Use of black roselle and the ferment thereof in prevention and treatment of dry eye

Abstract

The present invention relates to a use of black Roselle and its ferment in preparing a composition for the prevention and treatment of dry eye syndrome. The composition comprising black Roselle (as dried calyx powder or fermentedbroth) is used to alleviate symptoms of dry eye syndrome by the effects on promoting tear production, repairing corneal epithelial cell damage, ameliorating degeneration and apoptosis of lacrimal vesicle cell, and / or maintaining secretory functions of lacrimal gland.

Description

[Technical Field]

[0001] This invention relates to the use of a composition comprising black hibiscus calyx powder and / or its fermentation liquid for the prevention and treatment of dry eye syndrome. More particularly, this invention relates to the preparation of a composition using black hibiscus calyx powder or its fermentation liquid that promotes tear secretion, maintains the quality and stability of the tear film, repairs corneal epithelial cell damage, and / or improves dryness and discomfort caused by wearing contact lenses. [Previous Technology]

[0002] In a normal person's eye, a thin tear film covers the cornea and conjunctiva. This tear film consists of three layers: an oily layer, an aqueous layer, and a mucin layer. If any of these three layers malfunctions, insufficient tear secretion or uneven tear distribution can lead to dry eye syndrome. Dry eye syndrome (DES), also known as keratoconjunctivitis sicca (KCS), is a very common condition seen in ophthalmology clinics. Symptoms include eye allergies, bloodshot eyes, excessive eye discharge, and eye fatigue; blurred vision may also occur. Dry eye syndrome is a multifactorial disease, primarily caused by insufficient tear secretion, uneven tear distribution, or excessive tear evaporation, resulting in inadequate lubrication of the eyeball. Modern lifestyles, with prolonged exposure to dry, air-conditioned rooms and long hours staring at computer screens, are contributing to an increasing number of people experiencing dry eyes, and the age of onset is decreasing, making it a common modern ailment. Contact lenses are another culprit. Soft contact lenses are more serious than hard ones because soft lenses are larger and cover the entire iris, making the corneal nerves less sensitive and unable to secrete tears through normal reflex stimulation. This naturally causes dryness, discomfort, and peripheral vascular problems in the eyes.

[0003] The treatment of dry eye syndrome mainly focuses on alleviating the symptoms of dry eye, preventing corneal damage, and maintaining a smooth and clear surface of the eyeball. While artificial tears are a common treatment for dry eye syndrome, some artificial tears contain artificial preservatives to prolong their shelf life, and these ingredients can actually cause toxic damage to the eyes. The development of dry eye syndrome is closely related to daily eye habits. Preventing dry eye requires proper daily care. Doctors recommend that patients with dry eye syndrome maintain a regular sleep schedule, get enough sleep, avoid staying up late, and avoid prolonged excessive eye strain to allow the eyes to rest fully.

[0004] Hibiscus sabdariffa Linn., also known as roselle, is a species of the genus Hibiscus in the Malvaceae family. To increase the anthocyanin content of roselle, the Taitung District Agricultural Research and Extension Station of the Council of Agriculture, Executive Yuan (hereinafter referred to as Taitung Station) conducted nine years of breeding research and developed a new high-anthocyanin variety, "Taitung No. 6 - Black Crystal" (hereinafter referred to as Black Roselle). It was named on November 29, 2021, and obtained variety rights on August 29, 2022 (certificate number: A02915). The Black Roselle variety is characterized by its tightly packed calyxes (also known as flower calyxes) at the branch tips, with relatively uniform maturity, making it suitable for harvesting in clusters at once, significantly improving harvesting efficiency. It is also highly productive, yielding up to 1,200 kg of dried calyxes per hectare. Furthermore, the deep purple calyxes are rich in anthocyanins, with a dried calyx content as high as 30.6 mg / g, which is beneficial for the high-value application of roselle in the industry. Processing tests have shown that 60℃ hot air drying and freeze-drying methods are most suitable for producing high-performance raw materials, preserving a full range of functional components such as total anthocyanins, total polyphenols, flavonoids, and gallic acid.

[0005] Therefore, the present invention first attempts to apply black roselle calyx powder and its fermentation liquid to the prevention and treatment of dry eye syndrome. Through a series of experiments, it has been proven that black roselle calyx powder and its fermentation liquid can effectively improve dry eye syndrome caused by insufficient tear secretion or excessive tear evaporation, including increasing tear secretion, increasing tear film stability, reducing lacrimal gland cell degeneration and damage, and reducing dry eye-induced corneal damage. It can also improve ocular surface allergies, irritation reactions and peripheral vascular problems caused by wearing contact lenses, reduce tear lake height (TMH) loss and dryness and discomfort when wearing contact lenses, and increase the comfort of wearing contact lenses. [Summary of the Invention]

[0006] One aspect of the present invention relates to the use of black roselle calyx powder and its fermentation liquid in the manufacture of a composition for the prevention and / or treatment of dry eye syndrome. In some embodiments of the present invention, the composition is a health food composition. Furthermore, in some embodiments of the present invention, the composition is a pharmaceutical composition.

[0007] In one specific embodiment of the present invention, the black hibiscus calyx powder and its fermentation liquid are used to manufacture a composition for preventing and / or treating dry eye syndrome caused by insufficient tear secretion. In a preferred embodiment of the present invention, the black hibiscus calyx powder and its fermentation liquid are used to promote tear secretion. In a preferred embodiment of the present invention, the black hibiscus calyx powder and its fermentation liquid are used to slow down apoptosis of lacrimal gland acinar cells. In a preferred embodiment of the present invention, the black hibiscus calyx powder and its fermentation liquid are used to maintain the normal tear secretion function of the lacrimal gland.

[0008] In another specific embodiment of the present invention, the black hibiscus calyx powder and its fermentation liquid are used to manufacture a composition for preventing and / or treating dry eye syndrome caused by excessive tear evaporation. In a preferred embodiment of the present invention, the black hibiscus calyx powder and its fermentation liquid are used to prolong tear breakup time (TBUT). In a preferred embodiment of the present invention, the black hibiscus calyx powder and its fermentation liquid are used to improve the quality and stability of the tear film.

[0009] In another specific embodiment of the present invention, the black hibiscus calyx powder and its fermentation liquid are used to improve corneal surface damage caused by dry eye syndrome. In a preferred embodiment of the present invention, the black hibiscus calyx powder and its fermentation liquid are used to repair corneal epithelial cell damage.

[0010] In one embodiment of the present invention, the black hibiscus calyx powder and its fermentation liquid are used to manufacture a composition for improving peripheral vascular problems caused by wearing contact lenses. In a preferred embodiment of the present invention, the black hibiscus calyx powder and its fermentation liquid are used to reduce tear lake height (TMH) loss during contact lens wear. In another preferred embodiment of the present invention, the black hibiscus calyx powder and its fermentation liquid are used to improve dryness and discomfort caused by wearing contact lenses. [Simplified Explanation of the Diagram]

[0048] Figure 1 shows the analysis results of tear secretion performance at 30 min, 1 hr, 2 hr and 4 hr after oral administration of black roselle calyx powder (50 mg / kg), anthocyanin (50 mg / kg) and lutein extract (50 mg / kg) in a normal animal model.

[0049] Figure 2 shows the analysis results of tear secretion performance at 30 min, 1 hr, 2 hr and 4 hr after oral administration of black roselle calyx powder, and after separate anthocyanins and separate pectin polysaccharide microparticles isolated from black roselle calyx powder using a normal animal model.

[0050] Figure 3 shows the results of tear secretion performance analysis at 30 min, 1 hr, 2 hr and 4 hr after oral administration of 0% black rosemary liquid and 10% black rosemary fermentation liquid (200 μL) using a normal animal model.

[0051] Figure 4 shows that, in human trials, continuous oral administration of black roselle calyx powder for 20 days (3 times a day, 0.5 grams each time, taken before meals) significantly increased the basal tear secretion.

[0052] Figure 5 shows that black roselle calyx powder improves insufficient tear secretion induced by sleep deprivation (SD). Mice were induced to undergo sleep deprivation (SD) from day 1 to day 16. From day 5 to day 15 after dry eye induction, mice were orally administered black roselle calyx powder (10 mg / kg, BID, 100 mg / kg, BID and 200 mg / kg, four times a day). The tear secretion performance of mice was assessed on days 0, 5, 10 and 15.

[0053] Figure 6 shows that administration of black roselle calyx powder can effectively increase tear breakup time (TBUT). Mice were induced to sleep deprivation (SD) from day 1 to day 16. From day 5 to day 15 after dry eye induction, mice were orally administered black roselle calyx powder (10 mg / kg, BID, 100 mg / kg, BID, and 200 mg / kg, four times a day). Tear breakup time (TBUT) was analyzed by regression tracking on days 0, 5, 10, and 15.

[0054] Figure 7 shows the HE staining results of mouse lacrimal gland tissue sections after sleep deprivation (SD) induced vacuolation of lacrimal gland acinar cytoplasm by black roselle calyx powder. The arrows indicate significant vacuolation of acinar cytoplasm, which is a phenomenon of early cell apoptosis. Mice underwent sleep deprivation (SD) induction from day 1 to day 16. From day 5 to day 15 after dry eye induction, mice were orally administered black roselle calyx powder (10 mg / kg, BID, 100 mg / kg, BID, and 200 mg / kg, four times a day). At the end of the experiment on day 16, mouse lacrimal gland tissue sections were collected for HE staining.

[0055] Figure 8 shows how black roselle calyx powder improves sleep deprivation (SD)-induced corneal surface damage in mice. On day 16 of induced dry eye syndrome, Lissamine green reagent was used to analyze corneal dry eye damage indicators in mice. The following figures are enlarged views of the boxed areas in the above figures.

[0056] Figure 9 shows that black hibiscus calyx powder improves the loss of tear lake height (TMH) caused by wearing contact lenses. Before oral administration of black hibiscus calyx powder (day 0) and on day 20 after continuous oral administration of black hibiscus calyx powder (day 20), the tear lake height measured "before" wearing contact lenses was used as the baseline value, and the tear lake height was tracked and measured at 30 min, 2 hr, 5 hr and 8 hr when wearing contact lenses.

[0057] Figure 10 shows how black hibiscus calyx powder improves ocular surface allergies, irritation, and peripheral vascular problems caused by wearing contact lenses. Before oral administration of black hibiscus calyx powder (day 0) and on days 10 and 20 after continuous oral administration of black hibiscus calyx powder (day 10, day 20), the degree of ocular congestion observed "before" wearing contact lenses was used as the baseline. The degree of ocular congestion was tracked and measured at 30 min, 2 hr, 5 hr, and 8 hr when wearing contact lenses (CL 30 min, CL 2 hr, CL 5 hr, CL 8 hr), and 30 min after removing contact lenses (w / o 30 min).

Implementation Method

[0011] This invention relates to the use of black roselle calyx powder or its fermentation liquid in the preparation of compositions for the prevention and / or treatment of dry eye syndrome. The compositions may be a health food composition or a pharmaceutical composition.

[0012] In this article, "black roselle calyx powder" refers to the powder made from the dried calyx (also known as calyx) of roselle sunflower "Taitung No. 6-Black Crystal" after drying and processing. The particle size of the calyx powder ranges from about 30 to 850 μm. The flavonoid content can reach 3.53 mg / g, the total anthocyanin content is 32.6 mg / g, the total polyphenol content is 24.2 mg / g, and the gallic acid content is 23.4~23.7 mg / 100g. The content of each component is significantly better than that of fruits such as blueberries, bilberries, grapes, and blackcurrants.

[0013] In this article, “black roselle fermentation liquid” refers to the fermentation liquid obtained by using fermentation technology to ferment black roselle calyx powder raw material or black roselle extract with sugar water and bacteria such as yeast and acetic acid bacteria at 37°C for 6 to 15 days.

[0014] In this article, the term "dry eye syndrome" refers to the phenomenon that occurs when the amount of tear secretion is affected, or the tear distribution is uneven, the tear evaporates too quickly, or the tear composition is unstable, so that the tear cannot fully moisturize the eyes, which can lead to corneal abrasion, increased osmotic pressure, and cause eye discomfort, soreness, bloodshot eyes, foreign body sensation, pain, or even visual impairment.

[0015] Other features and advantages of the present invention will be further illustrated and explained in the following embodiments, which are only for auxiliary illustration and are not intended to limit the scope of the present invention.

[0016] Example 1: Black Roselle Calyx Powder / Fermentation Broth Increases Tear Secretion in Normal Animals

[0017] This example uses normal animal models and human trials to analyze the effect of oral administration of black roselle calyx powder or its fermentation liquid on increasing / promoting tear secretion.

[0018] Comparison of Black Roselle Calyx Powder, Lutein Extract, and Anthocyanins

[0019] Mice were orally administered black hibiscus calyx powder (50 mg / kg) and the same dose of anthocyanin and lutein extracts once. Tear secretion was analyzed at 30 min, 1 hour, 2 hours, and 4 hours. Figure 1 shows that the tear secretion curve in the black hibiscus calyx powder group was significantly increased compared to the control group (Normal + Vehicle), reaching its peak 2 hours after administration. At the same dose (50 mg / kg), compared to oral administration of anthocyanin (gray solid square) and lutein extract (50 mg / kg) (gray solid triangle), black hibiscus calyx powder (50 mg / kg) (black solid circle) significantly increased / promoted tear secretion, showing a significant difference. This indicates that oral administration of black hibiscus calyx powder can increase tear secretion, and its effect is superior to that of anthocyanin and lutein extracts alone.

[0020] Comparison of Black Roselle Calyx Powder with Isolated Anthocyanins and Pectin Polysaccharide Microparticles

[0021] Using a normal animal model, tear secretion was assessed at 30 min, 1 hr, 2 hr, and 4 hr after a single oral dose. Individual anthocyanins and pectin polysaccharide microparticles were isolated from black hibiscus calyx powder, and their effects on tear secretion were tracked and evaluated after a single oral dose. As shown in Figure 2, comparing the tear secretion-promoting effects at the same dose, oral black hibiscus calyx powder (50 mg / kg) (black solid circle) was significantly more effective than isolated anthocyanins (50 mg / kg) (gray solid square) and isolated pectin polysaccharide microparticles (50 mg / kg) (gray solid triangle) in increasing / promoting tear secretion. Repeated experiments confirmed that black hibiscus calyx powder possesses the highest bioactivity and best tear secretion-promoting efficacy due to its unique raw material structure. Once the indicator components, such as anthocyanins or pectin polysaccharide microparticles, were extracted and isolated separately, their tear secretion-promoting efficacy was lower than that of the raw black hibiscus calyx powder.

[0022] Black Roselle Fermented Liquid has the effect of increasing tear secretion.

[0023] The black roselle fermentation broth used in this example was prepared by mixing black roselle extract (obtained from "Nature Biotech Materials Co., Ltd.") with a sterilized 10% sucrose aqueous solution and stirring thoroughly. Then, 10% bacterial solution (commercially available yeast and acetic acid bacteria SCOBY) was added, and the bottle mouth was flammed. The bottle mouth was then covered with gauze and a rubber band and incubated in a 37°C incubator for 6-15 days. The resulting black roselle fermentation broth stock solution was then diluted with distilled water to prepare 5% (w / w) and 10% (w / w) black roselle fermentation broths.

[0024] Using a normal animal model, tear secretion was assessed at 30 min, 1 hr, 2 hr, and 4 hr after a single oral dose of black roselle fermented liquid. The results in Figure 3 indicate that the carrier group without added roselle fermented liquid did not show significant efficacy in promoting tear secretion. However, oral administration of 10% black roselle fermented liquid was more effective than 10% unfermented black roselle calyx powder solution in increasing / promoting tear secretion. Repeated experiments confirmed that black roselle calyx powder, after fermentation, still retains the effect of increasing tear secretion.

[0025] Improves basic tear secretion physiological function (human trial)

[0026] Take 0.5g of black roselle calyx powder three times a day for 20 days before meals. The efficacy of black roselle calyx powder in increasing / promoting tear secretion was evaluated using Schirmer's test (anesthesia-measured tear secretion over 1 minute) before administration (day 0) and on days 10 and 20 after administration (day 10 and day 20).

[0027] As shown in Figure 4, the human trial results indicate that continuous oral administration of black roselle calyx powder for 20 days significantly increases basal tear secretion. This suggests that black roselle calyx powder can improve the basic physiological function of tear secretion in the human body and increase tear volume.

[0028] Example 2: Black Roselle Calyx Powder / Fermentation Liquid Relieves Dry Eye Problems

[0029] Since sleep disorders are a cause of dry eye syndrome, the following example uses a sleep deprivation (SD) experiment to evaluate whether black roselle calyx powder can improve and prevent sleep deprivation-induced dry eye syndrome symptoms. The experiment was divided into five groups: a normal group, a sleep deprivation-induced group (SD + carrier), an oral low-dose black roselle calyx powder group (SD + 10 mg / kg, BID), an oral medium-dose black roselle calyx powder group (SD + 100 mg / kg, BID), and an oral high-dose black roselle calyx powder group (SD + 200 mg / kg, BID). Mice underwent sleep deprivation (SD) induction from day 1 to day 16 of the experiment. Tear secretion and tear breakup time (TBUT) were measured on days 0, 5, 10, and 15. Corneal dry eye damage markers were analyzed in mice before sacrifice on day 16. After the mice were sacrificed on day 16, lacrimal gland tissue was collected for HE staining analysis.

[0030] Improves insufficient tear production in dry eye syndrome and increases tear secretion function

[0031] Mice underwent sleep deprivation induction (SD) from day 1 to day 16 of the experiment. Tear secretion was measured on days 0, 5, 10, and 15. As shown in Figure 5, regression analysis showed that tear secretion in the Normal group (dashed hollow circle) tended to stabilize from day 0 to day 15. In the dry eye induction group (SD+Vehicle group) (dashed cross), a significant decrease in tear secretion was observed on day 5, day 10, and day 15. The experimental results showed that after dry eye induction, mice were continuously orally administered black roselle calyx powder (10 mg / kg, BID), (100 mg / kg, BID), and (200 mg / kg, four times a day) from day 5 to day 15, and the tear secretion significantly increased with the dosage and concentration of black roselle calyx powder administered orally. The levels of efficacy observed in the group following oral administration of black hibiscus calyx powder on Day 10 and Day 15 were significantly higher than those in the dry eye induction group (SD+Vehicle group). These results indicate that oral administration of black hibiscus calyx powder can increase tear secretion, thereby alleviating the symptoms of sleep deprivation-induced dry eye syndrome.

[0032] Improves tear evaporative dry eye syndrome by “increasing” the stability of the tear film.

[0033] Tear break-up time (TBUT) is an analytical method for assessing tear film quality and is often used as an indicator for evaluating dry eye. The more unstable and easily evaporated the tear film, the shorter the tear break-up time (TBUT) (sec). Mice were subjected to sleep deprivation induction (SD) from day 1 to day 16, and the tear break-up time (TBUT) was analyzed by regression tracking on days 0, 5, 10, and 15. As shown in the staining results in Figure 6, the normal group (dashed hollow circle) showed stable tear break-up time from day 0 to day 15. Compared with the normal group, it was clearly found that the dry eye induction group (SD+Vehicle group, dashed cross) showed a decrease in tear break-up time (TBUT) seconds on Day 5, Day 10, and Day 15 of the experiment, indicating that sleep deprivation (SD) does indeed lead to a significant decrease in tear break-up time (TBUT). As shown in Figure 6, in mice after dry eye induction, continuous oral administration of black roselle calyx powder (10 mg / kg, BID), (100 mg / kg, BID), and (200 mg / kg, four times a day) from Day 5 to Day 15 significantly increased tear breakup time (TBUT) with increasing dose concentration. The TBUT measured on Day 10 and Day 15 was significantly greater in the group receiving the dry eye induction treatment (SD+Vehicle group) than in the other two groups. Repeated experimental results confirmed that continuous administration of black roselle calyx powder can effectively increase tear breakup time (TBUT) and reduce tear film instability, thereby improving / alleviating dry eye caused by excessive tear evaporation.

[0034] Reduces degeneration and damage to lacrimal gland cells

[0035] The lacrimal gland is the tissue responsible for secreting tear fluid. The morphology and structure of the tissue were observed after staining tissue sections with hematoxylin and eosin (HE). Mice underwent sleep deprivation induction (SD) from day 1 to day 16 of the experiment. Mice were sacrificed on day 16, and lacrimal gland tissue was collected for HE staining analysis.

[0036] The staining results in Figure 7 show that, compared with the Normal group, the lacrimal gland tissue of the dry eye induction group (SD+Vehicle group) exhibited numerous cytoplasmic vacuolization and degenerative damage characteristics (indicated by the triangles). Furthermore, after mice were induced to develop dry eye, oral administration of black roselle calyx powder (10 mg / kg, BID), (100 mg / kg, BID), and (200 mg / kg, four times a day) from Day 5 to Day 15 effectively slowed down cytoplasmic vacuolization and degenerative damage, with the effect significantly increasing with dosage concentration. Repeated experimental results confirmed that oral administration of black roselle calyx powder can reduce lacrimal gland cell degeneration and death, demonstrating a health-promoting effect on lacrimal gland cells.

[0037] Prevention and improvement of corneal damage symptoms in dry eye syndrome

[0038] Mice underwent sleep deprivation induction (SD) from day 1 to day 16. On day 16, Lissamine green reagent was used to analyze corneal dry eye damage indicators, and corneal tissue sections were stained with hematoxylin and eosin (HE) to assess the corneal surface damage. Corneal staining is a method for observing whether the corneal epithelium is smooth and without defects; if there are irregular or uneven depressions or damages on the corneal surface, damaged staining areas will appear.

[0039] Figure 8 shows photographs taken with the original stained cornea, followed by software analysis to select punctate lesions, mark punctate areas, and quantify the lesion area. Results showed that, compared to the Normal group, the corneal surface of the dry eye induction group (SD+Vehicle group) exhibited irregular depressions or punctate staining characteristics, similar to clinical dry eye symptoms, after staining. Experimental results revealed that oral administration of black hibiscus calyx powder (10 mg / kg, BID), (100 mg / kg, BID), and (200 mg / kg, four times a day) for Day 5-Day 15 after dry eye induction significantly reduced irregular or uneven depressions or damage on the corneal surface, and the allergic effect increased significantly with increasing dose concentration. Repeated experimental results confirmed that oral administration of black hibiscus calyx powder can reduce dry eye-related irregular depressions or damage on the corneal surface and has a health-promoting effect on corneal cells.

[0040] Example 3: Black Roselle Calyx Powder Improves Peripheral Vascular Problems (Human Trial for Contact Lenses)

[0041] Reduces tear lake height (TMH) loss during contact lens wear

[0042] Tearful lake height (TMH) is highly correlated with the comfort of wearing contact lenses, and it is often used as a clinical assessment indicator for contact lens fitting. Tearful lake height (TMH) decreases with the wearing time of contact lenses (as shown by the dotted line). Human trials have shown that after 20 days of oral administration of black hibiscus calyx powder, the loss of tearful lake height (TMH) caused by contact lens wear can be slowed down, with a significant difference between 2 hours and 5 hours of contact lens wear. Black hibiscus calyx powder can reduce the loss of tearful lake height (TMH) during contact lens wear, thereby increasing the comfort of use. As shown in Figure 9, the results of the human trial indicate that after 20 days of oral administration of black hibiscus calyx powder, the loss of tearful lake height (TMH) caused by contact lens wear can be slowed down. Analysis of tearful lake height (TMH) after 2 hours of contact lens wear revealed that it was greater after oral administration of black hibiscus calyx powder than before. Black hibiscus calyx powder can reduce tear lake height (TMH) loss when wearing contact lenses, thus increasing comfort.

[0043] Improves ocular surface allergies, irritation, and peripheral vascular problems.

[0044] The surface of the eyeball can become congested due to tear film instability, insufficient tear film quality, irritation, and sensitivity. As shown in Figure 10, the human trial results, based on observations without contact lenses (baseline), showed that after 20 days of continuous oral administration of black hibiscus calyx powder, ocular surface allergic reactions, irritation, peripheral vascular problems, and congestion were improved, indicating that black hibiscus calyx powder can improve ocular surface allergies, irritation, and peripheral vascular problems. Furthermore, because contact lenses exacerbate ocular surface congestion and discomfort, observations during contact lens wearing (CL 30min, CL 2hr, CL 5hr, CL 8hr) and after contact lens removal (w / o 30min) showed that after 20 days of continuous oral administration of black hibiscus calyx powder, ocular surface allergies and congestion were effectively improved, irritation during contact lens wearing was reduced, and comfort was increased.

[0045] In summary, black roselle calyx powder and its fermentation liquid have the effects of increasing tear secretion, increasing tear film stability, reducing lacrimal gland cell degeneration and damage, and reducing dry eye-induced corneal damage. They can also improve ocular surface allergies, irritation reactions and peripheral vascular problems caused by wearing contact lenses, reduce tear lake height (TMH) loss and dryness and discomfort when wearing contact lenses, and increase the comfort of wearing contact lenses.

[0046] Although the embodiments of the present invention have been described with a limited number of examples, those skilled in the art may still make modifications or changes. Therefore, the scope of protection of the present invention should be limited only by the patent scope, and not by the above embodiments.

Claims

1. The use of Hibiscus sabdariffa Linn. (Taitung No. 6) calyx powder or its fermentation liquid for the manufacture of a composition for the prevention and / or treatment of dry eye syndrome, wherein the composition is a health food composition or a pharmaceutical composition, and wherein the fermentation liquid is obtained by culturing Hibiscus sabdariffa calyx powder raw material or Hibiscus sabdariffa extract with sugar water and microorganisms including yeast, acetic acid bacteria, etc., at 37°C for 6 to 15 days.

2. The use as described in claim 1, wherein the composition is for the prevention and / or treatment of dry eye syndrome caused by insufficient tear production.

3. The use as described in claim 2, wherein the composition is for promoting tear secretion.

4. The use as described in claim 2, wherein the composition is used to slow down the degeneration or apoptosis of lacrimal gland acinar cells.

5. The use as described in claim 2, wherein the composition is for maintaining the normal tear secretion function of lacrimal gland cells.

6. The use as described in claim 1, wherein the composition is for the prevention and / or treatment of dry eye syndrome caused by excessive tear evaporation.

7. The use as described in claim 6, wherein the composition is used to prolong tear breakup time (TBUT).

8. The use as described in claim 6, wherein the composition is used to improve the quality and stability of the tear film.

9. The use as described in claim 1, wherein the composition is for improving corneal surface damage caused by dry eye syndrome.

10. The use as described in claim 1, wherein the composition is for preventing tear lake height (TMH) loss and dryness / discomfort during contact lens wear.

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