CN106420816A - Compound lutein solid preparation for relieving asthenopia and improving vision function and preparation method thereof - Google Patents
Compound lutein solid preparation for relieving asthenopia and improving vision function and preparation method thereof Download PDFInfo
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- CN106420816A CN106420816A CN201610862675.6A CN201610862675A CN106420816A CN 106420816 A CN106420816 A CN 106420816A CN 201610862675 A CN201610862675 A CN 201610862675A CN 106420816 A CN106420816 A CN 106420816A
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- 208000011580 syndromic disease Diseases 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 230000000472 traumatic effect Effects 0.000 description 1
- 230000004304 visual acuity Effects 0.000 description 1
- 230000004382 visual function Effects 0.000 description 1
- 210000004127 vitreous body Anatomy 0.000 description 1
- 235000010930 zeaxanthin Nutrition 0.000 description 1
- 239000001775 zeaxanthin Substances 0.000 description 1
- 229940043269 zeaxanthin Drugs 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
- A61K31/047—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates having two or more hydroxy groups, e.g. sorbitol
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
- A61K31/07—Retinol compounds, e.g. vitamin A
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
- A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
- A61K31/355—Tocopherols, e.g. vitamin E
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/365—Lactones
- A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
- A61K31/51—Thiamines, e.g. vitamin B1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/24—Heavy metals; Compounds thereof
- A61K33/26—Iron; Compounds thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/24—Heavy metals; Compounds thereof
- A61K33/30—Zinc; Compounds thereof
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
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- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
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- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses a compound lutein solid preparation for relieving asthenopia and improving a vision function. The compound lutein solid preparation is characterized by comprising the following raw materials: 1-10 parts of lutein, 20-50 parts of vitamin A, 20-50 parts of vitamin C, 20-50 parts of vitamin E, 5-30 parts of vitamin B1, 1-5 parts of natural copper and 5-10 parts of natural zinc. Besides, the invention also discloses a preparation method for the compound lutein solid preparation. The compound lutein solid preparation disclosed by the invention can obviously relieve asthenopia and improve the vision function of the patient, and meanwhile can greatly increase the photopic vision persistence, and the total efficiency is as high as above 60%; and meanwhile, the symptoms of the patient, including blurred vision, dry eyes, eye distension, sore eyes, photaesthesia, and the like, can be greatly relieved.
Description
Technical field
The invention belongs to ophthalmic art field, is related to a kind of ophthalmically acceptable health care and treatment preparation, more particularly, to a kind of slow
Solve asthenopia and improve compound xanthophyll solid preparation of visual performance and preparation method thereof.
Technical background
In modern society, due to general and work and the increase of life stress of TV and computer, cause eyestrain
Increasingly increase with related eye class disease.Asthenopia is also known as eyestrain, and asthenopia (is included due to excess eye-using：Reading official documents and correspondence,
Operating computer, surf the Net, see the factors such as TV, driving) and environmental factorss (dry, air conditioner surroundings etc.) cause a series of
Eyes malaise symptoms, are mainly shown as the dry and astringent foreign body sensation of eyes, blurred vision, eyes acid is swollen etc..For people with visual impairment,
Above-mentioned malaise symptoms are particularly evident, have influence on its visual performance.
Research in recent years finds, phylloxanthin has important physiological function to human body.It is in protection vision, prevention of cardiovascular disease
With the physiological function with uniqueness in terms of cancer and enhancing immunity；While preventing free radical to biomembranous infringement, being quenched
Singlet oxygen and capture reactive oxygen free radical have compared with strong antioxidant action.Had while producing containing phylloxanthin in the market
Product, such as trade name " Bilberrywith lutein " etc., non-patent literature The Journal of Nutrition (Vol
132, April 2003, pp, 992) also reporting in product and retina lutein content can be improved containing phylloxanthin, improves old
Property macular degeneration disease, on market such product be usually be simply added two kinds of crude drug.Japan Patent JP2003238442 is also carried
And phylloxanthin shares the protective effect to eyes.
However, phylloxanthin is a class liposoluble substance, be insoluble in water, its chemistry, physical property highly unstable, to light,
Heat, air are more sensitive, especially maximum with light impact, significantly limit its range of application.Further, since which is insoluble in water,
Dispersion is difficult in water, and human bioavailability is relatively low.Although existing phylloxanthin stability and Study on dispersity document and patent report
Lead, Chinese patent CN00806761.9, the stable aqueous dispersions of phylloxanthin and stable water dispersible powder and its preparation and answers
With.In the patent documentation, if the ratio selection of water and organic solvent is improper, high agglomerate or ring cohesion is easily produced
Body.This high agglomerate or ring agglomerate show poor bioavailability in feedstuff.Meanwhile, the patent documentation is not public
Open or instruct the bioavailability for how preferably improving phylloxanthin in ophthalmically acceptable health care and treatment preparation.
For disadvantages mentioned above, regard in the urgent need to finding a kind of alleviation asthenopia that disclosure satisfy that application request and improvement
Feel compound xanthophyll preparation of function and preparation method thereof.
Content of the invention
Inventor has found, by adjusting phylloxanthin and the scientific matching of other active components such as vitamin, adds specific ratio
Example metallic element, for eye care using effect become apparent from, can effectively alleviate asthenopia and the improvement of eye
Visual performance.
One of the object of the invention is to overcome the deficiencies in the prior art, provides one kind and has alleviation asthenopia and improve vision work(
Energy and the compound xanthophyll solid preparation with the bioavailability for improving.
The two of the object of the invention are to provide a kind of method for preparing above-mentioned compound xanthophyll solid preparation.
For achieving the above object, on the one hand, the invention provides a kind of compound xanthophyll solid preparation, it is characterised in that
The raw material of the solid preparation includes：
1～10 part of phylloxanthin；
0～50 part of dehydroretinol；
20～50 parts of vitamin C；
20～50 parts of vitamin E；
5～30 parts of vitamin B1；
1～5 part of Pyritum；
5～10 parts of Native Zinc.
According to aforesaid compound xanthophyll solid preparation, its composition principle is as follows：
Phylloxanthin is the primary pigments for constituting human eye retina's macular region.Phylloxanthin effect phylloxanthin is a kind of important
Antioxidant, is a member of carotenoid family (the natural fat-soluble pigment for finding in one group of plant), also known as " plant Huang
Voxel ", is present jointly with cryptoxanthin in nature.Phylloxanthin has following primary efficacy.(1) primary pigments of retina
Composition：Phylloxanthin constitutes the key component of the plant pigment such as veterinary antibiotics, flowers, and human eye retina with zeaxanthin
The primary pigments of macular region.The eyes of the mankind contain the phylloxanthin of a large amount, and this element is that human body cannot be manufactured, it is necessary to lean on
Take in phylloxanthin to supplement, if lacking this element, eyes will be blind.(2) phototoxiss are protected the eyes from, delays eyes
Aging and prevent pathological changes：Ultraviolet in sunlight and blue light enter eyes and can produce a large amount of free radicals, cause cataract, yellow
Macular area is degenerated, or even cancer.Ultraviolet typically can be filtered out by cornea and crystalline lenses, but blue light can penetrate that eyeball is through to be regarded
Nethike embrane and macula lutea, the phylloxanthin in macula lutea can then filter out blue light, it is to avoid infringement of the blue light to eyes.The fatty outer layer of macular area
The oxidative damage of sunlight is particularly susceptible to, therefore this region is easily degenerated.(3) antioxidation, contributes to prevention machine
Cardiovascula sclerosis, coronary heart disease and tumor disease that asthenia causes always.(4) vision is protected：Phylloxanthin is protected as antioxidant and light
Shield is acted on, and can promote the regeneration of rhodopsin in retina cell (Rhodopsin), can prevent laser high myopia and retina stripping
From, and vision, protection vision can be promoted.It is particularly suitable for student, driver et al. to eat.(5) alleviate asthenopia symptom；(depending on thing mould
Paste, eye is dry and astringent, ophthalmic bloated, ophthalmalgia, photophobia etc.).(6) macular pigment optical density is improved, macula lutea is protected, promote macula lutea development.(7) prevent
Degeneration of macula and retinitis pigmentosa.(8) reduce the generation of glass-film wart, prevent the generation of AMD.
Vitamin A it can constitute the photoactive substance of retinal surface, the nyctalopia A that is deficient in vitamin causes.When long
Between stare at computer screen, vitamin A can be consumed in a large number.Vitamin A is also designated as " vitamin of eyes ".Vitamin A is dimension
The main nutrients of human epithelia's homergy are held, cornea can be maintained normal, bitot's patcheses, degeneration is not made, and has increasing
Strong in half-light regarding thing ability effect.It has the function of protect eyes mucosa, and therefore treatment eye disease is especially effective.
Vitamin B group is related to the health of optic nerve, also plays the role of to protect cornea.Lack vitamin B group, easily occur
Neuropathy, ocular photophobia, blurred vision, the symptom such as shed tears.Therefore, vitamin B group equally especially has to treating eyestrain
Effect.
Vitamin C can weaken infringement of the ultraviolet with oxygen to eye lens.Vitamin C is taken the photograph together with vitamin B1
Take, can more improve the asthenopic effect of alleviation.
Zinc and copper can resist film Oxidation, and anti-lipid peroxidation is acted on, the 26S Proteasome Structure and Function of stabilizing cell membrane.This
It is because in crystal that SOD is this when being copper-zinc enzyme, zinc deficiency or scarce copper, enzymatic activity reduces, memebrane protein lipid oxidation, film function
Abnormal, oxidative damage causes dark adaptation ability not good.Additionally, zinc deficiency or copper also result in visual disorder and color anomalopia chromatopsia.Zinc and
Copper can strengthen the regeneration of tissue and repair ability, affect the transport of optic nerve and the conductive process of nerve.
Inventor has found, by the synergism of above various active component, can obviously improve the asthenopia sense of patient with
And improve visual performance, while duration of photopic vision is greatly improved, total effective rate up to more than 60%.
Preferably, according to aforesaid compound xanthophyll solid preparation, the raw material of the solid preparation includes：
5～10 parts of phylloxanthin；
35～50 parts of vitamin A；
35～50 parts of vitamin C；
35～50 parts of vitamin E；
20～30 parts of vitamin B1；
1～5 part of Pyritum；
5～10 parts of Native Zinc.
According to aforesaid compound xanthophyll solid preparation, wherein, described phylloxanthin be phylloxanthin, in cryptoxanthin one
Plant or their arbitrary proportion mixture；Described Pyritum is copper oxide or a kind of or their arbitrary proportion in copper sulfate
Mixture, described Native Zinc is zinc oxide or a kind of or their the arbitrary proportion mixture in zinc sulfate.
According to aforesaid compound xanthophyll solid preparation, wherein, the raw material of the solid preparation is further included：
15～20 parts of glycerol；
10～12 parts of gelatin；
10～12 parts of soybean oil；
4～5 parts of Cera Flava；
5～8 parts of titanium dioxide；
3～5 parts of lemon yellow；
106～120 parts of purified water.
According to aforesaid compound xanthophyll solid preparation, the solid preparation includes, but not limited to powder, granule, piece
Agent, capsule, drop pill, membrane, etc..Preferably, the solid preparation is selected from tablet, granule and capsule.Most preferably
Ground, the solid preparation is selected from capsule.In a detailed embodiment, the capsule is soft capsule.
On the other hand, present invention also offers a kind of method for preparing aforementioned compound xanthophyll solid preparation, including respectively
The step of preparing premix material, glue and mixing oil plant；Premix material with the step of mixing oil plant and prepare content material；Content thing
The step of material prepares compound xanthophyll solid preparation with glue；The premix material of the solid preparation includes：
1～10 part of phylloxanthin；
0～50 part of dehydroretinol；
20～50 parts of vitamin C；
20～50 parts of vitamin E；
5～30 parts of vitamin B1；
1～5 part of Pyritum；
5～10 parts of Native Zinc.
According to the preparation method of aforesaid compound xanthophyll solid preparation, wherein, further comprising the steps：
(1) by the raw material pulverizing of following parts by weight, 100 mesh sieves are crossed：1～10 part of phylloxanthin, 20～50 parts of vitamin A,
20～50 parts of vitamin C, 20～50 parts of vitamin E, VITAMIN B15～30 part, 1～5 part of Pyritum, 5～10 parts of Native Zinc；
(2) each raw material mix homogeneously for obtaining step (1), obtains premix material；
(3) by 106～120 parts of purified water, 15～20 parts of being placed in glue tanks of glycerol, after being heated to 60 DEG C, by gelatin 10
～12 parts, 5～8 parts of titanium dioxide, in 3～5 parts of inputization glue tanks of lemon yellow, continue to be heated to 80 DEG C, stir in heating
Mix, make Gelatin complete, 1～2 hour is incubated, stand after foam floats, vacuumizing and defoaming, 100 mesh sieves are crossed, glue is obtained,
Insulation is standby；
(4) 10～12 parts of soybean oil, 4～5 parts of Cera Flava are taken be placed in blend tank, 70～80 DEG C is heated to, dissolving is stirred
Mixing is mixed, cooling, obtain mixing oil plant；
(5) premix material that step (2) is obtained is put in mixing oil plant, mixing and stirring, mixing time 20～30, then
Cross colloid mill grind 2～3 times after, vacuumizing and defoaming, cross 80 mesh sieves, obtain content material, standby；
(6) in the environment of 18～22 DEG C of room temperature, relative humidity≤45%, content material and glue are put into respectively
Pelleting in solid preparation machine, then shapes, washes ball, drying, picks ball, obtain final product aforementioned compound xanthophyll solid preparation.
According to the preparation method of aforesaid compound xanthophyll solid preparation, wherein, step (2), step (3) and step (4)
Enforcement order arbitrarily can exchange.That is, the enforcement order of step (2), step (3) and step (4) can be step
(2), step (3) and step (4), or step (2), step (4) and step (3)；Can also be step (3), step (2)
With step (4)；Can also be step (3), step (4) and step (2)；Can also be step (4), step (2) and step (3)；
Can also be step (4), step (3) and step (2).
According to the preparation method of aforesaid compound xanthophyll solid preparation, wherein, described in step (6) sizing, ball, dry is washed
Dry, pick ball process and be：The soft gelatin capsule sizing for obtaining after pelleting dries 2～4 hours, washes ball with the edible ethanol of 95wt% after sizing,
Go to again 25～28 DEG C of temperature, relative humidity be≤40% in the environment of dry 18～24 hours；Ball is picked after drying, rejects abnormity
Ball, there is the defective work of bubble or oil leak ball, obtain qualified soft gelatin capsule.
According to the preparation method of aforesaid compound xanthophyll solid preparation, wherein, regarding for alleviation that step (6) is obtained is tired
The specification of the solid preparation of labor is 0.5g/ grain.
According to the preparation method of aforesaid compound xanthophyll solid preparation, wherein, the production process of step (1)～(6) is equal
Operate under the conditions of 100,000 grades of production clean areas.
Compared with prior art, the present invention has following beneficial technique effect：
(1) the compound xanthophyll solid preparation of the present invention can be obviously improved asthenopia sense and the visual performance of patient,
While duration of photopic vision is greatly improved, total effective rate up to more than 60%.This shows, the compound xanthophyll solid preparation of the present invention
The bioavailability of Lutein is higher.
(2) compared with prior art, patient's blurred vision, eye be dry and astringent, the symptom such as ophthalmic bloated, ophthalmalgia, photophobia is substantially improved.
Specific embodiment
With reference to specific embodiment, the present invention is expanded on further.It should be understood that these embodiments are merely to illustrate this
Bright rather than restriction the scope of the present invention.In addition, it is to be understood that after present disclosure has been read, those skilled in the art
The present invention can be made various changes or modifications, these equivalent form of values equally fall within what the application appended claims were limited
Scope.
Embodiment 1：
The embodiment of the present invention 1 is used for alleviating asthenopic compound xanthophyll solid preparation, and concrete preparation process is as follows：
(1) by the raw material pulverizing of following parts by weight, 100 mesh sieves are crossed：3 parts of phylloxanthin, 35 parts of vitamin A, vitamin C
40 parts, 20 parts of vitamin E, 8 parts of vitamin B1,2 parts of copper oxide, 6 parts of zinc sulfate；
(2) each raw material mix homogeneously for obtaining step (1), obtains premix material；
(3) by 110 parts of purified water, 18 parts of being placed in glue tanks of glycerol, after being heated to 60 DEG C, by 11 parts of gelatin, titanium dioxide
In 6 parts of titanium, 4 parts of inputization glue tanks of lemon yellow, continue 80 DEG C are heated to, heat while stirring, make Gelatin complete, protect
Temperature 1 hour, stands after foam floats, vacuumizing and defoaming, crosses 100 mesh sieves, obtain glue, be incubated standby；
(4) 11 parts of soybean oil, 4 parts of Cera Flava are taken be placed in blend tank, 70 DEG C are heated to, stirring and evenly mixing is dissolved, cool down,
Oil plant must be mixed；
(5) premix material that step (2) is obtained is put in mixing oil plant, mixing and stirring, mixing time 25 minutes, then
Cross colloid mill grind 3 times after, vacuumizing and defoaming, cross 80 mesh sieves, obtain content material, standby；
(6) in the environment of 20 DEG C of room temperature, relative humidity≤45%, content material is put into flexible glue respectively with glue
Pelleting in capsule machine, then shapes, washes ball, drying, picks ball, obtains final product the embodiment of the present invention 1 for alleviating asthenopic compound recipe leaf Huang
Plain solid preparation.
Sizing described in step (6), wash ball, drying, pick ball process and be：The soft gelatin capsule sizing for obtaining after pelleting dries 3 hours,
Ball is washed with the edible ethanol of 95wt% after sizing, then to go to 26 DEG C of temperature, relative humidity be that to dry 20 in the environment of≤40% little
When；Ball is picked after drying, is rejected special-shaped ball, is had the defective work such as bubble or oil leak ball, obtains qualified soft gelatin capsule.The use that step (6) is obtained
It is 0.5g/ grain in the specification for alleviating asthenopic solid preparation.The production process of step (1)～(6) is all clean in 100,000 grades of productions
Operate under the conditions of net area.
Embodiment 2：
The embodiment of the present invention 2 is used for alleviating asthenopic compound xanthophyll solid preparation, and concrete preparation process is as follows：
(1) by the raw material pulverizing of following parts by weight, 100 mesh sieves are crossed：10 parts of phylloxanthin, 40 parts of vitamin A, vitamin C
45 parts, 35 parts of vitamin E, 0 part of vitamin B12,3 parts of copper sulfate, 7 parts of zinc oxide；
(2) each raw material mix homogeneously for obtaining step (1), obtains premix material；
(3) by 120 parts of purified water, 20 parts of being placed in glue tanks of glycerol, after being heated to 60 DEG C, by 12 parts of gelatin, titanium dioxide
In 8 parts of titanium, 5 parts of inputization glue tanks of lemon yellow, continue 80 DEG C are heated to, heat while stirring, make Gelatin complete, protect
Temperature 2 hours, stands after foam floats, vacuumizing and defoaming, crosses 100 mesh sieves, obtain glue, be incubated standby；
(4) 12 parts of soybean oil, 5 parts of Cera Flava are taken be placed in blend tank, 80 DEG C are heated to, stirring and evenly mixing is dissolved, cool down,
Oil plant must be mixed；
(5) premix material that step (2) is obtained is put in mixing oil plant, mixing and stirring, mixing time 30 minutes, then
Cross colloid mill grind 3 times after, vacuumizing and defoaming, cross 80 mesh sieves, obtain content material, standby；
(6) in the environment of 22 DEG C of room temperature, relative humidity≤45%, content material is put into flexible glue respectively with glue
Pelleting in capsule machine, then shapes, washes ball, drying, picks ball, obtains final product the embodiment of the present invention 2 for alleviating asthenopic compound recipe leaf Huang
Plain solid preparation.
Sizing described in step (6), wash ball, drying, pick ball process and be：The soft gelatin capsule sizing for obtaining after pelleting dries 4 hours,
Ball is washed with the edible ethanol of 95wt% after sizing, then to go to 28 DEG C of temperature, relative humidity be that to dry 24 in the environment of≤40% little
When；Ball is picked after drying, is rejected special-shaped ball, is had the defective work such as bubble or oil leak ball, obtains qualified soft gelatin capsule.The use that step (6) is obtained
It is 0.5g/ grain in the specification for alleviating asthenopic solid preparation.The production process of step (1)～(6) is all clean in 100,000 grades of productions
Operate under the conditions of net area.
Embodiment 3：
The embodiment of the present invention 3 is used for alleviating asthenopic compound xanthophyll solid preparation, and concrete preparation process is as follows：
(1) by the raw material pulverizing of following parts by weight, 100 mesh sieves are crossed：8 parts of phylloxanthin, 40 parts of vitamin A, vitamin C
30 parts, 45 parts of vitamin E, 5 parts of vitamin B12,4 parts of copper oxide, 10 parts of zinc oxide；
(2) each raw material mix homogeneously for obtaining step (1), obtains premix material；
(3) by 106 parts of purified water, 15 parts of being placed in glue tanks of glycerol, after being heated to 60 DEG C, by 10 parts of gelatin, titanium dioxide
In 5 parts of titanium, 3 parts of inputization glue tanks of lemon yellow, continue 80 DEG C are heated to, heat while stirring, make Gelatin complete, protect
Temperature 1 hour, stands after foam floats, vacuumizing and defoaming, crosses 100 mesh sieves, obtain glue, be incubated standby；
(4) 10 parts of soybean oil, 4 parts of Cera Flava are taken be placed in blend tank, 70 DEG C are heated to, stirring and evenly mixing is dissolved, cool down,
Oil plant must be mixed；
(5) premix material that step (2) is obtained is put in mixing oil plant, mixing and stirring, mixing time 20 minutes, then
Cross colloid mill grind 2 times after, vacuumizing and defoaming, cross 80 mesh sieves, obtain content material, standby；
(6) in the environment of 18 DEG C of room temperature, relative humidity≤45%, content material is put into flexible glue respectively with glue
Pelleting in capsule machine, then shapes, washes ball, drying, picks ball, obtains final product the embodiment of the present invention 3 for alleviating asthenopic compound recipe leaf Huang
Plain solid preparation.
Sizing described in step (6), wash ball, drying, pick ball process and be：The soft gelatin capsule sizing for obtaining after pelleting dries 2 hours,
Ball is washed with the edible ethanol of 95wt% after sizing, then to go to 25 DEG C of temperature, relative humidity be that to dry 18 in the environment of≤40% little
When；Ball is picked after drying, is rejected special-shaped ball, is had the defective work such as bubble or oil leak ball, obtains qualified soft gelatin capsule.The use that step (6) is obtained
It is 0.5g/ grain in the specification for alleviating asthenopic solid preparation.The production process of step (1)～(6) is all clean in 100,000 grades of productions
Operate under the conditions of net area.
Embodiment 4：
The embodiment of the present invention 4 is used for alleviating asthenopic compound xanthophyll solid preparation, and concrete preparation process is as follows：
(1) by the raw material pulverizing of following parts by weight, 100 mesh sieves are crossed：5 parts of phylloxanthin, 20 parts of vitamin A, vitamin C
35 parts, 35 parts of vitamin E, 0 part of orotic acid, 5 parts of copper oxide, 9 parts of zinc oxide；
(2) each raw material mix homogeneously for obtaining step (1), obtains premix material；
(3) by 112 parts of purified water, 20 parts of being placed in glue tanks of glycerol, after being heated to 60 DEG C, by 12 parts of gelatin, titanium dioxide
In 6 parts of titanium, 4 parts of inputization glue tanks of lemon yellow, continue 80 DEG C are heated to, heat while stirring, make Gelatin complete, protect
Temperature 1 hour, stands after foam floats, vacuumizing and defoaming, crosses 100 mesh sieves, obtain glue, be incubated standby；
(4) 12 parts of soybean oil, 4.5 parts of Cera Flava are taken be placed in blend tank, 70 DEG C is heated to, stirring and evenly mixing is dissolved, cold
But, mixing oil plant is obtained；
(5) premix material that step (2) is obtained is put in mixing oil plant, mixing and stirring, mixing time 20 minutes, then
Cross colloid mill grind 2 times after, vacuumizing and defoaming, cross 80 mesh sieves, obtain content material, standby；
(6) in the environment of 18 DEG C of room temperature, relative humidity≤45%, content material is put into flexible glue respectively with glue
Pelleting in capsule machine, then shapes, washes ball, drying, picks ball, obtains final product the embodiment of the present invention 4 for alleviating asthenopic compound recipe leaf Huang
Plain solid preparation.
Sizing described in step (6), wash ball, drying, pick ball process and be：The soft gelatin capsule sizing for obtaining after pelleting dries 3 hours,
Ball is washed with the edible ethanol of 95wt% after sizing, then to go to 25 DEG C of temperature, relative humidity be that to dry 19 in the environment of≤40% little
When；Ball is picked after drying, is rejected special-shaped ball, is had the defective work such as bubble or oil leak ball, obtains qualified soft gelatin capsule.The use that step (6) is obtained
It is 0.5g/ grain in the specification for alleviating asthenopic solid preparation.The production process of step (1)～(6) is all clean in 100,000 grades of productions
Operate under the conditions of net area.
Embodiment 5：
The embodiment of the present invention 5 is used for alleviating asthenopic compound xanthophyll solid preparation, and concrete preparation process is as follows：
(1) by the raw material pulverizing of following parts by weight, 100 mesh sieves are crossed：3 parts of phylloxanthin, 25 parts of vitamin A, vitamin C
25 parts, 45 parts of vitamin E, 5 parts of vitamin B12,4 parts of copper sulfate, 8 parts of zinc sulfate；
(2) each raw material mix homogeneously for obtaining step (1), obtains premix material；
(3) by 120 parts of purified water, 18 parts of being placed in glue tanks of glycerol, after being heated to 60 DEG C, by 11 parts of gelatin, titanium dioxide
In 7 parts of titanium, 3 parts of inputization glue tanks of lemon yellow, continue 80 DEG C are heated to, heat while stirring, make Gelatin complete, protect
Temperature 1 hour, stands after foam floats, vacuumizing and defoaming, crosses 100 mesh sieves, obtain glue, be incubated standby；
(4) 11 parts of soybean oil, 4 parts of Cera Flava are taken be placed in blend tank, 70 DEG C are heated to, stirring and evenly mixing is dissolved, cool down,
Oil plant must be mixed；
(5) premix material that step (2) is obtained is put in mixing oil plant, mixing and stirring, mixing time 20 minutes, then
Cross colloid mill grind 2 times after, vacuumizing and defoaming, cross 80 mesh sieves, obtain content material, standby；
(6) in the environment of 18 DEG C of room temperature, relative humidity≤45%, content material is put into flexible glue respectively with glue
Pelleting in capsule machine, then shapes, washes ball, drying, picks ball, obtains final product the embodiment of the present invention 5 for alleviating asthenopic compound recipe leaf Huang
Plain solid preparation.
Sizing described in step (6), wash ball, drying, pick ball process and be：The soft gelatin capsule sizing for obtaining after pelleting dries 4 hours,
Ball is washed with the edible ethanol of 95wt% after sizing, then to go to 25 DEG C of temperature, relative humidity be that to dry 20 in the environment of≤40% little
When；Ball is picked after drying, is rejected special-shaped ball, is had the defective work such as bubble or oil leak ball, obtains qualified soft gelatin capsule.The use that step (6) is obtained
It is 0.5g/ grain in the specification for alleviating asthenopic solid preparation.The production process of step (1)～(6) is all clean in 100,000 grades of productions
Operate under the conditions of net area.
Embodiment 6：
The embodiment of the present invention 6 is used for alleviating asthenopic compound xanthophyll solid preparation, and concrete preparation process is as follows：
(1) by the raw material pulverizing of following parts by weight, 100 mesh sieves are crossed：6 parts of phylloxanthin, 40 parts of vitamin A, vitamin C
30 parts, 30 parts of vitamin E, 0 part of vitamin B12,3 parts of copper oxide, 8 parts of zinc oxide；
(2) each raw material mix homogeneously for obtaining step (1), obtains premix material；
(3) by 115 parts of purified water, 17 parts of being placed in glue tanks of glycerol, after being heated to 60 DEG C, by 10 parts of gelatin, titanium dioxide
In 7 parts of titanium, 3 parts of inputization glue tanks of lemon yellow, continue 80 DEG C are heated to, heat while stirring, make Gelatin complete, protect
Temperature 1 hour, stands after foam floats, vacuumizing and defoaming, crosses 100 mesh sieves, obtain glue, be incubated standby；
(4) 11 parts of soybean oil, 5 parts of Cera Flava are taken be placed in blend tank, 70 DEG C are heated to, stirring and evenly mixing is dissolved, cool down,
Oil plant must be mixed；
(5) premix material that step (2) is obtained is put in mixing oil plant, mixing and stirring, mixing time 20 minutes, then
Cross colloid mill grind 2 times after, vacuumizing and defoaming, cross 80 mesh sieves, obtain content material, standby；
(6) in the environment of 18 DEG C of room temperature, relative humidity≤45%, content material is put into flexible glue respectively with glue
Pelleting in capsule machine, then shapes, washes ball, drying, picks ball, obtains final product the embodiment of the present invention 6 for alleviating asthenopic compound recipe leaf Huang
Plain solid preparation.
Sizing described in step (6), wash ball, drying, pick ball process and be：The soft gelatin capsule sizing for obtaining after pelleting dries 4 hours,
Ball is washed with the edible ethanol of 95wt% after sizing, then to go to 25 DEG C of temperature, relative humidity be that to dry 22 in the environment of≤40% little
When；Ball is picked after drying, is rejected special-shaped ball, is had the defective work such as bubble or oil leak ball, obtains qualified soft gelatin capsule.The use that step (6) is obtained
It is 0.5g/ grain in the specification for alleviating asthenopic solid preparation.The production process of step (1)～(6) is all clean in 100,000 grades of productions
Operate under the conditions of net area.
Alleviate asthenopia effect example
(1) it is 18～65 years old that study subject is pressed the principle of voluntariness and selects the age, uses eye, the fatigable experimenter of vision for a long time
120.Following experimenter is excluded when selecting：With infectious, traumatic ocular disease person；With cornea, crystal, vitreous body,
The inside and outside eye disease patient such as retinopathy；With the disease patient such as cardiovascular, cerebrovascular, liver, kidney, hemopoietic system；Take in a short time with
The relevant article of tested function, affects the judgement person to result；Long-term taking is about treating the medicine of vision, health food or making
Fail terminator with other treatment method；Inclusive criteria is not met, and tested material person or the not congruent impact of data is not eaten by regulation
Effect or safe sex determination person, carry out operated eye less than 3 months persons, gestation or women breast-feeding their children and allergic constitution patient.
(2) test method
Test packet：120 experimenters are divided into test-meal group and placebo group using random double-blind method, per group each 60
People, the factor such as age, sex, vision has comparability, tests and compares using between itself cross-reference and group.
Test-meal method：Test-meal group takes the embodiment of the present invention 1 for alleviating asthenopic compound xanthophyll solid preparation, right
Placebo is taken according to group, is that one time a day, 1 tablet once, Time of Administration be.
Observation index：Indices in test-meal on-test and at the end of each determine 1 time.
1) safety indexes：General physical examination blood, urine, feces routine, biochemical indicator of having a blood test, Chest X-rays, electrocardiogram, B ultrasonic inspection
Look into, untoward reaction is observed.
2) efficiency index：Detailed medical history-taking, eye subjective symptomss：Ophthalmic bloated, ophthalmalgia, photophobia, blurred vision, eye are dry and astringent
Deng.Integrated value is counted before and after test-meal by symptom weight (3 points of serious symptom, 2 points of moderate, 1 point of mild), and its cardinal symptom is improved
Situation (each symptom improves 1 and is divided into effectively, and improvement 2 is divided into effective), calculates symptom improvement rate.Ophthalmology routine examination：External eyes, eye
Bottom.Visuognosis persistence test：The photopic vision time is referred to as duration of photopic vision to the percentage ratio of fixation time, and minute is 3min, to survey
Determine to average for 2 times.Examination of distant vision：Checked using c chart.
Data processing and result judgement：Data processing calculates analytical data with statistical software STATA6.0.Own control is provided
Material adopts paired t-test, and two groups of means compare and adopt independent samples t-test, and the latter needs to carry out homogeneity test of variance, and abnormal is divided
Cloth or heterogeneity of variance analytical data carry out appropriate variable conversion, after normal state homogeneity of variance is met, carry out t with the data of conversion
Inspection；If change data can not still meet normal state homogeneity of variance requirement, t ' inspection or rank test is used instead；To the coefficient of variation too
Greatly, as the data of CV ＞ 50%, rank test is applied.Efficacy measures adopt X2Inspection judges P value.
Result judgement is effective：After test-meal test, test group itself is compared and is compared between matched group group, symptom total mark,
Duration of photopic vision and total effective rate are obviously improved, and difference has significance, and average duration of photopic vision improves >=0.1, can determine that this
Given the test agent has alleviates asthenopia function.Result judgement is invalid：Not up to above-mentioned standard person.
(3) result of the test
Observe 120 asthenopes altogether, be randomly divided into test-meal group, matched group each 60.At the end of test-meal, test-meal group has 2
Example does not take tested material by regulation, and 8 are not checked on time；Matched group has 9 not check on time, and 1 is dropped by the wayside.Test-meal group with
Matched group respectively has 10 to meet Subject Exclusion Criteria, and case depigmentation rate is 16.67%.Meet the test-meal group 50 of inclusive criteria
Example, wherein male 11, women 39；31～65 years old age, 56 years old mean age；Photopic vision time most short 69s, most long 129s,
Average course of disease 4.11.Matched group 50, wherein male 10, women 40；18～65 years old age, average 55.68 years old；Photopic vision
Time most short 71s, most long 122s, average course of disease 4.41.All experimenter is normal through interior eye, examination of external eye.Before test-meal
Two groups of indices no significant differences (P ＞ 0.05), concrete condition is shown in Table 1.
Before 1 test-meal of table, ordinary circumstance compares (X ± SD)
1) improve vision effect
Test-meal group itself compare before and after test-meal and test-meal after between group relatively equal significant difference (P ＜ 0.05), be shown in Table 2.
The comparison (X ± SD) of two groups of distant vision changes before and after 2 test-meal of table
Note：* itself compare P ＜ 0.05 before and after test-meal；Compare P ＜ 0.05 after # test-meal between group.
Duration of photopic vision change is compared
Test-meal group itself compare before and after test-meal and test-meal after between group relatively equal significant difference (P ＜ 0.05 or ＜ 0.01),
It is shown in Table 3.
Comparison (X ± SD) % of two groups of duration of photopic vision changes before and after 3 test-meal of table
Note：Itself compare P ＜ 0.01 before and after * test-meal；Compare P ＜ 0.05 after # test-meal between group.
2) cardinal symptom improves situation
In terms of each cardinal symptom improvement, test-meal group is notable (P ＜ 0.05) with matched group comparing difference, is shown in Table 4.
4 cardinal symptom of table improves situation
Note：* P ＜ 0.05 is compared with matched group.
3) duration of photopic vision effect compares
After test-meal, duration of photopic vision effective percentage substantially increases, notable (P ＜ 0.05) with matched group comparing difference, is shown in Table 5
After 5 test-meal of table, duration of photopic vision effect compares
Note：* P ＜ 0.05 is compared with matched group.
4) symptom integral statistics
Integration differential is counted before and after each group test-meal according to eye subjective symptomss and reach 1.30～2.66 points, before test-meal group test-meal
Itself comparing difference is notable (P ＜ 0.01) afterwards；After test-meal, symptom integral is significantly reduced, (P ＜ notable with matched group comparing difference
0.05).It is shown in Table 6.
6 symptom integral of table counts (X ± SD)
Note：Itself compare P ＜ 0.01 before and after * test-meal；Compare P ＜ 0.05 after # test-meal between group.
5) safety indexes observation
Biochemical 9, hematology 3, urine 10, stool routine, B ultrasonic, Chest X-rays and electrocardiogram etc. checked before and after test-meal
Each index shows no obvious abnormalities change all in range of normal value.
In this research, test-meal group asthenopia sense substantially mitigates, and duration of photopic vision averagely improves 21.90%, total effective rate
62.00%, symptom integral reduces 2.66 ± 1.44.Before and after test-meal test-meal group itself compare and group between compare and be statistically analyzed
Significant difference；Compare with matched group, test-meal group experimenter's blurred vision, eye are dry and astringent, the symptom such as ophthalmic bloated, ophthalmalgia, photophobia has and changes
Kind.Illustrate that this product has and alleviate asthenopic function.
Embodiment 7：
The embodiment of the present invention 7 is used for alleviating asthenopic compound xanthophyll solid preparation, and concrete preparation process is as follows：
(1) by the raw material pulverizing of following parts by weight, 100 mesh sieves are crossed：5 parts of phylloxanthin, 35 parts of vitamin A, vitamin C
25 parts, 25 parts of vitamin E, 5 parts of VB11,2 parts of copper oxide, 6 parts of zinc oxide；
(2) each raw material mix homogeneously for obtaining step (1), obtains premix material；
(3) by 115 parts of purified water, 17 parts of being placed in glue tanks of glycerol, after being heated to 60 DEG C, by 10 parts of gelatin, titanium dioxide
In 7 parts of titanium, 3 parts of inputization glue tanks of lemon yellow, continue 80 DEG C are heated to, heat while stirring, make Gelatin complete, protect
Temperature 1 hour, stands after foam floats, vacuumizing and defoaming, crosses 100 mesh sieves, obtain glue, be incubated standby；
(4) 11 parts of soybean oil, 5 parts of Cera Flava are taken be placed in blend tank, 70 DEG C are heated to, stirring and evenly mixing is dissolved, cool down,
Oil plant must be mixed；
(5) premix material that step (2) is obtained is put in mixing oil plant, mixing and stirring, mixing time 20 minutes, then
Cross colloid mill grind 2 times after, vacuumizing and defoaming, cross 80 mesh sieves, obtain content material, standby；
(6) in the environment of 18 DEG C of room temperature, relative humidity≤45%, content material is put into flexible glue respectively with glue
Pelleting in capsule machine, then shapes, washes ball, drying, picks ball, obtains final product the embodiment of the present invention 6 for alleviating asthenopic compound recipe leaf Huang
Plain solid preparation.
Sizing described in step (6), wash ball, drying, pick ball process and be：The soft gelatin capsule sizing for obtaining after pelleting dries 4 hours,
Ball is washed with the edible ethanol of 95wt% after sizing, then to go to 25 DEG C of temperature, relative humidity be that to dry 22 in the environment of≤40% little
When；Ball is picked after drying, is rejected special-shaped ball, is had the defective work such as bubble or oil leak ball, obtains qualified soft gelatin capsule.The use that step (6) is obtained
It is 0.5g/ grain in the specification for alleviating asthenopic solid preparation.The production process of step (1)～(6) is all clean in 100,000 grades of productions
Operate under the conditions of net area.
Improve visual performance embodiment
1st, materials and methods
1.1 diagnostic criteria：(according to Ministry of Public Health new Chinese medicine guideline of clinical investigations)
1.1.1 tcm diagnosis standard
1.1.1.1 regard nearly thing clear, cover depending on remote thing, depending on thing slur, often must foreign body in the eye and regard.
1.1.1.2 eyestrain, ophthalmic bloated is had a headache.
1.1.2 differential diagnosis in tcm standard
Syndrome of yin deficiency of liver and kidney：In addition to above-mentioned symptom, the dry and astringent discomfort of eye is had concurrently, it is impossible to watching for a long time, eyelid is tired to be closed, dry mouth and throat
Or things is fuzzy, or have a dizzy spell, or tinnitus is forgetful, red tongue with a little fluid, few tongue or no fur, thready pulse or count accurately.
1.1.3 Western medicine diagnostic criteria
1.1.3.1 definition
Pseudomyopia：School age population distant vision under normality regulation reduces<1.0, normal in myopia >=1.0, microcoria is examined
Shadow is Myopia ametropia, can improve the near vision state of vision using multiple spherical lenss, but using after atropine platycoria, myopia disappears
Lose, be rendered as facing or hypermetropia.
1.1.3.2 clinical manifestation：Things is smudgy, eyes tire easily, has slur, or ophthalmic bloated, front forehead depending on thing when serious
Pain etc..
1.2 experimenter's inclusive criterias
1.2.1 diagnostic criteria and differential diagnosis in tcm person are met；
1.2.2 6-15 year student of age；
1.2.3 far visual acuity >=0.1,1.0 bore hole near vision >=1.0；
1.2.4 platycoria examines shadow, and diopter is 0
1.3 exclusion standard
1.3.1 the patient for including age criterion is not met, to this product allergy sufferers；
1.3.2 with infectious eye part disease person, corneal nebula, keratoconuses；
1.3.3 suffer from fundus oculi disease or be associated with the severe primary disease such as cardiovascular, cerebrovascular, liver, kidney, hemopoietic system
Disease, psychotic.
1.3.4 long-term taking other about medicine or use other treatment method, fail terminator；
1.3.5 inclusive criteria is not met, does not use according to regulations this product, it is impossible to judge result of the test, or the not congruent shadow of data
Ring effect to judge or safety judgement person.
2. observation index
2.1 acuity：
2.1.1 distant vision observation：Checked with international standard distant vision test chart；
2.1.2 near vision observation：Checked with international standard near vision test type；
2.1.3 myopic refractive degree：Shadow is examined under microcoria, using negativity spherical lenss myopia correction, after atropine platycoria, examine shadow
(refractive diopter 0)
2.1.4 the observation of eye subjective symptomss and classification
The observation of 7 eye subjective symptomss of table and classification
| A, ophthalmic bloated： | No ophthalmic bloated | 0 point |
| Accidental ophthalmic bloated | 1 point | |
| Frequent ophthalmic bloated, but do not affect to learn, live | 2 points | |
| Continue ophthalmic bloated, impact study, life | 3 points | |
| B, ophthalmalgia： | No ophthalmalgia | 0 point |
| Accidental ophthalmalgia | 1 point | |
| Frequent ophthalmalgia, but do not affect to learn, live | 2 points | |
| Continue ophthalmalgia, impact study, life | 3 points | |
| C, eye are puckery： | Anophthalmia is dry and astringent | 0 point |
| Eye is dry and astringent not well, and tear soaks filter paper>5mm<10mm | 1 point | |
| The dry and astringent pain of eye, tear soaks filter paper 1mm-5mm | 2 points | |
| The dry causalgia of eye, tear soaks filter paper<1mm | 3 points | |
| D, xerostomia： | No xerostomia | 0 point |
| Dry mouth and throat is slight | 1 point | |
| Dry mouth and throat can tolerate | 2 points | |
| Dry mouth and throat is unbearably | 3 points | |
| E, have a dizzy spell： | No dizzy | 0 point |
| Accidentally dizzy | 1 point | |
| Often dizzy, do not affect to learn, live | 2 points | |
| Continue dizziness, impact study, life | 3 points | |
| F, tinnitus： | No tinnitus | 0 point |
| Accidentally there is tinnitus | 1 point | |
| Often tinnitus, does not affect to learn, lives | 2 points | |
| Persisting tinnitus, impact study, life | 3 points |
2.2 eyesight improving hand functional evaluation standards
2.2.1 vision
Clinical cure：Distant vision recovers normally >=1.0, diopter lab scale under microcoria, and symptom disappears.
Effective：Naked vision improves more than four rows, and symptom is obviously improved.
Effectively：Naked vision improves more than two rows, and clinical symptoms improve.
Invalid：Naked vision is no improved or is declined, and clinical symptoms no improve.
2.2.2 diopter
Effectively：Under microcoria, diopter lowers >=-0.50
Invalid：Under microcoria, diopter lowers not enough -0.50
2.3 safeties are investigated
2.3.1 before and after taking, a routine blood test is respectively looked into；
2.3.2 conventional physical examination is respectively carried out before and after taking once.
3. test method and test period
Test group and matched group are set up in this test, according to random, double blinding, contrast method, 70 false myopes are divided
For two groups, it is 35 people per group.
Test group：7 solid preparation of oral embodiment, 2 times a day, 1 every time, 30 days be one observation the cycle, per two weeks with
Visit once.
Matched group：Oral with tested group outside observe on all four blank formulation, 2 times a day, 1 every time, be within 30 days
The observation cycle, per follow-up in two weeks once.
4 results
4.1 physical data
70 false myopes of this group, male 28, women 42；Age is minimum 6 years old, maximum 15 years old, and average 11.2
± 2.26 years old.
8 test group of table and matched group packet situation (X ± SD)
| Packet | Number of cases | Man | Female | Age | Distant vision | Myopic refractive degree | Symptom integral before test |
| Test group | 35 | 12 | 23 | 11.31±2.43 | 0.43±0.19 | -1.17±0.46 | 2.34±1.45 |
| Matched group | 35 | 14 | 21 | 11.11±2.11 | 0.40±0.17 | -1.31±0.45 | 2.66±1.00 |
Through statistical test, two groups in sex, the age, distant vision, in terms of myopic refractive degree and clinical subjective symptomss, P>
0.05, no difference of science of statistics between two groups, with comparability.
4.2 improve visual function situation
Before and after test-meal, test group refers to following table with the eyesight improving situation of matched group
9 test group of table is compared with matched group eyesight improving situation
| Packet | Number of cases | Recovery from illness | Effective | Effectively | Invalid | Obvious effective rate % | Effective percentage % |
| Test group | 35 | 5 | 8 | 16 | 6 | 37.14 | 82.86# |
| Matched group | 35 | 1 | 2 | 7 | 25 | 8.57 | 28.57 |
# is through X2Experiment P<0.05, between two groups, there were significant differences.Show that test group eyesight improving situation is substantially better than control
Group.
4.3 visions change
The comparison (X ± SD) of distant vision change before and after table 10 liang of groups test-meal
| Packet | Eye number | Distant vision before test-meal | 14 days after test-meal | 30 days after test-meal | Difference |
| Test group | 70 | 0.43±0.19 | 0.56±0.23 | 0.66±0.30#* | 0.23 |
| Matched group | 70 | 0.40±0.17 | 0.47±0.19 | 0.51±0.20 | 0.11 |
# represents：Check through t, P<0.05
Upper table is visible, after test-meal 30 days, compares with before test-meal, and test group distant vision has significant difference.
*：Represent through t and test P<0.05
After showing test-meal, test group is compared with matched group, and distant vision has significant difference.
4.4 diopters improve situation and compare
11 diopter of table improves situation and compares
| Packet | Eye number | Effective eye number | Invalid eye number | Effective percentage % |
| Test group | 80 | 70 | 10 | 87.5 |
| Matched group | 80 | 7 | 73 | 8.75 |
# is through X2Test P<0.05, show that test group compares with matched group that there were significant differences.
4.5 myopic refractive degree changes
The comparison (X ± SD) of refraction of eye degree before and after table 12 liang of groups test-meal
| Packet | Eye number | Before test | After test | Difference |
| Test group | 80 | -1.17±0.46 | -0.73±0.57#* | 0.44 |
| Matched group | 80 | -1.31±0.45 | -1.20±0.53 | 0.11 |
#：Represent：Before and after test group test-meal, myopic refractive degree freely compares P<0.05 has significant difference.
*：Represent：Myopic refractive degree before and after test-meal, test group compares P with matched group<0.05 has significant difference.
4.6 eye subjective symptomss change
4.6.1 eye symptom integral contrast
13 test group of table counts (X ± SD) with matched group symptom integral
| Packet | Observation number of cases | Symptom integral before test-meal | Symptom integral after test-meal | Difference |
| Test group | 40 | 2.34±1.45 | 0.71±1.07#* | 1.63 |
| Matched group | 40 | 2.66±1.00 | 2.06±1.55 | 0.60 |
#：Represent：P is checked through t<0.05, before and after showing test-meal, test group own control has significant difference.
*：Represent：P is checked through t<0.05, show to compare between test group and matched group, have significant difference.
4.6.2 eye subjective symptomss compare
Symptom variation (X ± SD) before and after 14 test group of table and matched group test-meal
#：Represent through t and check P<0.05 has significant difference.
Upper table is visible, ophthalmic bloated before and after test group test-meal, and eye is dry and astringent, and dry mouth symptom has clear improvement.Ophthalmalgia symptom is from examination
Have clear improvement after testing.Have a dizzy spell, integrate after tinnitus test-meal and declined, but not statistically significant.
Safety before and after 4.7 tests is compared
Test group and matched group test anteroposterior diameter are had a blood test conventional and conventional physical examination, and every Index for examination is all in normal model
In enclosing.
5. discuss
5.1 self-control solid preparations have the health-care effect for improving vision.Compare with matched group, test group asthenopia sense is obvious
Mitigate, distant vision averagely improves 0.24, effective percentage is that 82.86%, eye myopic refractive degree averagely reduces by 0.43, and effective percentage is
87.5%, being statistically analyzed difference has significance.
5.2 are compared with matched group, and the solid preparation of the present invention is for the blurred vision of people with visual impairment, ophthalmic bloated, ophthalmalgia, eye
Dry and astringent, the asthenopia such as xerostomia symptom tool has a better role.That is, the solid preparation of the present invention has significantly improving
Visual performance effect.
5.3 test-meal groups are compared with matched group, and physiochemical indice and physical examination index are all without exception, do not see during test-meal
Observe allergy and and other untoward reaction, to examination, trencherman is healthy has no significant effect.
The preferred embodiments of the present invention are the foregoing is only, the present invention is not limited to, for the skill of this area
For art personnel, the present invention can have various modifications and variations.All within the spirit and principles in the present invention, made any repair
Change, equivalent, improvement etc., be all contained within protection scope of the present invention.
Claims (10)
1. a kind of solid preparation of compound xanthophyll, it is characterised in that the raw material of the solid preparation includes：
1～10 part of phylloxanthin；
20～50 parts of vitamin A；
20～50 parts of vitamin C；
20～50 parts of vitamin E；
5～30 parts of vitamin B1；
1～5 part of Pyritum；
5～10 parts of Native Zinc.
2. compound xanthophyll solid preparation according to claim 1, the raw material of the solid preparation includes：
5～10 parts of phylloxanthin；
35～50 parts of vitamin A；
35～50 parts of vitamin C；
35～50 parts of vitamin E；
20～30 parts of vitamin B1；
1～5 part of Pyritum；
5～10 parts of Native Zinc.
3. compound xanthophyll solid preparation according to claim 1 and 2, wherein, described phylloxanthin is phylloxanthin, Semen Maydiss
A kind of or their the arbitrary proportion mixture of Huang Zhizhong；Described Pyritum be the one kind in copper oxide or copper sulfate or they
Arbitrary proportion mixture, described Native Zinc is zinc oxide or a kind of or their the arbitrary proportion mixture in zinc sulfate.
4. compound xanthophyll solid preparation according to claim 3, wherein, the raw material of the solid preparation is wrapped further
Include：
15～20 parts of glycerol；
10～12 parts of gelatin；
10～12 parts of soybean oil；
4～5 parts of Cera Flava；
5～8 parts of titanium dioxide；
3～5 parts of lemon yellow；
106～120 parts of purified water.
5. a kind of method of the compound xanthophyll solid preparation for preparing described in any one of claim 1-4, pre- including preparing respectively
The step of batch mixing, glue and mixing oil plant；Premix material with the step of mixing oil plant and prepare content material；Content material and glue
The step of liquid prepares compound xanthophyll solid preparation；The premix material of the solid preparation includes：
1～10 part of phylloxanthin；
20～50 parts of vitamin A；
20～50 parts of vitamin C；
20～50 parts of vitamin E；
5～30 parts of vitamin B1；
1～5 part of Pyritum；
5～10 parts of Native Zinc.
6. the preparation method of compound xanthophyll solid preparation according to claim 5, wherein, further includes following step
Suddenly：
(1) by the raw material pulverizing of following parts by weight, 100 mesh sieves are crossed：1～10 part of phylloxanthin, 0～50 part of dehydroretinol, dimension life
20～50 parts of plain C, 20～50 parts of vitamin E, 5～30 parts of vitamin B1,1～5 part of Pyritum, 5～10 parts of Native Zinc；
(2) each raw material mix homogeneously for obtaining step (1), obtains premix material；
(3) by 106～120 parts of purified water, 15～20 parts of being placed in glue tanks of glycerol, after being heated to 60 DEG C, by gelatin 10～12
Part, 5～8 parts of titanium dioxide, in 3～5 parts of inputization glue tanks of lemon yellow, continue 80 DEG C are heated to, heat while stirring, make
Gelatin is complete, is incubated 1～2 hour, stands after foam floats, vacuumizing and defoaming, crosses 100 mesh sieves, obtain glue, be incubated standby
With；
(4) 10～12 parts of soybean oil, 4～5 parts of Cera Flava are taken be placed in blend tank, 70～80 DEG C is heated to, dissolving stirring is mixed
Even, cooling, obtain mixing oil plant；
(5) premix material that step (2) is obtained is put in mixing oil plant, mixing and stirring, mixing time 20～30, after glue
After body mill grinding 2～3 times, vacuumizing and defoaming, 80 mesh sieves are crossed, content material is obtained, standby；
(6) in the environment of 18～22 DEG C of room temperature, relative humidity≤45%, content material is put into flexible glue respectively with glue
Pelleting in capsule machine, then shapes, washes ball, drying, picks ball, obtain final product aforementioned compound xanthophyll solid preparation.
7. the preparation method of compound xanthophyll solid preparation according to claim 6, wherein, step (2), step (3) and
The enforcement order of step (4) arbitrarily can be exchanged.
8. the preparation method of compound xanthophyll solid preparation according to claim 6, wherein, sizing described in step (6),
Wash ball, drying, pick ball process and be：The soft gelatin capsule sizing for obtaining after pelleting dries 2～4 hours, with the edible second of 95wt% after sizing
Ball washed by alcohol, then to go to 25～28 DEG C of temperature, relative humidity be to dry 18～24 hours in the environment of≤40%；Ball is picked after drying,
Reject special-shaped ball, have the defective work of bubble or oil leak ball, obtain qualified soft gelatin capsule.
9. the preparation method of compound xanthophyll solid preparation according to claim 6, wherein, the compound recipe that step (6) is obtained
The specification of lutein solid preparation is 0.5g/ grain.
10. the preparation method of compound xanthophyll solid preparation according to claim 6, wherein, the life of step (1)～(6)
Product process is all operated under the conditions of 100,000 grades of production clean areas.
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