraviolet colorimetric method for determining in the compositions:
The preparation precision of reference substance solution takes by weighing orientin-2, and " O-β-L-galactoside reference substance processes the reference substance solution of 0.005mg/ml with dissolve with ethanol.
Compositions 5mg is got in the preparation of need testing solution, and accurate the title decides, and puts in the 100ml measuring bottle, adds ethanol 80ml, and ultrasonic 30min is placed to room temperature, and ethanol is settled to scale, shakes up, and precision is measured 1ml, puts in the 10ml measuring bottle, adds ethanol to scale, as need testing solution.
Algoscopy is got reference substance solution, need testing solution, blank respectively.According to spectrophotography (" an appendix V of Chinese pharmacopoeia version in 2005 B), measure trap respectively at wavelength 345nm place, calculate.
Be not less than 60% in orientin-2 " O-β-L-galactoside is that the compositions of main component contains total flavones with orientin-2 "-O-β-L-galactoside.
With orientin-2 " O-β-L-galactoside be main component compositions (hereinafter to be referred as the Flos Trollii flavone composition) (orientin-2 "-O-β-L-galactoside 45%, orientin 18%, apigenin-8-C-glucoside 4%, orientin-2 " O-β-galactoside 1.5%) effect with diseases such as control prostate; these pharmacological actions are confirmed through following pharmacodynamics test example.
1, the antiinflammatory action of Flos Trollii flavone composition
1.1 the influence of Flos Trollii flavone composition xylol induced mice auricle inflammation swelling
Get 50 of mices, male, body weight (20 ± 2) g is divided into 5 groups at random, and according to table 1 gastric infusion, every day 1 time, 7d behind last administration 1h, drips xylene 0.3mL in mouse right ear continuously, and left ear is not coated with does contrast.Behind the 2h mice cervical region dislocation is put to death, lay round auricle at the same position of left and right ear respectively with the card punch of diameter 9mm, weigh, the difference of calculating left and right auricle weight is as the swelling degree, the comparable group differences.The result sees table 1.
The influence of table 1 xylol induced mice auricle inflammation swelling
**P＜0.01，*P＜0.05。Compare with matched group
Visible from table 1, the swelling of the high, medium and low three kinds of dosage xylol induced mice auricle inflammation of Flos Trollii flavone composition all has significant inhibitory effect, shows that they all have significant antiinflammatory action.Equally, after positive control medicine indomethacin is irritated stomach, also has significant antiinflammatory action.
1.2 the Flos Trollii flavone composition is to the swollen influence that forms of rat granuloma
Get 50 of rats, be divided into 5 groups at random by sex and body weight.Insert the sterilized cotton ball of method operating procedure by cotton balls in subcutaneous each heeling-in one (30 ± 1) mg of groin.Postoperative administration on the same day, dosage be with table 2, and 7d puts to death animal in 8d continuously, peels off and take out the cotton balls granulation tissue, weighs after putting 60 ℃ of oven dried 12h, calculates swelling degree and suppression ratio.
Table 2, to the swollen influence that forms of rat granuloma
**P＜0.01，*P＜0.05。Compare with matched group
Visible from table 2, the high, medium and low dosage of Flos Trollii flavone composition has significant inhibitory effect, the significant antiinflammatory action of tool to swollen formation of rat granuloma.Compare with the normal saline matched group, show that granulation hyperplasia property inflammation is had significant antiinflammatory action.Indomethacin also has significant antiinflammatory action to granulation hyperplasia property inflammation.
2, the Flos Trollii flavone composition is to the therapeutical effect of prostatic hyperplasia
2.1 the Flos Trollii flavone composition causes the effect of castrated rats prostatic hyperplasia to androlin
Get 70 of male rats, wherein 10 are cut to sew up behind the scrotum under asepsis and are matched group, and 60 are divided into 6 groups at random at aseptic excision bilateral testes down after one week in addition, press table 3 administration.Every day 1 time, continuous gastric infusion after 14 days (subcutaneous injection androlin 5mg/kg simultaneously), with negative simulating groups relatively, the Flos Trollii flavone composition is high, in weight of prostate, the prostate index of two dose groups rats reduce (P＜0.01) to some extent.It is the strongest that proscar reverses the effect of prostatic hyperplasia.The effect of high dose Flos Trollii flavone composition is close with the QIANLIEKANG effect, but is weaker than the effect of proscar.
The treatment of table 3 pair castrated rats prostatic hyperplasia (n=10, X ± SD)
**P＜0.01，*P＜0.05。Compare with negative control group
2.2 the Flos Trollii flavone composition is to the therapeutical effect of mice prostatic hyperplasia
Get 90 of male mices, stay 10 and make normal control, all the other mices every days is subcutaneous injection androlin 5mg/kg successively; After 21 days, put to death wherein 10 mices, the normal control mice is also put to death equally; Take by weighing body weight and prostate and weigh and do pathology Histological section microscopy, after the confirmation prostate has hypertrophy, remaining mice is divided into seven groups; Every group 10, press the gastric infusion of dosage shown in the table 4.Every day 1 time, matched group and model control group give equal-volume water, continuous 1 month.Weighing mice body weight after the last administration with sacrifice of animal, is cutd open and is got prostate and weigh, and make pathology Histological section microscopy.The result sees table 4.
Table 4 Flos Trollii flavone composition is to the therapeutical effect of experimental mice prostatic hyperplasia (X ± SD)
**P＜0.01，*P＜0.05。Compare with negative control group
The result shows: the injection androlin is after 21 days, and the prostate of mice weighs and obviously shows increase, the obvious hypertrophy of prostate body of gland.Mice with prostatic hyperplasia was taken these article after 1 month, its weight of prostate administration group and model control group is apparent in view alleviates; The prostate index is also significantly less than normal, and microscopy treatment group prostatic hyperplasia degree obviously alleviates than matched group, is close to normal.Body weight no significant difference to mice.
3, the Flos Trollii flavone composition is to the therapeutical effect of zoopery property nonbacterial prostatitis
3.1 Flos Trollii flavone composition on Carrageenan causes the prostatitic influence of mice
Get 60 of male mices, be divided into 6 groups at random, press gastric infusion every day of dosage shown in the table 5 once, administration is 14 days altogether; Under the asepsis, hypogastric region cut, and was injecting 1% carrageenin 0.1ml near the seminal vesicle of prostate head lobe with 3% pentobarbital sodium intraperitoneal anesthesia in the 15th day; The normal control group is injected the sodium chloride 0.1ml of injection 0.9%, sews up the back and is being administered once, execution mice on the 16th; Remove the 10ul prostatic fluid with miniature injector, the note leukocyte count, the result sees table 5.Take out prostate and fix, carry out histological examination with 10% formalin.
Table 5 Flos Trollii flavone composition on Carrageenan causes the prostatitic influence of mice (n=10, X ± SD)
**P＜0.01。Compare with negative control group
Can find out that from table 5 leukocyte of negative model group significantly increases, each dose groups of Flos Trollii flavone composition and the leukocyte of QIANLIEKANG group significantly reduce.With negative model group significant difference is arranged relatively.
3.2 Flos Trollii flavone composition on Carrageenan causes the scorching influence of rat prostate
Get 60 of male rats, be divided into 6 groups at random, press gastric infusion every day of dosage shown in the table 6 once, administration is 14 days altogether; Under the asepsis, hypogastric region cut, and was injecting 1% carrageenin 0.1ml near the seminal vesicle of prostate head lobe with 3% pentobarbital sodium intraperitoneal anesthesia in the 15th day; The normal control group is injected the sodium chloride 0.1ml of injection 0.9%, sews up the back and is being administered once, execution mice on the 16th; Get the 10ul prostatic fluid with miniature injector, the note leukocyte count, the result sees table 6.Take out prostate and fix, carry out histological examination with 10% formalin.
Table 6 Flos Trollii flavone composition on Carrageenan causes the scorching influence of rat prostate (n=10, X ± SD)
**P＜0.01。Compare with negative control group
Can find out that from table 6 leukocyte of negative model group significantly increases, each dose groups of Flos Trollii flavone composition and the leukocyte of QIANLIEKANG group significantly reduce.With negative model group significant difference is arranged relatively.
Can know to have treatment prostatic hyperplasia and/or prostatitic effect from above pharmacodynamic experiment, compare that its therapeutic effect is superior to QIANLIEKANG, and is suitable with proscar with matched group with the Flos Trollii flavone composition.And take for a long time and be free from side effects.
Abundant with Flos Trollii flavone composition plant origin, low price is not seen toxic and side effects, preparation simple (patent No. CN101559066), and can process oral formulations and non-oral formulation, taking convenience.
The present invention executes example be achieved (confirmation) through following experiment
Embodiment 1, (capsule)
Composition material 100g, medical starch is an amount of, and mix homogeneously is granulated, drying, granulate, the capsule of packing into No. 1 is processed 1000, promptly gets.Each 3, every day 2 times.
Embodiment 2, (tablet)
Composition material 100g, medical starch is an amount of, and dextrin is an amount of, and mix homogeneously is granulated, drying, granulate, drying, the adding lubricant is an amount of, and tabletting is processed 1000, promptly gets.Each 3, every day 2 times.
Embodiment 3, (drop pill)
Take by weighing the 30g Macrogol 4000, in water-bath, melt, add composition material 20g, stir; In the impouring insulating tube, regulate thermostat, medicinal liquid is splashed in the liquid paraffin that cooled off, after dripping off under 80-90 ℃; With blotting liquid paraffin on the pill impouring filter paper, process 1000, promptly get.Each 15, every day 2 times.
Embodiment 4, (granule)
Composition material 150g, Icing Sugar 350g, mix homogeneously is used an amount of alcohol granulation, and drying, granulate, packing are processed 500 bags, promptly get.Each 1 bag, every day 2 times.
Claims (2)
1. one kind by orientin-2, and " O-β-L-galactoside is the application of compositions in the medicine of preparation prostatosis control of main component; wherein said compositions contains orientin-2 by weight percentage " O-β-L-galactoside 30%～65%, orientin 5%～30%, apigenin-8-C-glucoside 2%～10%; " O-β-galactoside 1%～6%, general flavone content is not less than 60% to orientin-2 in the compositions.
It is 2. according to claim 1 with orientin-2 that " O-β-L-galactoside is the application of compositions in preparation prostatosis control medicine of main component, it is characterized in that said prostatosis is prostatitis and prostatic hyperplasia.
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