Composition for treating dry eyes and preparation method thereof
By combining mineral ion solutions, plant active extracts, osmotic pressure regulators, and pH stabilizers, the side effects and risks of existing dry eye treatments are resolved, achieving safe and effective dry eye treatment results and enhancing tear film stability and anti-inflammatory repair capabilities.
Patent Information
- Application Number
- CN202511542194.2
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-10-27
- Publication Date
- 2025-12-12
AI Technical Summary
Existing treatments for dry eye have drawbacks, such as the potential side effects of preservatives on the ocular surface, and the risk of glaucoma and cataracts from long-term use of corticosteroids and immunosuppressive drugs. There is an urgent need to develop a safe, effective, easy-to-prepare, and stable dry eye treatment composition.
By combining mineral ion solutions, plant active extracts, osmotic pressure regulators, and pH stabilizers, the concentration ratio of zinc and calcium ions is optimized through chelation of metal ions and plant active extracts. Fermentation treatment is used to enhance anti-inflammatory and antioxidant effects and synergistically regulate the stability of tear film structure.
It significantly relieves dryness of the ocular surface, has anti-inflammatory and repairing effects, improves bioavailability, enhances tear film stability, reduces tear evaporation, avoids toxic reactions caused by excessive metal ions, and ensures the stability of the composition during storage.
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Abstract
Description
Technical Field
[0001] This application relates to the field of traditional Chinese medicine composition technology, and more specifically, it relates to a composition for treating dry eye and a method for preparing the same. Background Technology
[0002] The eyes are vital organs for humans to acquire information from the outside world, and also one of the most fatigued organs in daily life and work. With technological advancements and the widespread use of visualization tools, overuse and unhygienic use of the eyes have become increasingly common, making dry eye syndrome a prevalent ocular surface disease affecting people's lives. Common symptoms of dry eye syndrome include eye strain, eye fatigue, dryness, lack of tears, and a foreign body sensation. Inflammation plays a crucial role in the occurrence and development of dry eye. Tear film instability and tear hyperosmolarity activate a cascade of inflammatory events on the ocular surface, leading to the release of inflammatory mediators into the tears. This, in turn, causes damage and apoptosis of lacrimal glands and ocular surface epithelial cells, as well as goblet cell loss, further exacerbating dry eye symptoms.
[0003] Current clinical treatments for dry eye primarily focus on relieving symptoms and treating the underlying disease, with the goal of rebuilding the tear film and restoring ocular surface function as much as possible. Common methods include using artificial tears and other eye drops to relieve dryness; however, these eye drops often contain preservatives, which may cause side effects on the ocular surface, leading some patients to avoid them. For ocular surface inflammation, corticosteroids and immunosuppressive eye drops are mainly used, such as cyclosporine and fluorometholone eye drops; however, long-term use of these drugs carries risks such as glaucoma, cataracts, and corneal epithelial toxicity. Based on the above, the development of a safe, effective, simple-to-prepare, and stable composition for treating dry eye, along with its preparation method, is of significant clinical importance and market demand. Summary of the Invention In order to solve the technical problems mentioned in the background art, this application provides a composition for treating dry eye.
[0004] This application provides a composition for treating dry eye, employing the following technical solution: A composition for treating dry eye, comprising the following raw materials in parts by weight: 55-65 parts mineral ion solution, 20-30 parts plant active extract, 4-6 parts osmotic pressure regulator, and 3-5 parts pH stabilizer; The mineral ion solution is prepared as follows: first, anhydrous magnesium sulfate is added to water for injection, and the mixture is stirred at 40-50°C until it is evenly dispersed. Then, anhydrous calcium chloride is added and stirred evenly. Finally, zinc gluconate is added and stirred for 10-15 minutes. The pH is adjusted to 6.5-8.0, an amino acid chelating agent is added, and the mixture is stirred for 5-10 minutes. The mixture is then filtered to remove bacteria, and the mineral ion solution is obtained.
[0005] Preferably, the concentration of zinc ions in the mineral ion solution is 8-20 ppm, the concentration of magnesium ions is 12-20 ppm, the concentration ratio of zinc ions to calcium ions is 0.8-1.1:0.2-0.6, and all metal ions exist in the form of chelates.
[0006] Preferably, the amino acid chelating agent is one or more of glycine, alanine, and glutathione.
[0007] Preferably, the method for preparing the plant active extract includes the following preparation steps: Step 1: After washing, crush and mix licorice, scutellaria, dendrobium and ophiopogon japonicus, use 50-60% ethanol solution for ultrasonic extraction at 40-50℃, and obtain bioactive components after vacuum concentration, purification and low temperature drying. Step 2: Wash ginger, chamomile, and goji berries, dry them until the moisture content is ≤10%, and pulverize them into a mixed powder. Add deionized water to the mixed powder, stir evenly, adjust the pH of the system to 5.0-6.0, add enzyme, and enzymatically hydrolyze at 45-50℃ for 1.5-2 hours to obtain an enzymatic hydrolysate. After autoclaving the enzymatic hydrolysate, cool it to 35-37℃, inoculate it with a compound bacterial culture, stir evenly, and transfer it to a fermenter. Anaerobic fermentation is carried out at 32-37℃ and pH 4.2-5.5 for 60-72 hours to obtain a fermentation broth. The fermentation broth is heated to 80-85℃ and sterilized for 30-35 minutes. After cooling to room temperature, the supernatant is collected by centrifugation and concentrated under reduced pressure to obtain a concentrated fermentation broth. Step 3: Add bioactive components, menthol, and sodium hyaluronate to the fermentation concentrate, stir well, and the plant active extract is obtained.
[0008] Preferably, the mass ratio of licorice, scutellaria, dendrobium, ophiopogon japonicus, ginger, chamomile and wolfberry is 5-12:6-8:5-8:10-15:10-12:5-8:2-5.
[0009] Preferably, the amount of enzyme added in step 2 is 0.4-1% of the total mass of the mixed powder.
[0010] Preferably, the enzyme in step 2 is one or more of pectinase, hemicellulase, and cellulase.
[0011] Preferably, the inoculation amount of the compound strain in step 2 is 4-8% of the enzyme hydrolysate.
[0012] Preferably, the compound strain in step 2 consists of Lactobacillus pentosus, Lactobacillus brevis, and Isaac's yeast in a mass ratio of 5-8:2-5:1-3.
[0013] Preferably, in step 3, the mass ratio of fermentation concentrate, bioactive components, menthol and sodium hyaluronate is 35-45:1-3:0.1-0.3:0.5-1.
[0014] Preferably, the osmotic pressure regulator is one of sorbitol, trehalose, and sodium chloride.
[0015] Preferably, the pH stabilizer is a citrate buffer solution.
[0016] This application also provides a method for preparing a composition for treating dry eye, using the following technical solution: A method for preparing a composition for treating dry eye includes the following preparation steps: Plant active extracts are added to a mineral ion solution and mixed evenly. Then, an osmotic pressure regulator and a pH stabilizer are added to adjust the pH to 7.2-7.6 and the osmotic pressure to 280-320 mOsm / kg. After stirring evenly, the mixture is sterilized by autoclaving to obtain a composition for treating dry eye.
[0017] In summary, this application has the following beneficial effects: The dry eye treatment composition provided in this application exhibits significant advantages in relieving ocular surface dryness, anti-inflammatory repair, and improved bioavailability through precise design of raw material selection and preparation processes. In terms of raw material selection, mineral ions are chelated. The chelated structure prevents precipitation reactions between metal ions and polyphenols (such as baicalin) and organic acids in plant active extracts, ensuring the solution remains effective during storage. Furthermore, ocular surface epithelial cells have a stronger ability to absorb chelated metal ions, promoting corneal epithelial cell proliferation. Free ions, on the other hand, are difficult for cells to absorb efficiently and cannot fully exert their repair effects. Moreover, by optimizing the concentration ratio of zinc and calcium ions, the physiological functions of zinc and calcium ions are synergistically regulated, optimizing the improvement effect on the pathological state of dry eye. Calcium ions are important regulators of mucin and lipid layers in the tear film, promoting cross-linking between mucin molecules, enhancing their adhesion to ocular surface epithelial cells, and maintaining the orderly arrangement of the lipid layer, thus reducing tear evaporation. Zinc ions participate in the metabolism and repair of ocular surface mucosal cells, enhance the secretory activity of mucin, and reduce tear leakage by regulating the integrity of connections between ocular surface epithelial cells. In the chelated state, zinc and calcium compete for absorption and utilization. A specific ratio can prevent the two from reducing absorption efficiency due to competition for carriers. Excess calcium may lead to calcification or irritation of ocular surface tissues, while excessive zinc may cause cytotoxicity. When the ratio of the two is controlled within a specific range, functional antagonism caused by excessive single ion can be avoided, thereby synergistically maintaining the structural stability and normal function of the tear film.
[0018] In this application, the plant active extracts are processed using a differentiated method of "partial extraction + partial fermentation". Licorice, Scutellaria baicalensis, Dendrobium nobile, and Ophiopogon japonicus are extracted with ethanol. Glycyrrhizic acid in licorice and baicalin in Scutellaria baicalensis are key components for anti-inflammatory and ocular surface inflammation inhibition. They can be stably preserved through ethanol extraction. If fermentation is used, high temperature or microbial metabolism will destroy the activity of the components. Ginger, chamomile, and wolfberry are fermented to enhance the effect through fermentation transformation. The gingerol and curcumin in ginger are mostly in a bound state, which is difficult to fully release by simple extraction. They are converted into small molecule gingerol by compound strains. Gingerol works synergistically with the flavonoids in chamomile and the polysaccharides in wolfberry to further soothe irritation, penetrate the ocular surface barrier more easily, and enhance moisturizing and anti-inflammatory effects.
[0019] This application utilizes a combination of Lactobacillus pentosus, Lactobacillus brevis, and Isaac's yeast from Orientia. The three fermentation bacteria form a complementary function. Lactobacillus brevis can metabolize and produce adhesive polysaccharides such as galactooligosaccharides, which work synergistically with sodium hyaluronate to prolong the retention time of the tear film on the ocular surface and enhance tear film stability. In addition, Lactobacillus brevis can balance the lactic acid concentration produced by Lactobacillus pentosus, avoiding excessively low pH levels that could affect the activity of Isaac's yeast from Orientia. Isaac's yeast from Orientia, together with Lactobacillus pentosus and Lactobacillus brevis, enhances anti-inflammatory and antioxidant effects. Isaac's yeast from Orientia can decompose the polysaccharides in wolfberry into small molecule peptides, enhancing antioxidant capacity. Furthermore, the superoxide dismutase it produces can scavenge free radicals on the ocular surface and reduce corneal epithelial cell damage. Detailed Implementation
[0020] The present application will be further described in detail below with reference to the embodiments.
[0021] Zinc gluconate (pharmaceutical grade) used in the embodiments and comparative examples of this application was purchased from Ruichengkang Pharmaceutical Technology (Shaanxi) Co., Ltd.; anhydrous calcium chloride (pharmaceutical grade) was purchased from Langfang Nake New Material Technology Co., Ltd.; anhydrous magnesium sulfate (pharmaceutical grade) was purchased from Hebei Magnesium God Technology Co., Ltd.; pectinase was purchased from Shandong Xinxiong Biotechnology Co., Ltd.; and Lactobacillus pentosus (product number: B81267), Lactobacillus brevis (product number: B64456) and Isaac's orientalis (product number: B94945) were purchased from Ningbo Mingzhou Biotechnology Co., Ltd.
[0022] Examples 1-3 provide a composition for treating dry eye and a method for preparing the same.
[0023] Example 1 A composition for treating dry eye comprises the following raw materials in parts by weight: 55 parts mineral ion solution, 20 parts plant active extract, 4 parts osmotic pressure regulator, and 3 parts pH stabilizer; the osmotic pressure regulator is trehalose, and the pH stabilizer is citrate buffer. The preparation method of the mineral ion solution is as follows: Anhydrous magnesium sulfate was first added to water for injection and stirred at 200 rpm at 40°C until evenly dispersed. Then anhydrous calcium chloride was added and stirred evenly. Finally, zinc gluconate was added and stirred for 10 minutes. The pH was adjusted to 6.5, and 40 ppm of glycine was added and stirred for 5 minutes. The solution was then filtered to remove bacteria, yielding a mineral ion solution. The concentration of zinc ions in the mineral ion solution was 8 ppm, the concentration of magnesium ions was 12 ppm, the concentration ratio of zinc ions to calcium ions was 0.8:0.2, and the metal ions existed in the form of glycine chelates.
[0024] The preparation method of plant active extracts includes the following preparation steps: Step 1: After washing and mixing licorice, scutellaria, dendrobium and ophiopogon japonicus, the mixture was pulverized to a particle size of 15 μm. It was then extracted with a 50% ethanol solution at 40℃ for 30 min using ultrasonic extraction at a power of 100 W and a frequency of 60 kHz. After concentration under reduced pressure, purification and drying at 40℃ for 10 h, the bioactive components were obtained. Step 2: After washing ginger, chamomile, and goji berries, dry them at 50℃ until the moisture content is 8%, then pulverize them into a mixed powder. Add deionized water to the mixed powder, adjust the solid-liquid mass ratio to 1:10, stir evenly, adjust the pH of the system to 5.0, add pectinase at a rate of 0.4% of the total mass of the mixed powder, and enzymatically hydrolyze at 45℃ for 1.5 hours to obtain the enzymatic hydrolysate. After autoclaving the enzymatic hydrolysate, cool it to 35℃, and inoculate it with a compound bacterial strain at an inoculation rate of 4% of the enzymatic hydrolysate. After stirring evenly, transfer it to... The fermenter was anaerobic fermented for 60 hours at 32℃ and pH 4.2 to obtain fermentation broth. The fermentation broth was heated to 80℃ and sterilized for 30 minutes. After cooling to room temperature, the supernatant was collected by centrifugation and concentrated under reduced pressure to a relative density of 1.12 to obtain fermentation concentrate. The compound strain consisted of Lactobacillus pentosus, Lactobacillus brevis, and Isaac's yeast in a mass ratio of 5:2:1. The mass ratio of licorice, Scutellaria baicalensis, Dendrobium nobile, Ophiopogon japonicus, ginger, chamomile, and wolfberry was 5:6:5:10:10:5:2. Step 3: Add bioactive components, menthol, and sodium hyaluronate to the fermentation concentrate, stir well, and the plant active extract is obtained. The mass ratio of fermentation concentrate, bioactive components, menthol, and sodium hyaluronate is 35:1:0.1:0.5.
[0025] A method for preparing a composition for treating dry eye includes the following preparation steps: Plant active extracts are added to a mineral ion solution and stirred at 200 rpm for 30 minutes until homogeneous. Then, an osmotic pressure regulator and a pH stabilizer are added to adjust the pH to 7.24 and the osmotic pressure to 286 mOsm / kg. After stirring until homogeneous, the mixture is autoclaved at 121°C for 20 minutes to obtain a composition for treating dry eye.
[0026] Example 2 A composition for treating dry eye comprises the following raw materials in parts by weight: 60 parts mineral ion solution, 25 parts plant active extract, 5 parts osmotic pressure regulator, and 4 parts pH stabilizer; the osmotic pressure regulator is trehalose, and the pH stabilizer is citrate buffer. The preparation method of the mineral ion solution is as follows: Anhydrous magnesium sulfate was first added to water for injection and stirred at 250 rpm at 45°C until evenly dispersed. Then anhydrous calcium chloride was added and stirred until evenly dispersed. Finally, zinc gluconate was added and stirred for 12 minutes. The pH was adjusted to 7.2, and 50 ppm glycine was added and stirred for 8 minutes. The solution was then filtered to remove bacteria, yielding a mineral ion solution. The concentrations of zinc ions and magnesium ions in the mineral ion solution were 15 ppm and 15 ppm, respectively. The concentration ratio of zinc ions to calcium ions was 1:0.5, and the metal ions existed in the form of glycine chelates.
[0027] The preparation method of plant active extracts includes the following preparation steps: Step 1: After washing and mixing licorice, scutellaria, dendrobium and ophiopogon japonicus, the mixture was pulverized to a particle size of 12 μm. It was then extracted with 55% ethanol solution at 45℃ for 35 min by ultrasonic extraction at 110 W and 70 kHz. After concentration under reduced pressure, purification and drying at 50℃ for 11 h, the bioactive components were obtained. Step 2: After washing ginger, chamomile, and goji berries, dry them at 55℃ until the moisture content is 5%, then pulverize them into a mixed powder. Add deionized water to the mixed powder, adjust the solid-liquid mass ratio to 1.5:10, stir evenly, adjust the pH of the system to 5.5, add pectinase at a rate of 0.8% of the total mass of the mixed powder, and enzymatically hydrolyze at 48℃ for 1.8 hours to obtain the enzymatic hydrolysate. After autoclaving the enzymatic hydrolysate, cool it to 36℃, and inoculate it with a compound bacterial strain at an inoculation rate of 6% of the enzymatic hydrolysate. Stir evenly and then transfer... The mixture was placed in a fermenter and anaerobic fermented at 35℃ and pH 5.0 for 65 hours to obtain a fermentation broth. The fermentation broth was then heated to 82℃ and sterilized for 32 minutes. After cooling to room temperature, the supernatant was collected by centrifugation and concentrated under reduced pressure to a relative density of 1.14 to obtain a concentrated fermentation broth. The complex strain consisted of Lactobacillus pentosus, Lactobacillus brevis, and Isaac's yeast in a mass ratio of 7:4:2. The mass ratio of licorice, Scutellaria baicalensis, Dendrobium nobile, Ophiopogon japonicus, ginger, chamomile, and wolfberry was 9:7:6:12:11:7:4. Step 3: Add bioactive components, menthol, and sodium hyaluronate to the fermentation concentrate, stir well, and the plant active extract is obtained. The mass ratio of fermentation concentrate, bioactive components, menthol, and sodium hyaluronate is 40:2:0.2:0.8.
[0028] A method for preparing a composition for treating dry eye includes the following preparation steps: Plant active extracts are added to a mineral ion solution and stirred at 300 rpm for 32 minutes until homogeneous. Then, an osmotic pressure regulator and a pH stabilizer are added to adjust the pH to 7.46 and the osmotic pressure to 303 mOsm / kg. After stirring until homogeneous, the mixture is autoclaved at 121°C for 25 minutes to obtain a composition for treating dry eye.
[0029] Example 3 A composition for treating dry eye comprises the following raw materials in parts by weight: 65 parts mineral ion solution, 30 parts plant active extract, 6 parts osmotic pressure regulator, and 5 parts pH stabilizer; the osmotic pressure regulator is trehalose, and the pH stabilizer is citrate buffer. The preparation method of the mineral ion solution is as follows: Anhydrous magnesium sulfate was first added to water for injection and stirred at 300 rpm at 50°C until evenly dispersed. Then anhydrous calcium chloride was added and stirred until evenly dispersed. Finally, zinc gluconate was added and stirred for 15 minutes. The pH was adjusted to 8.0, and 60 ppm of glycine was added and stirred for 10 minutes. The solution was then filtered to remove bacteria, yielding a mineral ion solution. The concentrations of zinc ions and magnesium ions in the mineral ion solution were 20 ppm and 20 ppm, respectively. The concentration ratio of zinc ions to calcium ions was 1.1:0.6, and the metal ions existed in the form of glycine chelates.
[0030] The preparation method of plant active extracts includes the following preparation steps: Step 1: After washing and mixing licorice, scutellaria, dendrobium and ophiopogon japonicus, the mixture was pulverized to a particle size of 20 μm. It was then extracted with 60% ethanol solution at 50℃ for 40 min by ultrasonic extraction at 120 W ultrasonic power and 80 kHz ultrasonic frequency. After vacuum concentration, purification and low temperature drying at 60℃ for 12 h, the bioactive components were obtained. Step 2: After washing the ginger, chamomile, and goji berries, dry them at 60℃ until the moisture content is 10%, then pulverize them into a mixed powder. Add deionized water to the mixed powder, adjust the solid-liquid mass ratio to 2:10, stir evenly, adjust the pH of the system to 6.0, add pectinase at 1% of the total mass of the mixed powder, and enzymatically hydrolyze at 50℃ for 2 hours to obtain the enzymatic hydrolysate. After autoclaving the enzymatic hydrolysate, cool it to 37℃, inoculate it with a compound microbial culture at an inoculation rate of 8% of the enzymatic hydrolysate, stir evenly, and then transfer it to fermentation. The fermentation broth was obtained by anaerobic fermentation in a tank at 37℃ and pH 5.5 for 72 hours. The fermentation broth was then heated to 85℃ and sterilized for 35 minutes. After cooling to room temperature, the supernatant was collected by centrifugation and concentrated under reduced pressure to a relative density of 1.15 to obtain a concentrated fermentation broth. The complex strain consisted of Lactobacillus pentosus, Lactobacillus brevis, and Isaac's yeast in a mass ratio of 8:5:3. The mass ratio of licorice, Scutellaria baicalensis, Dendrobium nobile, Ophiopogon japonicus, ginger, chamomile, and wolfberry was 12:8:8:15:12:8:5. Step 3: Add bioactive components, menthol, and sodium hyaluronate to the fermentation concentrate, stir well, and the plant active extract is obtained. The mass ratio of fermentation concentrate, bioactive components, menthol, and sodium hyaluronate is 45:3:0.3:1.
[0031] A method for preparing a composition for treating dry eye includes the following preparation steps: Plant active extracts are added to a mineral ion solution and stirred at 400 rpm for 50 minutes until homogeneous. Then, an osmotic pressure regulator and a pH stabilizer are added to adjust the pH to 7.58 and the osmotic pressure to 317 mOsm / kg. After stirring until homogeneous, the mixture is autoclaved at 121°C for 30 minutes to obtain a composition for treating dry eye.
[0032] Comparative Example 1 A composition for treating dry eye comprises the following raw materials in parts by weight: 55 parts mineral ion solution, 20 parts plant active extract, 4 parts osmotic pressure regulator, and 3 parts pH stabilizer; the osmotic pressure regulator is trehalose, and the pH stabilizer is citrate buffer. The preparation method of the mineral ion solution is as follows: Anhydrous magnesium sulfate was first added to water for injection and stirred at 200 rpm at 40°C until it was evenly dispersed. Then anhydrous calcium chloride was added and stirred evenly. Finally, zinc gluconate was added and stirred for 10 minutes. The pH was adjusted to 6.5 and the solution was filtered to remove bacteria, thus obtaining a mineral ion solution. The concentration of zinc ions in the mineral ion solution was 8 ppm, the concentration of magnesium ions was 12 ppm, and the concentration ratio of zinc ions to calcium ions was 0.8:0.2.
[0033] The preparation method of plant active extracts includes the following preparation steps: Step 1: After washing and mixing licorice, scutellaria, dendrobium and ophiopogon japonicus, the mixture was pulverized to a particle size of 15 μm. It was then extracted with a 50% ethanol solution at 40℃ for 30 min using ultrasonic extraction at a power of 100 W and a frequency of 60 kHz. After concentration under reduced pressure, purification and drying at 40℃ for 10 h, the bioactive components were obtained. Step 2: After washing ginger, chamomile, and goji berries, dry them at 50℃ until the moisture content is 8%, then pulverize them into a mixed powder. Add deionized water to the mixed powder, adjust the solid-liquid mass ratio to 1:10, stir evenly, adjust the pH of the system to 5.0, add pectinase at a rate of 0.4% of the total mass of the mixed powder, and enzymatically hydrolyze at 45℃ for 1.5 hours to obtain the enzymatic hydrolysate. After autoclaving the enzymatic hydrolysate, cool it to 35℃, and inoculate it with a compound bacterial strain at an inoculation rate of 4% of the enzymatic hydrolysate. After stirring evenly, transfer it to... The fermenter was anaerobic fermented for 60 hours at 32℃ and pH 4.2 to obtain fermentation broth. The fermentation broth was heated to 80℃ and sterilized for 30 minutes. After cooling to room temperature, the supernatant was collected by centrifugation and concentrated under reduced pressure to a relative density of 1.12 to obtain fermentation concentrate. The compound strain consisted of Lactobacillus pentosus, Lactobacillus brevis, and Isaac's yeast in a mass ratio of 5:2:1. The mass ratio of licorice, Scutellaria baicalensis, Dendrobium nobile, Ophiopogon japonicus, ginger, chamomile, and wolfberry was 5:6:5:10:10:5:2. Step 3: Add bioactive components, menthol, and sodium hyaluronate to the fermentation concentrate, stir well, and the plant active extract is obtained. The mass ratio of fermentation concentrate, bioactive components, menthol, and sodium hyaluronate is 35:1:0.1:0.5.
[0034] A method for preparing a composition for treating dry eye includes the following preparation steps: Plant active extracts are added to a mineral ion solution and stirred at 200 rpm for 30 minutes until homogeneous. Then, an osmotic pressure regulator and a pH stabilizer are added to adjust the pH to 7.24 and the osmotic pressure to 286 mOsm / kg. After stirring until homogeneous, the mixture is autoclaved at 121°C for 20 minutes to obtain a composition for treating dry eye.
[0035] Comparative Example 2 A composition for treating dry eye comprises the following raw materials in parts by weight: 55 parts mineral ion solution, 20 parts plant active extract, 4 parts osmotic pressure regulator, and 3 parts pH stabilizer; the osmotic pressure regulator is trehalose, and the pH stabilizer is citrate buffer. The preparation method of the mineral ion solution is as follows: Anhydrous magnesium sulfate was first added to water for injection and stirred at 200 rpm at 40°C until evenly dispersed. Then anhydrous calcium chloride was added and stirred until evenly dispersed. Finally, zinc gluconate was added and stirred for 10 minutes. The pH was adjusted to 6.5, and 40 ppm of glycine was added and stirred for 5 minutes. The solution was then filtered to remove bacteria, yielding a mineral ion solution. The concentration of zinc ions in the mineral ion solution was 8 ppm, the concentration of magnesium ions was 12 ppm, the concentration ratio of zinc ions to calcium ions was 0.5:1, and the metal ions existed in the form of glycine chelates.
[0036] The preparation method of plant active extracts includes the following preparation steps: Step 1: After washing and mixing licorice, scutellaria, dendrobium and ophiopogon japonicus, the mixture was pulverized to a particle size of 15 μm. It was then extracted with a 50% ethanol solution at 40℃ for 30 min using ultrasonic extraction at a power of 100 W and a frequency of 60 kHz. After concentration under reduced pressure, purification and drying at 40℃ for 10 h, the bioactive components were obtained. Step 2: After washing ginger, chamomile, and goji berries, dry them at 50℃ until the moisture content is 8%, then pulverize them into a mixed powder. Add deionized water to the mixed powder, adjust the solid-liquid mass ratio to 1:10, stir evenly, adjust the pH of the system to 5.0, add pectinase at a rate of 0.4% of the total mass of the mixed powder, and enzymatically hydrolyze at 45℃ for 1.5 hours to obtain the enzymatic hydrolysate. After autoclaving the enzymatic hydrolysate, cool it to 35℃, and inoculate it with a compound bacterial strain at an inoculation rate of 4% of the enzymatic hydrolysate. After stirring evenly, transfer it to... The fermenter was anaerobic fermented for 60 hours at 32℃ and pH 4.2 to obtain fermentation broth. The fermentation broth was heated to 80℃ and sterilized for 30 minutes. After cooling to room temperature, the supernatant was collected by centrifugation and concentrated under reduced pressure to a relative density of 1.12 to obtain fermentation concentrate. The compound strain consisted of Lactobacillus pentosus, Lactobacillus brevis, and Isaac's yeast in a mass ratio of 5:2:1. The mass ratio of licorice, Scutellaria baicalensis, Dendrobium nobile, Ophiopogon japonicus, ginger, chamomile, and wolfberry was 5:6:5:10:10:5:2. Step 3: Add bioactive components, menthol, and sodium hyaluronate to the fermentation concentrate, stir well, and the plant active extract is obtained. The mass ratio of fermentation concentrate, bioactive components, menthol, and sodium hyaluronate is 35:1:0.1:0.5.
[0037] A method for preparing a composition for treating dry eye includes the following preparation steps: Plant active extracts are added to a mineral ion solution and stirred at 200 rpm for 30 minutes until homogeneous. Then, an osmotic pressure regulator and a pH stabilizer are added to adjust the pH to 7.24 and the osmotic pressure to 286 mOsm / kg. After stirring until homogeneous, the mixture is autoclaved at 121°C for 20 minutes to obtain a composition for treating dry eye.
[0038] Comparative Example 3 A composition for treating dry eye comprises the following raw materials in parts by weight: 55 parts mineral ion solution, 20 parts plant active extract, 4 parts osmotic pressure regulator, and 3 parts pH stabilizer; the osmotic pressure regulator is trehalose, and the pH stabilizer is citrate buffer. The preparation method of the mineral ion solution is as follows: Anhydrous magnesium sulfate was first added to water for injection and stirred at 200 rpm at 40°C until evenly dispersed. Then anhydrous calcium chloride was added and stirred evenly. Finally, zinc gluconate was added and stirred for 10 minutes. The pH was adjusted to 6.5, and 40 ppm of glycine was added and stirred for 5 minutes. The solution was then filtered to remove bacteria, yielding a mineral ion solution. The concentration of zinc ions in the mineral ion solution was 8 ppm, the concentration of magnesium ions was 12 ppm, the concentration ratio of zinc ions to calcium ions was 0.8:0.2, and the metal ions existed in the form of glycine chelates.
[0039] The preparation method of plant active extracts includes the following preparation steps: Step 1: After washing and mixing ginger, chamomile and wolfberry, crush them to a particle size of 15μm. Use a 50% ethanol solution to extract them by ultrasonic extraction at 40℃ for 30min, ultrasonic power 100W, ultrasonic frequency 60KHz. After vacuum concentration, purification and low temperature drying at 40℃ for 10h, the bioactive components are obtained. Step 2: After washing licorice, scutellaria, dendrobium, and ophiopogon japonicus, dry them at 50℃ until the moisture content is 8%, then pulverize them to obtain a mixed powder. Add deionized water to the mixed powder, adjust the solid-liquid mass ratio to 1:10, stir evenly, adjust the pH of the system to 5.0, add pectinase at a rate of 0.4% of the total mass of the mixed powder, and enzymatically hydrolyze at 45℃ for 1.5 hours to obtain an enzymatic hydrolysate. After autoclaving the enzymatic hydrolysate, cool it to 35℃, and inoculate it with a compound microbial strain at an inoculation rate of 4% of the enzymatic hydrolysate. Stir evenly and then transfer... The mixture was placed in a fermenter and anaerobic fermented at 32℃ and pH 4.2 for 60 hours to obtain a fermentation broth. The fermentation broth was then heated to 80℃ and sterilized for 30 minutes. After cooling to room temperature, the supernatant was collected by centrifugation and concentrated under reduced pressure to a relative density of 1.12 to obtain a concentrated fermentation broth. The complex strain consisted of Lactobacillus pentosus, Lactobacillus brevis, and Isaac's yeast in a mass ratio of 5:2:1. The mass ratio of licorice, Scutellaria baicalensis, Dendrobium nobile, Ophiopogon japonicus, ginger, chamomile, and wolfberry was 5:6:5:10:10:5:2. Step 3: Add bioactive components, menthol, and sodium hyaluronate to the fermentation concentrate, stir well, and the plant active extract is obtained. The mass ratio of fermentation concentrate, bioactive components, menthol, and sodium hyaluronate is 35:1:0.1:0.5.
[0040] A method for preparing a composition for treating dry eye includes the following preparation steps: Plant active extracts are added to a mineral ion solution and stirred at 200 rpm for 30 minutes until homogeneous. Then, an osmotic pressure regulator and a pH stabilizer are added to adjust the pH to 7.24 and the osmotic pressure to 286 mOsm / kg. After stirring until homogeneous, the mixture is autoclaved at 121°C for 20 minutes to obtain a composition for treating dry eye.
[0041] Comparative Example 4 A composition for treating dry eye comprises the following raw materials in parts by weight: 55 parts mineral ion solution, 20 parts plant active extract, 4 parts osmotic pressure regulator, and 3 parts pH stabilizer; the osmotic pressure regulator is trehalose, and the pH stabilizer is citrate buffer. The preparation method of the mineral ion solution is as follows: Anhydrous magnesium sulfate was first added to water for injection and stirred at 200 rpm at 40°C until evenly dispersed. Then anhydrous calcium chloride was added and stirred evenly. Finally, zinc gluconate was added and stirred for 10 minutes. The pH was adjusted to 6.5, and 40 ppm of glycine was added and stirred for 5 minutes. The solution was then filtered to remove bacteria, yielding a mineral ion solution. The concentration of zinc ions in the mineral ion solution was 8 ppm, the concentration of magnesium ions was 12 ppm, the concentration ratio of zinc ions to calcium ions was 0.8:0.2, and the metal ions existed in the form of glycine chelates.
[0042] The preparation method of plant active extracts includes the following preparation steps: Step 1: Wash licorice, scutellaria, dendrobium, ophiopogon, ginger, chamomile, and goji berries, then dry them at 50℃ until the moisture content is 8%. Grind them into a mixed powder. Add deionized water to the mixed powder, adjust the solid-liquid mass ratio to 1:10, stir evenly, adjust the pH of the system to 5.0, add pectinase at 0.4% of the total mass of the mixed powder, and enzymatically hydrolyze at 45℃ for 1.5 hours to obtain the enzymatic hydrolysate. After autoclaving the enzymatic hydrolysate, cool it to 35℃, and inoculate it with a compound bacterial strain at an inoculation rate of 4% of the enzymatic hydrolysate. Stir. After homogenization, the mixture was transferred to a fermenter and anaerobic fermented at 32℃ and pH 4.2 for 60 hours to obtain a fermentation broth. The fermentation broth was then heated to 80℃ and sterilized for 30 minutes. After cooling to room temperature, the supernatant was collected by centrifugation and concentrated under reduced pressure to a relative density of 1.12 to obtain a concentrated fermentation broth. The complex strain consisted of Lactobacillus pentosus, Lactobacillus brevis, and Isaac's yeast in a mass ratio of 5:2:1. The mass ratio of licorice, Scutellaria baicalensis, Dendrobium nobile, Ophiopogon japonicus, ginger, chamomile, and wolfberry was 5:6:5:10:10:5:2. Step 2: Add menthol and sodium hyaluronate to the fermentation concentrate, stir well, and the plant active extract is obtained. The mass ratio of fermentation concentrate, menthol and sodium hyaluronate is 35:0.1:0.5.
[0043] A method for preparing a composition for treating dry eye includes the following preparation steps: Plant active extracts are added to a mineral ion solution and stirred at 200 rpm for 30 minutes until homogeneous. Then, an osmotic pressure regulator and a pH stabilizer are added to adjust the pH to 7.24 and the osmotic pressure to 286 mOsm / kg. After stirring until homogeneous, the mixture is autoclaved at 121°C for 20 minutes to obtain a composition for treating dry eye.
[0044] Comparative Example 5 A composition for treating dry eye comprises the following raw materials in parts by weight: 55 parts mineral ion solution, 20 parts plant active extract, 4 parts osmotic pressure regulator, and 3 parts pH stabilizer; the osmotic pressure regulator is trehalose, and the pH stabilizer is citrate buffer. The preparation method of the mineral ion solution is as follows: Anhydrous magnesium sulfate was first added to water for injection and stirred at 200 rpm at 40°C until evenly dispersed. Then anhydrous calcium chloride was added and stirred evenly. Finally, zinc gluconate was added and stirred for 10 minutes. The pH was adjusted to 6.5, and 40 ppm of glycine was added and stirred for 5 minutes. The solution was then filtered to remove bacteria, yielding a mineral ion solution. The concentration of zinc ions in the mineral ion solution was 8 ppm, the concentration of magnesium ions was 12 ppm, the concentration ratio of zinc ions to calcium ions was 0.8:0.2, and the metal ions existed in the form of glycine chelates.
[0045] The preparation method of plant active extracts includes the following preparation steps: Step 1: After washing and mixing licorice, scutellaria, dendrobium and ophiopogon japonicus, the mixture was pulverized to a particle size of 15 μm. It was then extracted with a 50% ethanol solution at 40℃ for 30 min using ultrasonic extraction at a power of 100 W and a frequency of 60 kHz. After concentration under reduced pressure, purification and drying at 40℃ for 10 h, the bioactive components were obtained. Step 2: Wash the ginger, chamomile, and goji berries, dry them at 50℃ until the moisture content is 8%, and pulverize them into a mixed powder. Add deionized water to the mixed powder, adjust the solid-liquid mass ratio to 1:10, stir evenly, adjust the pH of the system to 5.0, add pectinase at a rate of 0.4% of the total mass of the mixed powder, and enzymatically hydrolyze at 45℃ for 1.5 hours to obtain the enzymatic hydrolysate. After autoclaving the enzymatic hydrolysate, cool it to 35℃, and inoculate it with a compound bacterial strain at an inoculation rate of 4% of the enzymatic hydrolysate, stirring evenly. Then, it was transferred to a fermenter and anaerobic fermented for 60 hours at a temperature of 32℃ and a pH of 4.2 to obtain a fermentation broth. The fermentation broth was heated to 80℃ and sterilized for 30 minutes. After cooling to room temperature, the supernatant was collected by centrifugation and concentrated under reduced pressure to a relative density of 1.12 to obtain a fermentation concentrate. The complex strain consisted of Lactobacillus brevis and Isaac's yeast in a mass ratio of 2:1. The mass ratio of licorice, Scutellaria baicalensis, Dendrobium nobile, Ophiopogon japonicus, ginger, chamomile and wolfberry was 5:6:5:10:10:5:2. Step 3: Add bioactive components, menthol, and sodium hyaluronate to the fermentation concentrate, stir well, and the plant active extract is obtained. The mass ratio of fermentation concentrate, bioactive components, menthol, and sodium hyaluronate is 35:1:0.1:0.5.
[0046] A method for preparing a composition for treating dry eye includes the following preparation steps: Plant active extracts are added to a mineral ion solution and stirred at 200 rpm for 30 minutes until homogeneous. Then, an osmotic pressure regulator and a pH stabilizer are added to adjust the pH to 7.24 and the osmotic pressure to 286 mOsm / kg. After stirring until homogeneous, the mixture is autoclaved at 121°C for 20 minutes to obtain a composition for treating dry eye.
[0047] Comparative Example 6 A composition for treating dry eye comprises the following raw materials in parts by weight: 55 parts mineral ion solution, 20 parts plant active extract, 4 parts osmotic pressure regulator, and 3 parts pH stabilizer; the osmotic pressure regulator is trehalose, and the pH stabilizer is citrate buffer. The preparation method of the mineral ion solution is as follows: Anhydrous magnesium sulfate was first added to water for injection and stirred at 200 rpm at 40°C until evenly dispersed. Then anhydrous calcium chloride was added and stirred evenly. Finally, zinc gluconate was added and stirred for 10 minutes. The pH was adjusted to 6.5, and 40 ppm of glycine was added and stirred for 5 minutes. The solution was then filtered to remove bacteria, yielding a mineral ion solution. The concentration of zinc ions in the mineral ion solution was 8 ppm, the concentration of magnesium ions was 12 ppm, the concentration ratio of zinc ions to calcium ions was 0.8:0.2, and the metal ions existed in the form of glycine chelates.
[0048] The preparation method of plant active extracts includes the following preparation steps: Step 1: After washing and mixing licorice, scutellaria, dendrobium and ophiopogon japonicus, the mixture was pulverized to a particle size of 15 μm. It was then extracted with a 50% ethanol solution at 40℃ for 30 min using ultrasonic extraction at a power of 100 W and a frequency of 60 kHz. After concentration under reduced pressure, purification and drying at 40℃ for 10 h, the bioactive components were obtained. Step 2: Wash the ginger, chamomile, and goji berries, dry them at 50℃ until the moisture content is 8%, and pulverize them into a mixed powder. Add deionized water to the mixed powder, adjust the solid-liquid mass ratio to 1:10, stir evenly, adjust the pH of the system to 5.0, add pectinase at a rate of 0.4% of the total mass of the mixed powder, and enzymatically hydrolyze at 45℃ for 1.5 hours to obtain the enzymatic hydrolysate. After autoclaving the enzymatic hydrolysate, cool it to 35℃, and inoculate it with a compound bacterial strain at an inoculation rate of 4% of the enzymatic hydrolysate, stirring evenly. Then, it was transferred to a fermenter and anaerobic fermented for 60 hours at a temperature of 32℃ and a pH of 4.2 to obtain fermentation broth. The fermentation broth was heated to 80℃ and sterilized for 30 minutes. After cooling to room temperature, the supernatant was collected by centrifugation and concentrated under reduced pressure to a relative density of 1.12 to obtain fermentation concentrate. The compound strain consisted of Lactobacillus pentosus and Isaac's yeast in a mass ratio of 5:1. The mass ratio of licorice, Scutellaria baicalensis, Dendrobium nobile, Ophiopogon japonicus, ginger, chamomile and wolfberry was 5:6:5:10:10:5:2. Step 3: Add bioactive components, menthol, and sodium hyaluronate to the fermentation concentrate, stir well, and the plant active extract is obtained. The mass ratio of fermentation concentrate, bioactive components, menthol, and sodium hyaluronate is 35:1:0.1:0.5.
[0049] A method for preparing a composition for treating dry eye includes the following preparation steps: Plant active extracts are added to a mineral ion solution and stirred at 200 rpm for 30 minutes until homogeneous. Then, an osmotic pressure regulator and a pH stabilizer are added to adjust the pH to 7.24 and the osmotic pressure to 286 mOsm / kg. After stirring until homogeneous, the mixture is autoclaved at 121°C for 20 minutes to obtain a composition for treating dry eye.
[0050] Comparative Example 7 A composition for treating dry eye comprises the following raw materials in parts by weight: 55 parts mineral ion solution, 20 parts plant active extract, 4 parts osmotic pressure regulator, and 3 parts pH stabilizer; the osmotic pressure regulator is trehalose, and the pH stabilizer is citrate buffer. The preparation method of the mineral ion solution is as follows: Anhydrous magnesium sulfate was first added to water for injection and stirred at 200 rpm at 40°C until evenly dispersed. Then anhydrous calcium chloride was added and stirred evenly. Finally, zinc gluconate was added and stirred for 10 minutes. The pH was adjusted to 6.5, and 40 ppm of glycine was added and stirred for 5 minutes. The solution was then filtered to remove bacteria, yielding a mineral ion solution. The concentration of zinc ions in the mineral ion solution was 8 ppm, the concentration of magnesium ions was 12 ppm, the concentration ratio of zinc ions to calcium ions was 0.8:0.2, and the metal ions existed in the form of glycine chelates.
[0051] The preparation method of plant active extracts includes the following preparation steps: Step 1: After washing and mixing licorice, scutellaria, dendrobium and ophiopogon japonicus, the mixture was pulverized to a particle size of 15 μm. It was then extracted with a 50% ethanol solution at 40℃ for 30 min using ultrasonic extraction at a power of 100 W and a frequency of 60 kHz. After concentration under reduced pressure, purification and drying at 40℃ for 10 h, the bioactive components were obtained. Step 2: Wash ginger, chamomile, and goji berries, dry them at 50℃ until the moisture content is 8%, and pulverize them into a mixed powder. Add deionized water to the mixed powder, adjust the solid-liquid mass ratio to 1:10, stir evenly, adjust the pH of the system to 5.0, add pectinase at a rate of 0.4% of the total mass of the mixed powder, and enzymatically hydrolyze at 45℃ for 1.5 hours to obtain the enzymatic hydrolysate. After autoclaving the enzymatic hydrolysate, cool it to 35℃, and inoculate it with a compound bacterial strain at an inoculation rate of 4% of the enzymatic hydrolysate. Stir evenly. After homogenization, the mixture is transferred to a fermenter and anaerobic fermented at 32℃ and pH 4.2 for 60 hours to obtain fermentation broth. The fermentation broth is then heated to 80℃ and sterilized for 30 minutes. After cooling to room temperature, the supernatant is collected by centrifugation and concentrated under reduced pressure to a relative density of 1.12 to obtain fermentation concentrate. The complex strain consists of Lactobacillus pentosus and Lactobacillus brevis in a mass ratio of 5:2. The mass ratio of licorice, Scutellaria baicalensis, Dendrobium nobile, Ophiopogon japonicus, ginger, chamomile, and wolfberry is 5:6:5:10:10:5:2. Step 3: Add bioactive components, menthol, and sodium hyaluronate to the fermentation concentrate, stir well, and the plant active extract is obtained. The mass ratio of fermentation concentrate, bioactive components, menthol, and sodium hyaluronate is 35:1:0.1:0.5.
[0052] A method for preparing a composition for treating dry eye includes the following preparation steps: Plant active extracts are added to a mineral ion solution and stirred at 200 rpm for 30 minutes until homogeneous. Then, an osmotic pressure regulator and a pH stabilizer are added to adjust the pH to 7.24 and the osmotic pressure to 286 mOsm / kg. After stirring until homogeneous, the mixture is autoclaved at 121°C for 20 minutes to obtain a composition for treating dry eye.
[0053] Performance testing The compositions for treating dry eye prepared in Examples 1-3 and Comparative Examples 1-7 of this application were formulated into sprays for treatment, and the specific treatment effects are shown in the table below; The diagnostic criteria for patients were formulated with reference to the "Chinese Expert Consensus on Dry Eye: Examination and Diagnosis (2020)".
[0054] Patient's subjective symptoms: (1) If a patient complains of one of the following subjective symptoms, such as dryness, foreign body sensation, burning sensation, fatigue, discomfort, redness, or fluctuating vision, and the tear film breakup time (BUT) is <5s or the tear secretion test (SIT) (without surface anesthesia) is <5mm / 5min, dry eye can be diagnosed; (2) If a patient complains of one of the following subjective symptoms, such as dryness, foreign body sensation, burning sensation, fatigue, discomfort, or fluctuating vision, and the 5s < BUT < 10s or 5mm / 5min < SIT (without surface anesthesia) < 10mm / 5min, and there is also a positive fluorescein staining (FL) of the cornea and conjunctiva, dry eye can be diagnosed.
[0055] Patient selection criteria: 300 patients with dry eye syndrome who met the above diagnostic criteria were selected. The patients were aged 20-70 years, had an onset time of 1-8 weeks, had no systemic immune diseases, no eyelid deformities, no history of glaucoma, were not pregnant, had not used other drugs for treatment, or had used other drugs but had stopped using them for more than 2 weeks and were willing to use the spray treatment. The above 300 patients were randomly divided into 10 groups of 30 patients each. They were treated with the spray made from the composition for dry eye treatment prepared in the examples and comparative examples. The treatment was carried out four times a day, in the morning, noon, afternoon and evening, with 0.3 mL each time, for one month.
[0056] Treatment effect: Significantly effective: Symptoms disappear, corneal and conjunctival fluorescein staining is negative, tear secretion test (SIT) > 10 mm / 5 min, tear film breakup time (BUT) > 10 s; Effective: Symptoms are relieved, corneal and conjunctival fluorescein staining is reduced, tear secretion test (SIT) is 5-10 mm / 5 min, and tear film breakup time (BUT) is 5-10 s; Ineffective: Symptoms do not improve significantly, corneal and conjunctival fluorescein staining shows sparse punctate staining, tear secretion test (SIT) <5mm / 5min, tear film breakup time (BUT) <5s; The treatment results are shown in Table 1.
[0057] Table 1. Therapeutic effects of the compositions for treating dry eye prepared in Examples 1-3 and Comparative Examples 1-7 As shown in Table 1, the dry eye treatment composition prepared in this application can effectively prolong the tear film breakup time and enhance tear film stability; reduce corneal epithelial damage, and the corneal fluorescein staining is negative after treatment; it can also increase tear secretion and improve mild tear secretion abnormalities, showing significant therapeutic effects on dry eye.
[0058] This specific embodiment is merely an explanation of this application and is not intended to limit it. After reading this specification, those skilled in the art can make modifications to this embodiment without contributing any inventive step, but such modifications are protected by patent law as long as they fall within the scope of the claims of this application.
Claims
1. A composition for treating dry eye, characterized in that, The ingredients include the following parts by weight: 55-65 parts mineral ion solution, 20-30 parts plant active extract, 4-6 parts osmotic pressure regulator, and 3-5 parts pH stabilizer; The mineral ion solution is prepared as follows: first, anhydrous magnesium sulfate is added to water for injection, and the mixture is stirred at 40-50°C until it is evenly dispersed. Then, anhydrous calcium chloride is added and stirred evenly. Finally, zinc gluconate is added and stirred for 10-15 minutes. The pH is adjusted to 6.5-8.0, an amino acid chelating agent is added, and the mixture is stirred for 5-10 minutes. The mixture is then filtered to remove bacteria, and the mineral ion solution is obtained.
2. The composition for treating dry eye according to claim 1, characterized in that, The mineral ion solution contains zinc ions at a concentration of 8-20 ppm, magnesium ions at a concentration of 12-20 ppm, and a zinc ion to calcium ion concentration ratio of 0.8-1.1:0.2-0.6, with the metal ions existing in the form of chelates.
3. The composition for treating dry eye according to claim 1, characterized in that, The preparation method of the plant active extract includes the following preparation steps: Step 1: After washing, crush and mix licorice, scutellaria, dendrobium and ophiopogon japonicus, extract with ethanol solution using ultrasound, concentrate under reduced pressure, purify and dry at low temperature to obtain bioactive components; Step 2: Wash and dry ginger, chamomile, and goji berries, then pulverize them into a mixed powder. Add deionized water to the mixed powder, stir well, adjust the pH of the system to 5.0-6.0, add enzyme, and hydrolyze at 45-50℃ for 1.5-2 hours to obtain an enzymatic hydrolysate. After autoclaving the enzymatic hydrolysate, cool it to room temperature, inoculate it with a compound bacterial culture, stir well, and transfer it to a fermenter. Perform anaerobic fermentation at 32-37℃ and pH 4.2-5.5 for 60-72 hours to obtain a fermentation broth. Sterilize the fermentation broth, cool it to room temperature, centrifuge it, collect the supernatant, and concentrate it under reduced pressure to obtain a concentrated fermentation broth. Step 3: Add bioactive components, menthol, and sodium hyaluronate to the fermentation concentrate, stir well, and the plant active extract is obtained.
4. The composition for treating dry eye according to claim 3, characterized in that, The mass ratio of licorice, scutellaria, dendrobium, ophiopogon, ginger, chamomile and wolfberry is 5-12:6-8:5-8:10-15:10-12:5-8:2-5.
5. The composition for treating dry eye according to claim 3, characterized in that, In step 2, the amount of enzyme added is 0.4-1% of the total mass of the mixed powder; the enzyme is one or more of pectinase, hemicellulase, and cellulase.
6. The composition for treating dry eye according to claim 3, characterized in that, In step 2, the inoculation amount of the compound microbial strain is 4-8% of the enzyme hydrolysate.
7. The composition for treating dry eye according to claim 3, characterized in that, In step 2, the compound strain consists of Lactobacillus pentosus, Lactobacillus brevis, and Isaac's yeast in a mass ratio of 5-8:2-5:1-3.
8. The composition for treating dry eye according to claim 3, characterized in that, In step 3, the mass ratio of fermentation concentrate, bioactive components, menthol, and sodium hyaluronate is 35-45:1-3:0.1-0.3:0.5-1.
9. The composition for treating dry eye according to claim 1, characterized in that, The osmotic pressure regulator is one of sorbitol and trehalose; the pH stabilizer is citrate buffer.
10. A method for preparing a composition for treating dry eye as described in any one of claims 1-9, characterized in that, The preparation steps include the following: Plant active extracts are added to a mineral ion solution and mixed evenly. Then, an osmotic pressure regulator and a pH stabilizer are added to adjust the pH to 7.2-7.6 and the osmotic pressure to 280-320 mOsm / kg. After stirring evenly, the mixture is sterilized under high pressure to obtain a composition for treating dry eye.