CN106491530B - A kind of medical composite for eye - Google Patents
A kind of medical composite for eye Download PDFInfo
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- CN106491530B CN106491530B CN201611143267.1A CN201611143267A CN106491530B CN 106491530 B CN106491530 B CN 106491530B CN 201611143267 A CN201611143267 A CN 201611143267A CN 106491530 B CN106491530 B CN 106491530B
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- composition
- osmotic pressure
- polyvinyl alcohol
- composition according
- sodium
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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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0048—Eye, e.g. artificial tears
-
- 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
- A61K31/74—Synthetic polymeric materials
- A61K31/765—Polymers containing oxygen
-
- 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
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
- A61K9/08—Solutions
Abstract
The present invention relates to a kind of medical composite for eye.It include polyvinyl alcohol and D- Glucosamine in the composition.According to mass percent meter, the content in the composition of the D- Glucosamine is 0.015wt% to 0.04wt%；It is preferred that the content in the composition of the D- Glucosamine is 0.02wt% to 0.035wt%.
Description
Technical field
The present invention relates to a kind of medical composite for eye.
Background technique
With the high speed development of economic society, air environment is increasingly severe, has encouraged being increasing for ophthalmology disease, especially
It is the people being chronically exposed under haze environment, eye tear layer is more easily damaged, and causes the uncomfortable diseases such as the dry and astringent, swelling and pain of eyes
Shape.Currently in order to preventing above-mentioned symptom from generating, mostly use hydroxypropyl methylcellulose, chondroitin sulfate, hyaluronic acid etc. that there is viscosity
Polymer substance solution as artificial tears, to improve tear layer state, but therapeutic effect has certain limitation, Bu Nengling
People is satisfied.In recent years, market is gradually released again, adds the ophthalmic preparation of Chinese medicine, such as: borneol, kuh-seng, olibanum, radix bupleuri, party
Ginseng, chrysanthemum, Chinese trumpet creeper, Radix Paeoniae Alba are dry and astringent to alleviate eye, but above-mentioned additive, and chemical structure is complicated and the mechanism of action is still unknown
Really, content of beary metal not can be effectively controlled, thus it is still necessary to studying more safe and effective composition to protect eye tear
Layer is without damage.
Summary of the invention
It include polyvinyl alcohol and D- aminoglucose in the composition the present invention provides a kind of medical composite for eye
Sugar.
In a specific embodiment, according to mass percent meter, the D- Glucosamine containing in the composition
Amount is 0.015wt% to 0.04wt%.
In a specific embodiment, according to mass percent meter, the D- Glucosamine containing in the composition
Amount is 0.017wt% to 0.038wt%.
In a specific embodiment, according to mass percent meter, the D- Glucosamine containing in the composition
Amount is 0.019wt% to 0.034wt%.
In a specific embodiment, according to mass percent meter, the D- Glucosamine containing in the composition
Amount is 0.02wt% to 0.035wt%.
In a specific embodiment, according to mass percent meter, the preferably described D- Glucosamine is in the composition
Content be 0.02wt% to 0.034wt%.
It in a specific embodiment, further include osmotic pressure regulator and pH adjusting agent in the composition.
Because the composition is generally directly applied to eye, thus its osmotic pressure molar density preferably with quality percentage
The osmotic pressure molar density for the chlorination sodium standard solution that content is 0.9% is suitable.So in a specific embodiment, institute
The osmotic pressure molar density for the chlorination sodium standard solution that the osmotic pressure molar density for stating composition is 0.9% with mass percentage
Ratio is 0.9 to 1.1.
In a specific embodiment, the osmotic pressure molar density of the composition and mass percentage are 0.9%
Chlorination sodium standard solution osmotic pressure molar density ratio be 0.95 to 1.08.
In a specific embodiment, the pH value of the composition is 5.7 to 7.0.
In a specific embodiment, the pH of the preferably described composition is 6.5 to 7.0.
In a specific embodiment, the osmotic pressure regulator includes sodium chloride, potassium chloride, glycerol, mannitol, cream
At least one of sour sodium and glucose.
In a specific embodiment, the preferably described osmotic pressure regulator is glycerol and sodium chloride.
In a specific embodiment, the pH adjusting agent includes sodium hydroxide, potassium hydroxide, sodium dihydrogen phosphate, phosphorus
At least one of sour disodium hydrogen, boric acid, borax, lactic acid acetic acid, ammonium acetate, acetic acid, sodium acetate and citrate buffer.
In a specific embodiment, the preferably described pH adjusting agent is sodium dihydrogen phosphate and disodium hydrogen phosphate.
In a specific embodiment, according to mass percent meter, the content of the polyvinyl alcohol in the composition is
0.1wt% to 0.26wt%.
In a specific embodiment, according to mass percent meter, the content of the polyvinyl alcohol in the composition is
0.12wt% to 0.23wt%.
Composition of the invention can be prepared into a variety of Ophthalmic formulations, such as: eye drops, gel for eye use, Eye ointments and eye
Film facilitates different crowd to use under various circumstances.
According to the other side of invention, the preparation method of composition of the invention is provided, is included the following steps: poly- second
Enol is dissolved in water for injection, obtained polyvinyl alcohol water solution, then with D- Glucosamine and optional pH adjusting agent
It is uniformly mixed at least one of osmotic pressure regulator, obtain the composition.
In a specific embodiment, it is also preferable to include to the composition degerming the step of.
In a specific embodiment, the composition of the composition, by mass percentage, polyvinyl alcohol 0.1% to
0.26%, D- Glucosamine 0.019% to 0.034%, sodium chloride 0.013% to 0.1%, disodium hydrogen phosphate 0.094% to
0.356%, sodium dihydrogen phosphate 0.087% to 0.439%, glycerol 0.5% to 5.3%, surplus are water for injection.The composition
Preparation method be respectively configured and remix with auxiliary material using main ingredient.
Specifically, the preparation method includes: that polyvinyl alcohol is dissolved in water for injection, obtained polyvinyl alcohol water
Solution, then be uniformly mixed with D- Glucosamine and at least one of optional pH adjusting agent and osmotic pressure regulator, it obtains
To the composition.
Preferably, the method comprises the steps of:
(1) the polyvinyl alcohol stirring and dissolving is obtained into solution A in water for injection；
(2) by D- Glucosamine, and optionally at least one of isotonic regulator and pH adjusting agent are dissolved in note
It penetrates in water, obtains solution B and be uniformly mixed with by acquired solution A in step 1, obtain solution C；
(3) filtration sterilization both obtains finished product after filling.
In the preparation method step (1) of the composition, polyvinyl alcohol solution temperature control range is 120 DEG C to 160 DEG C,
120 DEG C to 140 DEG C of preferable temperature control range.The preparation method avoids polyvinyl alcohol because of dissolution by control solution temperature
Temperature is too low and not sufficiently dissolved, and decomposes because temperature is excessively high, provides safeguard for the process stabilizing of product.
In the preparation method step (1) and (2), stirring refers to that being installed on agitating shaft in material-compound tank to forward speed is 20r/min
To 100r/min, preferably 60r/min to 90r/min, so that solution is sufficiently mixed uniformly.Filtration sterilization in the step (3)
It is by acquired solution C successively through 5 μm of stud filters, 0.45 μm of miillpore filter and 0.22 μm of miillpore filter.
More specifically include:
(1) polyvinyl alcohol of mass fraction 0.12% is accurately weighed, after being added into 100L material-compound tank, increases temperature extremely
130 DEG C, stirring rate 90r/min is dissolved in water for injection, obtains solution A；
(2) accurately weigh 0.021wt%D- Glucosamine, 0.82%wt% glycerol, 0.054wt% sodium chloride,
0.135wt% disodium hydrogen phosphate and 0.107wt% sodium dihydrogen phosphate are added into 50L material-compound tank, stirring rate 90r/min, molten
Solution obtains solution B after water for injection, is transferred in 100L material-compound tank；
(3) by the solution C after merging, water for injection is added and is successively filtered after mixing evenly through 5 μm of studs to 800mL
Device, 0.45 μm of micropore filtering film, 0.22 μm of micropore filtering film are got product after sterile filling.
The beneficial effect that the present invention can generate includes:
1) composition provided by the present invention has effect safety, persistently, and curative effect stabilization, it is dry and astringent to be effectively relieved eye,
Protect cornea Epithelial cell, the effect that prevention eye tear layer is destroyed.Meanwhile the composition preparation method is easy, compared with
The dissolution for controlling effective component polyvinyl alcohol well, reaches effective treatment concentration, prevents it from crossing thermal decomposition, the finished product of preparation meets state
Family's eye-drops preparations quality criteria requirements, more preferably meet clinical treatment demand.
2) according to the present invention the study found that D- Glucosamine provided by the present invention, having reduces polyvinyl alcohol table
Face tension enhances wetability, promotes it to form a film in ocular, achievees the purpose that delay the polyvinyl alcohol functions time.
Specific embodiment
Below in conjunction with specific example, technical scheme is described further, helps to understand the present invention, but simultaneously
The contents of the present invention are not limited, protection scope of the present invention is referring to described in claims.Term as used in the present invention,
Unless otherwise indicated, generally there is the normally understood meaning of those of ordinary skill in the art.In addition, prepare one kind prevent and/or
Alleviate main ingredient used in the dry and astringent composition of eye and auxiliary material is all satisfied medicinal supplementary material requirement.
Embodiment 1
Preparation is 0.15% containing polyvinyl alcohol mass concentration, and pH value is 6.5 to 7.0, and osmotic pressure molar density ratio is
1.0 eye drops, steps are as follows:
(1) it according to polyvinyl alcohol 1.2g described in table 1, is accurately weighed, is added into 100L material-compound tank, increases temperature extremely
130 DEG C, stirring rate 90r/min is dissolved in water for injection, obtains solution A；
(2) 0.25g D- Glucosamine, 10.21g glycerol, 0.48g sodium chloride, 0.90g phosphoric acid hydrogen are successively accurately weighed
Disodium and 0.79g sodium dihydrogen phosphate are added into 50L material-compound tank, and stirring rate 90r/min after being dissolved in water for injection, is obtained
Solution B is transferred in 100L material-compound tank；
(3) by the solution C after merging, water for injection is added and is successively filtered after mixing evenly through 5 μm of studs to 800mL
Device, 0.45 μm of micropore filtering film, 0.22 μm of micropore filtering film are got product after sterile filling.
The preparation method of composition step and embodiment 1 of embodiment 2 to embodiment 15 are consistent, difference be only constituent and
Proportion is different.The constituent and proportion of embodiment 1 to embodiment 15 are shown in Table 1.
The different compositions of 1 composition of table
Comparative example 1
D- Glucosamine is free of in eye drops, other are the same as embodiment 1.
Comparative example 2
It configures and contains 0.7g polyvinyl alcohol, 0.62g sodium chloride and 3.7g polyvinylpyrrolidone in 500mL eye drops, and
Successively through 5 μm of stud filters, 0.45 μm of micropore filtering film, 0.22 μm of micropore filtering film is got product after sterile filling.
Comparative example 3
It configures and contains polyvinyl alcohol 1.0g, polyvinylpyrrolidone 0.03g, xanthan gum 0.2g, rouge in 1000mL eye drops
Fatty alcohol 0.1g, sucrose ester 0.1g, olibanum 0.8g, potassium chloride 1.1g and tartaric acid 3.4g；And successively through 5 μm of stud filters,
0.45 μm of micropore filtering film, 0.22 μm of micropore filtering film are got product after sterile filling.
Comparative example 4
The physiological saline of sterilizing, i.e., the sodium chloride solution of sterile 0.9wt%.
Embodiment 16
The composition ocular fluid preparation that will be prepared in embodiment 1 to 15, according to Pharmacopoeia of People's Republic of China (2015
Version) four defined eye-drops preparations quality requirements, it tests, inspection result is as shown in table 2, table 3.
2 embodiment 1-15 partial test result of table
3 embodiment 1-15 partial test result of table
It is found that the embodiment 1 to 15 being prepared, meets Pharmacopoeia of People's Republic of China (2015 from table 2 and table 3
Version) four defined eye-drops preparations quality requirements.
Embodiment 17
By composition ocular fluid preparation made from embodiment 1 to 15 carry out clinical test, randomly select by tear reduce symptom,
Tired disease, the dry and astringent disease of eye, Si Yegelun syndrome, keratoconjunctivitis sicca, about two syndrome of Si-, Ocular pemphigus, eyelid
Edge is scorching, cuts with hypophasis or sensoparalysis, with strain membranous conjunctivitis, viral conjunctivitis, laser cornea
Cut the cornea including forming art is postoperative, postcataract with the patient with the dry and astringent symptom of eye caused by wearing contact lens etc.
900, stochastic averagina is divided into 18 groups, and group 1-15 is respectively corresponded using composition ocular fluid preparation obtained in 1-15 in embodiment,
Control group 1 uses composition ocular fluid obtained in comparative example 2 using composition ocular fluid preparation obtained in comparative example 1, control group 2
Preparation, control group 3 use the physiological saline in comparative example 4 using composition ocular fluid preparation obtained in comparative example 3, control group 4,
Breakup time of tear film and Schimer's test after study group and control group patient drip 2 times, 1 week daily, after observing use.
Curative effect of the ocular fluid preparation of 4 composition of table to the dry and astringent symptom of eye
As can be known from Table 4, it is proposed by the present invention it is a kind of prevent, to alleviate the dry and astringent composition of eye significant in efficacy, can
Effective protection improves eyes of patients tear layer.It is different from the maximum of control group composition, due to the addition of D- Glucosamine,
So that composition moistens intraocular function and greatly enhances, while the viscosity of composition is improved, so that the therapeutic effect time extends,
To show good therapeutic effect.
The above is only several embodiments of the present invention, not any type of limitation is done to the present invention, although this hair
It is bright to be disclosed as above with preferred embodiment, however be not intended to limit the invention, any person skilled in the art, it is not taking off
In the range of technical solution of the present invention, a little variation or modification are made using the technology contents of the disclosure above and is equal to
Case study on implementation is imitated, is belonged in technical proposal scope.
Claims (13)
1. a kind of medical composite for eye, which is characterized in that include polyvinyl alcohol and D- Glucosamine in the composition, press
According to mass percent meter, the content of the D- Glucosamine in the composition is 0.015wt% to 0.04wt%,
According to mass percent meter, the content of the polyvinyl alcohol in the composition is 0.1wt% to 0.26wt%.
2. composition according to claim 1, which is characterized in that according to mass percent meter, the D- Glucosamine
Content in the composition is 0.02wt% to 0.035wt%.
3. composition according to claim 1, which is characterized in that further include osmotic pressure regulator and pH in the composition
Regulator.
4. composition according to claim 1, which is characterized in that the osmotic pressure molar density and quality hundred of the composition
The osmotic pressure molar density ratio for the chlorination sodium standard solution that point content is 0.9% is 0.9 to 1.1.
5. composition according to claim 1, which is characterized in that the osmotic pressure molar density and quality hundred of the composition
The osmotic pressure molar density ratio for the chlorination sodium standard solution that point content is 0.9% is 0.95 to 1.08.
6. composition according to claim 1, which is characterized in that the pH value of the composition is 5.7 to 7.0.
7. composition according to claim 1, which is characterized in that the pH value of the composition is 6.5 to 7.0.
8. composition according to claim 3, which is characterized in that the osmotic pressure regulator include sodium chloride, potassium chloride,
At least one of glycerol, mannitol, sodium lactate and glucose；The pH adjusting agent includes sodium hydroxide, potassium hydroxide, phosphoric acid
At least one in sodium dihydrogen, disodium hydrogen phosphate, boric acid, borax, lactic acid, ammonium acetate, acetic acid, sodium acetate and citrate buffer
Kind.
9. composition according to claim 3, which is characterized in that the osmotic pressure regulator is glycerol and sodium chloride.
10. composition according to claim 3, which is characterized in that the pH adjusting agent is sodium dihydrogen phosphate and phosphoric acid hydrogen
Disodium.
11. composition according to claim 1, which is characterized in that according to mass percent meter, the polyvinyl alcohol is in group
Closing the content in object is 0.12wt% to 0.23wt%.
12. a kind of method for preparing the composition as described in any one of claim 1-11, which is characterized in that including as follows
Step: polyvinyl alcohol is dissolved in water for injection, obtained polyvinyl alcohol water solution, then with D- Glucosamine, Yi Jiren
At least one of the pH adjusting agent of choosing and osmotic pressure regulator are uniformly mixed, and obtain the composition.
13. according to the method for claim 12, which is characterized in that the method also includes the steps to the composition degerming
Suddenly.
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| CN201611143267.1A CN106491530B (en) | 2016-12-13 | 2016-12-13 | A kind of medical composite for eye |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201611143267.1A CN106491530B (en) | 2016-12-13 | 2016-12-13 | A kind of medical composite for eye |
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| CN106491530B true CN106491530B (en) | 2019-11-29 |
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