A composition having anti-inflammatory, antibacterial and anti-vaginitis effects and uses thereof

Abstract

The present application provides a kind of composition with anti-inflammatory, bacteriostatic and anti-vaginitis effect, it is prepared from the raw materials comprising the following weight ratio: mint leaf oil 2-10 parts, patchouli oil 10-60 parts, rose oil 1-5 parts, geranium oil 10-50 parts, pistachio seed oil 20-50 parts, above 100 parts;Mussel protein, the content in preparation is 0.02-1%.The present application also provides the use of the aforementioned composition.The present application composition has good bacteriostatic, anti-inflammatory effect, and has inhibitory effect on experimental vaginitis, can be prepared into cosmetics, hospital preparation, medicine or fragrance, air disinfectant, has strong practical application value.

Description

Technical Field

[0001] This invention relates to a composition having anti-inflammatory, antibacterial and antivaginal effects and its use in the preparation of cosmetics, hospital preparations, pharmaceuticals or fragrances, and air disinfectants. Background Technology

[0002] Vaginitis is a general term for various vaginal inflammations caused by different pathogens. More than 70% of women will experience it at some point in their lives. It is the most common gynecological infectious disease. The disease is prone to recurrence, affecting women's quality of life. Long-term inflammation can also easily lead to other diseases and tumors.

[0003] Pathogenic microorganisms that cause vaginitis include bacteria, fungi, and trichomonas, with bacterial vaginosis, candidal vaginitis, and trichomonal vaginitis being the most common. Treatment for vaginitis currently mainly involves targeted antibiotics, such as nitroimidazoles and clindamycin for bacterial vaginosis, imidazoles for candidal vaginitis, and metronidazole for trichomonal vaginitis. In addition, the acidic environment of the vagina can be improved by using probiotics such as lactobacillus preparations, thereby achieving a therapeutic goal.

[0004] These treatments are fast-acting, but they can lead to drug resistance and are also prone to recurrence.

[0005] Volatile components in traditional Chinese medicine and some plants have broad-spectrum antibacterial effects against a variety of bacteria and fungi, and also have anti-inflammatory effects. Long-term use can effectively maintain vaginal health, while having relatively few toxic side effects.

[0006] Mussel protein is a mucin extracted from the marine organism mussel, with a molecular weight of 100 kDa. After cross-linking, it has good biological properties, including good biocompatibility, as well as anti-inflammatory, antipruritic, analgesic, antibacterial, and anti-stress effects.

[0007] Our research found that adding mussel protein to a combination of plant extracts with anti-inflammatory and antibacterial effects significantly enhances their anti-inflammatory and antibacterial properties. The mechanism is related to the anti-inflammatory and antibacterial effects of mussel protein itself, as well as the sustained-release effect of the plant extracts due to the high adhesiveness of mussel protein. Summary of the Invention

[0008] This invention provides a composition with anti-inflammatory, antibacterial, and vaginitis treatment effects, prepared from raw materials comprising the following weight ratios: 2-10 parts peppermint leaf oil, 10-60 parts patchouli oil, 1-5 parts rose oil, 10-50 parts geranium oil, and 20-50 parts pistachio seed oil, totaling 100 parts; mussel protein, with a content of 0.02-1% in the preparation. This invention also provides the uses of the aforementioned composition. The composition of this invention has good antibacterial and anti-inflammatory effects, and its preparation has an inhibitory effect on experimental vaginitis. Combining long-term clinical experience in traditional Chinese medicine with modern scientific research, it has the characteristics of high safety and definite efficacy.

[0009] The composition of the present invention is characterized in that it is composed of raw materials comprising the following weight ratios: 2-10 parts peppermint leaf oil, 10-60 parts patchouli oil, 1-5 parts rose oil, 10-50 parts geranium oil, 20-50 parts pistachio seed oil, totaling 100 parts; and mussel protein, which is 0.02-1% in the preparation.

[0010] The formulation comprises the following ingredients in the indicated weight ratios: 3-6 parts peppermint leaf oil, 20-40 parts patchouli oil, 2-4 parts rose oil, 20-30 parts geranium oil, and 25-40 parts pistachio seed oil, totaling 100 parts; mussel protein is present in the formulation at a content of 0.05-0.5%. Preferably, the formulation comprises the following ingredients in the indicated weight ratios: 4 parts peppermint leaf oil, 35 parts patchouli oil, 3 parts rose oil, 25 parts geranium oil, and 33 parts pistachio seed oil, totaling 100 parts; mussel protein is present in the formulation at a content of 0.2%.

[0011] The present invention provides the use of any of the foregoing compositions in the preparation of cosmetics, hospital preparations, pharmaceuticals, or fragrances and air disinfectants having anti-inflammatory, antibacterial, or antivaginal effects.

[0012] The composition provided by this invention, possessing antibacterial, anti-inflammatory, and vaginitis-treating effects, was developed by the inventors based on rich theoretical background, long-term clinical application experience, and modern scientific research results. This composition consists of six kinds of plant volatile oils and mussel protein. Pharmacological studies have shown that it can inhibit acute inflammation, suppress environmental bacteria, and improve the pathological state of experimental vaginitis. Specifically, patchouli oil significantly enhances the anti-inflammatory and anti-vaginitis efficacy of plant oil combinations without patchouli oil; mussel protein also significantly enhances the anti-inflammatory and anti-vaginitis efficacy of the plant oil combination.

[0013] The composition of this invention consists entirely of legally permitted cosmetic ingredients, exhibiting good safety and clearly defined anti-inflammatory and antibacterial effects, particularly effective against vaginitis. It can be used to prepare cosmetics, hospital preparations, pharmaceuticals, fragrances, and air disinfectants, providing a new option for practical applications such as the prevention and treatment of vaginitis and environmental antibacterial properties.

[0014] Obviously, based on the above description of the present invention, and according to common technical knowledge and conventional methods in the field, various other modifications, substitutions, or alterations can be made without departing from the basic technical concept of the present invention.

[0015] The following detailed embodiments further illustrate the above-described content of the present invention. However, this should not be construed as limiting the scope of the present invention to the following examples. All technologies implemented based on the above-described content of the present invention fall within the scope of the present invention.

[0016] The following experimental examples demonstrate the beneficial effects of the present invention.

[0017] Experimental Example 1: Local anti-inflammatory effect of the composition of the present invention

[0018] Seventy male Kunming mice (KM) were randomly divided into seven groups according to body weight: model control group (distilled water), solvent control group (blank gel), positive control group (dexamethasone ointment), vegetable oil combination group (excluding patchouli oil and mussel protein in Example 2), vegetable oil combination group (excluding mussel protein in Example 2), mussel protein group (mussel protein dispersed in blank gel at a concentration of 0.05%), and Example 2 group. All animals were administered 0.2 ml (g) / animal topically to the right ear of the corresponding test substance or control substance (100 μL or 0.1 g), once daily for three consecutive days. Forty minutes after the last administration, 30 μL of xylene was applied to both sides of the right ear. The mice were sacrificed 20 minutes later, and both ears were excised along the base of the auricle, weighed, and the degree of swelling (difference between the two ears) and the swelling inhibition rate ((average swelling of the solvent control group - average swelling of the test group or other control groups) / average swelling of the solvent control group) were calculated. SPSS 23.0 was used to perform statistical analysis on the results.

[0019] Table 1. Effects and comparisons of Example 2 and its main components / combinations on xylene-induced ear swelling in mice (n=10, ...). )

[0020]

[0021]

[0022] Note: Compared with the solvent control group, *P<0.05, **P<0.01; compared with the group in Example 2, ▲▲P<0.01; compared with the vegetable oil group, ◆◆P<0.01

[0023] The experimental results are shown in Table 1. All tested samples showed inhibitory effects on xylene-induced acute inflammation. Among them, the six plant oil compositions showed good inhibitory effects, with an inhibition rate of 34.1%, and reduced ear swelling. The difference was statistically significant compared with the solvent control group (P<0.01). Their effects were superior to the five plant oil compositions without patchouli oil, with a statistically significant difference (P<0.01), suggesting that patchouli oil is an important component in the anti-inflammatory effect of the plant oil combinations. In Example 2, the swelling degree was significantly reduced compared with the mussel protein group or the plant oil combination group, with an inhibition rate of 56.6%, which was statistically significant compared with the solvent control group (P<0.01). The inhibition rate of mussel protein alone was only 16.4%.

[0024] The experimental results suggest that mussel protein, in addition to its own anti-inflammatory effects, can significantly enhance the anti-inflammatory effects of vegetable oil compositions, exhibiting a synergistic effect when used together. Its mechanism of action is presumably related to the anti-inflammatory properties of mussel protein and its formation of a protective layer on the skin.

[0025] Experimental Example 2: Antibacterial effect of the composition of the present invention in air.

[0026] Choose a well-ventilated office (10m²) that has not been disinfected within 3 days. 2 Place MH agar plates at three evenly distributed points, remove them after 30 minutes, incubate at 37°C for 24 hours, and count the colonies. Take 10 ml of the composition sample from Example 2 (excluding gel excipients), add it to 100 ml of water, and place it in an ultrasonic nebulizer; after sealing the same room, turn on the ultrasonic nebulizer for 10 minutes to treat the air, repeat the above operation, and count the colonies. Repeat the above experiment 3 times, compare the total colony count before and after treatment, and calculate the inhibition rate of environmental bacteria after treatment. Inhibition rate (%) = (Total colony count before treatment - Total colony count after treatment) / Total colony count before treatment * 100%.

[0027] Table 2. Antibacterial rate (%) of bacteria in the environment after ultrasonic atomization in Example 2.

[0028]

[0029] The results showed that the composition of Example 2, when used in the form of ultrasonic atomization for indoor fumigation, could significantly reduce the total number of colonies in the culture medium, with an antibacterial rate of 82.7%, suggesting that the use of Example 2 in the form of fragrance indoors can reduce the concentration of pathogenic microorganisms in the air.

[0030] Experimental Example 3: Effect of the composition of the present invention on experimental mouse vaginitis

[0031] One hundred and ten female KM mice were randomly divided into a blank control group (n=10) and a model group (n=100). All animals were subcutaneously injected every other day with 0.025 ml of estrogen E2 at a concentration of 1 mg / ml, followed by a subcutaneous injection of cyclophosphamide at a concentration of 50 mg / kg, with a 4-hour interval between the two injections. A density of 3*102 was collected. 7 30 μL of Candida albicans suspension (C. albicans / ml) was injected into the vagina of mice in the model group using a micropipette. The blank control group was given sterile PBS. The mice were then observed daily and scored according to symptom scores (0 for normal vulva with no discharge; 1 for slight vulvar redness and swelling without discharge; 2 for significant vulvar redness and swelling with visible discharge; 3 for significant vulvar redness and swelling with visible ulcers; 4 for death). Once more than 80% of the model group animals scored 2 or higher, unqualified animals and animals with low scores were removed. The selected animals were then stratified and randomly divided into 7 groups according to symptom scores: model control group (distilled water), solvent control group (blank gel), positive control group (clotrimazole ointment), vegetable oil group (excluding patchouli oil and mussel protein in Example 2), vegetable oil group (excluding mussel protein in Example 2), mussel protein group (mussel protein dispersed in blank gel at a concentration of 0.05%), and Example 2 group. The corresponding sample was administered via vaginal irrigation at a dose of 10 μL / animal daily for 3 consecutive days. On the 4th day, vaginal symptoms were observed and recorded. The vagina was then irrigated with PBS, and the irrigated fluid was cultured and counted. The experimental results were analyzed using SPSS 23 non-parametric tests.

[0032] The experimental results are shown in Table 3. The model animals exhibited significant vulvar redness and ulceration. Both the vegetable oil group and the Example 2 group showed improvement in vaginitis symptoms and reduced scores, with statistically significant differences compared to the solvent control group (P<0.01 or P<0.05). Example 2 group showed the best effect, with statistically significant differences compared to the vegetable oil-without patchouli oil group, the vegetable oil group, and the mussel protein group (P<0.01 or P<0.05). The colony count results were similar to the symptom observations; the colony count in Example 2 group was significantly lower than that in the vegetable oil group and the mussel protein group (P<0.01 or P<0.05). These results suggest that the vegetable oil group has significant anti-vaginitis efficacy, and the combination with mussel protein, i.e., Example 2 group, is even more effective.

[0033] Table 3. Effects and comparisons of Example 2 and its main components / combinations on Candida albicans-induced experimental vaginitis in mice (n=10, )

[0034]

[0035] Note: Compared with the blank control group, ◆◆P<0.01; compared with the solvent control group, *P<0.05, **P<0.01; compared with Example 2, ▲P<0.05, ▲▲P<0.01 Detailed Implementation

[0036] Example 1: Preparation of the composition of the present invention

[0037] In a mixing pot, combine peppermint oil (0.4ml), patchouli oil (3.5ml), rose oil (0.3ml), geranium oil (2.5ml), and pistachio seed oil (3.3ml), totaling 10ml. Stir well and filter to obtain the plant essential oil. Take 1ml of the above-mentioned mixed essential oil, add 99ml of jojoba oil and 0.5g of mussel protein, and slowly stir with a mixer for 5 minutes to obtain 100ml of massage oil containing 1% plant essential oil and 0.5% mussel protein.

[0038] Example 2: Preparation of the composition of the present invention (actually prepared sample)

[0039] In a mixing vessel, add peppermint oil (0.4ml), patchouli oil (3.5ml), rose oil (0.3ml), geranium oil (2.5ml), and pistachio seed oil (3.3ml), totaling 10ml. Stir well and filter to obtain plant essential oil. Measure 1ml and set aside (mixture 1). Mix AVC (0.1g), butylene glycol (5g), and glycerin (8g) until well combined and set aside (mixture 2). In a mixing vessel, add Arbopol Ultrez 20 Polymer (U20): 0.6g and purified water: 74.65g. After the Arbopol Ultrez 20 Polymer (U20) has completely absorbed the water, add the prepared mixture 2. Stir and heat in the mixing vessel to 80-85℃ and maintain the temperature for 20 minutes. Mix 0.4g of arginine, 0.2g of potassium sorbate, 0.05g of mussel extract, and 10g of purified water until dissolved and set aside (mixture 3). After incubation, stir and cool the mixture to 40-45℃. Add the prepared mixture 1 and mixture 3, and stir for 10 minutes to obtain 100ml of gel containing 1% plant essential oil and 0.05% mussel protein.

[0040] Example 3

[0041] In a water phase pot, add peppermint oil (0.4ml), patchouli oil (3.5ml), rose oil (0.3ml), geranium oil (2.5ml), and pistachio seed oil (3.3ml), totaling 10ml. Stir well and filter to obtain plant essential oil. Measure 1ml for later use (mixture 1). In an oil phase pot, add sorbitan oleate (0.6g), cetearyl alcohol (1.5g), caprylic / capric triglyceride (5g), mineral oil (5g), glyceryl stearate (2g), shea butter (2g), hydrogenated polyisobutylene (2g), and tocopheryl acetate (0.5g). Heat to 80-85℃, mix and stir well, and keep warm for 20 minutes. Add purified water (60.75g), sodium polyacrylate (0.35g), polysorbate-80 (1g), p-hydroxyacetophenone (0.5g), and butylene glycol (6g) sequentially to the emulsifying pot, mix and stir evenly, and keep warm for 20 minutes. After the warming period, transfer the mixture from the oil phase pot to the emulsifying pot and emulsify and homogenize for 3 minutes. After homogenization, stir and cool the mixture to 40-45℃. Mix and dissolve arginine (0.3g), mussel extract (0.5g), and 10g purified water evenly (mixture 2). Add the aforementioned mixture 1, mixture 2, 1,2-pentanediol (0.5g), and 1,2-hexanediol (0.5g) to the emulsifying pot, stir for 10 minutes, and filter to obtain 100ml of emulsion containing 1% plant essential oil and 0.5% mussel protein.

Claims

1. A composition characterized by: The composition comprises a combination of vegetable oils and mussel protein. The vegetable oils are composed of the following ingredients in the indicated weight ratios: 4 parts peppermint leaf oil, 35 parts patchouli oil, 3 parts rose oil, 25 parts geranium oil, and 33 parts pistachio seed oil. The mussel protein in the composition is 0.2%, and the mussel protein is a mucin extracted from the marine organism *Mussela purpurea* with a molecular weight of 100 kDa.

2. Use of the composition of claim 1 in the preparation of a medicament having anti-inflammatory, antibacterial, or antivaginal effects.

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