Children bitter lip balm capable of relieving and moisturizing and preparation method of children bitter lip balm

Abstract

The invention discloses a relieving and moisturizing bitter lip balm for children and a preparation method thereof. The lip balm is prepared from the following raw materials in parts by weight: 2 to 6 parts of propyl gallate, 1 to 3 parts of citrus peel oil, 3 to 6 parts of avocado oil, 8 to 10 parts of candelilla wax, 6 to 10 parts of olive fruit oil, 8 to 12 parts of synthetic jojoba oil, 16 to 18 parts of squalane, 8 to 12 parts of sunflower seed oil, 8 to 12 parts of caprylic / capric triglyceride, 0.5 to 1.5 parts of flat nuclear wood oil, 14 to 16 parts of petrolatum, 6 to 10 parts of cera alba and 1 to 2 parts of tocopherol. The preparation method comprises the following steps: heating and stirring the avocado oil, candelilla wax, synthetic jojoba oil, olea europaea fruit oil, squalane, sunflower seed oil, caprylic / capric triglyceride, flat-core wood oil, petrolatum and white beeswax according to corresponding parts by weight, adding tocopherol, propyl gallate, calendula extract and orange peel oil, and stirring to obtain a lipstick liquid. And filling, cooling and solidifying to obtain the lip balm. According to the present invention, the lip licking frequency of children can be reduced by using the orange peel fruit oil and the propyl gallate as the characteristics;

Description

Technical Field

[0001] The present invention relates to the technical field of cosmetic care products, and particularly relates to a soothing and moisturizing children's bitter lip balm and a preparation method thereof. Background Art

[0002] Compared with adults, children's skin is more delicate and sensitive, especially the skin of the lips. The stratum corneum and granular layer of children's lips are relatively thin, and lack the protection of melanocytes, so they are more vulnerable to the damage of external environmental factors, such as the influence of ultraviolet rays and dry air. In addition, the lip skin of children lacks sebaceous glands and cannot secrete sebum by itself to form a protective film, resulting in a much higher water loss rate than that of adult lips, and is prone to problems such as dryness and chapping.

[0003] The behavior of children often licking their lips may bring a series of adverse effects. Licking the lips will cause the moisture on the surface of the lips to evaporate rapidly and take away the internal moisture, forming a vicious cycle of licking more dry and getting drier and licking more, which will further cause chapped and painful lips, and even develop into chronic cheilitis. Secondly, amylase in saliva will adhere to the lips after evaporation, resulting in the contraction of connective tissue and mucosal wrinkling, thus aggravating the sense of dryness. The behavior of licking the lips may also cause irritant dermatitis, forming symptoms similar to dry eczema on the skin around the lips, resulting in rough local skin and pigmentation. Bacteria, dust and harmful substances in lipsticks contacted by the lips may enter the oral cavity through the behavior of licking the lips, thus affecting the overall health of children. Therefore, excessive lip licking is not only harmful to lip health, but may also cause skin problems and increase the risk of bacterial infection. Summary of the Invention

[0004] In view of the above deficiencies, the present invention provides a soothing and moisturizing children's bitter lip balm and a preparation method thereof, featuring orange peel oil and propyl gallate, which can reduce the frequency of children licking their lips.

[0005] To achieve the above object, the present invention provides the following technical solution: A soothing and moisturizing children's bitter lip balm, and the weight ratio of the raw materials of the lip balm is as follows: Propyl gallate, 2 - 6 parts; Orange peel oil, 1 - 3 parts; Avocado oil, 3 - 6 parts; Candelilla wax, 8 - 10 parts; Olive fruit oil, 6 - 10 parts; Synthetic jojoba oil, 8 - 12 parts; Squalane, 16 - 18 parts; Sunflower seed oil, 8 - 12 parts; Caprylic / capric triglyceride, 8 - 12 parts; Prinsepia utilis oil, 0.5 - 1.5 parts; Petrolatum, 14 - 16 parts; White beeswax, 6 - 10 parts; Tocopherol, 1 - 2 parts; Calendula officinalis extract, 0.5 - 1.5 parts.

[0006] As an improvement, in the weight ratio of the raw materials of the lip balm, propyl gallate is 4 - 6 parts, and citrus peel oil is 2 - 3 parts.

[0007] As an improvement, in the weight ratio of the raw materials of the lip balm, avocado oil is 5 - 6 parts, candelilla wax is 9 - 10 parts, olive fruit oil is 8 - 10 parts, synthetic jojoba oil is 10 - 12 parts, squalane is 17 - 18 parts, sunflower seed oil is 10 - 12 parts, caprylic / capric triglyceride is 10 - 12 parts, Prinsepia utilis Royle oil is 0.5 - 1.5 parts, petrolatum is 15 - 16 parts, white beeswax is 8 - 10 parts, tocopherol is 1.5 - 2 parts, and calendula officinalis extract is 0.5 - 1.5 parts.

[0008] According to the preparation method of a soothing and moisturizing children's bitter lip balm according to any one of the above, it includes the following steps: S1: Heat the candelilla wax and white beeswax in the first group of the formula to 70 - 85 °C, and stir until completely melted; S2: Add petrolatum, shea butter, olive fruit oil, sunflower seed oil, synthetic jojoba oil, natural squalane and GTCC in the second group of the formula to the molten wax base in step S1, maintain the temperature at 65 - 75 °C, and homogenize and mix for 10 - 20 minutes; S3: Cool the system to 55 - 65 °C, add tocopherol, Prinsepia utilis Royle oil and propyl gallate in the third group of the formula, and stir at a low speed of 200 - 500 rpm until evenly dispersed; S4: Continue to cool to 45 - 50 °C, add calendula officinalis extract and orange peel oil in the fourth group of the formula, and avoid high - speed shearing to prevent the degradation of active substances; S5: Inject the mixed material into the lip balm mold, cool to 10 - 15 °C and cure for 30 - 60 minutes, and obtain the finished product after demolding.

[0009] As an improvement, in step S2, the high - speed disperser is used for homogenizing and mixing, and the rotation speed is 1000 - 1500 rpm.

[0010] As an improvement, in step S4, the addition temperature of the active ingredients is 48 ± 2 °C, and the stirring time is 5 - 10 minutes.

[0011] Compared with the prior art, the advantages of the present invention are as follows: Propyl gallate and tangerine peel oil are specially added to the lip balm of the present invention. Both of these two ingredients have a certain bitterness and can work synergistically to jointly construct a dual bitterness system, enhancing the bitterness effect of the lip balm. This design aims to reduce the frequency of children licking their lips through bitter stimulation. When the weight parts of tangerine peel oil in the lip balm formula are 2 - 3 parts and the weight parts of propyl gallate in the lip balm formula are 4 - 6 parts, the bitterness of tangerine peel oil and the bitterness of propyl gallate synergistically enhance the effect, which can effectively reduce the frequency of children licking their lips, helping them gradually correct this bad habit, thereby protecting the lip skin from dryness and chapping caused by repeated infiltration of saliva; because tangerine peel oil is rich in natural antioxidant components such as flavonoids and coumarins, the lip balm can scavenge free radicals generated by external environmental stimuli on the lip skin, effectively delaying the aging process of the lip skin. With long-term use, the lip skin can be kept tender and elastic, reducing the appearance of problems such as dullness and sagging. Moreover, ingredients such as limonene have an inhibitory effect on common bacteria causing lip inflammation, can prevent and relieve possible lip inflammation, and promote the healing of lip wounds. This characteristic enables the lip balm to protect the lip skin from bacterial infection while accelerating the repair of damaged skin; and propyl gallate can not only enhance the bitterness effect of the lip balm, but also interact with ingredients such as tocopherol and bitter almond oil to form a hydrogen bond network, enhancing the stability of the formula. This helps prevent phenomena such as layering and oil separation during the storage and use of the lip balm, ensuring the consistency and stability of product quality; through the synergistic effect of ingredients such as avocado oil, squalane, and petrolatum, the present invention can form a long-lasting protective film on the lips, preventing water loss and improving lip roughness and chapping problems.

[0012] In the preparation method of the lip balm of the present invention, the components are divided into four groups. In the first group of the formula, candelilla wax and white beeswax need to be melted at a high temperature (70 - 85°C) first to form a uniform wax liquid matrix, which provides a stable carrier for the subsequent oil mixing. If heated synchronously with other low-temperature sensitive components, it may cause thermal degradation of the latter. In the second group of the formula, petrolatum, shea butter, olive fruit oil, sunflower seed oil, synthetic jojoba oil, natural squalane and GTCC are added at a slightly lower temperature (65 - 75°C) to avoid oil oxidation caused by long-term heating at high temperature, such as the deterioration of unsaturated fatty acids. Homogeneous mixing ensures the full compatibility of the wax base and the oil, preventing oil-wax separation or granularity after cooling. In the third group of the formula, tocopherol, Prinsepia utilis Royle oil and propyl gallate are added after the temperature drops to 55 - 65°C to avoid destroying the activity of antioxidants at high temperature. At the same time, low-speed stirring (200 - 500 rpm) is used to prevent accelerated oxidation caused by excessive introduction of air. In particular, the interaction between propyl gallate and components such as tocopherol and Prinsepia utilis Royle oil can form a hydrogen bond network, enhancing the stability of the formula and helping to prevent phenomena such as stratification and oil separation during the storage and use of the lip balm, while ensuring the uniform dispersion of each component. In the fourth group of the formula, calendula extract and orange peel fruit oil are added at a lower temperature (45 - 50°C) to avoid the thermal inactivation of the heat-sensitive active components in orange peel fruit oil and calendula extract, maximizing the efficacy of the active components. High-speed shearing is disabled in this step to prevent mechanical force from destroying the active molecular structure. The preparation method of the lip balm of the present invention adapts to the temperature tolerance limits of different components by cooling in stages, reducing thermal damage, and is based on comprehensive considerations such as the physical and chemical properties, thermal stability, functional priorities and process adaptability of each group of raw materials. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] The present invention will be further described in detail below with reference to the drawings and specific embodiments: Figure 1 It is a radar chart for the sensory evaluation of the lip balm; Figure 2 It is a diagram of the results of the chick embryo chorioallantoic membrane test; Figure 3 It is a diagram of the skin patch test results of 30 subjects; Figure 4 It is a diagram of the trans-epidermal water loss (TEWL) of the lips and its change rate; Figure 5 It is the change rate of skin erythema and the contrast of lip wrinkle texture; Figure 6 It is a diagram of the change of RedFestures (red area) of the subjects after using the lip balm product for 28 days; Figure 7 It is a diagram of the water content and growth rate of the skin stratum corneum at different time periods after using the lip balm; Figure 8It is a graph showing the moisture content of the skin stratum corneum at various time periods after using the lip balm and the percentage increase in moisture content between each stage; Figure 9 It is a graph showing the change in the desire to lick the lips after using the lip balm; Figure 10 It is a graph showing the time of change in the frequency of licking the lips after using the lip balm; Figure 11 It is a subjective judgment graph of the influence of bitterness on the frequency of licking the lips after using the lip balm. Detailed implementation manner

[0014] Example 1 As shown in the following table, S1: Accurately weigh 8 parts of candelilla wax and 6 parts of white beeswax according to the corresponding weight parts, add them to the reaction kettle, heat to 75 °C, and stir evenly at a stirring speed of 300 r / min; S2: Add 14 parts of petrolatum, 4 parts of shea butter, 6 parts of olive fruit oil, 8 parts of sunflower seed oil, 8 parts of synthetic jojoba oil, 16 parts of squalane and 8 parts of caprylic / capric triglyceride, and continue for 15 minutes at a speed of 1200 rmp / min; S3: Cool down to 60 °C, add 1 part of tocopherol, 2 parts of propyl gallate, and 1 part of Prinsepia utilis Royle oil, and stir evenly at a stirring speed of 400 r / min to obtain the lip balm liquid; S4: Cool down to 45 °C, add 1 part of calendula extract and 1 part of orange peel oil, and gently stir at a speed of 200 rmp / min for 8 min; S5: Fill the lip balm liquid into the lip balm tube and cool it at -5 °C for 5 min to obtain the lip balm; The lip balm prepared in this example has good moisturizing effects and can effectively improve the problem of dry lips. After being tried by 30 children, after one week of use, 80% of the children reported that the dryness of their lips was significantly reduced, and the number of times of licking their lips decreased by about 30%. At the same time, through the detection of the antioxidant performance of the lip balm, it was found that after 3 months of storage, the degree of oil oxidation was relatively low, indicating that the antioxidant effects of propyl gallate and orange peel oil were effectively exerted.

[0015] Example 2 As shown in the following table, S1: Accurately weigh 9 parts of candelilla wax and 8 parts of white beeswax according to the corresponding weight parts, add them to the reaction kettle, heat to 75 °C, and stir evenly at a stirring speed of 350 r / min; S2: Add 15 parts of petrolatum, 5 parts of shea butter, 8 parts of olive fruit oil, 10 parts of sunflower seed oil, 10 parts of synthetic jojoba oil, 17 parts of squalane and 10 parts of caprylic / capric triglyceride, and continue for 15 minutes at a speed of 1200 rmp / min; S3: Cool down to 60 °C, add 1.5 parts of tocopherol, 4 parts of propyl gallate, and 1 part of Prinsepia utilis Royle oil, and stir evenly at a stirring speed of 400 r / min to obtain the lip balm liquid; S4: Cool down to 45 °C, add 1 part of Calendula officinalis extract and 2 parts of citrus peel oil, and gently stir continuously at a speed of 200 rmp / min for 8 min; S5: Fill the lip balm liquid into the lip balm tube and cool it at -5 °C for 10 min to obtain the lip balm.

[0016] The texture of this lip balm is smoother and has a good application feeling. 40 children were tested. After two weeks, the dry and peeling phenomena of 90% of the children's lips were significantly improved, and the lip licking frequency decreased by about 40%. The antioxidant performance test shows that after 6 months of storage, the performance of the lip balm remains stable, and the synergistic stabilizing effect of propyl gallate and citrus peel oil on the formula is significant.

[0017] Example 3 As shown in the following table, S1: Weigh 10 parts of candelilla wax and 10 parts of white beeswax accurately according to the corresponding weight parts, add them to the reaction kettle, heat to 75 °C, and stir evenly at a stirring speed of 450 r / min; S2: Add 16 parts of petrolatum, 6 parts of shea butter, 10 parts of olive fruit oil, 12 parts of sunflower seed oil, 12 parts of synthetic jojoba oil, 18 parts of squalane, and 12 parts of caprylic / capric triglyceride, and continue for 15 minutes at a speed of 1250 rmp / min; S3: Cool down to 60 °C, add 2 parts of tocopherol, 6 parts of propyl gallate, and 1 part of Prinsepia utilis Royle oil, and stir evenly at a stirring speed of 400 r / min to obtain the lip balm liquid; S4: Cool down to 45 °C, add 1 part of Calendula officinalis extract and 3 parts of citrus peel oil, and gently stir continuously at a speed of 200 rmp / min for 8 min; S5: Fill the lip balm liquid into the lip balm tube and cool it at -10 °C for 3 min to obtain the lip balm.

[0018] The lip balm prepared in this example has stronger moisturizing persistence. After one-month follow-up testing of 50 children, 95% of the children's lips remained moisturized all the time, and the lip licking frequency decreased by about 50%. It has significant antibacterial and anti-inflammatory effects, outstanding antioxidant and formula stabilizing effects. After 9 months of storage, there is no obvious deterioration of the lip balm.

[0019] Example 4 As shown in the following table, S1: Weigh 10 parts of candelilla wax and 8 parts of white beeswax accurately according to the corresponding weight parts, add them to the reaction kettle, heat to 75 °C, and stir evenly at a stirring speed of 320 r / min; S2: Add 14 parts of petrolatum, 4 parts of shea butter, 8 parts of olive fruit oil, 10 parts of sunflower seed oil, 12 parts of synthetic jojoba oil, 16 parts of squalane and 8 parts of caprylic / capric triglyceride, and stir continuously at a speed of 1200 rmp / min for 15 minutes; S3: Cool down to 60 °C, add 1 part of tocopherol, 3 parts of propyl gallate, and 1 part of Prinsepia utilis Royle oil, and stir evenly at a stirring speed of 400 r / min to obtain the lipstick liquid; S4: Cool down to 45 °C, add 1 part of Calendula officinalis extract and 2 parts of orange peel oil, and stir gently at a speed of 200 rmp / min for 8 min; S5: Fill the lipstick liquid into the lipstick tube and cool it at -6 °C for 4 min to obtain the lip balm.

[0020] The lip balm prepared in this example has good comprehensive performance. 35 children were tested. After two weeks of use, the lip conditions of 85% of the children were significantly improved, and the number of lip licking times decreased by about 35%. The antioxidant and antibacterial properties are stable during actual use and storage.

[0021] Comparative Example 1 As shown in the following table, S1: Weigh 8 parts of candelilla wax and 6 parts of white beeswax accurately according to the corresponding weight parts, add them to the reaction kettle, heat to 75 °C, and stir evenly at a stirring speed of 300 r / min; S2: Add 14 parts of petrolatum, 4 parts of shea butter, 6 parts of olive fruit oil, 8 parts of sunflower seed oil, 8 parts of synthetic jojoba oil, 16 parts of squalane and 8 parts of caprylic / capric triglyceride, and stir continuously at a speed of 1200 rmp / min for 15 minutes; S3: Cool down to 60 °C, add 1 part of tocopherol and 1 part of Prinsepia utilis Royle oil, and stir evenly at a stirring speed of 400 r / min to obtain the lipstick liquid; S4: Cool down to 45 °C, add 1 part of Calendula officinalis extract, and stir gently at a speed of 200 rmp / min for 8 min; S5: Fill the lipstick liquid into the lipstick tube and cool it at -5 °C for 5 min to obtain the lip balm.

[0022] 30 children were tested. After one week, only 50% of the children reported that the dryness of their lips had decreased slightly, and the number of lip licking times did not decrease significantly, only about 10%. After storing for 1 month, the lipstick began to show slight oil oxidation, and the texture became slightly unstable. Compared with Example 1, it significantly highlights the important roles of propyl gallate and orange peel oil in aspects such as moisturizing, reducing the number of lip licking times, antioxidant, and stabilizing the formula.

[0023] Weight parts of each component in Example 1 to Comparative Example 1 Product experimental test: 1 Experimental part 1.1 Experimental reagents and instruments 1.1.1 Experimental reagents Deionized water, sterile normal saline (0.9%), sodium hydroxide solution (0.1 mol / L), olive oil, low-allergy tape.

[0024] 1.1.2 Instruments Electronic balance YH-C30002 (accuracy 0.01 g), digital display constant temperature water bath HH-2 (Guohua (Changzhou) Instrument Manufacturing Co., Ltd.), centrifuge, refrigerator BCD-240-SDPN, thermometer (100 °C, accuracy ±1 °C), reagent bottle (50 ml), PHSJ-6L pH meter (Shanghai Yidian Scientific Instrument Co., Ltd.), IT-09A5 magnetic stirrer (Shanghai Yiheng Instrument Co., Ltd.), volumetric flask (100 ml), beaker (100 ml), marker pen, ophthalmic scissors, disposable dropper, rubber nipple tube, ultraviolet-visible spectrophotometer (Shanghai Aoxi Scientific Instrument Co., Ltd.), filter paper, stereomicroscope (Beijing Puresight Instruments Co., Ltd.), electronic timer, automatic turntable incubator, egg candler, cold light source, skin moisture content tester Comeometer CM820 (CK, Germany), analytical balance, transdermal water loss tester Tewameter TM 300 (CK, Germany), patch tester, VISIA-CR Gen 5 Imaging System (Canfield Scientific, Inc., USA).

[0025] 1.2 Quality and safety evaluation (I) Stability test Heat and cold resistance test: Take out the lip balm after placing it at a high temperature of 45 ± 1 °C and a low temperature of -8 ± 1 °C for 24 h and restore it to room temperature, and observe whether there are phenomena such as softening, deformation, oil leakage, etc. compared with before the test; Freeze-thaw test: Store the lip balm at -8 °C and 45 °C ± 1 °C in cycles for 5 times, each time storing for 24 h respectively, that is, each cycle includes storing at -8 ± 1 °C for 24 h, storing at room temperature for 24 h, and then putting it into a constant temperature oven at 45 °C for 24 h, and cycling 5 times in turn, and observe the change of the sample state, such as whether there are phenomena such as solidification, oil separation, softening, cracking, etc.

[0026] (II) Determination of pH value Weigh 1 part (accurate to 0.1g) of lipstick sample, add 9 parts of deionized water without CO2, heat to 70℃, stir until uniform, cool to room temperature, and use as the test solution. After calibrating the instrument, wash the electrode with water, dry it with filter paper, insert the electrode into the sample to be tested, start the stirrer, wait for the pH meter reading to stabilize for 1 minute, stop the stirrer, and read the pH value directly from the instrument. Test twice, with an error range of ±0.1, and take the average reading value.

[0027] 3. Sensory evaluation test With reference to the standard GB / T 26513-2023, a double-blind test was conducted on 30 volunteers to verify the actual usage experience of the samples. The samples and a children's lip balm as the control group were evaluated on their appearance, color, smell, etc. by visual inspection, olfactory inspection, and lip application, supplemented by questionnaires.

[0028] 4. Chicken embryo chorioallantoic membrane test Select SPF-grade fertilized chicken embryos, incubate until the 8th day for examination, select chicken embryos with well-developed blood vessels to mark the position of the air chamber, start the test on the 9th day, peel off the eggshell part of the air chamber, expose the chorioallantoic membrane, take the test solution diluted 10 times with olive oil and act on the CAM, spread it as much as possible, and cover at least 50% of the area. After 3 minutes of action, touch the surface of the sample with the edge of the filter paper to absorb excess oil, and immediately observe the degree of change of each toxic effect under a stereo microscope and give a score.

[0029] 5. Human skin patch test Place the test substance into a standard patch tester at a dosage of 0.020-0.025 g. Use the closed patch method to stick the patch to the upper inner arm for 24 hours. Press several times to ensure that it will not fall off. Remove the patch after 24 hours, and record the redness, swelling, itching, pain and other sensations of the patch 30 minutes, 24 hours and 48 hours after removing the test substance patch tester. No swelling, itching or pain is considered "no" irritation, and redness, swelling, itching or pain is considered "yes" irritation.

[0030] 1.3 Human efficacy evaluation test 1. Volunteer screening Select at least 30 healthy subjects aged 18 - 60 years old, randomly selected by gender, with dry, peeling lips and obvious lip lines; Exclusion criteria: Pregnant or lactating women or those with a recent pregnancy plan; Highly sensitive constitution, with a history of allergic diseases or allergic reactions to cosmetics; Suffering from skin diseases such as psoriasis, eczema, atopic dermatitis, severe acne, or other chronic systemic diseases; The skin at the test site has birthmarks, pigmentation, inflammation, scars, pigmented moles, hirsutism, etc.; Having taken oral or topical anti-inflammatory drugs such as corticosteroids within the past month; Having used cosmetics with such effects or other products with similar effects within the past two weeks; Having participated in a human clinical trial of cosmetics within the past month; Other clinical evaluations consider it not suitable to participate in the trial. This study complies with the requirements of the Declaration of Helsinki revised in 2013. All subjects understand the entire purpose and process of the trial and sign an informed consent form.

[0031] (1) Evaluation of soothing effect Detection basis: The soothing effect is usually accompanied by barrier repair. The enhancement of the barrier function can be reflected by the decrease in the trans-epidermal water loss (TEWL) value. The VISA red area analysis method is used to quantitatively evaluate the soothing effect.

[0032] This experiment refers to the Technical Specifications for Cosmetics Safety. Referring to the research methods of scholars Zhuang Canzhan and Guo Huijun, at least 30 volunteers meeting the requirements are selected to participate in the experiment. The entire experiment is carried out in an environment with a constant temperature of 20°C - 22°C and a constant humidity of 40% - 60%. After cleaning the lips, the volunteers quantitatively take 5 mg of the lipstick sample and evenly apply it to the right side of the lips. The TEWL value is measured once every 30 minutes in the laboratory environment, and the average value is taken after 60 measurements to calculate the growth rate.

[0033] The volunteers apply the lipstick once in the morning and once in the evening for 28 consecutive days. On the 7th, 14th, and 28th days after use, the VISIA-CR is used to measure and analyze the image of the proportion of the red area of the lips.

[0034] (2) Evaluation of moisturizing effect Detection method: This study uses a self-control method. After the subjects clean their lips every day, the sample lip cream is evenly applied to the lips. After continuous use for 28 days, after cleaning the subjects' lips on the 0th, 14th, and 28th days, after waiting for 30 minutes under the constant temperature conditions of (21±1)°C and a humidity of 50%±10%, the moisture content of the stratum corneum of the lip skin is measured by a measuring instrument. The average value is taken after 6 measurements to calculate the hydration growth rate. The calculation formula is as follows: Hydration growth rate = (MMV t - MMV0) / MMV0 × 100% Among them, MMV tMMV skin water content at a certain time period after application; MMV0 is the MMV skin water content before application.

[0035] The statistical software is SPSS 25.0. Statistical tests were performed on each measured value. Descriptive analysis of skin physiological indicators was carried out using mean ± standard deviation. The Shapiro-Wilk Test was used to test the normality of the data. If p > 0.05, it shows a normal distribution. Paired sample t-tests were used to compare the index values before and after the samples. p < 0.05 was used as the standard for statistical significance of differences.

[0036] (III) Anti-lip-licking efficacy test Recruit volunteers who are willing to participate in the test. Try the lip balm samples and commercially available colorless and odorless lip balms respectively, and sit still for 1 h after use; then use a questionnaire to count whether the bitter lip balm containing propyl gallate will affect the lip-licking frequency. Select 30 eligible volunteers and adopt the self-before-and-after control method; the test uses a commercially available colorless and odorless lip balm of type A and a lip balm sample of type B with a bitter taste. Record the number of lip licks in 30 min under no intervention conditions in the laboratory. Evenly apply 5 mg of lip balm of type A with a latex finger cot and record the number of lip licks every 30 min. The lip balm of type B is also operated according to this step, and the subjects record the number of lip licks after applying the sample by themselves. The test video is recorded during the test, and the number of lip licks of the subjects is accurately counted after the test. Calculate the average number of lip licks per hour of each subject under non-intervention conditions and during the intervention period.

[0037] 2 Results and discussion 2.1 Results of quality and safety tests (I) Results of stability tests The stability of the product was verified by referring to GB / T 29679—2013 for heat resistance and cold resistance tests, freeze-thaw tests, and pH determination tests. The results showed that there was no separation or water layer phenomenon after the samples were kept in a constant temperature oven at 45°C ± 1°C for 24 h and in a refrigerator at -8 ± 1°C for 24 h and then returned to room temperature compared with before the test.

[0038] (II) Results of pH value determination The pH value was measured twice in parallel with a pH meter, and the measured values were 6.84 and 6.83 respectively, with an average value of 6.835, meeting the standard and being mild to the skin.

[0039] (III) Results of sensory evaluation tests Table 1 Sensory evaluation scoring criteria Refer to the sensory evaluation scoring standard designed according to GB / T 29679—2013, as shown in Table 1. Verify the actual usage experience of the sample through a double-blind test on 30 volunteers, and conduct a sensory evaluation of the sample from multiple aspects such as appearance, color, and smell by means of visual inspection, olfactory discrimination, lip application, etc., supplemented by a questionnaire.

[0040] Score each item of the sample through the questionnaire filled out by 30 volunteers after using the sample and Runben children's lip balm, and calculate the average value of the obtained scores as shown in the following Table 2 Lip Balm Sensory Evaluation Scoring Table. Figure 1 As shown in the radar chart of lip balm sensory evaluation, the test product is similar to the commercially available Runben children's product in evaluation. It performs well in terms of spreadability, fineness, glossiness, moisturizing degree, etc., and there is little difference from the commercially available Runben children's lip balm, with good performance.

[0041] Table 2 Lip Balm Sensory Evaluation Scoring Table (4) Results of the chicken embryo chorioallantoic membrane test Verify the irritation of the sample through the chicken embryo chorioallantoic membrane (CAM) test. Carefully observe and record the time when bleeding and hemolysis occur in the sample within 3 minutes under a stereomicroscope, and conduct scoring, as Figure 2 shown in Table 3. The results show that the chicken embryo using the sample showed blood coagulation breakage and slight capillary dissolution at 150 seconds, and started blood coagulation at 180 seconds. The ES value was calculated to be 1.33 according to the formula, and the final evaluation was carried out according to the reference standard SN / 2329-2009. The sample belongs to non / lightly irritating.

[0042] Table 3 Results Table of Chicken Embryo Chorioallantoic Membrane Test (5) Human skin patch test Observe the safety of the sample on human skin through the human patch test. Carefully inquire, examine and record any adverse events that occurred to the subjects during the use of the sample, including the manifestations, occurrence time, treatment measures and outcomes of the adverse events, and make a judgment on the relationship between the adverse events and the sample used. Refer to the grading standard of skin adverse reactions in the human trial test in the "Technical Specifications for Cosmetics Safety" (2015 edition). No skin adverse reactions were observed in 30 subjects (see Figure 3 ). The skin adverse reactions in the human patch test are shown in Table 4.

[0043] Table 4 Skin Adverse Reactions in Human Patch Test According to Figure 3As shown in Table 4, no adverse reactions on human skin occurred among all 30 subjects. Thus, it can be seen that this product is safe for humans.

[0044] 2.2 Results of Human Efficacy Tests (I)Results of Soothing Efficacy Evaluation A total of 30 people participated in the soothing efficacy evaluation experiment, including 13 males and 17 females, aged 18 - 23 years. The trans-epidermal water loss (TEWL) and its change rate of the lips are as Figure 4 shown.

[0045] According to Figure 4 the data, compared with the baseline value, the trans-epidermal water loss of the sample decreased significantly (p < 0.01) after 7 days, 14 days, and 28 days of application on the lip skin, by 9.33%, 12.37%, and 10.67% respectively. This indicates that the sample has excellent short-term and long-term barrier repair capabilities.

[0046] The ideal state of lip skin is soft and shiny, and the soothing effect is mainly reflected in relieving symptoms such as lip discomfort, erythema, tightness, and pain. Based on this, this study aimed to evaluate the erythema condition and smoothness of lip skin to reflect the soothing effect of the product. In this study, the VISIA-CR imaging technology was used in combination with the image analysis software Image-Pro® Plus to obtain more accurate lip skin color information.

[0047] As Figure 5 shown, the detection results reveal the change rate of skin erythema and the contrast of lip wrinkle texture. As Figure 6 shown is the change diagram of RedFestures (red area) of a subject after 28 days of using this lip balm product, further illustrating the improvement of lip skin condition. It can be observed that after using the sample, the lip skin shows a smoother texture and the erythema phenomenon is also alleviated.

[0048] (II)Results of Moisturizing Efficacy Evaluation A total of 30 people participated in this experiment, including 13 males and 17 females, aged 18 - 23 years. The test results of the change in the moisture content of the skin stratum corneum (MMV) and the growth rate at each time period after the subjects completed the experiment are as Figure 7As shown, the measured water content of the stratum corneum of the skin was higher at each time period after using the sample than before using the lip balm sample, with an average growth rate of 21.22%, showing significant differences (p < 0.05). The growth rate continued to rise and reached 24.55% after 1.5 hours of using the lip balm sample, indicating that using this lip balm sample has a good moisturizing effect in a short time. Due to factors such as the absorption of the active ingredients of the lip balm and the licking by the subjects, the growth rate decreased after 1.5 hours of applying the lip balm. However, the growth rate could still reach 17.36% 4 hours after applying the lip balm, and the water content of the stratum corneum of the skin still increased significantly (p < 0.05), indicating that this lip balm also has a good immediate moisturizing rate.

[0049] It can be seen from Figure 8 that after 14 days and 28 days of using the sample lip balm, compared with the baseline value before using the sample, the moisture content of the lip skin of the subjects increased significantly (p < 0.05), increasing by 18.58%, 26.96% and 23.86% respectively. The results show that after 7 days, 14 days and 28 days of using the sample lip balm, the water content of the stratum corneum of the lip skin increased significantly compared with before use, indicating that this sample has a good long-term moisturizing effect.

[0050] (III) Evaluation of the effect of preventing lip licking The results of the questionnaire include changes in the desire to lick the lips, such as Figure 9 shown, the change time of the lip licking frequency after use, such as Figure 10 shown, and the subjective judgment of the influence of bitterness on the lip licking frequency, such as Figure 11 shown. These data show that compared with using ordinary lip balms, more than 60% of the volunteers believe that after applying the bitter lip balm, the bitterness will affect the desire to lick the lips and reduce the lip licking frequency.

[0051] The present invention has been described exemplarily in combination with the accompanying drawings. Obviously, the specific implementation of the present invention is not limited by the above methods. As long as various non-substantive improvements are made by adopting the technical solution of the present invention, or the concept and technical solution of the present invention are directly applied to other occasions without improvement, they are all within the protection scope of the present invention.

Claims

1. A soothing and moisturizing children's bitter lip balm, characterized in that: The weight ratio of the raw materials of the lip balm is as follows: Propyl gallate, 2 - 6 parts; Orange peel oil, 1 - 3 parts; Avocado oil, 3 - 6 parts; Candelilla wax, 8 - 10 parts; Olive fruit oil, 6 - 10 parts; Synthetic jojoba oil, 8 - 12 parts; Squalane, 16 - 18 parts; Sunflower seed oil, 8 - 12 parts; Caprylic / capric triglyceride, 8 - 12 parts; Prinsepia utilis Royle oil, 0.5 - 1.5 parts; Petrolatum, 14 - 16 parts; White beeswax, 6 - 10 parts; Tocopherol, 1 - 2 parts; Calendula officinalis extract, 0.5 - 1.5 parts.

2. The soothing and moisturizing children's bitter lip balm according to claim 1, wherein: In the weight ratio of the raw materials of the lip balm, propyl gallate is 4 - 6 parts, and orange peel oil is 2 - 3 parts.

3. The soothing and moisturizing children's bitter lip balm according to claim 2, characterized in that: In the weight ratio of the raw materials of the lip balm, avocado oil is 5 - 6 parts, candelilla wax is 9 - 10 parts, olive fruit oil is 8 - 10 parts, synthetic jojoba oil is 10 - 12 parts, squalane is 17 - 18 parts, sunflower seed oil is 10 - 12 parts, caprylic / capric triglyceride is 10 - 12 parts, Prinsepia utilis Royle oil is 0.5 - 1.5 parts, petrolatum is 15 - 16 parts, white beeswax is 8 - 10 parts, tocopherol is 1.5 - 2 parts, and calendula officinalis extract is 0.5 - 1.5 parts.

4. The preparation method of a soothing and moisturizing children's bitter lip balm according to any one of claims 1 to 3, characterized in that, It includes the following steps: S1: Heat the candelilla wax and white beeswax in the first group of the formula to 70 - 85 °C and stir until completely melted; S2: Add petrolatum, shea butter, olive fruit oil, sunflower seed oil, synthetic jojoba oil, natural squalane and GTCC in the second group of the formula to the melted wax base in step S1, maintain the temperature at 65 - 75 °C, and homogenize and mix for 10 - 20 minutes; S3: Cool the system to 55 - 65 °C, add tocopherol, Prinsepia utilis Royle oil and propyl gallate in the third group of the formula, and stir at a low speed of 200 - 500 rpm until evenly dispersed; S4: Continue to cool to 45 - 50 °C, add calendula officinalis extract and orange peel oil in the fourth group of the formula, and avoid high - speed shearing to prevent degradation of active substances; S5: Inject the mixed material into a lip balm mold, cool to 10 - 15 °C and cure for 30 - 60 minutes, and obtain the finished product after demolding.

5. The preparation method of a soothing and moisturizing children's bitter lip balm according to claim 4, characterized in that, In step S2, the high - speed disperser is used for homogenizing and mixing, and the rotation speed is 1000 - 1500 rpm.

6. The preparation method of a soothing and moisturizing children's bitter lip balm according to claim 4, characterized in that, In step S4, the addition temperature of the active ingredient is 48 ± 2 °C, and the stirring time is 5 - 10 minutes.

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