A traditional Chinese medicine composition for treating dry eye syndrome, a fumigation and washing agent, its preparation method and application

Abstract

This invention belongs to the field of traditional Chinese medicine and relates to a traditional Chinese medicine composition for treating dry eye syndrome, a fumigation and washing agent, its preparation method and application. The traditional Chinese medicine composition for treating dry eye syndrome, by weight, includes 20-30 parts of chrysanthemum extract powder, 15-20 parts of wolfberry extract powder, 12-18 parts of ophiopogon japonicus extract powder, 5-10 parts of polygonatum odoratum extract powder, 10-20 parts of angelica sinensis extract powder, 5-15 parts of astragalus membranaceus extract powder, 8-14 parts of salvia miltiorrhiza extract powder, 11-17 parts of ampelopsis japonica extract powder, and 10-15 parts of sedum sarmentosum extract powder. This invention provides a traditional Chinese medicine composition comprising dried powders of chrysanthemum extract, dried powder of wolfberry extract, dried powder of ophiopogon japonicus extract, dried powder of polygonatum odoratum extract, dried powder of angelica sinensis extract, dried powder of astragalus membranaceus extract, dried powder of salvia miltiorrhiza extract, dried powder of ampelopsis japonica extract, and dried powder of sedum sarmentosum extract. The total effective rate of this traditional Chinese medicine composition in treating dry eye syndrome can reach over 90%.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition for treating dry eye syndrome, a fumigation and washing agent, its preparation method, and its application. Background Technology

[0002] Dry eye syndrome, also known as sicca conjunctival sicca, is a common eye disease characterized by insufficient tear production, excessive evaporation, or abnormal tear composition. Symptoms of dry eye syndrome include pain, a foreign body sensation, blurred vision, and dryness. In severe cases, it can also cause burning, soreness, redness, pain, and photophobia, and may progress to corneal damage. Therefore, timely treatment is necessary to prevent corneal ulcers, perforation, or secondary infections. With changes in modern lifestyles, prolonged use of electronic screens, air pollution, and air-conditioned environments have exacerbated the incidence of dry eye syndrome.

[0003] Currently, treatments for dry eye syndrome mainly include artificial tears, oral medications, and physical therapy. Among these, artificial tears are the most commonly used method to relieve symptoms, but long-term use of artificial tears may put a certain burden on the cornea. Oral medications may have side effects, and physical therapy is inconvenient to administer.

[0004] Therefore, existing treatments for dry eye have limited effectiveness and can cause allergic reactions or other adverse side effects. Thus, there is a need for a product that can effectively treat dry eye while minimizing side effects. Summary of the Invention

[0005] (a) Technical problems to be solved

[0006] In order to address the problems of poor therapeutic effects and side effects of existing products for treating dry eye syndrome, this invention provides a traditional Chinese medicine composition for treating dry eye syndrome, a fumigation and washing agent, its preparation method, and its application.

[0007] (II) Technical Solution

[0008] To achieve the above objectives, the main technical solutions adopted by the present invention include:

[0009] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating dry eye syndrome, comprising, by weight, 20-30 parts of chrysanthemum extract powder, 15-20 parts of wolfberry extract powder, 12-18 parts of ophiopogon japonicus extract powder, 5-10 parts of polygonatum odoratum extract powder, 10-20 parts of angelica sinensis extract powder, 5-15 parts of astragalus membranaceus extract powder, 8-14 parts of salvia miltiorrhiza extract powder, 11-17 parts of ampelopsis japonica extract powder, and 10-15 parts of sedum sarmentosum extract powder.

[0010] The traditional Chinese medicine composition for treating dry eye syndrome as described above preferably comprises, by weight, 24-26 parts of chrysanthemum extract powder, 16-19 parts of wolfberry extract powder, 14-16 parts of ophiopogon japonicus extract powder, 6-9 parts of polygonatum odoratum extract powder, 12-16 parts of angelica sinensis extract powder, 8-12 parts of astragalus membranaceus extract powder, 9-13 parts of salvia miltiorrhiza extract powder, 12-16 parts of ampelopsis japonica extract powder, and 12-14 parts of sedum sarmentosum extract powder.

[0011] The traditional Chinese medicine composition for treating dry eye syndrome as described above preferably comprises, by weight, 25 parts of chrysanthemum extract powder, 18 parts of wolfberry extract powder, 15 parts of ophiopogon japonicus extract powder, 8 parts of polygonatum odoratum extract powder, 15 parts of angelica sinensis extract powder, 10 parts of astragalus membranaceus extract powder, 11 parts of salvia miltiorrhiza extract powder, 14 parts of ampelopsis japonica extract powder, and 13 parts of sedum sarmentosum extract powder.

[0012] Secondly, the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps:

[0013] A1: Prepare dry powders of chrysanthemum extract, wolfberry extract, ophiopogon japonicus extract, polygonatum odoratum extract, angelica sinensis extract, astragalus membranaceus extract, salvia miltiorrhiza extract, ampelopsis japonica extract, and sedum sarmentosum extract respectively.

[0014] A2: Mix the various extract powders obtained in step A1 to obtain a traditional Chinese medicine composition.

[0015] The preparation method of the traditional Chinese medicine composition as described above, preferably, involves preparing the various extract powders in step A1 by the following method:

[0016] A11: Chrysanthemum, wolfberry, ophiopogon japonicus, polygonatum odoratum, angelica sinensis, astragalus membranaceus, salvia miltiorrhiza, ampelopsis japonica, and sedum sarmentosum are pulverized to obtain different medicinal powders;

[0017] A12: The above-mentioned medicinal powders are subjected to cell wall breaking treatment, and then water or ethanol is added to the various medicinal materials after cell wall breaking treatment, and pressure extraction treatment is carried out. Then the mixture is filtered to obtain different medicinal solutions.

[0018] A13: The above-mentioned medicinal liquids were concentrated under reduced pressure to obtain different concentrated liquids. Then, the above-mentioned concentrated liquids were spray-dried and then pulverized to obtain chrysanthemum extract powder, wolfberry extract powder, ophiopogon japonicus extract powder, polygonatum odoratum extract powder, angelica extract powder, astragalus extract powder, salvia miltiorrhiza extract powder, ampelopsis japonica extract powder and sedum sarmentosum extract powder.

[0019] In the preparation method of the traditional Chinese medicine composition as described above, preferably, in step A11, chrysanthemum, wolfberry, ophiopogon japonicus, polygonatum odoratum, angelica sinensis, astragalus membranaceus, salvia miltiorrhiza, ampelopsis japonica and sedum sarmentosum are pulverized to 80-120 mesh respectively.

[0020] In step A12, the volume of water or ethanol solution is 4-8 times the volume of the drug powder, the volume concentration of ethanol used is 50-95%, the pressure of the pressure extraction treatment is 0.3-0.5 MPa, and the pressure extraction treatment time is 2-4 hours.

[0021] Thirdly, the present invention provides a fumigation and washing agent for treating dry eye syndrome, comprising the above-mentioned traditional Chinese medicine composition.

[0022] Fourthly, the present invention provides a method for preparing the above-mentioned fumigation and washing agent for treating dry eye syndrome, comprising the following steps:

[0023] S1: Mix 20-30 parts of chrysanthemum extract powder, 15-20 parts of wolfberry extract powder, 12-18 parts of ophiopogon japonicus extract powder, 5-10 parts of polygonatum odoratum extract powder, 10-20 parts of angelica sinensis extract powder, 5-15 parts of astragalus membranaceus extract powder, 8-14 parts of salvia miltiorrhiza extract powder, 11-17 parts of ampelopsis japonica extract powder, and 10-15 parts of sedum sarmentosum extract powder evenly to obtain a traditional Chinese medicine composition.

[0024] S2: The traditional Chinese medicine composition is sterilized, then sterile water is added and heated to obtain a fumigation agent.

[0025] In the preparation method of the fumigation and washing agent for treating dry eye syndrome as described above, preferably, in step S2, the mass ratio of the traditional Chinese medicine composition to sterile water is 1:20-1:50.

[0026] Fifthly, the present invention also provides the application of the above-mentioned traditional Chinese medicine composition or the traditional Chinese medicine composition prepared by the above-mentioned preparation method in eye patches, eye ointments and atomizing liquids.

[0027] (III) Beneficial Effects

[0028] This invention provides a traditional Chinese medicine composition comprising dried powders of chrysanthemum extract, wolfberry extract, ophiopogon japonicus extract, polygonatum odoratum extract, angelica sinensis extract, astragalus membranaceus extract, salvia miltiorrhiza extract, ampelopsis japonica extract, and sedum sarmentosum extract. This composition exhibits significant efficacy in treating dry eye syndrome. Clinical trials have shown that the overall effective rate of this composition in treating dry eye syndrome can reach over 90%. The dosage of this composition is scientifically reasonable, with low adverse reactions, and the recurrence rate of dry eye syndrome treated with this composition is significantly reduced. Attached Figure Description

[0029] Figure 1This is a statistical chart showing the average tear secretion of mice in the blank control group, negative control group, and experimental groups 1-8 after 14 days of drug administration.

[0030] Figure 2 Statistical chart of corneal staining scores of mice in the blank control group, negative control group and experimental groups 1-8 14 days after drug administration. Detailed Implementation

[0031] To better explain and facilitate understanding of the present invention, the present invention will be described in detail below with reference to specific embodiments.

[0032] This invention provides a traditional Chinese medicine composition for treating dry eye syndrome. By weight, the composition comprises 20-30 parts of chrysanthemum extract powder, 15-20 parts of wolfberry extract powder, 12-18 parts of ophiopogon japonicus extract powder, 5-10 parts of polygonatum odoratum extract powder, 10-20 parts of angelica sinensis extract powder, 5-15 parts of astragalus membranaceus extract powder, 8-14 parts of salvia miltiorrhiza extract powder, 11-17 parts of ampelopsis japonica extract powder, and 10-15 parts of sedum sarmentosum extract powder.

[0033] Preferably, the traditional Chinese medicine composition of the present invention comprises, by weight, 24-26 parts of chrysanthemum extract powder, 16-19 parts of wolfberry extract powder, 14-16 parts of ophiopogon japonicus extract powder, 6-9 parts of polygonatum odoratum extract powder, 12-16 parts of angelica sinensis extract powder, 8-12 parts of astragalus membranaceus extract powder, 9-13 parts of salvia miltiorrhiza extract powder, 12-16 parts of ampelopsis japonica extract powder, and 12-14 parts of sedum sarmentosum extract powder.

[0034] More preferably, the traditional Chinese medicine composition of the present invention comprises, by weight, 25 parts of chrysanthemum extract powder, 18 parts of wolfberry extract powder, 15 parts of ophiopogon japonicus extract powder, 8 parts of polygonatum odoratum extract powder, 15 parts of angelica sinensis extract powder, 10 parts of astragalus membranaceus extract powder, 11 parts of salvia miltiorrhiza extract powder, 14 parts of ampelopsis japonica extract powder, and 13 parts of sedum sarmentosum extract powder.

[0035] Dry eye syndrome is mainly caused by insufficient tear secretion, excessive evaporation, or abnormal tear composition. The therapeutic principle of the traditional Chinese medicine composition of this invention for dry eye syndrome includes clearing the liver and improving vision, nourishing yin and promoting fluid production, replenishing qi and blood, nourishing blood and promoting blood circulation, and clearing heat and promoting diuresis. Specifically, the dried powders of chrysanthemum extract and wolfberry extract in the traditional Chinese medicine composition of this invention mainly have the effect of clearing the liver and improving vision; the dried powders of ophiopogon japonicus extract and polygonatum odoratum extract mainly have the effect of nourishing yin and promoting fluid production, which can replenish the body's yin fluid, increase tear secretion, and relieve dry eyes; the dried powders of angelica sinensis extract and astragalus membranaceus extract mainly have the effect of replenishing qi and blood, which can improve the body's qi and blood status, thereby nourishing the eyes; the dried powder of salvia miltiorrhiza extract mainly has the effect of nourishing blood and promoting blood circulation, which can improve blood circulation in the eyes, enhance the nutritional supply to the eyes, and reduce eye fatigue; and the dried powders of white peony root extract and sedum sarmentosum extract mainly have the effect of clearing heat and promoting diuresis, which can clear damp heat in the body, reduce inflammatory reactions, and improve the eye environment. In addition, the combination of chrysanthemum and wolfberry has significant neurotrophic activity.

[0036] The above describes the main effects of each component. The detailed pharmacological effects of each raw material component are as follows:

[0037] Chrysanthemum: Its flavor is pungent, sweet, and bitter; it is slightly cold in nature and enters the lung and liver meridians. It has the effects of dispersing wind-heat, clearing heat and detoxifying, and calming the liver and improving eyesight. Modern pharmacological studies have shown that chrysanthemum has a protective function for the liver, exhibits strong antioxidant activity, and can inhibit inflammatory responses and alleviate inflammatory symptoms. The vitamin A and β-carotene contained in chrysanthemum have a positive effect on protecting vision and improving eyesight.

[0038] Goji berries: Sweet and neutral in nature, they enter the liver and kidney meridians. Goji berries nourish the liver and kidneys, benefit essence and improve eyesight, and strengthen muscles and bones. Modern pharmacological studies have shown that goji berries are rich in antioxidants, such as beta-carotene, vitamin C, and vitamin E. These components can resist free radical damage and have anti-inflammatory, nerve-protective, liver-protective, and eye-protective effects, which are very beneficial to the health of the liver and eyes.

[0039] Ophiopogon japonicus: Sweet and slightly bitter in taste, cold in nature, and enters the heart, lung, and stomach meridians. Ophiopogon japonicus nourishes yin and moistens the lungs, benefits the stomach and promotes the production of body fluids, and clears the heart and relieves irritability. Modern pharmacological studies have shown that Ophiopogon japonicus exerts its anti-inflammatory effect by controlling the production of pro-inflammatory factors such as NO and TNF-α. The main active ingredient of Ophiopogon japonicus—steroidal saponins—has the properties of scavenging free radicals in the body, anti-oxidation, and has a protective effect on the liver.

[0040] Polygonatum odoratum: Sweet and slightly cold in nature, it enters the lung and stomach meridians. Polygonatum odoratum has the effects of promoting body fluid production and moistening the lungs, nourishing yin and stomach, and tonifying the kidneys. Its effects are mild and not greasy or astringent. Modern pharmacological studies have shown that Polygonatum odoratum has significant antioxidant activity, mainly based on Polygonatum odoratum polysaccharides and Polygonatum odoratum flavonoids. The active ingredients in Polygonatum odoratum, such as Polygonatum odoratum polysaccharides and saponins, can enhance the body's immune function and protect liver cells from damage.

[0041] Angelica sinensis: It is sweet, pungent in flavor and warm in nature, and belongs to the liver, heart and spleen meridians. Angelica sinensis has the effects of enriching blood and promoting blood circulation, regulating menstruation and relieving pain, and moistening the intestines and relaxing bowel movements. Modern pharmacological research shows that Angelica sinensis has the functions of enhancing and regulating immune function, antioxidation and anti-inflammation, can promote blood circulation and improve blood fluidity, and also has a certain antibacterial effect.

[0042] Astragalus membranaceus: It is sweet in flavor and slightly warm in nature, and belongs to the lung and spleen meridians. Astragalus membranaceus has the effects of replenishing qi and lifting yang, strengthening the superficial resistance to stop sweating, promoting diuresis to alleviate edema, promoting the production of body fluid and nourishing blood, expelling pus and toxin by supporting healthy qi, and promoting granulation for sore healing. Modern pharmacological research shows that Astragalus membranaceus has the effects of enhancing the body's immunity, antioxidation and relieving fatigue.

[0043] Salvia miltiorrhiza: It is bitter in flavor and slightly cold in nature, and belongs to the heart and liver meridians. Salvia miltiorrhiza has the effects of promoting blood circulation to remove blood stasis, clearing the heart and relieving restlessness, and calming the mind. Modern pharmacological research finds that Salvia miltiorrhiza has a certain antibacterial effect, can reduce inflammation, and has the ability to scavenge free radicals.

[0044] Ampelopsis japonica: It is bitter in flavor and slightly cold in nature, and belongs to the heart and stomach meridians. Ampelopsis japonica has the effects of clearing heat and detoxifying, dissipating swelling and carbuncles, and promoting granulation for sore healing. Modern pharmacological research shows that Ampelopsis japonica has the function of regulating immune activity, can protect liver cells, promote the regeneration of liver cells, and improve liver function.

[0045] Sedum sarmentosum: It is sweet, light in flavor and cool in nature, and has the effects of clearing heat and promoting diuresis, and detoxifying and detumescence. Modern pharmacological research shows that the flavonoid components in Sedum sarmentosum are its main chemical components, can significantly reduce the levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in the body, are the main active components for reducing enzyme and protecting the liver, repairing damaged liver cells and anti-inflammation, and have an obvious protective effect on the liver.

[0046] The present invention also provides a preparation method of the above traditional Chinese medicine composition, which includes the following steps:

[0047] A1: Respectively prepare dry powder of chrysanthemum extract, dry powder of wolfberry extract, dry powder of ophiopogon extract, dry powder of polygonatum odoratum extract, dry powder of angelica sinensis extract, dry powder of astragalus membranaceus extract, dry powder of salvia miltiorrhiza extract, dry powder of ampelopsis japonica extract and dry powder of sedum sarmentosum extract.

[0048] A2: Mix the various dry powders of extracts prepared in step A1 according to the ratio of 20 - 30 parts of dry powder of chrysanthemum extract, 15 - 20 parts of dry powder of wolfberry extract, 12 - 18 parts of dry powder of ophiopogon extract, 5 - 10 parts of dry powder of polygonatum odoratum extract, 10 - 20 parts of dry powder of angelica sinensis extract, 5 - 15 parts of dry powder of astragalus membranaceus extract, 8 - 14 parts of dry powder of salvia miltiorrhiza extract, 11 - 17 parts of dry powder of ampelopsis japonica extract, and 10 - 15 parts of dry powder of sedum sarmentosum extract to obtain the traditional Chinese medicine composition.

[0049] The preparation methods of the above various traditional Chinese medicine extract dry powders are as follows:

[0050] A11: Chrysanthemum, wolfberry, ophiopogon japonicus, polygonatum odoratum, angelica sinensis, astragalus membranaceus, salvia miltiorrhiza, ampelopsis japonica, and sedum sarmentosum are pulverized to 80-120 mesh to obtain different medicinal powders.

[0051] A12: The various medicinal powders described above are subjected to cell wall disruption treatment. Then, water or ethanol is added to each of the disrupted medicinal materials, and pressure extraction is performed. The mixture is then filtered to obtain different medicinal solutions. Preferably, in this step, the volume of the water or ethanol solution is 4-8 times the volume of the medicinal powder, the volume concentration of the ethanol used is 50-95%, the pressure of the pressure extraction is 0.3-0.5 MPa, and the pressure extraction time is 2-4 hours. More preferably, the pressure extraction can be performed 2-3 times, and the pressure extraction temperature can be 50-70℃.

[0052] A13: The above-mentioned medicinal liquids were concentrated under reduced pressure to obtain different concentrated liquids. Then, the above-mentioned concentrated liquids were spray-dried at a temperature of 50-60℃. After that, they were pulverized to obtain chrysanthemum extract powder, wolfberry extract powder, ophiopogon japonicus extract powder, polygonatum odoratum extract powder, angelica extract powder, astragalus extract powder, salvia miltiorrhiza extract powder, ampelopsis japonica extract powder, and sedum sarmentosum extract powder.

[0053] The present invention also provides a fumigation and washing agent comprising the above-mentioned traditional Chinese medicine composition, which can also be used to treat dry eye syndrome.

[0054] The fumigation and washing agent avoids the drawback of traditional Chinese medicine being too bitter to swallow, and it can act directly on the eyes. Furthermore, the fumigation itself can enhance the efficacy of the medicine and increase blood circulation. When using the fumigation and washing agent of this invention to treat dry eye syndrome, the recurrence rate after treatment is lower compared to existing technologies that treat dry eye syndrome with antibiotics or lacrimal gland-stimulating drugs.

[0055] Specifically, the preparation method of the above-mentioned fumigation and washing agent for treating dry eye syndrome includes the following steps:

[0056] S1: Mix 20-30 parts of chrysanthemum extract powder, 15-20 parts of wolfberry extract powder, 12-18 parts of ophiopogon japonicus extract powder, 5-10 parts of polygonatum odoratum extract powder, 10-20 parts of angelica sinensis extract powder, 5-15 parts of astragalus membranaceus extract powder, 8-14 parts of salvia miltiorrhiza extract powder, 11-17 parts of ampelopsis japonica extract powder, and 10-15 parts of sedum sarmentosum extract powder evenly to obtain a traditional Chinese medicine composition.

[0057] S2: The traditional Chinese medicine composition is sterilized, specifically by gamma ray sterilization or electron beam sterilization. Then, sterile water is added to make the mass ratio of the traditional Chinese medicine composition to sterile water 1:20-1:50. The mixed solution is then heated to 40-45℃ to obtain the fumigation agent.

[0058] In addition to fumigation agents, the traditional Chinese medicine composition of the present invention can also be used as a main ingredient in eye patches, atomizing liquids, and eye ointments.

[0059] To further clarify the present invention and its technological advancements, the following description is provided in conjunction with specific embodiments and technical effects.

[0060] Example 1

[0061] This embodiment provides a fumigation and washing agent for treating dry eye syndrome, comprising a traditional Chinese medicine composition and sterile water. The traditional Chinese medicine composition, by weight, comprises 25 parts of chrysanthemum extract powder, 18 parts of wolfberry extract powder, 15 parts of ophiopogon japonicus extract powder, 8 parts of polygonatum odoratum extract powder, 15 parts of angelica sinensis extract powder, 10 parts of astragalus membranaceus extract powder, 11 parts of salvia miltiorrhiza extract powder, 14 parts of ampelopsis japonica extract powder, and 13 parts of sedum sarmentosum extract powder.

[0062] The preparation method of the fumigation agent is as follows:

[0063] S1: Weigh the dry powder of the extracts of the above components, mix them evenly, and obtain the traditional Chinese medicine composition.

[0064] S2: The traditional Chinese medicine composition is sterilized by gamma rays, and then sterile water is added. The mass ratio of the traditional Chinese medicine composition to sterile water is 1:40. The mixed solution is then heated to 42°C to obtain a fumigation agent.

[0065] Example 2

[0066] This embodiment provides a fumigation and washing agent for treating dry eye syndrome, comprising a traditional Chinese medicine composition and sterile water. The traditional Chinese medicine composition, by weight, comprises 30 parts of chrysanthemum extract powder, 20 parts of wolfberry extract powder, 18 parts of ophiopogon japonicus extract powder, 10 parts of polygonatum odoratum extract powder, 20 parts of angelica sinensis extract powder, 15 parts of astragalus membranaceus extract powder, 14 parts of salvia miltiorrhiza extract powder, 17 parts of ampelopsis japonica extract powder, and 15 parts of sedum sarmentosum extract powder.

[0067] The preparation method of the fumigation agent is as follows:

[0068] S1: Weigh the dry powder of the extracts of the above components, mix them evenly, and obtain the traditional Chinese medicine composition.

[0069] S2: The traditional Chinese medicine composition is subjected to electron beam sterilization, and then sterile water is added. The mass ratio of the traditional Chinese medicine composition to sterile water is 1:50. The mixed solution is then heated to 45°C to obtain a fumigation agent.

[0070] Example 3

[0071] This embodiment provides a fumigation and washing agent for treating dry eye syndrome, comprising a traditional Chinese medicine composition and sterile water. The traditional Chinese medicine composition, by weight, comprises 24 parts of chrysanthemum extract powder, 16 parts of wolfberry extract powder, 14 parts of ophiopogon japonicus extract powder, 6 parts of polygonatum odoratum extract powder, 12 parts of angelica sinensis extract powder, 8 parts of astragalus membranaceus extract powder, 9 parts of salvia miltiorrhiza extract powder, 12 parts of ampelopsis japonica extract powder, and 12 parts of sedum sarmentosum extract powder.

[0072] The preparation method of the fumigation agent is as follows:

[0073] S1: Weigh the dry powder of the extracts of the above components, mix them evenly, and obtain the traditional Chinese medicine composition.

[0074] S2: The traditional Chinese medicine composition is subjected to electron beam sterilization, and then sterile water is added. The mass ratio of the traditional Chinese medicine composition to sterile water is 1:30. The mixed solution is then heated to 41°C to obtain a fumigation agent.

[0075] Example 4

[0076] This embodiment provides a fumigation and washing agent for treating dry eye syndrome, comprising a traditional Chinese medicine composition and sterile water. The traditional Chinese medicine composition, by weight, comprises 26 parts of chrysanthemum extract powder, 19 parts of wolfberry extract powder, 16 parts of ophiopogon japonicus extract powder, 9 parts of polygonatum odoratum extract powder, 16 parts of angelica sinensis extract powder, 12 parts of astragalus membranaceus extract powder, 13 parts of salvia miltiorrhiza extract powder, 16 parts of ampelopsis japonica extract powder, and 14 parts of sedum sarmentosum extract powder.

[0077] The preparation method of the fumigation agent is as follows:

[0078] S1: Weigh the dry powder of the extracts of the above components, mix them evenly, and obtain the traditional Chinese medicine composition.

[0079] S2: The traditional Chinese medicine composition is sterilized by gamma rays, and then sterile water is added. The mass ratio of the traditional Chinese medicine composition to the sterile water is 1:35. The mixed solution is then heated to 43°C to obtain a fumigation agent.

[0080] Example 5

[0081] This embodiment provides a fumigation and washing agent for treating dry eye syndrome, comprising a traditional Chinese medicine composition and sterile water. The traditional Chinese medicine composition, by weight, comprises 20 parts of chrysanthemum extract powder, 15 parts of wolfberry extract powder, 12 parts of ophiopogon japonicus extract powder, 5 parts of polygonatum odoratum extract powder, 10 parts of angelica sinensis extract powder, 5 parts of astragalus membranaceus extract powder, 8 parts of salvia miltiorrhiza extract powder, 11 parts of ampelopsis japonica extract powder, and 10 parts of sedum sarmentosum extract powder.

[0082] The preparation method of the fumigation agent is as follows:

[0083] S1: Weigh the dry powder of the extracts of the above components, mix them evenly, and obtain the traditional Chinese medicine composition.

[0084] S2: The traditional Chinese medicine composition is subjected to electron beam sterilization, and then sterile water is added. The mass ratio of the traditional Chinese medicine composition to sterile water is 1:20. The mixed solution is then heated to 40°C to obtain a fumigation agent.

[0085] Comparative Example 1

[0086] This comparative example provides a fumigation and washing agent for treating dry eye syndrome. The difference from Example 1 is that the proportion of dried powder of Ampelopsis japonica extract in the traditional Chinese medicine composition is 0.

[0087] Comparative Example 2

[0088] This comparative example provides a fumigation and washing agent for treating dry eye syndrome. The difference from Example 1 is that the proportion of dried powder of Sedum sarmentosum extract in the traditional Chinese medicine composition is 0.

[0089] Comparative Example 3

[0090] This comparative example provides a fumigation and washing agent for treating dry eye syndrome. The difference from Example 1 is that the proportions of dried powder of Ampelopsis japonica extract and dried powder of Sedum sarmentosum extract in the traditional Chinese medicine composition are both 0.

[0091] The effects of the traditional Chinese medicine compositions prepared in Examples 1-5 and Comparative Examples 1-3 on dry eye syndrome in mice were investigated. The specific details are as follows:

[0092] Healthy 8-week-old BALB / c mice, half male and half female, were selected. Before the experiment, mice with abnormal fluorescence staining and significant differences in tear secretion between the two eyes were excluded by bilateral corneal fluorescence staining scores and tear secretion measurements.

[0093] Mice were randomly divided into four groups: a blank control group, a negative control group, experimental group 1, experimental group 2, experimental group 3, experimental group 4, experimental group 5, experimental group 6, experimental group 7, and experimental group 8. Each group contained 8 mice, and each group had 16 eyes. The corneal staining score and tear secretion volume were calculated using the average value of the number of eyes.

[0094] Mice in the blank control group were fed normally without any treatment. A 1 mg / ml benzalkonium chloride solution was applied to both eyes of mice in the negative control group and experimental groups 1-8, three times a day for 14 consecutive days. After each instillation, the mouse's eyelids were closed for approximately 90 seconds.

[0095] After establishing the dry eye model, eye drops made from the traditional Chinese medicine compositions prepared in Examples 1-5 and Comparative Examples 1-3 were instilled into the eyes of mice in Experimental Groups 1-8, respectively, five times a day for 14 consecutive days. An equal volume of physiological saline was instilled into the eyes of mice in the blank control group and the negative control group daily.

[0096] The phenol red cotton thread test was used to measure the average tear secretion of mice in each group after successful modeling, and the tear secretion 14 days after drug administration. Specifically, the phenol red cotton thread was placed on the conjunctiva of the lower eyelid of the mouse at one-third of the distance from the outer corner of the eye. After 60 seconds, it was removed, and the wet length of the phenol red cotton thread (mm) was measured. The results are shown in Table 1 (average tear secretion after modeling, unit: mm). Figure 1 (Mean tear secretion after 14 days of administration, unit: mm, where AJ group corresponds to blank control group, negative control group, experimental group 1, experimental group 2, experimental group 3, experimental group 4, experimental group 5, experimental group 6, experimental group 7 and experimental group 8 respectively), the tear secretion in Table 1 is the mean ± standard deviation.

[0097] Table 1. Statistical table of average tear secretion in mice in the blank control group, negative control group, and experimental groups 1-8.

[0098]

[0099]

[0100] Figure 1 In the diagram, the same letters (abc) indicate no statistical difference between the corresponding groups (P>0.05), while different letters indicate a statistical difference between the corresponding groups (P<0.05).

[0101] Through Table 1 and Figure 1 It was found that the mice in the blank control group, without modeling or drug administration, maintained their average tear secretion within the normal range. After modeling, the average tear secretion of mice in the negative control group and experimental groups 1-8 decreased significantly. Under the condition of only instilling physiological saline, the average tear secretion of mice in the negative control group did not improve. After 14 days of drug administration, the average tear secretion of mice in experimental groups 1-5 returned to normal levels, greater than 5 mm / 1 min. The average tear secretion of mice in experimental groups 6-8 improved, but still did not reach 5 mm / 1 min, with the improvement in average tear secretion in experimental groups 6 and 7 being slightly greater than that in experimental group 8.

[0102] After the dry eye model was established (day 0 of successful modeling) and 14 days after drug administration, mice in the blank control group, negative control group, and experimental groups 1-8 were stained with 0.25 wt% sodium fluorescein solution. The 0.25 wt% sodium fluorescein solution was left on the ocular surface of each group of mice for 10 seconds, and then the excess dye was rinsed off with 0.9 wt% sodium chloride solution. The ocular surface was dried with cotton swabs, and the eyes of each group of mice were exposed for observation under a slit lamp. The images were taken at magnification, and the staining of the cornea of ​​each group of mice with sodium fluorescein solution was recorded.

[0103] The mouse cornea was divided into four quadrants: superior temporal, inferior temporal, superior nasal, and inferior nasal. Each quadrant was scored from 0 to 3 points. The scoring criteria were: no staining (0 points); 1-30 punctate stains (mild) (1 point); more than 30 punctate stains but not fused (moderate) (2 points); fused punctate stains, filamentous structures, and ulcers (severe) (3 points). Each corneal score was the sum of the scores from all four quadrants. The scoring results are shown in Table 2 (corneal staining scores after establishing the dry eye model). Figure 2 (Corneal staining scores 14 days after drug administration, with AJ group corresponding to blank control group, negative control group, experimental group 1, experimental group 2, experimental group 3, experimental group 4, experimental group 5, experimental group 6, experimental group 7 and experimental group 8 respectively). Corneal staining scores in Table 2 are mean ± standard deviation.

[0104] Table 2. Statistical table of corneal staining scores in blank group, negative control group, and experimental groups 1-8.

[0105]

[0106] Table 2 shows the rules for corneal staining scoring as follows: no staining is 0 points, 1-30 punctate stains (mild) is 1 point, more than 30 punctate stains but not fused (moderate) is 2 points, and fused punctate stains, filaments, and ulcers (severe) are 3 points. Specifically, a lower corneal score indicates a higher degree of corneal epithelial repair and better eye recovery in mice, while a higher score indicates more severe corneal damage. Figure 2 In the diagram, the same letters (abc) indicate no statistical difference between the corresponding groups (P>0.05), while different letters indicate a statistical difference between the corresponding groups (P<0.05).

[0107] Through Table 2 and Figure 2 It can be seen that the mice in the blank control group, without modeling or drug administration, maintained normal corneal function. In the negative control group and experimental groups 1-8, the corneal epithelial staining area significantly increased after modeling. After 14 days of drug administration, the corneal epithelial staining area in experimental groups 1-5 significantly decreased, showing a higher degree of recovery. The degree of corneal epithelial staining area repair in experimental groups 6-8 was significantly lower than that in experimental groups 1-5.

[0108] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A traditional Chinese medicine composition for treating dry eye, characterized in that, The product is made from 20-30 parts by weight of chrysanthemum extract powder, 15-20 parts of wolfberry extract powder, 12-18 parts of ophiopogon japonicus extract powder, 5-10 parts of polygonatum odoratum extract powder, 10-20 parts of angelica sinensis extract powder, 5-15 parts of astragalus membranaceus extract powder, 8-14 parts of salvia miltiorrhiza extract powder, 11-17 parts of ampelopsis japonica extract powder, and 10-15 parts of sedum sarmentosum extract powder.

2. The traditional Chinese medicine composition for treating dry eye according to claim 1, characterized in that, Based on weight, it is made from 24-26 parts of chrysanthemum extract powder, 16-19 parts of wolfberry extract powder, 14-16 parts of ophiopogon japonicus extract powder, 6-9 parts of polygonatum odoratum extract powder, 12-16 parts of angelica sinensis extract powder, 8-12 parts of astragalus membranaceus extract powder, 9-13 parts of salvia miltiorrhiza extract powder, 12-16 parts of ampelopsis japonica extract powder, and 12-14 parts of sedum sarmentosum extract powder. 3.The traditional Chinese medicine composition for treating dry eye according to claim 1, characterized in that, The product is made from 25 parts by weight of chrysanthemum extract powder, 18 parts of wolfberry extract powder, 15 parts of ophiopogon japonicus extract powder, 8 parts of polygonatum odoratum extract powder, 15 parts of angelica sinensis extract powder, 10 parts of astragalus membranaceus extract powder, 11 parts of salvia miltiorrhiza extract powder, 14 parts of ampelopsis japonica extract powder, and 13 parts of sedum sarmentosum extract powder.

4. A method for preparing the traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, Includes the following steps: A1: Prepare dry powders of chrysanthemum extract, wolfberry extract, ophiopogon japonicus extract, polygonatum odoratum extract, angelica sinensis extract, astragalus membranaceus extract, salvia miltiorrhiza extract, ampelopsis japonica extract, and sedum sarmentosum extract respectively. A2: Mix the various extract powders obtained in step A1 to obtain a traditional Chinese medicine composition.

5. The preparation method of the traditional Chinese medicine composition according to claim 4, characterized in that, The various extract powders in step A1 were prepared by the following method: A11: Chrysanthemum, wolfberry, ophiopogon japonicus, polygonatum odoratum, angelica sinensis, astragalus membranaceus, salvia miltiorrhiza, ampelopsis japonica, and sedum sarmentosum are pulverized to obtain different medicinal powders; A12: The above-mentioned medicinal powders are subjected to cell wall breaking treatment, and then water or ethanol is added to the various medicinal materials after cell wall breaking treatment, and pressure extraction treatment is carried out. Then the mixture is filtered to obtain different medicinal solutions. A13: The above-mentioned medicinal liquids were concentrated under reduced pressure to obtain different concentrated liquids. Then, the above-mentioned concentrated liquids were spray-dried and then pulverized to obtain chrysanthemum extract powder, wolfberry extract powder, ophiopogon japonicus extract powder, polygonatum odoratum extract powder, angelica extract powder, astragalus extract powder, salvia miltiorrhiza extract powder, ampelopsis japonica extract powder and sedum sarmentosum extract powder.

6. The preparation method of the traditional Chinese medicine composition according to claim 5, characterized in that, In step A11, chrysanthemum, wolfberry, ophiopogon japonicus, polygonatum odoratum, angelica sinensis, astragalus membranaceus, salvia miltiorrhiza, ampelopsis japonica, and sedum sarmentosum are pulverized to 80-120 mesh respectively; In step A12, the volume of water or ethanol solution is 4-8 times the volume of the drug powder, the volume concentration of ethanol used is 50-95%, the pressure of the pressure extraction treatment is 0.3-0.5 MPa, and the pressure extraction treatment time is 2-4 hours.

7. A fumigating agent for treating dry eye, characterized by comprising: Includes the traditional Chinese medicine composition according to any one of claims 1-3.

8. A method of preparing the fumigating agent for treating dry eye of claim 7, characterized by, Includes the following steps: S1: Mix 20-30 parts of chrysanthemum extract powder, 15-20 parts of wolfberry extract powder, 12-18 parts of ophiopogon japonicus extract powder, 5-10 parts of polygonatum odoratum extract powder, 10-20 parts of angelica sinensis extract powder, 5-15 parts of astragalus membranaceus extract powder, 8-14 parts of salvia miltiorrhiza extract powder, 11-17 parts of ampelopsis japonica extract powder, and 10-15 parts of sedum sarmentosum extract powder evenly to obtain a traditional Chinese medicine composition. S2: The traditional Chinese medicine composition is sterilized, then sterile water is added and heated to obtain a fumigation agent.

9. The method for preparing the fumigation and washing agent for treating dry eye syndrome according to claim 8, characterized in that, In step S2, the mass ratio of the traditional Chinese medicine composition to sterile water is 1:20-1:

50.

10. The use of a traditional Chinese medicine composition according to any one of claims 1-3 or a traditional Chinese medicine composition prepared by any one of claims 4-6 in the preparation of eye patches, eye ointments and nebulizers for treating dry eye syndrome.

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