CN102973802B - Drug composite for treating sensitive skin and preparation method thereof - Google Patents
Drug composite for treating sensitive skin and preparation method thereof Download PDFInfo
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Abstract
The invention provides a drug composite for treating sensitive skin and a preparation method thereof. The drug composite with an effect on treating sensitive skin is prepared from the following raw materials in parts by weight: 1-60 parts of radix sophorae flavescentis, 1-60 parts of herba schizonepetae, 1-60 parts of nervilia fordii schltr, 1-60 parts of houttuynia cordata and 1-60 parts of honeysuckle flowers. The drug composite provided by the invention has the advantages of obvious effect and safety on treating sensitive skin without stimulation or sensitization on skin.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition and preparation method thereof, particularly a kind of used for cosmetic pharmaceutical composition with the effect for the treatment of sensitive skin and its preparation method and application, is suitable for the cosmetics that make an addition to cream class, white class, newborn class, liquid class (except perfume).
Background technology
Sensitivity skin is as common puzzlement skin state ubiquity, although the definite definition of sensitive skin is not yet reached an agreement, but the description to its skin clinical symptoms and sign is consistent gradually, uncomfortable, the discomfort of most of patients nearly all shows face, comprise subjective sensory symptoms, as scorching hot, twinge, pruritus, numb, these symptoms can with or without erythema.(ProkschE, Weidinger S.New insights into the pathogenesis of sensitive skin.Hautarzt, 2011,62 (12): although 900-5) sensitive skin is not dermatosis, the skin discomfort that it causes directly affects people's quality of life.Along with social progress, people are to beautiful pursuit, and increasing people pays close attention to skin health and the quality of life of oneself, and this problem of sensitive skin also becomes increasingly conspicuous, particularly such line city in Shanghai.(remaining tinkling of pieces of jades, Wang Xueming. the Epidemiological study of District of Shanghai sensitive skin. clinical department of dermatologry magazine, 2011,40 (7): 403-406) a up-to-date epidemiological study of China shows, the average attack rate of Beijing, Shanghai, the responsive skin in three big cities, Guangzhou is 13%, Pekinese's average attack rate is 17.12%, the average attack rate in Shanghai is 9.10%, and the average attack rate in Guangzhou is the highest by 22.39%, wherein the sickness rate of the responsive skin of male is 8.62%, and the sickness rate of the responsive skin of women is 15.93%.(Xu F, Yan S, Wu M, et al.Self-declared sensitive skin in China:a community-based study in three top metropolises.J EurAcad Dermatol Venereol, 2012, Epub ahead of print) therefore study new treatment sensitive skin ways and means, become the study hotspot of current department of dermatologry educational circles and Management of Cosmetics Enterprises.(Bornkessel A, Flach M, Arens-Corell M, et al.Functional assessment of a washing emulsion for sensitiveskin:mild impairment of stratumcorneum hydration, pH, barrier function, lipid content, integrity and cohesion in a controlledwashing test.Skin Res Technol, 2005, 11 (1): 53-60) as number of patent application 200510079622.9, in this application, disclose a kind of for preventing and/or treating the cosmetic treatments way of sensitivity and/or dry skin, specifically comprise at least one microorganism of Orally administered at least effective dose, probiotic microorganisms particularly, and at least one bivalence inorganic cation of associating effective dose.As number of patent application 200680028396.4, in this application, disclose a kind of for preventing and/or treating cosmetic and/or the dermatological compositions of sensitivity and/or dry skin, at least one the special probiotic micro-organisms and/or its fragment or the metabolite that specifically comprise effective dose, it combines in acceptable carrier on physiology with at least one polyunsaturated fatty acid of effective dose and/or esters of polyunsaturated fatty acids and/or its salt or derivant.As number of patent application 200810147597.7, a kind of purposes of planting lysate for the treatment of sensitive-skinned Bifidobacterium (Bifidobacterium) is disclosed in this application, at least one lysate that specifically comprises at least one microorganism that the Bifidobacterium (Bifidobacterium) of effective dose is planted, and/or part is for preventing and/or process the beautifying use of skin barrier in sensitive skin situation.Chinese medicine extract also has good therapeutical effect to sensitive skin, as number of patent application 02826321.9, in this application, disclose screening and improved the method for the active component of pruritus, pachylosis or skin sensitivity or performance whitening effect by suppressing generation and/or the release of stem cell factor, and contained these active component, the medicine for improving pachylosis or skin sensitivity and/or brightening.Some clinical trial reports adopt the sings and symptoms that can alleviate sensitive skin containing the medical science skin care item of thermal water.(Pan Weihua, Liao Wanqing. Avene is relaxed and is protected the preliminary observation of spring water alive to 1050 routine sensitive skin and the sick auxiliary therapeutic action of inflammatory skin. clinical department of dermatologry magazine, 2005,34 (7): 473-474; Wang Shanshan, Liang Hong, Hu Yingzi etc. the protective action of functional cosmetics to sensitive skin. Chinese aesthetic medicine, 2009,18 (10): 1486-1489) have scholar find containing Herba portulacae and Radix Glycyrrhizae extract skin care item to sensitive skin have auxiliary therapeutic action (He Li, Wen Hai, Xu Limin etc. containing Herba portulacae and the clinical observation of Radix Glycyrrhizae extract skin care item to sensitive skin auxiliary therapeutic action, clinical department of dermatologry magazine, 2009,38 (6): 364-366)
The concept of sensitive skin proposes only short more than 20 years so far, and people also lack the effective means for the treatment of sensitive skin.Chinese medicine is a great treasure-house, and it has made huge contribution for compatriots' procreation of living of several thousand, and this treasure-house is furtherd investigate, and explores new treatment sensitive skin effective ways very necessary.
Summary of the invention
The object of the invention is in order to overcome weak point of the prior art, a kind of pharmaceutical composition and preparation method and purposes with the effect for the treatment of sensitive skin is provided.
The pharmaceutical composition with treatment sensitive skin effect of the present invention, take Radix Sophorae Flavescentis, Herba Schizonepetae, Folium Nerviliae fordii, Herba Houttuyniae and Flos Lonicerae to prepare as raw material, and be to prepare with the raw material of following parts by weight:
1～60 part of Radix Sophorae Flavescentis
1～60 part of Herba Schizonepetae
1～60 part of Folium Nerviliae fordii
1～60 part of Herba Houttuyniae
1～60 part of Flos Lonicerae
Preferably, described in there is the pharmaceutical composition for the treatment of sensitive skin effect, be to prepare with the raw material of following parts by weight:
1～50 part of Radix Sophorae Flavescentis
1～50 part of Herba Schizonepetae
1～50 part of Folium Nerviliae fordii
1～50 part of Herba Houttuyniae
1～50 part of Flos Lonicerae
The preparation method with the pharmaceutical composition for the treatment of sensitive skin effect of the present invention, comprises the following steps:
(1) each above-mentioned raw material being placed in to volumetric concentration is that 20%～80% ethanol soaks 2～48 hours, and the ethanol consumption that soaks use be 10～200 times of each raw material gross weight, and filtration, obtains soak;
Preferably, the soak with ethanol that filtration residue is 20%～80% by volumetric concentration again 2～48 hours, merges the solution after soaking, and obtains soak.
(2) soak is concentrated into 2～5% of former weight, and concentrated solution macroporous resin adsorption, then the ethanol of using volumetric concentration 5%～95% eluting repeatedly, collect eluent, is the described pharmaceutical composition with the effect for the treatment of sensitive skin;
Preferably, eluting is 40%～95% by the volumetric concentration of ethanol;
Described macroporous resin adopts Mitsubishi chemical company to take the HP20 type macroporous resin that polystyrene-divinylbenzene is matrix; The concentrated method of soak is conventional concentrating under reduced pressure.
Evidence, the pharmaceutical composition with the effect for the treatment of sensitive skin of the present invention, has multiple action, can be used in the cosmetics of preparation sensitivity skin skin care and the curative drug of skin.
The invention still further relates to a kind of skin care cosmetics, described in comprising, there is the pharmaceutical composition for the treatment of sensitive skin effect and the adjuvant that cosmetic field is used.
The invention still further relates to a kind of curative drug of skin, comprise the pharmaceutical composition with the effect for the treatment of sensitive skin described in claim and medically acceptable carrier.
Especially can, for the preparation of skin care cosmetics, comprise cream, emulsion, astringent, gel, facial film, liniment or lotion.
During preparation skin care cosmetics, can be by the extracting solution compositions making, through being evaporated to 10%～50% of former weight, obtain composition concentrated solution, mix mutually with the substrate of known cosmetics and medicine or adjuvant, carrier, additive, according to conventional method, be prepared, wherein, described composition concentrated solution accounts for 5%～10% of cosmetics gross weight.
The present invention is according to tcm theory, from a large amount of natural drugs, having selected Radix Sophorae Flavescentis, Herba Schizonepetae, Folium Nerviliae fordii, Herba Houttuyniae and Flos Lonicerae is raw material, prepared the described compositions with the effect for the treatment of sensitive skin, wherein, described Radix Sophorae Flavescentis is selected the root of leguminous plant Sophora flavescens Ait.; Herba Schizonepetae is selected the herb of Schizonepeta tenuifolia platymiscium Schizonepeta tenuifolia Schizonepetatenuifolia (L.) Briq.; Folium Nerviliae fordii is selected the herb of Nervilia fordii (Hance) Schltr. in orchid Nervilia; Flos Lonicerae is selected the dry flower of Radix Ophiopogonis Lonicera japonica Thunb. or the flower that band is just opened; Herba Houttuyniae is selected fresh herb or the dry aerial parts of saururaceae plant houttuynia cordata Houttuynia cordata Thunb..
According to < < Chinese Pharmacopoeia > > and document, record:
Radix Sophorae Flavescentis is the root of leguminous plant Sophora flavescens Ait., and Radix Sophorae Flavescentis is the effects such as one of China's Chinese medicine, tool heat clearing and damp drying, parasite killing, diuresis, is used for the treatment of hematodiarrhoea, have blood in stool, jaundice urine retention, leucorrhea with red and white discharge, swelling of the vulva pudendal pruritus, eczema, eczema, skin pruritus, scabies leprosy; The various diseases such as external treatment trichomonal vaginitis.Radix Sophorae Flavescentis contains number of chemical composition and has respectively different chemisms, and its main effective ingredient is alkaloids and flavone compound.The extensively pharmacological actions such as modern study shows, Radix Sophorae Flavescentis has antitumor, antiviral, anti-liver injury, arrhythmia, anti-hepatic fibrosis, maincenter inhibition, antifertility, relieving asthma.
Herba Schizonepetae is the herb of Schizonepeta tenuifolia platymiscium Schizonepeta tenuifolia Schizonepeta tenuifolia (L.) Briq., Herba Schizonepetae is clinical conventional Chinese medicine, warm in nature, acrid in the mouth, raw product have expelling pathogenic wind from the body surface, declare malicious rash, the effect of dissipating blood stasis hemostasis, curing mainly anemofrigid cold, laryngopharynx swelling and pain and multiple dermatosis, is tcm clinical practice common drug.Specially merit hemostasis after Herba Schizonepetae parch to black, can be used for haematemesis, epistaxis, has blood in stool, metrorrhagia, puerperal blood faints etc.
Folium Nerviliae fordii is the herb of Nervilia fordii (Hance) Schltr. in orchid Nervilia, have another name called only leaf lotus, Herba Phyllanthi Urinariae, Typhonium divaricatum (L.) Decne, clethra loosestrife root or herb, pendant is very heavy, chapeau de fer is sub, mountain rice, Radix Semiaquilegiae, enter ground Margarita, false Rhizoma Gastrodiae, unipods Radix Semiaquilegiae, Zhu Soft-Fleece grass, mill Burmannia coelestis D. Don., half of umbrella, little fat medicine, on tenterhooks etc., mainly be distributed in the ground such as Guangxi, Guangdong, Yunnan, Sichuan, in Hong Kong, also there is distribution in Thailand.Folium Nerviliae fordii is mainly grown under the tor sparse woods of 400～600 meters of height above sea level, the dark and damp place of the tor foot of the hill or thick forest, limit, field or fertile place, its sweet in the mouth is cool, cold in nature, nontoxic, can clearing heat and moistening lung, removing toxic substances and promoting subsidence of swelling, cure mainly that pulmonary tuberculosis spitting of blood, cough due to lung-heat, aphtha, laryngopharynx swelling and pain, scrofula, skin infection swell and ache, traumatic injury.In area, China Guangdong and Guangxi Provinces and south east asia, Folium Nerviliae fordii is the rare medicinal herbs of herbal tea ，Shi China tradition outlet of commonly using among the people.
Herba Houttuyniae is fresh herb or the dry aerial parts of saururaceae plant houttuynia cordata Houttuynia cordata Thunb..Herba Houttuyniae claims again Herba Houttuyniae, belongs to herbaceos perennial.Its extensive growth is in each provinces and regions of south China, and also there is distribution northwest, some areas, North China.Because it has a kind of distinctive fishy smell taste, therefore claim Herba Houttuyniae.Herba Houttuyniae is Saururaceae Ji platymiscium.Ji platymiscium only has a kind to be Herba Houttuyniae in China.Its dry product, fresh goods stem and leaf all can be used as medicine, and are one of conventional Chinese herbal medicine.It has the effects such as heat-clearing and toxic substances removing, inducing diuresis to remove edema, is mainly used in the diseases such as phlegm dyspnea is coughed, carbuncle sore tumefacting virus.The quintessence oil of Herba Houttuyniae has obvious protective effect to allergic asthma.Herba Houttuyniae quintessence oil strengthens immunocompetence in addition.In addition, Herba Houttuyniae has analgesia cough-relieving, and hemostasis suppresses serous secretion, promotes tissue regeneration isoreactivity.Because the volatile material of Herba Houttuyniae has significant drug effect, the quintessence oil saturated aqueous solution that pharmaceutical industry obtains with Herba Houttuyniae steam distillation is made Herba Houttuyniae injectio, is widely used in upper respiratory tract infection etc.
Flos Lonicerae is the dry flower of Radix Ophiopogonis Lonicera japonica Thunb. or the flower that band is just opened.Flos Lonicerae is the conventional traditional valuable ingredient of Chinese medicine of China, is also the important source material of making refreshment drink simultaneously, has the effect of " heat-clearing and toxic substances removing, wind-heat dissipating ", cures mainly carbuncle and treats the diseases such as skin ulcer, sore throat, erysipelas, toxic-heat and blood stasis, anemopyretic cold, epidemic febrile disease heating.
At present, there is not yet the relevant report that the compositions of Radix Sophorae Flavescentis, Herba Schizonepetae, Folium Nerviliae fordii, Herba Houttuyniae and Flos Lonicerae extract is used for the treatment of to sensitive skin both at home and abroad.
In sum, sensitive skin lacks effective treatment means at present, beneficial effect of the present invention is according to the cause of disease of sensitive skin and pathomechanism, has screened in a large number more than 1,000 kind of Chinese herbal medicine, finally filters out the pharmaceutical composition that can effectively treat sensitive skin.Pharmaceutical composition of the present invention confirms that through clinical trial effect is remarkable, and safety is good.Related composition has that effect is clear and definite, safety good, without any side effects and in cosmetic formulations stable feature; Comparing with existing like product, have effect outstanding feature, is a kind of compositions of effective natural drug extract of novel therapeutic sensitive skin.
The specific embodiment
Embodiment 1
At room temperature, get Radix Sophorae Flavescentis, Herba Schizonepetae, Folium Nerviliae fordii, Herba Houttuyniae and Flos Lonicerae each 10 kilograms (totally 50 kilograms), with 600 kilograms of immersions of ethanol of volumetric concentration 70%, extract, soak time is 24 hours, residue extracts with 600 kilograms of immersions of ethanol of volumetric concentration 70% for 24 hours again, then the solution after soaking is merged, after 200 object strainer filterings, 20 times of concentrating under reduced pressure, again by macroporous resin on concentrated solution, with the ethanol elution of volumetric concentration 50%, in the eluent of collection, contain needed effective ingredient, i.e. pharmaceutical composition in prescription of the present invention.
Embodiment 2
At room temperature, get 8 kilograms of Radix Sophorae Flavescentiss, 8 kilograms of Herba Schizonepetae, 12 kilograms of Folium Nerviliae fordiis, 12 kilograms of Herba Houttuyniae and 12 kilograms of Flos Loniceraes (totally 52 kilograms), with 1200 kilograms of immersions of ethanol of volumetric concentration 50%, extract, soak time is 24 hours, residue extracts with 1200 kilograms of immersions of ethanol of volumetric concentration 50% for 24 hours again, then the solution after soaking is merged, after 200 object strainer filterings, 40 times of concentrating under reduced pressure, again by macroporous resin on concentrated solution, ethanol elution by volumetric concentration 40%, in the eluent of collecting, contain needed effective ingredient in prescription of the present invention, it is pharmaceutical composition.
Embodiment 3
At room temperature, get 8 kilograms of Radix Sophorae Flavescentiss, 8 kilograms of Herba Schizonepetae, 15 kilograms of Folium Nerviliae fordiis, 15 kilograms of Herba Houttuyniae and 15 kilograms of Flos Loniceraes (totally 61 kilograms), with 1000 kilograms of immersions of ethanol of volumetric concentration 80%, extract, soak time is 24 hours, residue extracts with 1000 kilograms of immersions of ethanol of volumetric concentration 80% for 24 hours again, then the solution after soaking is merged, after 200 object strainer filterings, concentrate 25 times, again by macroporous resin on concentrated solution, ethanol elution by volumetric concentration 60%, in the eluent of collecting, contain needed effective ingredient in prescription of the present invention, it is pharmaceutical composition.
Embodiment 4
At room temperature, get 10 kilograms of Radix Sophorae Flavescentiss, 10 kilograms of Herba Schizonepetae, 12 kilograms of Folium Nerviliae fordiis, 12 kilograms of Herba Houttuyniae and 12 kilograms of Flos Loniceraes (totally 56 kilograms), with 2000 kilograms of immersions of ethanol of volumetric concentration 30%, extract, soak time is 24 hours, residue extracts with 2000 kilograms of immersions of ethanol of volumetric concentration 30% for 24 hours again, then the solution after soaking is merged, after 200 object strainer filterings, concentrate 50 times, again by macroporous resin on concentrated solution, ethanol elution by volumetric concentration 50%, in the eluent of collecting, contain needed effective ingredient in prescription of the present invention, it is pharmaceutical composition.
Embodiment 5
At room temperature, get 8 kilograms of Radix Sophorae Flavescentiss, 8 kilograms of Herba Schizonepetae, 10 kilograms of Folium Nerviliae fordiis, 10 kilograms of Herba Houttuyniae and 15 kilograms of Flos Loniceraes (totally 51 kilograms), with 1200 kilograms of immersions of ethanol of volumetric concentration 60%, extract, soak time is 24 hours, residue extracts with 1200 kilograms of immersions of ethanol of volumetric concentration 60% for 24 hours again, then the solution after soaking is merged, after 200 object strainer filterings, concentrate 30 times, again by macroporous resin on concentrated solution, ethanol elution by volumetric concentration 80%, in the eluent of collecting, contain needed effective ingredient in prescription of the present invention, it is pharmaceutical composition.
Embodiment 6
The liquid that embodiment 1 is obtained adopts concentrating under reduced pressure, is concentrated into 10%～50% of former weight, obtains pharmaceutical composition concentrated solution, and for the preparation of the essence for the treatment of sensitive skin, the percentage by weight of component is as follows:
Production technology: hyaluronate sodium is added to the water to dispersed with stirring even, then adds successively other composition, stir in 70 ℃ of situations.
Embodiment 7
The clinical experimental study report of medicine composite for curing sensitive skin: in following experiment, the compositions of drug extract used is the essence of the treatment sensitive skin prepared of the cosmetic formulations of embodiment 6.
1. materials and methods
1.1 sensitive skin patients' case selection
Altogether include 60 sensitive skin disease female patients of 24～42 years old in, inclusive criteria: experimenter signs Informed Consent Form voluntarily.By sensitive skin questionnaire, screen (to 17 problems, at least answer 5 "Yes", can include in).Clinical manifestation: face is prone to the nbjective symptoms such as erythema, pimple, desquamation, telangiectasis, or the subjective symptom such as pruritus, twinge, scorching hot, tight sense; Lactic acid irritant test score value >=3 are diagnosed as sensitive skin, within tested first 15 days, do not accept other antianaphylactic treatments with whole viewing duration.Exclusion standard: known to being subject to the composition allergy sufferers in trial product; Psychotic; Person within period of pregnancy, age of sucking or the later six months of giving a birth; There are serious hepatorenal disease, autoimmune disease (as systemic lupus erythematosus (sle), rheumatoid arthritis), HIV the infected: in nearly 12 months, be diagnosed as cutaneous tumor curer; Using and/or in first 14 days of test oral or external the medicine (glucocorticoid, immunosuppressant and antiallergic agent) of test forbidding; Using or testing and within first 1 month, used other like products person.
The essence You Zhonghe International Technology company limited of containing pharmaceutical composition of the present invention of 1.2 Therapeutic Method treatment groups provides, after the clean face of daily method, sooner or later be applied in whole face by the essence that contains pharmaceutical composition of the present invention twice every day, can make up, but except the day of return visit.Between the operating period, must not change this sample, and ban use of as skin care products such as moisturiser, cracking-off agent, facial film, anti-aging face creams.2 consultation times: use sample is front and use sample after 8 weeks, the result of use of assess sample.
1.3. effect assessment: lactic acid stimulation test is evaluated the sensitivity that experimenter uses skin before and after sample.Smear 10 times with 2mL 10% lactic acid and 2ml normal saline respectively simultaneously experimenter's nasolabial fold both sides.Lactic acid stimulated side and normal saline side are determined by random table.After smearing 1,2,3,4,5min evaluates experimenter's twinge degree, scoring yardstick is 0～4 minute, 0 is divided into painlessly, 4 to be divided into twinge strong.Clinical evaluation is undertaken by same dermatologist.Look-out station: forehead and buccal.By random table, determine assessment left side or right side.According to clinical erythema, dry, squama, elasticity, smooth deciding degree, be 0～3 minute: 0 minute, moist, poor flexibility, smooth poor, squama few, without erythema; 3 minutes, represent very dry, good springiness, smooth, squama is many, erythema clearly; 1 minute and 2 minutes, between 0 minute and 3 minutes.
1.4. the quantitative assessment of skin biological parameter: (1) skin erythema evaluation: by spectral photometric colour measuring meter
(Spectrophotometer-CM2600 Minolta, Japan) mensuration skin α value, this value reflection skin is red to green saturated level, indirectly reflects skin erythema improvement degree; (2) keratodermatitis water content is evaluated: by Corneometer (R)-CM825 (Courage+Khazaka, Germany), measured; (3) scaling of skin evaluation: measured by skin of living body surface analysis system Skin-Visiometer (R) SV600 (Courage+Khazaka, Germany).All detections are all that 23 ℃～25 ℃, humidity are that 50%～60% room carries out in temperature, all measure 3 times at same position at every turn, average.Last improvement degree and the acceptance level to this product by its cutaneous sensibility of experimenter's self-appraisal.
1.5. safety evaluatio carries out untoward reaction evaluation to experimenter when further consultation, and whether inquiry experimenter's target site former symptom increases the weight of or occur new skin lesion, as symptoms such as pruritus, dry, desquamation, twinge, redness, desquamations and whether hinder daily life.Severe: untoward reaction hinders daily routines, and experimenter's subjective symptoms is remarkable, is impatient at, and needs to stop using; Moderate: untoward reaction hinders daily life, and experimenter's subjective symptoms is obvious, but can stand, and need not stop using and be subject to trial product; Slight: can react by Intolerance, experimenter occasionally can experience.To there is the experimenter of untoward reaction, doctor carries out patch test to it. to determine the cause effect relation of untoward reaction and test products.Responsible doctor thinks that experimenter is not suitable for continuing test, or experimenter requires to stop, and stops this experimenter's test, and records stop reason and time.
1.6. statistical procedures biological parameter and lactic acid stimulate mark to adopt SSPS 11.5 softwares to carry out self front and back paired t-test.
2. result
All experimenters of this experiment all have the characteristic performance of sensitive skin, lactic acid stimulation is all positive (average 7.21) after treatment in 3 weeks, experimenter's lactic acid stimulates mark 7.21 ± 2.53 to drop to 2.37 ± 2.01 (P < 0.01, tables 1) after treatment from treating.
Lactic acid stimulation test and skin biological parameter comparison (n=60) before and after table 1 treatment
The result that skin biological parameter detects shows: used pharmaceutical composition of the present invention after 8 weeks, the Corneometer reading of patient skin significantly increases (P < 0.01), squama index obviously decline (P < 0.05), skin α value changes (P > 0.05) without significance, this prompting sensitive skin patient's xerosis cutis situation alleviates, skin has better hydration, squama still less, skin just has better barrier function like this, can protect dermal sensation nerve to avoid excessive stimulation, thereby contribute to improve skin symptom.
Product Safety assessment: untoward reaction does not all occur before and after treatment, come off without 1 routine patient.There is not the Adverse Event relevant to this test products in whole research process.
Adopt the pharmaceutical composition with the effect for the treatment of sensitive skin of other embodiment to carry out clinical trial, result also proves to have identical effect.
Embodiment 8
The skin irritation test research report of the pharmaceutical composition for the treatment of sensitive skin: by animal experiment, observe the zest for the treatment of sensitive skin pharmaceutical composition of the present invention to rabbit skin.In following experiment, the compositions of drug extract used is the pharmaceutical composition of embodiment 1.
1 animal
16 regular grade adult healthy new zealand rabbits, male and female half and half, 2.5kg～3.5kg, buys in Guangdong Medical Lab Animal Center, and laboratory animal production licence number is SCXK (Guangdong) 2008-0002, the animal quality certification number: Guangdong 2012A008.Raise in Animal House F4 room, new southern drug safety assessment centers general area (the experimental animal room quality certification number: 0060590.), duration of test, 20 ℃～22 ℃ of room temperatures, humidity 40%～67%, illumination 12h/12h round the clock light and shade replaces.The pharmaceutical composition that the pharmaceutical composition using in this experiment is the embodiment of the present invention 1, concentration is 1.0g crude drug/mL.
2 methods
According to the < < of Ministry of Health of the People's Republic of China cosmetics health standard (version in 2007) > >, adopt consubstantiality self left and right sides matching type, left side gives blank substrate (normal saline), and right side gives the pharmaceutical composition of 1.0g/mL.Before administration, prepare: 24h before administration, adopts mao method of shaving to remove family rabbit back spinal column both sides by hair, left and right each the about 3cm * 3cm of unhairing scope, application area 2.5cm * 2.5cm, not injured skin.Administration: get the about 0.5mL of tested material and spread upon on the skin of right side, left side is coated with normal saline in contrast, smears 1 time, continuously 14d every day.From second day, will be by hair before smearing at every turn.The double-deck hospital gauze sheet that medicinal liquid 0.5mL is soaked into 2.5cm * 2.5cm, is covered in plucked skin, covers one deck template, then fixes with nonirritant adhesive plaster and fixing band.After fixing about 4h, remove tested material, with warm water, remove residual tested material.Observed result after one hour.
3 results
Under this experiment condition, the pharmaceutical composition of smearing continuously 1.0g/mL reacts (specifically in Table 2) to rabbit skin nonirritant in 14 days.
Table 2 1.0.g/mL pharmaceutical composition is to rabbit irritation test result repeatedly
Embodiment 9
The hypersensitive experimentation report of the pharmaceutical composition for the treatment of sensitive skin: by animal experiment, observe the sensitization for the treatment of sensitive skin pharmaceutical composition of the present invention to Hartley guinea pig skin.The pharmaceutical composition that the pharmaceutical composition using in this experiment is the embodiment of the present invention 1.
1 animal
Select 50 of regular grade Hartley Cavia porcelluss, male and female half and half, weight range 180～250g, buys in Guangdong Medical Lab Animal Center, and laboratory animal production licence number is SCXK (Guangdong) 2008-0002, the animal quality certification number: Guangdong 2012A016.Raise in Animal House F4 room, new southern drug safety assessment centers general area (the experimental animal room quality certification number: 0060590.), duration of test, 20 ℃～22 ℃ of room temperatures, humidity 40%～67%, illumination 12h/12h round the clock light and shade replaces.By number Cavia porcellus is carried out to skin dyeing, with saturated picric acid solution (yellow) dye marker units, with 2% silver nitrate solution (coffee color) dye marker tens; By sex, separately raise, each cage box is put 5 Cavia porcelluss, and cage box is outer labelled, indicates special topic numbering, animal classification, group, sex, route of administration, cage number, number of animals and estimates to test the information such as commencement date and deadline.The pharmaceutical composition that the pharmaceutical composition using in this experiment is the embodiment of the present invention 1, concentration is 1.0g crude drug/mL.
2 methods
According to national < < medicine registration management way > >, < < chemicals zest, anaphylaxis and hemolytic investigative technique guideline > >.Be divided at random negative control group, positive controls, pharmaceutical composition group, 10 Cavia porcelluss of negative control group wherein, all the other respectively organize 20 Cavia porcelluss.Each organizes Cavia porcellus male and female half and half.Successively induce sensitization to contact experiment with exciting, the eluting phase of 10 days of being separated by between two experiments.Induction exposure experimental technique is front 24h preserved skin, cut off each 2cm * 2cm region, Cavia porcellus spinal column both sides by hair.Positive controls: get 2.5%2, the acetone soln 0.2g of 4-dinitro-chloro-benzene, use respectively two-layer gauze (2.5cm * 2.5cm) and one deck antistaling film to cover, with non-stimulated gauze, cover 6h, remove covering, with warm water, remove residual given the test agent, the 7th day and the 14th day, in kind repeat once; In negative control treated animal same area, be coated with distilled water 0.4ml, pharmaceutical composition group is coated with 0.5ml.By same step, carry out Induction exposure.Exciting contact is after last is to tested material sensitization contact 14 days (testing the 28th day), at experimental group and negative control group guinea pig back preserved skin place coating 0.5ml, package and fixing, after 6h, remove tested material, observe at once, then in 24h, 48h, 72h, again observe skin allergy situation.The acetone soln 0.2g of 2.5%2,4-dinitro-chloro-benzene for positive controls, negative control treated animal same area is coated with distilled water 0.4ml.After sensitization 1h, 24h and excite after 24h and 48h observe administration local skin erythema, edema and other abnormal responses.By skin allergy standards of grading, skin erythema and edema are marked, and calculate the anaphylaxis incidence rate of each group, press skin hypersensitivity evaluation criterion judgement anaphylaxis occurrence degree.Anaphylaxis incidence rate=(number of animals/this treated animal sum that occurs skin erythema, edema or systemic anaphylaxis in group) * 100%.
3 results:
Excite contact experiment rear 24, 48h, by the professional who does not know experiment content according to < < chemicals zest, anaphylaxis and hemolytic investigative technique guideline > > pass judgment on whether occur sensitization of skin reaction (table 3.7), sensitivity response scoring >=2 timesharing, judge that this animal skin sensitivity response is positive, calculate sensitization rate (>=2 minutes number of animals/these treated animal sum * 100%), and press < < chemicals zest, in anaphylaxis and hemolytic investigative technique guideline > >, sensitization of skin reaction test grade scale is judged the sensitization intensity (table 3) of pharmaceutical composition of the present invention to guinea pig skin.
Table 3 sensitization of skin extent of reaction standards of grading
First calculate to put each observing time and respectively organize integral mean value, then calculate and observe every animal integral mean value interior every day in time limit, by < < chemicals zest, anaphylaxis and hemolytic investigative technique guideline > >, evaluate.By following formula, calculate every animal average integral every day.
Table 4 sensitization of skin extent of reaction grade scale
Excite rear 24h, 48h, the Cavia porcellus of negative control group, pharmaceutical composition group excites position skin all not occur erythema, edema situation, does not also occur other abnormal response, and anaphylaxis incidence rate is 0, and anaphylaxis evaluation is and has no skin allergy.
Excite rear 24h, positive controls Cavia porcellus excites position skin all to occur erythema, and anaphylaxis incidence rate is 100%, and anaphylaxis is evaluated as extremely strong sensitization.Excite rear 48h, positive controls Cavia porcellus excites position skin still all to have erythema, and anaphylaxis incidence rate is 100%, and anaphylaxis evaluation is still extremely strong sensitization.
4 conclusions
Under this experiment condition, pharmaceutical composition Hartley guinea pig skin is carried out to 3 sensitization and excite for 1 time after have no skin allergy.
Claims (7)
1. a pharmaceutical composition for the treatment of sensitive skin, is characterized in that: be to be made by the raw material of following weight proportioning:
1～60 part of Radix Sophorae Flavescentis
1～60 part of Herba Schizonepetae
1～60 part of Folium Nerviliae fordii
1～60 part of Herba Houttuyniae
1～60 part of Flos Lonicerae.
2. the pharmaceutical composition for the treatment of sensitive skin according to claim 1, is characterized in that: be to be made by the raw material of following weight proportioning:
1～50 part of Radix Sophorae Flavescentis
1～50 part of Herba Schizonepetae
1～50 part of Folium Nerviliae fordii
1～50 part of Herba Houttuyniae
1～50 part of Flos Lonicerae.
3. according to the preparation method of the pharmaceutical composition of the treatment sensitive skin described in claim 1-2, it is characterized in that: comprise the following steps:
The first step: the soak with ethanol that is 20%～80% by volumetric concentration by above-mentioned Chinese prescription, the ethanol consumption that soaks use is 10～200 times of Chinese prescription gross weight, obtains soak;
Second step: soak is concentrated into 2～5% of former weight, concentrated solution macroporous resin adsorption, then the ethanol of using volumetric concentration 5%～95% eluting repeatedly, collect eluent, and eluent comprises the compositions of Chinese medicine extract.
4. the preparation method of the pharmaceutical composition for the treatment of sensitive skin according to claim 3, is characterized in that: in the first step, the described soak with ethanol time is 2～48 hours; Or Chinese prescription first uses soak with ethanol 2～48 hours, residue is used soak with ethanol 2～48 hours again, merges the solution after soaking, and obtains soak.
5. the preparation method of the pharmaceutical composition for the treatment of sensitive skin according to claim 3, is characterized in that: in second step, described eluting is 40%～95% by the volumetric concentration of ethanol.
6. the purposes of the pharmaceutical composition of the treatment sensitive skin making according to method described in claim 3-5, is characterized in that: for the preparation of skin care cosmetics, comprise cream, emulsion, astringent, gel, facial film, liniment and lotion.
7. the purposes of the pharmaceutical composition for the treatment of sensitive skin according to claim 6, it is characterized in that: by the pharmaceutical composition making through being evaporated to 10%～50% of former weight, obtain composition concentrated solution, for the preparation of skin care cosmetics, wherein, described composition concentrated solution accounts for 5%～10% of cosmetics gross weight.
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| CN105520882A (en) * | 2016-03-04 | 2016-04-27 | 佛山市聚成生化技术研发有限公司 | Chinese medicinal herb composition with sensitive skin repairing function and application thereof |
| CN105662972A (en) * | 2016-03-04 | 2016-06-15 | 佛山市聚成生化技术研发有限公司 | Composition with sensitive skin repairing effect and application thereof |
| CN105748351A (en) * | 2016-03-04 | 2016-07-13 | 佛山市聚成生化技术研发有限公司 | Plant composition and application thereof |
| CN107441343A (en) * | 2017-08-29 | 2017-12-08 | 广州青岚生物科技有限公司 | A kind of clarification process and method of quality control of the pharmaceutical composition with the effect of therapeutic sensitivity skin |
| CN108498409A (en) * | 2018-06-25 | 2018-09-07 | 廖海湘 | A kind of Chinese medicine bath cream |
| CN112933166B (en) * | 2021-03-08 | 2022-02-15 | 霸王（广州）有限公司 | External traditional Chinese medicine composition for improving scalp sensitivity intolerance |
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| CN1872282A (en) * | 2006-01-13 | 2006-12-06 | 广州中医药大学 | Active extractive of Foliumnerviliae, preparation method and application |
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| .2004,第总35卷(第262期),61-63. * |
| 慢性咳嗽中医证治研究进展〉.< * |
| 林色奇, 薛汉荣.< * |
| 林色奇, 薛汉荣.<慢性咳嗽中医证治研究进展〉.<江西中医药>.2004,第总35卷(第262期),61-63. |
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