Traditional Chinese medicine composition for preventing and improving juvenile myopia and asthenopia

Abstract

The invention relates to the technical field of medicines, and particularly discloses a traditional Chinese medicine composition for preventing and improving myopia and asthenopia of teenagers and application of the traditional Chinese medicine composition. The composition is prepared from nine medicinal materials including rhizoma gastrodiae, radix puerariae, semen cassiae, fructus lycii, semen sesami nigrum, mulberry, folium mori, mint and rhizoma imperatae, and a unique tonifying-clearing-rising three-dimensional treatment network is constructed on the basis of the compatibility concept of invigorating yang and dredging collaterals and applying clearing and tonifying at the same time. The composition can be prepared into various oral preparations such as granules, tablets, capsules, oral liquid and the like, and is suitable for preventing and treating juvenile myopia, pseudomyopia, asthenopia, eye dryness and blurred vision. Animal and clinical researches prove that the composition can effectively inhibit ocular axis growth, improve choroidal blood flow and relieve asthenopia, and has the advantages of being safe to take and suitable for long-term conditioning of teenagers.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical technology, specifically to a traditional Chinese medicine composition, preparation method, and uses. Based on the traditional Chinese medicine theories of "holistic view" and "syndrome differentiation and treatment," this composition utilizes the synergistic effects of calming the liver and extinguishing wind, relieving exterior syndromes with pungent and cool herbs, clearing heat and promoting diuresis, clearing the liver and improving eyesight, and tonifying the liver and kidneys to construct a three-dimensional "tonifying-clearing-raising" treatment network. This composition can be used as a medicine for clinical treatment, as well as as a health food or ordinary food for daily conditioning, and is particularly suitable for adolescents with heavy academic burdens and prolonged use of electronic products. Background Technology

[0002] The prevalence of myopia among children and adolescents worldwide has become one of the fastest-growing visual health burdens. With changes in learning methods, living environments, and digital device usage habits, myopia is showing a clear trend of affecting younger people globally, and this has a profound impact on future public health.

[0003] Accompanying the high incidence of myopia is the widespread prevalence of asthma. With the popularization of online education, the widespread use of digital learning tools, and the drastic reduction in outdoor activity time, the ciliary muscles of teenagers' eyes are in a state of high tension for a long time. The extraocular muscles are in a state of continuous contraction, leading to insufficient blood supply to the eyes and accumulation of metabolic products. Clinically, it often manifests as dry eyes, soreness, blurred vision, photophobia, tearing, headache, dizziness, and difficulty concentrating. If asthma is not treated or relieved in a timely and effective manner, it will further induce abnormal elongation of the axial length of the eye, accelerate the transformation from pseudomyopia to true myopia, and promote the development of low myopia to high myopia.

[0004] In the existing treatment system, interventions for myopia and eye strain in adolescents are mainly divided into two categories: Western medicine and traditional Chinese medicine. Western medicine treatments mainly include optical correction (glasses, contact lenses), drug control (such as low-concentration atropine eye drops), and surgical treatment (such as corneal refractive surgery, but usually only applicable to adults). However, optical correction can only improve vision and cannot fundamentally stop the progression of myopia. Although low-concentration atropine has a certain delaying effect, it also has side effects such as photophobia, decreased near vision, and rebound after discontinuation. Moreover, the safety of long-term use still needs to be observed over a longer period. Physical therapy, such as eye massagers, can temporarily relieve fatigue, but its effect on improving fundus microcirculation and regulating the function of the whole body's organs is very limited.

[0005] In traditional Chinese medicine, besides improper daily eye use, the development of myopia and eye strain in teenagers is most closely related to the liver and kidneys. Liver and kidney deficiency and stagnation of liver qi prevent the body's yang qi from ascending to nourish the eyes, which is a core and important cause of myopia and eye strain in teenagers. A detailed analysis of the causes is as follows: Insufficiency of the liver and kidney. Traditional Chinese medicine believes that "the liver governs the eyes and the kidney stores essence". If the essence and blood of the liver and kidney are deficient, the eye orifices will lack nourishment. As stated in "Huangdi Neijing", "The liver can see after receiving blood". For this cause, traditional representative medications include Liuwei Dihuang Pills, Qiju Dihuang Pills, Mingmu Dihuang Pills, etc. The main ingredients involve rehmannia root, cornelian cherry fruit, Chinese yam, oriental waterplantain rhizome, moutan bark, poria cocos, wolfberry fruit, chrysanthemum, angelica sinensis, white peony root, etc.

[0006] Stagnation of liver qi. The liver is in charge of dredging and regulating qi movement. If the liver qi is stagnant, qi and blood circulation will be不畅, the eye collaterals will be blocked, and the divine light cannot be emitted. For this cause, the traditional representative medication is Xiaoyao Pills, and the main ingredients involve bupleurum root, dried tangerine peel, chuanxiong rhizome, cyperus rotundus, bitter orange, peony root, liquorice root, etc.

[0007] Failure of yang qi to ascend. Insufficiency of the liver and kidney and stagnation of liver qi lead to abnormal ascending and descending of qi movement, and the body's yang qi cannot ascend to the head and face to nourish the eyes. This is the most crucial and often overlooked pathogenesis. Weakness of the spleen and stomach causes the clear yang qi not to ascend, or stagnation leads to obstruction of yang qi, resulting in unclear vision. For this cause, the traditional representative medication is Yiqi Congming Decoction, and the main ingredients involve ginseng, astragalus root, rhizoma cimicifugae, pueraria lobata, roasted liquorice root, peony root, phellodendron bark, vitex trifolia.

[0008] For the above three causes, there are classical Chinese patent medicine formulas that have withstood the test of a long history for treatment, but there is currently none on the market that can simultaneously address all three causes.

[0009] (I) Comparative analysis with the classical formula "Mingmu Dihuang Pills" The only one that can be勉强 compared with the present invention is Mingmu Dihuang Pills. Although Mingmu Dihuang Pills, on the basis of Liuwei Dihuang Pills, add chrysanthemum to relieve exterior syndrome with pungent and cool herbs, add calcined concha haliotidis to clear the liver and improve eyesight, add tribulus terrestris to calm the liver and extinguish wind, and add wolfberry fruit, angelica sinensis, and white peony root to enhance the efficacy of tonifying the liver and kidney. However, through quantitative comparative analysis of the medication categories of the two, significant deficiencies are found: According to the analysis of the herbs and dosages in the formula, the proportions of the present invention and Mingmu Dihuang Pills in each medication category are as follows: Herbs for relieving exterior syndrome with pungent and cool herbs: The proportion of the present invention is about 23.23%, while that of Mingmu Dihuang Pills is only about 6.82%.

[0010] Herbs for clearing heat and promoting diuresis: The proportion of the present invention is about 7.06%, while that of Mingmu Dihuang Pills is as high as 20.45%.

[0011] Herbs for calming the liver and extinguishing wind: The proportion of the present invention is about 4.65%, and that of Mingmu Dihuang Pills is about 6.82%.

[0012] Herbs for clearing the liver and improving eyesight: The proportion of the present invention is about 9.29%, and that of Mingmu Dihuang Pills is about 9.09%.

[0013] Herbs for tonifying the liver and kidney: The proportion of the present invention is about 55.76%, and that of Mingmu Dihuang Pills is about 56.82%.

[0014] Therefore, it is evident that the proportion of cooling and diaphoretic herbs in Mingmu Dihuang Wan (a traditional Chinese medicine formula) is relatively low, which means that while it nourishes the liver and kidneys, it cannot effectively guide Yang Qi to the head and face to nourish the eyes. Furthermore, its high proportion of heat-clearing and diuretic herbs further hinders the upward movement of Yang Qi. For middle-aged and elderly individuals, using a higher proportion of heat-clearing and diuretic herbs can enhance the efficacy of tonifying herbs on the liver and kidneys; however, for adolescents who are still growing and developing, their liver and kidney function is far stronger than that of middle-aged and elderly individuals. Therefore, after appropriately using liver and kidney tonifying herbs, the correct approach is to quickly mobilize Yang Qi to rise and reverse the decline in vision in both eyes to the greatest extent possible.

[0015] (II) Comparative Analysis with Existing Related Patent Technologies In addition to traditional classic prescriptions, the applicant also conducted an extensive search and in-depth analysis of existing related patent technologies. The comparison revealed that although some existing technologies overlap with this invention in terms of raw material selection (the maximum number of overlapping ingredients is five), they fail to meet the specific needs of adolescents with myopia who require "clearing the internal organs and promoting the flow of Yang" in terms of formulation approach, medication safety, and mechanism of action. A detailed comparative analysis is as follows: 1. Containing animal organs or excrement poses hygiene and digestive risks. Existing technologies such as CN1259843C (and CN1415222A) "Vision Enhancement Sugar and its Preparation Method" have five ingredients (cassia seed, wolfberry, mint, mulberry leaf, and black sesame) that overlap with this invention, but their core relies on animal organs such as carp eyes, rooster liver, and bull kidneys; another example is CN1123631A "Myopia Relief Tea," which has four ingredients (wolfberry, mulberry, cassia seed, and mulberry leaf) that overlap with this invention, but it uses "night-shining sand" (bat feces). Although the above solutions supplement nutrition or clear heat to some extent, animal organs and excrement pose hygiene and safety risks and have low taste acceptance. On the other hand, for adolescents with delicate spleen and stomach, consuming large amounts of rich, greasy, and dry foods can easily damage the stomach and spleen, leading to internal damp-heat, which in turn hinders the upward flow of clear yang qi to the eyes, which is not in line with the physiological characteristics of adolescents. The entire formula of this invention consists of medicinal and edible plant materials, which are safe, clean, and more suitable for long-term use by teenagers; 2. Formulas that are too complex, with dispersed medicinal effects and lacking lifting power, such as CN102028889A, "Traditional Chinese Medicine Preparations for Treating Presbyopia, Myopia, Hyperopia, and Glaucoma," although containing 5 overlapping ingredients (goji berries, cassia seeds, black sesame seeds, mulberries, and Imperata cylindrica root) with this invention, have a total of 35 ingredients. Such "large compound formulas" pile up large amounts of nourishing herbs like Rehmannia glutinosa and Cornus officinalis, resulting in excessive stagnation and cloying properties. Furthermore, their indications cover age-related diseases like presbyopia and glaucoma, lacking specificity for adolescents during their visual development period. More importantly, these large compound formulas lack "lifting" herbs to guide Yang Qi upwards, making it difficult to overcome the stagnation of Qi and blood in the eyes. This invention uses only 9 herbs, concise and refined, with a heavy emphasis on Pueraria lobata and Gastrodia elata, specifically targeting "lifting Yang and relieving muscle tension," resulting in stronger targeting. 3. Different routes of administration or product positioning fail to address the fundamental issues of the ascending and descending of Qi in the internal organs. For example, CN1660313A, "A drug for relieving fatigue and its preparation method," although it contains five herbs (peppermint, gastrodia, kudzu root, cassia seed, and mulberry leaf) that overlap with this invention, is an external application sachet (relieving symptoms through aroma). It can only temporarily relieve local symptoms through aromatic opening of the orifices and cannot improve the deficiency of liver and kidney essence and blood from the internal source. Another example is CN105919070A, "A functional food that can relieve eye fatigue." Although it contains four herbs (goji berries, black sesame seeds, mulberry leaf, and peppermint) that overlap with this invention, it mainly relies on ingredients such as blueberries and corn for nutritional supplementation and lacks the regulatory power of the "Qi transformation" function in traditional Chinese medicine.

[0016] Through the above patent comparison, although some drugs in the existing technology overlap with the present invention, no other technology can, like the present invention, precisely target the complex pathogenesis of "liver and kidney deficiency, liver qi stagnation, and failure of yang qi to rise" in adolescents without using animal organs and greasy substances. The present invention creatively integrates the three major components of "calming the liver and extinguishing wind (Gastrodia elata)," "cooling and yang-raising (Pueraria lobata)," and "nourishing the liver and kidneys (Lycium barbarum, Morus alba, and black sesame)," constructing a unique three-dimensional intervention system of "tonification-clearing-raising," which is a significant advantage that existing technologies do not possess.

[0017] In summary, existing technologies lack a traditional Chinese medicine composition that can precisely target the complex pathogenesis of myopia in adolescents—namely, "liver and kidney deficiency, liver qi stagnation, and failure of yang qi to ascend"—and can both tonify the liver and kidneys and relieve liver qi stagnation, as well as effectively guide yang qi upwards and improve blood and oxygen supply to the eyes. Furthermore, it should be convenient to take, highly safe, and suitable for long-term use. This invention was developed against this backdrop through in-depth theoretical research and practical screening. Summary of the Invention

[0018] Given the insufficient depth of understanding of myopia in existing technologies, this invention aims to overcome the limitations of traditional Chinese medicine formulation strategies for the prevention and treatment of myopia and eye strain in adolescents, and to provide a Chinese medicine composition that integrates prevention, treatment and improvement.

[0019] The core design concept of this invention is to take "raising yang and unblocking the meridians, and combining clearing and tonifying" as the general principle, and systematically and holistically solve the complete pathological chain of "liver and kidney deficiency (fundamental deficiency) - liver stagnation and fire (superficial excess) - failure of yang qi to rise (mechanism failure)" in adolescent myopia through multi-target and three-dimensional combination.

[0020] To achieve this goal, the present invention adopts a unique formulation strategy. First, it abandons the popular approach of using large amounts of greasy and stomach-damaging ingredients such as Rehmannia glutinosa in traditional prescriptions, and instead uses medicines that are both food and medicine, and are light and refreshing, in order to conform to the physiological characteristics of adolescents who are "clear and pure in their internal organs". Second, based on the physiological logic that "the eyes need Yang to see", this composition, on the basis of nourishing the liver and kidneys, uses a large amount of pungent and cool dispersing ingredients, aiming to strongly guide the essence and blood to rise and flow to the eyes.

[0021] In summary, the technical objective of this invention is to effectively prevent and improve myopia and eye strain in adolescents by nourishing the liver and kidneys while clearing liver qi stagnation, thereby guiding yang qi upward.

[0022] This invention discloses a composition for preventing and improving myopia and eye fatigue in adolescents. By weight, it consists of 1 part of liver-calming and wind-extinguishing medicinal materials, 2 parts of heat-clearing and diuretic medicinal materials, 2 parts of liver-clearing and vision-improving medicinal materials, 5 parts of pungent and cool exterior-releasing medicinal materials, and 10 parts of liver-tonifying and kidney-tonifying medicinal materials.

[0023] Liver-calming and wind-extinguishing medicinal materials refer to those used to suppress liver yang, extinguish internal wind, and calm the mind. Traditional Chinese medicine believes that the liver governs the free flow of qi; if liver yang is excessive or yin and blood are deficient, wind is easily generated, manifesting as dizziness, tremors, convulsions, eye distension, and fluctuating vision. The application of liver-calming and wind-extinguishing drugs aims primarily at harmonizing liver yang, calming the mind, and extinguishing wind and stopping spasms. In summary, liver-calming and wind-extinguishing drugs include abalone shell, oyster shell, mother-of-pearl, hematite, gastrodia elata, uncaria, tribulus terrestris, and silkworm pupae. For symptoms of internal liver wind and dizziness, this invention preferably uses gastrodia elata.

[0024] Heat-clearing and diuretic herbs are mainly used to clear damp-heat and promote urination. Traditional Chinese medicine believes that damp-heat obstruction, failure of the middle jiao to ascend, and congestion of the lower jiao often lead to scanty dark urine, fatigue, blurred vision, and even damp-heat disturbing the sensory orifices. Heat-clearing and diuretic herbs include Coptis chinensis, Gardenia jasminoides, Poria cocos, Alisma plantago-aquatica, Plantago asiatica, Imperata cylindrica, Talcum, Akebia trifoliata, Tetrapanax papyriferus, and Phaseolus angularis. For stagnation in the liver, a pathway must be established to expel it from the body. This invention preferentially uses Imperata cylindrica because its heat-clearing effect is mild and does not affect the upward movement of yang qi. Furthermore, the interconnected segments and long, thin rootlets of Imperata cylindrica, from the perspective of traditional Chinese medicine's analogical thinking, should have a good effect on unblocking the meridians, which is more conducive to the upward movement of yang qi and the relief of liver stagnation.

[0025] Liver-clearing and vision-improving medicinal herbs refer to those that can clear heat stagnation in the liver meridian, dispel wind-evil, and improve eye symptoms such as blurred vision, red and swollen eyes. Traditional Chinese medicine believes that the liver opens into the eyes; liver heat, liver stagnation, or wind-heat attacking the upper body can all lead to malnourishment of the eyes. Medicinal herbs for clearing the liver and improving vision include Prunella vulgaris, Gentiana scabra, Celosia argentea, Chrysanthemum morifolium, Vitex trifolia, Cassia tora, and Dendrobium nobile. Targeting the common problems of dry eyes, eye fatigue, and wind-heat in the liver meridian among modern teenagers, this invention preferentially uses Cassia tora, which, in addition to its good liver-clearing and vision-improving effects, can also aid bowel movements. Together with Imperata cylindrica, it opens channels in the body to expel stagnant substances from the liver.

[0026] Cooling and pungent exterior-releasing herbs are mainly used to dispel external wind-heat and promote lung qi circulation. Traditional Chinese medicine believes that wind-heat pathogens invading the skin surface often cause fever, headache, dry throat, red eyes, and eye swelling and discomfort. Cooling and pungent exterior-releasing herbs generally have the effect of dispelling wind and heat, and releasing pathogenic factors. These mainly include peppermint, chrysanthemum, mulberry leaves, angelica dahurica, burdock fruit, bupleurum, and kudzu root. Their characteristics are a pungent and cool nature, and they are particularly effective for redness, swelling, and pain in the eyes. For symptoms of wind-heat attacking the exterior, red and swollen eyes, and blurred vision, this invention preferentially uses mulberry leaves, peppermint, and kudzu root—three cooling and pungent exterior-releasing herbs. Kudzu root, though buried deep underground, has the medicinal power to dispel stagnant heat in the head and face. From the perspective of traditional Chinese medicine's analogical thinking, its ability to assist yang qi to rise from the liver and kidneys to the head and face is very strong. As the core ingredient of this invention, liver and kidney tonifying herbs aim to nourish liver blood and kidney essence, thus nourishing the eyes. Traditional Chinese medicine believes that "the liver governs the eyes, and the kidneys store essence," and that myopia and eye strain in adolescents are closely related to liver and kidney deficiency. Liver and kidney tonifying herbs include wolfberry, privet fruit, mulberry, eclipta prostrata, rehmannia root, black sesame, achyranthes root, and dodder seed. This invention specifically selects wolfberry, black sesame, and mulberry as the preferred liver and kidney tonifying herbs for blurred vision and difficulty seeing distant objects caused by liver and kidney deficiency and malnourishment of the eyes.

[0027] The five types of drugs mentioned above work together synergistically to achieve good results in preventing and improving male sexual dysfunction.

[0028] Existing traditional Chinese medicines for preventing and improving myopia and eye strain in adolescents each have their own focus. Some nourish the liver and kidneys, such as Qiju Dihuang Wan and Mingmu Dihuang Wan derived from Liuwei Dihuang Wan; some relieve liver stagnation, such as Xiaoyao Wan; and some promote the rise of Yang Qi, such as Yiqi Congming Tang. However, there is no medicine that can address all three of the above-mentioned causes. In response to the above shortcomings, this invention provides a medicine combination that has multiple effects, including nourishing the liver and kidneys, relieving liver stagnation, and promoting the rise of Yang Qi. Through the combination of nine medicinal materials, it achieves comprehensive conditioning that addresses both the symptoms and the root cause, thereby effectively solving myopia and eye strain in adolescents.

[0029] Specifically, the formula of this invention primarily uses wolfberry, black sesame, and mulberry to nourish the liver and kidneys. Wolfberry focuses on nourishing the liver and kidneys, while mulberry focuses on nourishing liver blood. These two ingredients work synergistically to prepare the body for the ascent of Yang energy from the liver. Black sesame focuses on nourishing kidney essence. The kidneys are the foundation of all Yang energy in the body; without a continuous supply from the kidneys, there cannot be enough Yang energy to ascend from the liver. Therefore, the liver is responsible for movement, and the kidneys for strength; only by nourishing both can sufficient and powerful Yang energy be delivered to the eyes. Kudzu root, mint, and mulberry leaves are used as supplementary ingredients to clear away stagnant heat and further promote the supply of Yang energy to the eyes. Combined with gastrodia elata to calm the liver and extinguish wind, and cassia seed and imperata root to expel stagnation from the liver, the liver can focus on delivering Yang energy to the eyes efficiently and without being affected by various factors.

[0030] The composition of the present invention has the following technical advantages: High safety: All ingredients are food-grade medicines, making them especially suitable for long-term conditioning in teenagers.

[0031] Highly targeted: It has a triple effect of nourishing the liver and kidneys, relieving liver stagnation, and promoting the rise of Yang energy, covering all factors that affect the eyesight of teenagers.

[0032] Complementary medicinal properties: Wind-dispelling and heat-clearing drugs rapidly improve the local environment of the eyes, relieving eye fatigue and soreness and distension caused by liver heat; liver-tonifying and kidney-tonifying drugs enhance the nutritional supply to the eyes, laying the foundation for the restoration of visual function; muscle-relaxing and meridian-clearing drugs relieve tension in the neck and periorbital muscles, improving the ciliary muscle's accommodation ability; damp-heat-clearing drugs maintain the overall environmental stability and prevent the tonifying drugs from causing stagnation, thus forming a multi-level regulatory system that combines "clearing, tonifying, dredging, and moisturizing".

[0033] The composition provided by the present invention, by weight, consists of the following raw materials: 1 part Gastrodia elata, 1.5-2.5 parts Pueraria lobata, 1.5-2.5 parts Cassia tora, 3.5-4.5 parts Lycium barbarum, 3.5-4.5 parts black sesame, 3.5-4.5 parts mulberry, 1.5-2.5 parts mulberry leaf, 0.5-1.5 parts peppermint, and 1.2-2.0 parts Imperata cylindrica.

[0034] Preferred ingredients, by weight, include: 1 part Gastrodia elata, 2 parts Pueraria lobata, 2 parts Cassia tora, 4 parts Lycium barbarum, 4 parts black sesame, 4 parts mulberry, 2 parts mulberry leaf, 1 part peppermint, and 1.5 parts Imperata cylindrica.

[0035] The compositions provided by this invention can be prepared into oral formulations. These oral formulations may contain a pharmaceutically acceptable carrier. All dosage forms suitable for oral administration are applicable to the compositions of this invention, such as pills, tablets, capsules, granules, suspensions, powders, oral liquids, chewable tablets, etc. Granules and oral liquids are particularly suitable when formulated as food products.

[0036] This invention provides a method for preparing a composition, in which all medicinal materials are pulverized to a particle size of less than 80 mesh. Various formulations are then prepared using conventional methods. Appropriate excipients can be added to produce tablets, granules, etc. To prevent moisture absorption, a coating layer can be added to the outside of the formulation.

[0037] While maintaining the core therapeutic composition unchanged, some medicinal herbs, such as jujubes and monk fruit, can be added to improve the taste, aroma, and appearance. An appropriate amount of natural honey can also be added for flavoring. Furthermore, those skilled in the art can routinely choose to add pharmaceutically acceptable flavoring agents or coloring agents; these auxiliary additions will not substantially affect the core therapeutic effect of the present invention.

[0038] The present invention also provides the use of the composition in the preparation of articles for the prevention and improvement of myopia, pseudomyopia and eye strain in adolescents.

[0039] The products mentioned therein can be pharmaceuticals, health foods, or ordinary foods.

[0040] The stated purpose is to improve blurred vision, dry eyes, soreness, and lack of concentration caused by myopia and eye strain in adolescents, relieve ciliary muscle spasm, improve microcirculation of blood and qi in the eyes, and prevent the transformation of pseudomyopia into true myopia and the progression of low myopia into high myopia.

[0041] The composition of this invention can be taken orally at a dose of 50-60 grams per day, divided into two doses, preferably once in the morning and once in the evening. The dosage can be adjusted according to the user's degree of myopia, degree of eye strain, daily eye use intensity, age, and physical condition. Detailed Implementation

[0042] Example 1: Preparation of fine powder Take 1 kg of Gastrodia elata, 2 kg of Pueraria lobata, 2 kg of Cassia tora, 4 kg of Lycium barbarum, 4 kg of black sesame seeds, 4 kg of mulberry fruit, 2 kg of mulberry leaves, 1 kg of peppermint, and 1.5 kg of Imperata cylindrica root. Dry each of the above medicinal materials separately at about 65℃ for 60 hours, then grind them into powder using a pulverizer, pass them through an 80-mesh sieve, and mix the powders to obtain a fine powder.

[0043] Example 2: Preparation of fine powder Take 1 kg of Gastrodia elata, 1.5 kg of Pueraria lobata, 1.5 kg of Cassia tora, 3.5 kg of Lycium barbarum, 2 kg of black sesame seeds, 3.5 kg of mulberry fruit, 1.5 kg of mulberry leaves, 0.5 kg of peppermint, and 1.2 kg of Imperata cylindrica root. Dry each of the above medicinal materials separately at about 65℃ for 60 hours, then grind them into powder using a pulverizer, pass them through an 80-mesh sieve, and mix the powders to obtain a fine powder.

[0044] Example 3: Preparation of fine powder Take 1 kg of Gastrodia elata, 2.5 kg of Pueraria lobata, 2.5 kg of Cassia tora, 4.5 kg of Lycium barbarum, 4.5 kg of black sesame seeds, 4.5 kg of mulberry fruit, 2.5 kg of mulberry leaves, 1.5 kg of peppermint, and 2.0 kg of Imperata cylindrica root. Dry each of the above medicinal materials separately at about 65℃ for 60 hours, then grind them into powder using a pulverizer, pass them through an 80-mesh sieve, and mix the powders to obtain a fine powder.

[0045] Example 4: Preparation of fine powder Take 1 kg of Gastrodia elata, 2 kg of Pueraria lobata, 2 kg of Cassia tora, 4 kg of Lycium barbarum, 4 kg of black sesame seeds, 4 kg of mulberry, 2 kg of chrysanthemum, 1 kg of peppermint, and 1.5 kg of Imperata cylindrica. Dry each of the above medicinal materials separately at about 65℃ for 60 hours, then grind them into powder using a pulverizer, pass them through an 80-mesh sieve, and mix the powders to obtain a fine powder.

[0046] Example 5: Preparation of fine powder Take 1 kg of Uncaria rhynchophylla, 2 kg of Pueraria lobata, 2 kg of Cassia tora, 4 kg of Lycium barbarum, 4 kg of black sesame seeds, 4 kg of mulberry fruit, 2 kg of mulberry leaves, 1 kg of peppermint, and 1.5 kg of Imperata cylindrica root. Dry each of the above medicinal materials separately at about 65℃ for 60 hours, then grind them into powder using a pulverizer, pass them through an 80-mesh sieve, and mix the powders to obtain a fine powder.

[0047] Comparative Example 1: Preparation of Fine Powder Take 1 kg of Gastrodia elata, 0.5 kg of Pueraria lobata, 2 kg of Cassia tora, 4 kg of Lycium barbarum, 4 kg of black sesame seeds, 4 kg of mulberry fruit, 2 kg of mulberry leaves, 1 kg of peppermint, and 1.5 kg of Imperata cylindrica root. Dry each of the above medicinal materials separately at about 65℃ for 60 hours, then grind them into powder using a pulverizer, pass them through an 80-mesh sieve, and mix the powders to obtain a fine powder.

[0048] Comparative Example 2: Preparation of Fine Powder Take 1 kg of Gastrodia elata, 2 kg of Pueraria lobata, 2 kg of Cassia tora, 6 kg of Lycium barbarum, 4 kg of black sesame seeds, 4 kg of mulberry fruit, 2 kg of mulberry leaves, 1 kg of peppermint, and 1.5 kg of Imperata cylindrica root. Dry each of the above medicinal materials separately at about 65℃ for 60 hours, then grind them into powder using a pulverizer, pass them through an 80-mesh sieve, and mix the powders to obtain a fine powder.

[0049] Example 6: Preparation of Compound Traditional Chinese Medicine Formula Granules (10g / bag) I. Prescription Information

[0050] According to the prescription and process parameters of this embodiment, the final 10-gram compound Chinese medicine formula granules prepared have an effective drug component equivalent to about 30 grams of raw medicinal materials.

[0051] II. Preparation Method This embodiment employs modern integrated production technology for traditional Chinese medicine formula granules, and performs step-by-step and coupled processing on the physicochemical properties of different medicinal materials. The specific steps are as follows: 1. Extraction and inclusion of peppermint volatile oil Weigh 10 kg of peppermint herbs and place them in a multi-functional extraction tank. Add 8 times the amount of water and extract the volatile oil using steam distillation. Collect the distilled volatile oil (approximately 0.1 kg) for later use. Collect the distilled aqueous solution (peppermint aromatic water) separately, and retain the peppermint residue.

[0052] Take 0.8-1.0 kg of β-cyclodextrin (6-8 times the amount of volatile oil), add an appropriate amount of water to prepare a saturated aqueous solution, place it in a container equipped with stirring and temperature control, stir at 45±2℃ and 800-1200 rpm, slowly add the extracted peppermint volatile oil, and continue stirring under these conditions for 2 hours after the addition is complete to ensure that the inclusion reaction is fully and completely completed.

[0053] The inclusion solution was refrigerated at 4°C and allowed to stand for 24 hours. After the inclusion compound was fully separated, it was filtered. The precipitate was dried under vacuum at 40°C to constant weight and then pulverized through an 80-mesh sieve to obtain peppermint oil β-cyclodextrin inclusion compound powder.

[0054] 2. Degreasing pretreatment of black sesame seeds Weigh 40 kg of black sesame seeds, roast them over a low flame until fragrant, then grind them into powder. Remove the oil using hydraulic cold pressing or subcritical fluid extraction technology, controlling the residual oil content of the sesame meal after defatting to below 15%. Collect the completely defatted black sesame meal for later use. This is to prevent the finished product from oxidizing and becoming rancid during storage, and to improve the filtration performance of the subsequent extract and the yield of the spray-dried product.

[0055] 3. Comprehensive extraction and vacuum concentration Gastrodia elata, kudzu root, cassia seed, wolfberry, mulberry, mulberry leaf, Imperata cylindrica root, the above defatted black sesame meal and peppermint residue are combined and put into a multi-functional extraction tank.

[0056] For the first decoction, add 10 times the amount of water, soak for 30 minutes, heat to a boil, then maintain a gentle boil and decoct for 1.5 hours. Filter, collect the filtrate, and set aside.

[0057] For the second decoction, add 8 times the amount of water to the dregs, heat to a boil, then maintain a gentle boil for 1 hour before filtering.

[0058] Combine the two filtrates, then add the peppermint aromatic water collected in step 1. The mixed extract is then purified by centrifugation to remove fine medicinal residues and precipitates.

[0059] The purified extract was placed in a double-effect vacuum concentrator and concentrated under reduced pressure at a vacuum of -0.07 MPa and a temperature of 65°C to a thick extract with a relative density of 1.15-1.20 (measured at 60°C). The solid content of the extract was then determined.

[0060] 4. Spray drying and dry granulation For preparation, calculate the dry paste volume based on the solid content of the thick extract, and add dextrin equivalent to 30%-50% of the dry paste volume as an anti-sticking agent, stirring thoroughly to dissolve. For drying, use a high-speed centrifugal spray dryer, setting the inlet air temperature to 175-185℃ and the outlet air temperature to 80-90℃, keeping the atomizer frequency or pressure stable, and automatically adjusting the feed rate according to the outlet air temperature.

[0061] Control the solid content of the feed liquid to 15%-25% (w / w) and collect the dry extract powder from the bottom of the tower and the cyclone separator.

[0062] For the final mixing, add the dry extract powder, the peppermint oil β-cyclodextrin inclusion complex powder prepared in step 1, and steviol glycosides into a three-dimensional motion mixer and mix for 30 minutes until homogeneous.

[0063] Granulation is performed using a dry granulator. Under a pressure of 3-5 kN / cm, the uniformly mixed powder is extruded into dense flakes, which are then crushed and granulated into 12-40 mesh particles through a crushing and granulation system. The proportion of particles in this size range is not less than 90%.

[0064] 5. Packaging and Specifications The packaging is done using a polyester / aluminum / polyethylene composite film that meets pharmaceutical packaging requirements (recommended oxygen permeability ≤0.5 cm³ / (m²·24h·atm), water vapor permeability ≤1.0 g / (m²·24h)) in strip bags, with each bag weighing 10 grams net.

[0065] Experimental Example 1: An animal study on myopia control based on a form deprivation model 1. Animal experiments a) Experimental Animals and Modeling Methods: Sixty healthy tricolor guinea pigs, 3 weeks old and weighing 200-250g, were purchased from a professional experimental animal center. Form deprivation myopia (FDM) was used to induce the model. Except for the normal control group, the remaining guinea pigs wore a semi-transparent headgear with 60% light transmittance in one eye (right eye) to induce form deprivation myopia for 4 weeks. b) The test environment was 22~25°C, humidity 45%~65%, lighting time 12 hours / day (500 lux), and free access to food and water; c) After 3 days of adaptive feeding, 60 guinea pigs were randomly divided into 6 groups: the high (HD), medium (MD), and low (LD) dose groups of Example 1, the positive control group (PC), the model group (FDM), and the normal control group (NC), with 10 guinea pigs in each group; d) Preparation of test drug Each group of test samples (fine powder from Example 1) was accurately weighed and added to distilled water, then sonicated for 30 minutes to prepare a homogeneous suspension of the target concentration. Based on the adult clinical daily dose of 50-60 grams (approximately 55 grams based on an adult standard weight of 60 kg), as clearly stated in the specification, the equivalent dose for guinea pigs was calculated using the "equivalent dose coefficient conversion method based on human and animal body surface area," yielding an estimated clinical equivalent medium dose of approximately 9.2 g / kg. To investigate a clear dose-response relationship, the medium dose group (MD) was set at 9.2 g / kg, the high dose group (HD) at twice the clinical equivalent medium dose (18.4 g / kg), and the low dose group (LD) at 0.5 times the clinical equivalent medium dose (4.6 g / kg). The positive control group received 0.05% atropine eye drops. The model group and the normal control group were administered an equal volume of physiological saline by gavage. e) Test methods The normal control group received no intervention. The model group wore a headgear and was administered physiological saline by gavage. In Example 1, each dosage group wore a headgear and was administered the corresponding dose of drug suspension by gavage at 9:00 AM daily, with a dosage volume of 10 mL / kg. The positive control group wore a headgear and received 0.05% atropine eye drops once daily, with a dosage volume of 5 μL. Administration continued for 4 weeks.

[0066] 2. Detection indicators Before the start of the trial and at the end of the fourth week, the refractive power (D) was measured using an infrared eccentric refractometer, and the axial length (AL) was measured using high-frequency A-mode ultrasound.

[0067] Test results Table 1. Changes in refractive error and axial length of guinea pigs in each group (mean ± SD)

[0068] 4. Experimental Conclusions a) Refractive error and axial length control: Compared with the model group (FDM), all dose groups in Example 1 significantly inhibited myopic drift and excessive axial elongation caused by form deprivation, and the effect was dose-dependent. Among them, the high-dose group in Example 1 showed the best symptom relief, with an average change in refractive error of -0.85 D and an average axial elongation of 0.08 mm. Furthermore, the symptom relief in each group of Example 1 showed a dose-response relationship, and the myopia control effect was significant. b) Consistent with the efficacy trend of positive drugs, the positive control group (atropine eye drops) also showed a clear myopia control effect, while the present invention, through oral administration, achieved a similar control trend to classic topical treatment drugs in animal models, proving the effectiveness of its systemic administration. c) Demonstrating the advantages of multi-target therapy: This invention is based on the theory of "tonifying-clearing-raising" and takes effect by regulating the whole body state through oral administration (such as tonifying the liver and kidneys and raising yang qi). Its mechanism of action is fundamentally different from the single mechanism of atropine through local ciliary muscle paralysis. It provides a new approach to myopia prevention and control that is oral, multi-target, and holistic.

[0069] The results of this study show that the formulation of Example 1 can not only effectively inhibit myopic drift and excessive elongation of the axial length caused by visual deprivation, but also, compared with the positive control group, Example 1 also shows a consistent trend with the simple anticholinergic drug (atropine), confirming the scientific nature of the "supplement-clear-lift" three-dimensional treatment network.

Claims

1. A traditional Chinese medicine composition for preventing and improving myopia and eye strain in adolescents, characterized in that, It is composed of the following raw materials: herbs that calm the liver and extinguish wind, herbs that relieve exterior syndromes with pungent and cool properties, herbs that clear heat and promote diuresis, herbs that clear the liver and improve eyesight, and herbs that tonify the liver and kidneys.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The herbs for calming the liver and extinguishing wind are selected from Gastrodia elata; the herbs for relieving exterior syndromes with pungent and cool properties are selected from Pueraria lobata, Morus alba, and Mentha haplocalyx; the herbs for clearing heat and promoting diuresis are selected from Imperata cylindrica; the herbs for clearing the liver and improving eyesight are selected from Cassia tora; and the herbs for tonifying the liver and kidneys are selected from Lycium barbarum, black sesame, and Morus alba.

3. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that, By weight, it consists of the following active pharmaceutical ingredients. Composition: 1 part Gastrodia elata, 1.5-2.5 parts Pueraria lobata, 1.5-2.5 parts Cassia tora, 3.5-4.5 parts Lycium barbarum, 3.5-4.5 parts black sesame, 3.5-4.5 parts mulberry, 1.5-2.5 parts mulberry leaf, 0.5-1.5 parts peppermint, and 1.2-2.0 parts Imperata cylindrica.

4. The traditional Chinese medicine composition according to claim 3, characterized in that, The preferred proportions of the raw materials by weight are: 1 part Gastrodia elata, 2 parts Pueraria lobata, 2 parts Cassia tora, 4 parts Lycium barbarum, 4 parts black sesame, 4 parts mulberry, 2 parts mulberry leaf, 1 part peppermint, and 1.5 parts Imperata cylindrica.

5. An oral preparation, characterized in that, Includes the traditional Chinese medicine composition according to any one of claims 1-4.

6. The oral formulation according to claim 5, characterized in that, It also includes pharmaceutically acceptable carriers.

7. The oral formulation according to claim 5 or 6, characterized in that, The dosage forms of the oral preparations are pills, tablets, capsules, granules, suspensions, powders, oral liquids, mixtures, or syrups.

8. A method for preparing the oral formulation of claim 5, characterized in that, Includes the following steps: (1) Weigh out the following ingredients in proportion: Gastrodia elata, Pueraria lobata, Cassia tora, Lycium barbarum, black sesame, mulberry, mulberry leaf, mint, and Imperata cylindrica root, and clean them to remove impurities. (2) Obtain the intermediate product using any of the following methods: Method A: Crush the cleaned raw materials and pass them through an 80-120 mesh sieve to obtain a mixed fine powder; Method B: The cleaned raw materials are boiled with water to extract the extract, and the extract is concentrated into a paste; (3) The fine powder and / or extract obtained in step (2) are mixed with a pharmaceutically acceptable carrier and formulated into pills, tablets, capsules, granules, suspensions, powders, oral liquids, mixtures or syrups according to the target dosage form.

9. The use of the traditional Chinese medicine composition according to any one of claims 1-4 in the preparation of medicines, health foods or ordinary foods for the prevention and treatment of myopia, pseudomyopia, eye fatigue, dry eyes and blurred vision in adolescents.

10. The application according to claim 9, characterized in that, The mechanisms of action of the aforementioned drugs or health foods involve calming liver yang, dispersing wind-heat, clearing damp-heat, nourishing the liver and kidneys, and guiding yang qi upward to nourish the eyes.

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