SOD (superoxide dismutase) oil mixture for improving vaginal atrophy and dryness and increasing vaginal elasticity

Abstract

The invention discloses an SOD (superoxide dismutase) oil mixture for improving vaginal atrophy and dryness and increasing vaginal elasticity, and relates to the technical field of laser cladding. The invention discloses a skin-care essence, which is prepared from the following ingredients in percentage by mass: 0.1 to 1 percent of superoxide dismutase, 10 to 20 percent of deep sea fish oil, 5 to 10 percent of vitamin E, 3 to 8 percent of squalane, 1 to 3 percent of sodium hyaluronate, 0.5 to 2 percent of chitosan quaternary ammonium salt, 1 to 3 percent of phytosterol, 0.1 to 0.5 percent of lavender essential oil, 0.1 to 0.5 percent of tea tree essential oil and the balance of purified water. According to the SOD oil mixture for improving the vaginal atrophy and dryness and increasing the vaginal elasticity, various components cooperate with one another, the SOD oil mixture plays a role in the aspects of oxidation resistance, inflammation resistance, moisturizing, repairing and the like, the symptoms of the vaginal atrophy and dryness can be effectively improved, the vaginal elasticity is increased, the treatment effect is improved, the components are natural, harmful chemical substances are not contained, and the SOD oil mixture does not irritate vaginal mucosa; no obvious side effect exists. Through detection of skin irritation index (PII) determination, biocompatibility experiment and the like, it is proved that the composition is good in safety and suitable for long-term use.

Description

Technical Field

[0001] This invention relates to the field of laser cladding technology, specifically to a mixture of SOD oils used to improve vaginal atrophy and dryness and increase vaginal elasticity. Background Technology

[0002] The vagina is an important female reproductive organ, connecting the uterus and external genitalia. It serves not only as the passage for menstruation and childbirth but also as the organ for sexual intercourse. Its structure consists of a mucosa, muscular layer, and adventitia, and it is highly elastic. The maintenance of normal vaginal physiological function is closely related to the normal vaginal microecological state; ovarian function, normal vaginal structure, vaginal microecological environment such as vaginal pH (normal range 3.8–4.4), microbial distribution, local cytokines, and immune function are all important factors affecting vaginal physiological function.

[0003] The invention disclosed in CN104548071A is a recombinant human collagen vaginal gel for vaginal dryness and its preparation method, comprising the following components in the indicated mass concentrations: recombinant human collagen 0.05-1%; poloxamer 4071 0-30%; poloxamer 188 0.5-6%; sodium hyaluronate 0.1-2%; glycerin 1-4%; antibacterial preservatives: phenoxyethanol 0.1-1%, sodium methylparaben 0.05-3%, sodium propylparaben 0.01-2%; water balance. As shown in the invention, the existing product can increase vaginal elasticity and improve vaginal atrophy; reduce dyspareunia and improve sexual satisfaction; improve vaginal dryness by increasing secretions and vaginal moisture, and repair itching, burning, and skin cracking caused by dryness; and alleviate vulvar and vaginal dryness and stinging symptoms. However, this product mainly improves symptoms through mechanisms such as restoring epithelial cell morphology with recombinant human collagen and moisturizing with sodium hyaluronate. The types of ingredients are relatively simple, and the synergistic effect is limited. Summary of the Invention

[0004] To address the shortcomings of existing technologies, this invention provides a mixture of SOD oils for improving vaginal atrophy and dryness and increasing vaginal elasticity, thus solving the existing problems.

[0005] To achieve the above objectives, the present invention is implemented through the following technical solution: a SOD oil mixture for improving vaginal atrophy and dryness and increasing vaginal elasticity, comprising the following components (by mass percentage): superoxide dismutase (SOD) 0.1%-1%, deep-sea fish oil 10%-20%, vitamin E 5%-10%, squalane 3%-8%, sodium hyaluronate 1%-3%, chitosan quaternary ammonium salt 0.5%-2%, phytosterols 1%-3%, lavender essential oil 0.1%-0.5%, tea tree essential oil 0.1%-0.5%, with the balance being purified water.

[0006] Preferably, the chitosan quaternary ammonium salt comprises 2-hydroxypropyltrimethylammonium chloride chitosan with a quaternization degree of 70%-95% and / or dimethyldiallylammonium chloride chitosan with a quaternization degree of ≥80%.

[0007] Preferably, the superoxide dismutase (SOD) is a recombinant human superoxide dismutase with improved stability, and its half-life at 37°C is extended by at least 20% compared with that before improvement.

[0008] Preferably, the mass ratio of DHA (docosahexaenoic acid) to EPA (eicosapentaenoic acid) in the deep-sea fish oil is (2-3):1.

[0009] This invention also discloses a method for preparing a mixture of SOD oils for improving vaginal atrophy and dryness and increasing vaginal elasticity, comprising the following steps:

[0010] Step 1: Raw material preparation: Accurately weigh the following ingredients according to the formula ratio: superoxide dismutase (SOD), deep-sea fish oil, vitamin E, squalane, sodium hyaluronate, chitosan quaternary ammonium salt, phytosterols, lavender essential oil, tea tree essential oil, and purified water.

[0011] Step 2, Oil phase preparation: Mix deep-sea fish oil, vitamin E, squalane, and phytosterols, and stir evenly at 50-60℃ to form an oil phase;

[0012] Step 3, Aqueous phase preparation: Dissolve sodium hyaluronate and chitosan quaternary ammonium salt in purified water and stir at 30-40℃ until completely dissolved to form an aqueous phase;

[0013] Step 4: Emulsification and Mixing: Slowly add the oil phase to the aqueous phase while turning on high-speed stirring. Emulsify at 40-50℃ for 30-40 minutes to form a uniform emulsion.

[0014] Step 5: Add essential oils: After the lotion has cooled to room temperature, add lavender essential oil and tea tree essential oil, and continue stirring for 10-15 minutes;

[0015] Step 6, Quality Inspection and Packaging: The prepared SOD oil mixture is subjected to quality inspection, and after passing the inspection, it is aseptically packaged.

[0016] Preferably, in the oil phase preparation step, the stirring speed is controlled at 200-300 rpm and the stirring time is 30-40 minutes.

[0017] Preferably, in the aqueous phase preparation step, the stirring speed is 100-150 rpm and the stirring time is 20-30 minutes.

[0018] The present invention also discloses the application of a mixture of SOD oils for improving vaginal atrophy and dryness and increasing vaginal elasticity, for use in preparing drugs or health products for treating vaginal atrophy and dryness and increasing vaginal elasticity.

[0019] Preferably, the drug or health product is administered vaginally as a local drug, and the dosage form is a gel, suppository, or spray.

[0020] Beneficial effects

[0021] This invention provides a mixture of SOD oils for improving vaginal atrophy and dryness and increasing vaginal elasticity.

[0022] Compared with existing technologies, it has the following advantages:

[0023] 1. This SOD oil mixture, used to improve vaginal atrophy and dryness and increase vaginal elasticity, has multiple ingredients that work synergistically to exert their effects in multiple aspects such as anti-oxidation, anti-inflammation, moisturizing, and repair. It can effectively improve the symptoms of vaginal atrophy and dryness, increase vaginal elasticity, and improve the treatment effect.

[0024] 2. This SOD oil mixture, used to improve vaginal atrophy and dryness and increase vaginal elasticity, is made of natural ingredients, contains no harmful chemicals, does not irritate the vaginal mucosa, and has no obvious side effects. Skin irritation index (PII) testing and biocompatibility experiments have proven its good safety profile, making it suitable for long-term use.

[0025] 3. This SOD oil mixture, used to improve vaginal atrophy and dryness and increase vaginal elasticity, has a simple and easy preparation process, readily available raw materials, and low production costs, making it suitable for large-scale industrial production and conducive to the promotion and application of the product. Attached Figure Description

[0026] Figure 1 This is a schematic diagram of the mixture preparation process of the present invention.

[0027] Figure 2 This is a schematic diagram comparing the effects of different combinations of components of the present invention on the proliferation of vaginal epithelial cells. Detailed Implementation

[0028] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0029] See also Figure 1-2 The present invention provides the following multiple technical solutions:

[0030] First implementation method: Preparation of SOD oil mixture

[0031] Accurately weigh 0.1 g of superoxide dismutase (SOD), 10 g of deep-sea fish oil, 5 g of vitamin E, 3 g of squalane, 1 g of sodium hyaluronate, 0.5 g of chitosan quaternary ammonium salt, 1 g of phytosterol, 0.1 g of lavender essential oil, 0.1 g of tea tree essential oil, and the remainder is purified water, and prepare a mixture of 100 g.

[0032] First, place the deep-sea fish oil, vitamin E, squalane, and phytosterols in a container and stir for 30 minutes at a stirring speed of 200 rpm under a constant temperature water bath at 50°C to ensure that all components are fully mixed to form a uniform oil phase.

[0033] Sodium hyaluronate and chitosan quaternary ammonium salt were slowly added to an appropriate amount of purified water and stirred at 100 rpm for 20 minutes at 30°C until completely dissolved to form an aqueous phase.

[0034] At 40°C, slowly pour the oil phase into the aqueous phase while simultaneously turning on high-speed stirring at 800 rpm and emulsifying for 30 minutes to ensure a uniform emulsion.

[0035] After the lotion has cooled to room temperature, add lavender essential oil and tea tree essential oil, and continue stirring for 10 minutes to evenly disperse the essential oils.

[0036] The prepared SOD oil mixture is subjected to quality testing. After all indicators are qualified, it is aseptically packaged to make a gel.

[0037] Clinical Application: Twenty female patients aged 35-50 years with symptoms of vaginal atrophy and dryness were selected. Patients used the gel prepared in this embodiment once daily, 2 grams each time, for one course of treatment (10 days). After use, changes in vaginal elasticity were measured using a vaginal elastography device, and patients were also asked to subjectively evaluate the relief of vaginal dryness. Results showed that 12 patients experienced significant relief of vaginal dryness and increased vaginal elasticity; 6 patients showed some improvement; and 2 patients showed no significant effect, with a total effective rate of 90%.

[0038] Second implementation method: Preparation of SOD oil mixture: Weigh 0.5 g of superoxide dismutase (SOD), 15 g of deep-sea fish oil, 7 g of vitamin E, 5 g of squalane, 2 g of sodium hyaluronate, 1 g of chitosan quaternary ammonium salt, 2 g of phytosterols, 0.3 g of lavender essential oil, 0.3 g of tea tree essential oil, with the remainder being purified water, for a total of 100 g. Prepare the SOD oil mixture gel using the same preparation process as in the first implementation method.

[0039] Clinical Application: Thirty patients aged 40-55 years with vaginal atrophy and dryness were selected. Patients used the gel prepared in this embodiment twice daily, 2.5 grams each time, for two consecutive courses of treatment (20 days). After use, using the same testing method, 25 patients showed significant improvement in vaginal atrophy and dryness symptoms and a marked increase in vaginal elasticity; 4 patients experienced symptom relief; and 1 patient showed no improvement, with a total effective rate of 96.7%.

[0040] The third implementation method: Preparation of the SOD oil mixture: Weigh 1 gram of superoxide dismutase (SOD), 20 grams of deep-sea fish oil, 10 grams of vitamin E, 8 grams of squalane, 3 grams of sodium hyaluronate, 2 grams of chitosan quaternary ammonium salt, 3 grams of phytosterols, 0.5 grams of lavender essential oil, 0.5 grams of tea tree essential oil, with the remainder being purified water, to prepare a 100-gram mixture. Following the established preparation process, the SOD oil mixture gel is obtained.

[0041] Clinical Application: Twenty-five patients aged 30-45 years with related symptoms were selected. Patients used the gel prepared in this embodiment twice daily, 3 grams each time, for one course of treatment (15 days). Testing showed that vaginal atrophy and dryness symptoms essentially disappeared in 20 patients, and vaginal elasticity returned to normal; symptoms were significantly alleviated in 4 patients; and the effect was moderate in 1 patient, with a total effective rate of 96%.

[0042] Fourth implementation method: Comparative Example 1 (lacking SOD component)

[0043] Preparation of the mixture: Weigh 10g of deep-sea fish oil, 5g of vitamin E, 3g of squalane, 1g of sodium hyaluronate, 0.5g of chitosan quaternary ammonium salt, 1g of phytosterols, 0.1g of lavender essential oil, 0.1g of tea tree essential oil, with the remainder being purified water, for a total of 100g. The preparation method is the same as in the first embodiment, to prepare a gel.

[0044] Clinical Application: Twenty patients with similar age and symptoms to those in Example 1 were selected. Patients used the gel once daily, 2 grams each time, for one course of treatment (10 days). After use, only 6 patients experienced slight relief of vaginal dryness symptoms with almost no change in vaginal elasticity; 10 patients showed no significant improvement; and 4 patients showed no effect, with an overall effective rate of 30%.

[0045] Fifth implementation method: Comparative Example 2 (lacking chitosan quaternary ammonium salt and phytosterols)

[0046] Preparation of the mixture: Weigh 0.1 g of superoxide dismutase (SOD), 10 g of deep-sea fish oil, 5 g of vitamin E, 3 g of squalane, 1 g of sodium hyaluronate, 0.1 g of lavender essential oil, 0.1 g of tea tree essential oil, and the remainder is purified water, for a total of 100 g. Prepare a gel according to the preparation process of the first embodiment.

[0047] Clinical Application: Twenty patients with similar symptoms were selected. Patients used the gel once daily, 2 grams each time, for one course of treatment (10 days). Results showed that vaginal dryness symptoms were relieved in 8 patients, but the effect was not significant, and vaginal elasticity was not significantly improved; 8 patients showed no significant improvement in symptoms; and 4 patients showed no effect, with a total effective rate of 40%.

[0048] The above embodiments are compared with the comparative examples, as shown in the table below:

[0049]

[0050]

[0051] The comparison between the examples and comparative examples clearly shows that the complete SOD oil mixture of the present invention is significantly more effective than the comparative product lacking certain components in improving vaginal atrophy and dryness and increasing vaginal elasticity. This fully demonstrates the importance of the synergistic effect of the components of the present invention, providing a more effective solution for treating vaginal atrophy and dryness and increasing vaginal elasticity.

[0052] Furthermore, all content not described in detail in this specification is existing technology known to those skilled in the art, and the model parameters of each electrical appliance are not specifically limited; conventional equipment can be used.

[0053] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such process, method, article, or apparatus.

[0054] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A mixture of SOD oils used to improve vaginal atrophy and dryness and increase vaginal elasticity, characterized in that, Composed of the following ingredients by weight percentage: superoxide dismutase 0.1%-1%, deep-sea fish oil 10%-20%, vitamin E 5%-10%, squalane 3%-8%, sodium hyaluronate 1%-3%, chitosan quaternary ammonium salt 0.5%-2%, phytosterols 1%-3%, lavender essential oil 0.1%-0.5%, tea tree essential oil 0.1%-0.5%, with the balance being purified water.

2. The SOD oil mixture according to claim 1 for improving vaginal atrophy and dryness and increasing vaginal elasticity, characterized in that: The chitosan quaternary ammonium salt includes 2-hydroxypropyltrimethylammonium chloride chitosan with a quaternization degree of 70%-95% and / or dimethyldiallylammonium chloride chitosan with a quaternization degree of ≥80%.

3. The SOD oil mixture according to claim 1 for improving vaginal atrophy and dryness and increasing vaginal elasticity, characterized in that: The superoxide dismutase is a recombinant human superoxide dismutase with improved stability, and its half-life at 37°C is extended by at least 20% compared with the unmodified version.

4. The SOD oil mixture for improving vaginal atrophy and dryness and increasing vaginal elasticity according to claim 1, characterized in that: The mass ratio of DHA to EPA in the deep-sea fish oil is 2-3:

1.

5. A method for preparing a SOD oil mixture as described in claims 1-4 for improving vaginal atrophy and dryness and increasing vaginal elasticity, characterized in that, Includes the following steps: Step 1: Raw material preparation: Accurately weigh the following ingredients according to the formula ratio: superoxide dismutase, deep-sea fish oil, vitamin E, squalane, sodium hyaluronate, chitosan quaternary ammonium salt, phytosterols, lavender essential oil, tea tree essential oil, and purified water. Step 2, Oil phase preparation: Mix deep-sea fish oil, vitamin E, squalane, and phytosterols, and stir evenly at 50-60℃ to form an oil phase; Step 3, Aqueous phase preparation: Dissolve sodium hyaluronate and chitosan quaternary ammonium salt in purified water and stir at 30-40℃ until completely dissolved to form an aqueous phase; Step 4: Emulsification and Mixing: Slowly add the oil phase to the aqueous phase while turning on high-speed stirring. Emulsify at 40-50℃ for 30-40 minutes to form a uniform emulsion. Step 5: Add essential oils: After the lotion has cooled to room temperature, add lavender essential oil and tea tree essential oil, and continue stirring for 10-15 minutes; Step 6, Quality Inspection and Packaging: The prepared SOD oil mixture is subjected to quality inspection, and after passing the inspection, it is aseptically packaged.

6. The method for preparing the SOD oil mixture for improving vaginal atrophy and dryness and increasing vaginal elasticity according to claim 5, characterized in that: In the oil phase preparation step, the stirring speed is controlled at 200-300 rpm, and the stirring time is 30-40 minutes.

7. The method for preparing the SOD oil mixture for improving vaginal atrophy and dryness and increasing vaginal elasticity according to claim 5, characterized in that: In the aqueous phase preparation step, the stirring speed is 100-150 rpm and the stirring time is 20-30 minutes.

8. The application of the SOD oil mixture as described in claim 1 for improving vaginal atrophy and dryness and increasing vaginal elasticity, characterized in that: Used to prepare drugs or health products for treating vaginal atrophy and dryness, and increasing vaginal elasticity.

9. The application of the SOD oil mixture according to claim 8 for improving vaginal atrophy and dryness and increasing vaginal elasticity, characterized in that: The medication or health product is administered vaginally as a local drug, and is available in the form of a gel, suppository, or spray.

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