WO2009128584A1

WO2009128584A1 - The composition for the prevention and treatment of striae distensae and atopy

Info

Publication number: WO2009128584A1
Application number: PCT/KR2008/003673
Authority: WO
Inventors: Hee-Jun Park
Original assignee: C.A. Pharm Co., Ltd.
Priority date: 2008-04-14
Filing date: 2008-06-26
Publication date: 2009-10-22

Abstract

Provided is a composition for prevention and treatment of striae distensae and atopy. The composition for prevention and treatment of striae distensae and atopy includes: 0.01-20 ppm epidermal growth factor and fibroblast growth factor; 1.0-5.0 wt% vegetable amino acid peptide; 0.1-1.0 wt% glabridin or ceramide; 0.1-3.0 wt% ubiquinone (coenzyme QlO); 0.1-2.0 wt% vegetable collagen (extensin N-200) or DNA-gel; 0.1-3.0 wt% polyglutamic acid; and 1.0-5.0 wt% cocoa butter. The composition exhibits superior effects on treatment and prevention of striae distensae and atop, which may occur when skin is stretched by growth of a fetus, together with the influence of adrenocortical hormone secreted for protecting the fetus during pregnancy, or may occur when a stretched belly is rapidly compressed after childbirth, or may occur due to over- secretion of adrenal cortical hormone in females, or may occur due to obesity and diet, or may occur due to endocrine disease, chronic wasting disease, and long-term administration of steroids, or may occur due to excessive muscle exercise or stretching.

Description

THE COMPOSITION FOR THE PREVENTION AND TREATMENT OF STRIAE DISTENSAE AND ATOPY

Technical Field

[1] The present invention relates to a composition for prevention and treatment of striae distensae and atopy. More particularly, the composition for prevention and treatment of striae distensae and atopy includes: 0.01-20 ppm epidermal growth factor and fibroblast growth factor; 1.0-5.0 wt% vegetable amino acid peptide; 0.1-1.0 wt% glabridin or ceramide; 0.1-3.0 wt% ubiquinone (coenzyme QlO); 0.1-2.0 wt% vegetable collagen (extensin N-200) or DNA-gel; 0.1-3.0 wt% polyglutamic acid; and 1.0-5.0 wt% cocoa butter. The composition exhibits superior effects on treatment and prevention of striae distensae and atop, which may occur when skin is stretched by growth of a fetus , together with the influence of adrenocortical hormone secreted for protecting the fetus during pregnancy, or may occur when a stretched belly is rapidly compressed after childbirth, or may occur due to over- secretion of adrenal cortical hormone in females, or may occur due to obesity and diet, or may occur due to endocrine disease, chronic wasting disease, and long-term administration of steroids, or may occur due to excessive muscle exercise or stretching. Background Art

[2] Generally, striae distensae commonly called stretch marks is caused by various factors. It has been known that striae distensae is related to increase of adrenocortical hormone in body due to physiological or pathological factors. A rapid increase or decrease of weight is one cause of striae distensae. That is, striae distensae is a symptom that skin is cracked by loss of elastin or damage of collagen fiber of skin derma, which is a principal ingredient that forms a connective tissue as protein belonging to collagen due to physiological or physical factors, and striae distensae occurs when such a symptom appears externally through skin.

[3] Skin is roughly divided into three layers: epidermis, dermis, and subcutaneous tissue.

The dermis is 15-40 times thicker than the epidermis and occupies most of the skin. Collagen supporting the skin structure, and elastin related to elasticity of skin are distributed in the dermis, and thus, the dermis is different from a simple skin wound. Striae distensae, once occurring, is very difficult to treat.

[4] Also, striae distensae is different according to its causes and types, but it has been known that it is commonly located on belly, thighs, abdomen, or breasts where there are many curved parts and body fats.

[5] When striae distensae shows signs, skin may be reddish and be accompanied by itchy symptoms, or light red lines may appear. If severe, those lines are further clarified. The shape of the line may look like stripes or bands. Since striae distensae is more slightly depressed than normal skin, the surface of skin feels uneven.

[6] Striae distensae is reddish at first or in progress and turns into whitish or milky color over long time. Since whitish striae distensae appears different in color from adjacent normal skin, skin appears unshapely in appearance.

[7] Striae distensae may occur when skin is stretched by growth of a fetus, together with the influence of adrenocortical hormone secreted for protecting the fetus during pregnancy, or may occur when a stretched belly is rapidly compressed after childbirth, or may occur due to over- secretion of adrenal cortical hormone in females, or may occur due to obesity and diet, or may occur due to endocrine disease, chronic wasting disease, and long-term administration of steroids, or may occur due to excessive muscle exercise or stretching. Since it is almost impossible to heal striae distensae, once occurring, in modern medical science, the term "improvement effect" is more pertinent than the term "treatment".

[8] A method for treatment or prevention of striae distensae is disclosed in Korean Patent

No. 656807, entitled "Composition for prevention and treatment of stretch mark comprising citric acid, zinc, and arginine." Korean Patent No. 656807 discloses a pharmaceutical composition for prevention and treatment of stretch mark and local coating, which contains citric acid, zinc, and arginine as active ingredients together with pharmaceutically acceptable carrier. However, such a composition is unsatisfactory in effect, and studies on methods for treatment and prevention of striae distensae are still lacking.

[9] Meanwhile, a physical constitution susceptible to allergy reaction is called atopic constitution. Skin disease developed by such persons is called atopic skin disease. Since such patients easily develop allergic rhinitis, asthma or the like, allergy factors must be eliminated from indoor environments such as pets or flower arrangement.

[10] Also, in the case of children, since the symptom may be worsened by food allergy, foods must be carefully chosen. Many infants are developed, and it has been reported that about 20% of infants develop atopic dermatitis. In the case of most infants, the atopic dermatitis disappears after 16-18 months, but if not healed, the infants suffer from sever dermatitis.

[11] The fundamental cause lies in allergic constitution, and postnatal conditions causing allergy should be taken care of. Allergy may easily occur at a location where there are many dusts in the room or hairs of animal are dispersed, or if persons eat foods having strong antigen. Factors causing allergy are contained in clothing or cosmetics made of synthetic fibers.

[12] In the case of infants, atopy begins from a face and eruption occurs in breast or abdomen from the first birthday. Reddish and thick eruption occurs in knees or their inside, and itch does not disappear. Moreover, if scratching an itchy spot, the symptom is further worsened.

[13] The specific symptom of the atopic dermatitis is to severely scratch an itchy spot.

The infants frequently fret without particular reasons. The atopic dermatitis is a chronic disease lasting for more than six weeks and often recurs. The patient himself and family also suffer from the atopic diseases (asthma, allergic rhinitis, atopic dermatitis). A specific eczema occurs in a face or folded portions of arms or legs. The dermatitis occurs more easily when skin is dried and a person is younger. Lips chap easily, and palms, the soles of feet or fingers get stripped and cracked. The atopic dermatitis is dark as if a neck is stained, and a sore oozes from teats. Also, teats are easily sore, or a skin around or under eyes is dark. A conjunctivitis easily occurs.

[14] Generally, an eruption area decreases with age, but a hard skin feeling tends to be severer.

[15] The best method for treatment of allergy is to keep away from the cause of allergy.

Adrenocortical hormone ointment is widely used for long-term allopathic treatment.

[16] Furthermore, it is effective to avoid skin stimulus, and it is favorable to maintain temperature inside a room at 18-23⁰C. Also, it is favorable to take a short bath at a temperature of 26-27⁰C. Sunbath or swimming may temporarily worsen the symptom, but living a life while getting out in the air suppresses the symptom.

[17] The atopic dermatitis, which is a representative disease of a sensitive skin and dry skin, repetitively recurs chronically and is called congenital fever. The atopic dermatitis is a chronic inflammatory skin lesion that is characteristic of a specific lesion distribution accompanied with pruritus (itching) and xeransis and a family history of allergy. A general dermatitis can be completely healed by an appropriate treatment such as steroid at hospital. However, since the atopic dermatitis is difficult to heal completely, there are frequent cases where an accompanying appropriate skin care is necessary. According to the study results till now, there is no doubt that the allergic reaction is one of the causes of the atopic dermatitis in an immunological view, but it is still impossible to explain various clinical features and symptoms of the atopic dermatitis in an immunological view alone.

[18] It should be noted that the recent studies explained that the malfunction of a skin barrier function is one of principal causes of the atopic dermatitis. It is necessary to understand the features of the atopic dermatitis in view of the malfunction of the skin barrier function and take into consideration the concept of an atopic skin care focused on the recovery of the skin barrier function. Since the atopic skin is easily affected by stimulants from the outside due to the malfunction of a barrier function of a keratinous layer, it is very important to moisturize and protect skins by a skin care. [19] As a conventional technique useful for atopy, Korean Patent Unexamined Publication No. 2005-0072378 discloses a cosmetic composition for treatment of atopic dermatitis, which contains herbal extracts extracted from Opuntia ficus-indica var. Saboten, Kochiae Fructus, Plantaginis Herba, Solanum nigrum, goosefoot, and Poncirus trifoliate Rafinesque in an amount of 0.1-10.0 wt%. Korean Patent Registration No. 0511494 discloses a composition for treating atopic dermatitis which contains Pleuropterus multflorus extract as effective ingredients. Various studies for atopy treatment have been conducted. However, the conventional atopy treating medicines have been unsatisfactory in treatment effects and have caused many side effects.

Disclosure of Invention Technical Problem

[20] Accordingly, the present invention is directed to providing a composition for prevention and treatment of striae distensae and atopy, which exhibits superior effects on treatment and prevention of striae distensae and atop, which may occur when skin is stretched by growth of a fetus , together with the influence of adrenocortical hormone secreted for protecting the fetus during pregnancy, or may occur when a stretched belly is rapidly compressed after childbirth, or may occur due to over- secretion of adrenal cortical hormone in females, or may occur due to obesity and diet, or may occur due to endocrine disease, chronic wasting disease, and long-term administration of steroids, or may occur due to excessive muscle exercise or stretching. Furthermore, the present invention is directed to providing a composition for prevention and treatment of striae and atopy, which has a superior stability to pregnant women and fetus, has no toxicity and exhibits superior effect on prevention and treatment of striae distensae and atopy. Technical Solution

[21] To achieve the above object and other objects, there is provided a composition for prevention and treatment of striae distensae and atopy, the composition including: 0.01-20 ppm epidermal growth factor and fibroblast growth factor; 1.0-5.0 wt% vegetable amino acid peptide; 0.1-1.0 wt% glabridin or ceramide; 0.1-3.0 wt% ubiquinone (coenzyme QlO); 0.1-2.0 wt% vegetable collagen (extensin N-200) or DNA-gel; 0.1-3.0 wt% polyglutamic acid; and 1.0-5.0 wt% cocoa butter. The composition is prepared in various formulations. When applying to the spots where striae distensae may occur or occurred, the composition exhibits a superior stability to pregnant women and fetus, has no toxicity and exhibits superior effect on prevention and treatment of striae distensae and atopy.

Advantageous Effects

[22] A composition for prevention and treatment of striae distensae and atopy according to the present invention includes: 0.01-20 ppm epidermal growth factor and fibroblast growth factor; 1.0-5.0 wt% vegetable amino acid peptide; 0.1-1.0 wt% glabridin or ceramide; 0.1-3.0 wt% ubiquinone (coenzyme QlO); 0.1-2.0 wt% vegetable collagen (extensin N-200) or DNA-gel; 0.1-3.0 wt% polyglutamic acid; and 1.0-5.0 wt% cocoa butter. The composition is prepared in various formulations. When applying to the spots where striae distensae may occur or occurred, the composition exhibits a superior stability to pregnant women and fetus, has no toxicity and exhibits superior effect on prevention and treatment of striae distensae and atopy. Brief Description of Drawings

[23] Figs. 1 to 6 are graphs showing treatment effects of the cream of example 2 on atopic dermatitis.

[24] Fig. 1 shows improvement in dry skin.

[25] Fig. 2 shows improvement in erythema symptom.

[26] Fig. 3 shows improvement in itching.

[27] Fig. 4 shows duration of moisturizing ability.

[28] Fig. 5 shows side effects.

[29] Fig. 6 shows satisfaction of patient.

Best Mode for Carrying out the Invention

[30] A composition for prevention and treatment of striae distensae and atopy includes

0.01-20 ppm epidermal growth factor and fibroblast growth factor, 1.0-5.0 wt% vegetable amino acid peptide, 0.1-1.0 wt% glabridin or ceramide, 0.1-3.0 wt% ubiquinone (coenzyme QlO), 0.1-2.0 wt% vegetable collagen (extensin N-200) or DNA-gel, 0.1-3.0 wt% polyglutamic acid, and 1.0-5.0 wt% cocoa butter.

[31] The epidermal growth factor used herein is a polypeptide with molecular weight of

6045 in which 53 amino acids called urogastrone and 3 disulfides are bonded together. The epidermal growth factor has activities such as promotion of mitosis, promotion of cell growth, and inhibition of gastric acid secretion with respect to various cells including epithelial cell and mesencymal cell, and thus, it has an effect on injury treatment of skin or cornea or treatment of gastric ulcer. Also, the epidermal growth factor plays an essential role in skin cell generation and regeneration, and reduces a turn-over of keratocyte by promoting division and growth of keratin cell that is the epithelial cell of the skin, thereby reinforcing the skin barrier function.

[32] It is preferable to add 0.01-20 ppm epidermal growth factor with respect to the entire composition. When the added amount of the epidermal growth factor is less than 0.01 ppm, the expression of the addition effect is insignificant. When the added amount of the epidermal growth factor is more than 20 ppm, the synergistic effect of the addition is so insignificant that it is uneconomical. [33] Meanwhile, the fibroblast growth factor used herein is a strong mitosis stimulating factor family of heparin binding with respect to normal diplophase fibroblast and established cell line. An FGF family includes acidic FGF (FGF-I), basic FGF (FGF-2), INT-2 (FGF-3), K-FGF/HST (FGF-4), FGF-5, FGF-6, KGF (FGF-7), AIGF (FGF-8), and FGF-9 to FGF- 18. All the FGFs have two cysteine residues as conservative residues, and the amino acid sequences have 30-50% homology. Those factors have mitosis promotion with respect to normal diplophase mesoblast derivative cell and neural crest cell, induced granulose cell, adrenocortical cell, chrondrocyte, myoblast, cornea and vascular endothelial cell (cow or human being), vascular smooth muscle cell, crystalline lens, retina and prostatic epithelial cell, oligodendrocyte, (glia) astrocyte, chrondrocyte, myoblast and osteoblast.

[34] The fibroblast growth factor may promote various cell types in a nondisjunction manner. The fibroblast growth factor promotes cell movement to the injured spot (chemotaxis), begins to form new vessels (angiogenesis), restores and supports nerves (neurotropism), controls endocrine functions, express specific cellular protein, produces extracellular matrix, and promotes or inhibits cell survival.

[35] The fibroblast growth factor promotes biosynthesis of collagen and elastin existing in the dermis to thereby prevent generation of striae distensae and enhance striae distensae being progressed, and simultaneously, promotes angiogenesis of skin cells to thereby reinforce nutrition and skin tightening.

[36] It is preferable to add 0.01-20 ppm fibroblast growth factor with respect to the entire composition. When the added amount of the fibroblast growth factor is less than 0.01 ppm, the expression of the addition effect is insignificant. When the added amount of the fibroblast growth factor is more than 20 ppm, the synergistic effect of the addition is so insignificant that it is uneconomical.

[37] If the fibroblast growth factor stimulates the fibroblast of the skin, the fibroblast is actively divided to generate collagen, elastin, or hyaluronic acid. Collagen or elastin is a fibrous protein occupying most of dermis and manages skin elasticity. Also, collagen or elastin has a sturdy mesh structure. Since moisture is sufficiently supplied between two fibers due to hyaluronic acid, an amount of moisture retained in the skin increases so that the skin is restored to an elastic state. Furthermore, since reactive oxygen causing an aging process is removed by an antioxidative action, it is possible to prevent the aging of skin. The action of cell growth factor and antioxidant increases the cell division capability of the skin, causes moist and elastic skin, improves skins such as wrinkles or striae distensae, and inhibits generation of excessive melanic pigment, thereby making skins white and moist.

[38] The glabridin used herein is an ingredient contained in Glycyrrhiza glabra. The glabridin suppresses skin pigmentation because of its strong whitening effect, thereby preventing change of skin color caused by generation of striae distensae.

[39] Moreover, the ceramide belongs to lipid and is not dissolved in water, and sph- ingosine and fatty acid are OH-coupled. Thus, the ceramide is dissolved in alcohol and has one amide bond and two alcohols. There is no carboxylic acid, but there is only alcohol.

[40] Protection of skin means prevention of moisture evaporation from skin and prevention of secondary skin infection. While various products are used as skin protection ingredients, the ceramide is used in the present invention. The ceramide maintains and protects moisture together with a moisturizing effect due to hyaluronic acid. Furthermore, the ceramide forms a primary skin barrier with an ingredient to reinforce a skin barrier function to thereby prevent penetration of allergy source or foreign substances.

[41] When the glabridin or ceramide is used for treatment or prevention of striae distensae, it is preferable to use 0.1-2.0 wt% glabridin with respect to the entire composition. When the glabridin or ceramide is used for treatment or prevention of atopy, it is preferable to use 0.1-2.0 wt% ceramide with respect to the entire composition. When the usage is less than 0.1 wt%, the expression of the addition effect is insignificant. When the usage is more than 2.0 wt%, the synergistic effect of the addition is so insignificant that it is uneconomical.

[42] In the present invention, ubiquinone (coenzyme QlO) is a physiologic essential ingredient widely spread in living organic body ranging from bacteria to mammal. The ubiquinone is a constituent of a mitochondrial electron transfer chain inside a cell of a living organic body. The ubiquinone manages an iterative oxidation-reduction reaction in vivo. The ubiquinone is a natural material that performs a strong antioxidative and whitening action and acts as a carrier in the electron transfer.

[43] It is preferable that a content of the ubiquinone is 0.1-3.0 wt% with respect to the entire composition. When the content of the ubiquinone is less than 0.1 wt%, the addition effect of the ubiquinone is insignificant. When the content of the ubiquinone is more than 3.0 wt%, precipitation may occur.

[44] Moreover, the vegetable collagen (extension N-200) used herein has a skin mois- turization and cell formation action. The DNA-gel performs a skin moisturization and cell tissue restorative action. When the vegetable collagen or the DNA-gel is used for treatment or prevention of striae distensae, it is preferable to use 0.1-2.0 wt% vegetable collagen with respect to the entire composition. When the vegetable collagen or the DNA-gel is used for treatment or prevention of atopy, it is preferable to use 0.1-2.0 wt% DNA-gel with respect to the entire composition. When the usage of the vegetable collagen or the DNA-gel is less than 0.1 wt%, the addition effect is insignificant. When the usage of the vegetable collagen or the DNA-gel is more than 2.0 wt%, the syn- ergistic effect of the addition is so insignificant that it is uneconomical.

[45] Meanwhile, the polyglutamic acid (PGA) used herein is an ingredient extracted from soybean. Since the polyglutamic acid (PGA) expresses the skin moisturization effect because of its superior moisturizing ability. The polyglutamic acid (PGA) has more than 50 times the moisturizing ability of the hyaluronic acid conventionally used as a moisturizing ingredient, and has more than 100 times the moisturizing ability of the collagen. It is preferable to use 0.1-3.0 wt% polyglutamic acid (PGA) with respect to the entire composition.

[46] When the usage of the polyglutamic acid (PGA) is less than 0.1 wt%, the addition effect is insignificant. When the usage of the polyglutamic acid (PGA) is more than 3.0 wt%, the synergistic effect of the addition is so insignificant that it is uneconomical.

[47] Moreover, the cocoa butter used herein exhibits superior effect on abdominal massage for pregnant women, and performs a skin flexibility action and a moisture supply action. It is preferable to use 1.0-5.0 wt% cocoa butter with respect to the entire composition. When the usage of the cocoa butter is less than 0.1 wt%, the addition effect is insignificant. When the usage of the cocoa butter is more than 5.0 wt%, the synergistic effect of the addition is so insignificant that it is uneconomical and a stability problem of formulation may occur.

[48] In addition to the epidermal growth factor, the fibroblast growth factor, the vegetable amino acid peptide, glabridin or ceramide, the ubiquinone, the vegetable collagen or DNA-gel, polyglutamic acid, and the cocoa butter, the composition of the present invention may further include fatty material, organic solvent, dissolvent, thickening agent and gelling agent, softener, antioxidant, suspending agent, stabilizer, foaming agent, flavoring agent, surfactant, water, ionic or non-ionic emulsifier, filler, metal ion sequestering agent and chelating agent, preservative agent, vitamin, blocking agent, wetting agent, essential oil, dye, pigment, hydrophilic or lipophilic active agent, lipid follicle, or supplementary agent such as other ingredients of cosmetics, which are generally used in cosmetics or skin science fields. The above-described ingredients may be added with quantity generally used in the skin science fields.

[49] Furthermore, formulations applicable when the ingredients of the present invention are mixed with the composition may include toilet water, cream, ointment, milky lotion, foundation, oil, pack, soap (including medicated soap), body soap, rouge, fingernail cosmetics, eye cosmetics, perfume, eye lotion, oral hygiene (toothpaste, mouse wash, and so on), deodorizer (underarm odor, foot odor, and so on), bath preparations, shampoo, rinse, hair tonic, hair spray, hairdye, and so on. The formulations are mixed by typical ingredients and methods.

[50] Moreover, various formulations mixed with the ingredients of the present invention may be used in a liquid type, a cream type, a paste type, a gel type, a jelly type, a foam type, a solid type, or a power type. [51] The present invention will be described in more detail in the following examples and experimental examples, which do not limit the scope of the present invention. [52] Experimental example 1 and comparative example 1

[53] A massage cream was prepared based on composition of Table 1 below by a typical method. [54] Table 1

[Table 1]

[Table ]

[55] Experimental example 1

[56] The massage creams of the example 1 and the comparative example 1 were administrated to experimental animals and various experiments were carried out.

[57] As the experimental animals, 45 10-week-old male Sprague-Dawley rats and 45

10-week-old female Sprague-Dawley rats were purchased from Samtako Korea, and were used in experiment after 3-week adaptation period. The experiments were carried out under conditions: temperature of 23+2⁰C, relative humidity of 50+10%, times of ventilation of 10-12 times/time, lighting time of 12 hours, and luminance of 150-300 lux. The experimental animals were free to ingest hard food (Samtako Korea) and sterilized water.

[58] The dosage of test material was 2,000 mg per weight (kg) which is the maximum volume applicable in dermal toxicity, and the test material was applied on the abdomen of a pregnant rat's body everyday from the seventh day to the seventeenth day of pregnancy, the organogenesis period of a rat fetus.

[59] During the experimental period, abnormalities of the animal such as a general symptom, a toxic symptom, a death or not, an abortion, a premature birth, and a hard labor were observed one time everyday. The weight was measured every two days, starting from the zeroth day of pregnancy to the final autopsy. Food and water intake was measured by using the amount of food and water remaining after feeding the food and water at zeroth, seventh, fourteenth and twentieth days. As a result of measurement, any symptom was not observed during the pregnancy period of the pregnant animal. Regarding the weight before crossbred and during the pregnancy period, statistic significance between the administered groups of the example 1 and the comparative example 1 was not acknowledged.

[60] Meanwhile, female rates and male rates were placed together in a ratio of 1 : 1 or 2: 1 in the wire-net breeding box. The data when spermatozoa were confirmed in vaginal plug or vaginal smear was defined as the zeroth day of pregnancy. The final determination of crossbred was made according to presence and absence of implantation marks of uterus through Caesarean operation, and the autopsy was made at the twentieth day of pregnancy. A visual examination was carried out on a whole organ including body surface, coelom, thoracic cavity, and abdominal cavity. During the autopsy, the weights of liver, kidney, spleen, heart, cerebrum, adrenal, and ovary were measured. As a result, in the autopsy at the twenty-first day of pregnancy, no special medical opinion was not observed in the administered groups of the example 1 and the comparative example 1. Any significant difference in the weight of organ was not acknowledged.

[61] In addition, all the experimental animal groups were anesthetized with ether one day before delivery, and the uterus was removed by Caesarean operation. Numbers were assigned from the ovary side of the left corneal. The odd numbers were used for skeletal examination, and the even numbers were used for viscera examination. Pregnancy index (number of corpus luteum, the number of implantation, the number of absorption, death of infant or not, weighs and sex of a living fetus) was measured. As a result of observing the external abnormality of the living embryos, significant difference between the example 1 and the comparative example 1 was not observed in the number of corpus luteum, the number of implantation, the resorption rate, the number of dead embryos, the delivery rate, and the sex ratio. Also, there was no significant difference in the weight of placenta. Statistic significant difference was not acknowledged in the weight and sex ratio of living embryos and the survival ratio and weight of embryos. No abnormality was observed in the external surface.

[62] Moreover, half the embryos were fixed in Bouin solution for more than one week and incised. Then, the organ abnormality was examined by Gleich and Fronhberg method. Living embryos per each fetus was fixed in 95% ethanol and dyed by Inouye's double skeletal, cartilage staining method. The skeletal abnormality and bone ossification were sequentially examined using a stereoscopic microscope with a low magnifying power of x7. Blood obtained from an abdominal aorta was coagulated by keeping it at room temperature for 30 minutes. Then, biochemical examination on serum obtained by a centrifugation (3,000 rpm x 10 minutes) at a refrigerating temperature was undertaken by using an automatic analyzer (Technicon RA-XT, Technicon Co., U.S.A). Weights of main internal organs such as liver, kidney, heart, cerebrum, and adrenal were measured. Serum was sufficiently fixed in 10% neutral formalin solution and embedded in paraffin (embedding system : Leica EG 116), and was segmented with 4 μm by using a rotary microtome (Leica 820). Then, histopathologic examination was carried out by observing the segments after Hematoxylin & Eosin staining. The result of examination showed that there was no significant difference in all the segments.

[63] Example 2

[64] Cream was prepared based on composition of Table 2 below by a typical method.

[65] Table 2 [Table 2] [Table ]

[66] [67] Experimental Example 2 [68] After using the cream of example 2 for four weeks to patients who visited a clinic center and have a serious atopic dermatitis, a survey of treatment effects was carried out on dry skin treatment effects, erythema treatment effects, itching treatment effects, duration of moisturizing ability, side effects, and satisfaction of patient, and then, those treatment effects were evaluated. The results of evaluation are shown in Figs. 1 to 6.

[69] In the clinical trials, men and women were classified based on age: persons of 5 years or younger, persons of 5-15 years old, and persons of 15 years old or older. Also, 35 men were classified into 3 persons of 5 years old or younger, 18 persons of 5-15 years old, and 14 persons of 15 years old or older. 25 women were classified into 3 persons of 5 years old or younger, 8 persons of 5-15 years old, and 14 persons of 15 years old or older.

[70] 10% of the atopic patients were so very serious that a sore oozed; 28% of them were serious; 38% of them were ordinary; 15% of them were mild; 7% of them were occasionally suffered from the atopy. Thus, 75% of the patients were serious.

[71] As can be seen from Figs. 1 to 6, 75% of the patients were satisfied with dry skin treatment effects; 55% of them showed improvements in erythema symptom; 52% of them showed improvement in itching; more than 90% of them showed 2-6 hours duration of moisturizing ability. Thus, it can be seen that the composition of the present invention has same moisturizing effect as the conventional moisturizer, and more than 90% of them showed negligible side effects, thereby ensuring the stability.

Claims

Claims[1] A composition for prevention and treatment of striae distensae and atopy, the composition comprising:0.01-20 ppm epidermal growth factor and fibroblast growth factor;

1.0-5.0 wt% vegetable amino acid peptide;

0.1-1.0 wt% glabridin or ceramide;

0.1-3.0 wt% ubiquinone (coenzyme QlO);

0.1-2.0 wt% vegetable collagen (extensin N-200) or DNA-gel;

0.1-3.0 wt% polyglutamic acid; and

1.0-5.0 wt% cocoa butter. [2] The composition for prevention and treatment of striae distensae according to claim 1, comprising:

0.01-20 ppm epidermal growth factor and fibroblast growth factor;

1.0-5.0 wt% vegetable amino acid peptide;

0.1-1.0 wt% glabridin;

0.1-3.0 wt% ubiquinone (coenzyme QlO);

0.1-2.0 wt% vegetable collagen (extensin N-200);

0.1-3.0 wt% polyglutamic acid; and

1.0-5.0 wt% cocoa butter. [3] The composition for prevention and treatment of striae distensae and atopy according to claim 1, comprising:

0.01-20 ppm epidermal growth factor and fibroblast growth factor;

1.0-5.0 wt% vegetable amino acid peptide;

0.1-1.0 wt% ceramide;

0.1-3.0 wt% ubiquinone (coenzyme QlO);

0.1-2.0 wt% DNA-gel;

0.1-3.0 wt% polyglutamic acid; and

1.0-5.0 wt% cocoa butter.