CN101485847B - Chinese medicinal composition for treating prostatic diseases and preparation method thereof - Google Patents
Chinese medicinal composition for treating prostatic diseases and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a traditional Chinese medicine composition for treating prostate disease and a preparation method thereof. The traditional Chinese medicine composition is prepared by 11 gouts of traditional Chinese medicine comprising semen coicis, fritillary bulb, Caulis Clematidis armandii, (sauted) gardenia, honeysuckle, inula flower, eupatorium, rhubarb, verdigris, licorice, (honey-roasted) hoantchy root. The medicine has the efficacies of clearing heat and promoting diuresis, dissipating stagnation and expelling bruises, and is mainly used for prostatic hyperplasia of moist heat and phlegm obstruction. Compared with the prior art, the formulation of the medicine is more reasonable; and clinical pharmacodynamics experiment research results show that the medicine has more remarkable effect of treating the prostatic hyperplasia of moist heat and phlegm obstruction than the prior medicinal composition.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition of treating prostatosis and preparation method thereof, belong to technical field of traditional Chinese medicine pharmacy.
Technical background
Prostatosis be a kind of commonly encountered diseases and frequently-occurring disease, particularly prostatic hyperplasia serious endangering the healthy of middle-aging male.Chinese patent gazette disclosed the name of being declared by the applicant and was called " a kind of medicine of treating hyperplasia of prostate and preparation method thereof " on August 22nd, 2007; Publication number is 101129870 patent application, and the weight proportion of forming each herbal medicine raw material of the said Chinese patent medicine of invention is: 180 parts of Semen Coiciss, 120 parts of Bulbus Fritillariae Thunbergiis, 108 parts of Caulis Clematidis Armandiis, 108 parts of Fructus Gardeniaes, 120 parts of Flos Loniceraes, 108 parts of Flos Inulaes, 108 parts of Herba Lycopi, 36 parts of Radix Et Rhizoma Rhei, 6 parts of Aerugo, 48 parts in Radix Glycyrrhizae, 144 parts of the Radixs Astragali.But we find that the effect of this Chinese patent medicine is desirable not enough in actual application.In the time of nearly a year and a half, we grope through a large amount of experiments on original basis; Found best prescription proportioning; And the Fructus Gardeniae and the Radix Astragali are concocted respectively, and its clinical pharmacodynamic experiment effect significantly improves, and we have processed granule, tablet, capsule by common process.
Summary of the invention
The objective of the invention is to: provide a kind of curative effect to treat the Chinese medicine composition of hyperplasia of prostate more significantly.The present invention is achieved in that according to components by weight percent and calculates that Chinese medicine composition of the present invention is to be prepared from by common process following materials of weight proportions: 188 parts of Semen Coiciss, 112 parts of Bulbus Fritillariae Thunbergiis, 108 parts of Caulis Clematidis Armandiis, 108 parts of Fructus Gardeniaes (stir-fry), 120 parts of Flos Loniceraes, 98 parts of Flos Inulaes, 108 parts of Herba Lycopi, 36 parts of Radix Et Rhizoma Rhei, 16 parts of Aerugo, 48 parts in Radix Glycyrrhizae, 144 parts of the Radixs Astragali (processed with honey); Said dosage form is granule, capsule, tablet.
With granule of the present invention is example; Pharmacodynamic test of active extract proves: raw material weight proportioning of the present invention: 144 parts of 188 parts of Semen Coiciss, 112 parts of Bulbus Fritillariae Thunbergiis, 108 parts of Caulis Clematidis Armandiis, 108 parts of Fructus Gardeniaes (stir-fry), 120 parts of Flos Loniceraes, 98 parts of Flos Inulaes, 108 parts of Herba Lycopi, 36 parts of Radix Et Rhizoma Rhei, 16 parts of Aerugo, 48 parts in Radix Glycyrrhizae, the Radix Astragali (processed with honey) are with former invention weight proportion: 180 parts of Semen Coiciss, 120 parts of Bulbus Fritillariae Thunbergiis, 108 parts of Caulis Clematidis Armandiis, 108 parts of Fructus Gardeniaes, 120 parts of Flos Loniceraes, 108 parts of Flos Inulaes, 108 parts of Herba Lycopi, 36 parts of Radix Et Rhizoma Rhei, 6 parts of Aerugo, 48 parts in Radix Glycyrrhizae, the Radix Astragali are compared for 144 parts, and results of pharmacodynamic test is significantly increased.
Pharmacodynamic test of active extract
Test objective: through pharmacological experiment study to effects such as antiinflammatory, analgesia, diuresis, microcirculation improvement, inhibition prostatitis and the prostatic hyperplasia of granule of the present invention and former invention granule; Granule of the present invention and former invention granule are compared, observe the power of its pharmacological action.
Test method: the influence of granule of the present invention and former invention granule xylol induced mice auricle edema; On Carrageenan causes the influence of mice foot swelling; Influence to mice acetic acid twisting model; Influence to mice hot plate pain model; Microcirculation of mouse auricle is influenced; Influence to Mice Auricle small artery VPV; Influence to normal rat urine; Influence to the mouse retention gential sinus property implanted prostatic hyperplasia model; Influence to androlin induced mice prostatic hyperplasia; The influence that the rabbit trigone of bladder flesh that norepinephrine is brought out shrinks; Influence to rat chronic prostatitis model; Influence to the rat nonbacterial prostatitis.
Experimental animal: Kunming kind male and female mice, body weight 18～22g; Male Kunming strain mice, body weight 27～30g; Wistar bull rat, body weight 210～250g; Livid purple blue rabbit.
Trial drug:
A, raw material:
A, granule group of the present invention: by Semen Coicis 188g, Bulbus Fritillariae Thunbergii 112g, Caulis Clematidis Armandii 108g, Fructus Gardeniae (stir-fry) 108g, Flos Lonicerae 120g, Flos Inulae 98g, Herba Lycopi 108g, Radix Et Rhizoma Rhei 36g, Aerugo 16g, Radix Glycyrrhizae 48g, the Radix Astragali (processed with honey) 144g preparation.(by 188 parts of Semen Coiciss of the present invention, 112 parts of Bulbus Fritillariae Thunbergiis, 108 parts of Caulis Clematidis Armandiis, 108 parts of Fructus Gardeniaes (stir-fry), 120 parts of Flos Loniceraes, 98 parts of Flos Inulaes, 108 parts of Herba Lycopi, 36 parts of Radix Et Rhizoma Rhei, 16 parts of Aerugo, 48 parts in Radix Glycyrrhizae, 144 parts of proportionings of the Radix Astragali (processed with honey))
B, former invention granule group: by Semen Coicis 180g, Bulbus Fritillariae Thunbergii 120g, Caulis Clematidis Armandii 108g, Fructus Gardeniae 108g, Flos Lonicerae 120g, Flos Inulae 108g, Herba Lycopi 108g, Radix Et Rhizoma Rhei 36g, Aerugo 6g, Radix Glycyrrhizae 48g, the Radix Astragali 144 preparations.(by 180 parts of Semen Coiciss of the present invention, 120 parts of Bulbus Fritillariae Thunbergiis, 108 parts of Caulis Clematidis Armandiis, 108 parts of Fructus Gardeniaes, 120 parts of Flos Loniceraes, 108 parts of Flos Inulaes, 108 parts of Herba Lycopi, 36 parts of Radix Et Rhizoma Rhei, 6 parts of Aerugo, 48 parts in Radix Glycyrrhizae, 144 parts of proportionings of the Radix Astragali)
B, method for making:
More than ten simply, Bulbus Fritillariae Thunbergii, Aerugo are ground into fine powder and cross 100 mesh sieves, and is subsequent use.Nine flavors such as all the other Caulis Clematidis Armandiis add 10 times of water gagings and decoct three times, and each 1 hour, collecting decoction filtered; Filtrate decompression concentrates the thick paste that (0.08Mpa, 80 ℃) to relative density is 1.20～1.25 (55 ℃, heat is surveyed), spray drying (160 ℃～180 ℃ of EATs; 70～75 ℃ of leaving air temps), (sucrose: dextrin=3: 1), mixing adds an amount of ethanol moistening to add above-mentioned fine powder, sucrose and dextrin; Granulate, pack promptly gets.
The concrete test as follows:
One, the influence of xylol induced mice auricle edema
50 of Male Kunming strain mice, body weight 18～22g is divided into 5 groups at random, 10 every group.Matched group is irritated the normal saline of stomach with volume; Groups of grains of the present invention is gastric infusion 0.8,1.6,3.2g crude drug/kg respectively; Former invention groups of grains gastric infusion 3.2g crude drug/kg.Successive administration 5d; Every day 1 time, behind the last administration 1h, only be applied to the inside and outside two sides of auris dextra with 100% xylene 0.05ml/; Left side ear is not done any processing; Behind the 1h animal etherization is put to death, ears are laid round auricle respectively with 8mm diameter macropore device under subtracting at the same position of mice, and electronic analytical balance is weighed.With the mice ear degree as acutely inflamed swelling index (mice ear degree=auris dextra sheet weight-left auricle weight) due to the xylene.See table 1
The influence of swelling due to the table 1 pair Mice Auricle xylene (x ± s)
Compare * * P＜0.01 with matched group; With former invention groups of grains than △ P＜0.05, #P＞0.05.
The result: groups of grains of the present invention and former invention groups of grains obviously suppress xylene induced mice ease auricle swelling, have compared significant difference with matched group.Significant difference that granule heavy dose of the present invention is organized and former invention groups of grains has been compared.Groups of grains of the present invention is stronger than the antiinflammatory action of former invention groups of grains.
Two, on Carrageenan causes the influence of mice foot swelling
50 of Kunming mouses, male and female half and half, body weight 18～22g is divided into 5 groups at random, 10 every group.Matched group is irritated the normal saline of stomach with volume; Groups of grains of the present invention is gastric infusion 0.8,1.6,3.2g crude drug/kg respectively; Former invention groups of grains gastric infusion 3.2g crude drug/kg.Every day 1 time; Successive administration 6d, 2h after the last administration, the right back sufficient plantar subcutaneous injection 1% carrageenin solution 50 μ l of every Mus; Measure the right back sufficient sole of the foot with micrometer callipers and give before the carrageenin and 1,2,3 and the thickness of 4h, the difference of right back sufficient sole of the foot thickness is the swelling degree before and after the proinflammatory agent to give.See table 2
Table 2 on Carrageenan causes the influence (x ± s) of mice foot swelling
Compare * P＜0.05 with matched group, * * P＜0.01; With former invention groups of grains than △ P＜0.05, #P＞0.05.
The result: groups of grains of the present invention and the foot swelling of former invention groups of grains on Carrageenan induced mice have obvious inhibitory action; The 4h inhibitory action is the strongest; Significant difference that 4h granule heavy dose of the present invention is organized and former invention groups of grains has been compared, each dose groups of 3h and matched group relatively have utmost point significant difference.Groups of grains of the present invention is stronger than the antiinflammatory action of former invention groups of grains.
Three, to the influence of mice acetic acid twisting model
50 of Kunming male mices, body weight 18～22g is divided into 5 groups at random, 10 every group.Matched group is irritated the normal saline of stomach with volume; Groups of grains of the present invention is gastric infusion 0.8,1.6,3.2g crude drug/kg respectively; Former invention groups of grains gastric infusion 3.2g crude drug/kg.Every day 1 time, successive administration 7d, behind the last administration 30min, the equal lumbar injection 0.6% acetic acid 0.2ml/ of every Mus, mouse writhing number of times in the record 15min, and calculate each and organize analgesia percentage rate.See table 3
The influence of table 3 Dichlorodiphenyl Acetate induced mice writhing response (x ± s)
Compare * * P＜0.01 with matched group; With former invention groups of grains than △ P＜0.05, #P＞0.05.
The result: groups of grains of the present invention and former invention groups of grains all make the acetic acid induced mice turn round the minimizing of body number of times; Dose-effect reaction relation is preferably arranged,, turn round the body number of times and reduce along with the increasing of dosage; It is inhibited that the Dichlorodiphenyl Acetate induced mice is turned round body, compares the difference that significance is arranged with matched group; Significant difference that granule heavy dose of the present invention is organized and former invention groups of grains has been compared.Groups of grains of the present invention is stronger than the analgesic activity of former invention groups of grains.
Four, to the influence of mice hot plate pain model
The electric hot plate appearance is transferred to (55 ± 0.5) ℃; To body weight is that the Kunming female mice of 18～22g screens, and the record mice is dropped into hot plate to the pain threshold of the time of metapedes as this mice occurring licking, 50 of the female mice of screening pain threshold in 30s; Be divided into 5 groups at random, 10 every group.Matched group is irritated the normal saline of stomach with volume; Groups of grains of the present invention is gastric infusion 0.8,1.6,3.2g crude drug/kg respectively; Former invention groups of grains gastric infusion 3.2g crude drug/kg.Successive administration 7d behind the last administration 1h, is placed on mice in the purple tube cylinder every day 1 time, and the time that metapedes occurs licking after the record administration, pain threshold was as difference before the pain threshold after the medication deducted medication.See table 4
Table 4 mice causes the influence (x ± s) of pain to hot plate
Compare * * P＜0.01 with matched group; With former invention groups of grains than △ P＜0.05, #P＞0.05.
The result: groups of grains of the present invention and former invention groups of grains all can prolong the pain threshold that hot plate causes the pain mice, with matched group utmost point significant difference are arranged relatively; The heavy dose of group of the granule of the present invention significant difference of having compared with former invention groups of grains.Groups of grains of the present invention is stronger than the analgesic activity of former invention groups of grains.
Five, microcirculation of mouse auricle is influenced
50 of Kunming male mices, body weight 18～22g is divided into 5 groups at random, 10 every group.Every mice intramuscular injection 20% urethane (0.07ml/10g body weight) anesthesia, auricle hair, QUMAO are gently drawn with the light subsides of medical rubber cream in the anesthesia back.Again mice is fixed on the mice observation platform, regulates the height of lucite ear holder, auricle is lain in the ear holder.In the ear holder, drip a little liquid paraffin, observation platform is placed on the microscope carrier, regulate cold light source brightness, under transillumination, with 75 times of sem observation Mice Auricle microcirculations with the auricle surface.The open number of the arteriole of auricle microcirculqtory system and venule external caliber (μ m) and blood capillary before the record administration (individual/mm).Gastric infusion then, volume is the 0.2ml/10g body weight, matched group is irritated the normal saline of stomach with volume; Groups of grains of the present invention is gastric infusion 0.8,1.6,3.2g crude drug/kg respectively; Former invention groups of grains gastric infusion 3.2g crude drug/kg.1h after the administration observes auricular microcirculation system difference before and after administration.Table 5
Table 5 pair microcirculation of mouse auricle influence (x ± s)
Compare * * P＜0.01 with matched group; With former invention groups of grains than △ P＜0.05, #P＞0.05.
The result: groups of grains of the present invention and former invention groups of grains can obviously be expanded Mice Auricle microcirculation arteriole and venule bore, significantly increase the open number of blood capillary, with matched group utmost point significant difference are arranged relatively; It is strong that groups of grains of the present invention is improved the blood circulation effect than former invention groups of grains.
Six, to the influence of Mice Auricle small artery VPV
50 of Kunming mouses, male and female half and half, body weight 18～22g is divided into 5 groups at random, 10 every group.Model group is irritated the normal saline of stomach with volume; Groups of grains of the present invention is gastric infusion 0.8,1.6,3.2g crude drug/kg respectively; Former invention groups of grains gastric infusion 3.2g crude drug/kg.Every day 1 time, successive administration 7d, behind the last administration 1h, every mouse tail vein injection pituitrin 0.05ml measures behind the 2min and respectively organizes Mice Auricle small artery VPV.See table 6
The influence of table 6 pair Mice Auricle small artery VPV (x ± s)
Compare * * P＜0.01 with model group; With former invention groups of grains than △ P＜0.05, #P＞0.05.
The result: groups of grains of the present invention and former invention groups of grains can significantly be accelerated Mice Auricle small artery VPV, have the effect that improves hemorheological property, have compared significant difference with model group.Significant difference that granule heavy dose of the present invention is organized and former invention groups of grains has been compared.Groups of grains of the present invention is stronger than the effect of former invention groups of grains microcirculation improvement.
Seven, to the influence of normal rat urine
50 of Wistar male rats, body weight 210～250g is divided into 5 groups at random, 10 every group.At metabolic cage endoadaptation 2d, water 18h is can't help in fasting before the experiment in advance, gently depresses abdomen during the experiment beginning, drains surplus urine.Matched group is irritated the normal saline of stomach with volume; Groups of grains of the present invention is gastric infusion 0.4,0.8,1.6g crude drug/kg respectively; Former invention groups of grains gastric infusion 1.6g crude drug/kg, volume is 1ml/100g.Immediately rat is put into metabolic cage after the administration, 2～3 in every cage, the urine amount of collecting 2h, and, use atomic absorption spectrometry K with 1000 times of the urine dilutions of collecting
+, Na
+Content.See table 7
The influence of table 7 pair normal rat urine (x ± s)
Compare * * P＜0.01 with matched group; With former invention groups of grains than △ P＜0.05, #P＞0.05.
Result: K during groups of grains of the present invention and former invention groups of grains can significantly increase the normal rat voided volume and urinate
+, Na
+Content, compared significant difference with matched group.Groups of grains of the present invention is stronger than the diuresis of former invention groups of grains.
Eight, the mouse retention gential sinus is planted the influence of human nature prostatic hyperplasia model
50 of Male Kunming strain mice, body weight 27～30g is divided into 5 groups at random, 10 every group.Pentobarbital sodium 50g/kg intraperitoneal anesthesia; The sterile working cuts hypogastric region open, carefully separates the prostate siphonal lobe, under anatomical lens, in two flank prostate, respectively implants the urogenital sinus tissue of three 16d ages with strain tire Mus with No. 10 syringe needles; Sew up stomach wall then, observe 3d.Matched group is irritated the normal saline of stomach with volume behind the 3d; Groups of grains of the present invention is gastric infusion 0.8,1.6,3.2g crude drug/kg respectively; Former invention groups of grains gastric infusion 3.2g crude drug/kg irritates stomach volume 0.2ml/10g, and 1 time/d, continuous 10d.Put to death whole mices next day after the last administration, cuts open to get two flank prostate and take by weighing weight in wet base, and obtain the weight of prostate coefficient.Two flank prostate are moved people's homogenizer process homogenate, add 6% trichloroacetic acid homogenate, put then that centrifugal in the high speed centrifuge (14000r/min * 10min), abandoning supernatant adds 1mol/LHClO again in precipitate
4Extract DNA, add HClO
4Fully in 70 ℃ of water, place 15min behind the mixing, continue then centrifugal (14000r/min * 10min), the supernatant that will contain DNA with ultraviolet spectrophotometer at 260nm place the mensuration ultraviolet absorption value, the content of mensuration DNA.See table 8
Table 8 pair mouse retention gential sinus is planted the influence (x ± s) of human nature prostatic hyperplasia model
Compare * * P＜0.01 with matched group; With former invention groups of grains than △ P＜0.05, #P＞0.05.
The result: groups of grains of the present invention and former invention groups of grains obviously reduce weight of prostate coefficient and the dna content that urogenital sinus is planted human nature prostatic hyperplasia mice, have compared significant difference with matched group.Groups of grains of the present invention is stronger than the effect that former invention groups of grains suppresses prostatic hyperplasia.
Nine, to the influence of androlin induced mice prostatic hyperplasia
60 of Kunming male mices, body weight 18～22g is divided into 6 groups at random, 10 every group.Matched group and model group are irritated the normal saline of stomach with volume; Groups of grains of the present invention is gastric infusion 0.8,1.6,3.2g crude drug/kg respectively; Former invention groups of grains gastric infusion 3.2g crude drug/kg irritates stomach volume 0.2ml/10g, every Corium Mus injected androlin 10mg/kg of while, 1 time/d, continuous 10d.Put to death whole mices next day after the last administration, measures prostate weight in wet base and PAS level respectively.See table 9
The influence of table 9 pair androlin induced mice prostatic hyperplasia (x ± s)
Compare * * P＜0.01 with model group; With former invention groups of grains than △ P＜0.05, #P＞0.05.
The result: groups of grains of the present invention and former invention groups of grains can significantly reduce the prostate weight in wet base of prostatic hyperplasia mice due to the androlin and the activity of PAS; Suppress prostatic hypertrophy; Action intensity is dosage and relies on, and has compared significant difference with model group.Groups of grains of the present invention is stronger than the effect that former invention groups of grains suppresses prostatic hyperplasia.
Ten, the influence that the rabbit trigone of bladder flesh that norepinephrine is brought out shrinks
Get livid purple blue rabbit, the occipitalia of tapping the head is put to death, the taking-up bladder of cutting open the belly, and the isolating bladder triangular muscle is processed the flesh sheet of 4mm～6mm, on the isolated organ analyzer, measures its tension force.Nutritional solution is that K-H liquid (feeds 95%O
2,+5%CO
2Gaseous mixture, pH7.3～7.4), temperature is 35 ℃, preload is 1g, begins experiment behind the balance 15min.In bath, add norepinephrine 10mol/L (final concentration) during experiment; Wait to shrink and peak the back with nutritional solution flushing 3 times; What its tension force is returned to add behind the baseline balance 10min people's variable concentrations receives reagent liquid 0.2ml, behind the balance 15min, adds the norepinephrine of above-mentioned concentration again.With norepinephrine shrinkage amplitude before the administration is 100%, the suppression ratio of norepinephrine shrinkage amplitude after the calculating administration.See table 10
The influence that the rabbit trigone of bladder flesh that table 10 pair norepinephrine brings out shrinks (x ± s)
Compare * * P＜0.01 with matched group; With former invention groups of grains than △ P＜0.05, #P＞0.05.
The result: groups of grains of the present invention and former invention groups of grains are shunk the inductive rabbit trigone of bladder of norepinephrine flesh and are had the obvious suppression effect, have compared significant difference with matched group.Significant difference that granule heavy dose of the present invention is organized and former invention groups of grains has been compared.Groups of grains of the present invention is stronger than the effect of former invention groups of grains anti-prostatic hyperplasia.
11, to the influence of rat chronic prostatitis model
60 of Wistar male rats, body weight 210～250g is divided into 6 groups at random, 10 every group.Anesthesia is the aseptic operation operation down, exposes the prostate siphonal lobe, injects in prostate with aseptic micro sample adding appliance and mixes proinflammatory agent (the formaldehyde Oleum Tiglii of 3.3mol/L 8: 2) 10 μ L, and matched group injects physiological saline solution 10 μ L in prostate.Postoperative 24h, matched group and model group are irritated the normal saline of stomach with volume; Groups of grains of the present invention is gastric infusion 0.4,0.8,1.6g crude drug/kg respectively; Former invention groups of grains gastric infusion 1.6g crude drug/kg irritates stomach volume 10ml/kg, and 1 time/d, continuous 10d.Fasting 8h on the 11st, the eye socket vein is got blood 0.5ml, and sacrificed by decapitation is cut open the belly rapidly, gets massage of prostate liquid 10 μ L and counts the leukocyte number in microscopically; Get complete prostate, weigh, calculate prostate dirty/body ratio.See table 11
The influence of table 11 pair rat chronic prostatitis model (x ± s)
Compare * * P＜0.01 with model group; With former invention groups of grains than △ P＜0.05, #P＞0.05.
Result: after groups of grains of the present invention and the former invention groups of grains rat process operation modeling; Numeration of leukocyte significantly raises in the blood; Prostata tissue obviously increases weight; Can make after the administration that numeration of leukocyte has decline in various degree in the operation rat serum, operation rat prostate tissue weight is increased has significant inhibitory effect, has compared significant difference with model group.Groups of grains of the present invention is stronger to the therapeutical effect of chronic prostatitis than former invention groups of grains.
12, to the influence of rat nonbacterial prostatitis
60 of Wistar male rats, body weight 210～250g is divided into 6 groups at random, 10 every group.Each group rat is removed ventral seta with 8% sodium sulfide depilatory before experiment, depilation back 2d begins modeling.Earlier with ketamine 0.1g/kg lumbar injection, anaesthetize successfully after, the about 2～3cm of median incision of lower abdomen under aseptic condition; Through abdominal cavity proposes bladder and both sides seminal vesicle, exposes to invest the inboard prostate notopodium of seminal vesicle; Bilateral injects 25% XIAOZHILING ZHUSHEYE 0.2mL respectively; With the multiple internal organs of prompt delivery, suture muscles, skin, wrapping.Matched group injection 0.2mL sterile saline.4d begins administration after modeling, and matched group and model group are irritated the normal saline of stomach with volume; Groups of grains of the present invention is gastric infusion 0.4,0.8,1.6g crude drug/kg respectively; Former invention groups of grains gastric infusion 1.6g crude drug/kg, 1 time/d, behind the successive administration 30d, weigh in, put to death rat, win prostate, calculate the prostate index, measure prostate volume with drainage.See table 12
The influence of table 12 pair rat nonbacterial prostatitis (x ± s)
Compare * * P＜0.01 with model group; With former invention groups of grains than △ P＜0.05, #P＞0.05.
The result: groups of grains of the present invention and former invention groups of grains can improve the prostate index of nonbacterial prostatitis rat model, the increase of inhibition prostate volume, have compared significant difference with model group.Groups of grains of the present invention is stronger to the therapeutical effect of nonbacterial prostatitis than former invention groups of grains.
Acute toxicity testing is the result show: with granule Cmax of the present invention, maximum volume gastric infusion, successive administration is 3 times in 24h, each 4h at interval, and accumulation medicine total amount reaches 65g crude drug/kg, is equivalent to 359 times of clinical plan consumption.After the administration in the 7d, mice is movable, feed, drain all normal, well-grown, the hair color light, its average body weight average increases with the prolongation of test period.8d puts to death every mice perusal heart of back dissection, liver, spleen, lung, kidney, brain, thymus, adrenal gland, prostate, stomach, intestinal etc. and does not all find color and paramophia.Show that this preparation does not have acute toxic reaction.
Long term toxicity test is the result show: grain fraction of the present invention is that basic, normal, high dosage is respectively 3.2,6.4,12.8g crude drug/kg/d; Be equivalent to 17.7,35.4,70.7 times of clinical dosage; Gastric infusion is after 12 weeks; Granule of the present invention does not all have significantly influence, the yet no abnormal pathological change of system's dissection, organ coefficient and histopathological examination to the general situation of animal, hematological indices, blood parameters etc.2 weeks of drug withdrawal are not seen obvious change yet.Granule of the present invention is not found overt toxicity reaction and delayed toxicity reaction in long term toxicity test.It is thus clear that, granule non-toxic reaction of the present invention, long-term prescription is safe and reliable.
Conclusion:
Groups of grains of the present invention and former invention groups of grains obviously suppress xylene induced mice ease auricle swelling; The foot swelling of on Carrageenan induced mice has obvious inhibitory action; It is inhibited that the Dichlorodiphenyl Acetate induced mice is turned round body; Can prolong the pain threshold that hot plate causes the pain mice; Obviously expansion Mice Auricle microcirculation arteriole and venule bore significantly increase the open number of blood capillary; Significantly accelerate Mice Auricle small artery VPV, have the effect that improves hemorheological property; K in increasing the normal rat voided volume and urinating
+, Na
+Content; Obviously reduce weight of prostate coefficient and the dna content that urogenital sinus is planted human nature prostatic hyperplasia mice; Can significantly reduce the prostate weight in wet base of prostatic hyperplasia mice due to the androlin and the activity of PAS; Contraction has the obvious suppression effect to the inductive rabbit trigone of bladder of norepinephrine flesh; The weight of leukocyte count and prostata tissue in the reduction chronic prostatitis rat model blood; Improve the prostate index of nonbacterial prostatitis rat model, the increase of inhibition prostate volume.The result shows that granule of the present invention obviously strengthens than effects such as the particulate antiinflammatory of former invention, analgesia, diuresis, microcirculation improvement, inhibition prostatitis and prostatic hyperplasia.It is thus clear that the particulate pharmacological action of the present invention is superior to former invention granule.
Clinical trial:
Clinical observation patient 246 examples of the present invention, outpatient's 177 examples wherein, inpatient's 69 examples.Clinical observation result shows: total effective rate of the present invention is 97.8%, and clinical efficacy is satisfied.After the patient used these article, relieve clinical symptoms was taken a course of treatment continuously at short notice; the urine number of times recovers normal, urethra causalgia, dribbling urination sx or disappearance, and recovery from illness appears in part prostatic hyperplasia patient on inspection; the clearing away heat-damp and promoting diuresis of these article is described, the exact efficacy of eliminating stagnation blood stasis dispelling is in the clinical observation process; do not find that the patient has untoward reaction and anaphylaxis, explain that these article are safe.
The specific embodiment of the invention:
Prescription
108 parts of 112 portions of Caulis Clematidis Armandiis of 188 parts of Bulbus Fritillariae Thunbergiis of Semen Coicis
98 parts of 120 parts of Flos Inulaes of 108 portions of Flos Loniceraes of Fructus Gardeniae (stir-fry)
16 parts of 36 parts of Aerugo of 108 parts of Radix Et Rhizoma Rhei of Herba Lycopi
144 parts of 48 parts of Radixs Astragali of Radix Glycyrrhizae (processed with honey)
1, the preparation of granule of the present invention:
More than ten simply, Bulbus Fritillariae Thunbergii, Aerugo are ground into fine powder and cross 100 mesh sieves, and is subsequent use.Nine flavors such as all the other Caulis Clematidis Armandiis add 10 times of water gagings and decoct three times, and each 1 hour, collecting decoction filtered; Filtrate decompression concentrates the thick paste that (0.08Mpa, 80 ℃) to relative density is 1.20～1.25 (55 ℃, heat is surveyed), spray drying (160 ℃～180 ℃ of EATs; 70～75 ℃ of leaving air temps), (sucrose: dextrin=3: 1), mixing adds an amount of ethanol moistening to add above-mentioned fine powder and an amount of sucrose and dextrin; Granulate, pack promptly gets granule of the present invention.
2, the preparation of capsule of the present invention:
More than ten simply, Bulbus Fritillariae Thunbergii, Aerugo are ground into fine powder and cross 100 mesh sieves, and is subsequent use.Nine flavors such as all the other Caulis Clematidis Armandiis add 10 times of water gagings and decoct three times, and each 1 hour, collecting decoction filtered; Filtrate decompression concentrates the thick paste that (0.08Mpa, 80 ℃) to relative density is 1.20～1.25 (55 ℃, heat is surveyed), spray drying (160 ℃～180 ℃ of EATs; 70～75 ℃ of leaving air temps), add above-mentioned fine powder and appropriate amount of starch, mixing adds an amount of ethanol moistening; Granulate, encapsulated, promptly get capsule of the present invention.
3, the preparation of tablet of the present invention:
More than ten simply, Bulbus Fritillariae Thunbergii, Aerugo are ground into fine powder and cross 100 mesh sieves, and is subsequent use.Nine flavors such as all the other Caulis Clematidis Armandiis add 10 times of water gagings and decoct three times, and each 1 hour, collecting decoction filtered, and filtrate decompression concentrates (0.08Mpa; 80 ℃) to relative density be 1.20～1.25 thick paste of (55 ℃, heat is surveyed), spray drying (160 ℃～180 ℃ of EATs, 70～75 ℃ of leaving air temps); Add above-mentioned fine powder and appropriate amount of starch, mixing adds an amount of ethanol moistening, granulates; Add an amount of magnesium stearate, mixing, tabletting promptly gets tablet of the present invention.
Claims (5)
1. Chinese medicine composition of treating prostatosis is characterized in that it is to be prepared from the following weight proportion raw material:
2. according to the said Chinese medicine composition of claim 1, it is characterized in that: said Chinese medicine composition is prepared into granule, capsule or tablet.
3. the preparation of compositions with claim 1 becomes the method for granule, and it is characterized in that: Bulbus Fritillariae Thunbergii, Aerugo are ground into fine powder and cross 100 mesh sieves, and is subsequent use; All the other Caulis Clematidis Armandiis, Semen Coicis, Fructus Gardeniae (parched), Flos Lonicerae, Flos Inulae, Herba Lycopi, Radix Et Rhizoma Rhei, Radix Glycyrrhizae, Radix Astragali (processed with Mel) totally nine flavors add 10 times of water gagings decoctions three times, each 1 hour, collecting decoction; Filter, filtrating concentrating under reduced pressure under the condition of 80 ℃ of time-0.08Mpa, recording relative density to 55 ℃ is 1.20～1.25 thick paste; At EAT is 160 ℃～180 ℃, and leaving air temp is under 70～75 ℃ the condition, spray drying; Add above-mentioned fine powder and an amount of sucrose: dextrin is 3: 1 sucrose and a dextrin, and mixing adds an amount of ethanol moistening; Granulate, pack promptly gets granule.
4. the preparation of compositions with claim 1 becomes the method for capsule, and it is characterized in that: Bulbus Fritillariae Thunbergii, Aerugo are ground into fine powder and cross 100 mesh sieves, and is subsequent use; All the other Caulis Clematidis Armandiis, Semen Coicis, Fructus Gardeniae (parched), Flos Lonicerae, Flos Inulae, Herba Lycopi, Radix Et Rhizoma Rhei, Radix Glycyrrhizae, Radix Astragali (processed with Mel) totally nine flavors add 10 times of water gagings decoctions three times, each 1 hour, collecting decoction; Filter, filtrating concentrating under reduced pressure under the condition of 80 ℃ of time-0.08Mpa, recording relative density to 55 ℃ is 1.20～1.25 thick paste; At EAT is 160 ℃～180 ℃, and leaving air temp is under 70～75 ℃ the condition, spray drying; Add above-mentioned fine powder and appropriate amount of starch, mixing adds an amount of ethanol moistening; Granulate, encapsulated, promptly get capsule.
5. the preparation of compositions with claim 1 becomes the method for tablet, and it is characterized in that: Bulbus Fritillariae Thunbergii, Aerugo are ground into fine powder and cross 100 mesh sieves, and is subsequent use; All the other Caulis Clematidis Armandiis, Semen Coicis, Fructus Gardeniae (parched), Flos Lonicerae, Flos Inulae, Herba Lycopi, Radix Et Rhizoma Rhei, Radix Glycyrrhizae, Radix Astragali (processed with Mel) totally nine flavors add 10 times of water gagings decoctions three times, and each 1 hour, collecting decoction filtered; Filtrating is concentrating under reduced pressure under the condition of 80 ℃ of time-0.08Mpa, and recording relative density to 55 ℃ is 1.20～1.25 thick paste, is 160 ℃～180 ℃ at EAT, and leaving air temp is under 70～75 ℃ the condition; Spray drying adds above-mentioned fine powder and appropriate amount of starch, mixing; Add an amount of ethanol moistening, granulate, add an amount of magnesium stearate; Mixing, tabletting promptly gets tablet.
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