CN114569546A - Disodium adenosine triphosphate external medicine for preventing and treating myopia and preparation method and application thereof - Google Patents
Disodium adenosine triphosphate external medicine for preventing and treating myopia and preparation method and application thereof Download PDFInfo
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- CN114569546A CN114569546A CN202011384182.9A CN202011384182A CN114569546A CN 114569546 A CN114569546 A CN 114569546A CN 202011384182 A CN202011384182 A CN 202011384182A CN 114569546 A CN114569546 A CN 114569546A
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- eye
- powder
- adenosine triphosphate
- parts
- disodium
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- OIRDTQYFTABQOQ-KQYNXXCUSA-N adenosine Chemical compound C1=NC=2C(N)=NC=NC=2N1[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O OIRDTQYFTABQOQ-KQYNXXCUSA-N 0.000 claims abstract description 62
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- FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical compound CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 claims abstract description 41
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- YVBGRQLITPHVOP-UHFFFAOYSA-L disodium;[hydroxy-[hydroxy(oxido)phosphoryl]oxyphosphoryl] hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])(=O)OP(O)(=O)OP(O)([O-])=O YVBGRQLITPHVOP-UHFFFAOYSA-L 0.000 claims abstract description 33
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- A61K9/00—Medicinal preparations characterised by special physical form
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- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
- A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
- A61K31/7064—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
- A61K31/7076—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines containing purines, e.g. adenosine, adenylic acid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
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- A—HUMAN NECESSITIES
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0048—Eye, e.g. artificial tears
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
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- A—HUMAN NECESSITIES
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- A61P27/00—Drugs for disorders of the senses
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
- A61P27/10—Ophthalmic agents for accommodation disorders, e.g. myopia
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Abstract
The invention discloses an adenosine disodium triphosphate external medicine for preventing and treating myopia and a preparation method and application thereof. The external medicine comprises disodium adenosine triphosphate eye drops and disodium adenosine triphosphate eye patches, wherein the disodium adenosine triphosphate eye patches comprise eye patch liquid and water-punched non-woven fabrics for the eye patches; the invention also discloses a medicament for preventing and treating myopia, which comprises an oral medicament and an external medicament; the disodium adenosine triphosphate eye drops and the disodium adenosine triphosphate eye patch comprise disodium adenosine triphosphate, L-methionine and a PH regulator. The disodium adenosine triphosphate eye patch effectively plays the prevention and treatment effects of disodium adenosine triphosphate in eye asthenopia, myopia and myopic amblyopia, and effectively avoids side effects brought in the use process. Can shorten the lengthened eye axis, remove or relieve astigmatism of crystalline lens, improve the naked eye distance vision, improve the functions of optic nerve and retina, and relieve some asthenopia and general discomfort symptoms caused by myopia.
Description
Technical Field
The invention belongs to the field of medicines, and particularly relates to an external disodium adenosine triphosphate medicine for preventing and treating myopia, and a preparation method and application thereof.
Background
The disodium adenosine triphosphate is an accessory enzyme drug, is a nucleotide derivative and participates in the metabolism of fat, protein, sugar, nucleic acid and nucleotide in vivo, and can penetrate through the blood cerebrospinal fluid barrier, improve the stability and reconstruction capability of a neural cell membranous structure and promote the regrowth of neurites. It can be used with pentose to synthesize nucleic acid under the action of in vivo enzyme, and with phospholipid cholestyramine to synthesize cephalin and cytidine monophosphate under the action of trans-cytidine hydrolase. Adenosine Triphosphate (ATP) is an energy substance in vivo, and when energy is required for absorption, decomposition, muscle contraction, biochemical synthesis reaction and the like in vivo, the ATP is decomposed into adenosine diphosphate and phosphate groups and releases the energy; adenosine triphosphate can expand peripheral blood vessels, promote blood circulation, improve local nutrition, promote the absorption of edema and exudates, and improve the functions of optic nerve and retina; the simultaneous edema of the extraocular muscles, the iris-ciliary body (namely the anterior uvea) and the crystalline lens in the eyes, which is caused by the rigid contraction of the eye muscle group due to the long-term near reflex triple movement of the eyes. Therefore, disodium adenosine triphosphate is a common raw material in medicines, but disodium adenosine triphosphate is generally used as an injection and clinically applied to various diseases caused by the decrease of the activity of tissue injury cell enzymes, such as heart failure, myocarditis, myocardial infarction, cerebral arteriosclerosis, coronary arteriosclerosis, progressive muscular atrophy, cerebral hemorrhage sequelae, acute and chronic hepatitis, hearing disorders and the like.
The rapid intravenous injection in the process of adopting the adenosine disodium triphosphate injection is easy to cause dizziness, head distension, chest distress, hypotension and the like, and the forward and reverse conduction of the bypass can be blocked or delayed by large dosage. It also has the effect of transiently augmenting the vagus nerve, thereby terminating arrhythmias caused by atrioventricular nodal reentry and bypass reentry mechanisms. Intramuscular injection of large doses causes local pain, and in a small number of patients joint soreness and pain in the lower extremities can occur.
Therefore, the disodium adenosine triphosphate has obvious side effect when being used by injection, and has not been applied to the prevention and treatment of asthenopia, myopia and myopic amblyopia.
Disclosure of Invention
Aiming at the problems, the invention provides an external disodium adenosine triphosphate for preventing and treating myopia and a preparation method and application thereof. The eye patch avoids injection, effectively prevents and treats asthenopia, myopia and myopia amblyopia by adopting a patch mode, and effectively avoids side effects caused by injection of disodium adenosine triphosphate.
The invention is realized by the following technical scheme
The disodium adenosine triphosphate eye drops for preventing and treating myopia are prepared from the following raw materials in parts by weight: adding 20-25 g of disodium adenosine triphosphate, 25-37 g of L-methionine, a pH regulator and water for injection to 2000 ml. The milliosmol molar concentration of the disodium adenosine triphosphate eye drops is 336.41-460.05 mosmol/Kg. The concentration of the disodium adenosine triphosphate in the eye drops is 0.010-0.013 g/ml.
Furthermore, the mass of the disodium adenosine triphosphate and the mass of the L-methionine in the eye drops are respectively 20.00-21.05 g and 30.30-35.35 g.
Further, the pH regulator is 30-38 ml of a 4% sodium hydroxide aqueous solution.
An external application of disodium adenosine triphosphate for preventing and treating myopia comprises the eye drops and a disodium adenosine triphosphate eye patch, wherein the disodium adenosine triphosphate eye patch comprises eye patch liquid and spunlace nonwoven fabrics for the eye patch; the eye patch liquid is prepared from the following raw materials in parts by weight: adding 20-25 g of disodium adenosine triphosphate, 25-37 g of L-methionine, a pH regulator and injection water to 3000 ml. The milliosmol molar concentration of the adenosine disodium triphosphate eye patch is 224.27-306.70 mosmol/Kg. The concentration of the adenosine disodium triphosphate in the eye patch liquid is 0.007-0.008 g/ml.
Further, the pH regulator is 30-38 ml of 4% sodium hydroxide aqueous solution; the mass of the disodium adenosine triphosphate and the mass of the L-methionine in the eye patch liquid are respectively 20.00-21.05 g and 30.30-35.35 g.
The preparation method of the disodium adenosine triphosphate eye patch comprises the following steps:
s1, preparing disodium adenosine triphosphate, L-methionine, a 4% sodium hydroxide aqueous solution of a pH regulator and water for injection according to required amount;
s2, heating 80% of the total volume of the injection water prepared in the step S1 to 20-30 ℃, adding the disodium adenosine triphosphate prepared in the step S1, and stirring for 5-15 minutes until the disodium adenosine triphosphate is completely dissolved to prepare a first solution;
s3, adding the prepared L-methionine into the first solution, and stirring for 5-15 minutes until the L-methionine is completely dissolved to obtain a second solution;
s4, slowly adding a prepared 4% sodium hydroxide aqueous solution of a pH regulator into the second solution, continuously stirring for 5-15 minutes to uniformly mix the solution, regulating the pH value of the solution to 7.85-8.85, adding the residual injection water at the temperature of 20-30 ℃ to full amount, and then fully stirring for 10-15 minutes to be 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 polyester medicinal eye drop bottle in an aseptic environment after the filtration is finished, plugging and capping to obtain eye patch liquid;
s6, taking the sterilized eye patch to be water-punched with non-woven fabrics, cutting into required shape, placing in a sealed ethylene oxide sterilizing cabinet, sterilizing for 6 hours, taking out, packaging 2 pieces in sterile environment with sterilized polyethylene plastic film bags, sealing, and placing in sterile environment for later use;
s7, taking the spunlace non-woven fabric slices for the eye patches prepared in the sterile environment of the step S6, and soaking 2 slices into eye patch liquid to obtain the disodium adenosine triphosphate eye patch;
preferably, the mass ratio of the adenosine disodium triphosphate in the step S2 to the water for injection is 21.05 g: 3000 ml; the content of the L-methionine in the step S3 is 30.30-35.35 g; in the step S4, the dosage of the pH regulator is 30-37.50 ml of 4% sodium hydroxide aqueous solution.
A medicine for preventing and treating myopia comprises oral medicine and topical medicine; the external medicine is the adenosine disodium triphosphate for preventing and treating myopiaExternally applied medicine; the oral 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 is characterized by comprising 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;
uniformly mixing the micro silica gel powder and magnesium stearate powder which are sieved by an 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:
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 80-mesh sieve, 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 passes through an 18-mesh nylon screen; more preferably, the dry granules 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 disodium adenosine triphosphate external-use medicine for preventing and treating myopia comprises the following steps:
(1) before use, the skin of hands and face is cleaned by clear water;
(2) applying the eye patch soaked with the eye patch liquid on the skin of eyes (the skin on the upper side and the lower side of the eyes), closing the eyes and resting for 20-30 minutes;
(3) after the application is finished, removing the eye patch, closing eyes and resting for 3-5 minutes; 1 time every 1-3 days;
(4) during the period of pasting and applying the eye patch, eye drops are alternately dropped into the eye, 2-6 times a day, and 1-2 drops are applied each time.
The eye drops and the eye patch can be bottled by adopting sterilized polyester medicinal eye drop bottles. The spunlace non-woven fabric of the disodium adenosine triphosphate eye patch can be separately sealed and packaged. When in use, the sterilized eye patch is soaked in the adenosine disodium triphosphate eye patch solution by using the spunlace nonwoven fabric to obtain the adenosine disodium triphosphate eye patch. The application of the adenosine disodium triphosphate eye patch and the eye drop of the adenosine disodium triphosphate are alternately used at the same time.
Compared with the prior art, the invention has the following positive beneficial effects
The disodium adenosine triphosphate eye patch effectively plays the prevention and treatment effects of disodium adenosine triphosphate in eye asthenopia, myopia and myopic amblyopia, and effectively avoids side effects brought in the using process. The eye patch can remove or relieve simultaneous edema of extraocular muscles, iris ciliary body (namely anterior uvea) and crystalline lens of eyes caused by long-term stress near reflex triple movement of the eyes, shorten lengthened eye axis, remove or relieve astigmatism of the crystalline lens and improve naked eye distance vision. At the same time, it can also expand peripheral blood vessel, promote blood circulation, improve local nutrition, promote absorption of edema and exudate, improve functions of optic nerve and retina, and relieve some asthenopia and general malaise symptoms caused by myopia.
The solution containing the disodium adenosine triphosphate is loaded on the spunlace non-woven fabric for the eye patch and directly pasted outside the eyes, the transdermal absorption of the disodium adenosine triphosphate can be quickly improved through a skin hydration method, the distribution concentration of the disodium adenosine triphosphate in local tissue cells of the eyes can be greatly improved, the disodium adenosine triphosphate can be quickly improved, the simultaneous edema of extraocular muscles, iris ciliary bodies (namely anterior uvea) and crystalline lenses in the eyes caused by long-term stress near reflex triple movement of the eyeballs can be improved, the lengthened part of ocular axis can be shortened, the astigmatism of the naked eyes can be removed or reduced, the distance vision can be improved, and the prevention and treatment effects of optic nerves and the retinas can be improved. The naked eye far vision of the asthenopia, myopia and myopic amblyopia patients can be improved by 1-3 lines, and some asthenopia and general discomfort symptoms caused by myopia are relieved. Especially for the myopic patients with asthenopia and myopia diopters within 300 degrees, the effect is more obvious.
Meanwhile, the external application avoids adverse reactions such as local pain, cough, chest distress and the like caused by the injection process, and the external application is convenient to use and carry and wide in application.
When the disodium adenosine triphosphate eye patch and the disodium adenosine triphosphate oral medicine are simultaneously applied, the distribution concentration of disodium adenosine triphosphate in local tissue cells of eyes can be greatly improved, the disodium adenosine triphosphate can be quickly improved, the simultaneous edema of extraocular muscles, an intraocular iris ciliary body (namely an anterior uvea) and a crystalline lens of an eyeball caused by long-term stress near reflex triple movement can be quickly improved, the lengthened part of axis of the eye can be shortened, the astigmatism of the crystalline lens can be removed or lightened, the distance vision of naked eyes can be improved, and the prevention and treatment effects of optic nerves and the retina can be improved. The combination of the two can not only obviously improve the prevention and treatment effect, but also shorten the prevention and treatment course of the adenosine disodium triphosphate, shorten the prevention and treatment course of asthenopia, myopia and myopic amblyopia patients by 1-4 weeks, and have good practical use effect. 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.
Preferred mass content of disodium adenosine triphosphate (calculated as anhydride, C) for external use in examples10H14N5Na2O13P3) More than or equal to 95 percent of disodium adenosine triphosphate (food grade); the L-methionine is preferably 99% by mass of L-methionine (food grade); the sodium hydroxide is preferably a sodium hydroxide aqueous solution (pharmaceutical grade) with the mass content of 4%, and the pharmaceutical water is water for injection.
The disodium adenosine triphosphate used in the oral medicine adopts the mass content (calculated according to anhydrous substance, and contains C)10H14N5Na2O13P3) Is not less than 95 percent of disodium adenosine triphosphate; l-methionine (namely L-methionine) with the mass content of more than or equal to 98.5 percent is adopted; the taurine is 99 percent by mass; 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 adopts DL- -acetic ester tocopherol dry powder with the mass content of (DL- -acetic ester tocopherol) of 50 percent; 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% and magnesium stearate with the mass content (calculated by dry products, magnesium element) of 4.0-5.0% (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
An adenosine disodium triphosphate eye drop for preventing and treating myopia is prepared from the following raw materials: adding 21.05g of disodium adenosine triphosphate and 30.30g of L-methionine into 80% injection water with the total volume of 2000ml, uniformly stirring until the disodium adenosine triphosphate and the L-methionine are completely dissolved, then adjusting the pH value of the solution to 8.00 by using 30ml of 4% sodium hydroxide aqueous solution, and adding the rest injection water to the full amount. The milliosmol molar concentration of the disodium adenosine triphosphate eye drops is 377.65 mosmol/Kg; the concentration of the adenosine disodium triphosphate in the eye drops is 0.011 g/ml; the pH value of the obtained disodium adenosine triphosphate eye drops is 8.00.
Example 2
An adenosine disodium triphosphate eye drop for preventing and treating myopia is prepared from the following raw materials: adding 21.05g of disodium adenosine triphosphate and 35.35g of L-methionine into 80% injection water with the total volume of 2000ml, uniformly stirring until the disodium adenosine triphosphate and the L-methionine are completely dissolved, then adjusting the pH value of the solution to 9.00 by adopting 37.50ml of 4% sodium hydroxide aqueous solution, and adding the rest injection water to the full amount. The milliosmol molar concentration of the disodium adenosine triphosphate eye drops is 426.49 mosmol/Kg; the concentration of the adenosine disodium triphosphate in the eye drops is 0.011 g/ml; the pH value of the obtained disodium adenosine triphosphate eye drops is 9.00.
Example 3
An external use medicine of disodium adenosine triphosphate for preventing and treating myopia, which comprises the eye drops and the disodium adenosine triphosphate eye patch in the embodiment 1-2;
the disodium adenosine triphosphate eye patch comprises eye patch liquid and a water-punched non-woven fabric for the eye patch, wherein the eye patch liquid is prepared from the following raw materials: disodium adenosine triphosphate 21.05g, L-methionine 30.30g, 4% sodium hydroxide solution 30ml, water for injection to 3000 ml. The milliosmol molar concentration of the adenosine disodium triphosphate eye patch is 251.77 mosmol/Kg;
the concentration of the adenosine disodium triphosphate in the eye patch liquid is 0.007 g/ml; the pH was adjusted to 7.85 with 30ml of 4% aqueous sodium hydroxide solution.
The number of the water-punched non-woven fabrics for eye patches is two, the two water-punched non-woven fabrics for eye patches are oval, the diameter of the transverse long axis of the oval is 8.1cm, and the diameter of the longitudinal short axis of the oval is 5.6 cm. And (3) placing the sterilized eye patch into the eye patch liquid for the eye patch to soak to obtain the disodium adenosine triphosphate eye patch.
Example 4
An external use medicine of disodium adenosine triphosphate for preventing and treating myopia, which comprises the eye drops and the disodium adenosine triphosphate eye patch in the embodiment 1-2;
the disodium adenosine triphosphate eye patch comprises eye patch liquid and a water-punched non-woven fabric for the eye patch, wherein the eye patch liquid is prepared from the following raw materials: disodium adenosine triphosphate 21.05g, L-methionine 35.35g, 4% sodium hydroxide solution 37.50ml, water for injection to 3000 ml. The milliosmol molar concentration of the adenosine disodium triphosphate eye patch is 284.33 mosmol/Kg;
the concentration of the adenosine disodium triphosphate in the eye patch liquid is 0.007 g/ml; adjusting the pH value to 8.85 by using 37.50ml of 4% sodium hydroxide aqueous solution;
the number of the water-punched non-woven fabrics for eye patches is two, the two water-punched non-woven fabrics for eye patches are oval, the diameter of the transverse long axis of the oval is 8.1cm, and the diameter of the longitudinal short axis of the oval is 5.6 cm. And (3) placing the sterilized eye patch into the eye patch liquid for the eye patch to soak to obtain the disodium adenosine triphosphate eye patch.
Example 5
A preparation method of disodium adenosine triphosphate eye patch for preventing myopia comprises the following steps:
s1, preparing 21.05g of raw material disodium adenosine triphosphate, 30.30g of L-methionine, 30ml of pH regulator 4% sodium hydroxide solution and 3000ml of water for injection;
s2, heating 80% of the total volume of the injection water prepared in the step S1 to 20-30 ℃, adding the disodium adenosine triphosphate prepared in the step S1, and stirring for 5-15 minutes until the disodium adenosine triphosphate is completely dissolved to prepare a first solution;
s3, adding the prepared L-methionine into the first solution, and stirring for 5-15 minutes until the L-methionine is completely dissolved to obtain a second solution;
s4, slowly adding a prepared 4% sodium hydroxide aqueous solution of a pH regulator into the second solution, continuously stirring for 5-15 minutes to uniformly mix the solution, regulating the pH value of the solution to 7.85, adding the residual water for injection at the temperature of 20-30 ℃ to full amount, and then fully stirring for 10-15 minutes to completely and uniformly mix 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 polyester medicinal eye drop bottle in an aseptic environment after the filtration is finished, plugging and capping to obtain eye patch liquid;
s6, taking the antibacterial eye patch, using water-punched non-woven fabric, cutting into a required shape, placing the eye patch in a sealed ethylene oxide sterilization cabinet, sterilizing for 6 hours, taking out, packaging 2 pieces of the eye patch in sterile polyethylene plastic film bags in a sterile environment, sealing, and placing the eye patch in the sterile environment for later use;
s7, taking the spunlace non-woven fabric slices for the eye patches prepared in the sterile environment of the step S6, and soaking 2 slices into eye patch liquid to obtain the disodium adenosine triphosphate eye patch;
example 6
A preparation method of disodium adenosine triphosphate eye patch for preventing myopia comprises the following steps:
s1, preparing 21.05g of raw material disodium adenosine triphosphate, 35.35g of L-methionine, 37.50ml of pH regulator 4% sodium hydroxide solution and 3000ml of injection water;
s2, heating 80% of the total volume of the injection water prepared in the step S1 to 20-30 ℃, adding the disodium adenosine triphosphate prepared in the step S1, and stirring for 5-15 minutes until the disodium adenosine triphosphate is completely dissolved to prepare a first solution;
s3, adding the prepared L-methionine into the first solution, and stirring for 5-15 minutes until the L-methionine is completely dissolved to obtain a second solution;
s4, slowly adding the prepared 4% sodium hydroxide aqueous solution as the pH regulator into the second solution, continuously stirring for 5-15 minutes to uniformly mix the solution, regulating the pH value of the solution to 8.85, adding the residual water for injection at the temperature of 20-30 ℃ to full volume, and then fully stirring for 10-15 minutes to be completely and uniformly mixed to obtain a third solution;
s5, performing primary circulating filtration on the third solution for 20 minutes by using an aseptic filter with the micropore diameter of 0.45um, performing secondary filtration by using a secondary aseptic filter with the micropore diameter of 0.22um, sub-packaging the third solution into a sterilized polyester medicinal eye drop bottle in an aseptic environment after the filtration is finished, plugging and capping to obtain eye patch liquid;
s6, taking the antibacterial eye patch, using water-punched non-woven fabric, cutting into a required shape, placing the eye patch in a sealed ethylene oxide sterilization cabinet, sterilizing for 6 hours, taking out, packaging 2 pieces of the eye patch in sterile polyethylene plastic film bags in a sterile environment, sealing, and placing the eye patch in the sterile environment for later use;
s7, taking the spunlace nonwoven fabric slices for the eye patches prepared in the sterile environment of the step S6, and soaking 2 slices into the eye patch liquid to obtain the disodium adenosine triphosphate eye patch.
Example 7
A medicine for preventing and treating myopia comprises oral medicine and topical medicine;
the external medicine is the disodium adenosine triphosphate external medicine for preventing and treating myopia prepared in the embodiment 3-6;
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:
(1) preparing an adenosine disodium triphosphate core-spun tablet core, which is concretely as follows;
according to mass fraction (calculated as anhydride, C content)10H14N5Na5O13P3) 5.26 to 21.05 parts of disodium adenosine triphosphate with the mass content of more than or equal to 95 percent, 0.30 to 1.22 parts of L-methionine with the mass content of more than or equal to 98.5 percent and anhydrous hydrogen phosphate with the mass content of 99 percent100 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 superfine silica powder and 0.80 part of magnesium stearate with the mass content (calculated as dry products and magnesium element) of 4.0-5.0 percent.
Adopting a conventional dry granulation and tabletting process, fully mixing various raw material powders except superfine silica gel powder and magnesium stearate which are respectively crushed and pass through a sieve of 80 meshes, extruding the mixture into large tablets by using a dry granulator, and crushing the large tablets into granules passing through a sieve of 16-24 meshes;
uniformly mixing the micropowder silica gel and magnesium stearate powder which are sieved by an 80-mesh sieve with the granules sieved by a 16-24-mesh sieve, pressing into tablets, and coating enteric coating (enteric coating well known to those skilled in the art) to obtain the core-spun tablet core.
(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 pregelatinized starch, the maltodextrin 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 screened through an 18 mesh nylon screen, more preferably, the dry particles are screened through a 16 mesh nylon screen;
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
And (3) pressing the core-spun tablet core prepared in the step (1) into the coating material prepared in the step (2) by using a core-spun tablet pressing machine to prepare the core-spun tablet plain 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.
Example 8
A medicine for preventing and treating myopia comprises oral medicine and topical medicine;
the external medicine is the disodium adenosine triphosphate external medicine for preventing and treating myopia prepared in the embodiment 3-6;
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, 0.40 part of vitamin A, 2.066 parts of beta-carotene and 33.75 multiplied by 10 parts of vitamin D-38 parts of vitamin E, -TE, 85.50 parts of vitamin C, 10.64 parts of vitamin B, 20.71 parts of vitamin B, 60.775 parts of vitamin B, 6.51 parts of nicotinamide, 121.46 parts of total calcium, 33.70 parts of total magnesium, 26.04 parts of potassium, 9.77 parts of zinc, 60X 10 parts of selenium-3Chromium 60X 10 parts-3And (4) portions are obtained.
The preparation of the oral medicine was the same as in example 7.
Example 9
A medicine for preventing and treating myopia comprises oral medicine and topical medicine;
the external medicine is the disodium adenosine triphosphate external medicine for preventing and treating myopia prepared in the embodiment 3-6;
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 calcium, 54.43 portions of 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.
The preparation of the oral medicine was the same as in example 7.
Examples of specific applications
Case statistics 1
From 3 months in 2018 to 6 months in 2019, 100 cases of myopic and myopic amblyopia patients with myopic diopter of 50-850 degrees and asthenopia (both eyes and naked eyes have distance vision not less than 5.0 but have asthenopia symptoms) patients are selected and divided into 2 groups, and each group comprises 50 people. The disease conditions were similar in both groups.
Experimental groups: simultaneously, the oral medicine and the external application plaster are used, and the adenosine disodium triphosphate eye drops are also alternately used for eye dropping while the external application plaster is used.
Control group: the patient only takes the oral medicine.
And (3) testing the effect: the patients in the test group had 38 patients with remarkable effects, 9 patients with remarkable effects and 3 patients with general effects.
The control group patients had 30 patients with significant effects, 14 patients with significant effects and 6 patients with general effects.
The clinical evaluation criteria of the control effect of the test groups are as follows:
the effect is remarkable: the naked eye distance vision is improved to more than 5.0, no change is caused within 3 months, and some asthenopia and general discomfort symptoms are eliminated; the treatment course is shortened by 3-4 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 2-3 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 malaise symptoms are not obviously relieved; the treatment course is shortened by 1-2 weeks compared with the control group.
The clinical evaluation criteria of the control group control effect are as follows:
the effect is remarkable: the naked eye distance vision is improved to more than 5.0, no change is caused within 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 malaise symptoms are obviously relieved or eliminated;
the effect is general: the naked eye distance vision is improved by 1-2 lines, and some asthenopia and general discomfort symptoms are not obviously relieved.
Case statistics 2
From 6 months to 3 months in 2019 in 2018, 60 cases of myopic and myopic amblyopia patients with myopic diopter of 50-800 degrees and asthenopia (both eyes and naked eyes have distance vision not less than 5.0 but have asthenopia symptoms) patients are selected, and the patients use the external application singly and simultaneously alternately adopt disodium triphosphate to drip eyes.
And (3) test effect display: the patients with obvious effect are 53, and the patients with general effect are 7.
The clinical evaluation criteria of the prevention and treatment effect are as follows:
the effect is obvious: the naked eye distance vision is improved by 2-3 lines, and some asthenopia and general discomfort symptoms are eliminated or obviously relieved;
the effect is general: the naked eye distance vision is improved by 0-1 line, and some asthenopia and general discomfort symptoms are not obviously relieved.
Typical case 1
Typical cases of experimental group
The oral medicine and the external application are used simultaneously, and the typical cases of myopia and myopic amblyopia patients and asthenopia patients with 50-850 degrees of myopic diopter are alternately used during the period of using the external application and the eye drops of the disodium adenosine triphosphate:
1. zhang Yi, Man, 7 years old, Luoyang, Luolong district fifth primary school (Nie Bay school district) student, Han nationality.
The medical history is as follows: parents complain about that children have inward sex, often watch mobile phones or televisions, often see things far away after 4 years old, and easily fall down when walking. The examination in hospital is: and (3) preparing a pair of glasses for myopia amblyopia with myopia astigmatism at two sides: right eye diopter-350 DS-150DC × 180-4.7, left eye diopter-375 DS-200DC × 165-4.6; there is no history of drug allergy.
Checking the condition: the height is 116cm, the weight is 20Kg, the body is lean, 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 fovea on the fundus of the two sides is low in growth; vision (distance vision): the naked eye vision of the right eye is 4.2, and the diopter is-525 DS-150DC multiplied by 180 degrees-4.7; the naked eye vision of the left eye is 4.1, and the diopter is-550 DS-200DC multiplied by 165 degrees-4.6 (the setting standard of the normal naked eye far vision of 7-year-old children in China is 5.2). Blood electrolyte examination: calcium, zinc, potassium and serum phosphorus are lower than normal minimum values, magnesium and selenium are in a normal range, the electrocardiogram is normal, and the renal function and urine volume are normal. The final diagnosis is: myopia amblyopia of both eyes with myopia astigmatism of both sides.
According to the diagnosis result, the patient takes the internal medicine, and the adenosine disodium triphosphate eye patch and the eye drops are applied to the eyes (the external medicine of the adenosine disodium triphosphate for preventing and treating myopia). During the treatment period, the oral medicine is taken 3 times a day, 1 tablet (taken with meal or after meal); the externally applied eye patch is applied for 1 time every 1-3 days (during the period of applying the eye patch, eye drops are alternately applied for eye dropping, 3-4 times a day, and 1-2 drops are applied for each time); the treatment course is 5 months +2 weeks. Entering a health care period after the treatment period, wherein the health care period comprises the following steps: the oral preparation is taken 1 time a day, 1 tablet (taken with meal or after meal), and the treatment course is 3 months.
Double-eye naked eye distance vision and diopter are checked once a week during the whole treatment period and the health care period; blood electrolytes, renal function and urine volume were reviewed every 3 months; the electrocardiogram was reviewed once in 6 months.
After 5 months and 2 weeks of treatment and 3 months of health care. The final inspection results are: the vitreous body on both sides is normal, and the fundus oculi on both sides is normal; the right-eye naked eye distance vision is improved to 4.6 diopters of minus 250DS-100DC multiplied by 180 degrees to 5.0, the left-eye naked eye distance vision is improved to 4.5 diopters of minus 275DS-150DC multiplied by 165 degrees to 4.9; blood electrolyte examination: calcium, zinc, potassium and serum phosphorus are supplemented to be within the normal range, and magnesium and selenium are still within the normal range; the electrocardiogram is normal, and the kidney function and the urine volume are normal. The weight is increased by 2Kg, and the height is increased by 5 cm.
2. One of Li, Yun, 26 years old, Nie Hai village, Ouyanzhen, Luoyang, Luolong.
The medical history is as follows: when the pregnancy is 3 months, a user sees more mobile phones in the front period, feels dry and astringent eyes and ache in a week, and sometimes has leg cramps and poor appetite; there is no history of drug allergy.
Checking the condition: the height is 156cm, the weight is 63Kg, the body is normal, conjunctiva is slightly dry, cornea is not pathological, sclera is normal, crystalline lens is normal, vitreous body is normal, fundus is normal; vision (distance vision): the right eye naked eye vision is 4.9 diopter-50 DS-5.0, and the left eye naked eye vision is 4.9 diopter-50 DS-5.0. Blood electrolyte examination: calcium, potassium and zinc are lower than normal minimum values, and magnesium, serum phosphorus and selenium are in normal range values; electrocardiogram is normal, kidney function and urine volume are normal, pregnancy is normal, and fetus is normal. The diagnosis is as follows: simple myopia of both eyes.
Aiming at the diagnosis result, the patients take the oral medicine and the external medicine. The details are as follows: during the treatment period, the oral preparation is taken 3 times a day, 5 tablets a day (2 tablets in the morning and at night, 1 tablet at noon) (taken with meal or after meal); the externally-applied eye patch is applied for 1 time every 1-3 days (after face is cleaned at night), and eye drops are alternately dripped into eyes during the period of applying the eye patch (5-6 times a day, 1-2 drops each time); the treatment period is 2 months. The health promotion period is followed by treatment period, wherein the oral preparation is taken 1 tablet (taken with meal or after meal) 2 times a day after 1 month, and the oral preparation is taken 1 tablet (taken with meal or after meal) 1 time a day after 1 month.
During the treatment and health care period, the binocular naked eye distance vision and diopter are rechecked once a week; blood electrolytes, renal function and urine volume, pregnancy and fetal development were reviewed once in 3 months.
After 2 months of treatment and 3 months of health care, the final examination results show: the naked eye far vision of the right eye is improved to 5.2, and the naked eye far vision of the left eye is improved to 5.2; blood electrolyte examination: calcium, potassium and zinc are supplemented to be within the normal range, and magnesium, serum phosphorus and selenium are still within the normal range; normal electrocardiogram, normal renal function and urine volume; pregnancy is normal, fetus is normal. Dry eyes, aching pain, and enhanced appetite, and no leg cramp.
Follow-up: the examination after stopping the medicine for 3 months shows that the naked eye far vision of the right eye is 5.2, the naked eye far vision of the left eye is 5.2, and the symptoms of dry eyes, ache, cramp of legs and good appetite do not exist. The baby is good in growth condition.
3. A certain week, male, 15 years old, and the forty-first student in Luolong district of Luoyang, Han nationality.
The medical history is as follows: parents complain about, children are in the first three years, the workload is large, the sitting posture is not correct at ordinary times, people can see distant places with old eyes, and recently, the children also have headache, dry eyes, photophobia, sweating due to debilitation and tiredness; there is no history of drug allergy.
Checking the condition: the height is 170cm, the weight is 66.5Kg, 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 right eye naked eye vision is 4.4, the diopter is-450 DS-100DC multiplied by 180 degrees-5.0, the left eye naked eye vision is 4.4, and the diopter is-425 DS-150DC multiplied by 165 degrees-5.0. Blood electrolyte examination: the phosphorus in the calcium, magnesium and serum is lower than the normal minimum value, and the zinc, potassium 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.
According to the diagnosis result, the patient takes the internal medicine, and the adenosine disodium triphosphate eye patch and the eye drops are applied to the eyes (the external medicine of the adenosine disodium triphosphate for preventing and treating myopia). During the treatment period, the oral medicine is taken 3 times a day, 2 tablets once (taken with or after meal); the external eye patch is applied 1 time every 1-3 days (during the period of applying the eye patch, eye drops are alternately applied for eye dropping, 5-6 times a day, and 1-2 drops each time); the treatment course is 5 months +1 week. Entering a health care period after the treatment period, wherein the health care period comprises the following steps: the oral preparation is taken 2 times a day, 1 tablet (taken with meal or after meal), and after one month, the oral preparation is taken 1 time a day, 1 tablet (taken with meal or after meal), and the oral preparation is taken for 2 months.
Double-eye naked eye distance vision and diopter are rechecked once per week during the whole treatment period and the health care period; blood electrolytes, renal function and urine volume were reviewed every 3 months; the electrocardiogram was reviewed once in 6 months.
After 5 months and 1 week of treatment and 3 months of health care. The final inspection results are: the distance vision of naked eyes of the right eye is improved to 4.7 diopters of-150 DS-5.0; the distance vision of naked eyes of the left eye is improved to 4.7 diopter-125 DS-5.0. Blood electrolyte examination: calcium, magnesium and serum phosphorus are supplemented to be within the normal range, and zinc, potassium and selenium are still within the normal range; the electrocardiogram is normal, and the kidney function and the urine volume are normal. The symptoms of headache, dry eyes and photophobia are obviously relieved, and the phenomena of sweating due to debilitation throughout the body are avoided.
4. At a certain norm, man, 36 years old, teacher in Luoyang Luolong district fifth primary school (Nie Bay school district), Han nationality.
The medical history is as follows: starting myopia from the high school, and fitting with glasses, the diopter of the eye is higher and higher, and the diopter of the last fitting is as follows: right eye-850 DS-150DC × 180-5.0, left eye-800 DS-200DC × 180-5.0. Headache, dizziness, dry eyes and eye pain symptoms appear in recent years, and a user feels palpitation and general weakness when the user has large amount of exercise; there is no history of drug allergy.
Checking the condition: 173cm in height and 73Kg in weight, belongs to normal constitution, conjunctiva is normal, cornea is slightly dry and has no pathological changes, pupils on two sides are bigger, crystalline lens has no turbidity, vitreous bodies on two sides are enlarged, leopard-shaped eyeground appears on two sides, and the right side is heavier; vision (distance vision): the naked eye vision of the right eye is 4.0, and the diopter is-850 DS-150DC multiplied by 180 degrees-5.0; the left eye has 4.0 of naked eye vision and diopter-800 DS-200DC multiplied by 180 degrees-5.0. 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; electrocardiographic examination showed myocardial ischemia, renal function and urine volume normality. The diagnosis is as follows: both eyes are myopic with bilateral myopic astigmatism.
For the diagnosis result, patients are allowed to use oral drugs and external drugs. The details are as follows: the oral preparation is taken 3 times a day during the treatment period, 2 tablets (taken with or after meal); the external eye patch is applied for 1 time to 1 day to 3 days (after face cleaning at night, the eye patch is applied), and eye drops are alternately dripped into eyes during the period of applying the eye patch (5 to 6 times per day, 1 to 2 drops each time); the treatment period is 8 months and 3 weeks. The oral medicine is taken 2 times a day, 1 tablet (taken with meal or after meal) for 1 month, 1 time a day, and 1 tablet (taken with meal or after meal) 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, 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 8 months and 3 weeks of treatment and 3 months of health care. The final inspection results are as follows: the pupils on both sides are normal, the vitreous bodies on both sides are close to normal, and the leopard-shaped eyeground on both sides is obviously improved. Vision (distance vision): the distance vision of naked eyes of the right eye is improved to 4.2, and diopter is-650 DS-75DC multiplied by 180 degrees-5.0; the distance vision of naked eyes of the left eye is improved to 4.2 diopters of-600 DS-100DC multiplied by 180 degrees-5.0. Blood electrolyte examination: calcium, magnesium, potassium and serum phosphorus are supplemented to be within the normal range, and zinc and selenium are still within the normal range; the electrocardiogram is normal, and the kidney function and the urine volume are normal. Headache, dizziness, dry eyes and eye pain are relieved, and the symptoms of palpitation and general weakness are absent.
5. Nie some, male, 9 years old, Luoyang, Luolong district fifth elementary school (Nie Bay school district) student, Han nationality.
The medical history is as follows: parents complain about that children stay up and watch mobile phones to play games in the near time, and symptoms of dry eyes, itching eyes, acid eyes and sweating are caused; there is no history of drug allergy.
Checking the condition: the height is 135cm, the weight is 32Kg, the body is normal, the conjunctiva is normal, the cornea is not diseased, the sclera is normal, the crystalline lens is normal, the vitreous body is normal, and the eyeground is normal; vision (distance vision): the right eye has 5.0 of naked eye vision, and the left eye has 5.0 of naked eye vision. Blood electrolyte examination: the phosphorus in the calcium and serum is lower than the normal minimum value, and the magnesium, the potassium, the zinc 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: visual fatigue of both eyes.
Aiming at the diagnosis result, the patients take the oral medicine and the external medicine. The details are as follows: during the treatment period, the oral medicine is taken 2 times a day, 2 tablets once (taken with meal or after meal in the morning and evening); the externally-applied eye patch is applied for 1 time every 1-3 days (after face is cleaned at night), eye drops are alternately dripped into eyes during the period of applying the eye patch (3-4 times a day, 1-2 drops each time); the treatment period is 1 month +1 week. The health promotion period is followed by treatment period, wherein the oral preparation is taken 1 tablet (taken with meal or after meal) 2 times a day after 1 month, and the oral preparation is taken 1 tablet (taken with meal or after meal) 1 time a day after 1 month.
During the treatment and 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.
After 1 month +1 week of treatment and 2 months of healthcare, the final examination results show: the naked eye far vision of the right eye is improved to 5.2, and the naked eye far vision of the left eye is improved to 5.2; blood electrolyte examination: calcium and serum phosphorus are supplemented to be within the normal range, magnesium, potassium, zinc and selenium are still within the normal range, the electrocardiogram is normal, and the renal function and the urine volume are normal. The symptoms of dry eyes, itching eyes and acid eyes with sweating due to deficiency disappear.
Follow-up: the inspection is carried out after the medicine is stopped for 3 months, the naked eye far vision of the right eye is 5.2, and the naked eye far vision of the left eye is 5.2. Has no symptoms of dry eyes, itching eyes, acid eyes and sweating due to deficiency.
Control group typical case
Typical cases of myopia and myopic amblyopia patients and asthenopia patients with the myopic diopter of 50-850 degrees and taking the oral medicine alone are as follows:
1. a certain old, male, 7 years old, students in the fifth primary school (Nie Bay school district) in Luoyang, Luoyong.
The medical history is as follows: parents complain about that children love to watch mobile phones and games from childhood, and often cannot see characters on a blackboard clearly in a kindergarten and a large school in the age of 5. The examination in hospital is: and (3) preparing a pair of glasses for myopia amblyopia with myopia astigmatism at two sides: right eye diopter-450 DS-150DC x 180-4.7, left eye diopter-400 DS-200DC x 180-4.7; there is no history of drug allergy.
And (4) checking the condition: the height is 118cm, the weight is 21.5Kg, the body is lean, the conjunctiva is normal, the cornea is not pathological, the sclera is normal, the crystalline lens is not turbid, the vitreous body is 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-150DC multiplied by 180 degrees-4.7; the naked eye vision of the left eye is 4.2, and the diopter is-500 DS-200DC multiplied by 180 degrees-4.7 (the setting standard of the normal naked eye far vision of 7-year-old children in China is 5.2). Blood electrolyte examination: the phosphorus in the calcium, the potassium and the serum is lower than the normal minimum value, and the magnesium, the zinc and the selenium are in the normal range; the electrocardiogram is normal, and the kidney function and the urine volume are normal. The final diagnosis is: myopia amblyopia of both eyes with myopia astigmatism of both sides.
Aiming at the diagnosis result, the patient takes the oral medicine separately. During the treatment period, the oral preparation is taken 3 times a day, 1 tablet (taken with meal or after meal), and the treatment course is 6 months. Entering a health care period after the treatment period, wherein the health care period comprises the following steps: the oral preparation is taken 1 time a day, 1 tablet (taken with meal or after meal), and the treatment course is 3 months.
Double-eye naked eye distance vision and diopter are rechecked once per week during the whole treatment period and the health care period; blood electrolytes, renal function and urine volume were reviewed every 3 months; the electrocardiogram was reviewed once in 6 months.
After 6 months of treatment and 3 months of health care. The final inspection results are: the vitreous body on both sides is normal, and the fundus oculi on both sides is normal; the distance vision of naked eyes of the right eye is improved to 4.5 diopters of-275 DS-100DC multiplied by 180 degrees-4.9; the distance vision of naked eyes of the left eye is improved to 4.5 diopters of-225 DS-125DC multiplied by 180 degrees-4.9. Blood electrolyte examination: calcium, potassium and serum phosphorus are supplemented to be within the normal range, and magnesium, zinc and selenium are still within the normal range; normal electrocardiogram, normal renal function and normal urine volume. The weight is increased by 2Kg, and the height is increased by 4.5 cm.
2. Yuan Yi (a certain Yuan, female, 24 years old, people in Anle Zhenye gulmura village in Luoyang city, Luoyang.
The medical history is as follows: when the pregnancy is carried out for 2 months, more games are played by watching a computer at ordinary times, and people often feel dry eyes, acid eyes, light fearing and sometimes lacrimation in the last month; lassitude throughout the body, abdominal distension; there was no history of drug allergy.
Checking the condition: the height is 160cm, the weight is 62Kg, the body is normal, the conjunctiva is normal, the cornea is not diseased, the sclera is normal, the crystalline lens is normal, the vitreous body is normal, and the eyeground is normal; vision (distance vision): the right eye naked eye vision is 4.9 diopter-50 DS-5.0, and the left eye naked eye vision is 4.9 diopter-50 DS-5.0. Blood electrolyte examination: calcium and potassium are lower than normal minimum values, and zinc, magnesium, serum phosphorus and selenium are in normal range values; normal electrocardiogram, renal function and urine volume; pregnancy is normal, fetus is normal. The diagnosis is as follows: simple myopia in both eyes.
Aiming at the diagnosis result, the patient takes the oral medicine separately. The details are as follows: during the treatment period, the oral preparation is taken 3 times a day, 5 tablets per day (2 tablets in the morning and evening, 1 tablet at noon) (taken with meal or after meal), and the treatment period is 3 months. The health promotion period is followed by treatment period, wherein the oral preparation is taken 1 tablet (taken with meal or after meal) 2 times a day after 1 month, and the oral preparation is taken 1 tablet (taken with meal or after meal) 1 time a day after 1 month.
During the treatment and health care period, the binocular naked eye distance vision and diopter are rechecked once a week; blood electrolytes, renal function and urine volume, pregnancy and fetal development were reviewed every 3 months.
After 3 months of treatment and 3 months of health care, the final examination results show: the naked-eye distance vision of the right eye is improved to 5.2, and the naked-eye distance vision of the left eye is improved to 5.2; blood electrolyte examination: calcium and potassium are supplemented to be within the normal range, and zinc, magnesium, serum phosphorus and selenium are still within the normal range; the electrocardiogram is normal, and the renal function and the urine volume are normal; pregnancy is normal, fetus is normal. The symptoms of dry eyes, acid eyes, photophobia and abdominal distension disappear, no lacrimation phenomenon exists, and the phenomenon of fatigue of the whole body is obviously improved.
Follow-up: after the medicine is stopped for 3 months, the naked eye far vision of the right eye is 5.2, the naked eye far vision of the left eye is 5.2, and symptoms such as dry eyes, sour eyes, lacrimation, photophobia and abdominal distension do not exist; no body fatigue occurs. The baby boy is a baby boy, and the baby boy has good development condition.
3. A certain hole is female, 15 years old, and the forty-first student of middle school, Han nationality in Luoyang Luolong district.
The medical history is as follows: parents complain about that children are short-sighted at first, and are not often worn with glasses, and the children also like to see mobile phones except reading and writing at ordinary times, and recently, the children often say headache, dry eyes, photophobia, leg cramps and dysphoria; there is no history of drug allergy.
Checking the condition: the height is 160cm, the weight is 58Kg, the body constitution is normal, conjunctiva is normal, cornea is not pathological, sclera is normal, crystalline lens is not turbid, vitreous body is normal, and eyeground is normal; vision (distance vision): the right eye naked eye vision is 4.4, the diopter is-450 DS-100DC multiplied by 180 degrees-5.0, the left eye naked eye vision is 4.4, and the diopter is-450 DS-100DC multiplied by 180 degrees-5.0. Blood electrolyte examination: the calcium, magnesium and potassium are lower than the normal minimum value, and the serum phosphorus, 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 of both eyes is accompanied by myopia astigmatism of both sides.
Aiming at the diagnosis result, the patient takes the oral medicine separately. During the treatment period, the oral preparation is taken 3 times a day, 5 tablets per day (2 tablets in the morning and evening, 1 tablet at noon) (taken with meal or after meal), and the treatment course is 6 months. Entering a health care period after the treatment period, wherein the health care period comprises the following steps: the oral preparation is taken 2 times a day, 1 tablet (taken with meal or after meal), 1 month later, 1 time a day, 1 tablet (taken with meal or after meal), and 2 months later.
Double-eye naked eye distance vision and diopter are checked once a week during the whole treatment period and the health care period; blood electrolytes, renal function and urine volume were reviewed every 3 months; the electrocardiogram was reviewed once in 6 months.
After 6 months of treatment and 3 months of health care. The final inspection results are: the right-eye naked eye distance vision is improved to 4.7 diopters of minus 150DS-75DC multiplied by 180 degrees to 5.0, the left-eye naked eye distance vision is improved to 4.7 diopters of minus 150DS-75DC multiplied by 180 degrees to 5.0; blood electrolyte examination: calcium, magnesium and potassium are supplemented to be within the normal range, and serum phosphorus, zinc and selenium are still within the normal range; normal electrocardiogram, normal renal function and normal urine volume. Headache, dry eyes and light intolerance are obviously relieved, and the phenomena of leg cramps and dysphoria are avoided.
4. Gongqi, a woman, 24 years old, Luoyang, Luolong district Anle town government accountant, Han nationality.
The medical history is as follows: the two eyes start to be short-sighted in the first two hours of the inventor, the spectacles are not worn frequently, the diopter of the eyes is increased quickly, and the diopter of the last spectacle prescription is as follows: right eye-825 DS-150DC × 165 degree-5.0, left eye-850 DS-150DC × 180 degree-5.0. Symptoms such as headache, dry eyes, eye soreness and photophobia often appear in recent two years, but also poor appetite, weakness all over the body and dry and yellow hair; there is no history of drug allergy.
Checking the condition: the height is 165cm, the weight is 66Kg, the body constitution is normal, conjunctiva is normal, cornea is slightly dry and has no pathological changes, pupils on two sides are bigger, crystalline lens has no turbidity, vitreous bodies on two sides are enlarged, and leopard-shaped eyeground appears on two sides. Vision (distance vision): the right eye naked eye vision is 4.0, the diopter is-825 DS-150DC multiplied by 165 degrees-5.0, the left eye naked eye vision is 4.0, and the diopter is-850 DS-150DC multiplied by 180 degrees-5.0. Blood electrolyte examination: the phosphorus in the calcium, zinc, potassium and serum is lower than the normal 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: both eyes are myopic with bilateral myopic astigmatism.
Aiming at the diagnosis result, the patient takes the oral medicine separately. The details are as follows: the oral preparation is taken 3 times a day, 5 tablets a day (2 tablets in the morning and evening, 1 tablet at noon) during the treatment period, and is swallowed with meal or after meal, and the treatment period is 9 months. The oral medicine is taken during the health promotion period, specifically 2 times a day, 1 tablet at a time, taken with meal or after meal, the mode is taken for 1 month, then 1 time a day, 1 tablet at a time, taken with meal or after meal, the mode is taken 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, 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 9 months of treatment and 3 months of health care. The final inspection results are as follows: the pupils on both sides are normal, the vitreous bodies on both sides are close to normal, and the leopard-shaped eyeground on both sides is obviously improved. Vision (distance vision): the naked eye distance vision of the right eye is improved to 4.2, and the diopter is-625 DS-75DC multiplied by 165 degrees-5.0; the left eye naked eye distance vision is improved to 4.2 diopters of-650 DS-75DC multiplied by 180 degrees-5.0. Blood electrolyte examination: calcium, zinc, potassium and serum phosphorus are supplemented to be within the normal range, and magnesium and selenium are still within the normal range; the electrocardiogram is normal, and the kidney function and the urine volume are normal. Headache, dry eyes, soreness and swelling of eyes and photophobia symptoms are relieved, appetite is increased, and phenomena of fatigue all over the body and dry and yellow hair are obviously improved.
5. Some of von, male, 8 years old, students in primary school in board and dragon, luoyang, and Han nationality.
The medical history is as follows: parents complain about that children read books and write at ordinary times at a relatively short distance, dry eyes, sour eyes and sometimes lacrimation symptoms begin to appear before one month, and sweat is better at ordinary times; there is no history of drug allergy.
Checking the condition: the height is 131cm, the weight is 25Kg, the body constitution is normal, the conjunctiva is normal, the cornea is not diseased, the sclera is normal, the crystalline lens is normal, the vitreous body is normal, and the eyeground is normal. Vision (distance vision): the right eye has 5.0 of naked eye vision, and the left eye has 5.0 of naked eye vision. Blood electrolyte examination: the calcium and the potassium are lower than normal minimum values, and the serum phosphorus, the magnesium, the zinc and the 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: visual fatigue of both eyes.
Aiming at the diagnosis result, the patient takes the oral medicine separately. The details are as follows: during the treatment period, the oral preparation is taken 2 times a day, 2 tablets (taken with meal or after meal in the morning and evening), and the treatment period is 2 months. The health promotion period is followed by treatment period, wherein the oral preparation is taken 1 tablet (taken with meal or after meal) 2 times a day after 1 month, and the oral preparation is taken 1 tablet (taken with meal or after meal) 1 time a day after 1 month.
During the treatment and 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 once in 3 months.
After 2 months of treatment and 2 months of health care, the final examination results show: the right eye naked eye distance vision is improved to 5.2, and the left eye naked eye distance vision is improved to 5.2. Blood electrolyte examination: the serum phosphorus of calcium and potassium is supplemented to be within the normal range value, and the serum phosphorus, magnesium, potassium, zinc and selenium are still within the normal range value; the electrocardiogram is normal, and the kidney function and the urine volume are normal. The symptoms of dry eyes, acid eyes and lacrimation disappear, and no hyperhidrosis exists.
Follow-up: after stopping taking the medicine for 3 months, the examination shows that the naked eye far vision of the right eye is 5.2, the naked eye far vision of the left eye is 5.2, and the symptoms of dry eyes, acid eyes, lacrimation and hyperhidrosis do not exist.
This gives: the treatment course of the patients with myopia and myopic amblyopia with 50-850 degrees of myopic diopter can be shortened by 1-4 weeks compared with that of a control group by simultaneously using the oral medicine and the external application eye patch (during which the eye drops are alternately used) of the invention.
Typical case 2
The typical cases of myopia and myopic amblyopia patients and asthenopia patients with 50-800 degrees of myopic diopter formed by eye drops of disodium triphosphate during the use of the external application and by alternative use of the external application are as follows:
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 watch mobile phones for games and television, and the children are found to be myopic amblyopia by 5 years old and are provided with glasses, so that the children often say dry eyes, soreness and distension of eyes, dizziness and hypodynamia in the early march; there was no history of drug allergy.
Checking the condition: the height is 103cm, the weight is 23Kg, the constitution is thin and 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 larger than normal, and the fovea on the fundus of the two sides is low in development. Vision (distance vision): the naked eye vision of the right eye is 4.2, and the diopter is-450 DS-100DC multiplied by 135 degrees-4.8; the naked eye vision of the left eye is 4.2, and the diopter is-500 DS-4.8 (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, the zinc, the potassium and the serum is lower than the normal minimum value, and the magnesium 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: myopia amblyopia of both eyes with myopia astigmatism of the right eye.
The external preparation of the present invention is administered to a patient for diagnosis. The details are as follows: the eye patch prepared by the invention is applied for 1 time every 1-3 days (after face cleaning at night), eye drops are alternately dripped into eyes during the application of the eye patch (2-3 times a day, 1-2 drops each time) and the eye patch is continuously used for 3 months.
During treatment, binocular naked eye distance vision and diopters were reviewed once a week.
After 3 months of use, the final examination showed: the distance vision of naked eyes of the right eye is improved to 4.5 diopters of-350 DS-75DC multiplied by 135 degrees-4.8; the left eye bare distance vision improves to 4.5 diopters-375 DS-4.8. The symptoms of dry eyes and soreness and distension of eyes are relieved, and the symptoms of dizziness and hypodynamia are obviously relieved.
2. Nie some, female, 15 years old, Luoyang City forty-first school student, Han nationality.
The medical history is as follows: parents complain about that eyes are close to books when children read and write at a short time, the sitting posture is incorrect, and eyes are painful, sore and weak muscles are often troubled at a short time; there is no history of drug allergy.
Checking the condition: 155cm in height and 52Kg in weight, and belongs to normal constitution, conjunctiva is normal, cornea is not diseased, sclera is normal, crystalline lens is normal, vitreous body is normal, and eyeground is normal. Vision (distance vision): the naked eye vision of the right eye is 4.9, and the diopter is-50 DS-5.0; left eye naked eye vision 4.9 diopter-75 DS-5.0. Blood electrolyte examination: the phosphorus in the calcium and serum is lower than the normal minimum value, and the magnesium, the potassium, the zinc 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.
Aiming at the diagnosis result, the external medicine is adopted for treatment. Specifically, the eye drop patch is applied for 1 time every 1-3 days (the eye patch is applied to the eyes after face cleaning at night), eye drops are alternately dripped into the eyes during the eye patch application period (5-6 times a day, 1-2 drops each time), and the eye drop patch is used for 3 months.
Binocular naked eye distance vision, diopters were reviewed once a week during treatment.
After 3 months of use, the final examination showed: the naked-eye distance vision of the right eye is improved to 5.1, and the naked-eye distance vision of the left eye is improved to 5.1. The symptoms of ophthalmalgia, soreness of the eyes and muscle weakness disappear.
3. Lu Yi, mai, 25 years old, Luo Yang Lu Long district Anle Zhen Dong village, Han nationality.
The medical history is as follows: the user starts to be short-sighted and is provided with glasses when the user complains about the high school, but the user does not wear the glasses frequently; at present, children just full of the years and still taking milk like watching mobile phones and televisions at ordinary times often feel dizziness, headache, dry eyes and sour eyes in recent years; there is no history of drug allergy.
Checking the condition: the height is 162cm, the weight is 65Kg, 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 right eye has a naked eye vision of 4.5, diopter-350 DS-100DC multiplied by 90 degrees-5.0, the left eye has a naked eye vision of 4.5, diopter-375 DS-75DC multiplied by 135 degrees-5.0. Blood electrolyte examination: the magnesium, zinc and potassium are lower than the normal minimum value, and the calcium, serum phosphorus 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.
The external preparation of the present invention is administered to a patient for diagnosis. The details are as follows: the eye patch prepared by the invention is applied for 1 time every 1-3 days (after face cleaning at night), eye drops are alternately dripped into eyes during the application of the eye patch (5-6 times a day, 1-2 drops each time) and the eye patch is continuously used for 3 months.
During treatment, binocular naked eye distance vision and diopters were reviewed once a week.
After 3 months of use, the final examination showed: the distance vision of naked eyes of the right eye is improved to 4.7, diopter is-150 DS-100DC multiplied by 90 degrees-5.0; the naked eye far vision of the left eye is improved to 4.7, and diopter is-175 DS-75DC multiplied by 135 degrees-5.0; the symptoms of dizziness, headache, dry eyes and sour eyes are obviously relieved.
4. Tian Yi, Man, 33 years old, teacher in Luoyang Luolong fifth primary school (Nie Bay school zone), Han nationality.
The medical history is as follows: beginning to realize myopia from the beginning of the first school and wearing the glasses, wherein the diopter of the glasses worn at present is as follows: right eye-750 DS-150DC × 135 degree-5.0, left eye-800 DS-100DC × 180 degree-5.0; insomnia, dizziness, hypodynamia, headache, dry eyes and eye pain often occur, and a plurality of small black spots in front of eyes float when eyeballs rotate; there is no history of drug allergy.
Checking the condition: 173cm and 73Kg in height, belonging to normal constitution, normal conjunctiva, no pathological changes of cornea, bigger pupil, no opacity of crystalline lens, light liquefaction of vitreous body on both sides, and partial leopard-shaped eyeground on both sides. Vision (distance vision): the naked eye vision of the right eye is 4.1, and the diopter is-750 DS-150DC multiplied by 135 degrees-5.0; the left eye has 4.1 of naked eye vision, and diopter is-800 DS-100DC multiplied by 180 degrees-5.0. Blood electrolyte examination: the calcium, potassium and serum phosphorus are lower than the normal minimum values, and the zinc, magnesium and selenium are in the normal range values; the electrocardiogram is normal, and the kidney function and the urine volume are normal. The diagnosis is as follows: myopia of both eyes is accompanied by myopic astigmatism of both sides and the vitreous body of both sides is liquefied lightly.
Aiming at the diagnosis result, the patient is separately treated by the externally applied medicine prepared by the invention. The eye patch is applied for 1 time every 1-3 days (the eye patch is applied to eyes after face cleaning at night), eye drops are alternately dripped into eyes during the period of external application of the eye patch (5-6 times a day, 1-2 drops each time), and the eye patch is continuously used for 3 months.
Binocular bare eye distance vision and diopters were reviewed once a week during treatment.
After 3 months of use, the final examination showed: the distance vision of naked eyes of the right eye is improved to 4.2, and diopter-675 DS-150DC multiplied by 135-5.0; the left eye naked eye distance vision is improved to 4.2 diopters of-725 DS-100DC multiplied by 180 degrees-5.0. The symptoms of insomnia, dizziness and hypodynamia are obviously relieved, and the symptoms of headache, dry eyes and eye pain are also relieved.
5. A certain pottery, a woman, 9 years old, students in the primary school of board of Luolong district, Luoyang city, and Han nationality.
The medical history is as follows: parents complain about that children read books and watch television at a close distance at ordinary times, and symptoms of dizziness, dry eyes, itchy eyes and photophobia begin to appear half a month ago; there is no history of drug allergy.
Checking the condition: the height is 125cm, the weight is 26Kg, the body constitution is normal, the conjunctiva is normal, the cornea is not diseased, the sclera is normal, the crystalline lens is normal, the vitreous body is normal, and the eyeground is normal. Vision (distance vision): the right eye has 5.0 of naked eye vision, and the left eye has 5.0 of naked eye vision. Blood electrolyte examination: calcium and magnesium are lower than normal minimum values, and serum phosphorus, potassium, zinc 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: visual fatigue of both eyes.
Aiming at the diagnosis result, the external medicine is adopted for treatment. Specifically, the eye drop patch is applied for 1 time every 1-3 days (the eye drop patch is applied to the eyes after face cleaning at night), eye drops are alternately dripped into the eyes during the eye patch application period (3-4 times a day, 1-2 drops each time), and the eye drop patch is used for 3 months.
Binocular naked eye distance vision, diopters were reviewed once a week during treatment.
After 3 months of use, the final examination showed: the naked eye far vision of the right eye is improved to 5.1, the naked eye far vision of the left eye is improved to 5.1, and symptoms of dizziness, dry eyes, itchy eyes and photophobia disappear.
This gives: when the externally-applied eye patch (eye drops are alternately used) is singly used by myopic and myopic amblyopic patients with myopic diopter of 50-800 degrees and asthenopia patients, the naked eye far vision of the patients can be improved to 1-3 lines, and some asthenopia and general discomfort symptoms can be relieved or eliminated.
Therefore, the prepared disodium adenosine triphosphate external eye patch for preventing and treating myopia (simultaneously, eye drops are alternately used) has good prevention and treatment effects on myopia with myopia diopters of 50-850 degrees, myopia amblyopia and asthenopia. The disodium adenosine triphosphate external-use medicine has good effects of preventing and treating myopia, myopia amblyopia and asthenopia.
Claims (9)
1. The disodium adenosine triphosphate eye drops for preventing and treating myopia are characterized by being prepared from the following raw materials in parts by weight: adding 20-25 g of disodium adenosine triphosphate, 25-37 g of L-methionine, a pH regulator and injection water to 2000 ml; the milliosmol molar concentration of the disodium adenosine triphosphate eye drops is 336.41-460.05 mosmol/Kg.
2. The disodium adenosine triphosphate eye drop according to claim 1, wherein the mass of disodium adenosine triphosphate and the mass of L-methionine in the eye drop are 20.00-21.05 g and 30.30-35.35 g, respectively.
3. The disodium adenosine triphosphate eye drops according to claim 1, wherein the pH regulator is a 4% sodium hydroxide aqueous solution of 30 to 38 ml.
4. An external medicine of disodium adenosine triphosphate for preventing and treating myopia, which is characterized in that the external medicine comprises eye drops and a disodium adenosine triphosphate eye patch as claimed in claim 1, wherein the disodium adenosine triphosphate eye patch comprises eye patch liquid and water-felted non-woven fabrics for the eye patch; the eye patch liquid is prepared from the following raw materials in parts by weight: adding 20-25 g of disodium adenosine triphosphate, 25-37 g of L-methionine, a pH regulator and water for injection to 3000 ml; the milliosmol molar concentration of the adenosine disodium triphosphate eye patch is 224.27-306.70 mosmol/Kg.
5. The disodium adenosine triphosphate external use agent according to claim 4, wherein the pH adjuster is a 4% sodium hydroxide aqueous solution of 30 to 38 ml; the mass of the disodium adenosine triphosphate and the mass of the L-methionine in the eye patch liquid are respectively 20.00-21.05 g and 30.30-35.35 g.
6. The method for preparing the disodium adenosine triphosphate eye patch according to claim 4, which comprises the following steps:
s1, preparing disodium adenosine triphosphate, L-methionine, a 4% sodium hydroxide aqueous solution of a pH regulator and water for injection according to required amount;
s2, heating 80% of the total volume of the water for injection prepared in the step S1 to 20-30 ℃, adding the disodium adenosine triphosphate prepared in the step S1, and stirring for 5-15 minutes until the disodium adenosine triphosphate is completely dissolved to prepare a first solution;
s3, adding the prepared L-methionine into the first solution, and stirring for 5-15 minutes until the L-methionine is completely dissolved to obtain a second solution;
s4, slowly adding a prepared 4% sodium hydroxide aqueous solution as a pH regulator into the second solution, continuously stirring for 5-15 minutes to uniformly mix the solution, regulating the pH value of the solution to 7.85-8.85, adding the residual water for injection at the temperature of 20-30 ℃ to full volume, and then, fully stirring for 10-15 minutes to be 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 polyester medicinal eye drop bottle in an aseptic environment after the filtration is finished, plugging and capping to obtain eye patch liquid;
s6, taking the antibacterial eye patch, using water-punched non-woven fabric, cutting into a required shape, placing the eye patch in a sealed ethylene oxide sterilization cabinet, sterilizing for 6 hours, taking out, packaging 2 pieces of the eye patch in sterile polyethylene plastic film bags in a sterile environment, sealing, and placing the eye patch in the sterile environment for later use;
s7, taking the spunlace non-woven fabric slices for the eye patches prepared in the sterile environment of the step S6, and soaking 2 slices into eye patch liquid to obtain the disodium adenosine triphosphate eye patch;
preferably, the mass ratio of the adenosine disodium triphosphate to the water for injection in the step S2 is 21.05 g: 3000 ml; the content of the L-methionine in the step S3 is 30.30-35.35 g; in the step S4, the dosage of the pH regulator is 30-37.50 ml of 4% sodium hydroxide aqueous solution.
7. A medicine for preventing and treating myopia is characterized by comprising an oral medicine and an external medicine; the external use medicine is the external use medicine of adenosine disodium triphosphate for preventing and treating myopia as claimed in claim 5; the oral 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 total calcium, 15.97 to 54.43 parts of total magnesium, 18.73 to 33.35 parts of potassium, 3.73 to 15.80 parts of zinc, and 10 to 10 parts of selenium (20 to 110)-3Part (20-110) 10 of chromium-3And (4) portions are obtained.
8. The medicament for treating the myopia according to claim 7, wherein the dosage form of the oral medicament comprises tablets and pills.
9. The medicament for treating myopia according to claim 7, wherein the preparation method of the oral medicament comprises the following steps:
(1) preparing an adenosine disodium triphosphate core-spun tablet core, which is concretely as follows;
c content by mass in terms of anhydride10H14N5Na2O13P35.26 to 21.05 parts of disodium adenosine triphosphate with the mass content of more than or equal to 95 percent, 0.30 to 1.22 parts of L-methionine with the mass content of more than or equal to 98.5 percent, 100 parts of anhydrous calcium hydrophosphate with the mass content of 99 percent, 27.10 to 42.98 parts of maltodextrin, 1.43 to 2.26 parts of pregelatinized starch, 8 parts of crospovidone, 0.40 part of superfine silica gel powder and mass0.80 part of magnesium stearate with the content of magnesium element being 4.0-5.0 percent calculated by dry product is prepared as raw material.
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 obtained 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 passes through an 18-mesh nylon screen; more preferably, the dry granules are screened through a 16 mesh nylon screen;
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.
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