CN104208242A - External-use patch for treating prostatitis and preparation method of external-use patch - Google Patents
External-use patch for treating prostatitis and preparation method of external-use patch Download PDFInfo
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- CN104208242A CN104208242A CN201410444156.9A CN201410444156A CN104208242A CN 104208242 A CN104208242 A CN 104208242A CN 201410444156 A CN201410444156 A CN 201410444156A CN 104208242 A CN104208242 A CN 104208242A
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Abstract
The invention relates to an external-use patch for treating prostatitis of a man. A preparation process comprises the following steps: based on prescription amounts, taking the following components: 65g of Cherokee rose root, 30g of semen plantaginis, 18g of radix angelicae sinensis, 15g of herba epimedii and 10g of poria cocos, grinding the components into coarse powders, screening by using a 40-mesh sieve, mixing uniformly, preparing fluid extract having relative density of 1.20 with 85% ethyl alcohol, uniformly mixing the fluid extract, rape pollen, nanometer silver gel, 5% ketoamine, ammonium leaf oil, refined honey (refined to be 85% of the original honey weight at 115 DEG C) according to the weight ratio of 2:1:0.2:0.1:0.2:0.3, and adding black plaster matrix the amount of which is three times that of the mixture obtained from the former step to prepare a coating, pasting, segmenting, covering and cutting into pieces to obtain the patch. The use method is as follows: the patch is pasted at the skin below the navel. The patch is convenient to use, has no toxic and side effect, and is accurate in curative effect and worthy of promotion.
Description
Technical field
The present invention relates to a kind of external use plaster compound Chinese medicinal preparation and nano silver gel and transdermal enhancer made, this patch has the prostatitic effect for the treatment of human male, and skin irritation is little, safe and effective.
Background technology
Prostatitis is a kind of disease the most common 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, normal easily recurrence.Treatment for bacterial prostatitis adopts the method such as broad ectrum antibiotic or surgical removal to treat usually.And for nonbacterial prostatitis, obviously should not adopt said method.Current, the prostatitis for the treatment of the type adopts the methods such as oral anti-inflammation analgesic (as NSAID (non-steroidal anti-inflammatory drug), allopurinol), physiotherapy (as microwave, radio frequency, ultrashort wave, medium wave and hot water hip-bath), alpha-receptor antagonist (as terazosin, tamsulosin) usually.Nonbacterial prostatitis adopts physiotherapy and western medicine only can play and reduces inflammation, and alleviating pain improves the effects such as symptom of urinating, and toxic and side effects is comparatively large, 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, because it has no side effect, can long-term taking, and be therefore able to extensive use clinical.
Although China's Chinese medicine before the treatment row adenitis has stronger advantage, because it is loose mainly with decoction for oral administration, ball, tablet is main, mouthfeel is poor, and patient is difficult to adhere to for a long time usually.In addition, the valid density that oral drugs reach lesions position is usually lower, is difficult to larger 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 completes the present invention.
The object of this invention is to provide one can effectively treat prostatitic external use plaster and its preparation method is provided.
One treats prostatitic external use plaster, it is characterized in that, it contains Radix Rosae Laevigatae, Semen Plantaginis, Cortex Phellodendri, Herba Epimedii, Poria, Pollen Brassicae campestris.
Also be 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, Poria 5-20 gram, shatter into coarse powder, cross 40 mesh sieves, mixing, the fluid extract that relative density is 1.1-1.5 made by ethanol with 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, the black plaster substrate adding 3 times of weight in addition makes coating, be 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, make each efficacy of drugs produce coordinative role, thus Mutiple Targets, treat prostatitis expeditiously.
Radix Rosae Laevigatae is wherein selected to be because its nature and flavor are sour and astringent, sweet, flat, nontoxic, enter kidney, large intestine channel, have convergence astringent or styptic treatment for spontaneous sweating, arresting bleeding and healing up ulcer, invigorates 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, scalds, toothache, stomachache, ascariasis, all bones are choked larynx, chyluria.Semen Plantaginis is selected to be that cold, enter kidney, urinary bladder channel, have diuretic, heat clearing away, improving eyesight, the function of eliminating the phlegm, controls urinary obstruction, stranguria with turbid discharge, leukorrhagia, hematuria, heat-damp in summer dysentery, cough ant phlegm, and arthralgia chiefly caused by damp pathogen, conjunctival congestion is hidden from view because its nature and flavor are sweet.Cortex Phellodendri is selected to be because its nature and flavor are 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 that temperature, returns liver, kidney channel, have kidney invigorating and YANG supporting, effect of expelling wind and removing dampness because its nature and flavor are pungent, sweet, control sexual impotence erectile problem, 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.Select Poria 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, controls dysuria, edema distending pain, phlegm retention cough with dyspnea, vomiting, and malignant histocytosis, has loose bowels, seminal emission, stranguria with turbid discharge, and palpitation with fear is forgetful.Select Pollen Brassicae campestris to be because its nature and flavor are cool, sweet, enter liver, spleen, lung meridian, there is 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.
Add a small amount of nano silver gel in patch, it 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.In addition, in patch, also add 5%(mass volume ratio) ammonia ketone and ammonium leaf oil as transdermal enhancer, add Mel (refining) as wetting agent, add black plaster substrate.
It is that inventor is through groping in a large number to sum up the preferable amount with optimum curative effect drawn that the present invention combines drug prescription consumption used.
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, and section, dries.
1.4 Herba Epimedii: clean herb, dry.
1.5 Poria: be soaked in water, clean and pull out, and after vexed, section, dries.
1.6 Pollen Brassicae campestriss: dry, shatter, and cross 80 mesh sieves.
2. the preparation of nano silver gel
2.1 newly prepare 0.1 mM AgNO
3solution and 0.01mM Cys solution, at ambient temperature by two kinds of solution according to mol ratio be 1.5:1 mixing.
Mixed white opacity liquid is irradiated 4.5 h at 100W by 2.2 under ballast high pressure mercury fluorescent lamp, obtains silver nanoclusters colloidal sol, and obtained after subsequently this solution room temperature being placed 2 h is protectant nano silver gel with Cys.
3. prepare
3.1 take the above-mentioned Radix Rosae Laevigatae of getting the raw materials ready 65 grams, Semen Plantaginis 30 grams, Cortex Phellodendri 18 grams, Herba Epimedii 15 grams, 10 grams, Poria, shatter into coarse powder, cross 40 mesh sieves, mixing.
3.2 add 75% ethanol 25ml in above-mentioned Chinese medicine coarse powder makes coarse powder evenly moistening, after expansion, gradation is evenly loaded in percolator, add 75% ethanol (volume fraction) submergence, dipping 15min, slowly percolation, flow velocity is 1/s, first collect the liquid 300ml of percolation, 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 are refined 85% to former honey quality) are 2:1:0.2:0.1:0.2:0.3 Homogeneous phase mixing according to mass ratio, the black plaster substrate adding 3 times of weight in addition makes coating, be 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 following advantage:
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 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 the acceptance of patient to medicine, more easily adheres to long-term prescription.
3) compared with Current therapeutic Drug safety, medicine of the present invention had both had the little advantage of natural Chinese medicine preparation untoward reaction, was again external preparation, and therefore medication effect is better and untoward reaction and side effect are also less.
4) patch of the present invention has anti-inflammation, nourishing YIN to lower pathogenic fire, heat clearing away, and 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.
Set forth the beneficial effect of medicine of the present invention further by the following examples, these embodiments comprise 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 from
henan 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, and section, dries.
1.4 Herba Epimedii: clean herb, dry.
1.5 Poria: be soaked in water, clean and pull out, and after vexed, section, dries.
1.6 Pollen Brassicae campestriss: dry, shatter, and cross 80 mesh sieves.
2. the preparation of nano silver gel
2.1 newly prepare 0.1 mM AgNO
3solution and 0.01mM Cys solution, at ambient temperature by two kinds of solution according to mol ratio be 1.5:1 mixing.
Mixed white opacity liquid is irradiated 4.5 h at 100W by 2.2 under ballast high pressure mercury fluorescent lamp, obtains silver nanoclusters colloidal sol, and obtained after subsequently this solution room temperature being placed 2 h is protectant nano silver gel with Cys.
3. prepare
3.1 take the above-mentioned Radix Rosae Laevigatae of getting the raw materials ready 65 grams, Semen Plantaginis 30 grams, Cortex Phellodendri 18 grams, Herba Epimedii 15 grams, 10 grams, Poria, shatter into coarse powder, cross 40 mesh sieves, mixing.
3.2 add 75% ethanol 25ml in above-mentioned Chinese medicine coarse powder makes coarse powder evenly moistening, after expansion, gradation is evenly loaded in percolator, add 75% ethanol (volume fraction) submergence, dipping 15min, slowly percolation, flow velocity is 1/s, first collect the liquid 300ml of percolation, 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 are refined 85% to former honey quality) are 2:1:0.2:0.1:0.2:0.3 Homogeneous phase mixing according to mass ratio, the black plaster substrate adding 3 times of weight in addition makes coating, be 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, and section, dries.
1.4 Herba Epimedii: clean herb, dry.
1.5 Poria: be soaked in water, clean and pull out, and after vexed, section, dries.
1.6 Pollen Brassicae campestriss: dry, shatter, and cross 80 mesh sieves.
2. the preparation of nano silver gel
2.1 newly prepare 0.1 mM AgNO
3solution and 0.01mM Cys solution, at ambient temperature by two kinds of solution according to mol ratio be 1.5:1 mixing.
Mixed white opacity liquid is irradiated 4.5 h at 100W by 2.2 under ballast high pressure mercury fluorescent lamp, obtains silver nanoclusters colloidal sol, and obtained after subsequently this solution room temperature being placed 2 h is protectant nano silver gel with Cys.
3. prepare
3.1 take the above-mentioned Radix Rosae Laevigatae of getting the raw materials ready 50 grams, Semen Plantaginis 15 grams, Cortex Phellodendri 10 grams, Herba Epimedii 10 grams, 5 grams, Poria, shatter into coarse powder, cross 40 mesh sieves, mixing.
3.2 add 75% ethanol 25ml in above-mentioned Chinese medicine coarse powder makes coarse powder evenly moistening, after expansion, gradation is evenly loaded in percolator, add 75% ethanol (volume fraction) submergence, dipping 15min, slowly percolation, flow velocity is 1/s, first collect the liquid 300ml of percolation, 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 are refined 85% to former honey quality) are 1:0.5:0.1:0.05:0.1:0.1 Homogeneous phase mixing according to mass ratio, the black plaster substrate adding 3 times of weight in addition makes coating, be coated with cream, cutting, lid lining, cut fritter, obtain patch of the present invention.
embodiment 3the 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, and section, dries.
1.4 Herba Epimedii: clean herb, dry.
1.5 Poria: be soaked in water, clean and pull out, and after vexed, section, dries.
1.6 Pollen Brassicae campestriss: dry, shatter, and cross 80 mesh sieves.
2. the preparation of nano silver gel
2.1 newly prepare 0.1 mM AgNO
3solution and 0.01mM Cys solution, at ambient temperature by two kinds of solution according to mol ratio be 1.5:1 mixing.
Mixed white opacity liquid is irradiated 4.5 h at 100W by 2.2 under ballast high pressure mercury fluorescent lamp, obtains silver nanoclusters colloidal sol, and obtained after subsequently this solution room temperature being placed 2 h is protectant nano silver gel with Cys.
3. prepare
3.1 take the above-mentioned Radix Rosae Laevigatae of getting the raw materials ready 80 grams, Semen Plantaginis 40 grams, Cortex Phellodendri 30 grams, Herba Epimedii 20 grams, 20 grams, Poria, shatter into coarse powder, cross 40 mesh sieves, mixing.
3.2 add 75% ethanol 25ml in above-mentioned Chinese medicine coarse powder makes coarse powder evenly moistening, after expansion, gradation is evenly loaded in percolator, add 75% ethanol (volume fraction) submergence, dipping 15min, slowly percolation, flow velocity is 1/s, first collect the liquid 300ml of percolation, 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 are refined 85% to former honey quality) are 3:2:1:0.2:0.3:0.5 Homogeneous phase mixing according to mass ratio, the black plaster substrate adding 3 times of weight in addition makes coating, be coated with cream, cutting, lid lining, cut fritter, obtain patch of the present invention.
embodiment 4the action effect of optimizing prescriptions combination to chronic non-bacterial type prostatitis rat model
Test method:
1) following patch is prepared respectively.(pasting 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; (pasting 8): only containing the patch that 5% ammonia ketone, ammonium leaf oil, refined honey, this four kinds of adjuvants of black plaster substrate are made; (pasting 9): the patch be 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 0.25 mg/kg subcutaneous injection, continuous 30d, can cause rat prostate generation chronic non-bacterial inflammation.
3) GP TH.Be divided into four groups: normal group (10), model group (10), patch treatment group (10 × 9=90 only), QIANLIEKANG treatment group (10 × 3=30 only).Normal group is normally without the rat of still where reason.Model group is by after above-mentioned chemical treatment, successful modeling but untreated rat.Patch treatment group is that modeling rat subsides 1-9 treats, and medication is: by same area depilation near rat model pubis side, stick 1-9(length × wide=10mm × 10mm respectively), every day 2 times, continuous 3 weeks.QIANLIEKANG treatment group is the treatment of modeling rat QIANLIEKANG PIAN gavage, and medication is: get QIANLIEKANG PIAN, puts into mortar, adds after a small amount of water is ground into homogeneous latex emulsion, is treated, every day 1 time, continuous 3 weeks by gastric infusion mode to rat model.If high dose group (6 each), middle dosage group (3 each) and low dose group (1 each).
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, the neutral formalin solution putting into 10% is fixed, 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 significantly declines; Often open prostate section HE coloration result and all show a large amount of inflammatory cell infiltrations.The above results indicates prostatitis rat model and is successfully built.Paste 1-7(alone crude drug) 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 of pasting 8 treatment groups (alone adjuvant) all with model group there was no significant difference.Paste 9 treatment groups (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, it recovers normal degree and is all less than the compositions using patch of the present invention used.
The therapeutic effect of table 1 optimizing prescriptions combination to chronic non-bacterial type prostatitis rat model
| Group | Leukocyte count (individual/mm 3） | 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: medicine patch of the present invention supplementary material complex used is more more obvious to the therapeutic effect of prostatitis rat than being used alone the patch made by each supplementary material, and it is better than the therapeutic effect of QIANLIEKANG PIAN high-dose therapy group.In addition, patch of the present invention is compared with QIANLIEKANG PIAN, more convenient to use.
embodiment 2in vitro Bactericidal Experiments
Test method: the blank patch of medicine patch of the present invention (embodiment 1-3) and not drug containing being made several diameters is that the round fritter of 1cm is stand-by.Draw the escherichia coli ATCC 25922 of fresh exponential phase, staphylococcus aureus ATCC 25923, Klebsiella Pneumoniae ATCC 700603, Pseudomonas aeruginosa ATCC 15442, proteus mirabilis ATCC 12453 bacterium liquid 0.1mL respectively, be spread evenly across on solid M-H agar plate with spreader, often kind of test bacterium is all coated with 2 pieces of flat boards, stick medicine patch and blank patch respectively, be placed in 37 DEG C of biochemical cultivation cases and cultivate 18-24 h, observe antibacterial circle diameter.Test parallel testing 5 times, averages and reports the result.
Result of the test: the average diameter of inhibition zone of patch of the present invention (embodiment 1) to above-mentioned five kinds of test bacterium is respectively 26.4mm, 22.2mm, 18.5mm, 11.2mm, 15.3mm; (embodiment 2) average diameter of inhibition zone to above-mentioned five kinds of test bacterium is respectively 25.4mm, 21.2mm, 17.5mm, 11.3mm, 14.2mm; (embodiment 3) average diameter of inhibition zone to above-mentioned five kinds of test bacterium is respectively 26.1mm, 22.0mm, 18.4mm, 11.4mm, 15.7mm, and blank patch is all without obvious inhibition zone.
Result shows: medicine patch of the present invention all has certain antibacterial effect to pathogen such as escherichia coli, staphylococcus aureus, Klebsiella Pneumoniae, Pseudomonas aeruginosa, proteus mirabilises.
embodiment 3anti-inflammation test
Test method: 30 kunming mices, male and female half and half, body weight 28-32 gram.Adopt dimethylbenzene method to build mice inflammatory model, operate as follows: get dimethylbenzene 25 μ L and be applied to mouse right ear, left ear then coats the normal saline of 25 μ L in contrast in same position.Be divided into 4 groups at random by body weight, i.e. model control group and embodiment 1-3, often organize 15, after the dimethylbenzene and normal saline drying of two ears paintings, give following treatment respectively.Model control group: the blank patch (length × wide=5mm × 5 mm) sticking not drug containing in mouse right ear affected part; Medication therapy groups: same to method, sticks onesize medicine patch of the present invention at mouse right ear.Treat after 4 hours, put to death mice, measure the ear method of double differences of mice left and right ear.Its assay method is: along auricle baseline, place cuts two ears, lays auricle, weigh with the card punch of 10mm at the same position of left and right ear, the ear method of double differences=auris dextra sheet 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 compared with model control group, the ear method of double differences obviously reduces (
p<0.01).The ear method of double differences of embodiment 2 is 4.31 ± 1.20mg.Medication therapy groups compared with model control group, the ear method of double differences obviously reduces (
p<0.01).The ear method of double differences of embodiment 1 is 4.25 ± 1.21mg.Medication therapy groups compared with model control group, the ear method of double differences obviously reduces (
p<0.01).
Result shows: patch of the present invention has significant antiphlogistic effects.
embodiment 4irritation test
Test method: the test method of irritation test is: rabbit 10, cut abdominal part part hair, and slough non-Rhizoma Imperatae with depilatory cream, by invention patch embodiment 1-3(normal dose and 10 times of patches made to normal dose) stick in the exposed position of rabbit unhairing, after 12 hours, observe and the erythema of evaluating skin and edema situation.
Result of the test: any erythema and edema all do not appear 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 5animal toxicity test (for embodiment 1)
Test method: get rabbit 12, male and female half and half, body weight 1.8-2.4 kg, takes off the baring skin region being about 1cm × 1cm size by rabbit abdominal region with depilatory cream.To be divided into 2 groups, often organize 6, one group is normal dose test group, and another group is normal dose test group (10 times of patches made to normal dose).Two groups of patches sticking the 5mm × 5 mm size of matched doses respectively, paste 2 every day, and with chelated iodine sterilization, after changing dressings continuously 21 days, observe administration reaction every day.
Result of the test: compared with non-administration rabbit, the activity, diet, excretion etc. of two administration group rabbit are all normal.
Result shows: patch of the present invention to rabbit without obvious adverse reaction and toxic and side effects.
embodiment 6pharmacodynamics test
Test method: male Wistar rat 60, is divided into model group, western medicine group, embodiment 1-3, normal group at random.Except normal group, other 50 adopt escherichia coli injection of prostate method to make bacterial prostatitis rat model.Wherein model group is the bacterial prostatitis rat model and non-treatment group set up; 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 × 5 mm size is sticked at rat abdomen unhairing place, pastes 2 every day; Normal group is normal not ill rat.Treat and put to death after 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 apparently higher than normal group, and has massive inflammatory cells infiltrated, shows 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, shows that it has the effect of certain resistance prostatitis.After patch treatment group treatment of the present invention, rat prostate weight in wet base is than alleviating obviously before treatment, inflammatory cell soaks
The scale of professional fees charged by a painter, writer or calligrapher also obviously reduces.
Result shows: patch of the present invention has good therapeutic effect to bacterial prostatitis.
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(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 with model control group
p<0.05, "
*" represent and compare with model control group
p<0.01;
"
#" represent and compare with ibuprofen group
p<0.05, "
##" represent and compare with ibuprofen group
p<0.01.
embodiment 7patch 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 examples, wherein age bracket 25-58 year, average 40.6 years old, the course of disease 8 months-12 years, married 104 examples, unmarried 16 is routine.Above patient has urethral symptom to a certain degree (as frequent micturition, urgent micturition, the heeltap not to the utmost etc.), and majority has local distending pain (as perineal position distending pain), minority has dizziness, weak, insomnia General Symptoms of Denging.All cases are all pointed out through prostate ultrasound diagnosis and digital rectal examination suffers from chronic prostatitis.Antibacterial can be detected in the prostatic fluid of wherein bacterial prostatitis patient exist
2. diagnostic criteria: press 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, each subsides 1 are pasted, and each 1 time sooner or later, use 6 weeks continuously.
4. efficacy assessment standard: cure---clinical symptom disappearance, press hydraulic fluid for 3 times all normally, ultrasound diagnosis and digital rectal examination normal; Taking a turn for the better---clinical symptoms makes moderate progress, and pressing fluid inspection leukocyte <10/HP, lecithin >10/HP, pyocyte disappears, and ultrasound diagnosis and digital rectal examination show mild inflammatory and change; Invalid---treatment before and after symptom, check unchanged.
Therapeutic outcome: as shown in table 3, table 4, for the prostatitis of two types, patch treatment group is compared matched group and is all had higher cure rate and improvement rate.
Result shows: patch of the present invention all has good therapeutic effect to chronic bacterial prostatitis and nonbacterial prostatitis, and uses this medicine patch 21 days continuously, and any untoward reaction does not appear in patient.
Table 3 patch of the present invention is to the therapeutic effect of 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% |
Table 4 patch of the present invention is to the therapeutic effect of 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% |
| Matched group | 10 examples | 0 day | 0 example | 1 example | 0.0% | 10.0% |
Claims (6)
1. treat a prostatitic external use plaster, it is characterized in that, it contains Radix Rosae Laevigatae, Semen Plantaginis, Cortex Phellodendri, Herba Epimedii, Poria and Pollen Brassicae campestris.
2. the one as described in claims 1 treats prostatitic external use plaster, it is characterized in that, is also added with skin permeation enhancers in described crude drug, and described permeation enhancers is 5% ammonia ketone, nano silver gel and ammonium leaf oil.
3. one as claimed in claim 1 treats prostatitic external use plaster, it is characterized in that, its effective ingredient
Be 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, Poria 5-20 gram, shatter into coarse powder, cross 40 mesh sieves, mixing, the fluid extract that relative density is 1.1-1.5 made by the ethanol with 75%; 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, the black plaster substrate adding 3 times of weight in addition makes coating, be coated with cream, cutting, lid lining, cut fritter, obtain patch of the present invention.
4. one according to claim 3 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, Poria, shatter into coarse powder, cross 40 mesh sieves, mixing, relative density made by ethanol with 75% is 1.20, gained fluid extract and Pollen Brassicae campestris, nano silver gel, 5% ammonia ketone, ammonium leaf oil, after refined honey is 2:1:0.2:0.1:0.2:0.3 Homogeneous phase mixing according to mass ratio, the black plaster substrate adding 3 times of weight in addition makes coating, be coated with cream, cutting, lid lining, cut fritter, obtain patch of the present invention.
5. one treats prostatitic external use plaster as claimed in claim 4, it is characterized in that, wherein the preparation method of fluid extract adopts percolation preparation, process is as follows: take above-mentioned recipe quantity coarse powder, adding 75% ethanol 25ml makes coarse powder evenly moistening, and after expansion, gradation is evenly loaded in percolator, add 75% ethanol submergence, dipping 15min, slowly percolation, flow velocity is 1/s, first collect the liquid 300ml of percolation, it is 1.20 that heating is concentrated into relative density.
6. the one as described in claims 2-4 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 0.1 mM AgNO newly prepared
3solution and 0.01mM Cys solution are 1.5:1 mixing according to mol ratio; Mixed white opacity liquid is irradiated 4.5 h at 100W under ballast high pressure mercury fluorescent lamp, obtains silver nanoclusters colloidal sol, obtained after subsequently this solution room temperature being placed 2 h is protectant nano silver gel with Cys.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN102114194A (en) * | 2011-03-02 | 2011-07-06 | 徐海彬 | Medicament for treating prostatic disease |
| CN103638269A (en) * | 2013-12-24 | 2014-03-19 | 王文兮 | Traditional Chinese medicine formula for radically treating chronic prostatitis |
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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 |
| CN102114194A (en) * | 2011-03-02 | 2011-07-06 | 徐海彬 | Medicament for treating prostatic disease |
| CN103638269A (en) * | 2013-12-24 | 2014-03-19 | 王文兮 | Traditional Chinese medicine formula for radically treating chronic prostatitis |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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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| CN104208242B (en) | 2016-07-13 |
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