CN106491530A - A kind of medical composite for eye - Google Patents
A kind of medical composite for eye Download PDFInfo
- Publication number
- CN106491530A CN106491530A CN201611143267.1A CN201611143267A CN106491530A CN 106491530 A CN106491530 A CN 106491530A CN 201611143267 A CN201611143267 A CN 201611143267A CN 106491530 A CN106491530 A CN 106491530A
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- CN
- China
- Prior art keywords
- compositionss
- osmotic pressure
- sodium
- polyvinyl alcohol
- glucosamine
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Classifications
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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.The compositionss include polyvinyl alcohol and D glucosamine.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 technology
With the high speed development of economic society, air ambient is increasingly severe, has encouraged being on the increase for ophthalmic diseasess, 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 eyes are dry and astringent, swell and ache
Shape.Currently in order to preventing above-mentioned symptom from producing, how there is viscosity using hypromellose, chondroitin sulfate, hyaluronic acid etc.
Polymer substance solution as artificial tearss, to improve tear layer state, but therapeutic effect has certain limitation, it is impossible to make
People is satisfied with.In recent years, market is progressively released again, adds the ophthalmic preparation of Chinese medicine, for example：Borneolum Syntheticum, Radix Sophorae Flavescentiss, Olibanum, Radix Bupleuri, party
Ginseng, Flos Chrysanthemi, Flos Campsiss, the Radix Paeoniae Alba are dry and astringent to alleviate eye, but above-mentioned additive, and chemical constitution is complicated and the mechanism of action is still failed to understand
Really, content of beary metal is unable to effective control, thus it is still necessary to studying more safe and effective compositionss to protect eye tear
Layer is without prejudice.
Content of the invention
The invention provides a kind of medical composite for eye, the compositionss include polyvinyl alcohol and D- aminoglucoses
Sugar.
In a detailed embodiment, according to mass percent meter, the D-glucosamine containing in the composition
Measure as 0.015wt% to 0.04wt%.
In a detailed embodiment, according to mass percent meter, the D-glucosamine containing in the composition
Measure as 0.017wt% to 0.038wt%.
In a detailed embodiment, according to mass percent meter, the D-glucosamine containing in the composition
Measure as 0.019wt% to 0.034wt%.
In a detailed embodiment, according to mass percent meter, the D-glucosamine containing in the composition
Measure as 0.02wt% to 0.035wt%.
In a detailed embodiment, according to mass percent meter, preferably described D-glucosamine is in the composition
Content be 0.02wt% to 0.034wt%.
In a detailed embodiment, osmotic pressure regulator and pH adjusting agent are also included in the compositionss.
Because the compositionss are typically directly applied to eye, therefore its osmotic pressure molar density preferably with quality percentage
Content is that the osmotic pressure molar density of 0.9% chlorination sodium standard solution is suitable.So, in a detailed embodiment, institute
The osmotic pressure molar density and weight/mass percentage composition for stating compositionss is the osmotic pressure molar density of 0.9% chlorination sodium standard solution
Ratio is 0.9 to 1.1.
In a detailed embodiment, the osmotic pressure molar density of the compositionss is 0.9% with weight/mass percentage composition
Chlorination sodium standard solution osmotic pressure molar density ratio be 0.95 to 1.08.
In a detailed embodiment, the pH value of the compositionss is 5.7 to 7.0.
In a detailed embodiment, the pH of preferably described compositionss is 6.5 to 7.0.
In a detailed embodiment, the osmotic pressure regulator includes sodium chloride, potassium chloride, glycerol, Mannitol, breast
At least one in sour sodium and glucose.
In a detailed embodiment, preferably described osmotic pressure regulator is glycerol and sodium chloride.
In a detailed embodiment, the pH adjusting agent includes sodium hydroxide, potassium hydroxide, sodium dihydrogen phosphate, phosphorus
At least one in sour disodium hydrogen, boric acid, Borax, lactic acid acetic acid, ammonium acetate, acetic acid, sodium acetate and citrate buffer.
In a detailed embodiment, preferably described pH adjusting agent is sodium dihydrogen phosphate and disodium hydrogen phosphate.
In a detailed embodiment, according to mass percent meter, polyvinyl alcohol content in the composition is
0.1wt% to 0.26wt%.
In a detailed embodiment, according to mass percent meter, polyvinyl alcohol content in the composition is
0.12wt% to 0.23wt%.
The compositionss of the present invention can be prepared into multiple Ophthalmic formulations, for example：Eye drop, gel for eye use, Eye ointments and eye
Membrane, facilitates different crowd to use under various circumstances.
According to the other side of invention, there is provided the preparation method of the compositionss of the present invention, comprise the steps：By poly- second
Enol is dissolved in water for injection, the polyvinyl alcohol water solution for obtaining, then with D-glucosamine, and optional pH adjusting agent
At least one mix homogeneously with osmotic pressure regulator, obtains the compositionss.
In a detailed embodiment, preferably also include the step degerming to the compositionss.
In a detailed embodiment, the composition of the compositionss, by mass percentage, polyvinyl alcohol 0.1% to
0.26%th, D-glucosamine 0.019% to 0.034%, sodium chloride 0.013% to 0.1%, disodium hydrogen phosphate 0.094% to
0.356%th, sodium dihydrogen phosphate 0.087% to 0.439%, glycerol 0.5% to 5.3%, balance of water for injection.The compositionss
Preparation method be respectively configured with adjuvant using principal agent and remix.
Specifically, the preparation method includes：Polyvinyl alcohol is dissolved in water for injection, the polyvinyl alcohol water for obtaining
Solution, then with D-glucosamine, and optional pH adjusting agent and osmotic pressure regulator at least one mix homogeneously, obtain
Arrive the compositionss.
Preferably, methods described is comprised the steps of：
(1) the polyvinyl alcohol stirring and dissolving is obtained solution A in water for injection；
(2) by D-glucosamine, and at least one optionally in isoosmotic adjusting agent and pH adjusting agent is dissolved in note
Penetrate with water, obtaining solution B and being uniformly mixed resulting solution A in step 1, obtain solution C；
(3) filtration sterilization, had both obtained finished product after fill.
In the preparation method step (1) of the compositionss, polyvinyl alcohol solution temperature span of control be 120 DEG C to 160 DEG C,
120 DEG C to 140 DEG C of preferable temperature span of control.The preparation method is by controlling solution temperature, it is to avoid polyvinyl alcohol is because of dissolving
Temperature is too low and not sufficiently dissolved, and decomposes because temperature is too high, is that the process stabilizing of product provides safeguard.
In preparation method step (1) and (2), stirring refers to that being installed on shaft in material-compound tank forwards speed for 20r/min
To 100r/min, preferably 60r/min to 90r/min so that solution is sufficiently mixed uniformly.Filtration sterilization in step (3)
It is successively through 5 μm of titanium rod filters, 0.45 μm of microporous filter membrane and 0.22 μm of microporous filter membrane by resulting solution C.
More specifically include：
(1) accurately weigh the polyvinyl alcohol of mass fraction 0.12%, in adding to 100L material-compound tanks after, rise high-temperature extremely
130 DEG C, stir speed (S.S.) is 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 phosphates and 0.107wt% sodium dihydrogen phosphate, in adding to 50L material-compound tanks, stir speed (S.S.) 90r/min is molten
Solution obtains solution B after water for injection, is transferred in 100L material-compound tanks；
(3) by merging after solution C, add water for injection to 800mL, after stirring, filter through 5 μm of titanium rods successively
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 be produced includes：
1) compositionss provided by the present invention, with effect safety, persistently, stable curative effect, it is dry and astringent effectively to alleviate eye,
Protection cornea Epithelial cell, the effect for preventing eye tear layer destroyed.Meanwhile, said composition preparation method is simple, compared with
The dissolving of effective ingredient polyvinyl alcohol is controlled well, effectively treatment concentration is reached, is prevented which from crossing thermal decomposition, the finished product of preparation meets state
Family's ophthalmic preparation quality criteria requirements, more preferably meet clinical treatment demand.
2) found according to the research of the present invention, D-glucosamine provided by the present invention, with reduction polyvinyl alcohol table
Face tension force, strengthens wettability, promotes which in ocular film forming, reach the purpose for delaying the polyvinyl alcohol functions time.
Specific embodiment
Technical scheme is described further below in conjunction with instantiation, contributes to understanding the present invention, but simultaneously
Present disclosure is not limited, and protection scope of the present invention is with reference to described in claims.The term for being used in the present invention,
Unless otherwise stated, the implication being typically generally understood that with those of ordinary skill in the art.In addition, prepare one kind prevent and/or
Alleviate principal agent and adjuvant used by the dry and astringent compositionss of eye and be satisfied by medicinal supplementary material requirement.
Embodiment 1
It is 0.15% to prepare containing polyvinyl alcohol mass concentration, and pH value is 6.5 to 7.0, and osmotic pressure molar density ratio is
1.0 eye drop, step are as follows：
(1) according to described in table 1, polyvinyl alcohol 1.2g is accurately weighed, in adding to 100L material-compound tanks, rises high-temperature extremely
130 DEG C, stir speed (S.S.) is 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 accurately weighed successively
Disodium and 0.79g sodium dihydrogen phosphate, in adding to 50L material-compound tanks, stir speed (S.S.) 90r/min, after being dissolved in water for injection, is obtained
Solution B, is transferred in 100L material-compound tanks；
(3) by merging after solution C, add water for injection to 800mL, after stirring, filter through 5 μm of titanium rods successively
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 of embodiment 2 to embodiment 15 is consistent with embodiment 1, difference be only constituent and
Proportioning is different.The constituent of embodiment 1 to embodiment 15 and proportioning are shown in Table 1.
The different prescription compositions of 1 compositionss of table
Comparative example 1
D-glucosamine is not contained in eye drop, other are with embodiment 1.
Comparative example 2
Contain 0.7g polyvinyl alcohol, 0.62g sodium chloride and 3.7g polyvinylpyrrolidones in configuration 500mL eye drops, and
Successively through 5 μm of titanium rod filters, 0.45 μm of micropore filtering film, 0.22 μm of micropore filtering film, get product after sterile filling.
Comparative example 3
Contain polyvinyl alcohol 1.0g, polyvinylpyrrolidone 0.03g, xanthan gum 0.2g, fat in configuration 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 titanium rod filters,
0.45 μm of micropore filtering film, 0.22 μm of micropore filtering film, gets product after sterile filling.
Comparative example 4
The normal saline of sterilizing, i.e., the sodium chloride solution of aseptic 0.9wt%.
Embodiment 16
By the compositionss ocular fluid preparation prepared in embodiment 1 to 15, according to Pharmacopoeia of People's Republic of China (2015
Version) four regulations ophthalmic preparation prescription, test, assay 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
Knowable in table 2 with table 3, the embodiment 1 to 15 for preparing meets Pharmacopoeia of People's Republic of China (2015
Version) four regulations ophthalmic preparation prescription.
Embodiment 17
Compositionss ocular fluid preparation obtained in embodiment 1 to 15 is carried out clinical trial, randomly select by oligodacrya symptom,
Tired disease, the dry and astringent disease of eye, Si Yegelun syndromes, keratoconjunctivitis sicca, the syndromes of Si-about two, Ocular pemphigus, eyelid
Edge is scorching, adjoint hypophasiies or sensoparalysis, adjoint strain membranous conjunctivitis, viral conjunctivitises, laser cornea are cut
Cut to be formed art interior cornea is postoperative, postcataract and the patient with the dry and astringent symptom of eye caused with wearing contact lens etc.
900, stochastic averagina is divided into 18 groups, organizes 1-15 respectively correspondingly using obtained compositionss ocular fluid preparation in 1-15 in embodiment,
, using obtained compositionss ocular fluid preparation in comparative example 1, matched group 2 is using obtained compositionss ocular fluid in comparative example 2 for matched group 1
Preparation, matched group 3 use the normal saline in comparative example 4 using obtained compositionss ocular fluid preparation in comparative example 3, matched group 4,
Seminar and matched group patient drop 2 times daily, the breakup time of tear film and Schimer's test after 1 week, after observation use.
Curative effect of the ocular fluid preparation of 4 compositionss of table to the dry and astringent symptom of eye
As can be known from Table 4, proposed by the present invention a kind of prevent, to alleviate the dry and astringent compositionss of eye evident in efficacy, can
Effective protection improves eye's tear layer.Maximum different from matched group prescription composition, due to the addition of D-glucosamine,
So that the function of compositionss moistening ophthalmic greatly strengthens, while improve the viscosity of compositionss so that therapeutical effect time lengthening,
So as to show good therapeutic effect.
The above, is only several embodiments of the present invention, not does any type of restriction to the present invention, although this
Bright disclosed as above with preferred embodiment, but and be not used to limit the present invention, any those skilled in the art are not taking off
In the range of technical solution of the present invention, a little variation is made using the technology contents of the disclosure above or modification is equal to
Effect case study on implementation, belongs in the range of technical scheme.
Claims (9)
1. a kind of medical composite for eye, it is characterised in that the compositionss include polyvinyl alcohol and D-glucosamine.
2. compositionss according to claim 1, it is characterised in that according to mass percent meter, the D-glucosamine
Content in the composition is 0.015wt% to 0.04wt%；It is preferred that according to mass percent meter, the D-glucosamine exists
Content in compositionss is 0.02wt% to 0.035wt%.
3. compositionss according to claim 1, it is characterised in that also include osmotic pressure regulator and pH in the compositionss
Regulator.
4. compositionss according to any one of claim 1-3, it is characterised in that the osmotic pressure molar density of the compositionss
Osmotic pressure molar density ratio with the chlorination sodium standard solution that weight/mass percentage composition is 0.9% is 0.9 to 1.1；It is preferred that described
The osmotic pressure molar density ratio of the osmotic pressure molar density of compositionss and the chlorination sodium standard solution that weight/mass percentage composition is 0.9%
It is worth for 0.95 to 1.08.
5. compositionss according to any one of claim 1-4, it is characterised in that the pH value of the compositionss be 5.7 to
7.0；It is preferred that the pH of the compositionss is 6.5 to 7.0.
6. compositionss according to any one in claim 3, it is characterised in that the osmotic pressure regulator includes chlorination
At least one in sodium, potassium chloride, glycerol, Mannitol, sodium lactate and glucose；It is preferred that the osmotic pressure regulator be glycerol and
Sodium chloride；The pH adjusting agent includes sodium hydroxide, potassium hydroxide, sodium dihydrogen phosphate, disodium hydrogen phosphate, boric acid, Borax, lactic acid
At least one in acetic acid, ammonium acetate, acetic acid, sodium acetate and citrate buffer；It is preferred that the pH adjusting agent is biphosphate
Sodium and disodium hydrogen phosphate.
7. compositionss according to any one in claim 1-6, it is characterised in that according to mass percent meter, described
Polyvinyl alcohol content in the composition is 0.1wt% to 0.26wt%；It is preferred that according to mass percent meter, the polyvinyl alcohol
Content in the composition is 0.12wt% to 0.23wt%.
8. a kind of method of the compositionss prepared as described in any one in claim 1-7, it is characterised in that including following step
Suddenly：Polyvinyl alcohol is dissolved in water for injection, the polyvinyl alcohol water solution for obtaining, then with D-glucosamine, and optionally
PH adjusting agent and osmotic pressure regulator at least one mix homogeneously, obtain the compositionss.
9. method according to claim 8, it is characterised in that methods described also includes the step degerming to the compositionss
Suddenly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| 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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| CN106491530A true CN106491530A (en) | 2017-03-15 |
| CN106491530B CN106491530B (en) | 2019-11-29 |
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Citations (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4131651A (en) * | 1977-10-25 | 1978-12-26 | Barnes-Hind Pharmaceuticals, Inc. | Treatment of dry eye |
| US20050129770A1 (en) * | 2003-12-11 | 2005-06-16 | Alcon, Inc. | Ophthalmic compositions containing a PVA/borate gelling system |
| US20070059274A1 (en) * | 2004-12-01 | 2007-03-15 | Bahram Asgharian | Ophthalmic compositions containing a PVA/borate gelling system |
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2016
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|---|---|---|---|---|
| US4131651A (en) * | 1977-10-25 | 1978-12-26 | Barnes-Hind Pharmaceuticals, Inc. | Treatment of dry eye |
| US20050129770A1 (en) * | 2003-12-11 | 2005-06-16 | Alcon, Inc. | Ophthalmic compositions containing a PVA/borate gelling system |
| US20070059274A1 (en) * | 2004-12-01 | 2007-03-15 | Bahram Asgharian | Ophthalmic compositions containing a PVA/borate gelling system |
| CN101396361A (en) * | 2007-09-27 | 2009-04-01 | 沈阳兴齐制药有限公司 | Medicine composition containing L-carnosine for suspending the development of the cataract |
| CN102099056A (en) * | 2008-06-19 | 2011-06-15 | 大塚制药株式会社 | A pharmaceutical composition |
| CN101474146A (en) * | 2009-01-06 | 2009-07-08 | 河北科技大学 | Timolol maleate eye drops without bacteriostatic agent and preparation method thereof |
| CN105982911A (en) * | 2015-01-29 | 2016-10-05 | 上海建华精细生物制品有限公司 | Preparation method of high-viscoelasticity injection composed of glucosamine and sodium hyaluronate |
| CN105726562A (en) * | 2016-01-28 | 2016-07-06 | 菏泽医学专科学校 | Eye drops of raw material marine organism |
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| Title |
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| 张仁俊等主编: "《实用眼科药物学》", 30 September 2015, 人民军医出版社 * |
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