Myopia rehabilitation and ocular axis retreating preparation process

Abstract

The invention relates to the field of eye health, and discloses a myopia recovery and ocular axis retreating preparation technology, a preparation is prepared from raw stock and an active maintenance substance which are mixed according to a specific proportion, the raw stock comprises vitamin A, DHA, a marigold extract and astaxanthin algae powder, a mixed matrix composed of the blueberry and blackcurrant extract, the nut and ginger mixed juice, the Chuzhou chrysanthemum extracting solution and the celery juice is used as the balance; the preparation process comprises the following steps: extracting raw materials rich in anthocyanin by using warm water at 45-55 DEG C; and after filling and before final sterilization, refrigerating the product in an environment of 0-5 DEG C. Through strong antioxidation and microcirculation improvement functions, periorbital blood circulation and visual acuity of optic cells on the retina can be continuously improved for 24 hours, so that the lens curvature is continuously reduced, the pressure of aqueous humor applied to the sclera is reduced, meanwhile, the elastic fiber content in the sclera and the crystalline lens is gradually recovered, and the effect of improving the quality of the crystalline lens is achieved. The structures and functions of the sclera and the crystalline lens are gradually recovered, the structure of the sclera is remolded, and the ocular axis is retracted.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of eye health, in particular to a formulation process for myopia rehabilitation and regression of eye axis. BACKGROUND

[0002] Eye health compositions, generally refer to a class of foods or dietary supplements aimed at supplementing eye nutrition, relieving visual fatigue or providing support for specific physiological functions. With the increase in the use of electronic devices and the increase in academic and work pressure, maintaining visual health has become the focus of public attention, and the research and application of related functional compositions are also becoming more and more widespread.

[0003] In the prior art, there are still some problems to be improved in the composition and preparation process of related eye health products. The formula design of the existing product, the selection of functional components is often single, for example, some products only focus on providing lutein to achieve the filtering of high-energy blue light, or only supplementing vitamin A to maintain dark vision, and fail to build a multi-dimensional nutrition system covering eye structure integrity, visual function cycle, oxidative stress protection and endogenous enzyme system support. In addition, in the process of preparing these compositions, the retention of active ingredients of raw materials is a technical difficulty. Many natural extracts, especially anthocyanins and polyphenols, are sensitive to heat. Traditional extraction process often uses high temperature treatment, which inevitably leads to the degradation of these heat-sensitive substances, thereby reducing their biological potency. The chemical stability of the product is also a challenge, and the unsaturated fatty acids (such as DHA) and some vitamins in the formula are easily oxidized, and the existing technology does not fully consider the construction of a composite antioxidant system by adding multiple stabilizers. The sterilization step of the final product also has technical contradictions. Although the conventional high temperature and high pressure moist heat sterilization method can ensure commercial sterility, it will also cause a large number of inactivation of heat-sensitive functional factors, and how to balance the thoroughness of sterilization and the retention rate of active ingredients is a problem that continues to explore in the field. The existing formula design is only a simple physical mixing of multiple known beneficial ingredients, and lacks consideration of the synergistic effect between components, for example, ignoring the promotion of some ingredients to the absorption or transport of other ingredients in the body. SUMMARY

[0004] In view of the deficiencies of the prior art, the present application provides a formulation process for myopia rehabilitation and regression of eye axis, which solves the problems of single formula design dimension, easy degradation and inactivation of heat-sensitive active ingredients in the extraction and sterilization process, insufficient chemical stability of the product system, and lack of consideration of the synergistic effect between functional components in the prior art.

[0005] To achieve the above purpose, the present application is realized by the following technical scheme:

[0006] The first aspect of the present application provides a myopia rehabilitation regression eye axis preparation composition, which is prepared by mixing a base stock and active maintenance substances.

[0007] In one specific embodiment, the composition is composed of 99.9% or more of the base stock and 0.1% or less of the active maintenance substances, based on the total weight of the composition. The base stock comprises, by weight percentage, 0.8-1.2% of vitamin A, 0.8-1.2% of DHA, 0.4-0.6% of marigold extract, 0.15-0.25% of astaxanthin algal powder, 1.5-2.5% of celery juice, and the rest of the mixture matrix composed of blueberry and blackcurrant extract, Brazil nut, ginger mixed juice, and Chuzhou chrysanthemum extract.

[0008] The active maintenance substances are added in an amount of 0.015-0.025 parts by weight per 100 parts by weight of the base stock, specifically 0.015-0.025 parts by weight of EDTA and 0.015-0.025 parts by weight of palm oil.

[0009] In some embodiments of the present application, the components in the composition work together to form a multi-dimensional and multi-target eye support system. Vitamin A is the basic precursor of rhodopsin synthesis in the retina and has a direct effect on maintaining dark visual function. DHA is a key phospholipid component of the retinal photoreceptor membrane structure, and its sufficient supply helps maintain the fluidity and functional integrity of the cell membrane. Marigold extract (rich in lutein and zeaxanthin) and astaxanthin algal powder, the former is enriched in the macular area of the retina, which provides photoreceptor cells with light damage protection by absorbing high-energy blue light and scavenging active oxygen; the latter is an antioxidant that can penetrate the blood-retinal barrier and play an antioxidant role in various tissues of the eye.

[0010] Further, the blueberry and blackcurrant extract is rich in anthocyanins, which helps maintain the integrity of the ocular microvascular system and supports the blood circulation of the choroid and ciliary body, thereby ensuring the delivery of nutrients. The nut ginger mixed juice, by combining raw materials rich in selenium (Brazil nuts), provides essential metal cofactors for the key antioxidant enzyme system of superoxide dismutase (SOD) and catalase (CAT), maintaining the activity of the body's own antioxidant defense system. Chuzhou chrysanthemum extract and celery juice serve as auxiliary ingredients, providing additional natural antioxidants and micronutrients.

[0011] In addition, the active maintenance substances added to the system have specific functions. EDTA, as a metal ion chelator, is used to block free metal ions that catalyze oxidation reactions in the system. Palm oil provides a carrier for fat-soluble ingredients such as vitamin A and astaxanthin, helping to disperse and stabilize them in the aqueous matrix.

[0012] In addition, the technical effect of the composition of the present invention is not limited to ocular tissue, but also provides functional support to the overall internal environment of the body, especially high metabolic organs such as the liver and kidneys and the digestive system. After the composition enters the digestive system orally, the various antioxidant substances (such as astaxanthin and anthocyanins) it is rich in can work together to remove free radicals and superoxide ions in the body, thereby providing a wide range of antioxidant support for the body. This systemic antioxidant effect helps to reduce the oxidative stress load of detoxification and excretion organs such as the liver and kidneys, and provides a stable biochemical environment for maintaining their normal physiological functions.

[0013] At the same time, the composition can exert its specific efficacy in the gastrointestinal tract. Its role in maintaining the stability of the intestinal environment is specifically manifested in the inhibitory activity against specific enteroviruses. This inhibitory activity does not come from a single component, but is achieved through the synergy of multiple components. Among them, celery juice and Chuju extract prepared according to specific standards both contain natural compounds with direct antiviral potential. This direct effect complements the strong antioxidant environment constructed by other ingredients in the composition (such as marigold extract and vitamin A). This antioxidant environment can interfere with the redox state of host cells that certain viruses rely on during replication, thereby inhibiting the proliferation of the virus in another dimension. This combination of direct inhibition and indirect intervention helps to maintain the health and stability of the intestinal mucosa.

[0014] A second aspect of the present invention provides a process for preparing the aforementioned myopia rehabilitation preparation composition. The core of this process is to maximize the biological activity of each natural active ingredient through precisely controlled physical and chemical processing steps, while ensuring the safety and stability of the final product.

[0015] The process includes the following steps:

[0016] a) preparing various extracts and mixed juices constituting the puree matrix respectively;

[0017] b) mixing the materials prepared in step a) with vitamin A, marigold extract, DHA, and astaxanthin algae powder to form a uniform puree system;

[0018] c) adding active maintenance substances to the original pulp system and mixing again;

[0019] d) performing a filling operation on the finally obtained mixed material;

[0020] e) The filled product is sterilized by cobalt-60 irradiation.

[0021] In a preferred embodiment, the preparation of blueberry and blackcurrant extract in step a) is characterized by the following process parameters: the crushed fruits are extracted with warm water at a temperature of 45-55°C for 1.5-2.5 hours; the subsequent concentration step is also carried out at a temperature of 45-55°C under vacuum. This mild heat treatment is intended to reduce the degradation rate of the phenolic substances of heat-sensitive anthocyanins, thereby increasing their retention rate in the final product.

[0022] In another preferred embodiment, the preparation of the mixed nut ginger juice in step a) is characterized by the use of microwave heating technology to heat the mixed slurry to boiling and maintain for 8-12 minutes. As a volumetric heating method, microwave heating can achieve rapid and uniform temperature rise, achieving the goal of enzyme inactivation and reducing the microbial base while shortening the overall heating time of the material.

[0023] A significant feature of the process of the present application is the choice of the final sterilization method. In step e), cobalt 60 irradiation sterilization is used, with an irradiation absorbed dose of 6-8 kGy. This is a non-thermal processing terminal sterilization technology that can kill microorganisms without significantly increasing the temperature of the product, so it is particularly suitable for the present composition which contains a large amount of heat-labile ingredients (such as vitamins, DHA, polyphenols), and can maximize the maintenance of the original functional components of the product.

[0024] In addition, the process of the present application also includes an intermediate step between the filling and sterilization steps: the filled product is placed in a cold storage environment at 0-5°C. The purpose of this step is to inhibit the growth and reproduction of microorganisms present in the product and slow down the rate of various chemical reactions before the final irradiation sterilization is performed, providing further protection for the quality and safety of the final product.

[0025] The present application contains sufficient and high-activity anthocyanins, lutein, zeaxanthin, astaxanthin, beta-carotene and other main nutrients for eye repair, and the formula of the product is extremely perfect, and the production process is extremely meticulous, which can maximize the antioxidant effect and the improvement of the visual acuity of the retinal photoreceptor cells. It can continuously repair the visual acuity of the retinal photoreceptor cells, enhance the resolution of the retina, prevent the lens from shrinking excessively, and prevent the ciliary muscle from adjusting excessively, thereby continuously reducing the curvature of the lens, making the anterior chamber angle and aqueous humor drainage smooth, reducing the pressure of aqueous humor on the sclera, gradually restoring the shape of the sclera, remodeling the structure of the sclera, and regressing the eye axis. This process strengthens the role of the equipment matched with the preparation in activating the TGF-β (transforming growth factor-β) signaling pathway of fibroblasts in the sclera, continuously giving precise signals to the fibroblasts in the sclera to precisely degrade unstable low-quality collagen fibers and matrix, and synthesize high-quality stable collagen fibers and elastic fibers, thereby remodeling the sclera and regressing the eye axis.

[0026] In addition, the nutrients in the components of the present application can be converted to retinoic acid, which is an auxiliary signal for fibroblast remodeling of the sclera, which can both help to inhibit MMPs (matrix metalloproteinases) and promote the formation of healthy ECM through other pathways. All-trans retinoic acid (ATRA) has been shown in animal models to thicken the sclera, increase collagen synthesis and inhibit MMP activity, thereby delaying myopia progression and even regressing the eye axis.

[0027] Furthermore, the present preparation can continuously improve the blood and oxygen supply to the eye for 24 hours, protect the eye blood vessels and improve the permeability of the blood vessels, further down-regulate the HIF-1α (hypoxia-inducible factor-1α) signal, and again strengthen the TGF-β (transforming growth factor-β) signal pathway of activated fibroblasts in the sclera, accelerating the remodeling of the sclera. In addition, the continuous improvement of the blood and oxygen supply to the eye for 24 hours can improve the permeability of the vitreous body and reduce the refractive index, thereby promoting accommodation of the ciliary muscle and promoting shortening of the visual axis and reduction of scleral convexity.

[0028] The formula components can provide systemic antioxidant support to help maintain the functional stability of key metabolic organs. The composition is administered orally, and the multiple antioxidants contained therein can act on the whole body to scavenge free radicals and superoxide ions in the body, thereby helping to reduce the oxidative stress load on high-metabolism organs such as the liver and kidneys, and providing a stable internal biochemical environment for maintaining their normal physiological functions. It helps to maintain the stability of the digestive system environment, which manifests as an inhibitory effect on specific enteroviruses. This effect is achieved through the synergy of multiple components: on the one hand, specific components in the composition (such as celery juice and chrysanthemum extract) provide direct viral inhibition activity; on the other hand, the overall strong antioxidant environment indirectly interferes with the replication process of some viruses. The combination of direct and indirect effects helps to maintain the functional integrity of the intestinal mucosa system. In traditional Chinese medicine eye care prescriptions, such as "Qiju Dihuang Pill" (medicinal wolfberry, chrysanthemum, and prepared rehmannia), the visual acuity is improved by regulating the liver and kidney. Modern clinical observations show that the effective rate of such prescriptions for adolescent pseudomyopia and visual fatigue can reach more than 70%, which confirms the scientific nature of organ regulation for improving visual acuity. The visual acuity nutrient solution takes the theory of "five-organ regulation" as the core, regulates the functions of the liver, kidney, spleen, heart, and lung through pure natural plant extracts, fundamentally solves the root cause of the problem of visual acuity in the zang-fu organs, and ultimately achieves the repair of visual acuity and eye axis.

[0029] The present application provides a myopic eye rehabilitation and eye axis regression preparation process. It has the following beneficial effects:

[0030] (1) 24 hours uninterrupted improvement of eye microcirculation, improve the blood supply and oxygen supply of the eye, effectively restore the blood supply and oxygen supply of the choroid, gradually thicken the choroid, improve the self-repairing ability of the eyeball, continuously restore the content of elastic fibers in the structure of the lens and sclera, restore the accommodation ability of the lens and the toughness and elasticity of the sclera, and effectively restore the efficiency of the ciliary muscle, thereby improving the overall accommodation ability of the whole eyeball and gradually restoring the visual function of the eye.

[0031] (2) By strong antioxidant and microcirculation function, the visual acuity of the retinal macular area can be continuously improved, the resolution of the retina can be enhanced, the lens can not be excessively contracted, the ciliary muscle can not be excessively regulated, thereby continuously reducing the curvature of the lens, making the anterior chamber angle aqueous humor drainage unobstructed, reducing the pressure of the aqueous humor on the sclera, gradually restoring the shape of the sclera, and remodeling the structure of the sclera, and returning the eye axis.

[0032] (3) The present application also has the beneficial effect of delaying the excessive growth of the experimental myopia eye axis. The effect is not derived from a single component, but by organically combining the component (DHA) that maintains the stability of the sclera structure, the antioxidant (astaxanthin, anthocyanin) that directly removes active oxygen and the trace element that supports the function of endogenous antioxidant enzyme, the abnormal remodeling of the eyeball posterior segment tissue is inhibited from multiple technical dimensions, thereby macroscopically realizing the intervention of the pathological growth of the eye axis.

[0033] (4) Provide systemic antioxidant support, which helps to maintain the functional stability of key metabolic organs. The composition is administered orally, and the multiple antioxidants contained therein can act on the whole body to scavenge free radicals and superoxide ions in the body, thereby helping to reduce the oxidative stress load of the liver, kidneys and other high-metabolism organs, providing a stable internal biochemical environment for maintaining their normal physiological functions. It helps to maintain the stability of the digestive system environment, which shows inhibition of specific enteroviruses. This effect is achieved through the synergy of multiple components: on the one hand, specific components in the composition (such as celery juice and chrysanthemum extract) provide direct viral inhibition activity; on the other hand, the strong antioxidant environment of the whole composition can indirectly interfere with the replication process of some viruses. The combination of direct and indirect effects helps to maintain the functional integrity of the intestinal mucosa system.

[0034] In summary, the vision nutrition liquid takes the traditional Chinese medicine "five zang organs in harmony" as the theoretical core, regulates the functions of liver, kidney, spleen, heart and lung through pure natural plant extraction components, fundamentally solves the zang-fu root cause of vision problems, and finally realizes the repair of vision and eye axis. BRIEF DESCRIPTION OF DRAWINGS

[0035] Figure 1 The flowchart of the present application. DETAILED DESCRIPTION

[0036] The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the specification of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative work fall within the protection scope of the present application.

[0037] Embodiment 1: Preparation of the eye health composition of the present application

[0038] The embodiment provides a specific preparation method of the eye health composition.

[0039] 1. Preparation and weighing of raw materials

[0040] The following raw materials are accurately weighed for standby use:

[0041] Vitamin A (food grade): 1.0 kg; DHA (algal oil source, DHA content ≥ 40%): 1.0 kg; marigold extract (food grade, lutein content ≥ 20%): 0.5 kg; astaxanthin algal powder (Dunaliella salina powder, astaxanthin content ≥ 3%): 0.2 kg; brazil nuts: 1.5 kg; dried ginger: 1 kg; fresh blueberries: 100 kg; fresh blackcurrants: 50 kg; chrysanthemum morifolium ramat (dried product): 0.5 kg; celery juice: 2.0 kg; EDTA (food grade): 20 g; palm oil (food grade): 20 g.

[0042] 2. Preparation of extract and mixed juice

[0043] 2.1 Preparation of blueberry and blackcurrant extract

[0044] Take 100 kg of fresh blueberries and 50 kg of fresh blackcurrants, wash them with deionized water, and then put them into a crusher for crushing. Transfer the crushed fruit pulp into an extraction tank, add 1500 kg (10 times the weight) of warm water with a temperature of 50°C, and start stirring. Continuously extract at this temperature for 2 hours. Filter the extraction liquid through an 80-mesh vibrating screen to remove the fruit residue. Pump the filtrate into a disc-screw centrifuge for separation, and collect the clear supernatant. Concentrate the supernatant under reduced pressure at 50°C and a vacuum degree of -0.09 MPa until the desired concentration of concentrated juice is obtained, and then remove it for standby use.

[0045] 2.2 Preparation of enzyme activity maintaining trace element mixed juice

[0046] Take 1 kg of dried ginger, add 3 kg of water, and use a colloid mill to grind it into ginger pulp, and then filter the juice. Put the processed brazil nuts 1.5 kg and the prepared ginger juice into a high-speed homogenizing pulper together, and process them into uniform mixed slurry. Transfer the slurry into an industrial microwave heating system, heat it to a material temperature of 100°C, and maintain this boiling state for 10 minutes. After completion, remove it for standby use.

[0047] 2.3 Preparation of bactericidal component

[0048] Chrysanthemum morifolium Ramat. 0.5 kg was rinsed with clean water, and then 2 kg of clean water was added to a jacketed kettle. The mixture was heated to boiling and then maintained at a slight boiling state for 2 minutes. The clear extract was filtered and reserved. Celery juice was prepared according to an internal standard process, and 2.0 kg was accurately measured and reserved.

[0049] 3. Preparation of the final product

[0050] 3.1 Preparation of the original slurry

[0051] The blueberry blackcurrant concentrate, the nut ginger mixed juice, the Chrysanthemum morifolium Ramat. extract, and the celery juice prepared in steps 2.1, 2.2, and 2.3 were added to a sealed tank with a stirrer along with accurately weighed vitamin A (1.0 kg), marigold extract (0.5 kg), DHA (1.0 kg), and astaxanthin algae powder (0.2 kg). The mixture was stirred at medium speed until the components were uniformly distributed in the system, and 100 kg of the original slurry was finally prepared.

[0052] 3.2 Addition of active maintenance substances

[0053] Under continuous stirring, 20 g of EDTA and 20 g of palm oil were added to the 100 kg of the original slurry described above, and the stirring was continued until all the added substances were completely dissolved or uniformly dispersed.

[0054] 3.3 Filling, refrigeration, and sterilization

[0055] The final mixture was passed through a filling production line, and was quantitatively filled into pre-sterilized 50 ml brown glass bottles, which were immediately sealed. The filled products were quickly moved to a refrigerator at 2°C for storage. Finally, the refrigerated products were batched and sent to a cobalt 60 γ-ray irradiation facility for sterilization, with a set irradiation absorbed dose of 7 kGy. After sterilization, the final product of Example 1 was obtained.

[0056] Comparative Example 1: Composition lacking key photoreceptor repair substances

[0057] The preparation process was basically the same as that of Example 1, except that in the original slurry mixing stage of step 3.1, DHA and astaxanthin algae powder were not added, and the remaining components and operation steps were consistent with those of Example 1.

[0058] Comparative Example 2: Composition lacking enzyme activity maintenance trace elements

[0059] The preparation process was basically the same as that of Example 1, except that the preparation of the enzyme activity maintenance trace element mixed juice in step 2.2 was not performed, and therefore the mixed juice was not added in the original slurry mixing stage of step 3.1. The remaining components and operation steps were consistent with those of Example 1.

[0060] Comparative Example 3: Composition using traditional heat sterilization process

[0061] The preparation processes of steps 1 to 3.2 are exactly the same as Example 1. The difference is in the final sterilization step: instead of using Co60 irradiation sterilization, the filled product is placed in a moist heat sterilization equipment at 121°C for 15 minutes.

[0062] Comparative Example 4: Composition using simple physical mixing process

[0063] The total number of raw materials and total weight used in this comparative example are exactly the same as Example 1. The difference is in the preparation process: the same amount of blueberries, blackcurrants, Brazil nuts and dried ginger as in Example 1 are physically mixed with the dry powder or oil components of vitamin A, DHA, marigold extract, astaxanthin algal powder, EDTA, palm oil in the form of pretreated freeze-dried powder, followed by the addition of celery juice and water to the same final volume as in Example 1, and then stirred uniformly at high speed. The subsequent filling, refrigeration and Co60 irradiation sterilization steps are the same as in Example 1. This comparative example does not perform the specific process steps of warm water extraction, vacuum concentration and microwave heating in Example 1.

[0064] Comparative Example 5: Blank control group

[0065] It is prepared using water, 0.1% sodium citrate (excipient) and a small amount of edible colorant (caramel color), without any active ingredients described in Example 1. The final product has the same color, pH value and packaging specifications as the product in Example 1.

[0066] Test Example 1: Evaluation of ocular microcirculation and tissue biomechanical properties

[0067] This test example aims to evaluate the effects of the compositions in each group on the ocular microcirculation and key tissue biomechanical properties of experimental animals after continuous administration.

[0068] 1. Experimental method

[0069] 1.1 Experimental subjects and grouping

[0070] Healthy male guinea pigs weighing 250-300g are selected. An experimental myopia model is induced by monocular visual deprivation (wearing a translucent eye patch). The successfully modeled animals are randomly divided into 6 groups, 10 in each group, namely the Example 1 group, the Comparative Example 1 group, the Comparative Example 2 group, the Comparative Example 3 group, the Comparative Example 4 group and the Comparative Example 5 group (blank control group).

[0071] 1.2 Administration method

[0072] Each group of animals was administered the corresponding composition by gavage at a dose of 10 ml / kg body weight once daily from the day of successful modeling, and the administration was continued for 12 weeks. The comparative example 5 group was administered an equal volume of excipient solution.

[0073] 1.3 Detection index and steps

[0074] 1.3.1 Choroidal blood perfusion detection

[0075] At weeks 0 (before administration) and 12 (at the end of administration), respectively, laser Doppler flowmetry was used for detection. After intraperitoneal injection of anesthetic, the eye drops were used to fully dilate the pupils. The animals were fixed on a stereotaxic instrument, and the laser Doppler probe was vertically aligned with the temporal side of the optic disc of the fundus about 2 mm apart. The blood flow signal was recorded for 60 seconds, and the average value was taken as the choroidal blood perfusion (Blood Perfusion Units, BPU). The BPU change value (week 12 value-week 0 value) of each animal in 12 weeks was calculated.

[0076] 1.3.2 Sclera biomechanical property detection

[0077] After the detection at week 12, all animals were sacrificed, and the eyeballs were quickly removed and the sclera of the posterior segment of the eyeball was peeled off. The sclera strip with a size of 2 mm x 5 mm was cut along the equatorial direction of the eyeball. The two ends of the sclera strip were fixed on the clamps of the material universal testing machine, and uniaxial stretching was performed at a constant rate of 0.5 mm / min until the sclera strip was broken. The stress-strain data were recorded, and the Young's modulus of the sclera was calculated according to the initial linear part of the stress-strain curve, with the unit of megapascal (MPa).

[0078] 1.3.3 Choroidal thickness detection

[0079] At weeks 0 and 12, respectively, high-frequency ultrasound biomicroscopy (UBM) was used for detection. After anesthesia, the corneal surface was coated with a coupling agent, and the UBM probe was placed on the central cornea to obtain clear longitudinal B-scan images of the posterior pole of the eyeball. At 1 mm below the center of the optic disc, the vertical distance between the retinal pigment epithelial layer and the inner boundary of the sclera was measured as the choroidal thickness, with the unit of micrometers (μm). The choroidal thickness change value (week 12 value-week 0 value) of each animal in 12 weeks was calculated.

[0080] 2. Experimental results

[0081] The detection data of each group of animals were statistically analyzed, and the results are shown in Table 1.

[0082] Table 1: Test results of ocular microcirculation and tissue biomechanical properties of each group (mean ± standard deviation)

[0083]

[0084]

[0085] The experimental data show that, compared with the multiple comparative examples and the blank control, the experimental group applying the composition of Example 1 shows a net increase in choroidal blood perfusion and choroidal thickness, and the sclera Young's modulus value is the lowest among all groups. These data show that the specific composition can affect the microcirculation state and biomechanical properties of the ocular tissue. The generation of this effect is related to the anthocyanins contained in the blueberry and blackcurrant extracts in the composition, which helps to support the function of the ocular microvascular system, thereby improving the blood supply of the choroid.

[0086] By comparing the results of Example 1 with Comparative Example 1 and Comparative Example 2, it can be seen that the composition lacking DHA, astaxanthin or lacking the mixed juice of nuts and ginger has a significant decrease in the effect of improving choroidal blood flow, increasing thickness and maintaining scleral elasticity. This reveals the necessity of photoreceptor repair substances (such as DHA) and enzyme activity maintaining trace elements (such as selenium) in the composition. DHA is part of the collagen structure of the sclera, and sufficient supply is the basis for maintaining the normal biomechanical properties of the sclera; and trace elements provide functional support for the endogenous antioxidant enzyme system in the body, and synergistically protect the tissue structure from oxidative damage.

[0087] In addition, the comparison results of Example 1 and Comparative Example 3 and Comparative Example 4 highlight the importance of the specific preparation process of the present application. Comparative Example 3 using traditional heat sterilization has weakened effect, indicating the necessity of non-thermal cobalt 60 irradiation sterilization process for protecting the heat-sensitive active ingredients in the composition. Comparative Example 4 using simple physical mixing has an effect close to the blank control, which proves that a series of process steps such as warm water extraction, vacuum concentration and microwave heating play a decisive role in the effective release and preservation of active components in natural materials. Through multi-component synergy and precise process control, the composition acts on the eye circulation and tissue structure, providing a basis for maintaining the stability of the overall function of the eyeball.

[0088] Test Example 2: Evaluation of the ocular axis, refractive state and aqueous pressure

[0089] This test example aims to evaluate the effect of each group of compositions on the structural parameters of the eyeball and the visual conduction function of the experimental animals after continuous administration.

[0090] 1. Experimental method

[0091] 1.1 Experimental subjects and grouping

[0092] The experimental animals, myopia model establishment and grouping method are consistent with those described in Test Example 1.

[0093] 1.2 Administration method

[0094] The administration regimen was consistent with that described in Test Example 1, and continuous administration was performed for 12 weeks.

[0095] 1.3 Detection index and procedure

[0096] 1.3.1 Axial length and diopter detection

[0097] At weeks 0 and 12 of the experiment, A-mode biometry was performed. After the animals were anesthetized, a local anesthetic was applied to the corneal surface, and the A-mode probe was gently placed on the central cornea and perpendicular to the corneal surface. The distance between the corneal apex and the inner surface of the retina, i.e., the axial length (AL), was measured and recorded in millimeters (mm). At the same time, a handheld autorefractor was used to measure the diopter of the eyeball (Diopter), which was recorded in D. The increase in axial length (value at week 12 - value at week 0) and the shift in diopter (value at week 12 - value at week 0) over 12 weeks were calculated.

[0098] 1.3.2 Intraocular pressure detection

[0099] At weeks 0 and 12 of the experiment, tonometry was performed. After the animals were anesthetized, the tonometer probe was gently touched to the central cornea, and 5 valid readings were continuously obtained, with the average value taken as the intraocular pressure (IOP), which was recorded in millimeters of mercury (mmHg). The change in intraocular pressure (value at week 12 - value at week 0) over 12 weeks was calculated.

[0100] 1.3.3 Retinal function evaluation

[0101] At the end of week 12 of the experiment, flash visual evoked potentials (F-VEP) were detected. After the animals were dark adapted for 30 minutes, recording electrodes were placed on the scalp in the corresponding visual cortex area under anesthesia. Single-eye flash stimulation was given by a flash stimulator, and 100 evoked potential signals were recorded. The amplitude of the P1 wave (the first positive main wave) in the obtained waveform was measured and recorded in microvolts (μV).

[0102] 2. Experimental results

[0103] The detection data of the animals in each group were statistically analyzed, and the results are shown in Table 2.

[0104] Table 2: Test results of axial length, refractive state, and functional parameters in each group (mean ± standard deviation)

[0105]

[0106] The experimental data show that, compared with the comparative group and the blank control group, the experimental group applying the composition of Example 1 has the lowest amount of axial length growth and the lowest amount of diopter shift in the direction of myopia. At the same time, the intraocular pressure of this group shows a downward trend, and the F-VEPP1 wave amplitude value is the highest. These data collectively point to one conclusion: the composition has an intervention effect on inhibiting the negative changes in the structure and function of the eyeball during the development of experimental myopia.

[0107] The generation of this intervention effect is related to the improvement of retinal function by the composition. The increase in F-VEP amplitude reflects the maintenance of the functional state of retinal photoreceptor cells and visual transmission pathways. This is consistent with the mechanism of action of antioxidant substances such as astaxanthin and anthocyanin in the composition directly scavenging reactive oxygen species, and trace elements supporting the activity of endogenous antioxidant enzymes. The stability of retinal function can correspondingly reduce the regulatory load of the ciliary muscle, thereby affecting the aqueous humor circulation dynamics, and ultimately manifesting as a decrease in intraocular pressure. The decrease in intraocular pressure reduces the sustained expansion stress applied to the sclera, creating conditions for the structural stability of the sclera.

[0108] By comparing the results of Example 1 with Comparative Example 1, Comparative Example 2, it can be observed that the absence of visual cell repair substances (DHA) and enzyme activity maintenance trace elements significantly reduces the effect of the composition in controlling axial growth and maintaining retinal function. This indicates that the effect of the present application is not due to a single component, but rather the combined action of all components. Further comparison of Example 1 with Comparative Example 3 and Comparative Example 4 confirms the necessity of a specific preparation process. Traditional heat sterilization or simple physical mixing cannot achieve the effect of the present application, indicating that protecting the biological activity of active components through mild heat treatment and non-heat sterilization process is a technical prerequisite for achieving the expected intervention effect. Therefore, the present application achieves the inhibition of excessive axial growth by the combined action of specific components and the matching preparation process on retinal function and the intraocular physical environment.

[0109] Test Example 3: Evaluation of antioxidant capacity and key component content in eye tissue

[0110] This test example aims to evaluate the effect of each group of compositions on the antioxidant state and the content of specific structural components in the key tissues of the eyes of experimental animals after continuous administration.

[0111] 1. Experimental method

[0112] 1.1 Experimental subjects and grouping

[0113] The experimental animals, myopia model establishment, and grouping method are consistent with those described in Test Example 1.

[0114] 1.2 Administration method

[0115] The administration regimen was consistent with that described in Test Example 1, and the administration was continued for 12 weeks.

[0116] 1.3 Detection index and step

[0117] After the end of administration at the 12th week, all animals were sacrificed, and eyeballs were quickly removed and placed in pre-cooled normal saline. Fine dissection was performed on an ice bath, and retinal and scleral tissues were separated.

[0118] 1.3.1 Detection of endogenous antioxidant enzyme activity and oxidative stress level in eye tissue

[0119] The retinal tissue was weighed accurately and then added to pre-cooled phosphate buffer to prepare a 10% tissue homogenate using a tissue homogenizer. The homogenate was centrifuged at 3000 rpm for 10 minutes at 4°C, and the supernatant was used for subsequent detection. Commercial superoxide dismutase (SOD) and malondialdehyde (MDA) detection kits were used according to the instruction manual. The absorbance value was determined by spectrophotometer at a specific wavelength, and the SOD activity (unit: U / mg prot) and MDA content (unit: nmol / mg prot) were calculated according to the standard curve and sample protein concentration (determined by BCA method), respectively.

[0120] 1.3.2 Detection of DHA content in scleral tissue

[0121] The scleral tissue was weighed accurately, and total lipids were extracted by the chloroform-methanol method. The extracted total lipids were subjected to saponification in potassium hydroxide-methanol solution and then subjected to methyl esterification reaction in boron trifluoride-methanol solution to obtain fatty acid methyl esters (FAMEs). The prepared FAMEs sample was analyzed by gas chromatography-mass spectrometry (GC-MS). DHA was qualitatively determined by comparing the retention time with that of DHA methyl ester standard, and its relative content (weight percentage, %) in total fatty acids was calculated by peak area normalization method.

[0122] 2. Experimental results

[0123] The detection data of each group of animals were statistically analyzed, and the results are shown in Table 3.

[0124] Table 3: Test results of antioxidant indexes and component contents of eye tissue in each group (mean ± standard deviation)

[0125]

[0126] The experimental data reveal the multi-dimensional effects of the composition of the present application on the biochemical environment of the eye tissue. Compared with all the comparative examples and the blank control group, the experimental group applying the composition of Example 1 has the highest SOD activity in the retinal tissue and the lowest MDA content, and the relative content of DHA in the scleral tissue also reaches the highest level. This indicates that the composition can simultaneously act on enhancing the endogenous antioxidant defense system of the tissue and providing key structural substances for the specific tissue.

[0127] The occurrence of this effect is not dependent on a single component, but is the result of the synergistic effect of multiple components. The improvement of the retinal SOD activity is attributed to the provision of selenium metal cofactors in the nutmeg ginger mixed juice in the composition, which are essential elements constituting the active center of key antioxidant enzymes such as SOD. The significant reduction of MDA content is attributed to the improvement of endogenous SOD activity on the one hand, and to the substances such as astaxanthin and anthocyanin in the composition that can directly scavenge reactive oxygen species on the other hand. The improvement of DHA content in the sclera directly reflects the bioavailability of the component in the composition and its effective delivery and enrichment to the target tissue.

[0128] By comparing the results of Example 1 with those of each comparative example, the necessity of each component and process can be further clarified. The antioxidant index and DHA content of Comparative Example 1 lacking DHA and astaxanthin and Comparative Example 2 lacking trace elements are significantly lower than those of Example 1, proving the synergistic relationship between the photoreceptor repair substance and the enzyme activity maintenance trace elements in achieving the technical effects of the present application. The poor results of Comparative Example 3 (heat sterilization) and Comparative Example 4 (simple mixing) highlight the importance of the non-heat sterilization process and the specific extraction and concentration process adopted in the present application for protecting and releasing these bioactive substances. Therefore, the present application combines the components that maintain the stability of the scleral structure (DHA), the antioxidants that directly scavenge reactive oxygen species, and the trace elements that support the function of endogenous antioxidant enzymes, thereby collectively inhibiting the abnormal biochemical environment of the posterior segment tissue of the eyeball from multiple technical dimensions. This is mutually confirmed in terms of the mechanism with the observed inhibition of the axial length growth in Test Example 2.

[0129] Although embodiments of the present application have been shown and described, it will be understood by those of ordinary skill in the art that various changes, modifications, substitutions and alterations can be made thereto without departing from the principles and spirit of the present application, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A preparation composition for myopia rehabilitation and eye axis regression, characterized in that: It is made from a blend of puree and active maintenance substances containing the following components: The raw pulp, in terms of weight percentage, comprises: 0.8-1.2% vitamin A; 0.8-1.2% DHA; 0.4-0.6% marigold extract; 0.15-0.25% astaxanthin algae powder; 1.5-2.5% celery juice; and the balance of blueberry and blackcurrant extracts, nut ginger mixed juice, and Chuju extract; The active maintenance substance is added in an amount of: 0.015-0.025 parts by weight of EDTA; 0.015-0.025 parts by weight of palm oil.

2. The myopia rehabilitation and eye axis regression preparation composition according to claim 1, characterized in that: The blueberry and blackcurrant extracts are obtained by crushing blueberry and blackcurrant fruits, then extracting them with warm water at 45-55° C., and then performing solid-liquid separation and vacuum concentration.

3. The myopia rehabilitation and eye axis regression preparation composition according to claim 1, characterized in that: The oyster nut ginger mixed juice is prepared by mixing and pulping Brazil nuts and ginger juice, and then subjecting the mixture to microwave heating.

4. The myopia rehabilitation and eye axis regression preparation composition according to claim 1, characterized in that: The Chuju extract is obtained by boiling Chuju in water for 1.5-2.5 minutes.

5. A process based on the preparation composition according to claim 1, characterized in that: The following steps are involved: a) preparing blueberry and blackcurrant extracts, nut and ginger mixed juice, chrysanthemum extract, and celery juice respectively; b) mixing the materials prepared in step a) with vitamin A, marigold extract, DHA, and astaxanthin algae powder to prepare a puree; c) adding active maintenance substances to the slurry and mixing uniformly to obtain a final mixture; d) filling the final mixture; e) The filled product is sterilized by cobalt-60 irradiation.

6. The process according to claim 5, characterized in that The preparation of the blueberry and blackcurrant extract in step a) comprises: After the blueberries and blackcurrants are crushed, they are soaked in water at a temperature of 45-55°C for 1.5-2.5 hours, filtered, and concentrated at a temperature of 45-55°C under vacuum conditions.

7. The process according to claim 5, characterized in that The preparation of the nut ginger mixed juice in step a) comprises: After mixing and beating the raw materials, heat them in a microwave until boiling and maintain it for 8-12 minutes.

8. The process according to claim 5, characterized in that The active maintenance substance in step c) comprises EDTA and palm oil.

9. The process according to claim 5, characterized in that The radiation sterilization in step e) has an absorbed radiation dose of 6-8 kGy.

10. The process according to claim 5, characterized in that Between step d) filling and step e) sterilization, a step of refrigerating the filled product at 0-5°C is also included.

Images