Application of traditional Chinese medicine composition in preparation of medicine for improving xerophthalmia

Abstract

The invention discloses application of a traditional Chinese medicine composition in preparation of a medicine for improving xerophthalmia, and belongs to the technical field of medicine. Pharmacological experiments prove that the traditional Chinese medicine composition processed by taking radix astragali preparata or radix astragali, fructus lycii, herba ecliptae, wine-processed fructus ligustri lucidi, radix polygalae preparata, rhizoma chuanxiong, radix panacis quinquefolii, rhizoma acori graminei and herba menthae as raw materials can relieve inflammation infiltration appearing in corneal stroma, increase the thickness of a corneal epithelial cell layer and improve the corneal growth rate. Tear secretion and corneal fluorescein sodium staining scores of dry eye mice are improved, corneal epithelial cell apoptosis and corneal inflammation are inhibited, and then the dry eye syndrome is improved. Therefore, the traditional Chinese medicine composition has a good application prospect in the aspect of clinical medicine for treating xerophthalmia.

Description

Technical Field

[0001] The present invention belongs to the technical field of medicine, and particularly relates to the application of a traditional Chinese medicine composition in the preparation of a drug for improving dry eye disease. Background Art

[0002] Dry eye disease (DED) is a chronic ocular surface disease, mostly caused by insufficient tear secretion, excessive tear evaporation or abnormal tear composition. Clinically, it is mostly manifested as dry eyes, eye fatigue, foreign body sensation, dryness, photophobia with tearing or blurred vision, etc. At present, in the clinical treatment of dry eye disease in Western medicine, artificial tears such as sodium hyaluronate eye drops and polyethylene glycol eye drops are mostly given to lubricate the eyes and relieve ocular surface dryness. The ocular symptoms of patients can be relieved in the short term, but the long-term curative effect is poor and it will cause a decrease in the secretion of its own tears, thus causing secondary dry eye disease. Traditional Chinese medicine believes that dry eye disease belongs to the category of "withering of divine water and white astringency syndrome". The main pathogenesis lies in the deficiency of liver and kidney yin. The liver stores blood, and when the liver fails to coordinate, the tear secretion is insufficient. The kidney stores essence, and when the essence of the kidney is insufficient, the body fluid production is insufficient. When the liver and kidney are yin-deficient, the essence and blood are insufficient, and the eyeball loses nourishment. Or due to the flaring up of deficient fire, burning and consuming body fluid, resulting in a decrease in tear secretion. Therefore, the treatment mainly focuses on nourishing the liver and kidney, replenishing qi and generating body fluid, and nourishing yin and moistening dryness. Therefore, the use of traditional Chinese medicine to treat dry eye disease can make up for the deficiencies in Western medicine treatment.

[0003] Chinese patent application for invention with publication number CN119258149A, a traditional Chinese medicine composition for restoring energy, refreshing the mind and anti-fatigue and its uses, discloses a traditional Chinese medicine composition for restoring energy, refreshing the mind and anti-fatigue composed of roasted astragalus root, wolfberry fruit, eclipta prostrata, glossy privet fruit, polygala tenuifolia, chuanxiong rhizome, American ginseng, acorus tatarinowii and mint. This traditional Chinese medicine composition for restoring energy, refreshing the mind and anti-fatigue has the effects of enhancing exercise ability and muscle tolerance, improving attention and memory, and enhancing immunity, and can effectively improve the fatigue state. However, there is no report yet that this traditional Chinese medicine composition for restoring energy, refreshing the mind and anti-fatigue can improve dry eye disease. Summary of the Invention

[0004] In order to overcome the above-mentioned disadvantages of the prior art, the purpose of the present invention is to provide the application of a traditional Chinese medicine composition in the preparation of a drug for improving dry eye disease.

[0005] In order to achieve the above purpose, the present invention adopts the following technical solutions to be realized: In the first aspect of the present invention, the application of a traditional Chinese medicine composition in the preparation of a drug for improving dry eye disease is disclosed. The traditional Chinese medicine composition is made from the following traditional Chinese medicine raw materials: 20 - 50 parts of roasted astragalus root or astragalus root, 10 - 30 parts of wolfberry fruit, 10 - 30 parts of eclipta prostrata, 5 - 20 parts of glossy privet fruit processed with wine, 5 - 20 parts of roasted polygala tenuifolia, 5 - 20 parts of chuanxiong rhizome, 5 - 15 parts of American ginseng, 5 - 15 parts of acorus tatarinowii, and 4 - 15 parts of mint.

[0006] Preferably, the traditional Chinese medicine composition is made from the following traditional Chinese medicine raw materials: roasted astragalus membranaceus or astragalus membranaceus 25 - 35 parts, wolfberry fruit 15 - 25 parts, eclipta prostrata 15 - 25 parts, ligustrum lucidum ait. processed with wine 12 - 18 parts, roasted polygala tenuifolia 12 - 18 parts, chuanxiong rhizome 10 - 15 parts, american ginseng 8 - 12 parts, acorus tatarinowii schott 8 - 12 parts, and mentha haplocalyx briq. 5 - 8 parts.

[0007] Preferably, the traditional Chinese medicine composition is made from the following traditional Chinese medicine raw materials: roasted astragalus membranaceus or astragalus membranaceus 30 parts, wolfberry fruit 20 parts, eclipta prostrata 20 parts, ligustrum lucidum ait. processed with wine 15 parts, roasted polygala tenuifolia 15 parts, chuanxiong rhizome 12 parts, american ginseng 10 parts, acorus tatarinowii schott 10 parts, and mentha haplocalyx briq. 6 parts.

[0008] Preferably, the traditional Chinese medicine composition is obtained by weighing each traditional Chinese medicine raw material according to the dosage, extracting with water, concentrating the obtained extract, and then spray - drying.

[0009] Preferably, the traditional Chinese medicine composition is obtained by weighing each traditional Chinese medicine raw material according to the dosage, heating and extracting with 5 - 20 times the amount of water for 2 - 5 times, filtering after each extraction for 1 - 3 h, combining the filtrates obtained each time, concentrating the obtained extract, and then spray - drying.

[0010] Preferably, the drug is a drug for relieving the inflammatory infiltration in the corneal stroma.

[0011] Preferably, the drug is a drug for increasing the thickness of the corneal epithelial cell layer.

[0012] Preferably, the drug is a drug for improving the tear secretion in dry - eye patients.

[0013] Preferably, the drug is a drug for inhibiting the apoptosis of corneal epithelial cells.

[0014] Preferably, the drug is a drug for inhibiting corneal inflammation.

[0015] Compared with the prior art, the present invention has the following beneficial effects: The application of the traditional Chinese medicine composition provided by the present invention in the preparation of drugs for improving dry eye. Pharmacological experiments have proved that the traditional Chinese medicine composition processed from roasted astragalus membranaceus or astragalus membranaceus, wolfberry fruit, eclipta prostrata, ligustrum lucidum ait. processed with wine, roasted polygala tenuifolia, chuanxiong rhizome, american ginseng, acorus tatarinowii schott, and mentha haplocalyx briq. can be used to improve dry eye. Specifically, this traditional Chinese medicine composition can relieve the inflammatory infiltration in the corneal stroma, increase the thickness of the corneal epithelial cell layer, improve the tear secretion and corneal fluorescein sodium staining score in dry - eye mice, inhibit the apoptosis of corneal epithelial cells and corneal inflammation, and thus improve dry eye. Therefore, this traditional Chinese medicine composition has good application prospects in the aspect of being used as a clinical drug for treating dry eye. Description of the Drawings

[0016] Figure 1Results graph of the improvement effect of the traditional Chinese medicine composition (SQFNXNP) on the comprehensive efficacy of DED mice; among them, A is the fluorescein sodium staining of mice; B is the quantification graph of fluorescein sodium; C and D are the hematoxylin-eosin (HE) staining graphs and quantification of the cornea respectively; E is the measurement of tear secretion volume; * p <0.05, ** p <0.01 vs Sham, # p <0.05, ## p <0.01 vs DED, Scale bar: 50 μm; Figure 2 Results graph of the improvement effect of the traditional Chinese medicine composition (SQFNXNP) on corneal epithelial cell apoptosis in DED mice; among them, A is the corneal staining result. The first row is the staining of terminal deoxynucleotidyl transferase dUTP nick-end labeling (TUNEL), and the second row is the staining of caspase-3 (CASP3). B is the quantification of TUNEL staining, and C is the quantification of CASP3 staining. * p <0.05, ** p <0.01 vs Sham, # p <0.05, ## p <0.01 vs DED, Scale bar: 50 μm; Figure 3 Results graph of the improvement effect of the traditional Chinese medicine composition (SQFNXNP) on corneal inflammatory factors in DED mice; among them, A is the corneal staining result. The first row is the staining of interleukin-1 beta (IL-1β), and the second row is the staining of tumor necrosis factor-alpha (TNF-α). B is the quantification of IL-1β staining, and C is the quantification of TNF-α staining. * p <0.05, ** p <0.01 vs Sham, #p <0.05, ## p <0.01 vs DED, Scale bar: 50 μm. Detailed implementation manners

[0017] To enable those skilled in the art to understand the features and effects of the present invention, only general descriptions and definitions of the terms and phrases mentioned in the specification and claims are provided below. Unless otherwise specified, all technical and scientific terms used herein shall have the ordinary meanings understood by those skilled in the art with respect to the present invention. In case of conflict, the definitions in this specification shall prevail.

[0018] The theories or mechanisms described and disclosed herein, whether correct or incorrect, shall not in any way limit the scope of the present invention, that is, the content of the present invention can be implemented without being limited by any specific theory or mechanism.

[0019] In this article, all features defined in the form of numerical ranges or percentage ranges, such as numerical values, quantities, contents, and concentrations, are only for the sake of brevity and convenience. Accordingly, the description of a numerical range or percentage range should be regarded as having covered and specifically disclosed all possible sub-ranges and individual numerical values within the range (including integers and fractions).

[0020] In this article, unless otherwise specified, "comprising", "including", "containing", "having" or similar terms cover the meanings of "consisting of" and "consisting essentially of". For example, "A comprises a" covers the meanings of "A comprises a and others" and "A only comprises a".

[0021] In this article, for the sake of concise description, all possible combinations of all technical features in each embodiment or example are not described. Therefore, as long as there is no contradiction in the combination of these technical features, the technical features in each embodiment or example can be combined arbitrarily, and all possible combinations should be considered as the scope described in this specification.

[0022] The present invention will be further described below in conjunction with specific embodiments. It should be understood that these embodiments are only used to illustrate the present invention and not to limit the scope of the present invention. In addition, it should be understood that after reading the content taught by the present invention, those skilled in the art can make various changes or modifications to the present invention, and these equivalent forms also fall within the scope defined by the appended claims of this application.

[0023] The following examples use conventional instruments and equipment in the art. For the experimental methods without specific conditions noted in the following examples, they are generally carried out under conventional conditions or according to the conditions recommended by the manufacturers. In the following examples, various raw materials are used. Unless otherwise stated, conventional commercially available products are used, and their specifications are the conventional specifications in the art.

[0024] I. Preparation of Traditional Chinese Medicine Composition (SQFNXNP) Refer to the preparation method in the Chinese patent application with the publication number CN119258149A, a traditional Chinese medicine composition for restoring energy, refreshing the mind and anti - fatigue and its uses, to prepare the traditional Chinese medicine composition (SQFNXNP).

[0025] Example 1 1. Weigh the following traditional Chinese medicine raw materials by weight: 30 parts of roasted astragalus membranaceus, 20 parts of wolfberry fruit, 20 parts of eclipta prostrata, 15 parts of ligustrum lucidum wine - processed, 15 parts of polygala tenuifolia roasted, 12 parts of chuanxiong rhizome, 10 parts of american ginseng, 10 parts of acorus tatarinowii, and 6 parts of mint. 2. Add pure water equivalent to 10 times the mass of the raw materials in Step 1, soak for 2 h, heat to boiling, cool, and filter to obtain extract a and residue a. 3. Add pure water equivalent to 10 times the mass of residue a obtained in Step 2, heat to boiling, cool, and filter to obtain extract b and residue b. 4. Add pure water equivalent to 10 times the mass of residue b obtained in Step 3, heat to boiling, cool, and filter to obtain extract c and residue c. 5. Combine extract a, extract b, and extract c, concentrate, and spray - dry to obtain the traditional Chinese medicine composition (SQFNXNP).

[0026] Example 2 The difference from Example 1 is that the weighed traditional Chinese medicine raw materials are: 20 parts of roasted astragalus membranaceus, 10 parts of wolfberry fruit, 10 parts of eclipta prostrata, 5 parts of ligustrum lucidum wine - processed, 5 parts of polygala tenuifolia roasted, 5 parts of chuanxiong rhizome, 5 parts of american ginseng, 5 parts of acorus tatarinowii, and 4 parts of mint.

[0027] Example 3 The difference from Example 1 is that the weighed traditional Chinese medicine raw materials are: 25 parts of roasted astragalus membranaceus, 15 parts of wolfberry fruit, 15 parts of eclipta prostrata, 12 parts of ligustrum lucidum wine - processed, 12 parts of polygala tenuifolia roasted, 10 parts of chuanxiong rhizome, 8 parts of american ginseng, 8 parts of acorus tatarinowii, and 5 parts of mint.

[0028] Example 4 The difference from Example 1 is that the weighed traditional Chinese medicine raw materials are: 35 parts of roasted astragalus membranaceus, 25 parts of wolfberry fruit, 25 parts of eclipta prostrata, 18 parts of ligustrum lucidum wine - processed, 18 parts of polygala tenuifolia roasted, 15 parts of chuanxiong rhizome, 12 parts of american ginseng, 12 parts of acorus tatarinowii, and 8 parts of mint.

[0029] Example 5 The difference from Example 1 is that the traditional Chinese medicine raw materials are weighed: 50 parts of roasted astragalus membranaceus, 30 parts of wolfberry fruit, 30 parts of eclipta prostrata, 20 parts of glossy privet fruit processed with wine, 20 parts of roasted polygala tenuifolia, 20 parts of chuanxiong rhizome, 15 parts of American ginseng, 15 parts of acorus tatarinowii, and 15 parts of mint.

[0030] II. Establishment of animal model and evaluation of curative effect 1. Experimental drugs and reagents Weigh the powder of the traditional Chinese medicine composition (SQFNXNP) prepared in Example 1, and prepare a traditional Chinese medicine composition solution with the required concentration using 0.9% sodium chloride solution. After preparation, store it at 4 °C for later use.

[0031] The experimental drugs and reagents required are: scopolamine hydrobromide (98%, CAS: 114 - 49 - 8, Shanghai Macklin Biochemical Co., Ltd.); phenol red cotton thread for tear detection (Tianjin Jingming Technology Development Co., Ltd.); one-step TUNEL cell apoptosis detection kit (Beyotime Biotechnology Co., Ltd.); IL-1β antibody and TNF-α antibody (GB12115, GB11188, Wuhan Sevier Co., Ltd.); CASP3 antibody (9664S, CST, USA).

[0032] 2. Experimental animals and grouping SPF-grade male Kunming mice aged 6 - 8 weeks, with a body weight of 18 - 22 g, are raised in the animal house of the Department of Pharmacy, the First Affiliated Hospital of Air Force Medical University, with 12 h light / 12 h darkness, and the animals are allowed to eat and drink freely.

[0033] 3. Establishment of dry eye model in mice A dry eye model is prepared by subcutaneous injection of scopolamine hydrobromide. Specifically, scopolamine hydrobromide is dissolved in physiological saline to make the final concentration 10 mg / mL. Each mouse is subcutaneously injected with 0.15 mL, and the injections are alternated between the two lower limbs. Each group is injected 2 times a day (at 10:00 am and 15:00 pm) for 14 consecutive days to obtain dry eye model mice.

[0034] 4. Animal grouping and drug administration Thirty-two mice are randomly divided into 4 groups, with 8 mice in each group: blank control group (Sham, 0.9% sodium chloride solution), model group (DED, 0.9% sodium chloride solution), low-dose traditional Chinese medicine composition group (SQFNXNP-L, 0.9 g / kg), and high-dose traditional Chinese medicine composition group (SQFNXNP-H, 6 g / kg). The mice in the DED, SQFNXNP-L, and SQFNXNP-H groups are all the mice obtained by the modeling method in step 3, and the mice in the Sham group are the mice that have not been modeled.

[0035] From 1 week before modeling, the mice in each group were administered drugs in the following manner: The mice in the Sham group and the DED group were respectively intragastrically administered 0.9% sodium chloride solution, and the mice in the SQFNXNP-L group (0.09 g / mL) and the SQFNXNP-H (0.6 g / mL) group were respectively intragastrically administered the corresponding concentration of the traditional Chinese medicine composition solution once a day, 0.25 mL each time. The intragastric administration continued until the end of modeling, and then various indicators of the mice in each group were detected and samples were taken.

[0036] 5. Analysis of the curative effect on dry eye 1) Improvement effect of the traditional Chinese medicine composition (SQFNXNP) on the comprehensive curative effect of DED mice The corneal epithelial damage was evaluated according to the degree of fluorescein sodium staining. The higher the score, the more severe the corneal damage. Specifically, after the administration ended, the mice in each group were anesthetized, 2 μL of 0.1% liquid fluorescein sodium was dropped into the conjunctival sac of the mice and the eyelids were closed 3 times. The excess residual fluorescein sodium around the eyes was washed with normal saline, and then the corneal staining was observed under a slit lamp microscope with a cobalt blue light sheet, photographed and scored for analysis.

[0037] The staining results are as Figure 1 shown in A and B. There was almost no corneal fluorescence staining in the Sham group. Compared with the Sham group, the corneal staining in the DED group increased significantly. The fluorescence staining scores in the SQFNXNP-L and SQFNXNP-H groups were improved to varying degrees, and the treatment effect in the SQFNXNP-H group was the best. The corneal epithelium is a highly sensitive tissue that can supplement moisture to the eyes. The normal structure of the ocular surface epithelial cell layer helps to maintain the stability and tension of the tear film. Severe dry eye will lead to corneal epithelial damage and changes in the structure of the corneal epithelial cell layer. The HE staining results of the corneal tissue pathological sections of the mice in each group are as Figure 1 shown in C and D. In the Sham group, the corneal epithelial cells were arranged tightly, distributed neatly, and had regular morphology. In the DED group, the corneal epithelial cell layer became thinner, the surface was rough, and there was inflammatory infiltration in the corneal stroma. Compared with the DED group, the above pathological damage of the corneal epithelial cells in the SQFNXNP-L and SQFNXNP-H groups was reduced. The statistical results of corneal thickness showed that compared with the Sham group, the corneal thickness in the DED group decreased, and the difference was statistically significant (p < 0.01). Compared with the DED group, the thickness of the corneal epithelial cell layer in the SQFNXNP-H group increased significantly (p < z0.05).

[0038] The phenol red cotton thread method was used to detect the tear secretion volume of the mice in each group. Specifically, after the administration ended, the mice in each group were anesthetized, the lower eyelid of the mice was pulled down to expose the lower conjunctival sac, the phenol red cotton thread was placed into the inner about 1 / 3 conjunctival sac of the lower eyelid for 15 s, and then the phenol red cotton thread was taken out. The length of the phenol red cotton thread wet by tears was measured with a vernier caliper and recorded to evaluate the tear secretion volume of the mice in each group.

[0039] The detection results are as Figure 1 shown in E. Compared with the Sham group, the tear secretion volume (the length of the phenol red cotton thread wetted) in the DED group was significantly reduced, and the difference was statistically significant (p < 0.01). Compared with the DED group, the tear secretion volume in the SQFNXNP-L and SQFNXNP-H groups was significantly increased (p < 0.01). These results indicate that SQFNXNP can effectively relieve dry eye symptoms in mice, suggesting that SQFNXNP can be used as a candidate drug for the treatment of dry eye disease.

[0040] 2) Improvement effect of traditional Chinese medicine composition (SQFNXNP) on corneal cell apoptosis in DED mice The one-step TUNEL cell apoptosis detection kit was used to detect the apoptosis of corneal epithelial cells in mice of each group. Specifically, after the administration was completed, the mice in each group were anesthetized, the eyeballs were removed, placed in 4% paraformaldehyde for fixation, paraffin sections were prepared, and the paraffin sections were successively placed in environmentally friendly dewaxing solution (G1128) I for 10 min - environmentally friendly dewaxing solution (G1128) II for 10 min - environmentally friendly dewaxing solution (G1128) III for 10 min - absolute ethanol I for 5 min - absolute ethanol II for 5 min - absolute ethanol III for 5 min - distilled water wash. 20 μg / mL proteinase K without DNase was added dropwise and incubated at 37°C for 30 min. Then, according to the instructions, the prepared TUNEL detection solution was added, incubated at 37°C in the dark for 60 min, washed 3 times with phosphate-buffered saline (PBS), and sealed with an anti-fluorescence quenching mounting medium containing 4',6-diamidino-2-phenylindole (DAPI), and observed under a fluorescence microscope.

[0041] The detection results are as Figure 2 shown in A and B. Compared with the Sham group, the number of apoptotic cells in the DED group was significantly increased, and the difference was statistically significant (p < 0.01), while the SQFNXNP-L and SQFNXNP-H groups could reduce the number of apoptotic cells to varying degrees (p < 0.01).

[0042] Immunofluorescence staining was used to detect CASP3 expression in mouse corneal epithelial cells. After administration, mice in each group were anesthetized, their eyeballs removed, and fixed in 4% paraformaldehyde. Paraffin sections were prepared and then washed in environmentally friendly deparaffinization solution I for 10 minutes, environmentally friendly deparaffinization solution II for 10 minutes, environmentally friendly deparaffinization solution III for 10 minutes, anhydrous ethanol I for 5 minutes, anhydrous ethanol II for 5 minutes, anhydrous ethanol III for 5 minutes, and finally distilled water. After briefly drying the sections, a circle was drawn around the tissue using a histochemical pen. Bovine serum albumin (BSA) was added dropwise and blocked for 30 minutes. The prepared CASP3 primary antibody was then added and incubated overnight at 4°C. The slides were washed three times in PBS for 5 min each time, and the corresponding secondary antibodies were added and incubated at room temperature in the dark for 50 min. The slides were washed three times for 5 min each time, and DAPI staining solution was added and incubated at room temperature in the dark for 10 min. The slides were washed three times and sealed with anti-fluorescence quenching sealing medium. The slides were observed under a fluorescence microscope and photographed.

[0043] Test results such as Figure 2 As shown in Figures A and C, the fluorescence intensity of CASP3 was significantly increased in the DED group compared with the sham group (p < 0.01), while the SQFNXNP-L and SQFNXNP-H groups reduced CASP3 expression to varying degrees (p < 0.01). These results suggest that SQFNXNP can improve dry eye symptoms in mice by inhibiting corneal epithelial cell apoptosis.

[0044] 3) Effect of the Chinese herbal composition (SQFNXNP) on improving corneal inflammatory factors in DED mice Insufficient tear secretion caused by dry eyes will cause the ocular surface to become dry, which in turn causes the ocular surface to form a hypertonic state, stimulating the inflammatory cascade reaction, leading to the recruitment of inflammatory cells and the massive secretion of inflammatory factors IL-1β and TNF-α. These inflammatory factors will further mediate the damage to the ocular surface epithelium under inflammatory conditions.

[0045] The expression of corneal inflammatory factors IL-1β and TNF-α in mice was detected by immunofluorescence staining. Specifically, after the administration was completed, the mice in each group were anesthetized, and the eyeballs were removed and fixed in 4% paraformaldehyde. Paraffin sections were prepared, and the sections were successively placed in environment-friendly dewaxing solution I for 10 min - environment-friendly dewaxing solution II for 10 min - environment-friendly dewaxing solution III for 10 min - absolute ethanol I for 5 min - absolute ethanol II for 5 min - absolute ethanol III for 5 min - distilled water wash. After the sections were slightly dried by shaking, a circle was drawn around the tissue with a histochemical pen, and BSA was added and incubated for 30 min. The prepared primary antibody of IL-1β or TNF-α was added and incubated overnight at 4°C. The slides were washed 3 times in PBS, 5 min each time, the corresponding secondary antibody was added, and incubated at room temperature in the dark for 50 min, washed 3 times, 5 min each time, DAPI staining solution was added, and incubated at room temperature in the dark for 10 min, washed 3 times, and sealed with an anti-fluorescence quenching mounting medium, and observed and photographed under a fluorescence microscope.

[0046] The detection results are as Figure 3 shown in A - C in the figure. Compared with the Sham group, the fluorescence intensities of IL-1β and TNF-α in the DED group were significantly increased, indicating that the mouse ocular surface was damaged and the model was successfully established. Compared with the DED group, the SQFNXNP-L and SQFNXNP-H groups could reduce the expression of IL-1β and TNF-α to varying degrees, and the differences were statistically significant (p < 0.05). These results suggest that SQFNXNP has an obvious anti-inflammatory effect and can inhibit corneal inflammation and improve dry eye symptoms by inhibiting the release of inflammatory factors.

[0047] III. Examples of dosage addition and subtraction of traditional Chinese medicine composition in improving dry eye 1. If qi deficiency and spleen deficiency are more severe, American ginseng (10 - 20 g) or / and astragalus membranaceus (30 - 50 g) can be appropriately increased to enhance the effect of invigorating the spleen and replenishing qi; 2. If liver and kidney yin deficiency and insufficient yin fluid are more severe, glossy privet fruit (15 - 25 g) or / and eclipta prostrata (2,000 - 30 g) or / and wolfberry fruit (20 - 30 g) can be appropriately increased to enhance the effect of nourishing the liver and kidney and promoting the production of yin fluid.

[0048] The above content is only to illustrate the technical idea of the present invention and cannot limit the protection scope of the present invention. Any modification made on the basis of the technical solution according to the technical idea proposed by the present invention falls within the protection scope of the claims of the present invention.

Claims

1. Use of a traditional Chinese medicine composition in the preparation of a drug for improving dry eye syndrome, characterized in that, The traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials: 20-50 parts of roasted Astragalus membranaceus or Astragalus membranaceus, 10-30 parts of Lycium barbarum, 10-30 parts of Eclipta prostrata, 5-20 parts of Ligustrum lucidum Ait. var. latifolium (Warb.) Kitam., 5-20 parts of roasted Polygala tenuifolia, 5-20 parts of Ligusticum chuanxiong, 5-15 parts of American ginseng, 5-15 parts of Acorus tatarinowii, and 4-15 parts of Mentha haplocalyx Briq.

2. The application according to claim 1, characterized in that, The traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials: 25-35 parts of roasted Astragalus membranaceus or Astragalus membranaceus, 15-25 parts of Lycium barbarum, 15-25 parts of Eclipta prostrata, 12-18 parts of Ligustrum lucidum Ait. var. latifolium (Warb.) Kitam., 12-18 parts of roasted Polygala tenuifolia, 10-15 parts of Ligusticum chuanxiong, 8-12 parts of American ginseng, 8-12 parts of Acorus tatarinowii, and 5-8 parts of Mentha haplocalyx Briq.

3. The application according to claim 1, characterized in that The traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials: 30 parts of roasted Astragalus membranaceus or Astragalus membranaceus, 20 parts of Lycium barbarum, 20 parts of Eclipta prostrata, 15 parts of Ligustrum lucidum Ait. var. latifolium (Warb.) Kitam., 15 parts of roasted Polygala tenuifolia, 12 parts of Ligusticum chuanxiong, 10 parts of American ginseng, 10 parts of Acorus tatarinowii, and 6 parts of Mentha haplocalyx Briq.

4. The application according to any one of claims 1 to 3, characterized in that The traditional Chinese medicine composition is obtained by weighing each traditional Chinese medicine raw material according to the dosage, extracting with water, concentrating the obtained extract, and then spray-drying.

5. The application according to claim 4, wherein The traditional Chinese medicine composition is obtained by weighing each traditional Chinese medicine raw material according to the dosage, heating and extracting with 5-20 times the amount of water for 2-5 times, filtering after each extraction for 1-3 h, combining the filtrates obtained each time, concentrating the obtained extract, and then spray-drying.

6. The application according to any one of claims 1 to 3, characterized in that The drug is for relieving the inflammatory infiltration in corneal stroma.

7. The application according to any one of claims 1 to 3, characterized in that, The drug is for increasing the thickness of corneal epithelial cell layer.

8. The application according to any one of claims 1 to 3, characterized in that The drug is for improving the tear secretion in dry eye patients.

9. The application according to any one of claims 1 to 3, characterized in that The drug is for inhibiting the apoptosis of corneal epithelial cells.

10. The application according to any one of claims 1 to 3, characterized in that, The drug is for inhibiting corneal inflammation.

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