CN102178732B - Chinese medicine nanoemulsion spraying agent for treating chronic eczema - Google Patents
Chinese medicine nanoemulsion spraying agent for treating chronic eczema Download PDFInfo
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Abstract
The invention relates to a Chinese medicine nanoemulsion spraying agent for treating chronic eczema, which can effectively solve the problems that the curative effect of a medicament drops because the concentration of the nanoemulsion spraying agent at a pathological change part gradually decreases due to transdermal absorption. The spraying agent is prepared from paeonol, matrine, oxymatrine, berberine hydrochloride, borneol, menthol crystal, ethoxylated hydrogenated castor oil, isopropyl myristate, ethylparaben, azone and ethanol, wherein the spraying agent is prepared by the following steps of: placing the ethoxylated hydrogenated castor oil and the isopropyl myristate into a container; placing the container in a water bath maintained at a temperature of 60 DEG C to dissolve ethoxylated hydrogenated castor oil and isopropyl myristate; adding the ethylparaben and the azone; uniformly mixing and filtering to obtain a filtrate for later use; then ultrasonically dissolving the paeonol, the matrine, the oxymatrine, the berberine hydrochloride, the borneol and the menthol crystal into ethanol to form a nanoemulsion; then mixing the nanoemulsion with the prepared filtrate; stirring until a mixture is clear; filtering the mixture, bottling the mixture into a spraying bottle and sealing the spraying bottle. The Chinese medicine nanoemulsion spraying agent is used for treating the chronic eczema effectively, has a favorable curative effect and an important clinic meaning and is easily produced.
Description
One, technical field
The present invention relates to field of medicaments, particularly a kind of Chinese medicine nano-emulsion spray (claiming eczema nano-emulsion spray again) of treating chronic eczema.
Two, background technology
Eczema (eczema) is commonly encountered diseases, the frequently-occurring disease of department of dermatologry, is divided into acute, subacute and three phases of chronic eczema because eczema Chang Yi shows effect repeatedly, change into chronic, so chronic eczema is seen the most clinically.
The traditional Chinese medical science has therapies such as determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs, Chinese patent medicine, folk prescription proved recipe, external treatment to the treatment of chronic eczema.External treatment has the medicine washout, is coated with etc. outward, and characteristics such as spray is rapid with its onset, and is easy to use receive liking of patient deeply; But certificate 57 tame institutes of traditional Chinese medicine, the department of dermatologry external Chinese patent medicine condition survey of doctor trained in Western medicine institute: mostly external Chinese patent medicine dosage form is ointment, lotion at present, and spray is few, and by in by the end of March, 2008, State Food and Drug Administration (SFDA) has issued the medicinal herb spray registration certificate of 45 kinds; Relate to 38 of kinds, wherein with treatment oral cavity and pharyngolaryngitis at most, have 11, promoting blood circulation and stopping pain, treat 7 of traumatic injury; Treat anginal 3,4 of burn and scald, 4 of rhinitis, 3 of Amino-Cervs; 4 of coldrexs, only 1 of 1 of hemorrhoid, dermatosis.Simultaneously; These sprays and chemical drugs spray product more also embody following characteristic: it is coarse to fill a prescription qualitatively, and quality standard is not high, sends with forms such as solution, suspension, emulsions because spray is many; It is simple relatively to fill a prescription, and quality control index is wide in range and coarse; In appearance because color and luster be prone to the pollution clothes, thereby patient's compliance is poor; Above-mentioned these problems seriously hamper the application of medicinal herb spray, in addition, as the eczema diseased region at skin; Medicine gets into blood circulation through skin absorbs after the spray agent administration; Cause reducing in diseased region concentration, so that Drug therapy is short action time, curative effect lasting time is short.Be difficult to effectively satisfy chronic eczema and require medicine to concentrate to play a role at the skin lesion position, it uses and is unsatisfactory.
Three, summary of the invention
To above-mentioned situation, for overcoming the defective of prior art, the object of the invention just provides a kind of Chinese medicine nano-emulsion spray of treating chronic eczema, can effectively solve treatment eczema medicinal herb spray some deficiency aspect quality, outward appearance, curative effect.
The technical scheme that the present invention solves is; Treatment characteristics according to Chinese materia medica principle and chronic eczema; The present invention adopts following component to process: paeonol 30-60g, matrine 10-30g, oxymatrine 10-30g, berberine hydrochloride 10-50g, Borneolum Syntheticum 60-150g, Mentholum 60-150g, polyoxyethylene ether castor oil hydrogenated (RH-40) 300-500g, isopropyl myristate (IPM) 60-130g, ethyl hydroxybenzoate 1-10g, azone 100-200mL, mass concentration are 70% ethanol 500-1000mL; Its preparation technology is: polyoxyethylene ether castor oil hydrogenated and isopropyl myristate are placed container, place 60 ℃ water water-bath dissolving, add ethyl hydroxybenzoate, azone; Mixing; Filter, must filtrate, subsequent use; In addition with paeonol, matrine, oxymatrine, berberine hydrochloride, Borneolum Syntheticum, Mentholum ultrasonic dissolution in mass concentration is 70% ethanol, become nano-emulsion, again nano-emulsion and above-mentioned subsequent use filtrating are mixed; Stir to clarify, filter, fill is in spray bottle; Sealing before described aerosol can uses, is immersed mass concentration earlier and is in 95% the ethanol and soaked 24 hours; Supersound washing is 15 minutes again, 3 times repeatedly, dries or dries up or cold drying.
Product of the present invention is effective to the treatment of chronic eczema, and good effect is prone to produce, and has the important clinical meaning.
Four, description of drawings
Fig. 1 is preparation technology's flow chart of the present invention.
Five, the specific embodiment
Below in conjunction with concrete condition and process chart, specific embodiments of the invention elaborates.
Embodiment 1
The present invention can adopt following component to process in practical implementation:
Paeonol 30g, matrine 10g, oxymatrine 10g, berberine hydrochloride 10g, Borneolum Syntheticum 60g, Mentholum 60g, polyoxyethylene ether castor oil hydrogenated (RH-40) 300g, isopropyl myristate (IPM) 60g, ethyl hydroxybenzoate 1g, azone 100mL, mass concentration are 70% ethanol 500mL, wherein, polyoxyethylene ether castor oil hydrogenated and isopropyl myristate are placed container; Place 60 ℃ water water-bath dissolving, add ethyl hydroxybenzoate, azone, mixing; Filter, must filtrate, subsequent use; In addition with paeonol, matrine, oxymatrine, berberine hydrochloride, Borneolum Syntheticum, Mentholum ultrasonic dissolution in mass concentration is 70% ethanol, become nano-emulsion, again nano-emulsion and above-mentioned subsequent use filtrating are mixed; Stir to clarify, filter, fill is in spray bottle; Every bottle of 80mL, sealing.
Embodiment 2
The present invention also can adopt following component to process in practical implementation:
Paeonol 60g, matrine 30g, oxymatrine 30g, berberine hydrochloride 50g, Borneolum Syntheticum 150g, Mentholum 150g, polyoxyethylene ether castor oil hydrogenated (RH-40) 500g, isopropyl myristate (IPM) 130g, ethyl hydroxybenzoate 10g, azone 200mL, mass concentration are 70% ethanol 1000mL, wherein, polyoxyethylene ether castor oil hydrogenated and isopropyl myristate are placed container; Place 60 ℃ water water-bath dissolving, add ethyl hydroxybenzoate, azone, mixing; Filter, must filtrate, subsequent use; In addition with paeonol, matrine, oxymatrine, berberine hydrochloride, Borneolum Syntheticum, Mentholum ultrasonic dissolution in mass concentration is 70% ethanol, become nano-emulsion, again nano-emulsion and above-mentioned subsequent use filtrating are mixed; Stir to clarify, filter, fill is in spray bottle; Every bottle of 80mL, sealing.
Embodiment 3
The present invention also can adopt following component to process in practical implementation:
Paeonol 45g, matrine 20g, oxymatrine 20g, berberine hydrochloride 30g, Borneolum Syntheticum 105g, Mentholum 105g, polyoxyethylene ether castor oil hydrogenated (RH-40) 400g, isopropyl myristate (IPM) 95g, ethyl hydroxybenzoate 5.5g, azone 150mL, mass concentration are 70% ethanol 750mL, wherein, polyoxyethylene ether castor oil hydrogenated and isopropyl myristate are placed container; Place 60 ℃ water water-bath dissolving, add ethyl hydroxybenzoate, azone, mixing; Filter, must filtrate, subsequent use; In addition with paeonol, matrine, oxymatrine, berberine hydrochloride, Borneolum Syntheticum, Mentholum ultrasonic dissolution in mass concentration is 70% ethanol, become nano-emulsion, again nano-emulsion and above-mentioned subsequent use filtrating are mixed; Stir to clarify, filter, fill is in spray bottle; Every bottle of 80mL, sealing.
Embodiment 4
The present invention also can adopt following component to process in practical implementation:
Paeonol 50g, matrine 30g, oxymatrine 16g, berberine hydrochloride 35g, Borneolum Syntheticum 100g, Mentholum 120g, polyoxyethylene ether castor oil hydrogenated (RH-40) 350g, isopropyl myristate (IPM) 100g, ethyl hydroxybenzoate 8g, azone 150mL, mass concentration are 70% ethanol 800mL, wherein, polyoxyethylene ether castor oil hydrogenated and isopropyl myristate are placed container; Place 60 ℃ water water-bath dissolving, add ethyl hydroxybenzoate, azone, mixing; Filter, must filtrate, subsequent use; In addition with paeonol, matrine, oxymatrine, berberine hydrochloride, Borneolum Syntheticum, Mentholum ultrasonic dissolution in mass concentration is 70% ethanol, become nano-emulsion, again nano-emulsion and above-mentioned subsequent use filtrating are mixed; Stir to clarify, filter, fill is in spray bottle; Every bottle of 80mL, sealing.
In the said components, wherein:
Paeonol: be the extract (conventional method is extracted, existing product) of Cortex Moutan or Radix Cynanchi Paniculati, have analgesia, antiinflammatory, analgesic and suppress allergic effect.All inhibited to II, III, IV allergic reaction type.Mottle, myalgia, skin pruritus, psoriasis, zona shingles, eczema had treatment and health-care effect preferably.Acrid in the mouth is bitter, cold in nature.The effect of promoting blood circulation and cooling blood is arranged, ability dissipating blood stasis blood, change disease piece, subduing inflammation.Be used for maculae caused by violent heat pathogen, tell, be defeated in battle, have blood in stool, the hectic fever due to YIN-deficiency consumptive fever, the amenorrhea dysmenorrhea, carbuncle sore tumefacting virus falls and pounces on the pain of injury.
Matrine, oxymatrine: be the extract (conventional method is extracted, existing product) of Radix Sophorae Flavescentis, Radix Sophorae Flavescentis (Sophoraflavescens Ait) is a cassia leguminous plant; Its nature and flavor bitter cold, GUIXIN, liver, kidney, large intestine, urinary bladder channel have heat clearing and damp drying; Wind dispelling insecticide, the diuretic function.Be used for hematodiarrhoea, have blood in stool, jaundice, urine retention, leucorrhea with red and white discharge, pudendal pruritus, eczema, eczema, skin itching, scabies leprosy, external treatment trichomonal vaginitis.Matrine has antiinflammatory, regulates effects such as immunity, maincenter inhibition, antiviral, antitumor, oxymatrine antiallergic, antiinflammatory action.
Berberine hydrochloride: be the extract (conventional method is extracted, existing product) of Rhizoma Coptidis or Cortex Phellodendri, Rhizoma Coptidis, hardship, cold.GUIXIN, spleen, stomach, liver, gallbladder, large intestine channel.Heat clearing and damp drying, eliminating fire and detoxication.Be used for damp and hot feeling of fullness, vomiting, dysentery, jaundice, unconsciousness due to high fever, hyperactivity of heart-fire, dysphoria and insomnia, heat in blood is told nosebleed, the conjunctival congestion acid regurgitation, the carbuncle furuncle is quenched one's thirst in toothache; External treatment eczema, eczema, auditory meatus is suppurated.Cortex Phellodendri, hardship, cold.Return kidney, bladder, large intestine channel.Heat clearing and damp drying, eliminating fire and detoxication removes the hectic fever due to YIN-deficiency clearind deficient heat.Be used for damp-heat dysentery, jaundice, leukorrhagia, pyretic stranguria, beriberi, flaccidity is warded off, hectic fever due to YIN-deficiency consumptive fever, night sweat, seminal emission, sore swollen toxin, eczema pruritus.Berberine hydrochloride has effects such as antiinflammatory, antiallergic, adjusting immunity, arrhythmia, and berberine all has antibacterial action to Hemolytic streptococcus, staphylococcus aureus, gonococcus and Fu Shi, dysentery bacterium, and the leukocyte of enhancing phagocytosis is arranged.Treatment gastroenteritis, bacillary dysentery, eczema etc. have been widely used in.
Borneolum Syntheticum: hot, bitter, cold.The refreshment of having one's ideas straightened out, reducing swelling and alleviating pain.In vitro tests has inhibitory action to escherichia coli, staphylococcus aureus.External is to scabies, skin infection, and aphtha is effective.
Mentholum: suffering, cold.Dispelling wind and heat pathogens, sore-throat relieving tomorrow, rash is ended miasma.Compendium of Material Medica: " throat, all diseases of ability to speak are controlled pyogenic infection of the pad of a finger scrofula skin infection, wind scabies urticaria." external can make the mucosa vasoconstriction, sensoparalysis and produce refrigerant sense, tool pain relieving, itching-relieving action, it is strong especially that it refines the effect of crystallization article, and external can be controlled skin pruritus.
All medicines are harmonious, and play the merit of heat clearing and damp drying, skin moistening and itch stopping, dispelling wind and removing obstruction in the collateral altogether.
The present invention particularly through the transdermal test in vitro test, can know that the nano-emulsion spray is identical with common spray release kinetic model, all meets the logistic function model through animal experiment and clinical.Nano-emulsion spray t
50%Be 11.78 hours, it is 3.844% that skin stores percentage rate, common spray t
50%Be 6.61 hours, it is 1.927% that skin stores percentage rate, and the former is than latter's transdermal speed slow 1.782 times; The former skin storage percentage rate is 1.994 times of the latter.Nano-emulsion spray transdermal speed stores percentage rate less than common spray, skin and is higher than common spray; Realized clinical external treatment chronic eczema being required the design concept that medicine is high at the skin corium reserves, the holdup time is long, percutaneous rate is slow, the Transdermal absorption amount is few; Reached the goal in research of skin target administration; Present this eczema nano-emulsion spray is used for clinical, evident in efficacy, and doctor patient gives higher evaluation to this preparation.The nano-emulsion spray of the treatment chronic eczema of the present invention's development does not all appear in the newspapers both at home and abroad.Relevant animal experiment situation and clinical practice situation data are following:
(1) ointment pharmacodynamics zoopery situation of the present invention
1, experiment material
1.1 medicine and reagent
The Chinese medicine nano-emulsion spray of treatment chronic eczema of the present invention (being called for short eczema nano-emulsion spray, as follows);
The grand solution Guangdong Xiangyang Pharmaceutical Factory of peace lot number 980730;
The xylene Changsha is state-run to prolong air slaking length of schooling agent factory one subsidiary factory's lot number on May 27th, 1998;
Shanghai biochemical research institute of histamine phosphate lot number 8510212;
Gentamicin injection liquid Hunan Dongting Pharmaceutical Co., Ltd. lot number 990121;
Itraconazole tablet Xi'an Janssen Pharmaceutica limited company lot number 990519710;
Skin health lotion Beijing Hua Yangkui dragon Pharma Inc. lot number 990416;
2, Beijing company of 4-dinitrochlorobenzene China Drug Co. lot number 960619;
Fresh Ovum Gallus domesticus album.
1.2 strain
Staphylococcus aureus, bacillus pyocyaneus, Escherichia coli, Candida albicans are the clinical isolates kind, are provided by Annex II institute of Hunan College of Traditional Chinese Medicine department of dermatologry.
1.3 culture medium
Cause of disease immunity teaching and research room of the husky Lei Shi culture medium of broth agar culture medium Hunan College of Traditional Chinese Medicine provides.
1.4 animal
Kunming mouse male and female half and half body weight 18-229;
Wistar rat male and female half and half body weight 120-1808;
Healthy albino guinea-pig male and female half and half body weight 250-4009 provides by Hunan Hygienic & Epidemic Prevention Station's animal center.
1.5 instrument
MA110 type electronic analytical balance Shanghai Second Balance Factory;
TP-1000 type electronic balance Hunan appearance balance equipment factory;
2, method and result
2.1 antiinflammatory experiment
2.1.1 the influence of xylol induced mice auricle edema
Get 50 of mices, be divided into 5 groups at random, 10 every group.If distilled water group: the grand solution group (positive control) of peace; Large, medium and small three dose groups of eczema nano-emulsion spray (2g/ml, 1g/ml, 0.5g/ml).Experiment was respectively organized the mice ears and be coated with relative medicine 0.05ml/20g once the same day, and each group is cleaned with the distilled water cotton balls and removed medicinal liquid behind the 1h, was used for cotton balls and cleaned, and only was coated with xylene 0.05ml/ to mouse right ear.Left side ear compares.Disconnected neck is put to death animal behind the 15min, lays the homalographic auricle with the card punch of diameter 8mm every animal ears same area, places on the electronic analytical balance and weighs.With left and right sides auricle weight difference is the swelling degree, and with the weight difference, left ear weight (%) is the swelling rate, and obtains inhibitory rate of intumesce.The result sees table 1.
The influence
of table 1 eczema nano-emulsion spray xylol induced mice auricle edema
Annotate: each group compares the swelling rate with the distilled water group, adopts the t check by the new drug approval requirement
Visible by table 1, the heavy dose of group of eczema nano-emulsion spray, small dose group and distilled water group relatively have the difference of highly significant; Relatively there were significant differences for dose groups and distilled water group in the eczema nano-emulsion spray.Grand solution group of peace and distilled water group more also have the difference of highly significant.Three dose groups of this explanation eczema nano-emulsion spray all have the effect of anti-xylene induced mice auricle edema.
2.1.2 to the shadow noon of rat Ovum Gallus domesticus album property pedal swelling
Get 50 of rats, be divided into 5 groups at random, 10 every group.If distilled water group, the grand solution group of peace, the large, medium and small dose groups of eczema nano-emulsion spray (2g/ml, 1g/ml, 0.5g/ml).The same day was at first respectively organized the right back sufficient normal volume of rat (ml) with self-control volume determination device mensuration in experiment, organized right back foot then and was coated with relative medicine to each.Behind the 1h, each only organizes right back sufficient subcutaneous injection 100% fresh albumen 0.05ml/.The right back sufficient volume of 1h, 2h, 4h, 6h behind the mensuration albumen injection.Causing the changing value of the right back sufficient volume in scorching front and back and the ratio of initial volume is the swelling rate, respectively organizes the difference of swelling rate.The result sees table 2.
Table 2 eczema nano-emulsion spray is to the bullate influence of the sole of the foot
of rat Ovum Gallus domesticus album property foot
Annotate: each group compares with the distilled water group, adopts t check, * P＜0.05 * * P＜0.01 by the new drug approval requirement
Can know that by table 2 heavy dose of group of eczema nano-emulsion spray and small dose group have the effect of pedal swelling due to certain antagonism Ovum Gallus domesticus album, and stronger at 4h and 6h effect.Dose groups also has antiphlogistic trend in the eczema spraying chaste tree.The grand solution of peace all has strong antiinflammatory action from 1h to 6h.
2.2 antipruritic experiment chicken roost
Get 50 of Cavia porcelluss, be divided into 5 groups at random, 10 every group.If distilled water group, the grand solution group of peace, the eczema spraying large, medium and small dose groups of chaste tree (2g/ml, 1g/ml, 0.5g/ml).24h before the experiment shaves hair to each right back instep of group Cavia porcellus, is coated with relative medicine once in shaving the hair place.Test the same day, respectively organize right back foot with the coarse sandpaper scratch and shave hair place, area 1cm
2, local repaste relative medicine once.Beginning is only dripped 0.01% 0.05ml/ of histamine phosphate behind the 10min at the wound surface place, and after this every separated 3min is according to 0.02%, 0.03% ... 0.1%, 0.2%, 0.3% ... Progressive concentration only is 0.05ml/ at every turn.Later licking the right back histamine phosphate's total amount that is given when sufficient until Cavia porcellus is itch-threshold.Record and relatively each group cause the Fujian of itching.The result sees table 3.
Table 3 eczema nano-emulsion spray causes the influence
of the reaction of itching to histamine phosphate
Annotate: each group compares with the distilled water group, adopts the t check by the new drug approval requirement
Can be known that by table 3 the heavy dose of group of eczema nano-emulsion spray, small dose group all have the effect of pruritus due to the tangible antagonism histamine phosphate, the grand solution of peace has the effect of pruritus due to the antagonism histamine phosphate of highly significant.
2.3 antibacterial experiment
2.3.1 tracing back, the medicine agar plate dilution method decides minimal inhibitory concentration
Eczema nano-emulsion spray medicinal liquid is added the sterilization plate, and with self-control nutrient agar two-fold dilution, its ultimate density is 0.5g/ml, 0.25g/ml, 0.125g/ml, 0.0625g/ml, 0.03125g/ml.After the condensation; Inoculate respectively staphylococcus aureus, bacillus pyocyaneus, Escherichia coli fresh bacterium liquid 0.1ml (900,000,000/ml); Place and cultivate 20h in 36.5 ℃ of calorstats, observe media surface bacterial growth situation, with gentamycin and the flat board that does not add medicinal liquid do contrast.The highest drug level of long bacterium is not minimal inhibitory concentration (MIC).The result sees table 4.
Table 4 eczema nano-emulsion spray minimal inhibitory concentration experiment (medicine agar plate dilution method)
Annotate :+show bacterial growth ,-no bacterial growth shown
Visible by table 4, eczema nano-emulsion spray all has certain inhibitory action to staphylococcus aureus, bacillus pyocyaneus, Escherichia coli.
2.3.2 dull and stereotyped punch method is measured antibacterial intensity
Get 30 of sterilization plates, 10 every group, be divided into 3 groups, i.e. staphylococcus aureus group, bacillus pyocyaneus group and Escherichia coli group.To make nutrient agar by oneself while hot in the impouring plate.After the condensation, three kinds of bacterium liquid of staphylococcus aureus, bacillus pyocyaneus, Escherichia coli of using the sterilization cotton swab will contain 900,000,000/ml of bacterium are respectively evenly coated on three groups of culture medium.Cut-off footpath 3mm sterilization glass-tube is made a call to 4 apertures on every ware culture medium, in each hole, add 50 μ l gentamicin injection liquids (40mg/ml), skin health lotion, eczema nano-emulsion spray (0.5g/ml), eczema nano-emulsion spray substrate respectively with sample injector.Place and cultivate 20h in 36.5 ℃ of calorstats, the diameter of the antibacterial ring of record media surface compares analysis.The result sees table 5.
The dull and stereotyped punch method of table 5 is measured antibacterial intensity
Annotate: with the contrast of skin health lotion, t checks by new drug approval requirements employing, * * p＜0.01 ,+show bacterial growth
Visible by table 5, eczema nano-emulsion spray substrate does not have antibacterial activity, and eczema nano-emulsion spray has stronger inhibitory action to staphylococcus aureus and bacillus pyocyaneus, and is relatively poor to the escherichia coli inhibitory action.Gentamycin all has above three kinds of antibacterials pretends usefulness.The skin health lotion is better to the staphylococcus aureus inhibitory action, and is a little less than bacillus pyocyaneus effect very, general to the Escherichia coli effect.
2.3.3 dull and stereotyped punch method is observed the oidiomycetic action intensity of white
Get 10 of plates of sterilization, with husky Lei Shi fungi agar medium while hot in the impouring plate, condensation.The Candida albicans bacterium liquid that will contain 600,000,000/ml of bacterium with the sterilization cotton swab is evenly coated on the culture medium.Cut-off footpath 3mm sterilization glass-tube is made a call to 4 apertures on every ware culture medium, in each hole, add 50 μ l itraconazole solution, skin health lotion, eczema nano-emulsion spray (0.5g/ml), eczema nano-emulsion spray substrate respectively with sample injector.Place and cultivate 20h in 36.5 ℃ of calorstats, the diameter of the antibacterial ring of record media surface.The result sees table 6.
Table 6 eczema nano-emulsion spray is to the oidiomycetic inhibitory action of white
Annotate :+bacterial growth shown
Can be known that by table 6 eczema nano-emulsion spray substrate does not suppress the effect of Candida albicans, eczema nano-emulsion spray and skin health lotion have the effect of the inhibition Candida albicans of moderate strength, and the inhibition Candida albicans effect of itraconazole is the strongest.
2.4. immunosuppressant experiment
Get 60 of mices, be divided into 6 groups at random, 10 every group.If distilled water group, the grand solution group of peace, the large, medium and small dose groups of eczema nano-emulsion spray (2g/ml, 1g/ml, 0.5g/ml), model group.After the grouping each group mouse web portion is shaved hair, area 3 * 3cm
2The distilled water group is coated with distilled water subsequently, and model group is coating not, and all the other each group is administered once, and is applied to 5%DNCB (2,4-dinitrochlorobenzene acetone soln) behind the 24h and organizes mouse web portion fully and shave hair-fields sensitization, and the distilled water group is not coated with.Respectively organize subsequently and sooner or later respectively be administered once separated continuous 8 days every day.Sensitization is applied to the 1%DNCB acetone soln after 7 days and organizes respectively that mouse right ear is wide to be attacked, and behind the 24h (1h after the last administration), disconnected neck is put to death mice, lays the homalographic auricle with the card punch of 8mm in mice ears same area, places on the electronic analytical balance and weighs.With about two ear weight differences be the swelling degree, be the swelling rate with two ear weight differences/left ear weight.The result sees table 7.Win mouse spleen and thymus simultaneously, calculate index and spleen index and spleen gland index.The result sees table 8.
Table 7 eczema nano-emulsion spray is to the influence
of DNCB induced mice SDH
Annotate: each group compares with model group, adopts the t check by the new drug approval requirement
Table 8 eczema nano-emulsion spray is to mouse immune organ weight's influence
Annotate: each group compares with model group, adopts the t check by the new drug approval requirement
By table 7; Table 8 can know that dose groups can make the spleen thick soup contract in the eczema nano-emulsion spray, and small dose group has anti-2; The effect of auricle edema also can make atrophy of thymus gland due to the 4-dinitrochlorobenzene, and the grand solution of peace then has extremely strong anti-immunoreation effect and can significantly suppress the growth of immune organ.
More than experiment has all obtained identical and akin result through repeated multiple times.
Brief summary
Above-mentioned situation shows, eczema nano-emulsion spray can resist rat paw edema due to xylene induced mice auricle edema and the fresh Ovum Gallus domesticus album: suppress golden Portugal bacterium, bacillus pyocyaneus, escherichia coli and Candida albicans: suppress pruritus due to the histamine phosphate; Suppress 2, the 4-dinitrochlorobenzene is induced the delayed allergic immune reaction and the mice auricle swelling that causes.
(2) clinic trial situation
1 data and method
1.1 clinical data
The diagnostic criteria reference " clinical dermatology " of chronic eczema: can more not form repeatedly by acute or subacute eczema, also can be chronic inflammatory disease at the beginning; Skin lesion is confined to a place or many places more, and limit office property or general property infiltration are plump, brownish red or band Lycoperdon polymorphum Vitt, pigmentation, rough surface, on cover a small amount of squama or be liquor-saturatedization of tongue; The chronic course of disease, but normal acute attack; Also there is obvious convulsion to itch, often is paroxysm.Include standard in: 1. meet diagnostic criteria; 2. at 18～65 years old age, can be morbidity or recidivist first; 3. signed Informed Consent Form person.Case exclusion standard: 1. age under-18s, over-65s, gestation or women breast-feeding their children; 2. known or suspicious to research pharmaceutical compositions allergy sufferers; 3. orally in nearly 2 weeks cross steroid medicine and/or 1 week was taken the antihistaminic medicine orally or corticosteroid hormone is crossed in external; 4. be associated with serious primary disease such as cardiovascular, cerebrovascular, liver, kidney and hemopoietic system, psychiatric patient.5. do not meet the standard of including in, not by the regulation medication, can't judge curative effect person.
Patient's 82 examples that meet chronic limitation eczema inclusion criteria are Hunan University of Traditional Chinese Medicine's second Affiliated Hospital's department of dermatologry in June, 2009～2010 year outpatient service in June and inpatient, wherein male 42 examples, women 38 examples; 42.54 ± 5.23 years old mean age; Minimum 20 years old, maximum 60 years old, the course of disease 1～15 year.Be divided into treatment group and matched group at random, each 41 example, two groups at no difference of science of statistics aspect sex and age, has comparability.
1.2 Therapeutic Method
The treatment group: after the warm water affected part cleaning, wipe dry.Squirt rash nano-emulsion spray, produced by the hospital preparation center, after extraction process, extracting solution adds Mentholum and cutaneous permeable agent), in apart from affected part 10～15cm, spray continuously, make medicinal liquid be uniformly distributed in the affected part.Matched group: give with halometasone (Hong Kong Australia U.S. pharmaceutical Co. Ltd), every day 2 times.1 week was 1 course of treatment, after finishing each course of treatment, had a rest and carried out the treatment of next course of treatment in 2 days again, and 3 courses of treatment are observed in treatment altogether.
1.3 criterion of therapeutical effect
Improvement situation with reference to pruritus degree, skin lesion form and area before and after the treatment of level Four method of weighting scores and EASI point system record: 1. pruritus degree: not having any pruritus is 0 minute; Pruritus once in a while, not medication, the life that do not interfere with one's studies is 1 minute; The paroxysmal pruritus, the time heavy when light, influence the sleep learning life, the need medication be 2 minutes; Violent pruritus, having a strong impact on the work and study life is 3 minutes.2. skin lesion form:, divide score with 0-3 according to the order of severity of skin lesion.0 minute=do not have, 1 minute=light, 2 minutes=in, 3 minutes=heavy; 3. skin lesion area: the little person of skin lesion area, by the estimation of keeping the score of burn palm, when patient's the five fingers closed up, the area of singlehanded palm accounted for 1% of body surface area; 1 be divided into＜10%, 2 be divided into less than 10%～29%, 3 are divided into 30%～40%, and 4 are divided into 41%～69%, and 5 are divided into 70%～89%, and 6 are divided into 90%～100%).Comprehensive therapeutic effect standard: integration * 100% before therapeutic index=(integration before the treatment-treatment back integration)/treatment.Recovery from illness is therapeutic index >=90%; Produce effects is a therapeutic index 60%～89%; Be therapeutic index 20%～59% effectively; Invalid is therapeutic index＜20%.Total effective rate adds produce effects in recovery from illness, after 3 weeks of treatment, carries out the curative effect assessment respectively.Follow-up observation June, recovery from illness patient symptomes complice sign integration >=2 minutes is recurrence.
1.4 the observation of clinical adverse events and assessment
Adverse events through the spontaneous report of patient or doctor's direct observation is estimated clinical safety.In addition, at every turn when examining, with inquiring the relevant adverse events situation of patient through non-inductive mode, or find when checking UP.
1.5 statistical method
Adopt SPSS13.0 version software processes, enumeration data relatively adopts X
2The t check is adopted in check, measurement data, and there is statistical significance P＜0.05 for difference.
2 results
2.1 clinical efficacy relatively
Comprehensive therapeutic effect compares: after treating for first course of treatment, treatment group total effective rate is 21.22%, and the matched group total effective rate is 53.66%, comparing difference not statistically significant (P＞0.05); After treating for second course of treatment, treatment group total effective rate is 60.98%, and the matched group total effective rate is 63.42%, comparing difference not statistically significant (P＞0.05); After treating for second course of treatment, treatment group total effective rate is 85.37%, and the matched group total effective rate is 70.73%, and comparing difference has statistical significance (P＜0.05).(seeing table 1)
Curative effect relatively after table 1 a liang group was treated first, second and third course of treatment
Annotate: total effective rate compares X after treating for three courses of treatment
2=4.385, ▲ P＜0.05, the treatment group obviously is superior to matched group.
2.2 untoward reaction
Untoward reaction does not take place after treating for three weeks.
Conclusion
Above-mentioned situation shows, eczema nano-emulsion spray of the present invention has the effect of heat clearing and damp drying, skin moistening and itch stopping, dispelling wind and removing obstruction in the collateral.Treat chronic limitation eczema determined curative effect, and easy to use, simple to operate, medicinal liquid is prone to absorb, and clinical effectiveness is good, and is little to the wound surface stimulation, has no side effect, evident in efficacy, is worth clinical expansion.
Claims (6)
1. a Chinese medicine nano-emulsion spray of treating chronic eczema is characterized in that, is processed by following component: paeonol 30-60g, matrine 10-30g, oxymatrine 10-30g, berberine hydrochloride 10-50g, Borneolum Syntheticum 60-150 g, Mentholum 60-150 g, polyoxyethylene ether castor oil hydrogenated 300-500 g, isopropyl myristate 60-130g, ethyl hydroxybenzoate 1-10g, azone 100-200mL and mass concentration are 70% ethanol 500-1000mL; Wherein, polyoxyethylene ether castor oil hydrogenated and isopropyl myristate are placed container, place 60 ℃ water water-bath dissolving; Add ethyl hydroxybenzoate, azone, mixing filters; Must filtrate, subsequent use, in addition with paeonol, matrine, oxymatrine, berberine hydrochloride, Borneolum Syntheticum, Mentholum ultrasonic dissolution in mass concentration is 70% ethanol; Become nano-emulsion; Again nano-emulsion and above-mentioned subsequent use filtrating are mixed, stir to clarify, filter; Fill seals in spray bottle.
2. the Chinese medicine nano-emulsion spray of treatment chronic eczema according to claim 1 is characterized in that described aerosol can; Immerse earlier mass concentration and be in 95% the ethanol and soaked 24 hours; Supersound washing is 15 minutes again, 3 times repeatedly, dries or dries up or cold drying.
3. the Chinese medicine nano-emulsion spray of treatment chronic eczema according to claim 1 is characterized in that, is that 70% ethanol 500mL processes by described paeonol 30g, matrine 10g, oxymatrine 10g, berberine hydrochloride 10g, Borneolum Syntheticum 60 g, Mentholum 60 g, polyoxyethylene ether castor oil hydrogenated 300 g, isopropyl myristate 60g, ethyl hydroxybenzoate 1g, azone 100mL, mass concentration; Wherein, polyoxyethylene ether castor oil hydrogenated and isopropyl myristate are placed container, place 60 ℃ water water-bath dissolving; Add ethyl hydroxybenzoate, azone, mixing filters; Must filtrate, subsequent use, in addition with paeonol, matrine, oxymatrine, berberine hydrochloride, Borneolum Syntheticum, Mentholum ultrasonic dissolution in mass concentration is 70% ethanol; Become nano-emulsion, again nano-emulsion and above-mentioned subsequent use filtrating are mixed, stir to clarify; Filter; Fill is in spray bottle, and every bottle of 80mL seals.
4. the Chinese medicine nano-emulsion spray of treatment chronic eczema according to claim 1 is characterized in that, is that 70% ethanol 1000mL processes by described paeonol 60g, matrine 30g, oxymatrine 30g, berberine hydrochloride 50g, Borneolum Syntheticum 150 g, Mentholum 150 g, polyoxyethylene ether castor oil hydrogenated 500 g, isopropyl myristate 130g, ethyl hydroxybenzoate 10g, azone 200mL, mass concentration; Wherein, polyoxyethylene ether castor oil hydrogenated and isopropyl myristate are placed container, place 60 ℃ water water-bath dissolving; Add ethyl hydroxybenzoate, azone, mixing filters; Must filtrate, subsequent use, in addition with paeonol, matrine, oxymatrine, berberine hydrochloride, Borneolum Syntheticum, Mentholum ultrasonic dissolution in mass concentration is 70% ethanol; Become nano-emulsion, again nano-emulsion and above-mentioned subsequent use filtrating are mixed, stir to clarify; Filter; Fill is in spray bottle, and every bottle of 80mL seals.
5. the Chinese medicine nano-emulsion spray of treatment chronic eczema according to claim 1 is characterized in that, is that 70% ethanol 750mL processes by described paeonol 45g, matrine 20g, oxymatrine 20g, berberine hydrochloride 30g, Borneolum Syntheticum 105 g, Mentholum 105 g, polyoxyethylene ether castor oil hydrogenated 400 g, isopropyl myristate 95g, ethyl hydroxybenzoate 5.5g, azone 150mL, mass concentration; Wherein, polyoxyethylene ether castor oil hydrogenated and isopropyl myristate are placed container, place 60 ℃ water water-bath dissolving; Add ethyl hydroxybenzoate, azone, mixing filters; Must filtrate, subsequent use, in addition with paeonol, matrine, oxymatrine, berberine hydrochloride, Borneolum Syntheticum, Mentholum ultrasonic dissolution in mass concentration is 70% ethanol; Become nano-emulsion, again nano-emulsion and above-mentioned subsequent use filtrating are mixed, stir to clarify; Filter; Fill is in spray bottle, and every bottle of 80mL seals.
6. the Chinese medicine nano-emulsion spray of treatment chronic eczema according to claim 1 is characterized in that, is that 70% ethanol 800mL processes by described paeonol 50g, matrine 30g, oxymatrine 16g, berberine hydrochloride 35g, Borneolum Syntheticum 100 g, Mentholum 120 g, polyoxyethylene ether castor oil hydrogenated 350 g, isopropyl myristate 100g, ethyl hydroxybenzoate 8g, azone 150mL, mass concentration; Wherein, polyoxyethylene ether castor oil hydrogenated and isopropyl myristate are placed container, place 60 ℃ water water-bath dissolving; Add ethyl hydroxybenzoate, azone, mixing filters; Must filtrate, subsequent use, in addition with paeonol, matrine, oxymatrine, berberine hydrochloride, Borneolum Syntheticum, Mentholum ultrasonic dissolution in mass concentration is 70% ethanol; Become nano-emulsion, again nano-emulsion and above-mentioned subsequent use filtrating are mixed, stir to clarify; Filter; Fill is in spray bottle, and every bottle of 80mL seals.
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