A traditional Chinese medicine composition for treating age-related macular degeneration and a preparation method thereof

Abstract

The application discloses a traditional Chinese medicine composition for treating senile macular retinal degeneration and a preparation method thereof. The traditional Chinese medicine composition is prepared from wolfberry fruit, chrysanthemum, milkvetch seed, dendrobium, panax notoginseng, raw safflower, and radix puerariae according to certain weight ratios. The traditional Chinese medicine composition is prepared into an oral preparation and has the effect of treating senile macular retinal degeneration.

Description

TECHNICAL FIELD

[0001] The present application relates to a traditional Chinese medicine composition for treating senile macular retinal degeneration and a preparation method thereof, and belongs to the field of traditional Chinese medicines. BACKGROUND

[0002] Senile macular retinal degeneration is the most common blinding eye disease in people over 50 years old, and the incidence rate is 11.6% in people aged 50-65 years old and 30% in people over 75 years old.

[0003] Since the affected area of the fundus is difficult to reach by general external use drugs, most of the fundus lesion treatments are mainly surgical treatment and supplemented by drug treatment, and there are few drugs for treating fundus diseases on the market.

[0004] Senile macular retinal degeneration is usually a natural result of aging, and with the increase of age, the retinal tissue degenerates and thins, causing the macula to functionally decline, thereby causing metamorphopsia, vision loss, and even blindness.

[0005] In western countries, macular degeneration is the main cause of blindness in people over 50 years old.

[0006] Due to old age, weakness, deficiency of visceral qi, or insufficient congenital endowment, deficiency of both the spleen and the kidney, and excessive fire due to liver stagnation, phlegm and dampness lead to early mild vision loss and metamorphopsia, which belongs to the category of dim vision and curved vision. When the disease further develops, the hemorrhage caused by the new blood vessels in the macular area leads to sudden severe vision loss, which belongs to blindness.

[0007] So far, western medicine still lacks effective drugs for specific treatment of macular degeneration. Therefore, it is particularly urgent to develop a drug that can inhibit retinal degeneration and control the disease without side effects on the human body. The existing technology shows that traditional Chinese medicine has certain advantages in this regard. SUMMARY

[0008] The present application provides a new traditional Chinese medicine composition, which has the effects of nourishing the liver and kidney, promoting blood circulation and improving eyesight, and is used for senile macular retinal degeneration, deficiency of the liver and kidney, and blood stasis blocking collaterals.

[0009] Another object of the present application is to provide a preparation method of the traditional Chinese medicine composition.

[0010] The present application also provides the application of the traditional Chinese medicine composition in preparing a drug for treating senile macular retinal degeneration.

[0011] The present application is achieved by the following technical solutions:

[0012] The traditional Chinese medicine composition for treating age-related macular degeneration provided by this invention is prepared from the following traditional Chinese medicine raw materials: wolfberry, chrysanthemum, psoralea corylifolia, dendrobium, notoginseng, raw cattail pollen, and kudzu root.

[0013] The traditional Chinese medicine composition for treating age-related macular degeneration described in this invention is prepared from the following raw materials in parts by weight:

[0014] 7-16 parts of wolfberry, 3-12 parts of chrysanthemum, 5-15 parts of psoralea corylifolia, 1-10 parts of dendrobium, 1-8 parts of notoginseng, 1-10 parts of raw cattail pollen, and 3-12 parts of kudzu root.

[0015] The preferred ingredients are: 10-15 parts wolfberry, 6-10 parts chrysanthemum, 7-12 parts astragalus complanatus, 3-8 parts dendrobium, 1-5 parts notoginseng, 3-8 parts raw cattail pollen, and 6-10 parts kudzu root.

[0016] A more preferred formulation is: 12 parts wolfberry, 8 parts chrysanthemum, 10 parts astragalus complanatus, 6 parts dendrobium, 3 parts notoginseng, 6 parts raw cattail pollen, and 8 parts kudzu root.

[0017] The above-mentioned active pharmaceutical ingredient of the present invention can be any raw medicinal material or any processed product and combination thereof.

[0018] This invention is based on traditional Chinese medicine theory, using the aforementioned effective drugs in combination to achieve the effects of nourishing the liver and kidneys, promoting blood circulation, and improving eyesight. It can be used as an effective formula for age-related macular degeneration. Among other things...

[0019] Goji berries: Sweet in taste, neutral in nature. They enter the liver and kidney meridians. They nourish the liver and kidneys, benefit essence and improve eyesight. Used for deficiency of essence and blood, lower back and knee pain, dizziness and tinnitus, impotence and seminal emission, internal heat and thirst, blood deficiency and chlorosis, and blurred vision. Main components include Lycium barbarum polysaccharides (LBP), betaine, carotenoids and carotenoid esters, vitamin C, hyoscyamine, various amino acids, and trace elements such as K, Na, Ca, Mg, Cu, Fe, Mn, Zn, and P. Pharmacological studies have shown that goji berries nourish the liver and kidneys, benefit essence and improve eyesight, and are used for deficiency of essence and blood, lower back and knee pain, dizziness and tinnitus, impotence and seminal emission, internal heat and thirst, blood deficiency and chlorosis, and blurred vision. Lycium barbarum polysaccharides (LBP) are the main active ingredient of goji berries, possessing multiple effects such as improving immunity, anti-aging, anti-tumor, lowering blood sugar, and scavenging free radicals. Recent studies have shown that wolfberry polysaccharides also have certain effects in preventing and treating eye diseases such as age-related macular degeneration, diabetic retinopathy, senile cataracts, and glaucoma.

[0020] Chrysanthemum: Sweet and bitter in taste, slightly cold in nature. It enters the lung and liver meridians. It has the effects of dispelling wind and clearing heat, calming the liver and improving eyesight, and clearing heat and detoxifying. It is used for wind-heat colds, headaches and dizziness, red and swollen eyes, blurred vision, and carbuncles and boils. It mainly contains flavonoids: luteolin, apigenin, geraniol, mongholic acid, farnesin, quercetin, lutein, geraniol-7-O-β-D-glucoside, apigenin-7-O-β-D-glucoside, luteolin-7-O-β-D-glucoside, farnesin-7-O-β-D-glucoside, gossypol pentamethyl 1-ether, 5-hydroxy-3',4',6,7-tetramethoxyflavonoids, hesperidin, robinin, hesperidin, robinin, farnesin-7-O-β-D-galactoside, apigenin-7-O-β-D-galactoside, 4'-methoxyluteolin-7-O-β-D-glucoside, farnesin-7-O-β-D-glucoside. Pharmacological studies have shown that chrysanthemum has the effects of dispelling wind and clearing heat, calming the liver and improving eyesight, and clearing heat and detoxifying. It is mainly used to treat headaches, dizziness, red eyes, chest and heart heat, boils, and carbuncles. Modern pharmacological studies have shown that chrysanthemum has antioxidant, antibacterial, antitumor, anti-inflammatory, antiviral, anti-aging, fatigue-relieving, and liver-protective effects.

[0021] Astragalus complanatus: Warm in nature, sweet in taste. It enters the liver and kidney meridians. It has the effects of warming and tonifying the liver and kidneys, consolidating essence, reducing urination, and improving eyesight. It is used for kidney deficiency with lower back pain, seminal emission, premature ejaculation, leukorrhea, dribbling urination, dizziness, and blurred vision. It mainly contains flavonoids, triterpenoids, organic acids, amino acids, polypeptides, proteins, tannins, sterols, trace elements, and other chemical components, including cannabinoids, myricetin 3-O-β-D-glucopyranoside, isoquercitrin, quercetin 3-O-α-L-arabinoside, verrucoside 7-O-β-D-glucopyranoside, gentianin, Siberian larch flavonoids 3-O-β-glucopyranoside, kaempferol 3-O-β-D-glucopyranoside, verrucoside, astragaloside A, and rhamnosin 3-O-β-D-glucopyranoside. Pharmacological effects: Astragalus complanatus has the effects of warming and tonifying the liver and kidneys, consolidating essence, reducing urination, and improving eyesight. It is mainly used to treat liver and kidney deficiency, soreness and weakness of the waist and knees, blurred vision, seminal emission and premature ejaculation, frequent urination, enuresis, hematuria, and leukorrhea. Modern pharmacological studies have confirmed that Astragalus complanatus can regulate immunity, blood rheology, blood pressure, and cerebral blood flow, and has the effects of lowering lipids, inhibiting platelet aggregation, protecting the liver, and anti-inflammation.

[0022] Dendrobium: Sweet in taste, slightly cold in nature. It enters the stomach and kidney meridians. It has the effects of nourishing the stomach and promoting body fluids, nourishing yin and clearing heat. It is used for febrile diseases with fluid depletion, dry mouth and thirst, stomach yin deficiency, poor appetite and dry retching, persistent low-grade fever after illness, yin deficiency with fire excess, steaming bone fever, blurred vision, and weakness of muscles and bones. Its main chemical components are alkaloids, sesquiterpenes, phenanthrene, bibenzyl groups, etc., and a small amount of polysaccharides. Dendrobine is its characteristic component. Pharmacological effects: Dendrobium has the effects of nourishing the stomach and promoting body fluids, nourishing yin and clearing heat, moistening the lungs and relieving cough. It can nourish kidney yin and reduce deficiency fire, and is suitable for blurred vision, weakness of muscles and bones due to kidney yin deficiency, and steaming bone fever due to yin deficiency with fire excess. Modern pharmacological research shows that Dendrobium has anti-tumor, anti-aging, hypoglycemic, and anti-cataract effects.

[0023] Panax notoginseng: Sweet and slightly bitter in taste; warm in nature. It enters the liver, stomach, heart, lung, and large intestine meridians. It has the effects of removing blood stasis and stopping bleeding, promoting blood circulation and relieving pain. It is used for hemoptysis, hematemesis, hematochezia, metrorrhagia, traumatic bleeding, swelling and pain from falls and injuries, and blood stasis syndrome. It mainly contains various active ingredients such as notoginseng saponins, flavonoids, notoginsenosides, notoginseng polysaccharides, amino acids, volatile oils, alkaloids, sterols, polyacetylenes, antibacterial protein sugars, inorganic salts, and inorganic ions. Among these, notoginseng saponins are one of the main components of Panax notoginseng. Pharmacological effects: Panax notoginseng has analgesic, hemostatic, antithrombotic, hematopoietic-promoting, anti-cerebral ischemia, anti-arrhythmic, anti-inflammatory, anti-tumor, and hepatoprotective effects. Panax notoginseng not only promotes blood circulation and removes blood stasis, but also resists platelet aggregation to achieve antithrombotic function. Panax notoginseng inhibits platelet aggregation, inhibits thrombin, and promotes fibrinolysis. The antiplatelet aggregation mechanism involves increasing the cAMP content in platelets, reducing the synthesis of thromboxane A2, and further inhibiting the release of platelet aggregation-related active substances such as Ca2+ and 5-HT, ultimately exerting a remarkable antiplatelet aggregation effect.

[0024] Typha pollen: Sweet in taste, neutral in nature. It enters the liver and pericardium meridians. It stops bleeding, removes blood stasis, and promotes urination. It is used for hematemesis, epistaxis, hemoptysis, metrorrhagia, traumatic bleeding, amenorrhea, dysmenorrhea, chest and abdominal pain, traumatic swelling and pain, and painful urination with blood. It mainly contains isorhamnetin-3-O-neohesperidin, typhain, flavonoids, sterols, alkanes, organic acids, polysaccharides, and tannins. Pharmacological effects: It promotes blood circulation and removes blood stasis. Raw typha pollen is often used for chest and abdominal pain and amenorrhea caused by blood stasis. Modern clinical studies also show that typha pollen can treat coronary heart disease, arteriosclerosis, diabetes, and hyperlipidemia.

[0025] Kudzu root: Sweet and slightly spicy in taste, with a clear fragrance, and cool in nature, it primarily enters the spleen and stomach meridians. It has the effects of releasing exterior pathogens, promoting yang and relieving rashes, clearing heat and generating fluids. It is used to treat spleen deficiency diarrhea, thirst due to febrile diseases, fever due to external pathogens, severe headache and neck pain, poor measles eruption, thirst due to febrile diseases, diabetes, alcohol poisoning, chest pain, and other ailments. Kudzu root contains 12% flavonoids, such as puerarin, daidzein, and genistein, as well as protein, amino acids, sugars, and essential minerals such as iron, calcium, copper, and selenium. It is a valuable tonic suitable for all ages and is known as "thousand-year-old ginseng." As early as the Han Dynasty, Zhang Zhongjing's *Treatise on Cold Damage* contained the famous formula "Kudzu Root Decoction," which remains an important formula for relieving exterior pathogens. Kudzu root can regulate bodily functions, strengthen the body, improve the body's disease resistance, resist aging, and maintain youthful vitality. Modern medical research shows that puerarin, an isoflavone compound found in kudzu root, has certain therapeutic effects on hypertension, hyperlipidemia, hyperglycemia, and cardiovascular and cerebrovascular diseases.

[0026] According to traditional Chinese medicine theory, macular degeneration, caused by old age, weakness, deficiency of internal organs, congenital insufficiency, spleen and kidney deficiency, liver stagnation and fire, and phlegm-dampness, initially presents as mild vision loss and distorted vision, falling under the categories of blurred vision and seeing straight objects as curved. As the condition progresses, neovascularization in the macular region can cause bleeding, leading to a sudden and severe decline in vision, resulting in sudden blindness. Therefore, this invention focuses on nourishing the liver and kidneys, promoting blood circulation, and improving vision. This invention uses a traditional Chinese medicine composition with wolfberry as the principal ingredient, chrysanthemum and astragalus as assistant ingredients, and dendrobium, notoginseng, raw cattail pollen, and kudzu root as adjuvant ingredients. This composition has been repeatedly verified through clinical trials and conforms to traditional Chinese medicine theory. This invention uses traditional Chinese medicinal herbs as raw materials, has no toxic side effects, tastes good, and is convenient to take.

[0027] When using the above-mentioned drugs, they can be used as raw materials in proportions equivalent to the stated weight ratios, which can be cleaned, dried, pulverized, and mixed to obtain granules or powders that meet the particle size requirements of the formulation for direct consumption. Alternatively, they can be used as raw materials in proportions equivalent to the stated weight ratios, appropriately processed, and then pharmaceutical excipients can be added to prepare various formulations as needed. In the process of preparing formulations from the above-mentioned raw materials, the raw materials can be processed using the following methods: extraction with water or ethanol of different concentrations, followed by concentration and drying of the extract to obtain a crude extract; or further purification using one or more of the following methods in combination: alcohol precipitation, water back-dissolution, organic solvent extraction, flocculation precipitation, and column chromatography to obtain a refined extract. Specific operations and / or methods for extracting the above-mentioned effective medicinal components can be either using the stated proportions of drug components as raw materials, extracting their effective medicinal components separately and then mixing them, or mixing the drug raw materials in the stated proportions and then extracting them together. Different extraction methods, equipment, and specific conditions such as ideal or optimal extraction temperature, solvent volume, extraction time, and number of extractions can be screened and found through experiments based on actual conditions.

[0028] To ensure that the raw materials of this drug exert their effects more effectively, the following preparation method is preferred for this invention:

[0029] There are two methods for preparing the effective components of the traditional Chinese medicine composition of this invention, as detailed below:

[0030] Preparation method 1:

[0031] Step 1: Weigh out the following ingredients by weight: wolfberry, chrysanthemum, psoralea corylifolia, dendrobium, notoginseng, raw cattail pollen, and kudzu root;

[0032] Step 2: Crush the Panax notoginseng from Step 1, sieve it, collect the Panax notoginseng powder, and set it aside;

[0033] Step 3: Take the Panax notoginseng powder from Step 2 and Dendrobium from Step 1, add ethanol and reflux to extract, collect the extract, filter, and recover the ethanol until there is no alcohol taste, to obtain liquid I. Store the residue in a separate container for later use.

[0034] Step 4: The dregs from Step 3 are combined with the five medicinal materials from Step 1—Astragalus complanatus, Chrysanthemum, Typha pollen, Lycium barbarum, and Pueraria lobata—and extracted with water. The mixture is then filtered to obtain medicinal liquid II.

[0035] Step 5: Combine medicinal solution I and medicinal solution II to obtain medicinal solution III. Concentrate medicinal solution III to a thick paste, dry it, and pulverize it into a powder to obtain the effective components of the traditional Chinese medicine composition of this invention.

[0036] In the above preparation method one, as a preferred embodiment, in step two, the industrial sieve used for sieving is 50 mesh, 65 mesh, 80 mesh, or 100 mesh; preferably, an 80 mesh industrial sieve is used for sieving.

[0037] In the above preparation method one, as a preferred embodiment, in step three, the amount of ethanol used for reflux extraction is 8-12 times the amount of medicinal material; preferably 10 times.

[0038] In the above preparation method one, as a preferred embodiment, in step three, the reflux extraction ethanol concentration is 50-90% ethanol, preferably 70% ethanol.

[0039] In the above preparation method one, as a preferred embodiment, in step three, the reflux extraction is performed 1-3 times, preferably 1 time.

[0040] In the above preparation method one, as a preferred embodiment, in step three, the reflux extraction time is 1-3 hours, preferably 2 hours.

[0041] In the above preparation method one, as a preferred embodiment, in step four, Astragalus complanatus and raw Typha pollen are extracted by wrapping and decocting.

[0042] In the above preparation method one, as a preferred embodiment, in step four, the amount of water used for extraction is 8-12 times the amount of medicinal material; preferably 10 times.

[0043] In the above preparation method one, as a preferred embodiment, in step four, the extraction is performed 1-3 times, preferably 2 times.

[0044] In the above preparation method one, as a preferred embodiment, in step four, the extraction time is 0.5-2 hours, preferably 1 hour.

[0045] In the above preparation method one, as a preferred embodiment, in step five, the liquid is concentrated and dried by depressurization.

[0046] Preparation method two:

[0047] Step 1: Weigh out the following ingredients by weight: Dendrobium, Astragalus complanatus, Chrysanthemum, Typha pollen, Panax notoginseng, Lycium barbarum, and Pueraria lobata.

[0048] Step 2: Crush the Panax notoginseng from Step 1, sieve it, collect the Panax notoginseng powder, and set it aside;

[0049] Step 3: Take the Panax notoginseng powder from Step 2 and the six medicinal materials from Step 1 (Dendrobium, Astragalus complanatus, Chrysanthemum, Typha pollen, Lycium barbarum, and Pueraria lobata) and extract them together with water. Filter the mixture, concentrate the filtrate to a thick paste, dry it, and pulverize it into a powder to obtain the effective components of the traditional Chinese medicine composition of this invention.

[0050] In the above-mentioned preparation method two, as a preferred embodiment, in step three, the amount of water used for extraction is 8-12 times the amount of medicinal material; preferably 10 times.

[0051] In the above preparation method two, as a preferred embodiment, in step three, the extraction is performed 1-3 times, preferably 2 times.

[0052] In the second preparation method described above, as a preferred embodiment, in step three, the extraction time is 0.5-2 hours, preferably 1 hour.

[0053] In the second preparation method described above, as a preferred embodiment, in step three, the filtrate is concentrated and dried under reduced pressure.

[0054] The effective components of the traditional Chinese medicine composition obtained in this invention can be directly used as medicine or prepared into desired formulations by adding pharmaceutically acceptable excipients using conventional processes. For example, it can be formulated into commonly used solid dosage forms such as tablets (dispersible tablets, effervescent tablets, orally disintegrating tablets, lozenges, chewable tablets, effervescent tablets), capsules (hard capsules, soft capsules), granules, pills (drop pills, honey pills, water-honey pills, concentrated pills), powders, and bagged tea preparations, or into liquid dosage forms such as syrups and oral liquids. Therefore, in addition to the extract of the traditional Chinese medicine composition, this pharmaceutical composition can also contain pharmaceutically acceptable excipients.

[0055] The excipients mentioned here may vary depending on the formulation. For example, in solid dosage forms such as tablets, capsules, and granules, commonly used excipients include diluents, disintegrants, excipients, binders, lubricants, surfactants, and fillers; in liquid dosage forms such as syrups and oral liquids, commonly used excipients include surfactants, diluents, preservatives, stabilizers, flavoring agents, thickeners, and flow aids.

[0056] Commonly used excipients include starch, lactose, dextrin, powdered sugar, microcrystalline cellulose, mannitol, xylitol, polyethylene glycol, calcium sulfate, dicalcium phosphate, calcium carbonate, modified starch, sorbitol, polyvinylpyrrolidone, heavy magnesium carbonate, sodium carboxymethyl cellulose, hydroxypropyl methyl cellulose, methyl cellulose, ethyl cellulose, sodium carboxymethyl starch, hydroxypropyl cellulose, povidone K30, kaolin, pregelatinized starch, magnesium stearate, talc, micronized silica gel, stevioside, betaine, aspartame, glycyrrhizin, sodium saccharin, citric acid, sorbic acid, potassium sorbate, ethylparaben, sucrose, starch paste, syrup, guar gum, steviol glycoside, sodium alginate, maltose, citric acid, malic acid, sucralose, menthol, coffee powder, monoglycerides, magnesium dodecyl sulfate, beta-cyclodextrin, etc.

[0057] The method for preparing the granules of the traditional Chinese medicine composition of the present invention is as follows:

[0058] Method 1:

[0059] Step 1: Weigh out the following ingredients by weight: wolfberry, chrysanthemum, psoralea corylifolia, dendrobium, notoginseng, raw cattail pollen, and kudzu root;

[0060] Step 2: Crush the Panax notoginseng from Step 1, sieve it, collect the Panax notoginseng powder, and set it aside;

[0061] Step 3: Take the Panax notoginseng powder from Step 2 and Dendrobium from Step 1, add ethanol and reflux to extract, collect the extract, filter, and recover the ethanol until there is no alcohol taste, to obtain liquid I. Store the residue in a separate container for later use.

[0062] Step 4: The dregs from Step 3 are combined with the five medicinal materials from Step 1—Astragalus complanatus, Chrysanthemum, Typha pollen, Lycium barbarum, and Pueraria lobata—and extracted with water. The mixture is then filtered to obtain medicinal liquid II.

[0063] Step 5: Combine medicinal solution I and medicinal solution II to obtain medicinal solution III. Concentrate medicinal solution III to a thick paste, dry it, and pulverize it into a powder to obtain the effective components of the traditional Chinese medicine composition of this invention.

[0064] Step Six: Add an appropriate amount of excipients to the effective components of the composition of the present invention obtained in Step Four, granulate, dry, and sizing to obtain granules.

[0065] In the above preparation method one, as a preferred embodiment, in step two, the industrial sieve used for sieving is 50 mesh, 65 mesh, 80 mesh, or 100 mesh; preferably, an 80 mesh industrial sieve is used for sieving.

[0066] In the above preparation method one, as a preferred embodiment, in step three, the amount of ethanol used for reflux extraction is 8-12 times the amount of medicinal material; preferably 10 times.

[0067] In the above preparation method one, as a preferred embodiment, in step three, the reflux extraction ethanol concentration is 50-90% ethanol, preferably 70% ethanol.

[0068] In the above preparation method one, as a preferred embodiment, in step three, the reflux extraction is performed 1-3 times, preferably 1 time.

[0069] In the above preparation method one, as a preferred embodiment, in step three, the reflux extraction time is 1-3 hours, preferably 2 hours.

[0070] In the above preparation method one, as a preferred embodiment, in step four, Astragalus complanatus and raw Typha pollen are extracted by wrapping and decocting.

[0071] In the above preparation method one, as a preferred embodiment, in step four, the amount of water used for extraction is 8-12 times the amount of medicinal material; preferably 10 times.

[0072] In the above preparation method one, as a preferred embodiment, in step four, the extraction is performed 1-3 times, preferably 2 times.

[0073] In the above preparation method one, as a preferred embodiment, in step four, the extraction time is 0.5-2 hours, preferably 1 hour.

[0074] In the above preparation method one, as a preferred embodiment, in step five, the liquid is concentrated and dried by depressurization.

[0075] In the above preparation method one, as a preferred embodiment, in step six, the excipients are fillers, lubricants, and flavoring agents; wherein, the fillers include starch, lactose, dextrin, powdered sugar, microcrystalline cellulose, modified starch, sodium carboxymethyl cellulose, hydroxypropyl methyl cellulose, methyl cellulose, ethyl cellulose, sodium carboxymethyl starch, hydroxypropyl cellulose, and pregelatinized starch; the lubricants include magnesium stearate, talc, and micronized silica gel; and the flavoring agents include stevioside, betaine, aspartame, glycyrrhizin, and sodium saccharin.

[0076] Method 2:

[0077] Step 1: Weigh out the following ingredients by weight: Dendrobium, Astragalus complanatus, Chrysanthemum, Typha pollen, Panax notoginseng, Lycium barbarum, and Pueraria lobata.

[0078] Step 2: Crush the Panax notoginseng from Step 1, sieve it, collect the Panax notoginseng powder, and set it aside;

[0079] Step 3: Take the Panax notoginseng powder from Step 2 and the six medicinal materials from Step 1 (Dendrobium, Astragalus complanatus, Chrysanthemum, Typha pollen, Lycium barbarum, and Pueraria lobata) and extract them together with water. Filter the mixture, concentrate the filtrate to a thick paste, dry it, and pulverize it into a powder to obtain the effective components of the traditional Chinese medicine composition of this invention.

[0080] Step 4: Add an appropriate amount of excipients to the effective components of the composition of the present invention obtained in Step 3, granulate, dry, and sizing to obtain granules.

[0081] In the above-mentioned preparation method two, as a preferred embodiment, in step three, the amount of water used for extraction is 8-12 times the amount of medicinal material; preferably 10 times.

[0082] In the above preparation method two, as a preferred embodiment, in step three, the extraction is performed 1-3 times, preferably 2 times.

[0083] In the second preparation method described above, as a preferred embodiment, in step three, the extraction time is 0.5-2 hours, preferably 1 hour.

[0084] In the second preparation method described above, as a preferred embodiment, in step three, the filtrate is concentrated and dried under reduced pressure.

[0085] In the above-mentioned preparation method two, as a preferred embodiment, in step four, the excipients are fillers, lubricants, and flavoring agents; wherein, the fillers include starch, lactose, dextrin, powdered sugar, microcrystalline cellulose, modified starch, sodium carboxymethyl cellulose, hydroxypropyl methyl cellulose, methyl cellulose, ethyl cellulose, sodium carboxymethyl starch, hydroxypropyl cellulose, and pregelatinized starch; the lubricants include magnesium stearate, talc, and micronized silica gel; and the flavoring agents include stevioside, betaine, aspartame, glycyrrhizin, and sodium saccharin.

[0086] The following detailed description of specific embodiments further illustrates the above-mentioned content of the present invention:

[0087] Specific implementation methods

[0088] Example 1:

[0089] 12g wolfberry, 8g chrysanthemum, 10g psoralea corylifolia, 6g dendrobium, 3g notoginseng, 6g raw cattail pollen, 8g kudzu root

[0090] The Panax notoginseng is crushed, passed through an 80-mesh sieve, and the crushed medicinal material is collected for later use. The following seven medicinal materials are extracted twice with 10 times the amount of water: Panax notoginseng powder, Astragalus complanatus (wrapped and decocted), raw Typha pollen (wrapped and decocted), Dendrobium nobile, Chrysanthemum morifolium, Lycium barbarum, and Pueraria lobata. The extracts are combined, filtered, and the filtrate is concentrated under reduced pressure to a thick paste. The paste is dried under reduced pressure, pulverized into powder, and then granulated with appropriate amounts of dextrin, soluble starch, and aspartame. The granules are dried and sized to obtain granules.

[0091] Example 2:

[0092] 7g wolfberry, 10g chrysanthemum, 7g psoralea corylifolia, 3g dendrobium, 1g notoginseng, 3g raw cattail pollen, 10g kudzu root

[0093] The Panax notoginseng is crushed and passed through an 80-mesh sieve. The crushed medicinal material is collected and set aside. Panax notoginseng powder and Dendrobium officinale are extracted once with 10 times the amount of 70% ethanol for 2 hours. The extract is collected, filtered through a 300-mesh sieve, and the ethanol is recovered until there is no alcohol taste, yielding liquid I. The residue is stored separately for later use. The ethanol-extracted residue is then extracted twice with five medicinal materials: Astragalus complanatus (wrapped and decocted), Chrysanthemum morifolium, Typha orientalis (wrapped and decocted), Lycium barbarum, and Pueraria lobata, with 10 times the amount of water, for 1 hour each time. The extracts are filtered through a 300-mesh sieve, and the extracts are combined to obtain liquid II. Liquid I and liquid II are combined to obtain liquid III. Liquid III is concentrated under reduced pressure to a thick paste, dried under reduced pressure, pulverized into a paste powder, and granulated with an appropriate amount of dextrin and microcrystalline cellulose. The granules are dried and sized to obtain granules.

[0094] Example 3:

[0095] 16g wolfberry, 3g chrysanthemum, 12g psoralea corylifolia, 1g dendrobium, 8g notoginseng, 10g raw cattail pollen, 3g kudzu root

[0096] Crush Panax notoginseng, pass it through an 80-mesh sieve, collect the crushed medicinal material, and set it aside. Take Panax notoginseng powder, Astragalus complanatus (wrapped and decocted), raw Typha pollen (wrapped and decocted), Dendrobium, Chrysanthemum, Lycium barbarum, and Pueraria lobata, add 8 times the amount of water and extract 3 times, 1 hour each time. Combine the extracts, filter, concentrate the filtrate to a thick paste, dry, pulverize into a paste powder, add appropriate excipients, granulate, dry, and granulate to obtain granules.

[0097] Example 4:

[0098] 10g wolfberry, 6g chrysanthemum, 5g psoralea corylifolia seed, 10g dendrobium, 3g notoginseng, 8g raw cattail pollen, 6g kudzu root

[0099] Crush Panax notoginseng, pass it through an 80-mesh sieve, collect the crushed medicinal material, and set it aside. Take Panax notoginseng powder, Astragalus complanatus (wrapped and decocted), raw Typha pollen (wrapped and decocted), Dendrobium, Chrysanthemum, Lycium barbarum, and Pueraria lobata, add 8 times the amount of water and extract 3 times, 0.5 hours each time. Combine the extracts, filter, concentrate the filtrate to a thick paste, dry, pulverize into a paste powder, add appropriate excipients, granulate, dry, and granulate to obtain granules.

[0100] Example 5:

[0101] 15g wolfberry, 12g chrysanthemum, 15g psoralea corylifolia seed, 6g dendrobium, 4g notoginseng, 2g raw cattail pollen, 12g kudzu root

[0102] The Panax notoginseng is crushed and passed through a 65-mesh sieve. The crushed medicinal material is collected and set aside. Panax notoginseng powder and Dendrobium officinale are extracted once with 6 times the amount of 50% ethanol for 3 hours. The extract is collected, filtered, and the ethanol is recovered until there is no alcohol taste to obtain liquid I. The residue is stored separately for later use. The ethanol-extracted residue is extracted three times with five medicinal materials: Astragalus complanatus (wrapped and decocted), Chrysanthemum, Typha orientalis (wrapped and decocted), Lycium barbarum, and Pueraria lobata, with 8 times the amount of water for 1 hour each time. The extracts are filtered and combined to obtain liquid II. Liquid I and liquid II are combined to obtain liquid III. Liquid III is concentrated to a thick paste, dried, pulverized into a paste powder, excipients are added, granulated, dried, and sized to obtain granules.

[0103] Example 6:

[0104] 9g wolfberry, 8g chrysanthemum, 10g psoralea corylifolia, 8g dendrobium, 5g notoginseng, 6g raw cattail pollen, 8g kudzu root

[0105] The Panax notoginseng is crushed and passed through a 50-mesh sieve. The crushed medicinal material is collected and set aside. Panax notoginseng powder and Dendrobium officinale are extracted twice with 10 times the amount of 50% ethanol, each time for 2 hours. The extract is collected, filtered, and the ethanol is recovered until there is no alcohol taste to obtain liquid I. The residue is stored separately for later use. The ethanol-extracted residue is extracted once with five medicinal materials: Astragalus complanatus (wrapped and decocted), Chrysanthemum, Typha orientalis (wrapped and decocted), Lycium barbarum, and Pueraria lobata, with 12 times the amount of water for 2 hours. The extract is filtered, and the extracts are combined to obtain liquid II. Liquid I and liquid II are combined to obtain liquid III. Liquid III is concentrated to a thick paste, dried, pulverized into a paste powder, and an appropriate amount of starch and sugar powder are added. The paste is granulated, dried, sized, magnesium stearate is added, mixed well, compressed into tablets, and coated or uncoated to obtain tablets.

[0106] Example 7:

[0107] 13g wolfberry, 11g chrysanthemum, 14g psoralea corylifolia, 2g dendrobium, 2g notoginseng, 4g raw cattail pollen, 11g kudzu root

[0108] The Panax notoginseng is crushed and passed through a 100-mesh sieve. The crushed medicinal material is collected and set aside. Panax notoginseng powder and Dendrobium officinale are extracted twice with 7 times the amount of 80% ethanol, each time for 1 hour. The extract is collected, filtered, and the ethanol is recovered until there is no alcohol taste, to obtain medicinal liquid I. The residue is stored separately for later use. The ethanol-extracted residue is extracted once with five medicinal materials: Astragalus complanatus (wrapped and decocted), Chrysanthemum, Typha orientalis (wrapped and decocted), Lycium barbarum, and Pueraria lobata, with 11 times the amount of water, for 1.5 hours. The extract is filtered, and the extracts are combined to obtain medicinal liquid II. Medicinal liquid I and medicinal liquid II are combined to obtain medicinal liquid III. Medicinal liquid III is concentrated to a thick paste, dried, pulverized into a paste powder, and an appropriate amount of excipients are added and mixed well to obtain pills.

[0109] Example 8:

[0110] 12g wolfberry, 8g chrysanthemum, 11g psoralea corylifolia seed, 4g dendrobium, 4g notoginseng, 5g raw cattail pollen, 8g kudzu root

[0111] The Panax notoginseng is crushed and passed through a 65-mesh sieve. The crushed medicinal material is collected and set aside. Panax notoginseng powder and Dendrobium officinale are extracted three times with 7 times the amount of 80% ethanol, each time for 1 hour. The extract is collected, filtered, and the ethanol is recovered until there is no alcohol taste to obtain liquid I. The residue is stored separately for later use. The ethanol-extracted residue is extracted twice with five medicinal materials: Astragalus complanatus (wrapped and decocted), Chrysanthemum, Typha orientalis (wrapped and decocted), Lycium barbarum, and Pueraria lobata, with 12 times the amount of water, for 1.5 hours each time. The extracts are filtered and combined to obtain liquid II. Liquid I and liquid II are combined to obtain liquid III. Liquid III is concentrated to a thick paste, dried, pulverized into a powder, and an appropriate amount of excipients is added and mixed to obtain a powder.

[0112] The following experimental examples further illustrate the beneficial effects of the compositions described in this invention:

[0113] I. General Information

[0114] Sixty patients diagnosed with age-related macular degeneration in outpatient settings, aged 52-81 years, with a disease duration of 1-9 months, were assigned to experimental groups 1-3 as examples 1-3 of this application. Each experimental group consisted of 20 patients who received oral administration of the drugs described in examples 1-3 of this application for 3 months. The observation indicators are as follows:

[0115] 1.1 Visual Acuity Treatment Standards

[0116] The visual acuity chart used is the International Logarithmic Visual Acuity Chart. Improvement: Visual acuity improves by 2 lines or more; Stable: Visual acuity improves or decreases by 1 line or remains unchanged; Decline: Visual acuity decreases by 2 lines or more.

[0117] 1.2 Fundus Treatment Standards

[0118] Significant effect: The area of ​​retinal hemorrhage and exudation is reduced by ≥75% compared to before treatment. Effective: The area of ​​retinal hemorrhage and exudation is reduced by 75%–25% compared to before treatment. Ineffective: The area of ​​retinal hemorrhage and exudation is reduced by less than 25% compared to before treatment, or even increased compared to before treatment.

[0119] II. Results

[0120] 1.1 Visual efficacy

[0121] significant effect effective ineffective experimental group 1 12 6 2 experimental group 2 11 5 4 experimental group 3 13 5 3

[0122] 2.1 Fundus treatment

[0123] significant effect effective ineffective experimental group 1 10 8 2 experimental group 2 12 4 4 experimental group 3 9 9 2

[0124] III. Conclusion

[0125] Based on the above results of visual and fundus efficacy, the traditional Chinese medicine composition provided by this invention has significant efficacy in treating visual loss and fundus hemorrhage caused by age-related macular degeneration. Furthermore, no serious reactions or complications occurred during the use of the composition. Therefore, the traditional Chinese medicine composition described in this invention is effective, convenient to use, and suitable for clinical application.

Claims

1. A traditional Chinese medicine composition for age-related macular degeneration, characterized in that, It is prepared from the following raw materials in parts by weight: 7-16 parts of wolfberry, 3-12 parts of chrysanthemum, 5-15 parts of psoralea corylifolia, 1-10 parts of dendrobium, 1-8 parts of notoginseng, 1-10 parts of raw cattail pollen, and 3-12 parts of kudzu root.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, It is prepared from the following raw materials in parts by weight: 10-15 parts of wolfberry, 6-10 parts of chrysanthemum, 7-12 parts of psoralea corylifolia, 3-8 parts of dendrobium, 1-5 parts of notoginseng, 3-8 parts of raw cattail pollen, and 6-10 parts of kudzu root.

3. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that, It is prepared from the following raw materials in parts by weight: 12 parts wolfberry, 8 parts chrysanthemum, 10 parts astragalus complanatus, 6 parts dendrobium, 3 parts notoginseng, 6 parts raw cattail pollen, and 8 parts kudzu root.

4. A method for preparing the traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, It is prepared as follows: Step 1: Weigh out the following ingredients by weight: wolfberry, chrysanthemum, psoralea corylifolia, dendrobium, notoginseng, raw cattail pollen, and kudzu root; Step 2: Crush the Panax notoginseng from Step 1, sieve it, collect the Panax notoginseng powder, and set it aside; Step 3: Take the Panax notoginseng powder from Step 2 and Dendrobium from Step 1, add ethanol and reflux to extract, collect the extract, filter, and recover the ethanol until there is no alcohol taste, to obtain liquid I. Store the residue in a separate container for later use. Step 4: The dregs from Step 3 are combined with the five medicinal materials from Step 1—Astragalus complanatus, Chrysanthemum, Typha pollen, Lycium barbarum, and Pueraria lobata—and extracted with water. The mixture is then filtered to obtain medicinal liquid II. Step 5: Combine medicinal solution I and medicinal solution II to obtain medicinal solution III. Concentrate medicinal solution III into a thick paste, dry it, and pulverize it into a powder to obtain the effective components of the traditional Chinese medicine composition.

5. The preparation method according to claim 4, characterized in that, In step two, the industrial sieves used for sieving have mesh sizes of 50, 65, 80, and 100 mesh. In step three, the amount of ethanol used for reflux extraction is 8-12 times the amount of the medicinal material; the ethanol concentration for reflux extraction is 50-90% ethanol; the number of reflux extractions is 1-3 times; and the reflux extraction time is 1-3 hours. In step four, Astragalus complanatus and Typha pollen are extracted by wrapping and decocting; the amount of water used for extraction is 8-12 times the amount of the medicinal material; the number of extractions is 1-3 times; and the extraction time is 0.5-2 hours. In step five, the medicinal liquid is concentrated and dried under reduced pressure.

6. A method for preparing the traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, It is prepared as follows: Step 1: Weigh out the following ingredients by weight: Dendrobium, Astragalus complanatus, Chrysanthemum, Typha pollen, Panax notoginseng, Lycium barbarum, and Pueraria lobata. Step 2: Crush the Panax notoginseng from Step 1, sieve it, collect the Panax notoginseng powder, and set it aside; Step 3: Take the Panax notoginseng powder from Step 2 and the six medicinal materials from Step 1, namely Dendrobium, Astragalus complanatus, Chrysanthemum, Typha pollen, Lycium barbarum, and Pueraria lobata, add water and extract, filter, concentrate the filtrate to a thick paste, dry, and pulverize into a paste powder to obtain the effective components of the traditional Chinese medicine composition. In step three, the amount of water used for extraction is 8-12 times the amount of medicinal material; the number of extractions is 1-3 times; the extraction time is 0.5-2 hours; and the filtrate is concentrated and dried under reduced pressure.

7. The traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, The traditional Chinese medicine composition is an oral preparation.

8. The traditional Chinese medicine composition according to claim 7, characterized in that, The oral preparations include tablets, granules, capsules, pills, powders, and oral liquid preparations.

9. The traditional Chinese medicine composition according to claim 7, characterized in that, The oral preparation is in granule form.

10. The method for preparing the granules according to claim 8 or 9, characterized in that, Granules are prepared as follows: Step 1: Weigh out the following ingredients by weight: wolfberry, chrysanthemum, psoralea corylifolia, dendrobium, notoginseng, raw cattail pollen, and kudzu root; Step 2: Crush the Panax notoginseng from Step 1, sieve it, collect the Panax notoginseng powder, and set it aside; Step 3: Take the Panax notoginseng powder from Step 2 and Dendrobium from Step 1, add ethanol and reflux to extract, collect the extract, filter, and recover the ethanol until there is no alcohol taste, to obtain liquid I. Store the residue in a separate container for later use. Step 4: The dregs from Step 3 are combined with the five medicinal materials from Step 1—Astragalus complanatus, Chrysanthemum, Typha pollen, Lycium barbarum, and Pueraria lobata—and extracted with water. The mixture is then filtered to obtain medicinal liquid II. Step 5: Combine medicinal solution I and medicinal solution II to obtain medicinal solution III. Concentrate medicinal solution III to a thick paste, dry it, and pulverize it into a powder to obtain the effective components of the traditional Chinese medicine composition. Step Six: Add an appropriate amount of excipients to the active ingredient of the composition obtained in Step Four, granulate, dry, and sizing to obtain granules.

11. The method for preparing granules according to claim 10, characterized in that, In step two, the industrial sieves used for sieving have mesh sizes of 50, 65, 80, and 100 mesh. In step three, the amount of ethanol used for reflux extraction is 8-12 times the amount of the medicinal material; the ethanol concentration for reflux extraction is 50-90% ethanol; the number of reflux extractions is 1-3 times; and the reflux extraction time is 1-3 hours. In step four, *Astragalus complanatus* and *Typha orientalis* are extracted separately by wrapping and decocting; the amount of water used for extraction is 8-12 times the amount of the medicinal material; the number of extractions is 1-3 times; and the extraction time is 0.5 hours. -2 hours; in step five, the liquid is concentrated and dried under reduced pressure; in step six, the excipients are fillers, lubricants, and flavoring agents; wherein, the fillers include starch, lactose, dextrin, powdered sugar, microcrystalline cellulose, sodium carboxymethyl cellulose, hydroxypropyl methyl cellulose, methyl cellulose, ethyl cellulose, sodium carboxymethyl starch, hydroxypropyl cellulose, and pregelatinized starch; the lubricants include magnesium stearate, talc, and micronized silica gel; the flavoring agents include stevioside, betaine, aspartame, glycyrrhizin, and sodium saccharin.

12. The method for preparing the traditional Chinese medicine composition according to claim 8 or 9, characterized in that, Granules are prepared as follows: Step 1: Weigh out the following ingredients by weight: Dendrobium, Astragalus complanatus, Chrysanthemum, Typha pollen, Panax notoginseng, Lycium barbarum, and Pueraria lobata. Step 2: Crush the Panax notoginseng from Step 1, sieve it, collect the Panax notoginseng powder, and set it aside; Step 3: Take the Panax notoginseng powder from Step 2 and the six medicinal materials from Step 1, namely Dendrobium, Astragalus complanatus, Chrysanthemum, Typha pollen, Lycium barbarum, and Pueraria lobata, add water and extract, filter, concentrate the filtrate to a thick paste, dry, and pulverize into a paste powder to obtain the effective components of the traditional Chinese medicine composition. Step 4: Add appropriate excipients to the active ingredients of the composition obtained in Step 3, granulate, dry, and sizing to obtain granules.

13. The method for preparing granules according to claim 12, characterized in that, In step three, the amount of water used for extraction is 8-12 times the amount of medicinal material; the number of extractions is 1-3 times; the extraction time is 0.5-2 hours; the filtrate is concentrated and dried under reduced pressure; in step four, the excipients are fillers, lubricants, and flavoring agents; wherein, the fillers include starch, lactose, dextrin, powdered sugar, microcrystalline cellulose, sodium carboxymethyl cellulose, hydroxypropyl methyl cellulose, methyl cellulose, ethyl cellulose, sodium carboxymethyl starch, hydroxypropyl cellulose, and pregelatinized starch; the lubricants include magnesium stearate, talc, and micronized silica gel; the flavoring agents include stevioside, betaine, aspartame, glycyrrhizin, and sodium saccharin.

14. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a drug for treating age-related macular degeneration.