CN102973555A - Pharmaceutical composition containing Ftibamzone compound and preparation method thereof - Google Patents
Pharmaceutical composition containing Ftibamzone compound and preparation method thereof Download PDFInfo
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- CN102973555A CN102973555A CN2012104772651A CN201210477265A CN102973555A CN 102973555 A CN102973555 A CN 102973555A CN 2012104772651 A CN2012104772651 A CN 2012104772651A CN 201210477265 A CN201210477265 A CN 201210477265A CN 102973555 A CN102973555 A CN 102973555A
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Abstract
The invention relates to a pharmaceutical composition containing Ftibamzone compound and a preparation method thereof. The pharmaceutical composition containing the Ftibamzone compound is prepared by a formulation consisting of the following components in percentage by weight: 2.5-3.5% of the Ftibamzone, 0.05-0.1% of tretinoin, 8.0-10.0% of mixture of hexadecyl alcohol and stearyl alcohol, 4.0-6.0% of liquid paraffin, 6.5-7.5% of glycerin monostearate, 0.5-1.5% of Twain-80, 0.15-0.25% of ethyl p-hydroxybenzoate, 10.2-12.2% of propylene glycol, 0.5-1.5% of lauryl sodium sulfate, 56.5-58.6% of purified water, 4.0-6.0% of dimethyl sulfoxide, 56.94% of the purified water and 4.0-6.0% of the dimethyl sulfoxide. The pharmaceutical composition, provided by the invention, is mainly used for treating plane warts, can reduce scars caused in treatment, and is simple in preparation process, good in stability, remarkable in treating effect and convenient to use.
Description
Technical field
The invention belongs to the external preparation of clinical medicine domain treatment dermatosis.The present invention is a kind of preparation method of new ftibamzone compound cream.
Background technology
Viral infection is the social topic that people are concerned about always, viral infection causes various diseases, the serious threat people's is healthy, viral dermatosis occupies critical positions in skin is ill, wherein verruca plana (Flat Wart) is a kind of benign cutaneous vegetation that is caused by the infection of Verrucosis poison.Verruca plana is the same with verruca vulgaris to be pathological changes outstanding on the skin that causes of human papillomavirus (HPV).Be more common in teenager, normal sending out in face and the back of the hand.Autoinoculation also can infect other people easily.Normal suddenly generation, again soon complete obiteration.The possibility of canceration occurs in only a few patient in addition, though the wart body is removed, effect is not good yet, makes many patient's disease damages district edema ulcer occur and stays many complication such as scar.At present, western medicine is antiviral to the Therapeutic Principle of verruca plana and prevents secondary infection, and multiselect is wiped with phthiobuzone ointment, fluorouracil cream, iodouracil desoxyriboside ointment, interferon ointment etc. are outer, but it is long to treat the effect cycle, easily recurs, and effect is not clearly.
Verruca plana not only affects attractive in appearance but also has infectiousness, because random thoughts are scratched where it itches during morbidity, can give like this patient's face and extremity scar, affect attractive in appearance, treat verruca plana and in original Ftibamzone cremer, add the compound Ftibamzone cremer that makes behind the tretinoin, effective percentage is high, and preventing from scar is simple and easy to do.
Ftibamzone (Ftibamzone), have another name called phthiobuzone, it is the pioneering antiviral drugs of China, its mechanism of action mainly is that inhibition viral DNA and early protein are synthetic, and very little on the synthetic impact of normal cell DNA, have Against Chlamydia Trachomatis and herpesvirus resisting activity and have preferably antifungic action and itching-relieving action.
Tretinoin (Tretinoin) is the metabolic intermediate of vitamin A in the body, the metabolism such as the growth of major effect bone and promotion epithelial hyperplasia, differentiation, cutin dissolving.Be used for the treatment of the diseases such as acne vulgaris, psoriasis, ichthyosis, lichen planus, pityriasis rubra pilaris, follicular keratosis, squamous cell carcinoma and melanoma.Its mechanism of action mainly is that epidermal keratinocytes, melanocyte and dermal fibroblast all are the important target cells of tretinoin effect.The melanin that tretinoin can affect melanocyte generates, its effect is multidigit point, the three type catalyzing enzyme activity such as tyrosine hydroxylase, dopase and dihydroxy indole oxidase there is inhibitory action, forms, alleviate cutaneous pigmentation thereby reduce melanin.
Dimethyl sulfoxide (dimethyl sulfoxide) colourless liquid, important polar non-solute.It can dissolve each other with many organic solvents and water.Dimethyl sulfoxide has the very easily special nature of skin permeation, causes the user of service to feel taste as the similar Concha Ostreae.Be widely used as solvent and reaction reagent, have very high selection extracting ability.Dimethyl sulfoxide also has raw material and the carrier that directly is used as some drugs in medical industry.Itself has anti-inflammatory analgetic dimethyl sulfoxide, diuresis, and calmness waits effect.
A lot of Drug therapy verruca plana are arranged in the market, and that Ftibamzone cremer uses in these medicines is comparatively common, but its effect not too desirable, treatment cycle is long, easily recurrence, and the cicatrix that may stay after treatment can't cancellation, is that the patient feels dissatisfied part.
Summary of the invention
The object of the invention provides a kind ofly can effectively treat verruca plana, and can also eliminate on the basis for the treatment of the pharmaceutical composition that contains the ftibamzone chemical compound of the cicatrix that stay after the treatment, returns to original skin after reaching treatment.The present invention also provides the preparation method of described pharmaceutical composition.
For achieving the above object, it is emulsifiable paste the pharmaceutical composition that contains the ftibamzone chemical compound provided by the invention, comprises the composition of following weight ratio: ftibamzone 2.5%-3.5%; Tretinoin 0.05%-0.1%; 16 mixed alcohol 8.0%-10.0%; Liquid paraffin 4.0%-6.0%; Glyceryl monostearate 6.5%-7.5%; Tween 80 0.5%-1.5%; Ethylparaben 0.15%-0.25%; Propylene glycol 10.2%-12.2%; Sodium lauryl sulphate 0.5%-1.5%; Purified water 56.5%-58.6%; Dimethyl sulfoxide 4.0%-6.0%.
Preferably include the composition of following weight ratio: ftibamzone 3.0%; Tretinoin 0.07%; Alcohol Cetylicuset Stearylicus 9.0%; Liquid paraffin 5.0%; Glyceryl monostearate 7.0%; Tween 80 1.0%; Ethylparaben 0.25%; Propylene glycol 11.2%; Sodium lauryl sulphate 1.0%; Purified water 57.48%; Dimethyl sulfoxide 5.0%.
The present invention also provides the preparation method of aforementioned pharmaceutical compositions, and it comprises the steps:
1) ftibamzone and tretinoin are added the dissolving of dimethyl sulfoxide heating in water bath after with a small amount of ethanol moistening, for subsequent use.
2) 16 mixed alcohols, liquid Paraffin and glyceryl monostearate are dropped into oil phase dissolving pan heating for dissolving mixing, be cooled to 80 ± 2 ℃ oil phase after the dissolving of adding ethylparaben, for subsequent use;
3) will heat mixing in propylene glycol and the purified water input aqueous phase dissolved pot; Tween 80 and sodium lauryl sulphate are dropped in the aqueous phase dissolved pot, after dissolving fully, be cooled to 80 ± 2 ℃ and get water, for subsequent use;
4) water, oil phase sieved through negative pressure successively sucking in the vacuum emulsification pot, again with step 1) solution that makes adds in the vacuum emulsification pot and carries out stirring and emulsifying, get product through being cooled to behind the homogenizing below 42 ℃.
Wherein, step 2) 16 mixed alcohols, liquid Paraffin and glyceryl monostearate are dropped into the oil phase dissolving pan, insulation is 30 minutes when being heated to 100 ± 2 ℃, after insulation finishes ethylparaben dropped into oil phase dissolving pan to complete dissolving be cooled to 80 ± 2 ℃ for subsequent use; The rotating speed that the oil phase pot stirs in the preparation oil phase process is 80 ± 5 rev/mins.
Wherein, step 3) propylene glycol and purified water are dropped in the aqueous phase dissolved pot, when being heated to 100 ℃, be incubated 30 minutes; Tween 80 and sodium lauryl sulphate are dropped in the aqueous phase dissolved pot, to complete dissolving, be cooled to 80 ± 2 ℃ for subsequent use; The rotating speed that the water pot stirs in the preparation water process is 80 ± 5 rev/mins.
Wherein, step 4) water, oil phase successively being sucked in the vacuum emulsification pot, with step 1 by 200 mesh sieves through negative pressure) solution that makes adds in the vacuum emulsification pot; Keep 80 ± 2 ℃, emulsifying 20 minutes was opened homogenizer 3～5 minutes.Open cooling water, stirring is cooled off, and is cooled to below 42 ℃ to get product.The rotating speed that vacuum emulsification pot stirs in mixing, emulsifying, cooling procedure is 65 ± 5 rev/mins, the maintenance negative pressure (〉=-0.07Mpa).
The pharmaceutical composition that contains the ftibamzone chemical compound of the present invention changes original making prescription, and it not only can effectively treat verruca plana, and can also eliminate the cicatrix that stay after the treatment on the basis for the treatment of, returns to original skin after reaching treatment.Embody clinically particularly evident.
The present invention contains the cream preparation of ftibamzone compound medicine compositions, equally is the dosage form that is easier to accept of extensive patients with other emulsifiable paste.Preparation technology is simple, and it not only can effectively treat verruca plana, and can also eliminate the cicatrix that stays after the treatment on the basis for the treatment of, and easy to use, effective percentage is high, and is simple and easy to do, and what the scope of application was wide has a few.
A kind of preparation method that contains the pharmaceutical composition of ftibamzone chemical compound that relates among the present invention, not only processing technology is simple, and good stability, and therapeutic effect is obvious, and is easy to use, the treatment short treating period, the state of an illness is difficult for repeatedly.
Specific implementation method:
Following examples further specify content of the present invention, but should not be construed as limitation of the present invention.Without departing from the spirit and substance of the case in the present invention, modification or replacement to the inventive method, step or condition are done all belong to scope of the present invention.
The percentage sign that relates among the present invention " % " if do not specify, refers to mass percent.If do not specialize, the conventional means that used technological means is well known to those skilled in the art among the embodiment.
Embodiment 1:
Prescription: ftibamzone 2.5%; Tretinoin 0.1%; Alcohol Cetylicuset Stearylicus 9.0%; Liquid paraffin 4.5%; Glyceryl monostearate 7.0%; Tween 80 1.0%; Ethylparaben 0.15%; Propylene glycol 11.2%; Sodium lauryl sulphate 1.5%; Purified water 58.55%; Dimethyl Asia 4.5%.
Preparation method: ftibamzone and tretinoin are added dimethyl sulfoxide after with a small amount of ethanol moistening put heating in water bath dissolving in the beaker, for subsequent use; Alcohol Cetylicuset Stearylicus, liquid Paraffin and glyceryl monostearate are dropped into the oil phase dissolving pan, and insulation is 30 minutes when being heated to 100 ± 2 ℃, after insulation finishes ethylparaben dropped into oil phase dissolving pan to complete dissolving be cooled to 80 ± 2 ℃ for subsequent use; Propylene glycol and purified water are dropped in the aqueous phase dissolved pot, when being heated to 100 ℃, be incubated 30 minutes; Tween 80, sodium lauryl sulphate are dropped in the aqueous phase dissolved pot, to complete dissolving, be cooled to 80 ± 2 ℃ for subsequent use.The rotating speed that oil phase, water pot stir in preparation oil phase, the water process is 80 ± 5 rev/mins.Water, oil phase are successively sucked in the vacuum emulsification pot by 200 mesh sieves through negative pressure.Dimethyl sulphoxide solution with ftibamzone and tretinoin adds in the vacuum emulsification pot again; Keep 80 ± 2 ℃, emulsifying 20 minutes.Opened homogenizer 3～5 minutes.Open cooling water, stirring is cooled off, and is cooled to below 42 ℃ to get product.
Embodiment 2
Prescription: ftibamzone 3.0%; Tretinoin 0.07%; Alcohol Cetylicuset Stearylicus 8.5%; Liquid paraffin 5.0%; Glyceryl monostearate 7.5%; Tween 80 1.5%; Ethylparaben 0.25%; Propylene glycol 10.7%; Sodium lauryl sulphate 1.0%; Purified water 57.48%; Dimethyl sulfoxide 5.0%.
Preparation method: ftibamzone and tretinoin are added dimethyl sulfoxide after with a small amount of ethanol moistening put heating in water bath dissolving in the beaker, for subsequent use; Alcohol Cetylicuset Stearylicus, liquid Paraffin and glyceryl monostearate are dropped into the oil phase dissolving pan, and insulation is 30 minutes when being heated to 100 ± 2 ℃, after insulation finishes ethylparaben dropped into oil phase dissolving pan to complete dissolving be cooled to 80 ± 2 ℃ for subsequent use; Propylene glycol and purified water are dropped in the aqueous phase dissolved pot, when being heated to 100 ℃, be incubated 30 minutes; Tween 80, sodium lauryl sulphate are dropped in the aqueous phase dissolved pot, to complete dissolving, be cooled to 80 ± 2 ℃ for subsequent use.The rotating speed that oil phase, water pot stir in preparation oil phase, the water process is 80 ± 5 rev/mins.Water, oil phase are successively sucked in the vacuum emulsification pot by 200 mesh sieves through negative pressure.Dimethyl sulphoxide solution with ftibamzone and tretinoin adds in the vacuum emulsification pot again; Keep 80 ± 2 ℃, emulsifying 20 minutes.Opened homogenizer 3～5 minutes.Open cooling water, stirring is cooled off, and is cooled to below 42 ℃ to get product.
Embodiment 3
Configuration: ftibamzone 3.0%; Tretinoin 0.07%; Alcohol Cetylicuset Stearylicus 9.0%; Liquid paraffin 5.0%; Glyceryl monostearate 7.0%; Tween 80 1.0%; Ethylparaben 0.25%; Propylene glycol 11.2%; Sodium lauryl sulphate 1.0%; Purified water 57.48%; Dimethyl sulfoxide 5.0%.
Preparation method: ftibamzone and tretinoin are added dimethyl sulfoxide after with a small amount of ethanol moistening put heating in water bath dissolving in the beaker, for subsequent use; Alcohol Cetylicuset Stearylicus, liquid Paraffin and glyceryl monostearate are dropped into the oil phase dissolving pan, and insulation is 30 minutes when being heated to 100 ± 2 ℃, after insulation finishes ethylparaben dropped into oil phase dissolving pan to complete dissolving be cooled to 80 ± 2 ℃ for subsequent use; Propylene glycol and purified water are dropped in the aqueous phase dissolved pot, when being heated to 100 ℃, be incubated 30 minutes; Tween 80, sodium lauryl sulphate are dropped in the aqueous phase dissolved pot, to complete dissolving, be cooled to 80 ± 2 ℃ for subsequent use.The rotating speed that oil phase, water pot stir in preparation oil phase, the water process is 80 ± 5 rev/mins.Water, oil phase are successively sucked in the vacuum emulsification pot by 200 mesh sieves through negative pressure.Dimethyl sulphoxide solution with ftibamzone and tretinoin adds in the vacuum emulsification pot again; Keep 80 ± 2 ℃, emulsifying 20 minutes.Opened homogenizer 3～5 minutes.Open cooling water, stirring is cooled off, and is cooled to below 42 ℃ to get product.
Embodiment 4
Configuration: ftibamzone 3.5%; Tretinoin 0.05%; 16 mixed alcohols 8.0%; Liquid paraffin 4.0%; Glyceryl monostearate 6.5%; Tween 80 0.5%; Ethylparaben 0.2%; Propylene glycol 12.2%; Sodium lauryl sulphate 0.5%; Purified water 58.55%; Dimethyl sulfoxide 6.0%.Preparation method is with embodiment 1.
Embodiment 5
Configuration: ftibamzone 3.5%; Tretinoin 0.05%; 16 mixed alcohols 10.0%; Liquid paraffin 6.0%; Glyceryl monostearate 7.5%; Tween 80 1.5%; Ethylparaben 0.25%; Propylene glycol 10.2%; Sodium lauryl sulphate 0.5%; Purified water 56.5%; Dimethyl sulfoxide 4.0%.Preparation method is with embodiment 1.
Embodiment 6
Trial drug: by the emulsifiable paste that does not add tretinoin of embodiment 1 method preparation, the emulsifiable paste (embodiment 1) that the present invention adds tretinoin;
Subjects: clinical definite verruca plana patient.
Test method: medicine is applied the affected part, 3 times on the one, observed 2 months.
Efficacy determination: 1, verruca plana is judged: cure as verruca plana and all disappear; Produce effects is that verruca plana disappears more than 70%; Effectively disappear more than 40% for verruca plana; Invalid is that verruca plana is without obvious change.2, Scar eliminating medicine is except judging: cure as cicatrix and all disappear; Produce effects is that cicatrix disappears more than 70%; Effectively disappear more than 40% for cicatrix; All the other are considered as invalid.
For the clinical effectiveness for the treatment of verruca plana, the clinical comparison the result is:
The clinical effectiveness of former Ftibamzone cremer treatment verruca plana: case 75 people, 45 people that fully recover, produce effects 10 people, effective 3 people, invalid 17 people, total effective rate 77.3%.
The clinical effectiveness that adds the ftibamzone compound cream treatment verruca plana of tretinoin: case 75 people, 50 people that fully recover, produce effects 18 people, effective 4 people, invalid 3 people, total effective rate 96.0%.
Above-mentioned two groups of contrasts, its conclusion is: the clinical effectiveness of ftibamzone compound cream treatment verruca plana that has fully confirmed to add tretinoin is well more a lot of than the clinical effectiveness of former Ftibamzone cremer treatment verruca plana.
For the clinical effectiveness of eliminating the cicatrix that stays after the treatment verruca plana, the clinical comparison the result is:
The clinical effectiveness of former Ftibamzone cremer treatment verruca plana: case 51 people, 15 people that fully recover, produce effects 10 people, effective 6 people, invalid 20 people, total effective rate 60.8%.
The clinical effectiveness that adds the ftibamzone compound cream treatment verruca plana of tretinoin: case 51 people, 36 people that fully recover, produce effects 8 people, effective 5 people, invalid 2 people, total effective rate 96.1%.
Above-mentioned two groups of contrasts, its conclusion is: it is high a lot of that the cicatrix elimination factor that the ftibamzone compound cream that has fully confirmed to add tretinoin stays after to the treatment verruca plana is compared the cicatrix elimination factor that former Ftibamzone cremer stays after to the treatment verruca plana.The emulsifiable paste that embodiment 2～5 makes has also been obtained similar effect.
Claims (7)
1. pharmaceutical composition that contains the ftibamzone chemical compound, it comprises the composition of following weight ratio: ftibamzone 2.5%-3.5%; Tretinoin 0.05%-0.1%; 16 mixed alcohol 8.0%-10.0%; Liquid paraffin 4.0%-6.0%; Glyceryl monostearate 6.5%-7.5%; Tween 80 0.5%-1.5%; Ethylparaben 0.15%-0.25%; Propylene glycol 10.2%-12.2%; Sodium lauryl sulphate 0.5%-1.5%; Purified water 56.5%-58.6%; Dimethyl sulfoxide 4.0%-6.0%.
2. pharmaceutical composition according to claim 1 is characterized in that comprising the composition of following weight ratio: ftibamzone 3.0%; Tretinoin 0.07%; Alcohol Cetylicuset Stearylicus 9.0%; Liquid paraffin 5.0%; Glyceryl monostearate 7.0%; Tween 80 1.0%; Ethylparaben 0.25%; Propylene glycol 11.2%; Sodium lauryl sulphate 1.0%; Purified water 57.48%; Dimethyl sulfoxide 5.0%.
3. claim 1 or the 2 described preparation methoies that contain the pharmaceutical composition of ftibamzone chemical compound, it comprises the steps:
1) ftibamzone and tretinoin are added the dissolving of dimethyl sulfoxide heating in water bath after with a small amount of ethanol moistening, for subsequent use.
2) 16 mixed alcohols, liquid Paraffin and glyceryl monostearate are dropped into oil phase dissolving pan heating for dissolving mixing, be cooled to 80 ± 2 ℃ oil phase after the dissolving of adding ethylparaben, for subsequent use;
3) will heat mixing in propylene glycol and the purified water input aqueous phase dissolved pot; Tween 80 and sodium lauryl sulphate are dropped in the aqueous phase dissolved pot, after dissolving fully, be cooled to 80 ± 2 ℃ and get water, for subsequent use;
4) water, oil phase sieved through negative pressure successively sucking in the vacuum emulsification pot, again with step 1) solution that makes adds in the vacuum emulsification pot and carries out stirring and emulsifying, get product through being cooled to behind the homogenizing below 42 ℃.
4. preparation method according to claim 3, step 2 wherein) 16 mixed alcohols, liquid Paraffin and glyceryl monostearate are dropped into the oil phase dissolving pan, insulation is 30 minutes when being heated to 100 ± 2 ℃, after insulation finishes ethylparaben dropped into oil phase dissolving pan to complete dissolving be cooled to 80 ± 2 ℃ for subsequent use; The rotating speed that the oil phase pot stirs in the preparation oil phase process is 80 ± 5 rev/mins.
5. preparation method according to claim 3, wherein step 3) propylene glycol and purified water are dropped in the aqueous phase dissolved pot, when being heated to 100 ℃, be incubated 30 minutes; Tween 80 and sodium lauryl sulphate are dropped in the aqueous phase dissolved pot, to complete dissolving, be cooled to 80 ± 2 ℃ for subsequent use; The rotating speed that the water pot stirs in the preparation water process is 80 ± 5 rev/mins.
6. preparation method according to claim 3, wherein step 4) water, oil phase are successively sucked in the vacuum emulsification pot, with step 1 by 200 mesh sieves through negative pressure) solution that makes adds in the vacuum emulsification pot; Keep 80 ± 2 ℃, emulsifying 20 minutes was opened homogenizer 3～5 minutes, opened cooling water, stirred cooling, was cooled to below 42 ℃ to get product.
7. preparation method according to claim 3, wherein step 4) vacuum emulsification pot stirs in mixing, emulsifying, cooling procedure rotating speed is 65 ± 5 rev/mins, keep negative pressure 〉=-0.07Mpa.
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Cited By (1)
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| CN104490870A (en) * | 2014-12-04 | 2015-04-08 | 宿州亿帆药业有限公司 | Compound topical cream and application thereof |
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| CN101342174A (en) * | 2008-08-26 | 2009-01-14 | 北京天川军威医药技术开发有限公司 | Phthiobuzonum/diclothane compound topical formulation |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101342174A (en) * | 2008-08-26 | 2009-01-14 | 北京天川军威医药技术开发有限公司 | Phthiobuzonum/diclothane compound topical formulation |
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Effective date of registration: 20160229 Address after: 234000 north side of Jin Jiang Road, Suzhou economic and Technological Development Zone, Anhui Applicant after: SUZHOU E-FAN PHARMACEUTICAL CO., LTD. Address before: 235200 No. 248 traffic road, Liuzhou Town, Suzhou, Anhui, Xiaoxian Applicant before: Anhui Xinglonghai Medicine Co., Ltd. |
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