CN101040977A - Medicine for treating prostate disease and method for preparing same - Google Patents
Medicine for treating prostate disease and method for preparing same Download PDFInfo
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- CN101040977A CN101040977A CN 200710090884 CN200710090884A CN101040977A CN 101040977 A CN101040977 A CN 101040977A CN 200710090884 CN200710090884 CN 200710090884 CN 200710090884 A CN200710090884 A CN 200710090884A CN 101040977 A CN101040977 A CN 101040977A
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Abstract
The invention provides a pharmaceutical composition for treating prostate gland diseases, which comprises Sabalberry extract and Egchinacea L. plant extract by a weight ratio of 1-5:1 as the active constituents. The invention also provides the preparation containing the pharmaceutical composition, the method for preparation and the use of the pharmaceutical composition.
Description
Technical field
The present invention relates to field of medicaments, specifically disclosing a kind of saw palmetto berry extract, genus echinacea plant extract is the compositions of active component preparation.
Technical background
(Chronic Prostatitis CP) is the high disease of a kind of sickness rate to chronic prostatitis, and nearly 50% man is in its influence that can run into the prostatitis symptom sometime in life.The cause of disease of chronic prostatitis, pathological change, clinical symptoms complexity are various, and (ED) has considerable influence to male erectile dysfunction, mainly shows: sexual hypofunction such as sex time are short, premature ejaculation, and to be subjected to inflammatory stimulus relevant with prostate for this.47.8% the CP patient that Screponi etc. investigation is found is with serious premature ejaculation, and suggestion premature ejaculation patient conscientiously checked prostatic situation before doing any treatment; CP shows the influence of male sterility: the sperm of discharging from testis, epididymis must be through refining nutrition, pass on, and just have and the bonded ability of ovum, and the main component of refining is a prostatic fluid.CP patient's seminal fluid routine shows as that motility of sperm is low, mortality rate is high.
Prostatic hyperplasia is to change the result that female, the androgen level that produce change comprehensive function because of the age.Intravital 5-AR enzyme can be converted into testosterone dihydrotestosterone (DHT), and conversion rate is directly proportional with the age, and DHT can stimulate the prostatic cell undue growth.On the other hand, too much estrogen can reduce the ability that body is removed DHT, further promotes prostatic hypertrophy.Prostatic hyperplasia is more common in elderly men, and its sickness rate increases with age growth, and most of male can learn the hypertrophy of meaning in a organized way after 60 years old, and clinical symptoms can appear in nearly 1/4 people.
Saw palmetto berry (Saw Palmetto) originates in the U.S. southeast and basin, middle part, is thought a kind of energetic medicine and can treat reproduction-diseases of urinary system such as benign prostatic hyperplasia by native American.These product of the second half in 19th century once came across among USP and the NF.The sixties,, people are become interested to its clinical practice by research to its chemical constitution.A large amount of clinical experiments of saw palmetto berry extract confirm the improvement effect to prostatic hyperplasia, and curative effect is better than existing medicine finasteride (Finasteride) or Poly is controlled (Proscar), and side effect is not obvious.Saw palmetto berry is the inhibitor of 5-AR enzyme, and therefore DHT makes DHT remove and be more prone to by transhipment or in conjunction with the weak inhibitor that plays a role again; On the other hand, saw palmetto berry extract contains estrogenic cupreol, competes receptor and blocks progesterone and the biosynthesis of androgen receptor with endogenous estrogen.
American-European developed country just is used for the treatment of various deficiency disorders, especially genitourinary system with saw palmetto berry and preparation thereof in 20 beginnings of the century.Chronic prostatitis and benign prostate hyperplasia clinical symptoms all attenuate with frequent micturition, dysuria, urine line, and range shortening etc. because of can not separating urine urine retention take place when serious; Night, frequent micturition was the symptom that is prone to most.External vast amount of clinical facts have proved that saw palmetto berry and preparation can significantly improve above-mentioned symptom and have no side effect, and patient has good compliance; It is present rare preferable medicine.
Narrow leaf Folium Rudbeckiae Laciniatae Echinacea angustifolia is a Compositae genus echinacea Echinacea plant.Originate in America, genus echinacea plant (hereinafter to be referred as Echinacea) is used existing history of more than one thousand years as medicinal plants abroad.The E.angustifolia preparation is subjected to generally paying attention in American-European countries just day by day, is one of the most promising immunostimulant and regulator.
Narrow leaf Folium Rudbeckiae Laciniatae contains the immune material of a large amount of influences, and by to the T lymphocyte, the stimulation of macrophage can strengthen the immunocompetence of human body, and the protection body is avoided infecting and the invasion and attack of virus; Narrow leaf Folium Rudbeckiae Laciniatae also contains the material to the immune system nonspecific action, as the inulin that is rich in the narrow leaf golden light Radix Chrysanthemi can activating immune system a part of auxiliary channel, its result is the movable enhancing of infected zone leukocyte, the immune complex dissolving, antibacterial, virus and other microorganisms are suppressed or kill.
Echinacea Echinacea Purpurea is a Compositae genus echinacea Echinacea plant, is at present in American-European countries's growing and cultivation kind the most widely.Echinacea is as the traditional plant preparation, use longly, 18 beginning of the century Flat heads just bring into use Echinacea, and 19th century, the North America immigrant also was extensive use of, gradually reach Europe, as the plant amedica commonly used for the treatment of upper respiratory tract infection and worm venom, herpes, measles etc. thereafter.Echinacea contains the material that can influence immunocompetence in a large number, is widely used in the world a kind of immunopotentiating agent and regulator.
Normal (the MADAUS AG of the big medicine of Germany doctor Ma, Germany) produce a kind of medical herbs compound preparation, the said preparation commodity are called Urgenin (Urgenin), be that (every contains saw palmetto berry extract 25mg, narrow leaf Folium Rudbeckiae Laciniatae extract 30mg by saw palmetto berry (serenoaserrulate) extract and Echinacea angustifolia (Echinacea angustifolia) extract, the ratio that is saw palmetto berry extract and narrow leaf Folium Rudbeckiae Laciniatae extract is 0.83: 1) form, be mainly used in the treatment of prostatic hyperplasia and chronic prostatitis.
Summary of the invention
Technical scheme of the present invention has provided a kind of saw palmetto berry extract and the genus echinacea plant extract is the pharmaceutical composition of active component.Another technical scheme of the present invention has provided this preparation of drug combination method and purposes, and the preparation that contains this pharmaceutical composition.
The invention provides a kind of pharmaceutical composition, it contains weight proportion is 1～5: 1 saw palmetto berry extract and genus echinacea plant extract.
Wherein, described saw palmetto berry extract is 60%～75% ethanol extraction; Described genus echinacea plant extract is 75%～90% ethanol extraction.
Further preferably, it is that 1～5: 1 saw palmetto berry extract and genus echinacea plant extract are formed by weight proportion.Still more preferably, the weight proportion of described saw palmetto berry extract and genus echinacea plant extract is: 1～3: 1.
Further preferably, the weight proportion of described saw palmetto berry extract and genus echinacea plant extract is: 1.5: 1,1.83: 1,2: 1.
Wherein, described saw palmetto berry is the dry fruit of Serenoa repens Serenoa repens; Genus echinacea (Echinacea) plant originates in America, and 9 kinds are arranged: narrow leaf Folium Rudbeckiae Laciniatae (E.angustifolia), black purple Folium Rudbeckiae Laciniatae (E.atrorubens), sliding leaf Folium Rudbeckiae Laciniatae (E.laevigata), white Echinacea (E.pallida.), strange shape Echinacea (E.paradoxa), Echinacea (E.purpurea), color Echinacea (E.sanguinea), mimic colouration Echinacea (E.simulata) and special Buddhist nun's Echinacea (E.tennesseensis).Three kind of plant wherein: narrow leaf Folium Rudbeckiae Laciniatae (E.angustifolia), Echinacea (E.Purpurea), white Echinacea (E.pallida) are used for health-care products and medicine, genus echinacea plant of the present invention is the dry product of this three kind of plant, and has similar drug effect.([1] McKeown, K.A.1999.A review of the taxonomy of the genus Echinacea.In:J.Janick (ed), Perspectives on new crops and new uses.ASHS Press, Alexandria, VA:.482-489..[2] Zhang Ying, Liu Ke, my upright army, genus echinacea medicinal plants study progress, Chinese herbal medicine [J], 2001,32 (9): 852-855)
The present invention also provides a kind of method of pharmaceutical compositions, and it comprises the following steps:
A, get an amount of saw palmetto berry, pulverize, with 60%～75% alcohol reflux, reclaim alcoholic solution, extractum adds the suitable quantity of water dilution, 2～8 ℃ of cold preservations, and separating oil extract layer and water layer are preserved oily extract layer, must saw palmetto berry extract;
B, get the genus echinacea plant, pulverize, extract with 75%～90% alcohol reflux solution, reclaiming alcoholic solution to extractum density is 1.02-1.12 (50 ℃), must the genus echinacea plant extract;
The genus echinacea plant extract of c, the saw palmetto berry extract of getting a step and b step is mixed in proportion, and gets pharmaceutical composition of the present invention.
" pharmaceutical composition " of the present invention is the compatible combination of raw extract (saw palmetto berry extract, genus echinacea plant extract), this combination can be formed directly in product, also can be used as semi-finished product, add acceptable accessories or complementary composition, prepare and conventional preparation.
The invention provides a kind of pharmaceutical preparation, it is to be active component by described pharmaceutical composition, adds the medicament that acceptable accessories or complementary composition are prepared from.
Wherein, described preparation is capsule, granule, tablet, powder, pill, oral liquid, syrup.
Wherein, the preparation method of described tablet is: saw palmetto berry extract, genus echinacea plant extract are mixed, add adjuvant, cross 80 mesh sieves, mixing adds 10% polyvinylpyrrolidone, 65% alcoholic solution, makes soft material, crossing 22 mesh sieves granulates, 60 ℃ of dryings, 22 mesh sieve granulate add 0.5% magnesium stearate, mixing, compacting are in flakes.
The invention provides the purposes of this pharmaceutical composition in the medicine of preparation treatment prostatosis.Further preferably, described medicine is that the treatment chronic prostatitis syndrome is or/and the medicine of benign prostatic hyperplasia.
The present invention is through great deal of experimental, discloses a kind of saw palmetto berry serenoaserrulate extract, genus echinacea plant Echinacea extract is the compositions of active component compatibility.Pharmaceutical composition of the present invention, the active component proportioning is suitable, has significantly improved the therapeutic effect of saw palmetto berry and genus echinacea plant extract combination results; Under the proportioning of two kinds of active component of medicine of the present invention, produced the effect of Synergistic, realized taking the compositions Urgenin that is better than Isodose evident in efficacy of Isodose, take the low dose group compound curative effect advantage suitable with existing Urgenin, be pharmaceutical composition of the present invention in disclosed dose-effect relationship scope, obviously be better than Urgenin.With pharmaceutical composition of the present invention is active component, adds adjuvant and is prepared from preparation pharmaceutically commonly used, has low-consuming, the evident in efficacy characteristics of raw material.Because of domestic narrow leaf Folium Rudbeckiae Laciniatae of plant and the Echinacea of not producing saw palmetto berry and genus echinacea, raw material all is derived from import; Utilize this method can when guaranteeing curative effect, save the consumption of saw palmetto berry and narrow leaf Folium Rudbeckiae Laciniatae, the former plant of Echinacea in a large number, reduce the import of raw material, can save foreign exchange for country.On the other hand, because of the consumption to former plant in leaching process reduces, reduced discharging wastes, thereby can alleviate pollution environment.
Obviously, according to foregoing of the present invention,, under the prerequisite that does not break away from the above-mentioned basic thought of the present invention, can also make modification, replacement and the change of other various ways according to the ordinary skill and the use means of this area.
The specific embodiment of form is described in further detail foregoing of the present invention by the following examples.But this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following example.All technology that realizes based on foregoing of the present invention all belong to scope of the present invention.
The specific embodiment
The preparation of embodiment 1 saw palmetto berry extract, narrow leaf Folium Rudbeckiae Laciniatae extract
1. it is an amount of to get saw palmetto berry, and coarse crushing adds 75% soak with ethanol 1 hour, adds 8 times of amount 75% ethanol, and heating and refluxing extraction 1.5 hours filters; Filtering residue adds 6 times of 75% ethanol, extracts 1 hour, filter, and merging filtrate, decompression recycling ethanol (50-60 ℃, vacuum＜-0.07Mpa).The extractum thin up stirs, and in 4 ℃ of cold preservations, filters, and separates oil reservoir and water layer, keeps oil reservoir, gets saw palmetto berry extract, and 50-60 ℃ of insulation heat fused preserved.
2. it is an amount of to get narrow leaf Folium Rudbeckiae Laciniatae, pulverizes, and adds 8 times of amount 75% alcoholic solution, heating and refluxing extraction 1 hour, filter, filtering residue adds 6 times of amount 75% alcoholic solution and extracted 1 hour, filters, merge filtrate twice, the extracting solution decompression recycling ethanol (50-60 ℃, vacuum＜-0.07Mpa) to the extractum relative density be 1.06-1.08 (50 ℃), narrow leaf Folium Rudbeckiae Laciniatae extract, drying under reduced pressure is pulverized, and preserves.
The preparation of embodiment 2 saw palmetto berry extracts, Echinacea extract
1. it is an amount of to get saw palmetto berry, and coarse crushing adds 65% soak with ethanol 1 hour, adds 8 times of amount 65% ethanol, and heating and refluxing extraction 1.5 hours filters; Filtering residue adds 6 times of 65% ethanol, extracts 1 hour, filter, and merging filtrate, decompression recycling ethanol (50-60 ℃, vacuum＜-0.07Mpa).The extractum thin up stirs, and in 4 ℃ of cold preservations, filters, and separates oil reservoir and water layer, keeps oil reservoir, gets saw palmetto berry extract, and 50-60 ℃ of insulation heat fused preserved.
2. it is an amount of to get Echinacea, pulverize, add 8 times of amount 80% alcoholic solution, heating and refluxing extraction 1 hour filters, filtering residue adds 6 times of amount 80% alcoholic solution and extracted 1 hour, filter, merge filtrate twice, (50-60 ℃ of extracting solution decompression recycling ethanol, vacuum＜-0.07Mpa) to the extractum relative density be 1.06-1.08 (50 ℃), Echinacea extract.Drying under reduced pressure is pulverized, and preserves.
The preparation of embodiment 3 saw palmetto berry extracts, Echinacea extract
1. it is an amount of to get saw palmetto berry, and coarse crushing adds 60% soak with ethanol 1 hour, adds 8 times of amount 65% ethanol, and heating and refluxing extraction 1.5 hours filters; Filtering residue adds 6 times of 60% ethanol, extracts 1 hour, filter, and merging filtrate, decompression recycling ethanol (50-60 ℃, vacuum＜-0.07Mpa).The extractum thin up stirs, and in 4 ℃ of cold preservations, filters, and separates oil reservoir and water layer, keeps oil reservoir, gets saw palmetto berry extract, and 50-60 ℃ of insulation heat fused preserved.
2. it is an amount of to get Echinacea, pulverize, add 10 times of amount 90% alcoholic solution, heating and refluxing extraction 1 hour filters, filtering residue adds 6 times of amount 90% alcoholic solution and extracted 1 hour, filter, merge filtrate twice, (50-60 ℃ of extracting solution decompression recycling ethanol, vacuum＜-0.07Mpa) to the extractum relative density be 1.06-1.08 (50 ℃), Echinacea extract.Drying under reduced pressure is pulverized, and preserves.
Embodiment 4 preparation of drug combination of the present invention
Composition:
Component 1: saw palmetto berry extract (pressing 1. preparation among the embodiment 1) 75g
Component 2: narrow leaf Folium Rudbeckiae Laciniatae extract (pressing 2. preparation among the embodiment 1) 15g
Uniform mixing component 1,2 promptly gets the present composition.
Embodiment 5 preparation of drug combination of the present invention
Composition:
Component 1: saw palmetto berry extract (pressing 1. preparation among the embodiment 1) 55g
Component 2: narrow leaf Folium Rudbeckiae Laciniatae extract (pressing 2. preparation among the embodiment 1) 30g
Uniform mixing component 1,2 promptly gets compositions of the present invention.
Embodiment 6 preparation of drug combination of the present invention
Component 1: saw palmetto berry extract (pressing 1. preparation among the embodiment 1) 18g
Component 2: narrow leaf Folium Rudbeckiae Laciniatae extract (pressing 2. preparation among the embodiment 1) 6g
Uniform mixing component 1,2 promptly gets compositions of the present invention.
Embodiment 7 preparation of drug combination of the present invention
Component 1: saw palmetto berry extract (pressing 1. preparation among the embodiment 2) 30g
Component 2: Echinacea extract (pressing 2. preparation among the embodiment 2) 30g
Uniform mixing component 1,2 promptly gets compositions of the present invention.
Embodiment 8 preparation of drug combination of the present invention
Component 1: saw palmetto berry extract (pressing 1. preparation among the embodiment 2) 60g
Component 2: Echinacea extract (pressing 2. preparation among the embodiment 2) 15g
Uniform mixing component 1,2 promptly gets compositions of the present invention.
Embodiment 9 preparation of drug combination of the present invention
Component 1: saw palmetto berry extract (pressing 1. preparation among the embodiment 3) 30g
Component 2: Echinacea extract (pressing 2. preparation among the embodiment 3) 15g
Uniform mixing component 1,2 promptly gets compositions of the present invention.
Embodiment 10 preparation of drug combination of the present invention
It is an amount of to get Poria, pulverizes, and measures 50% alcoholic solution reflux, extract, 2 times for 6 times, merges 2 times extracting solution, and decompression recycling ethanol promptly gets Poria extract to extractum relative density to 1.05 (50 ℃), and drying under reduced pressure is pulverized, and preserves.
Get saw palmetto berry extract 60mg (pressing 1. preparation among the embodiment 1), narrow leaf Folium Rudbeckiae Laciniatae 12mg (pressing 2. preparation among the embodiment 1) gets Poria extract 10mg, and mix homogeneously gets pharmaceutical composition of the present invention.
Embodiment 11 preparation of drug combination of the present invention
It is an amount of to get Herba Lophatheri, measures 30% alcoholic solution reflux, extract, 2 times for 6 times, merges 2 times extracting solution, and decompression recycling ethanol promptly gets Herba Lophatheri extract to extractum relative density to 1.03, and drying under reduced pressure is pulverized, and preserves.
Get saw palmetto berry extract 60mg (pressing 1. preparation among the embodiment 1), narrow leaf Folium Rudbeckiae Laciniatae 30mg (pressing 2. preparation among the embodiment 1) gets Herba Lophatheri extract 10mg, and mix homogeneously gets pharmaceutical composition of the present invention.
The preparation of embodiment 12 tablets of the present invention
Get the compositions 85g (pressing embodiment 4 preparations) of the embodiment of the invention 4 preparations, add adjuvant, cross 80 mesh sieves, mixing adds 10% polyvinylpyrrolidone, 65% alcoholic solution, adds the about 90g of HPMCLV100, the about 210g of lactose, make soft material, cross 22 mesh sieves and granulate 60 ℃ of dryings, 22 mesh sieve granulate, add 0.5% magnesium stearate, mixing, compacting wrap film-coat promptly in flakes.
The preparation of embodiment 13 capsules of the present invention
Get the compositions 75g (pressing embodiment 7 preparations) of the embodiment of the invention 3 preparations, add adjuvant, cross 90 mesh sieves, mixing, add 10% polyvinylpyrrolidone, 65% alcoholic solution, add starch 160g, microcrystalline Cellulose 40g, make soft material, cross 50 mesh sieves, add magnesium stearate 6g, micropowder silica gel 2g, stir, the dress gum cover gets capsule.
Below prove beneficial effect of the present invention by pharmacodynamics test.
Test example 1 pharmaceutical composition of the present invention to the influence of rat prostate chronic inflammatory disease and with the comparison of Urgenin preparation
1. be subjected to the reagent matter sample: sample is pressed embodiment 5 preparations, faces with preceding with distilled water diluting, processing, to desired concn.
2. Urgenin: 55mg (extract)/sheet is produced lot number: 727474 by Madaus AG.Face with preceding with dissolved in distilled water and be diluted to desired concn.
3. test method
Get 300-350g Wistar rat, under pentobarbital sodium 60mg/kg ip anesthesia, the sterile working, reach the abdominal cavity along median incision of lower abdomen, expose bladder dorsal part prostate (dorsal part leaf), inject 25% xiaozhiling injection 0.2ml modeling respectively, other gets 10 rats and injects 0.2ml sterile distilled water (Sham-operated control group) with method, restores back suture muscles and skin.Perform the operation the 7th day by the body weight random packet: (1) sham operated rats, ig is with the volume distilled water; (2) model group, ig is with the volume distilled water; (3) Urgenin group, 40mg/kg; (4), (5) sample sets dosage is respectively 20.11mg (extract), 40.2mg (extract)/kg, all continuous gastric infusion 21 days, 24 hours execution animals after the last administration, carefully cut open and get each leaf prostate, take by weighing weight in wet base, took by weighing dry weight in 24 hours in 60 ℃ of bakings again, and carry out the prostata tissue morphological examination.
4. test data
Optical microscope is following as seen: matter was not seen inflammatory cell infiltration mostly between the normal prostatic acinus reached, and minority is slightly soaked into, the slight hypertrophy of fibroblast.
After the modeling, prostate body of gland, smooth muscle and fibrous connective tissue are hypertrophy in various degree, in the acinus and in the matter inflammatory cell infiltration that more or less are arranged, simultaneously with epithelial cell that comes off and secretions, and the obvious hypertrophy of fibroblast.Experimental result such as table 1, table 2:
The influence of table 1 pair experimental prostatitis model weight of prostate (X ± S)
| Group | Dosage (mg/kg) | Prostate weight in wet base coefficient | Prostate dry weight coefficient | ||||
| n | Weight (mg/100g body weight) | Suppression ratio (%) | n | Weight (mg/100g body weight) | Suppression ratio (%) | ||
| Sham operated rats model group Urgenin sample sample | - - 40 20.11 40.2 | 10 10 10 10 10 | 35.9±4.5 * 49.7±13.1 38.3±4.8 * 38.8±6.8 * 29.9±6.3 *▲ | - - 22.9 21.9 39.8 | 10 10 10 10 10 | 4.40±1.36 5.30±1.85 4.47±0.83 4.24±0.73 3.37±0.49 *▲ | - - 15.7 20.0 36.4 |
Compare with model group
*P＜0.05; With Urgenin group comparison ▲ p＜0.05
The influence of table 2 pair experimental prostatitis model cell infiltration and fibroblast hyperplasia degree
| Group | Dosage (mg/k g) | n | Cell infiltration | The fibroblast hypertrophy | |||||||
| Severe | Slightly | Substantially normal | Severe | Slightly | Substantially normal | ||||||
| Sham-operation group model group Urgenin sample sample | - - 40 20.11 40.2 | Example number % example number % example number % example number % example number % | 8 100 8 100 8 100 8 100 8 100 | 0 0 7 87.5 2 25 2 25 1 12.5 | 2 25 1 12.5 4 50 4 50 3 37.5 | 6 75 0 0 2 25 2 25 4 50 | ** * * * | 0 0 5 62.5 0 0 0 0 0 0 | 5 62.5 2 25 5 62.5 7 87.5 3 37.5 | 3 37.5 1 12.5 3 37.5 1 12.5 5 62.5 | * * * |
Compare with model group
*P＜0.05
*P＜0.01;
4. result of the test
The prostate that sample can significantly reduce prostate chronic inflammation model rat dried, weight in wet base coefficient, the infiltration of the cell that reduces inflammation and the hypertrophy of fibroblast.
Sample 20.11mg/Kg dosage group is to prostate dry weight, weight in wet base coefficient, suitable with the Urgenin group to inflammatory cell infiltration, the outgrowth action effect of fibroblast, and sample 40.2mg/Kg dosage group is to prostate dry weight, weight in wet base coefficient, increase significantly than Urgenin 40mg/Kg group to cell infiltration, the outgrowth action effect of fibroblast.
Test example 2 pharmaceutical compositions of the present invention to the mouse retention gential sinus implant the property prostatic hyperplasia influence and with the comparison of Urgenin preparation
1. be subjected to the reagent matter sample: sample is pressed embodiment 4 preparation, faces with preceding with distilled water diluting, and processing is to desired concn.
Urgenin: 55mg (extract)/sheet is produced lot number: 727474 by Madaus AG.Face with preceding with dissolved in distilled water and be diluted to desired concn.
2. method
Get the 28-32g male mice in kunming, be divided into (1) sham operated rats: ig at random with the volume distilled water by body weight; (2) model group: ig is with the volume distilled water; (3) Urgenin group: 40mg (extract)/kg; (4) estradiol group: 15ng/ only, secondary weekly, lumbar injection; (5), (6) be two administration groups of sample, dosage is respectively 20.11mg (extract), 40.2mg (extract)/kg, every group of 20-25 animal.Animal is under pentobarbital sodium 60mg/kg ip anesthesia, the sterile working cuts lower abdomen open, careful separation front side siphonal lobe, under anatomical lens, be implanted into the urogenital sinus tissue of 3 16 days gestational age mices of the same race to the abdomen prostate with syringe needle, after confirming on inspection to implant, carefully, prevent to leach, then layer-by-layer suture with prostata disease.Other gets mice, and the abdomen prostate is only visited thorn three times with syringe needle, punctures slightly, as sham operated rats.Performing the operation began administration after three days, and except that the estradiol group, all the other each groups are gastric infusion.In 6 weeks of successive administration, after 24 hours, the disconnected neck of mice is put to death, and carefully cuts open and gets the mice prostate, takes by weighing weight in wet base, takes by weighing dry weight in 24 hours in 60 ℃ of bakings again, and carries out the prostata tissue morphological examination, measures its lumen of gland diameter and glandular epithelium height in the last administration.
3. test data
As seen, normal acinus epithelium is monolayer alignment more under the optical microscope, and acinus is less, and a prostate acinus and a matter all have hypertrophy in various degree after the modeling, and acinus is expansion in various degree.The epithelial cell height thickens, and mamillary is arranged to the intracavity projection.Administration epithelium posterius height and lumen of gland all have in various degree and reduce.
Result of the test is shown in table 3, table 4, table 5
The influence of the table 3 pair mouse retention gential sinus property implanted prostatic hyperplasia model weight of prostate (X ± S)
| Group | Dosage (mg/kg) | Prostate weight in wet base coefficient | Prostate dry weight coefficient | ||||
| N | Weight (mg/10g body weight) | Suppression ratio (%) | n | Weight (mg/10g body weight) | Suppression ratio (%) | ||
| The sham operated rats model group | - - | 22 20 | 2.90±0.95 * 6.70±2.10 | - - | 10 10 | 0.609±0.162 * 1.07±0.323 | - - |
| Urgenin estradiol sample sample | 40 $ 20.11 40.2 | 16 19 17 17 | 3.89±1.14 * 3.83±1.06 * 3.81±1.71 * 3.71±1.22 *▲ | 42.8 42.8 43.1 44.6 | 8 10 8 10 | 0.794±0.178 * 0.811±0.189 * 0.696±0.208 * 0.614±0.176 *▲ | 25.8 24.2 35.0 42.6 |
Compare with model group
*P＜0.05; With Urgenin group comparison ▲ p＜0.05
$ 15ng/ only
The influence of the table 4 pair mouse retention gential sinus property implanted prostatic hyperplasia model prostatic cell height (X ± S)
| Group | Dosage mg/kg | n | The glandular epithelium height | |
| Diameter (um) | Suppression ratio (%) | |||
| Sham operated rats model group Urgenin estradiol sample sample | - - 40 $ 20.11 40.2 | 55 86 60 53 66 72 | 2.41±0.52 * 4.09±1.09 3.00±0.62 * 3.22±1.08 * 3.06±1.18 * 2.72±0.91 *▲ | 26.7 21.3 25.2 33.5 |
Compare with model group
*P＜0.05; With Urgenin group comparison ▲ p＜0.05
$ 15ng/ only
The influence of the table 5 pair mouse retention gential sinus property implanted prostatic hyperplasia model lumen of gland diameter (X ± S)
| Group | Dosage (mg/kg) | N | The major diameter of lumen of gland | The wideest footpath of lumen of gland | ||
| Diameter (um) | Suppression ratio (%) | Diameter (um) | Suppression ratio (%) | |||
| Sham operated rats model group Urgenin estradiol sample sample | - - 40 $ 20.11 40.2 | 68 65 74 59 71 50 | 19.78±6.88 * 43.23±11.80 26.47±9.69 * 26.53±9.75 * 26.76±8.24 * 22.98±9.53 *▲ | - - 38.8 38.6 38.1 46.8 | 16.16±5.56 * 27.92±7.44 22.39±5.53 * 21.01±6.68 * 21.60±8.36 * 21.01±7.79 *▲ | - - 19.8 24.7 22.7 28.3 |
Compare with model group
*P＜0.05; Compare ▲ p＜0.05 with the Urgenin group
$ 15ng/ only
4. result of the test
Sample can significantly reduce prostate weight in wet base and the dry weight coefficient of the urogenital sinus property implanted prostatic hyperplasia model mice, significantly reduces the prostate epithelial cell height, significantly reduces its lumen of gland diameter.
Data show, sample 20.11mg dosage group is to the control of the weight of prostate of doing, wet, the effect of the control of glandular epithelium growing height and 40mg/Kg Urgenin group is suitable, sample 40.2mg/Kg dosage group is to the control of the weight of prostate of doing, wet, and the control of glandular epithelium growing height is compared curative effect than 40mg/Kg Urgenin group and is significantly increased.
Test example 3 pharmaceutical compositions of the present invention to the influence of rat androlin prostatic hyperplasia and with the comparison of Urgenin preparation
1. be subjected to the reagent matter sample: sample is pressed embodiment 6 preparation, faces with preceding with distilled water diluting, and processing is to desired concn.
Import Urgenin: 55mg (extract)/sheet is produced lot number: 727474 by Madaus AG.Face with preceding with dissolved in distilled water and be diluted to desired concn.
2. test method
Get the Wistar male rat, body weight 160-190g, 70, be divided into (1) normal control group by body weight, ig is with the volume distilled water; (2) model group, ig is with the distilled water of volume; (3) import Urgenin group, 40mg (extract)/kg; (4) estradiol group, ip 50ug/kg; (5), (6) be two dosage groups of sample, 20.11mg (extract), 40.2mg (extract)/kg.All the other each treated animals are under pentobarbital sodium 60mg/kg ip anesthesia except that the normal control group, and aseptic operation excises bilateral testes, and a week back subcutaneous injection androlin 0.5mg/0.1ml/ only.Begin drug treating simultaneously, continuous 50 days, put to death animal in the last medication after 24 hours, carefully cut open and get each leaf prostate, take by weighing the prostate weight in wet base, took by weighing dry weight in 24 hours in 60 ℃ of bakings again, calculate weight in wet base coefficient, dry weight coefficient, and do the tectology inspection, measure lumen of gland diameter and glandular epithelium height.
2. test data
Optical microscope as seen, normal acinus epithelium is monolayer alignment more, a matter has a spot of fibroblast.Visible prostatic acinus and fibrous tissue all have hypertrophy in various degree after the modeling, and acinus is expansion in various degree.The epithelial cell level increases, and mamillary is arranged to the intracavity projection.
Shown in table 6, table 7, table 8:
The influence of table 6 pair androlin rat prostate model of hyperplasia weight of prostate (X ± S)
| Group | Dosage (mg/kg) | Number of animals n | Prostate weight in wet base coefficient | Prostate dry weight coefficient | ||
| Weight (mg/10g body weight) | Suppression ratio (%) | Weight (mg/10g body weight) | Suppression ratio (%) | |||
| Normal group model group Urgenin estradiol sample sample | - - 40 0.05 20.11 40.2 | 10 10 10 10 10 10 | 12.14±2.85 ** 20.89±4.45 16.10±6.08 18.13±1.81 15.99±4.37 * 15.20±4.97 *▲ | - - 22.9 13.2 23.5 27.2 | 2.089±0.53 ** 3.159±0.67 2.810±0.87 3.086±0.62 2.791±0.71 2.49g±0.99 ▲ | - - 11.0 2.3 11.6 21.6 |
Compare with model group:
*P＜0.05
*P＜0.01; Compare with Urgenin: ▲ p＜0.05
The influence of table 7 pair androlin rat prostate model of hyperplasia prostatic cell height (X ± S)
| Group | Dosage (mg/kg) | n | The glandular epithelium height | |
| Diameter (um) | Suppression ratio (%) | |||
| Normal group model group import Urgenin estradiol sample sample | - - 40 0.05 20.11 40.2 | 42 33 43 46 44 39 | 2.9315±0.5376 ** 3.9094±0.7070 2.7511±0.4550 ** 2.9805±0.4076 ** 2.7301±0.3676 ** 2.5688±0.3635 **▲ | - - 29.6 23.8 30.2 34.3 |
Compare with model group
*P＜0.01; ▲ compare p＜0.05 with the Urgenin group
The influence of table 8 pair androlin rat prostate model of hyperplasia lumen of gland diameter (X ± S)
| Group | Dosage (mg/kg) | The major diameter of lumen of gland | The wideest footpath of lumen of gland | ||||
| n | Diameter (um) | Suppression ratio (%) | n | Diameter (um) | Suppression ratio (%) | ||
| Normal group model group import Urgenin estradiol sample sample | - - 40 0.05 20.11 40.2 | 42 33 43 46 44 39 | 79.09±24.53 * 93.69±29.74 82.81±25.01 80.90±18.29 ** 81.42±24.88 72.09±23.50 *▲ | 11.6 13.7 13.1 23.1 | 42 29 42 43 44 39 | 70.32±21.34 80.77±26.14 73.51±20.46 69.36±17.96 * 72.89±20.12 64.54±20.36 **▲ | 9.0 14.1 9.8 16.2 |
Compare with model group
*P＜0.01
*P＜0.05 is with Urgenin group comparison ▲ p＜0.05
3. result of the test
Sample can significantly reduce wet, the dry weight coefficient of androlin rat prostate model of hyperplasia prostate, reduces the prostate epithelial cell height, reduces the lumen of gland diameter.
Data show, sample 20.11mg/Kg dosage group are to the control of the weight of prostate of doing, wet, and to the glandular epithelium growing height, the control in lumen of gland length and width footpath is suitable with the effect of 40mg/Kg Urgenin group.40mg/Kg amount group to do, the control of wet weight of prostate, the glandular epithelium growing height, the control in lumen of gland length and width footpath is significantly increased than the effect of 40mg/Kg Urgenin group.
Above-mentioned pharmacodynamics test proves that pharmaceutical composition active component proportioning of the present invention is used, and in the dose-effect relationship scope that the present invention limits, all obviously is better than Urgenin, has reached the effect of Synergistic.
Claims (12)
1, a kind of pharmaceutical composition is characterized in that: it contains weight proportion is 1～5: 1 saw palmetto berry extract and genus echinacea plant extract.
2, pharmaceutical composition according to claim 1 is characterized in that: described saw palmetto berry extract is 60%～75% ethanol extraction; Described genus echinacea plant extract is 75%～90% ethanol extraction.
3, pharmaceutical composition according to claim 1 and 2 is characterized in that: it is that 1～5: 1 saw palmetto berry extract and genus echinacea plant extract are formed by weight proportion.
4, pharmaceutical composition according to claim 3 is characterized in that: the weight proportion of described saw palmetto berry extract and genus echinacea plant extract is: 1～3: 1.
5, pharmaceutical composition according to claim 4 is characterized in that: the weight proportion of described saw palmetto berry extract and genus echinacea plant extract is: 1.5: 1,1.83: 1 or 2: 1.
6, according to each described pharmaceutical composition of claim 1-5, it is characterized in that: the plant of described genus echinacea Echinacea comprises the dry product of narrow leaf Folium Rudbeckiae Laciniatae Echinaceaangustifolia, Echinacea Echinacea Purpurea, white Echinacea Echinacea pallida.
7, a kind of method for preparing the described pharmaceutical composition of claim 1, it comprises the following steps:
A, get saw palmetto berry, pulverize,, reclaim alcoholic solution with 60%～75% alcohol reflux, the extractum thin up, 2～8 ℃ of cold preservations, separating oil extract layer and water layer are preserved oily extract layer, must saw palmetto berry extract;
B, get the genus echinacea plant, pulverize, extract with 75%～90% alcohol reflux solution, reclaiming alcoholic solution to extractum density is 1.02-1.12,50 ℃, and must the genus echinacea plant extract;
The genus echinacea plant extract of c, the saw palmetto berry extract of getting a step and b step is mixed in proportion, and gets pharmaceutical composition of the present invention.
8, a kind of pharmaceutical preparation, it is to be active component by each described pharmaceutical composition of claim 1-6, adds the medicament that acceptable accessories or complementary composition are prepared from.
9, pharmaceutical preparation according to claim 8 is characterized in that: described preparation is capsule, granule, tablet, powder, pill, oral liquid, syrup.
10, pharmaceutical preparation according to claim 9 is characterized in that: the preparation method of described tablet is: saw palmetto berry extract, genus echinacea plant extract are mixed, add adjuvant, cross 80 mesh sieves, mixing adds 10% polyvinylpyrrolidone, 65% alcoholic solution, makes soft material, crossing 22 mesh sieves granulates, 60 ℃ of dryings, 22 mesh sieve granulate add 0.5% magnesium stearate, mixing, compacting are in flakes.
11, the purposes of the described pharmaceutical composition of claim 1 in the medicine of preparation treatment prostatosis.
12, purposes according to claim 11 is characterized in that: described medicine is that the treatment chronic prostatitis syndrome is or/and the medicine of benign prostatic hyperplasia.
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| CN105770876A (en) * | 2016-05-30 | 2016-07-20 | 广东天普生化医药股份有限公司 | Application of ulinastatin in preparing medicines for treating chronic prostatitis |
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| CN1560630A (en) * | 2004-02-17 | 2005-01-05 | 芳 方 | Qualitative of beta-sitosterol in sabal fruit extraction and its quantitative detecting method |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105770876A (en) * | 2016-05-30 | 2016-07-20 | 广东天普生化医药股份有限公司 | Application of ulinastatin in preparing medicines for treating chronic prostatitis |
| CN105770876B (en) * | 2016-05-30 | 2019-09-10 | 广东天普生化医药股份有限公司 | Purposes of the ulinastatin in preparation treatment chronic prostatitis drug |
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