A composition and its use in the prevention of stretch marks

Abstract

This invention relates to pharmaceutical preparations, and more particularly to a composition and its application in the prevention of stretch marks. The composition comprises, by weight, the following ingredients: 5-10 parts of Polygonatum sibiricum, 10-20 parts of Centella asiatica, 5-10 parts of Taxillus chinensis, 1-5 parts of Calendula officinalis, 10-15 parts of polyol, 0.5-1.2 parts of p-hydroxyacetophenone, 20-30 parts of vegetable oil, 1-2 parts of water-in-oil emulsifier, 1-3 parts of hydrogenated lecithin, 0.1-1 part of cetearyl alcohol, 1-2 parts of phytosterol, 0.1-0.5 parts of ascorbyl palmitate, 1-2 parts of hydrolyzed collagen, 1-2 parts of complex vitamins, 0.5-2 parts of schistosome extract, 0.1-0.3 parts of allantoin, 0.1-0.5 parts of sodium hyaluronate, 0.5-3 parts of liquid crystal emulsifier, 0.5-1 part of amino-terminated polyamide amine, 1-2 parts of preservative, and 60-80 parts of water. This invention can effectively stimulate fibroblast proliferation and effectively prevent and lighten the formation of stretch marks.

Description

Technical Field

[0001] This invention relates to pharmaceutical preparations, and more particularly to a composition and its use in the prevention of stretch marks. Background Technology

[0002] Stretch marks are caused by changes in the mother's adrenal glucocorticoid hormones during pregnancy and the mechanical stretching of the skin. This results in excessive protein breakdown, brittle and broken elastic fibers, and skin atrophy and thinning. They generally appear as pink or purplish-red wavy patterns of varying widths and lengths on the abdominal skin. After childbirth, the patterns disappear, leaving behind white or silvery-white scars.

[0003] Currently available interventions primarily focus on postpartum repair, such as laser therapy, dermabrasion, and chemical peels. However, these methods mainly target existing, old scars and generally suffer from long treatment cycles, significant pain, and high recurrence rates. More importantly, since stretch marks represent a permanent rupture of the dermis once formed, current methods cannot completely eliminate them; they can only improve appearance by stimulating regeneration. Furthermore, during pregnancy, due to concerns about fetal safety, most potent repair ingredients are strictly prohibited, resulting in a severe lack of safe and effective preventative measures during pregnancy.

[0004] While natural plant extracts are currently considered the preferred choice for skincare during pregnancy, their active ingredients often have large molecular weights, making it difficult for them to penetrate the skin barrier. This results in low transdermal absorption rates, hindering their ability to provide the necessary support and protection. Therefore, developing a preventative agent that combines high safety with high transdermal permeability to intervene before stretch marks form has significant market value. Summary of the Invention

[0005] The purpose of this invention is to address the shortcomings of existing technologies by proposing a composition and its application in the prevention of stretch marks.

[0006] A composition comprising, by weight, the following ingredients: 5-10 parts Polygonatum sibiricum, 10-20 parts Centella asiatica, 5-10 parts Taxillus chinensis, 1-5 parts Calendula officinalis, 10-15 parts polyol, 0.5-1.2 parts p-hydroxyacetophenone, 20-30 parts vegetable oil, 1-2 parts water-in-oil emulsifier, 1-3 parts hydrogenated lecithin, 0.1-1 part cetearyl alcohol, 1-2 parts phytosterol, 0.1-0.5 parts ascorbyl palmitate, 1-2 parts hydrolyzed collagen, 1-2 parts complex vitamins, 0.5-2 parts schizocarpine, 0.1-0.3 parts allantoin, 0.1-0.5 parts sodium hyaluronate, 0.5-3 parts liquid crystal emulsifier, 0.5-1 part amino-terminated polyamide amine, 1-2 parts preservative, and 60-80 parts water.

[0007] Preferably, the vegetable oil is at least one of jojoba seed oil, sweet almond oil, shea butter, camellia seed oil, macadamia seed oil, and squalane.

[0008] Preferably, the water-in-oil emulsifier is at least one of PEG-10 polydimethylsiloxane, sorbitol olive oil ester, and PEG-20 glyceryl triisostearate.

[0009] Preferably, the polyol is at least one selected from glycerol, butanediol, polyethylene glycol, and polyglycerol.

[0010] Preferably, the liquid crystal emulsifier includes at least one of lecithin-based liquid crystal emulsifiers and glycoside-based liquid crystal emulsifiers.

[0011] The method for preparing the above composition includes the following steps: S1. Add the water-in-oil emulsifier to the vegetable oil, homogenize at 75-85℃ for 2-6 minutes, add hydrogenated lecithin, cetearyl alcohol, phytosterol, and ascorbyl palmitate, continue homogenizing for 1-2 minutes, and keep warm to obtain the oil phase material. S2. Mix Polygonatum sibiricum, Centella asiatica, Taxillus chinensis and Calendula officinalis, and extract twice with ethanol aqueous solution under reflux for 1-2 hours each time. Combine the filtrates, recover the ethanol under reduced pressure and concentrate. Add polyol and p-hydroxyacetophenone, homogenize at 70-80℃ for 1-3 minutes, and keep warm to obtain the alcohol phase material. S3. Add hydrolyzed collagen and complex vitamins to water, stir and homogenize at 40-50℃ for 2-8 minutes, add schistosome, allantoin and sodium hyaluronate and stir until completely dissolved, keep warm to obtain aqueous phase material; S4. Add the alcohol phase material to the oil phase material and homogenize for 1-3 minutes. Add the liquid crystal emulsifier and the amino-terminated polyamide amine and homogenize for 1-2 minutes. Add the alcohol phase material to the water phase material and homogenize for 1-3 minutes. Add the preservative and stir until homogenized.

[0012] Preferably, the mass fraction of the ethanol aqueous solution is 60-80%.

[0013] Preferably, the depressurization recovery temperature is 50-60℃.

[0014] Preferably, the concentration is reduced to a relative density of 1.10-1.25 at 60°C.

[0015] The application of the above composition in the preparation of products for preventing stretch marks.

[0016] Compared with existing technologies, the present invention has the following advantages: This invention uses hydrogenated lecithin in the oil phase, combined with cetearyl alcohol and phytosterols, to form a flexible protective layer similar to a biological membrane on the skin surface. This effectively buffers the mechanical stress on the abdomen during pregnancy and reduces the risk of elastic fiber breakage from the source. At the same time, the alcohol extracts of traditional Chinese medicines such as Polygonatum and Centella asiatica are locked in the inner polyol phase, effectively isolating them from external oxidation. Combined with the sustained-release properties of the outermost aqueous phase, this invention not only solves the problem of low transdermal absorption rate of traditional Chinese medicines, but also avoids direct skin irritation from high concentrations of active ingredients, thus improving the gentleness and longevity of use.

[0017] This invention introduces schistosome extract into the outermost aqueous phase, which works synergistically with hydrolyzed collagen and vitamin complexes to form a moisturizing and repairing microenvironment on the skin surface. This specifically alleviates excessive collagen decomposition and significantly improves the safety and overall efficacy of stretch mark prevention without relying on strong irritating exfoliating ingredients. The synergistic effect of terminal amino polyamide amine and liquid crystal emulsifier effectively increases the stability of the system, further facilitates the formation of a liquid crystal network structure, and reduces the temperature sensitivity of the liquid crystal. At the same time, terminal amino polyamide amine tends to adsorb onto the interface, which not only has a spatial stabilizing effect but also improves the shape integrity of the liquid crystal and ensures the slow release process of the active ingredients in the outer aqueous phase.

[0018] The components of this invention produce a synergistic effect, which can effectively stimulate fibroblast proliferation, restore collagen fiber structure, and promote elastin synthesis, effectively preventing and fading the formation of stretch marks. At the same time, it has moisturizing and nourishing effects, promotes skin metabolism, improves dryness caused by excessive skin stretching, promotes the repair and renewal of skin tissue, and further repairs stretch marks. Moreover, the preparation method is simple and suitable for large-scale promotion and application. Attached Figure Description

[0019] Figure 1 The cumulative transdermal absorption curves of the compositions obtained in Example 5 and Comparative Examples 1-2 at various time points are shown.

[0020] Figure 2 The graph shows a comparison of ear swelling and swelling inhibition rate among mice in the blank control group, Example 5 group, Comparative Example 1 group, Comparative Example 2 group, and positive drug group. Detailed Implementation

[0021] The present invention will now be described in further detail with reference to specific embodiments. The given embodiments are merely illustrative of the invention and not intended to limit its scope. The embodiments provided below can serve as a guide for further improvements by those skilled in the art and do not constitute a limitation on the invention in any way.

[0022] Unless otherwise specified, the experimental methods used in the following examples are conventional methods, performed according to the techniques or conditions described in the literature in this field or according to the product instructions. Unless otherwise specified, the materials and reagents used in the following examples are commercially available.

[0023] The phytosterols used below were purchased from Zhengzhou Yuhe Food Additives Co., Ltd. The hydrolyzed collagen used below was purchased from Jinan Shenghe Chemical Co., Ltd. The compound vitamins used below were purchased from Zhuhai Jibaikang Biotechnology Co., Ltd., and their main components include vitamin A, vitamin C, and vitamin E. The amino-terminated polyamide amine (PAMAM, G3.0) used below was purchased from Xi'an Qiyue Biotechnology Co., Ltd. The preservatives used below were purchased from Jining Tangyi Chemical Co., Ltd., and their main component is phenoxyethanol. The liquid crystal emulsifier used below is a lecithin-based liquid crystal emulsifier, purchased from Zhina Technology. Example 1

[0024] A composition comprising the following ingredients: 5g of Polygonatum sibiricum, 10g of Centella asiatica, 5g of Taxillus chinensis, 1g of Calendula officinalis, 10g of polyethylene glycol, 0.5g of p-hydroxyacetophenone, 20g of jojoba seed oil, 1g of PEG-20 glyceryl triisostearate, 1g of hydrogenated lecithin, 0.1g of cetearyl alcohol, 1g of phytosterols, 0.1g of ascorbyl palmitate, 1g of hydrolyzed collagen, 1g of complex vitamins, 0.5g of schistosome extract, 0.1g of allantoin, 0.1g of sodium hyaluronate, 0.5g of liquid crystal emulsifier, 0.5g of amino-terminated polyamide amine, and 1g of preservative.

[0025] The method for preparing the above composition includes the following steps: S1. Add PEG-20 glyceryl triisostearate to jojoba seed oil, homogenize at 75℃ for 2 min, add hydrogenated lecithin, cetearyl alcohol, phytosterol, and ascorbyl palmitate and continue homogenizing for 1 min, keep warm to obtain oil phase material. S2. Mix Polygonatum sibiricum, Centella asiatica, Taxillus chinensis, and Calendula officinalis, and extract twice with a 60% ethanol aqueous solution, each time for 1 hour. Combine the filtrates, recover the ethanol under reduced pressure at 50°C, and concentrate to a relative density of 1.10 at 60°C. Add polyethylene glycol and p-hydroxyacetophenone, homogenize at 70°C for 1 minute, and keep warm to obtain the alcohol phase material. S3. Add hydrolyzed collagen and compound vitamins to 60g of deionized water, stir and homogenize at 40℃ for 2min, add schistosome, allantoin and sodium hyaluronate and stir until completely dissolved, keep warm to obtain aqueous phase material; S4. Add the alcohol phase material to the oil phase material and homogenize for 1 min. Add the liquid crystal emulsifier and the amino-terminated polyamide amine and homogenize for 1 min. Add the water phase material and homogenize for 1 min. During the homogenization process, cool to room temperature and add the preservative and stir until uniform. Example 2

[0026] A composition comprising the following ingredients: 10g of Polygonatum sibiricum, 20g of Centella asiatica, 10g of Taxillus chinensis, 5g of Calendula officinalis, 15g of polyglycerol, 1.2g of p-hydroxyacetophenone, 30g of jojoba seed oil, 2g of sorbitol olive oil ester, 3g of hydrogenated lecithin, 1g of cetearyl alcohol, 2g of phytosterols, 0.5g of ascorbyl palmitate, 2g of hydrolyzed collagen, 2g of complex vitamins, 2g of schistosome extract, 0.3g of allantoin, 0.5g of sodium hyaluronate, 3g of liquid crystal emulsifier, 1g of amino-terminated polyamide amine, and 2g of preservative.

[0027] The method for preparing the above composition includes the following steps: S1. Add sorbitol olive oil ester to jojoba seed oil, homogenize at 85℃ for 6 minutes, add hydrogenated lecithin, cetearyl alcohol, phytosterol, and ascorbyl palmitate and continue homogenizing for 2 minutes, keep warm to obtain oil phase material. S2. Mix Polygonatum sibiricum, Centella asiatica, Taxillus chinensis, and Calendula officinalis, and extract twice with an 80% ethanol aqueous solution, each time for 2 hours. Combine the filtrates, recover the ethanol under reduced pressure at 60℃ and concentrate to a relative density of 1.25 at 60℃. Add polyglycerol and p-hydroxyacetophenone, homogenize at 80℃ for 3 minutes, and keep warm to obtain the alcohol phase material. S3. Add hydrolyzed collagen and compound vitamins to 80g of deionized water, stir and homogenize at 50℃ for 8min, add schistosome, allantoin and sodium hyaluronate and stir until completely dissolved, keep warm to obtain aqueous phase material; S4. Add the alcohol phase material to the oil phase material and homogenize for 3 minutes. Add the liquid crystal emulsifier and the amino-terminated polyamide amine and homogenize for 2 minutes. Add the water phase material and homogenize for 3 minutes. During the homogenization process, cool to room temperature and add the preservative and stir until uniform. Example 3

[0028] A composition comprising the following ingredients: 7g Polygonatum sibiricum, 18g Centella asiatica, 7g Taxillus chinensis, 4g Calendula officinalis, 11g glycerin, 1g p-hydroxyacetophenone, 22g jojoba seed oil, 1.8g PEG-10 polydimethylsiloxane, 1.5g hydrogenated lecithin, 0.8g cetearyl alcohol, 1.3g phytosterols, 0.4g ascorbyl palmitate, 1.5g hydrolyzed collagen, 1.2g complex vitamins, 1.8g schistosome extract, 0.15g allantoin, 0.4g sodium hyaluronate, 1g liquid crystal emulsifier, 0.9g amino-terminated polyamide amine, and 1.2g preservative.

[0029] The method for preparing the above composition includes the following steps: S1. Add PEG-10 polydimethylsiloxane to jojoba seed oil, homogenize at 82℃ for 3 min, add hydrogenated lecithin, cetearyl alcohol, phytosterol, and ascorbyl palmitate and continue homogenizing for 1.5 min, keep warm to obtain oil phase material. S2. Mix Polygonatum sibiricum, Centella asiatica, Taxillus chinensis, and Calendula officinalis, and extract twice by reflux with a 75% ethanol aqueous solution for 80 min each time. Combine the filtrates, recover the ethanol under reduced pressure at 58℃ and concentrate to a relative density of 1.15 at 60℃. Add glycerol and p-hydroxyacetophenone, homogenize at 77℃ for 2 min, and keep warm to obtain the alcohol phase material. S3. Add hydrolyzed collagen and compound vitamins to 65g of deionized water, stir and homogenize at 48℃ for 4min, add schistosome, allantoin and sodium hyaluronate and stir until completely dissolved, keep warm to obtain aqueous phase material; S4. Add the alcohol phase material to the oil phase material and homogenize for 2 minutes. Add the liquid crystal emulsifier and the amino-terminated polyamide amine and homogenize for 1.5 minutes. Add the water phase material and homogenize for 2 minutes. During the homogenization process, cool to room temperature and add the preservative and stir until uniform. Example 4

[0030] A composition comprising the following ingredients: 9g of Polygonatum sibiricum, 12g of Centella asiatica, 9g of Taxillus chinensis, 2g of Calendula officinalis, 13g of glycerin, 0.6g of p-hydroxyacetophenone, 28g of jojoba seed oil, 1.2g of sorbitol olive oil ester, 2.5g of hydrogenated lecithin, 0.2g of cetearyl alcohol, 1.7g of phytosterols, 0.2g of ascorbyl palmitate, 1.5g of hydrolyzed collagen, 1.8g of complex vitamins, 0.6g of schistosome extract, 0.25g of allantoin, 0.2g of sodium hyaluronate, 2.4g of liquid crystal emulsifier, 0.7g of amino-terminated polyamide amine, and 1.8g of preservative.

[0031] The method for preparing the above composition includes the following steps: S1. Add sorbitol olive oil ester to jojoba seed oil, homogenize at 78℃ for 5 min, add hydrogenated lecithin, cetearyl alcohol, phytosterol, and ascorbyl palmitate and continue homogenizing for 1.5 min, keep warm to obtain oil phase material; S2. Mix Polygonatum sibiricum, Centella asiatica, Taxillus chinensis, and Calendula officinalis, and extract twice by reflux with a 65% ethanol aqueous solution for 100 min each time. Combine the filtrates, recover the ethanol under reduced pressure at 52℃ and concentrate to a relative density of 1.20 at 60℃. Add glycerol and p-hydroxyacetophenone, homogenize at 73℃ for 2 min, and keep warm to obtain the alcohol phase material. S3. Add hydrolyzed collagen and compound vitamins to 75g of deionized water, stir and homogenize at 42℃ for 6min, add schistosome, allantoin and sodium hyaluronate and stir until completely dissolved, keep warm to obtain aqueous phase material; S4. Add the alcohol phase material to the oil phase material and homogenize for 2 minutes. Add the liquid crystal emulsifier and the amino-terminated polyamide amine and homogenize for 1.5 minutes. Add the water phase material and homogenize for 2 minutes. During the homogenization process, cool to room temperature and add the preservative and stir until uniform. Example 5

[0032] A composition comprising the following ingredients: 8g of Polygonatum sibiricum, 15g of Centella asiatica, 8g of Taxillus chinensis, 3g of Calendula officinalis, 12g of glycerin, 0.8g of p-hydroxyacetophenone, 25g of jojoba seed oil, 1.5g of sorbitol olive oil ester, 2g of hydrogenated lecithin, 0.5g of cetearyl alcohol, 1.5g of phytosterols, 0.3g of ascorbyl palmitate, 1.5g of hydrolyzed collagen, 1.5g of complex vitamins, 1.2g of schistosome extract, 0.2g of allantoin, 0.3g of sodium hyaluronate, 1.7g of liquid crystal emulsifier, 0.8g of amino-terminated polyamide amine, and 1.5g of preservative.

[0033] The method for preparing the above composition includes the following steps: S1. Add sorbitol olive oil ester to jojoba seed oil, homogenize at 80℃ for 4 min, add hydrogenated lecithin, cetearyl alcohol, phytosterol, and ascorbyl palmitate and continue homogenizing for 1.5 min, keep warm to obtain oil phase material; S2. Mix Polygonatum sibiricum, Centella asiatica, Taxillus chinensis, and Calendula officinalis, and extract twice by reflux with a 70% ethanol aqueous solution for 90 min each time. Combine the filtrates, recover the ethanol under reduced pressure at 55℃ and concentrate to a relative density of 1.18 at 60℃. Add glycerol and p-hydroxyacetophenone, homogenize at 75℃ for 2 min, and keep warm to obtain the alcohol phase material. S3. Add hydrolyzed collagen and compound vitamins to 70g of deionized water, stir and homogenize at 45℃ for 5min, add schistosome, allantoin and sodium hyaluronate and stir until completely dissolved, keep warm to obtain aqueous phase material; S4. Add the alcohol phase material to the oil phase material and homogenize for 2 minutes. Add the liquid crystal emulsifier and the amino-terminated polyamide amine and homogenize for 1.5 minutes. Add the water phase material and homogenize for 2 minutes. During the homogenization process, cool to room temperature and add the preservative and stir until uniform.

[0034] Comparative Example 1 A composition comprising the following ingredients: 8g of Polygonatum sibiricum, 15g of Centella asiatica, 8g of Taxillus chinensis, 3g of Calendula officinalis, 12g of glycerin, 0.8g of p-hydroxyacetophenone, 25g of jojoba seed oil, 1.5g of sorbitol olive oil ester, 2g of hydrogenated lecithin, 0.5g of cetearyl alcohol, 1.5g of phytosterols, 0.3g of ascorbyl palmitate, 1.5g of hydrolyzed collagen, 1.5g of complex vitamins, 1.2g of schistosome extract, 0.2g of allantoin, 0.3g of sodium hyaluronate, 2.5g of liquid crystal emulsifier, and 1.5g of preservative.

[0035] The method for preparing the above composition includes the following steps: S1. Add sorbitol olive oil ester to jojoba seed oil, homogenize at 80℃ for 4 min, add hydrogenated lecithin, cetearyl alcohol, phytosterol, and ascorbyl palmitate and continue homogenizing for 1.5 min, keep warm to obtain oil phase material; S2. Mix Polygonatum sibiricum, Centella asiatica, Taxillus chinensis, and Calendula officinalis, and extract twice by reflux with a 70% ethanol aqueous solution for 90 min each time. Combine the filtrates, recover the ethanol under reduced pressure at 55℃ and concentrate to a relative density of 1.18 at 60℃. Add glycerol and p-hydroxyacetophenone, homogenize at 75℃ for 2 min, and keep warm to obtain the alcohol phase material. S3. Add hydrolyzed collagen and compound vitamins to 70g of deionized water, stir and homogenize at 45℃ for 5min, add schistosome, allantoin and sodium hyaluronate and stir until completely dissolved, keep warm to obtain aqueous phase material; S4. Add the alcohol phase material to the oil phase material and homogenize for 2 minutes. Add the liquid crystal emulsifier and homogenize for 1.5 minutes. Add the water phase material and homogenize for 2 minutes. During the homogenization process, cool to room temperature and add the preservative and stir until homogenized.

[0036] Comparative Example 2 A composition comprising the following ingredients: 15.5g of Polygonatum sibiricum, 15.5g of Taxillus chinensis, 3g of Calendula officinalis, 12g of glycerin, 0.8g of p-hydroxyacetophenone, 25g of jojoba seed oil, 1.5g of sorbitol olive oil ester, 2g of hydrogenated lecithin, 0.5g of cetearyl alcohol, 1.5g of phytosterols, 0.3g of ascorbyl palmitate, 1.5g of hydrolyzed collagen, 1.5g of complex vitamins, 1.2g of schistosome extract, 0.2g of allantoin, 0.3g of sodium hyaluronate, 1.7g of liquid crystal emulsifier, 0.8g of amino-terminated polyamide amine, and 1.5g of preservative.

[0037] The method for preparing the above composition includes the following steps: S1. Add sorbitol olive oil ester to jojoba seed oil, homogenize at 80℃ for 4 min, add hydrogenated lecithin, cetearyl alcohol, phytosterol, and ascorbyl palmitate and continue homogenizing for 1.5 min, keep warm to obtain oil phase material; S2. Mix Polygonatum sibiricum, Taxillus chinensis and Calendula officinalis, and extract twice by reflux with 70% ethanol aqueous solution for 90 min each time. Combine the filtrates, recover the ethanol under reduced pressure at 55℃ and concentrate to a relative density of 1.18 at 60℃. Add glycerol and p-hydroxyacetophenone, homogenize at 75℃ for 2 min, and keep warm to obtain the alcohol phase material. S3. Add hydrolyzed collagen and compound vitamins to 70g of deionized water, stir and homogenize at 45℃ for 5min, add schistosome, allantoin and sodium hyaluronate and stir until completely dissolved, keep warm to obtain aqueous phase material; S4. Add the alcohol phase material to the oil phase material and homogenize for 2 minutes. Add the liquid crystal emulsifier and the amino-terminated polyamide amine and homogenize for 1.5 minutes. Add the water phase material and homogenize for 2 minutes. During the homogenization process, cool to room temperature and add the preservative and stir until uniform.

[0038] Experimental Example 1 The compositions obtained in Example 5 and Comparative Examples 1-2 were diluted to 2.0%, 5.0% and 10.0% sample solutions using PBS buffer, and human immortalized keratinocytes (HaCaT) were used as cell models for cell safety testing.

[0039] HaCaT cells in the logarithmic growth phase were harvested at a concentration of 5 × 10⁻⁶. 3 Cells were seeded at a density of 1 cell per well in 96-well plates and incubated at 37°C in a 5% CO2 incubator for 24 hours until the cells adhered. The original culture medium was discarded, and sample solutions of different dilutions were added to each well, with 6 replicates per group. A blank control group (culture medium only) and a negative control group (0.1% Tween-80) were also set up. After culturing for another 24 hours, 10 μL of CCK-8 reagent was added to each well, and the cells were incubated in the dark for 2 hours. The absorbance (OD value) at 450 nm was measured using a microplate reader, and the cell viability was calculated.

[0040] Cell viability (%) = OD value of test group ÷ OD value of blank control group × 100%.

[0041] Cell survival rates were >80% in all groups with different dilutions (2.0%, 5.0%, and 10.0%). According to the safety standards of the Cosmetic Safety Technical Specifications, a cell survival rate ≥80% indicates no cytotoxicity, confirming that the compositions obtained in this invention and the comparative examples are feasible and can be used for topical skin application.

[0042] Experimental Example 2 Fresh pig abdominal skin was taken, subcutaneous fat was removed, and the skin was trimmed to a thickness of about 0.3 mm. After sterilization, it was used for preparation. Multiple sets of ex vivo pig skin were prepared as transdermal models. The transdermal efficiency was tested using a Franz vertical diffusion cell.

[0043] Isolated porcine skin was fixed between the supply and receiving chambers of a Franz diffusion cell, with the dermis facing the receiving chamber. PBS buffer containing 20% ​​ethanol was added to the receiving chamber, and the mixture was magnetically stirred at 300 rpm and 32°C to simulate human skin temperature. 0.5 g of the test sample (the compositions obtained in Example 5 and Comparative Examples 1-2) was added to the supply chamber and evenly spread on the porcine skin surface. At 0 h, 2 h, 6 h, and 12 h, 0.5 mL of receiving fluid was taken from the receiving chamber, and an equal volume of fresh receiving fluid was added simultaneously. The allantoin content in the receiving fluid was detected by LC-MS / MS, and the cumulative transdermal transdermal dose was calculated.

[0044] like Figure 1 As shown, the composition obtained in Example 5 had the highest cumulative transdermal absorption at each time point, which was significantly better than the comparative example.

[0045] Experimental Example 3 The inflammation-relieving test was conducted using a xylene-induced mouse ear swelling model. SPF-grade Kunming mice (half male and half female, 20±2g) were used as the test animals.

[0046] Mice were randomly divided into 5 groups of 15 mice each: a blank control group, Example 5 group, Comparative Example 1 group, Comparative Example 2 group, and an inflammation-positive drug group (compound dexamethasone acetate cream). During the experiment, the corresponding doses of 0.9% sodium chloride solution, the composition obtained in Example 5, the composition obtained in Comparative Example 1, the composition obtained in Comparative Example 2, and compound dexamethasone acetate cream were applied evenly to the mouse ears and massaged for 20 minutes. The drugs were administered once every 2 hours for 3 consecutive times. Before each administration, the application site was cleaned with 0.9% sodium chloride solution and allowed to dry before administration. One hour after the last administration, 0.05 mL of xylene was evenly applied to the front and back of the left ear to induce inflammation; the right ear was left untreated as a control. One hour after the inflammation and swelling were induced, the mice were euthanized by cervical dislocation. The left and right ear pieces were cut off from each mouse, and two ear pieces were punched at the same location using a 6mm diameter punch. The weights were measured using an electronic balance, and the difference in weight between the left and right ear pieces was used as the degree of swelling. The differences between the groups were compared, and the degree of swelling (mg) and the swelling inhibition rate were calculated.

[0047] Swelling inhibition rate = (swelling degree in blank control group - swelling degree in drug treatment group) ÷ swelling degree in blank control group × 100%.

[0048] like Figure 2 As shown, the compositions obtained in Example 5 and Comparative Examples 1-2 can effectively reduce ear swelling in xylene-induced mice, but the effect is inferior to that of compound dexamethasone acetate cream; while the composition obtained in Example 5 has a significantly better anti-inflammatory effect than that of Comparative Examples 1-2, indicating that Example 5 has a better ability to relieve acute inflammation.

[0049] Test Example 4 We recruited 21 healthy pregnant volunteers aged 23-35 who had no allergies to the product ingredients and had normal abdominal skin condition. Among them, 16 were first-time mothers and 5 were multiparous; 11 of them had stretch marks on their abdomen.

[0050] The healthy pregnant volunteers were randomly divided into 3 groups. There were no significant differences in age, body type (BMI), primiparity / multiple birth status, and presence of stretch marks in the abdomen among the groups.

[0051] Volunteers in each group used the compositions obtained in Example 5 and Comparative Examples 1-2 from the third month of pregnancy to one month postpartum. The compositions were used twice daily at regular intervals, with a dosage of 5g per use. During the test, no other products or drugs that could affect the formation of stretch marks were used. After the experiment, the appearance of new stretch marks was observed to evaluate the effect on stretch marks.

[0052] It was found that no new stretch marks appeared on the abdomens of the 7 pregnant women who used the composition obtained in Example 5; while new stretch marks appeared on the abdomens of the pregnant women who used the compositions obtained in Comparative Examples 1 and 2. Among them, 4 new stretch marks appeared on the abdomens of the 2 pregnant women who used the composition obtained in Comparative Example 1, and 9 new stretch marks appeared on the abdomens of the 6 pregnant women who used the composition obtained in Comparative Example 2.

[0053] The present invention has been described in detail above. Those skilled in the art will recognize that the invention can be practiced in a wide range of ways with equivalent parameters, concentrations, and conditions without departing from its spirit and scope, and without requiring unnecessary experiments. While specific embodiments have been provided, it should be understood that further modifications can be made to the invention. In summary, according to the principles of the invention, this application is intended to include any changes, uses, or improvements to the invention, including changes made using conventional techniques known in the art that depart from the scope disclosed herein.

Claims

1. A composition characterized in that, The raw materials, by weight, include: 5-10 parts Polygonatum sibiricum, 10-20 parts Centella asiatica, 5-10 parts Taxillus chinensis, 1-5 parts Calendula officinalis, 10-15 parts polyol, 0.5-1.2 parts p-hydroxyacetophenone, 20-30 parts vegetable oil, 1-2 parts water-in-oil emulsifier, 1-3 parts hydrogenated lecithin, 0.1-1 parts cetearyl alcohol, 1-2 parts phytosterol, 0.1-0.5 parts ascorbyl palmitate, 1-2 parts hydrolyzed collagen, 1-2 parts compound vitamins, 0.5-2 parts schizocarpine, 0.1-0.3 parts allantoin, 0.1-0.5 parts sodium hyaluronate, 0.5-3 parts liquid crystal emulsifier, 0.5-1 part amino-terminated polyamide amine, 1-2 parts preservative, and 60-80 parts water.

2. The composition of claim 1, wherein, The vegetable oil is at least one of jojoba seed oil, sweet almond oil, shea butter, camellia seed oil, macadamia seed oil, and squalane.

3. The composition of claim 1, wherein The water-in-oil emulsifier is at least one of PEG-10 polydimethylsiloxane, sorbitol olive oil ester, and PEG-20 glyceryl triisostearate.

4. The composition of claim 1, wherein, The polyol is at least one of glycerol, butanediol, polyethylene glycol, and polyglycerol.

5. The composition of claim 1, wherein Liquid crystal emulsifiers include at least one of lecithin-based liquid crystal emulsifiers and glycoside-based liquid crystal emulsifiers.

6. A process for the preparation of a composition according to any one of claims 1 to 5, characterised in that, Includes the following steps: S1. Add the water-in-oil emulsifier to the vegetable oil, homogenize at 75-85℃ for 2-6 minutes, add hydrogenated lecithin, cetearyl alcohol, phytosterol, and ascorbyl palmitate, continue homogenizing for 1-2 minutes, and keep warm to obtain the oil phase material. S2. Mix Polygonatum sibiricum, Centella asiatica, Taxillus chinensis and Calendula officinalis, and extract twice with ethanol aqueous solution under reflux for 1-2 hours each time. Combine the filtrates, recover the ethanol under reduced pressure and concentrate. Add polyol and p-hydroxyacetophenone, homogenize at 70-80℃ for 1-3 minutes, and keep warm to obtain the alcohol phase material. S3. Add hydrolyzed collagen and complex vitamins to water, stir and homogenize at 40-50℃ for 2-8 minutes, add schistosome, allantoin and sodium hyaluronate and stir until completely dissolved, keep warm to obtain aqueous phase material; S4. Add the alcohol phase material to the oil phase material and homogenize for 1-3 minutes. Add the liquid crystal emulsifier and the amino-terminated polyamide amine and homogenize for 1-2 minutes. Add the alcohol phase material to the water phase material and homogenize for 1-3 minutes. Add the preservative and stir until homogenized.

7. A process for the preparation of a composition according to claim 6, characterised in that, The mass fraction of the ethanol aqueous solution is 60-80%.

8. A process for the preparation of a composition according to claim 6, characterized in that, The depressurization recovery temperature is 50-60℃.

9. The method for preparing the composition according to claim 6, characterized in that, When concentrated to 60°C, the relative density is 1.10-1.

25.

10. The use of the composition according to any one of claims 1-5 in the preparation of a product for preventing stretch marks.

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