Summary of the invention
The technical problem to be solved in the present invention is to provide a kind of pharmaceutical composition that is used for the treatment of beriberi foot odor with bacterio static itching-relieving, antiperspirant deodorant function.
For solving the problems of the technologies described above, the present invention is achieved by the following technical solutions:
Treat a pharmaceutical composition for beriberi foot odor, described compositions contains the component of following percentage by weight:
5%~25% plant extract, described plant extract is lantana and/or Radix Sophorae Flavescentis extract;
5%~25% antiperspirant, described antiperspirant is chlorination hydroxyl aluminum and/or zinc phenolsulfonate;
0.5%~5% horny layer softening agent, described horny layer softening agent is salicylic acid;
0.5%~5% emollient, described emollient is ethylhexyl glycerol.
40%~89% aqueous carrier.
The pharmaceutical composition of the above treatment beriberi foot odor, described aqueous carrier is mainly water, also contains one or more combinations in solubilizing agent, freshener, pH adjusting agent, chelating agen, antiseptic.
Medicine of the present invention and compositions, described plant extract is to adopt lantana, Radix Sophorae Flavescentis conventional extractive technique in pharmaceutics to prepare, its preparation method can be:
The preparation of extract from Lantana camara: it is appropriate to get lantana, decocts with water, and filters, and filtrate is concentrated, to obtain final product.
The preparation of Radix Sophorae Flavescentis extract: get Radix Sophorae Flavescentis appropriate, decoct with water, filter, filtrate is concentrated, to obtain final product.
More priority method for preparing can be:
The preparation of extract from Lantana camara: get lantana 10kg, decoct with water 1~3 time, filter, merging filtrate, is concentrated into 100kg, to obtain final product.
The preparation of Radix Sophorae Flavescentis extract: get Radix Sophorae Flavescentis 10kg, decoct with water 1~3 time, filter, merging filtrate, is concentrated into 100kg, to obtain final product.
Pharmaceutical composition of the present invention, plant extract wherein accounts for 5~25% of compositions, is preferably 10%~20%.
Pharmaceutical composition of the present invention, antiperspirant wherein accounts for 5%~25% of compositions, and preferably 10%~20%.
The compositions for the treatment of beriberi foot odor of the present invention, wherein aqueous carrier basis and the compatibility of other component and content and the kind of needed other characteristic selection carrier of product.This aqueous carrier is mainly water, can contain the additives such as solubilizing agent, freshener, pH adjusting agent, chelating agen, antiseptic, the consumption of additives consumption and determining routinely.
Pharmaceutical composition of the present invention, aqueous carrier wherein accounts for 40%~89% of pharmaceutical composition gross weight, is preferably 45%~80%.
Pharmaceutical composition of the present invention, contains solubilizing agent in aqueous carrier wherein, such as ethanol, Cremophor RH40, oleth-20 etc.; Freshener, such as Borneolum Syntheticum, Mentholum etc.; PH adjusting agent, such as Borax, sodium hydroxide etc.; Chelating agen, for example disodiumedetate; Antiseptic, such as triclosan, sodium benzoate, hexamethylenamine etc.
Pharmaceutical composition of the present invention can be prepared into needed dosage form by any conventional method known in the art.The wherein the most applicable liquid preparation that is prepared into, preparation method can be:
1. get plant extract, as solution A;
2. get pH adjusting agent and add water and be stirred in right amount dissolving, obtain solution B;
3. in container, add solubilizing agent, be stirred to dissolving, add salicylic acid, Sensiva SC50, freshener, antiseptic, be stirred to dissolve, after mixing, solution B is added and stirred evenly, obtain solution C;
4. in Agitation Tank, add water, antiperspirant, chelating agen and solution A, stirring and dissolving, in 80 ℃~90 ℃ insulations 30 minutes, is cooled to below 45 ℃, and solution C is added, and stirs while adding, and makes to mix, and adds water to preparation full dose, filters, canned.
Using method: can be used to foot bath, put foot or spray foot on the skin.
Each raw material of pharmaceutical composition of the present invention, lantana, Radix Sophorae Flavescentis play safe bacterio static itching-relieving effect; Chlorination hydroxyl aluminum, the safe and effective antiperspirant of zinc phenolsulfonate, deodorization, resist the secretion that regulates sweat gland; Salicylic acid horny layer softening, removes cutin; Sensiva SC50 effectively suppresses to cause the bacterial growth breeding of stink, plays the effect of deodorization, and the effect of antibacterial, antipruritic, hidroschesis, deodorization is brought into play in the combination of above raw material jointly.
Adopt technical scheme of the present invention, make to have the good compatibility between this drug regimen raw material and adjuvant, human sense of comfort when use is good, and production cost is low, and constant product quality is suitable for producing in enormous quantities; Except the treatment for beriberi (tinea pedis), can also be used for the treatment of the fungal infection diseases such as tinea corporis, tinea cruris, the tinea manuum.
By reading description and appending claims below, can understand better these and other feature, aspect and advantage of the present invention.
The specific embodiment
Except as otherwise noted, hereinafter all percentage ratio used and ratio all by the weighing scale of total composition.Except as otherwise noted, all actual contents based on this composition of all percentage ratios, ratio and the content of related composition herein, and solvent, filler or other material that can combine with these compositions not included in commercially available prod.
Except as otherwise noted, all measurements of mentioning herein are all carried out at 25 ℃.
" comprise/comprise " herein and refer to and can add other step and the composition that do not affect final result.This term comprise term " by ... composition " and " substantially by ... form ".
As used herein, word " comprises ", to be intended to be nonrestrictive for " comprising " and its variant, and making narration in entry not get rid of other may be in compositions of the present invention also useful similar entry.
As used herein, word " preferably " and variant refer to embodiment of the present invention that specific beneficial effect can be provided under specific environment.But other embodiment can be also preferred under identical or other environment.In addition, the detailed description of one or more preferred embodiments does not represent that other embodiment is useless, and is not intended to get rid of from category of the present invention other embodiment.
raw material
Lantana is stem, the Ye Jihua of Verbenaceae lantana Lantana camara L..For Guangxi special medicinal material, effect of tool heat-clearing and toxic substances removing, can be used for treating eczema, dermatitis, skin pruritus etc.
Radix Sophorae Flavescentis is the dry root of leguminous plant Radix Sophorae Flavescentis Sophora flavescens Ait..For the medicinal herbs most in use in treatment beriberi proved recipe among the people, the effects such as tool is antibacterial, antiinflammatory, antiallergic, are used for the treatment of the dermatosiss such as eczema, dermatitis, skin pruritus.
The content of plant extract in compositions is 5%~25%, in order to send better beneficial effect, i.e. and balance between " antipruritic effect " and " production cost ", its content is preferably 10%~20%, and more preferably 12%~18%.
Pharmaceutical composition of the present invention comprises antiperspirant, and it accounts for 5%~25% in compositions.Antiperspirant comprises chlorination hydroxyl aluminum, zinc phenolsulfonate.Chlorination hydroxyl aluminum, is called again aluminium chlorhydroxide (BAC), for white or micro-yellow solid powder, is conventional antiperspirant.Zinc phenolsulfonate has good dissolubility in water, is widely used as antiperspirant, astringent.In order to send better beneficial effect, i.e. balance between " antiperspirant effect " and " production cost ", antiperspirant preferred content is 10%~20%, more preferably 12%~18%.
Compositions of the present invention comprises 0.5%~5% horny layer softening agent.As: salicylic acid.Salicylic acid can soften removal horny layer, promotes epidermis cell to upgrade fast simultaneously, and in medical industry, salicylic acid itself, as Cidex-7, infects for local hyperkeratosis and skin fungus.In order to send better beneficial effect, i.e. balance between " bating effect " and " compatibility in preparation ", preferred content is 0.8%~3%, more preferably 1%~2%.
Compositions of the present invention comprises 0.5%~5% emollient.As: Sensiva SC50.Sensiva SC50 is that one has polyfunctional wetting agent, except having good moisture-keeping functions, also has certain antibacterial effect.In order to send better beneficial effect, i.e. balance between " result of use of skin moistening moisturizing " and " compatibility in preparation ", preferred content is 0.5%~3%, more preferably 0.5%~2%.
aqueous carrier
Compositions of the present invention comprises aqueous carrier.According to selecting content and the kind of described carrier with the compatibility of other component and required other characteristic of product.This aqueous carrier contains freshener, solubilizing agent, pH adjusting agent, chelating agen, antiseptic, water, so that this product good stability, human sense of comfort etc. while guaranteeing to use.
Compositions of the present invention contains approximately 40%~89% aqueous carrier, preferably approximately 45%~80% aqueous carrier conventionally.
In aqueous carrier, contain other component.These components comprise: solubilizing agent, such as ethanol, Cremophor RH40, oleth-20 etc.; Freshener, such as Borneolum Syntheticum, Mentholum etc.; PH adjusting agent, such as Borax, sodium hydroxide etc.; Chelating agen, such as EDTA disodium etc.; Antiseptic, such as triclosan, sodium benzoate, hexamethylenamine etc.
product form
it is of the present invention that best to use dosage form be solution, can adopt different packings so that be used for foot bath, put foot or spray foot on the skin, also can use it for shoes inside, the socks etc. of direct contact feet.
clinical trial
1. case selection standard
1.1 diagnostic criteria
1. symptom:
Vesicle: between toe, grain of rice size appears in sufficient edge, vola, deeply in property vesicle, evacuates or distributes in groups, bleb wall is thicker, content is limpid, is difficult for breaking, and mutually merges and forms kerionic vesicle, tear bleb wall off, the rotten to the corn face of visible honeycomb substrate and cerise, violent pruritus.
Erosive type: local horny layer of epidermis is macerated and turned white, exfoliation, exposes the rotten to the corn face of cerise; Acute pruritus, is mainly between the 3rd, 4,5 toe seams.
Squama keratinization type: the sufficient sole of the foot, sufficient edge, heel portion skin toe thicken, coarse, desquamation, and squama slabbing or little point-like, come off repeatedly.
2. microscopy: the direct microscopy of fungus, is positive.
1.2 inclusive criteria
1. meet one of symptom of above-mentioned diagnostic criteria and the microscopy person of being positive.
2. the age is 18-65 year person.
1.3 exclusion standard
1.3.1 do not meet above-mentioned diagnostic criteria person.
Though 1.3.2 meet above-mentioned standard, there is the one of following situation simultaneously:
1. pregnant and lying-in women or women breast-feeding their children;
2. oral antifungal drug person in 3 months;
3. antimycotic medicine for external application person in 1 month;
4. to pharmaceutical composition allergy sufferers of the present invention;
5. fail according to course of therapy person;
6. prolonged application corticosteroid hormone, immunosuppressant or serious immunologic hypofunction person.
7. not medication in accordance with regulations, cannot judge that curative effect or data are not congruent to affect the treatment and safety judgement person.
2. efficacy determination
Carrying out comprehensive judgement point recovery from illness, effective, improvement, invalid 4 grade standards judges.
1. recovery from illness: fungus microscope examination is negative, and skin lesion disappears substantially, subjective symptoms disappears.
2. effective: fungus microscope examination is negative or rarely seen a small amount of broken mycelia of rupturing, being out of shape, and skin lesion disappears 60%, and gargalesthesia obviously alleviates or disappears.
3. take a turn for the better: fungus microscope examination is positive, and skin lesion goes down more than 20%, and gargalesthesia alleviates.
4. invalid: fungus microscope examination is positive, skin lesion changes little or expands, and gargalesthesia is the same or increase the weight of.
3. medication
1. treatment group: affected part is the outer product of putting embodiment 1 on the skin directly, and 2 times on the 1st, continuous 3 weeks is a course for the treatment of.
2. matched group: affected part is directly outer puts naftifine hydrochloride and ketoconazole cream on the skin, and 2 times on the 1st, continuous 3 weeks is a course for the treatment of.
4. result
Treatment group 65 examples, the routine patient of matched group 50 are through the treatment of a course for the treatment of, the results detailed in following table.
Efficacy result table
Result of the test shows: treatment group cure rate and total effective rate be a little higher than matched group all.Illustrate that pharmaceutical composition of the present invention can kill pathomycete, various Propagation Methods and the mode of blocking-up pathomycete; Containing Chinese medicine formula, through clinical verification, to epiderm skin tissue, subcutaneous tissue not damaged, non-stimulated and toxic and side effects; There is good bacterio static itching-relieving, antiperspirant deodorant function, can effectively improve foot's skin environment; Human body comfort is good compared with cream, and patient is happy to use.
the preparation of the pharmaceutical composition for the treatment of beriberi foot odor
The following example has further described and has proved the embodiment in the scope of the invention.These embodiment are only illustrative, but not limit the scope of the invention, because its many modification are possible in the situation that not deviating from the spirit and scope of the invention.
formula
The composition of embodiment 1~9 pharmaceutical composition: unit (%)
preparation method
Above the pharmaceutical composition of said embodiment 1~9 can be by any conventional method preparation known in the art.They can make by following appropriate ways:
the preparation method of embodiment 1~3
The preparation of extract from Lantana camara: get lantana 10kg, decoct with water 2 times, adding water for the first time 10 times to measure decocts 2 hours, and adding water for the second time 8 times to measure decocts 1.5 hours, filters, and merging filtrate, is concentrated into 100kg, to obtain final product.
The preparation of Radix Sophorae Flavescentis extract: get Radix Sophorae Flavescentis 10kg, decoct with water 2 times, adding water for the first time 10 times to measure decocts 2 hours, and adding water for the second time 8 times to measure decocts 1.5 hours, filters, and merging filtrate, is concentrated into 100kg, to obtain final product.
The preparation of finished product:
A. get plant extract by prescription, as solution A;
B. get pH adjusting agent and add water and be stirred in right amount dissolving, obtain solution B;
C. in container, add solubilizing agent, be stirred to dissolving, add salicylic acid, Sensiva SC50, freshener, antiseptic, be stirred to dissolve, after mixing, solution B is added and stirred evenly, obtain solution C;
D. in Agitation Tank, add water, antiperspirant, chelating agen and solution A, stirring and dissolving, in 80 ℃~90 ℃ insulations 30 minutes, is cooled to below 45 ℃, and solution C is added, and stirs while adding, and makes to mix, and adds water to preparation full dose, filters, canned.
the preparation method of embodiment 4~6(if in formula, not adding without this composition)
The preparation of extract from Lantana camara: get lantana 10kg, decoct with water 2 times, adding water for the first time 10 times to measure decocts 2 hours, and adding water for the second time 8 times to measure decocts 1.5 hours, filters, and merging filtrate, is concentrated into 100kg, to obtain final product.
The preparation of finished product:
A. get plant extract by prescription, as solution A;
B. get pH adjusting agent and add water and be stirred in right amount dissolving, obtain solution B;
C. in container, add solubilizing agent, be stirred to dissolving, add salicylic acid, Sensiva SC50, freshener, antiseptic, be stirred to dissolve, after mixing, solution B is added and stirred evenly, obtain solution C;
D. in Agitation Tank, add water, antiperspirant, chelating agen and solution A, stirring and dissolving, in 80 ℃~90 ℃ insulations 30 minutes, is cooled to below 45 ℃, and solution C is added, and stirs while adding, and makes to mix, and adds water to preparation full dose, filters, canned.
the preparation method of embodiment 7~9(if in formula, not adding without this composition)
The preparation of Radix Sophorae Flavescentis extract: get Radix Sophorae Flavescentis 10kg, decoct with water 3 times, adding water for the first time 10 times to measure decocts 2 hours, and adding water for the second time 8 times to measure decocts 1.5 hours, and adding water for the third time 8 times to measure decocts 1 hour, filters, and merging filtrate, is concentrated into 100kg, to obtain final product.
The preparation of finished product:
A. get plant extract by prescription, as solution A;
B. get pH adjusting agent and add water and be stirred in right amount dissolving, obtain solution B;
C. in container, add solubilizing agent, be stirred to dissolving, add salicylic acid, Sensiva SC50, freshener, antiseptic, be stirred to dissolve, after mixing, solution B is added and stirred evenly, obtain solution C;
D. in Agitation Tank, add water, antiperspirant, chelating agen and solution A, stirring and dissolving, in 80 ℃~90 ℃ insulations 30 minutes, is cooled to below 45 ℃, and solution C is added, and stirs while adding, and makes to mix, and adds water to preparation full dose, filters, canned.