CN101239066A - Triamcinolone acetonide econazole cream - Google Patents
Triamcinolone acetonide econazole cream Download PDFInfo
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- CN101239066A CN101239066A CNA2008100084001A CN200810008400A CN101239066A CN 101239066 A CN101239066 A CN 101239066A CN A2008100084001 A CNA2008100084001 A CN A2008100084001A CN 200810008400 A CN200810008400 A CN 200810008400A CN 101239066 A CN101239066 A CN 101239066A
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- triamcinolone acetonide
- cream
- polyoxyethylene
- econazole
- emulsifiable paste
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Abstract
The invention discloses a triamcinolone acetonide and econazole nitrate cream which contains econazole nitrate and triamcinolone acetonide. The invention is characterized in that the cream also contains octodecyl alcohol or hexadecanol. The triamcinolone acetonide and econazole nitrate cream is more subtle and even, is easy to be daubed and washed on and away from the skin and is harmless to skin, has no odor. No greasiness is to be felt when the cream is daubed on the skin, and the quality is more stable.
Description
Technical field
The invention belongs to field of medicaments, what relate in particular to is a kind of treatment eczema, tinea manus and pedis, tinea corporis, tinea cruris, tinea versicolor, diaper dermatitis, bridou, paronychial triamcinolone acetonide econazole cream prescription of being mainly used in.
Background technology
Dermatosis is a disease common in our daily life, and dermatosis sickness rate height is of a great variety at present, because of its pilosity is born in body surface, not only brings the injury of health to the patient; Also influenced patient's outward appearance and appearance, brought spiritual injury to the patient.
In recent years along with living standards of the people improve constantly, seek medical advice and dermopathic pharmaceutical requirements is also strengthened day by day dermopathic.The dermopathic medicament categories of treatment is various at present, mostly is various ointment, ointment.Triamcinolone acetonide econazole cream is a preparation commonly used at present.Triamcinolone acetonide is a glucocorticoid in this product, has antiinflammatory, antipruritic and anti-allergic effects; Econazole is an antifungal agent, and dermatophytosis such as candidiasis are had antibacterial activity, and is also effective to some gram positive bacteria; Two medicines are also with improving curative effect.
Learn that from SFDA official website the legal manufacturer of present domestic triamcinolone acetonide econazole cream has 9 families at present.Wherein a kind of cream formulation consists of triamcinolone acetonide, econazole nitrate, polyoxyethylene-7-stearate, polyoxyethylene-5-oleate, liquid Paraffin, benzoic acid, disodiumedetate, BHA, purified water.
The common holding conditions of emulsifiable paste is that airtight, shady and cool place preserves.The stability of cream preparation is also poor than other solid preparations.Therefore character takes place and changes in cream preparation easily when daily transportation, storage and clinical life-time service, as oil-water separation (breakdown of emulsion), color change, abnormal flavour etc. is arranged.The quality and the effective life of triamcinolone acetonide econazole cream have so just been reduced.
Summary of the invention
The deficiency that the stability that exists at present triamcinolone acetonide econazole cream, the object of the present invention is to provide a kind of new triamcinolone acetonide econazole cream, by optimizing the triamcinolone acetonide econazole cream prescription, in prescription, add hexadecanol or octadecanol, solve the shortcoming of this product kind quality poor stability, improve the stability of triamcinolone acetonide econazole cream, the effect duration of improving this kind.
A kind of triamcinolone acetonide econazole cream contains econazole nitrate, triamcinolone acetonide, also contains octadecanol or hexadecanol.
Can also contain polyoxyethylene-7-stearate, polyoxyethylene-5-oleate, BHA, liquid paraffin and purified water.
Further, can also contain benzoic acid or potassium sorbate.
Further, can also contain disodiumedetate or sodium sulfite.
The weight content of each component is preferably:
Econazole nitrate 0.8%～1.2%,
Triamcinolone acetonide 0.08%～0.13%,
Polyoxyethylene-7-stearate 11%～13%,
Polyoxyethylene-5-oleate 2.5%～3.5%,
Benzoic acid or potassium sorbate 0.08%～0.12%,
Disodiumedetate or sodium sulfite 0.08%～0.12%,
Octadecanol or hexadecanol 4.5%～5.5%,
BHA 0.01%～0.02%,
Liquid paraffin 8%～12%,
Purified water 65%～70%.
The present invention is optimized on the basis of commercially available emulsifiable paste prescription, by add hexadecanol or octadecanol in the emulsifiable paste prescription, has optimized the triamcinolone acetonide econazole cream prescription, has produced beyond thought result.By adding hexadecanol or octadecanol in the emulsifiable paste prescription emulsifying capacity is improved greatly; During with the microscopic examination granularity, commercially available triamcinolone acetonide econazole cream has just been seen particle under 100 power microscopes, and the triamcinolone acetonide econazole cream of formulation of the present invention is just seen particle under 400 power microscopes.Because the triamcinolone acetonide econazole cream granularity of formulation of the present invention is less, therefore the triamcinolone acetonide econazole cream of this bright formulation is fine and smooth more, even, is easy to coating and eccysis, and to the skin nonirritant, free from extraneous odour is embrocated and do not have greasy feeling, more stable quality on skin.
The specific embodiment
The invention will be further described below in conjunction with specific embodiment, to help understanding content of the present invention.
Embodiment 1
Triamcinolone acetonide econazole cream each composition weight such as table 1:
Each amounts of components of table 1 triamcinolone acetonide econazole cream
Econazole nitrate 20.0g
Triamcinolone acetonide 2.0g
Polyoxyethylene-7-stearate 250.0g
Polyoxyethylene-5-oleate 60.0g
Benzoic acid 2.0g
Disodiumedetate 2.0g
Octadecanol 100.0g
BHA 0.3g
Liquid paraffin 200.0g
Purified water 1370.0g
(1) preparation of mixture I: take by weighing after recipe quantity disodiumedetate, benzoic acid be dissolved in purified water, reheat to 80～90 ℃, insulation is as water.
(2) preparation of mixtures II: take by weighing octadecanol, polyoxyethylene-7-stearate, polyoxyethylene-5-oleate, liquid paraffin, the fusion of BHA mixing post-heating of recipe quantity, as oil phase.
(3) preparation of mixtures III: mixtures II is slowly added among the mixture I, and the limit edged stirs, and to be cooledly adds principal agent during to 40～50 ℃ and grinds.Promptly.
Emulsifiable paste is tested, the results are shown in Table 2
Table 2 triamcinolone acetonide econazole cream assay
| Test rating | Character | Granularity |
| Assay | White is tasteless | Do not see under 100 power microscopes and find particle |
The high temperature failure test: get emulsifiable paste, place the clean weighing botle of sealing, and then place in the thermostatic drying chamber, attemperation is 50 ℃, placed 5 hours, and breakdown of emulsion not, character is white tasteless.
Low temperature damage test: get emulsifiable paste, place the clean weighing botle of sealing, and then place in the refrigerator, attemperation is 0 ℃, placed 12 hours, and breakdown of emulsion not, character is white tasteless
Embodiment 2
Each composition weight of triamcinolone acetonide econazole cream sees Table 3
Each composition weight of table 3 triamcinolone acetonide econazole cream
Econazole nitrate 21.0g
Triamcinolone acetonide 2.5g
Polyoxyethylene-7-stearate 255.0g
Polyoxyethylene-5-oleate 63.0g
Potassium sorbate 2.6g
Sodium sulfite 2.4g
Hexadecanol 108.0g
BHA 0.4g
Liquid paraffin 209.0g
Purified water 1375.0g
(1) preparation of mixture I: take by weighing after recipe quantity sodium sulfite, potassium sorbate be dissolved in purified water, reheat to 80～90 ℃, insulation is as water.
(2) preparation of mixtures II: take by weighing hexadecanol, polyoxyethylene-7-stearate, polyoxyethylene-5-oleate, liquid paraffin, the fusion of BHA mixing post-heating of recipe quantity, as oil phase.
(3) preparation of mixtures III: mixtures II is slowly added among the mixture I, and the limit edged stirs, and to be cooledly adds principal agent during to 40～50 ℃ and grinds.Promptly.
Assay sees Table 4
Table 4 triamcinolone acetonide econazole cream assay
| Test rating | Character | Granularity |
| Assay | White is tasteless | Do not see under 100 power microscopes and find particle |
The high temperature failure test: get emulsifiable paste, place the clean weighing botle of sealing, and then place in the thermostatic drying chamber, attemperation is 50 ℃, placed 5 hours, and breakdown of emulsion not, character is white tasteless
Low temperature damage test: get emulsifiable paste, place the clean weighing botle of sealing, and then place in the refrigerator, attemperation is 0 ℃, placed 12 hours, and breakdown of emulsion not, character is white tasteless
Embodiment 3
Each composition weight sees Table 5
Each composition weight of table 5 triamcinolone acetonide econazole cream
Econazole nitrate 19.0g
Triamcinolone acetonide 2.2g
Polyoxyethylene-7-stearate 247.0g
Polyoxyethylene-5-oleate 62.0g
Benzoic acid 2.3g
Sodium sulfite 2.0g
Hexadecanol 103.0g
BHA 0.32g
Liquid paraffin 199.0g
Purified water 1382.0g
(1) preparation of mixture I: take by weighing after recipe quantity sodium sulfite, benzoic acid be dissolved in purified water, reheat to 80～90 ℃, insulation is as water.
(2) preparation of mixtures II: take by weighing hexadecanol, polyoxyethylene-7-stearate, polyoxyethylene-5-oleate, liquid paraffin, the fusion of BHA mixing post-heating of recipe quantity, as oil phase.
(3) preparation of mixtures III: mixtures II is slowly added among the mixture I, and the limit edged stirs, and to be cooledly adds principal agent during to 40～50 ℃ and grinds.Promptly.
Through check, the results are shown in Table 6
Table 6 triamcinolone acetonide econazole cream assay
| Test rating | Character | Granularity |
| Assay | White is tasteless | Do not see under 100 power microscopes and find particle |
The high temperature failure test: get emulsifiable paste, place the clean weighing botle of sealing, and then place in the thermostatic drying chamber, attemperation is 50 ℃, placed 5 hours, and breakdown of emulsion not, character is white tasteless
Low temperature damage test: get emulsifiable paste, place the clean weighing botle of sealing, and then place in the refrigerator, attemperation is 0 ℃, placed 12 hours, and breakdown of emulsion not, character is white tasteless.
In order to further specify the emulsifiable paste quality stability of formulation of the present invention, the emulsifiable paste of formulation of the present invention and commercially available triamcinolone acetonide econazole cream have been carried out stable contrast test.Stability test comprises high temperature failure test, low temperature damage test and accelerated test.
1, high temperature failure test
(its composition is triamcinolone acetonide, econazole nitrate, polyoxyethylene-7-stearate, polyoxyethylene-5-oleate, liquid Paraffin, benzoic acid, disodiumedetate, BHA, purified water to commercially available triamcinolone acetonide econazole cream.) place after 5 hours: breakdown of emulsion
By embodiment 1, embodiment 2 and embodiment 3 as can be seen, the emulsifiable paste of the present invention's prescription was placed after 5 hours: breakdown of emulsion not.
2, low temperature damage test
Commercially available triamcinolone acetonide econazole cream (its composition is triamcinolone acetonide, econazole nitrate, polyoxyethylene-7-stearate, polyoxyethylene-5-oleate, liquid Paraffin, benzoic acid, disodiumedetate, BHA, purified water) was placed after 12 hours: breakdown of emulsion
By embodiment 1, embodiment 2 and embodiment 3 as can be seen, the emulsifiable paste of the present invention's prescription was placed after 12 hours: breakdown of emulsion not.
Show that from high temperature failure test and low temperature damage test comparing result the more commercially available emulsifiable paste of the emulsifiable paste of the present invention's prescription is high temperature resistant and low temperature resistant, illustrates that quality is more stable at normal temperatures.Therefore holding conditions can be decided to be room temperature, is convenient to daily transportation, storage.
3, accelerated test
Accelerated test is to be that 30 ± 2 ℃, relative humidity are to place 12 months under 60 ± 5% the condition in temperature, detects in the 0th, 1,2,3,6,9,12 sampling at the end of month.Purpose is to investigate emulsifiable paste time dependent rule under the influence of temperature, humidity, light, investigates the quality stability of emulsifiable paste.The high spot reviews index is character, granularity, lamination, related substance, the content of emulsifiable paste.
Sample, adopt the emulsifiable paste in the embodiment of the invention 1, it consists of triamcinolone acetonide, econazole nitrate, polyoxyethylene-7-stearate, polyoxyethylene-5-oleate, liquid Paraffin, benzoic acid, disodiumedetate, octadecanol, BHA, purified water.
The commercially available emulsifiable paste of contrast product consist of triamcinolone acetonide, econazole nitrate, polyoxyethylene-7-stearate, polyoxyethylene-5-oleate, liquid Paraffin, benzoic acid, disodiumedetate, BHA, purified water.
Experimental result sees Table 7
Table 7 accelerated test comparing result
| Sample | Time | Character | Granularity | Lamination | Related substance (%) | Indicate content (%) | |
| Triamcinolone acetonide | Econazole nitrate | ||||||
| The emulsifiable paste of the present invention's prescription (example 1) | 0 month | White is tasteless | Up to specification | Not stratified | 1.02 | 100.0 | 100.6 |
| January | White is tasteless | Up to specification | Not stratified | 1.05 | 99.8 | 100.3 | |
| February | White is tasteless | Up to specification | Not stratified | 1.08 | 99.9 | 99.8 | |
| March | White is tasteless | Up to specification | Not stratified | 1.09 | 99.4 | 99.6 | |
| June | White is tasteless | Up to specification | Not stratified | 1.11 | 98.9 | 99.2 | |
| JIUYUE | White is tasteless | Up to specification | Not stratified | 1.18 | 98.4 | 98.7 | |
| December | White is tasteless | Up to specification | Not stratified | 1.29 | 98.1 | 98.2 | |
| Commercially available emulsifiable paste | 0 month | White is tasteless | Up to specification | Not stratified | 1.09 | 99.8 | 99.9 |
| January | White is tasteless | Up to specification | Not stratified | 1.24 | 98.9 | 98.8 | |
| February | White is tasteless | Up to specification | Not stratified | 1.32 | 98.0 | 97.9 | |
| March | White is tasteless | Up to specification | Not stratified | 1.69 | 97.1 | 97.2 | |
| June | White is tasteless | Up to specification | Not stratified | 2.48 | 96.4 | 96.2 | |
| JIUYUE | The white free from extraneous odour | Cohesion appears | Layering | 3.56 | 95.1 | 94.6 | |
| December | Little yellow free from extraneous odour | Cohesion appears | Layering | 4.35 | 94.4 | 93.9 | |
Note: the specification of triamcinolone acetonide econazole cream is that per 1 gram contains 1 milligram of triamcinolone acetonide, 10 milligrams of econazole nitrates.Indicating content (%) in the last table is two kinds of drug contents in the relative specification.
Show that from the accelerated test comparing result prescription emulsifiable paste of the present invention is in accelerated test 12 months, character, granularity, lamination, related substance, content do not have tangible change.And commercially available emulsifiable paste is in accelerated test after 6 months, and obvious change all takes place for character, granularity, lamination, and related substance obviously increases, and content obviously descends.Therefore, prescription emulsifiable paste more commercially available length of effective life of the present invention is convenient to clinical life-time service.
In sum, draw the emulsifiable paste of formulation of the present invention than commercially available triamcinolone acetonide econazole more stable quality by stable contrast test.
Claims (5)
1, a kind of triamcinolone acetonide econazole cream contains econazole nitrate, triamcinolone acetonide, it is characterized in that: also contain octadecanol or hexadecanol.
2, triamcinolone acetonide econazole cream as claimed in claim 1 is characterized in that: also contain polyoxyethylene-7-stearate, polyoxyethylene-5-oleate, BHA, liquid paraffin and purified water.
3, triamcinolone acetonide econazole cream as claimed in claim 2 is characterized in that: also contain benzoic acid or potassium sorbate.
4, triamcinolone acetonide econazole cream as claimed in claim 3 is characterized in that: also contain disodiumedetate or sodium sulfite.
5, triamcinolone acetonide econazole cream as claimed in claim 4 is characterized in that the weight content of each component of containing is:
Econazole nitrate 0.8%～1.2%,
Triamcinolone acetonide 0.08%～0.13%,
Polyoxyethylene-7-stearate 11%～13%,
Polyoxyethylene-5-oleate 2.5%～3.5%,
Benzoic acid or potassium sorbate 0.08%～0.12%,
Disodiumedetate or sodium sulfite 0.08%～0.12%,
Octadecanol or hexadecanol 4.5%～5.5%,
BHA 0.01%～0.02%,
Liquid paraffin 8%～12%,
Purified water 65%～70%.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2008100084001A CN101239066A (en) | 2008-03-11 | 2008-03-11 | Triamcinolone acetonide econazole cream |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2008100084001A CN101239066A (en) | 2008-03-11 | 2008-03-11 | Triamcinolone acetonide econazole cream |
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| CN101239066A true CN101239066A (en) | 2008-08-13 |
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|---|---|---|---|
| CNA2008100084001A Pending CN101239066A (en) | 2008-03-11 | 2008-03-11 | Triamcinolone acetonide econazole cream |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103142622A (en) * | 2013-03-21 | 2013-06-12 | 太极集团·四川天诚制药有限公司 | Triamcinolone acetonide and miconazole emulsion type gel |
| CN103860566A (en) * | 2014-04-08 | 2014-06-18 | 白玲强 | Triamcinolone acetonide and econazole cream and preparation method thereof |
| CN105534993A (en) * | 2015-12-24 | 2016-05-04 | 华润三九（南昌）药业有限公司 | Triamcinolone acetonide econazole cream and preparation method of triamcinolone acetonide econazole cream |
| CN106937955A (en) * | 2017-03-31 | 2017-07-11 | 天津迈拓思生物科技有限公司 | A kind of compound preparation for treating psoriasis |
| WO2018023193A1 (en) | 2016-08-04 | 2018-02-08 | Suncor Energy Inc. | Stabilized emulsions |
-
2008
- 2008-03-11 CN CNA2008100084001A patent/CN101239066A/en active Pending
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103142622A (en) * | 2013-03-21 | 2013-06-12 | 太极集团·四川天诚制药有限公司 | Triamcinolone acetonide and miconazole emulsion type gel |
| CN103142622B (en) * | 2013-03-21 | 2015-08-05 | 太极集团·四川天诚制药有限公司 | Triamcinolone acetonide econazole emulsion-type gel |
| CN103860566A (en) * | 2014-04-08 | 2014-06-18 | 白玲强 | Triamcinolone acetonide and econazole cream and preparation method thereof |
| CN105534993A (en) * | 2015-12-24 | 2016-05-04 | 华润三九（南昌）药业有限公司 | Triamcinolone acetonide econazole cream and preparation method of triamcinolone acetonide econazole cream |
| CN105534993B (en) * | 2015-12-24 | 2017-04-26 | 华润三九（南昌）药业有限公司 | Triamcinolone acetonide econazole cream and preparation method of triamcinolone acetonide econazole cream |
| WO2018023193A1 (en) | 2016-08-04 | 2018-02-08 | Suncor Energy Inc. | Stabilized emulsions |
| CN109788761A (en) * | 2016-08-04 | 2019-05-21 | 桑科能源股份有限公司 | Stabilized lotion |
| EP3493681A4 (en) * | 2016-08-04 | 2020-03-11 | Suncor Energy Inc. | Stabilized emulsions |
| CN106937955A (en) * | 2017-03-31 | 2017-07-11 | 天津迈拓思生物科技有限公司 | A kind of compound preparation for treating psoriasis |
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Open date: 20080813 |