An essential oil type dry eye wet contact lens composition, wet contact lens device, and paste

Abstract

The present application relates to the technical field of ophthalmic disease treatment, and particularly relates to a kind of essential oil type dry eye syndrome wet room mirror composition, which comprises menthol 0.1-0.30% by mass percentage, mild essential oil 0.05-0.10%, borneol 0.01-0.05%, perilla oil 3-5%, non-ionic emulsifier 1-4%, and the balance is traditional Chinese medicine water extract; the mild essential oil is at least one of jasmine essential oil and lavender essential oil; the traditional Chinese medicine water extract is water extract of medlar, houttuynia cordata, perilla frutescens, gentian and scutellaria baicalensis, and its relative density at 25 DEG C is 1.10-1.15. The present application designs the drug formula and uses mild essential oil to load the drug, and prepares a wet room mirror liquid with better drug formula effect, easier atomization and better transdermal absorption effect, significantly improves the treatment effect on dry eye syndrome, and improves the efficacy and convenience of wet room mirror use. The present application also provides a wet room mirror device and a paste comprising the essential oil type dry eye syndrome wet room mirror composition.

Description

Technical Field

[0001] This invention relates to the field of ophthalmic disease treatment technology, specifically to an essential oil-based dry eye wet chamber mirror composition, a wet chamber mirror device, and an ointment. Background Technology

[0002] Moisture chamber goggles (or dry eye relief glasses) are special eyeglasses designed to relieve dry eye symptoms. They help keep the surface of the eye moist by creating a tiny, humid environment, reducing tear evaporation and thus alleviating the discomfort caused by dry eye. For example, CN118634081A discloses a dual-vibration ultrasonic atomizing moisture chamber goggles, CN113332036A discloses a solution and cotton wool for moisture chamber goggles, as well as the goggles themselves. CN118717406A discloses a vacuum magnetically connected moisture chamber goggles that serve two purposes.

[0003] The structures of moisture chamber endoscopes are largely similar, generally featuring a dedicated cavity for holding the medication and a device for atomizing the medication. This device typically uses ultrasonic vibration, a spraying mechanism, or a heating element to create a mist within the moisture chamber. The medication remains in contact with the eyes for an extended period, keeping them moist and achieving the desired therapeutic effect. The efficacy of moisture chamber endoscopes primarily depends on the medication solution. CN113332036A discloses a medication solution for moisture chamber endoscopes composed of water extracts of 3-8 parts peppermint, 8-15 parts cassia seed, 5-20 parts honeysuckle, 8-20 parts buddleja officinalis, 8-15 parts sophora flavescens, 10-20 parts chrysanthemum, and 10-20 parts artemisia argyi. The medication is a pure water extract with poor volatility, requiring a high-power nebulizer or ultrasonic device for processing and atomization. This results in high power consumption for the humidification chamber endoscope, necessitating connection to mains power or the use of a high-capacity battery. Even after atomization, the water extract, being primarily hydrophilic, has poor transdermal absorption capacity, hindering the further movement of drug molecules within the body. All these factors affect the absorption rate and speed, leading to a less effective treatment for dry eye syndrome with the humidification chamber endoscope. This is mainly because hydrophilic substances generally have difficulty penetrating the skin or stratum corneum. Even with atomization through the humid environment created by the humidification chamber endoscope, these substances struggle to effectively penetrate the ocular tissues. Furthermore, the formulation of the medication is also a crucial factor determining the effectiveness of the humidification chamber endoscope in treating dry eye syndrome. Summary of the Invention

[0004] (a) Technical problems to be solved

[0005] In view of the above-mentioned shortcomings and deficiencies of the prior art, the present invention provides an essential oil-based wet chamber lens composition for dry eye. By designing the drug formulation and using mild and highly penetrating essential oils as drug carriers, a wet chamber lens solution with better drug formulation efficacy, easier atomization, and better transdermal absorption is obtained. This significantly improves the efficacy for dry eye and enhances the effectiveness and convenience of using wet chamber lenses, thereby solving the technical problems of poor formulation and difficulty in atomization and poor transdermal absorption of existing wet chamber lens solutions.

[0006] (II) Technical Solution

[0007] This invention provides an essential oil-based moisture chamber lens composition for dry eye, comprising, by weight percentage: 0.1-0.30% menthol, 0.05-0.10% mild essential oil, 0.01-0.05% borneol, 3-5% perilla oil, 1-4% nonionic emulsifier, and the balance being a traditional Chinese medicine aqueous extract; the mild essential oil is at least one of jasmine essential oil and lavender essential oil; the traditional Chinese medicine aqueous extract is an aqueous extract of wolfberry, houttuynia cordata, leonurus japonicus, gentian, and scutellaria baicalensis, with a relative density of 1.10-1.15 at 25°C.

[0008] According to a preferred embodiment of the present invention, the nonionic emulsifier is Tween 80 or Span 80 or a mixture of Tween 80 and Span 80, preferably a mixture in a 1:1 mass ratio.

[0009] According to a preferred embodiment of the present invention, the method for preparing the aqueous extract of traditional Chinese medicine is as follows:

[0010] S1. Thoroughly clean the medicinal herbs wolfberry, houttuynia cordata, leonurus japonicus, gentian and scutellaria baicalensis to remove impurities and dust, and pulverize them through a 50-mesh sieve.

[0011] S2. Soak the herbs in 8-10 times their weight of water for 1-2 hours to allow them to fully absorb water and swell. Pour the soaked herbs and soaking water into a decoction pot, bring to a boil over high heat, then simmer over low heat for 1.5-2 hours. Filter and collect the decoction, and keep the dregs for later use.

[0012] S3. Add 6-8 times the amount of the medicinal material to the dregs and water again. Bring to a boil over high heat, then simmer over low heat for 50-70 minutes. Filter and collect the decoction again.

[0013] S4. Combine the two decoctions, let stand overnight, take the supernatant, and concentrate it at ≤60℃ using a rotary evaporator or vacuum concentrator to obtain a decoction with a relative density of 1.10-1.15 at 25℃.

[0014] S5. Fine filtration removes residual solid particles and impurities, yielding a clear aqueous extract of traditional Chinese medicine.

[0015] According to a preferred embodiment of the present invention, in S5, fine filtration is performed using a sand core funnel or a microporous membrane.

[0016] According to a preferred embodiment of the present invention, step S5 further includes a step of sterilizing the aqueous extract of traditional Chinese medicine. The sterilization method is as follows: sterilization is performed using gamma rays at a temperature of 2-10°C and an irradiation dose of 9-15 Gy; after sterilization, the extract is stored at 2-8°C for later use.

[0017] According to a preferred embodiment of the present invention, in S1, when preparing the aqueous extract of traditional Chinese medicine, the dry weight ratio of the four medicinal materials, namely, wolfberry, houttuynia cordata, leonurus japonicus, gentian, and scutellaria baicalensis, is 5-10:2-4:2-4:2-4:2-4:5-10.

[0018] According to a preferred embodiment of the present invention, the dry weight ratio of the five medicinal materials, namely wolfberry, houttuynia cordata, leonurus japonicus, gentian, and scutellaria baicalensis, is 5:3:2:2:6.

[0019] According to a preferred embodiment of the present invention, the essential oil-based dry eye moist chamber lens composition is prepared by the following steps: menthol, borneol, and mild essential oil are added to perilla oil and mixed by stirring or ultrasonic treatment to obtain an oil phase; a nonionic emulsifier is added to the aqueous extract of traditional Chinese medicine and stirred to obtain an aqueous phase; the oil phase is added to the aqueous phase, and the aqueous phase is continuously stirred during the addition process until the addition is complete to obtain the essential oil-based dry eye moist chamber lens composition.

[0020] According to a preferred embodiment of the present invention, it comprises: 0.1% menthol, 0.05% jasmine essential oil, 0.05% lavender essential oil, 4% perilla oil, 0.02% borneol, 2% nonionic emulsifier, and the balance being a traditional Chinese medicine aqueous extract; the relative density of the traditional Chinese medicine aqueous extract at 25°C is 1.15; the dry weight ratio of the five medicinal materials, namely wolfberry, houttuynia cordata, leonurus japonicus, gentian, and scutellaria baicalensis, is 5:3:2:2:6.

[0021] Secondly, the present invention also provides a wet room mirror device for relieving dry eye syndrome, comprising a mirror frame and a receiving groove disposed on the mirror frame, and further comprising the essential oil-based dry eye wet room mirror composition of any of the above embodiments and a carrier. The carrier is a solid material with adsorption function, and the carrier is a sheet, block, pellet, granule, powder, or other material, including but not limited to absorbent paper, absorbent cotton, sponge, porous gel, molecular sieve pellets, diatomaceous earth pellets, activated carbon pellets, and bentonite pellets. When the particle size of the solid material is too small, if a powder material is used, it can also be made into a "small tea bag" form using a non-woven fabric bag.

[0022] When using the wet room lens device of the present invention, the carrier can be placed in the slot of the lens frame, and a certain amount of essential oil-based dry eye wet room lens composition can be dropped onto the carrier. The lens frame can then be worn on the patient's eyes for dry eye treatment. Alternatively, the essential oil-based dry eye wet room lens composition is pre-adsorbed onto the carrier at the time of product manufacturing, and the carrier with the adsorbed medicine is packaged as a separate product. When using, the sealed bag or sealed box is opened, and one or more pieces are taken out and placed into the slot of the lens frame. The lens frame can then be worn on the patient's eyes for dry eye treatment.

[0023] Thirdly, the present invention also provides an ointment for relieving dry eye syndrome, which is a paste made from the aforementioned essential oil-based dry eye moist chamber lens composition and ointment excipients. In use, the ointment can be applied around the eyes first, and then used in conjunction with the moist chamber lens device of the present invention or a regular moist chamber lens (such as a saline moist chamber lens). It can also be used with health care devices, such as facial massagers that emit far-infrared rays and provide massage, magnetic therapy, or other functions to improve microcirculation.

[0024] (III) Beneficial Effects

[0025] This invention designs a drug formulation comprising wolfberry, houttuynia cordata, leonurus japonicus, gentian, and scutellaria baicalensis. Wolfberry nourishes the liver and kidneys, improves vision, and clears away corneal opacity; houttuynia cordata and scutellaria baicalensis clear heat and detoxify, and dispel wind and heat; leonurus japonicus clears the liver, improves vision, cools the blood, and stops bleeding. The combination of these herbs utilizes methods such as nourishing the liver and kidneys, replenishing blood and improving vision, and dispelling wind and heat to treat dry eye syndrome caused by liver and kidney yin deficiency, insufficient qi and blood, and external wind-heat.

[0026] This invention uses low concentrations of mild essential oils such as jasmine and / or lavender essential oils, which are gentle yet possess strong penetrating power, as drug carriers. The low boiling point of these essential oils facilitates rapid drug evaporation within the moisture chamber and its application to the eye, reducing the power consumption of the moisture chamber, extending battery life after each charge, and improving ease of use. The composition of this invention can be used with moisture chamber devices employing ultrasonic, atomizing, or heating methods, or with a non-powered moisture chamber device. During the diffusion of essential oil molecules, water-soluble drug molecules carry essential oil molecules, giving these water-soluble molecules a certain degree of lipophilicity and enhancing their transdermal absorption capacity. Essential oil molecules and menthol, among others, help open the gaps in the stratum corneum, improving drug absorption efficiency, and the migratory properties of essential oil molecules further accelerate drug absorption by the body. Low concentrations of menthol itself promote tear secretion and protect damaged corneas; controlling the menthol concentration at 0.1-0.30% reduces its irritation to the eye, making the composition gentler and safer. The cooling properties of borneol help to quickly relieve eye fatigue and discomfort, providing immediate comfort to patients with dry eye syndrome. It also offers antibacterial, anti-inflammatory, and blood circulation-promoting effects. Furthermore, borneol acts as a transdermal absorption enhancer, helping other active ingredients to better penetrate the eye tissues and improve treatment efficacy. The combination of borneol and essential oils can significantly enhance the absorption and utilization rate of various components in the medication.

[0027] When perilla oil is used as a carrier oil, it is not easily volatile. It is mainly used as a base oil to dissolve and dilute highly volatile essential oils (jasmine essential oil, lavender essential oil, menthol, and borneol), slow down the evaporation rate of essential oils, prevent essential oils from evaporating too quickly, improve the storage stability of the composition, and provide certain moisturizing and anti-inflammatory effects.

[0028] The mild essential oil used in this invention is at least one of jasmine and lavender essential oils. These two essential oils not only possess soothing and anti-inflammatory properties but also provide psychological relaxation. Specifically, jasmine essential oil has antibacterial and anti-inflammatory, antioxidant, moisturizing and repairing, eye discomfort relief, tear film quality enhancement, eye tissue repair promotion, accelerated healing of damaged corneal and conjunctival epithelial cells, and overall eye health improvement effects. Lavender essential oil has calming and anti-anxiety, anti-inflammatory and antibacterial, wound healing promotion, eye fatigue reduction, reduced inflammatory response, and supportive lacrimal gland function effects. Some studies suggest that lavender essential oil may help stimulate lacrimal gland secretion and increase tear production. When these two essential oils are added at low concentrations to the moisture chamber mirror composition, they exhibit complementary effects, such as a combined anti-inflammatory effect, enhanced sensory experience, and improved moisturizing and repair properties. The concentration of essential oils used on the skin is generally 0.5-2%. In this application, the concentration of essential oils is controlled below 0.10%, which makes the moisture chamber mirror composition gentler, reduces the irritation of essential oils to the eyes, and allows it to exert its effect of increasing transdermal absorption.

[0029] In summary, this invention provides a wet chamber eye medication solution with better efficacy, easier atomization, and better transdermal absorption, thereby significantly improving the efficacy for dry eye syndrome and enhancing the effectiveness and convenience of using wet chamber eyeglasses. Attached Figure Description

[0030] Figure 1 This describes the tear secretion of animal models before and after drug administration in each experimental drug group and control drug group during animal experiments.

[0031] Figure 2 This shows the corneal fluorescein sodium scores of the experimental drug group and the control drug group in the animal experiments before and after drug administration. Detailed Implementation

[0032] To better explain and facilitate understanding of the present invention, the present invention will be described in detail below with reference to the accompanying drawings and specific embodiments.

[0033] To address the problems of poor volatility, difficulty in atomization, poor transdermal absorption of hydrophilic substances, and poor drug dispersion in existing wet room eye medication solutions which are pure water extracts, this invention provides an essential oil-based wet room eye medication composition for dry eye, comprising 0.1-0.30% menthol, 0.05-0.10% mild essential oil, 0.01-0.05% borneol, 3-5% perilla oil, 1-4% nonionic emulsifier, and the balance being a water extract of traditional Chinese medicine; the mild essential oil is at least one of jasmine essential oil and lavender essential oil; the water extract of traditional Chinese medicine is an extract of wolfberry, houttuynia cordata, leonurus japonicus, gentian, and scutellaria baicalensis, with a relative density of 1.10-1.15 at 25°C.

[0034] The herbal extract is made from wolfberry, houttuynia cordata, leonurus japonicus, gentian, and scutellaria baicalensis. Wolfberry nourishes the liver and kidneys, improves eyesight, and clears corneal opacity; houttuynia cordata and scutellaria baicalensis clear heat and detoxify, and dispel wind and heat; leonurus japonicus clears the liver, improves eyesight, cools the blood, and stops bleeding. This combination of herbs uses methods such as nourishing the liver and kidneys, nourishing blood and improving eyesight, and dispelling wind and heat to treat dry eye syndrome caused by liver and kidney yin deficiency, insufficient qi and blood, and external wind-heat. Specifically...

[0035] Goji berries: Rich in various antioxidants, such as carotene, vitamin C, and zinc, they can neutralize free radicals, reduce oxidative stress damage to eye tissues, improve the body's immune function, promote tear gland secretion, and maintain tear film stability. They are also beneficial for symptoms such as vision loss and dry eyes caused by liver and kidney yin deficiency.

[0036] Houttuynia cordata: Clears heat and detoxifies, antibacterial and anti-inflammatory. The volatile oils and flavonoids in Houttuynia cordata have significant anti-inflammatory effects, which can reduce eye inflammation. Its antibacterial properties help prevent or treat eye problems caused by bacterial infections, making it suitable for patients with dry eye syndrome accompanied by inflammation or infection symptoms.

[0037] Leonurus japonicus: It invigorates blood circulation and regulates menstruation, clears the liver and improves eyesight. It promotes blood circulation in the eyes, increases nutrient supply, and relieves eye fatigue and discomfort caused by blood stasis. It is suitable for dry eye syndrome caused by liver stagnation and fire or blood stasis.

[0038] Gentian root: Clears liver heat, promotes bile secretion and reduces jaundice, effectively clears liver fire, lowers eye temperature, and reduces redness, swelling and pain. The bitter components in gentian root have good anti-inflammatory and analgesic effects, which can quickly relieve acute eye discomfort, and are especially suitable for dry eye syndrome caused by excessive liver fire or damp-heat.

[0039] Scutellaria baicalensis: It clears heat and dries dampness, drains fire and detoxifies. The flavonoids it contains, such as baicalin, are powerful antioxidants that can fight free radicals and protect the cornea and conjunctiva from damage. Scutellaria baicalensis has broad-spectrum anti-inflammatory and antibacterial activities, which can effectively control eye inflammation and prevent secondary infections. It is suitable for various types of dry eye syndrome, especially those with significant inflammatory reactions.

[0040] Essential oil molecules and menthol can help open the gaps in the stratum corneum, improve drug absorption efficiency, and utilize the mobility of essential oil molecules to increase the speed at which drugs are absorbed by the body.

[0041] Low concentrations of menthol itself have anti-inflammatory properties, can act on facial nerves to promote tear secretion, and can protect against corneal epithelial damage. This is supported by research findings disclosed in patent applications such as CN117298073A and CN117883380A.

[0042] Jasmine essential oil has the following benefits:

[0043] ① Antibacterial and anti-inflammatory: Jasmine essential oil contains various bioactive components, such as parabens and citronellol, which can inhibit bacterial growth and reduce eye inflammation. ② Antioxidant: Rich in antioxidants, it helps neutralize free radicals and protects the eyes from oxidative stress damage. ③ Moisturizing and repairing: It promotes skin cell regeneration, helps maintain tear film stability, and reduces moisture evaporation. ④ Relieves eye discomfort: Through its anti-inflammatory and antibacterial properties, it can help reduce redness, pain, and itching caused by dry eye syndrome. ⑤ Enhances tear film quality: It improves the stability and durability of the tear film, reduces tear evaporation, and thus relieves dry eyes. ⑥ Promotes eye tissue repair: It accelerates the healing process of damaged corneal and conjunctival epithelial cells, improving overall eye health.

[0044] Lavender essential oil has the following benefits:

[0045] ① Sedative and anti-anxiety: Lavender essential oil is renowned for its excellent calming properties, effectively relieving tension and reducing stress. ② Anti-inflammatory and antibacterial: Possesses significant anti-inflammatory and antibacterial properties, preventing and treating eye problems caused by infection. ③ Promotes wound healing: Helps accelerate the recovery of skin and mucous membrane injuries, suitable for minor ocular surface trauma. ④ Reduces eye fatigue: Through its soothing and relaxing effects, it can relieve eye fatigue after prolonged screen time, improving comfort. ⑤ Reduces inflammatory response: Lowers the level of ocular inflammation caused by dry eye syndrome, preventing further deterioration of the condition. ⑥ Supports lacrimal gland function: Some studies suggest that lavender essential oil may help stimulate lacrimal gland secretion and increase tear production.

[0046] When jasmine and lavender essential oils are used together in moist chamber eye drops, they exhibit the following complementary effects: ① Comprehensive anti-inflammatory effect: Both possess strong anti-inflammatory capabilities, and their combined use can more comprehensively combat eye inflammation. ② Enhanced sensory experience: The unique aromas of the two essential oils work synergistically to create a relaxing and comfortable atmosphere, helping patients better accept treatment. ③ Enhanced moisturizing and repair: Together, they promote tear film stability and eye tissue repair, providing better long-term care for patients with dry eye syndrome. ④ Dilution ratio: Ensure the essential oils are adequately diluted to avoid irritation or allergic reactions from direct contact with the eyes; a concentration of no more than 0.1% is recommended.

[0047] Borneol, a natural dextrorotatory borneol, possesses strong transmembrane permeability, enabling deep drug delivery. It can form hydrogen bond networks with mucins, prolonging tear film adhesion time. Furthermore, borneol exhibits neuro-immunomodulatory effects, reducing pain and possessing good anti-inflammatory and antibacterial (e.g., against Staphylococcus aureus) activity, regulating ocular surface immune tolerance. During the acute phase of dry eye syndrome, a 0.05% borneol concentration is used; during the maintenance or preventative phase, a 0.02% borneol concentration can be used.

[0048] When used as a carrier oil, perilla oil is employed to dissolve jasmine essential oil, lavender essential oil, and menthol. Rich in alpha-linolenic acid (Omega-3 fatty acid) and other nutrients such as vitamin E and various minerals, perilla oil acts as an antioxidant, protecting the active ingredients in the herbal extracts. Its low volatility makes it primarily a base oil used to dilute highly volatile essential oils, slowing their evaporation and preventing excessively rapid evaporation and short duration of action, thus improving the storage stability of the composition and providing some moisturizing and anti-inflammatory effects. Nonionic emulsifiers are mainly used to increase the stability of the composition and prevent separation.

[0049] The essential oil-based wet chamber glasses for dry eye of this invention are highly flexible in their use. For example, the medicated solution can be combined with sponge balls, molecular sieves, absorbent paper, and washable cotton to make medicated pills or wipes, which can be used on the frame of a non-powered wet chamber glasses, greatly improving ease of use. Simply place the medicated pills or wipes into the reservoir of the frame (the frame also has a sealing ring extending towards the face around the eye socket). After the user wears the frame, the sealing ring around the lens contacts the skin around the eyes, forming a relatively sealed space. The reservoir is located inside the frame, within the sealed space, and the essential oil-based medicated solution in the reservoir naturally and slowly evaporates into small molecules, contacting the eyes and regulating dry eye symptoms. This mode is particularly suitable for people who use their eyes for long periods of time. The frame can be worn during afternoon naps, allowing the medicated solution to act on the eyes slowly and for a long time, promoting tear secretion, anti-inflammation, anti-oxidation, replenishing oils, and stabilizing the tear film. No electricity is required, there is no operating noise, and the frame is lighter and more comfortable than powered frames. The essential oil-based moisture chamber eye medication of this invention can also be used in combination with a powered moisture chamber eyeglass frame. The medication container of the powered moisture chamber eyeglass frame is equipped with ultrasonic, atomizing, or heating components. These components accelerate the release of essential oils, increase temperature, or refine molecules, promoting the opening of pores around the eyes and achieving a good drug delivery effect. Furthermore, the medication of this invention can be formulated into a paste-like form, similar to a lip balm. Using solid excipients, the composition can be made into a solid paste. When using it, first apply it around the eyes, then wear ordinary saline moisture chamber eyeglasses, heated eye masks, far-infrared / magnetic massagers, etc., to achieve the same conditioning effect on dry eye syndrome. Essential oils also have excellent skin-soothing properties, which can soothe the skin around the eyes, promote drug absorption, and the fragrance can improve the patient's mood and relieve anxiety.

[0050] The following describes the present invention and its technical effects in conjunction with preferred embodiments. Unless otherwise specified, "%" in the following embodiments refers to a percentage by mass.

[0051] Example 1

[0052] This embodiment provides an essential oil-based moisture chamber lens composition for dry eye syndrome, the preparation process of which is as follows:

[0053] (1) Preparation of aqueous extract of traditional Chinese medicine

[0054] Weigh out five medicinal herbs—wolfberry, houttuynia cordata, leonurus japonicus, gentian, and scutellaria baicalensis—in a mass ratio of 5:3:2:2:6. Clean them thoroughly, removing impurities and dust. Grind them through a 50-mesh sieve. Add 8 times the weight of the herbs in water and soak for 2 hours to allow the herbs to fully absorb water and swell. Pour the soaked herbs and soaking water into a decoction pot, bring to a boil over high heat, then simmer over low heat for 1.5 hours. Filter and collect the decoction, reserving the dregs. Add 6 times the weight of the herbs in water to the dregs again, bring to a boil over high heat, then simmer over low heat for 60 minutes. Filter and collect the decoction again. Combine the two decoctions, let stand overnight, and collect the supernatant. Concentrate the supernatant using a rotary evaporator or vacuum concentrator at ≤60℃ to obtain a liquid with a relative density of 1.15 at 25℃. Finely filter using a microporous membrane to remove residual solid particles and impurities, obtaining a clear aqueous extract of the traditional Chinese medicine. Sterilization was performed using gamma rays at a temperature of 4°C and an irradiation dose of 10 Gy; after sterilization, the product was stored at 4°C for later use.

[0055] (2) Preparation of the wet chamber mirror composition

[0056] The following formula was used to prepare an essential oil-based moisture chamber lens composition for dry eye, comprising 0.1% menthol, 0.05% jasmine essential oil, 0.05% lavender essential oil, 0.02% borneol, 4% perilla oil, 2% a mixture of Tween 80 and Span 80, with the remainder being a water extract of traditional Chinese medicine:

[0057] Menthol, jasmine essential oil, and lavender essential oil were added to perilla oil and ultrasonically treated for 30 minutes to obtain the oil phase. A nonionic emulsifier was added to the aqueous extract of the traditional Chinese medicine and stirred to obtain the aqueous phase. The oil phase was added to the aqueous phase, and the aqueous phase was continuously stirred at a speed of 1000 rpm until the addition was complete to obtain the essential oil-based dry eye moist chamber lens composition.

[0058] Example 2

[0059] This embodiment provides an essential oil-based moisture chamber lens composition for dry eye syndrome. The preparation process is the same as in Example 1, except that in step (1) of Example 1, when preparing the herbal extract, the ratio of Lycium barbarum, Houttuynia cordata, Leonurus japonicus, Gentiana scabra, and Scutellaria baicalensis is adjusted to 5:3:3:3:10. All other steps are the same as in Example 1.

[0060] Example 3

[0061] This embodiment provides an essential oil-based moisture chamber lens composition for dry eye syndrome. The preparation process is the same as in Example 1, except that in step (1) of Example 1, when preparing the aqueous extract of traditional Chinese medicine, the ratio of Lycium barbarum, Houttuynia cordata, Leonurus japonicus, Gentiana scabra, and Scutellaria baicalensis is adjusted to 8:2:2:2:5; at the same time, the composition ratio in step (2) is adjusted to: 0.1% menthol, 0.1% jasmine essential oil, 0.02% borneol, 4% perilla oil, 2% Tween 80, 1% Span 80, with the remainder being the aqueous extract of traditional Chinese medicine. All other steps are the same as in Example 1.

[0062] Example 4

[0063] This embodiment provides an essential oil-based wet chamber lens composition for dry eye syndrome. The preparation process of the aqueous extract is the same as in Example 1, except that the proportions of the composition in step (2) of Example 1 are adjusted as follows: 0.1% menthol, 0.1% lavender essential oil, 0.03% borneol, 4.5% perilla oil, 1% Tween 80, 2% Span 80, with the remainder being the aqueous extract of traditional Chinese medicine. All other steps are the same as in Example 1.

[0064] Comparative Example 1

[0065] This comparative example is an example in which the "perilla seed oil" component was removed from Example 1, and the portion of "perilla seed oil" removed was replenished with a Chinese herbal extract.

[0066] Comparative Example 2

[0067] This comparative example is an example in which "jasmine essential oil and lavender essential oil" were removed from Example 1, and the portion of "jasmine essential oil and lavender essential oil" was replenished using a Chinese herbal extract.

[0068] Comparative Example 3

[0069] This comparative example is an example in which the "menthol" component was removed from Example 1, and the portion of "menthol" removed was replenished with a Chinese herbal extract.

[0070] The efficacy of the above compositions in promoting tear secretion in patients with dry eye was compared through experiments.

[0071] 1. Animal experiments

[0072] Because mice are too small to easily create a suitable wet chamber microscope, larger New Zealand white rabbits were used for the experiment. Male New Zealand white rabbits (2.5±0.2 kg) were used to create a dry eye model, while the wet chamber microscope treatment served as a positive control. Drug administration was performed using an ultrasonic nebulizer wet chamber microscope. 10 mL of each drug mixture was placed in the wet chamber microscope's water tank. The wet chamber microscope was specially customized to fit the facial contours of the New Zealand white rabbits, ensuring a good fit between the treatment chamber and the area around the rabbit's eyes. The experimental methods are as follows:

[0073] (1) Grouping and processing of experimental animals

[0074] The dry stress environment chamber was set to constant temperature (24±2℃), constant humidity (30±5%), and constant wind speed (2.5±0.5km / s). Fifty-four healthy New Zealand white rabbits were randomly divided into the following groups, with six rabbits in each group:

[0075] Healthy white rabbit control group (physiological saline was used for modeling, and 4% perilla oil, 2% nonionic emulsifier and pure water were used for treatment);

[0076] The control group (after modeling, the treatment consisted of 4% perilla oil, 2% nonionic emulsifier, and pure water);

[0077] Experimental drug group 1 (using the composition of Example 1 after modeling);

[0078] Two groups of experimental drugs (using the composition from Example 2 after modeling);

[0079] Three groups of experimental drugs (using the composition from Example 3 after modeling);

[0080] Four groups of experimental drugs (the composition of Example 4 was used after modeling);

[0081] Comparative drug group 1 (using the composition of Comparative Example 1 after modeling);

[0082] Two groups of drugs were compared (the two groups were used as comparative example 2 after modeling);

[0083] Three groups of drugs were compared (the three comparative sample groups were used after modeling);

[0084] In the healthy white rabbit control group, 1 mL of physiological saline was subcutaneously injected into the hind limbs four times daily (8:00, 12:00, 16:00, and 20:00) during the day, and the rabbits were kept in a normal environment with a relative humidity of 55% ± 10% for 5 consecutive days, for a total of 10 days. In other groups besides the healthy white rabbit control group, 1 mL of 2.5 mg / mL scopolamine solution was subcutaneously injected into the hind limbs four times daily (8:00, 12:00, 16:00, and 20:00) per rabbit each time, and the rabbits were kept in a dry stress environment for a total of 10 consecutive days. During modeling, each group received 10 mL of medication through a wet chamber microscope customized according to the facial contours of New Zealand white rabbits, wearing the microscope for 10 minutes each time, three times daily. After successful modeling in the healthy control group and blank group, 4% perilla oil, 2% nonionic emulsifier, and pure water were administered through the wet chamber microscope three times daily for 10 minutes each time. Thirty minutes after the last administration after 10 days, various indicators of the rabbits in each group were measured.

[0085] (2) Measurement of tear secretion

[0086] Phenolic red cotton thread is a commonly used indicator for detecting tear secretion. The length of time the phenolic red cotton thread turns red can quantify the tear secretion of rabbits. Tear secretion was measured in each group of rabbits on day 10 of the modeling process. Simultaneously, under gas anesthesia, the lower eyelid of the rabbit was gently pulled up with ophthalmic forceps, and a phenolic red cotton thread was inserted into the inner side of the inferior conjunctival fornix. After 20 seconds, the thread was removed, and the length of the reddened cotton thread was measured and recorded using a ruler.

[0087] (3) Fluorescein staining

[0088] The corneal epithelial barrier function was observed using corneal fluorescein staining. New Zealand white rabbits were anesthetized with gas, and then 4 μL of 0.25% sodium fluorescein staining solution was applied topically to the cornea. After five manual blinks, the cornea was rinsed with 1 mL of physiological saline using a 1 mL syringe, and gross photography was performed under cobalt blue light using a slit microscope. For fluorescein staining grading, the cornea was divided into four quadrants, and each quadrant was scored. The four scores were added together to obtain the final score for each eye (minimum value 0, maximum value 16). The fluorescein scores for each quadrant were as follows: none, 0; mild punctate staining (less than 30 spots), 1; dense punctate staining (more than 30 spots), 2; severe diffuse staining, no positive patches, 3; fluorescein-positive patches, 4.

[0089] Ten days after modeling, sodium fluorescein was dropped onto the ocular surface of the rabbits, and then macroscopic photographs were taken under a slit lamp using cobalt blue light. The photographs were then clinically scored.

[0090] (4) Experimental Results

[0091] Depend on Figure 1It can be seen that the tear secretion volume in the healthy rabbit control group remained almost unchanged before and after drug administration, ranging from approximately 12.0 mm before modeling to 12.5 mm after drug administration. In contrast, the blank group, after modeling with scopolamine solution, was treated with a blank solvent (4% perilla oil, 2% nonionic emulsifier, and pure water). After treatment, the tear secretion volume decreased to below 6 mm, indicating that scopolamine injection leads to a decrease in tear secretion in fresh rabbits, thus creating a dry eye model. After treatment with experimental drug 1, tear secretion volume increased to approximately 11 mm. Furthermore, experimental drug groups 2, 3, and 4 all increased tear secretion volume in New Zealand white rabbits by 10.8-11.1 mm. Although the tear secretion volume recovered to the level of healthy rabbits before modeling, it was close to the level of healthy rabbits. After treatment with drugs 1 to 3, although the control group could also restore the tear secretion of rabbits to some extent, there was still a large gap compared with the tear secretion of healthy rabbits before modeling. This indicates that the drugs 1 to 3 had a slower effect on the tear recovery of the dry eye model.

[0092] Depend on Figure 2 It can be seen that the corneal fluorescein score of the blank control group increased (12.78±2.64 vs 0.62±0.24), meaning that the corneal fluorescein score before modeling was 0.62±0.24, and after modeling it increased to 12.78±2.64, indicating that modeling caused significant corneal epithelial damage in the animal models. After administration of the blank solvent to healthy control rabbits, the corneal epithelial score was not different from that before the experiment. In contrast, after 10 days of treatment, the corneal fluorescein staining scores of the animal models in each experimental drug treatment group decreased to 50-60% of the average score after modeling. The corneal fluorescein staining scores of the control drug groups 1-3 also decreased to some extent after treatment, by about 20-30%, indicating that control drugs 1-3 also had a role in reducing the degree of corneal damage in the animal models and had a restorative effect on corneal function, but its restorative effect was not as good as that of the experimental drug groups 1-4.

[0093] Furthermore, after administration of the compositions provided by this invention, no rabbits were observed scratching their eyes with their forepaws, indicating that the moisture chamber microscope compositions have no significant irritant properties and low eye irritation. In contrast, during administration of the control group 1, the rabbits appeared quite anxious, possibly due to the rapid release of the essential oils causing some eye irritation.

[0094] (5) Experimental Conclusion

[0095] Based on the above experimental results, it can be seen that the wet chamber mirror composition provided by the present invention can significantly promote tear secretion in rabbits with dry eye syndrome, and has good mildness.

[0096] 2. Subject experimental testing

[0097] Recruiting participants with dry eye syndrome. Inclusion criteria: (1) Fully understanding of this study and signing informed consent; (2) Age > 18 years, regardless of gender; (3) Subjective symptoms including dry eyes, foreign body sensation, burning sensation, fatigue, discomfort, redness, or fluctuating vision; (4) Schirmer tear secretion measured the day before the study, and participants with Schirmer tear secretion less than 5 mm / 5 min were included in the study. At the start of the study, participants were randomly divided into the following groups, 4 participants per group.

[0098] After grouping, each subject was administered medication using a dual-vibration ultrasonic nebulizer in a wet chamber (see CN118634081A for the structure of the wet chamber). 20 mL of each medication composition was placed in the wet chamber's water tank. After wearing the wet chamber, the subject activated the ultrasonic nebulizer to atomize the medication and deliver it into the treatment chamber. Eye sensations were recorded for each subject 10 minutes after application. Subjects in each group were randomly divided into two subgroups of two. Schirmer tear secretion was measured at 5 and 30 minutes after application. Simultaneously, subjects rated their compliance 30 minutes after medication administration.

[0099] Schirmer tear secretion value is an important indicator of eye comfort after treatment in dry eye patients. Clinically, it is generally considered that if the Schirmer tear secretion value reaches the normal value (i.e., Schirmer tear secretion value >15mm) 5 minutes after drug administration and the Schirmer tear secretion value is >10mm 30 minutes after drug administration, then the patient's eyes will have good comfort after treatment.

[0100] The rating criteria are as follows: 1 point (no irritation); 2 points (slightly irritating but acceptable); 3 points (irritating); 4 points (strong irritation, burning sensation, but no pain); 5 points (strong irritation, pain). An average score of 1 to 2 points (inclusive) indicates good compliance. Below 2 points, the lower the score, the better the compliance. An average score of 2 to 5 points (excluding 2 points) indicates poor compliance. The higher the score, the worse the compliance.

[0101] The experimental results are as follows:

[0102] Following the experimental method described above, Schirmer's tear secretion was measured after a certain period of time following drug administration, and the results are shown in Table 1 below.

[0103] Table 1. Tear secretion values ​​in the experimental group (*P<0.05 compared with before the experiment)

[0104] Group Before the experiment (n=4) 5 minutes after administration (n=2) 30 minutes after administration (n=2) Compliance score (n=4) Blank drug group 1.6±0.3 1.6±0.6 1.6±0.8 1 Experimental drug group 1 1.6±0.7 30.4±0.6* 17.5±0.7* 1 Experimental drug group 2 1.6±0.3 29.5±2.3* 17.1±1.2* 1 Experimental drug group 3 1.6±0.5 29.8±2.2* 17.3±2.2* 1 4 groups of experimental drugs 1.6±0.4 29.2±1.1* 16.9±1.4* 1 Comparison drug group 1 1.6±0.2 27.4±2.1* 14.1±1.5* 1.5 Comparison of drug groups 2 1.6±0.5 26.5±1.4* 13.8±1.2* 1 Comparison of 3 drug groups 1.6±0.6 24.7±1.6* 12.3±1.4* 1

[0105] The above experimental results show that the wet chamber mirror composition provided by the present invention can effectively promote tear secretion in subjects and the drug is mild. However, although the control drug group 1 also has a good effect on promoting tear secretion, the essential oil evaporates too quickly after wearing the wet chamber mirror, resulting in a high concentration of essential oil in a short period of time, which makes the subject experience poor and compliance low. Furthermore, the essential oil molecules are very small and easily escape, which cannot prolong the duration of action, making the effect of promoting tear secretion less than that of the experimental drug groups of the present invention.

[0106] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features. These modifications or substitutions, or combinations of technical features in the above embodiments that do not conflict with each other, can be made in accordance with the manner described in the embodiments. These modifications, substitutions or combinations do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. An essential oil-based moisture chamber lens composition for dry eye, characterized in that, The composition includes, by mass percentage: 0.1-0.30% menthol, 0.05-0.10% mild essential oil, 0.01-0.05% borneol, 3-5% perilla oil, 1-4% nonionic emulsifier, with the remainder being a water extract of traditional Chinese medicine; the mild essential oil is at least one of jasmine essential oil and lavender essential oil; the water extract of traditional Chinese medicine is an extract of wolfberry, houttuynia cordata, leonurus japonicus, gentian, and scutellaria baicalensis, with a relative density of 1.10-1.15 at 25°C; the dry weight ratio of the five medicinal materials (wolfberry, houttuynia cordata, leonurus japonicus, gentian, and scutellaria baicalensis) in preparing the water extract of traditional Chinese medicine is 5-10:2-4:2-4:2-4:5-10.

2. The essential oil-based moisture chamber lens composition for dry eye according to claim 1, characterized in that, The nonionic emulsifier is Tween 80 or Span 80 or a mixture of Tween 80 and Span 80.

3. The essential oil-based moisture chamber lens composition for dry eye according to claim 1, characterized in that, The method for preparing the aqueous extract of the traditional Chinese medicine is as follows: S1. Thoroughly clean the medicinal herbs wolfberry, houttuynia cordata, leonurus japonicus, gentian and scutellaria baicalensis to remove impurities and dust, and pulverize them through a 50-mesh sieve. S2. Soak the herbs in 8-10 times their weight of water for 1-2 hours to allow them to fully absorb water and swell. Pour the soaked herbs and soaking water into a decoction pot, bring to a boil over high heat, then simmer over low heat for 1.5-2 hours. Filter and collect the decoction, and keep the dregs for later use. S3. Add 6-8 times the amount of the medicinal material to the dregs and water again. Bring to a boil over high heat, then simmer over low heat for 50-70 minutes. Filter and collect the decoction again. S4. Combine the two decoctions, let stand overnight, take the supernatant, and concentrate it at ≤60°C using a rotary evaporator or vacuum concentrator to obtain a decoction with a relative density of 1.10-1.15 at 25°C. S5. Fine filtration removes residual solid particles and impurities, yielding a clear aqueous extract of traditional Chinese medicine.

4. The essential oil-based moisture chamber lens composition for dry eye according to claim 3, characterized in that, In S5, fine filtration is achieved using a sand core funnel or microporous membrane filtration.

5. The essential oil-based moisture chamber lens composition for dry eye according to claim 3, characterized in that, S5 also includes a step of sterilizing the aqueous extract of traditional Chinese medicine. The sterilization method is as follows: sterilization is carried out by gamma rays at a temperature of 2-10℃ and an irradiation dose of 9-15Gy. After sterilization, it is stored at 2-8℃ for later use.

6. The essential oil-based moisture chamber lens composition for dry eye according to claim 1, characterized in that, The preparation method of the essential oil-based dry eye moist chamber lens composition is as follows: menthol, borneol, and mild essential oil are added to perilla oil and mixed by stirring or ultrasonic treatment to obtain the oil phase; a nonionic emulsifier is added to the aqueous extract of traditional Chinese medicine and stirred to obtain the aqueous phase; the oil phase is added to the aqueous phase, and the aqueous phase is continuously stirred during the addition process until the addition is complete to obtain the essential oil-based dry eye moist chamber lens composition.

7. The essential oil-based moisture chamber lens composition for dry eye according to claim 1, characterized in that, The essential oil-based dry eye moist chamber lens composition comprises: 0.1% menthol, 0.05% jasmine essential oil, 0.05% lavender essential oil, 4% perilla oil, 0.02% borneol, 2% nonionic emulsifier, and the remainder is a traditional Chinese medicine aqueous extract; the relative density of the traditional Chinese medicine aqueous extract at 25°C is 1.15; the dry weight ratio of the five medicinal materials, namely wolfberry, houttuynia cordata, leonurus japonicus, gentian, and scutellaria baicalensis, is 5:3:2:2:

6.

8. A moisture chamber eyepiece for relieving dry eye syndrome, comprising a frame and a receiving groove disposed on the frame, characterized in that, It also includes the essential oil-based dry eye moist chamber lens composition according to any one of claims 1-7 and a carrier, wherein the carrier is a solid material with adsorption function.

9. A cream for relieving dry eye syndrome, characterized in that, It is an ointment made using the essential oil-based dry eye moist room lens composition according to any one of claims 1-7 and ointment excipients.

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