External medicine for treating atopic dermatitis of infants

Abstract

The invention relates to an external medicine for treating atopic dermatitis of infants, which is composed of active ingredients and medically acceptable auxiliary materials, and is characterized in that the active ingredients are prepared from the following raw material medicines in percentage by weight: 18.8-22.9% of perfoliote knotweed herb, 10.0-12.2% of Chinese arborvitae twig and leaf, 6.3-7.6% of folium artemisiae argyi, 12.5-15.3% of rhizoma polygonati, 10.0-12.2% of giant knotweed rhizome, 10.0-12.2% of cortex lycii radicis, 6.3-7.6% of peach kernel and 10.0-12.2% of fineleaf schizonepeta herb, and 6.3-7.6% of licorice root. The external medicine has a remarkable effect on treating atopic dermatitis of infants.

Description

Technical Field

[0001] The invention relates to a medical preparation, in particular to a medicine containing an undetermined structure from traditional Chinese medicine. The medicine is suitable for treating atopic dermatitis in infants and young children. Background Art

[0002] Atopic dermatitis (AD) is a chronic, recurrent, and refractory skin disease with a genetic tendency that is common in infants and young children. It manifests as recurrent severe skin itching and eczema-like changes, often combined with other atopic diseases such as allergic rhinitis and asthma, accompanied by increased blood eosinophils and IgE. Epidemiological surveys show that the global prevalence of AD is increasing year by year, affecting about 15-30% of children and 2-10% of adults worldwide. The prevalence of AD in China has increased rapidly in the past 10 years. In 2002, the total prevalence of AD in children aged 1 to 7 years in 10 cities in my country was 2.78%; in 2014, the prevalence of AD in children aged 1 to 7 years in 12 cities in my country was 12.94%; in 2019, a study of 5,967 infants under 1 year old in multiple cities in China showed that the overall prevalence of AD had reached 30.48%. The course of the disease is lingering and difficult to cure. It causes long-term and repeated discomforts such as itching, rash, disfigurement, and side effects, which seriously affect the growth and development and physical and mental health of children. The more severe the disease is, the greater the negative impact on the physical, emotional, social and economic components of family life. Therefore, it is of great significance to study the pathogenesis and treatment measures of AD.

[0003] AD is a chronic relapsing skin disease. The main goal of treatment is to steadily control the disease and reduce recurrences. Western medicine uses local emollients and corticosteroids, systemic photochemotherapy, hormones, immunosuppressants, and biological agents to temporarily relieve the patient's condition, but there are certain toxic side effects. AD usually occurs in early infancy, with symptoms as early as the second month after birth and reaching a peak in the third month. It has a great impact on the physical and mental health and growth and development of infants and young children. However, most of the drugs available in the current step-by-step treatment guidelines for AD are not suitable for infants and young children. Hormone topical preparations are still the preferred treatment method. Long-term topical use of hormones can lead to side effects such as skin atrophy, capillary dilation, pigmentation spots, and hirsutism. Even systemic absorption affects the growth and development of children. The relapse rate is high after discontinuation of the drug, and family members have poor compliance with the use of the drugs due to fear of side effects. Calcineurin inhibitors (tacrolimus, pimecrolimus) and small molecule PDE-4 inhibitors (crisborole) are indicated for children over 2 years old. There has been no long-term safety assessment for their use in infants and young children under 2 years old. Early use has side effects of burning and itching. Long-term topical use can increase the risk of skin infection. The cost is expensive (10-15 grams of ointment is about 125-400 yuan), and the efficacy is not satisfactory.

[0004] Atopic dermatitis belongs to the category of "milk ringworm", "wet sore" and "four-bend wind" in traditional Chinese medicine. Traditional Chinese medicine believes that its onset is caused by congenital intolerance, fetal toxicity and residual heat, and acquired disorders, spleen dysfunction, endogenous dampness and heat, and rheumatism and heat evil, which accumulate in the skin; or repeated attacks, long-term illness, consumption of yin fluid, insufficient blood, blood deficiency, wind and dryness, and skin malnutrition. Traditional Chinese medicine syndrome differentiation and external treatment of infantile dermatitis and eczema has a long history, with the advantages of positive efficacy, few adverse reactions, and easy acceptance by children and their families. Traditional Chinese medicine has its own characteristics and advantages in the treatment of AD, and has attracted widespread attention from scholars at home and abroad. Sheehan et al. have published clinical randomized controlled trials of traditional Chinese medicine treatment of AD in journals such as The Lancet and the British Journal of Dermatology, indicating that its efficacy is encouraging. Traditional Chinese medicine treatment is an optional treatment method, and the application of traditional Chinese medicine treatment can reduce the use of glucocorticoids. In recent years, the research and development of traditional Chinese medicine external preparations for infants and young children has been the focus and hot spot of AD research. Previous studies have shown that Chinese herbal medicines for external use are relatively safe and have a broad application space and market for relieving acute attacks of skin lesions and reducing recurrence of skin lesions. However, Chinese herbal medicines for external use are mostly composed of Chinese medicines for clearing heat, promoting dampness and detoxifying, and clinical reports are mostly case studies and experience. There is no in-depth discussion of their mechanisms of action such as repairing the skin barrier and regulating skin flora. Therefore, in-depth research on Chinese herbal medicines for external use that are simple, inexpensive, effective and safe for the clinical treatment of AD in infants and young children is very necessary. Summary of the invention

[0005] The purpose of the present invention is to provide an external medicine for treating atopic dermatitis in infants and young children, and the external medicine has a significant effect in treating atopic dermatitis in infants and young children.

[0006] The technical solution of the present invention to solve the above problems is as follows:

[0007] An external medicine for treating infantile atopic dermatitis, the external medicine is composed of an effective ingredient and a medically acceptable auxiliary material, characterized in that the effective ingredient is made of the following raw materials in percentage by weight:

[0008] Radix Angelicae Pubescentis 18.8-22.9%, Platycladus orientalis leaves 10.0-12.2%, Artemisia argyi 6.3-7.6%, Polygonatum sibiricum 12.5-15.3%, Polygonum cuspidatum 10.0-12.2%, Rehmannia glutinosa 10.0-12.2%, Peach kernel 6.3-7.6%, Schizonepeta tenuifolia 10.0-12.2%, Licorice root 6.3-7.6%.

[0009] The external-use medicine of the present invention, wherein the optimal ratio of the raw materials is:

[0010] Radix Angelicae Pubescentis 21.0%, Platycladus orientalis leaves 11.1%, Artemisia argyi 6.9%, Polygonatum sibiricum 13.9%, Polygonum cuspidatum 11.1%, Rehmannia glutinosa 11.1%, Prunus persica 6.9%, Schizonepeta tenuifolia 11.1%, and Licorice 6.9%.

[0011] The external-use medicine of the present invention, wherein the effective ingredient is prepared by the following method:

[0012] The external medicine of the present invention is characterized in that the active ingredient is added with an appropriate amount of medically acceptable auxiliary materials and prepared into an external washing liquid or granular washing agent according to a conventional method.

[0013] The prescription of the external medicine of the present invention is composed of 9 raw materials. Radix Angelicae Pubescentis, also known as Polygonum aviculare, is sour and bitter in taste and has a flat nature. It has the functions of clearing away heat and detoxicating, promoting dampness and reducing swelling, and is the main medicine; Polygonatum sibiricum, Platycladus orientalis and Artemisia argyi are all ministerial medicines, among which Platycladus orientalis is bitter and astringent in taste and cold in nature, and enters the lung, liver and spleen meridians, and has the functions of cooling blood and eliminating spots, dispelling wind and reducing swelling, and is used together with Radix Angelicae Pubescentis, Artemisia argyi is pungent and bitter in taste and warm in nature, and can eliminate dampness and relieve itching; Radix Polygoni Cuspidati, Cortex Lycii, Semen Persicae, and Herba Schizonepetae are all adjuvants, and Radix Polygoni Cuspidati is slightly bitter and cold, and helps the main medicine Radix Angelicae Pubescentis strengthen clearing heat and detoxicating and promoting dampness, Cortex Lycii helps Platycladus orientalis strengthen clearing heat and cooling blood and eliminating spots, Herba Schizonepetae relieves exterior wind and relieves itching, and Herba Peaches promotes blood circulation, removes blood stasis and moisturizes dryness; and Radix Licoricee is used as a guiding medicine to harmonize the various medicines. The various medicines are combined to play the functions of clearing heat and promoting dampness and detoxicating, cooling blood and removing wind and moisturizing dryness.

[0014] The therapeutic effect of the drug of the present invention on infantile atopic dermatitis can be further confirmed by the following experimental studies.

[0015] 1. Clinical Research

[0016] 1. Research content and methods: A total of 45 infants and young children with mild to moderate AD who visited the Dermatology Clinic of Guangdong Provincial Hospital of Traditional Chinese Medicine from February 2023 to December 2023 were collected and randomly divided into an experimental group and a placebo control group, with 28 people in the experimental group and 17 people in the placebo control group.

[0017] 2. Inclusion criteria: ① Age: infants and young children aged 6 to 36 months, regardless of gender; ② Meet the Hanifin & Rajka or Williams diagnostic criteria; ③ Meet mild to moderate AD, with an EASI score between 0 and 20 points; ④ No systemic use of antibiotics, antifungal drugs, glucocorticoid drugs, or immunosuppressants in the past month, and no local treatment except emollients within 1 week; ⑤ The family members of the child signed a written informed consent.

[0018] 3. Exclusion criteria: ① Combined with other skin diseases or clear signs of infection; ② Combined with other cardiopulmonary and neurological diseases.

[0019] 4. Grouping method: This study adopted the block randomization method. According to the block randomization method, the included subjects were randomly assigned to the experimental group and the placebo control group at a ratio of 2:1. The TCM Clinical Research Methodology Team of Guangdong Provincial Hospital of Traditional Chinese Medicine used SAS V9.4 software to complete the program writing and randomization operation to determine the grouping of the subjects. Neither the subjects nor the researchers could know or choose any treatment method in advance.

[0020] 5. Treatment plan: For the children in the experimental group, the external wash solution of Example 1 below was given for bathing and external washing treatment. The specific treatment method was to use 37°C warm water to dissolve and dilute the solution and then bathe and wash the whole body. Children with facial lesions used a wet towel to soak the solution for facial wet compress and cleaning, once a day, 10-15 minutes each time, for 2 consecutive weeks. For the children in the placebo control group, a placebo (the active ingredient in the external wash solution of Example 1 below was omitted) was given for bathing and external washing treatment, and the use method was the same as that of the experimental group.

[0021] Health education was provided to each patient and their family members. The patients were asked about their allergy history, diet, and gastrointestinal function in detail. Health brochures were distributed, and guidance on daily life and skin lesion care was provided. All oral medications such as hormones, immunosuppressants, antibiotics, and traditional Chinese medicine were avoided during medication.

[0022] 6. Efficacy evaluation: Two experienced physicians will evaluate and record the EASI score, and a dedicated person will record the severity of the target lesions (erythema, edema / infiltration / papule, scratches, exudation / scab, scaling / dry skin sign, lichenification) and take photos to record the lesion manifestations. Follow-up will be conducted on days 0, 3, 7, and 14 after treatment and the EASI score will be recorded. The target lesion severity score will be recorded again on days 7 and 14 after treatment. The clinical efficacy will be evaluated based on the improvement rate of the EASI score. EASI score improvement rate (%) = (EASI score before treatment - EASI score at the end of 2 weeks of treatment) / EASI score before treatment × 100%, which is divided into three levels: clinical cure, marked effect, improvement, and ineffectiveness: ① Clinical cure: EASI score improvement rate ≥ 90%; ② Marked effect: EASI score improvement rate 70% to 90%; ③ Improvement: EASI score improvement rate 30% to 70%; ④ Ineffectiveness: EASI score improvement rate less than 30%. Total effective rate = (number of patients cured + markedly effective + improved) / total number of patients in each group.

[0023] 7. Statistical methods

[0024] The data in this study were analyzed using SPSS 25.0 statistical software. The measurement data were first tested for normality. If they met the normal distribution, the measurement data were Indicates, otherwise M(P 25 , P 75) description. For two groups of measurement data: variance homogeneity test was performed for measurement data that met normal distribution. If normal distribution and variance homogeneity were met, independent sample t test or paired sample t test was used. If normal distribution was met but variance homogeneity was not met, corrected t test was used. For measurement data with non-normal distribution, Mann-Whitney U test or paired Wilcoxon test was used. For multiple groups of measurement data: if normal distribution and variance homogeneity were met, completely randomized ANOVA was used. If the results were statistically significant, LSD test was used for pairwise comparison; if normal distribution was not met or variance homogeneity was not met, Kruskal-Wallis rank sum test was used for analysis. If the results were statistically significant, LSD test was used for pairwise comparison. P<0.05 was considered statistically significant.

[0025] 8. Results

[0026] Observation on the clinical efficacy of the topical drugs described in this application

[0027] The clinical efficacy and effective rate of the two groups are shown in Table 1. In the experimental group, 3 cases were cured, 6 cases were markedly effective, 15 cases were improved, 4 cases were ineffective, and the total effective rate was 85.71%; in the placebo control group, 0 cases were cured, 1 case was markedly effective, 7 cases were improved, 9 cases were ineffective, and the total effective rate was 47.06%.

[0028] Table 1 Clinical efficacy and effective rate of the experimental group and the placebo control group

[0029]

[0030] Note: Chi-square test, X2=4.255, P=0.039, P<0.05, agreeing with H1 hypothesis, the total effective rate is statistically significant.

[0031] In this study, the target lesion severity score was used as a secondary evaluation index for treatment efficacy. The comparison of the target lesion severity scores at baseline and follow-up observation time points is shown in Tables 2 and 3. Figure 1 At baseline, the target lesion severity score P 25 =6.13 points, P 75 =10.00 points, the target lesion severity score of the placebo control group P 25 =5.50 points, P 75=8.50 points. After Mann-Whitney U test, there was no significant difference in the target lesion severity scores between the two groups at baseline (P=0.158). On the 3rd, 4th and 14th days after treatment, the target lesion severity scores of the two groups were shown in Table 3. There was no significant difference in the scores between the two groups at different observation time points (P=0.787, 0.525, 0.120). Combined with the box plot, the target lesion severity scores of the experimental group and the placebo control group decreased after treatment, and the decrease in the experimental group was greater. The latter three observation time points were all lower than the placebo control group, proving that the topical medication described in this application has better efficacy.

[0032] Table 2 Comparison of baseline target lesion severity scores between the two groups

[0033]

[0034] Note: Shapiro-Wilk normality test was used. The target lesion severity score of the placebo control group did not conform to the normal distribution at baseline, so the non-parametric Mann-Whitney U test was used to test whether there was any difference in the target lesion severity score between the two groups.

[0035] Table 3 Comparison of target lesion severity scores between the two groups at different observation times

[0036]

[0037] Note: Shapiro-Wilk normality test was used. The target lesion severity scores of the placebo control group on D7 and the target lesion severity scores of the two groups on D14 did not conform to the normal distribution. Therefore, the non-parametric Mann-Whitney U test was used to test whether there was any difference in the target lesion severity score between the two groups.

[0038] The comparison results of the severity of target lesions in the two groups before and after treatment are shown in Table 4. There was a significant difference in the target lesion severity score before and after treatment in the experimental group (P=0.000), and the severity of target lesions after treatment was significantly lower than that before treatment; while there was no significant difference in the score before and after treatment in the placebo control group (P=0.057), and the therapeutic effect was not good. It can be seen that the topical medication described in this application can improve the rash state.

[0039] Table 4 Comparison of target lesion severity scores before and after treatment between the experimental group and the placebo control group

[0040]

[0041] Note: The results of Shapiro-Wilk normality test were the same as above. Non-parametric paired Wilcoxon test was used to test whether there were any differences between the two groups before and after treatment.

[0042] 2. Animal Experiments

[0043] 1. Experimental Animals

[0044] A total of 24 SPF 6-8 week old BALB / c mice, 18-22 g, female, were provided by Guangdong Medical Experimental Animal Center.

[0045] 2. Experimental Grouping

[0046] 24 mice were divided into blank group, model group, positive group, experimental group 1 and experimental group 2, including 4 mice in the blank group and 5 mice in each of the other groups.

[0047] 3. Experimental Methods

[0048] 3.1 Rearing conditions

[0049] All mice were housed in the animal room of the Experimental Animal Center of the School of Biomedicine of Guangdong University of Technology. The indoor temperature of the animal room was maintained between 20-25℃, the humidity was 45-65%, and a 12-hour light / dark cycle lighting system was used. The mice were allowed to eat and drink freely for 24 hours. The experiment was carried out after 1-2 weeks of adaptive feeding.

[0050] 3.2 Model construction

[0051] On Day 1, the hair on the back of BALB / c mice was removed. On Day 3, the model was established by applying 100 μl of 0.15% 2,4-dinitrofluorobenzene (DNFB) on the back, and the blank group was applied with acetone olive oil (v:v=3:1). The application was repeated once on Day 7, for a total of two times; on Day 10, the stimulation was started by applying 100 μl of 0.2% DNFB on the back, and again on Day 13, for a total of two times, to establish the atopic dermatitis model.

[0052] 3.3 Administration

[0053] Drug administration began on Day 3. The blank group was coated with acetone olive oil (acetone volume: olive oil volume = 3:1), the model group was coated with acetone olive oil (acetone volume: olive oil volume = 3:1) plus 0.15% DNFB, the experimental group 1 was coated with the external wash of Example 1 (0.5 g crude drug / ml), the experimental group 2 was coated with the external wash of Example 2 (0.5 g crude drug / ml), and the control group was coated with dexamethasone, once a day for a total of 14 days.

[0054] 3.4 Observation

[0055] The back skin of BALB / c mice was photographed every day and the degree of skin lesions was scored. The transepidermal water loss of the back skin of mice was measured every three days using a transepidermal water loss meter.

[0056] 3.5 Collection of materials

[0057] Day 17 The experiment ended, and the body weight was recorded, photos of the back skin were taken, and transepidermal water loss was measured. The mice were then killed. Blood was collected by removing the eyeballs, and the blood was left to stand at room temperature for 2 hours. The blood was centrifuged at 1500g for 15 minutes at room temperature. The serum was divided into two tubes and stored at -80℃. The back skin was taken, and the local skin of the same part (about 2*2cm 2 The skin was fixed in tissue fixative (4% paraformaldehyde) and the remaining skin was stored at -80℃ for later use.

[0058] 3.6 Index detection

[0059] 3.6.1 Conventional indicator testing:

[0060] Skin lesion score, transepidermal water loss (TEWL), body weight, and back skin thickness.

[0061] 3.6.2ELISA test

[0062] Enzyme-linked immunosorbent assay (ELISA) was used to detect tissue immune factors and chemokines (IL-4, IL-6, IL-31, INF-γ), serum IgE, endothelin-1 (ET-1), vascular endothelial growth factor 4 (VGEF4), capsaicin receptor (Transient Receptor Potential Vanilloid 1, TRPV1), etc.

[0063] 3.7 Data Processing

[0064] Statistical analysis was performed using IBM SPSS Statistics 25.0. Indicates. If the variances are equal, one-way ANOVA is used, and the LSD test is used for multiple comparisons between groups. If the variances are unequal, the Welch-ANOVA test is used, and the Tamhane T2 test is used for multiple comparisons between groups. If the normal distribution is not satisfied, the nonparametric Kruskal-Wallis test is used, and the inter-group comparison is corrected by the Bonferroni test. Repeated measures ANOVA is used for the measurement data of paired samples. The Friedman test is used for comparison of the measurement data of skewed distribution at different time periods, and the Bonferroni test is used for correction. P<0.05 indicates that the difference is statistically significant.

[0065] 4. Animal experiment results:

[0066] 4.1 Changes in mouse body weight and transepidermal water loss

[0067] The body weight of mice in the model group and the positive group was significantly lower than that in the blank group (P < 0.05), and the body weight of mice in the experimental group was higher than that in the model group and the positive group (P < 0.05, P < 0.01). The TEWL of mice was detected on days 0, 7, 10, and 13. The TEWL of the skin increased significantly during the modeling process. There was a significant statistical difference between the blank group and the model group (P < 0.05). The positive group and the experimental group could inhibit the increase of TEWL, but there was no statistical significance (P > 0.05).

[0068] Table 5 Body weight of mice in each group

[0069]

[0070] Note: The normality test results showed that each group followed a normal distribution (P>0.05); the variance homogeneity test indicated that the variance was homogeneous (P>0.05). The inter-group comparison was performed using the LSD (Least-Significant Difference) test. Compared with the blank group, *P<0.05, **P<0.01; compared with the model group, # P<0.05, ## P<0.01; compared with the positive group, ※※ P<0.01, ※※※ P<0.01.

[0071] Table 6 Skin TEWL levels in each group

[0072]

[0073] Note: The normality test results showed that each group followed a normal distribution (P>0.05); the variance homogeneity test indicated that the variance was homogeneous (P>0.05). The LSD (Least-Significant Difference) test was used for inter-group comparison. Compared with the blank group, ***P<0.001.

[0074] 4.2 Efficacy of the topical drug described in this application on skin lesions in atopic dermatitis mouse model

[0075] In this study, a DNCB-sensitized mouse model of atopic dermatitis was used. Its skin lesions and pathological characteristics are very close to those of human atopic dermatitis. Compared with the model group, after the application of the experimental drug, the erythema and scaling symptoms of the mouse back skin were alleviated, and the skin lesions became thinner; the back skin thickness and skin lesion scores of the model group mice were significantly increased compared with those of the normal control group (P < 0.05); the back skin thickness of the experimental group was significantly reduced (P < 0.05), and was significantly lower than that of the positive group, and the difference was statistically significant (P < 0.05); the skin lesion score of the positive group was significantly reduced (P < 0.05), but the reduction in the back skin thickness was not obvious (P > 0.05).

[0076] Table 7 Skin thickness of each group

[0077]

[0078] Note: The normality test results showed that each group followed a normal distribution (P>0.05); the variance homogeneity test indicated that the variance was homogeneous (P>0.05). The inter-group comparison was performed using the LSD (Least-Significant Difference) test. Compared with the blank group, ***P<0.001; compared with the model group, ## P<0.01, ### P<0.001; compared with the positive group, ※ P<0.05, ※※ P<0.01.

[0079] 4.3 Effects of experimental drugs on cytokines and serum IgE in atopic dermatitis mouse model

[0080] ELISA was used to detect the levels of various cytokines in the back skin of mice and IgE in serum. It was found that the levels of IL-4, IL-6, IL-31, IFN-γ, IgE, VEGF4, and TEWL in the model group were significantly higher than those in the blank group (P < 0.05), while the levels of ET-1 and TRPV1 were not significantly higher. Compared with the model group, the high-concentration group and the low-concentration group could significantly reduce the expression of IL-4, IL-31, IFN-γ, and total IgE in the serum of mice after treatment, and the difference was statistically significant (P < 0.05). The experimental group could reduce the levels of IL-6 and VEGF4 in the serum, but the difference was not statistically significant (P > 0.05). There was no significant difference in the expression of IL-4, IL-6, and IFN-γ in the serum of the experimental group and the positive group. There was no significant difference in total IgE between the low-concentration group and the positive group (P>0.05); compared with the model group, the positive group could also significantly reduce the expression of IL-4, IL-31, IFN-γ, and total IgE in the mouse serum, and the difference was statistically significant (P<0.05). The positive group could reduce the expression of IL-6 and VEGF4 in the serum, but the difference was not statistically significant (P>0.05).

[0081] Table 8 Serum IL-4, IL-31, IFN-γ, and total IgE levels in each group

[0082]

[0083]

[0084] Note: The normality test results showed that each group followed a normal distribution (P>0.05); the variance homogeneity test indicated that the variance was homogeneous (P>0.05). The inter-group comparison was performed using the LSD (Least-Significant Difference) test. Compared with the blank group, **P<0.01, ***P<0.001; compared with the model group, # P<0.05, ## P<0.01, ### P<0.001, compared with the positive group, ※※ P<0.01.

[0085] Conclusion

[0086] This study evaluated the clinical efficacy and safety of the topical medication described in this application for the treatment of atopic dermatitis in infants and young children. The results of the study showed that the topical medication described in this application can improve the clinical symptoms of children with an effective rate of 85.71%, which is safe to use, and the total effective rate of the placebo group is 47.06%. The results of animal experiments showed that the experimental drug can significantly improve the severity of skin lesions in mice and reduce the thickness of the back skin, which is better than the dexamethasone-positive group, confirming its clinical efficacy. The mechanism of action of the topical medication described in this application may be through reducing the expression of IL-4, IL-31, IFN-γ, and total IgE. Compared with the dexamethasone-positive group, there is no significant difference between the two. BRIEF DESCRIPTION OF THE DRAWINGS

[0087] Figure 1 This is a box plot of the target skin lesion severity scores before and after treatment in the experimental group and the placebo control group. The control group in the legend is the placebo control group. In the figure, the ordinate is the target skin lesion severity score; the abscissa is the treatment time. DETAILED DESCRIPTION

[0088] Example 1 (external wash solution)

[0089] 1. Prescription:

[0090] 15g of Radix Angelicae Pubescentis, 8g of Platycladus orientalis leaves, 5g of Artemisia argyi, 10g of Polygonatum sibiricum, 8g of Polygonum cuspidatum, 8g of Rehmannia glutinosa, 5g of Peach Kernel, 8g of Schizonepeta tenuifolia, and 5g of Licorice.

[0091] 2. Preparation method:

[0092] (1) Take the above raw materials, add 1500 ml of water, and boil twice, each time for 2 hours;

[0093] (2) Combine the two decoctions, filter, and obtain 288 ml of Chinese medicine solution.

[0094] Example 2 (external wash solution)

[0095] 1. Prescription:

[0096] 16.5g of Radix Angelicae Pubescentis, 8.4g of Platycladus orientalis leaves, 5.0g of Artemisia argyi, 9.5g of Polygonatum sibiricum, 7.3g of Polygonum cuspidatum, 7.2g of Rehmannia glutinosa, 4.8g of Peach Kernel, 8.0g of Schizonepeta tenuifolia, and 5.3g of Licorice root.

[0097] 2. Preparation method:

[0098] (1) Take the above raw materials, add 1500 ml of water, and boil twice, each time for 2 hours;

[0099] (2) Combine the two decoctions and filter to obtain 144 ml of Chinese medicine solution.

[0100] Example 3 (external wash solution)

[0101] 1. Prescription:

[0102] 13.5g of Radix Angelicae Pubescentis, 7.6g of Platycladus orientalis leaves, 5.0g of Artemisia argyi, 10.5g of Polygonatum sibiricum, 8.7g of Polygonum cuspidatum, 8.8g of Rehmannia glutinosa, 5.2g of Peach Kernel, 8.0g of Schizonepeta tenuifolia, and 4.7g of Licorice.

[0103] 2. Preparation method:

[0104] (1) Take the above raw materials, add 1500 ml of water, and boil twice, each time for 2 hours;

[0105] (2) Combine the two decoctions, filter, and obtain 288 ml of Chinese medicine solution.

[0106] Example 4 (granular detergent)

[0107] 1. Prescription:

[0108] 15g of Radix Angelicae Pubescentis, 8g of Platycladus orientalis leaves, 5g of Artemisia argyi, 10g of Polygonatum sibiricum, 8g of Schizonepeta tenuifolia, 8g of Polygonum cuspidatum, 8g of Rehmannia glutinosa, 5g of Peach Kernel, and 5g of Licorice.

[0109] 2. Preparation method:

[0110] (1) Take slices of Radix Angelicae Pubescentis, Platycladus orientalis, Artemisia argyi, Polygonatum sibiricum, Polygonum cuspidatum, Cortex Lycii, Semen Persicae, and Radix Glycyrrhizae, add water and boil, filter, concentrate the filtrate into a clear paste, dry, add appropriate amount of auxiliary materials, and mix well.

[0111] (2) Take slices of Schizonepeta tenuifolia, add water and boil, collect an appropriate amount of volatile oil (encapsulate with an appropriate amount of β-cyclodextrin for later use), filter, concentrate the filtrate into a clear paste, add the volatile oil inclusion compound, dry, add an appropriate amount of auxiliary materials, and mix well.

[0112] (3) Take the extracts obtained in steps (1) and (2), mix them and prepare a granular lotion.

Claims

1. An external medicine for treating atopic dermatitis in infants and young children, the external medicine comprising an effective ingredient and a medically acceptable auxiliary material, characterized in that: The active ingredients are made from the following raw materials in percentage by weight: Radix Angelicae Pubescentis 18.8-22.9%, Platycladus orientalis leaves 10.0-12.2%, Artemisia argyi 6.3-7.6%, Polygonatum sibiricum 12.5-15.3%, Polygonum cuspidatum 10.0-12.2%, Rehmannia glutinosa 10.0-12.2%, Peach kernel 6.3-7.6%, Schizonepeta tenuifolia 10.0-12.2%, Licorice root 6.3-7.6%.

2. The external-use medicine for treating atopic dermatitis in infants and young children according to claim 1, characterized in that: The active ingredients are made from the following raw materials in percentage by weight: Radix Angelicae Pubescentis 21.0%, Platycladus orientalis leaves 11.1%, Artemisia argyi 6.9%, Polygonatum sibiricum 13.9%, Polygonum cuspidatum 11.1%, Rehmannia glutinosa 11.1%, Prunus persica 6.9%, Schizonepeta tenuifolia 11.1%, and Licorice 6.9%.

3. The external-use medicine for treating atopic dermatitis in infants and young children according to claim 1 or 2, characterized in that: The external medicine is an external washing liquid or a granular washing agent.

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