CN103845349A - Application of 20(R)-ginsenoside Rg3 in preparation of medicines for treating leucoderma - Google Patents
Application of 20(R)-ginsenoside Rg3 in preparation of medicines for treating leucoderma Download PDFInfo
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- CN103845349A CN103845349A CN201210501651.XA CN201210501651A CN103845349A CN 103845349 A CN103845349 A CN 103845349A CN 201210501651 A CN201210501651 A CN 201210501651A CN 103845349 A CN103845349 A CN 103845349A
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- ginsenoside
- medicine
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- ginsenoside rg3s
- skin
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Abstract
The invention discloses a novel application of 20(R)-ginsenoside Rg3 in preparation of medicines for relieving or/and treating leucoderma. Tests show that the 20(R)-ginsenoside Rg3 is significant in treating effects for the leucoderma, quick in effectiveness, low in toxic and side effects, safe, efficient, stable, simple in preparation process, suitable for industrial production, and prone to popularization. The application provides a novel medicine source for preventing and treating the leucoderma and complications thereof.
Description
Technical field
The present invention relates to field of medicaments, relate to one and treat leukodermic medicine or health food, particularly a kind of Chinese medicine Radix Ginseng extracts the application of composition in alleviation and/or treatment vitiligo medicine or health food.
Background technology
Vitiligo is a kind of common multiple pigmented dermatosis, and this disease forms white macula as feature taking local or general property depigmentation, is a kind of acquired, the de-white patch forming that loses of skin pigment.Vitiligo when morbidity white macula mostly is fingernail to coin size, and subcircular or similar round are the point-like speckle of losing lustre while also having onset, and how obvious boundary is, and some edges are around with pigment zone.Early stage white macula number is indefinite, can be confined to health a part or be distributed in a certain neural stage.According to statistics, China's total prevalence rate 0.72 ‰, male is more than women, and the north is more than south, and city is higher than rural area.Onset age male is mostly 20-39 year, and women is mostly 15-39 year, and sickness rate has the trend that rises and shift to an earlier date nearly ten years.
Relevant leukodermic pathogenesis is still not fully aware of so far, but studies have shown that relevantly with inherited genetic factors, autoimmune, psychic trauma, the neuro chemistry factor, melanocyte autoclasia etc., mainly contain at present the hypothesis of the following aspects: theory of heredity, theory of autoimmunity, spirit-neuro chemistry theory and melanin autoclasia theory.
Leukodermic pathogenic factor is had to a variety of suppositions, as theory of heredity, theory of autoimmunity, the mentalics melanin autoclasia theory of mediating a settlement.Theory of heredity thinks that vitiligo may be a kind of dermatosis of autosomal dominant inheritance, AD, research finds that 30% patient has Positive family history abroad, also find that in patient, two of monovular twinses all can be fallen ill, this has illustrated that inherited genetic factors and vitiligo are related to a certain extent.Theory of autoimmunity thinks that vitiligo may be relevant with autoimmune disease, research is found, in patient and family member thereof, merge autoimmune disease ratio higher, common are thyroiditis, diabetes, chronic adrenal hypofunction, pernicious anemia, rheumatic arthritis, malignant melanoma etc.Spirit theory is thought because hypertonicity, the depressed or dejected catecholamines that causes increase, and then melatonin secretion is increased, suppress melanocyte biochemistry, cause the toxicity intermediate product of Melanin Metabolism to be accumulated in melanocyte, make death of melanocytes finally cause vitiligo.Melanocyte autoclasia theory thinks that leukodermic basic lesion is partially or completely loss of function of epidermal melanophore, the possible reason of epidermal melanophore autoclasia is epidermal melanophore superfunction, short consume and decline in early days, and may be due to the gathering of the toxicity melanocyte synthetic due to cell itself, or by some chemical substance to melanocytic selective destruction, make skin depigmentation.Except these several suppositions, other factors also may cause leukodermic generation: as wound comprises wound, performs the operation, scratches etc. and can bring out vitiligo, some endocrinopathy, as hyperthyroidism, diabetes etc., the vitiligo that can occur together,, also easily there is vitiligo in solar exposure.Each is inferred certain basis, but has again limitation separately, mainly thinks that at present vitiligo is that affected by inherited genetic factors larger.
Therapy of vitiligo method has: the methods such as Drug therapy, phototherapy, Autologous epidermis transplanting or melanocyte transplantation treatment.Because its pathogenesis of vitiligo is comparatively complicated, various risk factors interknit again, impact each other, and treatment is quite difficult, the difference of individual's age, site of pathological change, health status in addition, and the patient degree difference of receiving treatment, there is obvious difference in curative effect.
At present, leukodermic treatment is mainly taking Drug therapy as main, and leukodermic drug treatment comprises corticosteroid hormone therapy, immunomodulator treatment, treatment by Chinese herbs etc. clinically.
Although corticosteroid hormone, immunomodulator have certain effect to therapy of vitiligo, conventionally there is certain side effect.As corticosteroid hormone can produce inhibitory action to body adrenal cortex function, make in the course of time body produce dependency.The lighter produces body to occur the side effect such as striped and atrophy, purpura, antibacterial and fungal infection as acne, acne rosacea, glaucoma, skin, severe one causes original kidney glandular secretion function to be suppressed and atrophy, lose the function of normal secretion adrenal hormone, once patient's drug withdrawal there will be seriousness rebound effect, cause the state of an illness to be more difficult to treatment.Immunomodulator treatment easily causes and feels sick, abdominal pain, hypogeusia, and easily bounce-back after drug withdrawal.And Chinese medicine is to the leukodermic curative effect of vitiligo especially progressive stage certainly, few side effects.Increasing people utilizes the leukodermic medicine of Chinese medicine exploitation treatment in recent years, and because it is evident in efficacy, and side effect is little, is day by day subject to the favor of extensive patients.For example:
Application number is that 200810049306.0 application for a patent for invention discloses one and treats leukodermic medicine, selecting Radix Ginseng, Radix Angelicae Sinensis, Fructus Atriplicis Sibiricae, Radix Saposhnikoviae, Radix Notoginseng ginseng, Radix Salviae Miltiorrhizae, the Radix Astragali, Fructus Psoraleae, the Radix Angelicae Dahuricae, Poria, Radix Polygoni Multiflori Cornu Cervi Pantotrichum, Moschus is raw material, the pharmaceutical composition being prepared from by certain technique, the raw materials used wide material sources of medicine, with low cost, the preparation method of pharmaceutical composition is simple, and there is significant curative effect clinical showing to therapy of vitiligo.
Application number is that 200910067121.7 application for a patent for invention discloses one and treats leukodermic medicine, it is characterized in that by Rhizoma Et Radix Notopterygii, Radix Angelicae Pubescentis, Radix Saposhnikoviae, the Radix Angelicae Dahuricae, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Fructus Psoraleae, Rhizoma Drynariae, Radix Polygoni Multiflori, Caulis Spatholobi, the Radix Astragali, Herba Ecliptae, Fructus Ligustri Lucidi, Radix Salviae Miltiorrhizae, Radix Codonopsis, Semen Persicae, Flos Carthami, Radix Glycyrrhizae, Semen Sesami Nigrum, Radix Rehmanniae Preparata is mixed, promoting blood circulation and detoxication, expelling wind and removing dampness, soothing liver-QI lung moistening, strengthening the spleen and stomach, wind dispelling is antipruritic, QI invigorating speckle dispelling, make the growth of skin damage melanin, white macula disappears, recover normal skin color, short treating period, instant effect, with low cost, handed down from one's ancestorsly go through so far more than 200 year, cure patient ten hundreds of, effective percentage reaches 100%.
Medicinal herbs most in use in Radix Ginseng Chinese medicine, modern medicine study shows that main effect and the effect of Radix Ginseng have: for the effect of nerve centre system, anticancer antitumor action, Immunologic Functions, diabetes effect, strengthens liver function effect, and cardiovascular and cerebrovascular vessel obstacle improves, arteriosclerosis effect, Blood pressure regulation, and climacteric obstacle and function of resisting osteoporosis, resisting fatigue, antioxidation, suppresses aging etc.Ginsenoside is as the main effective ingredient of Radix Ginseng, be widely studied and use, wherein noticeable with 20 (R)-ginsenoside Rg3s, it is as the main effective ingredient of Radix Ginseng, safety is good, be made into antitumor oral formulations and be applied to clinically, furtherd investigate as injection.
The inventor is by a large amount of modern scientific researches, adopt advanced separating and purifying technology from ginseng crude drug, to extract it and treat leukodermic effective ingredient 20 (R)-ginsenoside Rg3, and 20 (R)-ginsenoside Rg3s and corresponding pharmaceutical preparation thereof are carried out to the leukodermic pharmacodynamics for the treatment of, pharmaceutical research, result shows that 20 (R)-ginsenoside Rg3 monomer pharmacological actions are clear, treatment vitiligo effect is strong, toxic and side effects is low, safe, a kind of medicine of high-efficiency low-toxicity can be provided for patients with vitiligo.
Summary of the invention
Primary and foremost purpose of the present invention is the problem existing for above-mentioned prior art, provide 20 (R)-ginsenoside Rg3s to alleviate or/and performance and effect for the treatment of vitiligo disease, and the problem existing for above-mentioned prior art, 20 (R)-ginsenoside Rg3 is provided new pharmaceutical usage, in treatment, nurse one's health and alleviate the new application in leukodermic medicine or health food.
For achieving the above object, one aspect of the present invention provides a kind of 20 (R)-ginsenoside Rg3s the application in preparation alleviation and/or treatment vitiligo medicine or health product.
Have in the process of active skull cap components for the treatment of vitiligo effect in screening, inventor finds that 20 (R)-ginsenoside Rg3s in the chemical composition of Radix Ginseng have the effect of strong inhibition vitiligo mottle.
Wherein, described medicine is made up of 20 (R)-ginsenoside Rg3s and pharmaceutically acceptable carrier.
Wherein, 20 described (R)-ginsenoside Rg3 content are 1%～98%; Be preferably 30～80%, more preferably 60%.
Particularly, 20 described (R)-ginsenoside Rg3 content >=1%, be preferably >=30%, more preferably >=60%, be further preferably >=80%, be more further preferably >=98%.
Particularly, pharmaceutically acceptable carrier is used for this purpose and the non-active ingredient as medicament by sanitarian's accreditation conventionally.About pharmaceutically acceptable carrier compilation can in " handbook of pharmaceutical excipients ", (Handbook of Pharmaceutical excipients,, be edited by A.Wade and P.J.Weller by the 2nd edition; American Pharmaceutical Association publishes, Washington and The PharmaceuticalPress, London, 1994) etc. find in reference book.
Especially, described carrier comprises excipient, as starch, water etc.; Lubricant, as magnesium stearate etc.; Disintegrating agent, as microcrystalline Cellulose etc.; Filler, as lactose etc.; Binding agent, as pregelatinized Starch, dextrin etc.; Sweeting agent; Antioxidant; Antiseptic, correctives, spice etc.;
Wherein, described medicine exists with tablet, capsule, pill, powder, granule, syrup, solution, Emulsion, injection, spray, aerosol, gel-type, cream, tincture, cataplasma, rubber plaster unguentum or emplastrum form.
Particularly, described medicine exists with gel-type, cream, tincture or cataplasma form.
Especially, the adjuvant in described gel-type, cream, tincture or cataplasma preparation is one or more in water, glycerol, propylene glycol, ethanol, carbomer, arabic gum, hyaluronic acid, tragakanta, Polyethylene Glycol series, menthol, methylcellulose, starch, cetyl polyoxyethylene (20) ether, glyceryl stearate, hexadecanol, squalane, octadecanol misfortune dimethione ethylhexyl methoxy cinnamate; Preferably carbomer hydrogel matrix.
Particularly, described medicine exists with rubber plaster unguentum or emplastrum form.
Especially, described rubber plaster unguentum comprises 20 (R)-ginsenoside Rg3s, host material, tackifier, softening agent and filler, and wherein said host material is rubber; Described tackifier is selected Colophonium, esterase, Foral or nopinene; Described softening agent is vaseline, lanoline, liquid Paraffin or vegetable oil; Described filler zinc oxide or Griffith's zinc white.; Described emplastrum comprises 20 (R)-ginsenoside Rg3s, host material, and wherein said host material is acrylic resin, Oleum Verniciae fordii, oleum lini, Oleum sesami, Oleum Ricini, Colophonium, edible Gelatinum oxhide, Cera Flava, glycerol, maltose or zinc oxide.
Wherein, described gel is made up of following proportioning raw material according to every 100ml gel:
Wherein, described emplastrum is made up of following proportioning raw material according to every 100ml emplastrum:
Wherein, 20 described (R)-ginsenoside Rg3 content are 1%～98%; Be preferably 30～80%, more preferably 60%.
Particularly, 20 described (R)-ginsenoside Rg3 content >=1%, be preferably >=30%, more preferably >=60%, be further preferably >=80%, be more further preferably >=98%.
The present invention provides alleviation that one contains 20 (R)-ginsenoside Rg3s and/or medicine or the health product for the treatment of vitiligo disease on the other hand.
Wherein, 20 described (R)-ginsenoside Rg3 content >=1%, are preferably 1%～98%; Be preferably 30～80%, be further preferably 60%.
Particularly, 20 described (R)-ginsenoside Rg3 content >=1%, be preferably >=30%, more preferably >=60%, be further preferably >=80%, be more further preferably >=98%.
Particularly, the ratio of described 20 (R)-ginsenoside Rg3's weight and the gross weight of described external preparation is 0.01-10: 100, be preferably 0.1～10: 100, more preferably 1～10: 100.
Particularly, in described medicine or health product, also comprise Radix Notoginseng, Aloe, Radix Glycyrrhizae, the Radix Polygoni Multiflori, Semen Ginkgo, Semen Sesami Nigrum extract, Rhizoma Zingiberis Recens extract, Semen Vitis viniferae extract, Semen Granati extract, plants essential oil, arbutin, vitamin C and derivant thereof or vitamin E and derivant thereof.
Described medicine can adopt method well known in the art to make various dosage forms, as tablet, capsule, pill, powder, granule, syrup, solution, injection, spray, aerosol, gel-type, cream, tincture, cataplasma, rubber plaster unguentum or emplastrum etc.
The present invention also provides a kind of method for the treatment of vitiligo disease, comprise the pharmaceutical composition for the treatment of 20 (R)-ginsenoside Rg3s of effective dose to experimenter, its treatment effective dose is 0.06～12mg/kg.d, be preferably 1～6mg/kg.d, more preferably 1.5～3mg/kg.d.
Unless otherwise indicated, term used herein " treatment effective dose " is the consumption that need to produce the medicine of useful effect; " treatment effective dose " can be adjusted and change, and finally determined by medical worker, and its factor of considering comprises character, receiver's the ordinary circumstance such as body weight, age and character and the order of severity of the disease for the treatment of of route of administration and preparation.
Compared with prior art, the present invention has following obvious advantage:
1, the present invention has excavated new medical value to known compound 20 (R)-ginsenoside Rg3, use it for alleviation, treatment vitiligo, and can be prepared into and alleviate and/or treat leukodermic medicine or health food, thereby open up a new field for ginseng crude drug's application.
2, campaign of the present invention studies have shown that 20 (R)-ginsenoside Rg3s have significant alleviation, treat leukodermic effect, can significantly suppress the size of leukodermic white macula, significantly improve the number that stratum basale and spinous layer melanin distribute and has melanin hair follicle.
3,20 (R)-ginsenoside Rg3 pharmacological actions of the present invention are strong, and for alleviating, to nurse one's health and treat leukodermic effect remarkable, instant effect, toxic and side effects is little, safety good, can long-term taking, there is good prospect in medicine.
4, abundant, inexpensive, the clinical use safety in products material of the present invention source, preparation technology is simple, can be made into various dosage forms, and dosing is little, easy to use, is therefore easy to promote.
6, the present invention both can adopt 20 (R)-ginsenoside Rg3 active fraction preparations alleviations of single component and treat leukodermic medicine, can adopt again the common prescription of 20 (R)-ginsenoside Rg3s and other active component (for example, with Radix Notoginseng, Aloe, Radix Glycyrrhizae, the Radix Polygoni Multiflori, Semen Ginkgo, Semen Sesami Nigrum extract, Rhizoma Zingiberis Recens extract, Semen Vitis viniferae extract, Semen Granati extract, plants essential oil, arbutin, vitamin C and derivant thereof or vitamin E and derivant thereof), the leukodermic compound medicine of preparation treatment.
Detailed description of the invention
Further describe the beneficial effect of formula of the present invention below by detailed description of the invention, these embodiment have comprised 20 (R)-ginsenoside Rg3s' of the present invention cream, tincture, emplastrum, the pharmacodynamics test of gel.These embodiment are only exemplary, scope of the present invention are not formed to any restriction.It will be understood by those skilled in the art that and do not departing under formula thinking of the present invention, purposes scope and can the details of technical solution of the present invention and form modified or be replaced, but these amendments and replacement all fall within the scope of protection of the present invention.
Embodiment 1 Rg3 cream
1, prepare raw material according to following proportioning
1) according to as prepare A part material in proportioning:
2) according to as prepare B part material in proportioning:
2, under stirring, respectively A, B part material are mixed, heat and remain 70 DEG C, after stirring, be under the condition of 70 DEG C, while stirring B part mixed material to be joined in the raw material of A part, after stirring keeping temperature, add deionized water to 100%, cool to room temperature.
Embodiment 2 Rg3 gels
1, prepare raw material according to following proportioning
2, card pool nurse is joined in deionized water, stir after swelling, add ginsenoside Rg3, EDTA-Na2, essence, propylparaben, methyl hydroxybenzoate, after stirring, the sodium hydroxide solution that is 10% with mass percent concentration regulates the pH of mixed solution to be 6 (pH be 5～7 be also applicable to the present invention), stir, add deionized water to 100%.
Embodiment 3 Rg3 emplastrumes
1, prepare raw material according to following proportioning
2, ginsenoside Rg3 is mixed homogeneously with a small amount of water, then after adding EDTA-Na2 to dissolve, the sodium hydroxide solution that is 10% with mass percent concentration regulates the pH of mixed solution to be 6 (pH be 5～7 be also applicable to the present invention), then under stirring, add essence, propylparaben, methyl hydroxybenzoate, adds after being mixed in acrylic resin cream base, adds deionized water to 100%, fully be mixed, be coated on the emplastrum of making on backing non-woven fabrics.
Embodiment 4 Rg3 tinctures
1, prepare raw material according to following proportioning
2, get ginsenoside Rg3, Radix Polygoni Multiflori extract, Semen Sesami Nigrum extract, with adding deionized water to 100% after dissolve with ethanol, to obtain final product.
Embodiment 5 20 (R)-ginsenoside Rg3 treats vitiligo pharmacodynamic experiment
1 materials and methods
1.1 laboratory animals: Cavia porcellus, body weight 250 ± 20g, male and female dual-purpose, purchased from Dalian Medical Univ's Experimental Animal Center, the certification of fitness number: SCXK (13) 2002-0002.
1.2 medicines and instrument
Hydrogen peroxide: Zhen Ya chemical plant, Suzhou produces, lot number 20009303;
Ginsenoside Rg3's gel: Dalian Fu Sheng natural drug development corporation, Ltd. provides, lot number 20110315, specification: 10g/ props up;
Positive drug: new sicorten (Main Ingredients and Appearance is halometasone 0.05%, triclosan 1%) Novartis, lot number 200012;
7170A type automatic clinical chemistry analyzer, HIT.
1.3 experimental technique
1.3.1 preparation vitiligo animal model
Get 60 of black or black flower hair (dark skin) Cavia porcelluss, slough the about 40cm of back black wool with sodium sulfide
2.Be divided at random 6 groups, i.e. blank group; Model control group; Positive controls (new sicorten group): ginsenoside Rg3's gel low dose group (Rg3 concentration 0.1%): middle dosage group (Rg3 concentration 1%): high dose group (Rg3 concentration 10%), wherein, blank group: smear equivalent distilled water; Model control group: smear hydrogen peroxide modeling group (preparation vitiligo animal model group); Positive controls: smear new sicorten: ginsenoside Rg3's low dose group is smeared Rg3 concentration 0.1%: middle dosage group is smeared Rg3 concentration 1%: high dose group is smeared Rg3 concentration 10%.Every group of Cavia porcellus is with electronic device and the depilatory (5% sodium sulfide) of having one's hair cut by Cavia porcellus spinal column both sides unhairing, and unhairing district area is about 100cm
2, except blank group, other each group Cavia porcelluss are smeared 5% hydrogen peroxide in depilation district, use 0.5ml, every day 2 times, continuous 50 days at every turn.Blank group is smeared equivalent distilled water.During this period, respectively organizing Cavia porcellus loses hair or feathers 1 time in tested district at back with sodium sulfide weekly.
1.3.2 the treatment of ginsenoside Rg3's vitiligo gel to the pneumatic object model of leucoderma
Blank group and model group are not carried out any processing, and positive controls is smeared new sicorten treatment vitiligo; Ginsenoside Rg3's gel low dose group, middle dosage group, high dose group are smeared respectively ginsenoside Rg3's gel of corresponding dosage, every day 2 times, continuous 50 days.During treatment, each group Cavia porcellus loses hair or feathers 1 time in tested district at back with sodium sulfide weekly.
After treatment finishes, naked eyes gross examination of skeletal muscle is treated leukodermic curative effect.
Curative effect determinate standard: with Cavia porcellus agents area center 3cm
2be an observation unit, excellent is tested district (3cm
2) pigment recovers normal substantially; Goodly there is pigment area > 50% for tested district; In be tested district pigment area < 50%, poor be still pale or white macula shape for tested district skin; Total effective rate adds " good " in " excellent ".
With 20% urethane anesthesia, ventral aorta blood drawing, surveys acetylcholine esterase (ChE) activity.And get 1cm × 1cm skin in agents area center, and to fix with neutral formalin, paraffin embedding, cuts into slices, and carries out melanin dyeing by ferrous sulfate lillie method, arbitrarily observes 20 hair follicles, calculates and wherein has melanin hair follicle number and dermal melanin distribution situation.
1.3.3 Data Processing in Experiment experimental result represents with x ± s, adopts variance analysis and rank test.
2 results
2.1 perusals are in table 1.
Table 1 ginsenoside Rg3 treats leukodermic observation of curative effect (3cm
2observation unit)
Table 1 observed result table shows: blank group and model control group relatively have the difference (P < 0.01) of highly significant; New sicorten positive control drug group, ginsenoside Rg3 organize total effective rate and are respectively 70%, 80%, 90%, with blank group comparing difference without significance (P > 0.05).
2.2 histological observations are in table 2, and " +++ " shows that epidermal basal cell and spinous layer all have melanin; " ++ " shows that epidermal basal cell and spinous layer more than 1/2 have melanin; "+" shows that epidermal basal cell and spinous layer 1/2～1/3 have melanin; " ± " shows epidermal basal cell and the accidental melanin of spinous layer; "-" shows that epidermal basal cell and spinous layer are without melanin.From table 2, blank group, new sicorten positive controls, the basic, normal, high dosage group of ginsenoside Rg3 and model group more all have significant differences (P < 0.01); Ginsenoside Rg3's gel group and new sicorten group relatively there were significant differences property (P < 0.05).
The impact of table 2 ginsenoside Rg3 on the pneumatic object model dermal melanin of leucoderma
Note: * * p < 0.01, with model group comparison;
△p > 0.05, with blank comparison;
Δ Δp < 0.05, with positive control comparison.
Conclusion vitiligo is dermatology common disease, and clinical main manifestations is that dermal melanin reduces.Be subject to the feature of strong oxidizer hydrogen peroxide destroying according to melanin, this test selects 5% hydrogen peroxide that Cavia porcellus dark skin is decoloured.After continuous 50 days, the visible Cavia porcellus dark skin of naked eyes is pale, some appearance white maculas, and even original black wool director goes out white hair.Visible under skin biopsy mirror, in spinous layer and hair follicle, melanin reduces, and some hair follicle internal upper parts are white in color, centre is pigment change yellow, that bottom is black, show that vitiligo model group is successfully prepared.With ginsenoside Rg3's gel, treatment is after 50 days continuously, and ginsenoside Rg3's basic, normal, high dosage group and the new sicorten group of positive controls skin perusal pigment recover substantially, approach Normal group; In histological examination, the melanin hair follicle number of ginsenoside Rg3's gel group, obviously more than positive control (new sicorten) group (P < 0.05), shows that ginsenoside Rg3 is better than positive control drug in the effect aspect recovery melanin hair follicle.
Embodiment 6 Rg3 external preparation toxicology test researchs
1 material
1.1 medicine
Ginsenoside Rg3's external preparation (cream, tincture, patch, gel), above-mentioned preparation Rg3 concentration is high dose group (30%), low dosage (0.1%) group, Dalian Fu Sheng natural drug development corporation, Ltd. develops and lot number is provided: 20110816;
Positive drug: DNFB, Tianjin chemical reagent factory, lot number: 20100511;
Sodium sulfide, Guangzhou Chemical Reagent Factory, lot number: 20101105;
Acetone, Tianjin chemical reagent factory, lot number: 20111029.
1.2 animal
Healthy new zealand rabbit 2.5 ± 0.3kg, Kunming mouse 20 ± 2, all purchased from Dalian Medical Univ's Experimental Animal Center, the certification of fitness number: SCXK (13) 2002-0002.
2 experimental techniques
2.1 skin irritation test
Get 10 of healthy new zealand rabbit (2.5 ± 0.3) kg, before test, 24h adopts electronic device and the depilatory (5% sodium sulfide) of having one's hair cut by rabbit spinal column both sides unhairing, and unhairing district area is about 100cm
2, after unhairing 24h, get at random the rabbit of 5 skin zero damages as intact skin group; Damaged skin group is to adopt injection needles head at standardized " # " shape wound of its depilation sterilization skin in the depilation district of other 5 depilation new zealand rabbits, and length and width are about 5cm all, taking oozing of blood as degree.Use respectively ginsenoside Rg3's external preparation---cream, tincture, gel (Rg3 concentration 30%, exceed 300 times than minimum effective dose 0.1%) be evenly applied in back, rabbit left side, average thickness is about 1mm, observes the medication skin place situation of each rabbit after administration respectively at 2h, 12h, 24h, 48h, 72h; Ginsenoside Rg3's patch repeats above-mentioned experiment, and the dosage of subsides is 2 × 3cm
2.
2.2 skin acute toxicity tests
30 of healthy new zealand rabbit (2.5 ± 0.3) kg, male and female half and half.Before test, 24h is to rabbit unhairing, after unhairing 24h, be divided at random 6 groups, i.e. intact skin high dose group (external preparation Rg3 concentration 30%), intact skin low dose group (external preparation Rg3 concentration 0.1%), damaged skin high dose group (external preparation Rg3 concentration 30%), damaged skin low dose group (external preparation Rg3 concentration 0.1%), intact skin matched group, damaged skin matched group.Damaged skin group adopts injection needles head standardized " # " shape wound on new zealand rabbit depilation sterilization skin, and length and width are about 5cm all, taking oozing of blood as degree.Intact skin matched group, damaged skin matched group docile and obedient blank substrate respectively.Intact skin high dose group, damaged skin high dose group are used respectively ginsenoside Rg3's external preparation---cream, or tincture, gel are evenly applied in back, rabbit left side, average thickness is about 2mm, intact skin low dose group, damaged skin low dose group are used respectively ginsenoside Rg3's external preparation---and cream, tincture, gel are evenly applied in back, rabbit left side, average thickness is about 1mm, with the sterile gauze being of convenient length and nonirritant immobilization with adhesive tape, every animal divides cage to feed, and sticks after 24h and washes away residue with warm water.Be subject to 1h after reagent, 1 day, 2 days, 3 days, 7 days respectively at removal, observe and record movable and other poisoning manifestations of variation, breathing, central nervous system, the extremity of body weight, skin, hair, eye and the mucosa of animal.Ginsenoside Rg3's patch (high dose group Rg3%, low dose group Rg30.1%) repeats above-mentioned experiment, and administering mode is docile and obedient, dosage 2 × 3cm
2.
2.3 sensitization of skin tests
30 of healthy Kunming white mice (20 ± 2) g, male and female half and half, are divided into ginsenoside Rg3's experimental group, blank group and positive controls at random, and before administration, 24h is by back lateral symmetry unhairing (3cm × 3cm).
Sensitization: use respectively ginsenoside Rg3's (cream, or tincture, gel) evenly to smear ginsenoside Rg3's experimental mice, average thickness is about 1mm, is applied to depilation district, left side, and fixing means is the same, animal sub-cage rearing.After 6h, take off, wash away residue with warm water.The commensurability blank substrate of blank group mouse back left side depilation place coating; Positive controls back part of animal left side depilation place coating 1%2,4-dinitrochlorobenzene acetone soln 100 μ l.In addition in the 7th day and the 14th day each group all repeat 1 time.
Excite: ginsenoside Rg3's experimental group sticks ginsenoside Rg3's (cream at last, or tincture, gel) after 6h, remove them and wash away residue with warm water, again by ginsenoside Rg3's external (cream, or tincture, gel) be applied to depilation district, right side, after 6h, wash away medicine, observe at once, and observe respectively and record skin allergy situation in 24h, 48h, 72h.Positive controls uses the same method to excite with blank group and contacts and observed and recorded.Evaluate sensitization degree by standard scoring.
Result of the test, by the scoring of skin irritation reaction standards of grading, is calculated mean scores and is evaluated.Observe animal simultaneously and whether have the serious whole body allergy symptoms such as asthma, astasia or shock.Ginsenoside Rg3's patch, with docile and obedient mode administration, repeats the each step of above-mentioned test, its smear make into docile and obedient, administration scope 1 × 1cm
2.
3 experimental results
3.1 irritation test
After each rabbit medication, skin all occurs without the abnormal phenomena such as red, to swell, ooze out, and prompting ginsenoside Rg3 is to the equal nonirritant reaction of skin.
3.2 skin acute toxicity tests
Result shows: rabbit intact skin, damaged skin group contact ginsenoside Rg3 (cream, or tincture, gel, patch) after, the variation of body weight, skin, hair, eye and the mucosa of animal, breathing, central nervous system, extremity activity are showed no extremely, drug of topical application part has no the phenomenon such as erythema and edema, the relatively no abnormality seen reaction of consubstantiality left and right sides, relatively indifference.Illustrate ginsenoside Rg3's (cream, or tincture, gel, patch) to skin without acute toxic reaction.
3.3 sensitization of skin tests
Result shows: the anaphylaxis such as erythema, edema does not all appear in ginsenoside Rg3's experimental group and blank group.After positive control administration 6h, skin all has erythema to form, and without edema, is 1.7 points by standards of grading, and sensitization rate still has erythema while being 100%, 0h, 24h, 48h, 72h, has no edema and occurs.Each treated animal allergy meansigma methods and sensitization rate result are as shown in table 3.Each group mice is showed no the serious whole body sensitivity responses such as asthma, astasia or shock.Show ginsenoside Rg3's external preparation (cream, or tincture, gel, patch) to skin without sensitivity response.
Table 3 animal sensitivity response meansigma methods and sensitization rate (n=10)
Claims (10)
1.20 (R)-ginsenoside Rg3s are for the preparation of alleviating and/or treating the application in leukodermic medicine or health product.
2. application according to claim 1, is characterized in that described medicine is made up of 20 (R)-ginsenoside Rg3s and pharmaceutically acceptable carrier.
3. application according to claim 1 and 2, is characterized in that described medicine exists with tablet, capsule, pill, powder, granule, syrup, solution, Emulsion, injection, spray, aerosol, gel-type, cream, tincture, cataplasma, rubber plaster unguentum or emplastrum form.
4. application according to claim 1 and 2, purity >=1% of 20 (R)-ginsenoside Rg3s described in it is characterized in that.
5. application according to claim 4, the purity that it is characterized in that 20 described (R)-ginsenoside Rg3s is 1%～98%.
6. medicine or health product of alleviating and/or treating vitiligo disease, is characterized in that containing 20 (R)-ginsenoside Rg3s.
7. medicine according to claim 6, is characterized in that the ratio of described 20 (R)-ginsenoside Rg3s' weight and the gross weight of described medicine or health product is 0.01-10: 100.
8. medicine according to claim 6, is characterized in that 20 described (R)-ginsenoside Rg3s purity is >=1%.
9. medicine according to claim 8, is characterized in that 20 described (R)-ginsenoside Rg3s purity is 1%～98%.
10. medicine according to claim 6, is characterized in that also comprising Radix Notoginseng, Aloe, Radix Glycyrrhizae, the Radix Polygoni Multiflori, Semen Ginkgo, Semen Sesami Nigrum extract, Rhizoma Zingiberis Recens extract, Semen Vitis viniferae extract, Semen Granati extract, plants essential oil, arbutin, vitamin C and derivant thereof or vitamin E and derivant thereof.
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| WO2016110167A1 (en) * | 2015-01-06 | 2016-07-14 | 富力 | Applications of 20(r)-ginsenosides rg3 in preparing medicament or healthcare product for use in treatment of osteoporosis and medicament |
| CN105816470A (en) * | 2015-01-09 | 2016-08-03 | 富力 | Application of 20(R)-ginsenoside in preparation of medicine or health product for alleviating or/and treating diabetes and medicine thereof |
| WO2016127771A1 (en) * | 2015-02-11 | 2016-08-18 | 富力 | Application of 20(r)-ginsenoside rg3 in preparing drug or healthcare product for alleviating or/and treating rheumatoid disease and drug containing 20(r)-ginsenoside rg3 |
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| CN106924276A (en) * | 2017-05-09 | 2017-07-07 | 西北大学 | A kind of Panaxsaponin composition and its application in leucoderma is treated |
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| CN104644659A (en) * | 2013-11-22 | 2015-05-27 | 富力 | Application of 20 (R)-ginsenoside Rg3 to preparation of medicine for treating pharyngitis |
| CN105581974A (en) * | 2014-10-24 | 2016-05-18 | 熊慧 | External-use composition |
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| WO2016110167A1 (en) * | 2015-01-06 | 2016-07-14 | 富力 | Applications of 20(r)-ginsenosides rg3 in preparing medicament or healthcare product for use in treatment of osteoporosis and medicament |
| CN105816469A (en) * | 2015-01-06 | 2016-08-03 | 富力 | Application of 20(R)-ginsenoside Rg3 in preparation of medicine or health product for treating osteoporosis and medicine thereof |
| CN105816469B (en) * | 2015-01-06 | 2020-06-26 | 富力 | Application of 20(R) -ginsenoside Rg3 in preparation of medicine or health product for treating osteoporosis and medicine |
| CN105816470A (en) * | 2015-01-09 | 2016-08-03 | 富力 | Application of 20(R)-ginsenoside in preparation of medicine or health product for alleviating or/and treating diabetes and medicine thereof |
| CN105982905A (en) * | 2015-02-06 | 2016-10-05 | 富力 | Application of 20 (R)-ginsenoside Rg3 in preparing medicine for preventing and/or treating obesity and medicine |
| CN105982906A (en) * | 2015-02-11 | 2016-10-05 | 富力 | Application of 20(R)-ginsenoside Rg3 in preparing medicines or health products capable of alleviating or/and treating rheumatoid diseases and medicines |
| WO2016127771A1 (en) * | 2015-02-11 | 2016-08-18 | 富力 | Application of 20(r)-ginsenoside rg3 in preparing drug or healthcare product for alleviating or/and treating rheumatoid disease and drug containing 20(r)-ginsenoside rg3 |
| CN106138139A (en) * | 2015-05-15 | 2016-11-23 | 富力 | Radix Ginseng extract, ginsenoside, Hydrolizates application in the medicine or health product of preparation treatment cytomegalovirus infection disease |
| CN106138139B (en) * | 2015-05-15 | 2020-07-28 | 富力 | Application of ginseng extract, ginsenoside and ginsenoside derivative in preparation of medicine for treating cytomegalovirus infection diseases |
| CN106924276A (en) * | 2017-05-09 | 2017-07-07 | 西北大学 | A kind of Panaxsaponin composition and its application in leucoderma is treated |
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