External genital organ nursing spray and preparation method thereof

Abstract

The invention discloses an external genital organ care spray and a preparation method thereof, and the external genital organ care spray comprises an antibacterial composition, a humectant, a surfactant, an antioxidant, a thickening suspending agent, essence, a pigment, a pH balance regulator and the balance of deionized water; the antibacterial composition comprises a metal ion compound and a plant source antibacterial compound; the external genital organ nursing spray is convenient to use, targeted in administration, good in heat-resistant stability, mild, non-irritating and remarkable in effect, has an obvious inhibition effect on common pathogenic microorganisms causing external genital organ infection, such as staphylococcus, streptococcus, escherichia coli, candida, candida albicans and trichomonad vaginalis, is not easy to generate drug resistance, and can be used for treating external genital organ infection. The external genital infection and inflammation can be effectively prevented and relieved, the damaged skin can be repaired, and a good nursing effect is achieved.

Description

[0001] This divisional application of a patent for invention is for an invention patent application with an application date of August 14, 2023, an application number of CN202311019729.9, and an invention title of "An External Genitalia Care Spray and Its Preparation Method". Technical Field

[0002] The present invention belongs to the technical field of pharmaceutical sprays, and particularly relates to an external genitalia care spray and its preparation method. Background Art

[0003] Fungi, bacteria, and viruses are ubiquitous in life. When one's own immunity declines, daily physiological hygiene is not properly cleaned, or sexual life is irregular, one may be invaded by pathogenic microorganisms, causing infections and inflammations of the female vulva and male external genitalia. In recent years, the incidence of such diseases has been extremely high. Common pathogenic microorganisms infecting the external genitalia include Escherichia coli, Staphylococcus, Candida, Mycoplasma, Trichomonas vaginalis, etc., which usually cause various external genital inflammations including scrotal eczema, vaginitis, balanitis, and orchitis, manifested as local redness, swelling, pain, itching, abnormal secretions and other discomfort symptoms. In more severe cases, there may be purulent discharge, and it is prone to recurrence with a low cure rate. If not treated in time, it may cause the spread of inflammation and cross-infection, seriously endangering human health. Therefore, it is particularly important to prevent pathogenic microorganism infections through daily cleaning and care of the external genitalia or to treat external genital inflammations in a timely manner.

[0004] Genital care can prevent and eliminate the conditions conducive to pathogenic microorganism infection and enhance the non-specific defense function of the genitals against infection. Currently, the drugs for genital care are mainly divided into lotion, oral drugs, suppositories, antibacterial wipes, ointments, and nursing disinfection solutions, etc., which can play the roles of clearing heat and detoxifying, killing insects and relieving itching, and treating vulvar inflammation. Fuyanjie lotion can inhibit the growth of pathogenic microorganisms such as Escherichia coli, Candida albicans, and molds. Jieeryin lotion can kill all bacteria in the vagina. However, long-term use of lotion will lead to drug resistance of pathogenic bacteria and cause vulvar flora imbalance, resulting in side effects. Oral drugs (such as ornidazole tablets, metronidazole tablets, etc.) have a slow onset of effect, and are affected by gastric juice and food residues, resulting in loss of some drug effects, and have certain irritation to the stomach and liver. Long-term use of suppositories such as Daktarin suppository and ornidazole may damage the vaginal microbial environment, leading to repeated vaginal inflammation. Anti-inflammatory ointments such as fusidic acid cream and erythromycin may have a greater stimulating effect on the skin and mucosa, and may cause allergic reactions. Antibacterial wipes use non-woven fabric as the carrier, with a small amount of drug contained, poor antibacterial effect, and the wipes themselves are relatively wet, making it easier for genital bacteria to reproduce, and are not suitable for frequent use. Disinfection solutions such as chlorhexidine, alcohol, and oxidants can destroy the cell membrane and protein structure of pathogenic microorganisms, but these disinfection solutions have poor heat stability, are easy to volatilize or hydrolyze, may cause irritation to the skin of the genitals, and improper use may damage the natural protection barrier of the genitals, increasing the risk of infection. Summary of the Invention

[0005] Considering the side effects of the above-mentioned current genital care products, the purpose of the present invention is to provide a spray for genital care, including a metal ion compound spray with functions of preventing pathogenic bacteria infection, disinfection, antibacterial, anti-inflammatory, and repair, and its preparation method. The metal ion compound spray is convenient to use, has targeted drug delivery, good heat stability, is mild and non-irritating, has significant effects, has obvious inhibitory effects on common pathogenic microorganisms causing genital infections, is not easy to produce drug resistance, can effectively prevent and relieve genital infections and inflammation, and can repair damaged skin, having good nursing effects.

[0006] The present invention is realized through the following technical solutions: An external genital care spray contains the following components in weight percentages, including, Antibacterial composition 1wt% - 20wt%, humectant 2wt% - 6wt%, surfactant 0.3wt% - 1wt%, antioxidant 0.1wt% - 1wt%, thickening suspending agent 0.1wt% - 0.5wt%, essence 0.3wt% - 0.5wt%, pigment 0.1wt% - 0.5wt%, pH balance regulator 0.05wt% - 0.1wt%, and the rest is deionized water; The described antibacterial composition comprises 5 ppm to 0.5 wt% of metal ion compound and 1 wt% to 19.5 wt% of plant-derived antibacterial compound.

[0007] Preferably, the metal ion compound is obtained by dissolving one or a mixture of copper chloride, copper acetate, copper citrate, copper gluconate, sodium copper chlorophyllin, copper pyrrolidone carboxylate, zinc pyrithione, copper acetylmethionine, silver sulfate, amino acid chelated iron, zinc carbonate and hemin in water.

[0008] Preferably, the plant-derived antibacterial compound is one or a mixture of selaginella oil, sophora flavescens extract, cnidium monnieri extract, tea tree oil, thymol, rosemary oil and parabens.

[0009] Preferably, the pH balance regulator is one or a mixture of malic acid, citric acid, acidic amino acid, phosphate buffer solution, potassium hydroxide and succinic acid; Preferably, the surfactant is one or a mixture of sodium dodecyl sulfate, polysorbate alcohol ether, sodium dodecylbenzenesulfonate, coconut diethanolamide, cetyltrimethylammonium bromide, cetyl dimethyl ammonium bromide and cocamidopropyl betaine.

[0010] Preferably, the humectant is one or a mixture of glycerol, lanolin, urea, sodium hyaluronate, butanediol, sorbitol, polyethylene glycol, propylene glycol, polypropylene glycol and panthenol.

[0011] Preferably, the pigment is one or a mixture of carotene, chlorophyll, saffron pigment, gardenia yellow pigment, ginkgo yellow pigment and dandelion yellow pigment; the essence is one or a mixture of aromatic aldehyde, citronella oil, lavender oil, lemon essential oil, eucalyptus oil, rose oil, jasmine oil and eugenol.

[0012] Preferably, the antioxidant is one or a mixture of L-ascorbic acid, vitamin E, ergothioneine, squalane and grape seed extract.

[0013] Preferably, the thickening and suspending agent is one or a mixture of hydroxypropyl methylcellulose, gum arabic, sodium carboxymethyl cellulose, xanthan gum and polyvinylpyrrolidone.

[0014] A preparation method of an external genitalia care spray comprises the following steps: S1. Add a humectant and a thickening and suspending agent to deionized water, stir at a temperature of 70 - 85 °C until completely dissolved, and cool to 20 - 25 °C to obtain mixture A; S2. Sequentially add the antibacterial composition, antioxidant, and surfactant into the mixture of S1, and continuously stir until no particulate matter appears to obtain mixture B; S3. After adding essence and pigment into mixture B, stir evenly, and then add a pH balance regulator to adjust the pH of the nursing solution to acidic or neutral; S5. Filter the prepared metal ion compound nursing solution, and then fill it into a spray bottle under sterile conditions, and seal the pump head to obtain a metal ion compound spray for external genital care.

[0015] Compared with the prior art, the present invention has the following beneficial technical effects: The purpose of the present invention is to provide a spray for external genital care, including a metal ion compound spray with functions such as preventing pathogenic bacteria infection, disinfection, antibacterial, anti-inflammatory, and repair, and its preparation method. The metal ion compound spray of the present invention is convenient to use, has targeted drug delivery, good heat stability, is mild and non-irritating, and has remarkable effects; The present invention uses a combination of metal ion compounds and plant-derived antibacterial compounds as antibacterial agents. Compared with natural antibacterial agents, it has broad-spectrum antibacterial properties, good heat stability, is not prone to drug resistance, is safe and harmless, and has a long drug effect time. The combination of the metal ion compounds and plant-derived antibacterial compounds of the present invention can synergistically increase the antibacterial ability of plant essential oils. For example, copper or zinc compounds can stabilize the active compounds in the essential oils and inhibit the degradation in environments such as light, heat, and oxygen; some antioxidants or metal chelates may help reduce the oxidation of essential oil components and maintain their fragrance and characteristics; adding specific metal compounds can stabilize the spray formulation and prevent phase separation or component precipitation. In addition, metal compounds help to disrupt cell membranes, making microorganisms more sensitive to essential oils; some metal compounds, especially copper and iron ions, can induce the production of reactive oxygen species in microbial cells, and these reactive oxygen species cause oxidative stress and damage to cell components, ultimately leading to cell death; including copper and zinc, it has been proven to inhibit the formation of biofilms by disrupting the adhesion of microorganisms to surfaces, and this effect prevents the establishment of microbial communities; metal compounds such as copper and iron interfere with the activity of microbial enzymes, affect metabolic processes and inhibit microbial growth.

[0016] The combination of the metal ion compounds and plant-derived antibacterial compounds of the present invention can replace chemically synthesized preservatives, achieving no addition of preservatives and antibiotics in the nursing spray and improving the safety of the product. Among them, zinc and copper are important trace elements. Metal ion compounds can promote metabolism and can also promote the immune response of the body, protecting the body from pathogenic microorganisms. Trace amounts of Cu 2+ 、Zn 2+It is beneficial to human health but can kill various pathogenic microorganisms. The positively charged metal ions are tightly adsorbed on the negatively charged cell membrane surface, penetrate the cell wall, cause the cell wall to rupture, enter the cell interior, interfere with the normal metabolism of the cell and the action of various enzymes, and ultimately lead to cell death, achieving a bactericidal effect.

[0017] In addition, the nursing spray of the present invention is convenient to use, can deliver drugs directionally, does not stimulate the stomach and liver, does not lose the drug effect, is easy to reach the lesion site, is better absorbed by the human body, has little irritation to the skin, has a significant effect, and has an obvious inhibitory effect on common pathogenic microorganisms causing external genital infections such as staphylococcus, streptococcus, escherichia coli, candida, candida albicans, trichomonas vaginalis, etc., and is not easy to produce drug resistance. It can effectively prevent and relieve external genital infections and inflammations, and can repair damaged skin, having a good nursing effect.

[0018] Furthermore, the natural pH balance regulator of the present invention can adjust the pH value of the external genital nursing solution to acidic or neutral to adapt to the natural acidic environment of the genital skin and avoid damaging the natural protection barrier of the skin; Furthermore, the surfactant of the present invention can enhance the decontamination and cleaning functions of the external genital nursing solution after being added, remove skin dirt and grease, make the skin smooth and soft, have no irritation to the skin, and at the same time can improve the stability and permeability of the nursing spray; Furthermore, the moisturizer of the present invention has low volatility, can be retained on the skin surface, persistently maintain skin moisture, prevent skin dryness and itching, and relieve discomfort symptoms; Furthermore, the use of natural pigments and natural fragrances in the present invention can make the external genital nursing solution have a certain color and aroma, make the nursing solution easier to identify, and improve the purchase desire and use experience of consumers; Furthermore, the antioxidant of the present invention can moisten and repair the skin around the external genitalia, soothe the skin and increase skin elasticity; the thickening suspending agent has good biocompatibility and stability, and can adjust the viscosity and fluidity of the external genital nursing solution after being added, improving the use favorability of consumers. Specific embodiments

[0019] The following further elaborates on the present invention in conjunction with specific embodiments, which is an explanation rather than a limitation of the present invention.

[0020] To achieve the above object, the present invention provides an external genitalia care spray, which comprises the following components in weight percentages: antibacterial composition 1 wt% - 20 wt% (metal ion compound 5 ppm - 0.5 wt%, plant-derived antibacterial compound 1 wt% - 19.5 wt%), humectant 2 wt% - 6 wt%, surfactant 0.3 wt% - 1 wt%, antioxidant 0.1 wt% - 1 wt%, thickening and suspending agent 0.1 wt% - 0.5 wt%, essence 0.3 wt% - 0.5 wt%, pigment 0.1 wt% - 0.5 wt%, pH balance regulator 0.05 wt% - 0.1 wt%, and the balance is deionized water.

[0021] Zinc, copper, etc. are important trace elements. Metal ion compounds can promote metabolism and the body's immune response, and protect the body from pathogenic microorganisms. Trace amounts of Cu 2+ , Fe 2+ etc. are beneficial to human health, but can kill various pathogenic microorganisms. Positively charged metal ions tightly adsorb on the negatively charged cell membrane surface, penetrate the cell wall causing it to rupture, enter the cell interior to interfere with normal cell metabolism and the action of various enzymes, and ultimately lead to cell death, achieving a bactericidal effect.

[0022] The pH balance regulator can adjust the pH value of the external genitalia care solution to acidic or neutral to adapt to the natural acidic environment of the genital skin and avoid damaging the skin's natural protective barrier; after adding the surfactant, it can enhance the decontamination and cleaning functions of the external genitalia care solution, remove skin dirt and grease, make the skin smooth and soft, have no irritation to the skin, and at the same time can improve the stability and permeability of the care spray; the humectant has low volatility, can be retained on the skin surface, persistently maintain skin moisture, prevent skin dryness and itching, and relieve discomfort symptoms; the pigment and essence can give the external genitalia care solution a certain color and aroma, make the care solution easier to identify, improve consumers' purchase desire and usage experience; the antioxidant can moisturize and repair the skin around the external genitalia, soothe the skin and increase skin elasticity; the thickening and suspending agent has good biocompatibility and stability, and after adding, it can adjust the viscosity and fluidity of the external genitalia care solution and improve consumers' usage favorability.

[0023] Preferably, the metal ion compound spray for external genital care comprises the following components in weight percentages: 10wt% - 15.5wt% of antibacterial composition, 3wt% - 5wt% of humectant, 0.5wt% - 0.8wt% of surfactant, 0.5wt% - 1wt% of antioxidant, 0.1wt% - 0.3wt% of thickening suspending agent, 0.4wt% - 0.5wt% of essence, 0.1wt% - 0.3wt% of pigment, 0.05wt% - 0.08wt% of pH balance regulator, and the balance is deionized water. The present invention finds that the metal ion compound spray prepared according to this formula has the best effect in relieving external genital pathogenic microorganism infection and moisturizing effect.

[0024] Preferably, the antibacterial composition comprises the following components in weight percentages: 5 ppm - 0.25wt% of metal ion compound, 10wt% - 15.25wt% of plant-derived antibacterial compound; the antibacterial composition includes one of the metal ion compounds and one or more of the plant-derived antibacterial compounds; Preferably, the metal ion compound is obtained by dissolving one or more mixtures of copper chloride, copper acetate, copper citrate, copper gluconate, sodium copper chlorophyllin, copper pyrrolidone carboxylate, zinc pyrithione, copper acetylmethionate, silver sulfate, amino acid chelated iron, zinc carbonate and hemin in water; the plant-derived antibacterial compound is one or more mixtures of sophora flavescens extract, cnidium monnieri extract, tea tree essential oil, thymol, rosemary essential oil, p-hydroxybenzoate. The present invention finds that the antibacterial composition has broad-spectrum bactericidal property, has inhibitory effects on pathogenic microorganisms such as Escherichia coli, Trichomonas vaginalis, Candida, etc., and has effects such as anti-inflammatory and repairing damaged skin, and has no irritation to the skin; Preferably, the pH balance regulator is one or more mixtures of malic acid, citric acid, acidic amino acid, phosphate buffer solution, potassium hydroxide, succinic acid, basic amino acid; Preferably, the surfactant is one or more mixtures of sodium dodecyl sulfate, polysorbate alcohol ether, sodium dodecylbenzenesulfonate, coconut diethanolamide, cetyltrimethylammonium bromide, cetyl dimethylammonium bromide, cocamidopropyl betaine; Preferably, the humectant is one or more mixtures of glycerin, lanolin, urea, sodium hyaluronate, butanediol, sorbitol, polyethylene glycol, propylene glycol, polypropylene glycol, panthenol; Preferably, the pigment is one or more mixtures of carotene, chlorophyll, saffron pigment, gardenia yellow pigment, ginkgo yellow pigment, dandelion yellow pigment; the essence is one or more mixtures of aromatic aldehyde, citronella essential oil, lavender essential oil, lemon essential oil, eucalyptus essential oil, rose essential oil, jasmine essential oil, eugenol; Preferably, the antioxidant is one or more of L-ascorbic acid, vitamin E, ergothioneine, squalane, grape seed extract; Preferably, the thickening suspending agent is one or more of hydroxypropyl methylcellulose, gum arabic, sodium carboxymethylcellulose, xanthan gum, polyvinylpyrrolidone; Preferably, the method for preparing the metal ion compound spray for external genital care comprises the following steps: (1) Add a humectant and a thickening suspending agent to deionized water, stir on a magnetic stirrer at 70-85 °C until completely dissolved, and cool to 20-25 °C; (2) Sequentially add an antibacterial composition, an antioxidant, and a surfactant to the mixture in (1), and continuously stir until no particulate matter appears; (3) After adding essence and pigment, stir evenly; (4) Add a pH regulator to adjust the pH of the care solution; (5) Filter the prepared metal ion compound care solution through a filter, and fill it into a plastic spray bottle under sterile conditions, and seal the pump head to obtain the metal ion compound spray.

[0025] Preferably, the pH of the male care solution in step (4) is adjusted to between 6 and 7; the pH of the female care solution is adjusted to between 3.8 and 5; Preferably, the filtration accuracy of the filter in step (5) is 40-60 μm.

[0026] The present invention also provides a method for using the metal ion compound spray for external genital care, specifically: simply wash the area to be cared for with clean water, and after it is slightly dry, spray the metal ion compound spray around the external genitalia, spray 2-3 times each time, and gently massage until the skin completely absorbs it, and use it 2-3 times a day. During the use process, the spray should be avoided from contacting the eyes and mouth.

[0027] In order to enable those skilled in the art to better understand the solution of the present invention, the technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

[0028] Examples 1-5, metal ion compound sprays for female external genital care; Examples 6-10, metal ion compound sprays for male external genital care.

[0029] Example 1 A metal ion compound spray for female external genital care, with the raw material formula as follows: antibacterial composition 10.1 wt% (copper gluconate 0.1 wt%, sophora flavescens extract 4.5 wt%, cnidium monnieri extract 4 wt%, tea tree essential oil 1.5 wt%), humectant 6 wt% (glycerol 1 wt%, propylene glycol 5 wt%), surfactant 0.6 wt% (cetyltrimethylammonium bromide 0.3 wt%, cocamidopropyl betaine 0.3 wt%), antioxidant 1 wt% (L-ascorbic acid 0.5 wt%, vitamin E 0.5 wt%), thickening and suspending agent 0.1 wt% (sodium carboxymethylcellulose 0.05 wt%, xanthan gum 0.05 wt%), essence 0.4 wt% (lavender essential oil 0.3 wt%, jasmine essential oil 0.1 wt%), dandelion yellow pigment 0.1 wt% and malic acid 0.06 wt%, and the rest is deionized water.

[0030] The preparation of a metal ion compound spray for female external genital care comprises the following specific steps: adding the humectant and the thickening and suspending agent to deionized water, stirring on a magnetic stirrer at 70 °C until completely dissolved, and cooling to 25 °C; successively adding the antibacterial composition, the antioxidant and the surfactant to the mixture, and continuously stirring until no particulate matter appears; adding the essence and the pigment and stirring evenly; adding a pH regulator to adjust the pH of the care solution to 3.8; filtering the prepared metal ion compound care solution through a 50 μm filter, and filling it into a plastic spray bottle under sterile conditions, and then encapsulating the pump head to obtain the metal ion compound spray.

[0031] Example 2 A metal ion compound spray for female external genital care, with the raw material formula as follows: antibacterial composition 10.15 wt% (zinc pyrithione 0.15 wt%, sophora flavescens extract 4 wt%, cnidium monnieri extract 4 wt%, rosemary essential oil 2 wt%), humectant 6 wt% (glycerol 3 wt%, propylene glycol 3 wt%), surfactant 0.6 wt% (cetyltrimethylammonium bromide 0.3 wt%, cocamidopropyl betaine 0.3 wt%), antioxidant 0.5 wt% (L-ascorbic acid 0.5 wt%), thickening and suspending agent 0.1 wt% (gum arabic 0.05 wt%, xanthan gum 0.05 wt%), essence 0.4 wt% (jasmine essential oil 0.3 wt%, rose essential oil 0.1 wt%), gardenia yellow pigment 0.2 wt% and citric acid 0.06 wt%, and the rest is deionized water.

[0032] Preparation of a metal ion compound spray for female external genital care, the specific steps are as follows: Add a humectant and a thickening suspending agent to deionized water, stir on a magnetic stirrer at 80 °C until completely dissolved, and cool to 20 °C; sequentially add an antibacterial composition, an antioxidant, and a surfactant to the mixture, and continuously stir until no particulate matter appears; after adding essence and pigment, stir evenly; add a pH regulator to adjust the pH of the care solution to 4.2; filter the prepared metal ion compound care solution through a 50 μm filter, and fill it into a plastic spray bottle under sterile conditions, and encapsulate the pump head to obtain the metal ion compound spray.

[0033] Example 3 A metal ion compound spray for female external genital care, the raw material formula is as follows: antibacterial composition 12.2 wt% (hematin 0.2 wt%, Sophora flavescens extract 4 wt%, Cnidium monnieri extract 4 wt%, tea tree essential oil 2 wt%, rosemary essential oil 2 wt%), humectant 6 wt% (glycerol 3 wt%, polyethylene glycol 3 wt%), surfactant 0.6 wt% (sodium dodecyl sulfate 0.3 wt%, polysorbate alcohol ether 0.3 wt%), antioxidant 0.6 wt% (L-ascorbic acid 0.3 wt%, ergothioneine 0.3 wt%), thickening suspending agent 0.2 wt% (gum arabic 0.1 wt%, xanthan gum 0.1 wt%), essence 0.4 wt% (jasmine essential oil 0.3 wt%, rose essential oil 0.1 wt%), carotene 0.2 wt%, and acidic amino acid 0.08 wt%, and the rest is deionized water.

[0034] Preparation of a metal ion compound spray for female external genital care, the specific steps are as follows: Add a humectant and a thickening suspending agent to deionized water, stir on a magnetic stirrer at 85 °C until completely dissolved, and cool to 22 °C; sequentially add an antibacterial composition, an antioxidant, and a surfactant to the mixture, and continuously stir until no particulate matter appears; after adding essence and pigment, stir evenly; add a pH regulator to adjust the pH of the care solution to 5; filter the prepared metal ion compound care solution through a 50 μm filter, and fill it into a plastic spray bottle under sterile conditions, and encapsulate the pump head to obtain the metal ion compound spray.

[0035] Example 4 A metal ion compound spray for female external genital care has the following raw material formula: antibacterial composition 10 wt% (copper acetate 8 ppm, sophora flavescens extract 4 wt%, cnidium monnieri extract 4 wt%, rosemary essential oil 2 wt%), humectant 4 wt% (sodium hyaluronate 2 wt%, glycerol 2 wt%), surfactant 0.8 wt% (polysorbate alcohol ether 0.2 wt%, coconut fatty acid diethanolamide 0.6 wt%), antioxidant 1 wt% (L-ascorbic acid 0.4 wt%, vitamin E 0.4 wt%, squalane 0.2 wt%), thickening suspending agent 0.1 wt% (gum arabic 0.05 wt%, xanthan gum 0.05 wt%), essence 0.5 wt% (lemon essential oil 0.3 wt%, citronella essential oil 0.2 wt%), ginkgo biloba pigment 0.3 wt% and succinic acid 0.07 wt%, and the balance is deionized water.

[0036] The preparation of a metal ion compound spray for female external genital care comprises the following specific steps: adding a humectant and a thickening suspending agent to deionized water, stirring on a magnetic stirrer at 80 °C until completely dissolved, and cooling to 25 °C; sequentially adding an antibacterial composition, an antioxidant and a surfactant to the mixture, and continuously stirring until no particulate matter appears; adding an essence and a pigment, and stirring evenly; adding a pH regulator to adjust the pH of the care solution to between 4; filtering the prepared metal ion compound care solution through a 45 μm filter, and filling it into a plastic spray bottle under sterile conditions, and sealing the pump head to obtain the metal ion compound spray.

[0037] Example 5 A metal ion compound spray for female external genital care has the following raw material formula: antibacterial composition 15.25 wt% (silver sulfate 0.25 wt%, sophora flavescens extract 5 wt%, cnidium monnieri extract 5 wt%, tea tree essential oil 3 wt%, rosemary essential oil 2 wt%), humectant 5 wt% (sodium hyaluronate 2 wt%, sorbitol 3 wt%), surfactant 0.8 wt% (sodium dodecyl sulfate 0.4 wt%, coconut fatty acid diethanolamide 0.4 wt%), antioxidant 1 wt% (ergothioneine 0.5 wt%, squalane 0.5 wt%), thickening suspending agent 0.2 wt% (sodium carboxymethyl cellulose 0.1 wt%, polyvinylpyrrolidone 0.1 wt%), essence 0.4 wt% (eucalyptus essential oil 0.3 wt%, eugenol 0.1 wt%), saffron pigment 0.2 wt% and malic acid 0.05 wt%, and the balance is deionized water.

[0038] Preparation of a metal ion compound spray for female external genital care, the specific steps are as follows: Add a moisturizer and a thickening suspending agent to deionized water, stir on a magnetic stirrer at 75 °C until completely dissolved, and cool to 20 °C; sequentially add an antibacterial composition, an antioxidant, and a surfactant to the mixture, and continue stirring until no particulate matter appears; after adding essence and pigment, stir evenly; add a pH regulator to adjust the pH of the care solution to 5; filter the prepared metal ion compound care solution through a 40 μm filter, and fill it into a plastic spray bottle under sterile conditions, and encapsulate the pump head to obtain the metal ion compound spray.

[0039] Example 6 A metal ion compound spray for male external genital care, the raw material formula is as follows: antibacterial composition 10 wt% (ferrous amino acid chelate 5 ppm, sophora flavescens extract 4 wt%, cnidium monnieri extract 2 wt%, thymol 2 wt%, paraben 2 wt%), moisturizer 3 wt% (butylene glycol 2 wt%, polypropylene glycol 1 wt%), surfactant 0.5 wt% (cocamidopropyl betaine 0.5 wt%), antioxidant 0.5 wt% (L-ascorbic acid 0.4 wt%, grape seed extract 0.1 wt%), thickening suspending agent 0.2 wt% (polyvinylpyrrolidone 0.1 wt%, xanthan gum 0.1 wt%), essence 0.5 wt% (rose essential oil 0.4 wt%, aromatic aldehyde 0.1 wt%), carotene 0.2 wt% and phosphate buffer 0.08 wt%, and the rest is deionized water.

[0040] Preparation of a metal ion compound spray for male external genital care, the specific steps are as follows: Add a moisturizer and a thickening suspending agent to deionized water, stir on a magnetic stirrer at 85 °C until completely dissolved, and cool to 25 °C; sequentially add an antibacterial composition, an antioxidant, and a surfactant to the mixture, and continue stirring until no particulate matter appears; after adding essence and pigment, stir evenly; add a pH regulator to adjust the pH of the care solution to 7.0; filter the prepared metal ion compound care solution through a 60 μm filter, and fill it into a plastic spray bottle under sterile conditions, and encapsulate the pump head to obtain the metal ion compound spray.

[0041] Example 7 A metal ion compound spray for male external genital care, with the raw material formula as follows: antibacterial composition 11.15 wt% (copper citrate 0.15 wt%, cnidium monnieri extract 4 wt%, tea tree essential oil 3 wt%, rosemary essential oil 2 wt%, thymol 2 wt%), humectant 5 wt% (glycerol 3 wt%, lanolin 2 wt%), surfactant 0.8 wt% (cetyl dimethyl ammonium bromide 0.3 wt%, cocamidopropyl betaine 0.4 wt%), antioxidant 0.8 wt% (squalane 0.4 wt%, grape seed extract 0.4 wt%), thickening and suspending agent 0.1 wt% (hydroxypropyl methylcellulose 0.05 wt%, gum arabic 0.05 wt%), essence 0.4 wt% (lemon essential oil 0.4 wt%), chlorophyll 0.1 wt% and potassium hydroxide 0.05 wt%, and the rest is deionized water.

[0042] The preparation of a metal ion compound spray for male external genital care, the specific steps are as follows: add the humectant and thickening and suspending agent to deionized water, stir on a magnetic stirrer at 85 °C until completely dissolved, and cool to 25 °C; sequentially add the antibacterial composition, antioxidant and surfactant to the mixture, and continue stirring until no particulate matter appears; after adding the essence and pigment, stir evenly; add a pH regulator to adjust the pH of the care solution to between 6.0; filter the prepared metal ion compound care solution through a 50 μm filter, and fill it into a plastic spray bottle under sterile conditions, and seal the pump head to obtain the metal ion compound spray.

[0043] Example 8 A metal ion compound spray for male external genital care, with the raw material formula as follows: antibacterial composition 15 wt% (copper chloride 10 ppm, sophora flavescens extract 4 wt%, cnidium monnieri extract 4 wt%, tea tree essential oil 2 wt%, rosemary essential oil 2 wt%, thymol 2 wt%, p-hydroxybenzoate 1 wt%), humectant 4 wt% (propylene glycol 3 wt%, panthenol 1 wt%), surfactant 0.8 wt% (polysorbate alcohol ether 0.4 wt%, sodium dodecylbenzenesulfonate 0.4 wt%), antioxidant 0.7 wt% (vitamin E 0.4 wt%, ergothioneine 0.3 wt%), thickening and suspending agent 0.3 wt% (sodium carboxymethyl cellulose 0.2 wt%, xanthan gum 0.1 wt%), essence 0.5 wt% (citronella essential oil 0.15 wt%, jasmine essential oil 0.35 wt%), dandelion yellow pigment 0.3 wt% and basic amino acid 0.06 wt%, and the rest is deionized water.

[0044] Preparation of a metal ion compound spray for male external genital care, the specific steps are as follows: Add a humectant and a thickening suspending agent to deionized water, stir on a magnetic stirrer at 70 °C until completely dissolved, and cool to 25 °C; sequentially add an antibacterial composition, an antioxidant, and a surfactant to the mixture, and continuously stir until no particulate matter appears; after adding essence and pigment, stir evenly; add a pH regulator to adjust the pH of the care solution to 6.0; filter the prepared metal ion compound care solution through a 40 μm filter, and fill it into a plastic spray bottle under sterile conditions, and seal the pump head to obtain the metal ion compound spray.

[0045] Example 9 A metal ion compound spray for male external genital care, the raw material formula is as follows: antibacterial composition 10wt% (zinc carbonate 5 ppm, sophora flavescens extract 4wt%, cnidium monnieri extract 6wt%), humectant 3wt% (glycerol 2wt%, polyethylene glycol 1wt%), surfactant 0.5wt% (coco diethanolamide 0.3wt%, cetyltrimethylammonium bromide 0.2wt%), antioxidant 0.5wt% (L-ascorbic acid 0.5wt%), thickening suspending agent 0.1wt% (gum arabic 0.1wt%), essence 0.4wt% (eugenol 0.1wt%, jasmine essential oil 0.3wt%), gardenia yellow pigment 0.2wt% and basic amino acid 0.07wt%, and the rest is deionized water.

[0046] Preparation of a metal ion compound spray for male external genital care, the specific steps are as follows: Add a humectant and a thickening suspending agent to deionized water, stir on a magnetic stirrer at 80 °C until completely dissolved, and cool to 25 °C; sequentially add an antibacterial composition, an antioxidant, and a surfactant to the mixture, and continuously stir until no particulate matter appears; after adding essence and pigment, stir evenly; add a pH regulator to adjust the pH of the care solution to 7; filter the prepared metal ion compound care solution through a 50 μm filter, and fill it into a plastic spray bottle under sterile conditions, and seal the pump head to obtain the metal ion compound spray.

[0047] Example 10 A metal ion compound spray for male external genitalia care has the following raw material formula: antibacterial composition 15.15 wt% (sodium copper chlorophyllin 0.15 wt%, sophora flavescens extract 4.5 wt%, fructus cnidii extract 4 wt%, tea tree essential oil 3 wt%, rosemary essential oil 3.5 wt%), humectant 5 wt% (butylene glycol 2 wt%, propylene glycol 3 wt%), surfactant 0.6 wt% (cetyltrimethylammonium bromide 0.3 wt%, coconut oil amide propyl betaine 0.3 wt%), antioxidant 0.9 wt% (ergothioneine 0.5 wt%, grape seed extract 0.4 wt%), thickening and suspending agent 0.1 wt% (sodium carboxymethyl cellulose 0.1 wt%), essence 0.5 wt% (rose essential oil 0.4 wt%, citronella essential oil 0.1 wt%), chlorophyll 0.3 wt% and basic amino acid 0.08 wt%, and the rest is deionized water.

[0048] The preparation of a metal ion compound spray for male external genitalia care comprises the following specific steps: adding a humectant and a thickening and suspending agent to deionized water, stirring on a magnetic stirrer at 70 °C until completely dissolved, and cooling to 20 °C; sequentially adding an antibacterial composition, an antioxidant and a surfactant to the mixture, and continuously stirring until no particulate matter appears; adding essence and pigment and stirring evenly; adding a pH regulator to adjust the pH of the care solution to between 6 and 6.5; filtering the prepared metal ion compound care solution through a 50 μm filter, and filling it into a plastic spray bottle under sterile conditions and sealing the pump head to obtain the metal ion compound spray.

[0049] Example 11 A metal ion compound spray for male external genitalia care has the following raw material formula: antibacterial composition 1.0 wt% (copper chloride 0.15 wt%, selaginella tamariscina essential oil 0.25 wt%, sophora flavescens extract 0.15 wt%, fructus cnidii extract 0.1 wt%, paraben 0.15 wt%, thymol 0.2 wt%), humectant 2 wt% (butylene glycol 1 wt%, propylene glycol 1 wt%), surfactant 0.3 wt% (cetyltrimethylammonium bromide 0.1 wt%, coconut oil amide propyl betaine 0.2 wt%), antioxidant 0.1 wt% (ergothioneine 0.05 wt%, grape seed extract 0.05 wt%), thickening and suspending agent 0.1 wt% (sodium carboxymethyl cellulose 0.1 wt%), essence 0.3 wt% (rose essential oil 0.2 wt%, citronella essential oil 0.1 wt%), chlorophyll 0.1 wt% and basic amino acid 0.05 wt%, and the rest is deionized water.

[0050] Preparation of a metal ion compound spray for male external genitalia care, the specific steps are as follows: Add a humectant and a thickening suspending agent to deionized water, stir on a magnetic stirrer at 70 °C until completely dissolved, and cool to 20 °C; sequentially add an antibacterial composition, an antioxidant, and a surfactant to the mixture, and continue stirring until no particulate matter appears; after adding essence and pigment, stir evenly; add a pH regulator to adjust the pH of the care solution to between 6; filter the prepared metal ion compound care solution through a 40 μm filter, and fill it into a plastic spray bottle under sterile conditions, and encapsulate the pump head to obtain the metal ion compound spray.

[0051] Example 12 A metal ion compound spray for male external genitalia care, the raw material formula is as follows: antibacterial composition 20wt% (copper acetate 0.15wt%, copper gluconate 0.35wt%, sophora flavescens extract 4.5wt%, fructus cnidii extract 4wt%, tea tree essential oil 3wt%, rosemary essential oil 3.5wt%, paraben 4.5wt%), humectant 6wt% (glycerol 2wt%, lanolin 2wt%, sorbitol 3wt%), surfactant 1.0wt% (sodium dodecyl sulfate 0.2wt%, coconut diethanolamide 0.2wt%, cetyltrimethylammonium bromide 0.3wt%, cocamidopropyl betaine 0.3wt%), antioxidant 1.0wt% (L-ascorbic acid 0.5wt%, squalane 0.2wt%, vitamin E 0.3wt%), thickening suspending agent 0.5wt% (sodium carboxymethyl cellulose 0.2wt%, gum arabic 0.1wt%, xanthan gum 0.2wt%), essence 0.5wt% (jasmine essential oil 0.4wt%, eugenol 0.1wt%), saffron pigment 0.5wt% and basic amino acid 0.1wt%, and the rest is deionized water.

[0052] Preparation of a metal ion compound spray for male external genitalia care, the specific steps are as follows: Add a humectant and a thickening suspending agent to deionized water, stir on a magnetic stirrer at 70 °C until completely dissolved, and cool to 20 °C; sequentially add an antibacterial composition, an antioxidant, and a surfactant to the mixture, and continue stirring until no particulate matter appears; after adding essence and pigment, stir evenly; add a pH regulator to adjust the pH of the care solution to between 6.5; filter the prepared metal ion compound care solution through a 50 μm filter, and fill it into a plastic spray bottle under sterile conditions, and encapsulate the pump head to obtain the metal ion compound spray.

[0053] I. Determination of product sensory indicators, physical and chemical indicators, and spraying performance Appearance: Observe whether the spray color of the metal ion compounds prepared in Examples 1 - 10 is uniform, whether the texture is homogeneous, and whether there are impurities or foreign objects visible to the naked eye by visual inspection under non - direct sunlight and at room temperature. Odor: Identify by smell. The metal ion compound sprays prepared in Examples 1 - 10 should have no special unpleasant odor and conform to the specific aroma. pH: Measure the pH value of the metal ion compound sprays prepared in Examples 1 - 10 using a portable pH meter. The prepared metal ion compound sprays should conform to the specified pH value of the genital care solution. Stability test: Place the metal ion compound sprays prepared in Examples 1 - 10 at room temperature, 40 °C, or - 20 °C for 10 - 15 days, and observe whether there are phenomena such as precipitation, color change, or stratification. Spraying performance measurement: Press the pump head of the metal ion compound sprays prepared in Examples 1 - 10 and observe whether the care solution can be evenly sprayed.

[0054] The test results are shown in Table 1: Table 1 Sensory indicators, physical and chemical indicators, and spraying performance test results of the metal ion compound sprays prepared in Examples 1 - 10

[0055] II. Product antibacterial test Test method: (1) The pathogenic microorganisms used for testing are Escherichia coli, Candida albicans, and Streptococcus pyogenes. Scrape the bacteria from the activated plate with an inoculation loop and mix them in LB broth medium, then dilute them step - by - step to prepare a bacterial suspension with a certain concentration.

[0056] (2) Dilute the metal ion compound care solutions prepared in Examples 1 - 10 in a serial dilution with sterile water. Take 1 mL of the diluted care solution and mix it with 0.1 mL of the bacterial suspension, and incubate for 20 min. Use the mixture of sterile water and the bacterial suspension as a positive control. Take 0.1 mL of the above culture and quantitatively inoculate it into the agar medium, and incubate it in an incubator at 37 °C for 24 h. Calculate the antibacterial rate according to the following formula:

[0057] The test results are shown in Table 2: Table 2 shows the test results of the antibacterial properties of the metal ion compound sprays prepared in Examples 1 - 10 against different pathogenic microorganisms;

[0058] The results show that the metal ion compound sprays prepared in Examples 1 to 10 of the present invention have good inhibitory effects on Escherichia coli, Streptococcus pyogenes and Candida albicans, indicating that the metal ion compound sprays play an important role in preventing and treating external genital inflammation and enhancing the resistance of the external genitalia to pathogenic microorganism infections. Examples 5 and 8 are the optimal formulations for female and male external genital care sprays respectively.

[0059] III. Practical use effects of the product Six patients (3 females and 3 males) were randomly selected. Female and male patients used the metal ion compound sprays of Examples 5 and 8 respectively, 2 - 3 times a day, spraying 2 - 3 times each time, and the use effects were observed and recorded every 5 days.

[0060] (1) Ms. Li, 27 years old, with recurrent vaginitis, abnormal leucorrhea secretion, frequent urination and dysuria. After using the metal ion compound spray prepared in Example 5 2 times a day, spraying 2 - 3 times each time, after 5 days, the leucorrhea secretion tended to be normal and the itching symptoms were somewhat alleviated. After 10 days, the leucorrhea secretion was normal, and the dysuria and itching symptoms were significantly alleviated.

[0061] (2) Ms. Liu, 33 years old, with vulvar eczema and local burning sensation. After using the metal ion compound spray prepared in Example 5 once in the morning and once in the evening every day, spraying 2 - 3 times each time, after 5 days, the symptoms were not significantly alleviated; after 15 days, the symptoms were significantly improved, the local burning sensation disappeared, the erythema decreased and began to crust; after 20 days, the crusts fell off and the symptoms completely disappeared.

[0062] (3) Ms. Zhang, 45 years old, with vulvar itching, increased leucorrhea secretion, and Trichomonas vaginalis visible in vaginal secretions. After using the metal ion compound spray prepared in Example 5 once in the morning and once in the evening every day, spraying 2 - 3 times each time, after 5 days, although the itching symptoms were alleviated, the vaginal secretions were still positive for Trichomonas; after 15 days, the itching symptoms were alleviated to a certain extent, the leucorrhea secretion decreased, and the vaginal secretions were negative for Trichomonas; after 30 days, the itching symptoms completely disappeared, the leucorrhea secretion was normal, and the vaginal secretions were negative for Trichomonas.

[0063] (4) Mr. Yang, 26 years old, with balanitis, local swelling, severe itching and tenderness. After using the metal ion compound spray prepared in Example 8 3 times a day, spraying 2 - 3 times each time, after 5 days, the itching symptoms were somewhat alleviated, but there was still local swelling and tenderness; after 10 days, both the itching and swelling symptoms were significantly improved and the tenderness disappeared; after 15 days, it was completely cured.

[0064] (5) Mr. Wang, 38 years old, suffering from genital herpes, with local ulceration and slight itching. After using the metal ion compound spray prepared in Example 8 once in the morning and once in the evening every day, spraying 2 - 3 times each time, the itching symptom basically disappeared after 5 days, and the herpes on the prepuce significantly reduced; the ulcerated wound began to scab and the itching symptom disappeared after 10 days; the scab fell off after 15 days; no recurrence was seen after 20 days.

[0065] (6) Mr. Xu, 43 years old, suffering from orchitis, with testicular pain, swelling, and radiating pain in the groin. After using the metal ion compound spray prepared in Example 8 three times a day, spraying 2 - 3 times each time, the pain and swelling symptoms were relieved to a certain extent after 5 days; the symptoms improved significantly after 15 days, and the radiating pain in the groin disappeared; the symptoms completely disappeared and were completely cured after 20 days.

[0066] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the technical field to which this invention belongs. The terms used in the specification of this invention are only for the purpose of describing specific embodiments and are not intended to limit the invention. The term "and / or" used herein includes any and all combinations of one or more of the related listed items.

[0067] As described above, it is only the preferred embodiment of the present invention and does not impose any form of limitation on the present invention; any person of ordinary skill in the art can smoothly implement the present invention according to the description in the specification and the above description; however, any minor changes, modifications, and equivalent variations made by those skilled in the art within the scope of the technical solution of the present invention by using the technical content disclosed above are equivalent embodiments of the present invention; at the same time, any equivalent changes, modifications, and variations made to the above embodiments based on the essence of the present invention still fall within the protection scope of the technical solution of the present invention.

Claims

1. An external genitalia care spray, characterized in that, Comprising components in the following weight percentages, including, Antibacterial composition: 10.1wt% - 11.15%; Humectant: 5wt% - 6wt%; Surfactant: 0.6wt% - 0.8%; Thickening and suspending agent: 0.1wt%; Antioxidant 0.5wt% - 1wt%; Fragrance 0.4wt%; Pigment 0.1wt% - 0.2wt%; pH balance regulator: 0.05wt% - 0.06wt%; The balance is deionized water; The antibacterial composition includes 0.1wt% - 0.15wt% of metal ion compound and 10wt% - 11wt% of plant-derived antibacterial compound; The metal ion compound is selected from one of copper citrate, copper gluconate, and zinc pyrithione; The plant-derived antibacterial compound is selected from a mixture of multiple of cnidium fruit extract, sophora flavescens extract, tea tree essential oil, rosemary essential oil, and thymol.

2. The external genitalia care spray according to claim 1, wherein The metal ion compound is copper gluconate, and the dosage of copper gluconate is 0.1wt%.

3. The external genitalia care spray according to claim 1, wherein The pH balance regulator is selected from one of malic acid, citric acid, and potassium hydroxide.

4. The external genitalia care spray according to claim 1, wherein The surfactant is a mixture of at least two of coconut oil amide propyl betaine, cetyl trimethyl ammonium bromide, and cetyl trimethyl ammonium bromide.

5. The external genitalia care spray according to claim 1, wherein The humectant is a mixture of at least two of glycerol, propylene glycol, and lanolin.

6. The external genitalia care spray according to claim 1, characterized in that, The thickening and suspending agent is a mixture of at least two of hydroxypropyl methyl cellulose, sodium carboxymethyl cellulose, gum arabic, and xanthan gum.

7. A preparation method of an external genitalia care spray, based on the metal ion compound spray for external genitalia care according to any one of claims 1-6, characterized in that, Including the following steps: S1. Add the humectant and the thickening and suspending agent to deionized water, stir at a temperature of 70 - 85°C until completely dissolved, and cool to 20 - 25°C to obtain mixture A; S2. Sequentially add the antibacterial composition, antioxidant, and surfactant to the mixture in S1, and continuously stir until no particulate matter appears to obtain mixture B; S3. After adding the fragrance and pigment to mixture B, stir evenly, and then add the pH balance regulator to adjust the pH of the nursing solution to 3.8 - 6.0; S5. Filter the prepared metal ion compound nursing solution, and fill it into a spray bottle under sterile conditions, and seal the pump head to obtain a metal ion compound spray for external genital care.

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