CN102274377B - Chinese medicinal composition for treating superficial mycosis infection and medicinal composition thereof - Google Patents
Chinese medicinal composition for treating superficial mycosis infection and medicinal composition thereof Download PDFInfo
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Abstract
The invention relates to the technical field of traditional Chinese medicines, in particular to a Chinese medicinal composition for treating superficial mycosis infection and a medicinal composition thereof, and discloses a Chinese medicinal composition for treating superficial mycosis infection. The Chinese medicinal composition is characterized by comprising the following single traditional Chinese medicines in parts by weight: 15-25 parts of dye yam, 17-23 parts of lightyellow sophora root and 8-15 parts of alum. Compared with the prior art, the Chinese medicinal composition has the remarkable advantages of innovative formula, safety, no toxic or side effect, and wide application range.
Description
Technical field
The present invention relates to technical field of Chinese medicines, be specifically related to a kind of Chinese medicine composition and pharmaceutical composition thereof of treating mycotic infection of superficial part.
Background technology
Mycotic infection of superficial part is that clinical common skin is one of sick, belongs to that the traditional Chinese medical science is damp and hot invades excessive disease, erythema, pimple, vesicle are arranged, oozes out, symptoms such as erosion, desquamation, pruritus, pain, seriously hinders people's orthobiosis and work; And high, the protracted course of disease of this sick sickness rate.Mostly the medicine of treatment superficial skin fungus infection is two big types at present: one type is to be the medicine of main component with the Western medicine; How with chemicals and antibiotic symptomatic treatment, like ZUGUANG SAN, 1% Calamine Lotion, PINGYANPING RUANGAO, miconazole ointment, ketoconazole ointment etc.These Western medicine can only play some mitigations to the state of an illness, and can not change dermopathic natural history, and life-time service can produce drug resistance and causes failing to respond to any medical treatment.Another kind of be pure Chinese medicine ingredients like " JIEERYIN XIYE ", its main component is Chinese medicines such as Fructus Cnidii, Folium Artemisiae Argyi, Radix Angelicae Pubescentis, but this medicine is mainly used in gynaecopathia, and curative effect is not ideal enough, also there are problems such as dosage form is single, unsatisfactory curative effect in other Chinese medicines.
The Rhizoma Dioscoreae Cirrhosae classification is gone up and is belonged to the Dioscoreaceae Wild yam, is the perennial liana of unifacial leaf, mainly is distributed in the torrid zone and subtropical zone.In " South Uietnam notes ", Compendium of Material Medica and " China's book on Chinese herbal medicine " etc., medicinal record is arranged all, skin or as natural dye also is used to tan.The medicinal part of Rhizoma Dioscoreae Cirrhosae is its tuber, and chemical constituent mainly is tannin and glycoside, also contains compositions such as phenols and protein, saccharide, mucus.Rhizoma Dioscoreae Cirrhosae hardship, little acid, puckery, flat can blood circulation promoting and enrichings, astringent or styptic treatment for spontaneous sweating, the regulating QI to relieve pain of convergence, heat-clearing and toxic substances removing.Rhizoma Dioscoreae Cirrhosae can also make the protein coagulating in the exudate after the wound, forms the crust film, causes to reduce secretion and protect from infection, and the blood capillary of wound surface is shunk, and promotes anastalsis.Rhizoma Dioscoreae Cirrhosae all has a certain curative effect to gynecological bleeding, spitting of blood, purpura hemorrhagica, cancer are hemorrhage etc.Take orally and can be used for treating diseases such as gastrointestinal hemorrhage, ulcer and watery diarrhea.The Rhizoma Dioscoreae Cirrhosae hemostasis is rapid-action, the emergent curing when can be used for accident.In the patent that can retrieve aspect the Rhizoma Dioscoreae Cirrhosae medicinal application mainly is the patent that is used for child antidiarrhea (CN 1415327), treatment enteritis and dysentery (CN 1524564), treatment hemorrhoid (CN101428109, CN101361884 and CN1814130) or oncotherapy aspects such as (CN 1736457), does not still have the patent report that is not used to treat cutaneous fungal infection about Rhizoma Dioscoreae Cirrhosae.
Summary of the invention
The purpose of this invention is to provide a kind of treat mycotic infection of superficial part good effect, applied range, safely, the natural Chinese medicines preparation and the pharmaceutical composition thereof that have no side effect.
For this reason, the invention discloses a kind of Chinese medicine composition of treating mycotic infection of superficial part, it is characterized in that it comprises the single medicinal material by following weight part ratio:
Rhizoma Dioscoreae Cirrhosae 15-25 part,
Radix Sophorae Flavescentis 17-23 part,
Alumen 8-15 part.
In certain embodiments, said Chinese medicine composition is made up of the single medicinal material of following weight part ratio:
Rhizoma Dioscoreae Cirrhosae 15-25 part,
Radix Sophorae Flavescentis 17-23 part,
Alumen 8-15 part.
Wherein, optimum weight part ratio is: 9 parts of Rhizoma Dioscoreae Cirrhosaes, 10 parts of Radix Sophorae Flavescentiss, Alumen are 6 parts.
The present invention utilizes the determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs of the traditional Chinese medical science just, belongs to disease and damp and hotly invades excessive superficial skin fungus and infect and invent.This Chinese medicine preparation has the effect of heat clearing and damp drying, killing parasites for relieving itching and convergence.Be used for cutaneous fungal infection (hands, foot, body, tinea cruris) and belong to the damp and hot excessive disease of invading.Disease is seen affected part erythema, pimple, vesicle, is oozed out, erosion, desquamation, pruritus, pain etc.This Chinese medicine key component Rhizoma Dioscoreae Cirrhosae belongs to the Dioscoreaceae Wild yam, is the perennial liana of unifacial leaf, mainly is distributed in the torrid zone and subtropical zone.The medicinal part of Rhizoma Dioscoreae Cirrhosae is its tuber, and chemical constituent mainly is tannin and glycoside, also contains compositions such as phenols and protein, saccharide, mucus.In " not Lu ", South Uietnam notes ", Compendium of Material Medica and secretaries such as " China's books on Chinese herbal medicine " carry, the Rhizoma Dioscoreae Cirrhosae cold nature, nontoxic.Have heat-clearing and toxic substances removing, hemostasis is invigorated blood circulation, restrain antipruritic, promoting the circulation of QI to relieve pain, blood circulation promoting and blood stasis dispelling, function such as antibiotic.This maybe be relevant with its Main Ingredients and Appearance tannin.Be aided with in this composition and effectiveness have heat clearing and damp drying, the Radix Sophorae Flavescentis of dispelling wind for relieving itching and antipathogen effect and have detoxifcation, the Alumen etc. of controlling the effect of skin ulcer hemorrhoid scabies is main component, form have parasite killing dampness, the Chinese traditional compound medicine of convergence itching-relieving action.
In second aspect of the present invention, a kind of pharmaceutical composition of treating mycotic infection of superficial part is provided, its active substance and pharmaceutically acceptable carrier by following weight ratio is formed, and said active substance is the extract 1-99% of above-mentioned Chinese medicine composition; Pharmaceutically acceptable carrier surplus.
Said extract is the alcohol or the ketone water solution extract of above-mentioned Chinese medicine composition.Wherein said alcohol is methanol, ethanol, propanol or butanols, and said ketone is acetone.
Its preparation concrete steps do, after above-mentioned Chinese medicine composition is pulverized, with aqueous solutions such as ethanol or acetone soak, distill, concentrated and dry, finished product is the extract of above-mentioned Chinese medicine composition.
Said pharmaceutically acceptable carrier is one or more in excipient, binding agent, disintegrating agent, fluidizer and lubricant and the analog.
Said excipient is selected from one or more in carbomer resin, microcrystalline Cellulose, hydroxypropyl cellulose, sucrose, lactose, glucose, starch, modified starch, xanthan gum, sodium alginate, arabic gum, agar, pectin, gelatin, chitosan and the mannitol.
Said binding agent is selected from one or more in syrup, arabic gum, gelatin, Sorbitol, methylcellulose and the polyvinylpyrrolidone.
Said disintegrating agent is selected from one or more in starch, shuttle methylcellulose and salt, microcrystalline Cellulose, Polyethylene Glycol, crospolyvinylpyrrolidone, agar and the alginate.
Said fluidizer is selected from one or more in Pulvis Talci, magnesium stearate, calcium stearate and the tripoli.
Said lubricant is selected from one or more in magnesium stearate, sodium laurate and the glycerol.
The dosage form of said pharmaceutical composition comprises tablet, powder, gel, lotion, unguentum, membrane, cream, patch, suppository, effervescent tablet, instant, fast disintegrating tablet and foam.
Said mycotic infection of superficial part is that superficial skin fungus infects and/or women ' s genital tract infection.
It is rotten to the corn that said women ' s genital tract infection comprises bacterial vaginitis, monilial vaginitis, trichomonal vaginitis, Combination vaginitis, mycoplasma chlamydia infection, gonococcal infection, Uterine Cervix inflammation and official's neck.
Said superficial skin fungus infects and comprises the skin ulcer of fullying recover from an illness, acne, tineatonsurans or the dandruff, tinea barbae, tinea corporis, tinea cruris, the tinea manuum, tinea pedis or beriberi, tinea favosa, tinea unguium, psoriasis and tinea imbricata.
The present invention has following remarkable advantage compared with prior art:
Prescription innovation: the prepared herbal mixture of this problem is to be main component with the Rhizoma Dioscoreae Cirrhosae tannin; Rhizoma Dioscoreae Cirrhosae is the Chinese medicine in ethnic groups source; Carry according to secretaries such as " not Lu ", " book on Chinese herbal medicine ", Tang Materia Medicas; Rhizoma Dioscoreae Cirrhosae property emblem is cold, and is nontoxic, has heat-clearing and toxic substances removing, hemostasis and invigorates blood circulation, restrains antipruritic, promoting the circulation of QI to relieve pain, blood circulation promoting and blood stasis dispelling, function such as antibiotic.Rhizoma Dioscoreae Cirrhosae also has analgesia, hemostasis and astriction except that the fungicidal action of pressing down is arranged, this has great advantage as a kind of external skin medicine tool.And be aided with have heat clearing and damp drying, the Radix Sophorae Flavescentis of dispelling wind for relieving itching and antipathogen effect and have detoxifcation, the Alumen of controlling the effect of skin ulcer hemorrhoid scabies is main component.
Have no side effect safely: this Chinese medicine preparation utilizes pure Chinese medicine to process, and does not find untoward reaction such as skin exfoliation, twinge, redness, allergy in the test.This Chinese medicine powder of usefulness through skin toxicity test (2000mg/kg), is not seen untoward reaction to mice.
Applied range: the dermatosis to multiple shallow-layer cutaneous fungal infection all has significant curative effect.
Prescription of the present invention can also add the Chinese medicine that other has heat clearing and damp drying, killing parasites for relieving itching on the basis of above-mentioned three flavor medicines, like Mentholum, Borneolum Syntheticum, Flos Lonicerae, Radix Glycyrrhizae, Borax, artificial Calculus Bovis etc.
The specific embodiment
Rhizoma Dioscoreae Cirrhosae according to the invention is the tuber of Dioscoreaceae yam Rhizoma Dioscoreae hispidae (Dioscorea hispida Dennst.).
Radix Sophorae Flavescentis according to the invention is the dry root of leguminous plant Radix Sophorae Flavescentis (Sophora flavescens Ait.), and curing mainly function is heat clearing and damp drying, parasite killing, diuresis.Be used for hematodiarrhoea, have blood in stool, jaundice urine retention, leucorrhea with red and white discharge, swelling of the vulva pudendal pruritus, eczema, eczema, skin pruritus, scabies leprosy; External treatment trichomonal vaginitis.
Said extract is that the alcohol or the ketone aqueous solution of above-mentioned Chinese medicine composition mentioned thing.Wherein said alcohol is methanol, ethanol, propanol or butanols, and said ketone is acetone.
Its preparation concrete steps do, after above-mentioned Chinese medicine composition is pulverized, with aqueous solutions such as ethanol or acetone soak, distill, concentrated and dry, finished product is the extract of above-mentioned Chinese medicine composition.
If desired; With above-mentioned resulting Chinese medicine composition extract,, just can obtain the higher extract of purity again through subtractive process; Process for purification for example is to carry out the separation and purification one or many again with above-mentioned described column chromatography method respectively, just can obtain more highly purified extract as required; Or with above-mentioned resulting extract, the solvent with suitable polarity extracts respectively, and extracting solution reclaims solvent to the greatest extent, is concentrated into driedly, after the drying, just can obtain more highly purified extract as required.The solvent of said suitable polarity is selected from the methanol that volume ratio is 75-90: 25-10: water, ethanol: water, acetone: water, or ethyl acetate or chloroform.The extraction solvent that the present invention is used, when being mixed solvent, the ratio between each solvent can be proportioning commonly used in this area, for example the ethanol water of 30%, 60%, 70%, 90% (volume ratio) or methanol-water or acetone water.
Extraction of the present invention can be a method for distilling conventional in this area, like reflux, extract,, supersound extraction, ooze rumble extraction, supercritical carbon dioxide extraction etc.To those skilled in the art, this is conspicuous.
The used macroporous resin of the present invention, polyesteramine resin, polydextran gel resin etc. can be respectively resin materials commonly used in this area.For example macroporous resin is a D101 type macroporous resin, polydextran gel resin etc.The pretreatment of various resins and Regeneration Treatment etc. all are well known to those of ordinary skill in the art.
Said chromatographic column lock out operation is that the skilled person knows in this area; Described gradient elution, the gradient that determining alcohol changes in the eluant is that the skilled person is easy to confirm according to the situation of resin column in this area.During Fractional Collections; Can watch the colour band situation of resin column to carry out Fractional Collections through naked eyes; Also can carry out after equal-volume collects, the evaluation through routine contains merging of same composition after for example lamellae is identified; Also can carry out effluent and follow the tracks of discriminating, contain same composition and merge collection etc. through the means of routines such as thin layer chromatography technology.This is well-known to one skilled in the art.Thin layer chromatography technology can be referring to " Xu Rensheng " natural product chemistry " Science Press publishes the 589th page of June in 1997." for a person skilled in the art, this is conspicuous.
Drying of the present invention can be a drying means conventional in this area, as usually press dry dry, drying under reduced pressure, spray drying or lyophilization etc.
Chinese medicine composition according to the invention and extract thereof the purposes in the dermatosis of preparation shallow-layer cutaneous fungal infection.
Usually, when extract according to the invention was used for such use, they can process the pharmaceutical dosage form of body surface route of administration with one or more pharmaceutically acceptable carriers or mixed with excipients.
Said pharmaceutically acceptable carrier is one or more in excipient, binding agent, disintegrating agent, fluidizer and lubricant and the analog.
Said excipient is selected from one or more in carbomer resin, microcrystalline Cellulose, hydroxypropyl cellulose, sucrose, lactose, glucose, starch, modified starch, xanthan gum, sodium alginate, arabic gum, agar, pectin, gelatin, chitosan and the mannitol.
Said binding agent is selected from one or more in syrup, arabic gum, gelatin, Sorbitol, methylcellulose and the polyvinylpyrrolidone.
Said disintegrating agent is selected from one or more in starch, shuttle methylcellulose and salt, microcrystalline Cellulose, Polyethylene Glycol, crospolyvinylpyrrolidone, agar and the alginate.
Said fluidizer is selected from one or more in Pulvis Talci, magnesium stearate, calcium stearate and the tripoli.
Said lubricant is selected from one or more in magnesium stearate, sodium laurate and the glycerol.
Said control superficial skin fungus infects and the dosage form of women ' s genital tract infection medicine comprises tablet, powder, gel, lotion, unguentum, membrane, cream, patch, suppository, effervescent tablet, instant, fast disintegrating tablet and foam.
It is rotten to the corn that said women ' s genital tract infection comprises bacterial vaginitis, monilial vaginitis, trichomonal vaginitis, Combination vaginitis, mycoplasma chlamydia infection, gonococcal infection, Uterine Cervix inflammation and official's neck.
Said superficial skin fungus infects and comprises the skin ulcer of fullying recover from an illness, acne, tineatonsurans or the dandruff, tinea barbae, tinea corporis, tinea cruris, the tinea manuum, tinea pedis or beriberi, tinea favosa, tinea unguium, psoriasis and tinea imbricata.
Can having in the above-mentioned dosage form: aerosol, powder spray, powder through the body surface administration.The carrier instance that is fit in the powder spray comprises: lactose, glucosan, arabic gum, manna, glucose and sodium lauryl sulphate.The solvent that is fit in the aerosol is sterilized water, ethanol, vegetable oil, oleic acid.The propellant that is fit to is isceon, dichlorodifluoromethane, propane, iso-butane, carbon dioxide, nitrogen.
The method for preparing of Chinese medicine powder of treatment dermatomycosis is: the effect of getting it filled component raw material, at 60-80 ℃ of dry 30-40 minute, pulverize separately sieved, and dissolved by the weight proportion of composition and effectiveness, processed Chinese medicine powder.
The method for preparing of Chinese medicine lotion of treatment dermatomycosis is: by 1: the weight of 5-10, get it filled and imitate raw material and water, earlier Rhizoma Dioscoreae Cirrhosae and Radix Sophorae Flavescentis are decocted 10-25 minute after, add Alumen again and boiled 10-25 minute, filter, cooling, process Chinese medicine lotion.
The method for using of this preparation is: be used for affected part every day each 1 time sooner or later outward, 2-3 week is a course of treatment.To moist, erosive type skin infection, diseases such as foot odor, the mashed bifurcation of foot, available Chinese medicine powder is pounced on and is spread the affected part, and every day each 1 time sooner or later, 2-3 week is a course of treatment.Diseases such as adversary, foot, body, tinea cruris can be embrocated the affected part with Chinese medicine lotion stock solution, and every day each 1 time sooner or later, 2-3 week is a course of treatment; Or a with Chinese medicine lotion stock solution, add warm water 2-3 and doubly measure the back bathing, every day each 1 time sooner or later, 2-3 week is a course of treatment.To gynecological, andropathy such as women vaginitis, male's balanoposthitis, a capacity of available washing liquid stock solution adds warm water 1-2 and doubly measures the back seat bath, and every day each 1 time sooner or later, 2-3 week is a course of treatment.
The effective dose of pharmaceutical compositions for use can be with waiting that the order of severity of treating disease changes.Yet, usually when extract of the present invention every day with about 0.5-500mg/cm
2When the dosage of infection face gives, can obtain gratifying effect.
Below in conjunction with specific embodiment, further set forth the present invention.These embodiment only be used to the present invention is described and be not used in the restriction scope of the present invention.The experimental technique of unreceipted actual conditions in the following example is usually according to the normal condition or the condition of advising according to manufacturer.Only if definition separately, the same meaning that employed all specialties and scientific words and one skilled in the art are familiar with in the literary composition.In addition, any with the institute similar content of putting down in writing or the equalization method and material all can be applicable in the inventive method.The usefulness that preferable implementation method described in the literary composition and material only present a demonstration.
The preparation of embodiment 1 Chinese medicine composition and extract thereof
Table 1
| ? | Rhizoma Dioscoreae Cirrhosae | Radix Sophorae Flavescentis | Alumen |
| Powder 1 | 15 | 20 | 8 |
| Chinese medicine lotion 1 | 22 | 23 | 15 |
| Chinese medicine lotion 2 | 25 | 17 | 12 |
| Extract 1 | 9 | 10 | 6 |
| Extract 2 | 23 | 18 | 10 |
According to the listed proportioning of table 1, be prepared as follows:
The powder method for preparing: get it filled and imitate raw material (dry Rhizoma Dioscoreae Cirrhosae tuber need be pulverized), under 60-80 ℃ of temperature dry 35 minutes, pulverize respectively, sieve, match, mix by the weight proportion of above-mentioned composition and effectiveness, process Chinese powder medicine.
Chinese medicine lotion and preparation method thereof is undertaken by following mode:
By 1: the part by weight of 5-10 is got it filled and is imitated raw material and water, Rhizoma Dioscoreae Cirrhosae, Radix Sophorae Flavescentis, Alumen are progressively decocted 10-25 minute after, filter cleaner is cooled to room temperature, processes Chinese medicine lotion.
Extract and preparation method thereof is undertaken by following mode:
Rhizoma Dioscoreae Cirrhosae and method for preparing extractive thereof
The chemical constituent of Rhizoma Dioscoreae Cirrhosae is mainly tannin, and this has stronger antifungic action.Method for distilling is following: get dry Rhizoma Dioscoreae Cirrhosae tuber, pulverize the back and immerse other organic solvents such as 50%-70% ethanol or acetone, insulation was soaked 4 hours-6 hours; Ultrasonic 0.5 hour; Filter, filtering residue is with the similarity condition repetitive operation, and lixiviate is 3 times altogether; Merging filtrate, the centrifuging and taking supernatant, distilling under reduced pressure concentrates.After the concentrated solution drying, promptly get.Dye yam extract is a powdery, brownish red.
Main component in the Radix Sophorae Flavescentis, matrine have stronger antifungic action, and method for distilling is following:
Adopt the alcohol solvent extraction method: Radix Sophorae Flavescentis is dry, pulverizing, cross 20～60 mesh sieves then, the alcoholic solution with 60%, solid-liquid ratio are 1: 2, reflux, extract, 2 times.
Embodiment 2: the antifungal experiment
Method: in the preparation sabouraud culture medium and the triangular flask of packing into, autoclaving.Get respectively according to prepared Chinese medicine lotion stock solution among the embodiment 1 and 10,60,120 times of diluents and clotrimazole medicinal liquid stock solution and 10 times, 60 times, 120 times each 1ml of diluent with aseptic method and to inject in disinfectant plate; 5 plates of each dose groups (plate diameter 10cm); Inoculation 4 kinds of superficial mycosiss (trichophyton, trichophyton gypseum, Trichophyton floccosums when impouring Sha Shi cultivates then; The cenobium of the about 0.5mm of diameter); Cultivated for 1 weeks for 37 ℃, observe the colony growth state and have or not varied bacteria growing, measure colony diameter (mm) and with the contrast ware relatively.This Chinese medicine lotion has the mycocidal effect of good restraining as a result, and its effect is superior to clotrimazole.See table 1
The external antifungal experimental result of table 2 Chinese medicine lotion
* compares P＜0.01. with clotrimazole tinea liquid group
Embodiment 3, contained antibiotic preparation of extract.
Prepare by following prescription: (specification: the 200mg/ sheet)
Extract 1 among the embodiment 1 is mixed with starch, hydroxypropyl cellulose; Form the mixture of homogeneous, add polyethylene alkane ketone alkane ketone K30 aqueous solution again and granulate, coarse grain is crossed 16 mesh sieves; Dry; Granulate and mix with magnesium stearate is pressed into tablet with the gained granule more then, can it be dissolved in a certain amount of water during use and use.
Embodiment 4, contain the preparation of the effervescent tablet of extract.
Prepare by following prescription: (specification: the 100mg/ sheet)
Press above-mentioned weight proportion with extract 2, tartaric acid, sodium bicarbonate, low-substituted hydroxypropyl cellulose, methylcellulose, sodium lauryl sulphate mix homogeneously among the embodiment 1; Process soft material; Granulate through 20 mesh sieves, 60 ℃ dry down, reuse 18 mesh sieve granulate; Add the magnesium stearate mix homogeneously then, measure tabletting behind its content.
Embodiment 5, contained the preparation of the ointment of extract.
Prepare by following prescription:
Extract 1 30g among the embodiment 1
White vaseline 70g
Add up to 100g
With extract 1 among the embodiment 1, join in the white vaseline that has melted fill behind the mixing in the time of stirring.
Embodiment 6. contained the preparation of the powder of extract.
Prepare by following prescription:
Extract 1 99g among the embodiment 1
Methylcellulose 1g
Add up to 100g
With getting final product behind extract among the embodiment 11 and the methylcellulose mixing.
Embodiment 7, skin irritation test
Adult healthy New Zealand large ear rabbit, adaptability raised for 1 week.Powder is modulated to paste with adjuvant sodium carboxymethyl cellulose and glycerol (1: 40), is coated in the depilation district, covers one deck gauze, uses the nonirritant immobilization with adhesive tape, single sub-cage rearing.Intact skin group and artificial trauma skin group are established in test, in addition singly to be coated with adjuvant as matched group.
During test, after New Zealand's large ear rabbit back diamond wool cut short, with 20%Na 2S depilation, the QUMAO area was 10% of a body surface area, and no damaged skin New Zealand large ear rabbit is subsequent use behind the choosing depilation 24h.After the administration, continue to observe 3d, compare with matched group; No matter be intact skin or artificial trauma skin group, irritative responses such as pigmentation, petechia or edema are not all seen at the coating position, and the pachylosis situation is not seen notable difference yet; The result shows that this medicine does not have obvious irritation to skin.
Embodiment 8, acute dermal toxicity test
Test animal is selected, medicine is prepared, the test four together of animal depilation mode.Except that matched group, the drug test group is divided high, medium and low dose groups again, and the high dose group consumption reaches the 2g/kg body weight, establishes intact skin group and artificial trauma skin group again for every group, continues to observe 14d after the administration.No matter compare with matched group, be intact skin or artificial trauma skin group, do not see any discomfort or abnormal response, explains that this medicine uses no acute toxicity through skin.
[0101] scope of the present invention does not receive the restriction of said specific embodiments, and said embodiment also comprises the method and the component of functional equivalent only as the single example of illustrating various aspects of the present invention in the scope of the invention.In fact, except content as herein described, those skilled in the art can easily grasp multiple improvement of the present invention with reference to the description of preceding text.Said improvement also falls within the scope of appended claims.Every piece of list of references that preceding text are mentioned is listed this paper in as a reference all in full.
Claims (9)
1. Chinese medicine composition of treating mycotic infection of superficial part is characterized in that said Chinese medicine composition is made up of the single medicinal material of following weight part ratio: Rhizoma Dioscoreae Cirrhosae 15-25 part, Radix Sophorae Flavescentis 17-23 part, Alumen 8-15 part.
2. Chinese medicine composition as claimed in claim 1, it is characterized in that said Chinese medicine composition is made up of the single medicinal material of following weight part ratio: 9 parts of Rhizoma Dioscoreae Cirrhosaes, 10 parts of Radix Sophorae Flavescentiss, Alumen are 6 parts.
3. pharmaceutical composition of treating mycotic infection of superficial part, its active substance and pharmaceutically acceptable carrier by following weight ratio is formed,
Said active substance is the extract 1-99% of the said Chinese medicine composition of claim 1;
Pharmaceutically acceptable carrier surplus.
4. pharmaceutical composition as claimed in claim 3 is characterized in that said extract is that the alcohol or the ketone aqueous solution of the said Chinese medicine composition of claim 1 mentioned thing.
5. pharmaceutical composition as claimed in claim 3 is characterized in that said pharmaceutically acceptable carrier is one or more in excipient, binding agent, disintegrating agent, fluidizer and lubricant and the analog.
6. pharmaceutical composition as claimed in claim 3, the dosage form that it is characterized in that said pharmaceutical composition are tablet, powder, gel, lotion, unguentum, membrane, cream, patch, suppository, effervescent tablet, instant, fast disintegrating tablet or foam.
7. pharmaceutical composition as claimed in claim 3 is characterized in that said mycotic infection of superficial part is that superficial skin fungus infects and/or women ' s genital tract infection.
8. pharmaceutical composition as claimed in claim 7 is characterized in that said women ' s genital tract infection is bacterial vaginitis, monilial vaginitis, trichomonal vaginitis, Combination vaginitis, mycoplasma chlamydia infection, gonococcal infection, cervicitis or cervical erosion.
9. pharmaceutical composition as claimed in claim 7 is characterized in that said superficial skin fungus infection is the skin ulcer of fullying recover from an illness, acne, tineatonsurans or the dandruff, tinea barbae, tinea corporis, tinea cruris, the tinea manuum, tinea pedis or beriberi, tinea favosa, tinea unguium, psoriasis or tinea imbricata.
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| CN103285213B (en) * | 2013-06-09 | 2014-07-09 | 常智刚 | Broad spectrum external traditional Chinese medicine preparation for skins and preparation method thereof |
| CN103638095B (en) * | 2013-12-17 | 2015-09-16 | 山西大同大学 | A kind of preparation method of dermatosis treating medicine |
| CN110179956B (en) * | 2019-05-09 | 2021-07-20 | 重庆医药高等专科学校 | Traditional Chinese medicine external lotion for treating hyperhidrosis erosive beriberi |
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| 王庆蓉等.薯莨的药用价值.《职业与健康》.2009,第25卷(第6期),第649页第5段. |
| 薯莨的药用价值;王庆蓉等;《职业与健康》;20090331;第25卷(第6期);第649页第5段 * |
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