Rose hydrolat condom containing rose essential oil and preparation method

Abstract

The invention belongs to the technical field of contraceptive instruments, and discloses a rose hydrolat condom containing rose essential oil and a preparation method. The condom comprises a latex / polyurethane substrate layer, an outer surface slow-release layer (containing gelatin-Arabic gum microcapsules, wherein a capsule core is rose hydrolat containing rose essential oil) and an inner surface lubricating layer (rose hydrolat containing rose essential oil / glycerol / other compound systems). Release is synergistically regulated and controlled through a pH responsive isolating membrane, so that a long-acting moisturizing film is formed by citronellol (greater than or equal to 35%) in the rose hydrolat containing the rose essential oil and hyaluronic acid, and the moisture content of mucous membranes is increased by 40-60%; flavonoid substances (larger than or equal to 15 mg / g) inhibit release of inflammatory factors. Phenethyl alcohol (greater than or equal to 5%) relieves anxiety through an olfactory pathway. By combining a beta-cyclodextrin desensitization process and ultraviolet irradiation crosslinking, the problems of transient lubrication, sensitization and ingredient inactivation of a traditional product are solved, and the product has the functions of moisturizing for more than or equal to 4 hours, 99.9% bacteriostasis and emotion regulation.

Description

Technical Field

[0001] The present invention relates to the technical field of medicinal contraceptive devices, and more particularly to a rose hydrosol condom containing rose essential oil and a preparation method thereof. Background Art

[0002] Currently, condoms on the market primarily rely on silicone oil or water-based lubricants for lubrication. However, these lubricants are volatile and have poor durability (usually lasting 30-60 minutes). Prolonged use can easily dry out the mucous membranes, affecting user experience. Additionally, some products attempt to add plant essential oils (such as aloe vera and rose) to enhance moisturizing and skincare effects. However, direct exposure of essential oils to the latex surface can lead to the following problems:

[0003] 1. Poor stability: essential oils are easily oxidized and deteriorate, have low compatibility with latex, and long-term storage may cause material aging;

[0004] 2. Uncontrollable release: One-time release leads to rapid loss of active ingredients and cannot achieve long-term moisturizing;

[0005] 3. Risk of sensitization: Unprocessed essential oils may contain allergenic ingredients (such as citronellol) that can trigger allergic reactions.

[0006] Therefore, in view of the above problems, a rose hydrosol condom containing rose essential oil and a preparation method are proposed. Summary of the Invention

[0007] In order to overcome the above-mentioned defects of the prior art, an embodiment of the present invention provides a risk assessment model based on artificial intelligence in financial big data analysis to solve the problems raised in the above-mentioned background technology.

[0008] To achieve the above object, the present application provides the following technical solutions: a condom containing rose essential oil and a preparation method, comprising a substrate layer made of latex or polyurethane, a sustained-release layer coated on the outer surface of the substrate layer, and a lubricating layer arranged on the inner surface of the substrate layer; the sustained-release layer on the outer surface of the substrate layer comprises rose essential oil-containing rose hydrolat microcapsules and a hydrophilic polymer material, wherein the rose essential oil-containing rose hydrolat microcapsules realize continuous release of essential oil through a double mechanism of capsule wall rupture and penetration, the lubricating layer on the inner surface of the substrate layer comprises preservative 0.0046%, betaine 0.146%, sodium hyaluronate 0.0021%, sorbitol 0.0077%, rose hydrolat 0.35%, propylene glycol 0.046%, and glycerol 0.443%, the proportions of the components are calculated based on the total mass of the lubricating layer, and the penetration rate of the rose essential oil-containing rose hydrolat in the lubricating layer and the release rate of the microcapsules in the sustained-release layer form a synergistic effect, ensuring that the moisturizing duration of the inner and outer surfaces of the condom is greater than or equal to 4 hours; the capsule wall of the rose essential oil-containing rose hydrolat microcapsules is a gelatin-arabic gum composite wall material, the capsule core is rose hydrolat containing rose essential oil, and the mass ratio of the capsule core to the capsule wall is 1:(0.5-1.2), the rose essential oil is extracted from rose petals, and has the following functions:

[0009] (a) moisturizing and skin care function: taking citronellol (≥35%) as the core active ingredient, synergizing with hyaluronic acid to form a dynamic hydration film, increasing the mucosal water content by 40-60%, and realizing long-acting moisturizing for more than or equal to 4 hours through the penetration synergy of the microcapsule sustained-release layer and the lubricating layer;

[0010] (b) emotional soothing function: through the initial 30-minute targeted release of phenylethyl alcohol (≥5%), the limbic system is activated through the olfactory pathway, and clinical verification shows that the user's anxiety index is reduced by 30%;

[0011] (c) anti-inflammatory and antibacterial function: the flavonoid substance (≥15mg / g) contained therein inhibits the release of inflammatory factor TNF-α by 40%;

[0012] (d) endocrine regulation function: the phytosterol component regulates local microcirculation through mucosal penetration, increases blood oxygen saturation by 15-25%, and improves tissue metabolic balance.

[0013] Preferably, the particle size of the rose essential oil-containing rose hydrolat microcapsules in the sustained-release layer on the outer surface of the substrate layer is 10-200μm, and the microcapsules are uniformly distributed in the hydrophilic polymer material through electrostatic adsorption, the hydrophilic polymer material is polyvinylpyrrolidone or hydroxypropyl methyl cellulose, the molecular weight of the hydrophilic polymer material is 100-150 million daltons, and the mass ratio of the hydrophilic polymer material to the microcapsules is 1:(0.8-1.5), which is used to form a three-dimensional network structure to control the release interval time of the microcapsules to be 20-40 minutes per time.

[0014] Preferably, the concentration of rose hydrolat containing rose essential oil in the lubricating layer on the inner surface of the substrate layer is 5-15wt%, the total amount of vitamin E and glycerol added is 8-20% of the mass of the lubricating layer, and the mass ratio of vitamin E to glycerol is 1:(0.8-1.2), wherein the medical grade low molecular weight glycerol with a molecular weight of 500-2000 is used to enhance the affinity with the mucosa, the rose hydrolat containing rose essential oil is treated by supercritical CO2 extraction, and the content of the main active ingredient citronellol is ≥35%.

[0015] Preferably, the thickness of the substrate layer made of latex or polyurethane is 0.03-0.08mm, and the inside is embedded with nano-silver antibacterial particles, the particle size of the nano-silver particles is 10-50nm, and the addition amount is 0.01-0.1% of the mass of the latex or polyurethane base material.

[0016] Preferably, a cross-linked sodium alginate film is provided between the slow-release layer on the outer surface of the substrate layer and the lubricating layer on the inner surface of the substrate layer, the thickness of the cross-linked sodium alginate film is 2-10μm, and the porosity is 30-60%, wherein the cross-linking degree of sodium alginate is 50-80%, the cross-linking agent is a mixed solution of calcium chloride and glutaraldehyde, and the surface of the isolation film is modified with a polylysine coating layer with a thickness of 0.1-1μm, and the migration rate of rose hydrolat containing rose essential oil from the slow-release layer to the lubricating layer is controlled to be 0.2-0.8mg / (cm 2 ·h).

[0017] Preferably, the following steps are included:

[0018] S1, a latex or polyurethane prepolymer is first immersed to form a substrate layer semi-finished product, the immersion temperature is 25-35℃, and the immersion time is 30-90 seconds;

[0019] S2, rose hydrolat containing rose essential oil is prepared into microcapsules by complex coacervation, the reaction pH value is controlled to be 3.5-4.5, the stirring rate is 800-1500rpm, and it is mixed with a hydrophilic polymer solution with a mass concentration of 5-15% to form a slow-release liquid, and a slow-release layer is formed on the outer surface of the substrate layer by spraying process;

[0020] S3, rose hydrolat containing rose essential oil, vitamin E and glycerol are heated to 40-60℃ for homogenization, the homogenization pressure is 20-50MPa, and after cooling to 25-30℃, a lubricating layer is formed on the inner surface of the substrate layer, and the coating thickness is 10-30μm;

[0021] S4, secondary curing is carried out at 50-80℃ for 20-60 minutes, and ultraviolet irradiation treatment is carried out for 10-30 seconds at a wavelength of 365nm and an intensity of 50-200mW / cm 2 to form chemical cross-linking bonds between the layers.

[0022] Preferably, the atomization pressure of the spraying process in step (S2) is 0.2-0.5 MPa, the spraying rate is 5-15 mL / min, and the drug loading of the slow-release layer per unit area is 0.5-2 mg / cm 2 Immediately after spraying, pre-drying is performed at 40-50℃ for 3-5 minutes to fix the microcapsule distribution, wherein the solvent of the hydrophilic polymer solution is an ethanol-water mixed solution with a volume ratio of 1:1.

[0023] Preferably, before the ultraviolet irradiation treatment in step (S4), nitrogen is introduced to protect the environment, the oxygen content is controlled to be ≤200 ppm, the irradiation distance is 10-20 cm, and after irradiation, a gradient cooling process is adopted: the temperature is reduced to room temperature at a rate of 2-5℃ / min to prevent interlayer stress cracking.

[0024] Preferably, the rose hydrolate containing rose essential oil is subjected to desensitization treatment, specifically using a β-cyclodextrin inclusion process, the inclusion rate is 85-95%, the molar ratio of β-cyclodextrin to rose hydrolate containing rose essential oil is 1:(0.8-1.2), the inclusion temperature is 45-55℃, and the reaction time is 2-4 hours, and the incidence of allergic reactions after desensitization is ≤0.1%.

[0025] Preferably, the polylysine coating on the surface of the isolation film is grafted with a pH-responsive group, specifically a carboxymethyl chitosan-polylysine copolymer, which swells at a vaginal environment pH of 4.0-4.5, and the lubricating layer further comprises a preservative 0.0046%, betaine 0.146%, sodium hyaluronate 0.0021%, sorbitol 0.0077%, rose hydrolate 0.35%, propylene glycol 0.046%, glycerol 0.443%, and the proportions of each component are calculated based on the total mass of the lubricating layer.

[0026] Technical effects and advantages of the present application:

[0027] 1. Systematic integration of the six-dimensional functions of rose hydrolate containing rose essential oil

[0028] Through the innovative microcapsule-response coating-bionic structure ternary system, the targeted synergistic effect of rose hydrolat containing rose essential oil is achieved: deep moisturizing: citronellol (≥35%) in rose hydrolat cooperates with sodium hyaluronate to form a dynamic hydration film, increasing the moisture content of mucosal tissue by 40-60%, effectively solving the friction discomfort caused by dry environment; anti-inflammatory repair: microcapsule-encapsulated rose flavonoids (≥15 mg / g) form an antioxidant network with vitamin E, significantly inhibiting the release of inflammatory factors (TNF-α decreased by 40%), and accelerating the repair of epithelial microdamage; emotional relief: precise control of the release of phenylethanol (≥5%) within the initial 30 minutes activates the limbic system through the olfactory pathway, and the user's anxiety index is clinically verified to decrease by 30%; acid-base balance: the pH response layer triggers an intelligent release mechanism in the acidic environment of the vagina (pH 4.0-4.5), maintaining a weakly acidic environment (pH 5.2-5.8) on the contact surface, regulating the regional microecological balance; skin improvement: the surface microconvex structure promotes the penetration of rose polyphenols, increasing the local blood oxygen saturation by 15-25%, significantly enhancing the rosy luster of the private skin; antibacterial protection: rose tannins and nano-silver construct a composite antibacterial barrier with an antibacterial rate of ≥99.9% against pathogenic microorganisms such as Candida albicans without mucosal irritation.

[0029] 5.2-5.8), regulating the regional microecological balance; skin improvement: the surface microconvex structure promotes the penetration of rose polyphenols, increasing the local blood oxygen saturation by 15-25%, significantly enhancing the rosy luster of the private skin; antibacterial protection: rose tannins and nano-silver construct a composite antibacterial barrier with an antibacterial rate of ≥99.9% against pathogenic microorganisms such as Candida albicans without mucosal irritation.

[0030] 2. Long-acting moisturizing and precise release control

[0031] Innovatively adopts a time and space hierarchical release architecture: rose hydrolat containing rose essential oil is encapsulated in gelatin-arabic gum microcapsules, combined with a 45±5% porosity isolation film to achieve three-stage release: 50% essential oil is released within the initial 30 minutes to quickly form a lubricating film, 6-8% is released every hour in the medium term (30-180 minutes) to maintain moisture, and residual essential oil promotes tissue repair in the late stage (180-240 minutes); low molecular weight glycerol (molecular weight 1200) in the lubricating layer forms a lipid water-locking barrier, cooperatively delaying water evaporation, making the moisturizing duration break through to ≥4 hours (verified by ASTM D7251).

[0032] 3. Active preservation and biological safety enhancement

[0033] The molecular-level protection technology ensures the activity of essential oil and use safety: supercritical CO2 extraction process ensures that the retention rate of rose characteristic component citronellol is ≥98%, and β-cyclodextrin inclusion reduces the exposure of sensitizers to ≤0.1 ppm; nitrogen protection ultraviolet curing process (oxygen content ≤200 ppm) inhibits the photooxidation and deterioration of essential oil.

[0034] 4. Environment self-adaptive intelligent response mechanism

[0035] Dynamic adjustment based on carboxymethyl chitosan-polylysine copolymer coating: triggered by vaginal acidic environment (pH 4.0-4.5), the coating swells, making the porosity self-adaptively increase to 55-60%, and the essential oil release rate increases to 1.5 times of the benchmark value; a three-stage functional model of "lubrication-hydrating-repairing" is established: the initial stage (0-60 minutes) rapidly reduces the friction coefficient by 60%, the medium stage (60-180 minutes) maintains the mucosal water content rate ≥ 35%, and the later stage (180-240 minutes) promotes the epithelial cell migration rate by 25%, completely solving the lubrication fault of traditional products.

[0036] 5. Precision manufacturing and quality control system

[0037] Relying on process parameter closed-loop control to ensure performance stability: microcapsule electrostatic spraying uses 0.35±0.05MPa atomization pressure, realizes drug loading deviation ≤3.8%, and ultraviolet crosslinking strength 150mW / cm 2 Ensures interlayer bonding strength 2.8±0.3N / cm (reaches 1.8 times of the industry average); gradient cooling program (3℃ / min) eliminates thermal stress crystallization, making microcapsule breakage rate ≤0.7%, product defect rate controlled below 0.8%, and realizes large-scale high-yield production of active essential oil-containing condoms. BRIEF DESCRIPTION OF DRAWINGS

[0038] Figure 1 The system framework diagram of the present application. DETAILED DESCRIPTION

[0039] The technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative labor fall within the scope of protection of the present application.

[0040] (1) A rose hydrolat condom containing rose essential oil and a preparation method, comprising a substrate layer made of latex or polyurethane, a sustained-release layer coated on the outer surface of the substrate layer, and a lubricating layer provided on the inner surface of the substrate layer; the sustained-release layer on the outer surface of the substrate layer comprises rose hydrolat microcapsules containing rose essential oil and a hydrophilic polymer material, wherein the rose hydrolat microcapsules containing rose essential oil achieve sustained release of essential oil through a dual mechanism of capsule wall rupture and permeation, the lubricating layer on the inner surface of the substrate layer comprises preservative 0.0046%, betaine 0.146%, sodium hyaluronate 0.0021%, sorbitol 0.0077%, rose hydrolat 0.35%, propylene glycol 0.046%, and glycerol 0.443%, the proportions of the components are calculated based on the total mass of the lubricating layer, and the permeation rate of rose hydrolat in the lubricating layer and the release rate of the microcapsules in the sustained-release layer form a synergistic effect, ensuring that the moisturizing duration of the inner and outer surfaces of the condom is ≥4 hours; the capsule wall of the rose hydrolat microcapsules containing rose essential oil is a gelatin-arabic gum composite wall material, the capsule core is rose hydrolat containing rose essential oil, and the mass ratio of the capsule core to the capsule wall is 1:(0.5-1.2), the rose essential oil is extracted from rose petals, and has the following functions:

[0041] (a) Moisturizing and skin care function: using citronellol (≥35%) as the core active ingredient, synergizing with hyaluronic acid to form a dynamic hydration film, increasing the mucosal water content by 40-60%, and achieving long-acting moisturizing for ≥4 hours through the permeation synergy of the microcapsule sustained-release layer and the lubricating layer;

[0042] (b) Emotional soothing function: through the initial 30-minute targeted release of phenylethyl alcohol (≥5%), the limbic system is activated through the olfactory pathway, and clinical verification shows that the user's anxiety index is reduced by 30%;

[0043] (c) Anti-inflammatory and antibacterial function: the flavonoid content (≥15mg / g) inhibits the release of inflammatory factor TNF-α by 40%;

[0044] (d) Endocrine regulation function: plant sterol components penetrate the mucosa to regulate local microcirculation, increasing blood oxygen saturation by 15-25% and improving tissue metabolic balance, wherein the substrate layer is made of natural latex (solid content 62%) mixed with nano-silver (particle size 30nm, addition amount 0.05wt%), ultrasonically dispersed, and then immersed in a 35℃ mold to form a substrate with a thickness of 0.05mm; the sustained-release layer is prepared by complex coacervation, the capsule core is rose hydrolat containing rose essential oil, and the capsule wall is gelatin-arabic gum (1:1), the microcapsules are mixed with PVP K30 (mass ratio 1:1.2) and then sprayed onto the outer surface of the substrate layer, with a drug loading of 1.2mg / cm 2The lubricating layer is coated with rose hydrolat containing rose essential oil, vitamin E and glycerol (4:1.5:1.5) after homogenization at 50℃, with a thickness of 20μm, and achieves synergistic release with the sustained-release layer through a porosity of 45% sodium alginate isolation membrane, with a moisturizing duration of 4.5 hours.

[0045] (2) The particle size of the rose hydrolat microcapsules containing rose essential oil in the sustained-release layer on the outer surface of the matrix layer is 10-200μm, and is uniformly distributed in the hydrophilic polymer material by electrostatic adsorption, the hydrophilic polymer material being polyvinylpyrrolidone or hydroxypropyl methyl cellulose, wherein the molecular weight of the hydrophilic polymer material is 100-150 million Daltons, and the mass ratio of the hydrophilic polymer material to the microcapsules is 1:(0.8-1.5), used to form a three-dimensional network structure to control the microcapsule release interval of 20-40 minutes / time, wherein the microcapsule particle size D50 in the sustained-release layer is 80μm, the microcapsules are uniformly dispersed in the PVP solution (molecular weight 120 million) by using an electrostatic adsorption device (voltage 5kV, pole distance 10cm) to form a three-dimensional network structure, controlling the release of essential oil in each 20-minute wave, with a total release time of 4 hours; the mass ratio of the hydrophilic polymer to the microcapsules is 1:1, the solvent is ethanol-water (1:1), and the microcapsules are fixed in position after spraying and pre-drying (45℃, 5 minutes).

[0046] (3) The concentration of rose hydrolat containing rose essential oil in the lubricating layer on the inner surface of the matrix layer is 5-15wt%, the total amount of vitamin E and glycerol added is 8-20% of the mass of the lubricating layer, and the mass ratio of vitamin E to glycerol is 1:(0.8-1.2), wherein the medical-grade low-molecular-weight glycerol with a molecular weight of 500-2000 is used to enhance the affinity with the mucosa, the rose hydrolat containing rose essential oil is treated by supercritical CO2 extraction, and the main active ingredient citronellol content is ≥35%, wherein the concentration of rose hydrolat containing rose essential oil in the lubricating layer is 12wt%, the essential oil (citronellol content 38%) is extracted by supercritical CO2, compounded with medical glycerol with a molecular weight of 1000 and vitamin E (tocopherol content 97%) at a ratio of 4:1.5:1.5, homogenized at a pressure of 40MPa for 3 times, and a uniform film layer with a light transmittance of 92% is formed after coating, with a total vitamin E and glycerol addition amount of 18wt%, and a mucosa contact angle ≤15°.

[0047] (4) The thickness of the matrix layer made of latex or polyurethane is 0.03-0.08mm, and nanosilver antibacterial particles are embedded inside, the particle size of the nanosilver particles is 10-50nm, and the addition amount is 0.01-0.1% of the mass of the latex or polyurethane base material, wherein the nanosilver dispersion coefficient is ≤0.2 after ultrasonic treatment (40kHz, 30 minutes) after blending with the latex; after molding, the condom has an antibacterial rate of 99.95% against Escherichia coli, a tensile strength of 22MPa, and an elongation at break of 850%.

[0048] (5) The slow-release layer on the outer surface of the matrix layer is provided with a cross-linked sodium alginate film between the lubricating layer on the inner surface of the matrix layer, the thickness of the cross-linked sodium alginate film is 2-10 μm, the porosity is 30-60%, the cross-linking degree of sodium alginate is 50-80%, the cross-linking agent is a mixed solution of calcium chloride and glutaraldehyde, and the surface of the isolation film is modified with a polylysine coating layer with a thickness of 0.1-1 μm, and the migration rate of rose hydrolate containing rose essential oil from the slow-release layer to the lubricating layer is controlled to be 0.2-0.8 mg / (cm 2 ·h) by adjusting the grafting density of polylysine. 2 ·h) by adjusting the grafting density of polylysine.

[0049] (6) comprising the following steps:

[0050] S1, the latex or polyurethane prepolymer is first immersed to form a matrix layer semi-finished product, the immersion temperature is 25-35℃, and the immersion time is 30-90 seconds;

[0051] S2, rose hydrolate containing rose essential oil is prepared into microcapsules by complex coacervation, the reaction pH value is controlled to be 3.5-4.5, the stirring speed is 800-1500 rpm, and the slow-release liquid is formed by mixing with a hydrophilic polymer solution with a mass concentration of 5-15%, and the slow-release layer is formed on the outer surface of the matrix layer by spraying process;

[0052] S3, rose hydrolate containing rose essential oil, vitamin E and glycerol are homogenized at 40-60℃, the homogenization pressure is 20-50 MPa, and the lubricating layer is formed on the inner surface of the matrix layer after cooling to 25-30℃, and the coating thickness is 10-30 μm;

[0053] S4, secondary curing at 50-80℃ for 20-60 minutes, and ultraviolet irradiation treatment for 10-30 seconds at a wavelength of 365 nm and an intensity of 50-200 mW / cm 2 , wherein, during preparation, the matrix layer is immersed twice (35℃×60 seconds), and pre-cured (55℃×8 minutes); the slow-release layer microcapsules are synthesized by complex coacervation at pH 4.0, and the spraying parameters are 0.3 MPa atomization pressure and 12 mL / min rate; the lubricating layer is cross-linked by ultraviolet light (365 nm, 150 mW / cm 2× 20 seconds, nitrogen protection oxygen content ≤ 150 ppm), and finally gradient cooling (3 ° C / min) to room temperature.

[0054] (7) The atomization pressure of the spraying process in step (S2) is 0.2-0.5 MPa, the spraying rate is 5-15 mL / min, and the drug loading per unit area of ​​the sustained-release layer is 0.5-2 mg / cm 2 Immediately after spraying, pre-dry at 40-50°C for 3-5 minutes to fix the distribution of microcapsules. The solvent of the hydrophilic polymer solution is an ethanol-water mixed solution with a volume ratio of 1:1. In the spraying process, the nozzle diameter of the spray gun is 0.3mm, the spray distance is 15cm, the solid content of the sustained-release liquid is 12%, and pre-drying (45°C×5 minutes) after spraying makes the drug loading amount 1.0mg / cm 2 , error ≤ 3%; the volatility of the solvent ethanol-water (1:1) is controlled at 0.8g / (m 2 ·s), to avoid displacement of microcapsules.

[0055] (8) Before the ultraviolet irradiation treatment in step (S4), nitrogen is introduced to protect the environment, and the oxygen content is controlled at ≤200ppm. The irradiation distance is 10-20cm, and a gradient cooling process is adopted after irradiation: the temperature is lowered to room temperature at a rate of 2-5℃ / min to prevent interlayer stress cracking. Nitrogen is introduced before ultraviolet irradiation to make the oxygen content ≤180ppm, the irradiation distance is 15cm, and the intensity is 150mW / cm 2 , time 20 seconds, after irradiation, the temperature was gradually lowered at 4℃ / min, the interlayer peel strength reached 3.0N / cm, and no cracks were generated.

[0056] (9) The rose water containing rose essential oil is subjected to a desensitization treatment, specifically by adopting a β-cyclodextrin inclusion process, with an inclusion rate of 85-95%, wherein the molar ratio of β-cyclodextrin to rose water containing rose essential oil is 1:(0.8-1.2), the inclusion temperature is 45-55°C, the reaction time is 2-4 hours, and the incidence of allergic reaction after desensitization is ≤0.1%. wherein, the rose water containing rose essential oil is desensitized by adopting a β-cyclodextrin inclusion process, with a molar ratio of β-cyclodextrin to essential oil of 1:1, reacting at 50°C for 3 hours, with an inclusion rate of 92%, and the free rate of citronellol detected by HPLC is ≤0.08%, and the positive rate of the allergy test (patch method) is 0.05%.

[0057] (10) The polylysine coating modified on the surface of the isolation membrane is grafted with a pH-responsive group, specifically a carboxymethyl chitosan-polylysine copolymer, which swells when the pH value of the vaginal environment is 4.0-4.5. The lubricating layer further contains 0.0046% preservative, 0.146% betaine, 0.0021% sodium hyaluronate, 0.0077% sorbitol, 0.35% rose hydrosol, 0.046% propylene glycol, and 0.443% glycerol. The proportion of each component is calculated based on the total mass of the lubricating layer. Among them, the pH-responsive layer of the isolation membrane is copolymerized by carboxymethyl chitosan (deacetylation degree 85%) and polylysine (molecular weight 20,000) in a ratio of 1:1. At pH 4.2, the swelling degree reaches 150%, the porosity increases by 25%, and the essential oil sustained release rate increases from 0.4 mg / (cm 2 h) increased to 0.7 mg / (cm 2 h), and the release curve was consistent with the first-order kinetic model (R 2 ≥0.99).

[0058] Example 1: Multi-source data joint modeling scenario

[0059] Step 1: Matrix layer preparation

[0060] (1) Substrate preparation: Latex (natural rubber latex, solid content 60-65%) or polyurethane prepolymer (model TPU

[0061] 1185A, molecular weight 80,000-120,000) was placed in a reactor, and a surfactant, sodium dodecyl sulfate (SDS, concentration 0.1-0.3 wt%), was added and stirred evenly. Then, nanosilver particles (particle size 10-50 nm, addition amount 0.01-0.1 wt%) were added and treated with an ultrasonic disperser (frequency 40 kHz, power 300 W) for 30 minutes to ensure uniform dispersion of the nanosilver.

[0062] (2) Dipping molding: Preheat the mold (ceramic material, surface roughness Ra ≤ 0.8 μm) to 30-35 ° C and immerse it in the substrate liquid.

[0063] The immersion time is 45-60 seconds, and the pulling speed is 10-15 cm / min, forming a matrix layer wet film with a thickness of 0.03-0.08 mm. (3) Pre-curing: Place the wet film in a hot air circulation oven and preliminarily cure it at 50-60 ° C for 8-10 minutes to form a semi-finished matrix.

[0064] layer (moisture content ≤ 5%).

[0065] Step 2: Preparation of sustained-release layer

[0066] (1) Microcapsule synthesis:

[0067] (a) Capsule core preparation: rose hydrolate (citronellol content > 35%) containing rose essential oil was heated to 40°C and stirred (500 rpm) until homogeneous;

[0068] (b) Wall material solution preparation: gelatin (Bloom strength 250-300) and gum arabic (viscosity 150-200 mPa-s) were dissolved in deionized water at a mass ratio of 1:1, concentration 5 wt%, and pH adjusted to 4.0 ± 0.2;

[0069] (c) Complex coacervation reaction: the capsule core was slowly added to the wall material solution at a volume ratio of 1:1, the reaction temperature was controlled at 45°C, the stirring rate was 1200 rpm, and after 1 hour of reaction, the temperature was lowered to 10°C to induce wall material precipitation. After centrifugation (3000 rpm, 10 minutes) and washing, microcapsules with a particle size of 10-200 μm were obtained.

[0070] (2) Slow-release liquid preparation: microcapsules were mixed with polyvinylpyrrolidone (PVP K30, molecular weight 40,000) at a mass ratio of 1:

[0071] (0.8-1.5) and ethanol-water (volume ratio 1:1) solvent was added to prepare a suspension with a solid content of 10-15%.

[0072] (3) Spray coating process: a high-pressure spray gun (nozzle diameter 0.3 mm) was used to spray the slow-release liquid onto the outer surface of the substrate layer, with an atomization pressure of 0.3 MPa, a spraying rate of 10 mL / min, and a spraying distance of 15 cm. After spraying, the slow-release layer with a drug loading of 0.8-1.5 mg / cm 2 was formed by pre-drying under hot air at 45°C for 5 minutes.

[0073] Step 3: Isolation film formation

[0074] (1) Sodium alginate solution preparation: sodium alginate (viscosity 500-800 mPa-s) was dissolved in deionized water at a concentration of 3 wt%, and calcium chloride (0.5 wt%) and glutaraldehyde (0.2 wt%) were added as cross-linking agents, and the solution was stirred until it became transparent.

[0075] (2) Film formation and modification: the solution was applied to the surface of the slow-release layer by blade coating, with a wet film thickness of 50 μm. After drying at 50°C, a cross-linked film with a thickness of 5 μm (cross-linking degree 65-75%) was formed. Subsequently, the film was immersed in a polylysine-carboxymethyl chitosan copolymer solution (concentration 1 wt%, pH 4.5) for 10 seconds, and then solidified at 80°C for 2 minutes to form a pH-responsive coating layer with a thickness of 0.5 μm.

[0076] Step 4: Lubricating layer coating

[0077] (1) Lubricant formulation: the lubricating layer on the inner surface of the substrate layer contains preservative 0.0046%, betaine 0.146%, sodium hyaluronate 0.0021%, sorbitol 0.0077%, rose hydrolate 0.35%, propylene glycol 0.046%, glycerol 0.443%, the proportion of each component is calculated based on the total mass of the lubricating layer, after mixing, heated to 50°C and homogenized (pressure 30 MPa, cycle

[0078] 3 times) to a system transmittance ≥ 90%.

[0079] (2) Coating and shaping: use a precision coater to coat the lubricant on the inner surface of the substrate layer, coating speed 2 m / min, doctor blade gap 25 μm, form a lubricating layer with a thickness of 20 μm, then level off under nitrogen protection (oxygen content ≤ 100 ppm) for 10 minutes.

[0080] Step 5: Secondary curing and post-processing

[0081] (1) Thermal curing: place the semi-finished product in an oven, cure at 70°C for 30 minutes to promote molecular chain diffusion and bonding between layers.

[0082] (2) UV crosslinking: use a UV LED light source (wavelength 365 nm, intensity 150 mW / cm 2 ), irradiation distance 15 cm, irradiation time 20 seconds, to form covalent crosslinking bonds between the release film and the sustained-release layer (crosslinking density ≥ 80%).

[0083] (3) Gradient cooling: reduce the product from 70°C to room temperature at a rate of 3°C / min to eliminate internal stress.

[0084] Step 6: Quality testing and packaging

[0085] (1) Performance testing:

[0086] (a) Sustained-release testing: test in simulated body fluid (pH 4.2) for 4 hours, the cumulative release rate of essential oil should reach 95 ± 2%;

[0087] (b) Mechanical testing: tensile strength ≥ 20 MPa, elongation at break ≥ 800%;

[0088] (c) Biological safety: cytotoxicity test according to ISO 10993 standard (survival rate ≥ 90%).

[0089] (2) Sterilization and packaging: ethylene oxide sterilization (concentration 600 mg / L, temperature 40°C, humidity 60%, time 4 hours), vacuum aluminum foil packaging, each piece is individually sealed.

[0090] Finally should be explained a few points are: first, in the description of the present application, it should be pointed out that, unless otherwise specified and limited, the term "installation", "connected", "connection" should be broad, can be mechanical or electrical connection, but also can be two elements inside the communication, can be directly connected, "up", "down", "left", "right" and so on, only for indicating the relative position relationship, when the absolute position of the described object changes, the relative position relationship may change;

[0091] Second: the present application discloses the drawings in the embodiment, only involves the structure related to the present application, other structures can refer to the usual design, in the case of no conflict, the same embodiment and different embodiments of the present application can be combined with each other;

[0092] Finally: the above only for the preferred embodiment of the present application, and not for limiting the present application, any modification, equivalent replacement, improvement, etc. within the spirit and principles of the present application, should be included in the protection scope of the present application.

Claims

1. A rose hydrosol condom containing rose essential oil and a preparation method thereof, characterized in that: The invention comprises a matrix layer made of latex or polyurethane, a sustained-release layer coated on the outer surface of the matrix layer, and a lubricating layer arranged on the inner surface of the matrix layer; the sustained-release layer on the outer surface of the matrix layer comprises rose hydrosol microcapsules containing rose essential oil and a hydrophilic polymer material, wherein the rose hydrosol microcapsules containing rose essential oil realize sustained release of essential oil through the dual mechanisms of capsule wall rupture and penetration, and the lubricating layer on the inner surface of the matrix layer comprises 0.0046% of preservatives, 0.146% of betaine, 0.0021% of sodium hyaluronate, 0.0077% of sorbitol, 0.35% of rose hydrosol, The composition comprises 0.046% propylene glycol and 0.443% glycerol. The proportions of the components are calculated based on the total mass of the lubricating layer. The penetration rate of the rose hydrosol containing rose essential oil in the lubricating layer forms a synergistic effect with the release rate of the microcapsules in the sustained-release layer, ensuring that the inner and outer surfaces of the condom remain moisturized for ≥4 hours. The capsule wall of the rose hydrosol containing rose essential oil microcapsules is a gelatin-gum arabic composite wall material, and the capsule core is rose hydrosol containing rose essential oil. The mass ratio of the capsule core to the capsule wall is 1:(0.5-1.2). The rose essential oil is extracted from rose petals and comprises the following functions: (a) Moisturizing and skincare function: Citronellol (≥35%) is the core active ingredient, which synergizes with hyaluronic acid to form a dynamic hydration film, increasing the water content of the mucosa by 40-60%. The microcapsule sustained-release layer and the lubricating layer work together to achieve long-lasting moisturizing for ≥4 hours. (b) Emotional relief: Through the targeted release of phenylethanol (≥5%) within the first 30 minutes, it activates the limbic system via the olfactory pathway, and clinically verified to reduce the user's anxiety index by 30%; (c) Anti-inflammatory and antibacterial function: The flavonoids contained (≥15 mg / g) inhibit the release of inflammatory factor TNF-α by 40%; (d) Endocrine regulation function: Phytosterol components regulate local microcirculation through mucosal penetration, increase blood oxygen saturation by 15-25%, and improve tissue metabolic balance.

2. A rose hydrosol condom containing rose essential oil and a preparation method according to claim 1, characterized in that: The particle size of the rose hydrosol microcapsules containing rose essential oil in the sustained-release layer on the outer surface of the matrix layer is 10-200 μm, and they are evenly distributed in the hydrophilic polymer material by electrostatic adsorption. The hydrophilic polymer material is polyvinyl pyrrolidone or hydroxypropyl methylcellulose, wherein the molecular weight of the hydrophilic polymer material is 100,000-1.5 million Daltons, and the mass ratio of the hydrophilic polymer material to the microcapsule is 1:(0.8-1.5), which is used to form a three-dimensional network structure to control the release interval of the microcapsule to 20-40 minutes / time.

3. A rose hydrosol condom containing rose essential oil and a preparation method according to claim 1, characterized in that: The concentration of rose hydrosol containing rose essential oil in the lubricating layer on the inner surface of the matrix layer is 5-15wt%, the total added amount of vitamin E and glycerol is 8-20% of the mass of the lubricating layer, and the mass ratio of vitamin E to glycerol is 1:(0.8-1.2), wherein the glycerol adopts medical grade low molecular weight glycerol with a molecular weight of 500-2000 to enhance the affinity with the mucous membrane, the rose hydrosol containing rose essential oil is subjected to supercritical CO2 extraction treatment and the content of the main active ingredient citronellol is ≥35%.

4. The rose hydrosol condom containing rose essential oil and the preparation method thereof according to claim 1, wherein: The thickness of the matrix layer made of latex or polyurethane is 0.03-0.08mm, and nano silver antibacterial particles are embedded inside. The particle size of the nano silver particles is 10-50nm, and the addition amount is 0.01-0.1% of the mass of the latex or polyurethane substrate.

5. The rose hydrosol condom containing rose essential oil and the preparation method thereof according to claim 1, characterized in that: A cross-linked sodium alginate film is provided between the sustained-release layer on the outer surface of the matrix layer and the lubricating layer on the inner surface of the matrix layer. The thickness of the cross-linked sodium alginate film is 2-10 μm, and the porosity is 30-60%. The cross-linking degree of the sodium alginate is 50-80%, and the cross-linking agent is a mixed solution of calcium chloride and glutaraldehyde. The surface of the isolation membrane is modified with a polylysine coating with a thickness of 0.1-1 μm. By adjusting the grafting density of the polylysine, the migration rate of rose water containing rose essential oil from the sustained-release layer to the lubricating layer is controlled to be 0.2-0.8 mg / (cm 2 ·h).

6. A rose hydrosol condom containing rose essential oil and a preparation method thereof as claimed in any one of claims 1 to 5, characterized in that: The following steps are involved: S1. Dip-molding the latex or polyurethane prepolymer for the first time to obtain a semi-finished matrix layer product at a dipping temperature of 25-35° C. for 30-90 seconds; S2. Rose hydrosol containing rose essential oil is prepared into microcapsules by complex coacervation method, the reaction pH is controlled to 3.5-4.5, the stirring rate is 800-1500 rpm, and it is mixed with a hydrophilic polymer solution with a mass concentration of 5-15% to form a sustained-release solution, and a sustained-release layer is formed on the outer surface of the matrix layer by spraying process; S3, heating rose water containing rose essential oil, vitamin E and glycerin to 40-60° C. and homogenizing and mixing at a homogenizing pressure of 20-50 MPa, cooling to 25-30° C. and then applying to the inner surface of the matrix layer to form a lubricating layer with a coating thickness of 10-30 μm; S4, secondary curing at 50-80℃ for 20-60 minutes, using a wavelength of 365nm and an intensity of 50-200mW / cm 2 The film is then irradiated with ultraviolet light for 10-30 seconds to form chemical cross-linking bonds between the layers.

7. The rose hydrosol condom containing rose essential oil and its preparation method according to claim 6, characterized in that: The atomization pressure of the spraying process in step (b) is 0.2-0.5 MPa, the spraying rate is 5-15 mL / min, and the drug loading per unit area of ​​the sustained-release layer is 0.5-2 mg / cm 2 After spraying, it is immediately pre-dried at 40-50°C for 3-5 minutes to fix the distribution of the microcapsules, wherein the solvent of the hydrophilic polymer solution is an ethanol-water mixed solution with a volume ratio of 1:

1.

8. The rose hydrosol condom containing rose essential oil and its preparation method according to claim 6, characterized in that: Before the ultraviolet irradiation treatment in step (d), nitrogen is introduced into the protective environment, the oxygen content is controlled at ≤200ppm, the irradiation distance is 10-20cm, and a gradient cooling process is adopted after irradiation: the temperature is lowered to room temperature at a rate of 2-5℃ / min to prevent interlayer stress cracking.

9. The rose hydrosol condom containing rose essential oil and the preparation method thereof according to claim 1, characterized in that: The rose hydrosol containing rose essential oil is subjected to a desensitization treatment, specifically by adopting a β-cyclodextrin inclusion process, with an inclusion rate of 85-95%, wherein the molar ratio of β-cyclodextrin to the rose hydrosol containing rose essential oil is 1:(0.8-1.2), the inclusion temperature is 45-55° C., the reaction time is 2-4 hours, and the incidence of allergic reactions after desensitization is ≤0.1%.

10. The rose hydrosol condom containing rose essential oil and the preparation method thereof according to claim 5, characterized in that: The polylysine coating modified on the surface of the isolation membrane is grafted with pH-responsive groups, specifically carboxymethyl chitosan-polylysine copolymer, which swells when the pH value of the vaginal environment is 4.0-4.5.

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