CN1565459A - Dermatopathy therapeutic medicine compositions and its preparation method - Google Patents
Dermatopathy therapeutic medicine compositions and its preparation method Download PDFInfo
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- CN1565459A CN1565459A CN 03137395 CN03137395A CN1565459A CN 1565459 A CN1565459 A CN 1565459A CN 03137395 CN03137395 CN 03137395 CN 03137395 A CN03137395 A CN 03137395A CN 1565459 A CN1565459 A CN 1565459A
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Abstract
The invention relates to a dermatopathy therapeutic medicine compositions and its preparation method, in particular a propylene amine antimycotics, and suprarenal hormones medicinal compositions and its preparation method.
Description
Technical field
The present invention relates to dermopathic pharmaceutical composition of a kind of treatment and preparation method thereof, relate in particular to a kind of propylene amine antifungal drug and adrenal cortex hormones drug composition and method of making the same.
Background technology
Terbinafine HCl (is called for short terbinafine, Terbinafine) be propylene amine antifungal drug, it is characterized in that higher antifungal cure rate and lower in a short time relapse rate are arranged, but normal and dermatitis and eczema etc. of some dermatomycosis are hard to tell clinically, cause mistaken diagnosis.Triamcinolone acetonide acetate (is called for short triamcinolone acetonide, Triamcinoloni), betamethasone (Betamethasone) and halcinonidedcorten (Halcincnide) are Aeroseb-Dex, have effects such as antiinflammatory, there is not the fungicidal action of pressing down, above-mentioned one-component has can not effectively treat cutaneous fungal infection, dermatitis or eczema, and fungal infection, dermatitis and morbific shortcoming of eczema while.
After the inventor finds that terbinafine HCl adds a certain amount of triamcinolone acetonide acetate or betamethasone or halcinonidedcorten, great majority tests fungus there is in various degree potentiation, and simultaneously to dermatitis and eczema better efficacy.
Summary of the invention
The purpose of this invention is to provide dermopathic pharmaceutical composition of a kind of treatment and preparation method thereof, a kind of propylene amine antifungal drug and adrenal cortex hormones drug composition and method of making the same especially are provided, overcome above-mentioned one-component and can not effectively treat cutaneous fungal infection, dermatitis or eczema, and fungal infection, dermatitis and morbific shortcoming of eczema while
The objective of the invention is to be achieved through the following technical solutions:
A kind of pharmaceutical composition for the treatment of dermatosis is by the medicament that comprises that following proportioning ratio component is made, and terbinafine HCl: triamcinolone acetonide acetate or betamethasone or halcinonidedcorten are (0.3～3.0): (0.005～0.5); Described set of dispense is preferably than ratio: (0.5～2.0): (0.01～0.2); Be preferably: 1.0: 0.1;
Described compositions also can comprise available adjuvant on the pharmaceutics; Described adjuvant can also be for being selected from the antiseptic of benzoic acid, chlorhexidine acetate, neomycin or ciprofloxacin.
Described medicament is said any percutaneous drug delivery dosage form on the pharmaceutics;
Described pharmaceutical dosage form can be ointment, ointment, Emulsion, cream, gel, solution, tincture, oil preparation, spray, lotion, liniment, varnish.
Treatment dermatosis preparation of compositions method of the present invention, may further comprise the steps: in terbinafine HCl: triamcinolone acetonide acetate or betamethasone or halcinonidedcorten are (0.3～3.0): the ratio of (0.005～0.5) takes by weighing raw material, according to conventional enepidermic preparation method preparation promptly, described step can add available adjuvant on the medicament.
The present invention has following effect and advantage:
1) component of the present invention has obvious synergistic effect and potentiation.Utilize terbinafine HCl: two kinds of drug component effects separately of triamcinolone acetonide acetate or betamethasone or halcinonidedcorten, make up the back and find that composition medicine has synergism and potentiation aspect antifungal, and kept the antiinflammatory action of triamcinolone acetonide acetate, betamethasone and halcinonidedcorten.
2) good effect.Through the screening of variable concentrations prescription antibacterial action, also find terbinafine HCl and triamcinolone acetonide acetate or betamethasone or the halcinonidedcorten proportion about 1: 0.1, antifungic action is stronger; With described ratio prescription, add adjuvant and make compositions ointment, especially the treatment guinea pig skin is infected alpha fungus and Sabouraudites lanosus good effect.
3) dermatophytes, eczema or dermatitis as ointment, ointment and solution etc., can be treated by Yan Zhi compound external-use local application, and morbific dermatosis of while.Clinical principium test above-mentioned composition ointment, the patient of treatment this respect all obtains satisfied curative effect.
The synergism of pharmaceutical composition of the present invention and potentiation can illustrate by following laboratory pharmacodynamic study and clinical case report.
One, laboratory pharmacodynamic study
1. the external antibacterial action to several frequently seen cause a disease (representing bacterium) of pharmaceutical composition of the present invention and component thereof compares, experiment in vitro filters out each set of dispense of compositions of mycostasis than ratio, proves that pharmaceutical composition of the present invention is better to bacteriostasis and the minimal inhibitory concentration (MIC) thereof of fungus.
1.1 materials and methods
1.1.1 strain
Fungus is drawn from Nanjing institute of internal medicine, Beijing Medical University's attached First Academy department of dermatologry and air force general hospital department of dermatologry.
1.1.2 culture medium
Fungi culture medium is the Sha Shi broth bouillon, is made up of 1% peptone and 2% glucose etc., and pH is 6-6.5; Bacteria culture media is an ordinary broth, and pH is 7.
1.1.3 the preparation of medicinal liquid culture medium
In terbinafine HCl, triamcinolone acetonide acetate or betamethasone or the various ratio preparation of halcinonidedcorten (seeing chart).Each prescription adds sterile distilled water to 5ml more earlier with 1ml 95% dissolve with ethanol medicine; Respectively draw above-mentioned dosing 0.2ml then, be added to respectively in the culture medium of 1.8ml, shake up the medicinal liquid culture medium that the back two-fold dilution goes out variable concentrations.During experiment, add bacterium liquid 0.02ml among every pipe medicinal liquid culture medium 1ml; 1ml contains trichophyton 10
5-10
6Individual or yeast-like fungi 10
3-10
4Individual.Be put in after shaking up in 28 ℃ of incubators and cultivated 120-168 hour, wherein yeast-like fungi is 48 hours, observed result.
1.1.4 drug effect criterion
Meat soup is limpid with medicine blank pipe, for the bactericidal action of pressing down is arranged; Meat soup is obviously muddy, or the Mycoderma growth is arranged, then for there not being the bactericidal action of pressing down.
1.2 experimental result
1.2.1 show by terbinafine HCl, triamcinolone acetonide acetate or betamethasone or the external bacteriostatic test of halcinonidedcorten different proportion compatibility to the common fungus of 4 strains, terbinafine, triamcinolone acetonide or betamethasone or halcinonidedcorten are in (0.3～3.0): the compositions minimal inhibitory concentration (MIC) under the ratio of (0.005～0.50) is lower, (0.5～2.0): (0.01～0.20) effect better, especially the compositions under 1: 0.1 ratio, (MIC) is low for minimal inhibitory concentration, bacteriostasis strong (see Table 1, table 2, table 3).
The external bacteriostasis of table 1 terbinafine and triamcinolone acetonide variable concentrations compatibility to several frequently seen pathomycete (representing bacterium)
-------------------------------------------------------------------------
Minimal inhibitory concentration (MIC, μ g/ml)
Terbinafine: triamcinolone acetonide-------------------------------------------------------
Trichophyton alpha fungus Sabouraudites lanosus white is read bacterial strain
-------------------------------------------------------------------------
0.3∶0.005 0.0064 0.048 0.048 2.50
0.3∶0.5 0.0064 0.048 0.048 2.50
0.5∶0.005 0.0064 0.048 0.024 2.50
0.5∶0.01 0.0032 0.024 0.024 2.50
0.5∶0.1 0.0032 0.012 0.012 1.25
0.5∶0.2 0.0032 0.024 0.024 1.25
0.5∶0.5 0.0032 0.024 0.024 1.25
1.0∶0.005 0.0032 0.012 0.012 2.50
1.0∶0.01 0.0016 0.012 0.012 1.25
1.0∶0.1 0.0008 0.003 0.006 0.62
1.0∶0.2 0.0016 0.012 0.012 1.25
1.0∶0.5 0.0016 0.012 0.012 2.50
2.0∶0.005 0.0016 0.006 0.006 1.25
2.0∶0.01 0.0008 0.006 0.006 1.25
2.0∶0.1 0.0008 0.006 0.003 1.25
2.0∶0.2 0.0016 0.006 0.006 1.25
2.0∶0.5 0.0016 0.006 0.006 1.25
4.0∶0.1 --- --- --- ---
1.0: 0.0 (single medicine contrast) 0.0032 0.012 0.012 2.50
0.0: 0.1 (single medicine contrast) 0.000 0.000 0.000 0.00
--------------------------------------------------------------------------
Annotate: 1. trichophyton was cultivated 120-168 hour, 48 hours observed results of yeast-like fungi.
2. "---" drug solubility is relatively poor, can't observed result.
The external bacteriostasis of table 2 terbinafine and betamethasone variable concentrations compatibility to several frequently seen pathomycete (representing bacterium)
--------------------------------------------------------------------------
Minimal inhibitory concentration (MIC, μ g/ml)
Terbinafine: betamethasone--------------------------------------------------------
Trichophyton alpha fungus Sabouraudites lanosus white is read bacterial strain
--------------------------------------------------------------------------
0.3∶0.005 0.0128 0.048 0.048 2.50
0.3∶0.5 0.0064 0.048 0.048 2.50
0.5∶0.005 0.0064 0.048 0.024 2.50
0.5∶0.01 0.0032 0.012 0.012 1.25
0.5∶0.1 0.0032 0.012 0.012 1.25
0.5∶0.2 0.0064 0.024 0.024 1.25
0.5∶0.5 0.0064 0.024 0.024 1.25
1.0∶0.005 0.0032 0.012 0.012 2.50
1.0∶0.01 0.0016 0.006 0.012 1.25
1.0∶0.1 0.0008 0.003 0.006 0.62
1.0∶0.2 0.0016 0.012 0.012 1.25
1.0∶0.5 0.0016 0.012 0.012 2.50
2.0∶0.005 0.0016 0.006 0.006 1.25
2.0∶0.01 0.0016 0.006 0.006 1.25
2.0∶0.1 0.0008 0.006 0.003 0.62
2.0∶0.2 0.0016 0.006 0.006 1.25
2.0∶0.5 0.0016 0.006 0.006 1.25
4.0∶0.1 --- --- --- ---
1.0: 0.0 (single medicine contrast) 0.0032 0.012 0.012 2.50
0.0: 0.1 (single medicine contrast) 0.000 0.000 0.000 0.00
-------------------------------------------------------------------------
Annotate: 1. trichophyton was cultivated 120-168 hour, 48 hours observed results of yeast-like fungi.
2. "---" drug solubility is relatively poor, can't observed result.
The external bacteriostasis of table 3 terbinafine and halcinonidedcorten variable concentrations compatibility to several frequently seen pathomycete (representing bacterium)
-------------------------------------------------------------------------
Minimal inhibitory concentration (MIC, μ g/ml)
Terbinafine: halcinonidedcorten-------------------------------------------------------
Trichophyton alpha fungus Sabouraudites lanosus white is read bacterial strain
-------------------------------------------------------------------------
0.3∶0.005 0.0128 0.048 0.096 2.50
0.3∶0.5 0.0128 0.048 0.048 2.50
0.5∶0.005 0.0064 0.048 0.024 2.50
0.5∶0.01 0.0032 0.012 0.012 1.25
0.5∶0.1 0.0032 0.012 0.012 1.25
0.5∶0.2 0.0064 0.024 0.024 1.25
0.5∶0.5 0.0064 0.024 0.024 2.50
1.0∶0.005 0.0032 0.012 0.012 1.25
1.0∶0.01 0.0016 0.006 0.012 1.25
1.0∶0.1 0.0008 0.006 0.003 1.25
1.0∶0.2 0.0016 0.012 0.012 1.25
1.0∶0.5 0.0016 0.012 0.012 1.25
2.0∶0.005 0.0008 0.006 0.006 1.25
2.0∶0.01 0.0008 0.006 0.006 1.25
2.0∶0.1 0.0008 0.006 0.003 0.62
2.0∶0.2 0.0016 0.006 0.006 1.25
2.0∶0.5 0.0016 0.006 0.006 1.25
4.0∶0.1 --- --- --- ---
1.0: 0.0 (single medicine contrast) 0.0032 0.012 0.012 2.50
0.0: 0.1 (single medicine contrast) 0.000 0.000 0.000 0.00
--------------------------------------------------------------
Annotate: 1. trichophyton was cultivated 120-168 hour, 48 hours observed results of yeast-like fungi.
2. "---" drug solubility is relatively poor, can't observed result.
2. animal is compared guinea pig skin local infection fungus curative effect in body test-compositions and component ointment thereof, further proves the significant antibacterial action of the present composition.
2.1 materials and methods
Compositions ointment, and component terbinafine HCl and triamcinolone acetonide acetate or betamethasone or halcinonidedcorten ointment are the medicine chamber preparation of this institute, with O/W (oil/water) dosage form, excipient is preparations such as octadecanol, stearic acid, glyceryl monostearate, vaseline, glycerol and distilled water.Promptly use compositions ointment, terbinafine HCl ointment, triamcinolone acetonide acetate ointment, betamethasone ointment, halcinonidedcorten ointment and excipient ointment (the blank frost of no medicine) to carry out parallel comparative test.
Strain selects two kinds of fungal bacterial strain alpha funguses the most susceptible of Cavia porcellus and Sabouraudites lanosus to infect, and the bacterium pearl is provided by the air force general hospital department of dermatologry.
Cavia porcellus (Dunkin-Hartley strain) white, male female half and half, about body weight 250g, provide by the air force general hospital Experimental Animal Center.27-32 ℃ of Animal House temperature, relative humidity 65-75%.Selecting the back side of Cavia porcellus is the infected area, and every group of 10-15 only uses various Drug therapys respectively.10 is blank frost contrast, promptly observes the natural growth and decline of infecting.About 3 * the 4CM of hair is shaved at every Cavia porcellus back side
2, artificial challenge fungus according to a conventional method obviously forms to the 5th day local infection, and through cultivate behind the fungus microscope examination confirm after, just carry out Drug therapy, every infection place dosage 0.15g, 1 time/day, continuous 2 weeks.Carrying out fungus microscope examination and skin lesion in per 2 days observes.The evaluation of clinical curative effect standard is a secondary standard: 1, healing is disappeared continuous 2 the fungus feminine genders of microscopy for skin lesion; 2, invalidly do not disappear the microscopy fungus positive for skin lesion.
2.2 experimental result
2.2.1 compositions and component ointment thereof are to the curative effect of guinea pig skin local infection alpha fungus
Behind the Cavia porcellus of guinea pig skin local infection alpha fungus, respectively with containing 1% terbinafine and 0.1% triamcinolone acetonide acetate ointment or 0.1% betamethasone ointment or 0.1% halcinonidedcorten compositions ointment, and 1% terbinafine ointment, 0.1% triamcinolone acetonide acetate ointment, 0.1% betamethasone ointment, the treatment of 0.1% halcinonidedcorten one pack system ointment parallel control, the result shows compositions ointment group therapeutic effect best (see Table 4, table 5, table 6).One all cure rates are learned by statistics respectively and are handled, and compositions ointment group and its component medicine ointment group compare, significant difference (P＜0.01).
2.2.2 compositions and component ointment thereof are to the curative effect of guinea pig skin local infection Sabouraudites lanosus
The Cavia porcellus of guinea pig skin local infection Sabouraudites lanosus, also respectively with containing 1% terbinafine and 0.1% triamcinolone acetonide acetate ointment or 0.1% betamethasone ointment or 0.1% halcinonidedcorten compositions ointment, and 1% terbinafine ointment, 0.1% triamcinolone acetonide acetate ointment, 0.1% betamethasone ointment and the treatment of 0.1% halcinonidedcorten ointment parallel control, the result shows compositions ointment group therapeutic effect best (see Table 7, table 8, table 9).One all cure rates are learned by statistics respectively and are handled, and compositions ointment group and its component medicine ointment group compare, significant difference (P＜0.01).
Table 4 terbinafine and triamcinolone acetonide compositions ointment and component medicine ointment thereof are to guinea pig skin
The curative effect that infects alpha fungus compares
------------------------------------------------------------------
Medicine grouping number of animals is cured one week Tuesday of scope
(my god) healing (%) healing (%)
------------------------------------------------------------------
Terbinafine and Kin White 10 2-10 80.00 100.00
1% terbinafine ointment group, 10 4-12 50.00 100.00
0.1% Kin White group, 10 18-34 0.00 10.00
Excipient ointment group (contrast) 10 10-28 0.00 30.00
--------------------------------------------------------------------------------
Annotate: terbinafine and Kin White are compositions ointment, contain 1% terbinafine and 0.1% triamcinolone acetonide compositions ointment.
Table 5 terbinafine and betamethasone compositions ointment and component medicine ointment thereof are to guinea pig skin
The curative effect that infects alpha fungus compares
--------------------------------------------------------------------------------
Medicine grouping number of animals is cured one week Tuesday of scope
(my god) healing (%) healing (%)
--------------------------------------------------------------------------------
Terbinafine and betamethasone ointment 10 2-10 90.00 100.00
1% terbinafine ointment group, 10 4-12 50.00 100.00
0.1% betamethasone ointment group, 10 18-36 0.00 20.00
Excipient ointment group (contrast) 10 10-28 0.00 30.00
--------------------------------------------------------------------------------
Annotate: terbinafine and betamethasone ointment are compositions ointment, contain 1% terbinafine HCl and 0.1 betamethasone ointment.
Table 6 terbinafine and halcinonidedcorten compositions ointment and component medicine ointment thereof are to guinea pig skin
The curative effect that infects alpha fungus compares
--------------------------------------------------------------------------------
Medicine grouping number of animals is cured one week Tuesday of scope
(my god) healing (%) healing (%)
--------------------------------------------------------------------------------
Terbinafine and halcinonidedcorten ointment 10 2-10 80.00 100.00
1% terbinafine ointment group, 10 4-12 50.00 100.00
0.1% halcinonidedcorten ointment group, 10 18-32 0.00 10.00
Excipient ointment group (contrast) 10 10-28 0.00 30.00
-------------------------------------------------------------------------
Annotate: terbinafine and halcinonidedcorten ointment are compositions ointment, contain 1% terbinafine HCl and 0.1% halcinonidedcorten.
Table 7 terbinafine and triamcinolone acetonide compositions ointment and component medicine ointment thereof are to guinea pig skin
The curative effect that infects alpha fungus compares
-------------------------------------------------------------------------
Medicine grouping number of animals is cured one week Tuesday of scope
(my god) healing (%) healing (%)
-------------------------------------------------------------------------
Terbinafine and Kin White 10 2-10 80.00 100.00
1% terbinafine ointment group, 10 4-10 60.00 100.00
0.1% Kin White group, 10 18-32 0.00 30.00
Excipient ointment group (contrast) 10 12-30 0.00 30.00
-------------------------------------------------------------------------
Annotate: terbinafine and Kin White are compositions ointment, contain 1% terbinafine HCl and 0.1% triamcinolone acetonide.
Table 8 terbinafine and betamethasone compositions ointment and component medicine ointment thereof are to guinea pig skin
The curative effect of infected dogs sporidiole bacteria relatively
-------------------------------------------------------------------------
Medicine grouping number of animals is cured one week Tuesday of scope
(my god) healing (%) healing (%)
-------------------------------------------------------------------------
Terbinafine and betamethasone ointment 10 2-10 90.00 100.00
1% terbinafine ointment group, 10 4-10 60.00 100.00
0.1% betamethasone ointment group, 10 18-32 0.00 0.00
Excipient ointment group (contrast) 10 12-30 0.00 30.00
-------------------------------------------------------------------------
Annotate: terbinafine and betamethasone ointment are compositions ointment, contain 1% terbinafine HCl and 0.1% betamethasone.
Table 9 terbinafine and halcinonidedcorten compositions ointment and component medicine ointment thereof are to guinea pig skin
The curative effect of infected dogs sporidiole bacteria relatively
-------------------------------------------------------------------------
Medicine grouping number of animals is cured one week Tuesday of scope
(my god) healing (%) healing (%)
-------------------------------------------------------------------------
Terbinafine and halcinonidedcorten ointment 10 2-10 90.00 100.00
1% terbinafine ointment group, 10 4-10 60.00 100.00
0.1% halcinonidedcorten ointment group, 10 18-32 0.00 20.00
Excipient ointment group (contrast) 10 12-30 0.00 30.00
-------------------------------------------------------------------------
Annotate: terbinafine and halcinonidedcorten ointment are compositions ointment, contain 1% terbinafine HCl and 0.1% halcinonidedcorten.
Two, clinical case report
The present composition, be terbinafine HCl and triamcinolone acetonide acetate or betamethasone or halcinonidedcorten formula proportion, in 0.3～3.0: during the formulated dermatologic medicament of 0.005～0.5 weight portion proportioning ratio, ill with dermatitis and eczema while to treatment cutaneous fungal infection, dermatitis and eczema or fungal infection.Has better therapeutic effect.During especially in the formulated dermatologic medicament of 1.0: 0.1 weight portion proportioning ratios, evident in efficacy.
Case 1. warm XX, the women, 25 years old, because of itching, right cervical region skin lesion companion went to a doctor in 2 weeks, and the fungus microscope examination positive is diagnosed as tinea corporis, and sings and symptoms is obvious before the treatment, and fungal culture is a trichophyton.Then give the external of compositions ointment, 1 week of logotype, the clinical and mycology recovery from illness of the 2nd week.
Case 2. ten thousand XX, the male, 28 years old, because of itching, preceding chest and back skin lesion companion went to a doctor in 1 year, be diagnosed as tinea versicolor.Sings and symptoms is obviously long-pending before the treatment, the fungus microscope examination positive.Then give composition solution treatment, in 1 week of logotype, sings and symptoms disappears negative fungal examination, clinical recovery during the 2nd all drug withdrawal.
Case 3. king XX, the women, 46 years old, because of itching, double small shank skin lesion companion went to a doctor in 2 years, be diagnosed as eczema, give the treatment of compositions liniment then, in 2 weeks of logotype, sings and symptoms disappears during the 3rd all drug withdrawal, clinically is judged to healing.
Case 4. bag XX, the male, 50 years old, because of itching, the skin lesion companion of both shoulders portion goes to a doctor February, be diagnosed as fungal infection (tinea corporis) and dermatitis.Sings and symptoms is obvious before the treatment, and fungal culture is a trichophyton.Then give the treatment of compositions emulsifiable paste, in 2 weeks of logotype, the 3rd all sings and symptomses disappear, and fungus microscope examination and cultivation all show negative, clinical recovery.
5. meters XX of case, the male, 35 years old, because of skin lesion companion between the biped toe itches half a year, the state of an illness increased the weight of to go to a doctor recently, is diagnosed as type tinea pedis between toe.Sings and symptoms is all heavier before the treatment, and microscopy is cultivated and is alpha fungus.Then give the treatment of compositions spray, in 1 week of logotype, sings and symptoms disappears substantially during drug withdrawal, negative fungal examination; The 2nd week, clinical and fungus, bacteriology checking were all fully recovered.
Case 6. is thought XX, the male, and 20 years old, because of itching, upper left hand skin lesion companion went to a doctor in 5 days, be diagnosed as dermatitis.Sings and symptoms is obvious before the treatment, gives the treatment of compositions cream then, and in 1 week of logotype, the 2nd all sings and symptomses disappear clinical recovery.
Case 7. Yin XX, the male, 25 years old, the companion itched 2 years because of the both legs skin lesion, itched recently and scratched, and the state of an illness increases the weight of, and mixes red and swollen the prescription on individual diagnosis, is diagnosed as eczema and fungal infection.Sings and symptoms is all heavier before the treatment, and microscopy is cultivated and is alpha fungus, gives composition gels agent treatment then, and in 4 weeks of logotype, sings and symptoms disappears substantially during drug withdrawal, and fungus microscope examination is negative; The 5th all clinical recoveries.
Case 8. military XX, the male, 25 years old, because of itching, bifilar inboard skin lesion companion go to a doctor February, be diagnosed as tinea cruris.Sings and symptoms is obvious before the treatment, and fungal culture is a trichophyton.Then give the compositions lotion for treatment, in 1 week of logotype, the 2nd all sings and symptomses disappear, and fungus microscope examination and cultivation are all negative, clinical recovery.
Case 9. is practised XX, the woman, and 35 years old, because of itching, the aging companion of biped portion skin lesion went to a doctor in 2 years, and the fungus microscope examination positive is diagnosed as tinea pedis and chaps, and sings and symptoms is obvious before the treatment, and fungal culture is a trichophyton.Then give the external of compositions tincture, 4 weeks of logotype, the clinical and mycology recovery from illness of the 5th week.
Case 10. Lee XX, the male, 20 years old, because of itching, bifilar inboard skin lesion companion go to a doctor March, be diagnosed as tinea cruris.Sings and symptoms is obvious before the treatment, and fungal culture is a trichophyton.Then give the treatment of compositions varnish, in 1 week of logotype, the 2nd all sings and symptomses disappear, and fungus microscope examination and cultivation all show negative, clinical recovery.
The specific embodiment
Embodiment 1
Drug ointment agent of the present invention
Take by weighing terbinafine HCl 1.0 grams, triamcinolone acetonide acetate 0.1 gram by 1.0: 0.1 formula proportion, antiseptic chlorhexidine acetate 0.5 gram, dissolve with small amount of ethanol earlier, use the O/W dosage form, excipient is octadecanol 4 grams, stearic acid 4 grams, glyceryl monostearate 3.5 grams, vaseline 10 grams, glycerol 10 grams, and soil temperature-80 2 gram and surplus distilled water are mixed with ointment 100 grams.
Embodiment 2
Drug cream agent of the present invention
Take by weighing terbinafine HCl 1.5 grams, betamethasone 0.05 gram by 0.5: 0.05 formula proportion, dissolve with small amount of ethanol earlier, use the O/W dosage form, excipient is octadecanol 4 grams, stearic acid 10 grams, glyceryl monostearate 5 grams, vaseline 6 grams, glycerol 10 grams, and triethanolamine 0.8 gram and surplus distilled water are mixed with ointment 100 grams.
Embodiment 3
Drug solution agent of the present invention
Take by weighing terbinafine HCl 0.5 gram, halcinonidedcorten 0.5 gram by 0.5: 0.08 formula proportion, add 20ml ethanol, 20ml propylene glycol, the formulated solution 100ml of surplus distilled water.
Embodiment 4
Medicinal tincture of the present invention
Take by weighing terbinafine HCl 2.0 grams, triamcinolone acetonide acetate 0.05 gram by 2.0: 0.05 formula proportion, add 40ml ethanol, 20ml propylene glycol, the formulated tincture 100ml of 10ml glycerol and surplus distilled water.
Embodiment 5
Medicine oil preparation of the present invention
Take by weighing terbinafine HCl 1.0 grams, betamethasone 0.1 gram, 30ml ethanol, the formulated oil preparation 100ml of glycerol 50ml and surplus distilled water by 1.0: 0.1 formula proportion.
Embodiment 6
Medicine spray of the present invention
Take by weighing terbinafine HCl 0.8 gram, halcinonidedcorten 0.1 gram by 0.8: 0.1 formula proportion, antiseptic chlorhexidine acetate 0.3 gram adds 20ml ethanol, the formulated spray 100ml of 20ml glycerol and surplus distilled water.
Embodiment 7
Medicinal frost formulation of the present invention
Take by weighing terbinafine HCl 1.2 grams, halcinonidedcorten 0.08 gram by 1.2: 0.08 formula proportion, dissolve with small amount of ethanol earlier, use the O/W dosage form, excipient is octadecanol 4 grams, stearic acid 4 grams, glyceryl monostearate 3.5 grams, vaseline 10 grams, glycerol 10 grams, and soil temperature-80 2 gram and surplus distilled water are mixed with cream 100 grams.
Embodiment 8
Pharmaceutical emulsion of the present invention
Take by weighing terbinafine HCl 1.5 grams, betamethasone 0.05 gram by 1.5: 0.05 formula proportion, antiseptic ciprofloxacin 0.1 gram, earlier with the small amount of ethanol dissolving, stearic acid 2 grams, glycerol ml, triethanolamine 1ml and surplus distilled water, conventional method is mixed with Emulsion 100ml.
Embodiment 9
Drug lotion of the present invention
Take by weighing terbinafine HCl 0.5 gram, triamcinolone acetonide acetate 0.02 gram by 0.5: 0.02 formula proportion, add 20ml ethanol, the formulated lotion 100ml of 20ml glycerol and surplus distilled water.
Embodiment 10
Medicament gelling agent of the present invention takes by weighing terbinafine HCl 0.5 gram, triamcinolone acetonide acetate 0.2 gram by 0.5: 0.2 formula proportion, add the small amount of ethanol dissolving, propylene glycol 20g, Polyethylene Glycol-400 10 gram, EDTA-2Na 0.1 gram, tween 80 3 grams, triethanolamine 0.6 gram, the formulated gel 100g of surplus.
Embodiment 11
Medicine varnish of the present invention
Take by weighing terbinafine HCl 1.8 grams by 1.8: 0.05 formula proportion, triamcinolone acetonide acetate 0.5 gram adds ethanol 40ml dissolving, the formulated varnish 100ml of propylene glycol 10ml and surplus distilled water.
Embodiment 13
Medicine liniment of the present invention
Take by weighing terbinafine HCl 0.8 gram by 0.5: 0.1 formula proportion, betamethasone 0.05 gram adds ethanol 30ml dissolving, and glycerol 10ml and surplus are the formulated liniment 100ml of distilled water.
Claims (9)
1, a kind of pharmaceutical composition for the treatment of dermatosis is by the medicament that comprises that following proportioning ratio component is made.
Terbinafine HCl: triamcinolone acetonide acetate or betamethasone or halcinonidedcorten are (0.3～3.0): (0.005～0.5).
2, the pharmaceutical composition of treatment dermatosis according to claim 1, described set of dispense than ratio is:
Terbinafine HCl: triamcinolone acetonide acetate or betamethasone or halcinonidedcorten are (0.5～2.0): (0.01～0.2).
3, the pharmaceutical composition of treatment dermatosis according to claim 1, described set of dispense than ratio is:
Terbinafine HCl: triamcinolone acetonide acetate or betamethasone or halcinonidedcorten are 1.0: 0.1.
4, the pharmaceutical composition of treatment dermatosis according to claim 1, described compositions also comprise available adjuvant on the pharmaceutics.
5, the pharmaceutical composition of treatment dermatosis according to claim 4, described adjuvant can be for being selected from the antiseptic of benzoic acid, chlorhexidine acetate, neomycin or ciprofloxacin.
6, the pharmaceutical composition of treatment dermatosis according to claim 1, described medicament are said any percutaneous drug delivery dosage form on the pharmaceutics.
7, the pharmaceutical composition of treatment dermatosis according to claim 6, described pharmaceutical dosage form can be ointment, ointment, Emulsion, cream, gel, solution, tincture, oil preparation, spray, lotion, liniment, varnish, antiseptic.
8, a kind of treatment dermatosis preparation of compositions method, may further comprise the steps: in terbinafine HCl: triamcinolone acetonide acetate or betamethasone or halcinonidedcorten are that 0.3～3.0: 0.005～0.5 ratio takes by weighing raw material, according to conventional enepidermic preparation method preparation promptly.
9, preparation of drug combination method according to claim 8, described step also adds available adjuvant on the medicament.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03137395 CN1272012C (en) | 2003-06-23 | 2003-06-23 | Dermatopathy therapeutic medicine compositions and its preparation method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03137395 CN1272012C (en) | 2003-06-23 | 2003-06-23 | Dermatopathy therapeutic medicine compositions and its preparation method |
Publications (2)
| Publication Number | Publication Date |
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| CN1565459A true CN1565459A (en) | 2005-01-19 |
| CN1272012C CN1272012C (en) | 2006-08-30 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN 03137395 Expired - Fee Related CN1272012C (en) | 2003-06-23 | 2003-06-23 | Dermatopathy therapeutic medicine compositions and its preparation method |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100443085C (en) * | 2006-03-16 | 2008-12-17 | 中国人民解放军第二军医大学 | Externally applied compound gel and its preparing method |
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2003
- 2003-06-23 CN CN 03137395 patent/CN1272012C/en not_active Expired - Fee Related
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100443085C (en) * | 2006-03-16 | 2008-12-17 | 中国人民解放军第二军医大学 | Externally applied compound gel and its preparing method |
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| Publication number | Publication date |
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| CN1272012C (en) | 2006-08-30 |
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