Detection method for efficacy of hygienic product and application of detection method

Abstract

The invention relates to the technical field of biology, in particular to a detection method for the efficacy of a hygienic product and application of the detection method. According to the method, the functional substances on the surface layer of the sanitary napkin are extracted through directional extraction, the antioxidant function and safety of the product are further quantified through in-vitro experiments, and a standardized pretreatment process capable of directionally extracting the releasable functional components with biological activity from the complete sanitary napkin product is established. The invention provides a method capable of reflecting the efficacy in a real use scene, and avoids the deviation between the raw material test and the actual effect of the finished product. By designing the 3 * 3 cm patch, the friction and closed environment of the real sanitary towel is simulated, the repair effect of the sanitary towel is objectively evaluated through the skin barrier repair index, and the problems that a traditional sanitary towel is not matched in trial and data is distorted are solved.

Description

Technical Field

[0001] This invention relates to the field of biotechnology, specifically to a method for detecting the efficacy of hygiene products and its application. Background Technology

[0002] Women's menstrual hygiene products are personal care products used to absorb or collect menstrual blood during menstruation to maintain personal cleanliness and comfort. Common hygiene products include sanitary napkins, panty liners, tampons, and menstrual panties. With increasing consumer health awareness, adding functional ingredients such as probiotics, vitamins, and plant extracts to women's menstrual hygiene products like sanitary napkins and panty liners has become an important trend for product differentiation. However, contrary to this trend, the industry's efficacy verification system is severely lagging behind, with a widespread phenomenon of "emphasizing additives but neglecting verification." Currently, most companies can only provide Material Safety Data Sheets (MSDS) from raw material suppliers or efficacy certificates at the raw material level (such as an in vitro antioxidant report for a plant essential oil), and make efficacy claims for the finished product based on these.

[0003] This practice of "raw material-grade claims" has a fundamental technical flaw. The reason is that those skilled in the art know that sanitary napkins are a complex heterogeneous solid-liquid composite system composed of multiple layers of materials such as non-woven fabric, fluff pulp, superabsorbent polymer (SAP), and leak-proof membrane. After adding functional ingredients to this system, its effectiveness in actual use faces severe challenges, including but not limited to: (1) processing loss: hot melt adhesive bonding, high-temperature sterilization and other processing processes may cause a large number of heat-sensitive ingredients (such as probiotics, certain vitamins) to be inactivated; (2) absorption and locking effect: liquid runoff will be preferentially absorbed and fixed by the SAP superabsorbent polymer layer, resulting in the functional ingredients being physically trapped inside the absorbent layer and unable to be effectively released to the target point (skin surface); (3) unknown release rate and migration efficiency: the desorption efficiency of the ingredients from the product substrate, the solubility and stability in the liquid environment, and the migration rate to the skin surface are all complex "black box" issues. Therefore, there is a huge and unpredictable technical gap between "raw material efficacy" and "finished product efficacy". Claims based solely on raw material certification lack scientific basis and mislead consumers.

[0004] At the level of human efficacy evaluation, although it is the "gold standard" for verification, the special form of sanitary napkins, which are "large-area and non-adhesive", brings insurmountable obstacles to conventional human trials: (1) It is impossible to ensure that the product adheres evenly and closely to the skin, resulting in uncontrollable exposure dose and area, and introducing huge experimental errors; (2) The test is costly, has a long cycle, and is greatly affected by individual differences of the subjects; (3) In particular, there is a lack of highly adhesive and miniaturized body surface test models that can simulate the local physiological environment (temperature, humidity, pressure) of the human abdomen / groin and match the form of sanitary napkins, making it impossible to conduct efficient and reliable preliminary screening and verification in vitro.

[0005] In summary, a long-standing technical bias exists in the field regarding the efficacy verification of finished sanitary napkins: a tendency to rely on raw material testing reports or rigidly apply cosmetic testing methods, with a subconscious assumption that efficacy degradation from raw materials to finished products is acceptable or cannot be accurately assessed. Therefore, the industry urgently needs a new testing method for the efficacy of sanitary products to fill this technological gap, providing a reliable tool for the research and development and quality control of functional sanitary napkin products, and acting responsibly towards female consumers. Summary of the Invention

[0006] In view of this, the technical problem to be solved by the present invention is to provide a method for detecting the efficacy of hygiene products that is simple to operate, objective, highly accurate, widely applicable, and well-accepted by subjects, and its application.

[0007] This invention provides a method for testing the efficacy of hygiene products, the method including methods for testing the antioxidant function, safety, and repair function of the hygiene products, wherein:

[0008] The method for detecting the antioxidant function of the sanitary products includes: taking the sanitary products and extracting them with an extraction solution to obtain an extract, then using the DPPH method to test and obtain the antioxidant function results of the extract.

[0009] The safety testing method for the sanitary product includes: taking the sanitary product or its sodium chloride extract, and testing the intensity of the irritant reaction produced by the skin and / or vaginal mucosa of the experimental animal after repeated contact with the sanitary product or its sodium chloride extract.

[0010] The testing method for the repair function of the hygiene products includes the following steps:

[0011] Step 1: Randomly select a skin test area on the inner side of the subject's forearm, peel off the skin test area with tape, and measure the first transepidermal water loss of the skin test area;

[0012] Step 2: Apply the patch prepared from the sanitary product to the skin test area described in Step 1, and measure the second transepidermal water loss in the skin test area after application.

[0013] Step 3: Calculate the difference in transepidermal water loss described in Step 1 and Step 2, and obtain the result of the repair function based on the difference.

[0014] In some embodiments, the hygiene products include at least one of sanitary napkins, panty liners, and tampons.

[0015] In some specific embodiments, the sanitary product is a sanitary napkin.

[0016] In some embodiments, the extraction solution comprises n-hexane and n-butanol in a volume ratio of (1~3):(1~3), the mass-volume ratio of the sanitary product to the extraction solution is (0.1~0.5) g:(15~30) mL, and the extraction time is 20~60 min.

[0017] Since the antioxidants in sanitary napkins may be oil-soluble (such as vitamin E), water-soluble (such as polyphenols), or both, this invention uses a mixture of polar (n-butanol) and non-polar (n-hexane) solvents to extract the various types of antioxidant active ingredients that may be added to the product more comprehensively and efficiently. This simulates the dissolution state of these ingredients in the complex environment of menstrual blood and secretions (containing water and lipids) during actual use, thereby achieving a more accurate technical effect.

[0018] In some specific embodiments, the extraction solution comprises n-hexane and n-butanol in a volume ratio of 1:1, the mass-volume ratio of the sanitary product to the extraction solution is 0.3g:25mL, and the extraction time is 30min.

[0019] In some embodiments, the method for testing the safety of the sanitary product, specifically the method for testing the repeated contact of the sanitary product with the skin of experimental animals, includes the following steps:

[0020] S1. Experimental animals were set up as experimental group, positive control group and negative control group respectively. The hair on the left and right sides of the spine on the back of the experimental animals was removed to form a 3cm×3cm test area.

[0021] S2. Apply the patch prepared from the sanitary product after being soaked in sodium chloride to the left test area of ​​the experimental group. Apply a 0.6% solution of 2,4-dinitrochlorobenzene to the left test area of ​​the positive control group. No treatment is given to the negative control group. The test area is covered with two layers of gauze and one layer of cellophane and then fixed with adhesive tape. After 6 hours of treatment, the left test area of ​​the experimental animal is washed with warm water.

[0022] S3. Repeat S2 on day 7 and day 14 respectively;

[0023] S4. Fourteen days after the end of S2, the patch prepared by the sanitary product after being soaked in sodium chloride was applied to the right test area of ​​the experimental group and the negative control group. A 0.6% 2,4-dinitrochlorobenzene solution was applied to the right test area of ​​the positive control group, and the test area was covered with two layers of gauze and one layer of cellophane and fixed with adhesive tape in sequence.

[0024] S5. After 6 hours of treatment, wash the right test area of ​​the experimental animal with warm water, and observe and record the skin reaction at 24 hours and 48 hours.

[0025] In some embodiments, the method for testing the safety of the sanitary product, specifically the method for testing the repeated contact of the sanitary product with the vaginal mucosa of experimental animals, includes the following steps:

[0026] Step 1: Take sanitary products and extract them with sodium chloride to obtain an extract;

[0027] Step II: Inject the extract into the vagina of the experimental animals. The control group was injected with sodium chloride into the vagina of the experimental animals. Repeat Step II for 5 consecutive days.

[0028] Step III: After euthanizing the mice, the intact vaginas of the experimental and control groups were dissected, and the congestion and edema were observed and recorded. The vaginal tissues were then subjected to pathological examination using HE staining.

[0029] In some embodiments, the experimental animals include rabbits and / or mice.

[0030] In some embodiments, in step 1, the tape is a hypoallergenic tape, the tape peeling time is 5 to 10 seconds, and the tape peeling number of times is 3 to 10.

[0031] Compared to traditional patch repair methods that involve coating and patching raw materials, this invention uses an arm repair experiment to verify the repair performance of sanitary napkins. This method can more directly simulate the scenario of using sanitary napkins during menstruation. By using patches (top layer, diversion layer, and bottom film) that have been cut from the complete sanitary napkin body structure, it can more objectively and realistically explore the efficacy potential of sanitary napkins, thereby achieving more accurate technical results.

[0032] In some specific embodiments, in step 1, the tape is a hypoallergenic tape, the tape peeling time is 5 seconds, and the tape peeling number of times is 5.

[0033] In some embodiments, in step 2, the application time is 1 to 5 hours.

[0034] In some embodiments, in step 2, the application time is 2 hours.

[0035] In some embodiments, the method for testing the repair function of the sanitary product further includes a blank control group, which is a regular sanitary product without added active ingredients. After testing, the difference in transepidermal water loss of the blank control group is also obtained.

[0036] Step 3 further includes comparing and statistically analyzing the difference in transepidermal water loss between the experimental group and the blank control group to obtain the results of the repair function.

[0037] This invention provides the application of the aforementioned detection method in the detection or screening of functional hygiene products.

[0038] Compared with the prior art, the beneficial effects of the present invention include:

[0039] (1) This invention extracts the functional components of the surface layer of sanitary napkins through targeted extraction, and further quantifies the antioxidant function and safety of the product through in vitro experiments, establishing a standardized pretreatment process that can target the extraction of "releaseable, bioactive functional components" from complete sanitary napkin products. It provides a method that can reflect the efficacy in real-world usage scenarios, avoiding the deviation between raw material testing and the actual effect of the finished product.

[0040] (2) The present invention uses a mixture of polar (n-butanol) and non-polar (n-hexane) solvents, which can extract various types of antioxidant active ingredients that may be added to the product more comprehensively and efficiently, and simulate the dissolution state of these ingredients in the complex environment of menstrual blood and secretions (containing water and lipids) in actual use.

[0041] (3) The present invention uses an arm repair experiment to verify the repair performance of sanitary napkins. It uses a 3×3cm patch (top layer, diversion layer, bottom film) with the complete sanitary napkin body structure cut out, which can more directly simulate the use of sanitary napkins during menstruation, and can more objectively and realistically explore the efficacy potential of sanitary napkins. Through the skin barrier repair index, the repair effect of sanitary napkins can be objectively evaluated, solving the problems of unsuitability and data distortion in traditional sanitary napkin trials. Attached Figure Description

[0042] Figure 1 This chart shows the difference between the transepidermal water loss (TEWL) values ​​of different areas after treatment with sanitary napkin patches and the initial values. Detailed Implementation

[0043] This invention provides a method for testing the efficacy of hygiene products and its application. Those skilled in the art can refer to the content of this document and appropriately modify the process parameters to achieve the desired result. It should be particularly noted that all similar substitutions and modifications are obvious to those skilled in the art and are considered to be included in this invention. The method and application of this invention have been described through preferred embodiments. Those skilled in the art can clearly modify or appropriately change and combine the method and application described herein without departing from the content, spirit, and scope of this invention to realize and apply the technology of this invention.

[0044] This invention provides a method for verifying the efficacy of sanitary products, which are menstrual hygiene products for women, specifically including sanitary napkins, panty liners, and tampons. The verification method includes:

[0045] Take sanitary products and extract them with an extraction solution to obtain an extract. The extraction solution can be a mixture of n-hexane and n-butanol in a 1:1 ratio; the mass-to-volume ratio of sanitary products to the extraction solution is 0.3g:25mL; the extraction time is 30min; and the extract is obtained after extraction.

[0046] ① Antioxidant properties

[0047] The antioxidant properties of the extract were verified by the DPPH method.

[0048] ② Security verification

[0049] The safety performance of the sanitary products was verified through multiple vaginal mucosal irritation tests and skin allergy tests.

[0050] ③ Verification of epidermal repair function

[0051] Sanitary products were subjected to human tear tests to verify their repair properties.

[0052] The test materials used in this invention are all commercially available products. The invention will be further illustrated below with reference to specific embodiments.

[0053] Example 1

[0054] In this embodiment, a sanitary napkin containing 0.3% vitamin E and 0.7% squalane in its surface layer was used as a sample for testing. The specific verification method is as follows:

[0055] Take a sanitary napkin, cut off its surface layer, and extract it with a mixed solution of n-hexane and n-butanol in a volume ratio of 1:1. The mass-volume ratio of the sanitary napkin to the mixed solution is 0.3g:25mL. The extraction time is 30min to obtain the extract.

[0056] Because sanitary napkins come into contact with an extremely complex liquid environment during use, including menstrual blood (aqueous phase, proteins, salts, etc.) and various secretions (lipids, oils, etc.), this is a typical multiphase, broadly polar system. To simulate this complex environment in in vitro experiments and ensure the simultaneous and efficient extraction of antioxidants of different polarities (non-polar squalane and vitamin E with both lipophilic and polar functional groups), this method uses a 1:1 mixture of n-hexane (non-polar) and n-butanol (polar). This mixed solvent is widely applicable to active ingredients of different polarities, enabling simultaneous and efficient extraction. This solvent, based on simulated application scenarios rather than single solubility, greatly enhances the correlation and predictive value between in vitro antioxidant test results (such as the DPPH method) and the efficacy settings of sanitary napkins, making efficacy verification more scientific and closer to reality.

[0057] 1. Component determination

[0058] 1.1 Determination of Vitamin E and Squalane Content in Extract

[0059] The contents of vitamin E and squalane in the extract were determined by gas chromatography using TC-PG-XF-C47-2025. The results showed that the concentration of squalane in the extract was 0.35% and the concentration of vitamin E was 0.2%.

[0060] 1.2 Determination of the specific rotation of vitamin E in the extract

[0061] Take the extract and, according to the method in GB 1886.233-2016, measure its specific optical rotation [α]. D1 25℃ The specific rotation of vitamin E extracted from the extract was measured to be +21.4°, which is consistent with the characteristics of natural vitamin E.

[0062] 2. The antioxidant properties of the extracts were verified using the DPPH method, specifically including:

[0063] The reagents include: 0.12 mg / mL DPPH ethanol solution: Weigh 12 mg of 1,1-diphenyl-2-trinitrophenylhydrazine into a 250 mL beaker, add 100 mL of 95% ethanol, and stir with a glass rod until dissolved; Positive control: Vitamin E, purity ≥96%.

[0064] The positive control was dissolved and diluted with 95% ethanol to prepare a series of concentration gradients of 0.08 mg / mL, 0.04 mg / mL, 0.02 mg / mL, and 0.01 mg / mL to verify the test system.

[0065] Extraction solution treatment: Water-soluble extracts were diluted with water to prepare samples of multiple concentrations, and oil-soluble extracts were diluted with 95% ethanol to prepare samples of multiple concentrations.

[0066] Referring to Table 1, 10mL test tubes are used to set up sample tubes (T), sample background (T0), DPPH tubes (C) and solvent background (C0). For each sample, three parallel tubes are required for each test concentration of the sample tube (T), and three parallel tubes are also required for the DPPH tube (C).

[0067] Add 1 mL of sample solution of the same concentration to both the sample tube (T) and the sample background (T0).

[0068] Add solvent to all test tubes (T, T0, C, C0), using water for water-soluble samples and 95% ethanol for oil-soluble samples, to a total of 3 mL, and mix well.

[0069] Add 1 mL of DPPH ethanol solution to the sample tube (T) and DPPH tube (C), and replace the sample background (T0) and solvent background (C0) with 95% ethanol. Shake gently and let stand at room temperature for 5 minutes.

[0070] Each reaction solution was transferred into a 1 cm cuvette, and the absorbance was measured at 517 nm.

[0071] Table 1 Sample Addition Requirements

[0072]

[0073] The DPPH radical scavenging rate is calculated according to the following formula (1):

[0074] Equation (1)

[0075] Where: T - absorbance of the sample tube, i.e., the absorbance of the solution after the sample reacts with DPPH;

[0076] T0 - Sample background absorbance;

[0077] The average of three absorbance values ​​of the C-DPPH tube, i.e. the absorbance of the DPPH solution without the addition of sample;

[0078] C0 - Solvent background absorbance.

[0079] A positive control test is required for each batch of experiments. The IC50 of the positive control vitamin E (the test concentration of the sample corresponding to 50% scavenging effect) should be between 0.02 mg / mL and 0.06 mg / mL for the test system to be considered effective. The free radical scavenging rate of the sample at each test concentration is calculated according to formula (1), and the standard deviation (SD) between the scavenging rates of each group of parallel tubes is calculated. The SD value must be ≤3% for the parallelism of the experiment to be considered valid.

[0080] Result evaluation: The scavenging rate of the sample against DPPH free radicals at a certain tested concentration should be expressed as: average scavenging rate ± standard deviation (SD) between scavenging rates. For the expression of the free radical scavenging activity of the sample, it should not be stated without considering the tested concentration. When comparing the free radical scavenging activities between samples, a concentration-response curve of the tested concentration of the sample and the DPPH free radical scavenging rate can be plotted, and the IC50 of each sample can be calculated using the fitting formula (R2 ≥ 0.9). The smaller the IC50 of the sample, the stronger the activity.

[0081] In this experiment, the results obtained by using the above method showed that at a 100% concentration state, the free radical scavenging rate of the tested sample reached 18.37%, and the free radical scavenging rate of the positive control with a concentration of 0.04 mg / mL reached

[0081] 51.21%, while that of the negative control was 0. The results indicated that the tested sample had a certain antioxidant effect.

[0082] 3. Safety test

[0083] In this experiment, sanitary napkins containing 0.3% vitamin E and 0.7% squalane in the surface layer were used as samples for safety verification tests.

[0084] 3.1 Repeated vaginal mucosa irritation test

[0085] In this experiment, six female New Zealand white rabbits (ordinary grade, non-pregnant, weighing 2.36 - 2.48 kg) were selected and provided by Zhejiang Hongrun Biotechnology Co., Ltd. The animals were housed in a normal environment (temperature 22.5 - 23.8°C, relative humidity 47.8 - 57.7%), and were freely fed with standard feed and drank chlorinated treated RO ultrafiltrated water compliant with GB 5749 - 2022. All animal experiments were conducted in facilities with a qualified license (SYXK (Zhe) 2021 - 0032).

[0086] Sample treatment: According to the method in Appendix F of GB 15979 - 2024, the self-absorption capacity of the sample for sodium chloride injection was determined to be 21.440 mL / g. 1.00 g of the sample was cut transversely. In addition to the product absorption capacity, 10.0 mL of sodium chloride injection (source: Jimin Health Management Co., Ltd.; batch number: S240204E55) was added at a ratio of 1 g / 10 mL, sealed in an extraction container, stirred, and placed at (37 ± 1)°C for 24 h. After cooling to room temperature, the sample solution was sampled after stirring for inspection and used immediately after preparation.

[0087] The test methods include:

[0088] Animal selection and grouping: Healthy, newly-adult female white rabbits were selected. Before the experiment, the animals' vaginal openings were checked for discharge, congestion, edema, and other injuries. Animals with inflammation or / and injuries were discarded. The rabbits were divided into a poison-treated group and a control group, with three rabbits in each group.

[0089] Rabbits were fixed supine, exposing the perineum and vaginal opening. A catheter (approximately 8 cm long, disposable rectal administration tube connected to a 2 mL syringe) was moistened with the test substance and gently inserted into the vagina (4 cm). 2 mL of the test sample was slowly injected using the syringe, and the catheter was then withdrawn. This treatment was repeated every 24 hours for 5 consecutive days. Control group animals were treated with sodium chloride injection in the same manner. 24 hours after treatment, animals were euthanized using an air embolization method. The intact vagina was removed via laparotomy, longitudinally dissected, and visually inspected for signs of congestion and edema. The vagina was then fixed in 10% formalin solution for 48 hours. Tissue sections from the two ends and the middle of the vagina were prepared, stained with hematoxylin and eosin (HE), and subjected to histopathological examination.

[0090] Results evaluation method: Histopathological examination results were scored; the stimulation response scores of the three animals in the experimental group at three sites were added together and then divided by the total number of observations (number of animals × 3) to obtain the average score of vaginal mucosal stimulation response in the experimental group. The scoring method for the control group was the same. The stimulation index was obtained by subtracting the average score of the control group from the average score of the experimental group, and then the stimulation intensity was graded.

[0091] Twenty-four hours after exposure, no congestion, edema, or other abnormalities were observed in the vaginas of either the exposed or control groups upon visual inspection. Pathological examination showed that the vaginal mucosal irritation index in the experimental group was 0.56. The vaginal mucosal irritation response scores are shown in Table 2 below. All results indicate that, under the conditions of this experiment, the test sample elicited no irritation to the vaginal mucosa of rabbits.

[0092] Table 2 Summary of the test samples' irritation response scores to the vaginal mucosa of rabbits

[0093]

[0094] Note: 1) Average score = sum of stimulus response scores of 3 animals at 3 sites / total number of observations (number of animals × 3); 2) Stimulation index = average score of the poisoned group - average score of the negative control group.

[0095] 3.2 Skin allergy test

[0096] In this experiment, 52 white guinea pigs (ordinary grade, half male and half female, weighing 260.8 - 279.8 g) were selected and provided by Tongxiang Yinhai Animal Husbandry Professional Cooperative. The animals were raised in a normal environment (temperature 20.5 - 23.8 °C, relative humidity 51.1 - 63.6%), freely fed with standard commercial feed and drank chlorinated treated RO ultrafiltrated water compliant with GB 5749 - 2022. All animal experiments were conducted in facilities with the SYXK (Zhe) 2021 - 0032 use permit.

[0097] Test sample and control settings: The sanitary napkin was cut into pieces of 2.5 cm × 2.5 cm and moistened with sodium chloride injection solution for later use. The positive control was 2,4 - dinitrochlorobenzene, which was prepared using anhydrous ethanol, distilled water and acetone as solvents. The induction concentration was 0.6% (80% ethanol solution), and the challenge concentration was 0.2% (acetone solution).

[0098] Number of animals and grouping: There were 16 animals in the test group, 16 in the negative control group, and 20 in the positive control group. The animals needed to acclimatize in this laboratory for at least 3 days before the experiment. Approximately 24 hours before the experiment, the hair on the left side of the guinea pigs' backs was removed, and the hair - removal area was about 3 cm × 3 cm.

[0099] Dose levels: The induction dose was the highest concentration that caused a mild skin irritation reaction, and the challenge dose was the highest concentration that did not cause a skin irritation reaction. According to the pre - test results, the original sample did not cause a skin irritation reaction, so the original sample was directly used for testing. The specific doses are shown in Table 3.

[0100] Induction contact: On the 0th, 7th, and 14th days, the processed test samples (for the positive control, a 0.6% 2,4 - dinitrochlorobenzene solution) were applied to the hair - removed skin on the left side, covered with two layers of gauze and one layer of cellophane, and then fixed with non - irritating adhesive tape for 6 hours. After that, the dressing was removed and the residual test substances were cleared; the negative control group was only given the challenge treatment with the test substance.

[0101] Challenge contact: 14 days after the last induction, that is, on the 28th day, the processed test samples (for the positive control, a 0.2% 2,4 - dinitrochlorobenzene solution) were applied to the hair - removed skin on the right side of the guinea pigs' backs (hair removal 24 hours before contact) and fixed for 6 hours (the operation method was the same as that for induction contact).

[0102] The skin reactions were observed 24 hours and 48 hours after the challenge contact and scored (Table 4). The number of animals showing skin reactions (score ≥ 1) was divided by the number of experimental animals in the group to obtain the percentage of the sensitization rate. The results are shown in Table 3.

[0103] Table 3 Results of the guinea pig skin allergy test for the test sample (or positive substance)

[0104]

[0105] Table 4 Skin Irritation Response Scores

[0106]

[0107] The results showed that no erythema or edema or other irritant reactions were observed in the skin of the guinea pigs in the experimental group 24 h and 48 h after stimulation by contact with the test substance. Under the conditions of this experiment, the skin sensitization rate of the test sample in the experimental guinea pigs was 0%; the sensitization intensity was such that no skin allergic reaction was observed.

[0108] 4. Verification of epidermal repair function

[0109] In this experiment, sanitary napkins containing 0.3% vitamin E and 0.7% squalane in the surface layer were used as samples for human efficacy evaluation.

[0110] The repair efficacy was evaluated through a human tear test using a single, localized application. A total of 32 healthy subjects meeting the inclusion criteria participated, aged 18–58 years, with a mean age of 40.1 years. The testing environment required a temperature of 21℃±1℃ and a humidity of 50%RH±10%RH.

[0111] The specific experimental steps include:

[0112] 4.1 Upon the first visit, explain the trial to the participants and obtain their informed consent;

[0113] 4.2 On the day of the visit, the inner forearm area should not come into contact with water. Before the experiment, all subjects should clean the inner forearms of both hands by wiping them dry with a tissue. Measurement areas should be marked on the inner forearms of both subjects, each area being 3cm × 3cm, with at least 1cm between the test areas. The sample area and the blank control area should be randomly distributed in the marked area to ensure that the position of each area is statistically balanced.

[0114] 4.3 Subjects sat quietly for 30 minutes in a laboratory at a temperature of 21±1℃ and 50±10% RH, during which they could not drink water or beverages, their arms were exposed, and they remained relaxed.

[0115] 4.4 Tape Tearing (Timm): Low-allergenic adhesive tape was used to tear the sample area and the blank control area. A pressure bar was applied to the test area for 5 seconds, then the tape was torn off. This process was repeated 5 times. The transepidermal water loss (TEWL) value was measured immediately after the tearing process.

[0116] 4.5 Samples used: On the inner forearm of the subject, a single application of the test sample and control sample (ordinary sanitary napkin without added squalane and vitamin E) was made using a 3cm×3cm patch and fixed with medical hypoallergenic tape.

[0117] 4.6 Two hours after product use (T2h): Test the transepidermal water loss (TEWL) value for each area.

[0118] The statistical analysis methods for the test indicators are as follows:

[0119] SPSS statistical analysis software was used to perform statistical analysis on various test indicators. Measurement data are expressed as mean ± standard error. The difference between the sample area and the blank control area at the same time point was used to perform the Shapiro-Wilke test using SPSS software to determine whether the data conformed to a normal distribution. If the test data were normally distributed, the t-test was used for statistical analysis; if the test data were not normally distributed, the rank-sum test was used. All statistical methods used two-tailed tests, with a significance level of α = 0.05.

[0120] The results showed that a lower TEWL value indicates less transepidermal water loss per unit time and per unit cross-sectional area. Based on Fick's law of diffusion, the TEWL value of transepidermal water loss was obtained by measuring the water vapor partial pressure gradient at different points near the epidermis (within 1 cm) per unit time and per unit cross-sectional area.

[0121] Fick's law of diffusion formula:

[0122]

[0123] In the formula:

[0124] m - Moisture loss, in grams (g).

[0125] t - time, in hours (h);

[0126] D-diffusion constant, 0.0877 [g / (m·h·mmHg)];

[0127] A - Test cross-sectional area, in meters. 2 ;

[0128] P - partial pressure of water vapor, in mmHg;

[0129] x - Distance between temperature and humidity sensors at different points, in meters (m).

[0130] The detection results of this experiment are shown in Tables 5-7 below. Figure 1 As shown.

[0131] Table 5. Descriptive statistical results of transepidermal water loss (TEWL) values ​​in different regions. Unit: g / (h·m 2 )

[0132]

[0133] Table 6. Differences between TEWL values ​​and initial values ​​for each region. Unit: g / (h·m) 2 )

[0134]

[0135] Table 7 Comparison Statistical Results and Judgment Criteria

[0136]

[0137] The results in Tables 5-7 show that after 2 hours of sample application, the TEWL value of the sample area decreased significantly, with a difference of 17.21 ± 0.89 g / (h·m²) compared to the blank control area, and statistical analysis indicated that this difference was highly significant (p < 0.001). These results demonstrate that sanitary napkin application can effectively reduce transepidermal water loss and promote skin barrier repair in this experiment.

[0138] No adverse events occurred during the test, indicating that the sample was safe under the test conditions. In summary, this sanitary napkin has significant repair effects, consistent with its claimed repair function, and is suitable for improving skin barrier function.

[0139] The above are merely preferred embodiments of the present invention. It should be noted that those skilled in the art can make various improvements and modifications without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A method for testing the efficacy of hygiene products, characterized in that, The testing methods include methods for testing the antioxidant function, safety, and repair function of hygiene products, wherein: The method for detecting the antioxidant function of the sanitary products includes: taking the sanitary products and extracting them with an extraction solution to obtain an extract, then using the DPPH method to test and obtain the antioxidant function results of the extract. The safety testing method for the sanitary product includes: taking the sanitary product or its sodium chloride extract, and testing the intensity of the irritant reaction produced by the skin and / or vaginal mucosa of the experimental animal after repeated contact with the sanitary product or its sodium chloride extract. The testing method for the repair function of the hygiene products includes the following steps: Step 1: Randomly select a skin test area on the inner side of the subject's forearm, peel off the skin test area with tape, and measure the first transepidermal water loss of the skin test area; Step 2: Apply the patch prepared from the sanitary product to the skin test area described in Step 1, and measure the second transepidermal water loss in the skin test area after application. Step 3: Calculate the difference in transepidermal water loss described in Step 1 and Step 2, and obtain the result of the repair function based on the difference.

2. The detection method according to claim 1, characterized in that, The sanitary products include at least one of sanitary napkins, panty liners, and tampons.

3. The detection method according to claim 1 or 2, characterized in that, The extraction solution comprises n-hexane and n-butanol in a volume ratio of (1~3):(1~3), the mass-volume ratio of the sanitary product to the extraction solution is (0.1~0.5) g:(15~30) mL, and the extraction time is 20~60 min.

4. The detection method according to claim 1 or 2, characterized in that, The safety testing method for the aforementioned hygiene products, specifically the test method for repeated contact of the hygiene products with the skin of experimental animals, includes the following steps: S1. Experimental animals were set up as experimental group, positive control group and negative control group respectively. The hair on the left and right sides of the spine on the back of the experimental animals was removed to form a 3cm×3cm test area. S2. Apply the patch prepared from the sanitary product after being soaked in sodium chloride to the left test area of ​​the experimental group. Apply a 0.6% solution of 2,4-dinitrochlorobenzene to the left test area of ​​the positive control group. No treatment is given to the negative control group. The test area is covered with two layers of gauze and one layer of cellophane and then fixed with adhesive tape. After 6 hours of treatment, the left test area of ​​the experimental animal is washed with warm water. S3. Repeat S2 on day 7 and day 14 respectively; S4. Fourteen days after the end of S2, the patch prepared by the sanitary product after being soaked in sodium chloride was applied to the right test area of ​​the experimental group and the negative control group. A 0.6% 2,4-dinitrochlorobenzene solution was applied to the right test area of ​​the positive control group, and the test area was covered with two layers of gauze and one layer of cellophane and fixed with adhesive tape in sequence. S5. After 6 hours of treatment, wash the right test area of ​​the experimental animal with warm water, and observe and record the skin reaction at 24 hours and 48 hours.

5. The detection method according to claim 1 or 2, characterized in that, The safety testing method for the aforementioned sanitary products, specifically the test method for repeated contact of the sanitary products with the vaginal mucosa of experimental animals, includes the following steps: Step 1: Take sanitary products and extract them with sodium chloride to obtain an extract; Step II: Inject the extract into the vagina of the experimental animals. The control group was injected with sodium chloride into the vagina of the experimental animals. Repeat Step II for 5 consecutive days. Step III: After euthanizing the mice, the intact vaginas of the experimental and control groups were dissected, and the congestion and edema were observed and recorded. The vaginal tissues were then subjected to pathological examination using HE staining.

6. The detection method according to claim 1 or 2, characterized in that, The experimental animals include rabbits and / or mice.

7. The detection method according to claim 1 or 2, characterized in that, In step 1, the tape is a hypoallergenic tape, the tape peeling time is 5-10 seconds, and the tape peeling number of times is 3-10.

8. The detection method according to claim 1 or 2, characterized in that, In step 2, the application time is 1 to 5 hours.

9. The detection method according to claim 1 or 2, characterized in that, The method for testing the repair function of the hygiene products also includes a blank control group, which is a regular hygiene product without added active ingredients. After testing, the difference in transepidermal water loss of the blank control group was also obtained. Step 3 further includes comparing and statistically analyzing the difference in transepidermal water loss between the experimental group and the blank control group to obtain the results of the repair function.

10. The application of the detection method according to any one of claims 1 to 9 in the detection or screening of functional hygiene products.

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