CN101721528B - Medicine composition for treating chronic prostatitis - Google Patents
Medicine composition for treating chronic prostatitis Download PDFInfo
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Abstract
The invention relates to a medicine composition for treating chronic prostatitis, which belongs to the field of traditional Chinese medicines. The medicine composition is prepared from the following raw materials of medicines in parts by weight: 15-25 parts of yellow-corktree bark, 13-23 parts of kuhseng, 25-35 parts of vaccaria seed, 10-20 parts of tuckahoe, 10-20 parts of plantain, 10-20 parts of astragalus root, 10-20 parts of cherokee rose and 10-20 parts of twotooth achyranthes root. According to the clinical practical experience of more than 20 years, the invention develops a preparation with the functions of reducing fever, resolving dampness, relieving the stasis of blood and smoothing collaterals with meticulous care by integrating the ancient and modern literature reports.
Description
Technical field
The invention belongs to the field of Chinese medicines.
Background technology
Chronic prostatitis belongs to the traditional Chinese medical science " stranguria ", " stranguria caused by overstrain ", " turbid urine " category.Ancient Chinese medicine doctor has argumentation to primary disease more.
1, the traditional Chinese medical science is to the understanding of etiology and pathogenesis: stranguria is many by suffering from a deficiency of the kidney, and due to the damp-heat in the urinary bladder, disturbance in functioning of QI, disturbance in water passage, is anxious, not to the utmost dripping frequently with urine, Urethra astringent pain, and the lower abdomen contracture, pain is drawn the disease that the waist abdomen is a main clinical manifestation.Ancient Chinese medicine doctor has argumentation to primary disease more.The name beginning of pouring sees " interior warp ", and " element is asked the hexa-atomic big opinion piece of writing of just recording " is referred to as " drenching vexed "." interior warp " cloud: " all pouring are sent out all and are suffered from a deficiency of the kidney, damp-heat in the urinary bladder." pointed out that it is this that primary disease is suffered from a deficiency of the kidney, damp-heat in the urinary bladder is for marking." Medical Treasures of the Golden Chamber relieving thirst and treating dribbling urination arteries and veins card also control " said: " pourings be disease, obstructed urine as dripping, contraction in the lower abdomen, dragging pain in the navel." be early stage description to the stranguria clinical manifestation." Huatuo's Zhongzang classic " according to stranguria clinical manifestation difference, proposed to drench hot and cold, gas is arranged, labor, cream, sand, void, real eight kinds, be blank for the stranguria clinical classification." General Treatise on the Cause and Symptoms of Diseases " is divided into seven kinds of stone, labor, gas, blood, cream, cold, heat, and unites it with " all pouring ".It is perfect that Tang and Song Dynasty time, the classification of stranguria more become.The Tang Dynasty " prescriptions worth thousand gold ", " medical secrets of official " reduce stone, gas, cream, labor, hot five types of stranguria, and the Song dynasty recipes for Saving Lives is divided into five kinds in gas, stone, blood, cream, stranguria caused by overstrain again.The content of above-mentioned two kinds of five types of stranguria indications, its difference is having or not of stranguria with blood and pyretic stranguria, according to clinical practice, is divided into six kinds of qi stranguria, stranguria with blood, pyretic stranguria, stranguria marked by chyluria, stranguria caused by urinary stone at present mostly." General Treatise on the Cause and Symptoms of Diseases gonorrhea duke or princess under an emperor " is summarised as the sick position and the pathogenesis of primary disease: " Zhu Linzhe, so bladder heat is also by suffering from a deficiency of the kidney." Zhang Jingyue is " sick at the beginning of the pouring in approval, then invariably by popular drama " time; propose " obeying cold and cool for a long time "; " drenching more than for a long time " has " card that the sinking of QI of middle-JIAO and the gate of vitality are not solid "; " all hot persons are suitable clear, and puckery person is suitable sharp, the suitable ascending of the person of sinking thereby established, void person should mend, and admittedly the person should warming and recuperating the gate of life for yang-energy " execute and control principle.
The research of modern TCM medicine, the early stage traditional Chinese medical science is many from damp and hot opinion to the prostatitic cause of disease, and treatment is also based on the heat-clearing and toxic substances removing dampness removing, but for chronic prostatitis, the method general curative effect of simple clear profit is unsatisfactory.Along with Chinese medicine to the going deep into of etiology and pathogenesis understanding, many doctors family payes attention to the effect of blood stasis in the primary disease morbidity and the course of disease gradually.Prostate belongs to Liver Channel and follows capable position, damp-heat accumulation, blockage of meridian, then Liver Channel stagnation of QI-blood; Prolonged illness becomes the stasis of blood again, because of void causes the stasis of blood, also causes the smart chamber blood vessels stasis of blood and stagnates.
2, Chinese medicine therapy: eliminating damp-heat, activating blood and removing stasis Method are widely used in the chronic prostatitis treatment, and its utility ratio is more than 78.59% according to statistics.In addition, it serves as main in conjunction with the product of eliminating damp-heat, the medicine of blood circulation promoting and blood stasis dispelling also having with the kidney invigorating warming YANG method, nourishing the liver and kidney method, invigorating the spleen and benefiting QI method.How based on tcm treatment according to syndrome differentiation.Chinese patent medicine mainly contains with prostatitis return of spring capsule, treatment chronic prostatitis, all obtains certain curative effect.
3, therapy of combining Chinese and Western medicine: adopt Chinese medicine more, and in conjunction with conventional Western medicine partner treatment, select for use quinolones or sulfa drugs routine oral as antibiotic, oral oryzanol of while, perineal position and lower abdomen pain person add etidocine tablet, frequent micturition person's per os hora somni propantheline, urgent micturition or urine retention person join clothes terazosin hydrochloride capsule.The result shows that Chinese medicine and western medicine has good synergism, satisfactory effect, no obvious toxic-side effects.
4, other therapies: adopt acupuncture, massage, the qigong, physical therapy, demibain, umbilical compress therapy.Per urethra medicine-injecting method, Chinese medicine decoction retention enema and Chinese medicine suppository plug anus therapy etc. also obtain curative effect preferably.
Summary of the invention
The invention provides a kind of pharmaceutical composition for the treatment of chronic prostatitis, can clearing away heat-damp and promoting diuresis, disperse blood stasis and dredge collateral is used for the chronic prostatitis of dampness and heat stasis, and disease is seen the puckery pain of dribbling urination etc.
Chronic prostatitis that modern medicine is referred to as though there is not this title in motherland's medical literature, with regard to its clinical findings sings and symptoms, is similar to the category of Chinese medicine " stranguria ", " turbid urine " etc.Stranguria is many by suffering from a deficiency of the kidney, and due to the damp-heat in the urinary bladder, disturbance in functioning of QI, disturbance in water passage, is anxious, not to the utmost dripping frequently with urine, Urethra astringent pain, and the lower abdomen contracture, pain is drawn the disease that the waist abdomen is a main clinical manifestation.This research is established at its damp and hot stasis of blood network card, and the assertive evidence etiology and pathogenesis mostly is plain body congenital defect, and kidney essense is not filled; Or old deficiency of the kidney, or prolonged illness is impairment of the kidney, or excess of sexual intercourse etc., causes the cause of disease of suffering from a deficiency of the kidney, the assertive evidence etiology and pathogenesis is to be its pathogenesis core with damp and hot stasis of blood network generally.Its pathogenic characteristic is: the one side eating and drinking without temperance, and the pure wine savoury helps humidogene heat, damp-heat accumulation, the multiple abscess part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels, the basis of this disease; Because disease does not heal for a long time, and " pathogen usually intruding into collateral in protracted disease ", " for a long time pain go into network ", and damp invasion of lower energizer have easily caused the irregular operating and the defeated cloth of qi-blood-body fluid, damp and hot blood stasis is handed over knot, thereby the situation that the different deficiency and excess of degree is held concurrently mutually occurs on the other hand.Also have on the one hand, labor is desired excessively, kidney qi internal injury, the pathological change of positive so-called " suffer from a deficiency of the kidney and bladder heat also ".Thereby with clearing away heat-damp and promoting diuresis, disperse blood stasis and dredge collateral is basic method of treatment.
Chronic prostatitis belongs to the traditional Chinese medical science " stranguria ", " stranguria caused by overstrain ", " turbid urine " category.Often, with the passing of time do not heal because of experiencing damp and hot heresy, outbreak repeatedly, " pathogen usually intruding into collateral in protracted disease ", stasis of blood resistance channels causes damp and hot congestion and ties mutually, sends out to be primary disease.This policy is established this pathogenesis.
Monarch uses Cortex Phellodendri.Cortex Phellodendri, bitter in the mouth, cold in nature, be the good merchantable brand of clearing away heat-fire.Not only can detoxify, but also can dampness removing heat, yin nourishing, pathogenic fire reducing, carry it as Compendium of Material Medica: " heat clearing and damp drying, pathogenic fire purging remove steam, detoxifcation treats skin ulcer ", kind pyretic stranguria, eczema, the pruritus controlled, the modern study proof has the prostatitic effect of treatment, so be principal agent.
Minister Radix Sophorae Flavescentis, Semen Vaccariae.Radix Sophorae Flavescentis heat clearing and damp drying, parasite killing diuresis, " book on Chinese herbal medicine justice " are said: " Radix Sophorae Flavescentis, big bitter Great Cold, the drop-down of bringing down a fever; cleanse wet fire, its effect and a kind of reed mentioned in ancient books, company, Radix Gentianae are all close, and the hardship of Radix Sophorae Flavescentis is more; it is dry strong especially, thus can kill the damp and hot worm that gives birth to, than a kind of reed mentioned in ancient books, even the strength benefit is strong ".Semen Vaccariae, the property hardship, flavor is flat.Return liver, the stomach warp.Promoting blood circulation to restore menstrual flow is arranged, the curative effect of inducing diuresis for treating stranguria syndrome.Cure mainly multiple stranguria." book on Chinese herbal medicine justice " is said: " Semen Vaccariae, only the accumulation of heat person is advisable, and " herbal classic " main incised wound hemostasis goes out thorn by pain; " not Lu " ends vexed epistaxis, carbuncle malignant boil, the usefulness of all relieving inflammation or internal heat and invigorating blood circulation." this shows that with the passing of time Semen Vaccariae be more suitable for damp and hot, the disease of blood network stasis of blood resistance.This two flavors clearing away damp-heat and blood stasis dispelling is turbid be ministerial drug altogether, the principal drug assistance heat-clearing and toxic substances removing, and the energy blood stasis dispelling is treating stranguria.
Assistant is with Poria, Herba Plantaginis, the Radix Astragali, Fructus Rosae Laevigatae, Radix Achyranthis Bidentatae.Poria promoting diuresis to eliminate damp pathogen in the side, the spleen invigorating mind calming.Poria function promoting diuresis to eliminate damp pathogen, and the property of medicine is gentle, diuretic and do not hinder healthy energy is the promoting diuresis to eliminate damp pathogen key medicine.The disease of all dysuria, retention of water-damp, no matter be partial to cold-damp, or relatively damp and hot, or belong to insufficiency of the spleen wet poly-, but equal fit applications.Can treating of " property of medicine opinion " meaning: " married woman's pyretic stranguria." Herba Plantaginis is sweet in flavor and cold in property, have diuretic, heat clearing away, make eye bright, the expectorant effect.Cure mainly gonorrhea, hematuria, urinary obstruction etc." grass opinion " carried and said: " control hematuria, the energy tonifying five ZANG-organs makes eye bright, diuresis, logical five types of stranguria ".Two medicines and Cortex Phellodendri, Radix Sophorae Flavescentis share, and can strengthen the effect of its eliminating damp-heat.Fructus Rosae Laevigatae, it is flat that nature and flavor are sour and astringent, has the effect of controlling nocturnal emission with astringent drugs reducing urination." another name for Sichuan Province book on Chinese herbal medicine " carries and " controls the splenic diarrhea dysentery, end normal urination, arresting seminal emission gas." be intended to astringent or styptic treatment for spontaneous sweating kidney qi with this in the side, be the method that consolidates, instability of kidney QI is the pathogenesis basis of damp invasion of lower energizer, as the traditional Chinese medical science to the understanding of stranguria pathogenesis " suffer from a deficiency of the kidney and bladder heat also." Radix Astragali sweet in the mouth, the feeble QI temperature has the effect of invigorating QI to consolidate the body surface resistance diuresis poison holding, is the panacea of QI invigorating, and the Radix Astragali and Fructus Rosae Laevigatae compatibility make the temper abundance and the kidney qi pyknosis, and heresy can not be done also in healthy energy was deposited.And the Radix Astragali and Semen Vaccariae compatibility can be strengthened the power of blood stasis dispelling, lid gas heal void then blood be also more with fixed attention.These five tastes are adjuvant drug altogether, and assistant helps the monarch and his subjects to nourish the spleen kidney, the detoxifcation diuresis.
Assistant makes Radix Achyranthis Bidentatae.This has two layers of meaning Fang Zhongyong, and one, invigorating the liver and kidney, bone and muscle strengthening, promoting blood circulation to restore menstrual flow with Semen Vaccariae, Radix Astragali compatibility, focuses on blood circulation promoting and blood stasis dispelling.Say as " property of medicine opinion ": " control impotence, kidney tonifying, essence replenishing by stagnant blood stream knot, helps the twelve regular channels ".The two, it is descending to draw all medicines, inducing diuresis for treating stranguria syndrome.Say it as " Amplification on Materia Medica addendum ": " it is descending to draw all medicines." " detailed outline " say: " control the five types of stranguria hematuria." " Bencao Jingshu " also the road it: " Radix Achyranthis Bidentatae is walked and can be mended, and property is kind descending." a medicine multipotency, so make it key medicine for helping.
All medicines share, and receive clearing away heat-damp and promoting diuresis, the effect of disperse blood stasis and dredge collateral.Hold concurrently among full side's heat clearing away to support healthy energy, turn round and look at the spleen kidney, damp and hot worry that must not have hematozemia clearly; Blood stasis dispelling and collateral dredging do not have and hinder healthy energy, make blood vessels and and do not have a fraud of staying the stasis of blood; Set upright and be beneficial to eliminating evilly, eliminating evil and just do not hinder, giving consideration to both the incidental and fundamental is to reach the purpose of curing prostatitis.
The consumption of medicine fraction of the present invention also draws through groping in a large number to sum up through the inventor, and each amounts of components is for all having better curative effect in following weight range.
15～25 parts of Cortex Phellodendris, 13～23 parts of Radix Sophorae Flavescentiss, 25～35 parts of Semen Vaccariae, 10～20 parts in Poria,
10～20 parts of Herba Plantaginiss, 10～20 parts of the Radixs Astragali, 10～20 parts of Fructus Rosae Laevigatae, 10～20 parts of Radix Achyranthis Bidentataes.
Be preferably:
20 parts of Cortex Phellodendris, 18 parts of Radix Sophorae Flavescentiss, 30 parts of Semen Vaccariae, 15 parts in Poria,
15 parts of Herba Plantaginiss, 15 parts of the Radixs Astragali, 15 parts of Fructus Rosae Laevigatae, 15 parts of Radix Achyranthis Bidentataes.
Medicine of the present invention can adopt the conventional method of Chinese medicine preparation to be prepared into any conventional oral preparations.The preparation method of medicine activity component of the present invention is as follows:
(1) above eight flavor medical material roguings, wherein Poria and Radix Sophorae Flavescentis two flavor pulverizing medicinal materials become 10 order coarse powder, and all the other Six-element pulverizing medicinal materials become the coarse grain of diameter less than 1cm, and are standby;
(2) get Cortex Phellodendri, Radix Achyranthis Bidentatae adds 5～7 times of amount 60～70% ethanol extractions 2～3 times, and each 1～2 hour, merge alcohol extract, filter, medicinal residues are standby, and pure decompression filtrate recycling ethanol is to there not being the alcohol flavor, and is standby;
(3) medicinal residues and the Radix Astragali, Herba Plantaginis, Fructus Rosae Laevigatae, Semen Vaccariae four Chinese medicine material decocts with water 2～3 times, and each 1～2 hour, each amount of water was 7～9 times of medical material amount, collecting decoction filters, and filtrate and above-mentioned alcohol-extracted extract liquid merge, survey, relative density 1.25～1.30 when being concentrated into 60 ℃, add and pulverize, mix thoroughly, with 60～70 ℃ to the Poria of coarse powder and Radix Sophorae Flavescentis medical material, 0.09MPa drying under reduced pressure is ground into 120 order fine powders.
Be preferably:
(1) above eight flavor medical material roguings, wherein Poria and Radix Sophorae Flavescentis two flavor pulverizing medicinal materials become 10 order coarse powder, and all the other Six-element pulverizing medicinal materials become the coarse grain of diameter less than 1cm, and are standby;
(2) get Cortex Phellodendri, Radix Achyranthis Bidentatae adds 6 times of amount 65% ethanol extractions three times, and each 1.5 hours, merge alcohol extract, filter, medicinal residues are standby, and pure decompression filtrate recycling ethanol is to there not being the alcohol flavor, and is standby;
(3) medicinal residues and the Radix Astragali, Herba Plantaginis, Fructus Rosae Laevigatae, Semen Vaccariae four Chinese medicine material decocts with water three times, and each 1 hour, each amount of water was 8 times of medical material amount, collecting decoction filters, and filtrate and above-mentioned alcohol-extracted extract liquid merge, survey, relative density 1.25～1.30 when being concentrated into 60 ℃, add and pulverize, mix thoroughly, with 60～70 ℃ to the Poria of coarse powder and Radix Sophorae Flavescentis medical material, 0.09MPa drying under reduced pressure is ground into 120 order fine powders.
The active component of medicine of the present invention can add various conventional adjuvant required when preparing different dosage form, be prepared into any peroral dosage form commonly used as disintegrating agent, lubricant, binding agent etc. with the method for Chinese medicinal of routine, as granule, pill, powder, tablet, capsule, oral liquid etc.
The present invention is according to traditional Chinese medical science folk remedy, and according to the clinical practice experience in more than 20 years, comprehensively bibliographical information at all times, excavate meticulously, selected dosage form concentrated pill, granule, tablet, capsule etc. had both embodied the advance of modern pharmaceutical technology, had kept the advantage of traditional decoction again.Compare with conventional dosage forms, volume is little, dose is little, easy to carry, does not add any antiseptic, keeps the natural characteristic of Chinese medicine, because its slowly disintegrate in gastrointestinal tract discharges medicine gradually, meets the slow principle of controlling of slow disease simultaneously.Has clearing away heat and eliminating dampness, the prescription of disperse blood stasis and dredge collateral effect.Administrated method: this preparation, each 15 balls, every day 3 times, oral administration.
The specific embodiment
Below routine by experiment beneficial effect of further setting forth medicine of the present invention.These experimental examples comprise pharmacodynamic experiment of the present invention.
1. test material
1.1 animal: the Wistar rat, body weight 160-260g (each laboratory animal body weight ± 15g), male, quality certification SCXK-(Ji) 2003-0007 is provided by Jilin University's Experimental Animal Center; Kunming mouse, body weight 18-22g, male, available from Changchun Biological Products Institute, credit number: SCXK (Ji)-2006-0001.The drinking-water of freely ingesting.
1.2 medicine: the pharmaceutical composition of chronic prostatitis is provided lot number: 070803 by Changchun University of Traditional Chinese Medicine; QIANLIETAI JIAONANG, Dongtai Pharmaceutical Co., Ltd., Shaanxi Prov., specification: 0.44g/ grain, lot number: 070503,8D01.Other agents useful for same are commercially available.
2. test method and result
2.1 antiinflammatory action
2.1.1 influence to the rat carrageenan foot swelling
Get 50 of male rats, be divided into five groups at random: matched group, 1.5g/kg positive drug group, 2,1, three administration groups of pharmaceutical composition of 0.5g/kg chronic prostatitis, totally five groups.Successive administration 10 days, down inject 0.05% carrageenin 0.15ml/ only in the right back sufficient aponeurosis (aponeuroses) of rat in the last administration after 1 hour, surveyed its foot swelling (prior to injection before measurement normal rat foot girth) then in 1,2,3,4,5,6 hour in injection back, with in the difference of normal foot value as the swelling degree.The results are shown in Table 1.
The influence of table 1. pair rat carrageenan group swelling
Compare * p＜0.05, * * p＜0.01, * * * p＜0.001 with matched group.Following each table of x ± SD together.
As known from Table 1, foot swelling has very obvious suppression effect to the pharmaceutical composition of chronic prostatitis to the rat carrageenin, the inhibitory action of the pharmaceutical composition of 2g/kg, 1g/kg, 0.5g/kg chronic prostatitis sustainable 4,3,1 hours respectively.
2.1.2 influence to the formation of mice agar granuloma
Get 50 of male mices, be divided into five groups at random: matched group, 2.2g/kg positive drug group, 3,1.5, three administration groups of pharmaceutical composition of 0.75g/kg chronic prostatitis, totally five groups.Before the experiment mice is fixed, is enclosed within on the skin of back with special steel ring, subcutaneous injection 2% agar 0.2ml/ injects and begins to irritate stomach medicine or equal-volume water simultaneously, and continuous 10 days, the last administration puts to death mice after 1 hour, carefully peel off granuloma claimed weight in wet base (mg).The results are shown in Table 2.
The table 2. pair granulomatous influence of mice agar
Know that from table 2 the pharmaceutical composition senior middle school dosage of chronic prostatitis can obviously suppress the granulomatous formation of mice agar.
2.1.3 the influence of xylol induced mice dropsy of ear
Get 50 of male mices, be divided into matched group at random, 2.2g/kg positive drug group, 3,1.5, three administration groups of pharmaceutical composition of 0.75g/kg chronic prostatitis, totally five groups, 10 every group, administration every day 1 time, 10d behind last administration 40min, is coated with dimethylbenzene 20 μ l with mice left side ear continuously, put to death mice behind the 20min, utilize 9mm ferrum to sweep away animal left and right sides ear, as the swelling degree, carry out " t " check with animal left and right sides ear difference.The results are shown in Table 3.
The influence of table 3. xylol induced mice dropsy of ear
The result shows that the pharmaceutical composition xylol induced mice dropsy of ear of chronic prostatitis all has the obvious suppression effect.
2.2 influence to the rat acute and chronic prostatitis
2.2.1 the prostatitic influence of rat non-bacterial due to the on Carrageenan
Get 60 of healthy male rats, body weight is 220-240g, be divided into blank group, model group, 2.2g/kg positive drug group, the pharmaceutical composition ball group of 2g/kg chronic prostatitis, the pharmaceutical composition group of 1g/kg chronic prostatitis, the pharmaceutical composition group of 0.5g/kg chronic prostatitis at random, totally six groups.Normal control group and model group gavage the isometric(al) daily water consumption, give 10 days altogether, after the administration in the 9th day 1 hour, after animal is anaesthetized with 30mg/kg, 10ml/kg pentobarbital sodium, open abdomen under the aseptic condition, inject 1% carrageenin normal saline solution 0.1ml/ leaf in the prostate siphonal lobe, normal control group injection equivalent normal saline is sewed up the back routine disinfection.Give carrageenin after 24 hours (1h after the last administration), put to death animal, take out prostate and weigh, calculate organ index.In addition, get a leaf prostate and be dipped in the 1ml normal saline and it is broken, in order to detect leukocyte count and lecithin density with shears; Another leaf prostate is dipped in and carries out histological examination in 10% formalin.See Table 4,5 and appendix 1.
The influence that prostatitis rat Histological changes due to table 4. on Carrageenan (x ± s, n=10)
Annotate: 1. being full of a large amount of inflammatory cells in an intracavity or the matter is 3 grades, and the small part inflammatory cell is 2 grades in an intracavity or the matter, and being dispersed in a little inflammatory cell in an intracavity or the matter is 1 grade.Nothing or accidental inflammatory cell are 0 grade in an intracavity or the matter.
2. the interior fibroblast of matter mostly is 3 grades between, and fibroblast is 2 grades on a small quantity in the matter, and the interior fibroblast of a matter is accidental to be 1 grade, does not see fibroblast does not see to be 0 grade in the matter.
3. interstitial edema is evident as 3 grades, and the interstitial edema moderate is 2 grades, and interstitial edema slightly is 1 grade.Between matter not have edema be 0 grade.
4. represent X ± SD, result's statistics is the check of order nuclear.
Control rats prostata tissue softness, ruddy glossy is observed in gross anatomy.Model group rat prostate tissue and surrounding tissue have adhesion, gloss dimness in various degree.The pharmaceutical composition group prostata tissue of positive drug group and chronic prostatitis and the adhesion of surrounding tissue alleviate, and tissue surface gloss is normal substantially.
The prostatitic influence of rat non-bacterial due to table 5. on Carrageenan
Table 5 prompting, with model group relatively, basic, normal, high 3 the dosage groups of compositions and positive controls all can obviously reduce the total white blood cells in the prostatic fluid, increase lecithin density is with 2, the effect of 1g/kg dosage group is the strongest.
2.2.2 the prostatitic influence of on Carrageenan induced mice non-bacterial
Get 60 of healthy male mices, body weight is 19-22g, be divided into blank group, model group, 2.2g/kg positive drug group, the pharmaceutical composition group of 3g/kg chronic prostatitis, the pharmaceutical composition group of 1.5g/kg chronic prostatitis, the pharmaceutical composition of 0.7g/kg chronic prostatitis at random, totally six groups.Normal control group and model group such as gavage at ordinary water, give 10 days altogether, after the last administration 1 hour, after animal is anaesthetized with 50mg/kg, 10ml/kg pentobarbital sodium, open abdomen under the aseptic condition, only inject 1% carrageenin normal saline solution 0.02ml/ in the prostate siphonal lobe, normal control group injection equivalent normal saline is sewed up the back routine disinfection.Give carrageenin and put to death animal after 3 hours, take out prostate and weigh, calculate organ coefficient.
As known from Table 6, this product on Carrageenan causes that the prostatitic prostatauxe of mice non-bacterial has the obvious suppression effect.
The prostatitic influence of table 6 on Carrageenan induced mice
2.2.3 to the prostatitic influence of rat fibroplasia due to the xiaozhiling injection
Get 60 of SD male rats, grouping sees Table 7, is divided into 6 groups at random, 10 every group.After 30mg/kg, the anesthesia of 10ml/kg pentobarbital sodium, under aseptic condition, take off the through abdominal cavity of the about 1cm of abdominal part median incision, bladder and both sides seminal vesicle are proposed, exposure is attached to the prostate notopodium of seminal vesicle inboard, again 25% XIAOZHILING ZHUSHEYE 0.2mL is injected prostate bilateral notopodium (0.1ml/ leaf) respectively, suture muscles then, skin.Performing the operation begins administration (28d continuously) after 7 days, collect 6 hours urine of rat after the administration in the 27th day, recording volume, and 1h after the last administration, the sacrificed by decapitation rat is dissected, and perusal prostatic lesion state takes out prostate and weighs, and calculates organ coefficient.Prostata tissue is dipped in and carries out histological examination in 10% formalin.See Table 7,8 and appendix 2.
The influence of fibroplasia prostatitis rat urine amount due to the table 7. pair water load xiaozhiling injection
The influence of rat prostate fibroplasia inflammation due to the table 8. pair xiaozhiling injection
Annotate: the interior cell infiltration of matter mostly is 3 grades 1., and inflammatory cell mostly is 2 grades in the matter, and the interior cell infiltration of a matter is less to be 1 grade.Between do not have in the matter or accidental cell infiltration is 0 grade.
2. interstitial fibers hamartoplasia mostly is 3 grades, and interstitial fibers hamartoplasia mostly is 2 grades, and interstitial fibers hamartoplasia is less to be 1 grade, and the no hypertrophy of interstitial fibers tissue is 0 grade.
3. represent X ± SD, result's statistics is the check of order nuclear.
2.2.4 influence to rat bacterial prostatitis due to the escherichia coli
Male SD rat, body weight 230-260g is divided into 6 groups at random, and normal group and model group are irritated stomach and given ordinary water, the positive drug group is irritated stomach and is given QIANLIETAI JIAONANG 1.5g/kg, be subjected to the reagent group to give pharmaceutical composition 2,1, the 0.5g/kg of chronic prostatitis, continuous 10 days, after administration in the 7th day 1 hour, after pentobarbital sodium 30mg/kg, the 10ml/kg anesthesia, under aseptic condition, except that normal group, inject 5 * 10 in each Mus prostate notopodium
7Individual/ml escherichia coli normal saline solution 0.1ml/ leaf, inject physiological saline solution in the normal rats prostate notopodium, sew up.After 72 hours, put to death rat, take by weighing the prostate weight in wet base, detect leukocyte count and lecithin density in the prostatic fluid, and get part rat prostate tissue and carry out histological examination with the carrageenin test method.The results are shown in Table 9,10 and appendix 3.
See that from table 8 and appendix 3 tangible suppurative inflammation appears in the model group prostata tissue, more significantly destroying appears in gland structure, and a matter inflammatory reaction is also more obvious, and visible fibroblast proliferation, the model success.Positive drug group and each administration group prostatitis degree all have alleviating in various degree, and wherein the most obvious with the high dose group effect, middle dosage group lesion degree is close with the positive drug group, and the action effect of low dose group is very unobvious.This medicine of presentation of results has the certain protection effect to the prostatitis due to the escherichia coli.
Prostatitis rat Histological changes due to the table 9. pair escherichia coli influences x ± s, n=10)
Annotate: 1. be full of a large amount of inflammatory cells in an intracavity or the matter and represent with 3 grades, the small part inflammatory cell is represented with 2 grades in an intracavity or the matter, is dispersed in a little inflammatory cell in an intracavity or the matter and represents with 1 grade.Nothing or accidental inflammatory cell are represented with 0 grade in an intracavity or the matter.
2. between in the matter the more usefulness of fibroblast represent that fibroblast is a small amount of in the matter represents that the accidental usefulness of fibroblast is represented for 1 grade in the matter with 2 grades for 3 grades, do not see that the interior fibroblast of a matter does not see with 0 grade to represent.
3. interstitial edema obviously represents that with 3 grades the interstitial edema moderate represents that with 2 grades interstitial edema is slightly represented with 1 grade.Between matter do not have edema and represent with 0 grade.
4. represent X ± SD, result's statistics is the check of order nuclear.
The influence of rat bacterial prostatitis due to the table 10 pair escherichia coli
The data of table 9 have shown that fully the pharmaceutical composition of chronic prostatitis has tangible prevention and therapeutical effect to bacterial prostatitis, and the 2g/kg group is particularly evident.
3. to Immune Effects
3.1 the huge influence of biting system's phagocytic function of mouse monokaryon cell
Get 50 of male mices, be divided into matched group at random, 2.2g/kg positive drug group, 3,1.5, three administration groups of pharmaceutical composition of 0.75g/kg chronic prostatitis, totally five groups.Every day gastric infusion once, successive administration 10d, behind the last administration 1h, (10ml/kg, Chinese prepared Chinese ink: normal saline=1: 5), respectively at 2,15min gets blood 0.05ml by the eye socket vein, adds 5ml 0.1%NaHCO in mouse tail vein injection prepared Chinese ink
3In the solution, utilize 750 type spectrophotometers, and cut open and get liver and spleen is weighed, alpha value calculated in 650nm place colorimetric.The results are shown in Table 11.
3.2 the influence of mice hemolysin content
Get 50 of mices, press table 9 grouping, successive administration 10d, reference literature
[1]Method, the 4th day every Mus lumbar injection 0.5% chicken red blood cell 0.2ml of administration, immunity back 7d eye socket is got blood, the centrifugal serum that gets is got 100 times of serum 1ml of normal saline dilution and is mixed with 0.5ml 5% chicken red blood cell, adds 1% guinea pig serum 0.5ml in frozen water, 37 ℃ of insulation 30min, 0 ℃ of cessation reaction, supernatant the results are shown in Table 11 in 750 type spectrophotometer 540nm colorimetrics.
Table 11 shows that the pharmaceutical composition of chronic prostatitis improves significantly to mouse monokaryon macrophage system phagocytic function, and can improve the content of mice hemolysin, but no statistical significance.
Table 11. pair effect of immunologic function
4. to the influence of blood stasis hemorheology of rat
Get 60 of 180～210g male rats, be divided into three administration groups of pharmaceutical composition (totally six groups) of sham operated rats, model group, 1.5g/kg positive drug group, 2,1,0.5g/kg chronic prostatitis at random, 10 every group, administration every day 1 time, continuous 10 days.30min subcutaneous injection (S.C) 0.1% adrenalin hydrochloride 0.1ml/ only after the d12 administration, 30min relief rat ice bath 5min, allow rat ice bath 5min behind the d13 administration 1h again, 30min subcutaneous injection (S.C) 0.1% adrenalin hydrochloride 0.1ml/ only puts to death rat behind the d15 administration 1h after the d14 administration.Utilize fully automatic blood rheology fast measuring instrument to check its hemorheology by abdominal aortic blood.The results are shown in Table 12.
Know that by table 12 cause the hemorheology index of the rat of blood stasis to have some improvement to ice bath in conjunction with the subcutaneous injection adrenalin hydrochloride, the pharmaceutical composition of 2g/kg chronic prostatitis can effectively improve blood stasis hemorheology of rat index.
5. the influence of Dichlorodiphenyl Acetate induced mice writhing response
Get 50 of male mices, be divided into matched group at random, 2.2g/kg positive drug group, 3,1.5, three administration groups of pharmaceutical composition of 0.75g/kg chronic prostatitis, totally five groups.Every day gastric infusion once, successive administration 10d, behind the last administration 45min, lumbar injection (ip) 0.9% acetic acid 0.2ml/ only writes down mouse writhing number of times in its 15min.The results are shown in Table 13.
By table 13 as seen, 3,1.5g/kg this product is that cocoa obviously reduces white mice and turns round the body number of times.
The influence of table 13 pair mice acetic acid twisting reaction
Conclusion: the present invention has the effect of eliminating damp-heat, circulation of qi promoting intestinal stasis relieving, clots absorbing eliminating stagnation, warming YANG astringency inducing, nourishing kidney-YIN, is used for the treatment of acute and chronic prostatitis.In conjunction with prostatitic clinical manifestation, we study non-bacterial, prevention and therapeutical effect bacillary, fibroplasia prostatitis animal model from the present invention, result of the test shows, the present invention (2,1,0.5g/kg), due on Carrageenan and the escherichia coli in the prostatitis rat prostate liquid leukocyte number raise and the reduction of lecithin density all has the obvious suppression effect, and can alleviate that the rat prostate chamber is not of uniform size, the degree of cell infiltration and interstitial edema; The present invention (2,1g/kg) effect significantly.The present invention (2,1,0.5g/kg) can suppress the hypertrophy and the hypertrophy of chronic prostatitis rat body of gland due to the xiaozhiling injection, obviously alleviates the chronic inflammation cellular infiltration, and proliferation of fibrous tissue is inhibition trend, also can obviously increase the urine amount of chronic prostate rat.Set up rat carrageenan foot swelling, mice agar granuloma and form and three inflammatory models of mouse ear edema, be used for studying the influence of the present invention red, swollen, the granulation tissue hyperplasia of inflammation.Result of the test has effectively been illustrated the present invention all has significant inhibitory effect to the inflammation different phase, and antiinflammatory action is better than the positive drug Longbishu Jiaonang..Result of the test has also proved, the present invention (2g/kg), cause the hemorheology index of the rat of blood stasis to have some improvement to ice bath in conjunction with the subcutaneous injection adrenalin hydrochloride, particularly evident to the effect of whole blood viscosity, the humoral immune function to mice improves significantly simultaneously.The present invention in addition (3,1.5g/kg), the mouse writhing that Dichlorodiphenyl Acetate causes also has certain inhibitory action.
This result of the test has proved that fully this product has prevention and therapeutical effect to tentative bacterium property and non-bacterial acute and chronic prostatitis.
2. acute toxicity test
2.1 press the maximum dosage 40ml/kg of 20g/kg (0.5g/ml, 50%), to irritate stomach in the 24h and give this preparation of empty stomach mice three times, whole dosage is 60g/kg.
2.2 be equivalent to 400 times (becoming per capita, body weight is 60kg) of clinical adult's consumption every day.
2.3 maximum dosage is in one day: 60g/kg
2.4 this product does not have tangible influence to the weight of animals
Do not produce acute toxicity 2.5 show gastric infusion, clinical drug safety.
3. long term toxicity test
By 30ml/kg every day 1 continuous irrigation stomach give male rat 10.8,5.4,26 weeks of this preparation of 2.7g/kg.Observe rat outward appearance, behavior, secretions, feces, ingest, drinking-water situation and body weight gain situation, respectively at 12,26 week and convalescent periods after the administration, matched group and administration group are respectively got 10 rat sacrificed by decapitation, get blood examination and look into every indexs such as hematology, blood biochemical, coagulation function, and perform an autopsy on sb, claim weight in wet base and multiple organs and tissues pathological examination to main organs.Through with matched group relatively, behind the gastric infusion, each dosage group rat hair is glossy, movable active, outward appearance is normal, ingest, drinking-water, feces, secretions etc. there is no unusually, rat body weight increases and matched group more also zero difference; Hematology, blood biochemical, coagulation function and organs and tissues pathological examination etc. there is no change.Rat 10.8g/kg/ Japan preparation is equivalent to 72 times (by 60 kilograms of calculating of body weight per capita), pharmacodynamics effective dose 10.8 times of people's consumption every day approximately.
By PATHOMORPHOLOGICAL OBSERVATION OF PULLORUM to each histoorgan, 3 months administration groups, 6 months administration groups, convalescent periods are organized rat and examine histoorgan morphosis and normal control group indifference, the pathologic of not seeing clear regularity changes, and illustrates that this medicine does not have the overt toxicity effect to each internal organs of rat.
This result of the test demonstration this product and matched group comparison are not seen harmful effect to animal under the situation of heavy dose of long-term prescription.
The preparation of embodiment 1 medicinal tablet of the present invention
Cortex Phellodendri 300g, Radix Sophorae Flavescentis 260g, Semen Vaccariae 500g, Poria 200g,
Herba Plantaginis 200g, Radix Astragali 200g, Fructus Rosae Laevigatae 200g, Radix Achyranthis Bidentatae 200g.
The preparation method of medicine activity component of the present invention is as follows:
(1) above eight flavor medical material roguings, wherein Poria and Radix Sophorae Flavescentis two flavor pulverizing medicinal materials become 10 order coarse powder, and all the other Six-element pulverizing medicinal materials become the coarse grain of diameter less than 1cm, and are standby;
(2) get Cortex Phellodendri, Radix Achyranthis Bidentatae adds 5 times of amount 60% ethanol extractions 3 times, and each 1 hour, merge alcohol extract, filter, medicinal residues are standby, and pure decompression filtrate recycling ethanol is to there not being the alcohol flavor, and is standby;
(3) medicinal residues and the Radix Astragali, Herba Plantaginis, Fructus Rosae Laevigatae, Semen Vaccariae four Chinese medicine material decocts with water 3 times, and each 1 hour, each amount of water was 7 times of medical material amount, collecting decoction filters, and filtrate and above-mentioned alcohol-extracted extract liquid merge, survey relative density 1.25～1.30 when being concentrated into 60 ℃, add and pulverize, mix thoroughly, with 60 ℃ to the Poria of coarse powder and Radix Sophorae Flavescentis medical material, 0.09MPa drying under reduced pressure is ground into 120 order fine powders.
(4) add the conventional adjuvant for preparing tablet, tabletting.
The preparation of embodiment 2 medicine concentrated pills of the present invention
Cortex Phellodendri 400g, Radix Sophorae Flavescentis 360g, Semen Vaccariae 600g, Poria 300g,
Herba Plantaginis 300g, Radix Astragali 300g, Fructus Rosae Laevigatae 300g, Radix Achyranthis Bidentatae 300g.
(1) above eight flavor medical material roguings, wherein Poria and Radix Sophorae Flavescentis two flavor pulverizing medicinal materials become 10 order coarse powder, and all the other Six-element pulverizing medicinal materials become the coarse grain of diameter less than 1cm, and are standby;
(2) get Cortex Phellodendri, Radix Achyranthis Bidentatae adds 6 times of amount 65% ethanol extractions 3 times, and each 1.5 hours, merge alcohol extract, filter, medicinal residues are standby, and pure decompression filtrate recycling ethanol is to there not being the alcohol flavor, and is standby;
(3) medicinal residues and the Radix Astragali, Herba Plantaginis, Fructus Rosae Laevigatae, Semen Vaccariae four Chinese medicine material decocts with water 3 times, and each 1 hour, each amount of water was 8 times of medical material amount, collecting decoction filters, and filtrate and above-mentioned alcohol-extracted extract liquid merge, survey relative density 1.25～1.30 when being concentrated into 60 ℃, add and pulverize, mix thoroughly to the Poria of coarse powder and Radix Sophorae Flavescentis medical material, with 65 ℃, 0.09MPa drying under reduced pressure is ground into 120 order fine powders
(4), make concentrated pill 1000g, every ball 0.2g with water pill.
The preparation of embodiment 3 capsules of the present invention
Cortex Phellodendri 500g, Radix Sophorae Flavescentis 460g, Semen Vaccariae 700g, Poria 400g,
Herba Plantaginis 400g, Radix Astragali 400g, Fructus Rosae Laevigatae 400g, Radix Achyranthis Bidentatae 400g.
(1) above eight flavor medical material roguings, wherein Poria and Radix Sophorae Flavescentis two flavor pulverizing medicinal materials become 10 order coarse powder, and all the other Six-element pulverizing medicinal materials become the coarse grain of diameter less than 1cm, and are standby;
(2) get Cortex Phellodendri, Radix Achyranthis Bidentatae adds 7 times of amount 70% ethanol extractions 2 times, and each 2 hours, merge alcohol extract, filter, medicinal residues are standby, and pure decompression filtrate recycling ethanol is to there not being the alcohol flavor, and is standby;
(3) medicinal residues and the Radix Astragali, Herba Plantaginis, Fructus Rosae Laevigatae, Semen Vaccariae four Chinese medicine material decocts with water 2 times, and each 2 hours, each amount of water was 9 times of medical material amount, collecting decoction filters, and filtrate and above-mentioned alcohol-extracted extract liquid merge, survey, relative density 1.25～1.30 when being concentrated into 60 ℃, add and pulverize, mix thoroughly, with 70 ℃ to the Poria of coarse powder and Radix Sophorae Flavescentis medical material, 0.09MPa drying under reduced pressure is ground into 120 order fine powders.
(4) add the conventional adjuvant for preparing capsule, encapsulated.
Claims (4)
1. pharmaceutical composition for the treatment of chronic prostatitis is characterized in that it is to be made by the crude drug of following ratio of weight and number:
15～25 parts of Cortex Phellodendris, 13～23 parts of Radix Sophorae Flavescentiss, 25～35 parts of Semen Vaccariae, 10～20 parts in Poria,
10～20 parts of Herba Plantaginiss, 10～20 parts of the Radixs Astragali, 10～20 parts of Fructus Rosae Laevigatae, 10～20 parts of Radix Achyranthis Bidentataes.
2. pharmaceutical composition for the treatment of chronic prostatitis is characterized in that it is to be made by the crude drug of following ratio of weight and number:
20 parts of Cortex Phellodendris, 18 parts of Radix Sophorae Flavescentiss, 30 parts of Semen Vaccariae, 15 parts in Poria,
15 parts of Herba Plantaginiss, 15 parts of the Radixs Astragali, 15 parts of Fructus Rosae Laevigatae, 15 parts of Radix Achyranthis Bidentataes.
3. the preparation of drug combination method of treatment chronic prostatitis as claimed in claim 1 or 2 is characterized in that comprising the following steps:
(1) above eight flavor medical material roguings, wherein Poria and Radix Sophorae Flavescentis two flavor pulverizing medicinal materials become 10 order coarse powder, and all the other Six-element pulverizing medicinal materials become the coarse grain of diameter less than 1cm, and are standby;
(2) get Cortex Phellodendri, Radix Achyranthis Bidentatae adds 5～7 times of amount 60～70% ethanol extractions 2～3 times, and each 1～2 hour, merge alcohol extract, filter, medicinal residues are standby, and pure decompression filtrate recycling ethanol is to there not being the alcohol flavor, and is standby;
(3) medicinal residues and the Radix Astragali, Herba Plantaginis, Fructus Rosae Laevigatae, Semen Vaccariae four Chinese medicine material decocts with water 2～3 times, and each 1～2 hour, each amount of water was 7～9 times of medical material amount, collecting decoction filters, and filtrate and above-mentioned alcohol-extracted extract liquid merge, survey, relative density 1.25～1.30 when being concentrated into 60 ℃, add and pulverize, mix thoroughly, with 60～70 ℃ to the Poria of coarse powder and Radix Sophorae Flavescentis medical material, 0.09MPa drying under reduced pressure is ground into 120 order fine powders.
4. the preparation of drug combination method of treatment chronic prostatitis as claimed in claim 3 is characterized in that comprising the following steps:
(1) above eight flavor medical material roguings, wherein Poria and Radix Sophorae Flavescentis two flavor pulverizing medicinal materials become 10 order coarse powder, and all the other Six-element pulverizing medicinal materials become the coarse grain of diameter less than 1cm, and are standby;
(2) get Cortex Phellodendri, Radix Achyranthis Bidentatae adds 6 times of amount 65% ethanol extractions 3 times, and each 1.5 hours, merge alcohol extract, filter, medicinal residues are standby, and pure decompression filtrate recycling ethanol is to there not being the alcohol flavor, and is standby;
(3) medicinal residues and the Radix Astragali, Herba Plantaginis, Fructus Rosae Laevigatae, Semen Vaccariae four Chinese medicine material decocts with water 3 times, and each 1.0 hours, each amount of water was 8 times of medical material amount, collecting decoction filters, and filtrate and above-mentioned alcohol-extracted extract liquid merge, be concentrated into 60 ℃ of surveys, relative density 1.25～1.30, add and pulverize, mix thoroughly, with 65 ℃ to the Poria of coarse powder and Radix Sophorae Flavescentis medical material, 0.09MPa drying under reduced pressure is ground into 120 order fine powders.
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| CN103505695B (en) * | 2012-06-20 | 2015-07-08 | 陕西健民制药有限公司 | Traditional Chinese medicine combination for treating prostatitis and benign prostate hyperplasia and preparation method thereof |
| CN102743567B (en) * | 2012-06-30 | 2013-08-21 | 艾芹 | Traditional Chinese medicine for treating chronic prostatitis |
| CN115364165A (en) * | 2020-10-28 | 2022-11-22 | 上海雷云生物科技有限公司 | A topical Chinese medicinal composition for treating prostatitis, and its preparation method |
| CN113679757B (en) * | 2021-09-08 | 2022-05-31 | 上海交通大学医学院附属第九人民医院 | Pharmaceutical composition for improving bladder contractility and application thereof |
| CN116726083B (en) * | 2022-12-06 | 2024-01-26 | 谷医堂(湖南)健康科技有限公司 | Traditional Chinese medicine composition for treating chronic prostatitis |
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