CN104208242B - One treats prostatitic external use plaster and preparation method thereof - Google Patents
One treats prostatitic external use plaster and preparation method thereof Download PDFInfo
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Abstract
The present invention relates to one and treat the prostatitic external use plaster of human male.Its component and preparation process are as follows: take the Radix Rosae Laevigatae 65 grams of recipe quantity, Semen Plantaginis 30 grams, Cortex Phellodendri 18 grams, Herba Epimedii 15 grams, 10 grams of Poria, smash into coarse powder, cross 40 mesh sieves, mixing, making relative density with the ethanol of 85% is 1.20, gained fluid extract and Pollen Brassicae campestris, nano silver gel, 5% ammonia ketone, ammonium leaf oil, after refined honey (115 DEG C refining to the 85% of former honey qualities) is 2:1:0.2:0.1:0.2:0.3 Homogeneous phase mixing according to mass ratio, it is possible to additionally incorporate the black plaster substrate of 3 times of weight and make coating, it is coated with cream, cutting, lid lining, cut fritter, obtain patch of the present invention.Using method: be affixed under navel side skin place.This patch is easy to use, have no side effect, determined curative effect, is worthy to be popularized.
Description
Technical field
The present invention relates to a kind of external use plaster compound Chinese medicinal preparation made with nano silver gel and transdermal enhancer, this patch has the treatment prostatitic effect of human male, and skin irritation is little, safe and effective.
Background technology
Prostatitis is a kind of most commonly seen disease of Urology Surgery, is usually expressed as upset of urinating, basin sacrum pain and sexual dysfunction.Wherein maximum with nonbacterial prostatitis, often show as chronic, often easily recurrence.Treatment for bacterial prostatitis generally adopts the method such as broad ectrum antibiotic or surgical removal to treat.And for nonbacterial prostatitis, it is clear that said method should not be adopted.Currently, the prostatitis treating the type generally adopts the methods such as oral anti-inflammation analgesic (such as NSAID (non-steroidal anti-inflammatory drug), allopurinol), physiotherapy (such as microwave, radio frequency, ultrashort wave, medium wave and hot water hip-bath), alpha-receptor antagonist (such as terazosin, tamsulosin).Nonbacterial prostatitis adopts physiotherapy and western medicine to be only capable of playing and reduce inflammation, alleviating pain, improves the effects such as symptom of urinating, and toxic and side effects is relatively big, not easily long-term treatment.Therefore, Chinese medicine concrete toxicity in nonbacterial prostatitis treatment is little, can the advantage of long-term taking.Such as, QIANLIEKANG is using Pollen Brassicae campestris as main component, better for nonbacterial prostatitis therapeutic effect, although therapeutic process is longer, and cannot be completely cured, but owing to it has no side effect, can long-term taking, be therefore able to extensive use in clinic.
Although China's Chinese medicine row adenitis before the treatment has stronger advantage, but dissipate based on decoction for oral administration, ball owing to they are many, tablet, mouthfeel is poor, and patient is generally difficult to and adheres to for a long time.Additionally, the valid density that oral drugs generally reach lesions position is relatively low, it is difficult to bigger performance therapeutical effect.And make Chinese herbs paste, then patient more can be facilitated to use, and by after skin Transdermal absorption under umbilicus, the drug level reaching prostatic is better than oral formulations.
Summary of the invention
Technical problem:
For making up the deficiency of existing preparation technique, alleviate the misery of prostatitis patient, the invention provides one and treat prostatitic medicine, patch under the hilum that this medicine is made up of compound traditional Chinese medicine composite fluid extract, nano silver gel, cutaneous permeable agent and black plaster substrate.This patch treatment prostatitis is evident in efficacy, esy to use, safe and reliable, possesses wide potential applicability in clinical practice.
Technical scheme:
The present inventor, according to Chinese medical theory research and nanotechnology, uses modern medicines formulation method, thus completing the present invention.
It is an object of the invention to provide one can effectively treat prostatitic external use plaster and its preparation method is provided.
One treats prostatitic external use plaster, it is characterised in that it contains Radix Rosae Laevigatae, Semen Plantaginis, Cortex Phellodendri, Herba Epimedii, Poria, Pollen Brassicae campestris.
Also added with skin permeation enhancers in described crude drug, described permeation enhancers is 5% ammonia ketone, nano silver gel, ammonium leaf oil.
Its effective ingredient is made up of following crude drug: Radix Rosae Laevigatae 50-80 gram, Semen Plantaginis 15-40 gram, Cortex Phellodendri 10-30 gram, Herba Epimedii 10-20 gram, 5-20 gram of Poria, smash into coarse powder, cross 40 mesh sieves, mixing, the fluid extract that relative density is 1.1-1.5 is made with the ethanol of 75%, gained fluid extract and Pollen Brassicae campestris, nano silver gel, 5% ammonia ketone, ammonium leaf oil, after refined honey is 1-3:0.5-2:0.1-1:0.05-0.2:0.1-0.3:0.1-0.5 Homogeneous phase mixing according to mass ratio, it is possible to additionally incorporate the black plaster substrate of 3 times of weight and make coating, it is coated with cream, cutting, lid lining, cut fritter, obtain patch of the present invention.
Chinese medicine in patch of the present invention have selected Radix Rosae Laevigatae, Semen Plantaginis, Cortex Phellodendri, Herba Epimedii, Poria, Pollen Brassicae campestris, nano silver gel, 5% ammonia ketone, ammonium leaf oil, refined honey, black plaster substrate etc. as supplementary material, by the combination of these supplementary materials, each efficacy of drugs is made to produce coordinative role, thus Mutiple Targets, treating prostatitis expeditiously.
Wherein Radix Rosae Laevigatae is selected to be because its nature and flavor sour and astringent, sweet, flat, nontoxic, enter kidney, large intestine channel, there is convergence astringent or styptic treatment for spontaneous sweating, arresting bleeding and healing up ulcer, invigorate blood circulation in dispelling, pain relieving, effect of parasite killing, control spermatorrhea, the enuresis, dysentery, have loose bowels, hemoptysis, have blood in stool, metrorrhagia, leukorrhagia, proctoptosis, uterine prolapse, rheumatic arthralgia, traumatic injury, skin infection, scald, toothache, stomachache, ascariasis, all bones are choked larynx, chyluria.Semen Plantaginis is selected to be because its nature and flavor sweet, cold, enter kidney, bladder warp, have diuretic, heat clearing away, improving eyesight, the function eliminated the phlegm, control urinary obstruction, stranguria with turbid discharge, leukorrhagia, hematuria, heat-damp in summer dysentery, cough ant phlegm, arthralgia chiefly caused by damp pathogen, conjunctival congestion is hidden from view.Cortex Phellodendri is selected to be because its nature and flavor bitter, cold, enter lung, stomach, kidney channel, have nourishing YIN to lower pathogenic fire, moisturize effect of laxation, control dysphoria with smothery sensation and quench one's thirst, hectic fever due to YIN-deficiency consumptive fever, cough due to lung-heat, constipation due to dry stool, dysuria.Herba Epimedii is selected to be because its nature and flavor pungent, sweet, temperature, return liver, kidney channel, have kidney invigorating and YANG supporting, effect of expelling wind and removing dampness, controlling sexual impotence not lift, hemiplegia is unsuccessful, dribbling urination, and muscles and bones contraction is anxious, cough, optic atrohic blindness after being ill, toothache caused by fire of deficiency type, hemiplegia, weakness of the waist and knees, rheumatic arthralgia, extremity are meciless.Poria is selected to be because its property slightly sweet flavor, flat, enter the heart, spleen, lung meridian, have eliminating dampness and diuresis, strengthening the spleen stomach function regulating, effect of mind tranquilizing and the heart calming, control dysuria, edema distending pain, phlegm retention cough with dyspnea, vomiting, malignant histocytosis, have loose bowels, seminal emission, stranguria with turbid discharge, palpitation with fear, forgetful.Pollen Brassicae campestris is selected to be because its nature and flavor cool, sweet, enter liver, spleen, lung meridian, there are blood circulation promoting and blood stasis dispelling, removing toxic substances and promoting subsidence of swelling, wide intestinal relieving constipation, effect of building body, controls instability of kidney QI, soreness of the waist and knees, dribble of urine or incontinence, and the person that has above-mentioned symptom such as chronic prostatitis, prostatic hyperplasia.
Patch adds a small amount of nano silver gel, its can slow skin permeation enduringly, and internalization is to prostata tissue cell interior, plays excellent lasting antibacterial effect, has certain therapeutic effect for bacterial prostatitis.Additionally, patch is also added into 5%(mass volume ratio) ammonia ketone and ammonium leaf oil as transdermal enhancer, add Mel (refining) as wetting agent, addition black plaster substrate.
The present invention combines drug prescription consumption used, and to be inventor sum up the preferable amount with optimum curative effect drawn through groping in a large number.
The preparation method of this patch is as follows:
1. get the raw materials ready
1.1 Radix Rosae Laevigataes: pick decontamination, clean, and cut off, dry.
1.2 Semen Plantaginiss: pick decontamination, sieve removes spare and empty grain, dries.
1.3 Cortex Phellodendri: pick decontamination, wash, and pull out, run through, section, dry.
1.4 Herba Epimedii: clean herb, dry.
1.5 Poria: be soaked in water, clean and pull out, after vexed, and section, dry.
1.6 Pollen Brassicae campestriss: dry, smash, and cross 80 mesh sieves.
2. the preparation of nano silver gel
2.1 newly prepare 0.1mMAgNO3Two kinds of solution are 1.5:1 mixing according to mol ratio by solution and 0.01mML-cysteine solution at ambient temperature.
Mixed white opacity liquid is irradiated 4.5h by 2.2 under 100W self-ballasted high pressure mercury fluorescent lamp, obtains silver nanoclusters colloidal sol, prepares with Cys for protectant nano silver gel after subsequently this solution room temperature being placed 2h.
3. preparation
3.1 weigh the above-mentioned Radix Rosae Laevigatae got the raw materials ready 65 grams, Semen Plantaginis 30 grams, Cortex Phellodendri 18 grams, Herba Epimedii 15 grams, 10 grams of Poria, smash into coarse powder, cross 40 mesh sieves, mixing.
3.2 add 75% ethanol 25ml in above-mentioned Chinese medicine coarse powder makes coarse powder uniformly moisten, after expansion, gradation is uniformly filled in percolator, add 75% ethanol (volume fraction) submergence, dipping 15min, slowly percolation, flow velocity is 1/s, first collecting percolation liquid 300ml, it is 1.20 that heating is concentrated into relative density.
After the fluid extract of 3.3 above-mentioned gained and Pollen Brassicae campestris, nano silver gel, 5% ammonia ketone, ammonium leaf oil, refined honey (115 DEG C refining to the 85% of former honey qualities) are 2:1:0.2:0.1:0.2:0.3 Homogeneous phase mixing according to mass ratio, it is possible to additionally incorporate the black plaster substrate of 3 times of weight and make coating, it is coated with cream, cutting, lid lining, cut fritter, obtain patch of the present invention.
Beneficial effect:
Patch involved in the present invention is row adenitis aspect before the treatment, compared with prior art has the advantage that
1) compared with the therapeutic effect of Current therapeutic medicine, this patch composition medicine have employed plurality of Chinese component, nano silver gel, Percutaneous absorption enhancer etc., and target site is numerous, and targeted drug concentration is higher, improves therapeutic effect.
2) treatment prostatitis medicine is a lot of at present, and such as QIANLIEKANG etc., some medicines are that tablet has plenty of capsule, the present invention is compared with the dosage form of Current therapeutic medicine, patch used in the present invention uses more convenient, improves patient's acceptance to medicine, is more easy to and adheres to long-term prescription.
3) compared with Current therapeutic Drug safety, medicine of the present invention had both had the advantage that natural Chinese medicine preparation untoward reaction is little, was again external preparation, therefore medication effect more preferably and untoward reaction and side effect also less.
4) patch of the present invention has anti-inflammation, nourishing YIN to lower pathogenic fire, heat clearing away, diuretic, reinforces the kidney, effect of benefit essence, and treatment prostatitis is easy to use, instant effect, short treating period, and few recurrence all has good therapeutic effect for acute and chronic prostatitis and nonbacterial prostatitis.
The beneficial effect of of the present invention medicine is expanded on further by the following examples, and these embodiments include the antimicrobial antiphlogistic test of medicine of the present invention, Skin Irritation Test, animal toxicity test, pharmacodynamics test, clinical observation material.Scope is not limited with embodiment.
Detailed description of the invention
Black plaster substrate purchased fromHenan Kang Di medical instruments company limited
Embodiment 1
The preparation method of this patch is as follows:
1. get the raw materials ready
1.1 Radix Rosae Laevigataes: pick decontamination, clean, and cut off, dry.
1.2 Semen Plantaginiss: pick decontamination, sieve removes spare and empty grain, dries.
1.3 Cortex Phellodendri: pick decontamination, wash, and pull out, run through, section, dry.
1.4 Herba Epimedii: clean herb, dry.
1.5 Poria: be soaked in water, clean and pull out, after vexed, and section, dry.
1.6 Pollen Brassicae campestriss: dry, smash, and cross 80 mesh sieves.
2. the preparation of nano silver gel
2.1 newly prepare 0.1mMAgNO3Two kinds of solution are 1.5:1 mixing according to mol ratio by solution and 0.01mML-cysteine solution at ambient temperature.
Mixed white opacity liquid is irradiated 4.5h by 2.2 under 100W self-ballasted high pressure mercury fluorescent lamp, obtains silver nanoclusters colloidal sol, prepares with Cys for protectant nano silver gel after subsequently this solution room temperature being placed 2h.
3. preparation
3.1 weigh the above-mentioned Radix Rosae Laevigatae got the raw materials ready 65 grams, Semen Plantaginis 30 grams, Cortex Phellodendri 18 grams, Herba Epimedii 15 grams, 10 grams of Poria, smash into coarse powder, cross 40 mesh sieves, mixing.
3.2 add 75% ethanol 25ml in above-mentioned Chinese medicine coarse powder makes coarse powder uniformly moisten, after expansion, gradation is uniformly filled in percolator, add 75% ethanol (volume fraction) submergence, dipping 15min, slowly percolation, flow velocity is 1/s, first collecting percolation liquid 300ml, it is 1.20 that heating is concentrated into relative density.
After the fluid extract of 3.3 above-mentioned gained and Pollen Brassicae campestris, nano silver gel, 5% ammonia ketone, ammonium leaf oil, refined honey (115 DEG C refining to the 85% of former honey qualities) are 2:1:0.2:0.1:0.2:0.3 Homogeneous phase mixing according to mass ratio, it is possible to additionally incorporate the black plaster substrate of 3 times of weight and make coating, it is coated with cream, cutting, lid lining, cut fritter, obtain patch of the present invention.
Embodiment 2
The preparation method of this patch is as follows:
1. get the raw materials ready
1.1 Radix Rosae Laevigataes: pick decontamination, clean, and cut off, dry.
1.2 Semen Plantaginiss: pick decontamination, sieve removes spare and empty grain, dries.
1.3 Cortex Phellodendri: pick decontamination, wash, and pull out, run through, section, dry.
1.4 Herba Epimedii: clean herb, dry.
1.5 Poria: be soaked in water, clean and pull out, after vexed, and section, dry.
1.6 Pollen Brassicae campestriss: dry, smash, and cross 80 mesh sieves.
2. the preparation of nano silver gel
2.1 newly prepare 0.1mMAgNO3Two kinds of solution are 1.5:1 mixing according to mol ratio by solution and 0.01mML-cysteine solution at ambient temperature.
Mixed white opacity liquid is irradiated 4.5h by 2.2 under 100W self-ballasted high pressure mercury fluorescent lamp, obtains silver nanoclusters colloidal sol, prepares with Cys for protectant nano silver gel after subsequently this solution room temperature being placed 2h.
3. preparation
3.1 weigh the above-mentioned Radix Rosae Laevigatae got the raw materials ready 50 grams, Semen Plantaginis 15 grams, Cortex Phellodendri 10 grams, Herba Epimedii 10 grams, 5 grams of Poria, smash into coarse powder, cross 40 mesh sieves, mixing.
3.2 add 75% ethanol 25ml in above-mentioned Chinese medicine coarse powder makes coarse powder uniformly moisten, after expansion, gradation is uniformly filled in percolator, add 75% ethanol (volume fraction) submergence, dipping 15min, slowly percolation, flow velocity is 1/s, first collecting percolation liquid 300ml, it is 1.10 that heating is concentrated into relative density.
After the fluid extract of 3.3 above-mentioned gained and Pollen Brassicae campestris, nano silver gel, 5% ammonia ketone, ammonium leaf oil, refined honey (115 DEG C refining to the 85% of former honey qualities) are 1:0.5:0.1:0.05:0.1:0.1 Homogeneous phase mixing according to mass ratio, it is possible to additionally incorporate the black plaster substrate of 3 times of weight and make coating, it is coated with cream, cutting, lid lining, cut fritter, obtain patch of the present invention.
The preparation method of 3 patches of embodiment is as follows:
1. get the raw materials ready
1.1 Radix Rosae Laevigataes: pick decontamination, clean, and cut off, dry.
1.2 Semen Plantaginiss: pick decontamination, sieve removes spare and empty grain, dries.
1.3 Cortex Phellodendri: pick decontamination, wash, and pull out, run through, section, dry.
1.4 Herba Epimedii: clean herb, dry.
1.5 Poria: be soaked in water, clean and pull out, after vexed, and section, dry.
1.6 Pollen Brassicae campestriss: dry, smash, and cross 80 mesh sieves.
2. the preparation of nano silver gel
2.1 newly prepare 0.1mMAgNO3Two kinds of solution are 1.5:1 mixing according to mol ratio by solution and 0.01mML-cysteine solution at ambient temperature.
Mixed white opacity liquid is irradiated 4.5h by 2.2 under 100W self-ballasted high pressure mercury fluorescent lamp, obtains silver nanoclusters colloidal sol, prepares with Cys for protectant nano silver gel after subsequently this solution room temperature being placed 2h.
3. preparation
3.1 weigh the above-mentioned Radix Rosae Laevigatae got the raw materials ready 80 grams, Semen Plantaginis 40 grams, Cortex Phellodendri 30 grams, Herba Epimedii 20 grams, 20 grams of Poria, smash into coarse powder, cross 40 mesh sieves, mixing.
3.2 add 75% ethanol 25ml in above-mentioned Chinese medicine coarse powder makes coarse powder uniformly moisten, after expansion, gradation is uniformly filled in percolator, add 75% ethanol (volume fraction) submergence, dipping 15min, slowly percolation, flow velocity is 1/s, first collecting percolation liquid 300ml, it is 1.5 that heating is concentrated into relative density.
After the fluid extract of 3.3 above-mentioned gained and Pollen Brassicae campestris, nano silver gel, 5% ammonia ketone, ammonium leaf oil, refined honey (115 DEG C refining to the 85% of former honey qualities) are 3:2:1:0.2:0.3:0.5 Homogeneous phase mixing according to mass ratio, it is possible to additionally incorporate the black plaster substrate of 3 times of weight and make coating, it is coated with cream, cutting, lid lining, cut fritter, obtain patch of the present invention.
The embodiment 4 optimizing prescriptions combination action effect to chronic non-bacterial type prostatitis rat model
Test method:
1) following patch is prepared respectively.(patch 1-7): prepare by embodiment 1 method, respectively by single component in the Radix Rosae Laevigatae of recipe quantity, Semen Plantaginis, Cortex Phellodendri, Herba Epimedii, Poria, Pollen Brassicae campestris, nano silver gel, add the patch that the adjuvants such as 5% ammonia ketone, ammonium leaf oil, refined honey, black plaster substrate are made；(patch 8): the patch only made containing 5% ammonia ketone, ammonium leaf oil, refined honey, black plaster substrate these four adjuvant；(patch 9): the patch being made up of embodiment 1.
2) foundation of rat chronic nonbacterial prostatitis model.Modeling method: to male 1 one full year of life castration SD rat (500-800g) some, every daily estradiol benzoate 0.25mg/kg subcutaneous injection, continuous 30d, namely may result in rat prostate generation chronic non-bacterial inflammation.
3) GP TH.It is divided into four groups: normal group (10), model group (10), patch treatment group (10 × 9=90 is only), QIANLIEKANG treatment group (10 × 3=30 is only).Normal group is the normal rat without still where reason.Model group is by, after above-mentioned chemical treatment, successfully modeling but untreated rat.Patch treatment group is treated for modeling rat patch 1-9, and medication is: same area near rat model pubis side lost hair or feathers, and sticks 1-9(length × wide=10mm × 10mm respectively), every day 2 times, continuous 3 weeks.QIANLIEKANG treatment group is modeling rat QIANLIEKANG PIAN gavage treatment, and medication is: take QIANLIEKANG PIAN, puts in mortar, adds after a small amount of water is ground into homogeneous latex emulsion, by gastric infusion mode, rat model is treated, every day 1 time, continuous 3 weeks.If high dose group (6 are every time), middle dosage group (3 are every time) and low dose group (1 is every time).
4) prostate pathologic finding.After drug treatment, with 3.5% chloral hydrate anesthesia rat, aseptically dissect, cut abdominal cavity, cut off pubic symphysis, take out prostata tissue, extract a small amount of prostatic fluid and carry out cytoscopy, then by prostata tissue rinsed clean, put in the neutral formalin solution of 10% fixing, specimens paraffin embedding slices, HE dyes, and observes the performance of organ histopathology.
Result of the test: as shown in table 1, model group rats is compared with normal rats, and number of white blood cells significantly raises；Lecithin density fraction is remarkably decreased；Every prostate section HE coloration result all shows substantial amounts of inflammatory cell infiltration.The above results indicates prostatitis rat model and is successfully built.The patch alone crude drug of 1-7() treatment group rat leukocyte quantity has slight reduction；Lecithin density fraction has a small amount of rising；It is less that inflammatory cell infiltration example reduces number of cases.Above-mentioned three indexs pasting 8 treatment groups (alone adjuvant) all there was no significant difference with model group.Paste 9 treatment group (present composition) quantity of leucocyte and have significant reduction；Lecithin density fraction is increased significantly；Inflammatory cell infiltration number of cases reduces more.Although above-mentioned three indexs of QIANLIEKANG PIAN low dosage, middle dosage and high-dose therapy group all make moderate progress, but it recovers normal degree and is respectively less than the compositions used used by patch of the present invention.
The table 1 optimizing prescriptions combination therapeutic effect to chronic non-bacterial type prostatitis rat model
| Group | Leukocyte count (individual/mm3) | Lecithin density (mark) | Inflammatory cell infiltration (example) |
| Normal group | 34.2±9.8 | 3.1±0.62 | 0 |
| Model group | 2483.5±779.1 | 1.3±0.62 | 10 |
| Paste 1 treatment group | 1574.4±322.5 | 2.0±0.35 | 7 |
| Paste 2 treatment groups | 1980.6±317.6 | 1.6±0.26 | 9 |
| Paste 3 treatment groups | 1698.1±514.5 | 1.8±0.50 | 8 |
| Paste 4 treatment groups | 1718.1±616.7 | 1.9±0.62 | 8 |
| Paste 5 treatment groups | 2088.9±823.2 | 1.5±0.76 | 9 |
| Paste 6 treatment groups | 1312.2±112.5 | 1.8±0.23 | 8 |
| Paste 7 treatment groups | 1893.4±319.0 | 1.6±0.33 | 9 |
| Paste 8 treatment groups | 2344.5±933.2 | 1.4±0.40 | 10 |
| Paste 9 treatment groups | 488.3±95.1 | 2.7±0.39 | 3 |
| QIANLIEKANG PIAN (low dosage) treatment group | 1026.5±232.5 | 1.8±0.51 | 7 |
| QIANLIEKANG PIAN (middle dosage) treatment group | 897.2±100.7 | 2.2±0.65 | 5 |
| QIANLIEKANG PIAN (high dose) treatment group | 840.0±131.5 | 2.3±0.74 | 5 |
Result shows: the therapeutic effect of prostatitis rat is become apparent from by the supplementary material complex used by medicine patch of the present invention than the patch being used alone made by each supplementary material, and its than QIANLIEKANG PIAN high-dose therapy group therapeutic effect more preferably.Additionally, patch of the present invention is compared with QIANLIEKANG PIAN, more convenient to use.
Embodiment 2 In vitro Bactericidal Experiments
Test method: the blank patch of medicine patch of the present invention (embodiment 1-3) and not drug containing is made the round fritter that several diameters are 1cm stand-by.Draw the escherichia coli ATCC25922 of fresh exponential phase, staphylococcus aureus ATCC25923, Klebsiella Pneumoniae ATCC700603, Pseudomonas aeruginosa ATCC15442, proteus mirabilis ATCC12453 bacterium solution 0.1mL respectively, it is spread evenly across on solid M-H agar plate with spreader, every kind of test bacterium is coated with 2 pieces of flat boards, stick medicine patch and blank patch respectively, it is placed in 37 DEG C of biochemical cultivation cases and cultivates 18-24h, observe antibacterial circle diameter.Test parallel testing 5 times, report result of averaging.
Result of the test: patch of the present invention (embodiment 1) tests average diameter of inhibition zone respectively 26.4mm, 22.2mm, 18.5mm, 11.2mm, 15.3mm of bacterium to above-mentioned five kinds；(embodiment 2) tests average diameter of inhibition zone respectively 25.4mm, 21.2mm, 17.5mm, 11.3mm, 14.2mm of bacterium to above-mentioned five kinds；(embodiment 3) tests average diameter of inhibition zone respectively 26.1mm, 22.0mm, 18.4mm, 11.4mm, 15.7mm of bacterium to above-mentioned five kinds, and blank patch is all without obvious inhibition zone.
Result shows: the pathogen such as escherichia coli, staphylococcus aureus, Klebsiella Pneumoniae, Pseudomonas aeruginosa, proteus mirabilis are respectively provided with certain antibacterial effect by medicine patch of the present invention.
Embodiment 3 anti-inflammation test
Test method: 30 kunming mices, male and female half and half, body weight 28-32 gram.Adopting dimethylbenzene method to build mice inflammatory model, operate as follows: take dimethylbenzene 25 μ L and be applied to mouse right ear, left ear then coats the normal saline of 25 μ L as comparison in same position.It is randomly divided into 4 groups by body weight, i.e. model control group and embodiment 1-3, often group 15, treats that the dimethylbenzene of two ears paintings and normal saline are dried, give following treatment respectively.Model control group: stick the blank patch (length × wide=5mm × 5mm) of not drug containing in mouse right ear affected part；Medication therapy groups: same to method, sticks an equal amount of medicine patch of the present invention at mouse right ear.After treating 4 hours, put to death mice, measure the ear method of double differences of mice left and right ear.Its assay method is: cut two ears along auricle baseline place, lays auricle with the card punch of 10mm at the same position of left and right ear, weighs, the ear method of double differences=auris dextra tablet weight-left auricle weight.The ear method of double differences is as the evaluation index of medicine antiphlogistic effects.
Result of the test: the ear method of double differences of model control group is 11.36 ± 0.86mg；And the ear method of double differences of embodiment 1 is 4.65 ± 1.22mg.Medication therapy groups is compared with model control group, and the ear method of double differences is obviously reduced (P < 0.01).The ear method of double differences of embodiment 2 is 4.31 ± 1.20mg.Medication therapy groups is compared with model control group, and the ear method of double differences is obviously reduced (P < 0.01).The ear method of double differences of embodiment 1 is 4.25 ± 1.21mg.Medication therapy groups is compared with model control group, and the ear method of double differences is obviously reduced (P < 0.01).
Result shows: patch of the present invention has significant antiphlogistic effects.
Embodiment 4 irritation test
Test method: the test method of irritation test is: rabbit 10, cut abdominal portion hair, and slough non-Rhizoma Imperatae with depilatory cream, the patch that invention patch embodiment 1-3(normal dose and 10 times of normal doses are made) it is pasted on the exposed position of rabbit unhairing, after 12 hours, observe and evaluate erythema and the edema situation of skin.
Result of the test: any erythema and edema does not all occur in the test animal skin under two kinds of dosage.
Result shows: patch of the present invention to rabbit skin without obvious stimulation effect.
Embodiment 5 animal toxicity test (for embodiment 1)
Test method: take rabbit 12, male and female half and half, body weight 1.8-2.4kg, with depilatory cream, rabbit abdominal region is taken off the baring skin region being about 1cm × 1cm size.To be divided into 2 groups, often group 6, one group is normal dose test group, and another group is normal dose test group (patch that 10 times of normal doses are made).The patch of two groups of 5mm × 5mm sizes sticking matched doses respectively, pastes 2 every day, and sterilizes with chelated iodine, after changing dressings continuously 21 days, observes administration reaction every day.
Result of the test: compared with not being administered rabbit, the activity of two administration group rabbit, diet, excretion etc. are all normal.
Result shows: patch of the present invention to rabbit without obvious adverse reaction and toxic and side effects.
Embodiment 6 pharmacodynamics test
Test method: male Wistar rat 60, is randomly divided into model group, western medicine group, embodiment 1-3, normal group.Except normal group, other 50 makes bacterial prostatitis rat model only with escherichia coli injection of prostate method.Wherein model group be set up bacterial prostatitis rat model and do not treat group；Western medicine group adopts administration by gavage to give ibuprofen, every day 1 time, each 2mL (concentration is 0.5mg/mL)；Patch treatment group is the patch of the present invention that 5mm × 5mm size is sticked at rat abdomen unhairing place, pastes 2 every day；Normal group is normal not ill rat.Put to death after treating 21 days, take out rat prostate tissue and weigh and carry out HE chromoscopy.
Result of the test: as shown in table 2, the prostate weight in wet base of model group is apparently higher than normal group, and has massive inflammatory cells infiltrated, it was shown that prostatitis rat model is successfully established.After Western medicine ibuprofen, prostate weight in wet base alleviates to some extent than model group, and cell infiltration example also reduces to some extent, it was shown that it has the effect of certain resistance prostatitis.After patch treatment group of the present invention treatment, rat prostate weight in wet base alleviates substantially than before treatment, and inflammatory cell soaks
The scale of professional fees charged by a painter, writer or calligrapher also significantly reduces.
Result shows: bacterial prostatitis is had good therapeutic effect by patch of the present invention.
Model rat prostate weight in wet base meansigma methods and cell infiltration number of cases after table 2 patch treatment of the present invention
| Group | N(is only) | Prostate weight in wet base (μ g) | Inflammatory cell infiltration (example) |
| Normal group | 10 | 91.4±4.3 | 0 |
| Model group | 10 | 133.2±15.7 | 10 |
| Ibuprofen group | 10 | 121.5±7.8* | 6* |
| Embodiment 1 | 10 | 98.6±10.1** # | 1** ## |
| Embodiment 2 | 10 | 96.4±11.2** # | 1** ## |
| Embodiment 3 | 10 | 97.6±11.0** # | 1** ## |
“*" represent and compare P < 0.05 with model control group, "**" represent and compare P < 0.01 with model control group；
“#" represent and compare P < 0.05 with ibuprofen group, "##" represent and compare P < 0.01 with ibuprofen group.
Embodiment 7 patch of the present invention treats prostatitic clinical observation material
1. case-data: selection chronic bacterial prostatitis (50 example) and nonbacterial prostatitis (70 example) case totally 120 example, wherein age bracket 25-58 year, average 40.6 years old, the course of disease 8 months-12 years, married 104 examples, unmarried 16 examples.Above patient has a degree of urethral symptom (such as frequent micturition, urgent micturition, the heeltap is not to the utmost etc.), and majority has local distending pain (such as perineal position distending pain), the General Symptomies such as minority has dizziness, weak, insomnia.All cases are all pointed out through prostate ultrasound diagnosis and digital rectal examination suffers from chronic prostatitis.The prostatic fluid of bacterial prostatitis patient wherein can detect antibacterial exist
2. diagnostic criteria: pressing hydraulic fluid microscopy 3 according to patient clinical symptom, prostate palpation, prostate, possessing 2 persons can make a definite diagnosis.
3. Therapeutic Method: select above-described embodiment 1-3, every time patch 1 patch, each 1 time sooner or later, use 6 weeks continuously.
4. efficacy assessment standard: cure clinical symptom disappearance, presses hydraulic fluid for 3 times all normal, and ultrasound diagnosis is normal with digital rectal examination；Improvement clinical symptoms makes moderate progress, and presses fluid inspection leukocyte<10/HP, lecithin>10/HP, and pyocyte disappears, and ultrasound diagnosis changes with digital rectal examination performance mild inflammatory；Symptom before and after futile treatment, check unchanged.
Therapeutic outcome: as shown in table 3, table 4, for two kinds of prostatitis, patch treatment group is compared matched group and is respectively provided with higher cure rate and improvement rate.
Result shows: chronic bacterial prostatitis and nonbacterial prostatitis are respectively provided with good therapeutic effect by patch of the present invention, and use this medicine patch 21 days continuously, and any untoward reaction does not occur in patient.
The table 3 patch of the present invention therapeutic effect to patients with chronic bacterial prostatitis
| Group | Total cases | Treatment time | Cure | Take a turn for the better | Cure rate | Improvement rate |
| Embodiment 1 | 10 examples | 21 days | 7 examples | 3 examples | 70.0% | 30.0% |
| Embodiment 2 | 10 examples | 21 days | 6 examples | 4 examples | 60.0% | 40.0% |
| Embodiment 3 | 10 examples | 21 days | 7 examples | 3 examples | 70.0% | 30.0% |
| Matched group | 20 examples | 0 day | 1 example | 2 examples | 5.0% | 10.0% |
The table 4 patch of the present invention therapeutic effect to chronic nonbacterial prostatitis patient
| Group | Total cases | Treatment time | Cure | Take a turn for the better | Cure rate | Improvement rate |
| Embodiment 1 | 20 examples | 21 days | 14 examples | 6 examples | 70.0% | 30.0% |
| Embodiment 2 | 20 examples | 21 days | 12 examples | 8 examples | 60.0% | 40.0% |
| Embodiment 3 | 20 examples | 21 days | 15 examples | 5 examples | 75.0% | 25.0% 8 --> |
| Matched group | 10 examples | 0 day | 0 example | 1 example | 0.0% | 10.0% |
Claims (4)
1. treat prostatitic external use plaster for one kind, it is characterized in that, its effective ingredient is made up of the crude drug in following weight range: Radix Rosae Laevigatae 50-80 gram, Semen Plantaginis 15-40 gram, Cortex Phellodendri 10-30 gram, Herba Epimedii 10-20 gram, 5-20 gram of Poria, it is ground into coarse powder, cross 40 mesh sieves, mixing, makes, with the ethanol of 75%, the fluid extract that relative density is 1.1-1.5；After gained fluid extract and Pollen Brassicae campestris, nano silver gel, 5% ammonia ketone, ammonium leaf oil, refined honey are 1-3:0.5-2:0.1-1:0.05-0.2:0.1-0.3:0.1-0.5 Homogeneous phase mixing according to mass ratio, it is possible to additionally incorporate the black plaster substrate of 3 times of weight and make coating, it is coated with cream, cutting, lid lining, cut fritter, to obtain final product.
2. one according to claim 1 treats prostatitic external use plaster, it is characterized in that, its effective ingredient is made up of following crude drug: Radix Rosae Laevigatae 65 grams, Semen Plantaginis 30 grams, Cortex Phellodendri 18 grams, Herba Epimedii 15 grams, 10 grams of Poria, it is ground into coarse powder, cross 40 mesh sieves, mixing, makes, with the ethanol of 75%, the fluid extract that relative density is 1.20；Gained fluid extract and Pollen Brassicae campestris, nano silver gel, 5% ammonia ketone, ammonium leaf oil, refined honey it is possible to additionally incorporate the black plaster substrate of 3 times of weight and make coating, be coated with cream after being 2:1:0.2:0.1:0.2:0.3 Homogeneous phase mixing according to mass ratio, cutting, lid lining, cuts fritter, to obtain final product.
3. one according to claim 1 and 2 treats prostatitic external use plaster, it is characterised in that wherein the preparation method of fluid extract adopts percolation to prepare, process is as follows: weigh above-mentioned recipe quantity coarse powder, adding 75% ethanol 25ml makes coarse powder uniformly moisten, and after expansion, gradation is uniformly filled in percolator, add 75% ethanol submergence, dipping 15min, slowly percolation, flow velocity is 1/s, first collecting percolation liquid 300ml, it is 1.20 that heating is concentrated into relative density.
4. one according to claim 1 and 2 treats prostatitic external use plaster, it is characterized in that the preparation method of described nano silver gel is: under room temperature condition, by the 0.1mMAgNO3 solution newly prepared and 0.01mML-cysteine solution, it is 1.5:1 mixing according to mol ratio；Mixed white opacity liquid is irradiated under 100W self-ballasted high pressure mercury fluorescent lamp 4.5h, obtains silver nanoclusters colloidal sol, prepare with Cys for protectant nano silver gel after subsequently this solution room temperature being placed 2h.
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| CN104208242B true CN104208242B (en) | 2016-07-13 |
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| CN105832976A (en) * | 2015-01-14 | 2016-08-10 | 彭川 | External application medicine for treating prostate |
| CN106361850A (en) * | 2016-09-29 | 2017-02-01 | 南宁市沿海高利科技发展有限公司 | Sanitary patch special for males |
| CN108619485A (en) * | 2018-07-24 | 2018-10-09 | 张孝合 | A kind of compound navel patch and preparation method thereof for treating prostatic disorders |
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| CN101549131A (en) * | 2008-04-03 | 2009-10-07 | 北京中科仁和科技有限公司 | Traditional Chinese medicine formula for treating prostatitis |
| CN102114194B (en) * | 2011-03-02 | 2012-09-19 | 徐海彬 | Medicament for treating prostatic disease |
| CN103638269B (en) * | 2013-12-24 | 2016-05-18 | 王文兮 | A kind of Chinese medicine that effects a radical cure chronic prostatitis |
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