CN101797334B - External ointment for treating onychomycosis and paronychia - Google Patents
External ointment for treating onychomycosis and paronychia Download PDFInfo
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- CN101797334B CN101797334B CN2010101573159A CN201010157315A CN101797334B CN 101797334 B CN101797334 B CN 101797334B CN 2010101573159 A CN2010101573159 A CN 2010101573159A CN 201010157315 A CN201010157315 A CN 201010157315A CN 101797334 B CN101797334 B CN 101797334B
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Abstract
The invention relates to an external ointment for treating onychomycosis and paronychia, which is prepared by the following components by weight ratio: 15 of croton, 15 of rehmannia, 15 of angelica, 30 of salvia miltiorrhiza, 10 of cicada slough, 15 of radix sophorae falvescentis, 15 of Cortex dictamni, 6 of licorice, 15 of radix scutellariae, 30 of rhizoma smilacis glabrae, 10 ofborneol, 2 of miconazole nitrate, 9 of octodecyl alcohol, 6 of cetanol, 10 of glycerin monostearate, 205 of tween, 18 of glycerol, 1 of sodium benzoate and 55 of purified water. The invention for treating onychomycosis and paronychia has short duration of treatment, high curative effect and low recurrence rate.
Description
Technical field
The present invention relates to a kind of Chinese medicine and western medicine combination medicine for external use, be specifically related to a kind of tinea unguium, paronychial external-applied ointment of being used for the treatment of.
Background technology
Tinea unguium is tinea unguium again, and it is to be caused by the infected by microbes that a big class is called pathogenic fungi.After fungus is invaded deck or nail matrix, because a large amount of mycelia and the rapid breeding of spore, make a large amount of accumulation of horn on the nail matrix, naked eyes are checked, it is muddy that the deck becomes, opaque, the most important thing is that onychomycosis often accompanies paronychia, show as the invasion and attack (wherein seeing) that nail root portion or wall of nail portion skin and soft tissue be subjected to fungus more and make perionychium skin and soft tissue generation chronic inflammatory disease, even make that suppurative infection appears in (toe) first surrounding soft tissue so that candidiasis is more; Treatment paronychia and tinea unguium generally adopt pure western medicine therapy and operative treatment at present, western medicine therapy generally adopts antibiotics or antifungal drug, this treatment time is long, easily produces drug resistance, and curative effect is low, and healing rate variance, operative treatment need cut or push aside fingernail, and this treatment is painful big, the expense height, curative effect is low, and the relapse rate height.And the scope of application of most of medicines is little in the pure western medicine therapy, and effect is single, and is not obvious for paronychia type tinea unguium curative effect.
Summary of the invention
The objective of the invention is for overcoming disadvantages of background technology, and a kind of short treating period be provided, the curative effect height, the Chinese medicine and western medicine combination that medical expense is low and relapse rate is low be used for the treatment of tinea unguium, paronychial external-applied ointment.
To achieve these goals, the present invention has adopted following technical scheme: a kind of tinea unguium, paronychial external-applied ointment of being used for the treatment of, and this external-applied ointment is made by following components by weight ratio:
Fructus Crotonis 15, Radix Rehmanniae 15, Radix Angelicae Sinensis 15, Radix Salviae Miltiorrhizae 30, Periostracum Cicadae 10, Radix Sophorae Flavescentis 15, Cortex Dictamni 15, Radix Glycyrrhizae 6, Radix Scutellariae 15, Rhizoma Smilacis Glabrae 30, Borneolum Syntheticum 10, miconazole nitrate 2, octadecanol 9, hexadecanol 6, glyceryl monostearate 10, tween
205, glycerol 18, sodium benzoate 1, purified water 55, this external-applied ointment its preparation method is as follows:
(1) by above-mentioned formula ratio: Fructus Crotonis, Radix Rehmanniae, Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae, Periostracum Cicadae, Radix Sophorae Flavescentis, Cortex Dictamni, Radix Glycyrrhizae, Radix Scutellariae and Rhizoma Smilacis Glabrae are added 70% alcohol reflux 2～3 times, each 1.5～3 hours, reclaim ethanol, being concentrated into 70～80 ℃, to survey relative densities be 1.10～1.15 clear paste;
(2) by above-mentioned formula ratio: get octadecanol, hexadecanol, glyceryl monostearate, place the water-bath heating and melting, temperature remains on 70～80 ℃;
(3) by above-mentioned formula ratio: get sodium benzoate and add in the purified water, stirring and dissolving adds tween
20, stir evenly, and then add miconazole nitrate, stir and make it dissolving, add glycerol at last, stir evenly, place water-bath to heat, temperature keeps 70～80 ℃;
(4) get (2) liquid and add in (3) liquid, the limit edged stirs, and until being emulsified into colostrum, step (1) gained clear paste is added Ruzhong just, obtains intermixture;
(5) Borneolum Syntheticum of above-mentioned formula ratio is put in the mortar, repeatedly added 95% ethanol on a small quantity and grind, until whole dissolvings, treat after it dissolves fully solution to be added in step (4) the gained intermixture last homogenizing, homogenizing rotating speed 1000～1100r/min, homogenizing time 5～7min outgases into cream.
In the technique scheme:
Fructus Crotonis: acrid in the mouth, temperature cures mainly: it is long-pending to dispel under rushing down, the detumescence of relieving oedema or abdominal distension through diuresis or purgation.Be used for cold long-pending stagnation, distension and fullness of the chest and abdomen; External erosion bleb.Be used for the malignant boil scabies, nevus verrucosus, diphtheria, malaria, intestinal obstruction.
Radix Rehmanniae: sweet in the mouth; Bitter; Cold in nature, tool clearing away heat and cooling blood, the effect of promoting the production of body fluid and moisturizing.
Radix Angelicae Sinensis: sweet in the mouth, suffering, warm in nature, tool enriches blood and invigorates blood circulation, antibacterial effect.
Radix Salviae Miltiorrhizae: bitter in the mouth, be slightly cold, cure mainly menoxenia, the amenorrhea dysmenorrhea, lump in the abdomen, breast ventral spine pain, pyretic arthralgia pain, skin infection swells and ache, dysphoria and insomnia; Hepatosplenomegaly, angina pectoris.
Periostracum Cicadae: sweet in the mouth, cold in nature, be used for the wind heat extraction that looses, sore-throat relieving, rash, nebula removing, spasmolytic.Be used for anemopyretic cold, pharyngalgia, hoarseness, measles without adequate eruption, rubella pruritus, conjunctival congestion cataracta, convulsion with spasms, tetanus.
Radix Sophorae Flavescentis: bitter in the mouth; Cold in nature, function cures mainly: heat clearing and damp drying; Wind dispelling insecticide.Main damp-heat dysentery; Discharging fresh blood stool; Jaundice; Dysuria; Edema; Leukorrhagia; Pudendal pruritus; Scabies; Leprosy; Skin pruritus; The noxious dampness skin infection.
Cortex Dictamni: cold in nature; Bitter in the mouth, hardship, salty.Cure mainly: the rubella due to the wind heat noxious dampness; Eczema, scabies skin ulcer leprosy; Jaundice, dark coloured urine; Damp and hot; Rheumatic arthralgia.
Radix Glycyrrhizae: property is flat, and sweet in the mouth is returned 12 warps.Heat-clearing and toxic substances removing arranged, eliminate the phlegm, pain relieving, spasmolytic be so that pharmacological action such as anticancer.
Radix Scutellariae: the property hardship, flavor is cold.The tool heat clearing and damp drying, eliminating fire and detoxication, the effect of hemostasis.
Rhizoma Smilacis Glabrae: sweet light, flat, control syphilis, stranguria with turbid discharge, the muscles and bones spasm and pain, beriberi, furuncle is treated skin ulcer, carbuncle, scrofula.
Borneolum Syntheticum: hot, bitter, be slightly cold.Be used for the excess syndrome of stroke coma, be used for conjunctival congestion and swelling pain, the sore throat aphtha is used for skin infection and swells and ache, and does not hold back after bursting etc.
Miconazole nitrate: anti-fungal infection.
The said medicine combination has sterilization or bacteriostasis to multiple suppurative bacterium.Acute and chronic inflammation to local infection, different phase going bad in various degree occur, oozes out, hypertrophy has significant curative effect, also has anticorrosion, refrigeration function simultaneously, can reduce the permeability of blood capillary, blood vessel dilating reduces vascular pressure, minimizing is oozed out, alleviate and prevent tissue degeneratiaon and necrosis, shorten and alleviate the stimulation of the continuous action and the metabolite of pathogenic factor, prevent and eliminate hypertrophy.Analgesic activity is definite, can alleviate inflammatory exudate pressuring nerve end and reach metabolite, vasoactive amines, the slow pain that swashs the stimulation of inflammatory mediators such as skin and cause slightly, reduces potassium concentration.
Main pharmacodynamics research of the present invention:
Verify antiinflammatory of the present invention, antipruritic and antibacterial action from the zoopery aspect.
1 material
1.1 animal
Kunming mouse, regular grade, male and female half and half, body weight 18～22g is provided by Chengdu University of Traditional Chinese Medicine Animal Experimental Study center; The SD rat, male, body weight 180～220g is provided by Chengdu University of Traditional Chinese Medicine Animal Experimental Study center.
1.2 medicine and reagent
Modeling reagent: depilatory cream: Zhenping Zhong Jing pharmaceutcal corporation, Ltd, lot number: 20080102; Carrageenin: Sigma company; Histamine phosphate; Dimethylbenzene.
Medicine: the present invention: be used for the treatment of tinea unguium, paronychial external-applied ointment, to call in the following text: external-applied ointment.
Key instrument
Electronic balance PA2003: Shanghai balance equipment factory;
Electric-heated thermostatic water bath DSY 2224 holes: Beijing state China Medical Instruments factory;
Toes volumetric measurement instrument: Chengdu TME Technology Co., Ltd..
2 methods and result
2.1 the influence of xylol induced mice auricle edema
Get 30 of 18～22g Kunming mouses, be divided into two groups at random, 15 every group, male and female half and half, be respectively matched group, experimental group, matched group is coated with the miconazole ointment agent of producing with Xi'an Yang Sen pharmaceutical Co. Ltd, and test group is coated with respectively with external-applied ointment of the present invention in mouse right ear, and 0.59g/ only, every day 2 times, for three days on end, 1 hour each group is cleaned with dry cotton ball with distilled water flush away medicine behind the 4th day coating.Respectively organizing mouse right ear then with dimethylbenzene 0.05ml/ only is coated with, left side ear compares, put to death animal after 30 minutes, with the 8mm card punch the equal position of ear, mice left and right sides homalographic is downcut, using scales/electronic balance weighing, is the swelling degree with the difference of left and right sides auricle weight, calculates and respectively organizes the swelling degree, obtain inhibitory rate of intumesce, the results are shown in Table 2.
Table 1 external-applied ointment is to the influence of mice ear degree
| Group | N (only) | Dosage | Left and right sides ear weight difference (mg) |
| Contrast | 15 | 20g/kg | 5.810±1.7723 |
| Test group | 15 | 20g/kg | 3.022±1.3141 |
Annotate: compare P＜0.05 with matrix group.
The result shows that test group can obviously alleviate dimethylbenzene induced mice ear swelling degree, and the mice ear inflammation is had obvious inhibitory action.
2.2 Ovum Gallus domesticus album is caused the influence of rat paw edema
Get 20 of 150～180g SD rats, be divided into two groups at random, 10 every group, male and female half and half are respectively matched group, test group.The experiment proxima luce (prox. luc) is measured by the capillary tube amplifying method and is respectively organized the right back sufficient normal volume of rat (ml).Experiment each treated animal on the same day right back sufficient coating 0.2g/ only, administration after 1 hour right back sufficient plantar subcutaneous injection 100% fresh albumen 0.05ml/ only, simultaneously again coating once, matrix group is coated with equivalent substrate.Mensuration causes the right back sufficient volume of inflammation back 1h, 2h, 4h, and the difference that each rat causes the right back sufficient volume in scorching front and back is the swelling degree, respectively organizes the difference of swelling degree, the results are shown in Table 3.
Table 2 external-applied ointment is to the influence of rat toes swelling degree
Annotate: compare P＜0.05 with matched group.
The result shows, external-applied ointment can obviously alleviate rat toes swelling degree due to the Ovum Gallus domesticus album, has the obvious anti-inflammatory and anti effect.
2.3 itching-relieving action
Get 20 of Cavia porcelluss and be divided into two groups at random, 10 every group, male and female half and half are respectively matched group, test group.24h before the experiment shaves hair, coating 1 time to each right back instep of group Cavia porcellus.Test the same day, abrade right back foot with coarse sandpaper and shave hair place, area 1C m
2Local repaste medicine 1 time, beginning is only dripped 0.01% 0.05ml/ of histamine phosphate behind the 10min at the wound surface place, after this complies with 0.02% every 3min, and the 0.03%... progressive concentration only is 0.05ml/ at every turn.Later lick the right back histamine phosphate's total amount (μ g) that is given when sufficient until Cavia porcellus and be itch-threshold.Record and itch-threshold of relatively respectively organizing.The result shows: dehumidifying itching-relieving gels group itch-threshold (321 scholar 350.8) μ g, compare P＜0.01 with matrix group (55 scholar 47.2) μ g.As seen external-applied ointment has the effect of pruritus due to the tangible antagonism histamine phosphate.
2.4 bacteriostasis
Carry out external susceptibility MIC test:
Method: each test bacterium is made bacteria suspension with normal saline, and to be diluted to turbidity be the above bacteria suspension of 2.0McF, 100 times of reuse normal saline dilutions, 10 times of RPMII640 dilutions, test group (the present invention is used for the treatment of tinea unguium, paronychial external-applied ointment) and matched group (the miconazole ointment agent that Yang Sen pharmaceutical Co. Ltd in Xi'an produces) doubling dilution, cultivate 72-96h in 96 well culture plates, slight concussion, the 490nm place carries out photoelectric colorimetry.
Test organisms: Escherichia coli, bacillus pyocyaneus, staphylococcus aureus, klebsiella spp, yeast, Candida albicans, aspergillus niger, Cryptococcus histolyticus, red cryptococcus and trichophyton verrucum.
The external susceptibility MIC test of table 3
| Bacterial species | Test group (mg/ml) | Matched group (mg/ml) |
| Escherichia coli | 5 | 9 |
| Bacillus pyocyaneus | 4.8 | 8.3 |
| Staphylococcus aureus | 5.2 | 9.2 |
| Klebsiella spp | 5.1 | 8.9 |
| Yeast | 4 | 7.8 |
| Candida albicans | 6 | 10 |
| Aspergillus niger | 5.2 | 9 |
| Cryptococcus histolyticus | 5 | 9.1 |
| Red cryptococcus | 5.5 | 9.5 |
| Trichophyton verrucum | 5.5 | 9.5 |
3 conclusions
Mice ear test due to the xylol of the present invention, the rat toes swelling test due to the fresh albumen, the test of the guinea pig skin pruritus due to the histamine phosphate all have the inhibitory action (P＜0.05 or P＜0.01) of highly significant; Have a look at out through external susceptibility MIC test: the present invention all has strong antibacterial action to Escherichia coli, bacillus pyocyaneus, staphylococcus aureus, klebsiella spp, yeast, Candida albicans, aspergillus niger, Cryptococcus histolyticus, red cryptococcus and trichophyton verrucum.
Conclusion: removing damp to relieve itching gel of the present invention has antiinflammatory, antipruritic, antimicrobial effect.
The present invention is to tinea unguium 27 examples, paronychia 23 examples, and paronychia type tinea unguium 10 examples have been done clinical trial:
Treatment tinea unguium: strike off crisp sick first with little scraper, or frustrate the thin sick first that thickens, get the present invention then and be applied in the disease first in right amount, every day 2 times, 1 month course of treatment, followed up a case by regular visits to after the healing 3 months.
Treatment paronychia: get the present invention and be applied in the affected part in right amount, every day 2 times, 1 month course of treatment, followed up a case by regular visits to after the healing 3 months.
Treatment paronychia type tinea unguium: strike off crisp sick first with little scraper, or frustrate the thin sick first that thickens, get the present invention then and be applied in disease first and affected part in right amount, every day 2 times, 1 month course of treatment, followed up a case by regular visits to after the healing 3 months.
Its curative effect is as shown in table 4:
Table 4 clinical trial result
| ? | ? | The example number | Effective percentage | The example number | Effective percentage | The example number | The example number |
| Tinea unguium | 27 | 24 | 89％ | 22 | 81％ | 3 | 4 |
| Paronychia | 23 | 20 | 87％ | 19 | 83％ | 3 | 3 |
| Paronychia type tinea unguium | 10 | 9 | 90％ | 7 | 70％ | 1 | 2 |
The present invention treats tinea unguium, paronychia short treating period, and curative effect height and relapse rate are low.
The specific embodiment
Below we will the present invention is further illustrated in conjunction with specific embodiments:
(1) 15g Fructus Crotonis, 15g Radix Rehmanniae, 15g Radix Angelicae Sinensis, 30g Radix Salviae Miltiorrhizae, 10g Periostracum Cicadae, 15g Radix Sophorae Flavescentis, 15g Cortex Dictamni, 6g Radix Glycyrrhizae, 15g Radix Scutellariae and 30g Rhizoma Smilacis Glabrae are added 70% alcohol reflux 2～3 times, each 1.5～3 hours, reclaim ethanol, being concentrated into 70～80 ℃, to survey relative densities be 1.10～1.15 clear paste, standby;
(2) get 9g octadecanol, 6g hexadecanol and 10g glyceryl monostearate, place the water-bath heating and melting, temperature remains on 70～80 ℃, and is standby;
(3) get the 1g sodium benzoate and add in the 55g purified water, stirring and dissolving adds the 5g tween
20, stir evenly, and then add the 2g miconazole nitrate, stir and make it dissolving, add 18g glycerol at last, stir evenly, place water-bath to heat, temperature keeps 70～80 ℃, and is standby;
(4) get (2) liquid and add in (3) liquid, the limit edged stirs, and until being emulsified into colostrum, step (1) gained clear paste is added Ruzhong just, obtains intermixture;
(5) the 10g Borneolum Syntheticum is put in the mortar, repeatedly added 95% ethanol on a small quantity and grind, until whole dissolvings, treat after it dissolves fully solution to be added in step (4) the gained intermixture last homogenizing, homogenizing rotating speed 1000～1100r/min, homogenizing time 5～7min outgases into cream.
Above-mentioned gained unguentum quality evaluating method and result:
Texture directly perceived: color and luster colourity is better, and sophistication is suitable.
The stability centrifugal test: get unguentum sample 8 grams, adding has in the graduated centrifuge tube, and with the centrifugal 30min of 2500rpm speed, observation has or not lamination, and the result does not have lamination.
The stability heat resistant test: get 5 in unguentum sample, placed 55 ℃ of baking ovens 6 hours, observation has or not the oil-water separation phenomenon.Results sample is stable, no lamination.
The stability low temperature resistant test: get 5 in unguentum sample, placed-15 ℃ of cryogenic refrigerators 24 hours, observation has or not the oil-water separation phenomenon.Results sample is stable, no lamination.
Claims (1)
1. one kind is used for the treatment of tinea unguium, paronychial external-applied ointment, and it is characterized in that: this external-applied ointment is made by following components by weight ratio:
Fructus Crotonis 15, Radix Rehmanniae 15, Radix Angelicae Sinensis 15, Radix Salviae Miltiorrhizae 30, Periostracum Cicadae 10, Radix Sophorae Flavescentis 15, Cortex Dictamni 15, Radix Glycyrrhizae 6, Radix Scutellariae 15, Rhizoma Smilacis Glabrae 30, Borneolum Syntheticum 10, miconazole nitrate 2, octadecanol 9, hexadecanol 6, glyceryl monostearate 10, tween
205, glycerol 18, sodium benzoate 1, purified water 55, this external-applied ointment its preparation method is as follows:
(1) by above-mentioned formula ratio: Fructus Crotonis, Radix Rehmanniae, Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae, Periostracum Cicadae, Radix Sophorae Flavescentis, Cortex Dictamni, Radix Glycyrrhizae, Radix Scutellariae and Rhizoma Smilacis Glabrae are added 70% alcohol reflux 2～3 times, each 1.5～3 hours, reclaim ethanol, being concentrated into 70～80 ℃, to survey relative densities be 1.10～1.15 clear paste;
(2) by above-mentioned formula ratio: get octadecanol, hexadecanol, glyceryl monostearate, place the water-bath heating and melting, temperature remains on 70～80 ℃;
(3) by above-mentioned formula ratio: get sodium benzoate and add in the purified water, stirring and dissolving adds tween
20, stir evenly, and then add miconazole nitrate, stir and make it dissolving, add glycerol at last, stir evenly, place water-bath to heat, temperature keeps 70～80 ℃;
(4) get (2) liquid and add in (3) liquid, the limit edged stirs, and until being emulsified into colostrum, step (1) gained clear paste is added Ruzhong just, obtains intermixture;
(5) Borneolum Syntheticum of above-mentioned formula ratio is put in the mortar, repeatedly added 95% ethanol on a small quantity and grind, until whole dissolvings, treat after it dissolves fully solution to be added in step (4) the gained intermixture last homogenizing, homogenizing rotating speed 1000～1100r/min, homogenizing time 5～7min outgases into cream.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102743454B (en) * | 2012-01-22 | 2014-07-09 | 宁波市鄞州奥胜生物科技有限公司 | External paste for relieving paronychia pain |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102526567B (en) * | 2011-12-23 | 2014-01-22 | 成美余 | Ointment and medicine composite formula for removing tinea unguium and preparation method thereof |
| CN104623442B (en) * | 2015-02-12 | 2018-06-26 | 严德华 | A kind of drug for treating whelk |
| CN105727096A (en) * | 2016-03-20 | 2016-07-06 | 张慧 | Medicine for treating onychomycosis |
| CN107802680A (en) * | 2017-11-24 | 2018-03-16 | 广东名辰堂健康产业股份有限公司 | A kind of Chinese medicine external composition for treating paronychia and preparation method thereof |
| CN111067971A (en) * | 2020-01-17 | 2020-04-28 | 云南西草资源开发有限公司 | Traditional Chinese medicine composition for treating paronychia and using method thereof |
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