A traditional Chinese medicine composition for relieving and treating dry eye and a preparation method thereof

Abstract

This invention relates to the field of traditional Chinese medicine compositions, and discloses a traditional Chinese medicine composition for relieving and treating dry eye syndrome and its preparation method. The traditional Chinese medicine composition comprises the following components in parts by weight: 20-30 parts of Rehmannia glutinosa, 10-15 parts of Adenophora stricta, 8-12 parts of Ophiopogon japonicus, 5-10 parts of modified Gentiana scabra extract, 5-10 parts of Angelica sinensis, 10-15 parts of Lycium barbarum, 5-10 parts of Paeonia suffruticosa bark, 2-7 parts of Buddleja officinalis, and 3-5 parts of Melia toosendan; the modified Gentiana scabra extract is prepared using β-cyclodextrin. The esterification reaction of maleic anhydride yields maleic acid monoester cyclodextrin, which is then subjected to a Michael addition reaction with chitosan quaternary ammonium salt to obtain modified cyclodextrin, which is then used to encapsulate gentian root extract. This invention utilizes Rehmannia glutinosa, Adenophora stricta, Ophiopogon japonicus, Angelica sinensis, Lycium barbarum, Paeonia suffruticosa, Buddleja officinalis, and Melia toosendan as traditional Chinese medicine raw materials to extract traditional Chinese medicine extracts. The modified gentian root extract is added to the traditional Chinese medicine extracts for combined use, which can effectively achieve the long-term effect of the traditional Chinese medicine composition.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine composition technology, specifically relating to a traditional Chinese medicine composition for relieving and treating dry eye syndrome and its preparation method. Background Technology

[0002] Dry eye syndrome is a general term for a variety of diseases characterized by decreased tear film stability due to abnormalities in the quality and quantity of tears or abnormal tear dynamics caused by any reason, accompanied by eye discomfort and leading to lesions of the ocular surface tissue. Its clinical manifestations include eye fatigue, foreign body sensation, dryness, and burning sensation. In severe cases, it can cause decreased vision, affecting people's quality of life. It has become an increasingly serious public health problem, and the prevalence of dry eye syndrome gradually increases with age, with women having a higher risk of developing the disease than men.

[0003] Currently, the treatment of dry eye syndrome often involves using artificial tears, such as sodium hyaluronate eye drops, to increase tear secretion on the ocular surface and maintain its moisture. Dry eye syndrome is related to Toll-like receptor 4-mediated inflammatory responses. Artificial tears only provide temporary symptom relief and have limited effect on inhibiting ocular surface inflammation. Therefore, the treatment of dry eye syndrome should focus on regulating the overall mechanism and suppressing ocular surface inflammation to improve long-term efficacy. Traditional Chinese medicine has a saying that "the five internal organs transform fluids, with the liver producing tears," and dry eye syndrome falls under the category of "dryness and numbness." Therefore, the treatment principle should be to nourish the liver and kidneys, nourish yin and generate fluids, and clear heat and improve vision. There is an urgent need to provide a traditional Chinese medicine composition that can be used to relieve and treat dry eye syndrome. Summary of the Invention

[0004] To address the shortcomings mentioned in the background art, the present invention aims to provide a traditional Chinese medicine composition for relieving and treating dry eye syndrome and its preparation method. The composition utilizes Rehmannia glutinosa, Adenophora stricta, Ophiopogon japonicus, Angelica sinensis, Lycium barbarum, Paeonia suffruticosa, Buddleja officinalis, and Melia toosendan as raw materials to extract a traditional Chinese medicine extract. A modified Gentiana scabra extract is added to the traditional Chinese medicine extract for combined use, effectively achieving a long-lasting effect of the traditional Chinese medicine composition.

[0005] The objective of this invention can be achieved through the following technical solutions: A traditional Chinese medicine composition for relieving and treating dry eye syndrome, comprising the following components in parts by weight: 20-30 parts of Rehmannia glutinosa, 10-15 parts of Adenophora stricta, 8-12 parts of Ophiopogon japonicus, 5-10 parts of modified Gentiana scabra extract, 5-10 parts of Angelica sinensis, 10-15 parts of Lycium barbarum, 5-10 parts of Paeonia suffruticosa, 2-7 parts of Buddleja officinalis, and 3-5 parts of Melia toosendan. The modified gentian extract was prepared by encapsulating the gentian extract with a modified cyclodextrin obtained by esterification of β-cyclodextrin and maleic anhydride, followed by a Michael addition reaction of the modified cyclodextrin with chitosan quaternary ammonium salt.

[0006] Preferably, the preparation method of the modified gentian extract includes the following steps: (1) Soak dried gentian root in water for 0.5-1h, decoct three times, each time for 20-30min, then combine the decoctions, place at 4℃ for 24h, take the supernatant and concentrate to obtain concentrated solution, precipitate with alcohol and place at 4℃ for 24h, filter, recover ethanol from the filtrate, vacuum dry at 45-60℃ for 4-5h to prepare gentian root extract; (2) Take β-cyclodextrin, maleic anhydride and N,N-dimethylformamide in a reactor, stir and mix evenly, heat to 70~85℃ and react for 8~10h. After the reaction is completed, cool to room temperature, pour the reaction solution into dichloromethane, precipitate the product, filter, wash and dry the product to prepare maleic anhydride monoester cyclodextrin. (3) Take maleic acid monoester cyclodextrin, chitosan quaternary ammonium salt, and sodium hydroxide solution into a reactor, stir and mix evenly, heat to 45~55℃ and react for 10~12h, after the reaction is completed, cool to room temperature, pour the reaction solution into anhydrous ethanol, precipitate the product, filter and wash the solid product and dialyze it for three days with a dialysis bag, place the liquid in the dialysis bag at -18~-22℃ for 8~12h, and finally freeze dry under vacuum to prepare modified cyclodextrin; (4) Take the modified cyclodextrin, add water and mix, then add gentian extract and grind evenly. Then place it at 35~55℃ and shake for 4~8h to prepare the modified gentian extract.

[0007] Preferably, the ratio of dried gentian root to concentrated liquid in step (1) is 1~1.1g:1mL.

[0008] Preferably, in step (2), the mass ratio of β-cyclodextrin to maleic anhydride is 1~1.2:1.

[0009] Preferably, the concentration of sodium hydroxide solution in step (3) is 0.3~0.35%.

[0010] Preferably, the mass ratio of maleic acid monoester cyclodextrin to chitosan quaternary ammonium salt in step (3) is 1~1.2:1.

[0011] Preferably, the mass ratio of modified cyclodextrin to gentian extract in step (4) is 8~10:1.

[0012] A method for preparing a traditional Chinese medicine composition for relieving and treating dry eye syndrome includes the following steps: S1. Weigh each component according to its weight parts; S2. Take Rehmannia glutinosa, Adenophora stricta, Ophiopogon japonicus, Angelica sinensis, Lycium barbarum, Paeonia suffruticosa, Buddleja officinalis, and Melia toosendan, soak them in water for 0.5-1 hour, decoct them for 1-2 hours, filter them with non-woven gauze, and obtain the decoction. S3. Extract the residue with 75% ethanol for 1-1.5 hours, filter, and obtain the ethanol extract. S4. Combine the water decoction and alcohol extract, stir and mix evenly, remove ethanol by rotary evaporation under reduced pressure to obtain the Chinese herbal extract. S5. Mix the Chinese herbal extract and the modified gentian extract, concentrate them, add excipients, and prepare the Chinese herbal composition for relieving and treating dry eye syndrome according to conventional formulation methods.

[0013] Preferably, the traditional Chinese medicine composition for relieving and treating dry eye syndrome is a solid or liquid preparation.

[0014] Preferably, the traditional Chinese medicine composition for relieving and treating dry eye syndrome is an oral preparation or a topical preparation.

[0015] The beneficial effects of this invention are: This invention utilizes the esterification reaction between the hydroxyl groups in β-cyclodextrin and the anhydride groups in maleic anhydride to prepare maleic acid monoester cyclodextrin. Then, a Michael addition reaction is performed between the unsaturated double bonds in the maleic acid monoester cyclodextrin and the amino groups in chitosan quaternary ammonium salt to prepare modified cyclodextrin. Subsequently, gentian root extract is encapsulated with the modified cyclodextrin to prepare modified gentian root extract. The water-soluble chitosan quaternary ammonium salt grafted with maleic acid monoester cyclodextrin utilizes the hydrophobic cavity of β-cyclodextrin to load the gentian root extract. The main active components of gentian root are gentiopicrin and other iridoids and septidoglycan glycosides. The sustained-release results of the gentian root extract show that the drug reaches release equilibrium after 36 hours, with a cumulative release rate of 88.3%. The 1% reduction can decrease the dosage and frequency of medication, improve drug bioavailability, and enhance the antibacterial and moisturizing properties of chitosan quaternary ammonium salt. Furthermore, β-cyclodextrin has low solubility at room temperature; grafting it with chitosan quaternary ammonium salt improves its water solubility. Inclusion therapy masks the bitterness of gentian extract, improving patient compliance. This invention utilizes Rehmannia glutinosa, Adenophora stricta, Ophiopogon japonicus, Angelica sinensis, Lycium barbarum, Paeonia suffruticosa, Buddleja officinalis, and Melia toosendan as raw materials to extract a traditional Chinese medicine extract. A modified gentian extract is added to complement the extract, effectively alleviating symptoms such as liver and kidney yin deficiency, upward flaring of deficiency fire, depletion of body fluids, stagnant heat transforming into fire, upward attack on the eyes, and reduced tear production. Detailed Implementation

[0016] The technical solutions of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0017] Example 1: A method for preparing a modified gentian extract includes the following steps: (1) Take 440g of dried gentian and soak it in water for 1h. Boil it three times with water for 30min, 25min and 20min respectively. Then combine the decoctions and place them at 4℃ for 24h. Take the supernatant and concentrate it to 440mL. After ethanol precipitation, place it at 4℃ for 24h. Filter it and recover the ethanol from the filtrate. Dry it under vacuum at 50℃ for 5h to prepare gentian extract. (2) Take 11.4g of β-cyclodextrin, 10g of maleic anhydride and 60mL of N,N-dimethylformamide in a reactor, stir and mix evenly, heat to 80℃ and react for 10h. After the reaction is completed, cool to room temperature, pour the reaction solution into 60mL of dichloromethane, precipitate the product, filter, wash and dry the product to prepare maleic anhydride monoester cyclodextrin; (3) Take 4.4g maleic acid monoester cyclodextrin, 4g chitosan quaternary ammonium salt, and 100mL 0.33% sodium hydroxide solution into a reactor, stir and mix evenly, heat to 50℃ and react for 12h. After the reaction is completed, cool to room temperature, pour the reaction solution into 100mL anhydrous ethanol, precipitate the product, filter and wash the solid product and dialyze it for three days with a dialysis bag. Place the liquid in the dialysis bag at -20℃ for 12h, and finally freeze dry under vacuum to prepare modified cyclodextrin. (4) Take 0.8g of modified cyclodextrin and mix it with 10mL of water, then add 100mg of gentian extract and grind it evenly. Then place it at 45℃ and shake for 8h to prepare the modified gentian extract. Example 2 A traditional Chinese medicine composition for relieving and treating dry eye syndrome, comprising the following components in parts by weight: 22 parts of Rehmannia glutinosa, 10 parts of Adenophora stricta, 8 parts of Ophiopogon japonicus, 5 parts of modified Gentiana scabra extract prepared in Example 1, 5 parts of Angelica sinensis, 10 parts of Lycium barbarum, 5 parts of Paeonia suffruticosa, 2 parts of Buddleja officinalis, and 3 parts of Melia toosendan.

[0018] The preparation method of the above-mentioned traditional Chinese medicine composition for relieving and treating dry eye syndrome includes the following steps: S1. Weigh each component according to its weight parts; S2. Take Rehmannia glutinosa, Adenophora stricta, Ophiopogon japonicus, Angelica sinensis, Lycium barbarum, Paeonia suffruticosa, Buddleja officinalis, and Melia toosendan, soak them in water for 1 hour, decoct them for 1.5 hours, filter them with non-woven gauze, and obtain the decoction. S3. Extract the residue with 75% ethanol for 1 hour, filter, and obtain the ethanol extract. S4. Combine the water decoction and alcohol extract, stir and mix evenly, remove ethanol by rotary evaporation under reduced pressure to obtain the Chinese herbal extract. S5. Mix the Chinese herbal extract and the modified gentian extract, concentrate them, add excipients, and prepare the Chinese herbal composition for relieving and treating dry eye syndrome according to the solid dosage form method.

[0019] Example 3 A traditional Chinese medicine composition for relieving and treating dry eye syndrome, comprising the following components in parts by weight: 25 parts of Rehmannia glutinosa, 12 parts of Adenophora stricta, 10 parts of Ophiopogon japonicus, 7 parts of modified Gentiana scabra extract prepared in Example 1, 6 parts of Angelica sinensis, 13 parts of Lycium barbarum, 6 parts of Paeonia suffruticosa, 4 parts of Buddleja officinalis, and 4 parts of Melia toosendan.

[0020] The preparation method of the above-mentioned traditional Chinese medicine composition for relieving and treating dry eye syndrome is the same as in Example 2.

[0021] Example 4 A traditional Chinese medicine composition for relieving and treating dry eye syndrome, comprising the following components in parts by weight: 28 parts of Rehmannia glutinosa, 14 parts of Adenophora stricta, 12 parts of Ophiopogon japonicus, 9 parts of modified Gentiana scabra extract prepared in Example 1, 8 parts of Angelica sinensis, 15 parts of Lycium barbarum, 8 parts of Paeonia suffruticosa, 6 parts of Buddleja officinalis, and 5 parts of Melia toosendan.

[0022] The preparation method of the above-mentioned traditional Chinese medicine composition for relieving and treating dry eye syndrome is the same as in Example 2.

[0023] Comparative Example 1: A traditional Chinese medicine composition for relieving and treating dry eye syndrome, comprising the following components in parts by weight: 28 parts Rehmannia glutinosa, 14 parts Adenophora stricta, 12 parts Ophiopogon japonicus, 9 parts Gentiana scabra, 8 parts Angelica sinensis, 15 parts Lycium barbarum, 8 parts Paeonia suffruticosa, 6 parts Buddleja officinalis, and 5 parts Melia toosendan.

[0024] The preparation method of the above-mentioned traditional Chinese medicine composition for relieving and treating dry eye syndrome includes the following steps: S1. Weigh each component according to its weight parts; S2. Take Rehmannia glutinosa, Adenophora stricta, Ophiopogon japonicus, Gentiana scabra, Angelica sinensis, Lycium barbarum, Paeonia suffruticosa, Buddleja officinalis, and Melia toosendan, soak them in water for 1 hour, decoct them for 1.5 hours, filter them with non-woven gauze, and obtain the decoction. S3. Extract the residue with 75% ethanol for 1 hour, filter, and obtain the ethanol extract. S4. Combine the water decoction and alcohol extract, stir and mix evenly, remove ethanol by rotary evaporation under reduced pressure, concentrate and add excipients to prepare a traditional Chinese medicine composition for relieving and treating dry eye syndrome according to the solid dosage form method.

[0025] Comparative Example 2: A traditional Chinese medicine composition for relieving and treating dry eye syndrome, comprising the following components in parts by weight: 28 parts Rehmannia glutinosa, 14 parts Adenophora stricta, 12 parts Ophiopogon japonicus, 8 parts Angelica sinensis, 15 parts Lycium barbarum, 8 parts Paeonia suffruticosa, 6 parts Buddleja officinalis, and 5 parts Melia toosendan.

[0026] The preparation method of the above-mentioned traditional Chinese medicine composition for relieving and treating dry eye syndrome includes the following steps: S1. Weigh each component according to its weight parts; S2. Take Rehmannia glutinosa, Adenophora stricta, Ophiopogon japonicus, Angelica sinensis, Lycium barbarum, Paeonia suffruticosa, Buddleja officinalis, and Melia toosendan, soak them in water for 1 hour, decoct them for 1.5 hours, filter them with non-woven gauze, and obtain the decoction. S3. Extract the residue with 75% ethanol for 1 hour, filter, and obtain the ethanol extract. S4. Combine the water decoction and alcohol extract, stir and mix evenly, remove ethanol by rotary evaporation under reduced pressure, concentrate and add excipients to prepare a traditional Chinese medicine composition for relieving and treating dry eye syndrome according to the solid dosage form method.

[0027] Performance testing: A. Cytotoxicity detection: (1) The revived L929 cells were cultured in high glucose DMEM (10% serum) medium (at 37°C and 5% CO2) and the logarithmic growth phase cells were taken for use. (2) Set the cell density to 2×10 4 The cell suspension of cells / mL was seeded into 96-well plates (200 μL / well) and cultured for 24 h. (3) After 24 hours, the culture medium was aspirated and the cell culture plate was rinsed with PBS buffer. The traditional Chinese medicine composition prepared in Examples 2-4 was added to each well. Each group was repeated 3 times. The cells were then cultured for 24 hours. After the preset time was reached, CCK8 solution (20 μL / well) was added and the cells were incubated for another 4 hours. (4) Measure the absorbance of the solution at 450 nm. Calculate the survival rate of mouse fibroblasts based on the absorbance results. A survival rate greater than 75% is considered to be non-cytotoxic; a survival rate less than 50% is considered to be cytotoxic.

[0028] According to the test results, the survival rate of L929 cells was 81-88%, consistently remaining above 75%, indicating that the traditional Chinese medicine composition prepared in Examples 2-4 had no cytotoxicity.

[0029] B. The modified gentian extract prepared in Example 1 was evaluated using a bitterness score: The concentration of the modified gentian extract was fixed at 5 mg / mL, and the bitterness level was divided into 5 grades. Grade 1 (0-20 points): almost no bitterness; Grade 2 (21-40 points): bitterness was perceptible but tolerable; Grade 3 (41-60 points): bitterness was perceptible and unbearable; Grade 4 (61-80 points): strong bitterness, unbearable, and painful; Grade 5 (81-100 points): extremely bitter, unbearable, and should be spat out immediately. At a concentration of 5 mg / mL, the bitterness score was 100. The bitterness evaluation method was as follows: rinse mouth three times with warm water, then hold the test solution in the mouth for 10 seconds before spitting it out for evaluation.

[0030] The bitterness value of the modified gentian extract prepared in Example 1 was evaluated according to the bitterness evaluation standard. Its bitterness score was 10, which indicates that the inclusion effect and the masking effect are good.

[0031] C. Sustained-release experiment: The modified gentian extract prepared in Example 1 was transferred into a dialysis bag, and then the dialysis bag was placed in an Erlenmeyer flask containing 100 mL of PBS solution with pH=7.4. The flask was placed in a constant temperature shaker at 37℃ and 80 r / min. At a specific time point, 2 mL of solution was taken out and 2 mL of PBS solution was added back. The chromatogram was performed using an Agilent Eclipse XDB-C18 column (250 mm × 4.6 mm, 5 μm), with methanol:water (65:35) as the mobile phase and a flow rate of 1 mL / min, under chromatographic conditions with a detection wavelength of 220 nm.

[0032] According to the test results, the release of gentian extract reached equilibrium after 36 hours, at which point the cumulative release rate remained at 88.31%, providing a possibility for long-term treatment of dry eye syndrome.

[0033] D. Clinical efficacy (1) Patients involved in the treatment: 180 patients with liver and kidney yin deficiency type dry eye syndrome who met the inclusion criteria were collected, including 84 males and 96 females, with an average age of 37.6±10.2 years. The patients were randomly assigned to six groups (I, II, III, IV, V, VI) using a non-blind method. The baseline data were entered into statistical software for analysis, and there was no statistically significant difference (P>0.05).

[0034] (2) Diagnostic criteria: The Western medicine diagnostic criteria refer to the dry eye diagnostic criteria formulated by Liu Zugu; the TCM diagnostic criteria refer to the liver and kidney yin deficiency syndrome in the "Standards for Diagnosis and Efficacy of TCM Diseases and Syndromes".

[0035] (3) Detection method: Group I: General treatment such as reducing computer and mobile phone usage and improving lifestyle habits was given, plus 0.1% sodium hyaluronate eye drops (Santen Pharmaceutical (China) Co., Ltd.) eye drops, 1-2 drops / time, 3 times / day, and the patient was instructed to close their eyes and rest for 10 minutes after the eye drops were administered. Group II: Take the solid dosage form of the traditional Chinese medicine composition prepared in Example 2, 1g / tablet, 2 tablets / time, 2 times / day, for 4 consecutive weeks; Group III: Take the solid dosage form of the traditional Chinese medicine composition prepared in Example 3, 1g / tablet, 2 tablets / time, 2 times / day, for 4 consecutive weeks; Group IV: The solid dosage form of the traditional Chinese medicine composition prepared in Example 4 was taken at a dose of 1g / tablet, 2 tablets / time, 2 times / day, for 4 consecutive weeks. Group V: The solid dosage form of the traditional Chinese medicine composition prepared in Comparative Example 1 was taken at a dose of 1g / tablet, 2 tablets / time, 2 times / day, for 4 consecutive weeks; Group VI: The solid dosage form of the traditional Chinese medicine composition prepared in Comparative Example 2 was taken at a dose of 1g / tablet, 2 tablets / time, 2 times / day, for 4 consecutive weeks. (4) Observation of therapeutic effect: The efficacy criteria were formulated with reference to the "Standards for Diagnosis and Efficacy of Diseases and Syndromes in Traditional Chinese Medicine" issued by the State Administration of Traditional Chinese Medicine. Clinical relief: Significant improvement in symptoms and signs (efficacy index > 95%); Marked effect: Significant improvement in symptoms and signs (70% ≤ efficacy index < 95%); Effective: Improvement in symptoms and signs (30% ≤ efficacy index < 70%); Ineffective: No significant reduction or aggravation of symptoms and signs (efficacy index < 30%). The data results are shown in Table 1.

[0036] Table 1. Statistical Table of Clinical Efficacy As can be seen from the data in Table 1, the solid dosage forms of traditional Chinese medicine compositions prepared in Examples 2-4 of this invention have better effects in relieving and treating dry eye syndrome than Comparative Examples 1-2 and 0.1% sodium hyaluronate eye drops. In Comparative Example 1, the modified gentian extract was replaced with an equal amount of gentian, while no gentian was added in Comparative Example 2. The total effective rate of Comparative Example 2 was the most significantly lower than that of Examples 2-4, indicating that gentian and the modification of gentian extract have improved the effect of traditional Chinese medicine compositions in relieving and treating dry eye syndrome to a certain extent.

[0037] In the description of this specification, references to terms such as "an embodiment," "example," "specific example," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the invention. In this specification, illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0038] The foregoing has shown and described the basic principles, main features, and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited to the above embodiments. The embodiments and descriptions in the specification are merely illustrative of the principles of the invention. Various changes and modifications can be made to the invention without departing from its spirit and scope, and all such changes and modifications fall within the scope of the claimed invention.

Claims

1. A traditional Chinese medicine composition for relieving and treating dry eye syndrome, characterized in that, It includes the following components by weight: 20-30 parts of Rehmannia glutinosa, 10-15 parts of Adenophora stricta, 8-12 parts of Ophiopogon japonicus, 5-10 parts of modified Gentiana scabra extract, 5-10 parts of Angelica sinensis, 10-15 parts of Lycium barbarum, 5-10 parts of Paeonia suffruticosa, 2-7 parts of Buddleja officinalis, and 3-5 parts of Melia toosendan. The modified gentian extract was prepared by encapsulating the gentian extract with a modified cyclodextrin obtained by esterification of β-cyclodextrin and maleic anhydride, followed by a Michael addition reaction of the modified cyclodextrin with chitosan quaternary ammonium salt.

2. The traditional Chinese medicine composition for relieving and treating dry eye syndrome according to claim 1, characterized in that, The preparation method of the modified gentian extract includes the following steps: (1) Soak dried gentian root in water for 0.5-1h, decoct three times, each time for 20-30min, then combine the decoctions, place at 4℃ for 24h, take the supernatant and concentrate to obtain concentrated solution, precipitate with alcohol and place at 4℃ for 24h, filter, recover ethanol from the filtrate, vacuum dry at 45-60℃ for 4-5h to prepare gentian root extract; (2) Take β-cyclodextrin, maleic anhydride and N,N-dimethylformamide in a reactor, stir and mix evenly, heat to 70~85℃ and react for 8~10h. After the reaction is completed, cool to room temperature, pour the reaction solution into dichloromethane, precipitate the product, filter, wash and dry the product to prepare maleic anhydride monoester cyclodextrin. (3) Take maleic acid monoester cyclodextrin, chitosan quaternary ammonium salt, and sodium hydroxide solution into a reactor, stir and mix evenly, heat to 45~55℃ and react for 10~12h, after the reaction is completed, cool to room temperature, pour the reaction solution into anhydrous ethanol, precipitate the product, filter and wash the solid product and dialyze it for three days with a dialysis bag, place the liquid in the dialysis bag at -18~-22℃ for 8~12h, and finally freeze dry under vacuum to prepare modified cyclodextrin; (4) Take the modified cyclodextrin, add water and mix, then add gentian extract and grind evenly. Then place it at 35~55℃ and shake for 4~8h to prepare the modified gentian extract.

3. The traditional Chinese medicine composition for relieving and treating dry eye syndrome according to claim 2, characterized in that, In step (1), the ratio of dried gentian root to concentrated liquid is 1~1.1g:1mL.

4. The traditional Chinese medicine composition for relieving and treating dry eye syndrome according to claim 2, characterized in that, In step (2), the mass ratio of β-cyclodextrin to maleic anhydride is 1~1.2:

1.

5. The traditional Chinese medicine composition for relieving and treating dry eye syndrome according to claim 2, characterized in that, The concentration of sodium hydroxide solution in step (3) is 0.3~0.35%.

6. The traditional Chinese medicine composition for relieving and treating dry eye syndrome according to claim 2, characterized in that, In step (3), the mass ratio of maleic acid monoester cyclodextrin to chitosan quaternary ammonium salt is 1~1.2:

1.

7. The traditional Chinese medicine composition for relieving and treating dry eye syndrome according to claim 2, characterized in that, In step (4), the mass ratio of modified cyclodextrin to gentian extract is 8-10:

1.

8. A method for preparing a traditional Chinese medicine composition for relieving and treating dry eye syndrome according to any one of claims 1 to 7, characterized in that, Includes the following steps: S1. Weigh each component according to its weight parts; S2. Take Rehmannia glutinosa, Adenophora stricta, Ophiopogon japonicus, Angelica sinensis, Lycium barbarum, Paeonia suffruticosa, Buddleja officinalis, and Melia toosendan, soak them in water for 0.5-1 hour, decoct them for 1-2 hours, filter them with non-woven gauze, and obtain the decoction. S3. Extract the residue with 75% ethanol for 1-1.5 hours, filter, and obtain the ethanol extract. S4. Combine the water decoction and alcohol extract, stir and mix evenly, remove ethanol by rotary evaporation under reduced pressure to obtain the Chinese herbal extract. S5. Mix the Chinese herbal extract and the modified gentian extract, concentrate them, add excipients, and prepare the Chinese herbal composition for relieving and treating dry eye syndrome according to conventional formulation methods.

9. The method for preparing the traditional Chinese medicine composition for relieving and treating dry eye syndrome according to claim 8, characterized in that, The traditional Chinese medicine composition for relieving and treating dry eye syndrome is a solid or liquid preparation.

10. The method for preparing the traditional Chinese medicine composition for relieving and treating dry eye syndrome according to claim 8, characterized in that, The traditional Chinese medicine composition for relieving and treating dry eye syndrome is an oral or topical preparation.