A skin bacteriostatic gel and a preparation method thereof

Abstract

The application relates to the technical field of external drug preparations, and discloses a skin bacteriostatic gel and a preparation method thereof, and aims to solve the technical problems that in the prior art, Mongolian medicine multi-polar active ingredient extraction is insufficient, and when natural extract and chemical bacteriostatic agents are compounded, uneven dispersion, strong irritability and poor stability are prone to occur. The skin bacteriostatic gel is composed of Mongolian medicine extract, polyvinyl alcohol, xanthan gum, triclosan, glycerol, nicotinamide and other auxiliary materials; and the key of the preparation method is that: the Mongolian medicine is extracted by adopting a gradient process combining ultrasonic water extraction and microwave alcohol extraction, so that different polar active ingredients are fully reserved; triclosan is subjected to compound micro-capsulation treatment by being compounded with trehalose and sodium hyaluronate wall materials; an interpenetrating network matrix is constructed by using polyvinyl alcohol and xanthan gum, and laurocapram is introduced to optimize the transdermal performance, so that the extraction efficiency of the Mongolian medicine components is improved; the obtained gel has reliable bacteriostatic effect, stable long-term storage performance and low skin irritability, and can meet the skin bacteriostatic care demand.

Description

Technical Field

[0001] This invention relates to the field of topical pharmaceutical preparations, and in particular to a skin antibacterial gel and its preparation method. Background Technology

[0002] As the body's first line of defense, the skin is susceptible to microbial invasion, which can lead to diseases such as eczema and acne. Common pathogens include Propionibacterium acnes, Staphylococcus aureus, Escherichia coli, and Candida albicans, which can cause itching and inflammation, affecting quality of life.

[0003] Current treatments often rely on antibiotics or hormones, which can easily lead to drug resistance, gut microbiota imbalance, and dependence with long-term use. Natural medicines are preferred due to their mildness and low toxicity. Mongolian medicine, in particular, uses ingredients such as gardenia and chebula, and has accumulated rich experience in treating skin infections based on the theory of clearing heat and detoxifying. Therefore, combining traditional Mongolian medicine with modern gel formulation technology to develop a topical skin product that is both highly effective in inhibiting bacteria and gentle and non-irritating is of great significance in filling the gaps in existing treatment options and improving the care experience for patients with skin diseases.

[0004] Existing technology announcement number CN113368193B discloses a skin antibacterial gel and its preparation method. The gel is prepared by extracting and concentrating traditional Chinese medicines such as black nightshade, artemisia argyi, clove, and Cynanchum paniculatum in a 70% or higher ethanol aqueous solution. A concentrated traditional Chinese medicine solution is obtained by filtration and concentration. Using carbomer as a matrix, the concentrated traditional Chinese medicine solution, propylene glycol, wintergreen oil, etc., are mixed, the pH is adjusted to 4-8, and then 2,4,4'-trichloro-2'-hydroxydiphenyl ether and plant essential oils are added. The mixture is then processed using a colloid mill. This gel has inhibitory effects on Escherichia coli and Staphylococcus aureus, is suitable for children, spreads well, and is non-greasy. Existing technology announcement number CN113081928B also discloses a plant-based antibacterial gel, its preparation method, and its application. The gel uses alcohol extracts of traditional Chinese medicines such as Forsythia suspensa, Bletilla striata, and Sophora flavescens as the main components, combined with essential oils such as aloe vera juice and geranium oil, and supplemented with excipients such as carbomer and glycerin. Traditional Chinese medicine is extracted by reflux with 50%-80% ethanol, and then emulsified and stirred with excipients to form a gel. This gel is ethanol-free, non-irritating, and has a 100% antibacterial rate against E. coli and other bacteria. It can be used for disinfection without rinsing and also has moisturizing and skin care effects.

[0005] The above-mentioned and existing related technologies have the following drawbacks:

[0006] Existing technologies for processing multi-component natural medicines, such as those containing polar, weakly polar, and heat-sensitive components, generally simplify the extraction process. Some use a single solvent, such as water or ethanol, which leads to incomplete extraction of some components. For example, weakly polar components have low solubility in water, and some heat-sensitive active substances are destroyed by high-temperature decoction. As a result, the synergistic effect of multiple components in natural medicines cannot be fully realized, making it difficult to reproduce the antibacterial efficacy of traditional formulations.

[0007] In existing technologies, gel products that combine natural extracts and chemical antibacterial agents often suffer from uneven component dispersion and phase separation because the matrix structure is not optimized to account for the polarity differences between the two. This can lead to excessively high local concentrations causing irritation or excessively low concentrations reducing the antibacterial effect. At the same time, there is a lack of effective slow-release regulation. Chemical antibacterial agents are prone to rapid release, leading to short-term concentration imbalances, while natural ingredients are prone to oxidation, resulting in insufficient long-term antibacterial efficacy. As a result, safety and durability cannot be balanced. Summary of the Invention

[0008] The technical problem to be solved by the present invention is that the existing technology has the disadvantages of insufficient extraction and imbalance of compounding. To this end, we propose a skin antibacterial gel and its preparation method.

[0009] To achieve the above objectives, this application adopts the following technical solution: a skin antibacterial gel and its preparation method, comprising the following components in parts by weight: 70-80 parts Mongolian medicine extract, 5-9 parts polyvinyl alcohol, 0.5-2 parts xanthan gum, 3-5 parts glycerin, 3-5 parts nicotinamide, 1-3 parts triclosan, 0.5-2 parts trehalose, 0.5-2 parts menthol, 0.5-2 parts laurocapram, 0.05-0.2 parts sodium hyaluronate, 0.05-0.1 parts triethanolamine, 0.005-0.02 parts fragrance, and 2-5 parts purified water; the Mongolian medicine extract includes gardenia, chebula, Sichuan pepper, and smilax glabra. The raw material is Poria cocos, and the raw materials are formulated in a mass ratio of 31-38 parts: 22-27 parts: 20-26 parts: 15-23 parts. The Mongolian medicine extract is prepared by a gradient extraction process, and the extract contains geniposide, chebulic acid, azadirachtin, and Smilax glabra saponin. Triclosan is microencapsulated to obtain triclosan composite microcapsules. The wall material used in the composite microencapsulation process is a mixture of trehalose and sodium hyaluronate in a mass ratio of 1:1-3:1. The particle size of the triclosan composite microcapsules is 5-20 μm. Polyvinyl alcohol and xanthan gum jointly construct an interpenetrating network matrix to encapsulate the active ingredients in the Mongolian medicine extract and the triclosan composite microcapsules.

[0010] Preferably, in the gradient extraction process of the Mongolian medicine extract, after combining the aqueous extract and the alcohol extract, a purification step is required. After purification, the mass ratio of geniposide, chebulic acid, azadirachtin, and smilax glabra saponin in the extract is 30:20:1:15-46:12:1:25. The extract is concentrated under reduced pressure in the temperature range of 55-60℃, and the relative density of the concentrated extract is 1.04-1.05.

[0011] Preferably, the surface of the triclosan composite microcapsule is modified with chebulic acid from Mongolian medicine extract, and the hydroxyl groups of the microcapsule wall material form hydrogen bonds with the carboxyl groups of chebulic acid.

[0012] Preferably, the polyvinyl alcohol and xanthan gum form an interpenetrating network matrix, and the polyvinyl alcohol and xanthan gum are mixed at a mass ratio of 5:1 to 8:1.

[0013] Preferably, the mass ratio of laurocapram to Mongolian medicine extract is 1:35-1:80.

[0014] A method for preparing a skin antibacterial gel includes the following steps: S1: Weigh gardenia, chebula, Sichuan pepper, and smilax glabra according to the mass ratio, mix them, pulverize them through an 80-mesh sieve to obtain mixed powder, and then extract them sequentially by ultrasonic water extraction and microwave alcohol extraction. After collecting the extract, purify it with D101 macroporous resin to control the proportions of geniposide, chebulic acid, neemin, and smilax glabra saponin; S2: Dissolve triclosan in ethanol to obtain an oil phase, dissolve trehalose and sodium hyaluronate in purified water at a mass ratio of 1:1 to 3:1 to obtain an aqueous phase, add the oil phase dropwise to the aqueous phase and emulsify, freeze-dry the emulsion product to obtain triclosan composite microcapsules. S3: Mix polyvinyl alcohol and xanthan gum at a mass ratio of 5:1-8:1, add 50% of Mongolian medicine extract, dissolve under heating conditions, cool down, and adjust the pH of the system to 6.0-7.0 to form a selectively loaded matrix; S4: Disperse triclosan composite microcapsules in the remaining amount of Mongolian medicine extract, inject them into the selectively loaded matrix after ultrasonic treatment, and simultaneously introduce nitrogen gas for homogenization; S5: Add glycerin, nicotinamide, trehalose, menthol, laurocapram, sodium hyaluronate and fragrance, stir and mix, and then degas and treat with low frequency vibration to obtain a skin antibacterial gel.

[0015] Preferably, in step S1, 8-10 times the amount of purified water is added during ultrasonic water extraction of the mixed drug powder, and the power of ultrasonic water extraction is negatively correlated with the time.

[0016] Preferably, in step S2, the ethanol used in the oil phase preparation is 95% ethanol, and the amount used is 5-6 times the mass of triclosan; the amount of purified water used in the aqueous phase preparation is 10 times the total mass of trehalose and sodium hyaluronate; and the emulsification process is carried out by high-speed shearing at 3500-4500 rpm for 11-14 min.

[0017] Preferably, in step S4, the ultrasonic treatment power is 200W and the time is 5min; the triclosan composite microcapsule suspension is injected into the selectively loaded matrix at an injection rate of 5mL / min, the homogenization time is controlled at 5-7min, and the nitrogen flow rate is maintained at 0.5-1L / min.

[0018] Preferably, in step S5, the stirring and mixing rate is 800-1000 rpm; the vacuum degree of vacuum degassing is -0.08--0.1 MPa; the frequency of low-frequency vibration is 20-30 Hz; vacuum degassing and low-frequency vibration are carried out synchronously; and the degassing time is controlled at 10-14.5 min.

[0019] The technical effects and advantages of this invention are as follows:

[0020] This invention employs a synergistic technical solution combining Mongolian medicine gradient extraction and triclosan microencapsulation. The Mongolian medicine gradient extraction utilizes ultrasonic water extraction for targeted extraction of polar components such as geniposide and smilax glabra saponins, combined with microwave alcohol extraction for efficient enrichment of weakly polar components such as chebulic acid and azadirachtin. This overcomes the limitations of existing single extraction processes that cannot simultaneously capture the diverse active ingredients of Mongolian medicine, providing a material basis for the formulation's multi-component synergistic antibacterial action. Simultaneously, triclosan, after microencapsulation with a compound wall material of trehalose and sodium hyaluronate, not only solves the problems of easy aggregation and uneven distribution in the gel matrix, but also reduces the risk of skin irritation from direct contact with the skin through the sustained-release effect of the wall material, achieving a match with the release rate of the active ingredients in Mongolian medicine. This synergistic design ensures broad-spectrum antibacterial efficacy while improving safety, effectively avoiding the technical shortcomings of traditional formulations with single antibacterial components or excessively irritating properties.

[0021] In this invention, a transdermal synergistic formulation system is constructed by integrating polyvinyl alcohol, xanthan gum, and laurocapram. The interpenetrating network structure formed by polyvinyl alcohol and xanthan gum can stably encapsulate the gradient-extracted multi-active ingredients of Mongolian medicine and microencapsulated triclosan, effectively preventing sedimentation and stratification during storage, and ensuring the long-term physical stability and consistency of active ingredient ratios of the formulation. The precise introduction of laurocapram can directionally improve the transdermal penetration efficiency of the active ingredients of Mongolian medicine and triclosan, promote the rapid arrival of antibacterial components at the skin's target sites, shorten the antibacterial onset time, and without damaging the skin barrier function. Attached Figure Description

[0022] The disclosure of this invention is illustrated with reference to the accompanying drawings. It should be understood that the drawings are for illustrative purposes only and are not intended to limit the scope of protection of this invention. In the drawings, the same reference numerals are used to refer to the same parts:

[0023] Figure 1 The flowchart for preparing the antibacterial skin gel provided by this invention;

[0024] Figure 2 This is a schematic diagram illustrating the detection results of core functions between embodiments provided by the present invention;

[0025] Figure 3 This is a schematic diagram showing the core function detection results between the embodiments and comparative examples provided by the present invention. Detailed Implementation

[0026] It is readily understood that, based on the technical solution of this invention, those skilled in the art can propose various interchangeable structural methods and implementations without altering the essential spirit of the invention. Therefore, the following detailed embodiments and accompanying drawings are merely illustrative examples of the technical solution of this invention and should not be considered as the entirety of the invention or as limitations or restrictions on the technical solution of this invention. Example

[0027] This embodiment provides a skin antibacterial gel, the components of which are listed in parts by weight as follows: 72 parts Mongolian medicine extract, 6 parts polyvinyl alcohol, 0.8 parts xanthan gum, 3.5 parts glycerin, 3.5 parts nicotinamide, 1.5 parts triclosan, 1.0 part trehalose, 0.8 parts menthol, 0.8 parts laurocapram, 0.15 parts sodium hyaluronate, 0.06 parts triethanolamine, 0.01 parts fragrance, and 3.88 parts purified water.

[0028] This embodiment discloses a method for preparing the above-mentioned antibacterial skin gel, such as... Figure 1 As shown, the specific steps include S1-S3.

[0029] Step S1: Prepare Mongolian medicine extract.

[0030] Step S11: Weigh 32 parts of Gardenia, 22 parts of Terminalia chebula, 23 parts of Melia toosendan, and 23 parts of Smilax glabra according to the mass ratio, mix them, and then pulverize them through an 80-mesh sieve to obtain mixed medicinal powder.

[0031] It should be noted that the gardenia used in this step is the dried, mature fruit of Gardenia jasminoides, a plant of the Rubiaceae family, which meets the requirements of the Gardenia entry on page 128 of Part I of the 2020 edition of the Chinese Pharmacopoeia. The origin is Zhangshu, Jiangxi Province, and it has been confirmed by thin-layer chromatography to meet the medicinal standards.

[0032] Terminalia chebula is selected from the dried, mature fruit of Terminalia chebula, a plant of the Combretaceae family, and meets the requirements of the Terminalia chebula entry on page 135 of Part I of the 2020 edition of the Chinese Pharmacopoeia. The place of origin is Xishuangbanna, Yunnan Province, and the tested items are: moisture ≤12.0% and total ash ≤6.0%.

[0033] The dried, mature fruit of *Melia azedarach*, a plant of the Meliaceae family, meets the requirements of the *Melia azedarach* entry on page 154 of the 2020 edition of the Chinese Pharmacopoeia, with the place of origin being Jiangyou, Sichuan, and the content determination item showing azadirachtin ≥ 0.080%.

[0034] Smilax glabra rhizome is selected from the dried rhizome of Smilax glabra, a plant of the Liliaceae family. It meets the requirements of Smilax glabra on page 195 of the 2020 edition of the Chinese Pharmacopoeia. The place of origin is Changde, Hunan Province, and the identification of starch granules in the test items meets the requirements.

[0035] It should be further explained that in this embodiment, Smilax glabra is used as the principal herb and the core active ingredient, which can inhibit pathogenic bacteria such as Staphylococcus aureus, while also mitigating the irritation of other medicinal materials.

[0036] Gardenia, as an assistant herb, enhances the heat-clearing and antibacterial effects of the principal herb, especially against Propionibacterium acnes;

[0037] Sichuan pepper is also used as an adjuvant to help inhibit Candida albicans. When combined with gardenia, it enhances the broad-spectrum antibacterial effect of the principal herb.

[0038] As an adjuvant, Terminalia chebula contains tannins that can astringe the skin and mucous membranes, reducing the cold stimulation of the assistant herbs. At the same time, it works synergistically with the principal and assistant herbs to enhance the duration of antibacterial activity and avoid skin barrier damage caused by clearing without astringing.

[0039] It should be further explained that, after experimental verification, this embodiment limits the mixed medicinal powder to pass through an 80-mesh sieve. If the particle size is too large, the cell walls of the medicinal materials will not break down sufficiently, and the dissolution efficiency of polar components such as geniposide will be reduced. If the particle size is too small, it will easily cause clumping during extraction, affecting solvent penetration and making subsequent filtration difficult. Therefore, 80 mesh is the optimal particle size that simultaneously satisfies the requirements of extraction efficiency and filtration convenience.

[0040] Step S12: Take 50 kg of mixed powder, add 8 times the amount of purified water, place it in an ultrasonic extraction tank, and ultrasonically extract for 1.5 h at 45℃ and 250W power. Filter to obtain the aqueous extract, and keep the residue for later use.

[0041] It should be noted that the extraction vessel with temperature control and ultrasonic function is used in this step.

[0042] It should be noted that the pH of the aqueous extract should be between 5.5 and 6.0. If the pH is below 5.0, 0.1% sodium hydroxide solution needs to be added to adjust it. After the subsequent alcohol extraction is completed, the aqueous extract and alcohol extract should be combined and purified. When the highly acidic aqueous extract and alcohol extract are mixed, the liquid is prone to separation due to the difference in polarity and sudden change in pH.

[0043] It should be further explained that, in order to avoid the dissolution of impurities due to excessively high power and long time, or insufficient dissolution of active ingredients due to excessively low power and short time, it is necessary to achieve stable extraction efficiency through reverse matching of ultrasonic power and time.

[0044] Step S13: Add the above-mentioned residue to 6 times the amount of 75% ethanol aqueous solution, transfer to a microwave extraction tank, and microwave extract at 55℃ and 180W for 1.5h. Filter to obtain the ethanol extract.

[0045] Specifically, this step uses an MCR-600 microwave extraction vessel with stirring and temperature control functions.

[0046] It is worth mentioning that this step uses a 75% ethanol aqueous solution. Preliminary experiments have verified that the solubility of chebulic acid in 50% ethanol is only 60% of that in 75% ethanol. While the solubility increases with 90% ethanol, it will dissolve additional lipid-soluble impurities in the residue, such as resinous components, which will increase the difficulty of subsequent purification.

[0047] S14: Combine the aqueous extract and the alcohol extract, purify them by D101 macroporous resin column at a flow rate of 1.5 BV / h, elute with 50% ethanol at a flow rate of 1 BV / h, and collect the eluent; concentrate the eluent under reduced pressure at 55℃ to a relative density of 1.04 to obtain the Mongolian medicine extract.

[0048] S2: Preparation of composite microencapsulated triclosan.

[0049] S21: Weigh 1.5 parts of triclosan according to the mass ratio, dissolve it in 95% ethanol, stir until completely dissolved, and obtain the oil phase.

[0050] It should be noted that the amount of ethanol used in this step is 5 times the mass of triclosan. Preliminary experiments have verified that if the amount is less than 4 times, the solubility of triclosan at room temperature (25°C) is insufficient, and undissolved particles are easily left behind, which will lead to the formation of agglomerates during subsequent emulsification. If the amount is more than 6 times, although it can be completely dissolved, it will prolong the subsequent freeze-drying time, and excessive ethanol may damage the stability of the aqueous phase.

[0051] S22: Weigh 0.4 parts trehalose and 0.4 parts sodium hyaluronate by mass ratio, add 10 times the amount of purified water, stir in a 50°C water bath until completely dissolved, and obtain the aqueous phase.

[0052] It should be noted that, according to preliminary experiments in this embodiment, when trehalose is used alone, the microcapsule wall material is brittle and the wall material cracking rate increases after freeze-drying; when sodium hyaluronate is used alone, the viscosity of the aqueous phase exceeds 500 mPa·s, and it is difficult to disperse after the oil phase is added.

[0053] It should be further noted that after dissolution, the viscosity of the aqueous phase was measured using a rotational viscometer and controlled within 200-300 mPa·s. When the viscosity was below 200 mPa·s, the wall material concentration was insufficient, and the subsequent microcapsule encapsulation rate decreased; when the viscosity was above 300 mPa·s, the oil phase dispersion resistance increased.

[0054] S23: The oil phase was slowly dripped into the aqueous phase and emulsified at a high speed of 4000 rpm for 12 min to form an emulsion. The emulsion was placed in a freeze dryer, pre-frozen at -35℃ for 2.5 h, then sublimated and dried at 35℃ for 8 h, and finally desorbed and dried at 55℃ for 4 h. The dried material was collected and passed through a 100-mesh sieve to obtain triclosan composite microcapsules.

[0055] It should be noted that the sieved microcapsules should be placed in a brown wide-mouth bottle, anhydrous calcium chloride desiccant should be added, and the bottle should be sealed and stored in a refrigerator at 2-8℃, away from light.

[0056] S3: Prepare antibacterial gel for skin.

[0057] S31: Weigh 6 parts polyvinyl alcohol and 0.8 parts xanthan gum according to the mass ratio, mix them, add 50% Mongolian medicine extract, place them in a vacuum homogenizer and emulsifier, stir and dissolve at 88℃ for 30 min, cool to 55℃, add 0.06 parts triethanolamine, adjust the pH of the system to 6.5, and obtain the matrix precursor.

[0058] It is worth mentioning that if the ratio of polyvinyl alcohol to xanthan gum is less than 5:1, i.e., excessive xanthan gum will lead to excessively high matrix viscosity, making it difficult to inject the suspension later. If the ratio is higher than 8:1, the proportion of polyvinyl alcohol is too high, and the loading rate of the matrix for the weakly polar components chebulic acid and triclosan microcapsules will decrease. At the ratio of 7.5:1 in this step, the matrix forms an interpenetrating network structure, and the loading rate of geniposide, smilax glabra saponin, chebulic acid, and triclosan microcapsules is kept within a reasonable range.

[0059] One more thing to note is that when adjusting the pH, triethanolamine should be added slowly to avoid a sudden increase in local pH that could cause xanthan gum denaturation.

[0060] S32: Disperse the above-mentioned composite microencapsulated triclosan in the remaining 50% of Mongolian medicine extract, and sonicate at 200W for 5 min to obtain a suspension; inject the suspension into the matrix precursor at a homogenization rate of 1800 rpm, and simultaneously introduce nitrogen gas at a flow rate of 0.8 L / min, and homogenize for 6 min.

[0061] It should be noted that nitrogen gas is introduced to prevent the oxidation of phenolic components such as chebulic acid in triclosan and Mongolian medicine extracts.

[0062] One more thing to note is that the injection rate should be controlled at 5 mL / min during homogenization to avoid excessively high local matrix concentrations caused by injecting the suspension too quickly, which could lead to phase separation.

[0063] S33: Weigh 3.5 parts glycerol, 3.5 parts nicotinamide, and 0.6 parts trehalose by mass ratio, dissolve them in 3.88 parts purified water, and add them to the above system while stirring at 900 rpm; then add 0.8 parts menthol, 0.8 parts laurocapram, the remaining 0.05 parts sodium hyaluronate, and 0.01 parts flavoring in sequence, and continue stirring for 4 min.

[0064] S34: Place the system in a -0.09MPa vacuum environment and apply a 25Hz low-frequency vibration. Defoam for 12 minutes to obtain the skin antibacterial gel. Example

[0065] This embodiment provides a skin antibacterial gel, the components of which are listed in parts by weight as follows: 75 parts Mongolian medicine extract, 7 parts polyvinyl alcohol, 1.0 part xanthan gum, 4.0 parts glycerin, 4.0 parts nicotinamide, 1.8 parts triclosan, 1.2 parts trehalose, 1.0 part menthol, 1.0 part laurocapram, 0.12 parts sodium hyaluronate, 0.07 parts triethanolamine, 0.015 parts fragrance, and 3.895 parts purified water.

[0066] In this embodiment, the preparation method of the antibacterial gel for the skin is the same as in Example 1, except for the following parameters:

[0067] In step S1, 35% Gardenia jasminoides, 25% Terminalia chebula, 25% Melia toosendan, and 15% Smilax glabra were weighed according to the mass ratio. During extraction, the herbs were ultrasonically extracted with 9 times the amount of purified water at 48℃ and 280W for 1.2h. The residue was microwave extracted with 7 times the amount of 78% ethanol at 58℃ and 190W for 1.3h. During purification with D101 macroporous resin, the loading flow rate was 1.2 BV / h, the elution flow rate of 50% ethanol was 1.1 BV / h, and the solution was concentrated under reduced pressure at 58℃ to a relative density of 1.05.

[0068] In step S2, the mass ratio of trehalose to sodium hyaluronate is 1:1, with 0.6 parts of trehalose and 0.6 parts of sodium hyaluronate. The high-speed shear rate is 3500 rpm and the emulsification time is 14 min. The freeze-drying pre-freezing temperature is -32℃ and the pre-freezing time is 2.2 h. The sublimation drying temperature is 38℃ and the time is 7.5 h. The desorption drying temperature is 58℃ and the time is 3.5 h.

[0069] In step S3, the mass ratio of polyvinyl alcohol to xanthan gum is 7:1; the matrix dissolution temperature is 85℃, the dissolution time is 28 min, and the pH is adjusted to 6.2 after cooling to 52℃; the homogenization rate is 1600 rpm, the nitrogen flow rate is 0.6 L / min, and the homogenization time is 5 min; the stirring rate is 850 rpm, and the stirring time is 3.5 min; the vacuum degree is -0.085 MPa, the low-frequency vibration frequency is 22 Hz, and the degassing time is 11 min. Example

[0070] This embodiment provides a skin antibacterial gel, the components of which are listed in parts by weight as follows: 78 parts Mongolian medicine extract, 8 parts polyvinyl alcohol, 1.5 parts xanthan gum, 4.5 parts glycerin, 4.5 parts nicotinamide, 2.5 parts triclosan, 1.8 parts trehalose, 1.5 parts menthol, 1.5 parts laurocapram, 0.08 parts sodium hyaluronate, 0.09 parts triethanolamine, 0.018 parts fragrance, and 4.415 parts purified water.

[0071] In this embodiment, the preparation method of the antibacterial gel for the skin is the same as in Example 1, except for the following parameters:

[0072] In step S1, 38% Gardenia jasminoides, 24% Terminalia chebula, 22% Melia toosendan, and 16% Smilax glabra were weighed according to the following mass ratio; ultrasonic water extraction was performed using 9 times the amount of purified water at 48℃ and 280W for 1.3h; microwave alcohol extraction was performed using 6.5 times the amount of 78% ethanol in the residue at 56℃ and 190W for 1.4h; during purification with D101 macroporous resin, the loading flow rate was 1.8 BV / h, the elution flow rate with 50% ethanol was 1.2 BV / h, and the eluent was concentrated under reduced pressure at 58℃ to a relative density of 1.045;

[0073] In step S2, the mass ratio of trehalose to sodium hyaluronate is 2:1, with 0.6 parts of trehalose and 0.3 parts of sodium hyaluronate. The amount of ethanol used in the oil phase is 6 times the mass of triclosan. The high-speed shear rate is 4500 rpm and the emulsification time is 13 min. The freeze-drying pre-freezing temperature is -38℃ and the pre-freezing time is 2.8 h. The sublimation drying temperature is 36℃ and the time is 8.2 h. The desorption drying temperature is 56℃ and the time is 4.2 h.

[0074] In step S3, the mass ratio of polyvinyl alcohol to xanthan gum is 8:1; the matrix dissolution temperature is 92℃, the dissolution time is 31 min, and the pH is adjusted to 6.8 after cooling to 58℃; the homogenization rate is 1900 rpm, the nitrogen flow rate is 0.9 L / min, and the homogenization time is 7 min; when glycerol, nicotinamide, and the remaining 1.2 parts of trehalose are dissolved in purified water, the stirring rate is 950 rpm; after adding menthol, laurocapram, etc., the stirring time is 4.5 min; the vacuum degree is -0.095 MPa, the low frequency vibration frequency is 28 Hz, and the degassing time is 14 min. Example

[0075] This embodiment provides a skin antibacterial gel, the components of which are listed in parts by weight as follows: 79 parts Mongolian medicine extract, 5 parts polyvinyl alcohol, 0.8 parts xanthan gum, 3.5 parts glycerin, 3.5 parts nicotinamide, 1.5 parts triclosan, 0.7 parts trehalose, 0.7 parts menthol, 0.7 parts laurocapram, 0.08 parts sodium hyaluronate, 0.06 parts triethanolamine, 0.005 parts fragrance, and 4.455 parts purified water.

[0076] In this embodiment, the preparation method of the antibacterial gel for the skin is the same as in Example 1, except for the following parameters:

[0077] In step S1, 33% Gardenia jasminoides, 23% Terminalia chebula, 25% Melia toosendan, and 19% Smilax glabra were weighed according to the following mass ratio; ultrasonic water extraction was performed using 8.8 times the amount of purified water at 44℃ and 240W for 1.6h; microwave alcohol extraction was performed using 6.2 times the amount of 74% ethanol in the residue at 53℃ and 170W for 1.6h; during purification with D101 macroporous resin, the loading flow rate was 1.4 BV / h, the elution flow rate with 50% ethanol was 1.0 BV / h, and the eluent was concentrated under reduced pressure at 54℃ to a relative density of 1.04;

[0078] In step S2, the mass ratio of trehalose to sodium hyaluronate is 1.5:1, with 0.3 parts of trehalose and 0.2 parts of sodium hyaluronate. The amount of ethanol used in the oil phase is 5.2 times the mass of triclosan. The high-speed shear rate is 3800 rpm, the emulsification time is 12.5 min, the freeze-drying pre-freezing temperature is -34℃, the pre-freezing time is 2.6 h, the sublimation drying temperature is 34℃, the time is 8.5 h, and the desorption drying temperature is 54℃, the time is 4.3 h.

[0079] In step S3, the mass ratio of polyvinyl alcohol to xanthan gum is 6.25:1; the matrix dissolution temperature is 90℃, the dissolution time is 29 min, and the pH is adjusted to 6.4 after cooling to 54℃; the homogenization rate is 1700 rpm, the nitrogen flow rate is 0.7 L / min, and the homogenization time is 6.5 min; when glycerol, nicotinamide, and the remaining 0.4 parts of trehalose are dissolved in purified water, the stirring rate is 900 rpm; after adding menthol, laurocapram, etc., the stirring time is 4.2 min; the vacuum degree is -0.092 MPa, the low frequency vibration frequency is 25 Hz, and the degassing time is 13 min. Example

[0080] This embodiment provides a skin antibacterial gel, the components of which are listed in parts by weight as follows: 75 parts Mongolian medicine extract, 6.2 parts polyvinyl alcohol, 1.0 part xanthan gum, 3.8 parts glycerin, 3.8 parts nicotinamide, 2.0 parts triclosan, 1.3 parts trehalose, 1.3 parts menthol, 1.3 parts laurocapram, 0.13 parts sodium hyaluronate, 0.075 parts triethanolamine, 0.015 parts fragrance, and 4.08 parts purified water.

[0081] In this embodiment, the preparation method of the antibacterial gel for the skin is the same as in Example 1, except for the following parameters:

[0082] In step S1, 36% Gardenia jasminoides, 25% Terminalia chebula, 23% Melia toosendan, and 16% Smilax glabra were weighed according to the following mass ratio; ultrasonic water extraction was performed using 9.2 times the amount of purified water at 47℃ and 270W for 1.4h; microwave alcohol extraction was performed using 7.2 times the amount of 76% ethanol in the residue at 57℃ and 185W for 1.4h; during purification with D101 macroporous resin, the loading flow rate was 1.3 BV / h, the elution flow rate with 50% ethanol was 1.05 BV / h, and the eluent was concentrated under reduced pressure at 57℃ to a relative density of 1.048;

[0083] In step S2, the mass ratio of trehalose to sodium hyaluronate is 1.2:1, with 0.6 parts of trehalose and 0.5 parts of sodium hyaluronate. The amount of ethanol used in the oil phase is 5.8 times the mass of triclosan. The high-speed shear rate is 4300 rpm, the emulsification time is 13.5 min, the freeze-drying pre-freezing temperature is -37℃, the pre-freezing time is 2.7 h, the sublimation drying temperature is 37℃, the time is 8.1 h, and the desorption drying temperature is 57℃, the time is 4.1 h.

[0084] In step S3, the mass ratio of polyvinyl alcohol to xanthan gum was 6.2:1; the matrix dissolution temperature was 87℃, the dissolution time was 27 min, and the pH was adjusted to 6.3 after cooling to 53℃; the homogenization rate was 1850 rpm, the nitrogen flow rate was 0.85 L / min, and the homogenization time was 5.5 min; when glycerol, nicotinamide, and the remaining 0.7 parts of trehalose were dissolved in purified water, the stirring rate was 880 rpm; after adding menthol, laurocapram, etc., the stirring time was 3.8 min; the vacuum degree was -0.088 MPa, the low-frequency vibration frequency was 26 Hz, and the degassing time was 12 min. Example

[0085] This embodiment provides a skin antibacterial gel, the components of which are listed in parts by weight as follows: 71 parts Mongolian medicine extract, 7.8 parts polyvinyl alcohol, 1.3 parts xanthan gum, 4.6 parts glycerin, 4.6 parts nicotinamide, 2.6 parts triclosan, 1.5 parts trehalose, 1.5 parts menthol, 1.5 parts laurocapram, 0.17 parts sodium hyaluronate, 0.09 parts triethanolamine, 0.01 parts fragrance, and 3.33 parts purified water.

[0086] In this embodiment, the preparation method of the antibacterial gel for the skin is the same as in Example 1, except for the following parameters:

[0087] In step S1, 34% Gardenia jasminoides, 27% Terminalia chebula, 24% Melia toosendan, and 15% Smilax glabra were weighed according to the following mass ratio; ultrasonic water extraction was performed using 9.5 times the amount of purified water at 49℃ and 290W for 1.1h; microwave alcohol extraction was performed using 7.5 times the amount of 79% ethanol in the residue at 59℃ and 195W for 1.1h; during purification with D101 macroporous resin, the loading flow rate was 1.7 BV / h, the elution flow rate with 50% ethanol was 1.15 BV / h, and the eluent was concentrated under reduced pressure at 59℃ to a relative density of 1.05;

[0088] In step S2, the mass ratio of trehalose to sodium hyaluronate is 1.8:1, with 0.9 parts of trehalose and 0.5 parts of sodium hyaluronate. The amount of ethanol used in the oil phase is 5.5 times the mass of triclosan. The high-speed shear rate is 4400 rpm, the emulsification time is 11.5 min, the freeze-drying pre-freezing temperature is -31℃, the pre-freezing time is 2.3 h, the sublimation drying temperature is 39℃, the time is 7.8 h, and the desorption drying temperature is 59℃, the time is 3.9 h.

[0089] In step S3, the mass ratio of polyvinyl alcohol to xanthan gum is 6:1; the matrix dissolution temperature is 89℃, the dissolution time is 32 min, and the pH is adjusted to 6.7 after cooling to 57℃; the homogenization rate is 1950 rpm, the nitrogen flow rate is 0.95 L / min, and the homogenization time is 7.5 min; when glycerol, nicotinamide, and the remaining 0.6 parts of trehalose are dissolved in purified water, the stirring rate is 920 rpm; after adding menthol, laurocapram, etc., the stirring time is 4.8 min; the vacuum degree is -0.098 MPa, the low frequency vibration frequency is 29 Hz, and the degassing time is 14.5 min. Example

[0090] This embodiment provides a skin antibacterial gel, the components of which are listed in parts by weight as follows: 75 parts Mongolian medicine extract, 7 parts polyvinyl alcohol, 1.0 part xanthan gum, 4.0 parts glycerin, 4.0 parts nicotinamide, 2.0 parts triclosan, 1.5 parts trehalose, 1.0 part menthol, 1.0 part laurocapram, 0.15 parts sodium hyaluronate, 0.07 parts triethanolamine, 0.015 parts fragrance, and 3.265 parts purified water.

[0091] In this embodiment, the preparation method of the antibacterial gel for the skin is the same as in Example 1, except for the following parameters:

[0092] In step S1, 35% Gardenia jasminoides, 25% Terminalia chebula, 20% Melia toosendan, and 20% Smilax glabra were weighed according to the following mass ratio; ultrasonic water extraction was performed using 9 times the amount of purified water at 45℃ and 250W power for 1.5h; microwave alcohol extraction was performed using 7 times the amount of 75% ethanol on the residue at 55℃ and 180W power for 1.5h; during purification with D101 macroporous resin, the loading flow rate was 1.5 BV / h, the elution flow rate with 50% ethanol was 1.0 BV / h, and the eluent was concentrated under reduced pressure at 55℃ to a relative density of 1.04;

[0093] In step S2, the mass ratio of trehalose to sodium hyaluronate is 1.5:1, with 0.9 parts of trehalose and 0.6 parts of sodium hyaluronate. The amount of ethanol used in the oil phase is 5 times the mass of triclosan. The high-speed shear rate is 4000 rpm and the emulsification time is 12 min. The freeze-drying pre-freezing temperature is -35℃ and the pre-freezing time is 2.5 h. The sublimation drying temperature is 35℃ and the time is 8 h. The desorption drying temperature is 55℃ and the time is 4 h.

[0094] In step S3, the mass ratio of polyvinyl alcohol to xanthan gum is 7:1; the matrix dissolution temperature is 88℃, the dissolution time is 30 min, and the pH is adjusted to 6.5 after cooling to 55℃; the homogenization rate is 1800 rpm, the nitrogen flow rate is 0.8 L / min, and the homogenization time is 6 min (the dispersion spacing is monitored by an online particle size analyzer at 20 μm); when glycerol, nicotinamide, and the remaining 0.6 parts of trehalose are dissolved in purified water, the stirring rate is 900 rpm; after adding menthol, laurocapram, etc., the stirring time is 4 min; the vacuum degree is -0.09 MPa, the low frequency vibration frequency is 25 Hz, and the degassing time is 12 min. Example

[0095] This embodiment provides a skin antibacterial gel, the components of which are listed in parts by weight as follows: 73 parts Mongolian medicine extract, 6.5 parts polyvinyl alcohol, 1.2 parts xanthan gum, 3.6 parts glycerin, 3.6 parts nicotinamide, 1.7 parts triclosan, 1.1 parts trehalose, 0.9 parts menthol, 0.9 parts laurocapram, 0.11 parts sodium hyaluronate, 0.065 parts triethanolamine, 0.008 parts fragrance, and 4.217 parts purified water.

[0096] In this embodiment, the preparation method of the antibacterial gel for the skin is the same as in Example 1, except for the following parameters:

[0097] In step S1, 34% Gardenia jasminoides, 24% Terminalia chebula, 23% Melia toosendan, and 19% Smilax glabra were weighed according to the following mass ratio; ultrasonic water extraction was performed using 8.5 times the amount of purified water at 46℃ and 260W for 1.4h; microwave alcohol extraction was performed using 6.8 times the amount of 76% ethanol in the residue at 54℃ and 175W for 1.5h; during purification with D101 macroporous resin, the loading flow rate was 1.3 BV / h, the elution flow rate with 50% ethanol was 1.05 BV / h, and the eluent was concentrated under reduced pressure at 56℃ to a relative density of 1.042;

[0098] In step S2, the mass ratio of trehalose to sodium hyaluronate is 1.3:1, with 0.52 parts of trehalose and 0.4 parts of sodium hyaluronate. The amount of ethanol used in the oil phase is 5.5 times the mass of triclosan. The high-speed shear rate is 3900 rpm and the emulsification time is 12.8 min. The freeze-drying pre-freezing temperature is -36℃ and the pre-freezing time is 2.4 h. The sublimation drying temperature is 36℃ and the time is 8.3 h. The desorption drying temperature is 54℃ and the time is 4.1 h.

[0099] In step S3, the mass ratio of polyvinyl alcohol to xanthan gum was 5.4:1; the matrix dissolution temperature was 89℃, the dissolution time was 29 min, and the pH was adjusted to 6.4 after cooling to 54℃; the homogenization rate was 1750 rpm, the nitrogen flow rate was 0.75 L / min, and the homogenization time was 6.2 min; when glycerol, nicotinamide, and the remaining 0.58 parts of trehalose were dissolved in purified water, the stirring rate was 890 rpm; after adding menthol, laurocapram, etc., the stirring time was 4.1 min; the vacuum degree was -0.091 MPa, the low-frequency vibration frequency was 24 Hz, and the degassing time was 12.5 min. Example

[0100] This embodiment provides a skin antibacterial gel, the components of which are listed in parts by weight as follows: 76 parts Mongolian medicine extract, 5.5 parts polyvinyl alcohol, 0.9 parts xanthan gum, 3.9 parts glycerin, 3.9 parts nicotinamide, 2.2 parts triclosan, 1.4 parts trehalose, 1.2 parts menthol, 1.2 parts laurocapram, 0.14 parts sodium hyaluronate, 0.08 parts triethanolamine, 0.012 parts fragrance, and 3.668 parts purified water.

[0101] In this embodiment, the preparation method of the antibacterial gel for the skin is the same as in Example 1, except for the following parameters:

[0102] In step S1, 37% Gardenia jasminoides, 23% Terminalia chebula, 21% Melia toosendan, and 19% Smilax glabra were weighed according to the following mass ratio; ultrasonic water extraction was performed using 9.2 times the amount of purified water at 47℃ and 270W for 1.3h; microwave alcohol extraction was performed using 7.1 times the amount of 77% ethanol in the residue at 57℃ and 185W for 1.3h; during purification with D101 macroporous resin, the loading flow rate was 1.6 BV / h, the elution flow rate with 50% ethanol was 1.1 BV / h, and the eluent was concentrated under reduced pressure at 57℃ to a relative density of 1.046;

[0103] In step S2, the mass ratio of trehalose to sodium hyaluronate is 1.7:1, with 0.68 parts of trehalose and 0.4 parts of sodium hyaluronate. The amount of ethanol used in the oil phase is 5.3 times the mass of triclosan. The high-speed shear rate is 4200 rpm, the emulsification time is 13.2 min, the freeze-drying pre-freezing temperature is -33℃, the pre-freezing time is 2.7 h, the sublimation drying temperature is 37℃, the time is 7.9 h, and the desorption drying temperature is 56℃, the time is 3.8 h.

[0104] In step S3, the mass ratio of polyvinyl alcohol to xanthan gum was 6.1:1; the matrix dissolution temperature was 86℃, the dissolution time was 31 min, and the pH was adjusted to 6.6 after cooling to 56℃; the homogenization rate was 1880 rpm, the nitrogen flow rate was 0.82 L / min, and the homogenization time was 5.8 min; when glycerol, nicotinamide, and the remaining 0.72 parts of trehalose were dissolved in purified water, the stirring rate was 910 rpm; after adding menthol, laurocapram, etc., the stirring time was 3.9 min; the vacuum degree was -0.089 MPa, the low-frequency vibration frequency was 27 Hz, and the degassing time was 11.8 min. Example

[0105] This embodiment provides a skin antibacterial gel, the components of which are listed in parts by weight as follows: 70 parts Mongolian medicine extract, 8.5 parts polyvinyl alcohol, 1.8 parts xanthan gum, 4.8 parts glycerin, 4.8 parts nicotinamide, 2.9 parts triclosan, 1.9 parts trehalose, 1.9 parts menthol, 1.9 parts laurocapram, 0.19 parts sodium hyaluronate, 0.095 parts triethanolamine, 0.019 parts fragrance, and 2.496 parts purified water.

[0106] In this embodiment, the preparation method of the antibacterial gel for the skin is the same as in Example 1, except for the following parameters:

[0107] In step S1, 31% Gardenia jasminoides, 26% Terminalia chebula, 26% Melia toosendan, and 17% Smilax glabra were weighed according to the following mass ratio; ultrasonic water extraction was performed using 10 times the amount of purified water at 50℃ and 300W power for 1 hour; microwave alcohol extraction was performed using 8 times the amount of 80% ethanol from the residue at 60℃ and 200W power for 1 hour; during purification with D101 macroporous resin, the loading flow rate was 2 BV / h, the elution flow rate with 50% ethanol was 1.2 BV / h, and the eluent was concentrated under reduced pressure at 60℃ to a relative density of 1.05;

[0108] In step S2, the mass ratio of trehalose to sodium hyaluronate is 3:1, with 1.425 parts of trehalose and 0.475 parts of sodium hyaluronate. The amount of ethanol used in the oil phase is 6 times the mass of triclosan. The high-speed shear rate is 4500 rpm and the emulsification time is 11 min. The freeze-drying pre-freezing temperature is -30℃ and the pre-freezing time is 2 h. The sublimation drying temperature is 40℃ and the time is 7 h. The desorption drying temperature is 60℃ and the time is 3.5 h.

[0109] In step S3, the mass ratio of polyvinyl alcohol to xanthan gum is 4.7:1; the matrix dissolution temperature is 95℃, the dissolution time is 25 min, and the pH is adjusted to 7.0 after cooling to 60℃; the homogenization rate is 2000 rpm, the nitrogen flow rate is 1 L / min, and the homogenization time is 5 min; when glycerol, nicotinamide, and the remaining 0.475 parts of trehalose are dissolved in purified water, the stirring rate is 1000 rpm; after adding menthol, laurocapram, etc., the stirring time is 3 min; the vacuum degree is -0.08 MPa, the low frequency vibration frequency is 30 Hz, and the degassing time is 10 min. Example

[0110] This embodiment provides a skin antibacterial gel, the components of which are listed in parts by weight as follows: 74 parts Mongolian medicine extract, 6.8 parts polyvinyl alcohol, 1.1 parts xanthan gum, 3.7 parts glycerin, 3.7 parts nicotinamide, 1.6 parts triclosan, 1.2 parts trehalose, 0.85 parts menthol, 0.85 parts laurocapram, 0.12 parts sodium hyaluronate, 0.068 parts triethanolamine, 0.009 parts fragrance, and 4.003 parts purified water.

[0111] In this embodiment, the preparation method of the antibacterial gel for the skin is the same as in Example 1, except for the following parameters:

[0112] In step S1, 33% Gardenia jasminoides, 26% Terminalia chebula, 22% Melia toosendan, and 19% Smilax glabra were weighed according to the following mass ratio; ultrasonic water extraction was performed using 8.6 times the amount of purified water at 43℃ and 230W for 1.7h; microwave alcohol extraction was performed using 6.5 times the amount of 73% ethanol in the residue at 52℃ and 165W for 1.7h; during purification with D101 macroporous resin, the loading flow rate was 1.5 BV / h, the elution flow rate with 50% ethanol was 1.02 BV / h, and the eluent was concentrated under reduced pressure at 53℃ to a relative density of 1.041;

[0113] In step S2, the mass ratio of trehalose to sodium hyaluronate is 1.4:1, with 0.56 parts of trehalose and 0.4 parts of sodium hyaluronate. The amount of ethanol used in the oil phase is 5.4 times the mass of triclosan. The high-speed shear rate is 3700 rpm and the emulsification time is 12.2 min. The freeze-drying pre-freezing temperature is -35℃ and the pre-freezing time is 2.5 h. The sublimation drying temperature is 34℃ and the time is 8.4 h. The desorption drying temperature is 53℃ and the time is 4.2 h.

[0114] In step S3, the mass ratio of polyvinyl alcohol to xanthan gum was 6.2:1; the matrix dissolution temperature was 87℃, the dissolution time was 28 min, and the pH was adjusted to 6.3 after cooling to 53℃; the homogenization rate was 1720 rpm, the nitrogen flow rate was 0.72 L / min, and the homogenization time was 6.3 min; when glycerol, nicotinamide, and the remaining 0.64 parts of trehalose were dissolved in purified water, the stirring rate was 870 rpm; after adding menthol, laurocapram, etc., the stirring time was 4.3 min; the vacuum degree was -0.093 MPa, the low-frequency vibration frequency was 25 Hz, and the degassing time was 12.2 min. Example

[0115] This embodiment provides a skin antibacterial gel, the components of which are listed in parts by weight as follows: 77 parts Mongolian medicine extract, 5.2 parts polyvinyl alcohol, 0.7 parts xanthan gum, 4.2 parts glycerin, 4.2 parts nicotinamide, 2.1 parts triclosan, 1.6 parts trehalose, 1.3 parts menthol, 1.3 parts laurocapram, 0.16 parts sodium hyaluronate, 0.085 parts triethanolamine, 0.016 parts fragrance, and 3.429 parts purified water.

[0116] In this embodiment, the preparation method of the antibacterial gel for the skin is the same as in Example 1, except for the following parameters:

[0117] In step S1, 36% Gardenia jasminoides, 22% Terminalia chebula, 24% Melia toosendan, and 18% Smilax glabra were weighed according to the following mass ratio; ultrasonic water extraction was performed using 9.3 times the amount of purified water at 49℃ and 290W for 1.2h; microwave alcohol extraction was performed using 7.3 times the amount of 79% ethanol in the residue at 58℃ and 192W for 1.2h; during purification with D101 macroporous resin, the loading flow rate was 1.7 BV / h, and the elution flow rate with 50% ethanol was 1.12 BV / h. The eluent was concentrated under reduced pressure at 58℃ to a relative density of 1.047.

[0118] In step S2, the mass ratio of trehalose to sodium hyaluronate is 1.9:1, with 0.76 parts of trehalose and 0.4 parts of sodium hyaluronate. The amount of ethanol used in the oil phase is 5.7 times the mass of triclosan. The high-speed shear rate is 4300 rpm, the emulsification time is 13.1 min, the freeze-drying pre-freezing temperature is -32℃, the pre-freezing time is 2.6 h, the sublimation drying temperature is 38℃, the time is 7.7 h, and the desorption drying temperature is 58℃, the time is 3.7 h.

[0119] In step S3, the mass ratio of polyvinyl alcohol to xanthan gum was 7.4:1; the matrix dissolution temperature was 91℃, the dissolution time was 30 min, and the pH was adjusted to 6.7 after cooling to 57℃; the homogenization rate was 1830 rpm, the nitrogen flow rate was 0.83 L / min, and the homogenization time was 5.7 min; when glycerol, nicotinamide, and the remaining 0.84 parts of trehalose were dissolved in purified water, the stirring rate was 930 rpm; after adding menthol, laurocapram, etc., the stirring time was 3.7 min; the vacuum degree was -0.087 MPa, the low-frequency vibration frequency was 26 Hz, and the degassing time was 11.7 min.

[0120] To verify whether the antibacterial skin gels prepared in Examples 1-12 meet the design expectations and to evaluate their actual application performance, one tube of antibacterial skin gel, approximately 30g each, was prepared using the materials and methods of Examples 1-12. These gels were then subjected to finished product testing, which included basic performance testing, core efficacy testing, stability testing, and safety testing.

[0121] Basic performance testing includes sensory and physicochemical index testing and active ingredient content testing.

[0122] Specifically, an appropriate amount of the antibacterial skin gel prepared in Example 1 was taken, and its properties, pH value, net content, microcapsule distribution and particle size were tested. The specific results are shown in Table 1.

[0123] Table 1

[0124]

[0125] The results in Table 1 show that all examples exhibited a uniform yellow-brown gel appearance, free of visible impurities, and with a slight minty aroma, meeting the basic appearance and sensory requirements for topical gel products. The pH value was generally controlled within the range of 6.0-7.0, with a maximum fluctuation of no more than 0.5, adapting to the skin's physiological environment and avoiding irritation caused by excessively high pH levels. The net content deviation, calculated per 30g tube, was within ±1%, complying with the metrological requirements for pre-packaged products under the "Regulations on the Supervision and Management of Pre-packaged Commodities." The median microcapsule size was stable between 10-20μm, with a distribution uniformity ≥90%, indicating that the microcapsules were well dispersed in the gel matrix without significant aggregation or abnormal particle size. Example 7 showed the smallest net content deviation and the highest microcapsule distribution uniformity, with no abnormal fluctuations in the overall data.

[0126] In the detection of active ingredient content, the contents of geniposide, chebulic acid and smilax saponin in the Mongolian medicine extract were determined by high performance liquid chromatography to verify the gradient extraction effect. The encapsulation rate and free amount of triclosan after microencapsulation were verified according to Appendix D of GB / T27947-2020. The specific results are shown in Table 2.

[0127] Table 2

[0128]

[0129] Table 2 shows that the contents of geniposide, chebulic acid, and smilax glabra saponins in all examples were ≥1.3 mg / mL, ≥0.9 mg / mL, and ≥0.6 mg / mL, indicating stable and significant differences in the contents of the three active ingredients of Mongolian medicine. The contents of azadirachtin were ≤0.046 mg / mL, with no instances of exceeding the limit, thus avoiding the risk of skin irritation due to excessive azadirachtin. The encapsulation rate of triclosan was ≥88%, and the free amount was ≤0.12 mg / g, indicating that the microencapsulation process effectively encapsulates triclosan, reducing the amount that comes into direct contact with the skin. In Example 7, due to adjustments in the ratio of Mongolian medicine raw materials and optimization of gradient extraction parameters, the contents of geniposide, chebulic acid, and smilax glabra saponins reached 1.6 mg / mL, 1.2 mg / mL, and 0.9 mg / mL, respectively, with a triclosan encapsulation rate of 92%, the highest among all examples. The correlation between the data and the process parameters was clear, with no unreasonable fluctuations.

[0130] The core efficacy testing includes antibacterial rate testing and transdermal absorption efficiency testing.

[0131] Specifically, take an appropriate amount of the antibacterial skin gel prepared in Examples 1-12, and test its antibacterial performance according to Appendix C of GB15979. Data was collected every minute within 20 minutes of the original solution being applied to test for Propionibacterium acnes, Staphylococcus aureus, Escherichia coli, and Candida albicans.

[0132] The Franz diffusion cell method was used, with pigskin as the transdermal barrier, to determine the transdermal amounts of geniposide, chebulic acid, and triclosan within 2 hours. Samples were collected every 10 minutes to verify the synergistic transdermal effect of laurocapram.

[0133] See the core function test results. Figure 2 As shown. From Figure 2 As can be seen from the above, Example 7 has the best effect.

[0134] Stability testing includes accelerated stability testing, low-temperature stability testing, and centrifugal stability testing.

[0135] Specifically, an appropriate amount of the antibacterial skin gel prepared in Examples 1-12 was placed in a constant temperature and humidity chamber at 37°C and a relative humidity of 75% for 90 days. Samples were taken at 0, 30, 60 and 90 days to detect sensory properties, pH changes, triclosan content, encapsulation rate and antibacterial retention rate. The results are shown in Table 3.

[0136] Table 3

[0137]

[0138]

[0139] Table 3 shows that the sensory properties of each example remained uniform and free of impurities throughout 90 days, with no discoloration, layering, or off-odors. The pH value changed by ≤0.3 from the initial value to 90 days, indicating good acid-base stability of the system. The triclosan encapsulation rate decreased by ≤4%, without a significant decrease in the encapsulation rate leading to a surge in free triclosan. The antibacterial retention rate against Staphylococcus aureus was ≥90%, and the core antibacterial performance did not decrease significantly. In Example 7, due to the synergistic effect of -0.09MPa vacuum degassing and 25Hz low-frequency vibration molding process during preparation, the triclosan encapsulation rate still reached 88% after 90 days, and the antibacterial retention rate reached 95%, demonstrating better stability than other examples. The overall data met the basic requirements for accelerated stability testing of topical gels, with no component degradation or performance failure.

[0140] The samples were frozen at -10℃ for 7 days. After thawing at room temperature, the presence of ice crystals and stratification were observed to verify the freeze resistance of the gel matrix. The results are shown in Table 4.

[0141] Table 4

[0142]

[0143] Table 4 shows that, under the condition of freezing at -10℃ for 7 days, all examples maintained a uniform yellow-brown gel state after thawing, with no visible ice crystals formed, and no matrix delamination or structural damage caused by freezing. This result indicates that the interpenetrating network structure formed by polyvinyl alcohol and xanthan gum in the gel matrix can remain stable under low-temperature conditions, meeting the quality requirements of the product in low-temperature storage or transportation scenarios. The data of each example are highly consistent, and there are no low-temperature stability issues caused by differences in formulation or process.

[0144] Take 5 mL of gel into a centrifuge tube, centrifuge at 3000 rpm for 30 min, and observe whether there is layering or precipitation to verify the homogeneity of the system. The results are shown in Table 5.

[0145]

[0146] The results in Table 5 show that after centrifugation at 3000 rpm for 30 min, all examples maintained a uniform yellow-brown gel appearance without any layering or bottom sedimentation. This indicates that the active ingredients of Mongolian medicine and the triclosan composite microcapsules were well dispersed in the gel matrix and had good compatibility with the matrix, without phase separation or component aggregation due to centrifugal force.

[0147] Safety testing includes microbial limit testing, skin irritation testing, and heavy metal limit testing.

[0148] Specifically, an appropriate amount of the antibacterial skin gel prepared in Examples 1-12 was taken and tested according to Appendix B of GB15979 for total bacterial count, total fungal count, coliform bacteria, Staphylococcus aureus, Pseudomonas aeruginosa, and hemolytic streptococci. The results are shown in Table 6.

[0149] Table 6

[0150]

[0151] Table 6 shows that the total bacterial count in each example was ≤330 CFU / g, and the total fungal count was ≤78 CFU / g, meeting the basic microbial limits for topical antibacterial products. Harmful microorganisms such as coliforms, Staphylococcus aureus, Pseudomonas aeruginosa, and hemolytic streptococci were not detected, indicating no risk of microbial contamination. In Example 7, due to optimized elution parameters during purification of the Mongolian medicine extract using D101 macroporous resin and stricter control of relative humidity in the preparation environment, the total bacterial count was only 220 CFU / g, and the total fungal count was only 50 CFU / g, the lowest among all examples. This data demonstrates that the product's microbial safety is qualified and meets hygiene standards.

[0152] According to the "Disinfection Technical Specifications", three experimental rabbits were selected and 0.5g of the drug was applied to their backs for 14 consecutive days. The erythema and edema reactions were observed. No erythema or edema was found.

[0153] One vial of the antibacterial skin gel prepared in Examples 1-12 was randomly selected, and the concentrations of lead, arsenic, and mercury were determined according to the "Cosmetic Safety Technical Specifications". The concentrations of lead, arsenic, and mercury were 0.5 mg / kg, arsenic, and mercury, respectively. These values ​​did not exceed the limits for heavy metals in cosmetic products as specified in the specifications, proving that the heavy metal content of the product meets safety standards and there is no health risk caused by excessive heavy metals.

[0154] Based on the aforementioned basic performance, core efficacy, stability, and safety test results, it can be seen that the skin antibacterial gel of Example 7 performed best in key indicators: its content of Mongolian medicine active ingredients was the highest among all examples, its triclosan encapsulation rate reached 92%, its lowest free amount was 0.08 mg / g, and its antibacterial retention rate reached 95% and its microbial and heavy metal content was the lowest in the 90-day accelerated stability test. This proves that the raw material ratio, gradient extraction parameters, microencapsulation process, and matrix construction scheme of this example have been verified by experiments as the optimal scheme.

[0155] To further clarify the impact of key process steps and components on gel performance in this invention, six comparative examples were specifically established, each with a single variable adjusted around the core technical feature of Example 1: including changing the Mongolian medicine extraction process, canceling the triclosan composite microencapsulation treatment, replacing the single wall material of the microcapsules, adjusting the gel matrix composition, and removing laurocapsulone. By comparing the performance with that of Example 1 and Example 7, the necessity and synergistic effect of each key technical feature were verified.

[0156] This comparative example provides a skin antibacterial gel, whose components by mass, Mongolian medicine raw material ratio, and preparation process (excluding extraction steps) are consistent with those of Example 1. Only the preparation process of the Mongolian medicine extract is adjusted, as follows:

[0157] Take 50 kg of mixed medicinal powder, add 8 times the amount of 75% ethanol aqueous solution, transfer to a conventional reflux extraction tank, and reflux extract twice at 90℃ for 2 hours each time. Filter and combine the two extracts. Without the need for ultrasonic water extraction, microwave-assisted purification and macroporous resin purification steps, directly concentrate under reduced pressure at 55℃ to a relative density of 1.04 to obtain the Mongolian medicine extract of this comparative example.

[0158] The only difference between this comparative example and Example 1 is the preparation process of the Mongolian medicine extract. The remaining gel components, Mongolian medicine raw material ratios, preparation of composite microencapsulated triclosan, and gel preparation steps are completely consistent with Example 1. The specific differences are as follows:

[0159] Take 50 kg of the same mixed medicinal powder as in Example 1, add 10 times the amount of purified water, place it in a conventional decoction pot, and decoct twice at a constant temperature of 95°C for 2.5 hours each time. Filter and combine the two decoction liquids. Without the need for ultrasonic assistance, microwave alcohol extraction, or macroporous resin purification steps, directly concentrate under reduced pressure at 60°C to a relative density of 1.04 to obtain the Mongolian medicine extract of this comparative example.

[0160] The only difference between this comparative example and Example 1 is the method of adding triclosan. The composite microencapsulation treatment in Example 1 is omitted. The remaining gel components, Mongolian medicine raw material ratios, Mongolian medicine extract preparation, and gel preparation steps are completely consistent with Example 1. The specific differences are as follows:

[0161] Weigh 1.5 parts of triclosan, add 5 times the amount of 95% ethanol, and stir in a 50°C water bath until completely dissolved to obtain a triclosan ethanol solution. In the subsequent gel preparation, this triclosan ethanol solution is added to the system simultaneously with raw materials such as glycerin and nicotinamide in the "functional ingredient addition" step.

[0162] The only difference between this comparative example and Example 1 is the wall material composition of the triclosan composite microcapsules, which is replaced with trehalose. All other gel components, Mongolian medicine raw material ratios, Mongolian medicine extract preparation, gel preparation steps, and other microencapsulation operations are completely consistent with Example 1. Specific differences are as follows:

[0163] Weigh 0.8 parts of trehalose, add 10 times the amount of purified water, and stir in a 50°C water bath until completely dissolved to obtain a single trehalose aqueous phase; the oil phase preparation, emulsification and drying steps are the same as in Example 1.

[0164] The only difference between this comparative example and Example 1 is the composition of the gel matrix (omitted xanthan gum). All other gel components, Mongolian medicine raw material ratios, preparation of Mongolian medicine extract, preparation of composite microencapsulated triclosan, and other gel preparation steps are completely consistent with Example 1. Specific differences are as follows:

[0165] Weigh 6 parts of polyvinyl alcohol, add 50% of Mongolian medicine extract, place in a vacuum homogenizer and emulsifier, stir at 90°C for 40 minutes to ensure that the single polyvinyl alcohol is fully dissolved, cool to 55°C, add 0.06 parts of triethanolamine, adjust the pH of the system to 6.5, and obtain the matrix precursor; the steps of synergistic dispersion, functional component addition, and structural stabilization are consistent with those in Example 1.

[0166] The only difference between this comparative example and Example 1 is the omission of laurocapram and the addition of purified water to make up the total gel mass. All other gel components, Mongolian medicine raw material ratios, preparation of Mongolian medicine extract, preparation of composite microencapsulated triclosan, and gel preparation steps are completely consistent with Example 1. The specific differences, except for laurocapram, are as follows:

[0167] Weigh out 3.5 parts of glycerol, 3.5 parts of nicotinamide, and 0.8 parts of trehalose, and dissolve them in 4.43 parts of purified water. The amount of purified water used is increased by 0.8 parts compared to Example 1 to make up for the mass gap after removing laurocapram. Add the above solution to the system while stirring at 900 rpm. Then add only 0.8 parts of menthol and 0.01 parts of flavoring, and continue stirring for 4 min. The matrix construction, synergistic dispersion, and structural stabilization steps are the same as in Example 1.

[0168] To further verify the core performance advantages of the antibacterial gel for skin of the present invention, eight samples, including Examples 1 and 7 and Comparative Examples 1-6, were selected for core efficacy testing. The testing methods were consistent with those described above. Specific results are shown in [link to results]. Figure 3 As shown.

[0169] Figure 3 Data shows that the four key technical features of this invention—gradient extraction process, triclosan compound microencapsulation, polyvinyl alcohol-xanthan gum interpenetrating network matrix, and laurocapram to promote transdermal absorption—are not isolated but work synergistically to achieve the core effects of high-efficiency antibacterial activity, stable transdermal absorption, and low irritation. Example 7, due to the optimization of various technical parameters, became the best performing sample, further verifying the rationality and advancement of the technical solution of this invention.

[0170] The technical scope of this invention is not limited to the content described above. Those skilled in the art can make various modifications and variations to the above embodiments without departing from the technical concept of this invention, and all such modifications and variations should fall within the protection scope of this invention.

Claims

1. A skin bacteriostatic gel, characterized in that, It is composed of the following components in parts by weight: 70-80 parts Mongolian medicine extract, 5-9 parts polyvinyl alcohol, 0.5-2 parts xanthan gum, 3-5 parts glycerin, 3-5 parts nicotinamide, 1-3 parts triclosan, 0.5-2 parts trehalose, 0.5-2 parts menthol, 0.5-2 parts laurocapram, 0.05-0.2 parts sodium hyaluronate, 0.05-0.1 parts triethanolamine, 0.005-0.02 parts fragrance, and 2-5 parts purified water; The Mongolian medicine extract uses gardenia, chebula, Sichuan chinaberry, and smilax as raw materials, and the raw materials are formulated in a mass ratio of 31-38 parts: 22-27 parts: 20-26 parts: 15-23 parts. The Mongolian medicine extract is prepared by a gradient extraction process combining ultrasonic water extraction and microwave alcohol extraction. The gradient extraction process includes first extracting the Mongolian medicine raw materials with ultrasonic water to obtain an aqueous extract, and then extracting the residue after ultrasonic water extraction with microwave alcohol to obtain an alcohol extract. The aqueous extract and the alcohol extract are combined to obtain the Mongolian medicine extract, which contains geniposide, chebulic acid, neemin, and smilax saponin. The triclosan was subjected to a composite microencapsulation process to obtain triclosan composite microcapsules. The wall material used in the composite microencapsulation process was a mixture of trehalose and sodium hyaluronate in a mass ratio of 1:1 to 3:

1. The particle size of the triclosan composite microcapsules was 5-20 μm. The polyvinyl alcohol and xanthan gum together construct an interpenetrating network matrix for encapsulating the active ingredients in the Mongolian medicine extract and triclosan composite microcapsules.

2. A skin bacteria inhibiting gel as claimed in claim 1, wherein: In the gradient extraction process of the Mongolian medicine extract, the water extract and alcohol extract are combined and then purified. After purification, the mass ratio of geniposide, chebulic acid, azadirachtin, and smilax glabra saponin in the extract is 30:20:1:15-46:12:1:

25. The extract is concentrated under reduced pressure at a temperature of 55-60℃, and the relative density of the concentrated extract is 1.04-1.

05.

3. The skin bacteria inhibiting gel according to claim 1, wherein: The surface of the triclosan composite microcapsule is modified with chebulic acid from Mongolian medicine extract, and the hydroxyl groups of the microcapsule wall material form hydrogen bonds with the carboxyl groups of chebulic acid.

4. The skin bacteria-inhibiting gel according to claim 1, characterized in that: The polyvinyl alcohol and xanthan gum form an interpenetrating network matrix, and the polyvinyl alcohol and xanthan gum are mixed at a mass ratio of 5:1 to 8:

1.

5. The skin bacteria-inhibiting gel according to claim 1, wherein: The mass ratio of laurocapram to Mongolian medicine extract is 1:35-1:

80.

6. A process for the preparation of a skin antiseptic gel for use in the preparation of a skin antiseptic gel as claimed in any one of claims 1 to 5, characterised in that, Includes the following steps: S1: Weigh gardenia, chebula, Sichuan pepper, and smilax according to the mass ratio, mix them, pulverize them through an 80-mesh sieve to obtain mixed powder, and then extract them by ultrasonic water extraction and microwave alcohol extraction. After collecting the extract, purify it with D101 macroporous resin to control the proportion of geniposide, chebulic acid, neemin, and smilax saponin. S2: Dissolve triclosan in ethanol to obtain an oil phase, dissolve trehalose and sodium hyaluronate in purified water at a mass ratio of 1:1 to 3:1 to obtain an aqueous phase, add the oil phase to the aqueous phase and emulsify, freeze-dry the emulsion product to obtain triclosan composite microcapsules. S3: Mix polyvinyl alcohol and xanthan gum at a mass ratio of 5:1-8:1, add 50% of Mongolian medicine extract, dissolve under heating conditions, cool down, add triethanolamine to adjust the pH of the system to 6.0-7.0, and form a selectively loaded matrix; S4: Disperse the triclosan composite microcapsules in the remaining Mongolian medicine extract, inject them into the selectively loaded matrix after ultrasonic treatment, and simultaneously introduce nitrogen gas for homogenization; S5: Add glycerin, nicotinamide, menthol, laurocapram, fragrance, and the remaining trehalose and sodium hyaluronate. After stirring and mixing, the mixture is subjected to vacuum degassing and low-frequency vibration treatment to obtain a skin antibacterial gel.

7. A process for the preparation of a skin antiseptic gel as claimed in claim 6, wherein: In step S1, 8-10 times the amount of purified water is added during ultrasonic water extraction of the mixed powder, and the power of ultrasonic water extraction is positively correlated with the time.

8. A process for the preparation of a skin bacteriostatic gel as claimed in claim 6, wherein: In step S2, the ethanol used in the oil phase preparation is 95% ethanol, and the amount used is 5-6 times the mass of triclosan; the amount of purified water used in the aqueous phase preparation is 10 times the total mass of trehalose and sodium hyaluronate; the emulsification process uses high-speed shearing at 3500-4500 rpm for 11-14 min.

9. A process for the preparation of a skin bacteriostatic gel as claimed in claim 6, wherein: In step S4, the ultrasonic treatment power is 200W and the time is 5min; the triclosan composite microcapsules are dispersed in the remaining amount of Mongolian medicine extract and the resulting suspension is injected into the selectively loaded matrix at an injection rate of 5mL / min, the homogenization time is controlled at 5-7min, and the nitrogen flow rate is maintained at 0.5-1L / min.

10. A process for the preparation of a skin bacteriostatic gel as claimed in claim 6, wherein: In step S5, the stirring and mixing rate is 800-1000 rpm; the vacuum degree of vacuum degassing is -0.08-0.1 MPa; the frequency of low-frequency vibration is 20-30 Hz; vacuum degassing and low-frequency vibration are carried out synchronously; and the degassing time is controlled at 10-14.5 min.

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