CN102716394B - Medicine composition for treating skin diseases - Google Patents
Medicine composition for treating skin diseases Download PDFInfo
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- CN102716394B CN102716394B CN201210194487.2A CN201210194487A CN102716394B CN 102716394 B CN102716394 B CN 102716394B CN 201210194487 A CN201210194487 A CN 201210194487A CN 102716394 B CN102716394 B CN 102716394B
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Abstract
The invention relates to a medicine composition for treating skin diseases, in particular to a composition which is prepared with Chinese medicinal materials including radix sophorae flavescentis, rhizoma smilacis glabrae, oriental wormwood, golden cypress, rough gentian, cortex dictamni, purslane, broom cypress fruit, stemona, raw liquorice and optional menthol and borneol. The composition remarkably increases an itch irritating field, can effectively suppress mouse ear swelling, and has high expected safety. In addition, the composition can effectively suppress mouse ear swelling caused by dimethylbenzene, and can effectively suppress rat egg white induced paw swelling.
Description
Technical field
The invention belongs to technical field of Chinese medicines, relate to a kind of compositions that can be used for treatment or diseases such as eczema, pruritus of prevention dermatosis being prepared into by plurality of Chinese, particularly a kind of Chinese medicine composition that comprises Cortex Phellodendri, Radix Sophorae Flavescentis, Radix Gentianae, Radix Glycyrrhizae, Rhizoma Smilacis Glabrae etc.
Background technology
Take dermatosis that eczema, pruritus etc. are cardinal symptom for people's routine work and life puzzlement greatly.Eczema pathogenesis more complicated has important relationship with the allergic constitution of body with regard to intrinsic factor.In addition, overtired, psychentonia, insomnia, gastrointestinal function sexual disorders, emotion changes, and infection focus, dysbolism and endocrine function imbalance etc., all cause or increase the weight of the eczema state of an illness.External factor stimulates as sweltering heat, hyperhidrosis, scratch, friction, daylight, ultraviolet, cold, various animal skin, plant, chemical substance etc., all can bring out eczema.
In the situation that cannot removing extraneous risk factor, the control of eczema etc. mainly relies on Drug therapy.At present, Western medicine there is no specific short to eczema, adopts symptomatic treatment more.Take and take antihistamine drug treatment orally as many, as diphenhydramine, promethazine, chlorphenamine, Cyproheptadine etc., also can share with tranquilizer, vitamin C etc.Medicine for external use is conventional 3% boric acid solution, 5% lead acetate solution, reach inner Podbielniak (copper sulfate, zinc sulfate) solution, and corticosteroid cream, paste etc., if occur infecting, share antimicrobial ointment.Antihistamine drug has central inhibitory action, causes drowsiness and feeling of fatigue after taking.Hormone therapy is generally 2～3 weeks the course for the treatment of, but easily knock-on after drug withdrawal.There is more untoward reaction in hormone medicine, can cause atrophoderma, telangiectasis, acne, acne rosacea, purpura, Perioral Dermatitis etc., life-time service Hormonal ointment also may cause systemic side effects, as Decrease of Bone Mineral Density, HHA (HPA) axle inhibitory action, growth inhibited, cataract etc.Local immunity regulator is the series of new medicine recently occurring, can local topical, there is no the side effect of general immunosuppressant, and be that a class has the medicine of broad prospect of application in department of dermatologry field.Immunomodulator tacrolimus or pimecrolimus topical application can have good curative effect to dermatitis, eczema, and without the untoward reaction of external corticosteroid hormone.But can cause the systemic adverse reactions such as influenza-like symptom, heating, headache.The multicenter study of a placebo shows, there is influenza-like symptom in approximately 30% patient, there is headache in 19% patient, arthralgia, backache, skin tingling, photaesthesia, allergy etc. appear in only a few patient, is obviously not suitable for battlefield or disaster relief front and uses.
Chinese medical discrimination thinks that eczema belongs to syndrome of excessive dampness-heat, and the pathogeny of eczema comes from daily intemperance of taking food, injures taste, and dysfunction of the spleen in transportation causes retention of damp-heat in the interior, diseases caused by exogenous pathogenic factor rheumatism pathogenic heat again, and inside and outside two heresies are fought mutually, fill in space between skin and muscles contamination skin.Physical weakness, spleen for wet because of, failure of skin and muscle to be nourished.Or accumulate for a long time because of damp and hot, consumption impairment of YIN blood, the raw wind of dryness-transformation, and cause blood-deficiency and wind-dry, squamous and dry skin all can cause eczema.Damp, for the principal element of morbidity, because damp pathogen being sticky and stagnant in nature is weighing, is easily made things difficult for, therefore the dermatosis that damp causes, its skin lesion is pleomorphism, and the state of an illness is touching, is difficult to speed more.In treatment, always take damp eliminating as first, or cleaning heat and expelling wind dampness removing, or drying damp and strengthening spleen or invigorating the spleen for eliminating dampness, or the dehumidifying of invigorating blood circulation, or yin nourishing dehumidifying etc. treats with disease, often can receive expected effect.
Non-hormone Drug therapy is the orientation treatment of eczema, and treatment by Chinese herbs systemic side effects is little, and external preparation topical therapeutic is more direct, also can reduce the systemic side effects of medicine, and therefore, finding effective Chinese medicine for external application is an important directions for the treatment of eczema.
Pruritus is the top layer of skin and the sensation (gargalesthesia) that the mucosa adjacent with skin occurs.Gargalesthesia is a kind of parasite of perception skin surface and stimulus object to move the sensation of removing invader, stimulus object by pruritus.Pruritus is to be easily interpreted as to cause a kind of sensation of wanting the impulsion scratched, but its mechanism is understood not yet completely.
Disease with pruritus, with the itching skin disease of dermatosis (for example roughly can be categorized as, dermatitis, urticaria, psoriasis, xeroderma, tineatonsurans), and [for example do not accompany the kidney dialysis of dermatosis and viscera disease, diabetes, hematologic disease, cholestasis hepatopathy (primary biliary cirrhosis) and nephropathy], the pruritus that hyperthyroidism, multiple sclerosis etc. causes is skin pruritus (pruritus cutaneous).Other diseases with strong gargalesthesia can be enumerated the corneas such as anaphylaxis conjunctivitis, conjunctival disease.These diseases increase very fast in recent years, from the viewpoint of quality of life (QOL), are becoming large problem.A lot of common ground that the disease of pruritus occurs are to cause vicious cycle owing to scratching brokenly.The representative of having notified the material that causes pruritus has histamine, in external world's introducing or body, from mastocyte, dissociates and all can cause pruritus.
The treatment of itching skin disease can be used antihistaminic and anti-allergic drug, external steroid drugs etc.Yet they all occur side effect, also there is no to meet the medicine of the pruritus treatment that itching skin disease causes.And, report that recently the pruritus of atopic dermatitis has the histamine factor in addition to participate in, there is in fact clinically many cases to show that antihistaminic and anti-allergic drug do not have significant curative effect to the pruritus of atopic dermatitis.The treatment of skin pruritus is sometimes also with antihistaminic and external steroidal medicine prescription, but almost there is no effect, also there is no at present effective Therapeutic Method, there is no to meet the medicine of the treatment of the above-mentioned disease with pruritus, thirst for clinically no matter its disease is former thereby can effectively suppress the medicine of pruritus.
People conventionally will consider their therapeutic effect when searching can be used for the Chinese medicine for the treatment of or prevention dermatosis such as eczema, pruritus etc., and the safety of Chinese medicine and toleration conventionally than more excellent in chemicals.Still need clinically at present to have new for antipruritic method, particularly use the method for the treatment of by Chinese herbs or prevention dermatosis such as eczema, pruritus etc.
Summary of the invention
The object of the invention is to a kind of method that provides new treatment or diseases such as eczema, pruritus of prevention dermatosis for clinical, the inventor finds to take the compositions that Cortex Phellodendri, Radix Sophorae Flavescentis, Radix Gentianae, Radix Glycyrrhizae, Rhizoma Smilacis Glabrae etc. are prepared as medical material, has gratifying treatment or prevents the effect of diseases such as eczema, pruritus of dermatosis.The present invention is based on this discovery and be accomplished.
For this reason, first aspect present invention provides a kind of compositions, and it is by comprising that following Chinese crude drug is prepared into: Radix Sophorae Flavescentis, Rhizoma Smilacis Glabrae, Herba Artemisiae Scopariae, Cortex Phellodendri, Radix Gentianae, Cortex Dictamni, Herba Portulacae, the Fructus Kochiae, the Radix Stemonae, Radix Glycyrrhizae.
According to the compositions of first aspect present invention, in its medical material, Radix Sophorae Flavescentis is in 8 weight portions, and Rhizoma Smilacis Glabrae amount is 3-24 weight portion, for example 5-20 weight portion, for example 8-18 weight portion, for example 10-15 weight portion, for example approximately 12 weight portions.
According to the compositions of first aspect present invention, in its medical material, Radix Sophorae Flavescentis is in 8 weight portions, and Herba Artemisiae Scopariae amount is 2-16 weight portion, for example 3-15 weight portion, for example 4-12 weight portion, for example 5-10 weight portion, for example approximately 8 weight portions.
According to the compositions of first aspect present invention, in its medical material, Radix Sophorae Flavescentis is in 8 weight portions, and Cortex Phellodendri amount is 2-16 weight portion, for example 3-15 weight portion, for example 4-12 weight portion, for example 5-10 weight portion, for example approximately 8 weight portions.
According to the compositions of first aspect present invention, in its medical material, Radix Sophorae Flavescentis is in 8 weight portions, and Radix Gentianae amount is 1.5-12 weight portion, for example 2-10 weight portion, for example 3-9 weight portion, for example 4-8 weight portion, for example approximately 6 weight portions.
According to the compositions of first aspect present invention, in its medical material, Radix Sophorae Flavescentis is in 8 weight portions, and Cortex Dictamni amount is 2-16 weight portion, for example 3-15 weight portion, for example 4-12 weight portion, for example 5-10 weight portion, for example approximately 8 weight portions.
According to the compositions of first aspect present invention, in its medical material, Radix Sophorae Flavescentis is in 8 weight portions, and Herba Portulacae amount is 1.5-12 weight portion, for example 2-10 weight portion, for example 3-9 weight portion, for example 4-8 weight portion, for example approximately 6 weight portions.
According to the compositions of first aspect present invention, in its medical material, Radix Sophorae Flavescentis is in 8 weight portions, and Fructus Kochiae amount is 2-16 weight portion, for example 3-15 weight portion, for example 4-12 weight portion, for example 5-10 weight portion, for example approximately 8 weight portions.
According to the compositions of first aspect present invention, in its medical material, Radix Sophorae Flavescentis is in 8 weight portions, and Radix Stemonae amount is 2.5-20 weight portion, for example 3-18 weight portion, for example 5-15 weight portion, for example 8-12 weight portion, for example approximately 10 weight portions.
According to the compositions of first aspect present invention, in its medical material, Radix Sophorae Flavescentis is in 8 weight portions, and Radix Glycyrrhizae amount is 1.5-12 weight portion, for example 2-10 weight portion, for example 3-9 weight portion, for example 4-8 weight portion, for example approximately 6 weight portions.
According to the compositions of first aspect present invention, it is by comprising that following Chinese crude drug is prepared into: Radix Sophorae Flavescentis 8 weight portions, Rhizoma Smilacis Glabrae 3-24 weight portion, Herba Artemisiae Scopariae 2-16 weight portion, Cortex Phellodendri 2-16 weight portion, Radix Gentianae 1.5-12 weight portion, Cortex Dictamni 2-16 weight portion, Herba Portulacae 1.5-12 weight portion, Fructus Kochiae 2-16 weight portion, Radix Stemonae 2.5-20 weight portion, Radix Glycyrrhizae 1.5-12 weight portion.
According to the compositions of first aspect present invention, it is by comprising that following Chinese crude drug is prepared into: Radix Sophorae Flavescentis 8 weight portions, Rhizoma Smilacis Glabrae 8-18 weight portion, Herba Artemisiae Scopariae 4-12 weight portion, Cortex Phellodendri 4-12 weight portion, Radix Gentianae 3-9 weight portion, Cortex Dictamni 4-12 weight portion, Herba Portulacae 3-9 weight portion, Fructus Kochiae 4-12 weight portion, Radix Stemonae 5-15 weight portion, Radix Glycyrrhizae 3-9 weight portion.
According to the compositions of first aspect present invention, it is by comprising that following Chinese crude drug is prepared into: Radix Sophorae Flavescentis 8 weight portions, Rhizoma Smilacis Glabrae 12 weight portions, Herba Artemisiae Scopariae 8 weight portions, Cortex Phellodendri 8 weight portions, Radix Gentianae 6 weight portions, Cortex Dictamni 8 weight portions, Herba Portulacae 6 weight portions, the Fructus Kochiae 8 weight portions, the Radix Stemonae 10 weight portions, Radix Glycyrrhizae 6 weight portions.
According to the compositions of first aspect present invention, in wherein said medical material, also comprise Mentholum and/or Borneolum Syntheticum.In one embodiment, in described medical material, also comprise Mentholum.In one embodiment, in described medical material, also comprise Borneolum Syntheticum.In one embodiment, in described medical material, also comprise Mentholum and Borneolum Syntheticum.
According to the compositions of first aspect present invention, in its medical material, Radix Sophorae Flavescentis is in 8 weight portions, and Herba Menthae brain volume is 0.1-3 weight portion, for example 0.3-2 weight portion, for example 0.5-1 weight portion, for example 0.7-0.9 weight portion, for example approximately 0.8 weight portion.
According to the compositions of first aspect present invention, in its medical material, Radix Sophorae Flavescentis is in 8 weight portions, and Borneolum Syntheticum amount is 0.1-2 weight portion, for example 0.2-1.5 weight portion, for example 0.3-1.0 weight portion, for example 0.4-0.6 weight portion, for example approximately 0.53 weight portion.
According to the compositions of first aspect present invention, it is by comprising that following Chinese crude drug is prepared into: Radix Sophorae Flavescentis 8 weight portions, Rhizoma Smilacis Glabrae 3-24 weight portion, Herba Artemisiae Scopariae 2-16 weight portion, Cortex Phellodendri 2-16 weight portion, Radix Gentianae 1.5-12 weight portion, Cortex Dictamni 2-16 weight portion, Herba Portulacae 1.5-12 weight portion, Fructus Kochiae 2-16 weight portion, Radix Stemonae 2.5-20 weight portion, Radix Glycyrrhizae 1.5-12 weight portion, Mentholum 0.1-3 weight portion, Borneolum Syntheticum 0.1-2 weight portion.
According to the compositions of first aspect present invention, it is by comprising that following Chinese crude drug is prepared into: Radix Sophorae Flavescentis 8 weight portions, Rhizoma Smilacis Glabrae 8-18 weight portion, Herba Artemisiae Scopariae 4-12 weight portion, Cortex Phellodendri 4-12 weight portion, Radix Gentianae 3-9 weight portion, Cortex Dictamni 4-12 weight portion, Herba Portulacae 3-9 weight portion, Fructus Kochiae 4-12 weight portion, Radix Stemonae 5-15 weight portion, Radix Glycyrrhizae 3-9 weight portion, Mentholum 0.8-2 weight portion, Borneolum Syntheticum 0.2-1.5 weight portion.
According to the compositions of first aspect present invention, it is by comprising that following Chinese crude drug is prepared into: Radix Sophorae Flavescentis 8 weight portions, Rhizoma Smilacis Glabrae 12 weight portions, Herba Artemisiae Scopariae 8 weight portions, Cortex Phellodendri 8 weight portions, Radix Gentianae 6 weight portions, Cortex Dictamni 8 weight portions, Herba Portulacae 6 weight portions, the Fructus Kochiae 8 weight portions, the Radix Stemonae 10 weight portions, Radix Glycyrrhizae 6 weight portions, Mentholum 0.8 weight portion, Borneolum Syntheticum 0.53 weight portion.
According to the compositions of first aspect present invention, wherein also comprise the acceptable adjuvant of pharmacy.
According to the compositions of first aspect present invention, comprising the acceptable adjuvant of pharmacy.In one embodiment, the acceptable adjuvant of described pharmacy comprises carrier solvent.In one embodiment, described carrier solvent is selected from water and concentration lower than 50% ethanol.In one embodiment, described carrier solvent is 0-40% ethanol.In one embodiment, described carrier solvent is 10-30% ethanol.In one embodiment, described carrier solvent is approximately 20% ethanol.
According to the compositions of first aspect present invention, wherein said Radix Sophorae Flavescentis, Rhizoma Smilacis Glabrae, Herba Artemisiae Scopariae, Cortex Phellodendri, Radix Gentianae, Cortex Dictamni, Herba Portulacae, the Fructus Kochiae, the Radix Stemonae, Radix Glycyrrhizae join in described compositions through extracting.
According to the compositions of first aspect present invention, it is the form that is medicinal preparation for oral administration or topical agent.
According to the compositions of first aspect present invention, it is the form that is topical agent.
According to the compositions of first aspect present invention, it is to be to be selected from following medicine type: ointment, ointment, gel, liniment, spray.
According to the compositions of first aspect present invention, it is 10-500g that its every 100g or every 100ml amount to into crude drug total amount, for example 20-250g, for example 20-100g, for example 10-50g, for example 20-40g, for example 25-35g, for example about 30g.
According to the compositions of first aspect present invention, wherein also comprise and be selected from following adjuvant: acid-base modifier (such as hydrochloric acid, sodium hydroxide), antiseptic (such as mud pool tortoise beetle ester, ethyl ester, propyl ester), antibacterial (such as chlorobutanol), consistency modifiers (such as polyvidone, cellulose and derivatives class thereof) etc.
Second aspect present invention provides being combined in for the preparation of the purposes in the product for the treatment of or prevention mammal (such as people) dermatosis diseases such as eczema, pruritus of following traditional Chinese medicines material: Radix Sophorae Flavescentis, Rhizoma Smilacis Glabrae, Herba Artemisiae Scopariae, Cortex Phellodendri, Radix Gentianae, Cortex Dictamni, Herba Portulacae, the Fructus Kochiae, the Radix Stemonae, Radix Glycyrrhizae.
According to the purposes of second aspect present invention, in its medical material, Radix Sophorae Flavescentis is in 8 weight portions, and Rhizoma Smilacis Glabrae amount is 3-24 weight portion, for example 5-20 weight portion, for example 8-18 weight portion, for example 10-15 weight portion, for example approximately 12 weight portions.
According to the purposes of second aspect present invention, in its medical material, Radix Sophorae Flavescentis is in 8 weight portions, and Herba Artemisiae Scopariae amount is 2-16 weight portion, for example 3-15 weight portion, for example 4-12 weight portion, for example 5-10 weight portion, for example approximately 8 weight portions.
According to the purposes of second aspect present invention, in its medical material, Radix Sophorae Flavescentis is in 8 weight portions, and Cortex Phellodendri amount is 2-16 weight portion, for example 3-15 weight portion, for example 4-12 weight portion, for example 5-10 weight portion, for example approximately 8 weight portions.
According to the purposes of second aspect present invention, in its medical material, Radix Sophorae Flavescentis is in 8 weight portions, and Radix Gentianae amount is 1.5-12 weight portion, for example 2-10 weight portion, for example 3-9 weight portion, for example 4-8 weight portion, for example approximately 6 weight portions.
According to the purposes of second aspect present invention, in its medical material, Radix Sophorae Flavescentis is in 8 weight portions, and Cortex Dictamni amount is 2-16 weight portion, for example 3-15 weight portion, for example 4-12 weight portion, for example 5-10 weight portion, for example approximately 8 weight portions.
According to the purposes of second aspect present invention, in its medical material, Radix Sophorae Flavescentis is in 8 weight portions, and Herba Portulacae amount is 1.5-12 weight portion, for example 2-10 weight portion, for example 3-9 weight portion, for example 4-8 weight portion, for example approximately 6 weight portions.
According to the purposes of second aspect present invention, in its medical material, Radix Sophorae Flavescentis is in 8 weight portions, and Fructus Kochiae amount is 2-16 weight portion, for example 3-15 weight portion, for example 4-12 weight portion, for example 5-10 weight portion, for example approximately 8 weight portions.
According to the purposes of second aspect present invention, in its medical material, Radix Sophorae Flavescentis is in 8 weight portions, and Radix Stemonae amount is 2.5-20 weight portion, for example 3-18 weight portion, for example 5-15 weight portion, for example 8-12 weight portion, for example approximately 10 weight portions.
According to the purposes of second aspect present invention, in its medical material, Radix Sophorae Flavescentis is in 8 weight portions, and Radix Glycyrrhizae amount is 1.5-12 weight portion, for example 2-10 weight portion, for example 3-9 weight portion, for example 4-8 weight portion, for example approximately 6 weight portions.
According to the purposes of second aspect present invention, its medical material comprises: Radix Sophorae Flavescentis 8 weight portions, Rhizoma Smilacis Glabrae 3-24 weight portion, Herba Artemisiae Scopariae 2-16 weight portion, Cortex Phellodendri 2-16 weight portion, Radix Gentianae 1.5-12 weight portion, Cortex Dictamni 2-16 weight portion, Herba Portulacae 1.5-12 weight portion, Fructus Kochiae 2-16 weight portion, Radix Stemonae 2.5-20 weight portion, Radix Glycyrrhizae 1.5-12 weight portion.
According to the purposes of second aspect present invention, its medical material comprises: Radix Sophorae Flavescentis 8 weight portions, Rhizoma Smilacis Glabrae 8-18 weight portion, Herba Artemisiae Scopariae 4-12 weight portion, Cortex Phellodendri 4-12 weight portion, Radix Gentianae 3-9 weight portion, Cortex Dictamni 4-12 weight portion, Herba Portulacae 3-9 weight portion, Fructus Kochiae 4-12 weight portion, Radix Stemonae 5-15 weight portion, Radix Glycyrrhizae 3-9 weight portion.
According to the purposes of second aspect present invention, its medical material comprises: Radix Sophorae Flavescentis 8 weight portions, Rhizoma Smilacis Glabrae 12 weight portions, Herba Artemisiae Scopariae 8 weight portions, Cortex Phellodendri 8 weight portions, Radix Gentianae 6 weight portions, Cortex Dictamni 8 weight portions, Herba Portulacae 6 weight portions, the Fructus Kochiae 8 weight portions, the Radix Stemonae 10 weight portions, Radix Glycyrrhizae 6 weight portions.
According to the purposes of second aspect present invention, in wherein said medical material, also comprise Mentholum and/or Borneolum Syntheticum.In one embodiment, in described medical material, also comprise Mentholum.In one embodiment, in described medical material, also comprise Borneolum Syntheticum.In one embodiment, in described medical material, also comprise Mentholum and Borneolum Syntheticum.
According to the purposes of second aspect present invention, in its medical material, Radix Sophorae Flavescentis is in 8 weight portions, and Herba Menthae brain volume is 0.1-3 weight portion, for example 0.3-2.0 weight portion, for example 0.5-1 weight portion, for example 0.7-0.9 weight portion, for example approximately 0.8 weight portion.
According to the purposes of second aspect present invention, in its medical material, Radix Sophorae Flavescentis is in 8 weight portions, and Borneolum Syntheticum amount is 0.1-2 weight portion, for example 0.2-1.5 weight portion, for example 0.3-1.0 weight portion, for example 0.4-0.6 weight portion, for example approximately 0.53 weight portion.
According to the purposes of second aspect present invention, its medical material comprises: Radix Sophorae Flavescentis 8 weight portions, Rhizoma Smilacis Glabrae 3-24 weight portion, Herba Artemisiae Scopariae 2-16 weight portion, Cortex Phellodendri 2-16 weight portion, Radix Gentianae 1.5-12 weight portion, Cortex Dictamni 2-16 weight portion, Herba Portulacae 1.5-12 weight portion, Fructus Kochiae 2-16 weight portion, Radix Stemonae 2.5-20 weight portion, Radix Glycyrrhizae 1.5-12 weight portion, Mentholum 0.1-3 weight portion, Borneolum Syntheticum 0.1-2 weight portion.
According to the purposes of second aspect present invention, its medical material comprises: Radix Sophorae Flavescentis 8 weight portions, Rhizoma Smilacis Glabrae 8-18 weight portion, Herba Artemisiae Scopariae 4-12 weight portion, Cortex Phellodendri 4-12 weight portion, Radix Gentianae 3-9 weight portion, Cortex Dictamni 4-12 weight portion, Herba Portulacae 3-9 weight portion, Fructus Kochiae 4-12 weight portion, Radix Stemonae 5-15 weight portion, Radix Glycyrrhizae 3-9 weight portion, Mentholum 0.3-2 weight portion, Borneolum Syntheticum 0.2-1.5 weight portion.
According to the purposes of second aspect present invention, its medical material comprises: Radix Sophorae Flavescentis 8 weight portions, Rhizoma Smilacis Glabrae 12 weight portions, Herba Artemisiae Scopariae 8 weight portions, Cortex Phellodendri 8 weight portions, Radix Gentianae 6 weight portions, Cortex Dictamni 8 weight portions, Herba Portulacae 6 weight portions, the Fructus Kochiae 8 weight portions, the Radix Stemonae 10 weight portions, Radix Glycyrrhizae 6 weight portions, Mentholum 0.8 weight portion, Borneolum Syntheticum 0.53 weight portion.
According to the purposes of second aspect present invention, wherein said product comprises the acceptable adjuvant of pharmacy.In one embodiment, the acceptable adjuvant of described pharmacy comprises carrier solvent.In one embodiment, described carrier solvent is selected from water and concentration lower than 50% ethanol.In one embodiment, described carrier solvent is 0-40% ethanol.In one embodiment, described carrier solvent is 10-30% ethanol.In one embodiment, described carrier solvent is approximately 20% ethanol.
According to the purposes of second aspect present invention, wherein said Radix Sophorae Flavescentis, Rhizoma Smilacis Glabrae, Herba Artemisiae Scopariae, Cortex Phellodendri, Radix Gentianae, Cortex Dictamni, Herba Portulacae, the Fructus Kochiae, the Radix Stemonae, Radix Glycyrrhizae join in described product through extracting.
According to the purposes of second aspect present invention, wherein said product is the form that is medicinal preparation for oral administration or topical agent.
According to the purposes of second aspect present invention, wherein said product is the form that is topical agent.
According to the purposes of second aspect present invention, wherein said product is to be to be selected from following medicine type: ointment, ointment, gel, liniment, spray.
According to the purposes of second aspect present invention, it is 10-50g that the every 100g of wherein said product or every 100ml amount to into crude drug total amount, for example 20-40g, for example 25-35g, for example about 30g.
According to the purposes of second aspect present invention, in wherein said product, also comprise and be selected from following adjuvant: acid-base modifier (such as hydrochloric acid, sodium hydroxide), antiseptic (such as mud pool tortoise beetle ester, ethyl ester, propyl ester), antibacterial (such as chlorobutanol), consistency modifiers (such as polyvidone, cellulose and derivatives class thereof) etc.
Third aspect present invention provides the method for preparing compositions described in first aspect present invention any one, it comprises the following steps: by Radix Sophorae Flavescentis, Rhizoma Smilacis Glabrae, Herba Artemisiae Scopariae, Cortex Phellodendri, Radix Gentianae, Cortex Dictamni, Herba Portulacae, the Fructus Kochiae, the Radix Stemonae, Radix Glycyrrhizae solvent extraction, the extracting solution obtaining is concentrated, add optional Mentholum, Borneolum Syntheticum, and add the acceptable adjuvant of optional pharmacy, obtain.
According to the method for third aspect present invention, the solvent of wherein said extraction use is selected from water, aquiferous ethanol or ethanol.In one embodiment, the solvent of described extraction use is aquiferous ethanol.In one embodiment, described aquiferous ethanol is that concentration is the ethanol of 10-95%.In one embodiment, described aquiferous ethanol is that concentration is the ethanol of 20-90%.In one embodiment, described aquiferous ethanol is that concentration is the ethanol of 30-85%.In one embodiment, described aquiferous ethanol is that concentration is the ethanol of 40-80%.In one embodiment, described aquiferous ethanol is that concentration is the ethanol of 50-80%.Although the ethanol that the present invention is 50-80% at some example working concentrations is as the solvent that extracts use, the extract obtaining demonstrates excellent antipruritic effect, yet those skilled in the art understand, the ethanol of other concentration and water or ethanol all can be expected and obtained having the extract of good antipruritic effect, because in examples more of the present invention, direct Radix Sophorae Flavescentis 8 weight portions for oral use of experimenter, Rhizoma Smilacis Glabrae 12 weight portions, Herba Artemisiae Scopariae 8 weight portions, Cortex Phellodendri 8 weight portions, Radix Gentianae 6 weight portions, Cortex Dictamni 8 weight portions, Herba Portulacae 6 weight portions, the Fructus Kochiae 8 weight portions, the Radix Stemonae 10 weight portions, Radix Glycyrrhizae 6 weight portion crude drugs are directly pulverized the also compositions of encapsulated acquisition, under the dosage of 10g medical material/50kg body weight/day, reach the good antipruritic effect of total effective rate 88%.
In an embodiment of third aspect present invention method, the method comprises uses 65～85% alcohol reflux Radix Sophorae Flavescentiss, Rhizoma Smilacis Glabrae, Herba Artemisiae Scopariae, Cortex Phellodendri, Radix Gentianae, Cortex Dictamni, Herba Portulacae, the Fructus Kochiae, the Radix Stemonae, Radix Glycyrrhizae, concentrated extracting solution, add optional Mentholum, Borneolum Syntheticum, and add the acceptable adjuvant of optional pharmacy, obtain.
In an embodiment of third aspect present invention method, the method comprise and use 70～80% alcohol reflux Radix Sophorae Flavescentiss, Rhizoma Smilacis Glabrae, Herba Artemisiae Scopariae, Cortex Phellodendri, Radix Gentianae, Cortex Dictamni, Herba Portulacae, the Fructus Kochiae, the Radix Stemonae, Radix Glycyrrhizae 1-5 time altogether (for example 1-4 time, for example 1-3 time; Each 1-5 hour for example, each 1-4 hour for example, each 1-3 hour for example, for example each 2 hours), concentrated extracting solution to relative density is 1.01～1.30, filtering and impurity removing matter, add Mentholum, Borneolum Syntheticum, and (for example, solvent is as 0-50% ethanol to add the acceptable adjuvant of optional pharmacy, and antiseptic such as ethyl hydroxybenzoate etc.), obtain.
In one embodiment of the invention, the active component that wherein said compositions contains is counted 1-100g crude drug/100g compositions, for example 5-75g/100g with total raw medicinal herbs, 10-50g/100g for example, for example 20-40g/100g, for example 25-35g/100g, for example about 30g/100g.In one embodiment of the invention, wherein said compositions contains ethanol, and its concentration is 1-50%, 5-40% for example, 10-30% for example, 15-25% for example, for example approximately 20%.
Arbitrary embodiment of applicable equally other the arbitrary embodiment of arbitrary technical characterictic that arbitrary embodiment of either side of the present invention or this either side has or other either side, as long as they can be not conflicting, certainly, at where applicable each other, necessary words can be done suitably to modify to individual features.Be further described with feature to various aspects of the present invention below.
All documents that the present invention quotes from, their full content is incorporated to herein by reference, and if when the expressed implication of these documents and the present invention are inconsistent, be as the criterion with statement of the present invention.In addition, various terms and phrase that the present invention uses have the general sense of well known to a person skilled in the art, nonetheless, the present invention still wishes at this, these terms and phrase to be described in more detail and to be explained, the term of mentioning and phrase, if any inconsistent with known implication, are as the criterion with the implication that the present invention was explained.
In the present invention, can use the present composition of effective dose to be applied to the tested individuality that has needs.As described herein, term " effective dose " refers to and can in experimenter, realize the object dosage that prevents and/or treats situation of the present invention, obstacle, disease or disease.Those skilled in the art, according to the context of the invention, can easily determine the using dosage of the present composition.Especially, according to the present invention, term " effective dose " can be understood as the present composition with reasonable effect/risk of being applicable to any therapeutic treatment and/or prevention than the q.s that treats and/or prevents described situation, obstacle, disease or disease.But the total consumption per day that it should be understood that the present composition can maked decision within the scope of medical judgment reliably by those skilled in the art.For any concrete experimenter, concrete prevention effective dose level must be determined according to many factors, and described factor comprises experimenter's age, body weight, general health situation, sex and diet; The concrete compositions adopting; Other therapeutic active substance that is used in combination with the present composition or uses simultaneously; And the known similar factor of medical field.For the present invention, general daily dose scope is torn open and is counted as medical material meter, it can be 0.1～100g/kg body weight, 0.2～50g/kg body weight for example, for example 0.2～25g/kg body weight, for example 0.5～50g/kg body weight, for example 0.5～25g/kg body weight, for example 1～20g/kg body weight, for example 2～10g/kg body weight.
As described herein, term " compositions ", it can be medicine or any product that other makes for good health.Therefore, in the present invention, term " compositions " can exchange and use with " pharmaceutical composition ".In addition, the present composition can be used as the compositions that the uncomfortable state of prevention skin is used, such composition is also often called health-oriented products, such as sterile products etc., therefore, in the present invention, they have implication the most widely the term of mentioning " compositions " and " pharmaceutical composition ", both can refer to medicine, can also refer to health product, can also be sterile products.
As described herein, term " extract " will comprise the extract of any purity that can be used in the present invention object, and according to the present invention, spirit is appreciated that the DNA purity of extract of the present invention can change in the larger context to those skilled in the art.The extract that for example the multiple medicinal material extract of the present invention obtains, according to the difference of different process conditions, the total medical material of 1kg for example, through extracting the arbitrary amount between 10g to 500g that can obtain (50g to 200g, 50g to 150g for example) that is the extract of different purity, those skilled in the art can, according to different needs, allocate the compositions that is applicable to needs with the extract of different purity.
In the present invention, while mentioning " raw medicinal herbs " or " crude drug ", it comprises Radix Sophorae Flavescentis, Rhizoma Smilacis Glabrae, Herba Artemisiae Scopariae, Cortex Phellodendri, Radix Gentianae, Cortex Dictamni, Herba Portulacae, the Fructus Kochiae, the Radix Stemonae, Radix Glycyrrhizae, and (if present, can be understood as raw medicinal herbs or crude drug) Mentholum, Borneolum Syntheticum.
The invention provides and comprise the compositions formulated together with one or more nontoxic physiology's acceptable carriers.Described compositions can be mixed with solid or liquid form especially specially for Orally administered or for rectal administration, or is mixed with for injection and uses, or is mixed with for local application and for example supplies dermal administration.Compositions provided by the invention is particularly suitable for for example supplying dermal administration for local application.
Compositions of the present invention has the effects such as heat clearing and damp drying, antipruritic, removing toxic substances, according to Qi Chen chief editor's < < herbal medicine efficacy research method and thinking > >, we have carried out the pharmacodynamic study of antiinflammatory, antipruritic and antiallergic action aspect to it.These antiinflammatories, antipruritic and antiallergic action drug effect model be all well known in the art, can be used for evaluating medicine for preventing or treat the particularly typical model of the symptom such as eczema, pruritus of dermatosis.
The inventor causes by setting up Cavia porcellus histamine phosphate the model of itching, and take itch-threshold as index, observes the impact of Cavia porcellus on histamine phosphate's itch-threshold after each test group administration, evaluates the present composition different
The itching-relieving action of dosage group.From the present composition, Cavia porcellus histamine phosphate being caused to the result of reacting of itching can find out, the present composition has significance to increase to causing the territory of itching.
The inventor, by setting up delayed hypersensitivity model, be take ear swelling suppression ratio as index, observes the impact on mice ear suppression ratio after each test group administration, evaluates the anti-allergy action of present composition various dose group; And measure Thymus and spleen index, observe the impact on immune function of mice after administration.Result shows that the present composition can suppress mice ear effectively.From sample, on mouse immune organ weight's impact, can find out, all medicine groups and model group or blank group are compared all there was no significant differences, three dosage that are the present composition do not impact the spleen of mice and thymus, and positive drug has significant impact to the spleen of mice and thymus.Show that present composition expection has good safety.
The inventor, by setting up mice caused by dimethylbenzene xylene ear swelling test model, be take swelling as index, observes the impact that mice xylol after each test group administration causes mice auricle swelling, evaluates the itching-relieving action of present composition various dose group.Result shows that the present composition can suppress mice caused by dimethylbenzene xylene auricle edema effectively.
The inventor is by setting up rat Ovum Gallus domesticus album pedal swelling model, take paw swelling as index, observe pedal swelling degree after each test group administration, evaluate the impact of present composition various dose group on pedal swelling, and 1h, 2h, 4h, the impact of 6h medicine on rat paw edema after determination test.Measurement result from the present composition to rat Ovum Gallus domesticus album pedal swelling, the present composition can suppress rat Ovum Gallus domesticus album pedal swelling effectively.
The specific embodiment
Below by specific embodiment/experimental example, further illustrate the present invention, still, should be understood to, these embodiment and experimental example are only used for the use specifically describing more in detail, and should not be construed as for limiting in any form the present invention.
The present invention carries out generality and/or concrete description to the material and the test method that use in test.Although be well known in the art for realizing many materials and the operational approach that the object of the invention used, the present invention still does to describe in detail as far as possible at this.It will be apparent to those skilled in the art that hereinafter, if not specified, material therefor of the present invention and operational approach are well known in the art.
a, Preparation Example part
embodiment 1: prepare the present composition
Formula:
| radix Sophorae Flavescentis | 8g, | rhizoma Smilacis Glabrae | 12g, |
| herba Artemisiae Scopariae | 8g, | cortex Phellodendri | 8g, |
| radix Gentianae | 6g, | cortex Dictamni | 8g, |
| herba Portulacae | 6g, | the Fructus Kochiae | 8g, |
| the Radix Stemonae | 10g, | radix Glycyrrhizae | 6g, |
| mentholum | 0.8g, | borneolum Syntheticum | 0.53g. |
Method for making: get 10 taste medicines except Mentholum and Borneolum Syntheticum, with the alcohol reflux of the concentration 75% of 7.5 times of volumes 2 times, each 2 hours is 1.04g/ml by extracting solution concentration and recovery ethanol to the concentrated solution density of merging.Alcoholic solution to adding appropriate debita spissitudo in concentrated solution, makes raw medicinal herbs content and concentration of alcohol be respectively about 30g/100ml, approximately 20%, stirs evenly, and standing over night, impurity is removed in centrifugal filtration.Mentholum, Borneolum Syntheticum and ethyl hydroxybenzoate (making final concentration is 0.05%) are dissolved in appropriate ethanol, add in filtrate, stir evenly, and make raw medicinal herbs content and concentration of alcohol be respectively 30g/100ml and 20%, obtain the present composition.This pharmaceutical composition can be used as the dosage forms such as the solution, liniment, spray of external and uses.
embodiment 2: prepare the present composition
Formula:
| radix Sophorae Flavescentis | 8g, | rhizoma Smilacis Glabrae | 3g, |
| herba Artemisiae Scopariae | 16g, | cortex Phellodendri | 2g, |
| radix Gentianae | 12g, | cortex Dictamni | 2g, |
| herba Portulacae | 12g, | the Fructus Kochiae | 2g, |
| the Radix Stemonae | 20g, | radix Glycyrrhizae | 1.5g, |
| mentholum | 0.1g, | borneolum Syntheticum | 2g. |
Method for making: get 10 taste medicines except Mentholum and Borneolum Syntheticum, with 75% alcohol reflux of 6 times of amounts 2 times, each 2 hours, filter; In the extracting solution merging, add Mentholum and Borneolum Syntheticum, dissolve; Medicinal liquid is condensed into thick paste, is dried to powder 8.6g.By this dried powder 20% dissolve with ethanol, preparation cost invention pharmaceutical composition, the amount of amounting to raw medicinal herbs in every 100 grams of these pharmaceutical compositions is 30 grams, this pharmaceutical composition can be used as the dosage forms such as the solution, liniment, spray of external and uses.
embodiment 3: prepare the present composition
Formula:
| radix Sophorae Flavescentis | 8g, | rhizoma Smilacis Glabrae | 24g, |
| herba Artemisiae Scopariae | 2g, | cortex Phellodendri | 16g, |
| radix Gentianae | 1.5g, | cortex Dictamni | 16g, |
| herba Portulacae | 1.5g, | the Fructus Kochiae | 16g, |
| the Radix Stemonae | 2.5g, | radix Glycyrrhizae | 12g, |
| mentholum | 3g, | borneolum Syntheticum | 0.1g. |
Method for making: get 10 taste medicines except Mentholum and Borneolum Syntheticum, with 50% alcohol reflux of 10 times of amounts 1 hour, filter; By 80% alcohol reflux of 5 times of amounts 2 hours for filtering residue, filter again; In the extracting solution merging, add Mentholum and Borneolum Syntheticum, dissolve; Medicinal liquid is condensed into thick paste, is dried to powder 12.1g.By this dried powder water dissolution, and to add carbomer to make its amount be 5%, and add ethyl hydroxybenzoate to make its amount to be 0.05%, to be prepared into the pharmaceutical composition of the present invention that is gel, and the amount of amounting to raw medicinal herbs in every 100 grams of these pharmaceutical compositions is 30 grams.
embodiment 4: prepare the present composition
Formula:
| radix Sophorae Flavescentis | 8g, | rhizoma Smilacis Glabrae | 8g, |
| herba Artemisiae Scopariae | 12g, | cortex Phellodendri | 12g, |
| radix Gentianae | 3g, | cortex Dictamni | 4g, |
| herba Portulacae | 9g, | the Fructus Kochiae | 4g, |
| the Radix Stemonae | 15g, | radix Glycyrrhizae | 3g, |
| mentholum | 2g, | borneolum Syntheticum | 0.2g. |
Method for making: get 10 taste medicines except Mentholum and Borneolum Syntheticum, get 1 hour with 95% alcohol reflux of 6 times of amounts, filter; By 70% alcohol reflux of 5 times of amounts 1 hour for filtering residue, filter again; By the water reflux, extract, of 5 times of amounts 1 hour for filtering residue, filter again; In the extracting solution merging, add Mentholum and Borneolum Syntheticum, dissolve; Medicinal liquid is condensed into thick paste, is dried to powder 8.6g.By this dried powder 20% dissolve with ethanol, preparation cost invention pharmaceutical composition, the amount of amounting to raw medicinal herbs in every 100 grams of these pharmaceutical compositions is 50 grams, this pharmaceutical composition can be used as the dosage forms such as the solution, liniment, spray of external and uses.
embodiment 5: prepare the present composition
Formula:
| radix Sophorae Flavescentis | 8g, | rhizoma Smilacis Glabrae | 18g, |
| herba Artemisiae Scopariae | 4g, | cortex Phellodendri | 4g, |
| radix Gentianae | 9g, | cortex Dictamni | 12g, |
| herba Portulacae | 3g, | the Fructus Kochiae | 12g, |
| the Radix Stemonae | 5g, | radix Glycyrrhizae | 9g, |
| mentholum | 0.3g, | borneolum Syntheticum | 1.5g. |
Method for making: get 10 taste medicines except Mentholum and Borneolum Syntheticum, boil 1.5 hours with the decocting of 10 times of amounts, filter; By 90% alcohol reflux of 8 times of amounts 1 hour for filtering residue, filter again; By 70% alcohol reflux of 5 times of amounts 1 hour for filtering residue, filter again; In the extracting solution merging, add Mentholum and Borneolum Syntheticum, dissolve; Medicinal liquid is condensed into thick paste, is dried to powder 9.3g.By this dried powder 20% dissolve with ethanol, preparation cost invention pharmaceutical composition, the amount of amounting to raw medicinal herbs in every 100 grams of these pharmaceutical compositions is 10 grams, this pharmaceutical composition can be used as the dosage forms such as the solution, liniment, spray of external and uses.
In addition, the dried powder that inventor also obtains the present embodiment adds in the ointment substrate or ointment base of pharmaceutics classics, prepares respectively ointment and ointment, and the amount of amounting to raw medicinal herbs in every 100 grams of these ointments or ointment is 10 grams.
In addition, the dried powder water dissolution that the present embodiment is obtained, preparation cost invention medicinal herb spray, the amount of amounting to raw medicinal herbs in every 100 grams of these medicinal herb spray is 50 grams.In addition, by this dried powder 50% dissolve with ethanol, preparation cost invention medicinal herb spray, the amount of amounting to raw medicinal herbs in every 100 grams of these medicinal herb spray is 10 grams.In addition, by this dried powder 30% dissolve with ethanol, preparation cost invention medicinal herb spray, the amount of amounting to raw medicinal herbs in every 100 grams of these medicinal herb spray is 20 grams.
embodiment 6: prepare the present composition
Formula:
| Radix Sophorae Flavescentis | 8g， | Rhizoma Smilacis Glabrae | 12g， |
| Herba Artemisiae Scopariae | 8g， | Cortex Phellodendri | 8g， |
| Radix Gentianae | 6g， | Cortex Dictamni | 8g， |
| Herba Portulacae | 6g， | The Fructus Kochiae | 8g， |
| The Radix Stemonae | 10g， | Radix Glycyrrhizae | 6g |
Method for making: get 10 taste medicines, with 70% alcohol reflux of 6 times of amounts 2 times, each 1.5 hours, filter; The extracting solution of merging is condensed into thick paste, is dried to powder 8.5g.This dried powder is added to microcrystalline Cellulose with 1:1 ratio, mix homogeneously, encapsulated, every 250mg, obtains the present composition.Said composition can orally use, or for skin, smears use after can be dissolved in water/suspendible.
embodiment 7: prepare the present composition
Formula:
| Radix Sophorae Flavescentis | 8g， | Rhizoma Smilacis Glabrae | 8g， |
| Herba Artemisiae Scopariae | 12g， | Cortex Phellodendri | 12g， |
| Radix Gentianae | 3g， | Cortex Dictamni | 4g， |
| Herba Portulacae | 9g， | The Fructus Kochiae | 4g， |
| The Radix Stemonae | 15g， | Radix Glycyrrhizae | 3g， |
Method for making: get 10 taste medicines, be ground into the fine powder of 80 mesh sieves; The refined honey that adds 1/3 fine powder amount is made honeyed pill (weighing 3 grams) as binding agent, obtains the present composition.
embodiment 8: prepare the present composition
Formula:
| Radix Sophorae Flavescentis | 8g， | Rhizoma Smilacis Glabrae | 18g， |
| Herba Artemisiae Scopariae | 4g， | Cortex Phellodendri | 4g， |
| Radix Gentianae | 9g， | Cortex Dictamni | 12g， |
| Herba Portulacae | 3g， | The Fructus Kochiae | 12g， |
| The Radix Stemonae | 5g， | Radix Glycyrrhizae | 9g， |
Method for making: get 10 taste medicines, be ground into the fine powder of 80 mesh sieves; The refined honey that adds 1/3 fine powder amount is made honeyed pill (weighing 1 gram) as binding agent, obtains the present composition.
embodiment 9: prepare the present composition
Formula:
| radix Sophorae Flavescentis | 8g, | rhizoma Smilacis Glabrae | 12g, |
| herba Artemisiae Scopariae | 8g, | cortex Phellodendri | 8g, |
| radix Gentianae | 6g, | cortex Dictamni | 8g, |
| herba Portulacae | 6g, | the Fructus Kochiae | 8g, |
| the Radix Stemonae | 10g, | radix Glycyrrhizae | 6g, |
| mentholum | 1.5g, | borneolum Syntheticum | 1g. |
Method for making: get 10 taste medicines except Mentholum and Borneolum Syntheticum, with 95% alcohol reflux of 6 times of amounts 2 times, each 2 hours, filter; In the extracting solution merging, add Mentholum and Borneolum Syntheticum, dissolve; Medicinal liquid is condensed into thick paste, is dried to powder.By this dried powder 20% dissolve with ethanol, preparation cost invention pharmaceutical composition, the amount of amounting to raw medicinal herbs in every 100 grams of these pharmaceutical compositions is 30 grams, this pharmaceutical composition can be used as the dosage forms such as the solution, liniment, spray of external and uses.
embodiment 10: prepare the present composition
Formula:
| radix Sophorae Flavescentis | 8g, | rhizoma Smilacis Glabrae | 12g, |
| herba Artemisiae Scopariae | 8g, | cortex Phellodendri | 8g, |
| radix Gentianae | 6g, | cortex Dictamni | 8g, |
| herba Portulacae | 6g, | the Fructus Kochiae | 8g, |
| the Radix Stemonae | 10g, | radix Glycyrrhizae | 6g, |
| mentholum | 0.8g, | borneolum Syntheticum | 0.53g. |
Method for making: get 10 taste medicines except Mentholum and Borneolum Syntheticum, by the water boiling and extraction of 7 times of amounts 2 times, each 2 hours, filter; In the extracting solution merging, add Mentholum and Borneolum Syntheticum, dissolve; Medicinal liquid is condensed into thick paste, is dried to powder 9.2g.This dried powder is added to microcrystalline Cellulose with 1:1 ratio, mix homogeneously, encapsulated, every 250mg, obtains the present composition.Said composition can orally use, or for skin, smears use after can be dissolved in water/suspendible.
b: test example part
test example 1: the study on the stability of the present composition
Press the technology of the relevant steady quality Journal of Sex Research in < < medicine registration management way > >, the stability of the present composition is investigated.
Investigation project: character, discriminating, inspection and content.
The medicinal liquid of test specimen: embodiment 1 (be packaged in plastic bottle, can be used for external spray delivery, while in test example below, mentioning " spray ", refer to that the medicinal liquid of embodiment 1 is with the mode administration of spraying).
Test method (accelerated test): test specimen is put into the exsiccator (RH75%) of NaCl saturated solution, and be placed in climatic chamber, temperature was under 40 ± 2 ℃ of conditions, in 0,1,2,3,6 month sampling and measuring.Result of the test is in Table 1.
Table 1: accelerated test result
Conclusion: from result, compositions of the present invention meets the stability requirement that medicine is general.Although the form of compositions and formula ratio are different, yet applicant finds that the prepared present composition of other embodiment is in above-mentioned accelerated test method, all meet the stability requirement that medicine is general, what for example in each assay item, June, data compared differs and is no more than 10% in 0 month data.
test example 2: the present composition causes the impact of the reaction of itching on Cavia porcellus histamine phosphate
Set up Cavia porcellus histamine phosphate and cause the model of itching, take itch-threshold as index, observe the impact of Cavia porcellus on histamine phosphate's itch-threshold after each test group administration, evaluate the itching-relieving action of present composition various dose group.
1, test material:
Reagent: embodiment 1 compositions (spray-type, raw medicinal herbs content and concentration of alcohol are respectively 30g/100ml, 20%);
Positive control drug: three nine-day periods after the winter solstice PIYANPING (compound dexamethason acetate emulsifiable paste, China Resources Sanjiu Medical & Pharmaceutical Co., Ltd. produces);
Excipient: 20% ethanol;
Cause the agent of itching: histamine phosphate.
2, experimental animal: healthy qualified Cavia porcellus, KeYu animal cultivation center, Beijing, credit number: SCXK-(capital) 2007-0003.Body weight 250-300g, average 270g, half and half, 60 of male and female, are divided into 6 groups at random, 10 every group; 6 animal groups are respectively model control group, excipient matched group, PIYANPING group, the basic, normal, high dosage group of spray.
3, dosage, approach, test grouping
Model group: not administration.
Positive group: give PIYANPING 0.1g, dosage is equivalent to 370mg/Kg.
Excipient group: give excipient 20% ethanol 0.1ml, dosage is equivalent to 0.37ml/Kg.
Low dose group: give reagent spray 0.1ml.Cavia porcellus body weight is only calculated by average 270g/, and amounting to into crude drug amount dosage is 113mg/Kg.
Middle dosage group: give reagent spray 0.15ml.Cavia porcellus body weight is only calculated by average 270g/, and amounting to into crude drug amount dosage is 169mg/Kg.
High dose group: give reagent spray 0.2ml.Cavia porcellus body weight is only calculated by average 270g/, and amounting to into crude drug amount dosage is 226mg/Kg.
4, data and statistical procedures: measurement data is with " mean ± standard deviation (x ± s) "; Between many groups, sample average is relatively used variance analysis, and heterogeneity of variance person does corresponding conversion.
5, test method [with reference to carrying out with Publication about Document: bureau of drug policy & administration of Ministry of Health of the People's Republic of China compiles. study of tcm new drug guide (pharmacy, pharmacology, toxicology) [s]: 179]
Guinea pig skin pruritus model due to selection histamine phosphate, Cavia porcellus grouping: be divided at random 6 groups, model control group, excipient matched group, PIYANPING group, the basic, normal, high dosage group of sample, 10 every group.1d before test, each is organized the right back dorsal portion of Cavia porcellus and shaves hair, coating 1 time.Wherein excipient matched group is coated with 20% ethanol, and model control group is coating not.Test the same day, with No. 0 sand paper scratch, shave hair place, area 1cm
2.Part repastes medicine 1 time.After 10min, in wound surface Chu Di 0.01% 0.05ml/ of histamine phosphate only, after this every 3min, according to 0.01%, 0.02%, 0.03%, 0.04%...... concentration, increase progressively, be only 0.05mL/, until right back foot appears licking in Cavia porcellus at every turn.It is itch-threshold that the right back histamine phosphate's total amount being given when sufficient appears licking in the Cavia porcellus of take, record relatively itch-threshold of each group.
6, result of the test is shown in following table 2:
Table 2: the present composition causes the impact (x ± s) of the reaction of itching on Cavia porcellus histamine phosphate
| Group | n | Dosage (mg/kg) | Itch-threshold (total amount/μ g of histamine phosphate) |
| Model control group | 10 | - | 35±34 |
| Excipient contrast | 10 | - | 63±59 |
| PIYANPING group | 10 | 370mg/Kg | 84±54 ＊ |
| Agent group in sample | 10 | 169mg/Kg | 139±132 ＊ |
| The high agent group of sample | 10 | 226mg/Kg | 147±115 ＊＊ |
Note: each group and model control group comparison,
*p<0.05,
*p<0.01; N=10.
From the present composition, Cavia porcellus histamine phosphate being caused to the result of reacting of itching can find out, in positive controls, sample, dosage group, sample high dose group have been compared significant difference with model control group, and causing the territory of itching has significance to increase; In addition, low dose group is compared and is also had significant difference with model group.Vehicle group is compared there was no significant difference with model group.
test example 3: the antiallergic action test of the present composition
This test, by setting up delayed hypersensitivity model, be take ear swelling suppression ratio as index, the impact on mice ear suppression ratio after the administration of observation present composition test group, the anti-allergy action of evaluation present composition various dose group; And measure Thymus and spleen index, the impact on immune function of mice after observation administration, for clinical drug effect provides Data support.
1, test material:
Reagent: embodiment 1 compositions (spray-type, raw medicinal herbs content and concentration of alcohol are respectively 30g/100ml, 20%);
Positive control drug: three nine-day periods after the winter solstice PIYANPING (compound dexamethason acetate emulsifiable paste, China Resources Sanjiu Medical & Pharmaceutical Co., Ltd. produces);
Proinflammatory agent: 2.4-dinitrochlorobenzene (DNCB); Preparation: 2%DNCB, claims that 100mg is dissolved in (acetone: salad oil=2.5:2.5ml) in 5ml acetone salad oil
Excipient: 20% ethanol;
2, experimental animal: Kunming mouse, SPF level, Military Medical Science Institute's experimental animal center, credit number: SCXK-(army) 2007-004.Body weight 18-20g, half and half, 70 of male and female, are divided into 7 groups at random, 10 every group.7 animal groups are respectively:
Blank group: 75% ethanol 0.1ml, percutaneous drug delivery, repeats after 24h to 75% ethanol 0.1ml.
Model group: 2%DNCB 0.1ml, percutaneous drug delivery, repeats the 0.1ml to 2%DNCB after 24h.
Positive group: 2%DNCB 0.1ml, percutaneous drug delivery, repeats the 0.1ml to 2%DNCB after 24h, and gives positive drug PIYANPING 0.1g, successive administration 5 days.The dosage of positive drug group is equivalent to 370mg/Kg.
Excipient group: 2%DNCB 0.1ml, percutaneous drug delivery, repeats the 0.1ml to 2%DNCB after 24h, and gives excipient 20% ethanol 0.1ml, successive administration 5 days.The dosage of vehicle group is equivalent to 0.37ml/Kg.
Low dose group: 2%DNCB 0.1ml, percutaneous drug delivery, repeats the 0.1ml to 2%DNCB after 24h, and gives investigational agent reagent spray 0.1ml, successive administration 5 days.
Middle dosage group: 2%DNCB 0.1ml, percutaneous drug delivery, repeats the 0.1ml to 2%DNCB after 24h, and gives investigational agent reagent spray 0.15ml, successive administration 5 days.
High dose group: 2%DNCB 0.1ml, percutaneous drug delivery, repeats the 0.1ml to 2%DNCB after 24h, and gives investigational agent reagent spray 0.2ml, successive administration 5 days.
Basic, normal, high dosage group dosage is amounted to into crude drug amount and is respectively 113mg/Kg, 169mg/Kg, 226mg/Kg above.
3, data and statistical procedures: measurement data is with " mean ± standard deviation (x ± s) "; Between many groups, sample average is relatively used variance analysis, and heterogeneity of variance person does corresponding conversion.
4, test method: mice is divided into 7 groups at random, shaves hair, except blank group is coated with 0.1mL ethanol, each is organized mice and evenly coats depilation district sensitization with 2%DNCB 0.1mL; Next day, relative medicine is smeared in each administration group mice depilation district, and blank and model control group is smeared equivalent excipient, every day 1 time, continuously 5d.The 5th day, each was organized mice and with 1%DNCB, is evenly applied to both sides inside and outside auris dextra again and swashs quick.After 24h, cervical vertebra dislocation is put to death, and with the card punch of diameter 7mm, lays respectively mice two ear same area auricles, weighs, and is calculated as follows inhibitory rate of intumesce (%).Win mouse spleen and thymus simultaneously, calculate index and spleen index and thymus index.The results are shown in Table 3 and table 4.
Table 3: the present composition is on the impact of mice delayed hypersensitivity (x ± s)
| Group | n | Dosage (g/kg) | Swelling (/mg) | Suppression ratio (/ %) |
| Blank group | 10 | - | 1.0±1.45 | - |
| Model control group | 10 | - | 4.4±1.04 | - |
| Excipient group | 10 | - | 3.9±2.85 | 10.8 |
| PIYANPING group | 10 | 370mg/kg | 1.6±1.20 ＊＊ | 64.1 |
| Low dose of group of sample | 10 | 113mg/kg | 2.4±1.79 ＊＊ | 44.4 |
| Agent group in sample | 10 | 169mg/kg | 2.0±2.29 ＊＊ | 53.6 |
| The high agent group of sample | 10 | 226mg/kg | 2.0±1.40 ＊＊ | 54.7 |
Note: each group and model control group comparison,
*p<0.01; N=10.
Table 4: the present composition is on mouse immune organ weight's impact (x ± s)
| Group | n | Dosage (g/kg) | Thymus index (g/kg) | Spleen index (g/kg) |
| Blank group | 10 | - | 4.8±0.98 | 4.3±1.29 |
| Model control group | 10 | - | 4.7±0.66 | 3.9±0.98 |
| Excipient group | 10 | - | 4.4±0.92 | 3.4±0.72 |
| PIYANPING group | 10 | 370mg/kg | 1.8±0.29 ＊＊ | 1.0±0.32 ＊＊ |
| Low dose of group of sample | 10 | 113mg/kg | 4.6±1.16 | 3.9±0.82 |
| Agent group in sample | 10 | 169mg/kg | 4.7±1.19 | 3.9±0.72 |
| The high agent group of sample | 10 | 226mg/kg | 5.0±0.73 | 4.0±0.96 |
Note: each group and model control group comparison,
*p<0.01; N=10.
From the measurement result of swelling, model control group compares with blank group that there were significant differences, shows modeling success; Vehicle group is compared with model group, without significant difference, shows that excipient is without drug effect; The basic, normal, high dosage group of sample and positive group more all have significant difference with model group, and the swelling of the swelling of three groups of sample and positive group is all than the remarkable reduction of model group.
From sample, on mouse immune organ weight's impact, can find out, all medicine groups and model group or blank group are compared all there was no significant differences, three dosage that are medicine do not impact the spleen of mice and thymus, and positive drug has significant impact to the spleen of mice and thymus.
Therefore, the basic, normal, high dosage group of the present composition all has obvious antianaphylactic effect, but can not impact spleen and thymus.
test example 4: antiinflammatory experiment
This test, by setting up mice caused by dimethylbenzene xylene ear swelling test model, be take swelling as index, observes the impact that mice xylol after each test group administration causes mice auricle swelling, evaluates the antiinflammation of present composition various dose group.
1, test material:
Reagent: embodiment 1 compositions (spray-type, raw medicinal herbs content and concentration of alcohol are respectively 30g/100ml, 20%);
Positive control drug: three nine-day periods after the winter solstice PIYANPING (compound dexamethason acetate emulsifiable paste, China Resources Sanjiu Medical & Pharmaceutical Co., Ltd. produces);
Cause the agent of itching: histamine phosphate
Excipient: 20% ethanol;
2, experimental animal: Kunming mouse, SPF level, Military Medical Science Institute's experimental animal center, credit number: SCXK-(army) 2007-004.Body weight 18-20g, half and half, 60 of male and female, are divided into 6 groups at random, 10 every group.6 animal groups are respectively:
Model group: mouse right ear is evenly smeared dimethylbenzene 0.05mL, after 1.5h, cervical vertebra dislocation is put to death, and ear punching in left and right is weighed.
Positive group: mouse right ear is evenly smeared dimethylbenzene 0.05mL, after 30min, auris dextra is coated with PIYANPING 0.1g, and after 1h, cervical vertebra dislocation is put to death, and ear punching in left and right is weighed.The dosage of positive drug PIYANPING group is equivalent to 370mg/Kg.
Excipient group: mouse right ear is evenly smeared dimethylbenzene 0.05mL, after 30min, auris dextra is coated with excipient 0.1ml, and after 1h, cervical vertebra dislocation is put to death, and ear punching in left and right is weighed.The dosage of vehicle group is equivalent to 0.37ml/Kg.
Low dose group: mouse right ear is evenly smeared dimethylbenzene 0.05mL, after 30min, auris dextra is coated with present composition 0.1ml, gives continuously positive drug 5 days.After 1h, cervical vertebra dislocation is put to death, and ear punching in left and right is weighed.
Middle dosage group: mouse right ear is evenly smeared dimethylbenzene 0.05mL, after 30min, auris dextra is coated with present composition 0.15ml, gives continuously positive drug 5 days.After 1h, cervical vertebra dislocation is put to death, and ear punching in left and right is weighed.
High dose group: mouse right ear is evenly smeared dimethylbenzene 0.05mL, after 30min, auris dextra is coated with present composition 0.2ml, gives continuously positive drug 5 days.After 1h, cervical vertebra dislocation is put to death, and ear punching in left and right is weighed.
Above three medicine groups: it is 1.525g/Kg, 2.288g/Kg, 3.050g/Kg that the basic, normal, high dosage group of present composition dosage is amounted to into crude drug amount.
3, data and statistical procedures: measurement data is with " mean ± standard deviation (x ± s) "; Between many groups, sample average is relatively used variance analysis, and heterogeneity of variance person does corresponding conversion.
4, test method: mice caused by dimethylbenzene xylene ear swelling test [referring to, Xu Shuyun, Bian Rulian, old repairing. pharmacological experimental methodology [M]. the 3rd edition. Beijing: People's Health Publisher, 2002:906,1407,1429]: mice is divided into 6 groups at random, i.e. model control group, excipient matched group, PIYANPING group, the basic, normal, high dosage group of present composition spray, 10 every group.Each is organized mouse right ear and evenly smears dimethylbenzene 0.05mL, and after 30min, administration group mouse right ear is smeared relative medicine, and matched group is coated with excipient, every 0.1g.After medicine, 60min cervical vertebra dislocation is put to death, and with 7mm card punch, lays respectively mice ears same area auricle, weighs, and the difference of two auricle weight of take is swelling, and average swelling is respectively organized in calculating, and is calculated as follows inhibitory rate of intumesce (%).The results are shown in Table 5.
Table 5: present composition xylol causes the impact (x ± s) of mice auricle swelling
| Group | n | Dosage (g/kg) | Swelling (/mg) | Suppression ratio (/ %) |
| Model group | 10 | - | 10.6±3.40 | - |
| Excipient group | 10 | - | 11.0±3.87 | -4.1 |
| PIYANPING group | 10 | 370mg/kg | 6.5±3.67 ＊＊ | 38.3 |
| Low dose of group of sample | 10 | 1.525g/kg | 5.8±5.06 ＊＊ | 45.0 |
| Agent group in sample | 10 | 2.288g/kg | 7.0±3.41 ＊＊ | 34.0 |
| The high agent group of sample | 10 | 3.050g/kg | 6.8±3.95 ＊＊ | 35.9 |
Note: each group and model control group comparison,
*p<0.01; N=10.
From present composition xylol, cause the result that affects of mice auricle swelling, the basic, normal, high dosage group of sample and positive group more all have significant difference with model group, and the swelling of the swelling of three groups of sample and positive group is all than the remarkable reduction of model group; Vehicle group is compared with model group, without significant difference, shows that excipient is without drug effect; The basic, normal, high dosage group of sample and positive group inhibitory rate of intumesce are respectively 45.0%, 34.0%, 35.9%, 38.3%, there was no significant difference between each dosage group of sample; Also there was no significant difference between each dosage group of sample and positive group, shows that sample sets is suitable with the antiinflammatory action of positive group.
test example 4: the impact of the present composition on rat Ovum Gallus domesticus album pedal swelling
This test, by setting up rat Ovum Gallus domesticus album pedal swelling model, be take paw swelling as index, observes pedal swelling degree after each test group administration, evaluates the impact of present composition various dose group on pedal swelling.
Reagent: embodiment 1 compositions (spray-type, raw medicinal herbs content and concentration of alcohol are respectively 30g/100ml, 20%);
Positive control drug: three nine-day periods after the winter solstice PIYANPING (compound dexamethason acetate emulsifiable paste, China Resources Sanjiu Medical & Pharmaceutical Co., Ltd. produces);
Egg protein: 10% Fresh Egg is clear.
Excipient: 20% ethanol;
2, experimental animal: Wister rat, male and female dual-purpose, National Institute for Food and Drugs Control, credit number: SCXK-(capital) 2009-0017.Body weight 180-200g, half and half, 70 of male and female, are divided into 7 groups at random, 10 every group.7 animal groups are respectively:
Blank group: the right back sufficient sole of the foot is coated with distilled water 0.1ml, measures the right back sufficient volume of 2h, 3h, 5h, 7h.
Model group: the right back sufficient sole of the foot is coated with distilled water 0.1ml, after 1h, each only organizes right back sufficient subcutaneous injection 10% fresh albumen 0.05ml/.The right back sufficient volume of 1h, 2h, 4h, 6h after mensuration albumen injection.
Positive group: the right back sufficient sole of the foot is coated with PIYANPING 0.1g, after 1h, right back sufficient subcutaneous injection 10% fresh albumen 0.05ml/ only.The right back sufficient volume of 1h, 2h, 4h, 6h after mensuration albumen injection.The dosage of positive drug PIYANPING group is equivalent to 370mg/Kg.
Excipient group: the right back sufficient sole of the foot is coated with excipient 0.1ml, after 1h, right back sufficient subcutaneous injection 10% fresh albumen 0.05ml/ only.After 1h, right back sufficient subcutaneous injection 10% fresh albumen 0.05ml/ only.The right back sufficient volume of 1h, 2h, 4h, 6h after mensuration albumen injection.The dosage of excipient (20% ethanol) group is equivalent to 0.37ml/Kg.
Low dose group: the right back sufficient sole of the foot is coated with present composition 0.1ml, after 1h, right back sufficient subcutaneous injection 10% fresh albumen 0.05ml/ only.After 1h, right back sufficient subcutaneous injection 10% fresh albumen 0.05ml/ only.The right back sufficient volume of 1h, 2h, 4h, 6h after mensuration albumen injection.
Middle dosage group: the right back sufficient sole of the foot is coated with present composition 0.15ml, after 1h, right back sufficient subcutaneous injection 10% fresh albumen 0.05ml/ only.After 1h, right back sufficient subcutaneous injection 10% fresh albumen 0.05ml/ only.The right back sufficient volume of 1h, 2h, 4h, 6h after mensuration albumen injection.
High dose group: the right back sufficient sole of the foot is coated with present composition 0.2ml, after 1h, right back sufficient subcutaneous injection 10% fresh albumen 0.05ml/ only.After 1h, right back sufficient subcutaneous injection 10% fresh albumen 0.05ml/ only.The right back sufficient volume of 1h, 2h, 4h, 6h after mensuration albumen injection.
Above three medicine groups: it is 153mg/Kg, 229mg/Kg, 305mg/Kg that the basic, normal, high dosage group of present composition dosage is amounted to into crude drug amount.
3, data and statistical procedures: measurement data is with " mean ± standard deviation (x ± s) "; Between many groups, sample average is relatively used variance analysis, and heterogeneity of variance person does corresponding conversion.
4, test method: press document [Qi Chen. herbal medicine efficacy research method and thinking [M] Beijing: People's Health Publisher .2005:1083] method, get 70 of rats and be divided at random 7 groups, 10 every group.First experiment was measured and was respectively organized Rat Right metapedes normal volume with self-control volume determination device the same day, and then, to each group coating, matched group is coated with equivalent distilled water.After 1h, each only organizes right back sufficient subcutaneous injection 10% fresh albumen 0.05ml/.The right back sufficient volume of 1h, 2h, 4h, 6h after mensuration albumen injection.Causing the scorching front and back changing value of right back sufficient volume and the ratio of initial volume is swelling rate, respectively organizes the difference of swelling rate.Result is respectively in Table 6,7,8,9.
Table 6: compositions is on the impact of rat Ovum Gallus domesticus album pedal swelling (1h after injection) (x ± s)
| Group | n | Swelling (/mg) | Suppression ratio (/ %) |
| Blank group | 10 | -80±53.7 | - |
| Model group | 10 | 380±122.9 | - |
| Excipient group | 10 | 290±84.3 | 23.7 |
| PIYANPING group | 10 | 138±108.0 | 63.7 |
| Agent group in sample | 10 | 202±100.2 | 46.8 |
| The high agent group of sample | 10 | 199±105.8 | 47.6 |
Table 7: compositions is on the impact of rat Ovum Gallus domesticus album pedal swelling (2h after injection) (x ± s)
| Group | n | Swelling (/mg) | Suppression ratio (/ %) |
| Blank group | 10 | -60±73.8 | - |
| Model group | 10 | 320±75.3 | - |
| Excipient group | 10 | 355±89.6 | -10.9 |
| PIYANPING group | 10 | 194±104.2 | 39.4 |
| Agent group in sample | 10 | 138±117.8 | 56.9 |
| The high agent group of sample | 10 | 149±132.5 | 53.4 |
Table 8: compositions is on the impact of rat Ovum Gallus domesticus album pedal swelling (4h after injection) (x ± s)
| Group | n | Swelling (/mg) | Suppression ratio (/ %) |
| Blank group | 10 | 70±63.2 | - |
| Model group | 10 | 295±89.6 | - |
| Excipient group | 10 | 280±82.3 | 5.1 |
| PIYANPING group | 10 | 58±60.3 | 80.3 |
| Agent group in sample | 10 | 80±103.3 | 72.9 |
| The high agent group of sample | 10 | 92±105.5 | 68.6 |
Table 9: compositions is on the impact of rat Ovum Gallus domesticus album pedal swelling (6h after injection) (x ± s)
| Group | n | Swelling (/mg) | Suppression ratio (/ %) |
| Blank group | 10 | -91±86.0 | - |
| Model group | 10 | 285±88.3 | - |
| Excipient group | 10 | 350±110.6 | -22.8 |
| PIYANPING group | 10 | 20±147.1 | 93.0 |
| Agent group in sample | 10 | 145±106.6 | 49.1 |
| The high agent group of sample | 10 | 157±116.9 | 44.9 |
Measurement result from the present composition to rat Ovum Gallus domesticus album pedal swelling, model group has been compared significant difference with blank group, shows modeling success; The middle and high dosage group of sample, positive group have been compared significant difference with model group, show that the middle and high dosage group of sample and positive group can reduce the effect of rat Ovum Gallus domesticus album pedal swelling; The middle and high dosage group of sample and the positive effect there was no significant difference of organizing, i.e. effect is quite; Low dose group result of the test does not obtain.Visible, the present composition has the effect of the rat of reduction Ovum Gallus domesticus album pedal swelling.
In supplementary test, the spray that embodiment 2 and the embodiment 3 of take respectively obtains is reagent, according to above test 2,3,4 identical methods, test, result shows that embodiment 2 and the present composition result of the test of embodiment 3 and the above-mentioned result of the test of the present composition of embodiment 1 are basically identical statistically.
Claims (15)
1. a compositions that is used for the treatment of or prevents mammal skin disease, it is extracted to join in described compositions through aquiferous ethanol by Chinese crude drug Radix Sophorae Flavescentis, Rhizoma Smilacis Glabrae, Herba Artemisiae Scopariae, Cortex Phellodendri, Radix Gentianae, Cortex Dictamni, Herba Portulacae, the Fructus Kochiae, the Radix Stemonae, Radix Glycyrrhizae and is prepared into, and also optionally comprises Mentholum and/or Borneolum Syntheticum in said composition; Wherein the proportioning of each medical material is: Radix Sophorae Flavescentis 8 weight portions, Rhizoma Smilacis Glabrae 3-24 weight portion, Herba Artemisiae Scopariae 2-16 weight portion, Cortex Phellodendri 2-16 weight portion, Radix Gentianae 1.5-12 weight portion, Cortex Dictamni 2-16 weight portion, Herba Portulacae 1.5-12 weight portion, Fructus Kochiae 2-16 weight portion, Radix Stemonae 2.5-20 weight portion, Radix Glycyrrhizae 1.5-12 weight portion; And when described Mentholum and/or Borneolum Syntheticum exist, in described medical material, Radix Sophorae Flavescentis is in 8 weight portions, and the amount of Mentholum is 0.1-3 weight portion, and the amount of Borneolum Syntheticum is 0.1-2 weight portion.
2. according to the compositions of claim 1, wherein the proportioning of each medical material is: Radix Sophorae Flavescentis 8 weight portions, Rhizoma Smilacis Glabrae 8-18 weight portion, Herba Artemisiae Scopariae 4-12 weight portion, Cortex Phellodendri 4-12 weight portion, Radix Gentianae 3-9 weight portion, Cortex Dictamni 4-12 weight portion, Herba Portulacae 3-9 weight portion, Fructus Kochiae 4-12 weight portion, Radix Stemonae 5-15 weight portion, Radix Glycyrrhizae 3-9 weight portion.
3. according to the compositions of claim 1, wherein the proportioning of each medical material is: Radix Sophorae Flavescentis 8 weight portions, Rhizoma Smilacis Glabrae 12 weight portions, Herba Artemisiae Scopariae 8 weight portions, Cortex Phellodendri 8 weight portions, Radix Gentianae 6 weight portions, Cortex Dictamni 8 weight portions, Herba Portulacae 6 weight portions, the Fructus Kochiae 8 weight portions, the Radix Stemonae 10 weight portions, Radix Glycyrrhizae 6 weight portions.
4. according to the compositions of claim 1, in its medical material Radix Sophorae Flavescentis in 8 weight portions, Mentholum 0.3-2.0 weight portion.
5. according to the compositions of claim 1, in its medical material Radix Sophorae Flavescentis in 8 weight portions, Mentholum 0.5-1 weight portion.
6. according to the compositions of claim 1, in its medical material Radix Sophorae Flavescentis in 8 weight portions, Borneolum Syntheticum 0.2-1.5 weight portion.
7. according to the compositions of claim 1, in its medical material Radix Sophorae Flavescentis in 8 weight portions, Borneolum Syntheticum 0.3-1.0 weight portion.
8. according to the compositions of claim 1, wherein the proportioning of each medical material is: Radix Sophorae Flavescentis 8 weight portions, Rhizoma Smilacis Glabrae 8-18 weight portion, Herba Artemisiae Scopariae 4-12 weight portion, Cortex Phellodendri 4-12 weight portion, Radix Gentianae 3-9 weight portion, Cortex Dictamni 4-12 weight portion, Herba Portulacae 3-9 weight portion, Fructus Kochiae 4-12 weight portion, Radix Stemonae 5-15 weight portion, Radix Glycyrrhizae 3-9 weight portion, Mentholum 0.8-2 weight portion, Borneolum Syntheticum 0.2-1.5 weight portion.
9. according to the compositions of claim 1, wherein also comprise the acceptable adjuvant of pharmacy.
10. according to the compositions of claim 1, wherein said Radix Sophorae Flavescentis, Rhizoma Smilacis Glabrae, Herba Artemisiae Scopariae, Cortex Phellodendri, Radix Gentianae, Cortex Dictamni, Herba Portulacae, the Fructus Kochiae, the Radix Stemonae, Radix Glycyrrhizae join in described compositions through 10～95% ethanol extractions.
11. according to the compositions of claim 1, it is the form that is medicinal preparation for oral administration or topical agent.
12. according to the compositions of claim 1, and it is to be to be selected from following medicine type: ointment, ointment, gel, liniment, spray.
13. according to the compositions of claim 1, and wherein said mammal is people.
14. according to the compositions of claim 1, and wherein said dermatosis is selected from eczema, pruritus.
15. prepare the method for compositions described in claim 1-14 any one, it comprises the following steps: Radix Sophorae Flavescentis, Rhizoma Smilacis Glabrae, Herba Artemisiae Scopariae, Cortex Phellodendri, Radix Gentianae, Cortex Dictamni, Herba Portulacae, the Fructus Kochiae, the Radix Stemonae, Radix Glycyrrhizae are extracted with aquiferous ethanol, the extracting solution obtaining is concentrated, add optional Mentholum, Borneolum Syntheticum, and add the acceptable adjuvant of optional pharmacy, obtain.
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Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1413627A (en) * | 2002-05-04 | 2003-04-30 | 付研彪 | Medicine for treating dematosis |
| US20030152588A1 (en) * | 2002-01-14 | 2003-08-14 | Hsu-Shan Huang | Chinese traditional medicines for psoriasis |
| CN1943699A (en) * | 2006-10-23 | 2007-04-11 | 王信锁 | A Chinese traditional medicinal preparation for treatment of eczema |
| CN101129715A (en) * | 2007-09-03 | 2008-02-27 | 毕庆双 | Orally taken traditional Chinese medicine composition for treating acute salt rheum |
| CN101972342A (en) * | 2010-10-20 | 2011-02-16 | 罗志诣 | Chinese medicinal composition for treating horse chronic eczema |
| WO2011126295A2 (en) * | 2010-04-06 | 2011-10-13 | (주)아모레퍼시픽 | Wrapping fermentation method using medicinal leaves, and composition for external skin application using same |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2010035262A2 (en) * | 2008-09-25 | 2010-04-01 | Life Biotech Medical Research Ltd | Herbal formulations |
-
2012
- 2012-06-13 CN CN201210194487.2A patent/CN102716394B/en not_active Expired - Fee Related
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20030152588A1 (en) * | 2002-01-14 | 2003-08-14 | Hsu-Shan Huang | Chinese traditional medicines for psoriasis |
| CN1413627A (en) * | 2002-05-04 | 2003-04-30 | 付研彪 | Medicine for treating dematosis |
| CN1943699A (en) * | 2006-10-23 | 2007-04-11 | 王信锁 | A Chinese traditional medicinal preparation for treatment of eczema |
| CN101129715A (en) * | 2007-09-03 | 2008-02-27 | 毕庆双 | Orally taken traditional Chinese medicine composition for treating acute salt rheum |
| WO2011126295A2 (en) * | 2010-04-06 | 2011-10-13 | (주)아모레퍼시픽 | Wrapping fermentation method using medicinal leaves, and composition for external skin application using same |
| CN101972342A (en) * | 2010-10-20 | 2011-02-16 | 罗志诣 | Chinese medicinal composition for treating horse chronic eczema |
Non-Patent Citations (2)
| Title |
|---|
| 中西医结合外治急性肛周湿疹56例;王娟等;《陕西中医》;20011231;第22卷(第3期);第159页左栏治疗方法部分 * |
| 王娟等.中西医结合外治急性肛周湿疹56例.《陕西中医》.2001,第22卷(第3期),第159页左栏治疗方法部分. |
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Inventor after: Zhang Meikui Inventor after: Xu Fenghua Inventor after: Guo Rongrong Inventor after: Chen Tingting Inventor before: Zhang Meikui Inventor before: Xu Fenghua Inventor before: Guo Rongrong Inventor before: Chen Tingting |
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