CN100464770C - A medicine for treating chronic prostatitis and preparation method thereof - Google Patents
A medicine for treating chronic prostatitis and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a Chinese medicament for treating chronic prostatitis and process for preparation, wherein the medicament is prepared from ten kinds of Chinese herbs including corktree bark, herba patriniae, natural indigo, plantain seeds, talcum powder, grassleaved sweetflag rhizome, poria cocos, atractylodes rhizome and red sage root.
Description
Affiliated technical field
The invention belongs to the preparing technical field of pharmaceuticals, relating to a kind of is the medicine that is used for the treatment of chronic prostatitis of feedstock production and the preparation method of this medicine with the Chinese herbal medicine.
Background technology
Chronic prostatitis is with the infection of prostatitis glandular substance of prostate, congested, swelling, cell infiltration, and the glandular epithelium necrosis, even microabscess forms the common andropathy of main pathological change, one of genus difficult disease.According to statistics, sickness rate that at present should disease in the male adults crowd more than 35 years old is up to 40%.Because the remarkable and concealment of chronic prostatitis syndrome shape differs greatly, so clinically only to have remarkable symptom and property found or obstacle person prescription on individual diagnosis fertility after marriage, account for 1/3-1/2 of special outpatient clinic patient sum, the touching difficulty of its course of disease more, outbreak repeatedly, cure thornyly,, even cause sterile if obstinate then influences sexual function.
In many medical literatures and books report in the past, to the treatment of chronic prostatitis many with antibiotic as main treatment means, antibacterial culturing by prostatic fluid adds the susceptibility test can select effective antibiotic, but because prostatic membrane barrier action, at present clinical antibiotic commonly used is difficult for entering in the prostata tissue keeping effective drug level, thereby therapeutic effect is not good.Once the someone reported that adding SMZ with rifampicin can make and keep higher drug concentration in the prostate, but easily caused hepatic and renal function injure, and life-time service or abuse blindly are easy to produce drug resistance, destroy body flora balance.To abacterial prostatitis, antibiotic does not have definite effect.And the application of therapies such as traditional massage, demibain is very limited, and it is to the chronic prostatitis therapeutic advance, and document is dabbled also few recently.Treat clinically at present prostatitic Chinese patent medicine such as nineteen ninety-five the prostatitis newly recorded of the version pharmacopeia ball that relaxes form by Radix Rehmanniae Preparata, Fructus Corni, Rhizoma Dioscoreae etc., with strengthening the body resistance, the nourishing YIN for benefiting the kidney, diuresis is the rule of treatment; QIANLIETONG PIAN is made up of the Radix Astragali, succinum, Cortex Cinnamomi etc., and kidney and spleen invigorating is main; QIANLIEKANG PIAN and Prostat are Pollen Preparations, with Phenoxybenzamine (phenoxybenzamine hydrochloride) sheet be the mechanism of action with the receptor blocking, be mainly used in prostatic hyperplasia, hypertrophy; BAZHENG HEJI can be used for damp-heat type stranguria with turbid discharge, pyretic stranguria.More than all medicines all be the rule of treatment with the tonification, has curative effect preferably aspect treatment insufficiency of kidney-YANG or the liver-kidney yin deficiency prostatitis, but yet exist to a certain extent in the practice medication not comprehensively, problem such as dosage is big, curative effect is unstable and cure rate is low, influenced further applying of product.Up to now, this area does not still have treatment this sick ideal medicament and method.
Summary of the invention
The objective of the invention is to the problem at the prior art existence, providing a kind of is the efficient medicine that is used for the treatment of chronic prostatitis of feedstock production and the preparation method of this medicine with the Chinese herbal medicine.
The preparation scheme of medicine of the present invention comes from motherland's medical science about traditional determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs thoughts such as " radicallying reform ", " treatment must aim at the pathogenesis of disease ", and it is that the designer obtains by concentrated summary development according to clinical practice for many years and on the modern pharmacology experiment basis.Do not have " prostatitis " speech in motherland's medical literature ancient books, but the symptom of being put down in writing in the document and its performance, pathogenesis match.Male's prostate, the traditional Chinese medical science are referred to as " smart chamber ".In the YIN diseasei prostatitis one joint is arranged before " Surgery of Chinese Medicine " the 5th edition teaching material chapter 8 male, the traditional Chinese medical science thinks that the chronic prostatitis disease belongs to categories such as the traditional Chinese medical science " smart turbid ", " stranguria with turbid discharge ", " nebulousurine ".The title of pouring, the beginning sees " interior warp ", and " element is asked the hexa-atomic big opinion piece of writing of just recording " claims " drenching vexed ", and promptly " Medical Treasures of the Golden Chamber accumulation of pathogenic wind cold in five ZANG-organs disease " is " stranguria with urinary obstruction "." Medical Treasures of the Golden Chamber relieving thirst and treating dribbling urination " piece of writing is described as the symptom of " pourings ": " pourings be disease, obstructed urine as dripping, contraction in the lower abdomen, dragging pain in the navel." illustrate that this disease is is main symptom with the not well urethral irritation of urinating." Medical Treasures of the Golden Chamber accumulation of pathogenic wind cold in five ZANG-organs disease " thought: " drench heat in lower-JIAO." " General Treatise on the Cause and Symptoms of Diseases gonorrhea nobility " have speech: " and Zhu Linzhe, so bladder heat is also by suffering from a deficiency of the kidney ... the then frequent micturition of suffering from a deficiency of the kidney, bladder heat is then puckery under water, and is several and puckery, then drippingly do not declare, thus meaning for drenching." " Jing Yue's complete work stranguria with turbid discharge " piece of writing says: " and sick at the beginning of the pouring, then invariably by popular drama, do not have appearance and distinguish.……。" back physicians from a family for generations family thinks: this much more sick because long-pending bladder of heat, but also have owing to suffering from a deficiency of the kidney or hyperactivity of the ministerial fire is sent out." Lei Zheng Zhi Cai " stranguria with turbid discharge piece of writing is said: " turbid smart person, hyperactivity of the ministerial fire or contrary essence make so, and extremely essence is drowned and gone out." according to etiology and pathogenesis and performance, clinical in normal dialectical four types that are divided into of this disease, promptly damp and hot heap soil or fertilizer over and around the roots resistance card, the moving card of deficiency of YIN fire, spleen are suffered from a deficiency of the kidney and decreased card and syndrome of qi stagnation and blood stasis.Aspect treatment, Li Gao says: " if pathogenic heat are at part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels blood system, thirsty and urinary obstruction person ... method is when all thick with abnormal smells from the patient, and the medicine in the moon is controlled it, and Cortex Phellodendri, the Rhizoma Anemarrhenae are also." " medicine justice " speech: " man's nebulousurine, have a pain in the stem ， Rhizoma Dioscoreae Septemlobae master it." " bixie fenqing drink " in " danxi's experiential therapy " and " Medicine Comprehended " then be respectively the name side of treatment part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels deficiency and coldness and damp-heat in lower-JIAO nebulousurine.Control suitable heat-clearing and toxic substances removing according to motherland's medical science about chronic prostatitis, dampness removingization is turbid, assistant is with the spleen strengthening and damp drying, the Therapeutic Principle of blood circulation promoting and blood stasis dispelling, the present invention passes through Cortex Phellodendri Rhizoma Dioscoreae Hypoglaucae, Herba Patriniae, Indigo Naturalis, Semen Plantaginis, Talcum, Rhizoma Acori Graminei, Poria, Rhizoma Atractylodis, the in addition science preparation of Radix Salviae Miltiorrhizae ten flavor Chinese crude drugs, set up the side of one-tenth, full side has clearing away heat-damp and promoting diuresis, change turbid treating stranguria effect, be used for damp and hot heap soil or fertilizer over and around the roots resistance, the frequent micturition of syndrome of qi stagnation and blood stasis, urgent micturition, dysurea, the urine back sound of rain pattering not to the utmost, urethra scorching hot, pudendum humidity, urethra nebulousurine, perineum, the external genitalia district, few abdomen, suprapubic region, the waist sacrum, chronic prostatitis (strangurias with turbid discharge such as anus position pain or the bloated discomfort of bob, smart turbid) the treatment aspect of disease has fabulous curative effect, can make damp and hot heap soil or fertilizer over and around the roots resistance, the syndrome of qi stagnation and blood stasis sign is fundamentally improved.
The weight proportion that constitutes each component raw material of medicine of the present invention is:
Cortex Phellodendri 144-176 Rhizoma Dioscoreae Hypoglaucaes 288-352 Herba Patriniae 288-352
Indigo Naturalis 45-55 Talcums 171-209 Semen Plantaginiss 288-352
Rhizoma Acori Graminei 144-176 Poria 144-176 Rhizoma Atractylodis 144-176
Radix Salviae Miltiorrhizae 288-352
Medicine of the present invention is a kind of at the clinical effective Chinese medicine preparations of seeing damp and hot heap soil or fertilizer over and around the roots resistance type chronic prostatitis and developing more, its prescription, function and adapt to disease and meet that the traditional Chinese medical science is turbid to essence, the logos of stranguria with turbid discharge.Cortex Phellodendri, Rhizoma Dioscoreae Hypoglaucae energy clearing away heat-damp and promoting diuresis are monarch drug of the present invention in the side.Cortex Phellodendri bitter cold consolidating YIN, clearing ministerial fire; Rhizoma Dioscoreae Septemlobae can dehumidify, again can " hard muscles and bones ", and one side is dried, a controlling nocturnal emission with astringent drugs, biphase taking into account removed damp-heat in lower-JIAO altogether with Cortex Phellodendri." book on Chinese herbal medicine is just " speech: " Cortex Phellodendri, profit cold in nature is fallen, steepest reduces internal heat "." medicine justice " is said: " Cortex Phellodendri, bitter in the mouth are that pathogenic fire reducing can be capit ad calcem to the marrow, and the thorough marrow of the skin that sinks is thoughtful invariably, specially rush down the fire of kidney and bladder ".The soothing the liver spleen of Cortex Phellodendri and let out damp and hotly, clear bladder and to arrange the stasis of blood turbid very has prompt the effect, so be the kidney channel principal agent.Rhizoma Dioscoreae Hypoglaucae nature and flavor hardship, cold, go into stomach, kidney, urinary bladder channel.Say in " book on Chinese herbal medicine justice ": " Rhizoma Dioscoreae Septemlobae is gone into medicinal, and then heavy the bob descends, so cure mainly the part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels "." book on Chinese herbal medicine analyze mentally record " speech: " be the pure and impure agent of branchs later age with the Rhizoma Dioscoreae Septemlobae, also stretches turbid the falling of then clear liter by the moon sun.Promptly end frequent micturition, remove pains in the penis, all not going out is adopted ear ".Therefore Rhizoma Dioscoreae Septemlobae is that dampness removingization is turbid, controls the key medicine of nebulousurine.
But Herba Patriniae, Indigo Naturalis heat-clearing and toxic substances removing, removing heat from blood suppurate, and with heat clearing away, dampness removing, treating stranguria, the four Chinese medicine thing can strengthen the effect of monarch drug clearing away heat-damp and promoting diuresis among the present invention, is ministerial drug altogether with Talcum, Semen Plantaginis.Herba Patriniae nature and flavor hardship, flat, go into liver, kidney, large intestine channel, be good at heat-clearing and toxic substances removing, the evacuation of pus removing blood stasis with potent drugs." book on Chinese herbal medicine justice " speech: " this grass ... the energy heat clearing away is let out knot, inducing diuresis to remove edema, removing blood stasis with potent drugs evacuation of pus ".The Indigo Naturalis nature and flavor are sweet, and are cold, energy heat-clearing and toxic substances removing, removing heat from blood, arresting convulsion.Says in " Bencao Jingshu ": " Gu its chief, more ancient prescription has and is used for all blood disorder persons for Indigo Naturalis, the heat extraction that detoxifies." the Talcum nature and flavor are sweet, light, and are cold, go into lung, stomach, urinary bladder channel." Records of Tradition Chinese and Western Medicine in Combination " has speech: " because of hot dysuria person, Talcum is key medicine the most." " Bencao Jingshu " say: " and Talcum, sliding in order to all keys, the logical heap soil or fertilizer over and around the roots stagnates, and following dirt is bored with.Sweet with easing stomach-QI, cold, sweet cold sliding sharp with the long-pending heat of loosing, to close its usefulness, be to be the damp eliminating heat radiation, the diuretic dehumidifying, removing food stagnancy stagnates, the key medicine of sharp lower orifices ".It is exactly with Talcum folk prescription treatment pyretic stranguria, hot urination burning pain that " Shengji Zonglu " middle Talcum looses.As seen Talcum has inducing diuresis for treating stranguria syndrome, heat-clearing and toxic substances removing, and the effect of skin ulcer is held back in damp eliminating.The Semen Plantaginis nature and flavor are sweet, and are cold, go into liver, kidney, urinary bladder channel, the energy clearing away heat and promoting diuresis, and eliminating dampness by diuresis is treating stranguria.Li Gao says: " Semen Plantaginis can diuresis and not flat, with the same merit of Poria." also meaning in " Bencao Jingshu ": " logical kidney qi is also for Semen Plantaginis, its main stranguria due to disorder of QI, pain relieving.Key medicine for Liver and kidney bladder three warps." " medicine justice " add: " and Semen Plantaginis, son is main to descend, and lightly seasonedly goes into spleen, and it is descending to ooze heat, the then pure and impure branch of lid water channel profit, this is strong for spleen.”
Rhizoma Acori Graminei, Radix Salviae Miltiorrhizae, Poria and Rhizoma Atractylodis four flavors all have strengthening the spleen and stomach, the water transfer road, and blood stasis dispelling stagnates, and the function of qualcomm meridian is adjuvant altogether.The Rhizoma Acori Graminei restoring normal coordination between the heart and kidney makes heart-fire being not overabudant in last, and fire is not prosperous in following mutually, coordination between the heart and kidney; Share with Rhizoma Dioscoreae Septemlobae and can dampness removing to have one's ideas straightened out, divide Qinghua turbid, prescription is with Rhizoma Dioscoreae Septemlobae and the application of Rhizoma Acori Graminei compatibility, specially controls the inferior the nebulousurine due to the burnt turbid damp stasis.As saying in " danxi's experiential therapy ": " cover Rhizoma Acori Graminei and get Rhizoma Dioscoreae Septemlobae, the multitudinous dehumidifying and branch Qinghua is turbid." Poria, Rhizoma Atractylodis the spleen strengthening and damp drying, the enhancing body resistance makes heat clearing away blood stasis dispelling of the present invention and does not just hinder, and promptly calls it " lead the reason spleen of must holding concurrently among wet, it is wet that Tu Wang then can win, and soil is hard to coagulate, and then water is from clarification "; Ermiao san share with Cortex Phellodendri, Rhizoma Atractylodis in " danxi's experiential therapy ", is the wonderful recipe of heat clearing and damp drying.Radix Salviae Miltiorrhizae nature and flavor hardship is slightly cold." book on Chinese herbal medicine just " meaning be " the medicine of heart spleen, liver, kidney blood system." " book on Chinese herbal medicine justice " say: " Radix Salviae Miltiorrhizae is specially gone into blood system, its merit is in the promoting the circulation of blood of invigorating blood circulation, in reach internal organs and blood stasis dispelling stagnates, mass in the abdomen breaks so gather Xiao, blood circulation promoting and blood stasis dispelling, reducing swelling and alleviating pain, so can dredge smart chamber, make venation unobstructed, give full play to the clearing away heat-damp and promoting diuresis effect of the monarch and his subjects' medicines such as Cortex Phellodendri, therefore suppress advancing of disease, promoting the aspect that lapses to of disease to have important effect.
Prescription of the present invention is based on " leading to ", and having has benefit in disappearing, and unlikely gram cuts down healthy energy, and invigorating middle warmer has and disappears the characteristics of the damp of approximately being detained.Monarch in the side complements each other, and the pathogenesis that links closely is played clearing away heat-damp and promoting diuresis altogether, changes turbid treating stranguria effect, so the damp and hot heap soil or fertilizer over and around the roots resistance type of clinical treatment chronic prostatitis is received satisfied curative effect.Confirm through multinomial experimentation, effect such as this product has antiinflammatory, diuresis, invigorates blood circulation, antibacterial, no obvious toxicity can be taken continuously, has remedied the antibiotic life-time service and has easily caused drawbacks such as body flora imbalance.Dose is less, and is easy to carry and use.Be applied to clinically, removed sufferings, produced huge economic benefit and social benefit for extensive patients.
The above-mentioned medicine that is used for the treatment of chronic prostatitis can be made said multiple dosage form on the pharmaceutics, as tablet, capsule, granule etc.Wherein the preparation method of capsule dosage form is as described below: Cortex Phellodendri in the prescription is added 10～12 times of water gagings respectively, decoct three times, and 1.5 hours for the first time, second and third time each 1 hour, collecting decoction filters; Rhizoma Atractylodis, Rhizoma Acori Graminei distillating extracting oil, volatile oil beta-schardinger dextrin-inclusion, the inclusion complex drying, it is standby to be ground into coarse powder, and the aqueous solution after distillation device is in addition collected; Radix Salviae Miltiorrhizae adds 5.5～6.5 times of amount 80% ethanol extractions twice respectively, and each 1 hour, merge extractive liquid, filtered, and reclaims ethanol to there not being the alcohol flavor, and is standby; Add 10～12 times of water gagings respectively after residue and Rhizoma Dioscoreae Hypoglaucae, Herba Patriniae, Semen Plantaginis, Talcum, Poria mix and decoct twice, each 1.5 hours, collecting decoction filtered; Merge above each medicinal liquid, be condensed into thick paste, add Indigo Naturalis, drying is pulverized, and adds starch 5%～15%, granulates; Add the beta-cyclo dextrin included compound coarse powder, mixing incapsulates, and promptly makes capsule of the present invention.
In development process of the present invention, be therapeutic effect and the safety that proves this medicine, the designer has carried out the experimental study of pharmacodynamics, toxicology and clinicing aspect to the capsule that obtains according to above-mentioned preparation method, and the result is as follows in its experimental study:
1, cures mainly relevant pharmacodynamic study with function
Through capsule extracorporeal bacteria inhibitor test of the present invention is shown: with the liquid tube method measurement result show capsule of the present invention to prostatitic common pathogenic bacteria as: staphylococcus aureus, Staphylococcus albus, bacillus pyocyaneus, bacillus subtilis, Bacillus proteus, escherichia coli reference culture and clinical strains are had certain inhibitory action.
Adopt the prostatitis rat model of clinical isolating coli-infection to carry out experimental observation, experimental result shows: capsule of the present invention can suppress the weightening finish of prostate body of gland, reduce the bacterial content of pathological changes local organization, alleviate inflammatory cell infiltration and damage, the effect of treatment bacterial prostatitis is arranged; Can promote the rat model body weight gain, the peripheral white blood cell after the modeling of reduction antibacterial is pointed out it to have and is improved the influence of bacterial prostatitis disease to whole body.With XIAOZHILING ZHUSHEYE rat is carried out the nonbacterial prostatitis modeling, experiment shows: capsule of the present invention has above effect equally;
Capsule of the present invention can significantly suppress the seepage discharge that the swelling of mice caused by dimethylbenzene xylene ear and acetic acid cause mouse peritoneal ivens orchid, significantly alleviate swelling degree and the bullate weight of rat granuloma that Ovum Gallus domesticus album causes rat foot inflammation, point out capsule of the present invention that the active chronic inflammation of animal is had antiinflammatory action preferably.
Capsule of the present invention can significantly improve mice threshold value and the minimizing acetic acid that hot plate causes the pain reaction is caused the mouse writhing number of times, observes with mice hot water tail-flick method, and this product can significantly improve the mice TFL, points out capsule of the present invention that analgesic activity is preferably arranged.
Observe with " blood circulating out of vessels " type syndrome of blood stasis model, capsule of the present invention can significantly alleviate the weight of mice blood stasis piece, illustrates that capsule of the present invention has certain function of promoting blood circulation to disperse blood clots.
With the diuresis of metabolic cage method observation capsule of the present invention, capsule of the present invention as a result can significantly increase the voided volume of rat, illustrates that capsule of the present invention has certain diuresis.
2, toxicological study
The acute toxicity test of capsule of the present invention being done by the Institute of Chinese Medicine, Henan Province shows: the LD of capsule ig of the present invention administration
50Do not obtain, the oral maximum tolerated dose of mice is 212.85g (crude drug)/kg, is equivalent to 495 times of clinical plan consumption.
Observed capsule of the present invention to the relevant toxic and side effects of accumulating of rat by the long term toxicity test that do capsule of the present invention the Institute of Chinese Medicine, Henan Province, the result shows: capsule high dose group 25.8g of the present invention (crude drug)/kg/ day (being equivalent to 60 times of the clinical consumptions of people), low dose group 12.9g (crude drug)/kg/ day, continuous irrigation stomach 60 days, 120 days and drug withdrawal 15 days, vegetative activity to rat, body weight, appetite, hematological indices (red blood cell count(RBC), platelet count, numeration of leukocyte and classification, hemoglobin) and blood biochemical (AST, ALT, ALP, BUN, Crea, TP, ALB, Glu, T-BIL, index of T-CHO) and organ coefficient do not have obvious influence, postmortem and pathology do not have obvious change yet, point out capsule of the present invention at 25.8g (crude drug)/took four months below the kg dosage, rat is not had obvious toxic-side effects, is a kind of Chinese medicine preparation of safety.
3, clinical research
(1) II clinical trial phase
Capsule II clinical trial phase of the present invention carries out experiment work by five tame clinical research units such as Guang-amen Hospital, China Traditional Chinese Medicine Instls.Adopt positive drug parallel control, district's group at random, double blinding dual analog, multi-center clinical trial method for designing, the contrast medicine is selected QIANLIETAI PIAN for use.Test goes into to organize patient's 233 examples, test group 117 examples, matched group 116 examples altogether.Two groups of aspects such as antibacterial culturing, tongue arteries and veins in leukocyte, phospholipid body, the prostatic fluid in age, the course of disease, the state of an illness, treatment history, NIH-CPSI scoring score value, tcm symptom, prostate palpation, prostatic fluid, P〉0.05, have comparability.The symptom total mark, the test group integration is higher than matched group.The result is as follows for the test efficacy analysis:
1. the damp and hot heap soil or fertilizer over and around the roots resistance of traditional Chinese medical science card marquis curative effect is relatively: the two groups of damp and hot heap soil or fertilizer over and around the roots resistance of traditional Chinese medical science card marquis curative effects during 4 weeks, and test group cure rate 7.7%, obvious effective rate 44.4%, matched group cure rate 4.3%, obvious effective rate 37.1% is through rank test analysis, P=0.063; The two groups of damp and hot heap soil or fertilizer over and around the roots resistance of traditional Chinese medical science card marquis curative effects during 6 weeks, test group cure rate 7.7%, obvious effective rate 51.3%, matched group cure rate 4.3%, obvious effective rate 42.2% is through rank test analysis, P=0.028; The two groups of damp and hot heap soil or fertilizer over and around the roots resistance of traditional Chinese medical science card marquis curative effects during 8 weeks, test group cure rate 18.8%, obvious effective rate 43.6%, matched group cure rate 8.6%, obvious effective rate 44.0% is through rank test analysis, P=0.033.Illustrate that the test group curative effect all was better than matched group when 6 weeks were with 8 weeks.After considering center effect, during 8 weeks, the two groups of damp and hot heap soil or fertilizer over and around the roots resistance of traditional Chinese medical science card marquis curative effects are through MHCX2 check analysis, P=0.035.The test group curative effect is higher than matched group.
2. two groups of Syndrome in TCM marquis integrations: two groups treat the back and treat before difference relatively, the test group integration differential is 13.75 ± 8.12, the matched group integration differential is 11.05 ± 7.63, through the t check analysis, P=0.01, difference has statistical significance; Be divided into covariant to treat foreset, 4 weeks, 6 all integrations, through covariance analysis, P is all less than 0.05, and difference has statistical significance; It is 7.15 ± 6.18 that test group is treated the back integration, and it is 7.82 ± 6.01 that matched group is treated the back integration, and test group is treated the back integration and is lower than matched group.
3. chronic prostatitis NIH-CPSI scoring degree changes: through rank test analysis, P〉0.05, two group of difference not statistically significant.
4. two groups of NIH-CPSI scoring situations of change: the score value of the influence of pain scores, the score value of urinating, symptom, quality of life score value, through the t check analysis, P is all greater than 0.05, two group of equal not statistically significant of difference.
5. two groups of traditional Chinese medical science individual event symptom curative effects comparisons: urinate frequency urgency, dribble of urine not to the utmost, through the rank test analysis, P＜0.05, two group difference has statistical significance; And drip behind urethra scorching hot, perineum pain or discomfort, few abdomen pain or discomfort, waist and sacrum pain, testicular pain, dampness of scrotum, the urine white, through the rank test analysis, P〉0.05, two group of difference not statistically significant.
6. two groups of prostatic fluid are conventional changes: leukocyte, phospholipid body change, through rank test analysis, P〉0.05, two group of difference not statistically significant.
7. antibacterial culturing situation in the prostatic fluid: the test group negative conversion rate is 2/2 (100.0%), and the matched group negative conversion rate is 2/3 (66.7%).
8. treat back tongue arteries and veins situation for two groups: through the X2 check analysis, P is all greater than 0.05, two group of difference not statistically significant.
9. the case of fully recovering is followed up a case by regular visits to situation: treat the back between two groups, follow up a case by regular visits to, follow up a case by regular visits to and treat the back difference, through the t check analysis, P is all greater than 0.05, two group of difference not statistically significant.Relatively, through the paired t-test analysis, P is all less than 0.05 in the group, illustrate when treating the back and when following up a case by regular visits to difference statistical significance is all arranged.The back integration differential is followed up a case by regular visits to and treated to test group be-2.77 ± 2.94, and the back integration differential is followed up a case by regular visits to and treated to matched group be-1.80 ± 1.99, and visible two groups of overall scores of NIH-CPSI when following up a case by regular visits to all decrease than treatment afterwards the time.
In the generation of adverse events, test group 2/117 (1.7%), matched group 1/116 (0.9%) all maybe may have nothing to do with trial drug is irrelevant; There is not serious adverse events.The lab index context of detection, before find treating normal and treat the back unusual or treat before unusual and case that increase the weight of unusually after treating.Therefore II clinical trial phase result thinks: safely, effectively, III phase clinical research is proceeded in suggestion to capsule treatment chronic prostatitis of the present invention (damp and hot heap soil or fertilizer over and around the roots resistance card).
(2) III clinical trial phase
Capsule III clinical trial phase of the present invention still carries out experiment work by five tame clinical research units such as Guang-amen Hospital, China Traditional Chinese Medicine Instls.Adopt positive drug parallel control, district's group at random, double blinding dual analog, multi-center clinical trial method for designing, the contrast medicine is selected QIANLIETAI PIAN for use.The III phase tests and goes into to organize patient's 418 examples altogether, test group 314 examples, matched group 104 examples; Two groups of aspects such as antibacterial culturing, tongue arteries and veins in leukocyte, phospholipid body, the prostatic fluid in age, the course of disease, the state of an illness, treatment history, NIH-CPSI scoring score value, symptom total mark, tcm symptom, prostate palpation, prostatic fluid, except that yellowish fur, all has comparability.The result is as follows for the test efficacy analysis:
1. the damp and hot heap soil or fertilizer over and around the roots resistance of traditional Chinese medical science card marquis curative effect is relatively: ITT analytical test group cure rate 13.4%, and obvious effective rate 48.7%, matched group cure rate 8.7%, obvious effective rate 36.5% is through MHCX2 check analysis, P=0.005; PP analytical test group cure rate 13.5%, obvious effective rate 49.2%, matched group cure rate 8.7%, obvious effective rate 36.5% is through MHCX2 check analysis, P=0.004.ITT analyzes with PP and analyzes all demonstrations, and difference has statistical significance (P＜0.05), shows that the test group curative effect is better than matched group.
2. two groups of Syndrome in TCM marquis integrations: two groups treat the back and treat before difference relatively, difference has statistical significance, test group score value fall is greater than matched group, not statistically significant in the heart in each.The grouping with in do not have cross effect in the heart.ITT, PP be unanimity as a result.
3. chronic prostatitis NIH-CPSI scoring degree changes: through rank test analysis, P〉0.05, two group of difference not statistically significant.
4. two groups of NIH-CPSI overall score situations: before treating, treat back, difference, two groups relatively, the difference not statistically significant.Not statistically significant in the heart in each.ITT, PP be unanimity as a result.
5. two groups of NIH-CPSI scoring situations of change: the score value of the influence of symptom, after treatment, aspect the difference, two groups relatively, through the t check analysis, P＜0.05, difference has statistical significance, and the test group integration differential is 2.29 ± 1.54, the matched group integration differential is 1.94 ± 1.51, and test group score value fall is greater than matched group; Pain scores, the score value of urinating, quality of life score value, through t check analysis, P〉0.05, two group of difference not statistically significant.
6. two groups of traditional Chinese medical science individual event symptom curative effects are relatively: dribble of urine not to the utmost, few abdomen pain or discomfort, through the rank test analysis, P＜0.05, two group difference has statistical significance, the test group curative effect is better than matched group; And urine is frequently dripped in vain behind urgency, urethra scorching hot, perineum pain or discomfort, waist and sacrum pain, testicular pain, dampness of scrotum, the urine, through the rank test analysis, P〉0.05, two group of difference not statistically significant.ITT, PP be unanimity as a result.
7. two groups of prostatic fluid are conventional changes: leukocyte, phospholipid body change, through rank test analysis, P〉0.05, two group of difference not statistically significant.
8. antibacterial culturing situation in the prostatic fluid: the test group negative conversion rate is 2/12 (83.3%), and the matched group negative conversion rate is 2/9 (77.8%).
9. treat back tongue arteries and veins situations for two groups: except that yellow fur or yellow greasy, slippery and rapid pulse, two groups of difference not statistically significants.
10. the case of fully recovering is followed up a case by regular visits to situation: treat the back between two groups, follow up a case by regular visits to, follow up a case by regular visits to and treat the back difference, through the t check analysis, P is all greater than 0.05, two group of difference not statistically significant.Change in the test group, through the paired t-test analysis, P＜0.05, difference has statistical significance; Change in the matched group, through paired t-test analysis, P 0.05, the difference not statistically significant.
In the generation of adverse events, test group 13/314 (4.1%), matched group 6/104 (5.8%); The adverse events relevant: test group 6/314 (1.9%), matched group 2/104 (1.9%) with medicine; There is not serious adverse events.The lab index context of detection, before find treating normal and treat the back unusual or treat before unusual and case that increase the weight of unusually after treating.
Capsule II phase of the present invention, III clinical trial phase result show: capsule treatment chronic prostatitis of the present invention (damp and hot heap soil or fertilizer over and around the roots resistance card) safely, effectively.
The specific embodiment
Embodiment 1
Cortex Phellodendri 160g Rhizoma Dioscoreae Hypoglaucae 320g Herba Patriniae 320g Indigo Naturalis 50g
Talcum 190g Semen Plantaginis 320g Rhizoma Acori Graminei 160g Poria 160g
Rhizoma Atractylodis 160g Radix Salviae Miltiorrhizae 320g
Described dosage form is that the processing step of preparation method of capsule is as follows:
Cortex Phellodendri in the prescription is added water (12,10,10 times of amounts) decoct three times, 1.5 hours for the first time, second and third time each 1 hour, collecting decoction filters; Rhizoma Atractylodis, Rhizoma Acori Graminei distillating extracting oil, volatile oil beta-schardinger dextrin-inclusion, the inclusion complex drying, it is standby to be ground into coarse powder, and the aqueous solution after distillation device is in addition collected; Radix Salviae Miltiorrhizae adds 80% ethanol (6,6 times of amounts) and extracts twice, and each 1 hour, merge extractive liquid, filtered, and reclaims ethanol to there not being the alcohol flavor, and is standby; Residue and Rhizoma Dioscoreae Hypoglaucae, Herba Patriniae, Semen Plantaginis, Talcum, Poria add water (12,10 times of amounts) and decoct twice, and each 1.5 hours, collecting decoction filtered; Merge above each medicinal liquid, be condensed into thick paste, add Indigo Naturalis, drying is pulverized, and adds starch 5%～15%, granulates; Add the beta-cyclo dextrin included compound coarse powder, mixing incapsulates, promptly.
Embodiment 2
Cortex Phellodendri 170g Rhizoma Dioscoreae Hypoglaucae 310g Herba Patriniae 340g Indigo Naturalis 40g
Talcum 170g Semen Plantaginis 330g Rhizoma Acori Graminei 170g Poria 150g
Rhizoma Atractylodis 160g Radix Salviae Miltiorrhizae 320g
Described dosage form is that the processing step of preparation method of capsule is as follows:
Cortex Phellodendri in the prescription is added water (12,12,10 times of amounts) decoct three times, 2 hours for the first time, the second time 1.5,1 hour for the third time, collecting decoction filtered; Rhizoma Atractylodis, Rhizoma Acori Graminei distillating extracting oil, volatile oil beta-schardinger dextrin-inclusion, the inclusion complex drying, it is standby to be ground into coarse powder, and the aqueous solution after distillation device is in addition collected; Radix Salviae Miltiorrhizae adds 80% ethanol (6,5.5 times of amounts) and extracts twice, and each 1 hour, merge extractive liquid, filtered, and reclaims ethanol to there not being the alcohol flavor, and is standby; Residue and Rhizoma Dioscoreae Hypoglaucae, Herba Patriniae, Semen Plantaginis, Talcum, Poria add water (10,12 times of amounts) and decoct twice, and each 1.5 hours, collecting decoction filtered; Merge above each medicinal liquid, be condensed into thick paste, add Indigo Naturalis, drying is pulverized, and adds starch 6%～13%, granulates; Add the beta-cyclo dextrin included compound coarse powder, mixing incapsulates, promptly.
Embodiment 3
Cortex Phellodendri 175g Rhizoma Dioscoreae Hypoglaucae 325g Herba Patriniae 325g Indigo Naturalis 55g
Talcum 175g Semen Plantaginis 310g Rhizoma Acori Graminei 160g Poria 160g
Rhizoma Atractylodis 150g Radix Salviae Miltiorrhizae 325g
Described dosage form is that the processing step of preparation method of capsule is as follows:
Cortex Phellodendri in the prescription is added water (10,12,12 times of amounts), decoct three times, each 1.5 hours, collecting decoction filtered; Rhizoma Atractylodis, Rhizoma Acori Graminei distillating extracting oil, volatile oil beta-schardinger dextrin-inclusion, the inclusion complex drying, it is standby to be ground into coarse powder, and the aqueous solution after distillation device is in addition collected; Radix Salviae Miltiorrhizae adds 80% ethanol (6.5,6 times of amounts) and extracts twice, and each 1 hour, merge extractive liquid, filtered, and reclaims ethanol to there not being the alcohol flavor, and is standby; Residue and Rhizoma Dioscoreae Hypoglaucae, Herba Patriniae, Semen Plantaginis, Talcum, Poria add water (12,12 times of amounts) and decoct twice, and each 1.5 hours, collecting decoction filtered; Merge above each medicinal liquid, be condensed into thick paste, add Indigo Naturalis, drying is pulverized, and adds starch 4%～17%, granulates; Add the beta-cyclo dextrin included compound coarse powder, mixing incapsulates, promptly.
Embodiment 4
Cortex Phellodendri 144g Rhizoma Dioscoreae Hypoglaucae 288g Herba Patriniae 288g Indigo Naturalis 45g
Talcum 171g Semen Plantaginis 288g Rhizoma Acori Graminei 144g Poria 144g
Rhizoma Atractylodis 144g Radix Salviae Miltiorrhizae 288g
The preparation method of embodiment 4 is identical with the processing step of the preparation method of embodiment 1.
Claims (3)
1, a kind of medicine for the treatment of chronic prostatitis is characterized in that: the medicine of described treatment chronic prostatitis is the above a medicament of the pharmaceutics made by the Chinese medicine medicine material of following weight proportioning:
Cortex Phellodendri 144-176 Rhizoma Dioscoreae Hypoglaucaes 288-352 Herba Patriniae 288-352
Indigo Naturalis 45-55 Talcums 171-209 Semen Plantaginiss 288-352
Rhizoma Acori Graminei 144-176 Poria 144-176 Rhizoma Atractylodis 144-176
Radix Salviae Miltiorrhizae 288-352.
2, a kind of medicine for the treatment of chronic prostatitis according to claim 1 is characterized in that: the above medicament of the pharmaceutics that the medicine of described treatment chronic prostatitis is made by following materials of weight proportions:
Cortex Phellodendri 160 Rhizoma Dioscoreae Hypoglaucaes 320 Herba Patriniae 320 Indigo Naturaliss 50
Talcum 190 Semen Plantaginiss 320 Rhizoma Acori Graminei 160 Poria 160
Rhizoma Atractylodis 160 Radix Salviae Miltiorrhizaes 320.
3, a kind of medicine for the treatment of chronic prostatitis according to claim 1 and 2, it is characterized in that: described dosage form is a capsule, and the processing step of the preparation method of this capsule is as follows:
1. get Cortex Phellodendri and add 10～12 times of water gagings respectively, decoct three times, 1.5 hours for the first time, second and third time each 1 hour, collecting decoction filters;
2. Rhizoma Atractylodis, Rhizoma Acori Graminei distillating extracting oil, volatile oil beta-schardinger dextrin-inclusion, the inclusion complex drying, it is standby to be ground into coarse powder, and the aqueous solution after distillation device is in addition collected;
3. Radix Salviae Miltiorrhizae adds 5.5～6.5 times of amount 80% ethanol respectively, extracts twice, and each 1 hour, merge extractive liquid, filtered, and reclaims ethanol to there not being the alcohol flavor, and is standby;
4. add 10～12 times of water gagings respectively after residue and Rhizoma Dioscoreae Hypoglaucae, Herba Patriniae, Semen Plantaginis, Talcum, Poria mix and decoct twice, each 1.5 hours, collecting decoction filtered;
5. merge above each medicinal liquid, be condensed into thick paste, add Indigo Naturalis, drying is pulverized, and adds starch 5%～15%, granulates; Add the beta-cyclo dextrin included compound coarse powder, mixing incapsulates, and promptly makes capsule of the present invention.
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Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101721528B (en) * | 2009-12-30 | 2011-09-07 | 长春中医药大学 | Medicine composition for treating chronic prostatitis |
| CN101862407A (en) * | 2010-06-23 | 2010-10-20 | 南昌市男科医院 | Chinese compound heat clearing and blood circulation promoting suppository |
| CN105770241A (en) * | 2014-12-21 | 2016-07-20 | 徐跃 | Chronic prostatitis treatment medicine |
| CN106822780A (en) * | 2017-02-17 | 2017-06-13 | 成都风靡生物科技有限公司 | It is a kind of to treat the damp and hot Chinese medicine composition for stopping up resistance card of chronic prostatitis |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1383886A (en) * | 2002-06-07 | 2002-12-11 | 姚景孝 | Prostatosis treating pill made of 18 kinds of Chinese medicine material |
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1383886A (en) * | 2002-06-07 | 2002-12-11 | 姚景孝 | Prostatosis treating pill made of 18 kinds of Chinese medicine material |
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| CN1876088A (en) | 2006-12-13 |
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