CN105395471A - External use emulsifiable paste for treating skin diseases and with econazole nitrate as active component and preparation method - Google Patents
External use emulsifiable paste for treating skin diseases and with econazole nitrate as active component and preparation method Download PDFInfo
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- CN105395471A CN105395471A CN201510730138.1A CN201510730138A CN105395471A CN 105395471 A CN105395471 A CN 105395471A CN 201510730138 A CN201510730138 A CN 201510730138A CN 105395471 A CN105395471 A CN 105395471A
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Abstract
The invention provides external use emulsifiable paste for treating skin diseases and with econazole nitrate as an active component and a preparation method. The emulsifiable paste is basically prepared from, by weight, 10 parts of econazole nitrate, 3-10 parts of glycerin monostearate and glycerol distearate, 10-20 parts of stearic acid, 1-10 parts of albolene, 0.8-7 parts of light liquid paraffin, 8-17 parts of glycerinum, 1-10 parts of triethanolamine, 0.08-0.5 part of borax and 15-75 parts of distilled water. The preparation method includes the steps of oil phase preparation, water phase preparation and finished product preparation. The emulsifiable paste has the advantages that through the synergetic action of all the components in the formula, the transcutaneous permeation function of the medicine components is improved, and the treatment effect is improved. The econazole nitrate emulsifiable paste is good in stability, and the phenomenon of layering or crystal separation does not happen. The granularity of the econazole nitrate emulsifiable paste prepared through the method is small, so that it is guaranteed that the preparation is finer, uniform in content and convenient to use, and coating and clearing of the preparation are easy.
Description
Technical field
The invention belongs to field of medicaments, be specifically related to one and treat dermopathic medicine.。
Background technology
Econazole nitrate emulsifiable paste is made up of econazole nitrate, oil phase and aqueous phase.Econazole nitrate is a kind of imidazoles broad-spectrum antifungal medicine, effectively can kill the fungus such as gram-positive bacterium and dermatophytosis, candidiasis, trichophyton gypseum, red mentagrophytes, mycete of skin infection.In recent years, the skin tinea caused by fungal infection is as tinea manus and pedis, tinea cruris, tinea unguium, tinea capitis etc., and sickness rate is more and more higher, and has infectivity, easily recurrence or the feature such as infection again, to patient body with bring huge injury mentally.
The exterior-applied formulation of current treatment skin tinea has emulsifiable paste, microemulsion, gel etc., and comparatively other solid preparations are poor for the stability of cream preparation.Daily transport, storage and clinical life-time service time easily occur character change, this reduces quality and the effect duration of this medicine.
Econazole nitrate is easily molten in methanol, slightly soluble in chloroform, soluble,very slightly in water.Patent CN1813770A discloses triamcinolone acetonide econazole gel, by adding 80% propylene glycol, increase dissolubility, but propylene glycol stickiness is comparatively large, and has certain zest to skin.Therefore select suitable adjuvant most important.There is again the phenomenon of recurrent exerbation in dermatopathy, therefore improves the action time of this medicine, thorough therapeutic effect, is current problem demanding prompt solution.
Summary of the invention
The object of the invention is a kind of take econazole nitrate as dermatosis medicinal external emulsifiable paste and the preparation method of active component, overcomes the problems referred to above that this type of medicine existing exists.
Econazole nitrate emulsifiable paste basis of the present invention comprises: econazole nitrate 10 weight portion, single, double tristerin 3-10 weight portion, stearic acid 10-20 weight portion, white vaseline 1-10 weight portion, light liquid petrolatum 0.8-7 weight portion, glycerol 8-17 weight portion, triethanolamine 1-10 weight portion, Borax 0.08-0.5 weight portion, distilled water 15-75 weight portion.
The prescription that econazole nitrate emulsifiable paste of the present invention contains antibacterial and solvent is: econazole nitrate 10 weight portion, single, glycerol distearate 3-10 weight portion, stearic acid 10-20 weight portion, white vaseline 1-10 weight portion, light liquid petrolatum 0.8-7 weight portion, glycerol 8-17 weight portion, triethanolamine 1-10 weight portion, Borax 0.08-0.5 weight portion, dimethyl sulfoxide or ethanol or isopropyl alcohol 0.5-5 weight portion, one or several mixture 0.08-0.5 weight portion of the salt of ethyl hydroxybenzoate or sorbic acid or sorbic acid or benzoic acid or benzoic salt, distilled water 9-75.
The preparation process of emulsifiable paste of the present invention is as follows:
(1) oil phase preparation: with the ethyl hydroxybenzoate of the dmso solution formula ratio of formula ratio, then add single, double tristerin, stearic acid, white vaseline, the light liquid of formula ratio, be heated to 80 DEG C, insulated and stirred 30 minutes.For subsequent use.
(2) aqueous phase preparation: get the glycerol of formula ratio, triethanolamine adding distil water dissolves, be heated to 60 DEG C, the Borax then adding formula ratio is mixed evenly, and crosses 150 mesh sieves, as aqueous phase.Continue to be heated to 80 DEG C, insulated and stirred 30 minutes.
(3) finished product preparation: oil phase is crossed 200 mesh sieves, then 70 ~ 75 DEG C time, add econazole nitrate, first rapid stirring (1800 revs/min) about 10 minutes, mix homogeneously, stops rapid stirring; Add aqueous phase, low rate mixing (20 revs/min) is after about 10 minutes, and then cooling (temperature is probably at 38 ~ 42 DEG C), then rapid stirring 30 minutes, stops stirring, obtain econazole nitrate emulsifiable paste, embedding, get product.
Good effect of the present invention is: by the synergism of component each in formula, improves the transdermal penetration effect of drug component, and effectively treatment fungus and bacterium infects the composite skin disease caused, and increases curative effect.The econazole nitrate stability of cream formulated according to technical scheme of the present invention is good, layering can not be there is or have crystal to separate out phenomenon, the granularity of econazole nitrate emulsifiable paste prepared by formula of the present invention is less, therefore finer and smoother, the uniform content of this preparation is ensured, be easy to coating and eccysis, and non-stimulated to skin, free from extraneous odour, quality controllable, easy to use.
Detailed description of the invention
In order to make those skilled in the art person understand technical scheme of the present invention better, below in conjunction with detailed description of the invention, the present invention is described in further detail.
Embodiment 1
Econazole nitrate emulsifiable paste, 100g comprises following component: econazole nitrate 10g, single, double tristerin 5.5g, stearic acid 15.5g, white vaseline 3.7g, light liquid petrolatum 3.2g, glycerol 12.6g, triethanolamine 3.7g, ethyl hydroxybenzoate 0.15g, Borax 0.24g, dimethyl sulfoxide 2.5g, distilled water 15g.
The preparation method of econazole nitrate emulsifiable paste, concrete steps are as follows:
(1) oil phase preparation: with the ethyl hydroxybenzoate of the dmso solution formula ratio of formula ratio, then add single, double tristerin, stearic acid, white vaseline, the light liquid of formula ratio, be heated to 80 DEG C, insulated and stirred 30 minutes.For subsequent use.
(2) aqueous phase preparation: get the glycerol of formula ratio, triethanolamine adding distil water dissolves, be heated to 60 DEG C, the Borax then adding formula ratio is mixed evenly, and crosses 150 mesh sieves, as aqueous phase.Continue to be heated to 80 DEG C, insulated and stirred 30 minutes.
(3) finished product preparation: oil phase is crossed 200 mesh sieves, then 70 ~ 75 DEG C time, add econazole nitrate, first rapid stirring (1800 revs/min) about 10 minutes, mix homogeneously, stops rapid stirring; Add aqueous phase, low rate mixing (20 revs/min) is after about 10 minutes, and then cooling (temperature is probably at 38 ~ 42 DEG C), then rapid stirring 30 minutes, stops stirring, obtain econazole nitrate emulsifiable paste, embedding, get product.
Embodiment 2
Econazole nitrate emulsifiable paste, 100g comprises following component: econazole nitrate 10g, single, double tristerin 7g, stearic acid 18g, white vaseline 6g, light liquid petrolatum 5g, glycerol 15g, triethanolamine 7g, ethyl hydroxybenzoate 0.3g, Borax 0.32g, dimethyl sulfoxide 4g, distilled water 30g.
The preparation method of econazole nitrate emulsifiable paste, concrete steps are as follows:
(1) oil phase preparation: with the ethyl hydroxybenzoate of the dmso solution formula ratio of formula ratio, then add single, double tristerin, stearic acid, white vaseline, the light liquid of formula ratio, be heated to 80 DEG C, insulated and stirred 30 minutes.For subsequent use.
(2) aqueous phase preparation: get the glycerol of formula ratio, triethanolamine adding distil water dissolves, be heated to 60 DEG C, the Borax then adding formula ratio is mixed evenly, and crosses 150 mesh sieves, as aqueous phase.Continue to be heated to 80 DEG C, insulated and stirred 30 minutes.
(3) finished product preparation: oil phase is crossed 200 eye mesh screens, then 70 ~ 75 DEG C time, add econazole nitrate, first rapid stirring (1800 revs/min) about 10 minutes, mix homogeneously, stops rapid stirring; Add aqueous phase, low rate mixing (20 revs/min) is after about 10 minutes, and then cooling (temperature is probably at 38 ~ 42 DEG C), then rapid stirring 30 minutes, stops stirring, obtain econazole nitrate emulsifiable paste, embedding, get product.
Embodiment 3
Econazole nitrate emulsifiable paste, 100g comprises following component: econazole nitrate 10g, single, double tristerin 5g, stearic acid 12g, white vaseline 3.4g, light liquid petrolatum 1.2g, glycerol 10g, triethanolamine 3g, ethyl hydroxybenzoate 0.1g, Borax 0.12g, dimethyl sulfoxide 1g, distilled water 50g.
The preparation method of econazole nitrate emulsifiable paste, concrete steps are as follows:
(1) oil phase preparation: with the ethyl hydroxybenzoate of the dmso solution formula ratio of formula ratio, then add single, double tristerin, stearic acid, white vaseline, the light liquid petrolatum of formula ratio, be heated to 80 DEG C, insulated and stirred 30 minutes.For subsequent use.
(2) aqueous phase preparation: get the glycerol of formula ratio, triethanolamine adding distil water dissolves, be heated to 60 DEG C, the Borax then adding formula ratio is mixed evenly, and crosses 150 mesh sieves, as aqueous phase.Continue to be heated to 80 DEG C, insulated and stirred 30 minutes.
(3) finished product preparation: oil phase is crossed 200 eye mesh screens, then 70 ~ 75 DEG C time, add econazole nitrate, first rapid stirring (1800 revs/min) about 10 minutes, mix homogeneously, stops rapid stirring; Add aqueous phase, low rate mixing (20 revs/min) is after about 10 minutes, and then cooling (temperature is probably at 38 ~ 42 DEG C), then rapid stirring 30 minutes, stops stirring, obtain econazole nitrate emulsifiable paste, embedding, get product.
Embodiment 4
Econazole nitrate emulsifiable paste, 100g comprises following component: econazole nitrate 10g, single, double tristerin 7g, stearic acid 18g, white vaseline 6g, light liquid petrolatum 5g, Polyoxyethylene Sorbitan Monooleate 15.2g, triethanolamine 7g, sorbic acid 0.3g, Borax 0.32g, ethanol 4g, distilled water 75g.
The preparation method of econazole nitrate emulsifiable paste, concrete steps are as follows:
(1) oil phase preparation: with the ethyl hydroxybenzoate of the dmso solution formula ratio of formula ratio, then add single, double tristerin, stearic acid, white vaseline, the light liquid of formula ratio, be heated to 80 DEG C, insulated and stirred 30 minutes.For subsequent use.
(2) aqueous phase preparation: get the glycerol of formula ratio, triethanolamine adding distil water dissolves, be heated to 60 DEG C, the Borax then adding formula ratio is mixed evenly, and crosses 150 mesh sieves, as aqueous phase.Continue to be heated to 80 DEG C, insulated and stirred 30 minutes.
(3) finished product preparation: oil phase is crossed 200 eye mesh screens, then 70 ~ 75 DEG C time, add econazole nitrate, first rapid stirring (1800 revs/min) about 10 minutes, mix homogeneously, stops rapid stirring; Add aqueous phase, low rate mixing (20 revs/min) is after about 10 minutes, and then cooling (temperature is probably at 38 ~ 42 DEG C), then rapid stirring 30 minutes, stops stirring, obtain econazole nitrate emulsifiable paste, embedding, get product.
Experimental result
1. appearance character
The econazole nitrate emulsifiable paste prepared by embodiment of the present invention 1-4 and commercially available econazole nitrate emulsifiable paste evaluate its appearance character and stretchability.
Result shows, econazole nitrate emulsifiable paste prepared by embodiment of the present invention 1-4 is equally white emulsifiable paste with commercially available product.
2. accelerated test
Accelerated test be temperature be 30 ± 2 DEG C, under relative humidity 65 ± 5% condition, the econazole nitrate emulsifiable paste prepared by embodiment of the present invention 1-4 and commercially available econazole nitrate emulsifiable paste place 6 months, and in the 1st, 2,3,6 the end of month sampled respectively, compare with 0 month sample, check its appearance character, granularity, related substance and medicament contg, its result is as table:
As can be seen from the table, econazole nitrate emulsifiable paste prepared by the present invention is after 6 months Acceleration study, and appearance character, granularity and medicament contg all without obviously changing, are better than commercially available product, and therefore, econazole nitrate emulsifiable paste prepared by the present invention is stablized, and is convenient to Clinical practice.
Obviously, above-described embodiment, only in order to principle of the present invention and technical scheme to be described, is not limitation of the present invention.It should be pointed out that to those skilled in the art, under the premise without departing from the principles of the invention, to its some improvement made and modification in form or in details, be still in claims of the present invention limited range.
Claims (4)
1. one kind is that the dermatosis medicinal external emulsifiable paste of active component is characterized in that with econazole nitrate: comprising: econazole nitrate 10 weight portion, single, double tristerin 3-10 weight portion, stearic acid 10-20 weight portion, white vaseline 1-10 weight portion, light liquid petrolatum 0.8-7 weight portion, glycerol 8-17 weight portion, triethanolamine 1-10 weight portion, Borax 0.08-0.5 weight portion, distilled water 15-75 weight portion.
2. according to claim 1 is that the dermatosis medicinal external emulsifiable paste of active component is characterized in that with econazole nitrate: also comprise dimethyl sulfoxide or ethanol or isopropyl alcohol 0.5-5 weight portion, one or several mixture 0.08-0.5 weight portion of the salt of ethyl hydroxybenzoate or sorbic acid or sorbic acid or benzoic acid or benzoic salt.
3. claim 1 take econazole nitrate as the preparation method of the dermatosis medicinal external emulsifiable paste of active component, comprising:
(1) econazole nitrate 10 weight portion is got, single, double tristerin 3-10 weight portion, stearic acid 10-20 weight portion, white vaseline 1-10 weight portion, light liquid petrolatum 0.8-7 weight portion, glycerol 8-17 weight portion, triethanolamine 1-10 weight portion, Borax 0.08-0.5 weight portion, distilled water 15-75 weight portion;
(2) oil phase preparation: single, double tristerin, stearic acid, white vaseline, the light liquid step (1) got, be heated to 80 DEG C, insulated and stirred 30 minutes, for subsequent use;
(3) aqueous phase preparation: glycerol step (1) got, triethanolamine adding distil water dissolve, and are heated to 60 DEG C, then adds the Borax that step (1) gets and is mixed evenly, cross 150 mesh sieves, as aqueous phase, continue to be heated to 80 DEG C, insulated and stirred 30 minutes;
(4) finished product preparation: step (2) gained oil phase is crossed 200 mesh sieves, then 70 ~ 75 DEG C time, adds econazole nitrate, rapid stirring about 10 minutes under first 1800 revs/min of rotating speeds, mix homogeneously, stops rapid stirring; Add step (3) gained aqueous phase, under 20 revs/min of rotating speeds, low rate mixing is after about 10 minutes, is then cooled to 38 ~ 42 DEG C, then rapid stirring 30 minutes, stops stirring, and obtains econazole nitrate emulsifiable paste.
4. claim 2 take econazole nitrate as the preparation method of the dermatosis medicinal external emulsifiable paste of active component, comprising:
(1) econazole nitrate 10 weight portion is got, single, double tristerin 3-10 weight portion, stearic acid 10-20 weight portion, white vaseline 1-10 weight portion, light liquid petrolatum 0.8-7 weight portion, glycerol 8-17 weight portion, triethanolamine 1-10 weight portion, Borax 0.08-0.5 weight portion, dimethyl sulfoxide 0.5-5 weight portion, ethyl hydroxybenzoate 0.08-0.5 weight portion, distilled water 15-75 weight portion;
(2) oil phase preparation: the dmso solution ethyl hydroxybenzoate got by step (1), then adds single, double tristerin, stearic acid, white vaseline, light liquid that step (1) is got, be heated to 80 DEG C, and insulated and stirred 30 minutes is for subsequent use;
(3) aqueous phase preparation: get glycerol that step (1) gets, triethanolamine adding distil water dissolves, be heated to 60 DEG C, then adds the Borax that step (1) gets and is mixed evenly, cross 150 mesh sieves, as aqueous phase, continue to be heated to 80 DEG C, insulated and stirred 30 minutes;
(4) finished product preparation: step (2) gained oil phase is crossed 200 mesh sieves, then 70 ~ 75 DEG C time, adds the econazole nitrate that step (1) is got, rapid stirring about 10 minutes under first 1800 revs/min of rotating speeds, mix homogeneously, stops rapid stirring; Add step (3) gained aqueous phase, under 20 revs/min of rotating speeds, low rate mixing is after about 10 minutes, is then cooled to 38 ~ 42 DEG C, then rapid stirring 30 minutes, stops stirring, and obtains econazole nitrate emulsifiable paste.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201510730138.1A CN105395471A (en) | 2015-11-02 | 2015-11-02 | External use emulsifiable paste for treating skin diseases and with econazole nitrate as active component and preparation method |
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| CN201510730138.1A CN105395471A (en) | 2015-11-02 | 2015-11-02 | External use emulsifiable paste for treating skin diseases and with econazole nitrate as active component and preparation method |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107468637A (en) * | 2016-06-08 | 2017-12-15 | 厦门恩成制药有限公司 | Compound tazarotene urea external preparation and preparation method thereof |
| CN112791005A (en) * | 2021-03-11 | 2021-05-14 | 杨国峰 | Skin-care ointment and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4883792A (en) * | 1989-01-17 | 1989-11-28 | Peter Timmins | Steroid cream formulation |
-
2015
- 2015-11-02 CN CN201510730138.1A patent/CN105395471A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4883792A (en) * | 1989-01-17 | 1989-11-28 | Peter Timmins | Steroid cream formulation |
Non-Patent Citations (2)
| Title |
|---|
| HEALTHPOINT LTD: "Econazole Nitrate Cream 1%", 《CENTER FOR DURG EVALUATION AND RESEARCH(HTTPS://WWW.ACCESSDATA.FDA.GOV/DRUGSATFDA_DOCS/NDA/2004/076574_ORIGINAL%20APPROVAL_PACKAGE.PDF)》 * |
| 崔福德: "《药剂学第7版》", 31 August 2011 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107468637A (en) * | 2016-06-08 | 2017-12-15 | 厦门恩成制药有限公司 | Compound tazarotene urea external preparation and preparation method thereof |
| CN112791005A (en) * | 2021-03-11 | 2021-05-14 | 杨国峰 | Skin-care ointment and preparation method thereof |
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