Traditional Chinese medicine compound composition for treating eye diseases as well as preparation method and application of traditional Chinese medicine compound composition

Abstract

The invention provides a traditional Chinese medicine compound composition for treating eye diseases as well as a preparation method and application thereof. According to the composition, based on the traditional Chinese medicine theory of simultaneous treatment of liver and kidney and consideration of both symptoms and root causes, a formula system with three beans as a base, three herbs as a pivot and three joints as a pivot is innovatively established, and through strict compatibility of monarch, minister, assistant and guide, monarch drugs comprise mung bean coat, black bean coat and hyacinth bean coat; ministerial drugs: flos eriocauli, semen cuscutae and inula flower; the adjuvant drugs comprise cortex phellodendri, tangerine pith and fructus quisqualis; the conductant drugs comprise borneol and radix aucklandiae, so that multi-target collaborative treatment is realized. A multi-center random double-blind control test proves that the composition has a remarkable curative effect on eye diseases such as xerophthalmia, early cataract and asthenopia, the total effective rate reaches 89.7%, and no obvious adverse reaction is found.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of modernization of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine compound composition for treating eye diseases based on innovative compatibility according to traditional Chinese medicine theory, and particularly relates to an external preparation with synergistic effect of three mechanisms of nourishing yin and moistening eyes, dredging collaterals and clearing heat to protect eyes. BACKGROUND

[0002] The diversity, complexity and high rate of blindness of eye diseases continue to threaten human visual health. They include diseases of the refractive system such as myopia, hyperopia, astigmatism and presbyopia; diseases of the ocular surface such as conjunctivitis, keratitis, dry eye and blepharitis; diseases of the lens such as cataract and glaucoma; diseases of the fundus such as diabetic retinopathy, age-related macular degeneration (AMD) and retinal detachment; diseases of the optic nerve and visual pathway such as optic neuritis, anterior ischemic optic neuropathy and optic atrophy; and diseases of the eye such as chemical injury, mechanical injury and uveal melanoma.

[0003] The existing treatment of eye diseases currently faces the following technical bottlenecks: Single target limitation: existing eye drugs are mostly aimed at a single symptom, such as artificial tears for dry eye and anti-inflammatory drugs for inflammation, lacking systemic regulation.

[0004] Treating symptoms rather than the root cause: Western eye drops can quickly relieve symptoms, but cannot solve the root cause of liver and kidney yin deficiency and blockage of collaterals.

[0005] Drug penetration problem: conventional drugs are difficult to penetrate the blood-aqueous barrier, and long-term use of eye drops containing preservatives can easily cause damage to the ocular surface.

[0006] Patent CN106421198A discloses the use of a traditional Chinese medicine composition in the preparation of a medicine for treating dry eye. The therapeutic effect of the composition on dry eye is significantly enhanced after adding lily, sanchi and aconite, and it focuses on clearing heat and improving eyesight, but lacks ingredients for dredging collaterals and promoting blood circulation; patent CN1102398C discloses an eye ointment for treating myopia, which is composed of ligusticum chuanxiong, sanchi, concha margaritifera, safflower, dendrobium, cusparia, Chinese cork tree, chrysanthemum, mint, safflower, licorice, angelica, citron, plantago, poria cocos and radix codonopsis, and can dredge collaterals, open orifices, improve eyesight and regulate refractive error. The eye ointment is applied to acupoints to promote metabolism in the eye, and it emphasizes promoting blood circulation to remove blood stasis, ignoring nourishing yin and moistening dryness.

[0007] Patent CN104383168A discloses a kind of traditional Chinese medicine ointment for improving eyesight, including fuzi, chongpu, renshen, fushen, pearl, wuweizi, ziwaizi, huangbai, shengdihuang, gouqi, tusizi, dilong, red flower, huangqi, hanfangji, xuduan, winter worm summer grass and other raw materials.The traditional Chinese medicine ointment is applied on upper and lower eyelids, and in a short time, eyes moistening, eye fatigue relief, clear vision can be felt, which can effectively relieve visual fatigue and improve eyesight, with the effects of tonifying spleen and lung, tranquilizing mind and intelligence, nourishing liver and kidney, clearing heat and calming, clearing heart and relieving, clearing eyesight, benefiting essence and eyesight, nourishing liver and eyesight and the like.The same, the composition formula ignores the nourishing yin and moistening dryness in the formula. SUMMARY

[0008] The purpose of the present application is to provide a traditional Chinese medicine compound composition for treating eye diseases, with multiple efficacy synergies, multiple target regulation, disease combination, integrating the four functions of "moistening, dredging collaterals, cooling and tonifying" in one prescription, overcoming the limitations of focusing on a single aspect in the prior art.

[0009] Another purpose of the present application is to provide a preparation method of a traditional Chinese medicine compound composition for treating eye diseases, which can extract the effective components in the raw materials by decocting.

[0010] The present application solves the technical problem by using the following technical scheme.

[0011] In one aspect, the present application provides a traditional Chinese medicine compound composition for treating eye diseases, comprising the following raw materials: mung bean skin, lentil skin, black bean skin, tusizi, gugengcao, xuanfuhua, huangbai, jiluo, makejunzi, leek seed, jinyingzi, bingfen, puhuanggen, mukang, kuajinteng.

[0012] In some embodiments of the present application, the following raw materials are included by weight fraction: mung bean skin 1-3 parts, black bean skin 1-3 parts, lentil skin 1-3 parts, tusizi 2-4 parts, gugengcao 9-11 parts, xuanfuhua 7-10 parts, huangbai 6-8 parts, jiluo 4-7 parts, makejunzi 3-6 parts, leek seed 4-8 parts, jinyingzi 3-6 parts, bingfen 5-8 parts, puhuanggen 5-7 parts, mukang 5-8 parts, kuajinteng 3-7 parts, and beeswax 8-12 parts.

[0013] In some embodiments of the present application, the following raw materials are included by weight fraction: mung bean skin 2-4 parts, black bean skin 3-5 parts, lentil skin 4-5 parts, tusizi 3-5 parts, gugengcao 6-9 parts, xuanfuhua 3-5 parts, huangbai 3-6 parts, jiluo 4-8 parts, makejunzi 5-9 parts, leek seed 5-7 parts, jinyingzi 8-10 parts, bingfen 5-7 parts, puhuanggen 6-7 parts, mukang 8-10 parts, kuajinteng 5-7 parts, and beeswax 8-10 parts.

[0014] In some embodiments of the present application, the following raw materials are included by weight fraction: mung bean hull 1-3 parts, black bean hull 1-3 parts, horse gram 2-5 parts, semen cuscutae 3-6 parts, herba lepidagathis 7-9 parts, flos inulae 10-12 parts, phellodendri cortex 8-9 parts, pericarpium citri reticulatae 4-6 parts, quisqualis 4-7 parts, allium seed 6-9 parts, rosa davurica 5-8 parts, borneol 8-10 parts, radix curculiginis 7-9 parts, radix aucklandiae 9-12 parts, tetrastigma 7-10 parts, beeswax 6-10 parts.

[0015] The technical solution provided by the present application has the following innovative points: I. Composition theory innovation, the core innovation of the present application lies in establishing a three-layer three-dimensional therapy: 1. The monarch drug layer (the basis of nourishing yin and moistening the eyes) Mung bean hull (3 parts): clearing heat and reducing fire, modern research confirms that it contains vitexin which can inhibit corneal epithelial cell apoptosis; Black bean hull (3 parts): nourishing water and containing wood, rich in anthocyanins to protect retinal pigment epithelial cells; Horse gram (3 parts): invigorating spleen and removing dampness, improving tear film stability by regulating water metabolism; 2. The minister drug layer (key to clearing heat and brightening the eyes) Herba lepidagathis (10 parts): dispersing wind-heat, its flavonoid components can inhibit inflammatory factors such as IL-6 and TNF-α; Semen cuscutae (4 parts): tonifying liver and kidney, semen cuscutae polysaccharide promotes the antioxidant capacity of lens epithelial cells; Flos inulae (8 parts): descending qi and reducing phlegm, improving ocular microcirculation; 3. The auxiliary drug layer (key to dredging collaterals and opening the orifices) Phellodendri cortex (7 parts), pericarpium citri reticulatae (6 parts), and quisqualis (5 parts) are auxiliary drugs, which clear heat, dry dampness, and dredge collaterals and remove blood stasis; Borneol (6 parts) and radix aucklandiae (8 parts) are auxiliary drugs, which ascend drugs, open orifices, and penetrate membranes; Through response surface method optimization, it is found that: The three bean hulls are combined at a ratio of 1:1:1, which has the highest promotion rate for corneal epithelial cell proliferation; Herba lepidagathis and semen cuscutae are combined at a ratio of 10:4, which has the strongest protective effect on lens oxidative damage; When the amount of borneol is 6 parts, the drug corneal permeability is optimal, which is 2.3 times the conventional amount.

[0016] On the other hand, the present application provides a preparation method of a traditional Chinese medicine compound composition for treating eye diseases, comprising the following steps: S1, soak the medicinal materials in water at 5-10℃ for 2 hours, then simmer at 80-85℃ for 3-3.5 hours; S2, filtering the liquid medicine of step S1 through a 180-220 mesh filter screen, squeezing the filter residue through a squeezer at a pressure of 0.3-0.5 MPa for 20-30 minutes, combining the two filtrates and transferring them into a vacuum concentration tank, controlling the vacuum degree at -0.06 ~ -0.08 MPa and the temperature at 65±5℃, and concentrating the liquid to 1 / 3-1 / 4 of the initial soaking liquid volume; S3, under stirring, adding beeswax at 78-82℃, completely dissolving the beeswax, and continuing to stir for 40-60 minutes; S4, using a water circulation cooling system to reduce the temperature to 45-50℃ at a rate of 2-3℃ / min, adding nano-silicon dioxide, stirring uniformly, and transferring to an automatic filling machine for dispensing; S5, after filling, the ointment is aged in a constant temperature room with a humidity of ≤30% and a temperature of 10-15℃ for 24-48 hours, sterilized by ultraviolet light, and sealed and packaged.

[0017] In some embodiments of the present application, in step S3, the stirring rate is 120-150 r / min. In step S3, the beeswax is added in three portions with an interval of 10-15 minutes. In step S5, the radiation intensity of the ultraviolet light is ≥90 uW / cm 2 , and the exposure time is 30-45 s.

[0018] In a third aspect, the present application provides a use of the traditional Chinese medicine compound composition in the preparation of a medicament for treating eye diseases. Further, the use in the preparation of a medicament for improving the expression of corneal epithelial water channel protein AQP5. The eye diseases include ocular surface dysfunction, functional visual impairment, lens degenerative disease, ocular surface homeostasis disorder, functional visual impairment, and early stage of lens transparency loss.

[0019] Compared with the prior art, the embodiments of the present application have at least the following advantages or beneficial effects: (1) The present application has multiple effects synergistically, and treats both symptoms and root causes: The existing technology (such as single artificial tears, anti-inflammatory eye drops, nutritional supplements) often focuses on solving single problems such as ocular surface lubrication, inflammation or nutritional deficiency. The present application integrates multiple effects such as moisturizing (such as bean skin, cuscuta, cherry), dredging collaterals (such as orange peel, xuanfuhua, wood, wide tendon, puhuang root), cooling (such as green bean skin, huangbai, gucheng grass, ice), and kidney tonifying and essence consolidating (such as cuscuta, leek seeds, cherry) through careful matching of raw materials. The synergistic effect of each raw material not only improves the surface symptoms such as ocular surface dryness and burning (moisturizing + cooling), but also specifically regulates the possible internal pathogenesis of liver and kidney deficiency and deficiency of essence and blood (kidney tonifying and essence consolidating + moisturizing), which is an important internal pathogenesis of lens degenerative disease, and also dredges the collaterals and blood of the eye and related meridians (dredging collaterals), improves microcirculation, and may have a regulating effect on functional visual impairment (such as visual fatigue, blurred vision) and nervous factors. Achieve the effect of treating both symptoms and root causes, and make up for the shortcomings of single target treatment.

[0020] (2) Disease and syndrome combination, wider indications: Existing drugs usually target specific diseases (such as dry eye, conjunctivitis, early nutritional support for cataract) or specific symptoms (such as anti-inflammatory, lubrication). The design idea of the present application embodies the concept of treating different diseases with the same method in traditional Chinese medicine, targeting yin deficiency and heat, collateral obstruction, and liver and kidney deficiency, which is a core complex pathogenesis related to many eye diseases. Therefore, the compound composition of the present application has a wider application population and can be used simultaneously or separately for: lens degenerative disease (such as early cataract): through tonifying liver and kidney (cuscuta, leek seeds, cherry), clearing heat and improving eyesight (gucheng grass, huangbai, ice), and dredging collaterals (improving the metabolic environment of the lens) to play an auxiliary therapeutic role. Symptoms related to ocular surface dysfunction (such as dry eye, eye fatigue, burning sensation, chronic conjunctivitis): through moisturizing (bean skin), cooling and clearing heat (green bean skin, huangbai, gucheng grass, ice), and dredging collaterals (improving meibomian gland function, tear secretion and circulation) to comprehensively relieve symptoms. Functional visual impairment (such as blurred vision, fluctuating vision, visual fatigue): through dredging collaterals (orange peel, wide tendon, wood, xuanfuhua to improve blood supply and regulation function of optic nerve and ocular muscles), kidney tonifying and eyesight improving (cuscuta, gucheng grass), clearing head and eyes (ice, gucheng grass) for adjustment. Nerve eye disease (such as early optic atrophy, eye muscle paralysis auxiliary): dredging collaterals and activating blood (wide tendon, puhuang root, wood, orange peel), opening the orifices and awakening the spirit (ice), and kidney tonifying (cuscuta) may play an auxiliary supporting role. Eye skin problems (such as eyelid dermatitis, recurrent hordeolum): clearing heat and detoxifying (green bean skin, huangbai), drying (huangbai), dredging collaterals and resolving stasis (xuanfuhua, orange peel, wood) may be effective.

[0021] (3) Multi-target regulation of ocular and systemic physiology: Drugs with single components or simple combinations have relatively limited targets. This invention contains 15 herbs, covering a variety of active ingredients (such as flavonoids, alkaloids, volatile oils, polysaccharides, saponins, etc.), acting on multiple physiological processes. It can simultaneously or synergistically regulate: tear secretion and composition, ocular surface and intraocular microcirculation, antioxidant stress and anti-inflammatory response (mung bean husk, phellodendron bark, Eriocaulon buergerianum, borneol, etc.), nerve conduction and regulation (borneol), immune function, lens protein metabolism, and the functions of organs such as the liver and kidneys. It is more in line with the pathophysiological mechanisms of complex eye diseases.

[0022] (4) Natural drug combination: Compared with the side effects that may be caused by long-term use of artificial tears containing preservatives, hormone or antibiotic eye drops (such as preservative toxicity, hormone glaucoma, antibiotic resistance), as well as the liver and kidney burden of some oral Western medicines, the compound of Chinese medicinal materials in this invention has better safety and tolerability, and is more suitable for patients with chronic eye diseases who need long-term conditioning.

[0023] In summary, the traditional Chinese medicine compound formula of this invention embodies a multi-functional synergistic approach, multi-target regulation, and a combination of disease and syndrome differentiation. It integrates four effects—moisturizing, unblocking meridians, cooling, and strengthening the body—into a single formula, overcoming the limitations of existing technologies that often focus on a single aspect. It addresses the common complex pathogenesis of yin deficiency and dryness-heat, meridian obstruction, and liver and kidney deficiency, achieving both symptomatic and root-cause treatment. It covers a wide range of indications, from the ocular surface to the intraocular (lens), from functional abnormalities to degenerative changes, and from local to neuromodulation, thus broadening its application scope. Attached Figure Description

[0024] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present invention and should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0025] Figure 1 The physical sample of the composition of the present invention. Figure One ; Figure 2 The physical sample of the composition of the embodiments of the present invention. Figure Two . Detailed Implementation

[0026] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. Where specific conditions are not specified in the embodiments, conventional conditions or conditions recommended by the manufacturer shall apply. Reagents or instruments whose manufacturers are not specified are all conventional products that can be purchased commercially.

[0027] It should be noted that the embodiments in the present application and the features in the embodiments can be combined with each other in the case of no conflict. The present application will be described in detail below with reference to specific embodiments.

[0028] The features and performances of the present application will be further described in detail below in combination with embodiments.

[0029] Example 1: Treating symptoms related to ocular surface dysfunction The prescription of the traditional Chinese medicine component composition is as follows: mung bean coat 2 parts, black bean coat 3 parts, lentil coat 3 parts, dodder 2 parts, valerian 11 parts, inula flower 7 parts, golden cypress 8 parts, orange network 7 parts, quisqualis 3 parts, leek seed 4 parts, cherry fruit 6 parts, borneol 8 parts, cattail root 7 parts, costus 8 parts, wide muscle vine 7 parts, and beeswax 8 parts.

[0030] The above medicinal materials or extracts are prepared into an external ointment according to the prescription amount by the following method: S1, the medicinal materials are soaked in 5℃ mountain spring water for 2 hours, and then are placed in a perilla oil pot for decocting at 80-85℃ until slightly foaming, about 80 degrees, and are decocted for 3 hours at a small fire (about 85℃); S2, the medicinal liquid of step S1 is double-filtered through a 180-220 mesh stainless steel filter screen, the filter residue is extracted twice for 30 minutes by a presser at a pressure of 0.3-0.5 MPa, and the combined filtrate is transferred into a vacuum concentration tank, with a vacuum degree of -0.06 ~ -0.08 MPa and a temperature of 65±5℃, and is concentrated to a volume of 1 / 3-1 / 4 of the initial soaking liquid; S3, under the condition of stirring, 78-82℃, and a stirring rate of 120-150 r / min, beeswax 10 g is added in three times with an interval of 15 min, and after the complete dissolution of the beeswax, the stirring is continued for 40 min; S4, the water circulation cooling system is used to reduce the temperature to 45-50℃ at a rate of 2-3℃ / min, and nano-silicon dioxide 0.5-1.2 parts is added, and after uniform stirring, it is transferred to an automatic filling machine, and is completed in a purification workshop (cleanliness of 10,000 levels) for sub-packaging; S5, after filling, the ointment is aged in a constant temperature room with a humidity of ≤30% and a temperature of 10-15℃ for 24-48 hours, is sterilized by an ultraviolet sterilization tunnel (radiation intensity ≥90uW / cm 2 , exposure time 30-45s), and is sealed and packaged. As shown in the attached Figure 1

[0031] Effect test of the composition: ​Test subjects: 30 patients with abnormal ocular surface function (e.g. dry eye, visual fatigue). Test method: Apply the plaster once a day in the morning and evening, for 4 weeks. Results: The symptom improvement rate was 90% (eye dryness, eye itching, visual fatigue, and other symptoms were significantly relieved). Ocular surface function recovery time: average 3 days. Adverse reactions: no obvious adverse reactions, occasional mild skin allergy (incidence <2%).

[0032] Example 2: Treatment of functional visual impairment The formula of the traditional Chinese medicine component composition is as follows: green bean coat 4 parts, black bean coat 3 parts, lentil coat 4 parts, dodder seed 5 parts, valerian 6 parts, inula flower 5 parts, golden cypress 3 parts, orange network 48 parts, quisqualis 5 parts, leek seed 7 parts, gold cherry 8 parts, borneol 5 parts, cattail root 7 parts, costus 10 parts, wide muscle vine 5 parts, and beeswax 8 parts.

[0033] The compound composition of this example is prepared according to the preparation method of Example 1.

[0034] Effect test of the composition: Test subjects: 80 patients with functional visual impairment (e.g. myopia, hyperopia, blurred vision). Test method: Apply the plaster once a day in the morning and evening, for 6 weeks. Results: The visual acuity improvement rate was 70% (naked eye visual acuity increased by 0.1-0.3). Symptom relief time: average 20 days. Adverse reactions: no obvious adverse reactions.

[0035] Example 3: Treatment of lens degenerative disease The formula of the traditional Chinese medicine component composition is as follows: green bean coat 3 parts, black bean coat 3 parts, lentil coat 2 parts, dodder seed 3 parts, valerian 7 parts, inula flower 10 parts, golden cypress 8 parts, orange network 4 parts, quisqualis 7 parts, leek seed 9 parts, gold cherry 5 parts, borneol 10 parts, cattail root 9 parts, costus 12 parts, wide muscle vine 7 parts, and beeswax 6 parts.

[0036] The compound composition of this example is prepared according to the preparation method of Example 1.

[0037] Effect test of the composition: Test subjects: 40 patients with early lens degenerative disease (mild cataract). Test method: Apply the plaster once a day in the morning and evening, for 8 weeks. Results: The disease improvement rate was 75% (lens opacity was reduced). Symptom relief time: average 15 days. Adverse reactions: no obvious adverse reactions.

[0038] Example 4: Treatment of ocular surface homeostasis disorder The prescription of the Chinese medicine component composition is as follows: green bean coat 3 parts, black bean coat 2 parts, lentil coat 2 parts, dodder 6 parts, valerian 10 parts, inula flower 8 parts, golden cypress 8 parts, orange peel 7 parts, quisqualis 9 parts, leek seed 5 parts, gold cherry 9 parts, borneol 10 parts, cattail root 7 parts, costus 7 parts, wide tendon or its extract 7 parts, beeswax 8 parts.

[0039] The compound composition of the present example is prepared according to the preparation method of Example 1.

[0040] The composition effect test is as follows: Test object: 50 cases of ocular surface homeostasis disorder patients (allergic conjunctivitis, ocular surface inflammation). Test method: use the plaster once a day in the morning and evening, for 4 weeks. Results: the symptom improvement rate is 95% (eye redness, eye pain, secretion reduction). Symptom relief time: average 5 days. Adverse reactions: no obvious adverse reactions.

[0041] Example 5: treating functional visual impairment The prescription of the Chinese medicine component composition is as follows: green bean coat 2 parts, black bean coat 3 parts, lentil coat 2 parts, dodder 3 parts, valerian 6 parts, inula flower 7 parts, golden cypress 4 parts, orange peel 3 parts, quisqualis 5 parts, leek seed 5 parts, gold cherry 3 parts, borneol 5 parts, cattail root 5 parts, costus 8 parts, wide tendon 6 parts, beeswax 12 parts.

[0042] The compound composition of the present example is prepared according to the preparation method of Example 1. As shown in the accompanying Figure 2

[0043] The composition effect test is as follows: Test object: 70 cases of functional visual impairment patients (visual fatigue). Test method: use the plaster once a day in the morning and evening, for 6 weeks. Results: visual acuity improvement rate is 89% (naked eye visual acuity increases by 0.1-0.3). Symptom relief time: average 7 days. Adverse reactions: no obvious adverse reactions.

[0044] Example 6: treating loss of lens transparency The prescription of the Chinese medicine component composition is as follows: green bean coat 3 parts, black bean coat 3 parts, lentil coat 5 parts, dodder 5 parts, valerian 9 parts, inula flower 13 parts, golden cypress 20 parts, orange peel 8 parts, quisqualis 8 parts, leek seed 5 parts, gold cherry 3 parts, borneol 8 parts, cattail root 9 parts, costus 8 parts, wide tendon 7 parts, beeswax 10 parts.

[0045] The compound composition of the present example is prepared according to the preparation method of Example 1.

[0046] The composition effect test is as follows: ​Test object: 30 cases of patients with loss of lens transparency (mild cataract). Test method: Use plaster 1 time each morning and evening, for 10 weeks. Results: Disease improvement rate 60% (lens transparency partially recovered). Symptom relief time: average 10 days. Adverse reactions: no obvious adverse reactions.

[0047] Experimental example 1: multi-center randomized double-blind controlled trial Adopt three-arm design: test group (example 1), positive control group (a brand of Mingmu Dihuang pill), placebo group; Sample size: 360 cases, randomly allocated according to 1:1:1; Research period: 12 weeks; Inclusion criteria: meet the diagnostic criteria of TCM yin deficiency and collateral blockage, age 40-75 years old, dry eye score ≥8 points or early cataract (LOCS II classification I-II level), and sign the informed consent form; Exclusion criteria: severe liver and kidney dysfunction, serious eye diseases such as glaucoma and retinal detachment, and eye surgery within the past 1 month.

[0048] Dosage regimen: Test group: the eye ointment of the application, applied around the eyes 2 times a day; control group: used according to the instructions; placebo group: base ointment; Efficacy evaluation: Primary endpoint: change in TCM syndrome score; Secondary endpoints: visual acuity improvement, tear film break-up time, and lens opacity score.

[0049] The results are shown in Table 1.

[0050] Table 1 Comparison of efficacy after treatment of three groups of patients (n=120)

[0051] Statistical analysis showed that there were significant differences between the test group and the two control groups (P<0.01).

[0052] Experimental example 2: typical case analysis Case 1: Zhang, 52 years old, teacher, diagnosis: dry eye (severe), TCM syndrome: liver-kidney yin deficiency and collateral stasis; treatment: use the eye ointment of the application for 4 weeks; results: tear film break-up time was prolonged from 3s to 8s, and corneal fluorescein staining score was reduced from 6 points to 2 points.

[0053] Case 2: Li, 65 years old, retired. Diagnosis: early age-related cataract, LOCS II classification II level; treatment: use the eye ointment of the application for 12 weeks; results: lens opacity score improved by 1 level, and visual acuity improved from 0.5 to 0.7.

[0054] Example 3: Molecular mechanism study The extract of the composition of the present application can make the AQP5 mRNA expression of human corneal epithelial cells increase by 2.8 times; the protection rate of the lens epithelial cell oxidative damage induced by H2O2 is 67.3%; and the drug corneal penetration coefficient is 3.2 times of that of the conventional eye drops.

[0055] Example 4: Long-term follow-up study A 1-year follow-up was conducted on 90 patients who completed 12 weeks of treatment: the efficacy maintenance rate was 82.4%; the recurrence rate was 13.6%, which was significantly lower than that of the control group (34.2%); and the safety indicators were within the normal range.

[0056] In summary, the technical difficulty of the embodiment of the present application first proposes the theory of the composition of three beans as the base, three herbs as the pivot and three functions as the use, and breaks through the traditional single treatment method. Clinical significance: the strict clinical trial proves that the total effective rate is significantly better than that of the existing drugs (89.7% vs 73.5%, P<0.01).

[0057] Mechanism of action: up-regulation of water channel protein AQP5 expression, improvement of tear secretion; inhibition of Caspase-3 expression related to lens epithelial cell apoptosis; promotion of BDNF secretion of retinal ganglion cells; outstanding safety: 120 patients were continuously used for 12 weeks, and no serious adverse reactions were found, and there were no abnormal changes in liver and kidney function.

[0058] The above-described embodiments are part of the embodiments of the present application, rather than all the embodiments. The detailed description of the embodiments of the present application is not intended to limit the scope of the claimed application, but only represents selected embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative labor are within the scope of protection of the present application.

Claims

1. A traditional Chinese medicine compound composition for treating eye diseases, characterized in that, By weight, it includes the following ingredients: 1-3 parts mung bean husk, 1-3 parts black bean husk, 1-3 parts hyacinth bean husk, 2-4 parts dodder seed, 9-11 parts Eriocaulon buergerianum, 7-10 parts Inula japonica, 6-8 parts Phellodendron chinense, 4-7 parts Citrus reticulata peel, 3-6 parts Quisqualis indica, 4-8 parts leek seed, 3-6 parts Rosa laevigata, 5-8 parts borneol, 5-7 parts Typha orientalis root, 5-8 parts Aucklandia lappa, 3-7 parts Tinospora sinensis, 8-12 parts beeswax.

2. The traditional Chinese medicine compound composition for treating eye diseases according to claim 1, characterized in that, By weight, it includes the following ingredients: 2-4 parts mung bean husk, 3-5 parts black bean husk, 4-5 parts hyacinth bean husk, 3-5 parts dodder seed, 6-9 parts Eriocaulon buergerianum, 3-5 parts Inula japonica, 3-6 parts Phellodendron chinense, 4-8 parts Citrus reticulata peel, 5-9 parts Quisqualis indica, 5-7 parts leek seed, 8-10 parts Rosa laevigata, 5-7 parts borneol, 6-7 parts Typha orientalis root, 8-10 parts Costus root, 5-7 parts Tinospora sinensis, 8-10 parts beeswax.

3. The traditional Chinese medicine compound composition for treating eye diseases according to claim 1, characterized in that, By weight, it includes the following ingredients: 1-3 parts mung bean husk, 1-3 parts black bean husk, 2-5 parts hyacinth bean husk, 3-6 parts dodder seed, 7-9 parts Eriocaulon buergerianum, 10-12 parts Inula japonica, 8-9 parts Phellodendron chinense, 4-6 parts Citrus reticulata peel, 4-7 parts Quisqualis indica, 6-9 parts leek seed, 5-8 parts Rosa laevigata, 8-10 parts borneol, 7-9 parts Typha orientalis root, 9-12 parts Aucklandia lappa, 7-10 parts Tinospora sinensis, 6-10 parts beeswax.

4. A method for preparing the traditional Chinese medicine compound composition for treating eye diseases according to any one of claims 1-3, characterized in that, Includes the following steps: S1. Soak the medicinal materials in water at 5-10℃ for 2 hours, then boil them at 80-85℃ for 3-3.5 hours. S2, filter the medicinal liquid from step S1 through a 180-220 mesh filter, and extract the filter residue a second time for 20-30 minutes using a press at a pressure of 0.3-0.5 MPa. Combine the two filtrates and transfer them to a vacuum concentration tank, controlling the vacuum degree to -0.06 ~ -0.08 MPa and the temperature to 65±5℃, until the volume of the medicinal liquid is 1 / 3-1 / 4 of the initial soaking liquid. S3, while stirring, add beeswax at 78-82℃, and after it is completely dissolved, continue stirring for 40-60 minutes; S4 uses a water circulation cooling system to cool to 45-50℃ at a rate of 2-3℃ / min, adds nano-silica, stirs evenly, and then transfers to an automatic filling machine for dispensing; S5, after filling, the ointment is aged in a constant temperature room with humidity ≤30% and temperature 10-15℃ for 24-48 hours, then sterilized by ultraviolet light and sealed in packaging.

5. The preparation method of the traditional Chinese medicine compound composition for treating eye diseases according to claim 4, characterized in that, In step S3, the stirring rate is 120-150 r / min.

6. The preparation method of the traditional Chinese medicine compound composition for treating eye diseases according to claim 4, characterized in that, In step S3, beeswax is added in three portions, with an interval of 10-15 minutes between each addition.

7. The preparation method of the traditional Chinese medicine compound composition for treating eye diseases according to claim 4, characterized in that, In the step S5, the radiation intensity of the ultraviolet light is ≥ 90 uW / cm 2 , and the exposure time is 30-45 s.

8. The use of a traditional Chinese medicine compound composition as described in any one of claims 1-3, or a composition prepared by the method described in any one of claims 4-7, in the preparation of a medicament for treating eye diseases.

9. Use according to claim 8, characterized in that, Application in the preparation of drugs that improve the expression of aquaporin AQP5 in corneal epithelial cells.

10. Use according to claim 8, characterized in that, The eye diseases mentioned include ocular surface dysfunction, functional visual impairment, lens degeneration, ocular surface homeostasis disorder, functional visual impairment, and early stages of lens transparency loss.

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