CN112426462B - Hydrogel eye patch for adjuvant therapy of central serous chorioretinopathy and preparation method thereof - Google Patents

Hydrogel eye patch for adjuvant therapy of central serous chorioretinopathy and preparation method thereof Download PDF

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CN112426462B
CN112426462B CN202110008288.7A CN202110008288A CN112426462B CN 112426462 B CN112426462 B CN 112426462B CN 202110008288 A CN202110008288 A CN 202110008288A CN 112426462 B CN112426462 B CN 112426462B
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extract
tea
essential oil
eye patch
water
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CN112426462A (en
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陈玲
李晓
范毅
宁二娟
王学方
魏悦
李智宁
于立芹
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Henan Napu Biotechnology Co ltd
Henan Academy of Sciences
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Henan Napu Biotechnology Co ltd
Henan Academy of Sciences
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Abstract

The invention relates to a hydrogel eye patch for adjuvant therapy of central serous chorioretinopathy, which mainly comprises the following raw materials in percentage by weight: 0.01-0.04% of tea essential oil, 0.2-0.8% of tea polyphenol, 0.1-0.6% of theanine, 0.1-0.6% of tea pigment, 0.01-0.04% of jasmine essential oil, 0.2-1.0% of safflower extract, 0.2-1.0% of salvia miltiorrhiza extract, 0.2-1.5% of kudzu root extract, 0.2-1.5% of dandelion extract, 0.2-1.5% of feather cockscomb seed extract, 0.2-1.5% of rhizoma atractylodis extract, 0.2-1.0% of cluster mallow seed extract, 0.2-1.0% of liquorice extract, 10-25% of high polymer material, 20-30% of glycerol, 0.1-0.5% of citric acid, 1-3% of sorbitol, 0.1-0.3% of aluminum hydroxide and the balance of purified water. The hydrogel eye patch is an external patch, has the fragrance of jasmine green tea, can promote absorption of subretinal effusion, shorten course of disease, improve vision, and has effects of tranquilizing mind, removing wrinkle, etc.

Description

Hydrogel eye patch for adjuvant therapy of central serous chorioretinopathy and preparation method thereof
Technical Field
The invention belongs to the technical field of eye patches, and particularly relates to a hydrogel eye patch for adjuvant therapy of central serous chorioretinopathy and a preparation method thereof.
Background
Central Serous Chorioretinopathy (CSC), known as "intermediate serous fluid", is a common lesion of macular portion of the fundus oculi, which is characterized by macular region, mainly macular region, and localized serous superficial detachment of retinal neuroepithelium of the retina nearby, caused by retinal pigment epithelium damage. The disease is mostly seen in men of 20-45 years old, and is a self-limiting disease with the onset of monocular disease. The patient shows sudden monocular vision loss, blurred vision, poor color, diminished vision, distortion of straight lines, etc. Although most patients can recover themselves within 3-6 months, the patients who recover themselves are easy to relapse, and after the patients relapse for many times, irreversible damages such as visual function reduction and vision deterioration can be caused, which has great influence on the work and life of the patients.
The disease is induced by factors such as mental stress, poor sleep, emotional disorder, fatigue, irritation of smoking and wine, pathogen and systemic infection, allergic diseases, external cold influence, etc. Therefore, prevention and early treatment should be premised.
Belongs to the categories of symptoms such as Chinese traditional medicine vision awn-manow, vision blackness, vision positive and negative inclination, vision confusion and the like. It is mainly related to the dysfunction of liver, spleen and kidney. Spleen failing to transport and transform, damp turbidity rising, emotional damage to liver, liver depression, qi stagnation, qi, blood and body fluids abnormal transportation, blood stasis and damp stagnation, which are prone to cause this disease.
At present, the methods for treating CSC mainly comprise laser photocoagulation, photodynamic therapy (PDT), micro-pulse laser, transpupillary thermotherapy (TTT), indocyanine green mediated light embolism therapy and other treatment methods; however, the above treatment methods have certain limitations and adverse reactions, such as laser photocoagulation, which can accelerate the absorption of retinal edema, shorten the course of disease and reduce the incidence of diseases; but not for the cause, and cannot prevent recurrence. In the aspect of traditional Chinese medicine treatment, the treatment methods such as a traditional Chinese medicine extraction preparation, a compound preparation, an empirical formula and the like are adopted, so that the effect is better, but the traditional Chinese medicine treatment has the problems of long treatment course, inconvenience in use and the like.
Disclosure of Invention
The invention aims to overcome the defects of the prior art and provides a hydrogel eye patch for assisting in treating central serous chorioretinopathy, which is an external patch, has the faint scent of jasmine green tea, can promote absorption of subretinal effusion, shortens the course of disease, improves the vision, and has the effects of soothing the nerves, resisting wrinkles and the like.
The invention also provides a preparation method of the hydrogel eye patch for adjuvant therapy of central serous chorioretinopathy.
In order to achieve the purpose, the invention adopts the following technical scheme:
a hydrogel eye patch for adjuvant therapy of central serous chorioretinopathy is mainly composed of the following raw materials in percentage by weight: 0.01-0.04% of tea essential oil, 0.2-0.8% of tea polyphenol, 0.1-0.6% of theanine, 0.1-0.6% of tea pigment, 0.01-0.04% of jasmine essential oil, 0.2-1.0% of safflower extract, 0.2-1.0% of salvia miltiorrhiza extract, 0.2-1.5% of kudzu root extract, 0.2-1.5% of dandelion extract, 0.2-1.5% of feather cockscomb seed extract, 0.2-1.5% of atractylodes rhizome extract, 0.2-1.0% of cluster mallow seed extract, 0.2-1.0% of liquorice extract, 10-25% of high polymer material, 20-30% of glycerol, 0.1-0.5% of citric acid, 1-3% of sorbitol, 0.1-0.3% of aluminum hydroxide and the balance of purified water (preferably 40-60% of purified water).
Specifically, the polymer material is used as a hydrogel matrix, and can be one or a mixture of more than two of sodium polyacrylate, polyacrylic acid, polymethacrylic acid, polyvinyl alcohol, polyacrylamide, sodium carboxymethylcellulose and the like.
Specifically, the tea essential oil, the tea polyphenol and the theanine can be directly purchased from common commercial products, and can also be prepared by adopting the following steps:
pulverizing green tea (40 mesh), and performing CO treatment 2 Performing supercritical extraction to obtain tea essential oil, wherein the extraction temperature is 20-60 ℃, the pressure is 10-20MPa, and the extraction time is 1-6 h;
CO is introduced into 2 Adding water 10-30 times the weight of folium Camelliae sinensis residue into the folium Camelliae sinensis residue after supercritical extraction, extracting at 40-90 deg.C for 1-3h, filtering, concentrating the filtrate under reduced pressure to about 20% of the initial volume, separating and purifying with cation exchange resin (such as 732 cation exchange resin or Dowex 50 cation exchange resin, etc.), eluting with water 6-10 times the column volume, collecting eluate A; then using ammonia water with the pH value of 8-11 as an eluting solvent, collecting to obtain an eluent B, adjusting the pH value of the eluent B to be neutral by using dilute hydrochloric acid, concentrating under reduced pressure to obtain a paste, adding 90-95% ethanol which is 3-8 times of the weight of the paste to dissolve, filtering, standing the filtrate at low temperature (0-4 ℃) overnight to separate out crystals, and drying the crystals to obtain theanine with the purity of over 80%;
separating and purifying the eluent A with macroporous adsorbent resin (such as D101 or AB-8 macroporous adsorbent resin), washing with water until sugar-free solution flows out (determining sugar-free when Molish reaction is negative), washing with 40-90% ethanol 4-8 times column volume, collecting eluate, concentrating under reduced pressure until relative density is 0.9-1.1, and spray drying (air inlet temperature 140 deg.C, air outlet temperature 100 deg.C) to obtain tea polyphenols with purity of above 70%.
Specifically, the tea pigment can be directly purchased from common commercial products, and can also be prepared by adopting the following steps: mixing green tea with petroleum ether or ethyl acetate 6-10 times of green tea, reflux extracting (2-3 times for 1-2 hr each time), and concentrating the extractive solution under reduced pressure to obtain tea pigment with purity of over 50%.
Specifically, the jasmine essential oil can be directly purchased from common commercial products, and can also be prepared by adopting the following steps: pulverizing flos Jasmini sambac, and performing CO treatment 2 Super clinical medicineExtracting at 20-60 deg.C under 10-20MPa for 1-6h to obtain flos Jasmini sambac essential oil.
Further, the safflower extract, the salvia extract, the pueraria extract, the dandelion extract, the feather cockscomb seed extract, the atractylodes extract, the cluster mallow seed extract and the liquorice extract can be directly purchased from common commercial products, and can also be prepared by adopting the following steps: respectively mixing the raw material medicines of safflower, salvia miltiorrhiza, kudzu root, dandelion, feather cockscomb seed, rhizoma atractylodis, cluster mallow seed or liquorice with water which is 10-20 times of the weight of the raw material medicines, decocting for 1-2h, filtering, concentrating the filtrate under reduced pressure until the relative density is 0.9-1.1, and performing spray drying (the air inlet temperature is 140-.
The invention also provides a preparation method of the hydrogel eye patch for adjuvant therapy of central serous chorioretinopathy, which specifically comprises the following steps:
1) mixing tea polyphenols, theanine, Carthami flos extract, Saviae Miltiorrhizae radix extract, radix Puerariae extract, herba Taraxaci extract, semen Celosiae extract, rhizoma Atractylodis extract, semen Abutili extract, Glycyrrhrizae radix extract, part of polymer material, citric acid and purified water to form water phase;
2) mixing tea leaf essential oil, tea pigment, jasmine essential oil, glycerol, sorbitol, aluminum hydroxide and the balance of high polymer material uniformly to form a glycerol phase;
3) uniformly stirring the water phase and the glycerol phase to obtain a crude gel product; removing bubbles by using a vacuum defoaming stirrer, uniformly coating on non-woven fabric, laminating, and cooling to obtain the hydrogel eye patch.
In the hydrogel eye patch formula for the adjuvant therapy of central serous chorioretinopathy, the traditional Chinese medicine raw materials have the following effects:
the record of Shennong Ben Cao Jing records that the tea leaves taken for a long time can 'ease heart, tonify qi, lighten body and resist aging'. In the Ming Dynasty, the tea book of Yuan Qing is recorded: the tea has effects of quenching thirst, resolving food stagnation, eliminating phlegm, promoting urination, improving eyesight, benefiting intelligence, relieving restlessness, and removing greasiness. According to xi Rubia, the number of prescriptions for treating eye diseases is 130 in all the tea-containing prescriptions in all generations. Modern pharmacological research proves that the tea has multiple effects of resisting oxidation, resisting inflammation, resisting cancer, reducing blood pressure, reducing blood fat, protecting heart vessels and the like. The tea is rich in tea essential oil, tea polyphenol, tea pigment, tea polysaccharide, theanine and other components. The tea essential oil is essence in tea, has pleasant tea fragrance, and has effects of resisting oxidation and relieving nerve. Tea polyphenols have strong antioxidant effect, and can inhibit collagenase and elastase, prevent elastin content from decreasing or denaturing, maintain skin elasticity, and remove wrinkle. In addition, tea polyphenols can enhance resistance and elasticity of capillary vessel, increase blood flow, promote microcirculation of skin blood, and promote blood circulation for removing blood stasis. The research of Wangyuefei and the like finds that the tea polyphenol can enhance the oxidation resistance of the liver of a mouse and inhibit the liver injury caused by lipid peroxidation, thereby ensuring the normal function of the liver. Theanine is a non-protein amino acid in tea, is a main functional component of tea, and has physiological activities of resisting oxidation, resisting aging, relaxing nervous tension, protecting nervous system, etc. The tea pigment is a specific pure natural edible pigment in tea, mainly comprises theaflavin, theabrownin, thearubigins and theaviridin, can effectively reduce the formation of free radicals and inhibit lipid peroxidation, thereby having the function of resisting aging, and simultaneously having pharmacological actions of reducing blood fat, resisting atherosclerosis, enhancing immunologic function, improving microcirculation and the like.
The jasmine essential oil has the following effects: the jasmine essential oil has the effects of promoting blood circulation, removing blood stasis and soothing nerves, and is extremely relaxed. The jasmine essential oil is combined with the tea essential oil, so that the jasmine tea has jasmine green tea faint scent, can relieve nerves, relax body and mind and relax eyes, and has the effects of moisturizing, resisting wrinkles and the like.
Safflower, a dried flower of safflower belonging to the genus Carthamus of the family Compositae, is warm in nature, pungent in taste, and has the effects of activating blood and dredging meridians, removing blood stasis and relieving pain, and detoxifying, which were recorded in "Kaibao Bencao". Safflower contains rich active substances such as flavonoid, polysaccharide and yellow pigment, and has effects of inhibiting inflammation, resisting oxidation and cancer, inhibiting tyrosinase activity, and preventing cerebral or myocardial ischemia reperfusion injury. The safflower has the functions of changing the rheological property of blood, improving microcirculation, reducing blood viscosity and the like.
Dan Shen is slightly cold in nature and bitter in taste, entering heart and liver meridians. Has the effects of promoting blood circulation, regulating menstruation, removing blood stasis, relieving pain, cooling blood, resolving carbuncle, relieving restlessness and tranquilizing mind. Has effects in improving microcirculation, softening blood vessel, and improving myocardium. The salvia miltiorrhiza bunge and the main components thereof also have obvious protective effect on liver injury models prepared from carbon tetrachloride, D-galactosamine, alcohol and the like. Clinically, Dan and hong Hua are often combined to treat blood stasis and pain.
Radix Puerariae has effects of expelling pathogenic factors from muscles, reducing fever, promoting eruption, promoting fluid production, quenching thirst, invigorating yang and relieving diarrhea. The kudzuvine root has the efficacy of protecting the liver, is not easy to generate side effect, and can effectively assist in treating liver diseases. The pueraria flavonid has obvious protective effect on chronic liver injury animal models, and the puerarin which is the main active ingredient in the pueraria flavonid has the functions of resisting myocardial fibrosis injury, relaxing blood vessels, resisting artery calcification and atherosclerosis, promoting angiogenesis, improving micro blood flow, resisting platelet aggregation, reducing fat, resisting diabetes and the like. Puerarin can relieve oxidative stress injury caused by acute alcoholism, thereby protecting liver.
The dandelion and the dandelion are bitter in taste, cold in nature and non-toxic, enter liver and stomach channels, and have the effects of clearing away heat and toxic materials, reducing swelling and dissipating stagnation, and inducing diuresis for treating stranguria. Mainly contains chemical components of flavonoid, polysaccharide, organic acid substances and the like, and the effective components have the effects of improving the immunity of the organism, resisting bacteria, viruses, parasites, tumors, aging and the like.
Feather cockscomb seed, bitter and slightly cold. It enters liver meridian. Has the functions of clearing away liver heat, purging fire, improving eyesight and eliminating nebula. Can be used for treating liver heat with conjunctival congestion, nebula generation, blurred vision, and liver fire vertigo. Modern researches show that the Qinghuo has the effects of protecting liver, resisting cataract, resisting tumor, regulating immunity, resisting diabetes, resisting cardiovascular diseases, resisting bacteria and the like.
Cang Zhu is pungent and bitter in flavor and warm in nature. It enters spleen, stomach and liver meridians. Has the effects of eliminating dampness, strengthening spleen, dispelling pathogenic wind, dispelling cold, and improving eyesight. Mainly treats dampness obstruction of middle energizer, abdominal distention, diarrhea, edema, beriberi atrophy 36484, rheumatism and arthralgia, wind-cold type common cold, night blindness, dim eyes and unsmooth eyes. Pharmacological research shows that the rhizoma atractylodis and the extract thereof have the effects of resisting inflammation, resisting tumor, regulating immunity and the like.
Abelmoschus seeds, sweet in flavor and cold in nature. It enters large intestine, small intestine and bladder meridians. Is a common medicinal material of Mongolian, and has the effects of clearing away heat and toxic materials, promoting blood circulation, promoting urination, eliminating swelling and pain, and the like. Researches show that the malva seeds contain rich vegetable protein, anthocyanin and polysaccharide, and are beneficial to supplementing nutrition for patients, enhancing self resistance and repairing the capability of tissue damage.
Licorice root, radix Glycyrrhizae is sweet in flavor and neutral in nature. It enters heart, lung, spleen and stomach meridians. Has the effects of invigorating spleen and replenishing qi, clearing away heat and toxic materials, eliminating phlegm and stopping cough, relieving spasm and pain, and harmonizing the medicines.
In the formula of the hydrogel eye patch for assisting in treating central serous chorioretinopathy, tea essential oil, tea polyphenol, theanine, tea pigment, jasmine essential oil, a safflower extract, a salvia miltiorrhiza extract, a radix puerariae extract, a dandelion extract, a feather cockscomb seed extract, a rhizoma atractylodis extract, a cluster mallow seed extract and a liquorice extract are used as main functional components, a high polymer material is used as a hydrogel matrix, propylene glycol or glycerol is used as a humectant and a medicinal component dissolving agent, citric acid is used as a pH regulator, sorbitol is used as a humectant, and aluminum hydroxide is used as a cross-linking agent; compared with the prior art, the hydrogel eye patch has the following beneficial effects:
1) the hydrogel eye patch can effectively assist postoperative and traditional Chinese medicine and the like in treating central serous chorioretinopathy, can shorten the course of disease and improve vision, and has the effects of soothing nerves, resisting wrinkles and the like. The eye patch can be carried about and is convenient to use;
2) the effective components of the hydrogel eye mask traditional Chinese medicine are extracted from medicine-food homologous and conventional traditional Chinese medicines, and have no toxic or side effects and the like.
Detailed Description
The technical solution of the present invention is further described in detail with reference to the following examples, but the scope of the present invention is not limited thereto.
Example 1
A hydrogel eye patch for adjuvant therapy of central serous chorioretinopathy is prepared from the following raw materials in percentage by weight: 0.01% of tea essential oil, 0.2% of tea polyphenol, 0.5% of theanine, 0.2% of tea pigment, 0.01% of jasmine essential oil, 0.5% of safflower extract, 0.5% of salvia miltiorrhiza extract, 0.8% of kudzuvine root extract, 0.8% of dandelion extract, 1.0% of feather cockscomb seed extract, 0.2% of rhizoma atractylodis extract, 0.5% of cluster mallow seed extract, 0.5% of liquorice extract, 8% of polyacrylamide, 11% of sodium polyacrylate, 23% of glycerol, 0.2% of citric acid, 1% of sorbitol, 0.1% of aluminum hydroxide and 50.98% of purified water.
The preparation method of the tea essential oil comprises the following steps: pulverizing green tea (40 mesh), and performing CO treatment 2 Performing supercritical extraction at 30 deg.C under 10MPa for 2 hr to obtain tea essential oil. The preparation method of the jasmine essential oil refers to tea essential oil.
The preparation method of the theanine and the tea polyphenol comprises the following steps:
CO generated in the preparation process of the tea essential oil 2 Adding water which is 10 times of the weight of the tea leaves into the tea leaves after supercritical extraction, extracting for 1.5h at 40 ℃, filtering, extracting twice, combining filtrates of the two times, concentrating under reduced pressure to about 20% of the initial volume, separating and purifying by using 732 cation exchange resin, washing by using water which is 6 times of the column volume as an elution solvent, and collecting to obtain an eluent A; then, ammonia water with pH =8 is used as an elution solvent for washing, eluent B is collected and obtained, the pH of the eluent B is adjusted to be neutral by dilute hydrochloric acid, the eluent B is concentrated into paste under reduced pressure, 95% ethanol with the weight 8 times that of the paste is added for dissolving, the filtering is carried out, the filtrate is placed at low temperature (0-4 ℃) overnight for precipitating crystals, and the crystals are dried to obtain theanine with the purity of 80%. Separating and purifying the eluent A by using D101 macroporous adsorption resin, washing with a large amount of water until a sugar-free solution flows out (the molish reaction is negative), then washing with 40% ethanol with 4 times of column volume, collecting the eluent, concentrating under reduced pressure until the relative density is 1.1, and performing spray drying (the air inlet temperature is 140 ℃, and the air outlet temperature is 100 ℃) to obtain the tea polyphenol with the purity of more than 70%.
The preparation method of the tea pigment comprises the following steps: mixing green tea leaf with petroleum ether 6 times of green tea leaf, reflux extracting for 2 times (1 hr each time), mixing extractive solutions, and concentrating under reduced pressure to obtain tea pigment with purity of over 50%.
The safflower extract, the salvia extract, the kudzuvine root extract, the dandelion extract, the feather cockscomb seed extract, the atractylodes rhizome extract, the cluster mallow seed extract and the liquorice extract are prepared by adopting the following steps: respectively mixing the raw material medicines of safflower, salvia miltiorrhiza, kudzu root, dandelion, feather cockscomb seed, rhizoma atractylodis, cluster mallow seed and liquorice with water 15 times the weight of the raw material medicines, decocting for 1h (twice decocting), filtering, combining the two filtrates, concentrating under reduced pressure until the relative density is 1.0, and performing spray drying (the air inlet temperature is 140-.
The preparation method of the hydrogel eye patch for adjuvant therapy of central serous chorioretinopathy comprises the following specific steps:
1) mixing tea polyphenols, theanine, Carthami flos extract, Saviae Miltiorrhizae radix extract, radix Puerariae extract, herba Taraxaci extract, semen Celosiae extract, rhizoma Atractylodis extract, semen Abutili extract, Glycyrrhrizae radix extract, part of polymer material (polyacrylamide and sodium polyacrylate), citric acid and purified water, stirring to obtain water phase;
2) fully stirring and uniformly mixing tea essential oil, tea pigment, jasmine essential oil, glycerol, sorbitol, aluminum hydroxide and the balance of high polymer materials to form a glycerol phase, wherein no blocky solid exists in the glycerol phase;
3) adding the water phase into the glycerol phase, and continuously stirring for 30 minutes to uniformly mix to obtain a gel crude product; removing bubbles by using a vacuum defoaming stirrer to form a bubble-free hydrogel product, then uniformly coating the bubble-free hydrogel product on non-woven fabric by using a hydrogel coating machine, coating the non-woven fabric to the thickness of 1mm, covering a film, and cooling to obtain the hydrogel eye patch.
Example 2
A hydrogel eye patch for adjuvant therapy of central serous chorioretinopathy is prepared from the following raw materials in percentage by weight: 0.02% of tea essential oil, 0.3% of tea polyphenol, 0.4% of theanine, 0.1% of tea pigment, 0.04% of jasmine essential oil, 0.5% of safflower extract, 0.5% of salvia miltiorrhiza extract, 0.4% of kudzu root extract, 0.4% of dandelion extract, 0.8% of feather cockscomb seed extract, 1.0% of rhizoma atractylodis extract, 0.6% of cluster mallow seed extract, 0.2% of liquorice extract, 10% of polyacrylic acid, 10% of sodium polyacrylate, 30% of glycerol, 0.4% of citric acid, 1.8% of sorbitol, 0.2% of aluminum hydroxide and 42.34% of purified water.
The preparation method of the tea essential oil comprises the following steps: pulverizing green tea (40 mesh), and performing CO treatment 2 Performing supercritical extraction at 30 deg.C under 12MPa for 5 hr to obtain tea essential oil. The preparation method of the jasmine essential oil refers to tea essential oil.
The preparation method of the theanine and the tea polyphenol comprises the following steps:
CO generated in the preparation process of the tea essential oil 2 Adding water which is 20 times of the weight of the tea leaves into the tea leaves after supercritical extraction, extracting for 2h at 60 ℃, filtering, extracting twice, combining filtrates of the two times, concentrating under reduced pressure to about 20% of the initial volume, separating and purifying by Dowex 50 cation exchange resin, washing by using water which is 6 times of the column volume as an eluting solvent, and collecting to obtain an eluent A; then, ammonia water with the pH =9 is used as an elution solvent for washing, an eluent B is collected and obtained, the pH of the eluent B is adjusted to be neutral by dilute hydrochloric acid, the eluent B is concentrated into a paste under reduced pressure, 90% ethanol which is 5 times of the weight of the paste is added for dissolving, the filtering is carried out, the filtrate is placed at low temperature (0-4 ℃) overnight to separate out theanine crystals, and the theanine crystals with the purity of 80% are obtained after drying the crystals. Separating and purifying the eluent A by AB-8 macroporous adsorption resin, washing with a large amount of water until a sugar-free solution flows out (molish reaction is negative), then washing with 70% ethanol 6 times the column volume, collecting the eluent, concentrating under reduced pressure until the relative density is 1.0, and performing spray drying (air inlet temperature is 140 ℃, air outlet temperature is 100 ℃) to obtain the tea polyphenol with the purity of more than 70%.
The preparation method of the tea pigment comprises the following steps: mixing green tea with ethyl acetate 10 times of green tea, reflux extracting for 2 times (2 hr each time), mixing extractive solutions, and concentrating under reduced pressure to obtain tea pigment with purity of over 50%.
The safflower extract, the salvia extract, the kudzu root extract, the dandelion extract, the feather cockscomb seed extract, the rhizoma atractylodis extract, the cluster mallow seed extract and the liquorice extract are prepared by the following steps: mixing the raw material medicines of safflower, salvia miltiorrhiza, kudzu root, dandelion, feather cockscomb seed, rhizoma atractylodis, cluster mallow seed and liquorice with 14 times of water by weight of the raw material medicines respectively, decocting for 1h (twice decoction), filtering, combining the filtrates obtained twice, concentrating under reduced pressure until the relative density is 1.05, and performing spray drying (the air inlet temperature is 140-.
The preparation method of the hydrogel eye patch for assisting in treating central serous chorioretinopathy comprises the following specific steps:
1) mixing tea polyphenols, theanine, Carthami flos extract, Saviae Miltiorrhizae radix extract, radix Puerariae extract, herba Taraxaci extract, semen Celosiae extract, rhizoma Atractylodis extract, semen Abutili extract, Glycyrrhrizae radix extract, part of polymer material (polyacrylic acid and sodium polyacrylate), citric acid and purified water, and stirring to obtain water phase;
2) fully stirring and uniformly mixing tea essential oil, tea pigment, jasmine essential oil, glycerol, sorbitol, aluminum hydroxide and the balance of high polymer materials to form a glycerol phase, wherein no blocky solid exists in the glycerol phase;
3) adding the water phase into the glycerol phase, and continuously stirring for 30 minutes to uniformly mix to obtain a crude gel product; removing bubbles by using a vacuum defoaming stirrer to form a bubble-free hydrogel product, uniformly coating the hydrogel product on non-woven fabrics by using a hydrogel coating machine, coating the non-woven fabrics to the thickness of 1mm, laminating, and cooling to obtain the hydrogel eye patch.
Example 3
A hydrogel eye patch for adjuvant therapy of central serous chorioretinopathy is prepared from the following raw materials in percentage by weight: 0.04% of tea essential oil, 0.6% of tea polyphenol, 0.2% of theanine, 0.2% of tea pigment, 0.04% of jasmine essential oil, 0.5% of safflower extract, 0.5% of salvia miltiorrhiza extract, 1.0% of kudzuvine root extract, 1.0% of dandelion extract, 1.5% of feather cockscomb seed extract, 1.2% of rhizoma atractylodis extract, 0.8% of cluster mallow seed extract, 0.2% of liquorice extract, 12% of polymethacrylic acid, 10% of sodium polyacrylate, 3% of sodium carboxymethylcellulose, 25% of glycerol, 0.3% of citric acid, 2% of sorbitol, 0.3% of aluminum hydroxide and 36.62% of purified water.
The preparation method of the tea essential oil comprises the following steps: pulverizing green tea (40 mesh), and subjecting to CO extraction 2 Is obtained by supercritical extractionObtaining the tea essential oil, wherein the extraction temperature is 60 ℃, the pressure is 20MPa, and the extraction time is 1.5 h.
The preparation method of the jasmine essential oil refers to tea essential oil.
The preparation method of the theanine and the tea polyphenol comprises the following steps:
CO generated in the preparation process of the tea essential oil 2 Adding water 30 times the weight of the tea leaves into the tea leaves subjected to supercritical extraction, extracting for 3h at 90 ℃, filtering, extracting twice, combining filtrates, concentrating under reduced pressure to about 20% of the initial volume, separating and purifying by Dowex 50 cation exchange resin, washing by using water 10 times the column volume as an eluting solvent, and collecting to obtain an eluent A; then, ammonia water with pH =10 is used as an elution solvent for washing, eluent B is collected and obtained, the pH of the eluent B is adjusted to be neutral by dilute hydrochloric acid, the eluent B is concentrated into paste under reduced pressure, ethanol which is 4 times of the weight of the paste and is 92 percent is added for dissolving, the filtering is carried out, the filtrate is placed at low temperature (0-4 ℃) overnight to precipitate theanine crystals, and the crystals are dried to obtain theanine with the purity of 80 percent. Separating and purifying the eluent A by AB-8 macroporous adsorption resin, washing with a large amount of water until sugar-free solution flows out (molish reaction is negative), then washing with 90% ethanol with 8 times of column volume, collecting the eluent, concentrating under reduced pressure until the relative density is 0.9, and spray drying (air inlet temperature is 140 ℃, air outlet temperature is 100 ℃) to obtain the tea polyphenol with the purity of more than 70%.
The preparation method of the tea pigment comprises the following steps: mixing green tea with ethyl acetate 10 times of green tea, reflux extracting for 3 times (each time for 1 hr), mixing extractive solutions, and concentrating under reduced pressure to obtain tea pigment with purity of over 50%.
The safflower extract, the salvia extract, the kudzu root extract, the dandelion extract, the feather cockscomb seed extract, the rhizoma atractylodis extract, the cluster mallow seed extract and the liquorice extract are prepared by the following steps: mixing the raw material medicines of safflower, salvia miltiorrhiza, kudzu root, dandelion, feather cockscomb seed, rhizoma atractylodis, cluster mallow seed or liquorice with water of 20 weight times of the raw material medicines respectively, decocting for 2 hours (the filter residue is decocted once again, and the decoction is carried out twice in total), filtering, combining the two filtrates, and concentrating under reduced pressure until the relative density is 1.1, and carrying out spray drying (the air inlet temperature is 140 ℃ and the air outlet temperature is 100 ℃ and 140 ℃).
The preparation method of the hydrogel eye patch for adjuvant therapy of central serous chorioretinopathy comprises the following specific steps:
1) mixing tea polyphenols, theanine, Carthami flos extract, Saviae Miltiorrhizae radix extract, radix Puerariae extract, herba Taraxaci extract, semen Celosiae extract, rhizoma Atractylodis extract, semen Abutili extract, Glycyrrhrizae radix extract, part of high molecular material (polymethacrylic acid, sodium polyacrylate, and sodium carboxymethylcellulose), citric acid and purified water, stirring to obtain water phase;
2) fully stirring and uniformly mixing tea essential oil, tea pigment, jasmine essential oil, glycerol, sorbitol, aluminum hydroxide and the balance of high polymer materials to form a glycerol phase, wherein no blocky solid exists in the glycerol phase;
3) adding the water phase into the glycerol phase, and continuously stirring for 30 minutes to uniformly mix to obtain a crude gel product; removing bubbles by using a vacuum defoaming stirrer to form a bubble-free hydrogel product, uniformly coating the hydrogel product on non-woven fabrics by using a hydrogel coating machine, coating the non-woven fabrics to the thickness of 1mm, laminating, and cooling to obtain the hydrogel eye patch.
Statistical data of clinical trials
Clinical cases: the total 80 people are divided into observation group and control group according to random principle, and the age is 25-55 years. 40 cases (40 eyes) in the observation group, 32 cases in men, 8 cases in women, and 3 days-1.5 years in the course of disease, 40 cases (40 eyes) in the control group, 34 cases in men, 6 cases in women, and 3 days-2 years in the course of disease. The comparison difference between two groups of general data is not statistically significant (P > 0.05) and is comparable. Patients with internal eye surgery history and eye trauma history are excluded, and patients with serious cardiovascular and cerebrovascular diseases, keratitis, glaucoma, uveitis and other diseases are excluded.
The diagnosis standard of case:
symptoms are: the vision is blurred suddenly, the center of the visual field is blocked by a light shadow, the vision can be deformed and diminished, and the disease course is different. Eyes have no red swelling and hot pain, and no history of trauma.
Special examination: the degree of visual impairment varies from 0.1 to 0.8, and often there are deformities or dark spots when examined using an Amsler grid form. The anterior segment of the eye is checked to be free of abnormality, the retina of the posterior pole part can be seen in the eye fundus examination, the macula lutea is mostly taken as the center, the reflection is enhanced, the macula lutea is in a halo shape, and the fovea centralis is scattered in reflection. The severe patients showed discoid bulging of the macula retina, with no bleeding. No abnormality was found.
The unique expression of fundus angiography is as follows: the visible pigment epithelium layer plane in the vein phase of radiography has one or more strong fluorescence leakage focuses, the fluorescence leakage gradually occurs along with the prolonging of the radiography time, the fluorescence leakage is enlarged like ink or mushroom, the fluorescence is accumulated under the nerve epithelium at the later stage, a disc-shaped nerve epithelium separation area is delineated, and the optic disc and retinal blood vessels do not have obvious abnormal fluorescence.
The treatment method comprises the following steps:
the control group is administered with oral conventional medicine, and the compound XUESHUANTONG Capsule is administered at a dose of 1.5 g/time and 3 times/day for 2 months.
The treatment group used the eye patch of the present invention on the basis of the treatment of the control group, 2 times a day, once applied for 15-20 minutes, and continuously applied for 2 months.
The curative effect standard is as follows:
and (3) curing: the vision is recovered to the level or above before the disease, the retinal edema is resolved, the macula is exudated and absorbed, and the fluorescence contrast seepage disappears;
the method has the following advantages: vision is improved by 3 lines or more, retinal edema is reduced, macular exudation is reduced, and fluorography exudation is weakened.
And (4) invalidation: vision is unchanged or decreased, retinal edema is increased or not reduced, macular exudation is increased or not absorbed, and fluorography is leaky or not improved.
The treatment results are shown in table 1. After two months of treatment, the total effective rate of the control group is 80.0 percent, the total effective rate of the treatment group is 97.5 percent, and the effective rate of the treatment is greatly improved, which shows that the eye patch has the function of assisting in treating central serous chorioretinopathy.
TABLE 1 comparison of the two groups of therapeutic effects after 2 months of treatment
Group of Cure of disease Is effective Invalidation Total effective rate
Treatment group 7 32 1 97.5%
Control group 5 27 8 80.0%

Claims (5)

1. The hydrogel eye mask for assisting in treating the central serous chorioretinopathy is characterized by comprising the following raw materials in percentage by weight: 0.01-0.04% of tea essential oil, 0.2-0.8% of tea polyphenol, 0.1-0.6% of theanine, 0.1-0.6% of tea pigment, 0.01-0.04% of jasmine essential oil, 0.2-1.0% of safflower extract, 0.2-1.0% of salvia extract, 0.2-1.5% of kudzu root extract, 0.2-1.5% of dandelion extract, 0.2-1.5% of feather cockscomb seed extract, 0.2-1.5% of rhizoma atractylodis extract, 0.2-1.0% of cluster mallow seed extract, 0.2-1.0% of liquorice extract, 10-25% of high polymer material, 20-30% of glycerol, 0.1-0.5% of citric acid, 1-3% of sorbitol, 0.1-0.3% of aluminum hydroxide and the balance of purified water;
the jasmine essential oil is prepared by the following steps: mixing flos Jasmini sambacCrushing pollen, and treating with CO 2 Performing supercritical extraction to obtain flos Jasmini sambac essential oil, wherein the extraction temperature is 20-60 deg.C, the pressure is 10-20MPa, and the extraction time is 1-6 h;
the safflower extract, the salvia extract, the kudzuvine root extract, the dandelion extract, the feather cockscomb seed extract, the atractylodes rhizome extract, the cluster mallow seed extract and the liquorice extract are prepared by the following steps: mixing Carthami flos, Saviae Miltiorrhizae radix, radix Puerariae, herba Taraxaci, semen Celosiae, rhizoma Atractylodis, semen Abutili or Glycyrrhrizae radix with 10-20 weight times of water, decocting for 1-2 hr, filtering, concentrating the filtrate under reduced pressure to relative density of 0.9-1.1, and spray drying.
2. The hydrogel eye patch for adjunctive treatment of central serous chorioretinopathy according to claim 1, wherein the polymeric material is one or a mixture of two or more of sodium polyacrylate, polyacrylic acid, polymethacrylic acid, polyvinyl alcohol, polyacrylamide and sodium carboxymethylcellulose.
3. The hydrogel eye patch for the adjuvant treatment of central serous chorioretinopathy according to claim 1, wherein the tea essential oil, the tea polyphenol and the theanine are prepared by the following steps:
pulverizing green tea, and performing CO treatment 2 Performing supercritical extraction at 20-60 deg.C under 10-20MPa for 1-6 hr to obtain tea essential oil;
CO is introduced into 2 Adding water into the tea leaves subjected to supercritical extraction, extracting at 40-90 deg.C for 1-3h, filtering, concentrating the filtrate under reduced pressure, separating and purifying with cation exchange resin, eluting with water, and collecting eluate A; then using ammonia water with the pH value of 8-11 as an eluting solvent, collecting to obtain an eluent B, adjusting the pH value of the eluent B to be neutral by using dilute hydrochloric acid, concentrating under reduced pressure to form a paste, adding 90-95% ethanol with the weight of 3-8 times of that of the paste to dissolve, filtering, standing the filtrate at the low temperature of 0-4 ℃ overnight to precipitate crystals, and drying the crystals to obtain theanine;
separating and purifying the eluate A with macroporous adsorbent resin, washing with water until sugar-free solution flows out, washing with 40-90% ethanol, collecting eluate, concentrating under reduced pressure until relative density is 0.9-1.1, and spray drying to obtain tea polyphenols.
4. The hydrogel eye patch for the adjuvant treatment of central serous chorioretinopathy according to claim 1, wherein the tea pigment is prepared by the following steps: mixing green tea with petroleum ether or ethyl acetate 6-10 times of green tea, reflux extracting, and concentrating the extractive solution under reduced pressure to obtain tea pigment.
5. The preparation method of the hydrogel eye patch for the adjuvant therapy of central serous chorioretinopathy according to any one of claims 1 to 4, which is characterized by comprising the following steps:
1) mixing tea polyphenols, theanine, Carthami flos extract, Saviae Miltiorrhizae radix extract, radix Puerariae extract, herba Taraxaci extract, semen Celosiae extract, rhizoma Atractylodis extract, semen Abutili extract, Glycyrrhrizae radix extract, part of polymer material, citric acid and purified water to form water phase;
2) mixing tea leaf essential oil, tea pigment, jasmine essential oil, glycerol, sorbitol, aluminum hydroxide and the balance of high polymer material uniformly to form a glycerol phase;
3) uniformly stirring the water phase and the glycerol phase to obtain a crude gel product; removing bubbles by using a vacuum defoaming stirrer, uniformly coating on non-woven fabric, laminating, and cooling to obtain the hydrogel eye patch.
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CN104491403A (en) * 2014-12-08 2015-04-08 四川金堂海纳生物医药技术研究所 Medicine for treating central retinochoroiditis and preparation method

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CN112022938B (en) * 2020-10-22 2022-03-15 河南省纳普生物技术有限公司 Hydrogel eye patch for relieving asthenopia and preventing myopia and preparation method thereof

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CN102210841A (en) * 2011-05-18 2011-10-12 刘永华 Chinese medicinal preparation for treating central serous retinopathy
CN102827896A (en) * 2012-09-14 2012-12-19 向华 Method for extracting theaflavin and theanine from tea leaves
CN104491403A (en) * 2014-12-08 2015-04-08 四川金堂海纳生物医药技术研究所 Medicine for treating central retinochoroiditis and preparation method

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