External traditional Chinese medicine composition for outdoor protection of infants and children and preparation method of external traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of nursing products, and particularly discloses an external traditional Chinese medicine composition for outdoor protection of infants and children and a preparation method thereof, and the external traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 20-400 parts of centella asiatica, 30-400 parts of calendula officinalis, 30-400 parts of chamomile, 10-300 parts of artemisia apiacea and 7-400 parts of cactus. According to the external traditional Chinese medicine composition provided by the invention, by optimizing the components of substances and based on the compatibility principle of monarch, minister, assistant and guide, the components are simple, the medication is safe, and the external traditional Chinese medicine composition has multiple effects of preventing mosquitoes, relieving itching and relieving and is high in safety; according to the preparation method provided by the invention, enzymolysis, countercurrent extraction and ultrasonic-assisted extraction are taken as main processes, and the preparation process is optimized, so that the extracted effective components are more, and the extraction efficiency is high.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of nursing products, and particularly relates to an external use traditional Chinese medicine composition for outdoor protection of infants and children and a preparation method thereof. BACKGROUND

[0002] With the deepening of the concept of "delicate parenting" and "scientific parenting", the new generation of parents represented by the post-85s and post-90s are promoting the transformation of the infant and child care market from "function satisfaction" to "quality demand". They not only pay attention to basic cleaning and nursing, but also build a professional parenting knowledge system through component research, efficacy verification, safety traceability and other dimensions - from passive acceptance of product information to active interpretation of ingredient tables, inquiry of raw material sources and comparison of third-party test reports "component experts". In product selection, they show strong preference for "traceable certified raw materials", "visualization of efficacy mechanism" and "clinical verification endorsement", and are willing to pay a premium for high-quality products that combine safety, effectiveness and use experience. Data shows that infant and child skin care products containing natural plant extracts and dermatological tests have led the market growth in recent years, confirming the deepening of the trend of scientific care.

[0003] Contemporary parenting concepts encourage children to get close to nature through outdoor activities such as camping, hiking, picnicking and mountaineering, but the complex outdoor environment poses multiple threats to the skin of infants and children, ultraviolet rays cause erythema and sunburn, mosquito bites may induce contact dermatitis, wind-dryness, temperature difference, dust and other factors exacerbate the burden on the skin barrier. Infants and children are more prone to dryness, sensitivity, allergy and other problems due to thin keratin layer and less sebum secretion.

[0004] Market research shows that more than 60% of parents prefer "multi-effect in one" when purchasing outdoor care products, expecting to meet the needs of sun protection, mosquito repellent, soothing, repair and other needs at the same time, but existing products often have difficulty in balancing efficacy and mildness due to the irritability of chemical sunscreens and the safety of mosquito repellent ingredients, prompting the development of professional infant and child outdoor protection raw materials.

[0005] In view of the characteristics of infant and child skin "physiological barrier weakness and pathological reaction sensitivity", it is an important innovation direction to excavate safe and effective protection solutions from the treasure trove of traditional Chinese medicine. According to traditional Chinese medicine theory, infant and child skin belongs to "youthful yin and yang", and nursing should follow the concept of "preventive treatment", with the core of mild conditioning and strengthening the skin's own resistance, avoiding excessive dependence on chemical synthetic ingredients. Design an integrated infant and child outdoor protection composition with "protection-soothing-repair" to achieve systematic defense against multiple outdoor threats.

[0006] In the prior art, patent document CN118948685A provides a kind of infant protection milk and its application, and the protection milk includes the following components: 58%~62% water, 0.01%~0.1% polyaspartic acid sodium, 4~6% glycerol, 0.5~0.6% p-hydroxyacetophenone, 0.5~0.6% 1,2-hexanediol, 0.01~0.05% sodium hyaluronate, 0.15~0.3% (acrylate) class / C10-30 alkanol acrylate cross-linked polymer, 0.5~1.8% PEG-100 stearate, 0.5~1.8% glycerol stearate, 10~15% petrolatum, 3~5% avocado butter, 2~4% cetyl stearyl alcohol, 6~10% ethylhexyl palmitate, 0.5~2% polydimethylsiloxane, 0.15~0.3% arginine, 0.05~0.5% extract of chondrus, 0.01~0.02% extract of radix sophorae flavescens, 0.01~0.02% extract of radix scrophulariae, 0.01~0.02% extract of radix glycyrrhizae, 0.001~0.005% bisabalol, 0.1~0.15% hexyldecanol, 0.04~0.1% citrus fruit extract, 0.001~0.01% extract of gentiana. When the above product is used, the exposed parts of the hands and feet of infants are uniformly coated, comfortable and non-irritating, and have the effects of moisturizing and repairing. Although the above document mentions repairing and moisturizing, it focuses more on the mosquito repellent effect, and there is no clear evidence to support the repairing and moisturizing effects.

[0007] In view of this, the present application is proposed. SUMMARY

[0008] To solve the above technical problems, the present application provides an external use traditional Chinese medicine composition for outdoor protection of infants and children and a preparation method thereof. The external use traditional Chinese medicine composition has the effects of mosquito repellent, itching relief, soothing and repair, has definite curative effect, small side effects and high safety.

[0009] To achieve the above-mentioned purposes, the present application adopts the following technical solutions: In a first aspect, the present application provides an external use traditional Chinese medicine composition for outdoor protection of infants and children, which is prepared from the following raw materials in parts by weight: 20~400 parts of centella asiatica, 30~400 parts of calendula officinalis, 30~400 parts of chamomile, 10~300 parts of artemisia annua, and 7~400 parts of cactus.

[0010] Infants and children have thinner stratum corneum and less sebum secretion, so their barrier function is not perfect and they are more susceptible to bacteria, foreign substances and other external factors. At the same time, the stratum corneum is thinner than that of adults and more fragile, and has weaker defense ability to the external environment and stronger permeability. When children go outdoors (camping, hiking, outdoor play, etc.), they are exposed to nature and also to more complex outdoor environments (ultraviolet light, mosquitoes, plant irritation, etc.). After outdoor activities, the skin is prone to redness, itching, dryness, and other problems due to sun exposure, mosquito bites, sweat, etc. Therefore, after-sun repair and after-bite itching relief products are essential. Multi-effect protection is the trend, and products with multiple functions such as after-sun repair, mosquito repellent, moisturizing, and soothing are more attractive. The design of a "protection-soothing-repair" integrated composition, such as the scientific compounding of sunscreen components (physical sunscreen + traditional Chinese medicine light protection ingredients), anti-allergy components (natural antihistamine substances), and repair components (lipid-like imitation components), can achieve systematic defense against multiple threats outdoors. In the technical solution provided by the present invention, the design idea is to take protection as the core, soothing and repair as the wings, and at the same time consider the tolerance of children's delicate skin, to achieve the effect of prevention and care integration. The overall function of the formula is positioned to protect infants and children from mosquito bites, sunburn, plant scratches, and dryness and rash in outdoor activities.

[0011] Specifically, in the above technical solution, the monarch herb Artemisia annua has dual cores of mosquito repellent protection and multi-effect repair. Artemisia annua (containing artemisinin extracted from Artemisia annua) can interfere with the olfactory system of mosquitoes with its unique volatile odor, preventing bites from the source. Its core component artemisinin, which is highly effective in combating malaria, helped the Tu Youyou team win the Nobel Prize in Physiology or Medicine in 2015, and became the "Chinese miracle herb" known worldwide. In the field of skin care, Artemisia annua extract can repair the barrier, soothe redness and itching, and improve dryness, desquamation, redness, and pain, etc. It has the functions of repairing the skin and safe soothing.

[0012] Artemisia annua is bitter, pungent, and slightly cold, with a special aroma, and has activities such as anti-malaria, anti-virus, anti-tumor, anti-arrhythmia, heat-clearing and heat-clearing. There are folk methods of using Artemisia annua to repel mosquitoes. The mosquito-repelling mechanism of Artemisia annua extract may be that volatile oil components in the extract volatilize in the surrounding air to form aerosols, thereby forming an effective repellent space that mosquitoes avoid.

[0013] The ministerial medicine aloe and cactus strengthen the effect of anti-allergy and relieving itching, and soothing and protecting. Aloe has good soothing and astringent ability, and can quickly relieve redness and itching after outdoor abrasions and mosquito bites, prevent scratching and infection, and promote the healing of minor wounds, and is a "natural calming agent" for emergency repair of the skin. Cactus extract focuses on moisturizing and protection, and can form a breathable protective film on the surface of the skin, lock in moisture and enhance tolerance, and cope with dry discomfort caused by wind and sun. Its anti-inflammatory mechanism has significant effects on acute and chronic inflammation by inhibiting capillary permeability and improving macrophage activity, and has multiple values such as promoting blood circulation to remove blood stasis, anti-allergy, and skin care.

[0014] The auxiliary medicine gotu kola and chamomile provide deep care and accurately solve "complementary conditions". Gotu kola is known as a "natural repair master", and the core component of asiaticoside can promote the synthesis of collagen in depth, repair micro-damage and barrier weakening caused by ultraviolet rays, and has anti-inflammatory and antioxidant effects, strengthening the muscle base and improving mild inflammation. Chamomile contains bisabolol and apigenin, which can reduce skin stress response, relieve redness and itching in children and sensitive skin, and become a "calming expert" for sensitive skin with mild anti-allergic properties, and protect the skin stability in all directions.

[0015] In the composition of the present application, the artemisinin and terpenoids in the volatile oil of artemisia have a smell that mosquitoes hate, and build a natural mosquito repellent barrier; the polysaccharides and flavonoids in cactus can quickly inhibit the release of histamine, and play a key role in anti-allergy and relieving itching; the key active ingredients of asiaticoside in gotu kola, bisabolol in chamomile and flavonoids in aloe vera work together to inhibit the inflammatory pathway, promote the proliferation of fibroblasts and the synthesis of collagen, and achieve deep relief and damage repair through multiple targets. The five herbal ingredients form a complete care system from preventing external stimulation to solving skin damage through the multidimensional cooperation of the monarch herb for repellent protection, the ministerial medicine for synergistic anti-allergy and relieving itching, and the auxiliary medicine for deep soothing and repair, with natural safety and high functionality. Clinical efficacy research confirms that the traditional Chinese medicine composition has accurate and reliable, true, non-toxic and harmless, safe and reliable effects on infant outdoor protection, and no adverse reactions after use, and is safe for clinical use.

[0016] As a preferred embodiment of the above technical solution, the external use traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 20-300 parts of gotu kola, 30-300 parts of aloe, 30-300 parts of chamomile, 10-200 parts of artemisia, and 7-300 parts of cactus.

[0017] As a further preferred embodiment of the above technical solution, the external use traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 50-300 parts of gotu kola, 30-200 parts of aloe, 30-200 parts of chamomile, 10-100 parts of artemisia, and 50-300 parts of cactus.

[0018] As a further preferred embodiment of the above technical solution, the external application traditional Chinese medicine composition is, by way of example, prepared from the following raw materials: 100 parts Centella asiatica, 150 parts Calendula officinalis, 150 parts Chamomile, 80 parts Artemisia annua, and 150 parts Prickly pear cactus. Of course, the above dosages are merely illustrative descriptions, and those skilled in the art can adjust the dosages of each substance within the preferred range.

[0019] Secondly, the present invention also provides a method for preparing the above-mentioned topical traditional Chinese medicine composition, comprising the following steps: S1. Weigh out Centella asiatica, Calendula officinalis, Chamomile, Artemisia annua, and Prickly pear cactus by weight, dry them, pulverize them, and sieve them to obtain raw material powder for later use. S2. Take the raw material powder obtained in step S1, add water and soak in a water bath, then add HCl to adjust the pH value of the system, then add the compound enzyme activated in a water bath for enzymatic hydrolysis to obtain the enzymatic hydrolysate; then filter to obtain the enzymatic hydrolysate and primary filter residue. S3. Add the primary filter residue obtained in step S2 to an ethanol solution containing surfactant for countercurrent extraction. After extraction, centrifuge to separate the primary filtrate and secondary filter residue. S4. Add the secondary filter residue obtained in step S3 to water, then add citric acid, mix well and then perform ultrasonic extraction; after extraction, centrifuge to obtain the secondary filtrate. S5. Combine the enzymatic hydrolysate obtained in step S2, the primary filtrate obtained in step S3, and the secondary filtrate obtained in step S4, and then perform decolorization, desalting, and ultrafiltration treatments to obtain a topical Chinese medicine composition.

[0020] As a preferred embodiment of the above technical solution, in step S1, the material is sieved through a 25-100 mesh screen.

[0021] As a preferred embodiment of the above technical solution, in step S2, the water bath soaking temperature is 50~70℃, and the time is 10~60min; the mass ratio of raw material powder to water is 1:6~12; the concentration of HCl is 0.05~0.2mol / L; the pH value is 4.5~5.2; the water bath activation step involves activating the compound enzyme at 38~45℃ for 5~20min; the compound enzyme is composed of cellulase and pectinase in a mass ratio of 1:1; the amount of compound enzyme added is 0.1~0.6% of the mass of the raw material powder; the enzymatic hydrolysis temperature is 50~65℃, and the enzymatic hydrolysis time is 1~4h.

[0022] As a preferred embodiment of the above technical solution, in step S3, the mass ratio of the primary filter residue to the ethanol solution is 1:10~25; the concentration of the surfactant is 0.4~0.65wt%; the surfactant is composed of cocamidopropyl betaine and Tween 80 in a mass ratio of 1:1; the countercurrent extraction temperature is room temperature, and the extraction time is 15~30min.

[0023] As a preferred embodiment of the above technical solution, in step S4, the mass ratio of secondary filter residue to water is 1:5~10; the concentration of citric acid is 0.05~0.1wt%; the ultrasonic power is 50~150W; and the ultrasonic treatment time is 3~10min.

[0024] As a preferred embodiment of the above technical solution, activated carbon powder is used for decolorization in step S5.

[0025] It should be particularly emphasized that the above-mentioned external Chinese medicine composition can be used directly or made into different forms of products by adding excipients. The present invention does not limit or describe its specific application form, but allows those skilled in the art to implement it.

[0026] Compared with the prior art, the present invention has the following beneficial effects: (1) The external Chinese medicine composition provided by the present invention has simple ingredients, safe to use, and multiple effects such as mosquito prevention, itch relief and soothing, and high safety.

[0027] (2) The topical Chinese medicine composition provided by the present invention has a high extraction efficiency by optimizing the preparation process.

[0028] Specifically, considering the diversity of Chinese herbal raw materials, the present invention first enzymatically hydrolyzes the Chinese herbal raw materials to obtain a preliminary extract, and the remaining active substances that are difficult to enzymatically hydrolyze are obtained by countercurrent extraction and ultrasonic-assisted extraction.

[0029] In this invention, a compound enzyme is used for enzymatic hydrolysis to improve the extraction rate and bioavailability of active ingredients. The compound cellulase can completely decompose cellulose in plant cell walls, destroying the cell wall structure and making the active ingredients (such as polyphenols, flavonoids, polysaccharides, volatile oils, alkaloids, etc.) within the cells more easily dissolved. Compared with traditional water or alcohol extraction, enzymatic hydrolysis can significantly improve the yield of active substances; at the same time, the mild conditions of enzymatic hydrolysis help protect heat-sensitive and sensitive active substances from being destroyed.

[0030] In this invention, a surfactant is added during the countercurrent extraction process. Through screening, cocamidopropyl betaine and Tween 80 are used in combination to promote dissolution and permeability, enabling countercurrent extraction to be carried out at room temperature and greatly shortening the extraction time. To further utilize the residual filter residue, citric acid is added to assist ultrasonic extraction. The use of citric acid can effectively break down the active substances that have not been fully extracted, and the very small amount does not require special post-treatment, simplifying the post-processing. At the same time, the use of citric acid also greatly shortens the processing time and improves the processing efficiency.

[0031] In this invention, the post-processing steps involve decolorization and desalting, which improves the purity and safety of the extract. This removes impurities that may irritate infants' skin (such as excessively dark pigments, residual salt, and large molecular impurities), resulting in a purer and gentler final extract suitable for the delicate and sensitive skin of infants. Decolorization removes pigments that may be generated during the extraction process (such as plant polyphenol oxidation products or other impurity pigments), preventing the product from being too dark and reducing potential sensitizing components. Desalting removes excess inorganic salts, reducing irritation to the skin (especially the delicate skin of infants).

[0032] The above preparation processes complement each other, ensuring the efficacy of the prepared traditional Chinese medicine composition. Detailed Implementation

[0033] The technical solutions of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0034] Unless otherwise specified, all raw materials used in this invention can be purchased from ordinary pharmacies and their specifications meet national pharmaceutical standards. Specifically, Centella asiatica, Calendula officinalis, Chamomile, and Artemisia annua were purchased from Bozhou Tangdong Pharmaceutical Co., Ltd.; and Prickly pear cactus was purchased from Bozhou Anbo Pharmaceutical Co., Ltd.

[0035] It should be noted that, unless otherwise specified, all weight parts mentioned in this invention refer to mass. The weight parts mentioned can be scaled up or down proportionally, and the specific numerical limits do not constitute a strict limitation on the specific amount used.

[0036] Example 1 A topical traditional Chinese medicine composition for outdoor protection of infants and children, by weight, is made from the following raw materials: 100 parts Centella asiatica, 150 parts Calendula officinalis, 150 parts Chamomile, 80 parts Artemisia annua, and 150 parts Prickly pear cactus.

[0037] Example 2 A topical traditional Chinese medicine composition for outdoor protection of infants and children, by weight, is made from the following raw materials: 80 parts Centella asiatica, 160 parts Calendula officinalis, 140 parts Chamomile, 70 parts Artemisia annua, and 180 parts Prickly pear cactus.

[0038] Example 3 A topical traditional Chinese medicine composition for outdoor protection of infants and children, by weight, is made from the following raw materials: 110 parts Centella asiatica, 140 parts Calendula officinalis, 155 parts Chamomile, 85 parts Artemisia annua, and 140 parts Prickly pear cactus.

[0039] Example 4 A method for preparing a topical traditional Chinese medicine composition for outdoor protection of infants and children, characterized by comprising the following steps: S1. Weigh out Centella asiatica, Calendula officinalis, Chamomile, Artemisia annua and Prickly pear cactus according to the weight parts of Examples 1 to 3, dry them, place them in a universal pulverizer, sieve through 40 mesh to obtain raw material powder, and set aside. S2. Take the raw material powder obtained in step S1, add water at a material-to-liquid ratio of 1:8, and soak in a water bath (60℃, 30min). Then, add 0.1mol / L HCl to adjust the pH of the system to 4.80. Subsequently, add the compound enzyme activated in a water bath (cellulase + pectinase at a mass ratio of 1:1 dissolved in a little water and activated in a water bath at 40℃ for 10min), and perform enzymatic hydrolysis (60℃, 2h) to obtain the enzymatic hydrolysate. Then filter to obtain the enzymatic hydrolysate and the primary filter residue. The amount of compound enzyme added is 0.5% of the mass of the raw material powder. S3. The primary filter residue obtained in step S2 is added to an ethanol solution containing 0.46 wt% surfactant (composed of cocamidopropyl betaine and Tween 80 in a mass ratio of 1:1) for countercurrent extraction (room temperature, 20 min). After extraction, centrifugation is performed to obtain primary filtrate and secondary filter residue; wherein, the mass ratio of primary filter residue to ethanol solution is 1:15. S4. Add the secondary filter residue obtained in step S3 to water, then add citric acid (concentration of 0.06wt%), mix well and then perform ultrasonic extraction (80W, 5min); after extraction, centrifuge to obtain secondary filtrate; wherein, the mass ratio of secondary filter residue to water is 1:8; S5. Combine the enzymatic hydrolysate obtained in step S2, the primary filtrate obtained in step S3, and the secondary filtrate obtained in step S4, and then perform decolorization (add 1wt% activated carbon powder, 80℃, 5h), desalination (resin, using commercially available conventional resin), and ultrafiltration (through a 0.45μm microporous membrane) to obtain the external Chinese medicine composition.

[0040] Comparative Example 1 Compared with Example 1, the use of Artemisia annua was omitted in this comparative example, but all other aspects were the same; the preparation method was the same as in Example 4.

[0041] Comparative Example 2 Compared with Example 1, the use of calendula was omitted in this comparative example, but all other aspects were the same; the preparation method was the same as in Example 4.

[0042] Comparative Example 3 Compared with Example 1, the components of this comparative example are the same; in terms of preparation, compared with Example 4, in step S3, only cocamidopropyl betaine is used as the surfactant.

[0043] Comparative Example 4 Compared with Example 1, the components of this comparative example are the same; in terms of preparation, compared with Example 4, in step S3, only Tween 80 surfactant is used, and the rest are the same.

[0044] Comparative Example 5 Compared with Example 1, the components of this comparative example are the same; in terms of preparation, compared with Example 4, the use of citric acid is omitted in step S4, and the rest are the same.

[0045] Experimental Example 1 The products prepared according to the formulation of Example 1 and the products prepared according to Comparative Examples 3-5 were concentrated under reduced pressure (75℃, vacuum degree ≤ -0.08MPa) to a ratio of drug solution to medicinal material ≈ 3:2, with a concentrated drug solution specific gravity of approximately 1.08 (measured at 60℃), yielding a traditional Chinese medicine composition extract. The quality of the obtained traditional Chinese medicine composition extract was determined, and the contents of artemisinin and asiaticoside were also determined. The test results are shown in Table 1.

[0046] Table 1 Test Results As can be seen, the preparation method provided by this invention yields more effective components and has a higher extraction efficiency.

[0047] Experimental Example 2 In this study, safety was evaluated using a human patch test.

[0048] Test substance: Example 4 (prepared from the formulation of Example 1) Experimental group #1, Comparative Example 1 Control group #2, Comparative Example 2 Control group #3. Negative control: Spot tester + filter paper.

[0049] A total of 28 participants were selected, all of whom met the criteria for voluntary participation.

[0050] Patch test method: Using a patch test device (Beijing Baiyiyida Technology Development Co., Ltd.), approximately 0.020~0.025mL of the test substance was applied to the small chamber of the patch test device, and then applied externally with special adhesive tape to the back or flexor side of the forearm of the subject. After 24 hours, the patch test device was removed. If there was any remaining product, it was gently wiped away with a tissue. Skin reactions were observed at 0.5 hours, 24 hours, and 48 hours after removing the patch test device, and the results were recorded according to the skin reaction grading standards in the "Cosmetic Safety Technical Specifications" (2015). The test results are shown in Table 2 below.

[0051] Table 2 Experimental Example 3 This study investigated the in vitro NO inflammatory mediator content to evaluate its soothing function.

[0052] This experiment was conducted according to T / FDCA007-2022, "Evaluation of the Soothing Efficacy of Cosmetics: Determination of In Vitro NO Inflammatory Mediator Content in Lipopolysaccharide-Induced Macrophage RAW264.7 Cells." Specifically, the principle of bacterial lipopolysaccharide (LPS) inducing the secretion of the inflammatory mediator NO in the RAW264.7 macrophage cell line was utilized. LPS-induced RAW264.7 is a classic cell model for exploring inflammatory mechanisms. By comparing the differences in NO content after 24 hours of incubation with the blank control group, negative control group, and test sample group, the inhibitory effect of the test sample on NO was evaluated.

[0053] 3.1 Test Samples and Methods Main reagents: mouse macrophage leukemia cell line RAW264.7 (Cyber-Tech), dexamethasone (Sigma), NO detection kit (Beyotime), CCK-8 kit (Solarbio).

[0054] Sample preparation: Weigh 180 mg of the sample prepared in Example 4 (prepared with the formulation of Example 1), the sample prepared in Comparative Example 1, and the sample prepared in Comparative Example 2, respectively, and make up to 3 mL with LPS working solution. Then filter the samples through a 0.22 µm filter membrane for sterilization and set aside.

[0055] Positive control: Dexamethasone was dissolved in DMSO solution, shaken for 2 hours, and thoroughly mixed to prepare dexamethasone working solution (100 μg / mL), which was prepared fresh for use.

[0056] Negative control: LPS working solution (2 μg / mL).

[0057] Blank / solvent control: cell culture medium.

[0058] 3.2 Test Methods 3.2.1 Safe Dosage Screening The examples and comparative examples were used as experimental groups. Based on the characteristics of each dose, cell viability and cell morphology in the preliminary experiment, the sample dose (20000 μg / mL) with a cell viability >80% was selected as the safe dose of the experimental group. Blank / solvent control group, negative control group, Example 4 group, comparative example 1 group and comparative example 2 group were set up respectively. Among them, the blank / solvent control group was cell culture medium, the negative control group was LPS working solution and the positive control group was dexamethasone working solution.

[0059] 3.2.2 Testing of the test sample The day before the experiment, at 2×10 4HSF cells were seeded at a density of cells / well in 24-well plates, with 1 mL of cell culture medium added to each well. The plates were then incubated in a CO2 cell culture incubator for 24 h + 2 h. Before the experiment, the old cell culture medium in the 24-well plates was discarded, and the following procedures were followed for each group.

[0060] Experimental group: Add 1 mL of LPS working solution containing a safe concentration of the test substance to the corresponding well and incubate in a CO2 cell culture incubator for 24 h ± 2 h.

[0061] Blank / solvent control group: Add 1 mL of cell culture medium to the corresponding well and incubate in a CO2 cell culture incubator for 24 h ± 2 h.

[0062] Negative control group: Add 1 mL of LPS working solution to the corresponding well and incubate in a CO2 cell culture incubator for 24 h + 2 h.

[0063] Positive control group: 1 mL of LPS working solution containing dexamethasone was added to the corresponding well and cultured in a CO2 cell culture incubator for 24 h ± 2 h.

[0064] After incubation, collect 1 mL of cell supernatant from each well into a 1.5 mL sterile centrifuge tube, and then perform the detection according to the instructions of the corresponding NO kit.

[0065] The test results are shown in Table 3. The NO inhibition rate was calculated as: (Inhibition rate of negative control group - Inhibition rate of test group) / (Inhibition rate of negative control group - Inhibition rate of blank / solvent control group) * 100%.

[0066] Table 3 (Compared with the blank / solvent control group, p* < 0.05) Based on the effectiveness verification results, the NO content of the example samples was significantly reduced compared with the negative control (P<0.05), demonstrating the ability to inhibit NO synthesis, which can serve as evidence to support the product's claim of soothing efficacy. In addition, the NO inhibition rate of the example samples was higher than that of the comparative sample, indicating that the product of the present invention has better anti-inflammatory and soothing efficacy.

[0067] Test Example 4 In this experimental case, the effect of histamine phosphate on pruritus induced in guinea pigs was tested to evaluate its anti-allergic and antipruritic efficacy.

[0068] Fifty qualified guinea pigs were selected and randomly divided into 5 groups: (1) model group, (2) fluocinolone acetonide group (fluocinolone acetonide cream group), (3) Example 4 group (concentration of 50 mg / kg, prepared according to the formulation of Example 1), (4) Comparative Example 1 group (concentration of 50 mg / kg), and (5) Comparative Example 2 group (concentration of 50 mg / kg). One day before the experiment, the hair on the back of the right hind foot of each group of guinea pigs was shaved. Then, the experimental group was coated with the corresponding product of the example and comparative example once, the model control group was coated with physiological saline, and the fluocinolone acetonide group was coated with fluocinolone acetonide. The dosage was 0.1 mL / foot. On the day of the experiment, the shaved area on the back of the right hind foot of the guinea pig was scratched with sandpaper. The degree of scratching was to damage the epidermis but not the dermis, and to cause slight bleeding of the skin. The scratch area was about 1 cm. 2 Each group was treated with the corresponding product once more. Ten minutes after the last application, 0.01% histamine phosphate was applied to the wound, 0.05 mL per guinea pig. This was repeated every 3 minutes, increasing the concentration by 0.01%, 0.02%, 0.03%, 0.04%, and so on, with each application being 0.05 mL, until the guinea pig began licking its right hind paw. The total amount of histamine phosphate at the point where the guinea pig began licking its right hind paw was calculated; this was the pruritus threshold.

[0069] The results of the effect of histamine on histamine-induced pruritus in guinea pigs are shown in Table 4 below.

[0070] Table 4 (Compared to the model group, p* < 0.05, p** < 0.01) As shown in the table, compared with the model group, the fluocinolone acetonide group and the example group both had a significant inhibitory effect on histamine phosphate-induced skin pruritus in guinea pigs. The pruritus threshold of the comparative group was lower than that of the example group. This indicates that the product of the present invention can alleviate the pruritus symptoms caused by histamine phosphate and has a good antipruritic effect, which may be related to improving the skin's tolerance and barrier function.

[0071] The applicant declares that the technical solution of this invention is illustrated through the above embodiments, but this invention is not limited to the above embodiments, that is, it does not mean that this invention must rely on the above embodiments to be implemented. Those skilled in the art should understand that any improvements to this invention, equivalent substitutions of individual raw materials in the product of this invention, additions of auxiliary components, and selection of specific methods, all fall within the protection scope and disclosure scope of this invention.

Claims

1. A topical traditional Chinese medicine composition for outdoor protection of infants and children, characterized in that, It is prepared by weight from the following raw materials: 20-400 parts Centella asiatica, 30-400 parts Calendula officinalis, 30-400 parts Chamomile, 10-300 parts Artemisia annua, and 7-400 parts Prickly pear cactus.

2. The topical traditional Chinese medicine composition for outdoor protection of infants and children according to claim 1, characterized in that, It is prepared by weight from the following raw materials: 20-300 parts Centella asiatica, 30-300 parts Calendula officinalis, 30-300 parts Chamomile, 10-200 parts Artemisia annua, and 7-300 parts Prickly pear cactus.

3. The topical traditional Chinese medicine composition for outdoor protection of infants and children according to claim 1, characterized in that, It is prepared by weight from the following raw materials: 50-300 parts Centella asiatica, 30-200 parts Calendula officinalis, 30-200 parts Chamomile, 10-100 parts Artemisia annua, and 50-300 parts Prickly pear cactus.

4. The topical traditional Chinese medicine composition for outdoor protection of infants and children according to claim 1, characterized in that, It is made from the following raw materials in parts by weight: 100 parts Centella asiatica, 150 parts Calendula officinalis, 150 parts Chamomile, 80 parts Artemisia annua, and 150 parts Prickly pear cactus.

5. A method for preparing the external application traditional Chinese medicine composition according to any one of claims 1 to 4, characterized in that, Includes the following steps: S1. Weigh out Centella asiatica, Calendula officinalis, Chamomile, Artemisia annua, and Prickly pear cactus by weight, dry them, pulverize them, and sieve them to obtain raw material powder for later use. S2. Take the raw material powder obtained in step S1, add water and soak in a water bath, then add HCl to adjust the pH value of the system, then add the compound enzyme activated in a water bath for enzymatic hydrolysis to obtain the enzymatic hydrolysate; then filter to obtain the enzymatic hydrolysate and primary filter residue. S3. Add the primary filter residue obtained in step S2 to an ethanol solution containing surfactant for countercurrent extraction. After extraction, centrifuge to separate the primary filtrate and secondary filter residue. S4. Add the secondary filter residue obtained in step S3 to water, then add citric acid, mix well and then perform ultrasonic extraction; after extraction, centrifuge to obtain the secondary filtrate. S5. Combine the enzymatic hydrolysate obtained in step S2, the primary filtrate obtained in step S3, and the secondary filtrate obtained in step S4, and then perform decolorization, desalting, and ultrafiltration treatments to obtain a topical Chinese medicine composition.

6. The preparation method according to claim 5, characterized in that, In step S1, the sample is sieved through a 25-100 mesh screen.

7. The preparation method according to claim 5, characterized in that, In step S2, the water bath soaking temperature is 50~70℃, and the time is 10~60min; the mass ratio of raw material powder to water is 1:6~12; the concentration of HCl is 0.05~0.2mol / L; the pH value is 4.5~5.2; the water bath activation step involves activating the compound enzyme at 38~45℃ for 5~20min; the compound enzyme is composed of cellulase and pectinase in a mass ratio of 1:1; the amount of compound enzyme added is 0.1~0.6% of the mass of the raw material powder; the enzymatic hydrolysis temperature is 50~65℃, and the enzymatic hydrolysis time is 1~4h.

8. The preparation method according to claim 5, characterized in that, In step S3, the mass ratio of the primary filter residue to the ethanol solution is 1:10~25; the concentration of the surfactant is 0.4~0.65wt%; the surfactant is composed of cocamidopropyl betaine and Tween 80 in a mass ratio of 1:1; the countercurrent extraction temperature is room temperature, and the extraction time is 15~30min.

9. The preparation method according to claim 5, characterized in that, In step S4, the mass ratio of secondary filter residue to water is 1:5~10; the concentration of citric acid is 0.05~0.1wt%; the ultrasonic power is 50~150W; and the ultrasonic treatment time is 3~10min.

10. The preparation method according to claim 5, characterized in that, In step S5, activated carbon powder is used for decolorization.

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