KR20090056299A - External preparation composition for alleviating or treating diaper rash comprising zinc oxide stabilized with polyglyceryl-2 dipolyhydroxystearate - Google Patents

Abstract

The present invention relates to an external composition for diagnosing or treating a diaper rash, and more particularly, it is effective in reducing diaper rash using a polyglyceryl-2 dipolyhydroxystearate, which is a surfactant. The present invention relates to a diaper rash alleviation or therapeutic external preparation having an excellent effect of treating a diaper rash by stabilizing zinc oxide.

Description

Skin external composition for treating or alleviating diaper rash containing zinc oxide stabilized by polyglyceryl-2 dipolyhydroxystearate}

The present invention relates to an external composition for diagnosing or treating a diaper rash, and more particularly, it is effective in reducing diaper rash using a polyglyceryl-2 dipolyhydroxystearate, which is a surfactant. The present invention relates to a diaper rash alleviation or therapeutic external preparation having an excellent effect of treating a diaper rash by stabilizing zinc oxide.

These days, the skin of babies is suffering from various environmental hormones, environmental pollution and chemical products. In particular, babies under 30 months of age wearing diapers often suffer from sweat or diaper rash. This is because baby skin is thinner and softer than adult skin and is sensitive to external stimuli. In addition, the lack of ability to secrete sweat glands, heat stroke or sweat bands, and because the immune body is immature, bacterial infection (Arch Pediatr Adolesc Med, Sep 2000; 154: 943).

Diaper rash occurs as frequently as about 35% of newborns suffer from diaper rash, and serious symptoms such as tingling, bleeding and redness of the hips due to peeling of the epidermis at the diaper filling area beyond simple skin troubles It may also indicate. Diaper rash is most often caused by physical friction between the diaper and the skin or poor ventilation, and ammonia from urine or feces may acidify the baby's skin, soaking the skin or infecting the bacteria in a long-term wet environment. This may occur. In addition, residues of chemical detergents used to wash diapers or dyes in diapers may also be the cause of diaper rash. In addition, Candida albicans (Candida albicans), nurukgyun, Staphylococcus, Streptococcus and Pseudomonas aeru geo labor (Pseudomonas aerugionosa ) , especially Candida albicans ( Candida) It is common to see albicans as a causative agent of diaper dermatitis (Skin Science Color Book, Dermatology Research Committee, Book Publishing Jungdam, Seoul, 1999, pp718-723).

In general, if a problem occurs on the baby's skin, the powder may be applied unconditionally.For healthy skin, the powder may be applied to prevent sweat bands and keep the skin soft.However, if the diaper rash is applied, the powder may be applied to the baby's skin. You may not be able to breathe and your symptoms may worsen. In addition, talc contained in powder is more likely to deposit in the respiratory system and cause respiratory disorders. Diaper Rash Relief Cream is a powder replacement cream that does not have the risk of respiratory failure caused by powder dust.

Diaper Rash Relief Cream is usually applied evenly over the area where the diaper touches. Spreading the contents can form a thick protective film to prevent the penetration of various harmful substances and protect the baby's skin from diaper rash. It can also be applied to areas of the baby's neck, knees, elbows, and underarms that are prone to sweating.

Zinc oxide is the main ingredient in diaper rash relieving cream. Zinc Oxide is a very stable form of agonist, a skin astringent for baby powders, and a skin-safety-stimulating substance that is safe enough to be approved by the US Food and Drug Administration as a diaper rash treatement for babies. to be. It is also a hypoallergenic ingredient that is safe for atopy because it is not irritating to the skin. The content of zinc oxide can be used only 25% in cosmetic formulations based on the US FDA, and if more than 25% is classified as a quasi-drug.

The present inventors conducted a study for stabilizing zinc oxide, which is effective in alleviating diaper rash, in a formulation. As a result, a high content of the polyglyceryl-2 dipolyhydroxystearate was used as a surfactant. It has been found that the zinc oxide of can be stabilized. In addition, diaper due to the synergistic effect of each component when zinc oxide is used in combination with Allantoin, which has better skin protection effect, and Calendula Officinalis Extract, which enhances the antibacterial and healing properties, than zinc oxide alone. It has been found that the rash relief and treatment efficacy is better and the present invention has been completed.

Accordingly, it is an object of the present invention to stabilize a high content of zinc oxide and combine it with components having excellent skin protection effect, antibacterial activity and skin healing ability to provide a diaper rash alleviation or therapeutic external preparation composition excellent in diaper rash relieving effect. will be.

In order to achieve the above object, in the present invention, a diabetic rash alleviation or therapeutic external preparation composition containing zinc oxide stabilized using polyglyceryl-2 dipolyhydroxystearate (Polyglyceryl-2 Dipolyhydroxystearate) To provide.

In another aspect, the present invention provides a composition for alleviating or treating diaper rash, which further contains at least one of allantoin and calendula extract components.

The diaper rash alleviation or therapeutic external preparation composition according to the present invention was excellent in alleviating or treating diaper rash by stabilizing a high content of zinc oxide in the composition with polyglyceryl-2 dipolyhydroxystearate.

In addition, the composition according to the present invention further contains an allantoin or calendula extract together with zinc oxide, thereby further improving diaper rash relief or treatment effect due to the synergistic effect of each component.

Hereinafter, the present invention will be described in more detail.

The external preparation composition for diaper rash relief or treatment according to the present invention contains zinc oxide stabilized using polyglyceryl-2 dipolyhydroxystearate.

In the cosmetic composition according to the present invention, zinc oxide is 0.001 to 60% by weight, preferably 5 to 25% by weight based on the total weight of the composition, and 25 to 25% when formulated as an over-the-counter. It is contained at a concentration of 60% by weight. It is not expected to be effective at less than 0.001% by weight, and if it exceeds 25% by weight, it may not be used as a cosmetic formulation on the basis of the US FDA and may be used as a quasi-drug instead. In addition, in the case of more than 60% by weight, the cream has a lot of inner phase content, but if the ratio exceeds 60% by weight, formulation stability problems such as powder entanglement may occur.

Polyglyceryl-2 Dipolyhydroxystearate used in the present invention is a Glyceryl Esters-based W / O (Water / Oil, inner-water, outer-oil) surfactant As a result, the powder dispersibility is excellent in the formulation containing a high content of powder. In addition, there is an advantage that the stability over time for powder agglomeration phenomenon and entanglement of the surfactant and the powder, which is a concern in the formulation with a large powder content is maintained for a long time.

The content of the polyglyceryl-2 dipolyhydroxystearate is 0.001 to 20% by weight, preferably 0.1 to 10% by weight based on the total weight of the composition. This is a problem that the emulsion stability is worse than less than 0.001% by weight, if more than 20% by weight may affect the skin safety and emulsion formulation stability, it is not suitable for application as a cosmetic with a stiff and sticky feeling.

In addition, the external composition for diaper rash relief or treatment according to the present invention by further mixing one or more of allantoin (Allantoin) having excellent skin protection effect and Calendula Officinalis Extract to increase the antibacterial and skin healing power of each component The synergistic effect can further improve diaper rash relief or treatment. In addition, in the quasi-drug cosmetic composition using zinc oxide at least 25% by weight is characterized by more excellent diaper rash relief effect.

Allatoin used in the present invention is a natural ingredient mainly extracted from plants such as cherries, wheat germ, comfrey root, and bark of horse chestnut, cell proliferation, delaying skin aging, skin irritation, skin soothing It is famous for its excellent action and wound healing effect. In particular, the FDA-OTC Topical Review Panel is classified as an active skin protectant of category 1 (Stable and Efficacy) and promotes the growth of skin tissues. effective.

The content of allantoin is 0.001 to 20% by weight, preferably 0.1 to 10% by weight, based on the total weight of the composition. This is not expected to be effective at less than 0.001% by weight, and in excess of 20% by weight may affect skin safety and formulation stability and inferior economy.

Calendula Officinalis Extract used in the present invention is a herb extract with bright orange petals, also called Pot Marigold, and has been used to soothe reddish or slightly burned skin since ancient times. . In addition, it has antibacterial and wound healing ability to prevent infection and enhance skin healing ability.It also has anti-inflammatory, skin convergence, wound healing and bactericidal effect, so it is useful for skin diseases such as skin inflammation, eczema, acne and atopy. . The calendula extract may be prepared by a known method of drying and pulverizing a flower or leaf of calendula and extracting it with water or an organic solvent. At this time, the organic solvent may be a polar solvent such as ethanol, butanol and acetone; Nonpolar solvents such as ether, hexane, benzene, chloroform and ethyl acetate; And a mixed solvent of the nonpolar solvent and the polar solvent.

The content of the calendula extract is 0.001 to 20% by weight, preferably 0.1 to 10% by weight based on the total weight of the composition. This is not expected to be effective at less than 0.001% by weight, and over 20% by weight may affect skin stability and formulation stability in cosmetic formulations and are less economical.

The external preparation for diagnosing or treating diaper rash according to the present invention may be formulated in the form of a conventional cosmetic or quasi-drug.

Hereinafter, the present invention will be described in more detail with reference to Examples and Test Examples. However, the scope of the present invention is not limited to the following experimental examples and test examples.

[ Example  1 and Comparative Example 1 -3] Formulation Preparation by Surfactant Type

W / O (Water / Oil, Inner phase-water, Outer phase-water) In order to determine the high content of the powder dispersibility according to the type of surfactant, according to the composition shown in Table 1 of Example 1 and Comparative Examples 1-3 Cream was prepared. The oil used is not limited to this, and most cosmetic oil components are applicable to all. The following units are weight percent.

Example 1 was prepared by adding 3% by weight of polyglyceryl-2 dipolyhydroxystearate, and Comparative Example 1-3 was a W / O surfactant other than polyglyceryl-2 dipolyhydroxystearate. Was prepared to compare with the results of Example 1 by adding 3% by weight. However, the usable range of each component is not limited only to this ratio.

division ingredient Example 1 Comparative Example 1 Comparative Example 2 Comparative Example 3 Water component 1. Purified water Remaining amount Remaining amount Remaining amount Remaining amount 2. Glycerin 5.0 5.0 5.0 5.0 3. Butylene Glycol 2.0 2.0 2.0 2.0 4. Triethanolamine 0.18 0.18 0.18 0.18 5. Disodium ID 0.02 0.02 0.02 0.02 Oily ingredient 6.Argan Oil 2.0 2.0 2.0 2.0 7.Jojoba Oil 2.0 2.0 2.0 2.0 8.zinc oxide 20.0 20.0 20.0 20.0 9.Polyglyceryl-2 Dipolyhydroxystearate 3.0 - - - 10.Polyglyceryl-2 Sesquiisostearate - 3.0 - - 11.CetylPEG / PPG-10 / 1 Dimethicone - - 3.0 - 12.PEG-7 Dimethicone - - - 3.0 13. Carbomer 0.3 0.3 0.3 0.3 14. Incense Quantity Quantity Quantity Quantity 15. Preservative Quantity Quantity Quantity Quantity

<Production method>

1) Water phase components 1-5 were mixed and completely dissolved at 70 ° C.

2) The oily ingredients 6-15 were mixed and completely dissolved at 70 ° C.

3) While stirring the oil phase component of 2), the water phase component of 1) was gradually added and emulsified using a homogenizer.

4) After the addition of the aqueous phase component was continued stirring for 3-5 minutes, cooled to 30 ℃ and vacuum degassing to complete the cream.

[ Test Example  1] Stability of formulation according to surfactant type

The formulations of Example 1 and Comparative Examples 1-3 were stored for one month in a 45 ° C. thermostat to observe the stability of the formulations, and the results are shown in Table 2 and FIG. 1.

ingredient Room temperature High temperature (45 ℃) Powder dispersibility Example 1 Stable for over a month Stable for over a month Keep it evenly distributed 2. Comparative Example 1 Isolate in 14 days Isolate in 5 days Tangle 3. Comparative Example 2 Isolate in 10 days Isolate in 3 days Tangle 4. Comparative Example 3 Isolate immediately after manufacture Isolate immediately after manufacture Tangle

In the results of Table 2 and FIG. 1, the stability of the formulation was maintained for one month in a high temperature incubator at 45 ° C. for Example 1, whereas the formulation was separated for Comparative Examples 1-3. Through this, when polyglyceryl-2 dipolyhydroxystearate is used as a surfactant due to its molecular structure, it is excellent in powder dispersibility in formulations containing a high content of zinc oxide powder, and overlooks entanglement of surfactant and powder. It was confirmed that the stability was excellent.

[ Example  2-3] Diaper Rash Relief Cosmetic  Produce

To the cosmetic composition of Example 2-3 was prepared according to the composition shown in Table 3. The following units are weight percent. The usable range of each component is not limited only to this ratio.

Example 2 was prepared by adding 20% by weight of zinc oxide, 0.5% by weight of allantoin and 1% by weight of calendula extract, and Example 3 was a quasi-drug cream with 40% by weight of zinc oxide. The manufacturing process of Examples 2 and 3 is the same as Example 1 described above.

division ingredient Example 2 Example 3 Water component 1. Purified water Remaining amount Remaining amount 2. Glycerin 5.0 5.0 3. Butylene Glycol 2.0 2.0 4. Triethanolamine 0.18 0.18 5. Disodium ID 0.02 0.02 Oily ingredients 6.Argan Oil 2.0 2.0 7.Jojoba Oil 2.0 2.0 8.zinc oxide 20.0 40.0 9.Polyglyceryl-2 Dipolyhydroxystearate 3.0 3.0 10.Allantoin 0.5 - 11.calendula extract 1.0 - 12. Carbomer 0.3 0.3 13. Incense Quantity Quantity 14. Preservative Quantity Quantity

[ Test Example  2] antimicrobial activity test

In order to determine the diaper rash relief effect of the creams prepared in Examples 1 to 3, the following antibacterial activity test was carried out.

Embodiment perform microbiological tests according to Examples 1 to 3 of the sample of microorganisms SOP M-3 of the liquid medium dilution method (broth dilution) and Candida albicans (Candida albicans) ATCC 14053, Pseudomonas aeru geo labor (Pseudomonas aeruginosa ) ATCC 27853 and Staphylococcus epidermidis ) Using ATCC 12228, the test solution was inoculated in SD liquid broth, and the culture solution incubated at 25 ° C. for 2 days was prepared by diluting 1/100 dilution with SD liquid broth, and used as the test broth. . The dilution solution was prepared by adding 0.15 ml of the test bacteria solution to 15 ml of each broth and mixing well as a dilution solution. As a test substance of Examples 1 to 3, 0.2 g of each test substance dissolved in 1.8 ml of each medium was used as a sample.

In the antimicrobial test method, 180 μl of each sample was added to the first 96-hole plate and 20 μl of the 1/10 dilution of the test solution. The remaining wells were added with 100 μl of dilution solution. Mix the mixture of the first row well, take 100 μl, put it in the second row, mix well, and then add 100 μl to the third row to perform double dilution, and then at 25 ° C. After incubation for 24 hours, the presence of bacteria was determined to the extent of suspension, and the minimum concentration without growth of bacteria was determined as the MIC value. If the mixed solution is opaque and it is difficult to determine the growth of bacteria, it was confirmed by microscopic observation.

The control group is free of test substance and all other experimental conditions are the same. The number of bacteria in the experimental group and the control group at the beginning of the test and the number of bacteria after 24 hours were calculated, and the bacterial reduction rate was calculated according to Equation 1 below.

Bacterial Reduction (%) = (B-A) / B × 100

Wherein A is the number of bacteria regenerated from the test group incubated for 24 hours after sample application, and B is the number of bacteria regenerated from the control group incubated for 24 hours.

Strain sample Initial bacterial count Number of bacteria after 24 hours Bacteria Reduction Rate  Candida Albicans ATCC 14053 Control 1.4 x 10 ⁵ 7.2 x 10 ⁶ Example 1 1.4 x 10 ⁵ <100 99.9% Example 2 1.4 x 10 ⁵ <100 99.9% Example 3 1.4 x 10 ⁵ <10 99.9% Pseudomonas Arugionosa ATCC 27853 Control 1.2 x 10 ⁵ 5.5 x 10 ⁶ Example 1 1.2 x 10 ⁵ <100 99.9% Example 2 1.2 x 10 ⁵ <100 99.9% Example 3 1.2 x 10 ⁵ <10 99.9%   Staphylococcus ATCC 12228 Control 1.5 x 10 ⁵ 6.8 x 10 ⁶ Example 1 1.5 x 10 ⁵ <100 99.9% Example 2 1.5 x 10 ⁵ <100 99.9% Example 3 1.5 x 10 ⁵ <10 99.9%

In the results of Table 4, the compositions of Examples 1 to 3 according to the present invention have an effective antibacterial activity of 99.9% of bacteria reduction rate against Candida albicans , Pseudomonas aeruginosa , and Staphylococcus , which are the main causes of diaper dermatitis. I could confirm it.

[ Test Example  3] Diaper Rash Relief Efficacy Clinical Trial

In order to determine the diaper rash alleviation efficacy of the creams prepared in Examples 1 to 3, the following test was conducted. Thirty parents with babies suffering from diaper rash were asked to apply the creams of Examples 1-3 to the baby's diaper rash site five times daily for four weeks, followed by diaper rash before and two weeks after use of the product. The change of site was asked to observe. Diaper dermatitis symptoms in infants participating in the trial showed itching, redness of the skin, rashes, moistening of the skin, and rashes. At the end of the trial, clinical efficacy evaluations were conducted through a questionnaire survey on the effects of diaper rash reduction after using the creams of Examples 1-3. The questionnaire survey was to indicate the satisfaction level of diaper rash relief effect divided into very good, good, normal and poor, the results are shown in Table 5 below.

Diaper Rash Relief Effect Questionnaire sample Respondents Very good Good usually Inadequate Example 1 18 8 4 0 Example 2 20 7 3 0 Example 3 25 4 One 0

In the results of Table 5, when applying the cream of Example 1 containing 20% by weight of zinc oxide to the baby diaper rash site, respondents felt that the diaper rash site was relieved after 4 weeks of cosmetic use compared to 0 weeks There were a lot. In addition, when the cream of Example 2 formulated with a proper combination of allantoin and calendula extract components than when zinc oxide alone was used, the diaper rash area was alleviated more than the cream of Example 1 due to the synergistic effect of each component. Many respondents felt. In addition, in the case of using the quasi-drug cream of Example 3 containing 40% by weight of zinc oxide, many respondents felt that diaper rash relieving efficacy was much higher than those of Examples 1 and 2.

This results in better diaper rash relieving effect when allantoin and calendula extract ingredients are combined properly than zinc oxide alone, and the diaper rash relieving effect increases as the amount of zinc oxide that is effective for diaper rash increases. It was confirmed that the improvement.

1 is a photograph showing the formulation stability according to the type of surfactant.

Claims (5)

An external preparation composition for diaper rash alleviation or treatment comprising zinc oxide and polyglyceryl-2 dipolyhydroxystearate. According to claim 1, wherein the composition is allantoin (Allantoin) and Calendula Officinalis Extract (Calendula Officinalis Extract) The external preparation composition for diaper rash relief or treatment characterized in that it further contains. The method of claim 1, wherein the zinc oxide (Zinc Oxide) is a diaphragm rash relief or therapeutic external preparation composition, characterized in that contained in 0.001 to 60% by weight based on the total weight of the composition. According to claim 1, wherein the polyglyceryl-2 dipolyhydroxystearate (Polyglyceryl-2 Dipolyhydroxystearate) is diaper rash relief or therapeutic external preparation composition, characterized in that contained in 0.001 to 20% by weight relative to the total weight of the composition. . According to claim 2, Allantoin (Calendula Officinalis Extract) Allanin (Calendula Officinalis Extract) is an external composition for diaper rash relief or treatment characterized in that it contains 0.001 to 20% by weight based on the total weight of the composition.

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