Essential oil type xerophthalmia wet chamber mirror composition, wet chamber mirror device and ointment

Abstract

The invention relates to the technical field of ophthalmic disease treatment, in particular to an essential oil type xerophthalmia wet chamber lens composition, which is prepared from the following components in percentage by mass: 0.1 to 0.30 percent of menthol, 0.05 to 0.10 percent of mild essential oil, 0.01 to 0.05 percent of borneol, 3 to 5 percent of perilla oil, 1 to 4 percent of nonionic emulsifier and the balance of 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 a water extract of fructus lycii, herba houttuyniae, fructus leonuri, radix gentianae and radix scutellariae, and the relative density of the traditional Chinese medicine water extract at 25 DEG C is 1.10-1.15. According to the invention, a medicine formula is designed, and mild essential oil is used for carrying medicines, so that the wet chamber mirror liquid medicine which is better in curative effect of the medicine formula, easier to atomize and better in transdermal absorption effect is prepared, the treatment effect on xerophthalmia is remarkably improved, and the use effect and convenience of the wet chamber mirror are improved. The invention also provides a wet chamber mirror device and paste containing the essential oil type dry eye wet chamber mirror composition.

Description

Technical Field

[0001] The present invention relates to the technical field of ophthalmic disease treatment, and particularly relates to an essential oil-based dry eye moisture chamber goggles composition, a moisture chamber goggles device, and an ointment. Background Art

[0002] Dry eye moisture chamber goggles (Moisture Chamber Goggles or Dry Eye Relief Glasses) are special glasses designed specifically to relieve dry eye symptoms. They help keep the surface of the eyes moist by creating a tiny moist environment, reducing tear evaporation, and thus alleviating the discomfort caused by dry eye. For example, CN118634081A discloses a double-vibration ultrasonic atomizing moisture chamber goggles, and CN113332036A discloses a liquid medicine and cotton for a moisture chamber goggles and a moisture chamber goggles. CN118717406A discloses a moisture chamber goggles with dual functions of vacuum magnetic attraction connection.

[0003] The structures of moisture chamber goggles are generally the same. Generally, there is a special liquid medicine storage cavity and a device for driving the atomization of the liquid medicine. This device is generally an ultrasonic vibration, spraying device, or heating device, which enables the liquid medicine to enter the moisture chamber goggles to form a medicine mist. The drug remains in contact with the eyes for a long time, keeping the eyes moist and achieving the drug delivery effect. The curative effect of moisture chamber goggles mainly depends on the liquid medicine. Among them, the liquid medicine for moisture chamber goggles disclosed in CN113332036A is composed of water extracts of 3-8 parts of mint, 8-15 parts of cassia seed, 5-20 parts of honeysuckle flower, 8-20 parts of buddleja flower, 8-15 parts of sophora flavescens, 10-20 parts of chrysanthemum flower, and 10-20 parts of mugwort leaf. This liquid medicine is a pure water extract with poor volatility and requires a nebulizer or ultrasonic device with a relatively high power for treatment and atomization, making the moisture chamber goggles device consume more power and requiring connection to the mains power or the use of a battery with a relatively high battery life for driving. Even after the liquid medicine is atomized, since the water extract is mainly a hydrophilic substance, its ability to penetrate the skin by contact is poor, and the running effect of the drug molecules in the body is not good. These all affect the drug absorption rate and absorption speed, resulting in a poor treatment effect of the moisture chamber goggles on dry eye. This is mainly because hydrophilic substances are usually difficult to penetrate the skin or stratum corneum. Even if these substances are atomized through the moist environment formed by the moisture chamber goggles, they are difficult to effectively penetrate into the eye tissues. In addition, the design of the drug formula is also a key factor determining the treatment effect of moisture chamber goggles on dry eye. Summary of the Invention

[0004] (I) Technical Problems to be Solved

[0005] In view of the above-mentioned disadvantages and deficiencies of the prior art, the present invention provides an essential oil-based wet chamber mirror composition for dry eye. By designing the drug formula and using mild essential oils with strong penetration power to carry the drug, a wet chamber mirror liquid medicine with better drug formula efficacy, easier atomization, and better transdermal absorption effect is prepared, thereby significantly improving the curative effect on dry eye and enhancing the efficacy and convenience of using the wet chamber mirror, so as to solve the technical problems such as poor effect of the existing wet chamber mirror liquid medicine formula, difficult atomization, and poor transdermal absorption effect.

[0006] (II) Technical solution

[0007] The present invention provides an essential oil-based wet chamber mirror composition for dry eye, which includes, by mass percentage: menthol 0.1 - 0.30%, 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 the aqueous extract of traditional Chinese medicine; the mild essential oil is at least one of jasmine essential oil and lavender essential oil; the aqueous extract of traditional Chinese medicine is the aqueous extract of Chinese wolfberry, houttuynia cordata, motherwort, gentian, and scutellaria baicalensis, and its relative density at 25°C is 1.10 - 1.15.

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

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

[0010] S1. Thoroughly clean the Chinese wolfberry, houttuynia cordata, motherwort, gentian, and scutellaria baicalensis, remove impurities and dust, and crush them through a 50-mesh sieve.

[0011] S2. Add 8 - 10 times the mass of the medicinal materials of water and soak for 1 - 2 h to make the medicinal materials fully absorb water and swell. Pour the soaked medicinal materials together with the soaking water into a decocting pot, bring to a boil over high heat and then turn to low heat and simmer for 1.5 - 2 h, filter and collect the decoction, and reserve the medicinal residues.

[0012] S3. Add 6 - 8 times the mass of the medicinal materials of water to the medicinal residues again, bring to a boil over high heat and then turn to low heat and simmer for 50 - 70 min, and filter and collect the decoction again.

[0013] S4. Combine the two decoctions, let it stand overnight, take the supernatant, and use a rotary evaporator or vacuum concentration equipment to concentrate at ≤60°C to obtain a liquid medicine with a relative density of 1.10 - 1.15 at 25°C.

[0014] S5. Fine filter to remove residual solid particles and impurities to obtain 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 filter membrane.

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

[0017] According to a preferred embodiment of the present invention, in S1, when preparing the traditional Chinese medicine aqueous extract, the dry weight ratio of the four medicinal materials of wolfberry fruit, houttuynia herb, motherwort fruit, gentian root and scutellaria root 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 of wolfberry fruit, houttuynia herb, motherwort fruit, gentian root and scutellaria root is 5:3:2:2:6.

[0019] According to a preferred embodiment of the present invention, the essential oil type dry eye wet room mirror composition is prepared according to the following steps: adding menthol, borneol and mild essential oil to perilla oil, and mixing evenly by stirring or ultrasonic treatment to obtain an oil phase; adding a non-ionic emulsifier to the traditional Chinese medicine aqueous extract, and stirring and mixing evenly to obtain a water phase; adding the oil phase to the water phase, and continuously stirring the water phase during the adding process until it is completely added to obtain the essential oil type dry eye wet room mirror composition.

[0020] According to a preferred embodiment of the present invention, it contains: 0.1% menthol, 0.05% jasmine essential oil, 0.05% lavender essential oil, 4% perilla oil, 0.02% borneol, 2% non-ionic emulsifier, and the balance is the 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 of wolfberry fruit, houttuynia herb, motherwort fruit, gentian root and scutellaria root is 5:3:2:2:6.

[0021] In a second aspect, the present invention also provides a wet room mirror device for relieving dry eye, which includes a frame and a receiving groove provided on the frame, and it further includes the essential oil type dry eye wet room mirror composition and a carrier according to any one of the above embodiments. The carrier is a solid material with an adsorption function. The carrier is a material in the form of a sheet, block, pill shape, granule, powder, etc., for example, including but not limited to any one of absorbent paper, absorbent cotton, sponge, porous gel, molecular sieve pellets, diatomaceous earth pellets, activated carbon particles and bentonite particles, etc.; when the particle size of the solid material is too small, such as when using a powder material, it can also be made into a "small tea bag" form using a non-woven fabric bag.

[0022] When using the wet chamber glasses device of the present invention, the carrier can be placed in the receiving groove of the spectacle frame, and a certain amount of the essential oil type dry eye wet chamber glasses composition is dropped onto the carrier, then the spectacle frame can be worn on the patient's eye for dry eye treatment; alternatively, when the product leaves the factory, the essential oil type dry eye wet chamber glasses composition has been adsorbed by the carrier, and the carrier adsorbed with the medicinal solution is packaged as a separate product. When in use, open the sealed bag or sealed box, take out one piece or one granule and place it in the receiving groove of the spectacle frame, then the spectacle frame can be worn on the patient's eye for dry eye treatment.

[0023] In a third aspect, the present invention also provides an ointment for relieving dry eye, which is a paste made of the essential oil type dry eye wet chamber glasses composition and ointment adjuvants. When in use, the ointment can be first applied around the eyes, and then used in combination with the wet chamber glasses device of the present invention or an ordinary wet chamber glasses (such as a physiological saline wet chamber glasses), or can also be used in combination with health care instruments, such as a facial massager that can emit far infrared rays, perform massage, magnetic therapy, etc. to improve microcirculation.

[0024] (III) Beneficial effects

[0025] The present invention designs the drug formula, and the drug formula includes wolfberry fruit, houttuynia cordata, leonurus japonicus, gentiana scabra, and scutellaria baicalensis; among them, wolfberry fruit nourishes the liver and kidneys, improves eyesight and removes nebula; houttuynia cordata and scutellaria baicalensis are used for clearing heat and detoxifying, dispersing wind and heat; leonurus japonicus clears the liver and improves eyesight, cools blood and stops bleeding. The combination of the foregoing medicinal materials is used for treatment by methods such as nourishing the liver and kidneys, nourishing blood and improving eyesight, dispersing wind and heat, etc., so as to improve dry eye caused by factors such as liver-kidney yin deficiency, qi-blood deficiency, and exogenous wind-heat.

[0026] The present invention uses mild essential oils with low content and strong penetration power, such as jasmine essential oil and / or lavender essential oil, etc., for drug loading. The essential oils have low boiling points, which is beneficial for the rapid volatilization of drugs in the wet room mirror and their action on the eyes, reducing the power consumption of the wet room mirror, prolonging the usage time after each battery charge, and improving the convenience of use. The composition of the present invention can be used in wet room mirror devices by means of ultrasound, atomization or heating, etc., or can also adopt a non-powered wet room mirror device; when the essential oil molecules diffuse, the small water-soluble drug molecules carry the essential oil molecules, making the small water-soluble molecules also have a certain lipophilicity and improving the transdermal absorption ability of the small water-soluble molecules. The essential oil molecules and menthol, etc. can help open the gaps in the stratum corneum, improve the drug absorption efficiency, and utilize the running property of the essential oil molecules to increase the speed of drug absorption by the body. Low-concentration menthol itself has the effects of promoting tear secretion and protecting the damaged cornea. Controlling the menthol concentration at 0.1-0.30% can reduce its irritation to the eyes, making the composition milder and safer. The cooling property of borneol helps to quickly relieve eye fatigue and discomfort, bring immediate comfort to dry eye patients, and provide antibacterial, anti-inflammatory and blood circulation promoting effects. Moreover, borneol also serves as a transdermal absorption enhancer, helping other active ingredients to better penetrate into the eye tissues and improving the treatment effect. The combination of borneol and essential oils can greatly promote the absorption and utilization rate of each component in the liquid medicine.

[0027] Among them, when perilla oil is used as a carrier oil, it is not easy to volatilize. It mainly serves as a base oil for dissolving and diluting highly volatile essential oils (jasmine essential oil, lavender essential oil, menthol and borneol), slowing down the volatilization rate of the essential oils, avoiding the too-fast volatilization of the essential oils, improving the storage stability of the composition, and providing certain moisturizing and anti-inflammatory effects.

[0028] The mild essential oils used in the present invention are at least one of jasmine essential oil and lavender essential oil. These two essential oils not only have soothing and anti-inflammatory properties, but also provide psychological relaxation effects. Specifically, jasmine essential oil has antibacterial, anti-inflammatory, antioxidant, moisturizing and repairing effects, relieves eye discomfort, enhances the quality of the tear film, promotes the repair of eye tissues, accelerates the healing process of damaged corneal and conjunctival epithelial cells, and improves overall eye health. Lavender essential oil has sedative and anti-anxiety, anti-inflammatory and antibacterial, promotes wound healing, relieves eye fatigue, reduces inflammatory reactions, supports the function of the lacrimal gland and other effects. Some studies have shown that lavender essential oil may help stimulate the secretion of the lacrimal gland and increase tear production. The two essential oils are added to the wet chamber lens composition at a low concentration, and there are complementary effects between them, such as comprehensive anti-inflammatory effects, enhancing the sensory experience, and strengthening moisturizing and repair. The general concentration of essential oils used on the skin is 0.5-2%. In this application, the concentration of the essential oil is controlled below 0.10%, which can make the wet chamber lens composition more mild, reduce the irritation of the essential oil to the eyes, and exert its effect of increasing transdermal absorption.

[0029] In summary, the present invention prepares a wet chamber lens liquid medicine with better curative effect, easier atomization and better transdermal absorption effect, thereby significantly improving the curative effect on dry eye and enhancing the efficacy and convenience of using the wet chamber lens. Brief Description of the Drawings

[0030] Figure 1 It shows the tear secretion of the animal models in each experimental drug group and the control drug group before and after drug administration in the animal experiment.

[0031] Figure 2 It shows the corneal fluorescein sodium scores of the animal models in each experimental drug group and the control drug group before and after drug administration in the animal experiment. Detailed Embodiments

[0032] In order to better explain the present invention for easy understanding, the present invention will be described in detail below with reference to the accompanying drawings and through specific embodiments.

[0033] Aiming at the problems of poor volatility, difficult atomization, poor transdermal absorption of hydrophilic substances and poor drug penetration effect of the wet chamber lens liquid medicine being pure water extract in the prior art, the present invention provides an essential oil type dry eye wet chamber lens composition, which includes 0.1-0.30% of menthol, 0.05-0.10% of mild essential oil, 0.01-0.05% of borneol, 3-5% of perilla oil, 1-4% of non-ionic emulsifier, 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 the water extract of wolfberry fruit, houttuynia cordata, motherwort, gentiana scabra and scutellaria baicalensis, and its relative density at 25 °C is 1.10-1.15.

[0034] Among them, the traditional Chinese medicine aqueous extract is made from wolfberry fruits, houttuynia cordata, leonurus japonicus, gentiana scabra, and scutellaria baicalensis. Among them, wolfberry fruits, houttuynia cordata, leonurus japonicus, gentiana scabra, and scutellaria baicalensis; among them, wolfberry fruits nourish the liver and kidneys, improve eyesight and remove nebula; houttuynia cordata and scutellaria baicalensis are used for clearing heat and detoxifying, dispersing wind and heat; leonurus japonicus clears the liver and improves eyesight, cools blood and stops bleeding. The combination of the aforementioned medicinal materials is used for treatment by methods such as nourishing the liver and kidneys, nourishing blood and improving eyesight, and dispersing wind and heat, so as to improve dry eye caused by factors such as liver-kidney yin deficiency, qi and blood deficiency, and exogenous wind-heat. Specifically,

[0035] Wolfberry fruits: Rich in various antioxidant components such as carotene, vitamin C, and zinc, etc., which can neutralize free radicals, reduce the damage of oxidative stress to eye tissues, improve the body's immune function, promote lacrimal gland secretion, and maintain the stability of the tear film, for symptoms such as vision loss and dry eyes caused by liver-kidney yin deficiency.

[0036] Houttuynia cordata: Clears heat and detoxifies, antibacterial and anti-inflammatory. The volatile oil and flavonoid substances in houttuynia cordata have significant anti-inflammatory effects, which can reduce the eye inflammation reaction. Its antibacterial property helps prevent or treat eye problems caused by bacterial infections, and is suitable for dry eye patients with inflammatory or infectious symptoms.

[0037] Leonurus japonicus: Promotes blood circulation and regulates menstruation, clears the liver and improves eyesight, promotes blood circulation in the eyes, increases nutrient supply, and relieves eye fatigue and discomfort caused by blood stasis, and is suitable for dry eye of liver depression transforming into fire or blood stasis type.

[0038] Gentiana scabra: Clears the liver and purges fire, promotes bile drainage and reduces jaundice, effectively clears the hyperactivity of liver fire, reduces the eye temperature, and relieves swelling and pain. The bitter components in gentiana scabra have good anti-inflammatory and analgesic effects, and can quickly relieve acute eye discomfort, and are especially suitable for dry eye of exuberant liver fire or dampness-heat accumulation type.

[0039] Scutellaria baicalensis: Clears heat and dries dampness, purges fire and detoxifies. The flavonoid compounds such as baicalin contained in it are powerful antioxidants, which can fight against free radicals and protect the cornea and conjunctiva from damage. Scutellaria baicalensis has broad anti-inflammatory and antibacterial activities, can effectively control eye inflammation and prevent secondary infections, and is suitable for various types of dry eye, especially for cases with obvious inflammatory reactions.

[0040] Essential oil molecules and menthol, etc. can help open the gaps in the stratum corneum, improve the drug absorption efficiency, and utilize the penetration property of essential oil molecules to increase the speed of drug absorption by the body.

[0041] Low-concentration menthol itself has anti-inflammatory effects, acts on the facial nerve to promote tear secretion and protect the damaged corneal epithelium. For example, the research conclusions disclosed in patent applications such as CN117298073A and CN117883380A.

[0042] Jasmine Essential Oil has the following effects:

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

[0044] Lavender Essential Oil has the following effects:

[0045] ① Sedative and anti-anxiety: Lavender essential oil is famous for its excellent sedative effect, which can effectively relieve tension and reduce stress. ② Anti-inflammatory and antibacterial: It has significant anti-inflammatory and antibacterial properties and can prevent and treat eye problems caused by infections. ③ Promotes wound healing: Helps to accelerate the recovery of skin and mucosal injuries and is suitable for minor ocular surface traumas. ④ Reduces eye fatigue: Through its soothing and relaxing effects, it can relieve eye fatigue after long-term use of the eyes and improve comfort. ⑤ Reduces inflammatory responses: Lowers the level of eye inflammation caused by dry eye and prevents the condition from worsening. ⑥ Supports the function of the lacrimal gland: Some studies suggest that lavender essential oil may help stimulate the secretion of the lacrimal gland and increase tear production.

[0046] When jasmine essential oil and lavender essential oil are jointly applied to the wet chamber lens solution, there are the following complementary effects: ① Comprehensive anti-inflammatory effect: Both have strong anti-inflammatory capabilities, and their combined use can more comprehensively combat eye inflammation. ② Enhances the sensory experience: The unique aromas of the two essential oils can synergistically create a relaxing and comfortable atmosphere, which helps patients better accept treatment. ③ Strengthens moisturizing and repair: Jointly promotes tear film stability and eye tissue repair, providing better long-term care for dry eye patients. ④ Dilution ratio: Ensure that the essential oil is fully diluted to avoid irritation or allergic reactions caused by direct contact with the eyes. It is recommended that the essential oil concentration does not exceed 0.1%.

[0047] Borneol is a natural dextrorotatory borneol with strong transmembrane permeability, enabling deep drug delivery. Borneol can form a hydrogen bond network with mucin, prolonging the adhesion time of the tear film. In addition, borneol also has a neuro-immune regulatory effect, which can reduce pain and has good anti-inflammatory and antibacterial effects (such as Staphylococcus aureus), regulating ocular surface immune tolerance. In the acute stage of dry eye, a 0.05% borneol concentration is used, and in the maintenance or prevention period, a 0.02% borneol concentration can be used.

[0048] When used as a carrier oil, perilla oil dissolves jasmine essential oil, lavender essential oil, and menthol. Rich in α-linolenic acid (an omega-3 fatty acid), as well as other nutrients like vitamin E and various minerals, perilla oil acts as an antioxidant, protecting the active ingredients in traditional Chinese medicine extracts. Furthermore, perilla oil is nonvolatile and primarily serves as a base oil for diluting highly volatile essential oils, slowing their evaporation and preventing them from volatilizing too quickly and resulting in a short duration of action. This improves the storage stability of the composition and provides a certain degree of moisturizing and anti-inflammatory effects. Nonionic emulsifiers are primarily used to increase the stability of the composition and prevent stratification.

[0049] The essential oil-based dry eye wet-room goggles of the present invention are highly flexible in their use. For example, the drug solution can be combined with sponge balls, molecular sieves, absorbent paper, or water-washing cotton to form drug-containing pills or wet wipes. These can then be used in a non-powered wet-room goggles frame, greatly improving ease of use. Simply place the drug-rich pills or wet wipes into a receptacle in the frame (the frame also includes a sealing ring extending toward the face, corresponding to the eye socket). When the user wears the frame, the sealing ring surrounding the lens contacts the skin around the eye, forming a relatively sealed space. The receptacle is located inside the frame, within the sealed space. The essential oil-based drug solution in the receptacle naturally and slowly evaporates into small molecules, which contact the eye and provide a conditioning effect on dry eye. This mode is particularly suitable for those who use their eyes for a long time. The frame can be worn during naps, allowing the drug solution to slowly and long-term act on the eye, promoting tear secretion, providing anti-inflammatory and antioxidant benefits, replenishing oils, and stabilizing the tear film. The frame requires no electricity and is silent, and the frame is lighter and more comfortable than powered frames. The essential oil-based dry eye immersion lens solution of the present invention can also be used in combination with a powered immersion lens frame. The immersion lens frame's immersion lens reservoir is equipped with ultrasonic, atomizing, or heating components. These components accelerate the release of the essential oil, increase the temperature, or refine the molecules, promoting the opening of pores around the eyes, thereby achieving effective drug delivery. Furthermore, the solution of the present invention can be formulated into a paste similar to "lipstick." The composition can be made into a solid paste using solid excipients. When used, it can be applied to the area around the eyes, followed by wearing a standard saline immersion lens, heated eye mask, far-infrared / magnetic massager, etc., to similarly achieve a conditioning effect on dry eyes. Essential oils also have a strong skin-soothing effect, soothing the skin around the eyes and promoting drug absorption. The fragrance can improve the patient's mood and relieve anxiety.

[0050] The following describes the solution and technical effects of the present invention in conjunction with preferred embodiments. In the following embodiments, "%" refers to mass percentage unless otherwise specified.

[0051] Example 1

[0052] This example provides an essential oil-type wet chamber glasses composition for dry eye, and its preparation process is as follows:

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

[0054] Weigh wolfberry fruit, houttuynia herb, motherwort fruit, gentian root, and skullcap root in a mass ratio of 5:3:2:2:6, clean them, remove impurities and dust, crush them through a 50-mesh sieve, add 8 times the mass of water of the medicinal materials to the crushed medicinal materials and soak for 2 h to make the medicinal materials fully absorb water and swell. Pour the soaked medicinal materials together with the soaking water into a decocting pot, bring to a boil over high heat and then turn to low heat for slow decocting for 1.5 h, filter and collect the decoction, and reserve the medicinal residues; continue to add 6 times the mass of water of the medicinal materials to the medicinal residues, bring to a boil over high heat and then turn to low heat for slow decocting for 60 min, and filter and collect the decoction again; combine the two decoctions, let stand overnight, take the supernatant, use a rotary evaporator or vacuum concentration equipment to concentrate at ≤60 °C to obtain a medicinal liquid with a relative density of 1.15 at 25 °C. Use a microporous filter membrane for fine filtration to remove residual solid particles and impurities to obtain a clarified traditional Chinese medicine aqueous extract. Sterilize with γ-rays at a temperature of 4 °C and an irradiation dose of 10 Gy; after sterilization, store for standby at 4 °C.

[0055] (2) Preparation of wet chamber glasses composition

[0056] Weigh each component according to the formula of 0.1% menthol, 0.05% jasmine essential oil, 0.05% lavender essential oil, 0.02% borneol, 4% perilla oil, 2% mixture of Tween 80 and Span 80, and the balance being traditional Chinese medicine aqueous extract, and prepare the essential oil-type wet chamber glasses composition for dry eye according to the following process:

[0057] Add menthol, jasmine essential oil, and lavender essential oil to perilla oil, and ultrasonically treat for 30 min to mix evenly to obtain an oil phase; add a non-ionic emulsifier to the traditional Chinese medicine aqueous extract and stir to mix evenly to obtain a water phase; add the oil phase to the water phase, and continuously stir the water phase at a speed of 1000 rpm rapidly during the addition until the addition is complete to obtain the essential oil-type wet chamber glasses composition for dry eye.

[0058] Example 2

[0059] This example provides an essential oil-type wet room mirror composition for dry eye. The preparation process is referred to in Example 1, except that when preparing the traditional Chinese medicine water extract in step (1) of Example 1, the proportion of the medicinal materials of wolfberry fruit, houttuynia cordata, motherwort fruit, gentian and scutellaria baicalensis is adjusted to 5:3:3:3:10. The remaining steps are the same as those in Example 1.

[0060] Example 3

[0061] This example provides an essential oil-type wet room mirror composition for dry eye. The preparation process is referred to in Example 1, except that when preparing the traditional Chinese medicine water extract in step (1) of Example 1, the proportion of the medicinal materials of wolfberry fruit, houttuynia cordata, motherwort fruit, gentian and scutellaria baicalensis is adjusted to 8:2:2:2:5; at the same time, the composition ratio in step (2) is adjusted to: menthol 0.1%, jasmine essential oil 0.1%, borneol 0.02%, perilla oil 4%, tween 80 2%, span 80 1%, and the balance is the traditional Chinese medicine water extract. The remaining steps are the same as those in Example 1.

[0062] Example 4

[0063] This example provides an essential oil-type wet room mirror composition for dry eye. The preparation process of the medicine water extract is the same as that in Example 1, except that the composition ratio in step (2) of Example 1 is adjusted to: menthol 0.1%, lavender essential oil 0.1%, borneol 0.03%, perilla oil 4.5%, tween 80 1%, span 80 2%, and the balance is the traditional Chinese medicine water extract. The remaining steps are the same as those in Example 1.

[0064] Comparative Example 1

[0065] In this comparative example, the "perilla oil" component is removed in Example 1, and the removed part of the "perilla oil" is supplemented with the traditional Chinese medicine water extract.

[0066] Comparative Example 2

[0067] In this comparative example, the components of "jasmine essential oil and lavender essential oil" are removed in Example 1, and the removed part of the "jasmine essential oil and lavender essential oil" is supplemented with the traditional Chinese medicine water extract.

[0068] Comparative Example 3

[0069] In this comparative example, the "menthol" component is removed in Example 1, and the removed part of the "menthol" is supplemented with the traditional Chinese medicine water extract.

[0070] The above compositions were used in experiments to compare the curative effects of promoting tear secretion in dry eye patients.

[0071] 1. Animal experiments

[0072] Since mice are too small to easily make a wet chamber goggle that fits them, New Zealand white rabbits with a larger body size were used for the experiment. New Zealand white rabbits (male, 2.5±0.2 kg) were used to create a dry eye model, and treatment with a wet chamber goggle was used as the positive control group. An ultrasonic atomization wet chamber goggle was used for drug administration. 10 mL of each composition was loaded into the water tank of the wet chamber goggle. The wet chamber goggle was specifically customized according to the facial contour of the New Zealand white rabbit to enable a better fit between the treatment chamber and the area around the eyes of the New Zealand white rabbit. The experimental method is as follows:

[0073] (1) Grouping, modeling and treatment of experimental animals

[0074] The dry stress environment chamber was set to a constant temperature (24±2 °C), constant humidity (30±5%), and constant wind speed (2.5±0.5 km / s). Fifty-four healthy New Zealand white rabbits were randomly divided into the following groups, with 6 New Zealand white rabbits in each group, namely:

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

[0076] Blank group (after modeling, 4% perilla oil, 2% non-ionic emulsifier and pure water were used for treatment);

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

[0078] Experimental drug group 2 (the composition of Example 2 was used after modeling);

[0079] Experimental drug group 3 (the composition of Example 3 was used after modeling);

[0080] Experimental drug group 4 (the composition of Example 4 was used after modeling);

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

[0082] Comparative drug group 2 (the composition of Comparative Example 2 was used after modeling);

[0083] Comparative drug group 3 (the composition of Comparative Example 3 was used after modeling);

[0084] During the day in the healthy white rabbit control group, 1 mL of normal saline was subcutaneously injected into the hind limbs 4 times a day (at 8:00, 12:00, 16:00, and 20:00), and the rabbits were raised in a normal environment with a relative humidity of 55% ± 10% for 5 days, for a continuous 10 days. For the white rabbits in other groups except the healthy white rabbit control group, 2.5 mg / mL scopolamine solution was subcutaneously injected into the hind limbs 4 times a day (at 8:00, 12:00, 16:00, and 20:00), 1 mL per rabbit each time, and the rabbits were placed in a dry stress environment for 10 consecutive days. During the modeling, at the same time for each group, 10 mL of medicine was administered to the white rabbits through a wet room mirror customized according to the facial contour of New Zealand white rabbits each time, the wet room mirror was worn for 10 minutes each time, and the medicine was administered 3 times a day. After the healthy control group and the blank group successfully modeled, 4% perilla oil, 2% non-ionic emulsifier, and pure water were given through the wet room mirror 3 times a day, 10 minutes each time. 30 minutes after the last administration on the 10th day, various indicators of the white rabbits in each group were detected.

[0085] (2) Tear secretion measurement

[0086] Phenol red cotton thread is a commonly used indicator for detecting tear secretion. The tear secretion of white rabbits can be quantified by the length of the phenol red cotton thread turning red. The tear secretion of white rabbits in each group was measured on the 10th day of modeling. At the same time under gas anesthesia, the lower eyelid of the white rabbit was gently lifted with an ophthalmic forceps, the phenol red cotton thread was inserted into the inner side of the lower conjunctival fornix, taken out after 20 seconds, and the length of the red cotton thread was measured with a ruler and recorded.

[0087] (3) Fluorescein sodium staining

[0088] The corneal fluorescein staining method was used to observe the damage of the corneal epithelial barrier function. The New Zealand white rabbits were anesthetized with gas, and then 4 μL of 0.25% fluorescein sodium staining solution was topically applied to the cornea. Manual blinking was performed 5 times, 1 mL of normal saline was aspirated with a 1 mL syringe and rinsed, and gross photography was performed under cobalt blue light of a slit lamp microscope. For the grading of fluorescein staining, the cornea was divided into four quadrants and scored separately. The 4 scores were added up to obtain the final score of each eye (the minimum value was 0 and the maximum value was 16). The fluorescein score for each quadrant was as follows: none, 0; mild punctate staining less than 30 dots, 1; dense punctate staining with more than 30 spots, 2; severe diffuse staining, no positive plaque seen, 3; fluorescein positive plaque, 4.

[0089] 10 days after modeling, fluorescein sodium was dropped on the ocular surface of the white rabbits, and then gross photography was performed under cobalt blue light of a slit lamp, and clinical scoring was performed on the photos.

[0090] (4) Experimental results

[0091] From Figure 1It can be seen that there is almost no change in the tear secretion volume of the healthy white rabbit control group before and after drug administration. Before modeling, it was about 12.0 mm, and after drug administration, the tear secretion volume was 12.5 mm. While the blank group was treated with a blank solvent (4% perilla oil, 2% non-ionic emulsifier, and pure water) after being modeled by injecting scopolamine solution, and the tear secretion volume decreased to less than 6 mm after treatment. This indicates that injecting scopolamine solution can cause a decrease in tear secretion in fresh white rabbits, that is, a dry eye model. After treatment in Experimental Drug Group 1, the tear secretion volume increased to about 11 mm. In addition, in Experimental Drug Groups 2, 3, and 4, the tear secretion volume of New Zealand white rabbits can be increased between 10.8 - 11.1 mm. Although the tear secretion volume has recovered to the tear secretion volume of healthy white rabbits before modeling, it is already close to the tear secretion volume of healthy white rabbits. After treatment in Comparative Drug Groups 1 to 3, although the tear secretion volume of white rabbits can also be restored to a certain extent compared with the blank group, there is still a large gap from the tear secretion volume of healthy white rabbits before modeling. This shows that the tear restoration effect of Comparative Drug Groups 1 to 3 on the dry eye model is slower.

[0092] It can be seen from Figure 2 that the corneal fluorescein score of the blank control group increased (12.78 ± 2.64 VS 0.62 ± 0.24), that is, the corneal fluorescein score before modeling was 0.62 ± 0.24, and the corneal fluorescein score increased to 12.78 ± 2.64 after modeling, indicating that modeling caused obvious corneal epithelial damage in the animal model. After the healthy control white rabbits were administered with the blank solvent, there was no difference in the corneal epithelial score compared with before the experiment started. In contrast, after 10 days of treatment in each experimental drug treatment group, the corneal fluorescein staining score of each animal model decreased to 50 - 60% of the average score after modeling, while the corneal fluorescein staining score of the animal model also decreased to a certain extent after treatment in Comparative Drug Groups 1 - 3, with a decrease of about 20 - 30%. This shows that Comparative Drugs 1 - 3 also have the effect of reducing the degree of corneal damage in the animal model and have a restorative effect on corneal function, but their restoration effect is not as good as that of Experimental Drugs 1 - 4 groups.

[0093] Moreover, after the compositions of each group provided by the present invention were administered, no situation where the white rabbits scratched their eyes with their front paws was found. It can be seen that the wet chamber lens composition has no obvious irritation and has low irritation to the eyes. While in Comparative Drug Group 1 during drug administration, the white rabbits appeared very anxious, probably because the release rate of the essential oil was too fast, bringing certain irritation to the eyes.

[0094] (5) Experimental conclusions

[0095] Based on the above experimental results, it can be known that the wet chamber lens composition provided by the present invention can have a significant effect of promoting tear secretion on dry eye model white rabbits and has good mildness.

[0096] 2. Experimental tests on subjects

[0097] Recruit dry eye subjects. Inclusion criteria: (1) fully understand this experimental study and sign the informed consent form; (2) age > 18 years old, both genders are eligible; (3) complain of one of the subjective symptoms such as dryness, foreign body sensation, burning sensation, fatigue, discomfort, red eyes, vision fluctuation in the eyes; (4) One day before the experiment, measure the Schirmer tear secretion, and include the subjects with Schirmer tear secretion less than 5 mm / 5 min in the experiment. At the start of the experiment, the subjects are randomly divided into the following groups, 4 subjects / group.

[0098] After grouping, each subject is given a double-vibrating ultrasonic atomizing wet chamber mirror (for the structure of the wet chamber mirror, see CN118634081A) for drug administration. 20 mL of each composition is loaded into the water tank of the wet chamber mirror. After the subject wears the wet chamber mirror, turn on the ultrasonic atomizer of the wet chamber mirror so that the liquid medicine is atomized and enters the treatment chamber. After wearing for 10 minutes, each tester records the eye feeling. The subjects in each group are randomly divided into two subgroups, 2 subjects / subgroup. Measure the Schirmer tear secretion at 5 min and 30 min after application respectively. At the same time, let the subjects score their compliance 30 min after drug administration.

[0099] The Schirmer tear secretion value is an important indicator of eye comfort after treatment in dry eye patients. Clinically, it is generally considered that the Schirmer tear secretion value can reach the normal value (i.e., Schirmer tear secretion value > 15 mm) 5 min after drug treatment, and the Schirmer tear secretion value > 10 mm 30 min after drug treatment, then the patient has better eye comfort after treatment.

[0100] The scoring 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). The average score of 1 - 2 points (including 2 points) indicates good compliance. Below 2 points, the lower the score, the better the compliance. The average score of 2 - 5 points (excluding 2 points) indicates poor compliance, and the higher the score, the worse the compliance.

[0101] The experimental results are as follows:

[0102] According to the above experimental method, measure the Schirmer tear secretion after a certain period of drug administration, and the test results are shown in Table 1 below.

[0103] Table 1 Tear secretion values of the test groups (*P < 0.05 compared with before the experiment)

[0104] Group Before treatment (n = 4) 5 min after drug administration (n = 2) 30 min after drug 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 Experimental drug group 4 1.6±0.4 29.2±1.1* 16.9±1.4* 1 Comparative drug group 1 1.6±0.2 27.4±2.1* 14.1±1.5* 1.5 Comparative drug group 2 1.6±0.5 26.5±1.4* 13.8±1.2* 1 Comparative drug group 3 1.6±0.6 24.7±1.6* 12.3±1.4* 1

[0105] The above experimental results show that the wet goggle composition provided by the present invention can effectively promote the tear secretion of the subjects, and has good drug mildness. However, although the comparative drug group 1 also has a good effect on promoting tear powder, due to the too fast volatilization rate of the essential oil after wearing the wet goggles, the concentration of the essential oil is relatively high in a short time, resulting in a poor experience and low compliance of the subjects. Moreover, the essential oil molecules are very small and easily escape, unable to extend the action time, so the effect of promoting tear secretion is inferior to that of each experimental drug group 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, rather than to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that they can still modify the technical solutions described in the foregoing embodiments, or perform equivalent replacements on some or all of the technical features; and these modifications or replacements, or in the case where the technical features in the above embodiments do not conflict with each other, can be combined in the manner described in the embodiments, and these modifications, replacements or combinations do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. An essential oil-based wet room mirror composition for dry eye, characterized in that, Comprising, by mass percentage: menthol 0.1 - 0.30%, mild essential oil 0.05 - 0.10%, borneol 0.01 - 0.05%, perilla oil 3 - 5%, nonionic emulsifier 1 - 4%, and the balance being the aqueous extract of traditional Chinese medicine; the mild essential oil is at least one of jasmine essential oil and lavender essential oil; the aqueous extract of traditional Chinese medicine is the aqueous extract of wolfberry fruit, houttuynia cordata, motherwort fruit, gentian and scutellaria baicalensis, and its relative density at 25°C is 1.10 - 1.

15.

2. The essential oil-based dry eye wet room mirror composition according to claim 1, wherein The nonionic emulsifier is Tween 80 or Span 80 or a mixture of Tween 80 and Span 80.

3. The essential oil-based wet room mirror composition for dry eye according to claim 1, characterized in that The preparation method of the aqueous extract of traditional Chinese medicine is as follows: S1. Thoroughly clean the medicinal materials wolfberry fruit, houttuynia cordata, motherwort fruit, gentian and scutellaria baicalensis, remove impurities and dust, and pulverize through a 50 - mesh sieve. S2. Add 8 - 10 times the mass of water to the medicinal materials and soak for 1 - 2 h to allow the medicinal materials to fully absorb water and swell. Pour the soaked medicinal materials together with the soaking water into a decocting pot, bring to a boil over high heat and then turn to low heat and simmer for 1.5 - 2 h, filter to collect the decoction, and reserve the medicinal residues. S3. Add 6 - 8 times the mass of water to the medicinal residues again, bring to a boil over high heat and then turn to low heat and simmer for 50 - 70 min, and filter again to collect the decoction. S4. Combine the two decoctions, let stand overnight, take the supernatant, and use a rotary evaporator or vacuum concentration equipment to concentrate at ≤60°C to obtain a medicinal liquid with a relative density of 1.10 - 1.15 at 25°C. S5. Conduct fine filtration to remove residual solid particles and impurities to obtain a clear aqueous extract of traditional Chinese medicine.

4. The essential oil-based dry eye wet room mirror composition according to claim 3, characterized in that, In S5, fine filtration is carried out using a sand - core funnel or a microporous membrane filter.

5. The essential oil type dry eye wet room mirror composition according to claim 3, characterized in that, In S5, it also includes the step of sterilizing the aqueous extract of traditional Chinese medicine. The sterilization method is: sterilize using γ - ray irradiation at a temperature of 2 - 10°C and an irradiation dose of 9 - 15 Gy; after sterilization, store for standby at 2 - 8°C.

6. The essential oil-based dry eye wet room mirror composition according to claim 3, characterized in that, In S1, when preparing the aqueous extract of traditional Chinese medicine, the dry weight ratio of the four medicinal materials wolfberry fruit, houttuynia cordata, motherwort fruit, gentian and scutellaria baicalensis is 5 - 10:2 - 4:2 - 4:2 - 4:5 - 10.

7. The essential oil-based dry eye wet room mirror composition according to claim 1, characterized in that, The preparation method of the essential - oil - type dry - eye wet - room mirror composition is: add menthol, borneol, and mild essential oil to perilla oil, and mix evenly by stirring or ultrasonic treatment to obtain an oil phase; add the nonionic emulsifier to the aqueous extract of traditional Chinese medicine, stir and mix evenly to obtain a water phase; add the oil phase to the water phase, and continuously stir the water phase during the addition process until the addition is complete to obtain the essential - oil - type dry - eye wet - room mirror composition.

8. The essential oil-based dry eye wet room mirror composition according to claim 1, characterized in that, The essential - oil - type dry - eye wet - room mirror composition contains: menthol 0.1%, jasmine essential oil 0.05%, lavender essential oil 0.05%, perilla oil 4%, borneol 0.02%, nonionic emulsifier 2%, and the balance being the aqueous extract of traditional Chinese medicine; the relative density of the aqueous extract of traditional Chinese medicine at 25°C is 1.15; the dry - weight ratio of the five medicinal materials wolfberry fruit, houttuynia cordata, motherwort fruit, gentian and scutellaria baicalensis is 5:3:2:2:

6.

9. A wet room mirror device for relieving dry eye syndrome, comprising a frame and a receiving groove provided on the frame, characterized in that, It also includes the essential - oil - type dry - eye wet - room mirror composition according to any one of claims 1 - 8 and a carrier, and the carrier is a solid material with an adsorption function.

10. An ointment for relieving dry eye syndrome, characterized in that, It is a paste made from the essential oil type dry eye wet room mirror composition described in any one of claims 1-8 and a paste auxiliary material.

Images