A traditional Chinese medicine composition for treating high myopia

Abstract

This invention discloses a traditional Chinese medicine composition for treating high myopia, which is made from the following raw materials: Astragalus membranaceus, Angelica sinensis, Rehmannia glutinosa, Chaenomeles speciosa, Bupleurum chinense, Paeonia lactiflora, Cuscuta chinensis, Leonurus japonicus, and Glycyrrhiza uralensis. Clinical studies have demonstrated that this traditional Chinese medicine composition has a significant therapeutic effect on macular degeneration in high myopia.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition for treating high myopia. Background Technology

[0002] According to the latest WHO definition of high myopia, a refractive error greater than 5.00D is considered the diagnostic threshold for high myopia. High myopia is the result of a combination of factors, including genetics, race, and environment. With increasing axial length, deepening myopia, and age, the pathological changes in the eyeball worsen. Myopia increases the risk of eye-related diseases such as cataracts, glaucoma, macular degeneration, and retinal detachment (RD). High myopia also carries risks of RD, tears, retinal tears, macular hemorrhage, choroidal neovascularization (CNV), and open-angle glaucoma, which can lead to blindness in severe cases. Currently, the onset of myopia is occurring at increasingly younger ages, with higher levels of myopia, a year-on-year increase in incidence, and the blinding potential of pathological myopia.

[0003] Treatment for high myopia primarily involves refractive correction. For myopic tractional macular degeneration, procedures such as fundus laser surgery, vitrectomy, and intravitreal gas injection are performed depending on the situation. For CNV, anti-vascular endothelial growth factor (VEGF) therapy is administered. However, due to the high refractive error, even with glasses, the magnification affects image quality, resulting in poor visual quality for patients. Refractive surgery requires very strict indications, and the economic burden of surgery and medication ultimately impacts patients' quality of life. In 2019, the International Society for Myopia Research published a series of white papers covering various aspects of myopia prevention and control, summarizing existing myopia treatment programs. The results showed significant differences in intervention effectiveness, and no single method has yet been proven to effectively prevent and control the onset of myopia or slow its progression in all myopia-affected populations. Therefore, it is necessary to explore the effectiveness, safety, and potential mechanisms of compound traditional Chinese medicine treatment. Summary of the Invention

[0004] In view of the above problems, the present invention is proposed to provide a traditional Chinese medicine composition for treating high myopia.

[0005] As one aspect of the present invention, the present invention provides a traditional Chinese medicine composition for treating high myopia, the traditional Chinese medicine composition being made from the following raw materials: Astragalus membranaceus, Angelica sinensis, Rehmannia glutinosa, Chaenomeles speciosa, Bupleurum chinense, Paeonia lactiflora, Cuscuta chinensis, Leonurus japonicus, and Glycyrrhiza uralensis.

[0006] Preferably, the traditional Chinese medicine composition is made from the following raw materials: Astragalus membranaceus 9-54 parts by weight, Angelica sinensis 8-42 parts by weight, Rehmannia glutinosa 8-42 parts by weight, Chaenomeles speciosa 4-24 parts by weight, Bupleurum chinense 4-24 parts by weight, Paeonia lactiflora 4-24 parts by weight, Cuscuta chinensis 8-42 parts by weight, Leonurus japonicus 4-24 parts by weight, and Glycyrrhiza uralensis 3-18 parts by weight;

[0007] More preferably, the traditional Chinese medicine composition is made from the following raw materials: Astragalus membranaceus 15-45 parts by weight, Angelica sinensis 11-34 parts by weight, Rehmannia glutinosa 11-34 parts by weight, Chaenomeles speciosa 6-18 parts by weight, Bupleurum chinense 6-18 parts by weight, Paeonia lactiflora 6-18 parts by weight, Cuscuta chinensis 11-34 parts by weight, Leonurus japonicus 6-18 parts by weight, and Glycyrrhiza uralensis 4-12 parts by weight;

[0008] More preferably, the traditional Chinese medicine composition is made from the following raw materials: Astragalus membranaceus 23-37 parts by weight, Angelica sinensis 16-24 parts by weight, Rehmannia glutinosa 16-24 parts by weight, Chaenomeles speciosa 8-14 parts by weight, Bupleurum chinense 8-14 parts by weight, Paeonia lactiflora 8-14 parts by weight, Cuscuta chinensis 16-24 parts by weight, Leonurus japonicus 8-14 parts by weight, and Glycyrrhiza uralensis 5-8 parts by weight;

[0009] Most preferably, the traditional Chinese medicine composition is made from the following raw materials: 30 parts by weight of Astragalus membranaceus, 20 parts by weight of Angelica sinensis, 20 parts by weight of Rehmannia glutinosa, 10 parts by weight of Chaenomeles speciosa, 10 parts by weight of Bupleurum chinense, 10 parts by weight of Paeonia lactiflora, 20 parts by weight of Cuscuta chinensis, 10 parts by weight of Leonurus japonicus, and 6 parts by weight of Glycyrrhiza uralensis.

[0010] Alternatively, use 26 parts by weight of Astragalus membranaceus, 22 parts by weight of Angelica sinensis, 18 parts by weight of Rehmannia glutinosa, 12 parts by weight of Chaenomeles speciosa, 9 parts by weight of Bupleurum chinense, 12 parts by weight of Paeonia lactiflora, 18 parts by weight of Cuscuta chinensis, 12 parts by weight of Leonurus japonicus, and 5 parts by weight of Glycyrrhiza uralensis.

[0011] Alternatively, use 34 parts by weight of Astragalus membranaceus, 18 parts by weight of Angelica sinensis, 22 parts by weight of Rehmannia glutinosa, 9 parts by weight of Chaenomeles speciosa, 12 parts by weight of Bupleurum chinense, 9 parts by weight of Paeonia lactiflora, 22 parts by weight of Cuscuta chinensis, 9 parts by weight of Leonurus japonicus, and 8 parts by weight of Glycyrrhiza uralensis.

[0012] The traditional Chinese medicine composition described in this invention can be a composition formed by mixing various raw materials after pulverizing them, or it can be an extract obtained by mixing or extracting various raw materials individually, or it can be an effective part obtained by further refining and purifying the extract, or it can be a conventional dosage form made by adding pharmaceutically acceptable excipients to the extract / effective part.

[0013] The extraction methods include decoction extraction, reflux extraction, maceration extraction, ultrasonic extraction, percolation extraction, and microwave extraction; the purification methods include water extraction and alcohol precipitation, alkali dissolution and acid precipitation, and various column chromatography purification methods, such as macroporous resin columns, silica gel columns, gel columns, and reversed-phase columns; the conventional dosage forms include, but are not limited to, injections, capsules, tablets, granules, gels, sustained-release preparations, oral liquids, pellets, or nano-preparations; the pharmaceutically acceptable excipients include: fillers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives, and matrices. Fillers include: starch, pregelatinized starch, lactose, mannitol, chitosan, microcrystalline cellulose, sucrose, etc.; disintegrants include: starch, pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch, croscarmellose, low-substituted hydroxypropyl cellulose, croscarmellose sodium, etc.; lubricants include: magnesium stearate, sodium lauryl sulfate, talc, silica, etc.; suspending agents include: polyvinylpyrrolidone, microcrystalline cellulose, sucrose, agar, hydroxypropyl methylcellulose, etc.; binders include: starch paste, polyvinylpyrrolidone, hydroxypropyl methylcellulose, etc.

[0014] As another aspect of the present invention, the traditional Chinese medicine composition of the present invention may also use an extract of the raw material as a raw material. Therefore, the present invention further provides a traditional Chinese medicine composition for treating high myopia, the traditional Chinese medicine composition being made from the following raw materials:

[0015] Astragalus extract 9-54 parts by weight, Angelica sinensis extract 8-42 parts by weight, Rehmannia glutinosa extract 8-42 parts by weight, Chaenomeles speciosa extract 4-24 parts by weight, Bupleurum chinense extract 4-24 parts by weight, Paeonia lactiflora extract 4-24 parts by weight, Cuscuta chinensis extract 8-42 parts by weight, Leonurus japonicus extract 4-24 parts by weight, Glycyrrhiza uralensis extract 3-18 parts by weight;

[0016] Preferably, the traditional Chinese medicine composition is made from the following raw materials:

[0017] Astragalus extract 15-45 parts by weight, Angelica sinensis extract 11-34 parts by weight, Rehmannia glutinosa extract 11-34 parts by weight, Chaenomeles speciosa extract 6-18 parts by weight, Bupleurum chinense extract 6-18 parts by weight, Paeonia lactiflora extract 6-18 parts by weight, Cuscuta chinensis extract 11-34 parts by weight, Leonurus japonicus extract 6-18 parts by weight, Glycyrrhiza uralensis extract 4-12 parts by weight;

[0018] More preferably, the traditional Chinese medicine composition is made from the following raw materials:

[0019] Astragalus extract 23-37 parts by weight, Angelica sinensis extract 16-24 parts by weight, Rehmannia glutinosa extract 16-24 parts by weight, Chaenomeles speciosa extract 8-14 parts by weight, Bupleurum chinense extract 8-14 parts by weight, Paeonia lactiflora extract 8-14 parts by weight, Cuscuta chinensis extract 16-24 parts by weight, Leonurus japonicus extract 8-14 parts by weight, Glycyrrhiza uralensis extract 5-8 parts by weight;

[0020] Most preferably, the traditional Chinese medicine composition is made from the following raw materials: 30 parts by weight of Astragalus membranaceus extract, 20 parts by weight of Angelica sinensis extract, 20 parts by weight of Rehmannia glutinosa extract, 10 parts by weight of Chaenomeles speciosa extract, 10 parts by weight of Bupleurum chinense extract, 10 parts by weight of Paeonia lactiflora extract, 20 parts by weight of Cuscuta chinensis extract, 10 parts by weight of Leonurus japonicus extract, and 6 parts by weight of Glycyrrhiza uralensis extract.

[0021] The above-mentioned extracts may be aqueous extracts of the active pharmaceutical ingredients, or organic solvent extracts, or refined products obtained by further refining and purification processes of aqueous extracts / organic solvent extracts.

[0022] The organic solvent is selected from one or more of methanol, 20-95% ethanol solution, and acetone;

[0023] The extraction methods used to prepare the above extracts include any one of reflux extraction, maceration extraction, ultrasonic extraction or percolation extraction, or a combination of different extraction methods.

[0024] The raw materials involved in this invention, namely Astragalus membranaceus, Angelica sinensis, Rehmannia glutinosa, Chaenomeles speciosa, Bupleurum chinense, Paeonia lactiflora, Cuscuta chinensis, Leonurus japonicus, and Glycyrrhiza uralensis, all conform to the records in the Chinese Pharmacopoeia (2020 edition).

[0025] As another aspect of the present invention, the present invention also provides the use of the said traditional Chinese medicine composition in the preparation of a medicament for treating high myopia.

[0026] Preferably, the application of the traditional Chinese medicine composition of the present invention in the preparation of a medicament for treating macular degeneration in high myopia.

[0027] Technical effects of the present invention:

[0028] The formula of this invention is a traditional Chinese medicine compound for high myopia macular degeneration, proposed by the inventor based on many years of clinical experience in integrated traditional Chinese and Western ophthalmology. It combines the differentiation of syndromes based on viscera and the differentiation of syndromes based on qi, blood and body fluids. It targets the pathogenesis of high myopia macular degeneration, namely "deficiency of both qi and yin" and "malnourishment of tendons and vessels", as well as the pathological characteristics of "prolonged disease affecting the kidneys" and "prolonged disease inevitably leading to blood stasis". The main treatment principle is "regulating blood and softening tendons, nourishing yin and improving vision", which treats both the symptoms and the root cause, so as to achieve the effect of improving vision and brightening eyesight.

[0029] This formula consists of Astragalus membranaceus, Angelica sinensis, Rehmannia glutinosa, Chaenomeles speciosa, Bupleurum chinense, Paeonia lactiflora, Cuscuta chinensis, Leonurus japonicus, and Glycyrrhiza uralensis. It has the functions of invigorating qi and nourishing yin, softening the liver and relaxing muscles. Astragalus membranaceus is sweet and slightly warm in nature, entering the lung and spleen meridians. It excels at invigorating qi and strengthening the spleen, generating fluids and nourishing blood, and is mainly used for various symptoms caused by spleen qi deficiency and insufficient qi and blood. Angelica sinensis is sweet and pungent in taste, warm in nature, entering the liver, heart, and spleen meridians. It excels at nourishing and activating blood. Rehmannia glutinosa is sweet and slightly warm in nature, entering the liver and kidney meridians. It excels at tonifying the kidneys and replenishing essence, nourishing blood and yin, and is an essential medicine for nourishing kidney yin. Astragalus membranaceus, Angelica sinensis, and Rehmannia glutinosa are the chief herbs, focusing on invigorating qi, nourishing blood, and nourishing yin. Chaenomeles speciosa is sour and warm in nature, entering the liver and spleen meridians, invigorating qi and warming yang. Bupleurum chinense is bitter and pungent in taste, slightly cold in nature, and can soothe the liver and relieve depression, regulating qi and promoting the rise of yang qi. White peony root is bitter and sour in taste, and slightly cold in nature. Its functions include astringing the liver and nourishing the blood, softening the liver, and calming liver yang. It can harmonize yin and blood and guide them back to their respective meridians. In summary, Bupleurum has the strongest dispersing effect and is highly similar to the nature of the liver (wood element), mainly exhibiting ascending and moving characteristics. White peony root not only nourishes liver blood, ensuring sufficient liver blood to support the "use of yang," but also clears liver heat, allowing the "use of yang" to proceed in an orderly manner. The three herbs used together act as assistant herbs, conforming to the liver's characteristic of "yin in substance and yang in function," with dispersing and astringing working in tandem, nourishing both qi and blood, harmonizing dispersing and softening, and combining movement and stillness for mutual benefit. It is supplemented with Leonurus japonicus and Cuscuta chinensis. Cuscuta chinensis tonifies the liver and kidneys; Leonurus japonicus is good at promoting blood circulation and removing blood stasis, clearing liver fire, and tonifying while moving. Leonurus japonicus enters the liver meridian, its pungent and bitter properties dispersing and draining into the blood, improving eyesight and benefiting essence. "The liver receives blood and thus enables vision." The liver takes blood as its substance and qi as its function; blood should be harmonious and qi should flow smoothly. Simultaneously, "all the seeds descend, except for Leonurus japonicus seed, which ascends," guiding the nourishing herbs to their respective locations. Licorice harmonizes all the herbs. In summary, the entire formula works by regulating blood, softening tendons, nourishing yin, and improving vision. Clinical studies have shown it to have significant efficacy in treating macular degeneration in high myopia. Attached Figure Description

[0030] Figure 1 Light micrographs of guinea pig retinas in each group of Example 24 (×400);

[0031] Among them, A is the blank control group, B is the model group, C is the high-dose group of traditional Chinese medicine composition, D is the medium-dose group of traditional Chinese medicine composition, and E is the low-dose group of traditional Chinese medicine composition.

[0032] Figure 2 Light micrographs of the sclera of guinea pigs in each group of Example 24 (×400);

[0033] Among them, A is the blank control group, B is the model group, C is the high-dose group of traditional Chinese medicine composition, D is the medium-dose group of traditional Chinese medicine composition, and E is the low-dose group of traditional Chinese medicine composition.

[0034] Figure 3 Light micrographs (×400) of the retinal morphology of each group of guinea pigs in Example 25;

[0035] Among them, A is the blank control group, B is the model group, and C is the traditional Chinese medicine group.

[0036] Figure 4 Electron micrographs of guinea pig retinas in each group of Example 25 (×1200);

[0037] Among them, A is the blank control group, B is the model group, and C is the traditional Chinese medicine group.

[0038] Figure 5 Light micrographs (×400) of the sclera morphology of each group of guinea pigs in Example 25;

[0039] Among them, A is the blank control group, B is the model group, and C is the traditional Chinese medicine group.

[0040] Figure 6 Electron micrographs of the sclera of guinea pigs in each group of Example 25 (×1200);

[0041] Among them, A is the blank control group, B is the model group, and C is the traditional Chinese medicine group. Detailed Implementation

[0042] Embodiments of the present invention will now be described in more detail. It should be understood that the invention can be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided to enable a more thorough understanding of the invention and to fully convey the scope of the invention to those skilled in the art.

[0043] Example 1

[0044] Formula: Astragalus membranaceus 30g, Angelica sinensis 20g, Rehmannia glutinosa 20g, Chaenomeles speciosa 10g, Bupleurum chinense 10g, Paeonia lactiflora 10g, Cuscuta chinensis 20g, Leonurus japonicus 10g, Glycyrrhiza uralensis 6g;

[0045] Preparation method: Take each raw material in proportion, add water and decoct twice, then combine the decoctions;

[0046] Specifications and usage: One dose per day, 200ml, taken warm in the morning and evening.

[0047] Example 2

[0048] Formula: Astragalus membranaceus 26g, Angelica sinensis 22g, Rehmannia glutinosa 18g, Chaenomeles speciosa 12g, Bupleurum chinense 9g, Paeonia lactiflora 12g, Cuscuta chinensis 18g, Leonurus japonicus 12g, Glycyrrhiza uralensis 5g;

[0049] Preparation method: Take each raw material in proportion, add 50% ethanol and reflux twice, filter the extract, concentrate, and obtain the extract paste;

[0050] The extract was prepared into tablets using conventional tablet manufacturing processes.

[0051] Example 3

[0052] Formula: Astragalus membranaceus 34g, Angelica sinensis 18g, Rehmannia glutinosa 22g, Chaenomeles speciosa 9g, Bupleurum chinense 12g, Paeonia lactiflora 9g, Cuscuta chinensis 22g, Leonurus japonicus 9g, Glycyrrhiza uralensis 8g;

[0053] Preparation method: Take each raw material in proportion, add water and decoct twice, filter, take the decoction, concentrate, and obtain the extract.

[0054] The extract was prepared into granules using conventional granule formulation processes.

[0055] Example 4

[0056] Formula: Astragalus membranaceus 18g, Angelica sinensis 30g, Rehmannia glutinosa 12g, Chaenomeles speciosa 17g, Bupleurum chinense 6g, Paeonia lactiflora 17g, Cuscuta chinensis 13g, Leonurus japonicus 16g, Glycyrrhiza uralensis 4g;

[0057] Preparation method: Take each raw material in proportion, add 60% ethanol and reflux twice, filter the extract, concentrate and obtain the extract paste;

[0058] The extract was prepared into capsules using conventional capsule formulation processes.

[0059] Example 5

[0060] Formula: Astragalus membranaceus 42g, Angelica sinensis 12g, Rehmannia glutinosa 30g, Chaenomeles speciosa 6g, Bupleurum chinense 17g, Paeonia lactiflora 6g, Cuscuta chinensis 30g, Leonurus japonicus 7g, Glycyrrhiza uralensis 11g;

[0061] Preparation method: Take each raw material in proportion, add water and decoct twice, filter, take the decoction, concentrate, and obtain the extract.

[0062] The extract was prepared into tablets using conventional tablet manufacturing processes.

[0063] Example 6

[0064] Formula: Astragalus membranaceus 22g, Angelica sinensis 26g, Rehmannia glutinosa 14g, Chaenomeles speciosa 15g, Bupleurum chinense 8g, Paeonia lactiflora 15g, Cuscuta chinensis 15g, Leonurus japonicus 14g, Glycyrrhiza uralensis 5g;

[0065] Preparation method: Take each raw material in proportion, add 50% ethanol and reflux twice, filter the extract, concentrate, and obtain the extract paste;

[0066] The extract was prepared into granules using conventional granule formulation processes.

[0067] Example 7

[0068] Formula: Astragalus membranaceus 38g, Angelica sinensis 14g, Rehmannia glutinosa 26g, Chaenomeles speciosa 8g, Bupleurum chinense 15g, Paeonia lactiflora 7g, Cuscuta chinensis 26g, Leonurus japonicus 8g, Glycyrrhiza uralensis 9g;

[0069] Preparation method: Take each raw material in proportion, add water and decoct twice, filter, take the decoction, concentrate, and obtain the extract.

[0070] The extract was prepared into capsules using conventional capsule formulation processes.

[0071] Example 8

[0072] Formula: Astragalus membranaceus 10g, Angelica sinensis 40g, Rehmannia glutinosa 9g, Chaenomeles speciosa 22g, Bupleurum chinense 4g, Paeonia lactiflora 23g, Cuscuta chinensis 9g, Leonurus japonicus 23g, Glycyrrhiza uralensis 3g;

[0073] Preparation method: Take each raw material in proportion, add 60% ethanol and reflux twice, filter the extract, concentrate and obtain the extract paste;

[0074] The extract was prepared into tablets using conventional tablet manufacturing processes.

[0075] Example 9

[0076] Formula: Astragalus membranaceus 52g, Angelica sinensis 9g, Rehmannia glutinosa 40g, Chaenomeles speciosa 4g, Bupleurum chinense 22g, Paeonia lactiflora 4g, Cuscuta chinensis 40g, Leonurus japonicus 4g, Glycyrrhiza uralensis 16g;

[0077] Preparation method: Take each raw material in proportion, add water and decoct twice, filter, take the decoction, concentrate, and obtain the extract.

[0078] The extract was prepared into granules using conventional granule formulation processes.

[0079] Example 10

[0080] Formula: Astragalus membranaceus 13g, Angelica sinensis 36g, Rehmannia glutinosa 11g, Chaenomeles speciosa 19g, Bupleurum chinense 5g, Paeonia lactiflora 19g, Cuscuta chinensis 11g, Leonurus japonicus 19g, Glycyrrhiza uralensis 4g;

[0081] Preparation method: Take each raw material in proportion, add 50% ethanol and reflux twice, filter the extract, concentrate, and obtain the extract paste;

[0082] The extract was prepared into capsules using conventional capsule formulation processes.

[0083] Example 11

[0084] Formula: Astragalus membranaceus 47g, Angelica sinensis 10g, Rehmannia glutinosa 36g, Chaenomeles speciosa 6g, Bupleurum chinense 18g, Paeonia lactiflora 6g, Cuscuta chinensis 36g, Leonurus japonicus 5g, Glycyrrhiza uralensis 14g;

[0085] Preparation method: Take each raw material in proportion, add water and decoct twice, filter, take the decoction, concentrate, and obtain the extract.

[0086] The extract was prepared into capsules using conventional capsule formulation processes.

[0087] Example 12

[0088] Formula: Astragalus membranaceus extract 30g, Angelica sinensis extract 20g, Rehmannia glutinosa extract 20g, Chaenomeles speciosa extract 10g, Bupleurum chinense extract 10g, Paeonia lactiflora extract 10g, Cuscuta chinensis extract 20g, Leonurus japonicus extract 10g, Glycyrrhiza uralensis extract 6g.

[0089] Example 13

[0090] Formula: Astragalus membranaceus extract 26g, Angelica sinensis extract 22g, Rehmannia glutinosa extract 18g, Chaenomeles speciosa extract 12g, Bupleurum chinense extract 9g, Paeonia lactiflora extract 12g, Cuscuta chinensis extract 18g, Leonurus japonicus extract 12g, Glycyrrhiza uralensis extract 5g.

[0091] Example 14

[0092] Formula: Astragalus membranaceus extract 34g, Angelica sinensis extract 18g, Rehmannia glutinosa extract 22g, Chaenomeles speciosa extract 9g, Bupleurum chinense extract 12g, Paeonia lactiflora extract 9g, Cuscuta chinensis extract 22g, Leonurus japonicus extract 9g, Glycyrrhiza uralensis extract 8g.

[0093] Example 15

[0094] Formula: Astragalus membranaceus extract 18g, Angelica sinensis extract 30g, Rehmannia glutinosa extract 12g, Chaenomeles speciosa extract 17g, Bupleurum chinense extract 6g, Paeonia lactiflora extract 17g, Cuscuta chinensis extract 13g, Leonurus japonicus extract 16g, Glycyrrhiza uralensis extract 4g.

[0095] Example 16

[0096] Formula: Astragalus membranaceus extract 42g, Angelica sinensis extract 12g, Rehmannia glutinosa extract 30g, Chaenomeles speciosa extract 6g, Bupleurum chinense extract 17g, Paeonia lactiflora extract 6g, Cuscuta chinensis extract 30g, Leonurus japonicus extract 7g, Glycyrrhiza uralensis extract 11g.

[0097] Example 17

[0098] Formula: Astragalus membranaceus extract 22g, Angelica sinensis extract 26g, Rehmannia glutinosa extract 14g, Chaenomeles speciosa extract 15g, Bupleurum chinense extract 8g, Paeonia lactiflora extract 15g, Cuscuta chinensis extract 15g, Leonurus japonicus extract 14g, Glycyrrhiza uralensis extract 5g.

[0099] Example 18

[0100] Formula: Astragalus membranaceus extract 38g, Angelica sinensis extract 14g, Rehmannia glutinosa extract 26g, Chaenomeles speciosa extract 8g, Bupleurum chinense extract 15g, Paeonia lactiflora extract 7g, Cuscuta chinensis extract 26g, Leonurus japonicus extract 8g, Glycyrrhiza uralensis extract 9g.

[0101] Example 19

[0102] Formula: Astragalus membranaceus extract 10g, Angelica sinensis extract 40g, Rehmannia glutinosa extract 9g, Chaenomeles speciosa extract 22g, Bupleurum chinense extract 4g, Paeonia lactiflora extract 23g, Cuscuta chinensis extract 9g, Leonurus japonicus extract 23g, Glycyrrhiza uralensis extract 3g.

[0103] Example 20

[0104] Formula: Astragalus membranaceus extract 52g, Angelica sinensis extract 9g, Rehmannia glutinosa extract 40g, Chaenomeles speciosa extract 4g, Bupleurum chinense extract 22g, Paeonia lactiflora extract 4g, Cuscuta chinensis extract 40g, Leonurus japonicus extract 4g, Glycyrrhiza uralensis extract 16g.

[0105] Example 21

[0106] Formula: Astragalus membranaceus extract 13g, Angelica sinensis extract 36g, Rehmannia glutinosa extract 11g, Chaenomeles speciosa extract 19g, Bupleurum chinense extract 5g, Paeonia lactiflora extract 19g, Cuscuta chinensis extract 11g, Leonurus japonicus extract 19g, Glycyrrhiza uralensis extract 4g.

[0107] Example 22

[0108] Formula: Astragalus membranaceus extract 47g, Angelica sinensis extract 10g, Rehmannia glutinosa extract 36g, Chaenomeles speciosa extract 6g, Bupleurum chinense extract 18g, Paeonia lactiflora extract 6g, Cuscuta chinensis extract 36g, Leonurus japonicus extract 5g, Glycyrrhiza uralensis extract 14g.

[0109] The extracts described in Examples 12-22 above are aqueous extracts of each of the active pharmaceutical ingredients. The extracts are combined according to the formulation amounts and prepared into conventional oral dosage forms such as tablets, capsules, or granules using conventional pharmaceutical processes.

[0110] Example 23: Clinical observation of the formulation of the present invention in the treatment of macular degeneration in high myopia.

[0111] 1. Objects and Methods

[0112] 1.1 Research Subjects

[0113] This study included patients diagnosed with high myopia macular degeneration who visited the Department of Ophthalmology at the China-Japan Friendship Hospital between September 2017 and September 2019. The diagnoses included refractive errors, axial length measurement, fundus examination (direct or indirect ophthalmoscopy or slit-lamp microscopy with a front lens after mydriasis), color fundus photography, optical coherence tomography (OCT), fluorescein fundus angiography (FFA), and indocyanine green choroidal angiography (ICGA). A total of 50 patients were included, with one patient dropping out due to not being able to return to the hospital as scheduled, resulting in 49 patients (49 eyes) ultimately included. Only one eye was randomly selected from each of the two patients (one eye was randomly selected from each binocular patient) as the study subject.

[0114] 1.2 Diagnostic and Inclusion Criteria

[0115] 1.2.1 Diagnostic criteria

[0116] Based on the diagnostic criteria of the 3rd edition of Chinese Ophthalmology (Li Fengming, Xie Lixin, Beijing People's Medical Publishing House, 2014: 2277-2279) and the International Classification of High Myopia Macular Degeneration (Ohno-Matsui K, Kawasaki R, Jonas JB, et al. International photographic classification and grading system for myopic maculopathy[J]. Am J Ophthalmol. 2015, 159(5): 877-883), combined with clinical symptoms, refractive examination, fundus examination, color fundus photography, OCT, and FFA examination, the patient was diagnosed with high myopia macular degeneration.

[0117] Grading of macular degeneration in high myopia:

[0118] M0 level: No regressive changes;

[0119] M1 grade: Leopard-spot fundus;

[0120] M2 grade: Diffuse retinal and choroidal atrophy;

[0121] M3 grade: patchy retinal choroidal atrophy;

[0122] M4 grade: Macular atrophy;

[0123] Additional lesions: lacquer cracks, CNV, Fuchs spots.

[0124] 1.2.2 Case Inclusion Criteria

[0125] (1) Age 18 to 80 years old (inclusive), gender not limited;

[0126] (2) Myopia refractive error ≥ 5.00D, axial length > 24.00mm;

[0127] (3) One or both eyes meet the Western medical diagnostic criteria for macular degeneration in high myopia;

[0128] (4) The refractive media are basically clear, and fundus examination and FFA can be performed;

[0129] (5) They have good compliance and cooperate with researchers' observations and efficacy evaluations;

[0130] (6) Did not participate in other clinical trials within one month prior to treatment.

[0131] 1.2.3 Case Exclusion Criteria

[0132] (1) Patients with other fundus diseases such as glaucoma, retinal artery and vein occlusion, diabetic retinopathy, and optic neuropathy;

[0133] (2) Opacity of the refractive media (such as cataracts, vitreous hemorrhage, etc.) that prevents visualization of the fundus;

[0134] (3) Patients with serious cardiovascular, immune, hematopoietic, or other systemic diseases;

[0135] (4) Individuals with severe allergies to sodium fluorescein or indocyanine green;

[0136] (5) Patients who are participating in other drug clinical trials or using similar traditional Chinese medicines and other treatments in combination;

[0137] (6) Those who drop out midway.

[0138] 1.3 Research Methods

[0139] 1.3.1 Treatment Medications

[0140] The patient was given an oral decoction of a traditional Chinese medicine compound, which consisted of Astragalus membranaceus, Angelica sinensis, Rehmannia glutinosa, Chaenomeles speciosa, Bupleurum chinense, Paeonia lactiflora, Cuscuta chinensis, Leonurus japonicus, and Glycyrrhiza uralensis (the dosage and preparation method of each raw material are described in Example 1). One dose of 200ml was given daily, divided into two warm doses in the morning and evening, for a total of 6 months.

[0141] 1.3.2 Observation Indicators

[0142] The following relevant examinations were performed on the patients before treatment, 3 months after treatment, and 6 months after treatment: general ophthalmological examination (including best corrected visual acuity, intraocular pressure, slit-lamp examination, and direct ophthalmoscopy), refractive examination, axial length measurement, and OCT examination.

[0143] (1) Best Corrected Visual Acuity (BCVA): The best corrected visual acuity of patients was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart (Precision Vision, La Salle, IL Corporation) with E-charts. Specific examination methods and result representation standards are as follows:

[0144] Follow the principle of examining the right eye first, then the left. Cover the contralateral eye during measurement, but do not press on the eyeball. Under standard lighting, with the patient 4 meters away from the visual acuity chart and wearing best-corrected glasses, if the patient correctly reads more than 20 letters (visual acuity > 0.2), add 30 points to the score. If visual acuity < 0.2, instruct the patient to move to 1 meter away from the chart for the test; the score is the sum of the number of letters correctly read at 4 meters and the number correctly read at 1 meter. If the patient cannot correctly identify letters at 1 meter, record it as light perception or no light perception. Improvement: More than 5 more letters identified at the follow-up examination compared to the previous examination; Stable: The number of letters identified is the same as before the visit; Ineffective: The number of letters identified is less than before the visit.

[0145] (2) Intraocular pressure (Iop): A non-contact tonometer (NCT) (Topcon, Japan) was used. The patient was seated, with the chair and platform height adjusted, chin resting on the chin rest, forehead pressed against the forehead support, and the outer canthus aligned with the indicator next to the forehead support. The patient was instructed to open their eyes wide and focus both eyes on the red indicator point inside the instrument. Before measurement, the patient was informed that a slight airflow would occur during the measurement, and to avoid blinking or shifting their gaze. Three measurements were taken for each eye, and the average value was recorded.

[0146] (3) Refractive Examination: First, an automated computer refractometer is used for examination. This instrument changes the convergence and divergence of light entering the eye, allowing the test cursor to be clearly imaged on the retinal reflective surface, thereby calculating the refractive error of the examined eye. The examinee is instructed to focus on the cursor. Through optical path design, the cursor is placed at infinity, playing a "fogging" role. During measurement, a "fogged" cursor first enters the examinee's eye, then induces near perception accommodation. The test results show overcorrection of myopia or undercorrection of hyperopia. The test process is accelerated, and the measured diopter can be used as effective refraction reference data. Subjective refraction is then performed based on this. The examinee is instructed to sit comfortably in the examination chair. Those wearing glasses should remove their glasses, and the chair height is adjusted to ensure the examinee maintains a comfortable sitting posture. Preparation should be performed as follows: Disinfect the parts of the instrument that will come into contact with the examiner with alcohol. Place the phoropter head in front of the examinee's eyes, adjust the instrument's interpupillary distance to match the examinee's interpupillary distance, and observe whether the examinee's eyes are centered in the phoropter head's viewing aperture, whether the phoropter head is horizontal, and whether the examinee's eye-to-lens distance is appropriate. If there is any displacement or discomfort, adjust it promptly. Adjust the examinee's initial refractive power (including spherical power, astigmatism power, and astigmatic axis) onto the phoropter head. Follow the principle of "right eye first, then left eye," and be sure to cover the contralateral eye during measurement. Record the result as (subjective spherical power + astigmatism power / 2).

[0147] (4) Axial length measurement: The IOL Master partial optical coherence biometer (Zeiss IOL Master; Carl Zeiss AG, Oberkochen, Germany) was used. A quiet examination environment was selected, and the operation was performed in a dark room to avoid interference from external light sources. The examiner first patiently explained the operation steps and precautions to obtain the patient's maximum cooperation, thereby eliminating the influence of involuntary eye movements caused by the patient's tension on the examination results. The position of the machine's lifting platform was adjusted to help the patient maintain a comfortable posture. The chin and forehead were placed in appropriate positions on the chin rest and forehead strip, respectively, and kept as stable as possible. After the examiner entered the patient's basic information, the patient was instructed to look directly at the target on the instrument and perform a rough focus. Before the examiner informed the patient that the formal operation would begin, the patient could blink once to keep the cornea clear. First, measure the right eye. Move the joystick to the left; the left edge of the machine interface will then display white. Move the joystick to align with the cornea. When six points are clearly displayed on the cornea and form a regular hexagon, observe the red, yellow, and green indicator lights on the left. Measurement can only begin when the green indicator light is on. Measure five times for each eye and record the average. When measuring the left eye, move the joystick to the right and observe the red, yellow, and green indicator lights on the right. The method is the same as before and will not be repeated. Note that the data is only reliable when the five measurement results are displayed in black. If the data is displayed in red, repeat the above steps and measure again. The IOL Master is based on Partial Coherence Interference (PCI). Due to its non-contact nature, high measurement accuracy, small error, and simple operation, it is easily accepted by patients and can be used to measure axial length, corneal curvature, anterior chamber depth, etc.

[0148] (5) Topcon 3D frequency domain OCT: Before the examination, compound tropicamide eye drops (Santen Pharmaceutical Co., Ltd.) were administered to fully dilate the patient's pupils. Three-dimensional optical coherence tomography (3D-OCT) was performed with a scan length of 6.0mm×6.0mm. The 3D-OCT 2000 automatic analysis software was used to measure the optic disc area, myopia arc area, and choroidal atrophy arc area using fundus image analysis software.

[0149] Measurement of retinal thickness (RT) and choroidal thickness (CT): First, select the correct locations of the chorioscleral interface (CSI), Bruchs membrane (BM), retina pigment epithelium (RPE), and internal limiting membrane (ILM), and record the retinal and choroidal thickness data displayed in the report. When CSI, BM, RPE, and ILM are not in the correct locations, the choroidal thickness is obtained manually at five points at the level of the fovea (i.e., the fovea itself, 1.5 mm nasally, and 3 mm temporally from the fovea).

[0150] To ensure the accuracy and reliability of OCT data, the following operating procedures must be strictly followed during measurement.

[0151] Select CSI and align the center of the EDTR Grid with the fovea of ​​the macula. If they are not aligned, click "repository" to ensure the EDTR Grid center matches the fovea. You can then observe the changes in the relevant data and save. This step ensures the accuracy of various data in the EDTR Grid.

[0152] Click the ring data acquisition button to align the fovea position with the fovea position of the optic disc. If they do not align, click repositon to align the fovea position with the fovea position of the optic disc. You can then observe the changes in the relevant data and save it.

[0153] Observe the positions of CSI, BM, RPE, and ILM, and move the mouse to ensure that each level corresponds. If they do not correspond, the data automatically displayed in the image can only represent the data of a certain point in that level. If this data is directly included in the results analysis, there will be unavoidable errors. In this case, manual measurement should be performed.

[0154] 1.3.3 Safety Indicators

[0155] Complete blood count, urinalysis, liver function tests (AST / ALT / TBIL / AKP / γ-GT), and kidney function tests (BUN / Scr) were performed and recorded at three time points: before treatment, 3 months after treatment, and 6 months after treatment. Any adverse events related to medication that occurred during the study period were recorded, including all symptoms and signs.

[0156] 1.4 Statistical Analysis

[0157] SPSS Statistics 22.0 software was used for analysis. Quantitative data in this study are expressed as mean ± standard deviation. The data before and after treatment were analyzed using paired-samples t-tests; count data were analyzed using χ² tests. 2 For non-normal distributions, the Wilcoxon test is used, with P < 0.05 considered statistically significant.

[0158] 2 Results

[0159] 2.1 General Information

[0160] This study ultimately included 49 patients and 49 eyes. Among the participants, 11 were male (11 eyes) and 38 were female (38 eyes); the age range was 31–79 years, with a mean age of (56.47±12.04) years; the duration of disease ranged from 26 to 147 months, with a mean duration of (85.69±31.40) months; the best corrected visual acuity ranged from 3 to 50, with a mean best corrected visual acuity of (28.29±11.69); the intraocular pressure ranged from 12.7 to 18.9 mmHg, with a mean intraocular pressure of (15.93±1.47) mmHg; the refractive error ranged from -5.25 to -1575.00D, with a mean refractive error of (-9.44±2.34)D; the axial length ranged from 25.04 to 31.22 mm, with a mean axial length of (27.17±1.63) mm; and the myopic arc area ranged from 2.16 to 6.19 mm². 2 Between these values, the average area of ​​the myopic arc is (4.08±1.28) mm. 2 The area of ​​the choroidal atrophy arc ranged from 0.04 to 4.16 mm², with an average area of ​​(1.49 ± 0.23) mm². The thickness of the fovea ranged from 162 to 571 μm, with an average thickness of (368.77 ± 87.68) μm. The lesion height ranged from 139 to 402 μm, with an average height of (249.13 ± 39.11) μm. The thickness of the subfoveal choroid ranged from 87 to 192 μm, with an average thickness of (158.89 ± 16.15) μm.

[0161] 2.2 Best Corrected Visual Acuity

[0162] After all patients were fitted with best-corrected lenses, their best-corrected visual acuity was tested using the ETDRS visual acuity chart, and the number of letters they could recognize was recorded. Before treatment, the average best-corrected visual acuity was (28.29±11.69). After 3 months of treatment, the average best-corrected visual acuity was (28.69±11.58), with 5 eyes (10.2%) showing improvement, 36 eyes (73.5%) remaining stable, and 8 eyes (16.3%) showing no effect, for a total effective rate of 83.7%. After 6 months of treatment, the average best-corrected visual acuity was (30.08±11.67), with 16 eyes (32.7%) showing improvement, 29 eyes (59.1%) remaining stable, and 4 eyes (8.2%) showing no effect, for a total effective rate of 91.8%.

[0163] Statistical results showed that, compared with before treatment, the number of letters in ETDRS visual acuity improved after 3 months of treatment, but the difference was not statistically significant (P>0.05); after 6 months of treatment, the number of letters in ETDRS visual acuity improved significantly, and the difference was statistically significant (P<0.05). The results are shown in Tables 1, 2, and 3.

[0164] Table 1 Best corrected visual acuity after 3 months of treatment

[0165] Best corrected visual acuity efficient improve Stablize invalid Eye count 41 5 36 8 Proportion 83.7％ 10.2％ 73.5％ 16.3％

[0166] Table 2 Best corrected visual acuity after 6 months of treatment

[0167]

[0168]

[0169] Table 3 Comparison of the number of letters in ETDRS visual acuity before treatment and 3 and 6 months after treatment.

[0170] time Eye count ETDRS Vision Number of Letters Before treatment 49 28.29±11.69 3 months of treatment 49 28.69±11.58 Treatment for 6 months 49 <![CDATA[30.08±11.67 * ]]>

[0171] Note: Compared with before treatment * P<0.05

[0172] 2.3 Intraocular pressure

[0173] Non-contact intraocular pressure measurement results showed that the average intraocular pressure before treatment was (15.93±1.47) mmHg, the average intraocular pressure after 3 months of treatment was (16.01±2.16) mmHg, and the average intraocular pressure after 6 months of treatment was (15.87±3.07) mmHg.

[0174] Statistical results showed that compared with before treatment, there was no significant change in intraocular pressure after 3 months and 6 months of treatment, and the difference was not statistically significant (P>0.05). The results are shown in Table 4.

[0175] Table 4 Comparison of intraocular pressure values ​​before treatment and at 3 and 6 months after treatment.

[0176] time Eye count intraocular pressure Before treatment 49 15.93±1.47 3 months of treatment 49 16.01±2.16 Treatment for 6 months 49 15.87±3.07

[0177] 2.4 Refractive Examination

[0178] The refractive examination results showed that the average refractive error before treatment was (-9.44±2.34)D, the average refractive error after 3 months of treatment was (-9.29±1.28)D, and the average refractive error after 6 months of treatment was (-9.14±1.29)D.

[0179] Statistical results showed that compared with before treatment, the changes in refractive error were not significant after 3 months and 6 months of treatment, and the differences were not statistically significant (P>0.05). The results are shown in Table 5.

[0180] Table 5 Comparison of refractive error values ​​before treatment and 3 and 6 months after treatment.

[0181]

[0182]

[0183] 2.5 axial length

[0184] The IOL Master measurement results showed that the average axial length before treatment was (27.17±1.63) mm, the average axial length after 3 months of treatment was (27.06±0.27) mm, and the average axial length after 6 months of treatment was (27.01±1.29) mm.

[0185] Statistical results showed that, compared with before treatment, the changes in axial length were not significant after 3 months and 6 months of treatment, and the differences were not statistically significant (P>0.05). The results are shown in Table 6.

[0186] Table 6 Comparison of axial length before treatment and 3 and 6 months after treatment.

[0187] time Eye count axial length Before treatment 49 27.17±1.63 3 months of treatment 49 27.06±0.27 Treatment for 6 months 49 27.01±1.29

[0188] 2.6 Area of ​​the myopic arc

[0189] The results of OCT measurement of the myopic arc area showed that the average myopic arc area before treatment was (4.08±1.28) mm², and after 3 months of treatment, the average myopic arc area was (3.78±1.01) mm². 2 After 6 months of treatment, the average area of ​​the myopic arc was (3.46±1.13) mm. 2 .

[0190] Statistical results showed that, compared with before treatment, the area of ​​the myopic arc decreased after 3 months of treatment, but the difference was not statistically significant (P>0.05); after 6 months of treatment, the area of ​​the myopic arc decreased significantly, and the difference was statistically significant (P<0.05). The results are shown in Table 7.

[0191] Table 7 Comparison of myopic arc area before treatment and 3 and 6 months after treatment.

[0192] time Eye count Myopic arc area Before treatment 49 4.08±1.28 3 months of treatment 49 3.78±1.01 Treatment for 6 months 49 <![CDATA[3.46±1.13 * ]]>

[0193] Note: Compared with before treatment * P<0.05

[0194] 2.7 Area of ​​choroidal atrophy arc

[0195] OCT measurements of the choroidal atrophy arc showed that the average area of ​​the choroidal atrophy arc before treatment was (1.49±0.23) mm. 2 After 3 months of treatment, the average area of ​​choroidal atrophy was (1.36±0.19) mm. 2 After 6 months of treatment, the average area of ​​choroidal atrophy was (1.12±0.21) mm. 2 .

[0196] Statistical results showed that, compared with before treatment, the area of ​​choroidal atrophy arc decreased after 3 months of treatment, but the difference was not statistically significant (P>0.05); after 6 months of treatment, the area of ​​choroidal atrophy arc decreased significantly, and the difference was statistically significant (P<0.05). The results are shown in Table 8.

[0197] Table 8 Comparison of choroidal atrophy arc area before treatment and 3 and 6 months after treatment.

[0198] time Eye count choroidal atrophy arc area Before treatment 49 1.49±0.23 3 months of treatment 49 1.36±0.19 Treatment for 6 months 49 <![CDATA[1.12±0.21 * ]]>

[0199] Note: Compared with before treatment * P<0.05

[0200] 2.8 Macular foveal thickness

[0201] The results of OCT measurement of macular foveal thickness showed that the average macular foveal thickness before treatment was (368.77±87.68) μm, the average macular foveal thickness after 3 months of treatment was (321.33±66.14) μm, and the average macular foveal thickness after 6 months of treatment was (297.16±56.01) μm.

[0202] Statistical results showed that, compared with before treatment, the thickness of the macular fovea decreased after 3 months and 6 months of treatment, and the differences were statistically significant (all P<0.05). The results are shown in Table 9.

[0203] Table 9 Comparison of macular foveal thickness before treatment and 3 and 6 months after treatment.

[0204] time Eye count Macular foveal thickness Before treatment 49 368.77±87.68 3 months of treatment 49 <![CDATA[321.33±66.14 * ]]> Treatment for 6 months 49 <![CDATA[297.16±56.01 *# ]]>

[0205] Note: Compared with before treatment * P<0.05; compared with 3 months of treatment, # P<0.05.

[0206] 2.9 Lesion height

[0207] The results of OCT measurement of lesion height showed that the average lesion height before treatment was (249.13±39.11) μm, the average lesion height after 3 months of treatment was (210.16±26.02) μm, and the average lesion height after 6 months of treatment was (189.21±38.21) μm.

[0208] Statistical results showed that, compared with before treatment, the lesion severity decreased significantly after 3 months and 6 months of treatment, with statistically significant differences (all P<0.05). The results are shown in Table 10.

[0209] Table 10 Comparison of lesion severity before treatment and at 3 and 6 months after treatment.

[0210]

[0211]

[0212] Note: Compared with before treatment * P<0.05; compared with 3 months of treatment, # P<0.05.

[0213] 2.10 Thickness of the subfoveal choroid

[0214] The results of OCT measurement of subfoveal choroidal thickness showed that the average subfoveal choroidal thickness before treatment was (158.89±16.15) μm, the average subfoveal choroidal thickness after 3 months of treatment was (169.12±14.24) μm, and the average foveal thickness after 6 months of treatment was (176.11±12.21) μm.

[0215] Statistical results showed that, compared with before treatment, the thickness of the subfoveal choroid was significantly increased after 3 months and 6 months of treatment, with statistically significant differences (all P < 0.05). The results are shown in Table 11.

[0216] Table 11 Comparison of subfoveal choroidal thickness before treatment and 3 and 6 months after treatment.

[0217] time Eye count Thickness of the subfoveal choroid Before treatment 49 158.89±16.15 3 months of treatment 49 <![CDATA[169.12±14.24 * ]]> Treatment for 6 months 49 <![CDATA[176.11±12.21 *# ]]>

[0218] Note: Compared with before treatment, * P < 0.05; compared with 3 months after treatment, # P < 0.05.

[0219] 3 Conclusion

[0220] Traditional Chinese medicine has a long history and natural advantages in the treatment of high myopia macular degeneration. The inventors of this invention are good at applying the ideas of syndrome differentiation and treatment and overall regulation, not only focusing on local lesions, but also committed to adjusting the qi, blood, yin and yang of the whole body and balancing the functions of zang-fu organs. The application of the traditional Chinese medicine composition of this invention with the principle of "regulating blood and softening tendons, nourishing yin and improving eyesight" in high myopia macular degeneration has a certain effect in improving and stabilizing the eyesight of patients, increasing the blood supply of choroid and improving fundus lesions, and can improve the quality of life of patients to a certain extent.

[0221] Experimental study on the intervention of the formula of this invention in form-deprivation high myopia (FDHM) in guinea pigs in Example 24

[0222] 1 Materials and methods

[0223] 1.1 Experimental materials

[0224] 1.1.1 Experimental animals

[0225] Fifty three-color guinea pigs with a body weight of 100 g - 140 g and 2 weeks old were selected and purchased from Beijing Keyu Animal Breeding Center [License number: SCXK (Beijing) 2017 - 『0002』]. The Central Animal Laboratory of the Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences [License number: SYXK (Beijing) 2016 - 『0013』] was selected as the breeding site, and the laboratory environment and facilities met international requirements. All guinea pigs underwent fundus examination before the experiment, and those with binocular abnormalities were excluded. During the experiment, the guinea pigs were allowed to eat and drink freely, and the guinea pig feed was purchased from Beijing Keyu Animal Breeding Center.

[0226] 1.1.2 Experimental drugs [[ID=3G]]

[0227] Formula: Astragalus membranaceus, Angelica sinensis, Rehmannia glutinosa, Bupleurum chinense, Paeonia lactiflora, Chaenomeles sinensis, Leonurus japonicus, Cuscuta chinensis, Glycyrrhiza uralensis, decocted in water, filtered and concentrated, with concentrations of 2 g / ml, 1 g / ml, 0.5 g / ml respectively, then sterilized, vacuum-packed and stored in a refrigerator at 4℃. The medicinal liquid was provided by the Traditional Chinese Medicine Decoction Room of China-Japan Friendship Hospital.

[0228] 1.1.3 Main reagents

[0229] 4% paraformaldehyde fixative: Solarbio (Beijing) Science and Technology Co., Ltd. [[ID=LO]]

[0230] 2.5% glutaraldehyde fixative: Solarbio (Beijing) Science and Technology Co., Ltd.

[0231] 1.2 Experimental Methods

[0232] 1.2.1 Model Establishment and Grouping

[0233] Fifty guinea pigs were acclimatized for one week and then randomly divided into four groups using a random number table: a blank control group (n=10), a model group (n=10), a high-dose traditional Chinese medicine (TCM) composition group (high-dose HBFD) group (n=10), a medium-dose TCM composition group (medium-dose HBFD) group (n=10), and a low-dose TCM composition group (low-dose HBFD) group (n=10). The right eye of each guinea pig in the model group was used as the FDHM group, and the left eye was used as the self-control group. Three days prior to surgery, the model group guinea pigs were given prophylactic antibiotics, including levofloxacin eye drops in both eyes. Before surgery, anesthesia was administered via intraperitoneal injection of 1% sodium pentobarbital solution at 50 mg / kg body weight to ensure satisfactory anesthesia. First, carbomer eye drops were instilled into the left eye to prevent corneal dryness. Then, the guinea pig was placed in a left lateral decubitus position on the operating table. The hair around the right eye was trimmed, and routine disinfection was performed. The surgeon used a syringe to draw a mixture of gentamicin and saline solution to flush the conjunctival sac. Next, the surgeon gently lifted the upper eyelid with forceps in their left hand, while using ophthalmic scissors in their right hand to artificially "damage the eyelid margin structure," aiming to promote faster and better healing after suturing the upper and lower eyelids. The specific procedure was as follows: approximately 2 mm from the eyelid margin, a cut was made from the inner canthus to the outer canthus of the right eye; the same procedure was performed on the lower eyelid. Finally, the upper and lower eyelids were sutured with 5-0 silk sutures, and tobramycin-dexamethasone eye ointment was applied to the right eye. During the modeling process, the sutures needed to be checked daily for alignment. If any sutures came undone or fell off, they should be re-sutured immediately. The control group guinea pigs received no treatment.

[0234] 1.2.2 Drug intervention

[0235] Referring to Appendix 11-8 of Xu Shuyun's *Pharmacological Experimental Methodology*, "Equivalent Dose Ratios Between Humans and Animals Based on Body Surface Area," using 400g guinea pigs and 70kg adults as reference standards, the conversion factor between humans and guinea pigs was 0.031. The total daily dose of HBFD for adults is 116g / d. Calculations showed that: 116 × 0.031 / 400g = 8.99, and the guinea pig dosage was 8.99g / kg / d. Administration began on the second day after visual deprivation, with administration time fixed at 9-10 AM daily via gavage. The blank control group and the FDHM group received the same volume of physiological saline via gavage.

[0236] 1.2.3 Refractive power and ocular biometry

[0237] Refractive error and ocular biometry were performed on all guinea pigs at two time points: before form deprivation (week 0) and after 8 weeks of form deprivation. First, compound tropicamide eye drops were administered to both eyes every 5 minutes for a total of 5 times to paralyze the ciliary muscle. After 30 minutes, once the pupils were fully dilated, retinoscopy was performed in a dark room using a strip-shaped retinoscope. The examiner's working distance was 50 cm, and the assistant held the guinea pig with one hand and supported its rump with the other. Measurements were repeated three times for each eye, and the average value was taken. Astigmatism was included in the spherical power at half the average. Next, the guinea pigs were surface anesthetized, and oxybuprofen hydrochloride eye drops were administered to both eyes. Biometry was performed using an ODM-1000A ophthalmic ultrasound measuring instrument. The A-scan frequency was adjusted to 1 lmHZ, and the propagation speed of ultrasound in different intraocular media was set as follows: 1537 m / s for the anterior chamber and vitreous body, and 1532 m / s for the lens. During measurement, the A-scan probe is aligned with the center of the pupil, always perpendicular to the corneal plane without causing pressure. A measurement is complete when a stable, clear image appears on the screen, and both the posterior capsule and retinal peaks are above the baseline. The data is then read and recorded. Repeat the above steps for eight measurements and calculate the average. The main biometric data include: anterior chamber depth (including corneal thickness and anterior chamber depth), vitreous cavity depth, axial length, and lens thickness (axial length minus anterior chamber depth and vitreous cavity depth).

[0238] 1.2.4 Light microscopic observation of the retina and sclera

[0239] Eight weeks after visual deprivation, two groups of guinea pigs were euthanized by intraperitoneal injection of 1% sodium pentobarbital at a body weight of 150 mg / kg. On a clean workbench, the skin and fascia around the guinea pig's eyeballs were separated with scissors, the retrobulbar tissue was dissected, and the optic nerve was left intact for approximately 1–2 mm. Both eyeballs were enucleated, and the surrounding tissues were separated on an ice-cold petri dish. A small incision was made at the limbus of the sclera with an ophthalmic puncture blade, and the eyeball was cut open. The eyeball was then cut circumferentially along the limbus, and the anterior segment and vitreous body were removed. Eye cups were prepared, fixed in 4% paraformaldehyde solution, dehydrated, embedded in paraffin, and sectioned to a thickness of 5 μm. Hematoxylin-eosin staining was performed, and the staining of the retina and sclera was observed under a light microscope (10×40).

[0240] 1.3 Statistical Analysis

[0241] All data collected in the experiment were statistically analyzed using SPSS 22.0 software. Measurement data in this experiment were expressed as mean ± standard deviation. This indicates that t-tests, ANOVA, or nonparametric tests were used, with α = 0.05 as the test standard and P < 0.05 as the statistical significance of the difference.

[0242] 2 Results

[0243] 2.1 Changes in the refractive state of the eyes of guinea pigs in each group

[0244] Before form deprivation, the refractive error of each group of guinea pigs was measured, and there were no statistically significant differences in the experimental eyes among the groups (all P>0.05). Compared with before form deprivation, after 8 weeks of form deprivation, the hyperopic refractive error in all five groups decreased and progressed to myopia, with statistically significant differences (all P<0.05). Compared with the blank control group, the refractive error in the FDHM group increased significantly (all P<0.05). Compared with the FDHM group, the myopic refractive error in the high, medium, and low dose HBFD groups decreased significantly (all P<0.05), with the high dose HBFD group showing the slowest increase in myopic refractive error. The results are shown in Table 12.

[0245] Table 12 Refractive power of guinea pigs before and after visual deprivation in each group.

[0246]

[0247] Note: Compared with the blank control group, * P<0.05; compared with the FDHM group, # P<0.05; compared with before visual deprivation, △ P<0.05

[0248] 2.2 Anterior Chamber Depth

[0249] Before visual deprivation, the anterior chamber depth data of guinea pigs in each group showed no statistically significant differences (all P>0.05). After 8 weeks of visual deprivation, the anterior chamber depth increased in all five groups, but the statistical analysis showed no statistically significant differences (all P>0.05), and there were no statistically significant differences between groups (all P>0.05). The results are shown in Table 13.

[0250] Table 13 Anterior chamber depth of guinea pigs before and after visual deprivation in each group.

[0251]

[0252]

[0253] 2.3 Lens thickness

[0254] Before form deprivation, the lens thickness data of each group of guinea pigs were analyzed, and there were no statistically significant differences (all P>0.05). After 8 weeks of form deprivation, the lens thickness of all five groups of guinea pigs showed an increasing trend, but the differences were not statistically significant (all P>0.05), and there were no statistically significant differences between groups (all P>0.05). The results are shown in Table 14.

[0255] Table 14 Lens thickness before and after visual deprivation in each group of guinea pigs

[0256]

[0257] 2.4 Vitreous cavity depth

[0258] Before visual deprivation, data on vitreous cavity depth in each group of guinea pigs showed no statistically significant differences (all P>0.05). After 8 weeks of visual deprivation, vitreous cavity depth increased in all five groups, with statistically significant differences (all P<0.05). Compared with the blank control group, the FDHM group showed a significant increase in vitreous cavity depth (P<0.05). Compared with the FDHM group, the high, medium, and low dose HBFD groups showed a significant decrease in vitreous cavity depth (all P<0.05), with the high dose HBFD group showing the slowest increase in vitreous cavity depth. The results are shown in Table 15.

[0259] Table 15 Vitreous cavity depth before and after visual deprivation in each group of guinea pigs

[0260]

[0261] Note: Compared with the blank control group, * P<0.05; compared with the FDHM group, # P<0.05; compared with before visual deprivation, △ P<0.05

[0262] 2.5 axial length

[0263] Before visual deprivation, the axial length data of guinea pigs in each group showed no statistically significant differences (all P>0.05). After 8 weeks of visual deprivation, the axial length of all five groups increased, and the differences were statistically significant (all P<0.05). Compared with the blank control group, the axial length of the FDHM group increased significantly (P<0.05). Compared with the FDHM group, the axial length of the high, medium, and low dose HBFD groups decreased significantly (all P<0.05), with the high dose HBFD group showing the slowest increase in axial length. The results are shown in Table 16.

[0264] Table 16. Axial length of guinea pigs before and after visual deprivation in each group.

[0265]

[0266] Note: Compared with the blank control group, * P<0.05; compared with the FDHM group, # P<0.05; compared with before visual deprivation, △ P<0.05

[0267] 2.6 Results of light microscopy observation of the retina

[0268] Observation under an optical microscope (10×40) showed that the retinal tissue of the blank control group guinea pigs was intact and regularly arranged. The RGCs were evenly distributed, morphologically sound, and neatly arranged. IPL, INL, OPL, ONL, ELM, and RPE were tightly arranged, with no cell loss or deformation (see Figure 1 A); After 8 weeks of monocular form deprivation, the retinal tissue structure in the FDHM group was loose and significantly thinner, with a significant reduction in RGCs, INL, and ONL cells, and their arrangement was disordered (see...). Figure 1 B); Compared with the FDHM group, the HBFD high-dose group showed increased retinal tissue thickness and clearer structure (see B); Figure 1 C), retinal thickness did not change significantly in the medium and low dose groups (see...). Figure 1 D, E).

[0269] Statistical results showed that compared with the blank control group, the full-thickness thickness of the retina in the FDHM group was significantly reduced, and the INL and ONL were significantly thinner, with statistically significant differences (all P<0.05); compared with the FDHM group, the retina layers in the high-dose HBFD group were significantly thickened, with statistically significant differences (all P<0.05). The results are shown in Table 17. Figure 1 .

[0270] Table 17 Retinal thickness of guinea pigs in each group

[0271] Grouping RTL INL ONL Blank control group 192.20±19.18 28.21±9.57 66.06±9.18 FDHM Group <![CDATA[139.12±10.14 * ]]> <![CDATA[19.02±6.19 * ]]> <![CDATA[37.19±8.35 * ]]> HBFD high-dose group <![CDATA[176.38±11.01 # ]]> <![CDATA[26.12±8.18 # ]]> <![CDATA[61.09±10.17 # ]]> HBFD medium dose group 146.15±9.17 20.19±7.02 45.12±9.01 HBFD low-dose group 142.08±10.33 20.01±8.06 44.07±6.08

[0272] Note: Compared with the blank control group, * P<0.05; compared with the FDHM group, # P<0.01

[0273] 2.7 Results of scleral light microscopy observation

[0274] Observation under an optical microscope (10×40) revealed that the scleral collagen fibers of the blank control group guinea pigs were densely arranged and neatly oriented. The fibers were not completely independent, but rather existed in both lamellar and interwoven manner (see...). Figure 2 A); Compared with the blank control group, the sclera thickness of guinea pigs in the FDHM group was significantly reduced, collagen fibers were loose, and even fiber breakage and separation were visible, with disordered course and widened interfiber gaps (see Figure 2 B); Compared with the FDHM group, the sclera of guinea pigs in the high-dose HBFD group was thicker, and the collagen fiber structure was clearer and more tightly arranged, with a morphology similar to the blank control group. The connection between fibers was mainly lamellar, with less interlacing (see B). Figure 2 C); The changes in scleral structure and thickness were not significant in the medium and low dose groups (see...). Figure 2 D, E).

[0275] Statistical results showed that compared with the blank control group, the scleral thickness in the FDHM group was significantly decreased, with a statistically significant difference (P < 0.05); compared with the FDHM group, the scleral thickness in the high-dose HBFD group of guinea pigs was significantly increased, and the differences were all statistically significant (both P < 0.05). See Table 18. Figure 2 .

[0276] Table 18 Scleral thickness of guinea pigs in each group

[0277] Grouping scleral thickness Blank control group 0.38±0.12 FDHM Group <![CDATA[0.31±0.11 * ]]> HBFD high-dose group <![CDATA[0.36±0.04 # ]]> HBFD medium dose group 0.32±0.06 HBFD low-dose group 0.31±0.08

[0278] Note: Compared with the blank control group, * P < 0.05; compared with the FDHM group, # P < 0.01

[0279] 3 Conclusions

[0280] FDHM is the result of active scleral remodeling. Through the local retinal regulation mechanism, the visual signals received by the eyeball are first transduced to the retina. Then, the normal growth process of scleral fibroblasts is restricted, the mitotic activity is reduced, the synthesis and metabolism of collagen fibers are decreased, and the catabolism is accelerated, playing a role in regulating scleral tissue. The synthesis of glycosaminoglycans in the scleral extracellular matrix is reduced, the diameter of collagen fibers becomes smaller, and the scleral tissue becomes progressively thinner. Even the mechanical deformation caused by normal intraocular pressure is difficult for the scleral tissue to resist, ultimately leading to progressive elongation of the eye axis and causing the formation of myopia. The experimental results showed that the traditional Chinese medicine composition of the present invention can intervene in the progression of myopia in FDHM guinea pigs. Through dose-effect analysis, it was found that the high-dose group had the best therapeutic effect.

[0281] Example 25 Study on the therapeutic mechanism of the formula of the present invention in intervening in form deprivation high myopia in guinea pigs 1 Materials and methods

[0282] 1.1 Experimental materials

[0283] 1.1.1 Experimental animals

[0284] 60 three-color guinea pigs at 2 weeks of age, both male and female, with a body weight of 100 g to 140 g, were purchased from Beijing Keyu Animal Breeding Center [License number: SCXK (Beijing) 2017-0002], and the feeding environment was provided by the Central Animal Laboratory of the Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences [License number: SYXK (Beijing) 2016-0013]. The laboratory environment and facilities all met the international standard requirements. Before the experiment, all guinea pigs underwent fundus examinations to exclude guinea pigs with binocular abnormalities. During the experiment, the guinea pigs were allowed to eat and drink freely, and the guinea pig feed was purchased from Beijing Keyu Animal Breeding Center.

[0285] 1.1.2 Experimental drugs

[0286] Formula: Astragalus membranaceus, Angelica sinensis, Rehmannia glutinosa, Bupleurum chinense, Paeonia lactiflora, Chaenomeles speciosa, Leonurus japonicus, Cuscuta chinensis, Glycyrrhiza uralensis. Decoct in water, filter, concentrate the liquid to a concentration of 2g / ml, sterilize, vacuum pack, and store at 4℃ for later use. (The decoction was provided by the Traditional Chinese Medicine Decoction Room of the China-Japan Friendship Hospital).

[0287] 1.2 Experimental Methods

[0288] 1.2.1 Grouping and Model Preparation

[0289] After a one-week acclimatization period, 60 guinea pigs were randomly divided into a blank control group, an FDHM group, and a traditional Chinese medicine group (n=20 each) using a random number table. The right eye of each guinea pig in the model group was used as the FDHM group, and the left eye as the self-control group. Three days prior to surgery, the model group guinea pigs were given prophylactic antibiotics, including levofloxacin eye drops in both eyes. The modeling method and precautions were the same as in Example 24, "1.2.1". The blank control group guinea pigs received no treatment.

[0290] 1.2.2 Interventional drug administration

[0291] Referring to Appendix 11-8 of Xu Shuyun's *Pharmacological Experimental Methodology*, "Equivalent Dose Ratios Between Humans and Animals Based on Body Surface Area," using 400g guinea pigs and 70kg adults as reference standards, the conversion factor between humans and guinea pigs was 0.031. The total daily dose of HBFD for adults is 116g / d. Calculations showed that 116 * 0.031 / 400g = 8.99, meaning the dosage for guinea pigs was 8.99g / kg / d. Administration began on the second day after visual deprivation, with administration time fixed at 9-10 AM daily via gavage. The blank control group and the FDHM group received the same volume of physiological saline via gavage.

[0292] 1.2.3 Refractive power and ocular biometry

[0293] The methods and precautions for refractive power measurement and ocular biometry are the same as in Example 24, "1.2.3".

[0294] 1.2.4 Morphological observation of the sclera and retina

[0295] Eight weeks after visual deprivation, two groups of guinea pigs were euthanized by intraperitoneal injection of 1% sodium pentobarbital at a body weight of 150 mg / kg. On a clean workbench, the skin and fascia around the guinea pig's eyeballs were separated with scissors, the retrobulbar tissue was dissected, and approximately 1-2 mm of the optic nerve was left intact. Both eyeballs were enucleated, and the periorbital tissue was dissected on an ice-cold petri dish. A small incision was made at the limbus of the sclera with an ophthalmic puncture blade, and the eyeball was cut open. A circular incision was made along the limbus, and the anterior segment and vitreous body were removed. Eye cups were prepared, fixed in 4% paraformaldehyde solution, dehydrated, embedded in paraffin, and sectioned to a thickness of approximately 5 μm. The sections were stained with hematoxylin and eosin (HE) and examined under a light microscope. The staining of the retina and sclera was examined, and the tissue morphology was observed. Five eye cups from each group were used to prepare tissue blocks of approximately 1 mm × 1 mm in size. These blocks were placed in 2.5% glutaraldehyde fixative and fixed at 4°C for at least 72 hours. They were then fixed with 1% osmium tetroxide for 1–2 hours, dehydrated in a gradient of ethanol and acetone (from low to high concentration), infiltrated and embedded in epoxy resin, positioned under a light microscope, and ultrathinly sectioned to a thickness of approximately 10 nm. The sections were double-stained with 2% uranium acetate and lead citrate, and observed and photographed under a transmission electron microscope.

[0296] 1.2.5 Immunohistochemical detection of PKC and nNOS expression in guinea pig retina

[0297] (1) Retinal sampling

[0298] Eight weeks after visual deprivation, two groups of guinea pigs were euthanized by intraperitoneal injection of 1% sodium pentobarbital at a body weight of 150 mg / kg. On a clean workbench, the skin and fascia around the guinea pig's eyeballs were separated with scissors, and the retrobulbar tissue was dissected, leaving approximately 2 mm of the optic nerve intact. Both eyeballs were enucleated, and the surrounding tissues were separated on an ice-cold petri dish. A small incision was made at the limbus of the sclera with an ophthalmic puncture blade, and the eyeball was cut open to separate the anterior segment and vitreous body. The retina dissected with microforceps was placed in an EP tube and then stored in a liquid nitrogen tank for later use.

[0299] (2) Preparation of paraffin sections

[0300] Fixation: Fix the eye cups placed in 4% paraformaldehyde solution for 24-48 hours at 4℃;

[0301] Embedding: The eyecups were dehydrated with graded alcohols, cleared with xylene, and then embedded in paraffin.

[0302] Sectioning: Select longitudinal sections of the retina and sclera, and perform continuous sections with a thickness of approximately 4 μm;

[0303] Wax slice removal: Set the temperature of the water bath to 43℃, place the cut wax slices in the water bath, and remove them after they have fully expanded.

[0304] Baking: Spread the retrieved wax sheet flat on the glass slide, set the temperature of the baking stage to 60℃, and place the glass slide on the baking stage for about 2 hours for baking;

[0305] Drying slides: Set the oven temperature to 60℃ and store the glass slides inside for later use.

[0306] (3) Immunohistochemical staining

[0307] Dewaxing: This includes xylene dewaxing and alcohol dewaxing. The prepared sections were dewaxed with xylene I and II for 15 minutes each; then dewaxing was performed with a gradient of alcohol (concentration from high to low), without the sections remaining in the alcohol, followed by rinsing with running water for about 5 minutes.

[0308] Blocking: The dewaxed sections were placed in 0.3% H2O2 solution and immersed at room temperature for 15 minutes to block endogenous peroxidase.

[0309] Place the sealed sections in PBS (pH 7.4) buffer, let stand for 15 minutes, then remove the sections, gently shake off the adsorbed liquid, carefully wipe away any remaining liquid around the tissue, and place them horizontally in a humidified chamber.

[0310] First, dilute the PKC and nNOS antibodies at a ratio of 1:200. Pay attention to the dosage of antibodies used in the experiment. Generally, use a pipette to draw 50-100 μL and drop it onto the tissue. It is necessary to ensure that the antibody can completely cover the tissue. Use PBS instead of the primary antibody for the negative control. Store at 4°C for 24 hours.

[0311] After removing the slides, keep them in the humidified chamber at room temperature for 15 minutes. Then, place the slides in PBS (pH 7.4) buffer again and soak for 15 minutes. Remove the slides, gently shake off the adsorbed liquid, carefully wipe away any remaining liquid around the tissue, and place them horizontally in the humidified chamber.

[0312] The goat anti-rabbit secondary antibody was diluted at a ratio of 1:1000. Note the dosage of antibody used in the experiment. Generally, 50-100 μL was pipetted onto the tissue to ensure that the antibody completely covered the tissue. The incubation time at room temperature was about 1 hour.

[0313] Place the slides in PBS (pH 7.4) buffer again, soak for 15 minutes, remove them, gently shake off the adsorbed liquid, carefully wipe away any remaining liquid around the tissue, and place them horizontally in a humidified chamber.

[0314] Color development: First, use DAB solution to develop the color for 2 minutes, then use PBS buffer to stop the color development;

[0315] Counterstain cell nuclei with hematoxylin for about 1 minute, then rinse continuously with running water for about 10 minutes.

[0316] Dehydration: Dehydration is carried out using a gradient of alcohols (concentration from low to high), and the slices do not remain in the alcohol solution;

[0317] Transparency: Xylene I and II were used for transparency testing, each for 15 minutes;

[0318] Mounting: Use neutral resin for mounting;

[0319] Imaging: The sealed slides were placed under an optical microscope and observed comprehensively under 10x, 20x, and 40x objectives. Three fields of view were randomly selected from each slide for imaging and recording. The color intensity of positive expression in each retinal image was measured using Image Plus Pro 6.0 (IPP) image analysis software, and quantitative analysis was performed using integrated optical density (IOD).

[0320] (4) Colorimetric determination of SOD activity and MDA content in the retina.

[0321] Five guinea pigs were taken from each group, anesthetized and euthanized, and the retina was dissected using microforceps. The wet weight of the retina was weighed using a precision analytical balance, and double-distilled water was added. The retina was homogenized with 1 ml of pre-cooled reagent A to prepare a 10% homogenate. The homogenate was centrifuged at 3000 rpm for 5 min, and the supernatant was collected for analysis. The procedure was strictly followed according to the kit instructions.

[0322] Plotting the standard curve: Following the instructions of the kit, take 5 centrifuge tubes, add different reagents to each tube, mix them well, first add 1 ml of double-distilled water to each tube, mix quickly, then place them in a boiling water bath and boil for 50 min, then quickly place them in ice water to cool, centrifuge at 3000 r / min and 4℃ for 15 min, take the supernatant and read it at 532 nm.

[0323] Sample testing: Take 0.2 ml of homogenate supernatant, add 0.2 ml of reagent B, mix well, then add 1.5 ml each of reagent C and reagent D, mix again, add 1 ml of double-distilled water to each tube, and mix quickly. Place in a boiling water bath and boil for 50 min, then quickly cool in ice water, centrifuge at 3000 r / min and 4℃ for 15 min, and take the supernatant and read it at 532 nm.

[0324] Result Interpretation: Using the standard concentration as the x-axis and the OD value as the y-axis, connect the coordinate points of the standard with a smooth line. By observing the OD value of the sample, the corresponding concentration can be found on the standard curve. If the OD value of the sample is higher than the upper limit of the standard curve, and the corresponding concentration value cannot be found, the sample should be appropriately diluted and then measured again until the corresponding result appears. Note that the dilution factor should be included when recording the concentration.

[0325] SOD assay principle: The reaction system of xanthine and xanthine oxidase can generate superoxide anion free radicals, which, after the oxidation of hydroxylamine, produce nitrite. The chromogenic reagent can turn nitrite purple-red. Since SOD can inhibit superoxide anion free radicals, when the sample contains SOD, the nitrite content will decrease. Using a UV-Vis spectrophotometer, referencing the absorbance values ​​of the standard control tube, sample test tube, and blank control tube at 550 nm, the amount of SOD corresponding to a 50% SOD inhibition rate in 1 ml of reaction solution is equivalent to 1 unit of SOD activity (nU / ml). The total SOD (Total-SOD, T-SOD) activity in the sample is calculated using the formula: T-SOD activity (nU / ml) = (OD value of control tube - OD value of test tube) / OD value of control tube ÷ 50% × sample dilution factor;

[0326] MDA content determination principle: MDA is a product of lipid peroxidation degradation, which combines with thiobarbituric acid to form a red product. The MDA content in the sample is calculated using the formula based on the absorbance values ​​at 532 nm of the reference standard blank tube, sample test tube, and blank control tube. MDA content (nmol / ml) = (OD value of test tube - OD value of blank tube) / (OD value of standard tube - OD value of standard blank tube) × standard concentration (10 nmol / ml) × sample dilution factor.

[0327] (5) Western blotting to detect the expression of HIF-1α in the retina

[0328] Eight weeks after visual deprivation, five guinea pigs from each group were euthanized by intraperitoneal injection of 1% sodium pentobarbital at a dose of 150 mg / kg body weight. The retina dissected by microforceps was placed in an EP tube and then stored in liquid nitrogen for later use.

[0329] Protein extraction

[0330] Homogenization: First, pipette cold PBS into the retinal tissue and wash 2-3 times, then place it in a homogenization tube. Add protease inhibitor to the cytoplasmic protein extraction reagent, and after 10 minutes, pipette 10 times the tissue volume of the reagent into the homogenization tube. Place the tube in a homogenizer and select the appropriate program for thorough homogenization. Finally, mix the tissue and tissue homogenate, using a ratio of 200 μL of tissue homogenate per 60 mg of tissue, and homogenize thoroughly in a glass homogenizer in an ice bath environment.

[0331] Lysis: After homogenization, transfer the homogenate to a 1.5 ml centrifuge tube and vortex at 5-minute intervals. Then, incubate on ice for 30 minutes. To ensure complete cell lysis, repeatedly pipette the homogenate during this process.

[0332] Centrifugation: At 4℃ and 12000g, centrifugation time was set to 10min. After completion, the supernatant was collected, which is the total protein solution.

[0333] Determination of protein concentration

[0334] SDS-PAGE electrophoresis: Carefully clean the glass plates and let them dry. Take one frosted glass plate and one flat glass plate to form a pair. Leave a gap between the two glass plates for glue pouring. Place the glue applicator in the glass plate and insert wedges to fix the glass plates. Be careful to check whether the bottom is aligned to avoid glue leakage.

[0335] According to the experimental procedure, prepare a 10% separating gel, add TEMED, and immediately shake thoroughly and repeatedly before pouring the gel. Pour the separating gel to the appropriate height. Before pouring, it is best to test with a comb to ensure that the distance between the comb teeth and the surface of the separating gel is approximately 5-8 mm. Then, add pure water into the gaps until they are full. This process must be slow and even to avoid breaking up the gel. Allow the separating gel to solidify, which takes about 30 minutes. Pour off the water on top and use absorbent paper to dry the remaining moisture.

[0336] Prepare a 5% concentrated gel. After adding TEMED, shake it repeatedly until it is fully mixed. Then start filling the remaining space with concentrated gel. Next, insert the comb into the concentrated gel, and at this time, observe that there are no air bubbles under the comb.

[0337] After the separating gel has solidified, remove the gel casting apparatus, carefully remove the comb, and begin preparing for electrophoresis.

[0338] Place the gel casting apparatus in the electrophoresis tank, add sufficient electrophoresis buffer, add the sample to the wells, and begin electrophoresis. Set the voltage of the stacking gel to 75V and the separating gel to 120V. Stop electrophoresis when the bromophenol blue just runs out, and proceed to the next step of membrane transfer.

[0339] Transfer membrane

[0340] Prepare one PVDF membrane and six sheets of filter paper, each approximately 7×9cm in size. Note that the PVDF membrane should be activated with methanol before use.

[0341] Prepare a basin containing the transfer solution, and place a glass rod, two sponge pads, clamps for membrane transfer, an activated PVDF membrane, and six sheets of filter paper in the basin.

[0342] Use clips to open the black side, keeping it horizontal during the operation. Place a sponge pad and three layers of filter paper on the mat.

[0343] Gently peel off the separating gel and place it on the filter paper, keeping the membrane covering the gel. Cover the membrane with the remaining three sheets of filter paper, being careful to remove air bubbles during the process. Cover the filter paper with another sponge pad.

[0344] Transfer conditions, wet transfer

[0345] Rapid transfer is recommended. Parameters can be set to: 300mA constant current for 30 minutes, or 200mA for 60 minutes. The specific time and current during transfer should be adjusted according to experimental requirements. During this process, the transfer tank must be placed in ice water to cool it down.

[0346] Immune response

[0347] After the transfer was completed, the membrane was blocked with 5% skim milk (prepared with 0.5% TBST) on a decolorizing shaker at room temperature for 60 minutes.

[0348] Dilute the primary antibody (5% skim milk dissolved in TBST, and use 5% BSA dissolved in TBST for phosphorylated proteins) and incubate the antibody at 4°C for 24 hours.

[0349] All of the following were conducted at room temperature:

[0350] Wash with TBST 3 times on a decolorizing shaker, each time for 5 minutes;

[0351] Dilute the secondary antibody with TBST at a ratio of 3000 and incubate for 30 minutes.

[0352] Wash with TBST three times on a decolorizing shaker for a total of 15 minutes.

[0353] Chemiluminescence

[0354] Add equal volumes of ECLA and ECLB reagents to centrifuge tubes and mix well. This operation must be performed in a dark room. Then, attach double gloves or other transparent films to the exposure chamber, ensuring the protein side of the PVDF membrane is facing upwards. The correct position is between the two films of the exposure chamber. After adjusting the position, add the mixed ECL solution and allow it to react fully for about 2 minutes. Remove any residual liquid, cover with the top film, and begin exposure. Finally, develop and fix the exposed film using developing and fixing reagents, respectively. During the experiment, the exposure conditions need to be adjusted flexibly according to different light intensities.

[0355] Analysis of gel images

[0356] Scan the film and save it. Use Photoshop to process the image and Alpha software to analyze the OD value of the target band.

[0357] (6) Western blotting detection of scleral TGF-β2, MMP-2 and TIMP-2 protein expression

[0358] Follow the specific operational steps for scleral protein extraction, protein concentration determination, membrane transfer, immune reaction, chemical reaction, and gel imaging.

[0359] 1.3 Statistical Analysis

[0360] All measurement data in the experiment are expressed as mean ± standard deviation. The results were statistically analyzed using SPSS 22.0 software. The One Sample Kolmogrov-Smirnov Z-test was used to check whether the data conformed to a normal distribution. For normally distributed data, one-way ANOVA was used to compare multiple independent samples. For non-normally distributed data, homogeneity of variance analysis was performed. If the variances were homogeneous, one-way ANOVA was still used. If the variances were not homogeneous, a non-parametric test (K Independent Samples Test) was used. A p-value < 0.05 was considered statistically significant.

[0361] 2 Results

[0362] 2.1 Changes in refractive power of guinea pigs in each group

[0363] At birth, guinea pigs are hyperopic. After 8 weeks of form deprivation, the refractive error of all three groups of hyperopic guinea pigs decreased and progressed to myopia. The refractive error of the FDHM group reached approximately -8.00D, indicating high myopia.

[0364] Statistical results showed that the refractive error of the eyes of 3-week-old guinea pigs was approximately +3.50D. Before form deprivation (week 0), there were no statistically significant differences in refractive error among the groups (all P>0.05). Compared with the blank control group, after 8 weeks of form deprivation, the myopia refractive error in the FDHM group increased significantly (P<0.05); compared with the FDHM group, the myopia refractive error in the traditional Chinese medicine group was lower (P<0.05); compared with before form deprivation, the hyperopia refractive error in all three groups decreased significantly (all P<0.05). The results are shown in Table 19.

[0365] Table 19 Refractive power of guinea pigs before and after visual deprivation in each group.

[0366]

[0367] Note: Compared with the blank control group, * P<0.05; compared with the FDHM group, # P<0.05; compared with before visual deprivation, △ P<0.05

[0368] 2.2 Changes in biometric data of guinea pig eyes in each group

[0369] Statistical results showed that after 8 weeks of form deprivation, compared with the blank control group, the vitreous cavity depth and axial length of guinea pigs in the FDHM group were significantly increased and significantly longer (all P < 0.05); compared with the FDHM group, the vitreous cavity depth and axial length of the traditional Chinese medicine group were significantly decreased and significantly shorter (all P < 0.05); compared with before form deprivation (week 0), the vitreous cavity depth and axial length of guinea pigs in all three groups were significantly increased and significantly longer (all P < 0.05); analysis of the anterior chamber depth and lens thickness among the three groups before and after form deprivation showed no statistically significant differences (all P > 0.05). The results are shown in Tables 20-23.

[0370] Table 20 Anterior chamber depth of guinea pigs before and after visual deprivation in each group.

[0371]

[0372]

[0373] Table 21 Lens thickness before and after visual deprivation in each group of guinea pigs

[0374]

[0375] Table 22 Vitreous cavity depth before and after visual deprivation in each group of guinea pigs

[0376]

[0377] Note: Compared with the blank control group, * P<0.05; compared with the FDHM group, # P<0.01; compared with before visual deprivation, △ P<0.05

[0378] Table 23. Axial length of guinea pigs before and after visual deprivation in each group.

[0379]

[0380] Note: Compared with the blank control group, * P < 0.05; compared with the FDHM group, # P < 0.01; compared with before visual deprivation, △ P < 0.05

[0381] 2.3 Changes in retinal morphology

[0382] 2.3.1 Observation of guinea pig retinal morphology under a light microscope

[0383] Observation under an optical microscope (10×40) showed that the retinal tissues of the blank control group were dense, neatly arranged, and clearly demarcated. RGCs (retinocytes) were arranged in a single layer with large, deeply stained nuclei, appearing round or oval. The IPL (intra-intra-lower retina) was dense, while the INL (intra-lower retina) had larger, slightly darker stained nuclei. The OPL (intra-lower retina) was thinner, and the ONL (intra-lower retina) was thicker, with tightly packed cells, smaller, deeply stained nuclei. The EPL (extra-lower retina) was clear, and the photoreceptor cell layer was neatly arranged and dense. In contrast, the retinal tissues of the FDHM group were loose and disordered. The number of RGCs was significantly reduced, with condensed and scattered nuclei, showing chromatin marginalization. Some cells were necrotic, and nuclei were dissolved. The nerve fiber layer was atrophied, and the INL and ONL were significantly thinner with reduced cell numbers and lighter stained nuclei. The IPL, OPL, and ELM (intra-lower retina) were also thinner and looser in structure. The morphology of the retinal tissues in the traditional Chinese medicine group was superior to that in the FDHM group. (See results below.) Figure 3 .

[0384] Statistical results showed that, compared with the blank control group, after 8 weeks of form deprivation, the full-thickness thickness of the retina in the FDHM group was significantly decreased, with RGC atrophy appearing earliest, and both INL and ONL significantly thinning, all with statistically significant differences (all P<0.05). Compared with the FDHM group, the RGC and retinal thickness of the guinea pigs in the traditional Chinese medicine group were significantly increased, with statistically significant differences (all P<0.05). The results are shown in Table 24.

[0385] Table 24 Retinal thickness of guinea pigs in each group

[0386] Grouping RTL INL ONL Blank control group 196.16±12.26 26.15±10.36 62.35±10.11 FDHM Group <![CDATA[144.21±13.31 * ]]> <![CDATA[20.11±9.08 * ]]> <![CDATA[34.63±9.27 * ]]> Traditional Chinese Medicine Group <![CDATA[170.09±10.09 # ]]> <![CDATA[24.04±10.01 # ]]> <![CDATA[49.36±15.36 # ]]>

[0387] Note: Compared with the blank control group, * P<0.05; compared with the FDHM group, # P<0.01

[0388] 2.3.2 Observation of guinea pig retinal morphology under electron microscopy

[0389] Electron microscopy (×1200) revealed that the retinal discs in the blank control group were intact and regularly arranged, while the outer segment discs of the cone cells in the FDHM group showed damage and detachment. The retinal morphology of the guinea pigs in the traditional Chinese medicine group was superior to that in the FDHM group. Results are shown below. Figure 4 .

[0390] 2.4 Changes in the morphological structure of the sclera

[0391] 2.4.1 Observation of scleral morphology under a light microscope

[0392] Observation under an optical microscope showed that the sclera of guinea pigs in the blank control group had normal thickness and a compact structure. The scleral collagen fibers were generally uniform in diameter, regularly arranged, and normally oriented. After HE staining, the fibroblast nuclei showed a blue-purple color, and their shapes were mostly spindle-shaped and oblong. The extracellular matrix showed a pink color. After 8 weeks of form deprivation, the sclera of guinea pigs in the FDHM group showed a significant decrease in thickness and a looser structure. The diameter of the scleral collagen fibers was significantly reduced, and their distribution was disordered, twisted, and even broken and separated. The interfiber spaces widened, the fibroblast nuclei were twisted and deformed, and the extracellular matrix increased. The sclera of guinea pigs in the traditional Chinese medicine group showed a slight thinning, but no obvious abnormal changes in morphology. Results are shown below. Figure 5 .

[0393] Statistical results showed that, compared with the blank control group, after 8 weeks of form deprivation, the scleral thickness of the FDHM group was significantly thinner, with a statistically significant difference (P<0.05); compared with the FDHM group, the scleral thickness of the guinea pigs in the traditional Chinese medicine group was significantly increased, with statistically significant differences (all P<0.05). The results are shown in Table 25.

[0394] Table 25 Scleral thickness of guinea pigs in each group

[0395] Grouping scleral thickness Blank control group 0.36±0.01 FDHM Group <![CDATA[0.30±0.11 * ]]> Traditional Chinese Medicine Group <![CDATA[0.32±0.14 # ]]>

[0396] Note: Compared with the blank control group, * P<0.05; compared with the FDHM group, # P<0.01

[0397] 2.4.2 Observation of scleral morphology under electron microscopy

[0398] Electron microscopy revealed that fibroblasts and collagen fiber bundles together constitute the scleral tissue. Under the microscope, the collagen fiber bundles were observed to be distributed parallel to the eyeball wall, and collagen fibers form the framework of the scleral tissue. Compared with the blank control group, the cross-sectional diameter and fiber density of scleral collagen fibers in the FDHM group of guinea pigs were significantly reduced. Compared with the FDHM group, the density of scleral collagen fibers in the traditional Chinese medicine group was increased. Results are shown below. Figure 6 .

[0399] 2.5 Detection results of positive expression in guinea pig retina using immunohistochemistry

[0400] 2.5.1 PKC expression in guinea pig retina

[0401] Immunohistochemical staining showed that PKC positive expression in guinea pig retinal tissue was mainly observed in the ganglion cell layer, inner plexiform layer, outer plexiform layer, and photoreceptor cell layer. Under a light microscope, the positive reaction could be observed in the cytoplasm, appearing as brownish-yellow or brownish-red granular or punctate staining. In the blank control group, PKC expression was low in the guinea pig retina, and the color was pale yellow; in the FDHM group, PKC expression was high in the guinea pig retina, and the color was brownish-yellow; the area of ​​PKC expression in the guinea pig retina of the traditional Chinese medicine group was reduced compared to the FDHM group.

[0402] The mean optical density of PKC positive expression in guinea pig retina was measured using Image Plus Pro 6.0 image analysis software. Results showed that compared with the blank control group, the positive expression of PKC in the guinea pig retina of the FDHM group was significantly increased (P<0.01); compared with the FDHM group, after HBFD intervention, the expression of PKC in the retina of the traditional Chinese medicine group was reduced (P<0.05). This demonstrates that HBFD has an inhibitory effect on PKC expression in the retina. The results are shown in Table 26.

[0403] Table 26 shows the average optical density of PKC expression in the retina of guinea pigs in each group.

[0404]

[0405]

[0406] Note: Compared with the blank control group, * P<0.01; compared with the FDHM group, # P<0.05

[0407] 2.5.2 Expression of nNOS protein in guinea pig retina

[0408] Immunohistochemical staining showed that positive expression of nNOS protein in guinea pig retinal tissue was mainly observed in the retinal ganglion cell layer and nuclear layer. Under a light microscope, the positive reaction was observed to be uniformly scattered in the cytoplasm, appearing as brownish-yellow or brownish-red. In the blank control group, the nNOS protein expression in the guinea pig retina was pale yellow. Compared with the blank control group, the nNOS protein expression in the FDHM group was significantly increased, and the color was brownish-yellow. The number of positive cells for nNOS protein expression in the traditional Chinese medicine group was reduced compared with that in the FDHM group.

[0409] The mean optical density of the positive expression of nNOS protein in guinea pig retina was determined using Image Plus Pro 6.0 image analysis software. Statistical results showed that compared with the blank control group, the positive expression of nNOS protein in the guinea pig retina of the FDHM group was significantly increased (P<0.01); compared with the FDHM group, the expression of nNOS protein in the retina of the traditional Chinese medicine group was significantly decreased (P<0.05). This demonstrates that HBFD can inhibit the expression of nNOS protein in the retina. The results are shown in Table 27.

[0410] Table 27. Average optical density of nNOS protein expression in the retina of guinea pigs in each group.

[0411] Grouping nNOS Blank control group 0.10±0.02 FDHM Group <![CDATA[0.16±0.01 * ]]> Traditional Chinese Medicine Group <![CDATA[0.13±0.06 # ]]>

[0412] Note: Compared with the blank control group, * P<0.01; compared with the FDHM group, # P<0.05

[0413] 2.6 Changes in SOD activity and MDA content in guinea pig retina

[0414] The results showed that SOD activity and MDA content exhibited opposite trends. Under physiological conditions, such as in the blank control group, SOD activity was high in the guinea pig retina, while MDA content, as the main product of lipid peroxides, was low. However, after 8 weeks of visual deprivation, compared with the blank control group, SOD activity decreased and MDA content increased in the guinea pig retina of the FDHM group, with statistically significant differences (all P < 0.05); compared with the FDHM group, SOD activity increased and MDA content decreased in the traditional Chinese medicine group, with statistically significant differences (all P < 0.05). The results are shown in Table 28.

[0415] Table 28. SOD activity and MDA content in the retina of guinea pigs in each group.

[0416]

[0417]

[0418] Note: Compared with the blank control group, * P<0.01; compared with the FDHM group, # P<0.05 2.7 Results of Western blotting detection of retinal HIF-1α protein expression

[0419] Western blotting results showed that the relative expression level of HIF-1α protein in the retina of guinea pigs in the FDHM group was 0.79±0.11, while that in the blank control group and the traditional Chinese medicine group were 0.12±0.01 and 0.46±0.21, respectively. Compared with the blank control group, the expression of HIF-1α protein in the retina of guinea pigs in the FDHM group was significantly increased (P<0.01); compared with the FDHM group, the expression of HIF-1α protein in the retina of guinea pigs in the traditional Chinese medicine group was significantly decreased (P<0.01). The results are shown in Table 29.

[0420] Table 29 Gray values ​​of HIF-1α protein expression in the retina of guinea pigs in each group

[0421] Grouping HIF-1α Blank control group 0.12±0.01 FDHM Group <![CDATA[0.79±0.11 * ]]> Traditional Chinese Medicine Group <![CDATA[0.46±0.21 # ]]>

[0422] Note: Compared with the blank control group, * P<0.01; compared with the FDHM group, # P<0.01

[0423] 2.8 Results of Western blotting on TGF-β2 protein expression in the sclera

[0424] Western blotting results showed that TGF-β2 protein was positively expressed in the sclera of guinea pigs in the blank control group, FDHM group, and traditional Chinese medicine group. The relative expression level of TGF-β2 protein in the sclera of guinea pigs in the FDHM group was 0.17±0.14, while that in the blank control group and the traditional Chinese medicine group was 0.60±0.08 and 0.42±0.16, respectively. Compared with the blank control group, the expression of TGF-β2 protein in the sclera of guinea pigs in the FDHM group was significantly decreased (P<0.01); compared with the FDHM group, the expression of TGF-β2 protein in the sclera of guinea pigs in the traditional Chinese medicine group was significantly upregulated (P<0.01). The results are shown in Table 30.

[0425] Table 30 Gray values ​​of TGF-β2 protein expression in the sclera of guinea pigs in each group

[0426]

[0427]

[0428] Note: Compared with the blank control group, * P<0.01; compared with the FDHM group, # P < 0.01 2.9 Western blotting results of scleral MMP-2 and TIMP-2 protein expression.

[0429] Western blotting results showed that the sclera of guinea pigs in the blank control group, FDHM group, and traditional Chinese medicine group all positively expressed MMP-2 and TIMP-2 proteins. The relative expression levels of MMP-2 and TIMP-2 proteins in the sclera of guinea pigs in the FDHM group were 0.15±0.03 and 0.42±0.11, respectively, while those in the blank control group and traditional Chinese medicine group were 0.09±0.01 and 0.54±0.06, and 0.12±0.01 and 0.49±0.04, respectively. Compared with the blank control group, the content of MMP-2 protein in the sclera of guinea pigs in the FDHM group was significantly increased, and the content of TIMP-2 protein was significantly decreased, with statistically significant differences (P<0.01). Compared with the FDHM group, the content of MMP-2 protein in the sclera of guinea pigs in the traditional Chinese medicine group was significantly decreased, and the content of TIMP-2 protein was significantly increased, with statistically significant differences (P<0.01). The results are shown in Table 31.

[0430] Table 31 Gray values ​​of MMP-2 and TIMP-2 protein expression in the sclera of guinea pigs in each group

[0431] Group MMP-2 TIMP-2 Blank control group 0.09±0.01 0.54±0.06 FDHM Group <![CDATA[0.15±0.03 * ]]> <![CDATA[0.42±0.11 * ]]> Traditional Chinese Medicine Group <![CDATA[0.12±0.01 # ]]> <![CDATA[0.49±0.04 # ]]>

[0432] Note: Compared with the blank control group, * P<0.01; compared with the FDHM group, # P<0.05

[0433] 3. Conclusion

[0434] HBFD is effective in alleviating pathological damage to the retina and maintaining normal retinal structure and function in guinea pigs with FDHM, consistent with our clinical observations. HBFD can stabilize the visual acuity and the degree of fundus lesions in patients with high myopia and has the effects of invigorating qi and nourishing yin, and soothing the liver and relaxing muscles. Astragalus and Rehmannia glutinosa in HBFD can strongly inhibit lipid peroxidation induced by hydroxyl free radicals, while Bupleurum chinense and Paeonia lactiflora can effectively inhibit and scavenge oxygen free radicals. Papaya, Leonurus japonicus, and Glycyrrhiza uralensis not only have antioxidant and free radical scavenging effects, but also dilate blood vessels and improve microcirculation. This may be the pharmacological basis for the good efficacy of HBFD against FDHM.

Claims

1. A traditional Chinese medicine composition for treating macular degeneration in high myopia, characterized in that, The traditional Chinese medicine composition is made from the following raw materials: Astragalus membranaceus 9-54 parts by weight, Angelica sinensis 8-42 parts by weight, Rehmannia glutinosa 8-42 parts by weight, Chaenomeles speciosa 4-24 parts by weight, Bupleurum chinense 4-24 parts by weight, Paeonia lactiflora 4-24 parts by weight, Cuscuta chinensis 8-42 parts by weight, Leonurus japonicus 4-24 parts by weight, and Glycyrrhiza uralensis 3-18 parts by weight.

2. The traditional Chinese medicine composition as described in claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials: Astragalus membranaceus 15-45 parts by weight, Angelica sinensis 11-34 parts by weight, Rehmannia glutinosa 11-34 parts by weight, Chaenomeles speciosa 6-18 parts by weight, Bupleurum chinense 6-18 parts by weight, Paeonia lactiflora 6-18 parts by weight, Cuscuta chinensis 11-34 parts by weight, Leonurus japonicus 6-18 parts by weight, and Glycyrrhiza uralensis 4-12 parts by weight.

3. The traditional Chinese medicine composition as described in claim 2, characterized in that, The traditional Chinese medicine composition is made from the following raw materials: Astragalus membranaceus 23-37 parts by weight, Angelica sinensis 16-24 parts by weight, Rehmannia glutinosa 16-24 parts by weight, Chaenomeles speciosa 8-14 parts by weight, Bupleurum chinense 8-14 parts by weight, Paeonia lactiflora 8-14 parts by weight, Cuscuta chinensis 16-24 parts by weight, Leonurus japonicus 8-14 parts by weight, and Glycyrrhiza uralensis 5-8 parts by weight.

4. The traditional Chinese medicine composition as described in claim 3, characterized in that, The traditional Chinese medicine composition is made from the following raw materials: Astragalus membranaceus 30 parts by weight, Angelica sinensis 20 parts by weight, Rehmannia glutinosa 20 parts by weight, Chaenomeles speciosa 10 parts by weight, Bupleurum chinense 10 parts by weight, Paeonia lactiflora 10 parts by weight, Cuscuta chinensis 20 parts by weight, Leonurus japonicus 10 parts by weight, and Glycyrrhiza uralensis 6 parts by weight. Alternatively, use 26 parts by weight of Astragalus membranaceus, 22 parts by weight of Angelica sinensis, 18 parts by weight of Rehmannia glutinosa, 12 parts by weight of Chaenomeles speciosa, 9 parts by weight of Bupleurum chinense, 12 parts by weight of Paeonia lactiflora, 18 parts by weight of Cuscuta chinensis, 12 parts by weight of Leonurus japonicus, and 5 parts by weight of Glycyrrhiza uralensis. Alternatively, use 34 parts by weight of Astragalus membranaceus, 18 parts by weight of Angelica sinensis, 22 parts by weight of Rehmannia glutinosa, 9 parts by weight of Chaenomeles speciosa, 12 parts by weight of Bupleurum chinense, 9 parts by weight of Paeonia lactiflora, 22 parts by weight of Cuscuta chinensis, 9 parts by weight of Leonurus japonicus, and 8 parts by weight of Glycyrrhiza uralensis.

5. The traditional Chinese medicine composition according to any one of claims 1-4, characterized in that, The traditional Chinese medicine composition is a composition formed by mixing pulverized raw materials, or an extract obtained by water extraction of mixed raw materials, or a conventional dosage form made by adding pharmaceutically acceptable excipients to the composition / extract.

6. The use of the traditional Chinese medicine composition according to any one of claims 1-4 in the preparation of a medicament for treating high myopia.

7. The application as described in claim 6, characterized in that, Application of traditional Chinese medicine composition in the preparation of drugs for treating macular degeneration in high myopia.

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