CN103908425A - Antifungal flutrimazole ointment preparation and preparation method thereof - Google Patents
Antifungal flutrimazole ointment preparation and preparation method thereof Download PDFInfo
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- CN103908425A CN103908425A CN201410087206.2A CN201410087206A CN103908425A CN 103908425 A CN103908425 A CN 103908425A CN 201410087206 A CN201410087206 A CN 201410087206A CN 103908425 A CN103908425 A CN 103908425A
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Abstract
The invention discloses an antifungal flutrimazole ointment preparation and a preparation method thereof, and belongs to the field of pharmaceutical preparation. The antifungal flutrimazole ointment preparation comprises following ingredients, by weight, 1 to 1.5 parts of cetostearyl alcohol, 2 to 2.7 parts of glycerin monostearate, 2 to 2.7 parts of phenylcarbinol, 0.8 to 1.5 parts of tween-20, 1 to 1.5 parts of liquid paraffin, 0.05 to 0.2 part of albolene, 0.1 to 0.5 part of flutrimazole, 1.5 to 2.0 parts of polyethylene glycol 400, and 19 to 20.5 parts of purified water. The invention also provides the preparation method of the antifungal flutrimazole ointment preparation. The preparation method comprises following steps: (1) material preparing, (2) mixing, (3) emulsification, (4) emulsifiable paste preparation, and (5) finished product preparation. A few accessory materials are used for preparing the antifungal flutrimazole ointment preparation; the preparation method is simple; and product quality of the antifungal flutrimazole ointment preparation is stable.
Description
Technical field
The present invention relates to a kind of antifungal flutrimazole ointment formulation and preparation technology thereof, belong to pharmaceutical preparations technology field.
Background technology
Along with the extensive use of high-efficiency broad spectrum antibiotic, adrenocortical hormone and immunosuppressant in recent years, and human organ tissue transplantation, increasing gradually of surgery interventional therapy and spreading of many viruses, fungal infection has day by day serious trend, obviously raise at some regional the incidence of infection, the appearance of some endurance strains simultaneously, also to mycosis, treatment has proposed challenge.
The medicine for the treatment of clinically at present fungal infection mainly contains following three major types: the antifungal drug that, acts on fungal cell membrane: 1. polyenoid class antifungal agent: it is combined by the ergosterol on fungus cytoplasmic membrane, decomposes film or increase membrane permeability, cause cellular content excessive and dead.2, pyroles antifungal agent, is lanosterol 14a-demethylation enzyme inhibitor, is divided into imidazoles and triazole type, and triazole type is the widest antifungal agent of current clinical practice, and curative effect is better.3, propylamine antifungal agent is cyclooxygenase inhibitors of squalene.Two, act on the antifungal drug of fungal cell wall.Three, the medicine of Antifungi Nucleic acid: representative is 5-flurocytosine, and clinical practice is wideless because its curative effect is relatively poor, relapse rate is high.
Flutrimazole is a kind of typical imidazoles antifungal agent, the same with other imidazoles antifungal agent, flutrimazole is synthesizing by the ergosterol of the activity interference fungus of inhibition lanosterol-14a-demethylase, thereby the permeability that causes fungal cell membrane increases, and causes the loss of potassium and other cellularity thing.There is the less Desenex of toxicity that broad spectrum of activity and toleration are good, confirm after deliberation to have in good body and external activity.In vitro: flutrimazole shows potent broad spectrum of activity, can resist dermatomycosis, to the pathogenic filamentous fungi of humans and animals and saprophytic fungus.
In use, find, flutrimazole can infiltrate different epidermal areas fast, but percutaneous absorbtivity is considerably less, therefore can be by the mode of ointment to affected part medication.But at present the adjuvant of ointment formulation is numerous, be difficult to select to be applicable to the pharmaceutical adjunct that flutrimazole uses, cannot determine mutual relation and consumption foundation between adjuvant, can not obtain that a kind of adjuvant materials are few, the simple ointment formulation of method and technique.
Summary of the invention
The problem existing for above-mentioned prior art, the invention provides a kind of antifungal flutrimazole ointment formulation and preparation technology thereof, and the adjuvant of preparing ointment formulation needs is few, and preparation technology is simple, ointment constant product quality.
To achieve these goals, a kind of antifungal flutrimazole ointment formulation that the present invention adopts, comprises the component of following weight portion, cetostearyl alcohol, 1 ~ 1.5 part; Glyceryl monostearate, 2 ~ 2.7 parts; Benzyl alcohol, 2 ~ 2.7 parts; Tween 20,0.8 ~ 1.5 part; Liquid paraffin, 1 ~ 1.5 part; White vaseline, 0.05 ~ 0.2 part; Flutrimazole, 0.1 ~ 0.5 part; PEG400,1.5 ~ 2.0 parts; Purified water, 19 ~ 20.5 parts.
The present invention also provides a kind of preparation technology of flutrimazole ointment formulation, comprises the following steps:
(1) batching: take by weight, the cetostearyl alcohol of 1 ~ 1.5 part, the glyceryl monostearate of 2 ~ 2.7 parts, the benzyl alcohol of 2 ~ 2.7 parts, the tween 20 of 0.8 ~ 1.5 part, the liquid paraffin of 1 ~ 1.5 part, the white vaseline of 0.05 ~ 0.2 part, above-mentioned oil phase component is placed in to heat insulation tank and heats up and melt, get 1.5 ~ 2.0 parts of PEG400s, 19 ~ 20.5 parts purified water as water add in another heat insulation tank, be warming up to 82 ~ 85 ℃ for subsequent use;
(2) mix: after the oil phase in step (1) melts completely, add the flutrimazole of 0.1 ~ 0.5 part, insulated and stirred is entirely molten to emulsion, be heated to after 80 ~ 82 ℃, emulsion suction to be warming up in the vacuum emulsification tank of 75 ~ 85 ℃;
(3) emulsifying: in stirring, the water in step (1) is evacuated in the vacuum emulsification tank of step (2), slowly stirs 2 ~ 10min, then divide 2 ~ 5 emulsifyings;
(4) emulsifiable paste: after emulsifying finishes, be cooled to mastic in stirring and form, finish to stir;
(5) finished product: subpackage flexible pipe.
Further, the emulsifying of step (3) is carried out at twice, homogenizing 10min for the first time, and homogenizing 5min for the second time, twice homogenizing interval 2min, in homogenizing process, emulsion tank temperature is at 75 ~ 85 ℃.
Further, in step (4), being cooled to mastic by water-bath forms.
The lower cost for material that the present invention adopts, select PEG400 as emulsifiable paste matrix, profit is all had to certain affinity, can mix with wound surface exudate, secretions, function effect to normal skin is little, adds drug release piece, and transdermal is also fast, can with medicament mixed, simultaneously also easy cleaning; Select cetostearyl alcohol, glyceryl monostearate, benzyl alcohol, tween 20, liquid paraffin, white vaseline etc. as pharmaceutical adjunct, adjuvant materials are few and without interaction, medicinal safe, the emulsifiable paste of preparation meets the viscosity requirement of ointment; The process route that the present invention adopts is simple, with high content of technology, and product is more stable under freeze thawing and illumination condition, and shading preservation effect duration reaches 18 months in the cool.
The specific embodiment
Below in conjunction with embodiment, the invention will be further described.
Embodiment mono-
A preparation technology for flutrimazole ointment formulation for antifungal, comprises the following steps:
(1) batching: take by weight, the cetostearyl alcohol of 1 part, the glyceryl monostearate of 2 parts, the benzyl alcohol of 2 parts, the tween 20 of 0.8 part, the liquid paraffin of 1 part, the white vaseline of 0.05 part, above-mentioned oil phase component is placed in to heat insulation tank and heats up and melt, get 1.5 parts of PEG400s, 19 parts purified water as water add in another heat insulation tank, be warming up to 82 ℃ for subsequent use;
(2) mix: after the oil phase in step (1) melts completely, add the flutrimazole of 0.1 part, insulated and stirred is entirely molten to emulsion, be heated to after 80 ℃, emulsion suction to be warming up in the vacuum emulsification tank of 75 ℃;
(3) emulsifying: in stirring, the water in step (1) is evacuated in the vacuum emulsification tank of step (2), slowly stirs 2min, carry out at twice again emulsifying, homogenizing 10min for the first time, for the second time homogenizing 5min, twice homogenizing interval 2min, in homogenizing process, emulsion tank temperature is at 75 ~ 85 ℃;
(4) emulsifiable paste: after emulsifying finishes, be cooled to mastic in stirring and form, finish to stir;
(5) finished product: subpackage flexible pipe.
Embodiment bis-
A preparation technology for flutrimazole ointment formulation for antifungal, comprises the following steps:
(1) batching: take by weight, the cetostearyl alcohol of 1.2 parts, the glyceryl monostearate of 2.3 parts, the benzyl alcohol of 2.3 parts, the tween 20 of 1 part, the liquid paraffin of 1.3 parts, the white vaseline of 0.1 part, above-mentioned oil phase component is placed in to heat insulation tank and heats up and melt, get 1.7 parts of PEG400s, 20 parts purified water as water add in another heat insulation tank, be warming up to 83 ℃ for subsequent use;
(2) mix: after the oil phase in step (1) melts completely, add the flutrimazole of 0.3 part, insulated and stirred is entirely molten to emulsion, be heated to after 81 ℃, emulsion suction to be warming up in the vacuum emulsification tank of 80 ℃;
(3) emulsifying: in stirring, the water in step (1) is evacuated in the vacuum emulsification tank of step (2), slowly stirs 5min, then divide 3 emulsifyings, each homogenizing 7min, twice homogenizing interval 2min, in homogenizing process, emulsion tank temperature is at 80 ℃;
(4) emulsifiable paste: after emulsifying finishes, be cooled to mastic by water-bath from the beginning in stirring and form, finish to stir;
(5) finished product: subpackage flexible pipe.
Embodiment tri-
A preparation technology for flutrimazole ointment formulation for antifungal, comprises the following steps:
(1) batching: take by weight, the cetostearyl alcohol of 1.5 parts, the glyceryl monostearate of 2.7 parts, the benzyl alcohol of 2.7 parts, the tween 20 of 1.5 parts, the liquid paraffin of 1.5 parts, the white vaseline of 0.2 part, above-mentioned oil phase component is placed in to heat insulation tank and heats up and melt, get 2.0 parts of PEG400s, 20.5 parts purified water as water add in another heat insulation tank, be warming up to 85 ℃ for subsequent use;
(2) mix: after the oil phase in step (1) melts completely, add the flutrimazole of 0.5 part, insulated and stirred is entirely molten to emulsion, be heated to after 82 ℃, emulsion suction to be warming up in the vacuum emulsification tank of 85 ℃;
(3) emulsifying: in stirring, the water in step (1) is evacuated in the vacuum emulsification tank of step (2), slowly stirs 10min, then divide 5 emulsifyings, each homogenizing 5min, twice homogenizing interval 2min, in homogenizing process, emulsion tank temperature is at 85 ℃;
(4) emulsifiable paste: after emulsifying finishes, in stirring, water-bath is cooled to mastic formation, finishes to stir;
(5) finished product: subpackage flexible pipe.
The lower cost for material that the present invention adopts, select PEG400 as emulsifiable paste matrix, profit is all had to certain affinity, can mix with wound surface exudate, secretions, function effect to normal skin is little, adds drug release piece, and transdermal is also fast, can with medicament mixed, simultaneously also easy cleaning; Select cetostearyl alcohol, glyceryl monostearate, benzyl alcohol, tween 20, liquid paraffin, white vaseline as pharmaceutical adjunct, adjuvant materials are few and without interaction, medicinal safe, the emulsifiable paste of preparation meets the annual requirement of ointment; The process route that the present invention adopts is simple, with high content of technology, and product is more stable under freeze thawing and illumination condition, and shading preservation effect duration reaches 18 months in the cool.
Claims (4)
1. an antifungal flutrimazole ointment formulation, is characterized in that, comprises the component of following weight portion, cetostearyl alcohol, 1 ~ 1.5 part; Glyceryl monostearate, 2 ~ 2.7 parts; Benzyl alcohol, 2 ~ 2.7 parts; Tween 20,0.8 ~ 1.5 part; Liquid paraffin, 1 ~ 1.5 part; White vaseline, 0.05 ~ 0.2 part; Flutrimazole, 0.1 ~ 0.5 part; PEG400,1.5 ~ 2.0 parts; Purified water, 19 ~ 20.5 parts.
2. a preparation technology for flutrimazole ointment formulation claimed in claim 1, is characterized in that, comprises the following steps:
(1) batching: take by weight, the cetostearyl alcohol of 1 ~ 1.5 part, the glyceryl monostearate of 2 ~ 2.7 parts, the benzyl alcohol of 2 ~ 2.7 parts, the tween 20 of 0.8 ~ 1.5 part, the liquid paraffin of 1 ~ 1.5 part, the white vaseline of 0.05 ~ 0.2 part, above-mentioned oil phase component is placed in to heat insulation tank and heats up and melt, get 1.5 ~ 2.0 parts of PEG400s, 19 ~ 20.5 parts purified water as water add in another heat insulation tank, be warming up to 82 ~ 85 ℃ for subsequent use;
(2) mix: after the oil phase in step (1) melts completely, add the flutrimazole of 0.1 ~ 0.5 part, insulated and stirred is entirely molten to emulsion, be heated to after 80 ~ 82 ℃, emulsion suction to be warming up in the vacuum emulsification tank of 75 ~ 85 ℃;
(3) emulsifying: in stirring, the water in step (1) is evacuated in the vacuum emulsification tank of step (2), slowly stirs 2 ~ 10min, then divide 2 ~ 5 emulsifyings;
(4) emulsifiable paste: after emulsifying finishes, be cooled to mastic in stirring and form, finish to stir;
(5) finished product: subpackage flexible pipe.
3. the preparation technology of flutrimazole ointment formulation according to claim 2, is characterized in that, the emulsifying of described step (3) is carried out at twice, homogenizing 10min for the first time, homogenizing 5min for the second time, twice homogenizing interval 2min, in homogenizing process, emulsion tank temperature is at 75 ~ 85 ℃.
4. the preparation technology of flutrimazole ointment formulation according to claim 2, is characterized in that, is cooled to mastic forms in described step (4) by water-bath.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106018581A (en) * | 2016-05-11 | 2016-10-12 | 江苏省中医院 | Method for measuring concentration of flutrimazole in plasma |
| CN113134075A (en) * | 2021-04-29 | 2021-07-20 | 江苏普莱医药生物技术有限公司 | Antibacterial peptide emulsifiable paste and preparation method thereof |
| CN113520993A (en) * | 2021-07-30 | 2021-10-22 | 海南海神同洲制药有限公司 | Preparation method of low-viscosity sertaconazole nitrate cream and product prepared by same |
Citations (1)
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|---|---|---|---|---|
| KR20020028124A (en) * | 2000-10-07 | 2002-04-16 | 안상기 | Fungicides comprising tourmalines |
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2014
- 2014-03-11 CN CN201410087206.2A patent/CN103908425B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20020028124A (en) * | 2000-10-07 | 2002-04-16 | 안상기 | Fungicides comprising tourmalines |
Non-Patent Citations (2)
| Title |
|---|
| AMALIA DEL PALACIO ET AL.: "Topical treatment of dermatophytosis and cutaneous candidosis with flutrimazole 1% cream: double-blind,randomized comparative trial with ketoconazole 2% cream", 《MYCOSES》, vol. 42, 31 December 1999 (1999-12-31), pages 649 - 655 * |
| 侯飞燕 等: "HPLC法测定氟曲马唑乳膏的含量及其有关物质", 《中国药师》, vol. 15, no. 3, 31 December 2012 (2012-12-31), pages 362 - 364 * |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106018581A (en) * | 2016-05-11 | 2016-10-12 | 江苏省中医院 | Method for measuring concentration of flutrimazole in plasma |
| CN113134075A (en) * | 2021-04-29 | 2021-07-20 | 江苏普莱医药生物技术有限公司 | Antibacterial peptide emulsifiable paste and preparation method thereof |
| CN113134075B (en) * | 2021-04-29 | 2024-05-10 | 江苏普莱医药生物技术有限公司 | Antibacterial peptide cream and preparation method thereof |
| CN113520993A (en) * | 2021-07-30 | 2021-10-22 | 海南海神同洲制药有限公司 | Preparation method of low-viscosity sertaconazole nitrate cream and product prepared by same |
| CN113520993B (en) * | 2021-07-30 | 2022-07-29 | 海南海神同洲制药有限公司 | Preparation method of low-viscosity sertaconazole nitrate cream and product prepared by same |
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| CN103908425B (en) | 2016-01-20 |
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Inventor after: Liu Xiuying Inventor after: Gao Zizhen Inventor after: Wang Lianmin Inventor after: Fan Yu Inventor after: He Jingliang Inventor before: Wang Lianmin Inventor before: Duan Guangxin Inventor before: Fan Yu Inventor before: He Jingliang Inventor before: Zheng Tao Inventor before: Li Peng Inventor before: Wang Yuemei |