A stable high content sodium hyaluronate composition and its use, a skin care product

Abstract

The application belongs to the technical field of cosmetics, and discloses a stable high-content sodium hyaluronate composition, application and skin care product thereof.The composition is compounded by a ternary stable solubilizing system composed of methyl glucose alcohol polyether-20, coconut acyl hydrolyzed collagen potassium and PPG-13-decyl tetradecanol polyether-24, a specific cross-linked polymer stabilizer and a specific composite silicone oil component, a system capable of stably bearing 0.5% to 2% sodium hyaluronate is constructed, and in the specific content range, the precise synergistic compatibility successfully enables the high-content sodium hyaluronate composition to have excellent long-term storage stability and actual use skin feel.The composition is used for daily care, and after continuous use, the effect of the composition on skin moisturizing, barrier repair and anti-aging can reach or be superior to that of single sodium hyaluronate water-light needle injection.

Description

Technical Field

[0001] This invention belongs to the field of cosmetic technology and discloses a stable high-content sodium hyaluronate composition and its applications in skin care products. Background Technology

[0002] Sodium hyaluronate, formed by the alternating linkage of D-glucuronic acid and N-acetylglucosamine, is a major component of the extracellular matrix. Due to its excellent water absorption, biocompatibility, and biodegradability, hyaluronic acid has been widely used in the pharmaceutical, cosmetic, and aesthetic medicine fields. In cosmetics, sodium hyaluronate is widely used as a moisturizer, enhancing the skin's natural protective barrier, combating aging and glycation, and promoting active skin repair. In aesthetic medicine, hyaluronic acid filler injections have become a common method for improving facial depressions, static wrinkles, and facial contours. In particular, the "water light injection" technique, which involves injecting high concentrations of sodium hyaluronate into the dermis, can achieve immediate plumping, long-lasting hydration, and anti-aging effects. However, this invasive procedure carries numerous risks and inconveniences, including infection, bruising, long recovery periods, high costs of repeated treatments, and even serious consequences such as vascular complications leading to vision loss. Given the invasiveness and potential risks of aesthetic injections, developing non-invasive skincare solutions to simulate or even achieve the effects of water light injections in daily skincare has become a hot topic in cosmetic research and development.

[0003] Incorporating high concentrations of sodium hyaluronate into cosmetic formulations presents significant technical challenges. When the concentration of sodium hyaluronate reaches 0.5% or higher, its strong water absorption and large molecular size lead to a sharp increase in the viscosity of the product system. This high viscosity can have a series of negative effects. High concentrations of hyaluronic acid molecules easily entangle and aggregate in the aqueous phase, causing sedimentation, stratification, or precipitation during storage, making it difficult to guarantee physical stability and shortening the product's shelf life. The high hydrophilicity and high molecular weight of hyaluronic acid significantly increase the apparent viscosity of the system, resulting in a thick, poorly spreadable product that feels sticky after application. More importantly, high concentrations of hyaluronic acid are prone to incompatibility with electrolytes, thickeners, or powders in the formulation or other subsequent skincare products, forming flocculation on the skin surface and causing severe "pilling," which greatly affects the user experience and efficacy. To address the aforementioned issues with high-content sodium hyaluronate, existing technologies typically employ two compromise approaches: one is to sacrifice the effective content by using only low-concentration hyaluronic acid, but the final effect is not ideal; the other is to rely on a high proportion of oils or traditional thickening systems to maintain stability, but this can lead to products that are greasy and heavy, deviating from consumers' pursuit of a refreshing and breathable skin feel.

[0004] Based on this, the technical problem that this invention needs to solve is: how to provide a high-content sodium hyaluronate composition with good stability, a refreshing, smooth, non-sticky feel, and the ability to effectively prevent pilling. Summary of the Invention

[0005] The purpose of this invention is to provide a stable high-content sodium hyaluronate composition, which has good stability, a refreshing, smooth, and non-sticky feel on the skin, and can effectively prevent pilling.

[0006] In addition, the present invention also provides the application of the high-content sodium hyaluronate composition and skin care products containing the high-content sodium hyaluronate composition.

[0007] To achieve the above objectives, the present invention provides the following technical solution:

[0008] A stable high-content sodium hyaluronate composition, wherein the high-content sodium hyaluronate composition comprises the following components: 0.5-2 wt% sodium hyaluronate, 0.3-1 wt% stabilizer, 1.94-5 wt% composite silicone oil, 0.5%-2 wt% methyl glucanol polyether-20, 0.001-0.02 wt% cocoyl hydrolyzed collagen potassium, 0.015-2 wt% PPG-13-decyltetradecyl alcohol polyether-24, 7-10 wt% polyol, 1-5 wt% hydroxyethyl urea, and the balance being water;

[0009] The stabilizer is polyacrylate crosslinker-6;

[0010] The composite silicone oil is a combination of polydimethylsiloxane, diphenylsiloxyphenyl polytrimethylsiloxane, and polydimethylsiloxane alcohol;

[0011] The polyol is at least one of butanediol and glycerol.

[0012] The high-content sodium hyaluronate composition provided by this invention can simultaneously overcome the contradictions in stability, skin feel, and efficacy caused by high-content sodium hyaluronate. It is speculated that the mechanism by which this effect is achieved may be:

[0013] The stabilizer polyacrylate crosslinker-6 selected in the composition can hydrate and swell in the aqueous phase, forming a robust three-dimensional crosslinked polymer network. This network acts like a microscopic "fishing net" or "skeleton," enabling the high concentration of sodium hyaluronate segments to be evenly distributed within the network, preventing flocculation caused by charge repulsion. The presence of polyols (butanediol, glycerin) further provides a highly hydrated environment for sodium hyaluronate, allowing its molecular chains to fully extend and avoiding inter-chain entanglement caused by dehydration. Together with the polymer network, this ensures the long-term uniformity and stability of the system. High-content sodium hyaluronate is often accompanied by severe stringiness and stickiness. The composite silicone oil component utilizes siloxanes with different volatility and spreading coefficients. When applied to the skin, it can quickly spread and fuse into a continuous, smooth, and breathable hydrophobic film, providing an immediate and lasting silky, refreshing feel, effectively neutralizing the stickiness that may result from high-molecular-weight hyaluronic acid. Meanwhile, the silicone oil component acts as a lubricant in the network constructed by the stabilizer, helping to maintain the microstructure of the system and preventing excessive aggregation of sodium hyaluronate molecules.

[0014] However, a physical "skeleton" and "lubricating interface" alone are insufficient to permanently bind the highly active, highly charged sodium hyaluronate molecular chains. The methyl glucan-20, cocoyl hydrolyzed collagen potassium, and PPG-13-decyltetradecyl alcohol polyether-24 of this invention play a crucial role in dispersion and compatibility assurance. In this system, PPG-13-decyltetradecyl alcohol polyether-24, as a high-molecular-weight nonionic surfactant, has its long polyoxyethylene / polyoxypropylene segments adsorbed at multiple points on the surface of the sodium hyaluronate molecular chains through van der Waals forces, forming a dense, hydrodynamically solvated film. This solvated film provides a strong steric hindrance effect, physically preventing the close proximity and mechanical entanglement between the sodium hyaluronate macromolecular chains. Meanwhile, potassium cocoyl hydrolyzed collagen, as an anionic active component, exhibits electrostatic repulsion with the carboxyl groups of sodium hyaluronate molecules due to its negatively charged centers, further inhibiting polymer chain aggregation. Its collagen peptide backbone demonstrates excellent interfacial affinity, acting as an interfacial balancer to uniformly encapsulate and embed the subsequently introduced composite silicone oil component into the hyaluronic acid network, solving the problem of high-concentration polymers repelling oily components. Building upon this, methyl glucol polyether-20 plays a crucial "molecular bridge" role. Its abundant hydroxyl structure can competitively associate and specifically break the original rigid hydrogen bond network between sodium hyaluronate molecules, transforming the system's rheological behavior from high viscoelasticity to easily spreadable shear-thinning properties. This effect not only effectively couples the steric hindrance layer and electrostatic repulsion layer onto the long hyaluronic acid chain, forming a stable and dynamically elastic three-dimensional network, but also significantly reduces the system's surface tension. This system fundamentally solves the inherent thermodynamic instability problem of high-content sodium hyaluronate in complex systems. In summary, the synergistic mechanism of this invention addresses suspension stability using a polymer three-dimensional network as a framework, resolves dispersion and compatibility issues using a ternary stable solubilizing system, addresses skin feel and pilling problems using a composite silicone oil component as an interface, and further enhances and drives the entire system to achieve superior efficacy through a multi-element moisturizing system. These components are not simply additive but rather interdependent and mutually reinforcing, collectively achieving a balance of stability, user experience, and efficacy at high active ingredient content.

[0015] Preferably, the mass ratio of polydimethylsiloxane, diphenylsiloxyphenyl polytrimethylsiloxane, and polydimethylsiloxane alcohol in the composite silicone oil is 1.4~3.8:0.5~1:0.04~2.

[0016] Preferably, the high-content sodium hyaluronate composition further includes 0.4-2 wt% of a preservative, wherein the preservative is at least one selected from p-hydroxyacetophenone and 1,2-hexanediol.

[0017] Preferably, the weight-average molecular weight of the sodium hyaluronate is selected from one or more combinations of 0.2~0.5kDa, 8~12kDa, 15~25kDa, 25~35kDa, 45~55kDa, and 55~70kDa.

[0018] Furthermore, this invention discloses a method for preparing the high-content sodium hyaluronate composition as described above, comprising the following steps:

[0019] Step 1: Add the stabilizer to the water and stir at 800-1500 rpm for 8-15 minutes until it is evenly dispersed; Step 2: Add the premixed sodium hyaluronate and polyol to the product of Step 1, and heat to 80~85℃; Step 3: After confirming that the product from Step 2 is mixed evenly, add p-hydroxyacetophenone to the product from Step 2 and disperse it evenly in the dispersion tray; after confirming that the material is uniform, start cooling. Step 4: Cool to 40~45℃, then add 1,2-hexanediol, methylglucanol polyether-20, cocoyl hydrolyzed collagen potassium, PPG-13-decyltetradecyl alcohol polyether-24, hydroxyethyl urea and composite silicone oil in sequence, and homogenize at 1800-2500 rpm for 1~3 minutes to obtain the high-content sodium hyaluronate composition.

[0020] Furthermore, this invention discloses the application of the high-content sodium hyaluronate composition described above in the preparation of non-invasive skin care products.

[0021] Preferably, the non-invasive skincare product is a skincare product used for moisturizing, repairing, anti-wrinkle, or firming.

[0022] Preferably, the non-invasive skincare product, applied twice daily (morning and evening) for eight consecutive weeks, achieves better results than a single hyaluronic acid injection in terms of skin hydration, barrier repair, soothing, anti-wrinkle effects, and improved skin smoothness and translucency.

[0023] Finally, this invention discloses a skin care product containing a high content of sodium hyaluronate composition as described above.

[0024] Preferably, the amount of the high-content sodium hyaluronate composition added is 25~100wt%.

[0025] Compared with the prior art, the beneficial effects of the present invention are:

[0026] 1. The stable high-content sodium hyaluronate composition of the present invention successfully adds a high content of sodium hyaluronate, and through the synergistic effect of the three-dimensional polymer network constructed by the stabilizer and the ternary stable solubilizing system composed of methyl glucol polyether-20, cocoyl hydrolyzed collagen potassium, and PPG-13-decyltetradecyl alcohol polyether-24, the stability of the high-content sodium hyaluronate composition is synergistically improved, solving the storage problem of high-content sodium hyaluronate system and achieving long-term physical stability without sedimentation or stratification.

[0027] 2. The high-content sodium hyaluronate composition prepared by the method of this invention has a light texture and good spreadability, leaving the skin feeling refreshed, silky, and non-sticky after application. The unique silicone oil system effectively prevents pilling when used with subsequent skincare products, significantly improving the user experience.

[0028] 3. The high-content sodium hyaluronate composition prepared by the method of the present invention, when used as a daily skin care product, can achieve significantly better results than a single 2 mL (5 mg / mL) hyaluronic acid injection in terms of skin moisture content, transepidermal water loss rate, skin elasticity, skin radiance, and wrinkle improvement by applying it once in the morning and once in the evening for 8 consecutive weeks. This provides a non-invasive, water-light injection-like skin care solution.

[0029] 4. The preparation method of the high-content sodium hyaluronate composition of the present invention is simple and mild, effectively ensuring the stability and uniform dispersion of the highly active ingredients. The process is simple and controllable, making it very suitable for industrial production. Attached Figure Description

[0030] Figure 1 These are photographs of the compositions of Examples 1-4 after being stored at room temperature for two months;

[0031] Figure 2 These are photographs of the compositions of Examples 1-4 after being stored at 48°C for two months;

[0032] Figure 3 These are photographs of the compositions of Examples 1-4 after being stored at 4°C for two months;

[0033] Figure 4 These are photographs of the compositions of Examples 1-3 after being stored at -18°C for two months;

[0034] Figure 5 Photographs of the compositions of Comparative Examples 1, 3, 7, 10, 14, 18, and 19 after being stored at room temperature for one week;

[0035] Figure 6 Photographs of the compositions of Comparative Examples 1, 3, 7, 10, 14, 18, and 19 after being stored at room temperature for one month;

[0036] Figure 7 Photographs of the compositions of Comparative Examples 1, 3, 7, 10, 14, 18, and 19 after storage at 48°C for one week;

[0037] Figure 8 Photographs of the compositions of Comparative Examples 1, 3, 7, 10, 14, 18, and 19 after storage at 4°C for one week;

[0038] Figure 9 Photographs of the compositions of Comparative Examples 1, 3, 7, 10, 14, 18, and 19 after storage at 4°C for one month;

[0039] Figure 10 Photographs of the compositions of Comparative Examples 1, 3, 7, 10, 14, 18, and 19 after storage at -18°C for one week;

[0040] Figure 11 Photographs of the compositions of Comparative Examples 1, 3, 7, 10, 14, 18, and 19 after storage at -18°C for one month;

[0041] Figure 12 Photographs of the compositions of Comparative Examples 1, 3, 7, 10, 14, 18, and 19 after being stored at -18°C for two months. Detailed Implementation

[0042] The technical solution 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 some embodiments of the present invention, and not all 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.

[0043] Product Information:

[0044] Sodium hyaluronate HA20, HA0.3, and HA60 (all with full molecular weight) were purchased from Shandong Guantianxia Biotechnology Co., Ltd.

[0045] Polyacrylate crosspolymer-6 was purchased from SEPPIC SA;

[0046] Methyl glucetol polyether-20 was purchased from Lubrizol Management (Shanghai) Co., Ltd.

[0047] Potassium cocoyl hydrolyzed collagen was purchased from SEIWA KASEI;

[0048] PPG-13-decyltetradecyl alcohol polyether-24 was purchased from Dongguan Weiqi Technology Co., Ltd.

[0049] Diphenylsiloxyphenyl polytrimethylsiloxane is purchased from Xinyue Organosilicon International Trading (Shanghai) Co., Ltd.

[0050] Polydimethylsiloxane and polydimethylsiloxane alcohol were purchased from Dow (Zhangjiagang) Investment Co., Ltd.

[0051] Hydroxyethylurea was purchased from Guangzhou Baifurun Chemical Co., Ltd.

[0052] 1,2-Hexanediol was purchased from Ashland LLC;

[0053] Butanediol was purchased from Wanhua Chemical Group Co., Ltd.

[0054] Glycerin was purchased from Tyco Brown Chemical (Zhangjiagang) Co., Ltd.

[0055] p-Hydroxyacetophenone was purchased from Beijing Tianhong Tianda Technology Co., Ltd.

[0056] The formulations of the high-content sodium hyaluronate compositions in Examples 1-4 are shown in Table 1;

[0057] Table 1. Formulation of high-content sodium hyaluronate compositions in Examples 1-4 (wt%)

[0058]

[0059] The preparation methods of Examples 1-4 are as follows: Step 1: Add phase A material to the main pot and homogenize for 15 minutes at 900 rpm to ensure the material in the main pot is uniform; Step 2: Premix the B phase material completely, add it to the main pot, disperse it on the dispersion plate for 4 minutes at 1200 rpm, and start heating; Step 3: Heat to 82℃, confirm that the materials in the main pot are evenly mixed, then add the C phase raw material to the main pot and stir (20 rpm) evenly. Homogenize for 2 minutes at 1000 rpm. After confirming that the materials are evenly mixed, start cooling. Step 4: Cool down to 40℃, add phase D raw material and phase E raw material to the main pot in sequence, homogenize for 1 minute at 1500 rpm; confirm that the material in the main pot is uniform, and start cooling; cool down to 38℃, and filter with 200 mesh double layer pressure to obtain a high content sodium hyaluronate composition.

[0060] The formulations of the sodium hyaluronate compositions in Comparative Examples 1 to 6 are shown in Table 2;

[0061] Table 2. Formulation of high-content sodium hyaluronate compositions for comparative examples 1-6 (wt%)

[0062]

[0063] The formulations of the sodium hyaluronate compositions of Comparative Examples 7-12 are shown in Table 3;

[0064] Table 3 Formulation table (wt%) of Comparative Examples 7-12

[0065]

[0066] The formulations of the sodium hyaluronate compositions in Comparative Examples 13-17 are shown in Table 4;

[0067] Table 4 Formulation table (wt%) of Comparative Examples 13-17

[0068]

[0069] The preparation methods for Comparative Examples 13-17 are as follows: Step 1: Add phase A material to the main pot and homogenize for 15 minutes at 900 rpm to ensure the material in the main pot is uniform; Step 2: Premix the B phase material completely, add it to the main pot, disperse it on the dispersion plate for 4 minutes at 1200 rpm, and start heating; Step 3: Heat to 82℃, confirm that the materials in the main pot are evenly mixed, then add the C phase raw material to the main pot and stir (20 rpm) evenly. Homogenize for 2 minutes at 1000 rpm. After confirming that the materials are evenly mixed, start cooling. Step 4: Cool down to 40 degrees Celsius, add phase D and phase E raw materials to the main pot in sequence, homogenize for 1 minute at 1500 rpm; confirm that the materials in the main pot are uniform, and start cooling; cool down to 38 degrees Celsius, and filter under pressure using a 200-mesh double-layer filter to obtain the composition.

[0070] Comparative Example 18

[0071] It is largely the same as Example 4, except that an equal amount of hydroxyethyl cellulose 250HHR is used to replace the polyacrylate crosslinker-6.

[0072] Comparative Example 19

[0073] It is largely the same as Example 4, except that an equal amount of sunflower seed oil is used to replace the composite silicone oil.

[0074] Performance testing

[0075] Stability testing of high-content sodium hyaluronate compositions

[0076] To ensure the quality of cosmetics during various distribution channels and actual use, a shelf life of at least three years is generally required for the formulation. However, due to the excessive time required, accelerated testing under equivalence conditions is typically employed. Extensive research data indicates that storing a formulation at 45°C for two months effectively simulates a cosmetic's three-year shelf life at room temperature. To investigate the stability of high-content sodium hyaluronate compositions, the high-content sodium hyaluronate compositions from each example and comparative example were dispensed into uniform-capacity plastic bottles and stored at room temperature, 48°C, 4°C, and -18°C, respectively. The stability of the high-content sodium hyaluronate compositions at different storage temperatures was monitored at 1 week, 1 month, and 2 months.

[0077] The test results are shown in Table 5 and Figures 1-12 As shown, Figures 1-12 These are test photographs for examples and some comparative examples.

[0078] Table 5 Stability Test Results

[0079]

[0080] From Table 5 and Figures 1-12 It can be known that:

[0081] 1. The high-content sodium hyaluronate composition of this application did not show any stratification or flocculation after two months of testing at various test temperatures, indicating that it has good long-term physical stability.

[0082] 2. Comparing Example 1 with Comparative Examples 1-6, it can be found that the three components constituting the ternary stable solubilizing system—methylglucol polyether-20, potassium cocoyl hydrolyzed collagen, and PPG-13-decyltetradecyl alcohol polyether-24—must be present simultaneously and are indispensable. The absence of any one or more components will directly lead to phase separation during storage. Furthermore, the amount of these three components is also crucial. Comparative Example 13 (high content of methylglucol polyether-20) and Comparative Example 17 (high content of PPG-13-decyltetradecyl alcohol polyether-24) also exhibited stratification; while Comparative Example 14 (low content of methylglucol polyether-20), Comparative Example 16 (low content of PPG-13-decyltetradecyl alcohol polyether-24), and Comparative Example 15 (high content of potassium cocoyl hydrolyzed collagen) also failed the stability test. The above results demonstrate that the amount of each key component must be precisely controlled within the range defined by this invention. Too high or too low a amount will disrupt the precise balance of the system and fail to achieve the expected stable effect.

[0083] 3. Comparative Examples 7 to 12 all showed stratification under storage conditions of room temperature, 4°C and 48°C. This result clearly demonstrates that the ternary composite silicone oil components (polydimethylsiloxane, diphenylsiloxyphenyl polytrimethylsiloxane, polydimethylsiloxane alcohol) used in this invention are a synergistic whole, and each component is indispensable.

[0084] 4. Comparative Examples 18 and 19 fully demonstrate that the specific crosslinking polymer stabilizer and specific composite silicone oil component selected in this invention are irreplaceable. They have unique compatibility with other components in the composition and are irreplaceable key elements for building a long-term stable system.

[0085] In summary, the technical solution of the present invention utilizes a ternary stable solubilizing system composed of methyl glucan polyether-20, cocoyl hydrolyzed collagen potassium and PPG-13-decyltetradecyl alcohol polyether-24, a specific crosslinking polymer stabilizer and a specific composite silicone oil component, and achieves precise synergistic compatibility within a specific content range, thus successfully realizing the long-term physical stability of a high-content sodium hyaluronate composition.

[0086] Testing of the pilling properties of high-content sodium hyaluronate compositions

[0087] The high hydrophilicity and high molecular weight of sodium hyaluronate significantly increase the apparent viscosity of the system, resulting in a thick, heavy texture, poor spreadability, and a sticky feel after application. More importantly, high concentrations of hyaluronic acid are prone to incompatibility with electrolytes, thickeners, or powders in the formulation or other subsequent skincare products, forming flocculation on the skin surface and causing severe pilling, greatly affecting the user experience and efficacy. Therefore, while ensuring the stability of the high-concentration sodium hyaluronate composition, the pilling effect of the high-concentration sodium hyaluronate composition was further investigated. Based on the stability test results, the pilling risk of Examples 1-3 and Comparative Example 13 needs further evaluation.

[0088] The test was conducted independently by 10 sensory evaluators. Evaluators cleaned their hands with a standardized cleaning product, patted them dry with lint-free absorbent paper, and rested for 3 minutes before starting the test. 0.05 mL of the product was applied to the back of the hand using a fingertip cloth. Evaluators applied the high-content sodium hyaluronate composition at a rate of 1 revolution per second. If pilling occurred, the evaluator stopped applying and recorded the number of revolutions at which pilling occurred. For evaluators who did not experience pilling, they continued applying the product for 30 seconds until pilling occurred, recording the number of revolutions at which pilling occurred. After 30 seconds without pilling, evaluators rested for 2 minutes before applying the product at a rate of 1 revolution per second until absorption, recording the number of revolutions when absorption was complete (within 90 seconds). The test results are shown in Table 6.

[0089] Table 6 Results of the Kneading Experiment

[0090] Example 1 none No pilling occurred until absorption. Example 1 none No pilling occurred until absorption. Example 1 none No pilling occurred until absorption. Comparative Example 13 yes Within 30 seconds of application, all 10 testers experienced pilling.

[0091] As shown in Table 6, in the pilling test conducted by professional evaluators, none of the products in Examples (1-3) of this invention exhibited any pilling phenomenon. Evaluators were able to smoothly and evenly apply the product and achieve complete absorption, with a refreshing and smooth feel on the skin throughout the process. In contrast, in Comparative Example 13, pilling occurred in all 10 testers within 30 seconds of application. It is particularly noteworthy that the effects of higher methyl glucosyl ether-20 content varied: lower content directly led to high-temperature delamination; higher content, however, resulted in pilling during use.

[0092] The results of comprehensive stability tests and pilling experiments demonstrate that the technical solution of this invention utilizes a ternary stable solubilizing system composed of methyl glucosyl polyether-20, cocoyl hydrolyzed collagen potassium, and PPG-13-decyltetradecyl alcohol polyether-24, along with a specific crosslinking polymer stabilizer and a specific composite silicone oil component, and achieves precise synergistic compatibility within a specific content range. This successfully overcomes the technical contradictions between long-term storage stability and actual skin feel in high-content sodium hyaluronate compositions.

[0093] Efficacy testing of high-content sodium hyaluronate compositions

[0094] Seventy volunteers (women aged 30 to 63 years with no history of skin diseases or cosmetic allergies; reporting sensitive facial skin with a facial skin moisture content <50 au; TEWL value >15 g / m²h) were recruited to evaluate the effects of the high-content sodium hyaluronate composition (Composition 1) prepared in Example 1 and hyaluronic acid injections. Based on a randomized, pre- and post-controlled design, a total of 66 eligible female volunteers participated in the test. During the test, one group of volunteers used Composition 1 (applied twice daily, morning and evening), while the other group received a single hyaluronic acid injection followed by a sodium hyaluronate-free base composition (applied twice daily, morning and evening). The same daily skincare products, except for the test sample, were used on the entire face for 8 consecutive weeks, maintaining the same brand and usage method. Before use (D0), 10 minutes after use (D0T10min), after 1 week of use (D7), after 3 weeks of use (D21), and after 8 weeks of use (D56), the same technician performed the following instrument tests on both cheeks: skin moisture content (Corneometer® CM825), transepidermal water loss rate (Tewameter® TM Hex), skin radiance (Glossymeter® GL200), skin translucency (Translucencymeter® TLS855), skin elasticity and firmness (Cutometer® dualMPA580), and skin texture (Visioscan® VC20plus). Facial wrinkles (including frown lines, crow's feet, nasolabial folds, cheek wrinkles, and forehead wrinkles) were assessed using Antera 3D®, and a visual evaluation was also conducted by an expert. The results are shown in Table 7 and Table 7 (continued).

[0095] Using Excel, descriptive statistics were performed on each measurement, including mean, standard deviation, median, minimum, and maximum. Using R, the Shapiro-Wilk Test was used to test the significance of the normal distribution of the data differences. If P(two-tailed) > 0.05, the data is normally distributed, and a one-sample t-test was performed with a significance level of α = 0.05. If P(two-tailed) < 0.05, the data is not normally distributed, and a Wilcoxon signed-rank test was performed with a significance level of α = 0.05.

[0096] Change rate after product use = (Data after use - Data before use) / Data before use

[0097] Table 7 Comparison of changes in skin parameters

[0098] Table 7 (Continued) Comparison of changes in skin parameters

[0099] Table 7 (Continued) Comparison of changes in skin parameters

[0100] Table 7 (Continued) Comparison of changes in skin parameters

[0101] Table 7 (Continued) Comparison of changes in skin parameters

[0102] Table 7 (Continued) Comparison of changes in skin parameters

[0103] Note: Values ​​are expressed as mean ± standard deviation. 'a' represents the p-value of the two-sample t-test (or Mann-Whitney U test) between the high-content sodium hyaluronate composition prepared in Example 1 and the hyaluronic acid injection group.

[0104] Comparative analysis of long-term use effects (D56) between the two groups:

[0105] After 8 weeks of continuous use, Composition 1 demonstrated significantly better long-term effects than the hyaluronic acid injection group across several key indicators. Regarding skin barrier function and hydration, Composition 1 showed a significantly higher increase in skin moisture content (+36.84%) than the hyaluronic acid injection group (+14.18%), and its decrease in transepidermal water loss (-30.97%) was also significantly greater than that of the hyaluronic acid injection group (-24.28%). This indicates that Composition 1 provides more lasting and powerful hydration and barrier repair capabilities. In terms of skin radiance, Composition 1 also showed a significantly higher improvement rate (+26.51%) than the hyaluronic acid injection group (+13.54%), demonstrating its superior long-term effects in improving skin tone and texture. In terms of soothing sensitivity and improving redness, Composition 1 also demonstrated outstanding performance: after 8 weeks of use, the reduction in redness a value (-23.23%) was significantly better than that of the hyaluronic acid injection group (-13.06%), and the reduction rate of redness area (-46.72%) was far greater than that of the hyaluronic acid injection group (-24.83%), with both differences reaching statistical significance (P<0.05). Regarding skin texture, Composition 1 exhibited superior refining effects: the improvement in skin smoothness (SEsm) (-20.83%) was significantly greater than that of the hyaluronic acid injection group (-16.09%), indicating that it made the skin surface smoother; at the same time, the improvement rate of skin roughness (SEr) (+38.53%) was also significantly higher than that of the hyaluronic acid injection group (+21.43%), indicating that its effect on optimizing skin texture was more significant. In addition, in terms of skin translucency, the ALPHA value of composition group 1 (-9.66%) was significantly lower than that of the water-light injection group (-5.16%), suggesting that it can improve the clarity and radiance of the skin to a greater extent.

[0106] Of particular note is the comprehensive and significant advantage of Composition 1 in its core anti-wrinkle efficacy. Instrumental testing results showed that after 8 weeks of use, Composition 1 significantly outperformed the hyaluronic acid injection group in terms of the average width and depth of wrinkles on the cheeks (-36.17% and -21.14%, respectively) compared to the hyaluronic acid injection group (-23.43% and -15.01%, respectively). Similarly, for wrinkles in specific areas such as nasolabial folds, crow's feet, frown lines, and interocular wrinkles, Composition 1 also significantly outperformed the hyaluronic acid injection group in terms of wrinkle width and depth (P values ​​less than 0.05). For example, the average depth improvement rate for nasolabial folds reached -49.49%, the average width improvement rate for crow's feet reached -31.47%, the average width improvement rate for frown lines reached -27.79%, and the average width improvement rate for interocular wrinkles reached -30.40%. These data strongly demonstrate that Composition 1 of the present invention has superior long-term efficacy in reducing various types of facial wrinkles.

[0107] Dynamic analysis of changes within each of the two groups over time:

[0108] Analysis of data from different time points within the two groups revealed distinctly different onset mechanisms for the two treatments. Composition 1 exhibited an "immediate onset and sustained enhancement" characteristic. Within just 10 minutes of application (DOT10min), skin moisture increased significantly by 62.64%, and transepidermal water loss was immediately reduced, demonstrating rapid moisturizing and occlusive effects. Subsequently, with prolonged use, the improvement rates of most indicators showed a steady upward trend. For example, skin moisture content increased from +10.94% on D7 to +36.84% on D56; the improvement in cheek wrinkle width increased from -13.96% on D7 to -36.17% on D56, reflecting the cumulative and sustained repair effects of daily use. In contrast, the hyaluronic acid injection group exhibited a "significant early effect, but diminishing effect later." Its immediate moisturizing effect at DOT10min (+57.95%) was comparable to, but slightly lower than, Composition 1. However, the peak of its long-term effects mostly occurs on days 7 or 21, followed by a significant decline on day 56. For example, the improvement in skin moisture content peaks on day 21 (+33.04%), then drops to +14.18% on day 56; the improvement in transdermal water loss rate also peaks on day 21 (-29.03%), then declines to -24.28% on day 56. Regarding anti-wrinkle effects, several indicators in the hyaluronic acid injection group, such as the improvement rates of cheek wrinkle width and nasolabial fold depth, are lower on day 56 than on day 21, indicating that the effects of a single injection have a limited duration and a declining trend.

[0109] Based on the above data, the composition 1 described in this invention demonstrated significant advantages over a single hyaluronic acid injection in an 8-week trial. It not only provides faster and longer-lasting hydration and barrier repair effects, but more importantly, it achieves superior wrinkle reduction in multiple areas, including the cheeks, nasolabial folds, crow's feet, frown lines, and interorbital wrinkles, in terms of both width and depth. Simultaneously, it also exhibits significant and superior effects in improving facial redness, reducing skin roughness, and enhancing skin smoothness and translucency. This continuous accumulation and strengthening effect is far superior to the tendency for the effects of hyaluronic acid injections to diminish over time. Therefore, the product of this invention, as a convenient, safe, and long-lasting skincare solution, has significant application value in moisturizing, repairing, and effectively reducing wrinkles.

[0110] It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above, and that the invention can be implemented in other specific forms without departing from the spirit or essential characteristics of the invention. Therefore, the embodiments should be considered in all respects as exemplary and non-limiting, and the scope of the invention is defined by the appended claims rather than the foregoing description. Thus, it is intended that all variations falling within the meaning and scope of equivalents of the claims be included within the present invention.

Claims

1. A stable high-content sodium hyaluronate composition, characterized in that, The high-content sodium hyaluronate composition comprises the following components: 0.5-2 wt% sodium hyaluronate, 0.3-1 wt% stabilizer, 1.94-5 wt% composite silicone oil, 0.5%-2 wt% methyl glucanol polyether-20, 0.001-0.02 wt% cocoyl hydrolyzed collagen potassium, 0.015-2 wt% PPG-13-decyltetradecyl alcohol polyether-24, 7-10 wt% polyol, 1-5 wt% hydroxyethyl urea, and the balance being water; The stabilizer is polyacrylate crosslinker-6; The composite silicone oil is a combination of polydimethylsiloxane, diphenylsiloxyphenyl polytrimethylsiloxane, and polydimethylsiloxane alcohol; The polyol is at least one of butanediol and glycerol.

2. The high-content sodium hyaluronate composition according to claim 1, characterized in that, The mass ratio of polydimethylsiloxane, diphenylsiloxyphenyl polytrimethylsiloxane, and polydimethylsiloxane alcohol in the composite silicone oil is 1.4~3.8:0.5~1:0.04~2.

3. The high-content sodium hyaluronate composition according to claim 1, characterized in that, The high-content sodium hyaluronate composition further includes 0.4-2 wt% of a preservative, wherein the preservative is at least one selected from p-hydroxyacetophenone and 1,2-hexanediol.

4. The high-content sodium hyaluronate composition according to claim 1, characterized in that, The weight-average molecular weight of the sodium hyaluronate is selected from one or more combinations of 0.2~0.5kDa, 8~12kDa, 15~25kDa, 25~35kDa, 45~55kDa, and 55~70kDa.

5. A method for preparing a high-content sodium hyaluronate composition as described in any one of claims 1 to 4, characterized in that, Includes the following steps: Step 1: Add the stabilizer to the water and stir at 800-1500 rpm for 8-15 minutes until it is evenly dispersed; Step 2: Add the premixed sodium hyaluronate and polyol to the product of Step 1, and heat to 80~85℃; Step 3: After confirming that the product from Step 2 is mixed evenly, add p-hydroxyacetophenone to the product from Step 2 and disperse it evenly in the dispersion tray; after confirming that the material is uniform, start cooling. Step 4: Cool to 40~45℃, then add 1,2-hexanediol, methylglucanol polyether-20, cocoyl hydrolyzed collagen potassium, PPG-13-decyltetradecyl alcohol polyether-24, hydroxyethyl urea and composite silicone oil in sequence, and homogenize at 1800-2500 rpm for 1~3 minutes to obtain the high-content sodium hyaluronate composition.

6. The use of the high-content sodium hyaluronate composition as described in any one of claims 1 to 4 in the preparation of non-invasive skin care products.

7. The application according to claim 6, characterized in that, The non-invasive skincare products mentioned are skincare products used for moisturizing, repairing, anti-wrinkle, or firming.

8. The application according to claim 6, characterized in that, The non-invasive skincare product, applied twice daily (morning and evening) for eight consecutive weeks, achieves superior results compared to a single hyaluronic acid injection in terms of skin hydration, barrier repair, soothing, anti-wrinkle effects, and improved skin smoothness and translucency.

9. A skincare product, characterized in that, The skin care product contains a high-content sodium hyaluronate composition as described in any one of claims 1 to 4.

10. The skincare product according to claim 8, characterized in that, The amount of the high-content sodium hyaluronate composition added is 25~100wt%.

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