Background technology
Chronic prostatitis (chronic prostatitis, CP) is a kind of intractable Urology Surgery common disease, and its course of disease easily delays recurrence, obviously affects the quality of life of patient, and may cause serious impact to the healthy reproduction of its spouse.Chronic prostatitis belongs to the category of " stranguria ", " difficulty in urination " in Chinese medicine, and its origin cause of formation is often by retention of damp-heat in the interior, and retardance mechanism of qi, with the passing of time becomes the stasis of blood, undermine caused by kidney yang, kidney yin.Therefore also according to the difference of clinical syndrome differentiation, and the method for clearing away heat-damp and promoting diuresis, blood circulation promoting and blood stasis dispelling or the kidney invigorating and essence nourishing can be taked to its treatment.Special due on prostate anatomy position, conventional route of administration as oral or vein and operative treatment curative effect all not very good.
The traditional Chinese medical science thinks that its cause of disease one is addicted to food cigarette, wine, pungent, delicious food savoury, and impairing the spleen and stomach, makes raw damp and hot, the multiple abscess part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels; Two is intemperate sexual intercourse, directly contaminates, and Shi Re Bing Pian drives in the wrong direction, and stations the part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels; Three is society and environmental factors, the impacts such as medium stimulation, and libido can not get normal catharsis, frequent masturbation, intemperate sexual intercourse, bears essence not let out, and causes prostate repeatedly congested, and retention of corruptive essence essence room, accumulates and make poison for a long time, hinder in meridians; Or feelings will is smooth, depressed rage impairing the liver, irritability is lost in catharsis, for a long time then hematogenous blockage and cause coagulation of QI-blood, and coagulation of QI-blood can increase the weight of again Shi Re Bing Pian and be formed, both reciprocal causations.The symptom of chronic prostatitis varies with each individual, and is mainly divided into following two kinds: a kind of is pain symptom, containing hypogastric region, lumbosacral region, perianal, perineal position and the tract pain such as testis, penis; Another kind is discomfort of urinating, and as unable in urine retention, frequent micturition, urgent micturition, urine, urine drips white etc.General Symptoms is mainly that anxiety, energy are not concentrated, lassitude, and it is abnormal to be also attended by sexual function, as ejaculate too fast, erection is not hard, hyposexuality etc.Prostatitis is divided into Four types I, acute bacterial prostatitis by NIH (NIH), II, chronic bacterial prostatitis, III, chronic nonbacterial prostatitis, the struvite prostatitis of IV, silent.Wherein III type is divided into two hypotypes according to prostatic fluid (EPS) microscopy, WBC (leukocyte) more than 10/HP is a type, below WBC10/HP and pH value lower be b type, i.e. chronic nonbacterial prostatitis/Pelvic pain syndrome (CAP/CPPS).
Primary treatments at present for chronic prostatitis is Drug therapy and naturopathy, its drug treatment comprises each antibiotics, α receptor blocking agent, immunosuppressant and supplementary zinc and vitamin, and route of administration is for oral administration, injection, rectal perfusion, anus filling, body of gland injection etc.; Wherein naturopathy comprises microwave, muscle electric stimulation, hot water hip-bath, massage of prostate, the administration of two capsule four cavities conduit pipe, direct injection (per rectum or perineum), medicine iontophoresis.Primary disease also causes very large psychological problems, also comprises Mental Intervention in Treatment, mainly based on psychological counseling in current Therapeutic Method.But adopt above-mentioned Therapeutic Method, patient is comparatively painful, the treatment persistent period is longer, and effect is not ideal.Various way above, damage testicular spermatogenic, be only auxiliary treatment means, even certain methods complicated operation, and problems such as dangerous, cross infection in addition, the suppository of other rectals, unguentum exist that dosage form is unreasonable, the compatibility drawback that science, therapeutic effect are not poor.
Summary of the invention
In order to make up the deficiencies in the prior art, alleviate the misery of prostatitis patient, the invention provides one and treat prostatitic Chinese medicine composition, it is evident in efficacy, safe and reliable, has wide potential applicability in clinical practice.
Technical scheme of the present invention is:
One treats prostatitic Chinese medicine composition, and this Chinese medicine composition is made up of the raw material of following weight portion: Rhizoma Corydalis 10-12 part, Cortex Cinnamomi 5-8 part, Herba Epimedii 6-9 part, Rhizoma dioscoreae 3-5 part, Radix Achyranthis Bidentatae 10-12 part, Semen Cuscutae 10-12 part, Radix Polygalae 3-5 part, Pericarpium Citri Reticulatae 3-5 part, Radix Salviae Miltiorrhizae 10-12 part, Flos Lonicerae 8-10 part, Rhizoma Polygoni Cuspidati 6-9 part, Polyalthia nemoralis A. D C. 10-12 part, Radix Angelicae Dahuricae 10-12 part, Radix Codonopsis 10-12 part, Rhizoma Cyperi 12-15 part, Radix Et Caulis Acanthopanacis Senticosi 9-12 part.
In Chinese medicine composition described above, Radix Glycyrrhizae 5-8 part and Fructus Ligustri Lucidi 12-15 part can also be contained.These two kinds of Chinese medicines can strengthen the anti-inflammatory pain-stopping effect of the above-mentioned Chinese medicine composition of the present invention further.
The present invention also asks to protect the purposes of above-mentioned Chinese medicine composition in preparation treatment prostatitis medicine.Pharmaceutical composition of the present invention before the treatment row adenitis time, demonstrate remarkable anti-inflammatory and antalgic activity.Test examples 7 of the present invention shows, give positive drug and Chinese medicine composition of the present invention all can obtain significant antiphlogistic effects, wherein the antiphlogistic effects of Chinese medicine composition high dose group of the present invention and positive controls have pole significant difference, Chinese medicine composition low dose group and positive controls have significant difference, and this shows that the high dose group of Chinese medicine composition of the present invention and the antiphlogistic effects of low dose group significantly will be better than positive controls.Test examples 8 mice of the present invention licks foot response latency time showing, compare with model group, after administration 1h and 2h, the incubation period that the mice of each administration group of Chinese medicine composition of the present invention adds foot reaction is all greater than model group, there is dose-dependence, and be significantly greater than the incubation period of high dose group model group (
p< 0.05).What illustrate that this Chinese medicine composition of the present invention can extend that mice stimulates hot plate adds the sufficient response latency, has certain analgesic activity.Under same experiment condition, positive control drug also extends the incubation period that mice adds foot reaction, has certain analgesic activity, but its analgesic effect and model group there was no significant difference.
In order to express Chinese medicine composition of the present invention better, Chinese medicine composition of the present invention can be prepared into dosage form conventional clinically.Such as, the preparations such as powderous preparations, powder, pill, sublimed preparation, unguentum, granule, oral liquid, syrup, tablet, capsule, described pharmaceutical preparation all can prepare according to Chinese medicine preparation preparation method well-known to those skilled in the art.Preferably, Chinese medicine composition of the present invention conveniently preparation technology be prepared into powder, water preparation, tablet or capsule.
Present invention also offers a kind of preparation method of Chinese medicine composition described above, it mainly comprises following step: get the above-mentioned Chinese crude drug of recipe quantity and be broken into coarse powder, the alcoholic solution that volumetric concentration is 40% ~ 95% is added according to 4 ~ 9 times of coarse powder gross weight, reflux, extract, three times, return time is 2 ~ 5h, filters, filtrate recycling ethanol, cold filtration, washes with water, namely obtains Chinese medical concrete after drying; Those skilled in the art can technically prepare conventional Chinese medicine pharmaceutical dosage form clinically, as tablet, capsule etc. in this preparation method.
Chinese medicine composition of the present invention is row adenitis aspect before the treatment, compared with prior art has following advantage:
1) compared with the chemotherapeutic agent of Current therapeutic, Chinese medicine composition of the present invention is natural pure Chinese medicinal preparation, and untoward reaction and side effect significantly reduce, and Chinese medicine composition effect of the present invention is comprehensive, medication effect is better, and improves the quality of life of patient.
2) contain multi-medicament component in Chinese medicine composition of the present invention, action target spot is numerous, improves patient to the acceptance of medicine and compliance.
Detailed description of the invention
Further describe the present invention below by way of specific embodiment, but those skilled in the art should know, described embodiment does not also limit the present invention in any way.
one) example of formulations part
embodiment 1 Chinese medicine composition of the present invention and preparation method
The weight portion of Chinese medicinal components: Rhizoma Corydalis 10, Cortex Cinnamomi 5, Herba Epimedii 6, Rhizoma dioscoreae 3, Radix Achyranthis Bidentatae 10, Semen Cuscutae 10, Radix Polygalae 3, Pericarpium Citri Reticulatae 3, Radix Salviae Miltiorrhizae 10, Flos Lonicerae 8, Rhizoma Polygoni Cuspidati 6, Polyalthia nemoralis A. D C. 10, the Radix Angelicae Dahuricae 10, Radix Codonopsis 10, Rhizoma Cyperi 12, Radix Et Caulis Acanthopanacis Senticosi 9.
Preparation method: get the above-mentioned Chinese crude drug of recipe quantity and be broken into coarse powder, add according to 4 ~ 9 times of coarse powder gross weight the alcoholic solution that volumetric concentration is 40% ~ 95%, reflux, extract, three times, return time is 2 ~ 5h, filters, filtrate recycling ethanol, cold filtration, washes with water, namely obtains Chinese medical concrete after drying; Those skilled in the art can technically prepare conventional Chinese medicine pharmaceutical dosage form clinically, as tablet, capsule etc. in this preparation method.
embodiment 2 Chinese medicine composition of the present invention and preparation method
The weight portion of Chinese medicinal components: Rhizoma Corydalis 12, Cortex Cinnamomi 8, Herba Epimedii 9, Rhizoma dioscoreae 5, Radix Achyranthis Bidentatae 12, Semen Cuscutae 12, Radix Polygalae 5, Pericarpium Citri Reticulatae 5, Radix Salviae Miltiorrhizae 12, Flos Lonicerae 10, Rhizoma Polygoni Cuspidati 9, Polyalthia nemoralis A. D C. 12, the Radix Angelicae Dahuricae 12, Radix Codonopsis 12, Rhizoma Cyperi 15, Radix Et Caulis Acanthopanacis Senticosi 12.
Preparation method is with embodiment 1.
embodiment 3 Chinese medicine composition of the present invention and preparation method
The weight portion of Chinese medicinal components: Rhizoma Corydalis 11, Cortex Cinnamomi 7, Herba Epimedii 7, Rhizoma dioscoreae 4, Radix Achyranthis Bidentatae 11, Semen Cuscutae 11, Radix Polygalae 4, Pericarpium Citri Reticulatae 4, Radix Salviae Miltiorrhizae 11, Flos Lonicerae 9, Rhizoma Polygoni Cuspidati 8, Polyalthia nemoralis A. D C. 11, the Radix Angelicae Dahuricae 11, Radix Codonopsis 11, Rhizoma Cyperi 13, Radix Et Caulis Acanthopanacis Senticosi 10.
Preparation method is with embodiment 1.
embodiment 4 Chinese medicine composition of the present invention and preparation method
The weight portion of Chinese medicinal components: Rhizoma Corydalis 10, Cortex Cinnamomi 5, Herba Epimedii 6, Rhizoma dioscoreae 3, Radix Achyranthis Bidentatae 10, Semen Cuscutae 10, Radix Polygalae 3, Pericarpium Citri Reticulatae 3, Radix Salviae Miltiorrhizae 10, Flos Lonicerae 8, Rhizoma Polygoni Cuspidati 6, Polyalthia nemoralis A. D C. 10, the Radix Angelicae Dahuricae 10, Radix Codonopsis 10, Rhizoma Cyperi 12, Radix Et Caulis Acanthopanacis Senticosi 9, Radix Glycyrrhizae 5, Fructus Ligustri Lucidi 13 parts
Preparation method is with embodiment 1.
embodiment 5 Chinese medicine composition of the present invention and preparation method
The weight portion of Chinese medicinal components: Rhizoma Corydalis 12, Cortex Cinnamomi 8, Herba Epimedii 9, Rhizoma dioscoreae 5, Radix Achyranthis Bidentatae 12, Semen Cuscutae 12, Radix Polygalae 5, Pericarpium Citri Reticulatae 5, Radix Salviae Miltiorrhizae 12, Flos Lonicerae 10, Rhizoma Polygoni Cuspidati 9, Polyalthia nemoralis A. D C. 12, the Radix Angelicae Dahuricae 12, Radix Codonopsis 12, Rhizoma Cyperi 15, Radix Et Caulis Acanthopanacis Senticosi 12,8 parts, Radix Glycyrrhizae, Fructus Ligustri Lucidi 12.
Preparation method is with embodiment 1.
embodiment 6 Chinese medicine composition of the present invention and preparation method
The weight portion of Chinese medicinal components: Rhizoma Corydalis 11, Cortex Cinnamomi 7, Herba Epimedii 7, Rhizoma dioscoreae 4, Radix Achyranthis Bidentatae 11, Semen Cuscutae 11, Radix Polygalae 4, Pericarpium Citri Reticulatae 4, Radix Salviae Miltiorrhizae 11, Flos Lonicerae 9, Rhizoma Polygoni Cuspidati 8, Polyalthia nemoralis A. D C. 11, the Radix Angelicae Dahuricae 11, Radix Codonopsis 11, Rhizoma Cyperi 13, Radix Et Caulis Acanthopanacis Senticosi 10,6 parts, Radix Glycyrrhizae, Fructus Ligustri Lucidi 15.
Preparation method is with embodiment 1.
(2) test examples part
the antiinflammatory action of embodiment 7 Chinese medicine composition xylol of the present invention induced mice inflammatory model
Hydrocortisone has stronger anti-inflammatory activity, be synthetic be also naturally occurring glucocorticoid, after hydrocortisone enters cell, activate cytoplasmic receptor, nucleus is entered after allosteric, be combined with DNA response element, cause suppression or the induction of genetic transcription, the expression of inflammation related proteins is changed.
, experimental technique:
50 KM mices, male and female half and half, body weight 25-30 gram, 5 groups are divided at random, i.e. dosage group in model control group, compositions high dose group, compositions, compositions low dose group, positive controls by body weight, often organize 10, each administration group mice gives following medicine respectively:
Model control group: gavage gives the normal saline of same volume;
Positive controls: gavage gives the hydrocortisone drug solution of 5mg/kg;
Compositions high dose group: gavage gives 50mg/kg embodiment 1 Chinese medicine composition Chinese medicine composition by crude drug gauge;
Dosage group in compositions: gavage gives 20 mg/kg embodiment 1 Chinese medicine compositions, and Chinese medicine composition presses crude drug gauge;
Compositions low dose group: gavage gives 5 mg/kg embodiment 1 Chinese medicine compositions, and Chinese medicine composition presses crude drug gauge;
Each administration group is administered once every day, successive administration 7d.Get dimethylbenzene 20 μ l after last administration, be applied to each mouse right ear.Get after 30 minutes and be respectively evenly applied to mouse right ear respectively by reagent 0.03 ml, auris dextra is put to death after 3.5 hours to dimethylbenzene, measures each group of mice left and right ear method of double differences.Ear method of double differences assay method: place cuts two ears along auricle baseline, lays auricle with 8mm card punch at the same position of left and right ear, weighs, the ear method of double differences=auris dextra sheet weight-left auricle weight.The ear method of double differences can be used as evaluates antiinflammatory index.
, experimental result:
Measure the antiphlogistic effects that each experimental mice ear method of double differences evaluates each medication group medicine.Measurement result is in table 1.
Table 1 each experimental mice ear method of double differences compares
Compare with model control group,
* p< 0.05; Compare with model control group,
* p< 0.01;
Compare with positive controls,
# p< 0.05; Compare with positive controls,
## p< 0.01.
Result display gives positive drug and Chinese medicine composition of the present invention all can obtain significant antiphlogistic effects, wherein the antiphlogistic effects of Chinese medicine composition high dose group of the present invention and positive controls have pole significant difference, Chinese medicine composition low dose group and positive controls have significant difference, and this shows that the high dose group of Chinese medicine composition of the present invention and the antiphlogistic effects of low dose group significantly will be better than positive controls.
embodiment 8 Chinese medicine composition of the present invention affects mouse hot-plate analgesic
1 mouse hot-plate pain model makes
About body weight 20g female mice is placed on hot plate dolorimeter, screen qualified ♀ mice 90 (to lick metapedes time < 5 s or > 30 s to throw aside, scald for preventing foot, also deadline should be established, be generally 60s), the incubation period of metapedes reaction is added for threshold of pain index with mice, get 72 jennies, be divided into 6 groups, 12/group, i.e. model group, cydiodine, Rhizoma dioscoreae supernatant sheet group, Chinese medicine composition of the present invention (obtaining by Chinese medicine composition prescription described in embodiment 1 and preparation technology) low dose group, middle dosage group and high dose group.Each group is gastric infusion, and 1 times/day, dosage is as shown in table 10, and after successive administration 14d, after measuring last medicine, 60 min, 120 min add the time of foot reaction.
2 Chinese medicine compositions of the present invention are on the impact of licking the foot response latency in mouse hot-plate analgesic experiment
Mice licks foot response latency time showing, compare with model group, after administration after 1h and 2h, the incubation period that the mice of each administration group of Chinese medicine composition of the present invention adds foot reaction is all greater than model group, there is dose-dependence, and be significantly greater than the incubation period of high dose group model group (
p< 0.05).What illustrate that this Chinese medicine composition of the present invention can extend that mice stimulates hot plate adds the sufficient response latency, has certain analgesic activity.Under same experiment condition, positive control drug cydiodine group (
p< 0.05) and Rhizoma dioscoreae supernatant sheet group (1h,
p< 0.05; 2h,
p< 0.01) also extend the incubation period that mice adds foot reaction, there is certain analgesic activity, but its analgesic effect and model group there was no significant difference.The results are shown in Table 3.
Table 2 mice lick foot response latency timetable (
)
Note: compare with model group, *
p< 0.05, * *
p< 0.01.
embodiment 9 Chinese medicine composition of the present invention is to the therapeutical effect of chronic prostatitis rat model
Male Wistar rat 60, is divided into model group, Western medicine (indometacin) matched group, Chinese medicine composition group of the present invention (high dose group, middle dosage group, low dose group), normal group at random.Except normal group, the method for totally 50 employing escherichia coli injection of prostate makes bacterial prostatitis rat model.High, normal, basic group of Chinese medicine composition of the present invention respectively gavage prepares Chinese medicine composition suspension of the present invention according to the embodiment of the present invention 1, high, normal, basic group of 3ml/d(Chinese medicine be respectively 5g/ml, 2g/ml, 0.5g/ml containing crude drug amount), western medicine group gavage indometacin solution 3ml/d(content of dispersion 0.4mg/ml) model group, Normal group gavage normal saline.Gavage was put to death after 30 days, was separated prostata tissue and weighed parallel pathologic finding.
Model rat prostate weight in wet base meansigma methods after table 3 traditional Chinese medicine composition for treating of the present invention
Compare with model control group,
p< 0.05; Compare with model control group,
p< 0.01;
Compare with positive controls,
p< 0.05; Compare with positive controls,
p< 0.01.
the prostatitic clinical data of embodiment 10 traditional Chinese medicine composition for treating of the present invention
1, physical data: selected 360 routine patients, are divided into treatment group and matched group at random, treatment group 180 example, 25 ~ 60 years old age, average 43.2 years old; The course of disease 10 months ~ 9 years, average 4.5 years; Married 60 examples; Matched group 180 example, 23 ~ 55 years old age, average 40.1 years old; The course of disease 5 months ~ 10 years, average 5.0 years; Married 65 examples; In the symptom of above patient: urethral symptom refer to frequent micturition, urgent micturition, dysurea and the heeltap not to the utmost, drip after urine white; Local distending pain refers to perineal position distending pain or companion's lumbago and backache; General Symptoms finger is dizzy, weak, the symptoms such as insomnia.Two groups of cases are all through the super inspection of body of prostate B, and use Hitachi EUB-26 type diasonograph, result all cases all has echo to change, skewness, and edge is irregular, prompting chronic prostatitis, and all cases per rectum refers to inspection, all points out chronic prostatitis; Age, the state of an illness, the course of disease between two groups, little etc. situation difference, there is comparability.
2, diagnostic criteria: with reference to the standard that 1993 " the 3rd whole nation combination of Chinese and Western medicine andropathy scientific seminar of boundary " is agreed, press hydraulic fluid (EPS) microscopy 3 according to patient's medical history, clinical symptoms, prostate palpation, prostate, possessing 2 persons can make a definite diagnosis.Clinical symptoms: (1) paruria: urethral orifice adularescent mucoid secretions when frequent micturition, urgent micturition, dysurea, dribble of urine, urine end or stool, urethra scorching hot, scratchy and urinate not smooth (possessing more than 3); (2) local pain: perineum genital area, lower abdomen suprapubic region, lumbosacral region (at least one position continues more than 3 months).Prostate palpation (anus refers to inspection): Prostatic Surface is uneven, or asymmetric, and quality soft or hard is uneven, maybe can touch inflammatory tubercle, have local tenderness.Prostate is by hydraulic fluid (EPS) microscopy: every high power field leukocyte is more than more than 10, and lecithin reduces or disappears.
3, Therapeutic Method: treatment group orally uses Chinese medicinal composition capsules agent of the present invention (preparing by the embodiment of the present invention 1), takes medicine every day once, taking dose is 3g crude drug amount/d.Matched group: oral hydrochloride levofloxacin tablet 200 milligrams, every day 2 times; Terazosin sheet 2 milligrams, 1 time every night, respectively treats 3 courses for the treatment of for two groups.
4, criterion of therapeutical effect: according to chronic prostatitis criterion of therapeutical effect evaluation relevant in " disease clinical diagnosis and criterion of therapeutical effect ", cure: transference cure, 3 massage liquid inspections are all normal, and B is super and digital rectal examination is normal; Take a turn for the better: symptom is improved, massage liquid checks leukocyte < 10/HP, lecithin > 10/HP, and pyocyte disappears, and B surpasses and digital rectal examination shows that mild inflammatory changes; Invalid: treatment before and after symptom, check unchanged.
Table 4 treatment group and treatment of control group result synopsis
Treatment group is compared matched group and is had higher cure rate and improvement rate, thinks thus, and Drug therapy prostatitis of the present invention has good effect, and through the Ureteral Calculus of month, takes medicine of the present invention and do not occur any toxic and side effects.