Summary of the invention
The purpose of this invention is to provide a kind of medicine that effects such as antiinflammatory, antibiotic, spasmolytic, diuresis, pain relieving are the treatment chronic prostatitis produced of raw material obviously and with the Chinese herbal medicine that has.
Medicine of the present invention is the medicament that makes with following materials based on weight:
Radix Salviae Miltiorrhizae 700-1100 part, Pollen Typhae 300-800 part, Radix Notoginseng 70-110 part, Radix Et Rhizoma Rhei 150-650 part, Radix Linderae 150-650 part, Fructus Evodiae 150-650 part, Cortex Phellodendri 400-800 part, Radix Sophorae Flavescentis 300-700 part, Herba Taraxaci 400-800 part, Radix Trichosanthis 700-1100 part.
Medicine of the present invention fill a prescription preferably (in parts by weight) be:
Radix Salviae Miltiorrhizae 800-1000 part, Pollen Typhae 400-680 part, Radix Notoginseng 80-100 part, Radix Et Rhizoma Rhei 250-450 part, Radix Linderae 250-450 part, Fructus Evodiae 250-450 part, Cortex Phellodendri 500-700 part, Radix Sophorae Flavescentis 400-600 part, Herba Taraxaci 500-700 part, Radix Trichosanthis 80-100 part.
Medicine optimum formula of the present invention (in parts by weight) is:
900 parts of Radix Salviae Miltiorrhizaes, 540 parts of Pollen Typhaes, 90 parts of Radix Notoginseng, 360 parts of Radix Et Rhizoma Rhei, 360 parts of the Radixs Linderae, 360 parts of Fructus Evodiaes, 600 parts of Cortex Phellodendris, 540 parts of Radix Sophorae Flavescentiss, 600 parts of Herba Taraxacis, 900 parts of Radix Trichosanthis.
Pharmaceutical preparation of the present invention is capsule, and its preparation method comprises following process:
(1) gets 700-1100 part Radix Salviae Miltiorrhizae, add the ethanol of 8 times of Radix Salviae Miltiorrhizae weight therein, refluxed 1.5 hours, filter, it is 1.26 extractum that filtrate is evaporated to relative density in 55-60 ℃, the Radix Notoginseng powder that adds 70-110 part in extractum, mixing, vacuum drying, Radix Salviae Miltiorrhizae decoction dregs is standby;
(2) get 150-650 part Radix Linderae and 150-650 part Fructus Evodiae, 6 times of water that add the Radix Linderae and Fructus Evodiae weight, soak steam distillation after 1 hour, extract volatile oil, extraction time is 8 hours, 6 times the beta-schardinger dextrin-that in volatile oil, adds volatile oil weight then, be dissolved in again in 100 times of water of volatile oil and β-Cyclodextrin weight, 50 ℃ of following enclose 1 hour, refrigerator and cooled was hidden 24 hours, filter, the clathrate that obtains was in 50 ℃ of bakings 3 hours, and it is standby after filtering to extract the Aromatic water and the medicinal residues that obtain behind the volatile oil;
(3) Radix Linderae, the Fructus Evodiae medicinal residues with 300-800 part Pollen Typhae, 150-650 part Radix Et Rhizoma Rhei, 400-800 part Cortex Phellodendri, 300-700 part Radix Sophorae Flavescentis, 400-800 part Herba Taraxaci, 700-1100 part Radix Trichosanthis and step (1) Radix Salviae Miltiorrhizae decoction dregs and step (2) mix, 12 times the water that adds its weight, reflux, extract, 2 times, each 2 hours, obtain extracting solution;
(4) Aromatic water of the extracting solution of step (3) and step (2) merges, and is concentrated into relative density 1.13, and adding ethanol, to transfer to determining alcohol be 75%, placed 30 minutes, centrifugal, get supernatant, reclaim ethanol, vacuum drying, dry product that the dry product of gained and step (1) and step (2) obtain merges weighs, and adds starch to 1000 part, pulverizes, mix homogeneously, the encapsulated required product that promptly obtains.
Medicine of the present invention cure mainly difficulty and pain in micturition that acute and chronic prostatitis causes, the heeltap not to the utmost, perineum, lower abdomen and testicular pain, hyposexuality, pain in the lumbar region, prostatic fluid is conventional unusual etc.; Usage and consumption: oral, one time 4, three times on the one, 1 month course of treatment; Store method: airtight, shady and cool dry place preserves 2 years shelf-lifves.
Advantage of the present invention and effect:
Medicine of the present invention is based on blood circulation promoting and blood stasis dispelling, and assistant at the main pathology link of chronic prostatitis, promotes local blood circulation and drug absorption with the clearing away heat-damp and promoting diuresis antiinflammatory, can alleviate spasmic pain, inducing diuresis for treating stranguria syndrome; Also by integrally-regulated, improve General Symptoms simultaneously as the insomnia anxiety, sexual dysfunction etc., human body immunity improving power, prevention reduces recurrence; Drug efficacy study confirms: medicine of the present invention has good antiinflammation, the effect that having regulates the flow of vital energy relieves the pain, and mice normally reaches water load diuretic test result and shows tangible inducing diuresis for treating stranguria syndrome effect.Clinical observation shows that medicine of the present invention has ideal curative effect to chronic prostatitis, and the acute and chronic toxicological experiment shows, has no side effect.
In order to confirm the effect of medicine of the present invention, through hospital's 120 routine clinical observations, report content is as follows:
Object of study and method
One, object of study
Allly meet CP Western medicine diagnose standard and get rid of case standard person, all can include the object of study scope in.120 routine patients are nineteen ninety-five JIUYUE to the 1996 air force general hospital department of Chinese medicine in year April and the outpatient of andrology.Western medicine diagnose standard reference " diagnostics " (Qi Renduo chief editor, Beijing: People's Health Publisher, 1993:501), " clinical disease diagnosis standard and national health check-up standard " (chief editor such as Yu Dechun, front page, Liaoning: Liaoning science tech publishing house, 1991:61) and according to this paper EPS experimental check index formulate; (first volume, Beijing: Ministry of Health of the People's Republic of China makes and issue, 1993:192-206) to get rid of case standard reference " new Chinese medicine clinical research guideline "
Two, observation item
The patient carries out the subjective symptom inquiring before and after treatment, comprise pain or malaise symptoms, urinary tract symptom, property and four groups of symptoms such as reproduction symptom and General Symptoms; Whether the prostate touch unusual, comprise unusually large and small, hard, bitterly, six aspects such as heat, knot; The relative analysis of EPS objective determination comprises EPS-PH pH-value determination pH, EPS routine and differs the microimaging inspection.
Three, Therapeutic Method
Before the treatment, have a blood test, urine, stool routine examination regulating liver-QI, renal function, normal person's administration.After one month, check blood, urine, stool routine examination regulating liver-QI, renal function.
Shu An capsule (product of the present invention, as follows) is 4/time before the treatment, and every day three times, continuous use 1 month does not add during the treatment and uses other medicines, carries out observation of curative effect research.
Four, clinical efficacy
1. doing well,improving situation
To CP doing well,improving situation, we observe from pain or malaise symptoms, urinary tract symptom, property and reproduction symptom and four aspects of General Symptoms, the results are shown in Table 1 for the ease of Shu An before inquiring into.
Symptom | n | Recovery from illness | Produce effects | Take a turn for the better | Invalid | Effectively (%) |
Pain or uncomfortable urinary tract symptom and reproduction symptom | 102 118 96 | ?34 ?55 ?33 | ?27 ?24 ?18 | ?30 ?39 ?21 | ?11 ?0 ?24 | ?89.22 ?100.00 ?75.00 |
General Symptoms | 104 | ?45 | ?12 | ?37 | ?10 | ?90.39 |
Table 1 shows, preceding Shu An all has a better role to the pain of CP or malaise symptoms, urinary tract symptom, property and reproduction symptom and General Symptoms, and is good especially to the urinary tract symptom curative effect.
2. prostate touch situation
Prostate touch situation analysis relatively can reflect the improvement effect of medicine to the local sign of prostate, the results are shown in Table 2.
The prostate touch changes (n=120) before and after table 2 treatment
Recovery from illness | Produce effects | Take a turn for the better | Invalid | Effectively (%) |
56 | ?27 | ?15 | ?22 | ?81.67% |
Table 2 shows that preceding Shu An has better action to the local sign of prostate, the recovery from illness example, and produce effects 27 examples, the recovery from illness obvious effective rate is 69.17%, total effective rate 81.67%.
3.EPS-pH change
The EPS-pH value compares (X ± SD) (n=120) before and after table 3 treatment
Before the treatment | After the treatment | P |
6.81±0.27 | 6.34±0.24 | <0.01 |
Table 3 shows, descends before treatment back EPS-pH value is treated very obviously (P<0.01).Shu Anneng descends the EPS-pH value of CP before illustrating, and effect is obvious.
4.EPS routine examination situation
(1) EPS lecithin
Can occur normally before the EPS lecithin treatment of CP, treatment back change can reduce because of the disease end of loveization.Therefore in order to add up convenient, we adopt ranked data, and lecithin is covered with the visual field (+++), a large amount of (++), (+) in a small amount, and regulation +++be 3 minutes, ++ be 2 minutes ,+be 1 minute, the results are shown in Table 4.
EPS lecithin score value compares (X ± SD) (n+120) before and after table 4 treatment
Before the treatment | After the treatment | ????P |
????1.75±0.58 | ????1.73±0.71 | ????>0.05 |
Table 4 shows, difference (P>0.05) that there are no significant before treatment back lecithin was treated, and its reason may not have specificity with this index of lecithin, and changes more relevant during the treatment.
2.EPS leukocyte the results are shown in Table 5.
The leukocytic variation of EPS (n=120) before and after table 5 treatment
Normally | Reduce | Do not have and improve | Effectively (%) |
32 | ????62 | ????26 | ??78.33 |
Table 5 shows, treatment back EPS leukopenia, and effective percentage 78.33%, Shu An is inhibited to the inflammatory reaction of CP before showing.
5. side effect is observed
120 routine CP patients do not have significant discomfort behind the Shu An capsule before taking, and blood, urine, stool routine examination regulating liver-QI, kidney function test are all normal.
6. comprehensive therapeutic effect evaluation
With reference to the therapeutic evaluation standard, 120 routine CP patients cure 54 examples (45.00%), produce effects 27 examples (8.33%), and 22 examples that take a turn for the better (18.33%), invalid 17 examples (14.1%) the results are shown in Table 6.
Table 6 comprehensive therapeutic effect evaluation (n=120)
Recovery from illness | Produce effects | Take a turn for the better | Invalid | Effectively (%) |
??54 | ??27 | ??22 | ??17 | ??85.83% |
Table 6 shows that preceding Shu An has the good curing effect to CP, recovery from illness+produce effects 81 examples (67.50%), total effective rate 85.83%.
Five. the mechanism of action
1. reduce the EPS-pH value
About the EPS-pH value rising reason of CP, we think that this may have ureaplasma urealyticum infection relevant by CP.Because urine easily blows back into prostate, provide required carbamide for separating the former bulk-growth of rami glandulares, and Ureaplasma urealyticum itself has urease, and the energy decomposing urea produces NH3, and (Cao Yupu etc. write, and go into the laboratory diagnosis technology of mycoplasma infection, Beijing: Chinese Medical Association's microorganism and immunology meeting mycoplasma group, 1992:28-29), the EPS-pH value of slant acidity is raise, very person's meta-alkalescence, destroy the acid-base balance of EPS, caused the prostate dysfunction.Preceding Shu An treatment back EPS-pH value descends, and illustrates that this medicine has the effect of killing Ureaplasma urealyticum, thereby the EPS-pH value is descended.
2. promote that the drainage of prostate conduit is unobstructed
The alluvial of EPS leukocyte is in heaps, is the microcosmic sign of prostate conduit drainage difficulty.Can not illustrate with the disappearance that urethra drips white phenomenon clinically the prostate conduit drain unobstructed because this might be the result of PD.Generally think, EPS leukocyte rickle, in heaps, a large amount of inflammation scope that reflects the prostate conduit respectively in heaps, rickle is that 1-2 root conduit inflammation is blocked, and in heaps is that 3-5 root conduit inflammation is blocked, and in heaps in a large number is that many conduit inflammation are blocked.Preceding Shu An makes the EPS leukopenia, illustrates that this medicine has promotion prostate conduit to drain unobstructed effect, from the inflammatory reaction with inhibition CP.