CN102397379B - Compound oil-in-water phellodendron oil nanoemulsion composition - Google Patents
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Abstract
The invention discloses a compound oil-in-water phellodendron oil nanoemulsion composition. The grain size of the nanoemulsion composition is 1 to 100mm, and the nanoemulsion composition is prepared from the following raw materials in percentage by mass: 1.0 to 8.0 percent of phellodendron oil, 0.1 to 4.0 percent of cinnamyl aldehyde, 0.1 to 3.8 percent of camphor oil, 0.01 to 1.3 percent of terbinafine, 0.01 to 1.6 percent of olive oil, 0.01 to 1.5 percent of cosurfactant, 20.0 to 33.8 percent of surfactant, and the balance of distilled water, and the sum of the mass percentages of all the raw materials is 100 percent. The nanoemulsion has the effects of resisting fungi, bacteria, trichomonas vaginalis, promoting local blood circulation and protecting skin, and can be used for treating bedsore, trichomonas vaginitis, and various pathogenic dermatomycosis of animals and people.
Description
Technical field
The invention belongs to field of medicaments, relate to a kind of compound phellodendron bark oil nanometer emulsion that can treat for animal and human's decubital ulcer, trichomonal vaginitis and various pathogenic dermatomycosis.
Cortex Phellodendri oil is the Chinese medicine oil extracting from rutaceae Cortex Phellodendri.Cortex Phellodendri nature and flavor hardship, cold; Return kidney, bladder, large intestine channel; Major function is heat clearing and damp drying, eliminating fire and detoxication, reducing the asthenic fever etc.Cure mainly clinically damp-heat dysentery, jaundice, night sweat due to yin deficiency, sore swollen toxin etc.The upper book on Chinese herbal medicine of veterinary is collected " the low thing of multipotency " volume seven and is herded and support apoplexy due to endogenous wind and have and " control horse jaundice side: Cortex Phellodendri, Realgar, Semen Momordicae.Respectively be divided into end, use vinegar mixing batter, in cold painting skin ulcer, paper pastes.First meeting general edema with yellowish skin rises, just with pin all over the swollen place of thorn, on coating " record.Modern medicine shows, Cortex Phellodendri oil has stronger inhibitory action to pathogenic dermatophytes, trichomonas vaginitis and multiple gram negative bacilli and positive coccus; Can be used for clinically treating decubital ulcer, trichomonal vaginitis and various dermatomycosis.
Decubital ulcer is the patient that do not rise due to long-term bed or because of the disease animal on sleeping ground for a long time, owing to organizing long-term pressurized and friction, blood circulation generation obstacle, continuous ischemia, anoxia, malnutrition and the pressure ulcer of formative tissue necrosis, tissue now loses resistance, cause the even parasitic infection of invasive organism, with limitation shallow skin injury, the open sore part is prolonged is not more principal character.Patient's life quality and the production capacity of animal are had a strong impact on.Once decubital ulcer occurs, cure comparatively difficulty.
Trichomonal vaginitis per vaginam trichomonacide infects and causes, rare with leucorrhoea grow in quantity, matter, V&V pruritus, has the burning sensation common colpitis that even pain is main manifestations, conventionally excites antibacterial to infect, and has a strong impact on the life of female patient.
Summary of the invention
The present invention is directed to the defect of the problems referred to above and prior art, provide a kind of skin permeation rate high, bioavailability is good, the compound oil-in-water phellodendron oil nanoemulsion composition of what stability was high be used for the treatment of animal and human's decubital ulcer, trichomonal vaginitis and various pathogenic dermatomycosiss.Said composition safely, have no side effect and action time lasting.
The technical scheme that realizes foregoing invention object is compound oil-in-water phellodendron oil nanoemulsion composition, and it is made up of the raw material of following mass percent:
Cortex Phellodendri oil 1.0%～8.0%
Cinnamic aldehyde 0.15%～4.0%
Oleum Camphora 0.15%～3.8%
Terbinafine 0.1%～1.3%
Olive oil 0.1%～1.6%
Cosurfactant 0.1%～1.5%
Surfactant 20.0%～33.8%
Surplus is distilled water, and the mass percent sum of above-mentioned raw materials is 100%
The optimum ratio of compound oil-in-water phellodendron oil nanoemulsion composition of the present invention:
Cortex Phellodendri oil 1.6%～7.0%
Cinnamic aldehyde 0.1%～3.3%
Oleum Camphora 0.1%～3.3%
Terbinafine 0.01%～1.0%
Olive oil 0.01%～1.3%
Cosurfactant 0.01%～1.3%
Surfactant 23.0%～31.0%
Surplus is distilled water, and the mass percent sum of above-mentioned raw materials is 100%.
The best proportioning of compound oil-in-water phellodendron oil nanoemulsion composition of the present invention is:
Cortex Phellodendri oil 5.8%
Cinnamic aldehyde 0.3%
Oleum Camphora 0.4%
Terbinafine 0.7%
Olive oil 0.7%
Ethanol 0.6%
Polyoxyethylene ether (40) castor oil hydrogenated 27.5%
Distilled water 64.0%.
The present invention, in the selection of surfactant, selects the nonionic surfactant of avirulence and good biocompatibility.Nonionic surfactant is more stable in solution, is not subject to the impact of strong electrolyte, inorganic salts, is not also subject to the impact of soda acid, and good with the compatibility of other surfactants, and haemolysis is less.In theory, the preparation of O/W type nanometer emulsion needs the HLB value of surfactant between 8～18, consider preparation technology's simplicity, be the easy formative of nano-emulsion and the stability of the nano-emulsion preparing, the present invention selects the liquid nonionic surfactant of HLB between 10～15.Preferably use polyoxyethylene ether (40) castor oil hydrogenated.
Cosurfactant of the present invention is dehydrated alcohol.Nano-emulsion forms and requires to have of short duration negative surface tension.Therefore, often need the effect of cosurfactant.Cosurfactant has three aspects: effect: assist decreasing by surfactant interfacial tension, reduce the repulsive force between surfactant molecule; Increase interface motion, the interface bending energy while reducing nano-emulsion formation, makes the spontaneous formation of nano-emulsion energy; The HLB value of reconciliation statement surface-active agent, makes surfactant have larger absorption at oil-water interface.These requirements have determined that cosurfactant must all reach certain concentration on oil phase and interface.Because alcohol surfactants can improve drug loading, increase drug solubility, increase nano-emulsion stability, the nano-emulsion district scope of formation is large, and therefore, this compositions preferentially selects dehydrated alcohol as cosurfactant.
The present invention selects Cortex Phellodendri oil, cinnamic aldehyde, Oleum Camphora, terbinafine and olive oil as combination, is because Cortex Phellodendri oil has the effect of anti-pathogenic fungus, trichomonas vaginitis and multiple gram negative bacilli and positive coccus; Cinnamic aldehyde has very strong biocidal efficacies, and its fungicidal spectrum is wide, can make up the deficiency of Cortex Phellodendri oil antimicrobial spectrum; Oleum Camphora not only has certain anticorrosion and astriction, and its distinctive taste can repel mosquitoes and flies, and makes it away from the humans and animals of suffering from decubital ulcer, in order to avoid lay eggs at decubitus ulcer place; Terbinafine is propylamine antifungal agent, and its anti-fungus spectra is wide, and dermatophytes is had to killing action, and effect is certain, can make the antifungal efficacy of Cortex Phellodendri oil nanometer emulsion compositions greatly improve.Olive oil has the effect of skin protection, utilizes impaired skin early recovery.
The present invention detects through transmission electron microscope, and droplet diameter distribution is between 1～100nm, and outward appearance is colourless or flaxen transparency liquid, has good stability:
1, ageing stability
Ageing stability refers to when nano-emulsion is preserved under room temperature nature change condition, and outward appearance extends and the degree that changes in time.This Cortex Phellodendri oil nanometer emulsion compositions, after storage, through the lasting clear of check outward appearance, is not found the breakdown of emulsion such as muddiness or precipitation situation, illustrates that ageing stability is good.
2, heat storage stability
This Cortex Phellodendri oil nanometer emulsion compositions is sub-packed in several vials, after sealing, is placed in 50 ℃ of calorstats and stores 15d, observe every 5d sampling.Result shows, after this liquid heat storage, checks outward appearance still to keep the outward appearance of clear, does not find the breakdown of emulsion such as muddiness or layering situation, illustrates that heat storage stability is good.
3, anti-freeze-stable
By this Cortex Phellodendri oil nanometer emulsion compositions in refrigerator-10 ℃ preserve after one week.Return to room temperature.If nano-emulsion is solid at-10 ℃, return to room temperature, still clear of outward appearance after dilution check, and place after one week and continue check, do not find the breakdown of emulsion such as muddiness or precipitation situation, think that freezing-resistance is good.
4, accelerated stability
This Cortex Phellodendri oil nanometer emulsion compositions is placed in to test tube, sealing, under the rotating speed of 15000r/min centrifugal 20 minutes, there is not profit layering, clear still after dilution check, does not find the breakdown of emulsion such as muddiness or precipitation situation.
5, light stability experiment
Part Cortex Phellodendri oil nanometer emulsion compositions is loaded in vial, and sealing is placed under daylight, and light at room temperature is according to 10d, in 1d, 3d, 5d, 10d sampling.Result shows, this nanoemulsions still keeps clear, without the breakdown of emulsion such as muddiness or layering situation, shows that light stability is good.
Compound oil-in-water phellodendron oil nanoemulsion composition of the present invention has effect for the treatment of animal and human's decubital ulcer, trichomonal vaginitis and various pathogenic dermatomycosiss.
Usage: directly spray or be applied in affected part.
Compound oil-in-water phellodendron oil nanoemulsion composition of the present invention compared with prior art, has the following advantages:
1) there is higher thermodynamic stability.The nano-emulsion of preparation stores not phase-splitting, does not precipitate between-10 ℃ and 50 ℃, and stability improves;
2) use convenient.Can be produced into spray and liniment according to its function and purposes;
3) good transdermal effect.Cortex Phellodendri oil nanometer emulsion compositions emulsion droplet particle diameter, between 1 ~ 100nm, can see through epidermis and enter more deep tissues, thereby biocidal efficacies is more obvious, has improved bioavailability;
4) reduced former medicine oil volatility, delayed the regression time of Cortex Phellodendri oil, effective drug duration is longer;
5) method technique is simple, is applicable to large-scale production.
The specific embodiment
Further set forth below the beneficial effect of medicine of the present invention by pharmacodynamics test and contrast test.
test example 1the comparative efficacy test of Cortex Phellodendri oil nanometer emulsion compositions treatment sheep decubital ulcer and the former medicine of Cortex Phellodendri oil
Suffer from degree of approximation decubital ulcer (ulcer wound surface size is more or less the same) sheep by 60 and be divided at random three groups of matched group, the Cortex Phellodendri former medicine group of oil and compound phellodendron bark oil nanometer emulsion groups, 20 every group.60 sick sheep all carry out the affected part processing of same steps before treatment, comprise cropping, wound surface cleaned, remove wound surface slough etc. with normal saline.By sick sheep isolated rearing, require colony house ventilate, ground is clean, temperature is suitable, have substantial light shine.Three groups of sick sheep are under equal conditions raised.The former medicine group of Cortex Phellodendri oil adopts true yellow pitch to embrocate ulcer portion 20 every days, uses sufficient enough doses according to ulcer area size, smears and requires evenly, every day 3 times; 20 employings of compound phellodendron bark oil nanometer emulsion group method medication identical with former medicine group; Matched group is not taked any measure.During sick sheep medication, ban use of other similar drugs, be set as 14 days the course for the treatment of.
Curative effect judging standard:
Cure: the healing of ulcer wound surface entirety, form a scab and come off, there is virgin wool to grow;
Effective: have granulation tissue growth, ulcer area obviously reduces, and secretes without secretions;
Take a turn for the better: ulcer area reduces to some extent, wound surface restrains oneself, is dried;
Invalid: ulcer wound surface feature with treatment before compare unchanged or aggravation.
table 1the Cortex Phellodendri former medicine group of oil and compound phellodendron bark oil nanometer emulsion group treatment sheep decubital ulcer comparative efficacy test result
Result: relatively three groups of therapeutic effect, matched group after 14 days cure rate be 0, obvious effective rate is 0, improvement rate is 25%, inefficiency is 75%, total effective rate is 25%; The former medicine group of Cortex Phellodendri oil after 14 days cure rate be 30%, obvious effective rate is 25%, improvement rate is 25%, inefficiency is 20%, total effective rate is 80%; Compound phellodendron bark oil nanometer emulsion group after 14 days cure rate be 50%, obvious effective rate is 30%, improvement rate is 15%, inefficiency is 5%, total effective rate is 95%.
As can be seen from the results: compound phellodendron bark oil nanometer emulsion is being better than the former medicine of Cortex Phellodendri oil aspect the curative effect for the treatment of decubital ulcer.
test example 2compound phellodendron bark oil nanometer emulsion and other preparation for treating dermatophytes dermatitis Piglet s colibacillosis
Choose adult rabbit natural infection case 100 examples of suffering from tinea pedis, between its course of disease 10 ~ 15 days, main manifestations is affected part depilation, red swelling of the skin, and rabbit constantly stings its foot, causes that foot festers, hemorrhage, incrustation.Trouble rabbit is divided into two treatment groups at random, 50 every group.Smear affected part with the compound ketoconazole ointment of buying on market for first group, 2 times/day, sooner or later respectively once; Second group of compound phellodendron bark oil nanometer emulsion with preparation smeared affected part, and method is the same.Suffer from before rabbit treatment, require affected part removals of form a scab, the processing such as cleaning and sterilizing, smear evenly, forbid other similar external preparation during medication, and be 10 days the course for the treatment of.
Curative effect determinate standard:
The range estimation pars affecta skin transference cure that festers, forms without new incrustation, and outward appearance skin is normal or approach normally, has virgin wool to grow as effective; The transference cure that festers, form, but skin still has inflammation without new incrustation, and virgin wool grows not obvious, and rabbit still has the symptom of stinging its foot for effectively once in a while; Symptom there is not change or aggravation person into invalid substantially with treatment is front.
Result: compound ketoconazole ointment group 50 examples, effective 21 examples, obvious effective rate 42%, effective 14 examples, effective percentage 28%, invalid 15 examples, inefficiency 30%, total effective rate is 70%; Effective 30 examples of compound phellodendron bark oil nanometer emulsion group, obvious effective rate 60%, effective 16 examples, effective percentage 32%, invalid 4 examples, inefficiency 8%, total effective rate 92%.The effect of compound phellodendron bark oil nanometer emulsion treatment dermatophytes dermatitis is better than compound ketoconazole ointment as can be seen from the results, and liquid preparation is more more convenient than ointment medication, absorb comparatively fast, compare with ointment and reduced rabbit and lick and sting the local drug loss causing.
Further set forth below composition and the preparation method of medicine of the present invention by specific embodiment.
Embodiment 1
A kind of compound oil-in-water phellodendron oil nanoemulsion composition, the quality of each component:
Cortex Phellodendri oil 5.8g, cinnamic aldehyde 0.3g, Oleum Camphora 0.4g, terbinafine 0.7g, olive oil 0.7g, ethanol 0.6g, polyoxyethylene ether (40) castor oil hydrogenated 27.5g, distilled water 64.0g.
Above-mentioned each component is made compound oil-in-water phellodendron oil nanoemulsion composition, comprises the following steps:
1) accurately take the quality of polyoxyethylene ether (40) castor oil hydrogenated, Cortex Phellodendri oil, cinnamic aldehyde, Oleum Camphora, olive oil, terbinafine, ethanol, distilled water by filling a prescription, for subsequent use;
2) Cortex Phellodendri oil, cinnamic aldehyde, Oleum Camphora, the mixed with olive oil of described amount are stirred, as oil phase;
3) terbinafine of described amount is added to oil phase, and stir until terbinafine dissolves, then add the ethanol of described amount fully to stir, now, terbinafine can be dissolved in the middle of oil phase completely;
4) polyoxyethylene ether of described amount (40) castor oil hydrogenated joined in the middle of oil phase and stir;
5) using distilled water as water, at room temperature stir rapidly oil phase and polyoxyethylene ether (40) hydrogenated castor oil mixture, when stirring, slowly drip water, this mixture system there will be by rare retrogradation, last again by thick thinning a series of variations, until system is transparent liquid, obtain compound phellodendron bark oil nanometer emulsion compositions.
Embodiment 2
A kind of compound oil-in-water phellodendron oil nanoemulsion composition, the quality of each component:
Cortex Phellodendri oil 7.0g, cinnamic aldehyde 1.0g, Oleum Camphora 1.2g, terbinafine 0.7g, olive oil 0.5g, ethanol 0.7g, polyoxyethylene ether (40) castor oil hydrogenated 27.9g, distilled water 61.0g.
Embodiment 3
A kind of compound oil-in-water phellodendron oil nanoemulsion composition, the quality of each component:
Cortex Phellodendri oil 3.2g, cinnamic aldehyde 1.3g, Oleum Camphora 1.3g, terbinafine 1.0g, olive oil 0.6g, ethanol 1.2g, polyoxyethylene ether (40) castor oil hydrogenated 25.4g, distilled water 66.0g.
Embodiment 4
A kind of compound oil-in-water phellodendron oil nanoemulsion composition, the quality of each component:
Cortex Phellodendri oil 4.5g, cinnamic aldehyde 0.3g, Oleum Camphora 0.3g, terbinafine 1.0g, olive oil 1.3g, ethanol 0.6g, polyoxyethylene ether (40) castor oil hydrogenated 26.0g, distilled water 66.0g.
Embodiment 5
A kind of compound oil-in-water phellodendron oil nanoemulsion composition, the quality of each component:
Cortex Phellodendri oil 3.3g, cinnamic aldehyde 0.7g, Oleum Camphora 3.3g, terbinafine 1.0g, olive oil 0.2g, ethanol 0.3g, polyoxyethylene ether (40) castor oil hydrogenated 26.6g, distilled water 64.6g.
Embodiment 6
A kind of compound oil-in-water phellodendron oil nanoemulsion composition, the quality of each component:
Cortex Phellodendri oil 6.5g, cinnamic aldehyde 1.3g, Oleum Camphora 1.5g, terbinafine 0.7g, olive oil 0.6g, ethanol 0.6g, polyoxyethylene ether (40) castor oil hydrogenated 23.0g, distilled water 65.8g.
Embodiment 7
A kind of compound oil-in-water phellodendron oil nanoemulsion composition, the quality of each component:
Cortex Phellodendri oil 4.5g, cinnamic aldehyde 2.0g, Oleum Camphora 1.3g, terbinafine 0.6g, olive oil 0.6g, ethanol 0.6g, polyoxyethylene ether (40) castor oil hydrogenated 26.0g, distilled water 64.4g
Embodiment 8
A kind of compound oil-in-water phellodendron oil nanoemulsion composition, the quality of each component:
Cortex Phellodendri oil 4.0g, cinnamic aldehyde 2.7g, Oleum Camphora 0.6g, terbinafine 0.7g, olive oil 0.3g, ethanol 0.6g, polyoxyethylene ether (40) castor oil hydrogenated 26.8g, distilled water 64.3g.
Embodiment 9
A kind of compound oil-in-water phellodendron oil nanoemulsion composition, the quality of each component:
Cortex Phellodendri oil 3.8g, cinnamic aldehyde 0.9g, Oleum Camphora 0.9g, terbinafine 1.0g, olive oil 0.6g, ethanol 1.3g, polyoxyethylene ether (40) castor oil hydrogenated 25.0g, distilled water 66.5g.
Embodiment 10
A kind of compound oil-in-water phellodendron oil nanoemulsion composition, the quality of each component:
Cortex Phellodendri oil 2.6g, cinnamic aldehyde 0.3g, Oleum Camphora 0.1g, terbinafine 0.4g, olive oil 0.2g, ethanol 0.6g, polyoxyethylene ether (40) castor oil hydrogenated 29.0g, distilled water 66.8g.
Embodiment 11
A kind of compound oil-in-water phellodendron oil nanoemulsion composition, the quality of each component:
Cortex Phellodendri oil 4.2g, cinnamic aldehyde 0.1g, Oleum Camphora 0.8g, terbinafine 0.5g, olive oil 1.2g, ethanol 0.6g, polyoxyethylene ether (40) castor oil hydrogenated 27.0g, distilled water 65.6g.
Claims (2)
1. a compound oil-in-water phellodendron oil nanoemulsion composition, is characterized in that, the particle diameter of this nano-emulsion, between 1～100nm, is made up of the raw material of following mass percent:
Cortex Phellodendri oil 1.0%～8.0%, cinnamic aldehyde 0.1%～4.0%, Oleum Camphora 0.1%～3.8%, terbinafine 0.01%～1.3%, olive oil 0.01%～1.6%, cosurfactant 0.01%～1.5%, surfactant 20.0%～33.8%, surplus are distilled water, and the mass percent sum of above-mentioned raw materials is 100%;
Described surfactant is polyoxyethylene ether (40) castor oil hydrogenated;
Described cosurfactant is dehydrated alcohol.
2. compound oil-in-water phellodendron oil nanoemulsion composition according to claim 1, is characterized in that, is made up of the raw material of following mass percent:
Cortex Phellodendri oil 1.6%～7.0%, cinnamic aldehyde 0.15%～3.3%, Oleum Camphora 0.15%～3.3%, terbinafine 0.1%～1.0%, olive oil 0.1%～1.3%, cosurfactant 0.1%～1.3%, surfactant 23.0%～31.0%, surplus are distilled water, and the mass percent sum of above-mentioned raw materials is 100%;
Described surfactant is polyoxyethylene ether (40) castor oil hydrogenated;
Described cosurfactant is dehydrated alcohol.
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| CN1927181A (en) * | 2006-09-20 | 2007-03-14 | 西北农林科技大学 | Terbinafine nano milk-like liquid antifungal medicine and its preparation |
| CN102065851A (en) * | 2008-04-25 | 2011-05-18 | 纳米生物公司 | Nanoemulsions for treating fungal, yeast and mold infections |
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| CN1927181A (en) * | 2006-09-20 | 2007-03-14 | 西北农林科技大学 | Terbinafine nano milk-like liquid antifungal medicine and its preparation |
| CN102065851A (en) * | 2008-04-25 | 2011-05-18 | 纳米生物公司 | Nanoemulsions for treating fungal, yeast and mold infections |
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