A traditional Chinese medicine eye patch for intervening myopia and a preparation method thereof

Abstract

This invention discloses a traditional Chinese medicine eye patch for myopia intervention and its preparation method, belonging to the field of traditional Chinese medicine technology. The herbal composition comprises 15 parts Astragalus membranaceus, 15 parts Angelica sinensis, 15 parts Paeonia lactiflora, 15 parts Ligusticum chuanxiong, 15 parts Pueraria lobata, 12 parts Prunella vulgaris, 12 parts Vitex trifolia, and 1 part Borneol. Verification has shown that the herbal eye patch provided by this invention (especially the high-concentration version) can safely and effectively delay the progression of refractive error and axial elongation in experimentally myopic guinea pigs. Its effect is closely related to improving choroidal thickness and blood flow density, and maintaining the normal structure of the choroid. This invention provides a new option and technical basis for the clinical treatment of myopia.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to a traditional Chinese medicine eye patch for myopia intervention and its preparation method. Background Technology

[0002] Myopia has become a global public health problem, with its prevalence continuing to rise and showing a general trend towards younger age of onset and increased severity. Risk prediction studies show that for every 100-degree increase in myopia, the risk of myopic retinopathy, retinal detachment, and open-angle glaucoma increases by 57%, 21%, and 20%, respectively. The treatment costs for related complications also increase accordingly, imposing a significant economic burden on society and individuals. While myopia affects children and adolescents' learning efficiency, quality of life, and career choices, it also poses a potential talent constraint in key fields such as national defense, aerospace, and precision manufacturing. Reports indicate that high myopia-related fundus diseases have become the leading cause of irreversible blindness in adults in some parts of my country. The period between 6 and 12 years old is a critical window for visual development and a golden stage for myopia prevention and control. Effective intervention during this period is of great significance in delaying refractive error progression and reducing the risk of blindness caused by high myopia.

[0003] The development of myopia is a complex process involving the interaction of genetic and environmental factors, and its pathological mechanism involves the cascade regulation of the retinal-choroid-scleral signaling pathway. In recent years, the core role of the choroid in myopia regulation has become increasingly prominent. Studies have shown that there is a negative correlation between axial length and choroidal thickness; choroidal thinning precedes structural changes in the retina and sclera and can be considered a leading indicator driving subsequent changes in the entire eyeball. As a highly vascularized tissue of the eye, the choroid primarily supplies blood to the retina. When choroidal blood perfusion is insufficient, it can lead to ischemia and hypoxia in adjacent retinal and scleral tissues, thereby activating downstream signaling pathways, inducing scleral fibroblast differentiation and extracellular matrix remodeling, and ultimately promoting abnormal axial length growth.

[0004] Traditional Chinese medicine (TCM) has accumulated rich clinical experience in myopia prevention and control. Its holistic approach and core theories of syndrome differentiation and treatment are highly compatible with the multi-factorial and multi-stage pathological characteristics of myopia. However, the promotion and application of appropriate TCM techniques still face many challenges. While external therapies such as acupuncture, massage, and iontophoresis are effective, they require professional operation, leading to frequent visits to medical institutions for children and making compliance difficult to guarantee. Although decoctions can regulate qi and blood internally, children have poor acceptance and find long-term use difficult. Therefore, developing safe, effective, highly compliant, and family-friendly appropriate TCM techniques for myopia prevention and control has become an urgent clinical problem to be solved. Summary of the Invention

[0005] The purpose of this invention is to provide a traditional Chinese medicine eye patch for myopia intervention and its preparation method, thereby solving the problems existing in the prior art. Verification has shown that the traditional Chinese medicine eye patch provided by this invention (especially the high-concentration version) can safely and effectively delay the progression of refractive error and axial elongation in experimentally myopic guinea pigs. Its effect is closely related to improving choroidal thickness and blood flow density, and maintaining the normal structure of the choroid. This invention provides a new option and technological basis for the clinical treatment of myopia.

[0006] To achieve the above objectives, the present invention provides the following solution: This invention provides a traditional Chinese medicine composition for intervening in myopia. By weight, the traditional Chinese medicine composition is made of the following components: 15 parts Astragalus membranaceus, 15 parts Angelica sinensis, 15 parts Paeonia lactiflora, 15 parts Ligusticum chuanxiong, 15 parts Pueraria lobata, 12 parts Prunella vulgaris, 12 parts Vitex trifolia, and 1 part Borneol.

[0007] The present invention also provides a traditional Chinese medicine eye patch for intervening in myopia, the traditional Chinese medicine eye patch being composed of a traditional Chinese medicine composition and an eye patch drug-carrying matrix; The traditional Chinese medicine composition is made from the following components by weight: 15 parts Astragalus membranaceus, 15 parts Angelica sinensis, 15 parts Paeonia lactiflora, 15 parts Ligusticum chuanxiong, 15 parts Pueraria lobata, 12 parts Prunus armeniaca, 12 parts Vitex trifolia and 1 part Borneol. The drug-loaded matrix of the eye patch consists of hydrogel, glycerin, NOVETAC VP-20, NOVETAC P55N, aluminum hydroxyl, disodium EDTA, tartaric acid, BIOGUARD-CP, and NOVEPHIL 100.

[0008] This invention also provides a method for preparing the aforementioned traditional Chinese medicine eye patch, comprising the following steps: Astragalus membranaceus, Angelica sinensis, Paeonia lactiflora, Ligusticum chuanxiong, Pueraria lobata, Prunella vulgaris, and Vitex trifolia were decocted twice with water. The resulting filtrate was concentrated under reduced pressure, dried, and pulverized to obtain a Chinese herbal extract powder. Borneol was pulverized to obtain fine borneol powder. NOVETAC VP-20, NOVETAC P55N, aluminum hydroxyacetate, and disodium EDTAC were added to glycerin and stirred to form a uniform paste-like semi-fluid, which is phase A. The herbal extract powder was dissolved in water to obtain phase B1. Water, tartaric acid, BIOGUARD-CP, and NOVEPHIL 100 were added to it and stirred to obtain phase B2. The borneol powder was dissolved in alcohol to obtain phase C. Phase B1 and phase B2 were added to a hydrogel mixer, and phase A and phase C were added in sequence and stirred to obtain a soft herbal eye patch material. The soft material of the Chinese herbal eye patch is fed into the hopper of the hydrogel coating machine. After coating, the patch is cured and cut to obtain the Chinese herbal eye patch.

[0009] Optionally, the procedure of decocting Astragalus membranaceus, Angelica sinensis, Paeonia lactiflora, Ligusticum chuanxiong, Pueraria lobata, Prunella vulgaris, and Vitex trifolia twice with water is as follows: add 10 times the volume of water to Astragalus membranaceus, Angelica sinensis, Paeonia lactiflora, Ligusticum chuanxiong, Pueraria lobata, Prunella vulgaris, and Vitex trifolia, decoct for 60 minutes, filter the extract to obtain the first filtrate and the residue; add 8 times the volume of water to the residue, decoct for 60 minutes, filter to obtain the second filtrate, and combine the first filtrate and the second filtrate.

[0010] Optionally, the weight ratio of the glycerin to the traditional Chinese medicine extract powder is 5:1; The weight ratio of the glycerol, NOVETAC VP-20, NOVETAC P55N, aluminum hydroxyhydroxyacetate, and disodium ethylenediaminetetraacetate is 40:12:2:0.4 to 0.44:0.1.

[0011] Optionally, in phase B1, the weight ratio of water to the traditional Chinese medicine extract powder is 79.26–81.3:8–12; In the B2 phase, the weight ratio of water, tartaric acid, BIOGUARD-CP, NOVEPHIL 100, and the traditional Chinese medicine extract powder is 57.44:0.16:0.4:0.2:8-12.

[0012] Optionally, the weight ratio of the borneol powder to the alcohol is 1:1.

[0013] Optionally, the amount of the herbal extract powder applied is 0.4g to 0.6g per patch.

[0014] The present invention also provides the application of the aforementioned traditional Chinese medicine composition or the aforementioned traditional Chinese medicine eye patch in the preparation of products for treating myopia.

[0015] The present invention discloses the following technical effects: Verification has shown that the herbal eye patch provided by this invention (especially the high-concentration version) can safely and effectively delay the refractive error progression and axial elongation in experimental myopic guinea pigs. Its effect is closely related to improving choroidal thickness and blood flow density and maintaining the normal structure of the choroid. Specifically, it is manifested in the following ways: (1) Clear myopia intervention effect: In the classic lens-induced myopia (LIM) guinea pig model, after continuous use of the eye patch of this invention (high-concentration group) for 4 weeks, the refractive error of the guinea pigs was -2.05±0.65 D and the axial length was 8.39±0.07 mm, which were significantly better than the model group's -3.52±0.46 D and 8.62±0.07 mm (P<0.05), indicating that it can significantly delay the progression of myopia. (2) Improved choroidal microcirculation: After 4 weeks of intervention, the choroidal thickness of guinea pigs in the high-concentration group of the eye patch of this invention was 71.09±1.86μm, and the blood flow density was 65.97±1.31%, both significantly better than those in the model group (61.86±1.63μm, 57.62±2.19%) (P<0.05), indicating that it can effectively increase choroidal thickness and blood perfusion, and improve oxygen supply to the posterior pole of the eyeball. (3) High safety: The results of acute eye irritation test and toxicity test (continuous administration for 28 days) showed that the eye patch of this invention had no obvious irritant or toxic reaction to the conjunctiva, cornea, liver and kidney function of guinea pigs (P>0.05), and the local application was safe and reliable. This invention provides a new option and technical basis for the clinical treatment of myopia. Attached Figure Description

[0016] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0017] Figure 1 Changes in refractive power of guinea pigs in each group before and after intervention; Figure 2 Changes in axial length of guinea pigs before and after intervention; Figure 3 Changes in choroid thickness in each group of guinea pigs before and after intervention; Figure 4 Changes in choroidal blood flow density in each group of guinea pigs before and after intervention; Figure 5 The pathological tissue sections of the choroid were observed at 2 weeks and 4 weeks of intervention. ①③⑤⑦ correspond to the NC group, LIM group, LC eye patch group, and HC eye patch group at 2 weeks of intervention, respectively. ②④⑥⑧ correspond to the NC group, LIM group, LC eye patch group, and HC eye patch group at 4 weeks of intervention, respectively. The red arrows indicate the degree of tissue loosening. Detailed Implementation

[0018] Various exemplary embodiments of the present invention will now be described in detail. This detailed description should not be considered as a limitation of the present invention, but rather as a more detailed description of certain aspects, features, and embodiments of the present invention.

[0019] It should be understood that the terminology used in this invention is merely for describing particular embodiments and is not intended to limit the invention. Furthermore, with respect to numerical ranges in this invention, it should be understood that each intermediate value between the upper and lower limits of the range is also specifically disclosed. Any stated value or intermediate value within a stated range, as well as each smaller range between any other stated value or intermediate value within said range, is also included in this invention. The upper and lower limits of these smaller ranges may be independently included or excluded from the range.

[0020] Unless otherwise stated, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. While only preferred methods and materials have been described herein, any methods and materials similar or equivalent to those described herein may be used in the implementation or testing of this invention. All references to this specification are incorporated by way of citation to disclose and describe methods and / or materials associated with those references. In the event of any conflict with any incorporated reference, the content of this specification shall prevail.

[0021] Various modifications and variations can be made to the specific embodiments described in this specification without departing from the scope or spirit of the invention, as will be apparent to those skilled in the art. Other embodiments derived from this specification will also be apparent to those skilled in the art. This specification and embodiments are merely exemplary.

[0022] The terms “include,” “including,” “have,” “contain,” etc., used in this article are all open-ended terms, meaning that they include but are not limited to.

[0023] This invention's prescription is based on the traditional Chinese medicine theory of "harmonizing qi and blood, and balancing yin and yang." The prescription is explained below: The principal herbs are Astragalus membranaceus and Angelica sinensis. Astragalus membranaceus is sweet and slightly warm in nature, and enters the spleen and lung meridians. It is good at tonifying qi and consolidating the exterior, as well as replenishing qi and generating fluids. Angelica sinensis is sweet, pungent and warm in nature, and enters the liver, heart and spleen meridians. It is good at tonifying blood and promoting blood circulation. When combined with Astragalus membranaceus, it can tonify both qi and blood, making qi and blood abundant, and nourishing the eyes. This is the key to treating the root cause.

[0024] The assistant herbs are: Chuanxiong (Ligusticum striatum), Baishao (Paeonia lactiflora), and Xia Tianwu (Xia Tianwu). Chuanxiong is pungent and warm in nature, entering the liver, gallbladder, and pericardium meridians. Its nature ascends to the head and eyes, acting as a "qi-regulating herb in the blood," capable of unblocking qi and blood, and improving symptoms of qi and blood stagnation in the eyes. Baishao is bitter, sour, and slightly cold in nature, entering the liver and spleen meridians. Its function is to nourish blood and soften the liver. Combined with Chuanxiong, one disperses while the other astringes, ensuring blood flows without depletion and the liver is softened without stagnation. Xia Tianwu is bitter, slightly pungent, and cool in nature, entering the liver and spleen meridians. It invigorates blood, unblocks meridians, promotes qi circulation, and relieves pain. It enhances the meridian-clearing power of Chuanxiong, addressing blurred vision and periorbital soreness caused by qi and blood stagnation. Its cooling nature also harmonizes the warming properties of Chuanxiong. These three herbs together serve as assistant herbs, assisting the principal herb in harmonizing qi and blood, thus ensuring unblocking the eye meridians.

[0025] Adjuvant herbs: Kudzu root and Vitex trifolia fruit. Kudzu root is sweet, pungent, and cool in nature, and enters the spleen and stomach meridians. It excels at raising yang, relieving muscle tension, generating fluids, and relaxing tendons, thus alleviating eye muscle fatigue and promoting blood circulation. Vitex trifolia fruit is pungent and cool in nature, and enters the liver, stomach, and bladder meridians. It excels at dispersing wind-heat and clearing the head and eyes. These two herbs work synergistically with the principal and assistant herbs to raise clear yang, clear the head and eyes, relieve eye discomfort, and enhance the overall efficacy of the formula.

[0026] The guiding ingredient is borneol. Borneol is pungent, bitter, and slightly cold; it enters the heart, spleen, and lung meridians. It is aromatic and penetrating, opening the orifices and penetrating the skin to reach the affected area directly, promoting the absorption of the drug through the skin around the eyes.

[0027] This formula works synergistically to invigorate Qi and blood circulation, clear the orifices, and improve vision. Through application around the eyes, the medicinal ingredients are continuously absorbed transdermally, reaching directly to the eyes, improving blood supply to the choroid in the posterior pole of the eyeball, thereby delaying abnormal elongation of the eye axis and achieving the goal of myopia prevention and control.

[0028] Example 1 A traditional Chinese medicine eye patch for myopia prevention and control comprises a traditional Chinese medicine composition and an eye patch drug-carrying matrix; the traditional Chinese medicine composition includes: Astragalus membranaceus 15g, Angelica sinensis 15g, Paeonia lactiflora 15g, Ligusticum chuanxiong 15g, Pueraria lobata 15g, Prunella vulgaris 12g, Vitex trifolia 12g, and Borneol 1g; the eye patch drug-carrying matrix consists of hydrogel, glycerin, NOVETAC VP-20, NOVETAC P55N, aluminum hydroxyacetate, disodium EDTA-2NA, tartaric acid, BIOGUARD-CP, and NOVEPHIL 100.

[0029] The preparation method of traditional Chinese medicine eye patches includes the following steps: (I) Preparation of Chinese herbal extract powder (1) Extraction: Weigh out the seven medicinal materials (Astragalus membranaceus, Angelica sinensis, Paeonia lactiflora, Ligusticum chuanxiong, Pueraria lobata, Prunella vulgaris, and Vitex trifolia) according to the prescription and put them into the extraction tank. For the first extraction, add 10 times the volume of drinking water, turn on the steam heating, and start timing when the temperature reaches 98℃. Control the temperature at 100±2℃ and decoct for 60 minutes. After filtering the extract through a filter (150 mesh), the first filtrate and the residue are obtained. The first filtrate is stored in a storage tank for later use. The residue obtained from filtration is used for the second extraction. Add 8 times the volume of drinking water to the residue and decoct for 60 minutes in the same way. After filtration, the second filtrate is obtained. Combine the two filtrates.

[0030] (2) Concentration: The combined filtrate is pumped into a double-effect energy-saving concentrator and concentrated under reduced pressure at a temperature below 80℃ and a vacuum of -0.06MPa to -0.10MPa until it is concentrated to an extract with a relative density of 1.08 to 1.13 (measured at 60 to 65℃).

[0031] (3) Drying: Transfer the above extract to a vacuum drying oven, control the steam pressure to <0.1MPa, the temperature to below 80℃, and the vacuum pressure to <-0.08MPa, and carry out vacuum drying until the moisture content drops to below 5% to obtain dried extract.

[0032] (4) Pulverization: Put the dried extract blocks into a pulverizer, pulverize them and pass them through an 80-mesh sieve to obtain Chinese herbal extract powder for later use.

[0033] (5) Borneol processing: Crush borneol and pass it through an 80-mesh sieve to obtain fine borneol powder for later use.

[0034] (II) Preparation of the drug-loaded matrix for eye patches (1) Preparation of Phase A (oil phase / gelling agent phase): First, add 5 times the weight of glycerol of the Chinese herbal extract powder to the mixer, then add NOVETAC VP-20, NOVETAC P55N, aluminum hydroxyl, and EDTA-2NA (the weight ratio of glycerol, NOVETAC VP-20, NOVETAC P55N, aluminum hydroxyl and EDTA-2NA is 40:12:2:0.4~0.44:0.1), turn on medium speed and stir for 10 minutes until a uniform paste semi-fluid is formed with no visible powder particles, and set aside.

[0035] (2) Preparation of phase B (aqueous phase / drug phase): In another mixer, purified water and the above-mentioned traditional Chinese medicine extract powder are added according to the weight ratio of purified water: traditional Chinese medicine extract powder = 79.26~81.3: 8~12. After stirring and dissolving, phase B1 is obtained. Purified water, tartaric acid, BIOGUARD-CP and NOVEPHIL 100 are slowly added under high speed stirring (the weight ratio of purified water, tartaric acid, BIOGUARD-CP and NOVEPHIL 100 to traditional Chinese medicine extract powder is 57.44:0.16:0.4:0.2:8~12). The mixture is stirred at high speed for 15~20 minutes until it is completely uniform and free of particles. It is then allowed to stand for more than 2 hours (preferably prepared one day in advance) to obtain phase B2.

[0036] (3) Preparation of C phase (permeability-enhancing phase): Borneol powder is dissolved in alcohol at a weight ratio of 1:1 to obtain C phase.

[0037] (4) Mixing and stirring: Add the prepared B1 phase and B2 phase to the hydrogel mixer, add phase A, then add phase C, turn on the vacuum until the pressure is below -0.08MPa, then stir quickly (50Hz) for 3 minutes, then stir at medium speed (30Hz) for 2 minutes until a uniform viscous colloid is formed, and the soft material of the Chinese medicine eye patch is obtained.

[0038] (III) Coating and Molding (1) Coating: Discharge the above soft material into the hopper of the hydrogel coating machine (the time from discharge to coating is controlled within 15 minutes), adjust the coating speed (30%~60%) and coating thickness, and coat the soft material evenly on the backing layer and cover it with the anti-stick layer.

[0039] (2) Curing and slicing: After the coating is applied, the patch is left to cure at room temperature for 12 hours, and then sliced ​​according to the specifications to obtain the finished Chinese medicine eye patch.

[0040] (iv) Product Specifications The prepared herbal eye patch contains 2% to 4% by mass of herbal extract powder (i.e., the coating amount is 0.4g to 0.6g of the herbal extract powder per patch).

[0041] Application Example 1 1. Experimental Methods Two-week-old male tricolor guinea pigs were randomly divided into four groups: normal control group (NC), model group (LIM), low-concentration eye patch group (LC, 2%), and high-concentration eye patch group (HC, 4%), with 16 rats in each group. Except for the NC group, the right eye of the guinea pigs in the other groups was fitted with a -6.00D lens to establish the LIM model. In the LC and HC groups, the corresponding concentration of eye patch was applied to the periorbital area of ​​the right eye for 30 minutes daily for 4 consecutive weeks during model establishment. The NC and LIM groups did not receive the treatment. The refractive power and axial length of the right eye of the guinea pigs were measured before intervention, 2 weeks after intervention, and 4 weeks after intervention. After 4 weeks of intervention, the animals were sacrificed, and the eyeballs were harvested to examine the choroidal thickness, blood flow density, and pathological structure. Serum ALT, AST, BUN, and Cr levels were measured using routine methods.

[0042] 2. Experimental Results 2.1 Refractive power and axial length like Figures 1-2 As shown in Tables 1-2, after 4 weeks of intervention, compared with the NC group (1.41±0.44 D, 8.19±0.05 mm), the LIM group showed a significant increase in myopia, with a refractive error of -3.52±0.46 D and a significant increase in axial length to 8.62±0.07 mm (P<0.05), indicating successful modeling. Compared with the LIM group, the LC eye patch group (-2.48±0.53 D, 8.51±0.08 mm) and the HC eye patch group (-2.05±0.65 D, 8.39±0.07 mm) both showed significant reductions in myopia refractive error and axial length (P<0.05), with the HC group showing better results than the LC group.

[0043] Table 1. Changes in refractive power of guinea pigs in each group before and after intervention. Note: * indicates a comparison with before intervention. P <0.05; 'a' indicates a comparison with the NC group. P <0.05; b indicates comparison with the LIM group, P <0.05; c indicates comparison with the LC eye patch group, P <0.05; d indicates comparison with the HC eye patch group, P <0.05. Same as the table below.

[0044] Table 2. Changes in axial length of guinea pigs in each group before and after intervention. 2.2 Choroidal thickness and blood flow density like Figures 3-4As shown in Tables 3-4, after 4 weeks of intervention, the choroidal thickness (61.86±1.63 μm) and blood flow density (57.62±2.19%) in the LIM group were significantly lower than those in the NC group (79.54±1.52 μm, 70.74±1.24%) (P<0.05). In contrast, the choroidal thickness (71.09±1.86 μm) and blood flow density (65.97±1.31%) in the HC eye patch group were significantly higher than those in the LIM group (P<0.05). HE staining results also confirmed that the HC eye patch group effectively reduced damage to the choroidal tissue structure and maintained choroidal thickness and normal vascular morphology, while the choroid in the LIM group was significantly thinner and the vascular arrangement was sparse and disordered.

[0045] Table 3 Comparison of choroidal thickness in guinea pigs before and after intervention Table 4 Comparison of choroidal blood flow density in guinea pigs before and after intervention 2.3 Security As shown in Table 5, after 28 days of continuous medication, there were no statistically significant differences in serum ALT, AST, BUN, and Cr levels between the high- and low-concentration eye patch groups and the blank control group (P>0.05). Choroidal histopathological tissue section results ( Figure 5 The results showed that at 2 weeks of intervention, the choroid thickness of guinea pigs in the NC group was normal, with regular tissue morphology and distinct layers. The choroidal vascular smooth muscle fiber cells were abundant, with bluish-purple nuclei, mostly spindle-shaped or oblong, arranged neatly along the vessel wall, exhibiting a dense and orderly distribution of blood vessels within the choroid. In the LIM group, the choroid thickness was significantly thinner, the cell number was significantly reduced, the vessel diameter was dilated, and the blood vessel distribution was sparse. The HC eye patch intervention group showed a slight decrease in choroid thickness, accompanied by a relative decrease in cell number and mild vascular dilation. The LC eye patch group showed changes in various indicators between the LIM and HC groups. At 4 weeks of intervention, the pathological changes in the choroid of the LIM group intensified, mainly manifested as significantly thinner thickness, a continued decrease in cell number, and a more sparse arrangement of blood vessels. In the LC and HC eye patch groups, changes such as a lower cell number and looser blood vessel arrangement still existed, but compared with the LIM group, the pathological changes did not show significant progression, with the HC eye patch group exhibiting the mildest lesions.

[0046] The results of conjunctival hyperemia, corneal fluorescein sodium staining, and conjunctival impression cytology showed no significant differences between the drug-treated groups and the blank control group (P>0.05). This indicates that the traditional Chinese medicine eye patch prepared in this invention has no irritating or toxic effects on the ocular surface or liver and kidney function.

[0047] Table 5 Comparison of serum biochemical indicators of guinea pigs in different groups after the experiment Based on the above experimental results, the herbal eye patch provided by this invention (especially the high-concentration version) can safely and effectively delay the refractive error progression and axial elongation in experimental myopic guinea pigs. Its effect is closely related to improving choroidal thickness and blood flow density and maintaining the normal structure of the choroid. Specifically, it is manifested as follows: (1) Clear myopia intervention effect: In the classic lens-induced myopia (LIM) guinea pig model, after continuous use of the eye patch of this invention (high-concentration group) for 4 weeks, the refractive error of the guinea pigs was -2.05±0.65 D and the axial length was 8.39±0.07 mm, which were significantly better than the model group's -3.52±0.46 D and 8.62±0.07 mm (P<0.05), indicating that it can significantly delay the progression of myopia. (2) Improved choroidal microcirculation: After 4 weeks of intervention, the choroidal thickness of guinea pigs in the high-concentration group of the eye patch of the present invention was 71.09±1.86μm and the blood flow density was 65.97±1.31%, both significantly better than those in the model group (61.86±1.63μm, 57.62±2.19%) (P<0.05), indicating that it can effectively increase choroidal thickness and blood perfusion, and improve oxygen supply to the posterior pole of the eyeball. (3) High safety: The results of acute eye irritation test and toxicity test (continuous administration for 28 days) showed that the eye patch of the present invention had no obvious irritation or toxicity to the conjunctiva, cornea and liver and kidney function of guinea pigs (P>0.05), and the local application was safe and reliable.

[0048] The embodiments described above are merely preferred embodiments of the present invention and are not intended to limit the scope of the present invention. Various modifications and improvements made by those skilled in the art to the technical solutions of the present invention without departing from the spirit of the present invention should fall within the protection scope defined by the claims of the present invention.

Claims

1. A traditional Chinese medicine composition for intervening in myopia, characterized in that, The traditional Chinese medicine composition, by weight, is made from the following components: 15 parts Astragalus membranaceus, 15 parts Angelica sinensis, 15 parts Paeonia lactiflora, 15 parts Ligusticum chuanxiong, 15 parts Pueraria lobata, 12 parts Prunella vulgaris, 12 parts Vitex trifolia, and 1 part Borneol.

2. A traditional Chinese medicine eye patch for intervening in myopia, characterized in that, The herbal eye patch is composed of a herbal composition and an eye patch drug-carrying matrix; The traditional Chinese medicine composition is made from the following components by weight: 15 parts Astragalus membranaceus, 15 parts Angelica sinensis, 15 parts Paeonia lactiflora, 15 parts Ligusticum chuanxiong, 15 parts Pueraria lobata, 12 parts Prunus armeniaca, 12 parts Vitex trifolia and 1 part Borneol. The drug-loaded matrix of the eye patch consists of hydrogel, glycerin, NOVETAC VP-20, NOVETAC P55N, aluminum hydroxyl, disodium EDTA, tartaric acid, BIOGUARD-CP, and NOVEPHIL 100.

3. The preparation method of the traditional Chinese medicine eye patch as described in claim 2, characterized in that, Includes the following steps: Astragalus membranaceus, Angelica sinensis, Paeonia lactiflora, Ligusticum chuanxiong, Pueraria lobata, Prunella vulgaris, and Vitex trifolia were decocted twice with water. The filtrate was concentrated under reduced pressure, dried, and pulverized to obtain a Chinese herbal extract powder. Borneol was pulverized to obtain fine borneol powder. NOVETAC VP-20, NOVETAC P55N, aluminum hydroxyacetate, and disodium EDTAC were added to glycerin and stirred to form a uniform paste-like semi-fluid, which is phase A. The herbal extract powder was dissolved in water to obtain phase B1. Water, tartaric acid, BIOGUARD-CP, and NOVEPHIL 100 were added to it and stirred to obtain phase B2. The borneol powder was dissolved in alcohol to obtain phase C. Phase B1 and phase B2 were added to a hydrogel mixer, and phase A and phase C were added in sequence and stirred to obtain a soft herbal eye patch material. The soft material of the Chinese herbal eye patch is fed into the hopper of the hydrogel coating machine. After coating, the patch is cured and cut to obtain the Chinese herbal eye patch.

4. The preparation method according to claim 3, characterized in that, The procedure of decocting twice with water is as follows: take Astragalus membranaceus, Angelica sinensis, Paeonia lactiflora, Ligusticum chuanxiong, Pueraria lobata, Prunella vulgaris and Vitex trifolia, add 10 times the volume of water, decoct for 60 minutes, filter the extract to obtain the first filtrate and the residue; add 8 times the volume of water to the residue, decoct for 60 minutes, filter to obtain the second filtrate, and combine the first filtrate and the second filtrate.

5. The preparation method according to claim 3, characterized in that, The weight ratio of the glycerin to the traditional Chinese medicine extract powder is 5:1; The weight ratio of the glycerol, NOVETAC VP-20, NOVETAC P55N, aluminum hydroxyhydroxyacetate, and disodium ethylenediaminetetraacetate is 40:12:2:0.4 to 0.44:0.

1.

6. The preparation method according to claim 3, characterized in that, In phase B1, the weight ratio of water to the traditional Chinese medicine extract powder is 79.26–81.3:8–12. In the B2 phase, the weight ratio of water, tartaric acid, BIOGUARD-CP, NOVEPHIL 100, and the traditional Chinese medicine extract powder is 57.44:0.16:0.4:0.2:8-12.

7. The preparation method according to claim 3, characterized in that, The weight ratio of the borneol powder to the alcohol is 1:

1.

8. The preparation method according to claim 3, characterized in that, The application amount is 0.4g to 0.6g of the herbal extract powder per patch.

9. The use of the traditional Chinese medicine composition as described in claim 1 or the traditional Chinese medicine eye patch as described in claim 2 in the preparation of products for treating myopia.

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