CN114146075A

CN114146075A - Taurine external use medicine for treating myopia and its preparation method and use

Info

Publication number: CN114146075A
Application number: CN202011375658.2A
Authority: CN
Inventors: 裴丽林; 罗茜茜
Original assignee: Individual
Current assignee: Individual
Priority date: 2020-11-16
Filing date: 2020-11-16
Publication date: 2022-03-08

Abstract

The invention discloses a taurine external medicine for treating myopia and a preparation method and application thereof. The external medicine comprises taurine eye drops and taurine eye patches; the taurine eye mask comprises taurine eye mask liquid and water-punched non-woven fabrics for the eye mask; the taurine eye drops and the taurine eye patch liquid both comprise taurine, boric acid, anhydrous borax, ethylparaben and ethanol. The invention also discloses a medicament for treating myopia, which comprises an external medicament and an internal medicament. The taurine external-use medicine is pasted outside eyes, and the absorption of taurine in eye tissues can be obviously promoted through a skin hydration method, so that the distribution concentration of taurine in the eye tissues is greatly improved, and the eye diseases caused by the imbalance of taurine metabolism can be effectively treated. And the eye patch is directly pasted on the eye without injection, is convenient and quick and is convenient to carry.

Description

Taurine external use medicine for treating myopia and its preparation method and use

Technical Field

The invention belongs to the technical field of medicines, and particularly relates to a taurine external medicine for treating myopia and a preparation method and application thereof.

Background

Taurine is a sulfur-containing amino acid with a simple structure in an animal body, and is widely distributed in various tissues and organs in the body. Taurine is the most abundant amino acid in the retina, vitreous, lens, cornea, iris and ciliary body. It can promote the development of infant brain tissue and intelligence, and improve nerve conduction and visual function. If the infants lack taurine in vivo, the phenomena of intelligence development retardation and retina dysfunction can occur; for a patient who is transfused with intravenous nutrition for a long time, if the nutrient solution does not contain taurine, the electroretinogram of the patient can be changed, and the change can be corrected only by supplementing a large dose of taurine. Taurine also has important functions of adjusting the osmotic pressure of crystalline lens, resisting oxidation and the like, and can inhibit the occurrence and development of cataract. During the development of cataract, the content of sorbitol in crystalline lens is increased, the osmotic pressure of crystalline lens is increased, the concentration of taurine which is an important substance for adjusting the osmotic pressure is obviously reduced, the antioxidation is weakened, the protein in the crystalline lens is excessively oxidized, thus the cataract is caused or aggravated, and the supplement of taurine can effectively inhibit the development of cataract. Taurine also affects glycometabolism, can be combined with insulin receptors, promotes cell uptake and glucose utilization, accelerates glycolysis and reduces blood sugar concentration, so that the taurine supplement can eliminate or reduce edema of crystalline lens and vitreous body of a patient with myopia or myopia amblyopia caused by stress hyperglycemia (eyeball makes stress near reflex movement for a long time and also can generate stress hyperglycemia in a long-term triple way, and in the aspect of human stress, glycogen decomposition and gluconeogenesis are obviously enhanced in the aspect of sugar metabolism, so that the blood sugar is obviously increased, the stress hyperglycemia and the blood sugar are increased, the glucose concentration in the aqueous humor is also increased along with the increase, and the glucose rapidly diffuses into the crystalline lens and the vitreous body, the activity of hexokinase is saturated, aldose reductase is activated, and excessive glucose is metabolized and converted into sorbitol and fructose through a sorbitol channel, sorbitol in the lens and the vitreous body is not easy to seep out through membranes of the lens and the vitreous body, so that the sorbitol is accumulated in the lens and the vitreous body, the osmotic pressure in the lens and the vitreous body is increased, and then excessive water enters the lens and the vitreous body to maintain the internal and external osmotic pressure balance of the lens and the vitreous body, thereby causing edema of the lens and the vitreous body).

At present, taurine is usually added into milk powder for promoting the development of infant brain tissues and intelligence, and is prepared into eye drops for treating cataract, acute viral conjunctivitis, herpetic conjunctivitis and the like caused by taurine metabolic disorder. But the eye drops are used independently, and the dosage of each time is small, so that the treatment effect is ensured not only by maintaining more use times per day, but also by longer treatment course; in addition, the eye drops can stimulate anterior tissues of eyes, dilate blood vessels and lymphatic vessels of conjunctiva, increase the elimination of medicine from peripheral blood vessels, and increase lacrimal secretion. Excessive tears will dilute the concentration of the drug and overflow the eyes or enter the nasal cavity and the oral cavity, thereby affecting the absorption and utilization of the drug and reducing the drug effect. And the application of the compound in treating myopia and myopic amblyopia does not appear.

Disclosure of Invention

Aiming at the problems, the invention provides a taurine external medicine for treating myopia and a preparation method and application thereof. The taurine external-use medicine is pasted outside eyes, and the absorption of taurine in eye tissues can be obviously promoted through a skin hydration method, so that the distribution concentration of taurine in the eye tissues is greatly improved, and the eye diseases caused by the imbalance of taurine metabolism can be effectively treated. And the eye patch is directly pasted on the eye without injection, is convenient and quick and is convenient to carry.

The invention is realized by the following technical scheme

A taurine external medicine for treating myopia comprises taurine eye drops and taurine eye patch; the taurine eye mask comprises taurine eye mask liquid and water-punched non-woven fabrics for the eye mask; the taurine eye patch liquid is prepared from the following raw materials in percentage by weight: 50-55 g of taurine, 9.30-12.09 g of boric acid, 0.57-4.78 g of anhydrous borax, 0.20-0.35 g of ethylparaben, 1-1.75 ml of 50-95% ethanol and 1500ml of distilled water. The milliosmolarity of the taurine eye patch liquid is 389.02-445.67 mosmol/kg; the concentration of taurine in the taurine eye patch liquid is 0.033-0.037 g/ml.

Furthermore, the water-punched non-woven fabric for the eye patch is oval, the diameter of the transverse long axis is 8.1cm, and the diameter of the longitudinal long axis is 5.6 cm.

Further, the taurine eye drops are prepared from the following raw materials in parts by weight: 50-55 g of taurine, 9.30-12.09 g of boric acid, 0.57-4.78 g of anhydrous borax, 0.20-0.35 g of ethylparaben, 1-1.75 ml of 50-95% ethanol and 1000ml of distilled water; the milliosmolarity of the taurine eye drops is 583.53-668.51 mosmol/kg; the concentration of taurine in the taurine eye drops is 0.050-0.055 g/ml.

Further, the mass of the taurine, the boric acid and the anhydrous borax in the taurine eye patch liquid are respectively 50-50.51 g, 11.22-12.09 g and 0.57-1.91 g; the mass of the taurine in the taurine eye drops, the boric acid and the anhydrous borax is respectively 50-50.51 g, 11.22-12.09 g and 0.57-1.91 g.

The preparation method of the taurine eye patch comprises the following steps:

s1, preparing taurine, boric acid, anhydrous borax, ethylparaben, ethanol and distilled water according to required amount;

s2, heating 80% of the total volume of the distilled water prepared in the step S1 to 65-85 ℃, adding the boric acid and the anhydrous borax prepared in the step S1 in sequence into the distilled water, fully stirring for 5-15 minutes until the boric acid and the anhydrous borax are fully dissolved, then adding the prepared taurine, fully stirring for 5-15 minutes until the taurine is fully dissolved, naturally cooling until the temperature of the liquid medicine is less than or equal to 35 ℃, and preparing a first solution;

s3, adding the prepared ethylparaben into a container filled with prepared ethanol, and stirring for 5-10 minutes until the ethylparaben is completely dissolved to prepare a second solution;

s4, slowly adding the second solution into the first solution, fully stirring until the second solution is completely dissolved, adding the residual distilled water with the temperature of 25-35 ℃ to the full amount, and fully stirring for 10-15 minutes until the second solution is completely and uniformly mixed to obtain a third solution;

s5, performing first-stage circulating filtration on the third solution for 20 minutes by using an aseptic filter with the micropore diameter of 0.45um, performing second-stage filtration by using a second-stage aseptic filter with the micropore diameter of 0.22um, subpackaging the third solution in a sterilized low-density polyethylene or polyester medicinal eye drop bottle in an aseptic environment after the filtration is finished, plugging and capping to obtain the taurine eye patch liquid;

s6, taking the eye patch after the antibacterial finishing, using water-punched non-woven fabrics, cutting according to the required shape, then putting the eye patch into a closed ethylene oxide ring sterilization cabinet for sterilization and disinfection for 6 hours, taking out, packaging 2 pieces of eye patch in sterile environment by using a sterilized polyethylene plastic film bag, sealing, and placing the eye patch in sterile environment for later use;

s7, taking the eye patches reserved in the sterile environment in the step S6, and immersing 2 pieces of eye patches into eye patch liquid to obtain taurine eye patches;

preferably, the milliosmolarity of the taurine eye patch liquid is 410.99-418.85 mosmol/kg; the mass ratios of taurine to boric acid and anhydrous borax are respectively 50.51g, 11.22-12.09 g and 0.57-1.91 g, and the mass ratio of taurine to ethylparaben is 50.51 g: 0.25-0.30 g; the mass concentration of the ethanol is 95%.

A medicine for treating myopia comprises topical medicine and oral medicine; the external medicine is the taurine external medicine for treating myopia, and the internal medicine comprises the following components in parts by weight: 5-22 parts of disodium adenosine triphosphate, 0.30-1.25 parts of L-methionine, 100-410 parts of taurine, 1.50-12 parts of lutein, 0.175-0.63 part of vitamin A, 0.898-3.234 parts of beta-carotene and 10 parts of vitamin D3 (1.50-6)^-32 to 14 parts of vitamin E, -TE, 54 to 135 parts of vitamin C, 10.15 to 1.15 parts of vitamin B, 20.15 to 1.28 parts of vitamin B, 60.13 to 1.45 parts of vitamin B, 1.50 to 11.52 parts of nicotinamide, 95.82 to 150.10 parts of calcium, 15.97 to 54.43 parts of magnesium, 18.73 to 33.35 parts of potassium, 3.73 to 15.80 parts of zinc and 10 parts of selenium (20 to 110)^-3Part (20-110) 10 of chromium^-3And (4) portions are obtained.

Furthermore, the dosage forms of the oral medicines comprise tablets and pills.

Further, the preparation method of the oral medicine comprises the following steps:

(1) preparing an adenosine disodium triphosphate core-spun tablet core, which comprises the following steps:

according to mass fraction (calculated as anhydride, C content)₁₀H₁₄N₅Na₂O₁₃P₃) The raw materials are 5.26-21.05 parts of disodium adenosine triphosphate with the mass content of more than or equal to 95%, 0.30-1.22 parts of L-methionine with the mass content of more than or equal to 98.5%, 100 parts of anhydrous calcium hydrophosphate with the mass content of 99%, 27.10-42.98 parts of maltodextrin, 1.43-2.26 parts of pregelatinized starch, 8 parts of crospovidone, 0.40 part of superfine silica gel powder and 0.80 part of magnesium stearate with the mass content (calculated according to dry products and magnesium element) of 4.0-5.0%.

Adopting a conventional dry granulation and tabletting process, firstly fully mixing various raw material powders except the superfine silica gel powder and the magnesium stearate which are respectively crushed and uniformly sieved by a sieve of 80 meshes, then extruding into large sheets by using a dry granulator, and crushing into granules sieved by a sieve of 16-24 meshes;

and uniformly mixing the superfine silica gel powder and the magnesium stearate powder which are sieved by a sieve of 80 meshes with the granules sieved by a sieve of 16-24 meshes, pressing into tablets, and coating enteric coating to obtain the core-spun tablet cores.

(2) Preparing a wrapping layer, which comprises the following steps:

a: respectively pulverizing and sieving 75% of corn starch, maltodextrin, pregelatinized starch and crospovidone, and mixing to obtain mixed powder A; preferably, the corn starch, the maltodextrin, the pregelatinized starch and the crospovidone powder are sieved by a sieve of 80 meshes, and the time for uniformly mixing is preferably 5-15 minutes;

b: respectively crushing and sieving lutein, beta-carotene and zinc citrate dihydrate, adding beta-carotene powder into the lutein powder, mixing for 5-10 minutes, adding zinc citrate dihydrate powder into the lutein powder, and mixing for 5-10 minutes to obtain mixed powder B; preferably, the lutein powder, the beta-carotene powder and the zinc citrate dihydrate powder are sieved by a 60-mesh sieve;

c: respectively crushing calcium citrate, DL- -acetate tocopherol, chromium picolinate, vitamin D3, riboflavin, vitamin A acetate and thiamine nitrate powder which are sieved by a 60-mesh sieve, mixing the calcium citrate powder and the DL- -acetate tocopherol powder for 5-10 minutes, then adding the chromium picolinate, the vitamin D3, the riboflavin, the vitamin A acetate and the thiamine nitrate powder into the mixture one by one in sequence for mixing, mixing for 5-10 minutes after adding each raw material, adding the thiamine nitrate powder, mixing for 10-15 minutes, and uniformly mixing to obtain mixed powder C;

d: taking anhydrous calcium hydrogen phosphate powder, heavy magnesium carbonate powder, taurine, nicotinamide and selenium-enriched yeast powder which are respectively crushed and are uniformly sieved by a sieve of 80 meshes, firstly adding the heavy magnesium carbonate powder into the anhydrous calcium hydrogen phosphate powder, mixing for 5-10 minutes, then sequentially adding the taurine and the nicotinamide powder, respectively mixing for 5-10 minutes, finally adding the selenium-enriched yeast powder, then mixing for 10-15 minutes, and uniformly mixing to obtain mixed powder D;

e: sequentially adding the B, C, D mixed powder into the A mixed powder one by one, mixing for 5-15 minutes, adding the last D mixed powder, mixing for 10-25 minutes, and mixing uniformly to obtain a first mixed material;

f: taking potassium chloride, pyridoxine hydrochloride and L-sodium ascorbate powder which are respectively crushed and uniformly screened by a nylon sieve of 80 meshes, sequentially adding the sieved potassium chloride, pyridoxine hydrochloride and L-sodium ascorbate powder into a proper amount of purified water at 20-25 ℃, and continuously stirring until the added raw materials are completely dissolved and uniformly mixed to prepare the wetting agent;

g: adding the wetting agent in the step f into the first mixture, and uniformly mixing to obtain a soft material; wherein the time for adding the wetting agent into the first mixture to be uniformly mixed is preferably 15-25 minutes;

h: g, extruding, sieving and granulating the soft material prepared in the step g, drying for 5-8 hours at the temperature of 45-55 ℃ to prepare dry granules with the moisture mass content of less than 12%, and sieving and grading; preferably, the soft material is sieved through an 18 mesh nylon sieve, more preferably, the dry particles are sieved through a 16 mesh nylon sieve;

i: sequentially adding 25% of powder, flow aid micropowder silica gel powder and lubricant magnesium stearate powder which are respectively crushed and uniformly sieved by a 80-mesh sieve to the sieved and sized dry granules prepared in the step h, mixing, adding one auxiliary agent each, mixing for 5-15 minutes, and uniformly mixing to prepare a coating material;

(3) pressing together

Pressing the core-spun tablet core prepared in the step (1) into the wrapping layer material prepared in the step (2) by using a core-spun tablet pressing machine to prepare a core-spun tablet;

(4) and (4) coating the coated tablet obtained in the step (3) with a film to obtain a finished product of the coated tablet.

The application method of the taurine external medicine for treating myopia comprises the following specific steps:

cleaning hands and faces with clear water; closing the eyes, and sticking the taurine eye patch on the eyes for 20-30 minutes; after the application is finished, the eye patch is uncovered, and the eyes are closed for 3-5 minutes. The eye patch is applied for 1 time every 1-3 days; during the period of pasting the eye patch, the taurine eye drops are alternately dripped into the eyes for 2-5 times per day, and 1-2 drops are dripped each time.

The taurine eye drops and the taurine eye patch can be bottled by adopting a low-density polyethylene or polyester medicinal eye drop bottle which is sterilized and disinfected; the eye patch is also packaged by sealing with spunlace nonwoven fabric. When in use, the disinfected and sterilized eye patch is soaked in the taurine eye patch liquid by using the spunlace nonwoven fabric to obtain the taurine eye patch. Taurine eye patch is used alternately with taurine eye drops (i.e., external medicine) for eye dropping.

Compared with the prior art, the invention has the following positive beneficial effects

The taurine eye patch can be directly pasted outside eyes to treat eye diseases. Can be effectively used for treating eye diseases such as cataract, acute viral conjunctivitis, herpes conjunctivitis and the like caused by taurine metabolic disorder, does not need injection, is absorbed by the skin of the eyes in a penetration way through a skin hydration method, and has good using and treating effects.

The taurine eye patch is applied to the eyes, can improve nerve conduction and visual function of a patient with myopia and myopic amblyopia, prevent retinal dysfunction, effectively reduce edema of crystalline lens and vitreous body of the patient with myopia and myopic amblyopia caused by stress hyperglycemia, assist in removing or reducing astigmatism of the crystalline lens, shorten lengthened part of ocular axis, improve naked eye distance vision, inhibit the occurrence and development of cataract and resist fatigue. Especially has obvious treatment effect on myopia and myopic amblyopia patients with myopia diopter of more than 100 degrees, the naked eye far vision of the patients can be improved by 1-3 lines, and some asthenopia and general discomfort symptoms are reduced or eliminated.

This taurine eye patch uses simultaneously with the oral medicine, because taurine in the taurine eye patch liquid can be at the abundant absorption of eye, improve the distribution concentration of taurine in eye tissue cell greatly, promote the improvement nerve conduction and the visual function of taurine fast, the myopia that arouses because of stress nature hyperglycemia and myopic amblyopia patient's crystalline lens and vitreous edema more effectively alleviate, so can shorten 1-3 weeks to diopter myopia and myopic amblyopia patient's more than 150 treatment courses of treatment, the effect is more showing. The method is also applied to prevention and control work for realizing the goal that the new myopia rate of the teenagers in the country is obviously reduced by 2023 and 2030.

Detailed Description

The present invention will be described in more detail with reference to the following embodiments for understanding the technical solutions of the present invention, but the present invention is not limited to the scope of the present invention.

In the embodiment, the taurine used for the external medicine is preferably taurine (medicinal grade) with the mass content of 99%; boric acid is preferably 99.5% boric acid (pharmaceutical grade); anhydrous boric acid (medicinal grade) with the mass content of 99.9 percent is preferably selected as borax; the preferred mass content of the ethylparaben is 99 percent of ethylparaben (pharmaceutical grade); the ethanol is preferably 95% ethanol (pharmaceutical grade); the water for preparing medicine is preferably distilled water.

Oral medicine instituteThe disodium adenosine triphosphate is used, and the mass content of the disodium adenosine triphosphate (calculated according to anhydrous substance, and the content of C)₁₀H₁₄N₅Na₂O₁₃P₃) More than or equal to 95 percent of adenosine disodium triphosphate; the L-methionine is L-methionine with the mass content of more than or equal to 98.5 percent; the taurine is 99 percent of taurine (taurine); the lutein is lutein powder with 20% of (lutein) mass content; the vitamin A adopts (vitamin A acetate) dry powder with the mass content of 325000 IU/g; the beta-carotene adopts beta-carotene powder with the mass content of 10 percent; the vitamin D is vitamin D3 water-soluble powder (vitamin D3) with the mass content of more than or equal to 100000 IU/g; vitamin E is DL- -acetate tocopherol dry powder with the mass content of (DL- -acetate tocopherol) being 50%; the vitamin C adopts (sodium L-ascorbate) with the mass content of 99 percent; vitamin B1 is thiamine nitrate with the mass content of 99%; vitamin B2 adopts riboflavin with (riboflavin) content of 99% by mass; vitamin B6 adopts pyridoxine hydrochloride with the mass content of 99%; the nicotinamide adopts nicotinamide with the mass content of 99 percent; the calcium adopts (calcium citrate) mass content (calculated by dry basis, contains C)₁₂H₁₀Ca₃O₁₄) 97.5 to 100.5 percent of calcium citrate and 99 percent of anhydrous calcium hydrophosphate (the mass ratio of the calcium citrate to the anhydrous calcium hydrophosphate is (1 to 4) to (9 to 16)); the magnesium is heavy magnesium carbonate with the mass content (calculated by magnesium oxide) of 40-43.5 percent and magnesium stearate with the mass content (calculated by dry products, magnesium element) of 4.0-5.0 percent (the mass ratio of the magnesium stearate to the heavy magnesium carbonate is (1-2.4): 3-10)); the potassium is potassium chloride with the mass content of 99%; the zinc is zinc citrate dihydrate with the mass content of 99 percent (zinc citrate dihydrate); the selenium is selenium-enriched yeast powder with the mass content (calculated by selenium-containing element) of 0.2 percent; the chromium is chromium picolinate with the mass content of more than or equal to 98 percent.

Example 1

A taurine eye drop for treating myopia is prepared from the following raw materials: 50.51g of taurine, 12.09g of boric acid, 0.57g of anhydrous borax, 0.30g of ethylparaben, 1.50ml of 95% ethanol and distilled water added to 1000 ml. The milliosmolarity of the taurine eye drops is 628.27 mosmol/kg; the concentration of taurine in the taurine eye drops is 0.051 g/ml. The pH value of the taurine eye drops is 6.77.

Example 2

A taurine eye drop for treating myopia is prepared from the following raw materials: 50.51g of taurine, 11.22g of boric acid, 1.91g of anhydrous borax, 0.25g of ethylparaben, 1.25ml of 95% ethanol and distilled water added to 1000 ml. The milliosmolarity of the taurine eye drops is 618.48 mosmol/kg; the concentration of taurine in the taurine eye drops is 0.051 g/ml. The pH value of the taurine eye drops is 7.36.

Example 3

A taurine external medicine for treating myopia comprises taurine eye drop and taurine eye patch;

the taurine eye drops are the taurine eye drops described in embodiment 1 or embodiment 2;

the taurine eye mask comprises taurine eye mask liquid and water-thorn non-woven fabrics for the eye mask, and the taurine eye mask liquid is prepared from the following raw materials: 50.51g of taurine, 12.09g of boric acid, 0.57g of anhydrous borax, 0.30g of ethylparaben, 1.50ml of 95% ethanol and 1500ml of distilled water. The milliosmolarity of the taurine eye patch liquid is 418.85 mosmol/kg; the concentration of taurine in the taurine eye patch liquid is 0.034 g/ml. The pH value of the taurine eye patch liquid is 6.90. The water-punched non-woven fabric for eye patches is oval, the diameter of the transverse long axis is 8.1cm, and the diameter of the longitudinal long axis is 5.6 cm.

The preparation method of the taurine eye patch comprises the following steps:

example 4

the taurine eye mask comprises taurine eye mask liquid and water-thorn non-woven fabrics for the eye mask, and the taurine eye mask liquid is prepared from the following raw materials: 50.51g of taurine, 11.22g of boric acid, 1.91g of anhydrous borax, 0.25g of ethylparaben, 1.25ml of 95% ethanol and 1500ml of distilled water. The milliosmolarity of the taurine eye patch liquid is 410.99 mosmol/kg; the concentration of taurine in the taurine eye patch liquid is 0.034 g/ml. The pH value of the taurine eye patch liquid is 7.23. The water-punched non-woven fabric for eye patches is oval, the diameter of the transverse long axis is 8.1cm, and the diameter of the longitudinal long axis is 5.6 cm.

The preparation method of the taurine eye patch is the same as that of example 3.

Example 5

A medicine for treating myopia comprises topical medicine and oral medicine.

The externally applied medicine is the taurine externally applied medicine for treating myopia described in embodiment 3 or embodiment 4.

The oral medicine comprises the following components in parts by weight: 5 parts of disodium adenosine triphosphate, 0.30 part of L-methionine, 100 parts of taurine, 1.50 parts of lutein, 0.175 part of RE, 0.898 part of beta-carotene and 31.50 multiplied by 10 parts of vitamin D^-3Parts by weight, vitamin E2 parts -TE, vitamin C54 parts, vitamin B10.15 parts, vitamin B20.15 parts, vitamin B60.13 parts, nicotinamide 1.50 parts, calcium total 95.82 parts, magnesium total 15.97 parts, potassium 18.73 parts, zinc 3.73 parts, selenium 20 multiplied by 10 parts^-3Part(s) of chromium 20X 10^-3And (4) portions are obtained.

The preparation method of the oral medicine comprises the following steps:

The disodium adenosine triphosphate core-spun tablet core comprises the following components in parts by weight: 5-20 parts of disodium adenosine triphosphate, 0.30-1.20 parts of L-methionine, 29.16 parts of calcium, 27.10-42.98 parts of maltodextrin, 1.43-2.26 parts of pregelatinized starch, 8 parts of crospovidone, 0.40 part of micropowder silica gel and 0.04 part of magnesium;

the disintegrant is preferably crospovidone;

(2) preparing a wrapping layer, which comprises the following steps:

a: respectively pulverizing and sieving 75% of corn starch, maltodextrin, pregelatinized starch and disintegrant crospovidone, and mixing to obtain mixed powder A; preferably, the corn starch, the maltodextrin, the pregelatinized starch and the crospovidone are sieved by a sieve of 80 meshes, and the time for uniformly mixing is preferably 5-15 minutes;

i: sequentially adding 25% of powder of the total amount of the disintegrant crospovidone, the flow aid micropowder silica gel powder and the lubricant magnesium stearate which are respectively crushed and sieved by a sieve of 80 meshes into the sieved and granulated dry granules prepared in the step h for mixing, adding one auxiliary agent each for mixing for 5-15 minutes, and uniformly mixing to prepare a coating material;

(3) pressing together

Example 6

The same contents of the example 6 and the example 5 are not repeated, and the difference is that the oral medicine comprises the following components in parts by weight: 12.50 parts of disodium adenosine triphosphate, 0.75 part of L-methionine, 250 parts of taurine, 6.75 parts of lutein, 0.403 part of vitamin A, 2.066 parts of beta-carotene and 33.75 multiplied by 10 parts of vitamin D^-38 portions of vitamin E, -TE, 85.50 portions of vitamin C, 10.64 portions of vitamin B, 20.71 portions of vitamin B, 60.78 portions of vitamin B, 6.51 portions of nicotinamide, 121.46 portions of calcium total, 33.70 portions of magnesium total, 26.04 portions of potassium, 9.77 portions of zinc, 60 multiplied by 10 portions of selenium^-3Chromium 60X 10 parts^-3And (4) portions are obtained.

Example 7

Example 7 the same as example 5 is not repeated, except that the oral medicine comprises the following components in parts by weight: 22 parts of adenosine disodium triphosphate, 1.25 parts of L-methionine, 410 parts of taurine, 12 parts of lutein, 0.63 part of RE, 3.234 parts of beta-carotene and 36 multiplied by 10 parts of vitamin D^-314 portions of vitamin E, -TE, 135 portions of vitamin C, 11.15 portions of vitamin B, 21.28 portions of vitamin B, 61.45 portions of vitamin B, 11.52 portions of nicotinamide, 150.10 portions of total calcium, 54.43 portions of total magnesium, 33.35 portions of potassium, 15.80 portions of zinc, 110 multiplied by 10 portions of selenium^-3Part of chromium 110X 10^-3And (4) portions are obtained.

Examples of specific applications

Case statistics 1

50 cases of myopic and myopic amblyopic patients with myopic diopter between 100-825 degrees are selected from 5-3 2019 in 2018, and the taurine eye patch (the external application of the eye patch and the dropping of eye drops are alternately used) is independently used for eyes.

The results show that: 46 persons with remarkable effect and 4 persons with general effect.

The clinical evaluation standard of the treatment effect has obvious effect: the naked eye far vision is improved by 2-3 lines, and some asthenopia and general discomfort symptoms are obviously relieved or eliminated; the effect is general: the distance vision of naked eyes is improved by 0-1 line, and some asthenopia and general discomfort symptoms are not obviously relieved.

Case statistics 2

100 cases of myopic and myopic amblyopic patients with myopic diopter between 150-875 degrees are selected to be divided into 2 groups from 5 months in 2018 to 6 months in 2019, 50 patients in each group are similar to the diseased conditions in the two groups.

Experimental groups: the medicine for treating myopia, oral medicine and external application (when external application is used, eye drops are alternatively dripped into eyes) are used simultaneously (specifically, the use methods of the oral medicine and the external application are described in the above content);

control group: only oral administration is used.

The experimental results are as follows:

the experimental group had 43 patients with remarkable effect, 5 patients with remarkable effect, and 2 patients with general effect.

The control group had 35, 10 and 5 significant effects.

The clinical evaluation standard of the treatment effect of the experimental group has remarkable effect: the naked eye distance vision is improved to more than 5.0, no change occurs in 3 months, and some asthenopia and general discomfort symptoms are eliminated; the treatment course is shortened by 3 weeks compared with the control group; the effect is obvious: the naked eye far vision is improved by more than 3 lines, and some asthenopia and general discomfort symptoms are obviously relieved or eliminated; the treatment course is shortened by 2 weeks compared with the control group; the effect is general: the naked eye far vision is improved by 1-2 lines, and some asthenopia and general discomfort symptoms are not obviously relieved; the treatment course is shortened by 1 week compared with the control group.

The clinical evaluation standard of the treatment effect of the control group has obvious effect: the naked eye distance vision is improved to more than 5.0, no change occurs in 3 months, and some asthenopia and general discomfort symptoms are eliminated; the effect is obvious: the naked eye far vision is improved by more than 3 lines, and some asthenopia and general discomfort symptoms are obviously relieved or eliminated; the effect is general: the distance vision of naked eyes is improved by 1-2 lines, and some asthenopia and general discomfort symptoms are not obviously relieved.

Typical case (experiment group typical case)

One in the beam, female, age 40, teacher in twenty-four of Luoyang city, Han nationality.

The medical history is as follows: the writing or the object which is read when reading a book or watching a television appears double-shadow from the half year ago, and the cataract under the capsular sac after the eyes is detected before one month; the hot pepper and the garlic are favored to be eaten at ordinary times, the symptoms of headache and eye pain appear when the lesson preparation time is long, and the phenomena of insomnia and inattention also appear in a short period of time; the weight gain is nearly 10Kg in the last two years; there is no history of drug allergy.

Checking the condition: 162cm in height, 75Kg in weight, belonging to the fat-like constitution, with the heart rate of 86 times/min, the blood pressure of 135/83mmHg, and the fasting blood sugar of 6.3 mmol/L; and (3) for the right eye: 4.2-600DS-5.0, left eye: 4.2-550DS-100DC × 165 ° -5.0; the pressure of the right eye is 17.0mmHg, and the pressure of the left eye is 17.0 mmHg; the conjunctiva on both sides is normal, the cornea is transparent and has no pathological changes, the pupil is round, the diameter is about 3.8mm, and the light reflection exists; large pupil filling and dispersion and examination under a slit lamp: approximately 45% of the superficial cortex under the posterior capsule of the bilateral lens appears brownish yellow and turbid, and the vitreous body is normal; performing ophthalmoscopy: mild pigment disturbance in bilateral macular areas. The diagnosis is as follows: taurine metabolic disorder cataract with myopia left side myopic astigmatism of both eyes.

For the diagnostic results: the taurine external-use medicine for treating myopia (1 time/1-3 days, specifically used according to the using method) is singly used by a patient, eye drops (1-2 drops/time, 3-5 times/day) are alternately dripped into eyes during the period of applying the eye patch, and the treatment course is 5 months.

After 5 months of treatment, the examination results were: heart rate of 81 times/min, blood pressure of 125/78mmHg, and fasting blood glucose of 5.6 mmol/L; and (3) for the right eye: 4.5-350DS-5.0, left eye: 4.5-300DS-75DC × 165 ° -5.0; the pressure of the right eye is 13.5mmHg, and the pressure of the left eye is 13.5 mmHg; large pupil filling and dispersion and examination under a slit lamp: 45% of the brown-yellow turbidity of the superficial cortex under the posterior capsule of the lens at the two sides is desalted, and the vitreous body is normal; performing ophthalmoscopy: the pigment disorder of bilateral macular area is obviously improved. The double shadow does not appear on the handwriting or the object when the user reads the book or the television; the symptoms of insomnia, headache and eye pain are obviously relieved, the attention is obviously concentrated, and the body weight is reduced by 3 Kg.

Typical case (typical case of control group)

One of von, male, 63 years old, zheng zhou railway office luoyang department of machinary retirement employee, han nationality.

The medical history is as follows: when people like to eat hot peppers and drink wine at ordinary times, the people always have insomnia in 2 years, are dysphoric and easy to fatigue and difficult to recover, the weight is obviously increased, the eyesight is obviously reduced, and the people cannot see clearly; there is no history of drug allergy.

Checking the condition: 168cm in height, 83kg in weight, obesity constitution, heart rate of 92 times/min, blood pressure of 160/95mmHg, and fasting blood glucose of 6.5 mmol/L; right eye 4.4-400DS-150DC × 180 ° -5.0, left eye 4.4-450 DS-5.0; the pressure of the right eye is 21.0mmHg, and the pressure of the left eye is 21.0 mmHg; the conjunctiva on both sides is normal, the cornea is transparent and has no pathological changes, the pupil circle and the diameter are about 3.5mm, and the light reflection exists; large pupil filling and dispersion and examination under a slit lamp: approximately 30% of the superficial cortex under the posterior capsule of the lens at both sides appears brownish yellow and turbid, and the vitreous body is normal; performing ophthalmoscopy: pigment disorder in the macula area on both sides, scattered in drusen. The diagnosis is as follows: taurine metabolic disorder cataract is accompanied by myopia right side astigmatism and macular degeneration of eyes.

According to the diagnosis result, when a patient receives antihypertensive treatment, only taurine eye drops for treating myopia are used for eye dropping (1-2 drops/time and 5 times/day), and the treatment course is 6 months.

After 6 months of treatment, the final examination results were: heart rate of 82 times/min, blood pressure of 136/82mmHg, fasting blood glucose of 5.7mmol/L, right eye 4.6-200DS-100DC × 180 ° -5.0, left eye 4.6-250 DS-5.0. The pressure of the right eye is 15.6mmHg, the pressure of the left eye is 15.6mmHg, and the pupil is dilated. Checking under a slit lamp: the brown-yellow turbidity of the superficial cortex 30% below the posterior capsule of the bilateral lens is reduced, and the vitreous body is normal. Performing ophthalmoscopy: the pigment disorder in the macular area can be improved, and the pigment disorder scattered on the drusen part is reduced. The insomnia and dysphoria symptoms are obviously reduced, the eyes see clearly, the fatigue symptoms are improved, and the weight is reduced by 2.5 Kg.

From the above examples, it is understood that the taurine external preparation for treating myopia of the present invention can effectively treat taurine dysbolism cataract caused by taurine dysbolism.

Typical case 1 was used

The taurine external medicine of the invention is applied to patients with acute viral conjunctivitis and herpetic conjunctivitis. The method comprises the following specific steps:

1. certain horse, female, 8 years old, and five pupils in Chan river Hui nationality area in Luoyang city, Hui nationality.

The medical history is as follows: parents mainly state that after a child gets up in the morning, the conjunctiva of both eyes of the child becomes red, the right eye becomes severe, and tears flow; there is no history of drug allergy.

Checking the condition: the body temperature is 38.2 ℃, redness and edema of bulbar conjunctiva on both sides are severe, and the right side is severe; the examination result of the conjunctival scraping blade is as follows: see large numbers of monocytes; the culture is free of bacteria. The diagnosis is as follows: acute viral conjunctivitis.

According to the diagnosis result, when a patient receives symptomatic treatment of antiviral fever, the externally applied taurine preparation of the invention (1 time per 1-3 days, the externally applied taurine preparation is applied to the eyes, specifically, the externally applied taurine preparation is used according to the using method), eye drops are alternately dripped into the eyes (1-2 drops/time, 2-3 times/day) during the period of applying the taurine eye patch, and the treatment course is 12 days.

After 12 days of treatment, the final examination results were: at the body temperature of 36.7 ℃, there is no hyperemia and edema in bilateral bulbar conjunctiva, and tears flow.

2. Hua somewhat, women, age 33, teacher of sports school in Luoyang city, Henan, and Han nationality.

The medical history is as follows: the self-describing person is a sports teacher, students are often trained outdoors, dust enters eyes before 3 days, then phenomena of eye itching, eye pain and lacrimation occur, a bleb is found in the side of the cornea on the inner side of the left eye conjunctiva in the morning, and the peripheral conjunctiva becomes red; there is no history of drug allergy.

Checking the condition: the body temperature was 37.3 ℃ and the conjunctiva medial aspect of the left eye, scleral limbus, and the bulbar conjunctiva showed a grayish red herpes of approximately 2mm size, localized hyperemia of the peripheral conjunctiva. The examination result of the conjunctival scraping blade is as follows: epithelial cells are flaked and have consistent nuclear size, and most of the epithelial cells are neutral and lymphocytes with a small amount of eosinophilic granulocytes. The diagnosis is as follows: herpetic conjunctivitis.

According to the diagnosis result, when a patient receives the antibacterial and antiallergic symptomatic treatment, the externally applied taurine preparation (1 time per 1-3 days, the externally applied taurine preparation is applied to the eyes, specifically, the externally applied taurine preparation is used according to the using method), and eye drops are alternately dripped into the eyes (1-2 drops/time and 3-5 days) during the period of applying the taurine eye patch, wherein the treatment course is 10 days.

After 10 days of treatment, the final examination results were: the body temperature was 36.5 ℃ and the redness of the bulbar conjunctiva was removed at the medial corneoscleral limbus of the left eye, and the surrounding conjunctiva was not congested.

From the above examples, the taurine external medicine for treating myopia of the present invention can effectively treat acute viral conjunctivitis and herpetic conjunctivitis.

Typical case 2 is used

The taurine external-use medicine for treating myopia provided by the invention is used for treating myopia with myopia diopter of 100-825 degrees and myopia amblyopia. The method comprises the following specific steps:

1. dong a certain student, male, 10 years old, school of Luoyang fifth of Luolong district (Nie bay school district), Han nationality.

The medical history is as follows: parents complain about that the students love holding mobile phones to play games in a short time, the sitting posture is incorrect when writing homework, and the eyes are close to books; when a child is suffered from myopia amblyopia at age of 6, the child starts wearing eyes; dizziness, dry eyes, eye pain and anxiety appear in the near segment; there is no history of drug allergy.

Checking the condition: 139cm in height and 31Kg in weight, belonging to a lean constitution, normal conjunctiva, no pathological changes of cornea, normal sclera, no opacity of crystalline lens, slight enlargement of vitreous on both sides, and low development of fovea on both sides of fundus. Vision (distance vision): the naked eye vision of the right eye is 4.1, and the diopter is-650 DS-4.8; the naked eye vision of the left eye is 4.1, and the diopter is-600 DS-100DC multiplied by 180-4.8. Blood electrolyte examination: the phosphorus in the calcium, magnesium, potassium and serum is lower than the normal minimum value, and the zinc and selenium are in the normal range; the electrocardiogram is normal, and the kidney function and the urine volume are normal. The diagnosis is as follows: myopia amblyopia of both eyes with myopic astigmatism on the left.

According to the diagnosis result, the taurine external medicine for treating myopia is used for treating by a patient, the taurine external medicine is pasted for 1 time every 1-3 days (the taurine external medicine is pasted after face cleaning at night), eye drops are alternately used for dropping for 1-2 drops/time and 3-4 times/day during the pasting period, and the taurine external medicine is continuously used for 3 months.

During the treatment period using the taurine external medicine, the naked eye far vision and diopter of the two eyes are rechecked once a week.

After 3 months of use, the final examination results were: the vitreous body on both sides is partially retracted, and the development of the fovea on the fundus oculi on both sides is not obviously improved. The distance vision of naked eyes of the right eye is improved to 4.4, and diopter is-450 DS-4.8; the distance vision of naked eyes of the left eye is improved to 4.4, and diopter is-425 DS-75DC multiplied by 180-4.8. Dizziness is improved, and symptoms of dry eyes, eye pain and anxiety are obviously relieved.

2. Dou, 32 years old, teacher in Luoyang, Luolong district fifth primary school (Nie Bay school district), Han nationality.

The medical history is as follows: myopia starts from the early middle school till the work; recently, the eyesight is increasingly poor, the diopter is increasingly high, and symptoms of insomnia, headache and ophthalmalgia are frequently appeared; there is no history of drug allergy.

Checking the condition: 158cm in height and 49Kg in weight, belonging to a lean constitution, with normal conjunctiva, no pathological changes in cornea, normal sclera, no opacity in crystalline lens, and enlarged vitreous on both sides, with mild leopard-shaped eyeground on both sides. Vision (distance vision): the naked eye vision of the right eye is 4.0, and the diopter is-800 DS-150DC multiplied by 90-5.0; the naked eye has 4.0 of eyesight, and diopter-825 DS-100DC multiplied by 90-5.0. Blood electrolyte examination: the phosphorus content of magnesium, zinc, potassium and serum is lower than the normal minimum value, and the calcium and selenium are in the normal range; the electrocardiogram is normal, and the kidney function and the urine volume are normal. The diagnosis is as follows: both eyes are myopic with bilateral myopic astigmatism.

For the diagnostic results: the taurine external-use medicine for treating myopia (used according to the using method for 1 time/1-3 days) is used by a patient, eye drops (1-2 drops/time, 4-5 times/day) are alternately dripped into eyes during the eye pasting period, and the eye drops are continuously used for 3 months.

During the period of using the taurine externally applied medicine, the binocular naked eye distance vision and diopter are rechecked once a week.

After 3 months of use, the final examination showed: the small part of the expanded vitreous bodies on both sides is retracted, and the bilateral leopard-shaped eyeground is slightly improved. The naked eye distance vision of the right eye is improved to 4.1, and the diopter is-700 DS-100DC multiplied by 90-5.0; the distance vision of naked eyes of the left eye is improved to 4.1, and diopter is-700 DS-100DC multiplied by 90-5.0. Insomnia, headache, and eye pain are somewhat alleviated.

3. A certain Liu is a female, 26 years old, Anle Zhen ren in Luo Longzong, Luoyang.

The medical history is as follows: frequently watching a mobile phone or a television during the 3 months of pregnancy; symptoms of dizziness, eye pain and hypomnesis appear in nearly half a month; there is no history of drug allergy.

Checking the condition: the height is 156cm, the weight is 64Kg, the body is normal, the conjunctiva is normal, the cornea is not diseased, the sclera is normal, the crystalline lens is not turbid, the vitreous body is normal, and the eyeground is normal. Vision (distance vision): the naked eye vision of the right eye is 4.8, and the diopter is-100 DS-5.0; the distance vision of naked eyes of the left eye is 4.8, and the diopter is-100 DS-5.0. Blood electrolyte examination: calcium and potassium are lower than normal minimum values, and magnesium, zinc, serum phosphorus and selenium are in normal range values; the electrocardiogram is normal, and the kidney function and the urine volume are normal. The diagnosis is as follows: simple myopia of both eyes.

For the diagnostic results: the taurine external medicine for treating myopia is adopted by patients to treat myopia. The eye patch is externally applied (1 time/1-3 days), eye drops are alternately applied (1-2 drops/time, 4-5 times/day) during the use period, and the eye patch is continuously used for 3 months.

During the use period, the binocular naked eye distance vision and diopter are reviewed once a week.

After 3 months of use, the final examination results were: the naked eye far vision of the right eye is improved to 5.0, and the naked eye far vision of the left eye is improved to 5.0; dizziness and eye pain symptoms are eliminated, and memory is improved.

The taurine external medicine for treating myopia can effectively treat myopia and myopic amblyopia patients with myopia diopters of 100-825 degrees, can improve the naked eye far vision of the patients by 1-3 lines, and can relieve or eliminate asthenopia and general discomfort symptoms.

Typical cases 3 are used

Typical cases of experimental groups

The medicine (external application and internal medicine) for treating myopia is applied to myopia and myopic amblyopia patients with myopia diopters of 150-875 degrees. The method comprises the following specific steps:

1. wang A in a man, 6 years old, Anle Zhen Wang Zhuang ren in Luo Longzong, Luoyang, Han nationality.

The medical history is as follows: parents complain about that children have incorrect writing, working and sitting postures, and often play games by using mobile phones; the preschool census has the vision of 4.7 for the naked eye of the right eye and 4.7 for the naked eye of the left eye; soreness of the eyes, lacrimation, abdominal distension, sometimes leg muscle twitching at night, occur before march; there is no history of drug allergy.

Checking the condition: the height is 130cm, the weight is 24Kg, the body constitution is normal, conjunctiva is normal, cornea is not diseased, sclera is normal, crystalline lens is not turbid, vitreous body is normal, and eyeground is normal. Vision (distance vision): the naked eye vision of the right eye is 4.7, and the diopter is-150 DS-75DC multiplied by 165-5.0; the naked eye vision of the left eye is 4.7, and the diopter is-175 DS-5.0 (the standard for setting the normal naked eye distance vision of a 6-year-old child in China is more than or equal to 5.0). Blood electrolyte examination: magnesium and potassium are lower than normal minimum values, and calcium, zinc, serum phosphorus and selenium are in normal range values; the electrocardiogram is normal, and the kidney function and the urine volume are normal. The diagnosis is as follows: binocular myopia with right myopic astigmatism.

For the diagnostic results: the invention is suitable for patients to apply the external medicine and the internal medicine for treating myopia. During the treatment period, the oral medicine is taken 2 times per time and 3 times per day (taken with meal or after meal); the external medicine is specifically applied and dropped into the eyes according to the using method of the external medicine, the external medicine is applied for 1 time every 1-3 days (the external medicine is applied after face cleaning at night), and the taurine eye drops are alternately applied to the eyes (2-3 times per day, 1-2 drops per time) during the application period; the oral medicine and the external medicine are applied for 5 months and 1 week. Then entering a health care period, wherein the oral medicine is taken 2 times a day (swallowed with meal or after meal in the morning and evening) and 1 tablet/time for 1 month continuously; then 1 time daily (swallowed with or after supper) for 1 tablet/time, and continuously taking for 2 months.

During the treatment period and the health care period, the binocular naked eye distance vision and diopter are rechecked once a week; blood electrolytes, renal function and urine volume were reviewed every 3 months; the electrocardiogram was reviewed once in 6 months.

After a treatment period of 5 months +1 week and a health care period of 3 months, the final examination result is as follows: the right eye naked eye distance vision is improved to 5.1, and the left eye naked eye distance vision is improved to 5.1. Blood electrolyte examination: magnesium and potassium are supplemented to be within the normal range, and calcium, zinc, serum phosphorus and selenium are within the normal range; the electrocardiogram is normal, and the kidney function and the urine volume are normal. The symptoms of sour eyes, lacrimation, abdominal distension and leg muscle twitch disappear.

Follow-up: after stopping the drug for 3 months, the eye-free distance vision of the left eye is 5.1, and the eye-free distance vision of the left eye is 5.1. Has no symptoms of acid in eyes, lacrimation, abdominal distension and twitch of muscles of legs.

2. History of a certain history, male, 9 years old, students in primary school of board of Luolong district in Luoyang city, Han nationality.

The medical history is as follows: parents complain about, children like to watch the mobile phone to play games at ordinary times, and when the eyesight is generally checked at a grade of one year, the eyes are 4.9; in recent writing, headache, eye pain, eye soreness, lacrimation, anorexia and muscle weakness are frequent; there is no history of drug allergy.

Checking the condition: the height is 136cm, the weight is 29Kg, the body constitution is normal, conjunctiva is normal, cornea is not diseased, sclera is normal, crystalline lens is not turbid, vitreous body is normal, and fundus is normal. Vision (distance vision): the naked eye vision of the right eye is 4.5, and the diopter is-375 DS-5.0; left eye naked eye vision 4.5 diopter-375 DS-5.0. Blood electrolyte examination: the phosphorus in the calcium, magnesium and serum is lower than the normal minimum value, and the potassium, zinc and selenium are in the normal range; the electrocardiogram is normal, and the kidney function and the urine volume are normal. The diagnosis is as follows: simple myopia of both eyes.

For the diagnostic results: the invention is suitable for patients to apply the external medicine and the internal medicine for treating myopia. During the treatment period, the oral medicine is taken 3 times a day, 2 tablets respectively in the morning and at night, and 1 tablet in the noon, and is swallowed with meals or after meals; the external medicine is specifically applied and dropped into the eyes according to the using method of the external medicine, the external medicine is applied for 1 time every 1-3 days (the external medicine is applied after face cleaning at night), and the taurine eye drops are alternately applied to the eyes (3-4 times/day, 1-2 drops/time) during the application period; the oral medicine and the external medicine are applied for 5 months and 2 weeks. Then entering a health care period, wherein the oral medicine is taken 2 times a day (swallowed with meal or after meal in the morning and evening) and 1 tablet/time for 1 month continuously; then 1 time daily (swallowed with or after supper) for 1 tablet/time, and continuously taking for 2 months.

After a treatment period of 5 months +2 weeks and a health care period of 3 months, the final examination result is as follows: the distance vision of naked eyes of the right eye is improved to 4.9 diopters, namely minus 75DS-5.0 diopters; the left eye naked eye distance vision is improved to 4.9 diopter-75 DS-5.0. Blood electrolyte examination: calcium, magnesium and serum phosphorus are supplemented to be within the normal range, and potassium, zinc and selenium are within the normal range; the electrocardiogram is normal, and the kidney function and the urine volume are normal. Has no symptoms of headache, ophthalmalgia, sour eye, lacrimation and anorexia, and obviously improves muscle weakness.

3. One of Zeng, male, 15 years old, the forty-first school student in Luoyang, Han nationality.

The medical history is as follows: the parents complain, the child likes to take food from childhood, like to watch television, and the child checks that the child is binocular myopia amblyopia with right-eye myopia astigmatism in a hospital at the age of 5 years old and starts to wear the glasses; the diopter of the current wearing glasses is: right eye-550 DS-100DC x 90 ° -4.7, left eye-575 DS-4.7; in the near period, there are also symptoms of soreness of the eyes, swelling of the eyes, asthenia and abdominal distension; there is no history of drug allergy.

Checking the condition: the height is 156cm, the weight is 56Kg, the body is weak, the conjunctiva is normal, the cornea is not pathological, the sclera is normal, the crystalline lens is not turbid, the vitreous bodies on the two sides are slightly enlarged, and the fundus fovea is low in development. Vision (distance vision): the right eye naked eye vision is 4.2, the diopter is-550 DS-100DC multiplied by 90-4.7, the left eye naked eye vision is 4.2, and the diopter is 575 DS-4.7. Blood electrolyte examination: the calcium, magnesium, zinc and potassium are lower than the normal minimum value, and the phosphorus and selenium in the serum are in the normal range; the electrocardiogram showed mild myocardial ischemia, normal renal function and urine volume. The diagnosis is as follows: myopia amblyopia of both eyes with myopia astigmatism of the right eye.

For the diagnostic results: the invention is suitable for patients to take the external and internal medicine for treating myopia. Firstly, in the treatment period, the oral medicine is taken 3 times a day, 2 tablets each time (taken with meals or after meals in the morning, at noon and evening); meanwhile, the external medicine is applied and dropped into the eyes according to the using method, the external medicine is applied for 1 time every 1-3 days (the external medicine is applied after face cleaning at night), eye drops are alternately dropped into the eyes (4-5 times/day and 1-2 drops/time) while the external medicine is applied, and the external medicine and the internal medicine are continuously used for 5 months +2 weeks together in the treatment period. Then entering health care period, wherein the oral preparation is taken 2 times a day (taken with dinner or after meal) 1 tablet/time, and after 2 months of continuous administration, the oral preparation is taken 1 time a day (taken with dinner or after meal) 1 tablet/time, and 1 month of continuous administration.

During the treatment period and the health care period, the binocular naked eye distance vision and diopter are rechecked once a week, the blood electrolyte, the renal function and the urine volume are rechecked once every 3 months, and the electrocardiogram is rechecked once every 6 months.

After a treatment period of 5 months +2 weeks and a health care period of 3 months, the final examination result is: the vitreous bodies on both sides return to normal, and the eyeground is normal. The naked eye distance vision of the right eye is improved to 4.5, and the diopter is-250 DS-75DC multiplied by 90-5.0; the left eye bare eye distance vision improves to 4.5 diopters-275 DS-5.0. Blood electrolyte examination: calcium, magnesium, zinc and potassium are supplemented to be within the normal range, and serum phosphorus and selenium are within the normal range; the electrocardiogram is normal, and the kidney function and the urine volume are normal. Has no symptoms of hypodynamia and abdominal distension, and obviously improves symptoms of asthenopia, ocular distension and food preference.

4. Nie is a certain, female, 25 years old, Nie Hay village people in Anle Town, Luoyang.

The medical history is as follows: the diopter of the eyes is increased every year from the beginning of the primary school of the inventor. The phenomena of eye dryness, eye swelling and eye pain begin to appear in the early middle school, and the eye drop for relieving the visual fatigue is usually used for eye dropping, so the effect is not obvious; in recent years, small black spots in front of eyes flutter, and also cause sweating due to debilitation and alopecia; there is no history of drug allergy.

Checking the condition: 158cm in height and 56Kg in weight, and belongs to normal constitution, conjunctiva on both sides is slightly dry, cornea is not diseased, sclera is normal, crystalline lens is not turbid, vitreous on both sides is slightly liquefied, and pigment in macular area on both sides of eyeground is slightly disturbed. Vision (distance vision): the naked eye vision of the right eye is 4.0, and the diopter is-825 DS-200DC multiplied by 165-5.0; the naked eye has 4.0 of eyesight, and diopter-875 DS-100DC multiplied by 180-5.0. Blood electrolyte examination: the calcium, potassium, selenium and serum phosphorus are lower than the normal minimum value, and the zinc and magnesium are in the normal range; the electrocardiogram is normal, and the kidney function and the urine volume are normal. The diagnosis is as follows: myopia of both eyes with myopia astigmatism on both sides, liquefaction of vitreous on both sides, macular degeneration on both sides.

Aiming at the diagnosis result, the patient uses the external medicine and the internal medicine for treating the myopia. Firstly, the oral medicine is taken 3 times a day in the morning and evening, 2 tablets respectively and 1 tablet in noon (taken along with meal or after meal); the external medicine is used at the same time, the application and eye dropping are carried out according to the using method of the external medicine, the application is carried out for 1 time every 1-3 days (the application is carried out after the face is cleaned at night), the eye dropping of eye drops is alternately adopted while the eye patch is applied (4-5 times/day, 1-2 drops/time), and the continuous use lasts for 8 months +3 weeks. Then, the oral medicine is taken 2 times a day (taken with dinner or after meal) and 1 tablet/time in the health care period, and after 2 months of continuous taking, the oral medicine is changed into 1 time a day (taken with dinner or after dinner) and 1 tablet/time in the health care period, and the oral medicine is taken for 1 month continuously.

After 8 months +3 weeks of treatment and 3 months of health care, the final examination result is: the vitreous liquefaction at both sides is improved, the volume is slightly reduced, and the pigment at the macular area of the eyeground is close to normal. The naked eye distance vision of the right eye is improved to 4.2, and the diopter is-600 DS-125DC multiplied by 165-5.0; the distance vision of naked eyes of the left eye is improved to 4.2 diopters of-650 DS-75DC multiplied by 180-5.0. Blood electrolyte examination: calcium, potassium, selenium and serum phosphorus are supplemented to be within the normal range, and zinc and magnesium are within the normal range; the electrocardiogram is normal, and the kidney function and the urine volume are normal. The symptoms of sweating, fatigue, alopecia, dry eyes, ophthalmalgia and eye distension are not obvious.

Control group typical case

The oral medicine for treating myopia is independently adopted, is applied to myopia and myopic amblyopia patients with myopia diopter of 150-875 degrees, and specifically comprises the following components:

1. nie a certain person, male, 6 years old, Nie Hai village people in Anle Zhen Hai province in Luo-Long district, Luoyang, Han nationality.

The medical history is as follows: parents complain about that children often play games with mobile phones from the age of 5 years, and symptoms of dry eyes, acid eyes, photophobia and leg cramps appear half a year ago; there is no history of drug allergy.

Checking the condition: the body height is 128cm, the weight is 23Kg, the body constitution is normal, the conjunctiva is normal, the cornea is not diseased, the sclera is normal, the crystalline lens is not turbid, the vitreous body is normal, and the eyeground is normal. Vision (distance vision): the naked eye vision of the right eye is 4.7, and the diopter is-175 DS-5.0; the naked eye vision of the left eye is 4.7, and the diopter is-175 DS-5.0 (the standard for setting the normal naked eye distance vision of a 6-year-old child in China is more than or equal to 5.0). Blood electrolyte examination: the phosphorus in the calcium and serum is lower than the normal minimum value, and the magnesium, the zinc, the potassium and the selenium are in the normal range; the electrocardiogram is normal, and the kidney function and the urine volume are normal. The diagnosis is as follows: simple myopia of both eyes.

For the diagnostic results: the oral medicine of the invention can be taken by patients for treating myopia independently. During the treatment period, the oral preparation is taken 2 times per day and 3 times per day, and is swallowed with meal or after meal for 6 months. Then entering a health care period, wherein the oral medicine is taken 2 times a day (swallowed with meal or after meal in the morning and evening) and 1 tablet/time for 1 month continuously; then 1 time daily (swallowed with or after supper) for 1 tablet/time, and continuously taking for 2 months.

After 6 months of treatment and 3 months of health care, the final examination result is as follows: the right eye naked eye distance vision is improved to 5.1, and the left eye naked eye distance vision is improved to 5.1. Blood electrolyte examination: calcium and serum phosphorus are supplemented to be within the normal range, and magnesium, zinc, potassium and selenium are within the normal range; the electrocardiogram is normal, and the kidney function and the urine volume are normal. Dry eyes, acid eyes, photophobia and leg cramps disappear.

Follow-up: after stopping the drug for 3 months, the eye-free distance vision of the left eye is 5.1, and the eye-free distance vision of the left eye is 5.1. There were no symptoms of dry eyes, acid eyes, photophobia and cramps in legs.

2. Xie a certain, male, 9 years old, Luoyang, Luolong district Wangzhuang primary school student, Han nationality.

The medical history is as follows: parents complain about that children have irregular writing posture, eyes are close to a desk, people stay up at night, and headache, dry eyes, itching eyes, sweating due to deficiency and muscle weakness begin to appear before one year; there is no history of drug allergy.

Checking the condition: the height is 135cm, the weight is 28Kg, the body is normal, the conjunctiva is normal, the cornea is not diseased, the sclera is normal, the crystalline lens is not turbid, the vitreous body is normal, and the eyeground is normal; vision (distance vision): the naked eye vision of the right eye is 4.5, and the diopter is-375 DS-5.0; left eye naked eye vision 4.5 diopter-350 DS-5.0. Blood electrolyte examination: calcium, magnesium and phosphorus in blood are lower than normal minimum values, potassium, zinc and selenium are in normal range values, electrocardiogram is normal, and renal function and urine volume are normal. The diagnosis is as follows: simple myopia of both eyes.

For the diagnostic results: the oral medicine of the invention can be taken by patients for treating myopia independently. During the treatment period, the oral medicine is taken 3 times a day, 2 tablets respectively in the morning and at night, and 1 tablet in the noon, and is swallowed with meals or after meals; the administration is continued for 6 months. Then entering a health care period, wherein the oral medicine is taken 2 times a day (swallowed with meal or after meal in the morning and evening) and 1 tablet/time for 1 month continuously; then 1 time daily (swallowed with or after supper) for 1 tablet/time, and continuously taking for 2 months.

After 6 months of treatment and 3 months of health care, the final examination result is as follows: the right eye naked eye distance vision is improved to 4.9 diopter minus 75DS-5.0, and the left eye naked eye distance vision is improved to 4.9 diopter minus 50 DS-5.0. Blood electrolyte examination: calcium, magnesium and serum phosphorus are supplemented to be within the normal range, and potassium, zinc and selenium are within the normal range; the electrocardiogram is normal, and the kidney function and the urine volume are normal. Has no symptoms of headache, dry eyes, itchy eyes and sweating due to deficiency, and obviously improves the muscle weakness.

3. Ching in Tao, male, 12 years old, Luoyang, Luolong district fifth school student, Han nationality.

The medical history is as follows: parents complain that we are both near-sighted, children play games with a mobile phone from a small favorite, the children check that the eyes are near-sighted and weak sight with double-side near-sighted astigmatism in a hospital at the age of 4, the children start wearing glasses, the auxiliary glasses are replaced before march, and the diopter is: right eye-550 DS-100DC x 90 ° -4.7, left eye-525 DS-150DC x 90 ° -4.7; dry eyes and sour eyes appear one year ago, and anorexia, monophagia and leg cramps appear half year ago; there is no history of drug allergy.

Checking the condition: the height is 146cm, the weight is 38Kg, the body is weak, the conjunctiva is normal, the cornea is not diseased, the sclera is normal, the crystalline lens is not turbid, the vitreous bodies on the two sides are slightly enlarged, and the fundus fovea is low in development. Vision (distance vision): the naked eye vision of the right eye is 4.2, and the diopter is-550 DS-100DC multiplied by 90-4.7; the naked eye vision of the left eye is 4.2, and the diopter is-525 DS-150DC multiplied by 90-4.7. Blood electrolyte examination: the phosphorus in the calcium, magnesium, zinc and serum is lower than the normal minimum value, and the potassium and selenium are in the normal range; the electrocardiogram showed mild myocardial ischemia, normal renal function and urine volume. The diagnosis is as follows: myopia amblyopia of both eyes with myopia astigmatism of both sides.

For the diagnostic results: the oral medicine of the invention can be taken by patients for treating myopia independently. Firstly, in the treatment period, the oral medicine is taken 3 times a day, 2 tablets each time (taken with meals or after meals in the morning, at noon and evening); the administration is continued for 6 months. Then entering health care period, wherein the oral preparation is taken 2 times a day (taken with dinner or after meal) and 1 tablet/time, and after 2 months of continuous taking, the oral preparation is taken 1 time a day (taken with dinner or after meal) and 1 tablet/time and is taken 1 month continuously.

After 6 months of treatment and 3 months of health care, the final examination result is: the vitreous bodies on both sides return to normal, and the eyeground is normal. The naked eye distance vision of the right eye is improved to 4.5, and the diopter is-250 DS-75DC multiplied by 90-5.0; the naked eye far vision of the left eye is improved to 4.5 diopters of-225 DS-125DC multiplied by 90-5.0. Blood electrolyte examination: calcium, magnesium, zinc and serum phosphorus are supplemented to be within a normal range, and potassium and selenium are within the normal range; the electrocardiogram is normal, and the kidney function and the urine volume are normal. Has no symptoms of anorexia, monophagia and leg cramp, and obviously improves the symptoms of dry eyes and acid eyes.

4. Yuan Yi (a certain form of Yuan-Gong), male, 28 years old, the Cone of Anle town in Luoyang, and Han nationality.

The medical history is as follows: the self-help book reading is realized in a love, the myopia starts in the first two days, the vision is reduced fastest in the period of high school and middle school, and the computer is commonly used when the user walks to a working post; headache, dry eyes, and sour and swollen eyes in recent two years, and the eyeball rotates and also swings like small black worms; appetite reduction, abdominal distension and body fatigue appear five months before; there is no history of drug allergy.

Checking the condition: 175cm in height and 69Kg in weight, belonging to normal constitution, with dry conjunctiva on both sides, no pathological changes on cornea, normal sclera, no opacity of crystalline lens, light liquefaction of vitreous on both sides, and pigment disorder in macular area on both sides of eyeground. Vision (distance vision): the naked eye vision of the right eye is 4.0, and the diopter is-850 DS-200DC multiplied by 180-5.0; the naked eye has 4.0 of eyesight, and diopter-875 DS-150DC multiplied by 180-5.0. Blood electrolyte examination: the calcium, potassium, zinc and serum phosphorus are lower than the normal minimum value, and the magnesium and selenium are in the normal range; the electrocardiogram is normal, and the kidney function and the urine volume are normal. The diagnosis is as follows: myopia of both eyes with myopia astigmatism on both sides, liquefaction of vitreous on both sides, macular degeneration on both sides.

Aiming at the diagnosis result, the patient can take the oral medicine for treating the myopia independently. Firstly, the treatment period is that the oral medicine is taken 3 times a day, 2 tablets each time (taken with meals or after meals in the morning, at noon and evening); the administration is continued for 9 months. Then, the oral medicine is taken 2 times a day (taken with dinner or after meal) and 1 tablet/time in the health care period, and after 2 months of continuous taking, the oral medicine is changed into 1 time a day (taken with dinner or after dinner) and 1 tablet/time in the health care period, and the oral medicine is taken for 1 month continuously.

After 9 months of treatment and 3 months of health care, the final examination result is as follows: the vitreous body on both sides is liquefied and improved, the volume is also partially reduced, and the pigment in the macular area of the eyeground is close to normal; the naked eye distance vision of the right eye is improved to 4.2, and the diopter is-650 DS-150DC multiplied by 180-5.0; the naked eye distance vision of the left eye is improved to 4.2 diopters-675 DS-100DC multiplied by 180 DEG-5.0. Blood electrolyte examination: calcium, potassium, zinc and serum phosphorus are supplemented to be within the normal range, and magnesium and selenium are within the normal range; the electrocardiogram is normal, and the kidney function and the urine volume are normal. The appetite is enhanced, and the symptoms of abdominal distension, body fatigue and headache, dry eyes and soreness and distension of eyes are not obviously relieved.

Therefore, the taurine external-use medicine for treating myopia has a good treatment effect on myopia with the myopia diopter of 100-875 degrees and myopia amblyopia.

And the medicine (taurine external medicine) and the oral medicine are used together, so that compared with the single oral medicine, the treatment course of the myopia and the myopic amblyopia with the myopia diopter of 150-875 degrees can be shortened by 1-3 weeks, namely the taurine eye patch has good effect of treating the myopia and the myopic amblyopia.

Claims

1. A taurine external use medicine for treating myopia is characterized in that the external use medicine comprises taurine eye drops and taurine eye patches;

the taurine eye mask comprises taurine eye mask liquid and water-punched non-woven fabrics for the eye mask; the taurine eye patch liquid is prepared from the following raw materials in percentage by weight: 50-55 g of taurine, 9.30-12.09 g of boric acid, 0.57-4.78 g of anhydrous borax, 0.20-0.35 g of ethylparaben, 1-1.75 ml of 50-95% ethanol and 1500ml of distilled water. The milliosmolarity of the taurine eye patch liquid is 389.02-445.67 mosmol/kg; the concentration of taurine in the taurine eye patch liquid is 0.033-0.037 g/ml.

2. The taurine external use medicine for treating myopia according to claim 1, wherein the spunlace nonwoven fabric for eye patch has an oval shape, a transverse major axis diameter of 8.1cm, and a longitudinal major axis diameter of 5.6 cm.

3. The taurine external use medicine for treating myopia according to claim 1, wherein the taurine eye drops are prepared from the following raw materials in percentage by weight: 50-55 g of taurine, 9.30-12.09 g of boric acid, 0.57-4.78 g of anhydrous borax, 0.20-0.35 g of ethylparaben, 1-1.75 ml of 50-95% ethanol and 1000ml of distilled water; the milliosmolarity of the taurine eye drops is 583.53-668.51 mosmol/kg; the concentration of taurine in the taurine eye drops is 0.050-0.055 g/ml.

4. The taurine external use medicine for treating myopia according to any one of claims 1 to 3, wherein the mass of taurine in the taurine eye patch liquid is 50 to 50.51g, 11.22 to 12.09g, 0.57 to 1.91g respectively with the mass of boric acid and the mass of anhydrous borax; the mass of the taurine in the taurine eye drops, the boric acid and the anhydrous borax is respectively 50-50.51 g, 11.22-12.09 g and 0.57-1.91 g.

5. A method for preparing a taurine eye patch according to any one of claims 1 to 4, comprising the steps of:

s6, taking the sterilized eye patch to be water-punched with non-woven fabrics, cutting according to the required shape, putting the eye patch into a sealed ethylene oxide sterilization cabinet to sterilize and disinfect for 6 hours, taking out, packaging 2 pieces of eye patch in sterile environment by using a sterilized polyethylene plastic film bag, sealing, and placing the eye patch in the sterile environment for later use;

6. The medicine for treating myopia is characterized by comprising an external medicine and an internal medicine; the externally applied medicine is the taurine externally applied medicine for treating myopia as described in any one of claims 1-4, and the orally applied medicine comprises the following components in parts by weight: 5-22 parts of disodium adenosine triphosphate, 0.30-1.25 parts of L-methionine, 100-410 parts of taurine, 1.50-12 parts of lutein, 0.175-0.63 part of vitamin A, 0.898-3.234 parts of beta-carotene and 10 parts of vitamin D3 (1.50-6)^-32 to 14 parts of vitamin E, -TE, 54 to 135 parts of vitamin C, 10.15 to 1.15 parts of vitamin B, 20.15 to 1.28 parts of vitamin B, 60.13 to 1.45 parts of vitamin B, 1.50 to 11.52 parts of nicotinamide, 95.82 to 150.10 parts of calcium, 15.97 to 54.43 parts of magnesium, 18.73 to 33.35 parts of potassium, 3.73 to 15.80 parts of zinc and 10 parts of selenium (20 to 110)^-3Part (20-110) 10 of chromium^-3And (4) portions are obtained.

7. The medicament for treating the myopia according to claim 6, wherein the dosage form of the oral medicament comprises tablets and pills.

8. The medicament for treating myopia according to claim 6, wherein the preparation method of the oral medicament comprises the following steps:

c content calculated as anhydrous substance in terms of mass content₁₀H₁₄N₅Na₂O₁₃P₃Preparing raw materials including 5.26-21.05 parts of disodium adenosine triphosphate of not less than 95%, 0.30-1.22 parts of L-methionine with the mass content of not less than 98.5%, 100 parts of anhydrous calcium hydrogen phosphate with the mass content of 99%, 27.10-42.98 parts of maltodextrin, 1.43-2.26 parts of pregelatinized starch, 8 parts of crospovidone, 0.40 part of superfine silica gel powder and 0.80 part of magnesium stearate with the mass content of 4.0-5.0% of magnesium element calculated according to a dry product;

and uniformly mixing the superfine silica gel powder and the magnesium stearate powder which are sieved by a 80-mesh sieve with the granules sieved by a 16-24-mesh sieve, pressing into tablets, and coating enteric coating to obtain the core-spun tablet cores.

(2) Preparing a wrapping layer, which comprises the following steps:

(3) pressing together