Hydrogel eye pad for treating xerophthalmia as well as preparation method and application of hydrogel eye pad

Abstract

The invention relates to the technical field of traditional Chinese medicines, in particular to a hydrogel eye patch for treating xerophthalmia as well as a preparation method and application thereof, and discloses a traditional Chinese medicine composition which comprises the following components in parts by weight: 6-15 parts of ginseng, 6-15 parts of fructus alpiniae oxyphyllae, 6-15 parts of bidens bipinnata, 6-15 parts of chrysanthemum, 6-15 parts of corydalis tuber, 6-15 parts of asparagus cochinchinensis, 6-15 parts of fructus aurantii and 3-9 parts of mint. The hydrogel eye pad prepared from the traditional Chinese medicine composition can improve cornea fluorescent staining, prolong tear film rupture time and increase tear secretion, clinical symptoms of xerophthalmia patients are effectively relieved, eye irritation is small when the eye pad is used, and patient compliance is improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, in particular to a hydrogel eye patch for treating dry eye and a preparation method and application thereof. BACKGROUND

[0002] With the improvement of people's living standards, the increasing richness of electronic products, the incidence of eye diseases has increased accordingly, among which dry eye is particularly significant. Dry eye is a common and frequently-occurring disease in ophthalmology, and the incidence of the disease increases by several times every year. Due to its difficulty in curing, high incidence, long treatment cycle, easy recurrence, and poor clinical maintenance effect, it is difficult for dry eye patients to adhere to the treatment, which aggravates the eye disease. The main pathophysiological mechanism of dry eye is the imbalance of tear film homeostasis and the increase of tear osmotic pressure. There are many reasons for this pathological state, and chronic inflammation of the ocular surface is one of the main reasons. IL-6 is considered an important inflammatory factor in the pathogenesis of dry eye. Changes in its level can not only be observed earliest, but also are related to the severity of the disease. Therefore, the concentration of IL-6 in the tears of patients is often used as a marker of ocular surface inflammatory response. As a typical marker of dry eye, high osmotic pressure of tears can induce the release of inflammatory mediators such as TNF-α, directly or indirectly damaging the ocular surface, reducing tear film stability, and causing a vicious cycle. The high levels of inflammatory mediators in the conjunctival epithelium and tears of dry eye patients confirm this.

[0003] In recent years, the treatment of this disease by traditional Chinese medicine has found that the combination of various internal and external therapies of traditional Chinese medicine for the treatment of clinical symptoms and psychological and physiological intervention of dry eye patients is effective. Its treatment methods mainly focus on oral traditional Chinese medicine, acupuncture, fumigation, ear acupoint, iontophoresis, etc. Many doctors have satisfactory effects on this disease by using traditional Chinese medicine or external therapy of integrated traditional Chinese and western medicine, such as using traditional Chinese medicine fumigation and steaming meibomian gland massage therapy, using self-made Rundangmingmu fumigation and steaming formula (mulberry leaf, chrysanthemum, cortex moutan, rehmannia glutinosa, ophiopogon, dendrobium, medlar) to fumigate and steam eyelid, and auxiliary meibomian gland massage, which has achieved good effects. However, most dry eye patients are busy at work and cannot come to the hospital for treatment during working hours. If they apply hot compress at home, they still use the method of soaking a towel in hot water and applying it to the eyes. Since the temperature of this method is not easy to control, it is difficult to apply it for a long time every day, so the effect is not good.

[0004] In view of the above problems, in addition to traditional Chinese medicine fumigation and steaming, atomization hot compress and other methods, traditional Chinese medicine patch therapy using eye patch as a carrier can play an important role in the prevention and treatment of dry eye disease, and the eye patch has the advantages of convenient use and safety, providing a new local treatment method for instant relief of visual fatigue and self-conscious symptoms of dry eye patients. SUMMARY

[0005] In view of the above-mentioned disadvantages of the prior art, the present application aims to provide a hydrogel eye patch for treating dry eye and a preparation method and use thereof, for solving the problems in the prior art.

[0006] To achieve the above object and other related objects, the present application first provides a traditional Chinese medicine composition for treating dry eye, which comprises the following components in parts by weight: 6-15 parts of ginseng, 6-15 parts of yizhi- ren, 6-15 parts of pabupin, 6-15 parts of chrysanthemum, 6-15 parts of corydalis, 6-15 parts of radix asparagi, 6-15 parts of fructus aurantii, and 3-9 parts of mentha.

[0007] The present application also provides a preparation method of the above-mentioned traditional Chinese medicine composition, which comprises: mixing the components thoroughly.

[0008] The present application also provides a traditional Chinese medicine extract, which is prepared from the above-mentioned traditional Chinese medicine composition.

[0009] The present application also provides a preparation method of a traditional Chinese medicine extract, which comprises: extracting the above-mentioned traditional Chinese medicine composition to obtain an extract, and the obtained extract is the traditional Chinese medicine extract.

[0010] The present application also provides a traditional Chinese medicine hydrogel, which comprises the above-mentioned traditional Chinese medicine extract and a gel matrix, and the addition amount of the traditional Chinese medicine extract is 2-10 g / L based on the mass of the gel matrix.

[0011] The present application also provides a traditional Chinese medicine hydrogel eye patch, which comprises a non-woven fabric base film and the above-mentioned traditional Chinese medicine hydrogel, and the addition amount of the traditional Chinese medicine hydrogel is 0.15-0.2 g / cm2 relative to the area of the non-woven fabric base film. 2 .

[0012] The present application also provides a combination product for treating or assisting in treating dry eye, which comprises:

[0013] a) the above-mentioned pharmaceutical composition, or the above-mentioned traditional Chinese medicine extract, or the above-mentioned traditional Chinese medicine hydrogel, or the above-mentioned traditional Chinese medicine hydrogel eye patch;

[0014] b) eye drops.

[0015] As described above, the present application of a traditional Chinese medicine composition for treating dry eye and a preparation method and use thereof have the following advantages

[0016] Advantages:

[0017] The hydrogel eye patch prepared from the traditional Chinese medicine composition can improve corneal fluorescent staining, prolong tear film break-up time and increase tear secretion, effectively relieve the clinical symptoms of patients with dry eye, has small irritation to the eyes when the eye patch is used, and increases the compliance of patients, especially children.

[0018] It is proved by clinical test data that the hydrogel eye patch has good heat-clearing and vision-improving effects and the effects of regulating yin and yang when used for treating and adjuvant treating dry eye, the synergistic effect of the components can improve the circulation around the eyes and relieve eye fatigue, has small irritation and no other adverse reactions, and can be used for treating or adjuvant treating dry eye.

[0019] In addition, the traditional Chinese medicine hydrogel eye patch can be carried around, can provide a new type of eye patch suitable for dry eye for consumers, can effectively improve eye congestion and pain, has a stimulating effect on eye acupoints and can relieve eye fatigue. BRIEF DESCRIPTION OF DRAWINGS

[0020] Figure 1 The figure shows the schematic diagram of the hydrogel eye patch obtained in the application. DETAILED DESCRIPTION

[0021] The application first provides a traditional Chinese medicine composition, which comprises the following components by weight:

[0022] Radix ginseng 6-15 parts, Fructus evodia 6-15 parts, Radix mori 6-15 parts, Flos chrysanthemi 6-15 parts, Rhizoma corydalis 6-15 parts, Radix asparagi 6-15 parts, Fructus aurantii 6-15 parts and Herba menthae 3-9 parts.

[0023] In some embodiments of the application, the Radix ginseng in the traditional Chinese medicine composition is selected from any one of the following ranges by weight: 6-8 parts, 8-10 parts, 10-12 parts, 12-14 parts and 14-15 parts.

[0024] In some embodiments of the application, the Fructus evodia in the traditional Chinese medicine composition is selected from any one of the following ranges by weight: 6-8 parts, 8-10 parts, 10-12 parts, 12-14 parts and 14-15 parts.

[0025] In some embodiments of the application, the Radix mori in the traditional Chinese medicine composition is selected from any one of the following ranges by weight: 6-8 parts, 8-10 parts, 10-12 parts, 12-14 parts and 14-15 parts.

[0026] In some embodiments of the application, the Flos chrysanthemi in the traditional Chinese medicine composition is selected from any one of the following ranges by weight: 6-8 parts, 8-10 parts, 10-12 parts, 12-14 parts and 14-15 parts.

[0027] In some embodiments of the present invention, the Corydalis rhizome in the traditional Chinese medicine composition is selected from any of the following ranges by weight: 6-8 parts, 8-10 parts, 10-12 parts, 12-14 parts, or 14-15 parts.

[0028] In some embodiments of the present invention, the Asparagus in the traditional Chinese medicine composition is selected from any of the following ranges by weight: 6-8 parts, 8-10 parts, 10-12 parts, 12-14 parts, or 14-15 parts.

[0029] In some embodiments of the present invention, the Citrus aurantium in the traditional Chinese medicine composition is selected from any of the following ranges by weight: 6-8 parts, 8-10 parts, 10-12 parts, 12-14 parts, or 14-15 parts.

[0030] In some embodiments of the present invention, the peppermint in the herbal composition is selected from any of the following ranges by weight: 3-4 parts, 4-5 parts, 5-6 parts, 6-7 parts, 7-8 parts, or 8-9 parts.

[0031] In a preferred embodiment of the present invention, the traditional Chinese medicine composition comprises, by weight, the following components:

[0032] Ginseng 9-13 parts, Alpinia oxyphylla 8-14 parts, Prickly ash 7-13 parts, Chrysanthemum 6-14 parts, Corydalis yanhusuo 6-12 parts, Asparagus cochinchinensis 8-13 parts, Citrus aurantium 9-15 parts, Mentha haplocalyx 4-8 parts.

[0033] In a preferred embodiment of the present invention, the traditional Chinese medicine composition comprises, by weight, the following components:

[0034] Ginseng 9-11 parts, Alpinia oxyphylla 9-11 parts, Prickly ash 8-12 parts, Chrysanthemum 8-14 parts, Corydalis yanhusuo 7-11 parts, Asparagus cochinchinensis 8-11 parts, Citrus aurantium 10-12 parts, Mentha haplocalyx 5-7 parts.

[0035] In this formula, ginseng and Alpinia oxyphylla are the principal herbs, which have the effects of nourishing yin and blood, replenishing essence and marrow, nourishing the liver and kidneys and improving eyesight; chrysanthemum and peppermint are the assistant herbs, which have the effects of dispersing wind-heat, calming the liver and improving eyesight, and eliminating swelling; Citrus aurantium, Citrus aurantium and Corydalis are the adjuvant herbs, which, when used together, can promote blood circulation, reduce swelling and relieve pain, and are suitable for eye fatigue and eye swelling and pain; Asparagus cochinchinensis is the guiding herb, which has the effects of nourishing yin and tonifying the kidneys and reducing deficiency fire, and can relieve dry and itchy eyes caused by liver and kidney yin deficiency.

[0036] Ginseng has the effect of nourishing yin and promoting body fluid production, which can improve the dry eye symptoms of dry eye syndrome caused by insufficient body fluid. Ginseng can dilate microvessels, promote blood supply to the fundus, and increase the oxygen and nutrient supply to eye tissues. This effect not only helps relieve eye fatigue, but also has an auxiliary conditioning effect on vascular eye diseases such as diabetic retinopathy.

[0037] Alpinia oxyphylla has the effect of improving eyesight and protecting the eyes. It can relieve eye fatigue and dryness. It can also inhibit the synthesis of prostaglandins, enhance memory and learning ability, and has the effects of calming the nerves, anti-oxidation and protecting nerves.

[0038] Chrysanthemums have the effects of clearing heat and detoxifying, calming the liver and improving eyesight, and relieving eye fatigue. They are slightly cold in nature and are often used in traditional Chinese medicine or for daily health maintenance. The active ingredients in chrysanthemums, such as flavonoids, help clear internal heat toxins and improve symptoms such as red, swollen, and painful eyes and sore throat caused by excessive internal heat, thus indirectly relieving eye discomfort. In addition, chrysanthemums also contain nutrients such as vitamin A. Using a decoction of chrysanthemums to steam the eyes can promote local blood circulation and moisturize the conjunctiva, reducing soreness and fatigue after prolonged eye use.

[0039] Citrus aurantium can break up qi stagnation and resolve phlegm, and can also remove blood stasis, which is beneficial to the circulation and distribution of body fluids. It has a certain therapeutic effect on dry eye syndrome caused by obstruction of the orifices.

[0040] Asparagus has the effects of nourishing yin and promoting body fluids, moistening the lungs and relieving cough, and nourishing the liver and improving eyesight. It can nourish yin fluids, promote body fluids and relieve dryness, and is effective in treating symptoms such as yin deficiency fever, dry cough due to lung dryness, consumptive cough, and thirst due to fluid depletion. By nourishing yin and the liver, asparagus can help regulate liver function and keep it in a normal state, thereby alleviating problems such as dry eyes, fatigue, and decreased vision caused by insufficient liver yin.

[0041] The flavonoids and phenolic acids contained in the ointment can regulate cholinergic receptors (M receptors), enhance glandular contraction function, and thus stimulate tear secretion. Its cholinergic effect can bind to M receptors in the accessory lacrimal glands and meibomian glands, lower the reflex arc threshold, enhance the contraction of exocrine gland myoepithelial cells, promote tear and lipid secretion, and empty residual secretions in the accessory lacrimal glands and meibomian glands.

[0042] Traditional Chinese medicine believes that "the eyes can see by receiving blood." Corydalis rhizome can improve blood circulation in the eyes by promoting blood circulation and qi circulation, and can relieve symptoms such as eye fatigue, dryness and pain caused by poor blood circulation.

[0043] Peppermint has a pungent flavor and cooling properties, entering the lung and liver meridians. It can dispel wind-heat, clear the head and eyes, soothe the throat and promote rash eruption, and soothe the liver and regulate qi. Components in peppermint can stimulate the nerves around the eyes, promote blood circulation, and relieve eye fatigue and discomfort. The volatile oils in peppermint have anti-inflammatory and antibacterial effects, which can prevent and treat eye inflammation and infections.

[0044] Borneol is pungent and bitter, slightly cold in nature, and enters the heart, spleen, and lung meridians. It has the effects of clearing the orifices, dispersing stagnant heat, opening the mind and refreshing the brain, removing pterygium and improving eyesight, and reducing swelling and cooling.

[0045] The present invention also provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising: thoroughly mixing the components.

[0046] The present invention also provides a traditional Chinese medicine extract, which is prepared from the above-mentioned traditional Chinese medicine composition.

[0047] The present invention also provides a method for preparing a traditional Chinese medicine extract, the method comprising: extracting the above-mentioned traditional Chinese medicine composition to obtain an extract, the obtained extract being the traditional Chinese medicine extract.

[0048] In some embodiments of the present invention, the extraction method is a decoction method.

[0049] In some embodiments of the present invention, the solvent for extraction is water.

[0050] In some embodiments of the present invention, a pretreatment of the traditional Chinese medicine composition is further included before extraction. This pretreatment involves soaking the traditional Chinese medicine composition in a solvent used for extraction, or increasing the extraction time of some components. The above pretreatment operations promote the full dissolution of the active ingredients.

[0051] In some embodiments of the present invention, the weight ratio of the traditional Chinese medicine composition to the solvent during extraction is 1:(10-20). The weight ratio of the traditional Chinese medicine composition to the solvent is selected from any of the following ranges: 1:(10-12), 1:(12-14), 1:(14-16), 1:(16-18), 1:(18-20).

[0052] In some embodiments of the present invention, the extraction temperature for components other than peppermint is 80-90°C, and the extraction temperature for peppermint is 40-60°C.

[0053] In some embodiments of the invention, the peppermint extract is combined with extracts of other components.

[0054] In some embodiments of the present invention, the extraction time is 60 to 120 minutes. The extraction time is selected from any of the following ranges: 60 to 75 minutes, 75 to 90 minutes, 90 to 105 minutes, and 105 to 120 minutes.

[0055] In some embodiments of the present invention, the extraction is performed more than twice.

[0056] In some embodiments of the present invention, the filtrates are combined after extraction.

[0057] In some embodiments of the present invention, the preparation method further includes concentrating and drying the collected extract.

[0058] Furthermore, the concentration temperature is 33–58°C. The concentration temperature is selected from any of the following ranges: 33–40°C, 40–45°C, 45–50°C, 50–55°C, and 55–58°C.

[0059] Furthermore, the relative density of the product obtained from the concentration is 0.9 to 1.1.

[0060] Furthermore, the concentration is vacuum concentration, and even further, the pressure of the vacuum concentration is 10–20 MPa. The pressure of the vacuum concentration is selected from any of the following ranges: 10–12 MPa, 12–14 MPa, 14–16 MPa, 16–18 MPa, or 18–20 MPa.

[0061] Furthermore, the drying method is spray drying; even further, the inlet temperature of the spray dryer is 140-180°C; and the outlet temperature is 100-140°C.

[0062] The present invention also provides a traditional Chinese medicine hydrogel, wherein the hydrogel comprises the above-mentioned traditional Chinese medicine extract and a gel matrix, and the concentration of the traditional Chinese medicine extract is 2-10 g / L based on the volume of the gel matrix. The concentration of the traditional Chinese medicine extract is selected from any of the following ranges: 2-4 g / L, 4-6 g / L, 6-8 g / L, 8-10 g / L.

[0063] The gel matrix serves as a dispersion carrier to disperse the traditional Chinese medicine extract, ensuring its uniform distribution and stability within the gel system.

[0064] In some embodiments of the present invention, the gel matrix comprises, by weight, the following components:

[0065] The ingredients are: 1-5 parts borneol, 10-20 parts sodium carboxymethyl cellulose, 20-30 parts glycerol, 1-3 parts citric acid, 1-3 parts sorbitol, 0.1-0.3 parts aluminum hydroxide, and 150-300 parts water. The number average molecular weight of the sodium carboxymethyl cellulose is 250-300.

[0066] In some embodiments of the present invention, the borneol in the gel matrix is ​​selected from any of the following ranges by weight: 1 to 2 parts, 2 to 3 parts, 3 to 4 parts, or 4 to 5 parts.

[0067] In some embodiments of the present invention, the sodium carboxymethyl cellulose in the gel matrix is ​​selected from any of the following ranges by weight: 10-12 parts, 12-14 parts, 14-16 parts, 16-18 parts, or 18-20 parts.

[0068] In some embodiments of the present invention, the glycerol in the gel matrix is ​​selected from any of the following ranges by weight: 20-22 parts, 22-24 parts, 24-26 parts, 26-28 parts, and 28-30 parts.

[0069] In some embodiments of the present invention, the citric acid in the gel matrix is ​​selected from any of the following ranges by weight: 1 to 1.5 parts, 1.5 to 2 parts, 2 to 2.5 parts, and 2.5 to 3 parts.

[0070] In some embodiments of the present invention, the sorbitol in the gel matrix is ​​selected from any of the following ranges by weight: 1 to 1.5 parts, 1.5 to 2 parts, 2 to 2.5 parts, and 2.5 to 3 parts.

[0071] In some embodiments of the present invention, the aluminum hydroxide in the gel matrix is ​​selected from any of the following ranges by weight: 0.1 to 0.15 parts, 0.15 to 0.2 parts, 0.2 to 0.25 parts, and 0.25 to 0.3 parts.

[0072] In some embodiments of the present invention, the water in the gel matrix, by weight, is selected from any of the following ranges: 150-170 parts, 170-210 parts, 210-240 parts, 240-270 parts, or 270-300 parts.

[0073] Among them, borneol has cooling, refreshing, anti-inflammatory and calming effects, which can promote blood circulation in the eyes and relieve muscle tension and fatigue caused by excessive eye use. Its volatile substances can penetrate through the skin to improve discomfort symptoms such as dryness and soreness in the eyes. Sodium carboxymethyl cellulose is a stabilizer and thickener for the gel. Glycerol can moisturize the skin and has antibacterial and antiviral properties. Citric acid makes the skin more shiny, and the acidic environment it creates can inhibit the growth of bacteria and has a preservative effect. Sorbitol, as an excipient, moisturizer and antifreeze, can maintain the lubrication and color of the gel, enhance the extensibility and lubricity of the gel, and facilitate long-term storage. Aluminum hydroxide is a buffer to make the gel system more stable.

[0074] The present invention also provides a traditional Chinese medicine hydrogel eye patch, the eye patch comprising a non-woven fabric base film and the aforementioned traditional Chinese medicine hydrogel, wherein the amount of the traditional Chinese medicine hydrogel used is 0.15–0.2 g / cm² relative to the area of ​​the non-woven fabric base film. 2 .

[0075] In some embodiments of the present invention, the material of the nonwoven fabric base film is polyester fiber material.

[0076] In some embodiments of the present invention, the basis weight of the nonwoven fabric base film is 70–100 g / m³. 2 .

[0077] In a preferred embodiment of the present invention, the basis weight of the woven base film is 80 g / m³. 2 .

[0078] In some embodiments of the present invention, the nonwoven fabric base film has a size of 40–80 cm.2 / stick.

[0079] In a preferred embodiment of the present invention, the nonwoven fabric base film has a size of 48 cm. 2 / stick.

[0080] The present invention also provides the use of the above-mentioned traditional Chinese medicine composition, or the above-mentioned traditional Chinese medicine extract, or the above-mentioned traditional Chinese medicine hydrogel, or the above-mentioned traditional Chinese medicine hydrogel eye patch in the preparation of products for treating or adjuvant treatment of dry eye syndrome.

[0081] The above-mentioned traditional Chinese medicine composition, or the above-mentioned traditional Chinese medicine extract, or the above-mentioned traditional Chinese medicine hydrogel, or the above-mentioned traditional Chinese medicine hydrogel eye patch has any one or more of the following effects:

[0082] 1) Improves corneal fluorescein staining;

[0083] 2) Prolong tear film breakup time;

[0084] 3) Increase tear secretion.

[0085] The present invention also provides a combination product for preparing a treatment or adjunctive treatment for dry eye syndrome, the combination product comprising:

[0086] a) The above-mentioned pharmaceutical composition, or the above-mentioned traditional Chinese medicine extract, or the above-mentioned traditional Chinese medicine hydrogel, or the above-mentioned traditional Chinese medicine hydrogel eye patch;

[0087] b) Eye drops.

[0088] In some embodiments of the present invention, the eye drops are sodium hyaluronate eye drops.

[0089] The herbal hydrogel eye patch is applied to both eyes during use, covering the Jingming, Taiyang, Chengqi, and Tongziliao acupoints.

[0090] The herbal hydrogel eye patch is to be used for 10-30 minutes each time, once a day, for a course of treatment of 7 days a week.

[0091] The following specific examples illustrate the implementation of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention.

[0092] Before further describing specific embodiments of the present invention, it should be understood that the scope of protection of the present invention is not limited to the specific embodiments described below; it should also be understood that the terminology used in the embodiments of the present invention is for describing specific embodiments and not for limiting the scope of protection of the present invention; in the specification and claims of the present invention, unless otherwise expressly stated in the text, the singular forms "a", "an" and "this" include the plural forms.

[0093] When numerical ranges are given in the embodiments, it should be understood that, unless otherwise stated in the present invention, both endpoints of each numerical range and any value between the two endpoints may be selected. Unless otherwise defined, all technical and scientific terms used in this invention have the same meaning as commonly understood by one of ordinary skill in the art. In addition to the specific methods, apparatus, and materials used in the embodiments, based on the knowledge of the prior art possessed by one of ordinary skill in the art and the description of this invention, any prior art methods, apparatus, and materials similar to or equivalent to those described, apparatus, and materials in the embodiments of this invention may be used to implement the present invention.

[0094] The raw materials (or medicinal materials) used in this invention can all be purchased from ordinary pharmacies or Chinese medicine sales companies, and their specifications comply with national pharmaceutical standards or relevant regulations such as the Chinese Pharmacopoeia.

[0095] In the following embodiments of the present invention, a specific nonwoven fabric is used. The nonwoven fabric is made of polyester fiber, with a size of 6cm × 8cm / sheet and a weight of 0.4g.

[0096] Example 1

[0097] The specific steps for preparing traditional Chinese medicine extracts are as follows:

[0098] 1) Take 15g of ginseng, 15g of Alpinia oxyphylla, 15g of Pteris vittata, 15g of chrysanthemum, 15g of Corydalis yanhusuo, 15g of Asparagus cochinchinensis, 15g of Citrus aurantium, and 7g of peppermint.

[0099] 2) After mixing the above raw material components, add water and boil for 1 hour. The amount of water added is 1 kg.

[0100] 3) After decoction, the filtrate is collected by filtration and concentrated to a relative density of 1.0 to water. The pressure for vacuum concentration is 15 MPa.

[0101] 4) The concentrated filtrate is spray-dried at an inlet temperature of 150°C and an outlet temperature of 120°C to obtain the Chinese herbal extract.

[0102] Example 2

[0103] The specific steps for preparing traditional Chinese medicine extracts are as follows:

[0104] 1) Take 12g of ginseng, 12g of Alpinia oxyphylla, 12g of Pteris vittata, 12g of chrysanthemum, 12g of Corydalis yanhusuo, 12g of Asparagus cochinchinensis, 12g of Citrus aurantium, and 6g of peppermint.

[0105] 2) After mixing the above raw material components, add water and boil for 1 hour. The amount of water added is 1 kg.

[0106] 3) After decoction, the filtrate is collected by filtration and concentrated to a relative density of 1.0 to water. The pressure for vacuum concentration is 15 MPa.

[0107] 4) The concentrated filtrate is spray-dried at an inlet temperature of 150°C and an outlet temperature of 120°C to obtain the Chinese herbal extract.

[0108] Example 3

[0109] The specific steps for preparing traditional Chinese medicine extracts are as follows:

[0110] 1) Take 10g of ginseng, 10g of Alpinia oxyphylla, 10g of Pteris vittata, 10g of chrysanthemum, 10g of Corydalis yanhusuo, 10g of Asparagus cochinchinensis, 10g of Citrus aurantium, and 5g of peppermint.

[0111] 2) After mixing the above raw material components, add water and boil for 1 hour. The amount of water added is 1 kg.

[0112] 3) After decoction, the filtrate is collected by filtration and concentrated to a relative density of 1.0 to water. The pressure for vacuum concentration is 15 MPa.

[0113] 4) The concentrated filtrate is spray-dried at an inlet temperature of 150°C and an outlet temperature of 120°C to obtain the Chinese herbal extract.

[0114] Example 4

[0115] The specific steps for preparing traditional Chinese medicine hydrogels are as follows:

[0116] 1) Take 6g of the Chinese herbal extract prepared in Example 1, 10g of sodium carboxymethyl cellulose (number average molecular weight of 263.2), 2g of citric acid, 200g of purified water, 3g of borneol, 25g of glycerol, 2g of sorbitol, and 0.2g of aluminum hydroxide, mix them well, and obtain crude gel.

[0117] 2) Remove air bubbles using a vacuum degassing mixer to obtain a Chinese herbal hydrogel.

[0118] Example 5

[0119] The specific steps for preparing traditional Chinese medicine hydrogels are as follows:

[0120] 1) Take 7.8g of the Chinese herbal extract prepared in Example 2, 10g of sodium carboxymethyl cellulose (number average molecular weight of 263.2), 2g of citric acid, 200g of purified water, 3g of borneol, 25g of glycerol, 2g of sorbitol, and 0.2g of aluminum hydroxide, mix them well, and obtain crude gel.

[0121] 2) Remove air bubbles using a vacuum degassing mixer to obtain a Chinese herbal hydrogel.

[0122] Example 6

[0123] The specific steps for preparing traditional Chinese medicine hydrogels are as follows:

[0124] 1) Take 9.8g of the herbal extract prepared in Example 3, 10g of sodium carboxymethyl cellulose (number average molecular weight of 263.2), 2g of citric acid, 200g of purified water, 3g of borneol, 25g of glycerol, 2g of sorbitol, and 0.2g of aluminum hydroxide, mix them well, and obtain crude gel.

[0125] 2) Remove air bubbles using a vacuum degassing mixer to obtain a Chinese herbal hydrogel.

[0126] Example 7

[0127] Prepare combination products for the treatment or adjunctive treatment of dry eye syndrome, including herbal hydrogel eye patches and sodium hyaluronate eye drops.

[0128] The preparation method of the herbal hydrogel eye patch is as follows: Take 9.2g of the herbal hydrogel prepared in Example 4, coat the gel evenly on the non-woven fabric base film, cover it, and cool it to obtain the patch.

[0129] Example 8

[0130] Prepare combination products for the treatment or adjunctive treatment of dry eye syndrome, including herbal hydrogel eye patches and sodium hyaluronate eye drops.

[0131] The preparation method of the herbal hydrogel eye patch is as follows: take 10.3g of the herbal hydrogel prepared in Example 5, coat the gel evenly on the non-woven fabric base film, cover it, and cool it to obtain the patch.

[0132] Example 9

[0133] Prepare combination products for the treatment or adjunctive treatment of dry eye syndrome, including herbal hydrogel eye patches and sodium hyaluronate eye drops.

[0134] The preparation method of the herbal hydrogel eye patch is as follows: Take 11.1g of the herbal hydrogel prepared in Example 6, coat the gel evenly on the non-woven fabric base film, cover it, and cool it to obtain the patch.

[0135] Application Example 1

[0136] The efficacy of the combined product prepared in Example 7 of this invention was tested.

[0137] Clinical cases: A total of 800 people with dry eye syndrome were included. Patients with a history of intraocular surgery, ocular trauma, or serious cardiovascular and cerebrovascular diseases, glaucoma, uveitis, etc. were excluded.

[0138] They were randomly divided into a combination treatment group, a single treatment group, and a control group, aged 4 to 60 years.

[0139] The combined treatment group consisted of 400 patients (400 eyes), including 220 males and 180 females, with a disease course ranging from 3 days to 2 years.

[0140] The single treatment group consisted of 400 patients (400 eyes), including 210 males and 190 females, with a disease course ranging from 3 days to 2 years.

[0141] The control group consisted of 400 cases (400 eyes), including 240 males and 160 females, with a disease course ranging from 3 days to 2 years.

[0142] There were no statistically significant differences in general characteristics among the three groups (P>0.05), indicating they were comparable.

[0143] The combined treatment group was given sodium hyaluronate eye drops four times a day for two consecutive weeks, and combined with the herbal hydrogel eye patch provided in Example 7 of this invention, once a day for 15-20 minutes each time, for two consecutive weeks.

[0144] The medication method for the single treatment group was as follows: the herbal hydrogel eye patch provided in Example 7 of the present invention was used once a day for 15-20 minutes each time, and the patch was used continuously for 2 weeks.

[0145] The control group received sodium hyaluronate eye drops four times a day for two consecutive weeks.

[0146] The three groups of patients were observed and recorded on the first day of their visit and at each follow-up visit at the end of the week, for a total of 2 weeks. On the day of each follow-up visit, before treatment, the clinical ocular FL, SIT, BUT, and tear TNF-α and IL-6 levels were observed and recorded.

[0147] Observation indicators

[0148] The efficacy evaluation criteria are based on the "drying of the divine water" standard to assess the overall efficacy of the patient's treatment.

[0149] ① Cured, efficacy index (N) = 70%, FL negative, tear secretion test (Schirmer Itest, SIT) > 10 mm / 5 min without topical anesthesia, tear film breakup time (BUT) > 10 s;

[0150] ② Improvement, 30%≤N<70%, with significant improvement in fluorescein staining (FL) of the cornea and conjunctiva, while SIT and BUT show an increasing trend;

[0151] ③ Invalid, N<30%, other indicators unchanged. FL, SIT, and BUT were measured. FL was measured using a 12-point method, divided into four quadrants, and scored at four levels. The specific scores were calculated to obtain the conclusions.

[0152] Detection of TNF-α and IL-6 levels in tears

[0153] ① Before and two weeks after treatment, nursing staff need to collect 15 μL of tears from the patient's tear duct using a capillary aspiration method in the morning and store it in a refrigerator at -80°C for subsequent examination.

[0154] ② The instrument used is the Synergy2 multifunctional microplate reader. TNF-α and IL-6 are both measured using enzyme-linked immunosorbent assay (ELISA).

[0155] Statistical analysis was performed using SPSS 25.0. Count data were expressed as [n(%)] and analyzed using the chi-square test; continuous data were expressed as (x±s) and analyzed using the t-test. P<0.05 was considered statistically significant.

[0156] The experimental results were statistically analyzed. Table 1 shows the comparison of efficacy among the three groups after 2 weeks of treatment; Table 2 shows the comparison of TNF-α and IL-6 levels among the three groups; Table 3 shows the comparison of FL, SIT, and BUT levels before and after treatment among the three groups.

[0157] Table 1. Effective rates in the three groups of patients

[0158] Group Cure Markedly effective Effective Ineffective Total effective rate Combination therapy group 60 150 160 30 0.925 1,2) ]]> Single therapy group 45 132 134 89 0.7775 Control group 40 130 130 100 0.75

[0159] Note: 1) indicates that the total effective rate of the combined treatment group was significantly different from that of the control group (P < 0.05); 2) indicates that the total effective rate of the combined treatment group was significantly different from that of the single treatment group (P < 0.05).

[0160] As shown in Table 1, the total effective rate of the combined treatment group was 92.5%, which was higher than the total effective rate of 75.0% in the control group. Meanwhile, the total effective rate of the single treatment group was 77.8%, also higher than the total effective rate of the control group. Furthermore, the cure index, significant effect index, and effective index of both the combined treatment group and the single treatment group were higher than those of the control group. This indicates that the combined treatment method provided by this invention or the hydrogel eye patch prepared by this invention alone can effectively treat dry eye syndrome.

[0161] Table 2 Comparison of TNF-α and IL-6 levels in tears of the three groups of patients

[0162]

[0163] Note: *P<0.01 compared with the group before treatment, 1)P<0.01 compared with the control group after treatment, 2)P<0.01 compared with the single treatment group after treatment.

[0164] Table 2 shows that all three treatment regimens significantly reduced the levels of TNF-α and IL-6 in tears (all P < 0.01). Specifically, the levels of TNF-α (15.3 ± 1.8 ng / L) and IL-6 (30.8 ± 5.7 ng / L) in the combined treatment group were significantly lower than those in the control group and the single treatment group (all P < 0.01). Although there was no statistically significant difference between the single treatment group and the control group, the single treatment group was more effective than the control group. The results indicate that the combined treatment regimen is superior to single treatment and the control treatment in treating dry eye syndrome.

[0165] Table 3 Comparison of FL, SIT, and BUT levels before and after treatment in the three groups of patients

[0166]

[0167] *Compared with the group before treatment, P<0.01; 1)Compared with the control group after treatment, P<0.01; 2)Compared with the single treatment group after treatment, P<0.01.

[0168] Table 3 shows that all three treatment groups showed significant improvements in FL score, SIT value, and BUT compared to pre-treatment levels (P < 0.01). The combined treatment group had a significantly lower FL score (0.86 ± 0.25) than the control group (1.51 ± 0.32) and the single treatment group (1.41 ± 0.23), while the combined treatment group had significantly higher SIT (9.72 ± 1.23 mm) and BUT (9.83 ± 1.01 s) than the control group (8.12 ± 0.99 mm, 7.01 ± 1.56 s) and the single treatment group (8.30 ± 0.97 mm, 7.77 ± 1.43 s), with statistically significant differences (all P < 0.01). There were no statistically significant differences in these indicators between the control group and the single treatment group. These results suggest that the combined treatment regimen is superior to single treatment and conventional control treatment in improving corneal fluorescein staining, prolonging tear film breakup time, and increasing tear secretion.

[0169] The above embodiments are for illustrating the implementation schemes disclosed in this invention and should not be construed as limiting the invention. Furthermore, various modifications and variations of the methods listed herein will be apparent to those skilled in the art without departing from the scope and spirit of the invention. Although the invention has been specifically described in conjunction with various specific preferred embodiments, it should be understood that the invention should not be limited to these specific embodiments. In fact, various modifications as described above that are obvious to those skilled in the art to obtain the invention should be included within the scope of this invention.

Claims

1. A traditional Chinese medicine composition, characterized in that, By weight, it includes the following components: Ginseng 6-15 parts, Alpinia oxyphylla 6-15 parts, Prickly ash 6-15 parts, Chrysanthemum 6-15 parts, Corydalis yanhusuo 6-15 parts, Asparagus cochinchinensis 6-15 parts, Citrus aurantium 6-15 parts, Mentha haplocalyx 3-9 parts.

2. A traditional Chinese medicine extract, characterized in that, It is prepared from the traditional Chinese medicine composition described in claim 1.

3. The method for preparing the traditional Chinese medicine extract according to claim 2, characterized in that, The traditional Chinese medicine composition of claim 1 is extracted to obtain an extract, which is the traditional Chinese medicine extract.

4. The method according to claim 3, characterized in that, The extraction method is a decoction method; And / or, the solvent for the extraction is water; And / or, it also includes pretreatment of the traditional Chinese medicine composition before soaking; preferably, the pretreatment is soaking; And / or, during extraction, the weight ratio of the traditional Chinese medicine composition to the solvent is 1:(10-20); And / or, the extraction temperature for components other than peppermint is 80–90°C, and / or, the extraction temperature for peppermint is 40–60°C; And / or, the extraction time is 60–120 min; And / or, it also includes concentrating and drying the collected extract; preferably, the relative density of the concentrated product is 0.9 to 1.

1.

5. A traditional Chinese medicine hydrogel, characterized in that, The herbal hydrogel comprises the herbal extract and gel matrix as described in claim 2; the concentration of the herbal extract is 2-10 g / L, based on the volume of the gel matrix.

6. The herbal hydrogel according to claim 5, characterized in that, The gel matrix, by weight, comprises the following components: Borneol 1-5 parts, sodium carboxymethyl cellulose 10-20 parts, glycerol 20-30 parts, citric acid 1-3 parts, sorbitol 1-3 parts, aluminum hydroxide 0.1-0.3 parts, water 150-300 parts.

7. A traditional Chinese medicine hydrogel eye patch, characterized in that, The eye patch comprises a nonwoven fabric base film and the traditional Chinese medicine hydrogel as described in claim 5, wherein the amount of the traditional Chinese medicine hydrogel is 0.15–0.2 g / cm² relative to the area of ​​the nonwoven fabric base film. 2 .

8. The herbal hydrogel eye patch according to claim 7, characterized in that, The nonwoven fabric base film is made of polyester fiber.

9. Use of the traditional Chinese medicine composition as described in claim 1, the traditional Chinese medicine extract as described in claim 2, the traditional Chinese medicine hydrogel as described in claim 5, or the traditional Chinese medicine hydrogel eye patch as described in claim 7 in the preparation of products for the treatment or adjunctive treatment of dry eye syndrome.

10. The use according to claim 9, characterized in that, The product has one or more of the following effects: 1) Improves corneal fluorescein staining; 2) Prolong tear film breakup time; 3) Increase tear secretion.

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