JP2005298359A - Low-irritative body-washing agent composition and the low-irritative body-washing agent composition received in container - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a low-irritative body-washing agent composition excellent in detergency and foamability, scarcely stinging the skin because of having very low irritating properties, and capable of being suitably used for a sufferer from skin disease, and to provide the low-irritative body-washing agent composition received in a container. <P>SOLUTION: This low-irritative body-washing agent composition comprises an aqueous solution which contains a polyglycerol fatty acid ester as a surfactant and an inorganic salt as an osmotic pressure regulating agent, and does not substantially contain an antiseptic agent, nor an alcohol, wherein the composition has an osmolarity of 250 mOsm to 315 mOsm. <P>COPYRIGHT: (C)2006,JPO&NCIPI

Description

  The present invention relates to a hypoallergenic body cleanser composition for washing the body, face, hands, etc., such as a body shampoo and face wash, and a hypoallergenic body cleanser composition in a container. More specifically, the present invention relates to a hypoallergenic body cleansing composition that is very low in irritation and difficult to stain the skin, and a hypoallergenic body cleansing composition in a container.

  As a kind of cleaning composition, cleaning compositions for washing the body, such as body shampoos and facial cleansers, are known. Conventionally used body cleansing compositions contain higher fatty acid salts (so-called soaps) as cleaning ingredients. Therefore, although such a body cleaning composition has a peculiar refreshing feeling, it also has an unpleasant feeling, and in recent years, it has been pointed out that there is irritation to the skin. Accordingly, development of a cleansing ingredient having low irritation to the skin is underway, and in particular, polyglycerol fatty acid esters are expected.

  Polyglycerin fatty acid esters are known to be extremely mild surfactants with high detergency and low irritation to skin and hair, in addition to their proven use as food additives. And some body-cleaning compositions using the suitable property of such polyglycerin fatty acid ester are proposed conventionally (for example, refer patent documents 1 and 2). In these Patent Documents 1 and 2, for example, a body shampoo composed of polyglycerin fatty acid ester, glycerin, ethylene glycol distearate, preservative, pH adjuster and purified water is disclosed. In addition, various additives (alcohol, thickener, coloring agent, etc.) may be added to such a body cleaning composition as needed.

Moreover, although it is not necessarily a body cleaning composition containing polyglycerin fatty acid ester, as a similar one, a liquid injection type skin cleaning agent in which an aerosol pressure resistant container is filled with a cleaning liquid such as physiological saline and a propellant A composition has also been conventionally proposed (see, for example, Patent Document 3). Patent Document 3 discloses washing away dirt and sweat adhering to the skin surface by the pressure of a liquid cleaning agent sprayed vigorously from a container.
JP 2002-201485 A (paragraph [0020] etc.) JP 2002-201486 A (paragraph “0021” etc.) JP 2002-65854 A

  By the way, such a body cleaning composition may be used not only for a normal person who does not have a skin disease but also for a person who has a skin disease. For example, when treating many skin diseases such as eczema / dermatitis group including atopic dermatitis, contagious impetigo, contagious molluscum, and burns, This is because it is absolutely necessary to clean the affected area.

  However, the skin of a skin diseased person is more sensitive to stimulation than the healthy person's skin, even at sites other than the affected part, and is much more sensitive to the affected part. Therefore, when a general body cleanser is used, the skin often “stains”, that is, the skin is often painful. And when such a pain is felt, a skin disease person often stops washing.

  Moreover, although the body washing | cleaning agent containing the polyglyceryl fatty acid ester of patent documents 1 and 2 is certainly hypoallergenic compared with many other washing | cleaning agents, it is enough as a body washing | cleaning agent for skin disease persons. It does not have a low level of hypoallergenicity. Therefore, when the said body cleaning composition containing a polyglyceryl fatty acid ester is used for a skin disease person, there also exists a fault that it will also permeate skin.

  In addition, the physiological saline contained in the skin cleansing composition described in Patent Document 3 is considered to be less irritating than simple tap water or distilled water. However, even if it is hypoallergenic physiological saline, if it is applied to a skin lesion part vigorously, the skin lesion part will receive a big physical load. Therefore, there is a high possibility that the skin will be stained. In addition, since the skin cleansing composition described in Patent Document 3 contains no or almost no surfactant, it is difficult to say that no foam is formed at the time of use and that it has sufficient cleanability. Further, such a skin cleanser composition is suitable for applications in which a relatively narrow range is washed (for example, for washing wounds), but for applications in which a wide range is washed (for example, for use in body shampoos). Is not suitable.

  The present invention has been made in view of the above-mentioned problems, and its purpose is excellent in cleanability and foaming property, and it is very low in irritation, so it is difficult to stain the skin, and is suitable for use in people with skin diseases. The object is to provide a hypoallergenic body cleanser composition and a hypoallergenic body cleanser composition in a container.

  Therefore, in order to solve the above-mentioned problems, the inventor of the present application conducted intensive research to find out the factors that cause the body cleaning composition described in Patent Documents 1 and 2 to cause pain in the skin of a skin disease person. Focusing on the osmotic pressure and constituents of the body cleaning composition, the following conclusions were reached. That is, the body cleansing compositions described in Patent Documents 1 and 2 contain a plurality of components in addition to the polyglycerol fatty acid ester that is a surfactant, and as a result, many solutes exist in the solvent. To do. Therefore, the value of osmolarity exceeds 350 mOsm, which is considerably higher than the osmotic pressure value of human body fluid (about 286 mOsm). Therefore, the body cleansing composition easily penetrates into the skin, which is one factor of pain. The polyglycerin fatty acid ester itself has antibacterial and antibacterial properties, but the body cleansing compositions described in Patent Documents 1 and 2 are further added with a preservative to improve storage stability. ing. However, preservatives are potential irritating ingredients, and their inclusion is a factor in pain.

  Therefore, in order to realize a body cleaning composition with very low irritation, the inventor of the present application reduces the difference between the osmotic pressure of human body fluids by lowering the osmotic pressure of A) the cleaning composition. B) It was inferred that potential stimulating components represented by preservatives should be reduced. However, in order to reduce the osmotic pressure of the detergent composition and reduce the difference from the osmotic pressure of human body fluids, the dissolved mass in the solvent may be reduced, but in that case, it is necessary for the detergent composition. Care must be taken not to impair the properties (detergency, foaming, storage, etc.). The present inventor has conducted further research in view of the above, and a) significantly reduces other components (particularly potential stimulating components) while leaving polyglycerol fatty acid esters, and b) inorganics that are not potential stimulating components. The inventors arrived at a specific means of adjusting the osmotic pressure to a suitable range using salt, and finally completed the following invention.

  That is, the invention according to claim 1 is a hypoallergenic body cleanser composition containing a polyglycerin fatty acid ester and an inorganic salt, substantially free of preservatives and alcohol, and having an osmolality of 250 mOsm to 315 mOsm. Is the gist.

  Therefore, the cleaning composition according to claim 1 has an osmolarity in the range of 250 mOsm to 315 mOsm, so that the difference from the osmotic pressure of human body fluid is smaller than that of the conventional, and antiseptic which is a potential irritant component It does not contain any agent or alcohol. Therefore, compared with the conventional body washing | cleaning composition containing a polyglyceryl fatty acid ester, irritation | stimulation becomes still lower and it becomes a body washing | cleaning composition which is hard to be absorbed on the skin of not only a healthy person but a skin disease person. Moreover, since the polyglyceryl fatty acid ester is contained as a surfactant, the body cleaning composition is excellent in foaming properties, detergency, and preservability.

  The invention described in claim 2 is a hypoallergenic body comprising polyglycerin fatty acid ester and inorganic salt, substantially free of preservatives and alcohol, and having an osmotic pressure approximately isotonic with human body fluids. The gist is a cleaning composition.

  Therefore, the detergent composition according to claim 2 has an osmotic pressure that is almost isotonic with human body fluids, and is substantially free of preservatives and alcohols as potential stimulating components. . Therefore, compared with the conventional body washing | cleaning composition containing a polyglyceryl fatty acid ester, irritation | stimulation becomes still lower and it becomes a body washing | cleaning composition which is hard to be absorbed on the skin of not only a healthy person but a skin disease person. Moreover, since the polyglyceryl fatty acid ester is contained as a surfactant, the body cleaning composition is excellent in foaming properties, detergency, and preservability.

  In this case, a hypoallergenic body cleansing composition that further contains a pH adjusting agent and has a pH of 4.0 to 7.0 is preferable. Further, the polyglycerin fatty acid ester is contained in an amount of 10% to 20% by weight, the inorganic salt is contained in an amount of 0.01% to 0.5% by weight, the pH adjuster is contained in an amount of 0.2% to 1% by weight, and the pH is adjusted. It is good to set it as the hypoallergenic body cleaning composition which is 5.0-6.0 (Claim 4). Moreover, the fatty acid which comprises the said polyglyceryl fatty acid ester is 1 type, or 2 or more types of mixtures chosen from C8-C12 linear saturated fatty acid, The monoester content is 70% or more low irritation A body cleansing composition is preferred (Claim 5). Moreover, it is good to set it as the low irritation | stimulation body washing | cleaning agent composition whose skin irritation | stimulation index | exponent of a patch test is 10 or less by calculation by a Sugai method (Claim 6). Moreover, it is good to set it as the low irritation | stimulation body washing | cleaning agent composition used for skin washing of a skin disease person (Claim 7).

  The invention according to claim 8 contains the hypoallergenic body cleaning composition according to any one of claims 1 to 7 in a push pump type container that can be discharged in the form of foam. The gist of the present invention is a hypoallergenic body cleansing composition containing a container.

  Therefore, since the cleaning composition according to claim 8 is in contact with the skin in a foamed state, it does not give a large physical load to the skin, unlike the conventional aerosol type sprayed vigorously. . In other words, this detergent composition is hard to stain the skin, and is therefore extremely suitable for use for people with skin diseases. In addition, since it contains a polyglycerin fatty acid ester which is a suitable surfactant, it is excellent in cleanability as compared with a conventional aerosol-type cleaning composition.

  Therefore, according to the first to seventh aspects of the invention, the low-irritant body wash that is excellent in cleanability and foaming properties, is not very irritating and is difficult to stain the skin, and is suitable for use in people with skin diseases. An agent composition can be provided. In addition, according to the invention described in claim 8, the hypoallergenic body in a container is excellent in cleaning properties and foaming properties, is not easily irritated to the skin because of its very low irritation property, and is suitable for use for people with skin diseases. A cleaning composition can be provided.

  Hereinafter, a container-less hypoallergenic body cleansing composition embodying the present invention will be described in detail.

  The body cleansing composition of the present embodiment contains water as a solvent, polyglycerin fatty acid ester as a surfactant, inorganic salt as an osmotic pressure adjusting agent, and a pH adjusting agent. It is a liquid that does not substantially contain an irritating ingredient. In addition, this body cleaning composition has an osmolality adjusted to 250 mOsm to 315 mOsm and a pH adjusted to 4.0 to 7.0.

  As a fatty acid which comprises the polyglycerol fatty acid ester in this embodiment, it is good that it is 1 type, or 2 or more types of mixtures chosen from a C8-C22 saturated or unsaturated fatty acid. In this case, C8-16 is preferable and C8-12 is more preferable. The fatty acid may be linear or branched, but is preferably linear. Fatty acids may be saturated or unsaturated, but are preferably saturated. From the above, it can be said that a suitable fatty acid used in the present embodiment is one or a mixture of two or more selected from linear saturated fatty acids having 8 to 12 carbon atoms. The polyglycerin fatty acid ester having a fatty acid that satisfies these conditions as a constituent element has not only sufficient cleaning properties, foaming properties, and low irritation required for the cleaning agent of the present embodiment, but also suitable antibacterial properties. It is because it also has sex and antibacterial properties.

  Examples of the method for synthesizing polyglycerol of the polyglycerol fatty acid ester in the present embodiment include a heat dehydration polymerization method of glycerol, an addition polymerization method of glycidol, and an addition polymerization method of epichlorohydrin. In some cases, distillation purification and decolorization may be performed. Examples of the reaction when producing the polyglycerol fatty acid ester of the present embodiment include esterification reaction between polyglycerol and fatty acid, ester exchange reaction between polyglycerol and fatty acid esters, and ester exchange between polyglycerol and fats and oils. The reaction can be illustrated. In addition, even if it does not use polyglycerol, it is possible to obtain polyglycerol fatty acid ester also by the addition polymerization reaction of glycidol to a fatty acid, for example. That is, when producing a polyglycerin fatty acid ester, any of the above reactions can be selected, but it is particularly preferable to select an addition polymerization reaction of glycidol to a fatty acid. In addition, polyglycerol fatty acid ester is obtained by carrying out distillation refinement | purification and a decoloring process as needed, or mix | blending 2 or more types of polyglycerol fatty acid ester depending on the case.

  The average degree of polymerization of the polyglycerol of the polyglycerol fatty acid ester of the present embodiment is 3 or more, preferably 4 to 20, and more preferably 4 to 10. Further, the monoester content of the polyglycerol fatty acid ester is preferably 50% or more, more preferably 70% or more. Moreover, the compounding quantity of polyglyceryl fatty acid ester is 1 to 50 weight%, Preferably it is 5 to 30 weight%, More preferably, it is 10 to 20 weight%. The reason is that by setting the blending amount within the above preferred range, sufficient detergency and foaming properties and very low irritation can be obtained. In addition, when there are too few compounding quantities of polyglyceryl fatty acid ester, although realization of very low irritation | stimulation is attained, sufficient detergency cannot be obtained. On the other hand, if the blending amount of the polyglycerin fatty acid ester is too large, sufficient detergency can be obtained, but the value of the osmotic pressure becomes high, so that it is difficult to realize very low irritation.

  Examples of suitable inorganic salts used as the osmotic pressure adjusting agent in the present embodiment include salts such as sodium, potassium, calcium, magnesium, and ammonium. The inorganic salts listed here are not potential stimulating components in the first place, and have been used as solutes such as physiological saline and Ringer's solution. For this reason, even if the said inorganic salt is used, it is because the mildness of a body cleaning composition is not impaired at all. These inorganic salts may be used alone or in combination of two or more. In this embodiment, the compounding amount of the inorganic salt is 0.001 wt% to 0.9 wt%, preferably 0.01 wt% to 0.5 wt%. In addition, when there are too few compounding quantities of an inorganic salt, the role as an osmotic pressure regulator may not fully be fulfilled. On the other hand, if the amount of the inorganic salt is too large, the detergency and foamability may be lowered in some cases.

  In this embodiment, the osmolality of the body cleaning composition is set to 250 mOsm to 315 mOsm. The osmolarity is preferably set to 270 mOsm to 300 mOsm, more preferably 280 mOsm to 290 mOsm, and most preferably 286 mOsm ± 3 mOsm (ie, approximately isotonic with human body fluids). The reason is that if the osmolarity is less than 250 mOsm or more than 315 mOsm, the difference in osmotic pressure between the body cleansing composition and human body fluid becomes large, and it is difficult to realize very low irritation.

  Examples of the pH adjuster used in this embodiment include polycarboxylic acids such as succinic acid, citric acid, malic acid, lactic acid, tartaric acid, and fumaric acid, aminocarboxylic acids such as glutamic acid, glycine, and alanine, and oxycarboxylic acids. Examples thereof include acids or metal salts thereof. Water-soluble salts of carbonic acid, bicarbonate, silicic acid, crystalline aluminosilicic acid and amorphous aluminosilicic acid can also be used, and pyrophosphoric acid, orthophosphoric acid, polyphosphoric acid, phosphonic acid salts, etc. can also be used. . Among the acids and salts listed here, an organic acid or a metal salt thereof is preferably selected. Specifically, it is preferable to select citric acid, succinic acid, malic acid, lactic acid, tartaric acid and their metal salts, and it is particularly preferable to select citric acid and its metal salts. This is because these organic acids or metal salts thereof are extremely safe and are not potential stimulating components.

  The body cleansing composition of the present embodiment is adjusted from the neutral range to the weakly acidic range using the above pH adjuster, in other words, to a pH value close to the pH value of the body (about 5.5). It is preferable to adjust. The reason is that the closer the pH value is to the body, the easier it is to achieve very low irritation. Specifically, it is preferable to adjust the pH to 4.0 to 7.0, and it is particularly preferable to adjust the pH to 5.0 to 6.0.

  In the present embodiment, the blending amount of the pH adjuster is 0.01 wt% to 5 wt%, preferably 0.1 wt% to 2 wt%, more preferably 0.2 wt% to 1 wt%. . The reason is that if the amount of the pH adjusting agent is too small, it may be difficult to stably maintain the pH of the aqueous solution. On the other hand, if the amount of the pH adjuster is too large, the value of the osmotic pressure becomes high, and it may be difficult to realize very low irritation. In addition, said pH adjuster may serve as the osmotic pressure adjuster. That is, the osmotic pressure adjusting agent in the present embodiment is not limited to only inorganic salts.

  In addition, it is desirable that the body cleaning composition of the present embodiment should not contain additives as much as possible in principle, but it is allowed to contain some additives as long as the original purpose is not impaired. The That is, it is permissible to add a small amount of a fragrance or a coloring agent on the condition that it is not a potential stimulating component. On the other hand, since lower alcohols such as ethanol, polyhydric alcohols such as propylene glycol, preservatives (antibacterial agents, antibacterial agents) and the like are potential stimulating components, the body cleaning composition is substantially It is desirable not to contain these. In this embodiment, “substantially free of preservatives and alcohol” varies depending on the degree of irritation of the individual stimulating components, for example, the total amount of the preservative and alcohol is less than 0.1% by weight. It means that. Of course, the total amount of the preservative and the alcohol is more preferably less than 0.01% by weight, and further preferably less than 0.001% by weight. In other words, it is desirable that the content of the preservative and the alcohol is less than the detection limit.

  The body cleaning composition of the present embodiment is contained in a push pump type container capable of discharging a liquid content in the form of foam. The container is not particularly limited, and a conventionally well-known commercial product can be used as it is as a body shampoo container or the like. However, it is desirable that only the body cleaning composition is contained in the container, and it is desirable that no propellant such as compressed gas is contained. This is because when a propellant is used, the physical load on the skin increases, and very low irritation may not be achieved.

  Hereinafter, although some examples and comparative examples that further embody the present embodiment will be described, the scope of the present invention is not limited thereto.

[Example 1]
In Example 1, after preparing the body washing | cleaning agent composition which has the following component, this composition was filled into the push pump type container which can discharge the contents in foamy form. The decaglyceryl monolaurate used here has a high monoester content by a novel production method. Specifically, “Sunsoft M-12J” (trade name) manufactured by Taiyo Kagaku Co., Ltd. was used. The decaglyceryl monolaurate has high sebum detergency, high foaming power, low protein denaturation, low elution of free amino acids from the skin, low skin persistence, antibacterial properties, and low irritation It has some very favorable properties such as.
・ Decaglyceryl monolaurate (surfactant) 15.0% by weight
・ Citric acid (pH adjuster) 0.1% by weight
・ Na citrate (pH adjuster) 0.3% by weight
・ Sodium chloride (osmotic pressure regulator) 0.11% by weight
Deionized water (solvent) 84.49% by weight

  The body cleaning composition had an osmolality of 287 mOsm and a pH of 5.5.

[Example 2]
In Example 2, after preparing the body washing | cleaning agent composition which has the following component, this composition was filled into the push pump type container which can discharge the contents in foamy form.
・ Decaglyceryl monolaurate (surfactant) 18.5% by weight
・ Citric acid (pH adjuster) 0.1% by weight
・ Na citrate (pH adjuster) 0.3% by weight
・ Sodium chloride (osmotic pressure regulator) 0.01% by weight
Deionized water (solvent) 81.09% by weight

  The body cleaning composition had an osmolality of 313 mOsm and a pH of 5.5.

[Example 3]
In Example 3, after preparing the body washing | cleaning agent composition which has the following component, this composition was filled into the push pump type container which can discharge the contents in foamy form.
・ Decaglyceryl monolaurate (surfactant) 10.0% by weight
・ Citric acid (pH adjuster) 0.1% by weight
・ Na citrate (pH adjuster) 0.3% by weight
・ Sodium chloride (osmotic pressure regulator) 0.26% by weight
Deionized water (solvent) 89.34% by weight

  The body cleaning composition had an osmolality of 252 mOsm and a pH of 5.5.

[Example 4]
In Example 4, after preparing the body washing | cleaning agent composition which has the following component, this composition was filled into the push pump type container which can discharge the contents in foamy form.
・ Decaglyceryl monolaurate (surfactant) 10.0% by weight
・ Citric acid (pH adjuster) 0.1% by weight
・ Na citrate (pH adjuster) 0.3% by weight
・ Sodium chloride (osmotic pressure regulator) 0.4% by weight
Deionized water (solvent) 89.2% by weight

  The body cleaning composition had an osmolality of 297 mOsm and a pH of 5.5.

[Example 5]
In Example 5, after preparing the body washing | cleaning agent composition which has the following component, this composition was filled into the push pump type container which can discharge the contents in foamy form.
・ Decaglyceryl monolaurate (surfactant) 15.0% by weight
・ Citric acid (pH adjuster) 0.15% by weight
・ Na citrate (pH adjuster) 0.3% by weight
・ Sodium chloride (osmotic pressure regulator) 0.11% by weight
Deionized water (solvent) 84.44% by weight

  The body cleaning composition had an osmolarity of 288 mOsm and a pH of 5.0.

[Example 6]
In Example 6, after preparing the body washing | cleaning agent composition which has the following component, this composition was filled into the push pump type container which can discharge the contents in foamy form.
・ Decaglyceryl monolaurate (surfactant) 15.0% by weight
・ Citric acid (pH adjuster) 0.05% by weight
・ Na citrate (pH adjuster) 0.3% by weight
・ Sodium chloride (osmotic pressure regulator) 0.11% by weight
Deionized water (solvent) 84.54% by weight

  The body cleaning composition had an osmolality of 287 mOsm and a pH of 6.4.

[Example 7]
In Example 7, after preparing the body washing | cleaning agent composition which has the following component, this composition part was filled into the push pump type container which can discharge the contents in foam form.
・ Decaglyceryl monocaprate (surfactant) 14.0% by weight
・ Citric acid (pH adjuster) 0.1% by weight
・ Na citrate (pH adjuster) 0.3% by weight
・ Sodium chloride (osmotic pressure regulator) 0.11% by weight
Deionized water (solvent) 85.49% by weight

  The body cleaning composition had an osmolality of 283 mOsm and a pH of 5.5.

[Comparative Example 1]
In Comparative Example 1, after preparing a body cleansing composition having the following components, this composition part was filled into a push pump type container capable of discharging the contents in a foam form. This body cleansing composition was prepared with reference to the composition of the body shampoo disclosed in Patent Document 1.
・ Polyglycerin (10) capric acid ester (surfactant) 10.0% by weight
・ Polyglycerin (10) laurate (surfactant) 15.0% by weight
・ Glycerin 5.0% by weight
・ Ethylene glycol distearate 3.0% by weight
・ Preservative 0.5% by weight
・ PH adjuster appropriate amount ・ Purified water (solvent) balance

  The body cleaning composition had an osmolality of 1020 mOsm and a pH of 7.0. As described above, the body cleansing composition of Comparative Example 1 is considerably hypertonic as compared with human body fluids, and has a level of hypoallergenicity required for a body cleansing composition for persons with skin diseases. I thought it was not.

[Comparative Example 2]
In Comparative Example 2, after preparing a body cleansing composition having the following components, this composition part was filled in a push pump type container capable of discharging the contents in a foam form. This body cleansing composition was prepared with reference to the composition of the body shampoo disclosed in Patent Document 2.
・ Polyglycerin (10) laurate (surfactant) 16.0% by weight
・ Polyglycerin (20) laurate (surfactant) 4.0% by weight
・ Glycerin 5.0% by weight
・ Ethylene glycol distearate 3.0% by weight
・ Preservative 0.5% by weight
・ PH adjuster appropriate amount ・ Purified water (solvent) balance

  The body cleaning composition had an osmolality of 910 mOsm and a pH of 6.7. As described above, the body cleansing composition of Comparative Example 2 is considerably hypertonic compared to human body fluids, and has the level of hypoallergenicity required for a body cleansing composition for persons with skin diseases. I thought it was not.

[Example 8]
Next, using the container cleanser composition of Example 1 as a sample, a patch test and a use test described later were performed.

A. About patch testing

A-1 Subject of Patch Test In order to confirm the safety of the body cleaning composition, a patch test was first performed before the use test was actually performed. In the patch test, 17 patients (3 men and 14 women) who consulted dermatologists were subjects. The age of the subjects is 21 to 74 years (average 47.5 years), and the breakdown of the disease is 4 atopic dermatitis, 3 palmoplantar pustulosis, 3 lichen planus, 3 contact dermatitis, There were 2 metal allergies and 2 drug eruptions. Prior to the start of the study, the contents of the study and the body cleaning composition were fully explained to the patient or family in advance. The test was conducted after obtaining consent.

  A-2 Test method for patch test

  The normal patch test is carried out using a relatively low concentration aqueous solution such as 1% or 5% in consideration of the usage method of washing away and the stimulation of a high concentration cleaning agent. However, it was expected that the body cleanser composition of Example 1 used in this patch test would have a very low irritation and would not stain the skin. Therefore, this time, the stock solution of the body cleaning composition of Example 1, a 10% aqueous solution (10% distilled water diluted solution) obtained by diluting the stock solution with distilled water, and 10% obtained by diluting the stock solution with physiological saline. A patch test was conducted using each of the aqueous solutions (diluted solution of 10% physiological saline). In addition, a patch test was conducted using 100% distilled water and 100% physiological saline as diluents as controls (see Table 1).

  In this patch test, the sample was affixed to the normal skin of the subject for 48 hours using Finn Chamber and Scanpor tape. “Finn Chamber and Scanpor tape” are trade names of skin sensitization test kits. The skin was observed 48 hours (30 to 60 minutes after unit removal) and 72 hours after applying the sample, respectively, and the strength of irritation (positive or weakness) was determined according to Japanese standards. In this Japanese standard,-(no response), ± (mild erythema), + (erythema), ++ (erythema + edema), +++ (erythema + edema + papules to small blisters) was set. . This criterion is based on the judgment standard of the patch test by the Sugai method described in pages 210 to 222 of “Skin Vol. 19, No. 2, May 1977”.

  A-3 Evaluation criteria

  In accordance with the criteria for the patch test by the Sugai method, the positiveness of the stronger one of the two patch tests (Japanese standards) was adopted. Then,-, ±, +, ++, and +++ were given scores of 0, 0.5, 1.0, 2.0, and 3.0, respectively, and the percentage of the quotient obtained by dividing the total score by the total number of subjects was expressed as “skin Stimulus index ". The “skin irritation index” is described on pages 210 to 222 of “Skin Vol. 19, No. 2, May 1977”. In the evaluation of skin safety, according to the safety standards for external preparations, those with a skin irritation index of 5.0 or less are safety products, those with 5.0 to 15.0 are acceptable, and those with 15 to 30 are required. Improved products, more than 30 were considered dangerous products.

  A-4 Result

The results of the patch test are as shown in Table 2. The skin irritation index of the stock solution and the 10% distilled water diluted solution was 5.9, which was consistent with the value of 100% distilled water. The skin irritation index of the 10% physiological saline diluted solution was 2.9, which was consistent with the skin irritation index of 100% physiological saline. That is, it was considered that the body cleansing composition itself of Example 1 entered the category of acceptable products on the basis of Sugai, and had the same level of safety as distilled water. In addition, 10% saline dilution was in the category of safety products like saline. In any case, it was concluded that the body cleanser composition of Example 1 is a safe body cleanser composition with very low skin irritation. In Table 2, “AD” means atopic dermatitis, “CD” means contact dermatitis, and “PPP” means palmoplantar pustulosis.

B. Usage test B-1 Products used

  Here, a use test was performed using the body cleaning composition of Example 1 whose safety was confirmed by the patch test.

  B-2 Subject of use test

  Among the dermatological patients who visited dermatology in July-November 2003, 45 subjects (17 men, 28 women) who complained that the affected area was swollen during washing were subjects. The breakdown of the age of the subjects was 0 to 76 years (average 27.69 years), 9 infants (0 to 6 years) and 2 schoolchildren (7 to 10 years). The breakdown of the disease is 27 atopic dermatitis, 3 contagious impetigo, 3 fever, 2 burns, 2 contact dermatitis, 2 allergic dermatitis, eczema, erythema papule eczema Crohn's disease, dermatomyositis, bed sores, and photoaging were one each. Before starting the test, the contents of the test and the body cleaning composition were fully explained to the patient or family in advance. And this test was implemented after obtaining consent.

  B-3 Usage

  The test site was the hand and body, and the body cleansing composition was used for the disease site to be cleaned. Also, the treatment content was not changed before and after use. If the patient or his / her relative requested to cancel the study, the use study was stopped and the reason was recorded.

  B-4 Evaluation items

  For each hand and body, they were asked whether they had a subjective symptom of seeing. In addition, for each of the hands and body, they were asked to answer in a three-step (good, normal, bad) writing system regarding touch, detergency, and foam retention.

  B-5 Use test results and clinical evaluation

  a) The results of the use test are shown in Table 3. 36 respondents answered that they were used on their hands, and 39 respondents answered that they were used on their bodies. In addition, about the result of clinical evaluation, it shows to the graph of Fig.1 (a) and (b).

  b) Clinical evaluation

  Evaluation of “stain” or “stainless”: As shown in Table 3, 94.4% of the respondents answered “stainless” and 97.4% of the body. In addition, all 11 infants and schoolchildren were not painful, and “stainless” was 100%. Therefore, it was almost demonstrated that the body cleansing composition of Example 1 was not stained.

  Evaluation of touch: The evaluation of touch is considered to be a comprehensive evaluation such as a refreshing feeling after washing, a moist feeling, a crispness, and a crispness. Those who answered “good” were 58.3% for hands and 55.3% for bodies. That is, I felt that nearly 60% of people were good. In addition, 97.2% of the respondents answered “ordinary or better” and 94.7% of the body. In other words, about 90% felt that it was more than normal. This is considered to be due to the property that the amount of amino acid elution from the skin by decaglyceryl monolaurate, which is a surfactant, is low, there is no protein denaturation, and the water retention amount after washing is large.

  Evaluation of detergency: Regarding detergency, 30.6% of the respondents answered “good” by hand, and 58.3% of respondents answered “normal”. On the other hand, 25.6% of respondents answered “good” for the body, and 64.1% of respondents answered “normal”. In other words, 88.9% of the people in the hands and 89.7% of the people in the body felt more than normal. This can be considered that the use of decaglyceryl monolaurate, which has a strong sebum cleaning action, as a surfactant worked favorably.

  Evaluation of foam retention: Foam retention indicates the persistence of foam. Those who answered “good” were 38.9% by hand and 38.5% by body, and those who answered “normal” were 50.0% by hand and 30.8% by body. In other words, 88.9% of the hands and 69.3% of the body felt more than normal. As described above, the body was slightly weak in foaming, but the hand was almost satisfactory.

Details of subjects who answered that they were spotted: 9, no. 22, no. Three of 26 subjects complained of seeing. The details were as follows. No. Nine subjects had atopic dermatitis and used their hands, but they discontinued their use because they were spotted. However, there was no effect on the rash. No. Twenty-two subjects had atopic dermatitis and used the hands. Stain was used continuously. The skin eruption had no effect, and the evaluation was good. No. Twenty-six subjects had atopic dermatitis, not only when the use site was a hand, but when the use site was a body. When he continued to use it, there was no effect on skin eruption, the evaluation was good, and he wanted to continue using it. In other words, there were 3 cases in total, 2 cases by hand and 1 case by body. One case of the hand was discontinued because it soaked, but the rash was not affected.
C. Consideration

Since wounds / inflammation sites that are highly sensitive to various stimuli are only soaked with water, body cleansing compositions with low interfacial tension are often exposed. In that regard, the above-described use test was attempted in anticipation that the body cleanser composition of Example 1 adjusted to be approximately isotonic with human body fluids would be difficult to stain. As a result, the results were as good as expected, and most people wished to continue using it. By age group, there were three subjects who responded that they were spotted: 20 years old, 39 years old, and 56 years old. On the other hand, since 11 children 0 to 10 years old all answered “stainless”, particularly excellent non-pain was confirmed for children. Taking these results together, it can be said that the body cleansing composition of Example 1 is very suitable for use in persons with skin diseases because it is very low in irritation and is difficult to stain the skin.

  The embodiment of the present invention may be modified as follows without departing from the spirit of the invention.

  In the above embodiment, an example in which the body cleaning composition of the present invention is mainly used for cleaning the skin has been shown, but in order to clean a part other than the skin in the body, for example, a mucous membrane part without skin It is also possible to use it.

  -Moreover, although the example which wash | cleans a human body with the body cleaning composition of this invention was shown in the said embodiment, even if this is used for the washing | cleaning of the body of animals (dogs, cats, etc.) other than a human being I do not care.

  -The body cleansing composition of the present invention may be a product form prepared in advance to a concentration suitable for actual use, as in Example 1, but as a product form concentrated by reducing the amount of water. Can also be established. In this case, it may be prepared by diluting with water at the time of use so that the osmolality is 250 mOsm to 315 mOsm.

  Next, the technical ideas grasped by the embodiment described above are listed below.

  (1) Atopic dermatitis, palmoplantar pustulosis, lichen planus, contact dermatitis, metal allergy, drug eruption, contagious impetigo, fever, burns, allergic dermatitis, eczema, erythema papule eczema, The hypoallergenic body wash according to any one of claims 1 to 7, which is for skin washing of a person having at least one skin disease selected from Crohn's disease, dermatomyositis, bed sores and photoaging. Agent composition.

  (2) An aqueous solution containing a polyglycerin fatty acid ester, an inorganic salt, and a pH adjuster, substantially free of preservatives and alcohol, having an osmolality of 280 mOsm to 290 mOsm, and a pH of 4.0 to 7. A hypoallergenic body cleanser composition that is zero.

  (3) The hypoallergenic body cleaning composition according to any one of claims 1 to 5, wherein the skin irritation index of the patch test is 6 or less as calculated by the Sugai method.

  (4) A hypoallergenic body cleansing composition comprising a polyglycerin fatty acid ester and an inorganic salt, substantially free of preservatives and alcohol, wherein the osmotic pressure is approximately isotonic with physiological saline.

  (5) A hypoallergenic body cleanser composition that contains polyglycerin fatty acid ester and inorganic salt, and is substantially free of preservatives and alcohol, and does not cause pain in the skin diseased part of a person with skin disease Stuff.

  (6) A hypoallergenic body cleanser composition containing a polyglycerol fatty acid ester and an inorganic salt and substantially free of preservatives and alcohol, diluted with water so that the osmolality is 250 mOsm to 315 mOsm A hypoallergenic body cleanser composition for use in a condition.

(a) And (b) is a graph which shows the result of clinical evaluation at the time of using the body cleaning composition of Example 1. FIG.

Claims (8)

  A hypoallergenic body cleansing composition comprising an aqueous solution containing a polyglycerin fatty acid ester and an inorganic salt, substantially free of preservatives and alcohol, and having an osmolality of 250 mOsm to 315 mOsm.   A hypoallergenic body cleanser composition comprising a polyglycerin fatty acid ester and an inorganic salt, substantially free of preservatives and alcohol, wherein the osmotic pressure is approximately isotonic with human body fluids.   The hypoallergenic body cleansing composition according to claim 1 or 2, further comprising a pH adjuster and having a pH of 4.0 to 7.0.   10 wt% to 20 wt% of the polyglycerin fatty acid ester, 0.01 wt% to 0.5 wt% of the inorganic salt, 0.2 wt% to 1 wt% of the pH adjuster, and a pH of 5 The hypoallergenic body cleanser composition according to claim 3, which is 0.0 to 6.0.   The fatty acid constituting the polyglycerin fatty acid ester is one or a mixture of two or more selected from linear saturated fatty acids having 8 to 12 carbon atoms, and the monoester content is 70% or more. The hypoallergenic body cleaning composition of any one of these.   The hypoallergenic body cleaning composition according to any one of claims 1 to 5, wherein the skin irritation index of the patch test is 10 or less as calculated by the Sugai method.   The hypoallergenic body cleansing composition according to any one of claims 1 to 6, which is used for skin washing of a skin disease person.   8. A hypoallergenic container containing the hypoallergenic body cleaning composition according to any one of claims 1 to 7 in a push pump type container capable of being discharged in the form of foam. Sexual body cleanser composition.

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