JP4883596B2 - Dermatological composition or bath preparation - Google Patents

Description

[0001]
BACKGROUND OF THE INVENTION
The present invention belongs to the technical field of dermatologic compositions and bath preparations used for dermatological drugs, particularly atopic dermatitis.
[0002]
[Prior art]
Conventionally, atopic dermatitis is a itchy eczema that develops when sensitive skin is easily dried and various irritation is applied to it. Atopic dermatitis usually develops from infancy to school age and gradually improves as it grows up. However, symptoms continue after adolescence or become adult. The number of cases that develop after that tends to increase. In particular, there are many cases in which adults become severe and the treatment period is prolonged.
Atopic dermatitis occurs mainly in people who have a predisposition to atopy that is sensitive to various stimuli and is prone to inflammation. It is also said that the onset of atopic dermatitis is related to the allergic reaction and the reduction of skin barrier function due to dry skin, etc., but the human body tries to exclude foreign substances coming from outside the body. It is said that an allergic reaction occurs when this function is excessive.
[0003]
The cause of allergic reactions is called allergens, and foods such as mites, dust (house dust), cedar pollen, and eggs, milk, and soybeans can also become allergic cancers. It causes many allergic reactions in small children, who may gradually improve as they grow.
The skin functions as a barrier to prevent foreign bodies from entering the body, but when the skin's stratum corneum becomes rough and the skin dries, this barrier function decreases and the clothing and skin are rubbed together. When the barrier is broken, various strong stimuli from the outside are directly received, and the allergen easily enters.
Further, when the skin is dry, itching tends to occur, and it causes inflammation by scratching the skin, further aggravating the skin symptoms, and further it causes a vicious circle in which the skin is scratched and itching itself becomes stress and exacerbates dermatitis.
[0004]
The basis of treatment for atopic dermatitis is skin care. To prevent it, it is important to eliminate the cause of allergic reactions and avoid skin irritation. Use drugs or internal medicine.
Topical steroids are mainly used as topical drugs, but they are very effective, so in anticipation of such effects, people who apply strong topical steroids even with mild inflammation or who use for a long time to prevent inflammation There are also many.
[0005]
In addition, as a topical medicine for atopic dermatitis in which a plant extract is blended, Japanese Patent Application Laid-Open No. Hei 9-1071010 and the like have been proposed in which a pomegranate extract is blended.
[0006]
[Problems to be solved by the invention]
However, if the steroid topical medicine is used for a long time, the following side effects appear, and atopic dermatitis is worsened.
In other words, side effects of topical steroids include systemic side effects and local side effects, the former has a significant effect of suppressing adrenal function, and the latter has cephalitis, purpura, capillary dilation, skin atrophy. The skin condition of the application site becomes thin, and the medical condition such as the skin being easily damaged by mild irritation or being easily infected with bacteria is exacerbated.
In addition, steroid drugs, which have been used in large quantities for a long period of time regardless of whether they are used externally or internally, have a risk of causing a rebound phenomenon where symptoms are extremely worsened and extremely intense inflammation occurs when the use is suddenly stopped.
Since atopic dermatitis has a characteristic that itching is strong, the patient is scratching the inflammatory site, creating a vicious circle that further worsens the inflammation. It leads to treatment of inflammation.
To suppress itching, it is common to use antihistamines that suppress the action of histamine, which causes itchiness, or antiallergic agents that suppress the release of histamine in the skin. There is a drawback that it cannot be used during the day to wake up.
[0007]
Atopic dermatitis is premised on having an atopic predisposition (allergic constitution), and allergic factors such as mites, house dust, milk / egg foods, cedar pollen, Mold, fungi, and non-allergenic factors (detergents (shampoos, rinses, etc.), contact irritation, curettage, stress, infections (cavities, etc.)) cause inflammation, dry skin, etc. It is generally known to cause strong itching while the symptoms are intricately intertwined.
For the treatment of allergic dermatitis, the causes of allergy and the aggravating factors of atopic dermatitis are investigated by tests such as patch test, serum antibody test (RAST method), skin test (scratch test, prick test), etc. It is premised on removing the causative substance, and then, taking care of skin using a moisturizer (ointment, cream, lotion, etc.), steroids, antihistamines, antihistamines There is a need for drug therapy such as allergies.
In addition, a topical drug for atopic dermatitis containing a plant extract such as pomegranate has been proposed, but its efficacy and safety are not always clear.
[0008]
However, various side effects have been reported in pharmacotherapy, mainly for topical steroids, and the use of steroids over a long period of time continuously dilates the capillaries of the skin, causing reddish skin (Sake-like dermatosis). ) Followed by atrophy of the connective tissue of the skin, resulting in thinning of the skin and accompanying bleeding, and continued use over time, the skin becomes harder and thicker like an elephant's skin, losing moisture and thickening .
In addition, the protein catabolism and the potassium excretion promoting action of steroids cause muscle protein loss, resulting in a decrease in overall physical strength (steroid myopathy). It is easy to suffer from herpes (simple herpes), Kaposi varicella-like rash, etc., and it is easy to catch a cold, and eye disorders such as cataract and glaucoma are likely to develop.
In addition, it has been reported that Moonface buffalo jaws and the like develop to facilitate the accumulation of subcutaneous fat.
Moisturizers for skin care are also oily ointments (eg petrolatum), emulsion ointments (hydrophilic ointment, urea / collagen / squalane ointment etc.), oily agents (camellia oil, olive oil etc.) There is a need to use different lotion agents.
[0009]
In addition, the atopic dermatitis topical preparation formulated with the pomegranate extract proposed in Japanese Patent Application Laid-Open No. Hei 9-110710 does not have an actual therapeutic effect.
[0010]
The present invention has been made in view of the above-mentioned problems, and the object thereof is to suppress skin inflammation without using steroids having many problems in use and to have a moisturizing function. An object of the present invention is to provide a dermatological composition and a bath preparation for safely treating atopic dermatitis without using an agent.
[0011]
[Means for Solving the Problems]
  To solve the above problem,The invention of claim 1, Fresh leaves of tsuruna, orSoDry milling agent, orSoExtracts of these or combinations of theseAnd a dermatological composition for atopic dermatitis for forming a film on the skin, which contains, as an active ingredient, and jellyfish, dodami, tea, or a combination thereof.
  The invention of claim 2, Fresh leaves of tsuruna, orSoDry milling agent, orSoExtracts of these or combinations of theseAnd a bath agent for atopic dermatitis for atopic dermatitis for forming a film on the skin, which contains, as an active ingredient, velvet beetle, dokudami, tea, or a combination thereof.
[0012]
That is, the present inventor has extensively searched for the existence of a herbal medicine component that suppresses skin inflammation and has a moisturizing function without using steroids having many problems in use, and has repeated research, In particular, extensive research was conducted on how to treat atopic dermatitis without the use of steroids and what would be effective.
As a result of investigating herbal medicines that combine the anti-inflammatory effects of steroids with the skin moisturizing effect of moisturizers, and further research, they can find these effects in the sea shore plant, Tulna (aka Hamachisha). As a result of further research based on this fact, the present invention has been completed.
[0013]
The dermatological agent according to the present invention comprises an extract extracted from fresh leaves and dried products of the seashore plant Tuluna (also known as Hamajisha, English New Zealand Spinach) with water, alcohol or a mixture of both, ointment, cream, gel. , An external preparation prepared by adding to a dosage form such as Papp, tincture, lotion, spray, etc. at an appropriate concentration.
As another form of use, the dried product is cut or pulverized to a certain length and applied externally as a bath agent.
[0014]
The dermatological composition and bath preparation according to the present invention are mainly composed of tulna as a means of external treatment for dermatoses, particularly atopic dermatitis. Tsuruna is a caroten, vitamin A, B1, Contains B2, C, niacin, viscous polysaccharide. Carotene is one of the carotenoids that are terpene pigments and has a high antioxidant effect. Vitamin A maintains normal function and structure of epithelial cells, vitamin B1 (also known as thiamine) has anti-nerve action, and vitamin B2 (also known as riboflavin) is thought to cause inflammation of the skin and mucous membranes. Vitamin C (also known as ascorbic acid) has a strong reducing power and excellent antioxidant action, niacin (also known as nicotinic acid) is a vitamin B complex that has anti-pellagra action, and if deficient, stomatitis, stomatitis, glossitis It is thought to cause sudden / chronic dermatitis, peripheral circulatory disturbance, etc., and these ingredients comprehensively improve skin inflammation and form a film with viscous polysaccharides infiltrating the skin. By increasing the moisture retention function of the skin, itching is suppressed and it contributes to skin regeneration.
Ointments, creams, gels, lotions, tinctures, pops, sprays, and other external preparations prepared using extracts obtained by extracting these ingredients with water, alcohol or a mixture of both, and dried tuna Even in a bathing agent, it is possible to improve atopic dermatitis by comprehensive action on the skin such as anti-inflammatory effect, moisturizing effect and antioxidant effect of the active ingredient of tsuruna.
[0015]
DETAILED DESCRIPTION OF THE INVENTION
The preferred embodiment of the present invention will be described. The essence of the present invention is to treat atopic dermatitis without using a steroid, and it has both an anti-inflammatory effect of a steroid and a skin moisturizing effect of a moisturizer. As a herbal medicine, we can find their effects on the seaside plant Tsuruna (aka Hamachisha), which is based on this fact.
[0016]
[Example 1]
The first embodiment is a creamy dermatological composition containing a tsuruna extract for adult atopic dermatitis (AD), in which the tsuruna extract is blended in a creamy dosage form.
First, an extract extracted from dried tuna with water / alcohol mixture (water: alcohol = 80: 20) was obtained, and a cream agent was prepared according to the following formulation containing 8 w / w% of this tuna extract. (Hereinafter referred to as cream agent).
Moreover, as Comparative Example 1, a cream preparation containing no tsuruna extract in Example 1 was prepared.
[0017]
(Comparative Example 1)
Liquid paraffin ... 3.0 (w / w%: parts)
Glycerin ... 10.0
1,3-Butylene glycol ... 1.0
Carboxymethylcellulose sodium 0.1
Sodium hyaluronate ... 0.01
Methylparaben ... 0.1
Purified water ......... Amount that makes the total amount 100.0 (w / w%: parts)
[0018]
(Example 1)
Tsuruna extract ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ 8.0 (w / w%: part)
Liquid paraffin ... 3.0
Glycerin ... 10.0
1,3-Butylene glycol ... 1.0
Carboxymethylcellulose sodium 0.1
Sodium hyaluronate ... 0.01
Methylparaben ... 0.1
Purified water ......... Amount that makes the total amount 100.0 (w / w%: parts)
[0019]
The cream of Example 1 was used on 28 skins of adult atopic dermatitis patients (over 18 years old) as subjects, and the cream of Comparative Example 1 was similarly used for adult atopic skin. Used on the skin of 8 patients with inflammation (over 18 years old).
In addition, the concomitant drugs with the creams of the examples are drugs that are thought to affect the evaluation of drug efficacy during the investigation period (antiallergic agents, antihistamines, steroids, nonsteroidal anti-inflammatory agents, tranquilizers, colds). The use of medicines, antipruritics and other internal medicines and injections was avoided, and steroids were generally prohibited during the study period. However, depending on the situation, strong or less steroids were used and mild steroids were used. Changes to the agent were also implemented.
[0020]
The changes were observed using the skin of the subjects, and the observation evaluation items were as follows, according to the schedule in [Table 1]: the start date of the survey, every 2 weeks after the start of the survey, and at the end of the survey (at the time of termination) Occasionally, the following items were observed and evaluated.
1) As the observational evaluation of symptoms, two types of evaluation were performed: (1) evaluation of itchiness and (2) evaluation of skin rash.
(1) Evaluation of itching
The following symptom items were observed at each observation evaluation date (survey start date, every 2 weeks after the survey start, at the end of the survey (at the time of discontinuation), and judged according to the following five stages with reference to the severity of pruritus.
++++: Altitude ++: Moderate +: Mild ±: Minor −: None
(2) Evaluation of skin eruption
The extent of skin eruption, the area of skin examination, and scratches were observed. However, the diseased part of the neck and above (neck, face, head, etc.) and limbs (wrist and ankle ahead) were excluded from the assessment.
▲ 1 ▼ degree of rash
The extent of the skin eruption was observed, and the severity was determined in the following five stages.
++++: Altitude ++: Moderate +: Mild ±: Minor −: None
(2) The area of the skin eruption was observed and the degree thereof was evaluated in the next stage.
(Excludes the neck, face, head, and limbs)
0, ~ 25%, ~ 50%, ~ 75%, ~ 100%
▲ 3 ▼ Scratch marks
The scratch marks were observed and their degree was determined in the following five stages.
++++: Altitude ++: Moderate +: Mild ±: Minor −: None
Regarding the side effects that occurred during the survey period, the type, date of onset, degree, treatment, course / outcome, causality, etc. were investigated.
[0021]
Based on the above criteria and methods, (1) general improvement, (2) general safety, and (3) usefulness were evaluated as clinical evaluations.
(1) As the general improvement degree, every 2 weeks after the start of the survey and at the end of the survey, the general improvement level compared to the start date of the survey is based on the changes in itching and rash (scratch marks, extent of rash, area) as shown below. Evaluation was made at each stage, and the degree of general improvement on the final observation evaluation date was defined as the final general improvement degree.
1. Significant improvement 2. Moderate improvement 3. Minor improvement 4. No change 5. Worsening
In addition, from the presence and extent of side effects at the end of the survey, (2) overall safety was judged comprehensively and evaluated according to the following 4 levels.
1. No problem with safety
2. Almost no problem in safety: Although there were side effects, no further treatment was required, and the study drug could be administered continuously.
3. Slight safety problem: Although there were side effects, treatment such as weight loss was performed and the investigational drug could be administered continuously.
4. Safety issues: The study drug was discontinued due to side effects.
Furthermore, (3) The usefulness was evaluated at the following five levels by comprehensively judging the overall improvement and overall safety over time at the end of the survey.
1. Extremely useful 2. Useful 3. Slightly useful 4. Not considered useful 5. Unfavorable
[0022]
Based on the above evaluation criteria, (1) Looking at the changes in skin symptoms, the cream of Example 1 shows that the degree of pruritus, rash and scratch marks is +++: 4 points, ++: 3 points, +: 2 points , ±: 1 point-: 0 point, and when these transitions and the transition of the area of the skin rash are shown in the graphs of FIGS. 1 to 4, both are significantly decreased from 2 weeks after the cream administration. That is, as shown in the graph of FIG. 1, the degree of pruritus (3.0 → 1.6: reduction rate 46.7%) decreased after 8 weeks of administration, and the degree of rash (3.0 → 1.8: reduction rate) as shown in the graph of FIG. 40%) decreased, and as shown in the graph of FIG. 3, the degree of scratch marks (2.8 → 1.5: decrease rate 46.4%) also decreased and greatly improved.
Moreover, as shown in the graph of FIG. 4, the area of the skin eruption reflected the above phenomenon (62.0 → 40.5: reduction rate 34.7%) and recorded a decrease, and an overall improvement tendency of the skin eruption was recognized. On the other hand, although the thing of the comparative example 1 is not shown on a graph, the change of transition of the skin symptom was hardly seen.
(2) Regarding the side effects of Example 1, there were no cases showing side effects.
(3) For overall evaluation, the overall improvement and final overall improvement are shown in Table 1-1 and Table 2-1, respectively. The general improvement of the cream of Example 1 is more than moderate improvement, and administration is started. From 2nd week: 50.0%, 4th week: 57.1%, 6th week: 64.3%, 8th week: 60.1%, and final overall improvement was also significant improvement: 35.7%, moderate improvement: 50.0%, mild improvement: 14.3%, and there were no cases of unchanged or worsening.
Above the moderate improvement, 24 of 28 cases were effective and showed an improvement rate of 85.7%.
In contrast, the general improvement degree of the cream of Comparative Example 1 is shown in Table 1-2, and the final general improvement degree is shown in Table 2-2. It was 0.1% to the extent that it was considered to be due to the moisturizing action such as glycerin.
(4) Overall safety level The results of Example 1 are shown in Table 3. The overall safety level is 96.4% with no safety problems, almost no problems with safety: 3.6%, somewhat problematic and problematic. Both were 0.0%.
(5) Regarding usefulness, the results of usefulness determined from general improvement and overall safety are shown in Table 4-1, but for Example 1, 10 out of 28 cases (35.7%) are extremely useful, 14 cases (50.0%) were useful, 4 cases (14.3%) were slightly useful, and the useful rate was 85.7% above useful, but in Comparative Example 1, almost as shown in Table 4-2 Sex was not observed.
[0023]
Here, the tuna extract of Example 1 was set to 8.0 w / w%. However, the increase in the amount of the tsuruna extract not only improved the effect but also increased the price. May develop. Actually, it is preferably 30.0 w / w% or less, and conversely, if it is 2.0 w / w% or less, the effect cannot be confirmed. In the range of 3.0 w / w% to 20.0 w / w%, good results are obtained.
[0024]
[Example 2]
In the second example, the cream of the dosage form of the component of Example 1 is mixed with vulgari and dokudami, and the component ratio is as follows.
[0025]
(Example 2)
Tsuruna extract ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ 8.0 (w / w%: part)
Vulture (extract extract) ... 5.0
Dokudami (extract extract) ... 3.0
Liquid paraffin ... 3.0
Glycerin ... 10.0
1,3-Butylene glycol ... 1.0
Carboxymethylcellulose sodium 0.1
Sodium hyaluronate ... 0.01
Methylparaben ... 0.1
Purified water ......... Amount that makes the total amount 100.0 (w / w%: parts)
[0026]
The cream prepared above was used on the skin of 10 adult atopic dermatitis patients (18 years of age or older) as subjects in the same manner as in Example 1. The effect was confirmed.
(1) The changes in skin symptoms were all significantly decreased from 2 weeks after the cream administration as in the cream of Example 1, and the degree of pruritus after 8 weeks of administration (3.0 → 1.5: rate of decrease 50.0%) ), The degree of rash (3.0 → 1.8: reduction rate 40%), and the degree of scratching marks (2.8 → 1.4: reduction rate 50.0%). In addition, the area of the skin eruption was recorded (60.0 → 37.5: reduction rate 37.5%) reflecting the above phenomenon, and the tendency to improve the skin rash was slightly more than that of Example 1.
(2) Regarding the side effects of Example 2, there were no cases showing side effects.
(3) For overall evaluation, the overall improvement and final overall improvement are shown in Tables 1-4 and 2-4, respectively. The overall improvement of the cream of Example 2 is slightly higher than that of Example 1. is doing.
(4) The overall safety level was over 90% with no safety problems.
(5) Regarding usefulness, the results of usefulness determined from general improvement and overall safety are shown in Table 4-3. For Example 2, 4 out of 10 cases (40%) are extremely useful. Five cases (50.0%) were useful, one case (10.0%) was slightly useful, and the usefulness rate was 90.0%.
[0027]
Here, the tuna extract of Example 2 was set to 8.0 w / w%. However, as with Example 1, if it is too much, it would be difficult to apply the cream to the skin, and rash and the like may occur in some cases. From the above, 30.0 w / w% or less is good, and conversely, if it is 2.0 w / w% or less, the effect cannot be confirmed, so the range is preferably 2.0 w / w% to 30.0 w / w%, more preferably The range of 3.0w / w% to 20.0w / w% is good, and for the same reason, the range of Vulgaris (extract extract) is preferably 4-8w / w%, and the amount of dokudami (extract extract) is 2-7w / A range of w% is good.
[0028]
[Example 3]
In the third example, green tea powder is mixed into the cream of the dosage form of the component of Example 1, and the component ratio is as follows.
[0029]
Example 3
Tsuruna extract ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ 8.0 (w / w%: part)
Green tea extract extract ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ 5.0
Dokudami (extract extract) ... 3.0
Liquid paraffin ... 3.0
Glycerin ... 10.0
1,3-Butylene glycol ... 1.0
Carboxymethylcellulose sodium 0.1
Sodium hyaluronate ... 0.01
Methylparaben ... 0.1
Purified water ......... Amount that makes the total amount 100.0 (w / w%: parts)
[0030]
The cream prepared above was used on the skin of 10 adult atopic dermatitis patients (18 years of age or older) as subjects in the same manner as in Example 1. The effect was confirmed.
(1) The changes in skin symptoms were all significantly decreased from 2 weeks after the cream administration as in the cream of Example 1, and the degree of pruritus after 8 weeks of administration (3.0 → 1.5: rate of decrease 50.0%) ), The degree of rash (3.0 → 1.8: reduction rate 40%), and the degree of scratching marks (2.8 → 1.4: reduction rate 50.0%).
In addition, the area of the skin eruption was recorded (60.0 → 37.5: reduction rate 37.5%) reflecting the above phenomenon, and the tendency to improve the skin rash was slightly more than that of Example 1.
(2) Regarding the side effects of Example 2, there were no cases showing side effects.
(3) For overall evaluation, the overall improvement and final overall improvement are shown in Tables 1-4 and 2-4, respectively. The overall improvement of the cream of Example 2 is slightly higher than that of Example 1. is doing.
(4) The overall safety level was over 90% with no safety problems.
(5) Regarding usefulness, the results of usefulness determined from general improvement and overall safety are shown in Table 4-3. For Example 2, 5 out of 10 cases (50%) are extremely useful. Four cases (40.0%) were useful, one case (10.0%) was slightly useful, and the useful rate was 90.0%.
[0031]
Here, the tuna extract of Example 2 was set to 8.0 w / w%, but just as in Example 1, not only did it increase the effect without increasing the effect, but it was also difficult to apply to the skin. In some cases, rash and the like may occur, and 30.0 w / w% or less is good. Conversely, if it is 2.0 w / w% or less, the effect cannot be confirmed, and preferably 2.0 w / w% to 30.0 w. The range of / w% is good, more preferably 3.0w / w% to 20.0w / w%, and for the same reason, the green tea extract is preferably in the range of 4-8w / w%.
[0032]
[Example 4]
Next, Example 4 which is a tsuruna bath agent will be described.
The tuna bathing agent is a tea bag of 3 g / bag obtained by cutting dry tuna into a length of about 2 mm.
The above tea bag is used by putting 3 packs (9g) of dry tuna pack (3g) into a pan containing 5l of water, boiling for about 20 minutes until boiling on low heat, and for 5 minutes after boiling. Heated and extracted with low heat. The boiled extract was placed in hot water (150-200 l) in a domestic tub and stirred well before bathing.
[0033]
The subjects were 15 patients with atopic dermatitis (over 18 years of age: with oral consent) who were therapies (eg antihistamines, antiallergic agents corti) The use of costeroids was avoided as much as possible.
The evaluation method is as follows: (1) The skin findings are observed for “pruritus”, “erythema”, “papules”, and “desquamation”, and the degree is determined in five levels: severe, moderate, mild, minor, and none. However, (2) Record the area where the rash is present as the site of the eruption, and (3) Use the skin keratin moisture measuring device SKICON-200 (IBS) as the skin conductance. For the eruption, measure the same site three times and use the average of the three measurements as the measurement value. (4) The overall improvement compared to before the test is a cure for the overall improvement compared to before the test. The evaluation was made on a 6-point scale of slightly light, unchanged, and worse.
As for side effects, when side effects occurred during the period of use or when the use was discontinued, the details were entered in a predetermined column.
In addition, on the last day of the study, the patient was asked about the increase / decrease in bathing frequency, improvement in symptoms, and final evaluation compared to before the test, and the bathing frequency was increased, unchanged, decreased in three stages, and the improvement in symptoms was , Improved, Slightly improved, Unchanged, Slightly worsened, 5 levels of worsened, Final evaluation is good, Slightly good, Neither good, Not good, Not good, 5 levels Each was evaluated from the report.
In determining the usefulness, the general usefulness of the bath preparation at the end of the study was evaluated in consideration of skin symptoms, general improvement, patient declaration and side effects. The evaluation criteria consisted of four levels: extremely useful, useful, slightly useful, and useless.
[0034]
The results of evaluation based on the evaluation criteria as described above will be described. The test subjects were 15 patients with atopic dermatitis, but it was confirmed that there was no improvement in the occurrence of eruption in normal bathing.
And by using the above-mentioned Example 4,
(1) Regarding skin findings, the eruption score before and after the test is shown in Table 5, but “pruritus” and “erythema” were 3 cases, 2 cases, and 5 cases, respectively, before the test. 4 cases were observed, but after the test, all of them were moderate or over and shifted to mild, minor and none.
“Papules” and “desquamation” were not high before the test, but moderate in 1 and 4 cases, respectively, but shifted to mild, slight, and none after the test. In general, “pruritus”, “erythema”, “papules” and “desquamation” showed a tendency to improve after the test compared to before the test.
(2) Regarding the skin eruption site, the increase / decrease of the eruption site after the test is shown in Table 6. The decrease in the site of the skin eruption was observed in 13 cases (86.7%) of 15 cases, and 2 cases (13.3 %), And there were no increased cases.
(3) In order to see the moisturizing effect of the skin, the change in skin conductance before and after the test was measured, and this result is shown in Table 7 and increased after using the bathing agent compared to before the test (24.6 → 55.7), and there was a significant difference between the two.
(4) Table 8 shows the overall improvement compared to before the study. Of the 15 cases, 3 cases (20.0%) “remarkably light”, 8 cases (53.3%) “very light”, and 3 cases “slightly light” ( 20.0%), and 1 case (6.7%) were “invariant”, and there were no cases that worsened.
In addition, 11 cases (73.3%) out of 15 cases were "very light" or more.
(5) Regarding side effects, no symptoms that seemed to be side effects were observed during the study period.
(6) Usefulness determination is shown in Table 9 for the usefulness determination results obtained from efficacy and side effects. Among 15 cases, 2 cases were “very useful” (13.3%) and 10 cases were “useful” (66.7 %), 2 “somewhat useful” cases (13.3%), and “useless” 1 case (6.7%), and 12 cases (80.0%) higher than useful cases were recognized.
[0035]
In this example, 3 packs (9 g) were used as a 3 g / bag tea bag shape with the dried tuna cut to about 2 mm in length. However, the effect is not improved, and 2 to 6 packs are usually appropriate for 150 to 200 l of hot water.
[0036]
[Example 5]
Next, Example 5 which is a tuna bathing agent will be described.
The tsuruna bathing agent is about 3g of dried tuna cut to about 2mm in length.
About 0.5 g of dried edible cuts, about 0.5 g of dried dokudami cuts, and about 0.5 g of tea powder are combined into a tea bag form (4.5 g / bag). is there.
To use the above tea bag, put the above 3 packs (13.5g) into a pan containing 5 liters of water, boil for about 20 minutes until boiling on low heat, and then heat on low heat for 5 minutes after boiling. ·Extracted. The boiled extract was placed in hot water (150-200 l) in a domestic tub and stirred well before bathing.
Although Example 5 was prescribed to 9 people as in Example 4 and the degree of improvement was improved, the overall degree of improvement compared to that before the test of Example 5 is shown in Table 10, but “remarkably light” in 9 cases. There were 2 cases (22.2%), 5 cases (55.6%), “Slightly light”, 2 cases (22.2%), “No change”, 0 cases (0.0%). Was 77.8%, and the degree of improvement was slightly improved as compared with Example 4.
[0037]
As described in Examples 1 to 5 above, each example in which the component of tuna, which is a beach plant, is mixed as a herbal medicine having both an anti-inflammatory effect and a skin moisturizing effect of a moisturizing agent. It was confirmed that atopic dermatitis can be safely cured without using steroids with many problems.
[0038]
In addition, as long as the characteristics of the present invention are not impaired, it is needless to say that the present invention is not limited to the above-described examples. For example, in the bath preparation of Example 4, the dried tuna is cut into a length of about 2 mm. Although a crushed dry pulverizer may be used, crushed fresh leaves of tsuruna (cut material) or the crushed extract used in Example 1 may be used. In addition, cuts of jellyfish, dokudami, and tea were used, but if they are equivalent active ingredients, they may be extracted extracts as bathing agents, and these may be used alone or in combination.
[0039]
【The invention's effect】
  As explained above, according to the invention described in claim 1, the fresh leaves of tsuruna, orSoDry milling agent, orSoExtracts of these or combinations of theseWhen, Vulgaris or dokudami, or tea, or a combination of theseAnd as an active ingredient,On the skinForm a filmTo makeSince it is a dermopharmaceutical composition for atopic dermatitis, it can effectively prevent skin inflammation and function as a moisturizer without using problematic steroids. Forms a film with saccharides infiltrated into the skin, suppresses itching by enhancing the skin's moisturizing function, contributes to the regeneration of the skin, and is particularly effective for the treatment of atopic dermatitis .
  Furthermore, the effect of further suppressing the inflammation of the skin can be obtained by mixing the glutinous oak, dokudami, tea, or a combination thereof.
  Further, according to the invention described in claim 2, fresh leaves of tsuruna, orSoDry milling agent, orSoExtracts of these or combinations of theseWhen, Vulgaris or dokudami, or tea, or a combination of theseAnd as an active ingredient,On the skinForm a filmTo makeSince it is a bath preparation for atopic dermatitis, it can be used in daily bathing to safely suppress the inflammation of the skin and function as a moisturizing agent. By forming a film in a state infiltrated into the skin and enhancing the moisture retention function of the skin, itching is suppressed, contributing to the regeneration of the skin, and particularly effective for the treatment of atopic dermatitis.
  Furthermore, the effect of further suppressing the inflammation of the skin can be obtained by mixing the glutinous oak, dokudami, tea, or a combination thereof.
[Brief description of the drawings]
FIG. 1 is a graph showing changes in the degree of pruritus according to Example 1 of the present invention;
FIG. 2 is a graph showing changes in the degree of skin rash according to Example 1 of the present invention;
FIG. 3 is a graph showing changes in the degree of scratch marks in Example 1 of the present invention;
FIG. 4 is a graph showing changes in the area of skin rash according to Example 1 of the present invention;
FIG. 5 is a table 1-1 of general improvement of Example 1 of the present invention;
FIG. 6 is a table 1-2 showing the general improvement degree of Comparative Example 1;
FIG. 7 is a table 1-3 of general improvements of Example 2 of the present invention;
FIG. 8 is a table 1-4 of general improvements of Example 3 of the present invention.
FIG. 9 is a table 2-1 of final general improvement in Example 1 of the present invention;
FIG. 10 is a table 2-2 of final general improvement in Comparative Example 1.
FIG. 11 is a table 2-3 of final general improvement in Example 2 of the present invention;
FIG. 12 is a table 2-4 of final general improvement in Example 3 of the present invention,
FIG. 13 is a table 3 of overall safety levels of the first embodiment of the present invention.
FIG. 14 is a table 4-1 of usefulness of Example 1 of the present invention;
15 is a table 4-2 of usefulness of Comparative Example 1, FIG.
FIG. 16 is a table 4-3 of usefulness of Example 2 of the present invention;
FIG. 17 is a table 4-4 of usefulness of Example 3 of the present invention;
FIG. 18: Table 5 for comparison of skin eruption scores for Example 4 of the present invention,
FIG. 19 is a table 6 of sites of skin eruption in Example 4 of the present invention;
FIG. 20 is a table 7 of skin conductance of Example 4 of the present invention.
FIG. 21 is a table 8 showing the general improvement degree of Example 4 of the present invention.
FIG. 22 is a table 9 for determining usefulness of Example 4 of the present invention.
FIG. 23 is a table 10 showing general improvements in Example 5 of the present invention.

Claims (2)

Leaves of Crna, or its dry grinding agent, or its the extract, or as a combination thereof, Quercus salicina, or Houttuynia cordata, or tea, or containing as a combination thereof as an active ingredient, a film on the skin dermopharmaceutical composition for dermatitis - atopic for forming. Leaves of Crna, or its dry grinding agent, or its the extract, or as a combination thereof, Quercus salicina, or Houttuynia cordata, or tea, or containing as a combination thereof as an active ingredient, a film on the skin bath agents for dermatitis - atopic for dermatitis - atopic for forming.

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