Traditional Chinese medicine composition for treating age-related macular degeneration and preparation method thereof

Abstract

The invention provides a traditional Chinese medicine composition for treating age-related macular degeneration and a preparation method thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 9 to 12 parts of flos eriocauli, 9 to 12 parts of flos buddlejae, 5 to 10 parts of dried herba dendrobii, 9 to 12 parts of fructus tribuli, 5 to 9 parts of flos chrysanthemi, 5 to 10 parts of fructus lycii, 9 to 12 parts of wine-processed rhizoma polygonati, 3 to 5 parts of radix glycyrrhizae, 6 to 10 parts of spica prunellae, 6 to 10 parts of wine-processed fructus ligustri lucidi, 9 to 15 parts of fried semen ziziphi spinosae and 10 to 15 parts of fried fructus hordei germinatus. The traditional Chinese medicine composition disclosed by the invention has the beneficial effects that the traditional Chinese medicine composition is a traditional Chinese medicine compound researched and developed based on the pathogenesis characteristics of kidney deficiency and liver hyperactivity of senile macular degeneration and by taking liver and kidney nourishing, liver calming and eyesight improving as main treatment methods. The traditional Chinese medicine composition adopts a scientific ratio, the components can coordinate and promote each other to achieve a synergistic effect, and the traditional Chinese medicine composition has the effects of nourishing liver and kidney, calming liver and improving eyesight, is convenient to take, good in patient tolerance and free of adverse reaction after being taken for a long time, and can promote traditional Chinese medicine standardized treatment after being prepared into a standard Chinese patent medicine preparation.

Description

Technical Field

[0001] The present application belongs to the technical field of traditional Chinese medicine, and in particular relates to a traditional Chinese medicine composition for treating age-related macular degeneration and a preparation method thereof. Background Art

[0002] Age-related macular degeneration (AMD) is the third leading cause of blindness in the world. By 2020, the number of AMD patients worldwide is about 200 million, and it is expected to affect nearly 288 million people worldwide by 2040. With the accelerated aging of the population in my country, the incidence of AMD is increasing year by year. In 2005, a study in Shanghai showed that the prevalence of AMD was 15.5% among people aged 50 years and above. In 2007, AMD patients in the population aged ≥60 years in Beixinjing Street, Shanghai accounted for 13.36% of the examined population. AMD has become a major public health problem with significant socioeconomic impact. Studies have shown that compared with patients without AMD of similar age, AMD patients have greater life stress, lower satisfaction, lower activity levels, and more severe depression. When treatment results do not meet expectations, depression is prevalent, even in patients who have received anti-vascular endothelial growth factor (VEGF) treatment. Compared with patients with other serious chronic diseases, AMD patients report similar or lower health-related quality of life. The quality of life of AMD patients has been widely affected, and the prevention and treatment of AMD has become a very urgent task in the ophthalmology community.

[0003] Clinically, AMD is divided into two types: dry and wet. The fundus manifestations of dry AMD are abnormal retinal pigment epithelium (RPE) and drusen formation. In the late stage, RPE, choroidal blood vessels and photoreceptors progressively atrophy, forming round or oval pigmentation and loss, and central vision is significantly reduced. Some dry AMD will progress to wet AMD; the characteristic pathological changes of wet AMD are choroidal neovascularization (CNV) formation, which causes retinal exudation and hemorrhage, and severe visual impairment. At present, the treatment of wet AMD is mainly aimed at the formation of CNV. The main methods are photodynamic therapy and drug therapy. As mentioned above, VEGF has been proven to play an important role in the formation of CNV. Anti-VEGF drugs are a milestone in the treatment of wet AMD. For example, ranibizumab and conbercept are the most important advances made in the ophthalmology field in recent years.

[0004] There is no definite and effective treatment for dry AMD. Based on current evidence-based medicine, it is recommended that patients with early to mid-stage AMD supplement with antioxidant vitamins, zinc (zinc oxide or zinc sulfate), lutein, zeaxanthin, or mixed antioxidant vitamins and minerals; antioxidant vitamin and mineral supplementation must reach a certain dose to produce corresponding benefits; and beta-carotene supplementation may cause yellowing of the skin and increase the risk of lung cancer in smokers. Zinc supplementation may increase the risk of hospitalization due to urinary system diseases and may cause copper deficiency anemia. When considering long-term supplementation of the above nutrients, it must be combined with the patient's overall condition, so drug treatment is still the main direction. Summary of the invention

[0005] The purpose of the present application is to provide a Chinese medicine composition for treating age-related macular degeneration, aiming to solve the problem that there is still no definite and effective treatment measure for dry AMD.

[0006] In order to achieve the above application purpose, the technical solution adopted in this application is as follows:

[0007] In the first aspect of the present application, a traditional Chinese medicine composition for treating age-related macular degeneration is provided, comprising the following raw materials in parts by weight: 9-12 parts of Herba Codonopsis pilosulae, 9-12 parts of Buddleja buddleja, 5-10 parts of dried Dendrobium officinale, 9-12 parts of Tribulus terrestris, 5-9 parts of Chrysanthemum, 5-10 parts of Lycium barbarum, 9-12 parts of Polygonatum sibiricum, 3-5 parts of Licorice, 6-10 parts of Prunella Vulgaris, 6-10 parts of Ligustrum lucidum, 9-15 parts of stir-fried Ziziphus jujuba seeds, and 10-15 parts of stir-fried malt.

[0008] Herba Glehniae: neutral in nature, pungent and sweet in taste, enters the liver and lung meridians. It has the effect of dispersing wind-heat, improving eyesight and removing cataracts. It is commonly used clinically for wind-heat red eyes, swelling, pain, photophobia, cataracts, wind-heat headaches, etc.

[0009] Modern pharmacological research: It mainly contains glutamic acid, and the whole plant contains alkaloids, phenolic components, organic acids, flavonoids and their glycosides, volatile oils, phytosterols, anthraquinones, tannins and other components. Among them, the main component of volatile oil of glutamic acid is palmitic acid; the flavonoid components mainly include tartaric acid, rough ragweed, tartaric acid, quercetin and its derivatives, etc., which have the effects of resisting pathogenic microorganisms, anti-oxidation, inhibiting α-glucosidase and protecting neurons.

[0010] Buddleja buddha: sweet, slightly cold, enters the liver meridian. Mainly expel evil, and strengthen the body. It can clear liver heat and nourish liver blood. It is an important medicine for treating eye diseases, and is suitable for those with liver fire inflammation or liver blood deficiency with heat.

[0011] Modern pharmacological research: Buddleja buddleja extract has antibacterial effect on Staphylococcus aureus and beta-hemolytic streptococcus in vitro. Buddleja buddleja ethanol extract has hypoglycemic effect. In addition, it has the effects of anti-vascular endothelial cell proliferation, regulating sex hormone levels in the body, inhibiting lacrimal gland cell apoptosis, relieving spasm, promoting choleresis and diuresis.

[0012] Dried Dendrobium: Sweet, slightly cold. Enters the stomach and kidney meridians. Sweetness nourishes, and slightly coldness clears and purges, so it is used for nourishing. Entering the stomach meridian, it can nourish stomach yin and produce body fluids, and treat thirst caused by body fluid damage or stomach yin deficiency; entering the kidney meridian, it can nourish kidney yin and clear away heat, and treat persistent heat caused by yin deficiency. In addition, by nourishing yin and clearing heat, it can also improve eyesight and strengthen the waist. Fresh use is more effective.

[0013] Modern pharmacological research: It mainly contains dendrobium alkaloids, dendrobamine, dendrobium alkaloids, etc., which have the main effects of anti-cataract, intestinal stimulation, immune regulation, anti-tumor, antioxidant, hypoglycemic and antibacterial.

[0014] Tribulus terrestris: bitter, pungent, neutral, enters the liver meridian. It has the effects of calming the liver and relieving depression, dispelling wind and improving eyesight. It is used for symptoms such as dizziness and headache caused by liver yang, pain in the ribs caused by liver depression, headache caused by wind and heat, red and swollen eyes, and itchy skin.

[0015] Modern pharmacological research: It contains volatile oils, saponins, fatty oils, nitrates, resins, flavonoid compounds and trace alkaloids, etc. It has the functions of regulating blood lipids, regulating the content of trace elements in the body, antibacterial and analgesic, and protecting retinal nerve cells.

[0016] Chrysanthemum: bitter, sour, cool in nature. It has the effect of clearing away heat and detoxifying, and is mainly used for carbuncle, eczema, etc.

[0017] Modern pharmacological research: It mainly contains volatile oils, including borneol, camphor and chrysanthemum cyclohexane, which have certain antibacterial effects on Staphylococcus aureus, various pathogenic bacteria and skin fungi. It can also significantly dilate the coronary arteries of the heart, increase coronary blood flow, and improve the tolerance of myocardial cells to hypoxia.

[0018] Lycium barbarum: sweet, neutral, enters the liver and kidney meridians. It is moist and sweet, neutral and slightly warm, good at nourishing the liver and kidney and improving eyesight, treating liver and kidney yin deficiency and vision loss; it can nourish the lung yin and relieve cough, treating yin deficiency cough.

[0019] Modern pharmacological research: It mainly contains polysaccharides, betaine, cerebrosides, Lycium A and B, which have the effects of promoting immunity and protecting the liver, inhibiting the activity of angiotensin-converting enzyme, and also has the effects of antibacterial, anti-mutagenic, anti-aging, and anti-radiation damage.

[0020] Polygonatum sibiricum: sweet in taste, neutral in nature. Enters the spleen, lung and kidney meridians. Has the effects of nourishing the kidneys and lungs, tonifying the spleen and replenishing qi.

[0021] The preparation method of Huangjing with wine includes taking clean Huangjing, stewing or steaming it thoroughly according to the wine stewing method or wine steaming method (General Rule 0213), letting it dry for a while, cutting it into thick slices, and drying it. For every 100kg of Huangjing, 20kg of yellow wine is used.

[0022] Modern pharmacological research: Polygonatum sibiricum has the pharmacological effects of lowering blood pressure, inhibiting hyperglycemia, and preventing and treating atherosclerosis and fatty infiltration of the liver. According to the information, using Polygonatum sibiricum as the main drug and other Chinese medicinal materials has a significant effect on the treatment of hemoptysis caused by pulmonary tuberculosis, coronary heart disease, angina pectoris, dry cough caused by dry lung and whooping cough.

[0023] Licorice: Sweet in taste, neutral in nature, as the main drug, it can replenish qi and tonify the middle, relieve acute pain, moisten the lungs and relieve cough, and purge fire and detoxify. As a blending agent, it can blend various drugs, alleviate the strong and toxic effects of other medicinal materials, and reduce the bitterness and spiciness of the drugs. It is mainly used to treat fatigue, poor appetite, palpitations, shortness of breath, abdominal pain, loose stools, pain in the limbs, cough and asthma, sore throat, drug and food poisoning, etc.

[0024] Modern pharmacological research: It mainly contains triterpenoid saponins, such as glycyrrhizin, which have the effects of anti-peptic ulcer, regulating gastrointestinal activity, resisting liver damage, enhancing immunity, delaying aging, anti-virus, antibacterial, detoxifying, anti-lung damage, and inhibiting uterine smooth muscle contraction.

[0025] Prunella Vulgaris: Spicy and bitter in taste, cold in nature, enters the liver and gallbladder meridians. It mainly clears liver fire, dissipates depression, nourishes blood and calms the liver. It can be used for liver fire, hyperactivity of yang and phlegm and stagnation. It is an essential medicine for clearing the liver and improving eyesight, especially for night pain in the eyes caused by blood deficiency and liver heat.

[0026] Modern pharmacological research: This product contains organic acids, triterpenes, flavonoids, steroids, coumarins, volatile oils and other ingredients, which have the effects of clearing the liver and purging fire, improving eyesight, dispersing nodules and reducing swelling.

[0027] Fructus Ligustri Lucidi: Sweet, bitter, cool in nature. Enters the liver and kidney meridians. It is a cooling tonic. Good at nourishing the yin of the liver and kidneys, and clearing away heat and improving eyesight.

[0028] The preparation method of wine-cooked Ligustrum lucidum fruit comprises taking clean Ligustrum lucidum fruit, and stewing it according to the wine stewing method or wine steaming method (General Rule 0213) until the wine is completely absorbed or steamed through.

[0029] Modern pharmacological research: Ligustrum lucidum contains triterpenoids, cyclopentane glycosides, flavonoids, fatty acids, volatile oils, polysaccharides and other ingredients.

[0030] Ziziphus jujuba seed: sweet, sour, neutral in nature. Enters the liver, gallbladder, and heart meridians. Good at nourishing the heart, tonifying the liver, benefiting the gallbladder, and calming the mind. It is an essential medicine for treating restlessness, insomnia, and palpitations caused by yin and blood deficiency. It can also restrain sweating, and can be used to treat physical weakness and excessive sweating.

[0031] The preparation method of stir-fried Chinese jujube kernels comprises: taking clean Chinese jujube kernels, stir-frying them according to the stir-frying method (general rule 0213) until they swell and their color becomes slightly darker, and crushing them before use.

[0032] Modern pharmacological research: This product contains triterpenoid saponins, alkaloids, flavonoids, volatile oils, sugars, proteins, organic acids, etc. It has the effects of nourishing the heart and liver, calming the mind, astringing sweat, and promoting the production of body fluids.

[0033] Malt: It is sweet and neutral in nature, and belongs to the spleen, stomach, and liver meridians. It is mainly used to treat symptoms such as indigestion, abdominal distension and pain, spleen deficiency and loss of appetite, accumulation of milk and sweat, breast distension and pain, and weaning in women.

[0034] The preparation method of roasted malt includes: taking clean malt, roasting it according to the stir-frying method (General Rule 0213) until it turns brown, cooling it, and sifting out ash.

[0035] Modern pharmacological research: This product contains α and β amylase, which seem to have a slight promoting effect on the secretion of gastric acid and pepsin. The hordenine A and B contained in this product have antifungal activity.

[0036] Age-related macular degeneration (AMD) is a liver-kidney disease, and its basic pathological feature is kidney deficiency and liver hyperactivity. The yin and yang of the liver and kidney affect each other pathologically. On the one hand, the kidney is prone to deficiency, and the liver and kidney yin and blood are deficient; on the other hand, the liver is prone to hyperactivity, and liver yang, liver wind, and liver fire are disturbed. Zong Li Zhongzi's "Medical Essential Reading: Yi and Gui Have the Same Origin" proposed the idea of ​​"Yi and Gui have the same origin, and the kidney and liver are treated together". Traditional Chinese medicine advocates that nourishing the liver and kidney, calming the liver and improving eyesight should be the main treatment method. In the Chinese medicine composition described in this application, Huangjing, Ligustrum lucidum, and Lycium barbarum are all monarch drugs, all of which are excellent products for nourishing yin and kidney, nourishing liver and improving eyesight. They complement each other and directly hit the root of the pathogenesis. The minister drugs are dried dendrobium to nourish yin and produce body fluid, chrysanthemum to calm the liver and improve eyesight, and stir-fried Ziziphus jujuba seeds to nourish the heart and calm the mind and nourish the liver. These three drugs help the monarch drugs nourish the liver and kidney. The adjuvants are Prunella Vulgaris, Tribulus Terrestris, Herba Glechomae, and Buddleja Buddleja, aiming to clear liver fire, calm liver yang, and dispel wind and heat to improve eyesight. Malt (adjuvant) soothes the liver and strengthens the spleen, promotes the smooth flow of qi, and helps to restore liver and kidney functions; Licorice (adjuvant) harmonizes the various drugs to enhance the overall efficacy. The prescription is precisely matched with the various drugs, hits the pathogenesis, and is precisely applied, mainly to nourish the liver and kidneys, and also to dispel wind and heat, improve eyesight and eliminate cataracts, reflecting the essence of the holistic concept and syndrome differentiation and treatment of traditional Chinese medicine.

[0037] Traditional Chinese medicine believes that the deficiency of the root and the excess of the superficial, liver and kidney deficiency and spleen deficiency are the main etiology and pathogenesis of AMD. In recent years, studies have found that AMD nourishes yin and inhibits apoptosis mechanisms. Chinese medicine with the effects of nourishing yin and clearing away heat can play a therapeutic role in AMD to a certain extent by inhibiting the apoptosis of retinal pigment epithelial RPE cells and photoreceptors. The Chinese medicine composition described in this application is based on the pathological characteristics of "kidney deficiency and liver hyperactivity" in age-related macular degeneration, and is a Chinese medicine compound developed by the main treatment method of "nourishing the liver and kidney, calming the liver and improving eyesight". The Chinese medicine composition of this application adopts a scientific ratio, and the components can coordinate and promote each other, playing a synergistic effect.

[0038] The Chinese medicine composition described in the present application has the effects of nourishing the liver and kidneys, calming the liver and improving eyesight, and is easy to take, has good patient tolerance, and has no adverse reactions after long-term use. After being made into a standardized Chinese patent medicine preparation, it can promote standardized treatment with Chinese medicine.

[0039] According to some embodiments of the traditional Chinese medicine composition described in the present application, the following raw materials are included in weight parts: 10-11 parts of Herba Polygoni Multiflori, 10-11 parts of Buddleja Buddleja, 6-8 parts of dried Dendrobium Officinale, 10-11 parts of Tribulus Terrestris, 6-8 parts of Chrysanthemum, 6-8 parts of Lycium barbarum, 10-11 parts of Polygonatum sibiricum, 4-5 parts of Licorice, 7-8 parts of Prunella Vulgaris, 8-9 parts of Ligustrum lucidum, 10-13 parts of stir-fried Ziziphus jujuba seeds, and 11-13 parts of stir-fried malt.

[0040] According to some embodiments of the Chinese medicine composition described in the present application, the following raw materials are included in weight parts: 9 parts of Herba Polygoni Multiflori, 10 parts of Buddleja Buddleja, 5 parts of dried Dendrobium, 10 parts of Tribulus Terrestris, 5 parts of Chrysanthemum, 5 parts of Lycium barbarum, 9 parts of Polygonatum sibiricum, 3 parts of Licorice, 6 parts of Prunella Vulgaris, 6 parts of Ligustrum lucidum, 9 parts of stir-fried Ziziphus jujuba seeds, and 10 parts of stir-fried malt.

[0041] According to some embodiments of the Chinese medicine composition described in the present application, the following raw materials are included in weight parts: 10 parts of Herba Codonopsis pilosulae, 10 parts of Buddleja buddleja, 6 parts of dried Dendrobium officinale, 10 parts of Tribulus terrestris, 6 parts of Chrysanthemum, 6 parts of Lycium barbarum, 10 parts of Polygonatum sibiricum, 4 parts of Licorice, 7 parts of Prunella Vulgaris, 8 parts of Ligustrum lucidum, 10 parts of stir-fried Ziziphus jujuba seeds, and 11 parts of stir-fried malt.

[0042] According to some embodiments of the Chinese medicine composition described in the present application, the following raw materials are included in weight parts: 11 parts of Herba Codonopsis pilosulae, 11 parts of Buddleja buddleja, 8 parts of dried Dendrobium candidum, 11 parts of Tribulus terrestris, 8 parts of Chrysanthemum, 8 parts of Lycium barbarum, 11 parts of Polygonatum sibiricum, 5 parts of Licorice, 8 parts of Prunella Vulgaris, 9 parts of Ligustrum lucidum, 13 parts of stir-fried Ziziphus jujuba seeds, and 13 parts of stir-fried malt.

[0043] According to some embodiments of the Chinese medicine composition described in the present application, the following raw materials are included in weight parts: 12 parts of Herba Codonopsis pilosulae, 12 parts of Buddleja buddleja, 10 parts of dried Dendrobium candidum, 12 parts of Tribulus terrestris, 9 parts of Chrysanthemum, 10 parts of Lycium barbarum, 12 parts of Polygonatum sibiricum, 5 parts of Licorice, 10 parts of Prunella Vulgaris, 10 parts of Ligustrum lucidum, 15 parts of stir-fried Ziziphus jujuba seeds, and 15 parts of stir-fried malt.

[0044] The second aspect of the present application provides a method for preparing the Chinese medicine composition described in the first aspect of the present application, comprising the following steps: boiling Herba Polygoni Multiflori, Buddleja Buddleja, dried Dendrobium, Tribulus Terrestris, Chrysanthemum, Fructus Lycii, Polygonatum sibiricum, Licorice, Spica Prunellae, Fructus Ligustri Lucidi, stir-fried Semen Ziziphi Spinosae and stir-fried malt in water to obtain the Chinese medicine composition.

[0045] According to some embodiments of the preparation method described in the present application, Herba Polygoni Multiflori, Buddleja Buddleja, dried Dendrobium, Tribulus Terrestris, Chrysanthemum, Fructus Lycii, Polygonatum sibiricum, Licorice, Spica Prunellae, Fructus Ligustri Lucidi, stir-fried Semen Ziziphi Spinosae and stir-fried malt are respectively decocted with water for extraction, and after the extraction is completed, the extracts are combined and filtered.

[0046] According to some embodiments of the preparation method described in the present application, the weight ratio of the total amount of the Herba Polygoni Multiflori, the Buddleja Buddleja, the dried Dendrobium, the Tribulus Terrestris, the Chrysanthemum, the Fructus Lycii, the Polygonatum sibiricum, the Radix Glycyrrhizae, the Spica Prunellae, the Fructus Ligustri Lucidi, the stir-fried Semen Ziziphi Spinosae and the stir-fried malt to water is 1:(8-12), for example, 1:8, 1:9, 1:10, 1:12.

[0047] The boiling temperature is 90-100°C, for example 90°C, 95°C, 98°C, 100°C, and the boiling time is 40-60min, for example 40min, 45min, 46min, 50min, 52min, 58min, 60min.

[0048] According to some embodiments of the preparation method described in the present application, the preparation method also includes concentrating the extract obtained by boiling; the concentration temperature is 60-80°C, for example, 60°C, 65°C, 70°C, 75°C, 80°C; the relative density of the product obtained by concentration is 1.15-1.20, for example, 1.15, 1.18, 1.19, 1.20.

[0049] The third aspect of the present application provides a traditional Chinese medicine preparation for treating age-related macular degeneration, wherein the traditional Chinese medicine preparation comprises the traditional Chinese medicine composition described in the first aspect of the present application or the traditional Chinese medicine composition obtained by the preparation method described in the second aspect of the present application.

[0050] According to some embodiments of the traditional Chinese medicine preparation described in the present application, the dosage form of the traditional Chinese medicine preparation is tablets, pills, powders, capsules, oral liquids or granules.

[0051] According to some embodiments of the Chinese medicine preparation described in the present application, the Chinese medicine preparation is a granule;

[0052] The preparation method of the granules comprises: mixing the Chinese medicine composition described in the first aspect of the present application or the Chinese medicine composition obtained by the preparation method described in the second aspect of the present application with dextrin, and granulating to obtain the granules.

[0053] According to some embodiments of the traditional Chinese medicine preparation described in the present application, the granulation is spray drying granulation.

[0054] According to some embodiments of the traditional Chinese medicine preparation described in the present application, the inlet air temperature of the spray drying is 90-100°C.

[0055] The beneficial effects of the present application are as follows: the Chinese medicine composition described in the present application is a Chinese medicine compound developed based on the pathological characteristics of "kidney deficiency and liver hyperactivity" of age-related macular degeneration, with "nourishing the liver and kidney, calming the liver and improving eyesight" as the main treatment method. The Chinese medicine composition of the present application adopts a scientific ratio, and the components can coordinate and promote each other to play a synergistic role. It has the effects of nourishing the liver and kidney, calming the liver and improving eyesight, and is easy to take, has good patient tolerance, and has no adverse reactions after long-term use. After being made into a standardized Chinese patent medicine preparation, it can promote standardized treatment of Chinese medicine. BRIEF DESCRIPTION OF THE DRAWINGS

[0056] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0057] Figure 1 a is the optical coherence tomography vascular imaging image of mice in the normal group;

[0058] Figure 1 b is the optical coherence tomography vascular imaging image of mice in the model group;

[0059] Figure 1 c is the optical coherence tomography vascular imaging image of mice in the ranibizumab group;

[0060] Figure 1 d is the optical coherence tomography vascular imaging image of mice in the nourishing yin and improving eyesight group;

[0061] Figure 2 The statistical graphs of the optical coherence tomography angiography results of the model group, ranibizumab group, and nourishing yin and improving eyesight group;

[0062] Figure 3 HE staining images of the retina-choroid-sclera tissues of mice in the normal group, model group and Yin-nourishing and eye-brightening group;

[0063] Figure 4 The choroidal immunofluorescence images of mice in the model group, ranibizumab group, and nourishing yin and improving eyesight group;

[0064] Figure 5 The diagram shows the fundus fibrosis area of ​​mice in the model group, ranibizumab group, and nourishing yin and improving eyesight group;

[0065] Figure 6 The CNV area quantification bar graphs of mice in the model group, ranibizumab group, and nourishing yin and improving eyesight group;

[0066] Figure 7The Western Blot experimental results of mice in the normal group, model group, ranibizumab group and nourishing yin and improving eyesight group;

[0067] Figure 8 VEGF expression levels of mice in the normal group, model group, ranibizumab group, and nourishing yin and improving eyesight group;

[0068] Fig. 9 is the VEGFR2 expression level of mice in the normal group, model group, ranibizumab group and nourishing yin and improving eyesight group;

[0069] Fig.10 is the p38 expression level of mice in the normal group, model group, ranibizumab group and nourishing yin and improving eyesight group;

[0070] Fig.11 The ERK1 / 2 phosphorylation levels of mice in the normal group, model group, ranibizumab group and nourishing yin and improving eyesight group. DETAILED DESCRIPTION

[0071] In order to make the technical problems, technical solutions and beneficial effects to be solved by the present application more clearly understood, the present application is further described in detail below in conjunction with the embodiments. It should be understood that the specific embodiments described herein are only used to explain the present application and are not used to limit the present application.

[0072] In this application, the term "and / or" describes the association relationship of associated objects, indicating that there may be three relationships. For example, A and / or B can mean: A exists alone, A and B exist at the same time, and B exists alone. A and B can be singular or plural. The character " / " generally indicates that the associated objects are in an "or" relationship.

[0073] In this application, "at least one" means one or more, and "plurality" means two or more. "At least one of the following" or similar expressions refers to any combination of these items, including any combination of single items or plural items. For example, "at least one of a, b, or c", or "at least one of a, b, and c" can all mean: a, b, c, ab (i.e., a and b), ac, bc, or abc, where a, b, c can be single or multiple, respectively.

[0074] It should be understood that in the various embodiments of the present application, the size of the serial numbers of the above-mentioned processes does not mean the order of execution, some or all of the steps can be executed in parallel or sequentially, and the execution order of each process should be determined by its function and internal logic, and should not constitute any limitation on the implementation process of the embodiments of the present application.

[0075] The terms used in the embodiments of the present application are only for the purpose of describing specific embodiments, and are not intended to limit the present application. The singular forms "a", "said" and "the" used in the embodiments of the present application and the appended claims are also intended to include plural forms, unless the context clearly indicates other meanings.

[0076] The weight of the relevant components mentioned in the embodiment description of the present application can not only refer to the specific content of each component, but also represent the proportional relationship between the weights of the components. Therefore, as long as the content of the relevant components is proportionally enlarged or reduced according to the embodiment description of the present application, it is within the scope disclosed in the embodiment description of the present application. Specifically, the mass described in the embodiment description of the present application can be a mass unit known in the chemical industry such as μg, mg, g, kg, etc.

[0077] Example 1

[0078] A traditional Chinese medicine composition for treating age-related macular degeneration comprises the following raw materials in parts by weight: 9g of Herba Corydalis, 10g of Buddleja Buddleja, 5g of dried Dendrobium, 10g of Tribulus Terrestris, 5g of Chrysanthemum, 5g of Lycium barbarum, 9g of Polygonatum sibiricum, 3g of Licorice, 6g of Prunella Vulgaris, 6g of Ligustrum lucidum, 9g of stir-fried Semen Ziziphi Spinosae, and 10g of stir-fried malt.

[0079] The preparation method of the Chinese medicine composition comprises the following steps:

[0080] Herba Polygoni Multiflori, Buddismia Monnieri, dried Dendrobium, Tribulus Terrestris, chrysanthemum, wolfberry, Polygonatum sibiricum, liquorice, herba Prunellae, Ligustrum lucidum, stir-fried Semen Ziziphi Spinosae and stir-fried malt are boiled in water respectively, the boiling temperature is 100°C, the boiling time is 40 minutes, the weight ratio of water to each raw material is 10:1, after the decoction is completed, the boiled liquid is combined, filtered to obtain an extract, and the extract is vacuum concentrated at a temperature of 60°C to a relative density of 1.15 to obtain the Chinese medicine composition.

[0081] Example 2

[0082] A traditional Chinese medicine composition for treating age-related macular degeneration comprises the following raw materials in parts by weight: 10g of Herba Corydalis, 10g of Buddleja Buddleja, 6g of dried Dendrobium, 10g of Tribulus Terrestris, 6g of Chrysanthemum, 6g of Lycium barbarum, 10g of Polygonatum sibiricum, 4g of Licorice, 7g of Prunella Vulgaris, 8g of Ligustrum lucidum, 10g of stir-fried Semen Ziziphi Spinosae, and 11g of stir-fried malt.

[0083] The preparation method of the Chinese medicine composition comprises the following steps:

[0084] Herba Polygoni Multiflori, Buddismia Buddismiae, dried Dendrobium, Tribulus Terrestris, chrysanthemum, wolfberry, Polygonatum sibiricum, liquorice, herba Prunellae, Ligustrum lucidum, stir-fried Semen Ziziphi Spinosae and stir-fried malt are boiled in water respectively, the boiling temperature is 100°C, the boiling time is 40 minutes, the weight ratio of water to each raw material is 10:1, after the decoction is completed, the boiled liquid is combined, filtered to obtain an extract, and the extract is vacuum concentrated at a temperature of 60°C to a relative density of 1.16 to obtain the Chinese medicine composition.

[0085] Example 3

[0086] A traditional Chinese medicine composition for treating age-related macular degeneration comprises the following raw materials in parts by weight: 11g of Herba Corydalis, 11g of Buddleja Buddleja, 8g of dried Dendrobium, 11g of Tribulus Terrestris, 8g of Chrysanthemum, 8g of Lycium barbarum, 11g of Polygonatum sibiricum, 5g of Licorice, 8g of Prunella Vulgaris, 9g of Ligustrum lucidum, 13g of stir-fried Semen Ziziphi Spinosae, and 13g of stir-fried malt.

[0087] The preparation method of the Chinese medicine composition comprises the following steps:

[0088] Boil Herba Polygoni Multiflori, Buddismia Buddismiae, dried Dendrobium, Tribulus Terrestris, Chrysanthemum, Fructus Lycii, Polygonatum sibiricum, Licorice, Spica Prunellae, Fructus Ligustri Lucidi, stir-fried Semen Ziziphi Spinosae and stir-fried malt in water at a temperature of 100° C. for 40 min. The weight ratio of water to each raw material is 10:1. After the decoction is completed, the boiled liquid is combined and filtered to obtain an extract. The extract is vacuum concentrated at a temperature of 60° C. to a relative density of 1.17 to obtain the Chinese medicine composition.

[0089] Example 4

[0090] A traditional Chinese medicine composition for treating age-related macular degeneration comprises the following raw materials in parts by weight: 12g of Herba Corydalis, 12g of Buddleja Buddleja, 10g of dried Dendrobium, 12g of Tribulus Terrestris, 9g of Chrysanthemum, 10g of Lycium barbarum, 12g of Polygonatum sibiricum, 5g of Licorice, 10g of Prunella Vulgaris, 10g of Ligustrum lucidum, 15g of stir-fried Semen Ziziphi Spinosae, and 15g of stir-fried malt.

[0091] The preparation method of the Chinese medicine composition comprises the following steps:

[0092] Boil Herba Polygoni Multiflori, Buddismia Buddismiae, dried Dendrobium, Tribulus Terrestris, Chrysanthemum, Fructus Lycii, Polygonatum sibiricum, Licorice, Spica Prunellae, Fructus Ligustri Lucidi, stir-fried Semen Ziziphi Spinosae and stir-fried malt in water at a temperature of 100° C. for 40 min. The weight ratio of water to each raw material is 10:1. After the decoction is completed, the boiled liquid is combined and filtered to obtain an extract. The extract is vacuum concentrated at a temperature of 60° C. to a relative density of 1.20 to obtain the Chinese medicine composition.

[0093] Study on the efficacy of the Chinese medicine composition for treating age-related macular degeneration described in Example 1 of the present application:

[0094] Experimental Animals:

[0095] Forty SPF-grade C57BL / 6 mice were selected, male, 6 months old, and weighed (30±2) g. They were purchased from Sibeifu (Beijing) Biotechnology Co., Ltd., and the animal quality certificate number was SCXK (Beijing) 20190010. They were kept in the SPF-grade animal room of Jiangsu Provincial Hospital of Traditional Chinese Medicine, with a temperature of 22-26°C and a humidity of 50%-70%. This animal experiment complied with animal ethics standards.

[0096] Modeling: Laser photocoagulation-induced choroidal neovascularization (CNV) model in mice

[0097] After the mice were fully dilated, they were anesthetized by intraperitoneal injection of 0.2 ml / 10 g of ready-to-use 1.25% Avertin. After complete anesthesia, hyaluronic acid gel was applied to the eyes. After the cornea was flattened with a coverslip, the mice were fixed on a bracket and photocoagulated with krypton yellow laser (wavelength 577 nm, parameters: spot diameter 100 μm, exposure time 0.1 s, power 100-120 mW) under a 120D special front mirror. The photocoagulation was performed at 5-6 points between the large retinal blood vessels around the optic disc, 2-4 disc diameters away from the optic disc. The basement membrane (Bruch's membrane) of the choroidal capillaries was broken to produce small bubbles, which were regarded as effective photocoagulation points. Mice with fundus hemorrhage were eliminated.

[0098] Animal grouping and drug administration

[0099] After one week of adaptive feeding, the mice were randomly divided into 4 groups: normal group, model group, ranibizumab group, nourishing yin and improving eyesight group (administered with the Chinese medicine composition described in Example 1 of the present application), 10 mice in each group, a total of 40 mice. The Chinese medicine composition prepared in Example 1 of the present application was dissolved in distilled water to prepare the Chinese medicine liquid. From the second day after laser modeling, 1.086g / ml (7.24g / kg) of Chinese medicine liquid was gavaged according to the equivalent dosage ratio table of human and animal body surface area conversion, and the gavage volume was 0.2ml each time, once a day. The ranibizumab group was injected with 1μL of ranibizumab injection into the vitreous cavity (avoid reflux of the liquid, high intraocular pressure, corneal whitening, and eyeball bleeding during injection), once a day. The model group and the normal group were gavaged with 0.2ml of distilled water, once a day. Each group was intervened for 14 days.

[0100] Imaging tests

[0101] After modeling and after the 14-day observation period, the mice were fully dilated and anesthetized by intraperitoneal injection of 1.25% Avertin. After complete anesthesia, the mice were placed in a special bracket for optical coherence tomography scanner, 0.9% saline was applied to the eyes to protect the cornea, and the Angio9x9 scanning mode (V3.0116) was selected to select as many laser spots as possible, and the optical coherence tomography angiography (OCTA) image acquisition was completed quickly. The area of ​​choroidal neovascularization (CNV) lesions was quantified using the software provided by the device. The results are shown in the figure. Figure 1 As shown in Figure 2, the results of optical coherence tomography angiography are statistically shown in Figure 2. Figure 2 As shown, Figure 1 a is the normal group, Figure 1 b is the model group, Figure 1 c is the ranibizumab group, Figure 1 d is the Yin-nourishing and eyesight-improving group.

[0102] from Figure 1 It can be seen that the retinal layers of the normal group mice are closely connected and have a clear structure;

[0103] Compared with the model group, the subretinal fluid at the laser spot in the ranibizumab group and the experimental group was gradually absorbed, the mass-like high-reflective lesions were more localized, the boundaries were clearer, and the CNV lesion area was smaller.

[0104] from Figure 2 It can be seen that there are statistically significant differences between the experimental group and the model group *P<0.05, **P<0.01.

[0105] HE staining to observe histopathological changes

[0106] The animals were killed 2 weeks after modeling and drug administration, and the eyeballs were immediately removed and fixed with FAS eyeball fixative for 24 hours. The fascia was peeled off and the anterior segment was cut off under a microscope, and then the eye cup was placed in FAS eyeball fixative for more than 24 hours. Dehydrated with gradient ethanol, embedded in paraffin, fixed in a 4°C refrigerator for 10 hours, set the slicer to 5μm slices, spread in 45°C constant temperature water and then dried. After dewaxing, HE staining was performed according to the process, and the slides were sealed with neutral gum. The HE staining results of the retinal-choroid-scleral tissues of each group of mice were observed under an optical microscope. Figure 3 shown.

[0107] from Figure 3 It can be seen that the retinal tissue structure of the normal group is clear and distinct. In the model group, the retinal thickness increased at the laser spot, the structures of the retinal layers were disordered, the human retinal pigment epithelium (RPE) layer and the basement membrane (Brunch membrane) of the choroid capillaries were bulging and damaged, and a variety of cells infiltrated from the choroid from the defect to the inner side of the retina, and choroidal neovascularization (CNV) was formed (white arrow). Compared with the model group, the retinal thickness and structural damage of the experimental group were reduced compared with the model group.

[0108] Quantitative analysis of CNV area by choroidal flat mount immunofluorescence

[0109] Two weeks after modeling and drug administration, the animals were anesthetized and perfused with 4% paraformaldehyde in the heart, then the eyeballs were removed, and the anterior segment of the eyeball and the neural retina were carefully separated under a microscope. After the sclera was removed, four radial incisions were made to avoid the laser spot, and the RPE-choroid tissue was spread on a slide, blocked with 0.1% Triton X-100 and 1% bovine serum albumin (BSA) in a 4°C refrigerator overnight, and 50μl of diluted rabbit anti-VEGF antibody and mouse anti-Collagen-I antibody were added to cover the tissue, and 50-100μl of fluorescent secondary antibody (dilution ratio 1:500) was added, and 50-100μl of DAPI staining solution was added. The slide was sealed with anti-fluorescence quenching sealing agent, and the laser lesions were observed and photographed under a confocal microscope. ImageJ software (NIH, version1.8.0) was used to quantitatively analyze the CNV area marked by the flat slide. The immunofluorescence image of the choroidal flat slide is shown in the following figure. Figure 4 As shown; the quantitative bar graphs of fundus fibrosis area and CNV area are shown Figure 5 and Figure 6 shown.

[0110] Note: Collagen-I expression is red fluorescence, VEGF expression is green fluorescence, DAPI (cell nucleus) is blue fluorescence, scale bar: 100 μm.

[0111] from Figure 4 It can be seen that the results of Collagen-I fluorescence intensity showed that compared with the model group, the fibrosis area in the experimental group and the ranibizumab group was reduced, and the difference was statistically significant (P < 0.05).

[0112] The results of VEGF fluorescence intensity showed that compared with the model group, the CNV area in the experimental group and the ranibizumab group was reduced, and the difference was statistically significant (P<0.05 or P<0.01).

[0113] The DAPI fluorescence results showed that the cell nuclei in the spread samples were clearly stained.

[0114] The Merge fluorescence results showed that the fibrosis area represented by red fluorescence exceeded the CNV area represented by green fluorescence, which was consistent with basic biological significance.

[0115] from Figure 5It can be seen that the fibrosis area obtained by ImageJ software analysis is 70.33±5.686 in the model group (MX), 55.33±4.933 in the positive drug group (YX), and 52.33±5.132 in the high-dose group of the Ziyinmingmu prescription (ZG). Compared with the model group, the fibrosis area of ​​mice in the positive drug group after treatment with ranibizumab was significantly reduced, and the difference was statistically significant (P<0.05). Compared with the model group, the fibrosis area of ​​mice in the Chinese medicine prescription treatment was significantly reduced, and the difference was statistically significant (P<0.05).

[0116] from Figure 6 It can be seen that the CNV area obtained by ImageJ software analysis was 57.00±5.568 in the model group (MX), 37.67±4.726 in the positive drug group (YX), and 42.67±4.163 in the high-dose group of the Ziyin Mingmu prescription (ZG). Compared with the model group, the CNV area of ​​mice in the positive drug group was significantly reduced after treatment with ranibizumab, and the difference was statistically significant (P<0.01). Compared with the model group, the CNV area of ​​mice after treatment with the Chinese medicine prescription was significantly reduced, and the difference was statistically significant (P<0.05).

[0117] Effect of the Chinese medicine composition described in the present application on the expression of proteins related to vascular endothelial growth factor (VEGF) and mitogen-activated protein kinase (MAPK) pathway in CNV mice

[0118] The protein of retinal-choroid-sclera complex tissue was extracted from each group, and the protein concentration was detected by BCA method (BCA is an alkaline water-soluble complex). After boiling water denaturation of protein, 30 μg was loaded for sample loading. After electrophoresis and transfer, diluted primary antibody VEGF, p-VEGFR2, VEGFR2, p-p38, p38, ERK1 / 2, p-ERK1 / 2, β-actin antibody (dilution ratio 1:1000) was added and incubated at 4°C overnight, and then goat anti-rabbit HRP secondary antibody (1:5000) was added. β-Actin was used as internal reference, and chemiluminescence substrate (TanonECL) was used for chemiluminescence. The images were taken under Tanon5200 chemiluminescence imager, and grayscale value analysis and comparison were performed using ImageJ software. The results of Western Blot experiment are shown in Figure 2. Figure 7 The expression levels of VEGF, phosphorylation levels of VEGFR2, p38, and ERK1 / 2 in each group of mice were compared as shown in Figure 8 , Fig. 9 , Fig.10 , Fig.11 shown.

[0119] from Figure 7It can be seen that compared with the normal group, the VEGF protein level in the model group was significantly increased, while compared with the model group, the VEGF protein levels in the experimental group and the ranibizumab group were significantly decreased, and the differences were statistically significant (P < 0.01);

[0120] Compared with the normal group, the phosphorylation level of VEGFR2 protein in the model group was significantly increased (P<0.05), while compared with the model group, the phosphorylation level of VEGFR2 protein in the experimental group and ranibizumab group was decreased (P<0.01);

[0121] Compared with the normal group, the phosphorylation levels of p38 protein and ERK1 / 2 protein in the model group were significantly increased, while compared with the model group, the phosphorylation levels of p38 protein and ERK1 / 2 protein in the experimental group and ranibizumab group were significantly decreased, and the differences were statistically significant (P<0.01).

[0122] Clinical efficacy evaluation of the Chinese medicine composition for treating age-related macular degeneration described in this application:

[0123] Effects of the Chinese medicine composition for treating age-related macular degeneration described in this application on vision:

[0124] Experimental method: Thirty subjects aged 45-75 years old and of any gender who met the diagnostic criteria for AMD and the TCM differentiation criteria for liver-kidney deficiency were selected and randomly divided into two groups, the experimental group and the control group.

[0125] The experimental group took the Chinese medicine composition for treating age-related macular degeneration prepared in Example 1 of the present application, 90 g each time, twice a day.

[0126] The control group took Leshiding Capsules, with an oral dose of 1 capsule once a day.

[0127] Laishiding Capsules were selected as the control drug. The drug approval number is: National Food and Health G2015005. Laishiding Capsules are health food made from lutein suspension (lutein, corn oil), β-carotene suspension (β-carotene, corn oil), zinc gluconate, vitamin E (dl-α-tocopherol acetate), etc. as the main raw materials. Each 100g contains: lutein 2.2g, β-carotene 0.64g, zinc 1.125g. The specification is 0.35g / capsule. Laishiding Capsules have been shown to reduce the risk of progression to late-stage age-related macular degeneration (AMD). Therefore, the use of Laishiding Capsules as the control drug can play the currently recognized and recommended therapeutic and health care role.

[0128] After taking it for 90 days, the test results were tested, and the results are shown in Table 1:

[0129] Table 1 Comparison of visual acuity between the two groups before and after treatment (number of letters, )

[0130] Group Number of cases Before taking After taking Experimental Group 15 51.87±2.87 55.56±3.78* Control group 15 51.84±3.96 52.95±3.44

[0131] Note: Before taking refers to the visual acuity score value checked by using the ETDRS visual acuity chart before taking the composition described in Example 1 or the Leshiding capsule;

[0132] After taking refers to the visual acuity score value checked by using the ETDRS visual acuity chart before taking the composition described in Example 1 or the Leshiding capsule;

[0133] As can be seen from Table 1: Comparison of visual acuity before and after treatment between the two groups of cases: the visual acuity of the experimental group was significantly improved, while that of the control group was not significantly improved, with a comparison between before and after treatment, *P<0.05.

[0134] The Chinese medicine composition for treating age-related macular degeneration described in the present application affects the area of ​​extracellular deposits (drusen) of lipids, proteins and cell debris in the retinal layer.

[0135] Test method: 30 subjects aged 45-75 years old and of any gender who met the diagnostic criteria for AMD and the TCM criteria for liver and kidney deficiency were randomly divided into two groups, the experimental group and the control group.

[0136] The experimental group took the Chinese medicine composition for treating age-related macular degeneration prepared in Example 1 of the present application, 90 g each time, twice a day; the control group took Leshiding Capsules, with an oral dose of 1 capsule, once a day.

[0137] The Angio blood flow imaging mode in Vision OCTA (Inlight, China) was used, and the 33Line scanning program was used to scan the dAMD lesion range. The imageJ software measured the drusen area in the 33Line scanning range. The test results are shown in Table 2:

[0138] Table 2 Comparison of Drusen area before and after Chinese medicine treatment in 30 cases of dry macular degeneration (mm 2 , )

[0139]

[0140] Remark:

[0141] The visit time refers to the observation after taking the medicine for 90 days

[0142] The P value is a parameter for determining the results of hypothesis testing. When calculating in SPSS, it will give the degrees of freedom (related to the sample size, assuming the sample size is 20, the degrees of freedom is 19), the data that conforms to the normal distribution is the t value, and the data that does not conform to the normal distribution is displayed by the rank sum test as the Z value. The P value is less than 0.05, which means the difference is significant. From Table 2, it can be seen that the Z test value is -3.806, and the significance level P is less than 0.01, indicating that the result is significant.

[0143] Statistical methods: SPSS27.0 was used for statistical analysis, and the Shapiro-Wilk method was used for normality test. The measurement data that conformed to the normal distribution were expressed as mean ± standard deviation (χ ± s), and the paired sample t test was used to compare the same patient before and after treatment; the measurement data of non-normal distribution were expressed as median (25% and 75% quartiles), and the related sample Wilcoxon signed rank test was used to compare the same patient before and after treatment. P < 0.05 was considered statistically significant.

[0144] It can be seen from Table 2 that the drusen area was significantly reduced after treatment in the experimental group.

[0145] Effect of the Chinese medicine composition for treating age-related macular degeneration described in the present application on the macular scar area of ​​the eye

[0146] Experimental method: Thirty subjects aged 45-75 years old and of any gender who met the diagnostic criteria for AMD and the TCM differentiation criteria for liver-kidney deficiency were selected and randomly divided into two groups, the experimental group and the control group.

[0147] The experimental group took the Chinese medicine composition for treating age-related macular degeneration prepared in Example 1 of the present application, 90 g each time, twice a day; the control group took Leshiding Capsules, with an oral dose of 1 capsule, once a day.

[0148] The Angio blood flow imaging mode of Vision OCTA (Inlight, China) was used, and the Angio6*6 scanning program was used to scan the range of dAMD lesions, and the area of ​​macular scar lesions was quantified using the device's own software.

[0149] The test results are shown in Table 3:

[0150] Table 3 Comparison of macular scar area between the two groups before and after treatment (mm 2 , )

[0151] Group Number of cases Before treatment After treatment Experimental Group 15 0.73±0.23 0.69±0.24* Control group 15 0.72±0.30 0.71±0.21

[0152] As can be seen from Table 3: the macular scar in the experimental group was significantly reduced before and after treatment, while there was no significant change in the control group.

[0153] Clinical effect study of the Chinese medicine composition for treating age-related macular degeneration described in Example 1 of the present application:

[0154] Zhao, female, 66 years old, had blurred vision in her left eye for more than a year. She was diagnosed with macular degeneration and had received anti-VEGF treatment three times. Some lesions of fundus neovascularization were scarred. In the past two weeks, she felt that her right eye vision had decreased, and black shadows were floating in front of her eyes. She went to the outpatient clinic for treatment. Scattered drusen were seen in the fundus. Taking the Chinese medicine composition described in Example 1 of the present application 90g each time, twice a day, and taking it for 90 days, the patient was compared before and after treatment for clinical observation. Whether it was the main observation indicator of vision, macular tomography scanning; or the secondary indicator of Chinese medicine syndrome integral efficacy index evaluation, the patient was improved compared with before treatment.

[0155] The above description is only a preferred embodiment of the present application and is not intended to limit the present application. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present application should be included in the protection scope of the present application.

Claims

1. A Chinese medicine composition for treating age-related macular degeneration, It is characterized in that The invention comprises the following raw materials in parts by weight: 9-12 parts of Herba Codonopsis pilosulae, 9-12 parts of Buddleja buddleja, 5-10 parts of dried dendrobium, 9-12 parts of Tribulus terrestris, 5-9 parts of chrysanthemum, 5-10 parts of wolfberry, 9-12 parts of polygonatum sibiricum, 3-5 parts of liquorice, 6-10 parts of selfheal, 6-10 parts of Ligustrum lucidum, 9-15 parts of stir-fried spiny jujube seeds and 10-15 parts of stir-fried malt.

2. The Chinese medicine composition according to claim 1, It is characterized in that The invention comprises the following raw materials in parts by weight: 10-11 parts of Herba Codonopsis pilosulae, 10-11 parts of Buddleja buddleja, 6-8 parts of dried dendrobium, 10-11 parts of Tribulus terrestris, 6-8 parts of chrysanthemum, 6-8 parts of wolfberry, 10-11 parts of Polygonatum sibiricum, 4-5 parts of liquorice, 7-8 parts of Prunella vulgaris, 8-9 parts of Ligustrum lucidum, 10-13 parts of stir-fried Ziziphus jujuba seeds and 11-13 parts of stir-fried malt.

3. The Chinese medicine composition according to claim 1, It is characterized in that The invention comprises the following raw materials in parts by weight: 9 parts of Herba Corydalis, 10 parts of Buddleja Buddleja, 5 parts of dried Dendrobium, 10 parts of Tribulus Terrestris, 5 parts of Chrysanthemum, 5 parts of Lycium barbarum, 9 parts of Polygonatum sibiricum, 3 parts of Licorice, 6 parts of Prunella Vulgaris, 6 parts of Ligustrum lucidum, 9 parts of stir-fried Semen Ziziphi Spinosae, and 10 parts of stir-fried Malt; And / or, comprising the following raw materials in parts by weight: 10 parts of Herba Corydalis, 10 parts of Buddleja Buddleja, 6 parts of dried Dendrobium, 10 parts of Tribulus Terrestris, 6 parts of Chrysanthemum, 6 parts of Lycium barbarum, 10 parts of Polygonatum sibiricum, 4 parts of Licorice, 7 parts of Prunella Vulgaris, 8 parts of Ligustrum lucidum, 10 parts of stir-fried Semen Ziziphi Spinosae, and 11 parts of stir-fried malt; And / or, comprising the following raw materials in parts by weight: 11 parts of Herba Codonopsis pilosulae, 11 parts of Buddleja buddleja, 8 parts of dried dendrobium, 11 parts of Tribulus terrestris, 8 parts of chrysanthemum, 8 parts of wolfberry, 11 parts of Polygonatum sibiricum, 5 parts of liquorice, 8 parts of Prunella vulgaris, 9 parts of Ligustrum lucidum, 13 parts of stir-fried Semen Ziziphi spinulosae, and 13 parts of stir-fried malt; And / or, comprising the following raw materials in parts by weight: 12 parts of Herba Codonopsis pilosulae, 12 parts of Buddleja buddleja, 10 parts of dried Dendrobium officinale, 12 parts of Tribulus terrestris, 9 parts of Chrysanthemum, 10 parts of Lycium barbarum, 12 parts of Polygonatum sibiricum, 5 parts of Licorice, 10 parts of Prunella Vulgaris, 10 parts of Ligustrum lucidum, 15 parts of stir-fried Ziziphus jujuba seeds, and 15 parts of stir-fried malt.

4. A method for preparing the Chinese medicine composition according to any one of claims 1 to 3, It is characterized in that The following steps are involved: The Chinese medicinal composition is obtained by boiling Herba Polygoni Multiflori, Buddleja Buddleja, dried Dendrobium Officinale, Tribulus Terrestris, chrysanthemum, Lycium Barbarum, Polygonatum Officinale, Licorice, Prunella Vulgaris, Ligustrum Lucidum Fruit, stir-fried Semen Ziziphi Spinosae and stir-fried malt.

5. The preparation method according to claim 4, It is characterized in that The weight ratio of the total amount of the Herba Polygoni Multiflori, the Buddleja Buddleja, the dried Dendrobium Officinale, the Tribulus Terrestris, the Flos Chrysanthemi, the Fructus Lycii, the Polygonatum Sinensis, the Root of Licorice, the Herba Prunellae, the Fructus Ligustri Lucidi, the stir-fried Semen Ziziphi Spinosae and the stir-fried Malt to water is 1:(8-12); The boiling temperature is 90-100° C., and the boiling time is 40-60 min.

6. The preparation method according to claim 4, It is characterized in that The preparation method further comprises concentrating the extract obtained by boiling; the concentration temperature is 60-80° C., and the relative density of the product obtained by concentration is 1.15-1.

20.

7. A Chinese medicine preparation for treating age-related macular degeneration, It is characterized in that The Chinese medicine preparation comprises the Chinese medicine composition according to any one of claims 1 to 3 or the Chinese medicine composition obtained by the preparation method according to any one of claims 4 to 6.

8. The Chinese medicine preparation according to claim 7, It is characterized in that The dosage form of the Chinese medicine preparation is tablets, pills, powders, capsules, oral liquids or granules.

9. The Chinese medicine preparation according to claim 8, It is characterized in that The Chinese medicine preparation is a granule; The preparation method of the granules comprises: mixing the traditional Chinese medicine composition according to any one of claims 1 to 3 or the traditional Chinese medicine composition obtained by the preparation method according to any one of claims 4 to 6 with dextrin, and granulating to obtain the granules.

10. The Chinese medicine preparation according to claim 9, It is characterized in that The granulation is spray drying granulation; Preferably, the inlet air temperature of the spray drying is 90-100°C.

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