CN1843494A - Compound econazole nitrate zedoary turmeric oil emulsion type foam aerosol and its preparation method - Google Patents
Compound econazole nitrate zedoary turmeric oil emulsion type foam aerosol and its preparation method Download PDFInfo
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- CN1843494A CN1843494A CN 200610045819 CN200610045819A CN1843494A CN 1843494 A CN1843494 A CN 1843494A CN 200610045819 CN200610045819 CN 200610045819 CN 200610045819 A CN200610045819 A CN 200610045819A CN 1843494 A CN1843494 A CN 1843494A
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- econazole nitrate
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Abstract
The invention relates to a compound aromatic turmeric oil emulsion type foam aerosol of Econazole nitrate and its preparing process, wherein each 1000mL of the aerosol contains the following constituents (by mass ratio): Econazole nitrate 1-100g, aromatic turmeric oil 1-200g, emulsifying agent 5-250g, preservative agent 0.1-20g, projection agent 50-500g, and balancing dissolvent. The aerosol can be used for treating vaginitis, cervical erosion and uterine neck disease.
Description
(1) technical field
The present invention relates to the medical and health technology field, a kind of compound econazole nitrate zedoary turmeric oil emulsion type foam aerosol and preparation method thereof of definitely saying so.
(2) background technology
Econazole nitrate (EconazoleNitrate) is synthetic broad-spectrum antifungal medicine, and the disease that is caused by skin wire-like bacteria, candidiasis, yeast, black filamentous bacteria, aspergillosis, penicillium, actinomycotic infection for treatment has better curative effect.Its has a broad antifungal spectrum, better tolerance, main metabolites also have higher antifungal activity.Oleum Curcumae is the effective ingredient that extracts through steam distillation from the dry rhizome of zingiberaceous plant Rhizoma Curcumae (Curcuma phaeocaulis Val.), Guangxi zedoary (Curcuma kwangsiensis S.G.Lee et C.F.Liang) or RADIX CURCUMAE (Curcumawenyujin Y.H.Chen et C.Ling).It has promoting flow of QI and blood, removing food stagnancy pain relieving, activating blood circulation to dissipate blood stasis, removing the necrotic tissue and promoting granulation, antitumor, antiviral, antifungal effect.After econazole nitrate, Oleum Curcumae be prepared into the compound recipe emulsion type foam aerosol, medicine will be brought into play synergism, drug effect is stronger, main absorption pattern is pinocytosis, this absorption pattern can make antifungal, antiviral and antitumor drug are easier to be entered in the cell, thereby plays a role better.
Yet the dissolubility of econazole nitrate in water is extremely low, and the physicochemical property that the dissolubility in oil phase is also extremely low has limited the development of its emulsion-type preparation.Chinese patent publication number CN03110917.9 has reported a kind of compound econazole nitrate zedoary turmeric oil ointment machin its preparation method; Chinese patent publication number CN03109769.3 has reported a kind of compound econazole nitrate zedoary turmeric oil preparation and preparation method thereof, comprises suppository, capsule, three kinds of dosage forms of gel: Chinese patent publication number CN200410029626.1 has reported the application of a kind of compound econazole nitrate zedoary turmeric oil bolt in preparation treatment bacterial vaginosis medicine.But above-mentioned disclosed several preparation method ubiquity dosage forms fall behind, and drug loading is few, and bioavailability is low, and awkward weakness has limited the extensive use of this compound preparation.
(3) summary of the invention
The object of the invention is to provide a kind of synergistic, obvious results compound econazole nitrate zedoary turmeric oil emulsion type foam aerosol that has
The preparation method that is to provide a kind of compound econazole nitrate zedoary turmeric oil emulsion type foam aerosol of another day of the present invention.
Emulsion type foam aerosol of the present invention adopts following technical scheme:
Contain in every 1000ml Emulsion: econazole nitrate 1g～100g, Oleum Curcumae 1g～200g, emulsifying agent 5g～250g, propellant 50g～500g, antiseptic 0.1g～20g, surplus is a solvent.
A kind of preparation method of compound econazole nitrate zedoary turmeric oil emulsion type foam aerosol, with this Emulsion of preparation 1000ml is example, and it is standby to get nitric acid benefit health 1-100g, Oleum Curcumae 1-200g, emulsifying agent 5-250g, propellant 50-500g, antiseptic 0.1-20g and solvent.Solvent is the surplus of removing in the 1000ml Emulsion after above-mentioned econazole nitrate, Oleum Curcumae, emulsifying agent, propellant and the antiseptic.Its preparation process is as follows: the 5-250g emulsifying agent is dissolved in the 1-200g Oleum Curcumae as oil phase.
1-100g econazole nitrate and 0.1-20g antiseptic are dissolved in the solvent as water.Be heated to 25-80 ℃ respectively, the biphase mixing of profit then, stir and in tissue mashing machine dispersion and emulsion get colostrum.Colostrum is even through high pressure dispersing emulsification machine breast, gets compound econazole nitrate zedoary turmeric oil emulsion.Canned sealing promptly got the compound econazole nitrate zedoary turmeric oil emulsion type foam aerosol after compound econazole nitrate zedoary turmeric oil emulsion added the 50-500g propellant.
The another kind of preparation method of compound recipe nitric acid benefit azoles zedoary turmeric oil emulsion type foam aerosol is an example with this Emulsion of preparation 1000ml, and step is as follows: 1-100g econazole nitrate and partial solvent are dissolved in the 1-200g Oleum Curcumae as oil phase; 5-250g emulsifying agent and 0.1-20g antiseptic are dissolved in the remaining solvent as water.Be heated to 25-80 ℃ respectively, the biphase mixing of profit then, stir and in tissue mashing machine dispersion and emulsion get colostrum.Colostrum is even through high pressure dispersing emulsification machine breast, gets compound econazole nitrate zedoary turmeric oil emulsion.Canned sealing promptly got the compound econazole nitrate zedoary turmeric oil emulsion type foam aerosol after compound econazole nitrate zedoary turmeric oil emulsion added the 50-500g propellant.
Emulsifying agent is selected from anhydrate one or more mixture of sorbic acid cetylate, poly yamanashi esters, the smooth apoplexy due to endogenous wind of fatty acid Pyrusussuriensis of lecithin, hydroxylated lecithin, soybean phospholipid, soybean lecithin, hydrogenated soya phosphatide, Ovum Gallus domesticus Flavus lecithin, poloxamer, cholesterol, (deoxidation) sodium cholate, lauroyl diethanolamine, cocos nucifera oil acyl diethanolamine, cocos nucifera oil acyl monoethanolamine, polyglycereol Palmic acid diol ester, acetic acid esters of mono, polyoxyethylene.
Solvent is selected from one or more the mixture in water, glycerol, PEG400 dimethyl sulfoxide, propylene glycol, Polyethylene Glycol, the ethanol.
Antiseptic is selected from one or more the mixture in parabens, benzoic acid, sodium benzoate, sorbic acid and its esters, vitamin C, the vitamin E.Wherein said parabens is selected from one or more the mixture in methyl parahydroxybenzoate, ethylparaben, propyl p-hydroxybenzoate, the butyl p-hydroxybenzoate.
Described propellant is selected from one or more the mixture in propane, normal butane, the iso-butane.
Described emulsification method has phase conversion emulsifying, PIT emulsion process, replaces liquid feeding emulsion process, continuous emulsifying method, Mechanical Method (stirring and emulsifying device, dispersing emulsification machine, colloid mill, ultrasonic emulsification device), low-energy emulsification method etc.
The invention has the advantages that: the solvent by special prescription preparation has solved insoluble, the oily insoluble difficult problem of econazole nitrate water.By preparing this compound econazole nitrate zedoary turmeric oil emulsion, realized having the emulsion type foam aerosol preparation of synergistic antifungal, antiviral drugs first.Above-mentioned two kinds of bioavailability of medicament all obtain bigger raising when more individually dosed.Simultaneously, adopt foam type aerosol drug delivery mode can make less medicine amount liquid volume can produce a large amount of foams and be uniformly distributed in the surface, affected part, improve therapeutic effect, reduced pollution, more help patient's use medicated clothing.
(4) specific embodiment:
Embodiment one
The present invention contains following mass number in every 1000mL Emulsion: econazole nitrate 2g, and Oleum Curcumae 2g, tween 80 5g, sodium benzoate 0.1g, iso-butane 50g, surplus is aqueous solvent and propylene glycol, the charge ratio of water and propylene glycol is 1: 1.
Preparation method: the 5g tween 80 is dissolved in the 2g Oleum Curcumae as oil phase: 2g econazole nitrate and 0.1g sodium benzoate are dissolved in the solvent as water.Biphasely stir respectively and be heated to about 60 ℃ respectively, water slowly is added drop-wise in the oil phase, the limit edged stirs, and adds the back and continues to stir 15 minutes, and dispersion and emulsion in tissue mashing machine makes colostrum then.Colostrum gets breast eventually for three times with the homogenize of homogenizer high pressure.Breast is crossed 0.45 μ m microporous filter membrane eventually, adds 50g iso-butane, fill then, seals, sterilizes, and gets product.
Embodiment two
The present invention contains following mass number in every 1000mL Emulsion: econazole nitrate 98g, and Oleum Curcumae 198g, soybean phospholipid 125g, hydroxybenzoate 10g. normal butane 250g, all the other are aqueous solvent and PEG400.The charge ratio of water and PEG400 is 1: 1.
Preparation method: 98g econazole nitrate, partial solvent are dissolved in the 198g Oleum Curcumae as oil phase; 125g soybean phospholipid and 10g hydroxybenzoate are dissolved in the remainder solvent as water.Biphasely stir respectively and be heated to about 80 ℃ respectively, oil phase slowly is added drop-wise to aqueous phase, the limit edged stirs, and adds the back and continues to stir 40 minutes, and dispersion and emulsion in tissue mashing machine makes colostrum then.Colostrum gets breast eventually for three times with the homogenize of homogenizer high pressure.Breast is crossed 0.45 μ m microporous filter membrane eventually, adds 250g normal butane, fill then, seals, sterilizes, and gets product.
Embodiment three
The present invention contains following mass number in every 1000mL Emulsion: econazole nitrate 99g, and Oleum Curcumae 150g, poloxamer 125g, ethylparaben 10g, propane 250g, all the other are aqueous solvent and ethanol.Water and alcoholic acid charge ratio are 1: 1.
Preparation method: heat the 25g poloxamer in right amount with 95% ethanol and make it dissolving, to wherein adding 99g econazole nitrate and 150g Oleum Curcumae as oil phase: 100g poloxamer and 10g ethylparaben are dissolved in the solvent as water.Biphasely stir respectively and make temperature rise to about 25 ℃ respectively, oil phase slowly is added drop-wise to aqueous phase, the limit edged stirs, and adds the back and continues to stir 80 minutes, and dispersion and emulsion in tissue mashing machine makes colostrum then.Colostrum gets breast eventually for five times with the homogenize of homogenizer high pressure.Breast is crossed 0.45 μ m microporous filter membrane eventually, adds 250g propane, fill then, seals, sterilizes, and gets product.
Claims (10)
1, compound econazole nitrate zedoary turmeric oil emulsion type foam aerosol, it is characterized in that containing in every 1000mL Emulsion the raw material composition of following per distribution ratio: econazole nitrate 1g～100g, Oleum Curcumae 1g～200g, emulsifying agent 5～250g, propellant 50g～500g, antiseptic 0.1g～20g, surplus is a solvent.
2, compound econazole nitrate zedoary turmeric oil emulsion type foam aerosol according to claim 1, it is characterized in that, in every 1000mL Emulsion, contain following mass number: econazole nitrate 2g, Oleum Curcumae 2g, tween 80 5g, sodium benzoate 0.1g, iso-butane 50g, surplus is aqueous solvent and propylene glycol, and the charge ratio of water and propylene glycol is 1: 1.
3, compound econazole nitrate zedoary turmeric oil emulsion type foam aerosol according to claim 1, it is characterized in that, in every 1000mL Emulsion, contain following mass number: econazole nitrate 98g, Oleum Curcumae 198g, soybean phospholipid 125g, hydroxybenzoate 10g, normal butane 250g, all the other are aqueous solvent and PEG400, and the charge ratio of water and PEG400 is 1: 1.
4, compound econazole nitrate zedoary turmeric oil emulsion type foam aerosol according to claim 1, it is characterized in that, in every 1000mL Emulsion, contain following mass number: econazole nitrate 99g, Oleum Curcumae 150g, poloxamer 125g, ethylparaben 10g, propane 250g, all the other are aqueous solvent and ethanol, and water and alcoholic acid charge ratio are 1: 1.
5, compound econazole nitrate zedoary turmeric oil emulsion type foam aerosol according to claim 1 is characterized in that described emulsifying agent is soybean phospholipid, soybean lecithin, Ovum Gallus domesticus Flavus lecithin, lecithin, cholesterol, hydrogenated soya phosphatide, hydroxylated lecithin, (deoxidation) sodium cholate, poloxamer, lauroyl diethanolamine, cocos nucifera oil acyl diethanolamine, polyglycereol Palmic acid diol ester, acetic acid esters of mono, cocos nucifera oil acyl monoethanolamine, polyoxyethylene at least a of sorbic acid cetylate, poly yamanashi esters, the smooth apoplexy due to endogenous wind of fatty acid Pyrusussuriensis of anhydrating; Described solvent, at least a in water or PEG400, glycerol, dimethyl sulfoxide, propylene glycol, poly-diethanol, the ethanol; Described antiseptic, at least a in parabens or benzoic acid, sodium benzoate, sorbic acid and its esters, vitamin C, the vitamin E; Described propellant, at least a in propane, normal butane, the iso-butane; Parabens, at least a in methyl parahydroxybenzoate, ethylparaben, propyl p-hydroxybenzoate, the butyl p-hydroxybenzoate.
6, the preparation method of a kind of compound econazole nitrate zedoary turmeric oil emulsion type foam aerosol according to claim 1, with this Emulsion of preparation 1000ml is example, and it is standby to it is characterized in that getting nitric acid benefit health 1-100g, Oleum Curcumae 1-200g, emulsifying agent 5-250g, propellant 50-500g, antiseptic 0.1-20g and solvent; Solvent is the surplus of removing in the 1000ml Emulsion after above-mentioned econazole nitrate, Oleum Curcumae, emulsifying agent, propellant and the antiseptic, and its preparation process is as follows: the 5-250g emulsifying agent is dissolved in the 1-200g Oleum Curcumae as oil phase; 1-100g econazole nitrate and 0.1-40g antiseptic are dissolved in the solvent as water, be heated to 25-80 ℃ respectively, the biphase mixing of profit then, stir and in tissue mashing machine dispersion and emulsion get colostrum, colostrum is even through high pressure dispersing emulsification machine breast, get compound econazole nitrate zedoary turmeric oil emulsion, canned sealing promptly got the compound econazole nitrate zedoary turmeric oil emulsion type foam aerosol after compound econazole nitrate zedoary turmeric oil emulsion added the 50-500g propellant.
7, the preparation method of a kind of compound econazole nitrate zedoary turmeric oil emulsion type foam aerosol according to claim 1, with this Emulsion of preparation 1000ml is example, it is characterized in that 1-100g econazole nitrate and partial solvent are dissolved in the 1-200g Oleum Curcumae as oil phase; 5-250g emulsifying agent and 0.1-20g antiseptic are dissolved in the remaining solvent as water, be heated to 25-80 ℃ respectively, the biphase mixing of profit then, stir and in tissue mashing machine dispersion and emulsion get colostrum, colostrum is even through high pressure dispersing emulsification machine breast, get compound econazole nitrate zedoary turmeric oil emulsion, canned sealing promptly got the compound econazole nitrate zedoary turmeric oil emulsion type foam aerosol after compound econazole nitrate zedoary turmeric oil emulsion added the 50-500g propellant.
8, the preparation method of compound econazole nitrate zedoary turmeric oil emulsion type foam aerosol according to claim 1 is an example with this Emulsion of preparation 1000ml, it is characterized in that the 5g tween 80 is dissolved in the 2g Oleum Curcumae as oil phase; 2g econazole nitrate and 0.1g sodium benzoate are dissolved in the solvent as water, biphasely stir respectively and be heated to about 60 ℃ respectively, water slowly is added drop-wise in the oil phase, and the limit edged stirs, and adds the back and continues to stir 15 minutes, dispersion and emulsion in tissue mashing machine then, make colostrum, colostrum with homogenizer high pressure homogenize three times breast eventually, breast is crossed 0.45 μ m microporous filter membrane eventually, add 50g iso-butane, fill then, seal, sterilize, get product; Solvent is the surplus of removing in the 1000ml Emulsion behind above-mentioned tween, Oleum Curcumae, econazole nitrate, sodium benzoate, the different western alkane, is that water and propylene glycol are formed with 1: 1 proportioning.
9, the preparation method of compound econazole nitrate zedoary turmeric oil emulsion type foam aerosol according to claim 1 is an example with this Emulsion of preparation 1000ml, it is characterized in that 98g econazole nitrate, partial solvent are dissolved in the 198g Oleum Curcumae as oil phase; 125g soybean phospholipid and 10g hydroxybenzoate are dissolved in the remainder solvent as water, biphasely stir respectively and be heated to about 80 ℃ respectively, oil phase slowly is added drop-wise to aqueous phase, and the limit edged stirs, and adds the back and continues to stir 40 minutes, dispersion and emulsion in tissue mashing machine then, make colostrum, colostrum with homogenizer high pressure homogenize three times breast eventually, breast is crossed 0.45 μ m microporous filter membrane eventually, add 250g normal butane, fill then, seal, sterilize, get product; Solvent is the surplus behind the above-mentioned econazole nitrate of removal, Oleum Curcumae, soybean phospholipid, hydroxybenzoate and the normal butane in the 1000ml Emulsion, is that water and PEG400 form with 1: 1 proportioning.
10, the preparation method of compound econazole nitrate zedoary turmeric oil emulsion type foam aerosol according to claim 1, with this Emulsion of preparation 1000ml is example, it is characterized in that heating the 25g poloxamer in right amount with 95% ethanol makes it dissolving, to wherein adding 99g econazole nitrate and 150g Oleum Curcumae as oil phase; 100g poloxamer and 10g ethylparaben are dissolved in the solvent as water, biphasely stir respectively and make temperature rise to about 25 ℃ respectively, oil phase slowly is added drop-wise to aqueous phase, and the limit edged stirs, and adds the back and continues to stir 80 minutes, dispersion and emulsion in tissue mashing machine then, make colostrum, colostrum with homogenizer high pressure homogenize five times breast eventually, breast is crossed 0.45 μ m microporous filter membrane eventually, add 250g propane, fill then, seal, sterilize, get product; Solvent is the surplus of removing in the 1000ml Emulsion behind econazole nitrate, Oleum Curcumae, poloxamer, para hydroxybenzene methyl ethyl ester, the propane, is that water and ethanol are formed with 1: 1 proportioning.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN 200610045819 CN1843494A (en) | 2006-02-10 | 2006-02-10 | Compound econazole nitrate zedoary turmeric oil emulsion type foam aerosol and its preparation method |
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| CN 200610045819 CN1843494A (en) | 2006-02-10 | 2006-02-10 | Compound econazole nitrate zedoary turmeric oil emulsion type foam aerosol and its preparation method |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20120101140A1 (en) * | 2010-10-26 | 2012-04-26 | Quinnova Pharmaceuticals, Inc. | Econazole Composition and Methods of Treatment Therewith |
| CN103689303A (en) * | 2013-12-04 | 2014-04-02 | 浙江省农业科学院 | Canned foam jam and production method thereof |
-
2006
- 2006-02-10 CN CN 200610045819 patent/CN1843494A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20120101140A1 (en) * | 2010-10-26 | 2012-04-26 | Quinnova Pharmaceuticals, Inc. | Econazole Composition and Methods of Treatment Therewith |
| US10071054B2 (en) | 2010-10-26 | 2018-09-11 | Exeltis Usa Dermatology, Inc. | Econazole composition and methods of treatment therewith |
| US10543172B2 (en) * | 2010-10-26 | 2020-01-28 | Paragon Nordic Ab | Econazole composition and methods of treatment therewith |
| CN103689303A (en) * | 2013-12-04 | 2014-04-02 | 浙江省农业科学院 | Canned foam jam and production method thereof |
| CN103689303B (en) * | 2013-12-04 | 2015-03-04 | 浙江省农业科学院 | Canned foam jam and production method thereof |
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