CN102973802A - 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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- CN102973802A CN102973802A CN2012104827122A CN201210482712A CN102973802A CN 102973802 A CN102973802 A CN 102973802A CN 2012104827122 A CN2012104827122 A CN 2012104827122A CN 201210482712 A CN201210482712 A CN 201210482712A CN 102973802 A CN102973802 A CN 102973802A
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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 the perfume).
Background technology
The 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, namely uncomfortable, it is facial that the discomfort of most of patients nearly all shows, comprise subjective sensory symptoms, such 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 the progress of society, people are to the pursuit of the beauty, 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 studies new treatment sensitive skin ways and means, become the study hotspot of present 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) such as number of patent application 200510079622.9, a kind of cosmetic treatments way be used to preventing and/or treating sensitivity and/or dry skin is disclosed in this application, specifically comprise at least a microorganism, particularly probiotic microorganisms of Orally administered at least effective dose, and at least a bivalence inorganic cation of associating effective dose.Such as number of patent application 200680028396.4, a kind of cosmetic and/or dermatological compositions be used to preventing and/or treating sensitivity and/or dry skin disclosed in this application, at least a special probiotic micro-organisms and/or its fragment or the metabolite that specifically comprise effective dose, it combines in acceptable carrier on the physiology with at least a polyunsaturated fatty acid of effective dose and/or esters of polyunsaturated fatty acids and/or its salt or derivant.Such 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 a lysate that specifically comprises at least a microorganism that the Bifidobacterium (Bifidobacterium) of effective dose is planted, and/or part is used for prevention and/or processes the beautifying use of skin barrier in the sensitive skin situation.Chinese medicine extract also has good therapeutical effect to sensitive skin, such as number of patent application 02826321.9, disclose screening in this application and improved the method for the active component of pruritus, pachylosis or skin sensitivity or performance whitening effect by generation and/or the release that suppresses stem cell factor, and the medicine that contains these active component, is used for improving pachylosis or skin sensitivity and/or brightens.Some clinical trial reports adopt the medical science skin care item that contain thermal water can alleviate the sings and symptoms of sensitive skin.(Pan Weihua, Liao Wanqing. Avene is relaxed and is protected spring water alive to the preliminary observation of 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. functional cosmetics is to the protective action of sensitive skin. Chinese aesthetic medicine, 2009,18 (10): 1486-1489) have the scholar find to contain Herba portulacae and Radix Glycyrrhizae extract skin care item to sensitive skin have auxiliary therapeutic action (He Li, Wen Hai, Xu Limin etc. contain Herba portulacae and Radix Glycyrrhizae extract skin care item to the clinical observation of 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 the treasure-house of a greatness, and it has made huge contribution for compatriots' procreation of living in several thousand, and this treasure-house is furtherd investigate, and it is very necessary to explore new treatment sensitive skin effective ways.
Summary of the invention
The objective 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.
Pharmaceutical composition with treatment sensitive skin effect of the present invention, the preparation take Radix Sophorae Flavescentis, Herba Schizonepetae, Folium Nerviliae fordii, Herba Houttuyniae and Flos Lonicerae as raw material, and be with the raw material preparation 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 pharmaceutical composition with treatment sensitive skin effect is with the raw material preparation 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
Preparation method with pharmaceutical composition for the treatment of sensitive skin effect of the present invention may further comprise the steps:
(1) each above-mentioned raw material being placed volumetric concentration is that 20%～80% ethanol soaked 2～48 hours, and the ethanol consumption that soaks usefulness be 10～200 times of each raw material gross weight, and filtration gets soak;
Preferably, filtration residue is 20%～80% soak with ethanol 2～48 hours with volumetric concentration again, merges the solution after soaking, and gets soak.
(2) soak is concentrated into 2～5% of former weight, the concentrated solution macroporous resin adsorption, and the ethanol of using again volumetric concentration 5%～95% is eluting repeatedly, collects eluent, is described pharmaceutical composition with the effect for the treatment of sensitive skin;
Preferably, eluting is 40%～95% with the volumetric concentration of ethanol;
Described macroporous resin adopts the HP20 type macroporous resin of Mitsubishi chemical company take polystyrene-divinylbenzene as 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, comprise described the have pharmaceutical composition for the treatment of sensitive skin effect and the adjuvant that cosmetic field uses.
The invention still further relates to a kind of curative drug of skin, comprise that claim is described and have the pharmaceutical composition for the treatment of sensitive skin effect and a medically acceptable carrier.
Especially can for the preparation of skin care cosmetics, comprise cream, emulsion, astringent, gel, facial film, liniment or lotion.
During the preparation skin care cosmetics, can be with the extracting solution compositions that makes, 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, method according to routine is prepared, and 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 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 the 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 the 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, the product of giving birth to have expelling pathogenic wind from the body surface, declare malicious rash, the effect of dissipating blood stasis hemostasis, cure mainly anemofrigid cold, laryngopharynx swelling and pain and multiple dermatosis, be the tcm clinical practice common drug.Specially merit hemostasis behind the 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 the 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 mainly is 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, but 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 herbal tea of commonly using among the people, is the rare medicinal herbs of China's tradition outlet.
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 flavor, so claim Herba Houttuyniae.Herba Houttuyniae is Saururaceae Ji platymiscium.The 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 Chinese herbal medicine commonly used.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.The Herba Houttuyniae quintessence oil strengthens immunocompetence in addition.In addition, Herba Houttuyniae has the analgesia cough-relieving, and hemostasis suppresses serous secretion, promotes the tissue regeneration isoreactivity.Because the volatile material of Herba Houttuyniae has significant drug effect, pharmaceutical industry is made Herba Houttuyniae injectio with the quintessence oil saturated aqueous solution that the Herba Houttuyniae steam distillation obtains, and 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 China's traditional valuable ingredient of Chinese medicine commonly used, also is simultaneously the important source material of making refreshment drink, 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 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 characteristics; Comparing with existing like product, have the 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), 600 kilograms of immersions of ethanol with volumetric concentration 70% are extracted, soak time is 24 hours, residue extracted with 600 kilograms of immersions of ethanol of volumetric concentration 70% in 24 hours again, then the solution after will soaking merges, behind 200 purpose strainer filterings, 20 times of concentrating under reduced pressure, again with macroporous resin on the concentrated solution, with the ethanol elution of volumetric concentration 50%, contain needed effective ingredient, i.e. pharmaceutical composition in the prescription of the present invention in the eluent of collection.
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), 1200 kilograms of immersions of ethanol with volumetric concentration 50% are extracted, soak time is 24 hours, residue extracted with 1200 kilograms of immersions of ethanol of volumetric concentration 50% in 24 hours again, then the solution after will soaking merges, behind 200 purpose strainer filterings, 40 times of concentrating under reduced pressure, again with macroporous resin on the concentrated solution, with the ethanol elution of volumetric concentration 40%, contain needed effective ingredient, i.e. pharmaceutical composition in the prescription of the present invention in the eluent of collection.
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), 1000 kilograms of immersions of ethanol with volumetric concentration 80% are extracted, soak time is 24 hours, residue extracted with 1000 kilograms of immersions of ethanol of volumetric concentration 80% in 24 hours again, then the solution after will soaking merges, through concentrating 25 times behind the 200 purpose strainer filterings, again with macroporous resin on the concentrated solution, ethanol elution with volumetric concentration 60%, contain needed effective ingredient, i.e. pharmaceutical composition in the prescription of the present invention in the eluent of collecting.
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), 2000 kilograms of immersions of ethanol with volumetric concentration 30% are extracted, soak time is 24 hours, residue extracted with 2000 kilograms of immersions of ethanol of volumetric concentration 30% in 24 hours again, then the solution after will soaking merges, through concentrating 50 times behind the 200 purpose strainer filterings, again with macroporous resin on the concentrated solution, ethanol elution with volumetric concentration 50%, contain needed effective ingredient, i.e. pharmaceutical composition in the prescription of the present invention in the eluent of collecting.
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), 1200 kilograms of immersions of ethanol with volumetric concentration 60% are extracted, soak time is 24 hours, residue extracted with 1200 kilograms of immersions of ethanol of volumetric concentration 60% in 24 hours again, then the solution after will soaking merges, through concentrating 30 times behind the 200 purpose strainer filterings, again with macroporous resin on the concentrated solution, ethanol elution with volumetric concentration 80%, contain needed effective ingredient, i.e. pharmaceutical composition in the prescription of the present invention in the eluent of collecting.
Embodiment 6
The liquid that embodiment 1 is obtained adopts concentrating under reduced pressure, is concentrated into 10%～50% of former weight, gets the 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: it is even that hyaluronate sodium is added to the water dispersed with stirring, then adds successively other composition, and stirring in 70 ℃ of situations gets final product.
Embodiment 7
The report of the clinical experimental study of medicine composite for curing sensitive skin: in the following experiment, the compositions of used drug extract is the essence for the treatment of sensitive skin of the cosmetic formulations preparation of embodiment 6.
1. materials and methods
1.1 sensitive skin patient's case is selected
Altogether include 60 sensitive skin disease female patients of 24～42 years old in, inclusive criteria: the experimenter signs Informed Consent Form voluntarily.Screen (to 17 problems, answer at least 5 "Yes", can include in) by the sensitive skin questionnaire.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, and tested front 15 days and whole viewing duration were not accepted other antianaphylactic treatments.Exclusion standard: known to being subjected to the composition allergy sufferers in the trial product; The psychotic; Be in period of pregnancy, age of sucking or childbirth interior person later six months; Serious hepatorenal disease, autoimmune disease (such as systemic lupus erythematosus (sle), rheumatoid arthritis), HIV the infected are arranged: be diagnosed as cutaneous tumor and curer in nearly 12 months; Using and/or in front 14 days of test oral or external the medicine (glucocorticoid, immunosuppressant and antiallergic agent) of test forbidding; Using or test and used other like products person in front 1 month.
1.2 the essence that contains pharmaceutical composition of the present invention of Therapeutic Method treatment group closes the International Technology company limited by the crowd and provides, behind daily method cleaning face, sooner or later the essence that will contain pharmaceutical composition of the present invention every day for twice is applied in whole face, can make up, but except the day of return visit.Must not change this sample between the operating period, and ban use of such as skin care products such as moisturiser, cracking-off agent, facial film, anti-aging face creams.2 consultation times: the use sample is front and use sample after 8 weeks, the result of use of assess sample.
1.3. effect assessment: the lactic acid stimulation test is estimated the sensitivity that the experimenter uses sample front and back skin.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 estimates experimenter's twinge degree, the 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.Determine assessment left side or right side by random table.Be 0～3 minute according to clinical erythema, drying, squama, elasticity, smooth deciding degree: 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 the spectral photometric colour measuring meter
(Spectrophotometer-CM2600 Minolta, Japan) measures skin α value, and it is red to green saturated level that this is worth reflection skin, indirectly reflects skin erythema improvement degree; (2) the keratodermatitis water content is estimated: measured by Corneometer (R)-CM825 (Courage+Khazaka, Germany); (3) scaling of skin evaluation: measured by the skin of living body surface analysis Skin-Visiometer of system (R) SV600 (Courage+Khazaka, Germany).All detect all in temperature is that 23 ℃～25 ℃, humidity are that 50%～60% room carries out, and all measures 3 times at same position at every turn, averages.At last by the improvement degree of its cutaneous sensibility of experimenter's self-appraisal with to the acceptance level of this product.
1.5. safety evaluatio carries out the untoward reaction evaluation to the experimenter when further consultation, whether the former symptom of inquiry experimenter's target site increases the weight of or new skin lesion occurs, reaches whether hinder daily life such as symptoms such as pruritus, drying, desquamation, twinge, redness, desquamations.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 is subjected to trial product; Slightly: but the Intolerance reaction, and the experimenter can experience by chance.To the experimenter of untoward reaction occurring, the doctor carries out patch test to it. to determine the cause effect relation of untoward reaction and test products.Responsible doctor thinks that the experimenter is not suitable for continuing test, or the experimenter requires to stop, and namely stops this experimenter's test, and record 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, after lactic acid stimulates all be positive (average 7.21) through the treatment of 3 weeks, experimenter's lactic acid stimulates mark to drop to rear 2.37 ± 2.01 (P＜0.01, the tables 1) for the treatment of from treating front 7.21 ± 2.53.
Lactic acid stimulation test and skin biological parameter compare (n=60) before and after table 1 treatment
The result that the 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 descend (P＜0.05); skin α value then 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 the dermal sensation nerve to avoid excessive stimulation, thereby help to improve skin symptom.
Product Safety assessment: untoward reaction does not all occur before and after the treatment, come off without 1 routine patient.The Adverse Event relevant with this test products do not occur 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, the 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 treatment sensitive skin pharmaceutical composition of the present invention to the zest of rabbit skin.In the following experiment, the compositions of used drug extract 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 the laboratory animal production licence number is SCXK (Guangdong) 2008-0002, the animal quality certification number: Guangdong 2012A008.Raise in new southern drug safety assessment centers general area Animal House F4 room (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.Employed pharmaceutical composition is the pharmaceutical composition of the embodiment of the invention 1 in this experiment, and concentration is 1.0g crude drug/mL.
2 methods
According to 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, the left side gives blank substrate (normal saline), and the right side gives the pharmaceutical composition of 1.0g/mL.Prepare before the administration: 24h before the administration, adopt 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, the left side is coated with normal saline in contrast, smears every day 1 time, continuously 14d.From second day, will be by hair before smearing at every turn.Medicinal liquid 0.5mL is soaked into the double-deck hospital gauze sheet of 2.5cm * 2.5cm, be covered in plucked skin, cover one deck template, fix with nonirritant adhesive plaster and fixing band again.Remove tested material behind fixing about 4h, remove residual tested material with warm water.Observed result after one hour.
3 results
Under this experiment condition, smear continuously the pharmaceutical composition 14 days of 1.0g/mL to rabbit skin nonirritant reaction (specifically seeing Table 2).
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 treatment sensitive skin pharmaceutical composition of the present invention to the sensitization of Hartley guinea pig skin.Employed pharmaceutical composition is the pharmaceutical composition of the embodiment of the invention 1 in this experiment.
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 the laboratory animal production licence number is SCXK (Guangdong) 2008-0002, the animal quality certification number: Guangdong 2012A016.Raise in new southern drug safety assessment centers general area Animal House F4 room (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 skin dyeing, with saturated picric acid solution (yellow) dye marker units, with 2% silver nitrate solution (coffee color) dye marker tens; Separately raise by sex, each cage box is put 5 Cavia porcelluss, and the 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.Employed pharmaceutical composition is the pharmaceutical composition of the embodiment of the invention 1 in this experiment, and concentration is 1.0g crude drug/mL.
2 methods
According to country " 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, 10 days the eluting phase of being separated by between two experiments.The Induction exposure experimental technique is front 24h preserved skin, cuts off the quilt hair in each 2cm of Cavia porcellus spinal column both sides * 2cm zone.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) cover with one deck antistaling film, cover 6h with non-stimulated gauze, remove covering, remove residual given the test agent with warm water, the 7th day and the 14th day, in kind repeat once; Be coated with distilled water 0.4ml in negative control treated animal same area, the pharmaceutical composition group is coated with 0.5ml.Carry out Induction exposure by same step.Exciting contact then is after last is to the tested material sensitization contact 14 days (namely testing the 28th day), at experimental group and negative control group guinea pig back preserved skin place coating 0.5ml, package and fixing, remove tested material behind the 6h, observe at once, then again observe the skin allergy situation in 24h, 48h, 72h.Positive controls is coated with distilled water 0.4ml with the acetone soln 0.2g of 2.5%2,4-dinitro-chloro-benzene, negative control treated animal same area.24h and 48h observe administration local skin erythema, edema and other abnormal responses at 1h, 24h after the sensitization and after exciting.By the skin allergy standards of grading skin erythema and edema are marked, and calculate the anaphylaxis incidence rate of each group, press the skin hypersensitivity evaluation criterion and judge the anaphylaxis occurrence degree.Anaphylaxis incidence rate=(occurring the number of animals of skin erythema, edema or systemic anaphylaxis/this treated animal sum in the 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 sensitization of skin reaction (table 3.7) whether occurs, 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 by " chemicals zest, anaphylaxis and hemolytic investigative technique guideline " in sensitization of skin reaction test grade scale judge that pharmaceutical composition of the present invention is to the sensitization intensity (table 3) of guinea pig skin.
Table 3 sensitization of skin extent of reaction standards of grading
At 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, estimate by " chemicals zest, anaphylaxis and hemolytic investigative technique guideline ".Calculate every animal average integral every day by following formula.
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 erythema, edema situation all not to occur, other abnormal response also do not occur, and the anaphylaxis incidence rate is 0, and the anaphylaxis evaluation is and has no skin allergy.
Excite rear 24h, the positive controls Cavia porcellus excites position skin erythema all to occur, and the anaphylaxis incidence rate is 100%, and anaphylaxis is evaluated as extremely strong sensitization.Excite rear 48h, the positive controls Cavia porcellus excites position skin that erythema is still all arranged, and the anaphylaxis incidence rate is 100%, and the anaphylaxis evaluation still is extremely strong sensitization.
4 conclusions
Under this experiment condition, pharmaceutical composition the Hartley guinea pig skin is carried out 3 sensitization and excite for 1 time after have no skin allergy.
Claims (7)
1. 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. the preparation method of the pharmaceutical composition of described treatment sensitive skin according to claim 1-2 is characterized in that: may further comprise the steps:
The first step: be 20%～80% soak with ethanol with above-mentioned Chinese prescription volumetric concentration, the ethanol consumption that soaks usefulness is 10～200 times of Chinese prescription gross weight, gets soak;
Second step: soak is concentrated into 2～5% of former weight, the concentrated solution macroporous resin adsorption, and the ethanol of using again volumetric concentration 5%～95% is eluting repeatedly, collects eluent, comprises the compositions of Chinese medicine extract in the eluent.
4. the preparation method of the pharmaceutical composition for the treatment of sensitive skin according to claim 3, it is characterized in that: in the first step, the described soak with ethanol time is 2～48 hours; Or Chinese prescription used first soak with ethanol 2～48 hours, and residue was used soak with ethanol 2～48 hours again, merged the solution after soaking, and got soak.
5. the preparation method of the pharmaceutical composition for the treatment of sensitive skin according to claim 3, it is characterized in that: in the second step, described eluting is 40%～95% with the volumetric concentration of ethanol.
6. the purposes of the pharmaceutical composition of the treatment sensitive skin that makes of described method is characterized in that: for the preparation of skin care cosmetics, comprise cream, emulsion, astringent, gel, facial film, liniment and lotion according to claim 3-5.
7. the purposes of the pharmaceutical composition for the treatment of sensitive skin according to claim 6, it is characterized in that: with the pharmaceutical composition that makes 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 |
| CN112933166A (en) * | 2021-03-08 | 2021-06-11 | 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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| 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 |
| CN112933166A (en) * | 2021-03-08 | 2021-06-11 | 霸王（广州）有限公司 | External traditional Chinese medicine composition for improving scalp sensitivity intolerance |
| 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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| CN102973802B (en) | 2014-01-29 |
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