CN102100665B - Eye drops containing vitamin E derivatives and preparation method thereof - Google Patents
Eye drops containing vitamin E derivatives and preparation method thereof Download PDFInfo
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- CN102100665B CN102100665B CN2011100086812A CN201110008681A CN102100665B CN 102100665 B CN102100665 B CN 102100665B CN 2011100086812 A CN2011100086812 A CN 2011100086812A CN 201110008681 A CN201110008681 A CN 201110008681A CN 102100665 B CN102100665 B CN 102100665B
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Abstract
The invention discloses eye drops containing vitamin E derivatives and a preparation method thereof. The eye drops comprise main components of water soluble vitamin E derivatives, a thickening agent, a pH regulator, an isotonic agent and water for injection. The eye drops are mainly used for treating dry eye syndrome, and active pharmacological components can be added according to the need and are used for adjuvant treatment of cataract, retinopathy, macular degeneration, keratitis, conjunctivitis and other various ocular diseases. The eye drops have good effects of moisturizing and lubricating, have antioxidation function, can inhibit lipid peroxide reactions in eyes, have effects of expanding peripheral blood vessels, improving blood circulation, protecting, and accelerating injuries to heal, and have good curative effects on various ocular diseases.
Description
Technical field
The invention belongs to field of pharmaceutical technology.Relate to a kind of eye drop and preparation method thereof, be specifically related to a kind of eye drop that contains vitamin e derivative and preparation method thereof.Eye drop of the present invention is mainly used in the treatment xerophthalmia, but also multiple ophthalmic diseasess such as auxiliary treatment cataract, retinopathy, degeneration of macula, keratitis, conjunctivitis.
Background technology
Ophthalmic diseases mainly comprises diseases such as xerophthalmia, cataract, glaucoma, ocular infection property inflammation, degeneration of macula, retinopathy.Wherein xerophthalmia is meant because the matter of tear or amount unusual, or the unstable and eye surface damage of tear film that causes unusually of the kinetics of tear, causes one type of disease of symptoms such as ophthalmic uncomfortable.Environmental pollution, wear contact lens, unhygienic with eye, take some drugs and age growth all possibly cause xerophthalmia.The clinical manifestation of xerophthalmia is symptoms such as eye dryness, foreign body sensation, photophobia, blurred vision or vision fluctuation.Show that according to the investigation of epidemiological study in recent years 10%～20% people suffers from xerophthalmia in various degree.
Contain abundant polyvalent unsaturated fatty acid on the biological cell membrane; Therefore be easy to receive the attack of free radical and lipid peroxidation takes place, and lipid peroxidation is a kind of chain reaction process by free radical mediated, the generation of a small amount of lipid free radical; Can cause the continuous oxidation consumption of lipid on the cell membrane; And produce a large amount of MDAs, and finally make the cell membrane major injury, cause multiple ophthalmic diseases.
At present, the opthalmological dosage form of treatment ophthalmic diseases mainly contains eye drop, ointment, tablet and granule etc.Wherein the eye drop dosage form is the most frequently used ophthalmic drug delivery mode, occupies more than 85% of dosage form ratio, its simple and convenient preparation, and cheap, easy to use, patient dependence is better.Early stage eye drop mainly is that antibiotics, antiviral class medicine etc. directly is dissolved in the distilled water, uses after being mixed with finite concentration.The type eye drop often by quick drainage, receives stopping of tear film, cornea, conjunctival epithelium barrier on the eye surface simultaneously, causes the drug absorption time short, and local concentration is low, and bioavailability is low, and the effect persistent period is short, can't reach better therapeutic effect.In eye drop, add thickening agent and can improve medicine and eye table action time, improve drug bioavailability.Thickening agent commonly used is hyaluronate sodium, methylcellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, chitosan, polyvinyl alcohol, polyvinylpyrrolidone etc.Wherein, hyaluronate sodium is to extract in the animal tissue or through the macromolecule mucopolysaccharide of fermentation technology gained, have the viscoelasticity of height, and has non-newtonian flow volume property and good pharmacology and pharmacodynamics performance and receive much concern.
Vitamin E is paid much attention to by the world of medicine for a long time always; Its unique antioxidation makes it bring into play different physiological roles clinically; Can be used as the insatiable hunger of antioxidant protection multivalence closes fatty acid and avoids oxidation and destroy; Keep biomembranous normal configuration, multiple ophthalmic diseasess such as treatment xerophthalmia, cataract, diabetic renal papillary necrosis, degeneration of macula, optic atrophy, ophthalmoplegia, corneal degeneration, keratitis are had good assosting effect.
Summary of the invention
The purpose of this invention is to provide a kind of eye drop that contains vitamin e derivative and preparation method thereof.Be used to treat ophthalmic diseasess such as xerophthalmia.
Eye drop of the present invention contains watermiscible vitamin E derivant---polyethylene glycol 1000 vitamin E succinic acid ester, has unique antioxygenic property and physiological function, and in addition, this material still is a kind of good emulsifying agent and solubilizing agent.Have active group in its molecule, can discharge active hydrogen, capturing free radicals, thereby the chain reaction of blocking-up free radical.The intervention of polyethylene glycol 1000 vitamin E succinic acid ester is arranged in course of reaction, and free radical is removed midway, just can interrupt the carrying out that react, thereby make biological cell, tissue, organ can not receive the attack of free radical, keeps biomembranous normal configuration.Therefore; The eye drop that adds polyethylene glycol 1000 vitamin E succinic acid ester has not only kept the preserving moisture of eye drop, lubrication; Can also increase an active constituents of medicine and an action time of table; And have unique antioxidation, multiple ophthalmic diseasess such as treatment xerophthalmia, cataract, diabetic renal papillary necrosis, degeneration of macula, optic atrophy, ophthalmoplegia, corneal degeneration, keratitis are had good effect.
The present invention seeks to realize through following method:
A kind of eye drop that contains vitamin e derivative, filling a prescription is:
In the 1000ml eye drop, contain watermiscible vitamin E derivant 0.01～2 gram, thickening agent 0.1～10 gram, pH regulator agent 0.1～20 gram, isotonic agent 0.1～50 gram, all the other are water for injection.
Watermiscible vitamin E derivant according to the invention is a polyethylene glycol 1000 vitamin E succinic acid ester; Thickening agent is one or more in hyaluronate sodium, methylcellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, chitosan, polyvinyl alcohol or the polyvinylpyrrolidone; The pH regulator agent is that carbonic acid-carbonate buffering cushions reagent reagent or boric acid-borate reagent, phosphoric acid-phosphate-buffered; Isotonic agent is one or more in sodium chloride, potassium chloride, mannitol, sorbitol, glucose, dextran or the glycerol.
The eye drop that contains vitamin e derivative according to the invention also can add antibiotics, antiviral class medicine, anti-microbial type medicine, non-steroid antiinflammatory drug or antiallergic class medicine in the prescription as required.
Antibiotics according to the invention is gentamycin sulfate, lincomycin or chloromycetin; Said antiviral class medicine is acyclovir or ribavirin; Said anti-microbial type medicine is a levofloxacin; Said non-steroid antiinflammatory drug is a diclofenac sodium; Said antiallergic class medicine is a sodium cromoglicate.
The method for preparing that contains the eye drop of vitamin e derivative according to the invention may further comprise the steps:
(1) take by weighing vitamin e derivative and be dissolved in 50～90 ℃ of waters for injection, it is subsequent use to be cooled to room temperature;
(2) by the prescription of the said eye drop of claim 1; Take by weighing thickening agent, pH regulator agent and isotonic agent, in the vitamin e derivative solution that adding step (1) makes, add water for injection behind the mix homogeneously; Regulating pH is 6.5～7.4; Osmotic pressure is 280～340mOsM, with filtering with microporous membrane degerming or the high pressure steam sterilization of 0.2 μ m, gets eye drop of the present invention after the packing.
The eye drop that contains vitamin e derivative according to the invention, the application in dry eye treatment.
The eye drop that contains vitamin e derivative according to the invention, the application in auxiliary treatment cataract, retinopathy, degeneration of macula, keratitis or conjunctivitis.
The present invention compared with prior art has following beneficial effect:
1. add thickening agents such as hyaluronate sodium, can make medicinal liquid delay flow rate, increase an active constituents of medicine and an action time of table, improve therapeutic effect;
2. the adding vitamin e derivative has unique antioxidation;
3. can add other active pharmaceutical components and be used for multiple ophthalmic diseasess such as auxiliary treatment cataract, retinopathy, degeneration of macula, keratitis, conjunctivitis.
The specific embodiment
Following embodiment further specifies of the present invention, is not limitation of the present invention.
Embodiment 1
Take by weighing 0.01 gram polyethylene glycol 1000 vitamin E succinic acid ester and be dissolved in the water for injection of 90 ℃ of 50ml, it is subsequent use to be cooled to room temperature; Take by weighing hyaluronate sodium 0.1 gram and be dissolved in 80 ℃ of waters for injection of 100ml, it is subsequent use to be cooled to room temperature; Taking by weighing phosphoric acid-phosphate-buffered is dissolved in the 700ml water for injection reagent 0.1 gram and sodium chloride 5.8 grams; Add refrigerative polyethylene glycol 1000 vitamin E succinic acid ester liquid and hyaluronate sodium liquid; Add water for injection and be settled to 1000ml; Adjustment pH is 6.5～7.4, and high pressure steam sterilization promptly gets eye drop of the present invention.
Embodiment 2
Take by weighing 0.1 gram polyethylene glycol 1000 vitamin E succinic acid ester and be dissolved in the water for injection of 80 ℃ of 50ml, it is subsequent use to be cooled to room temperature; Take by weighing hyaluronate sodium 0.2 gram and be dissolved in 80 ℃ of waters for injection of 100ml, it is subsequent use to be cooled to room temperature; Taking by weighing phosphoric acid-phosphate-buffered is dissolved in the 700ml water for injection reagent 5 grams and potassium chloride 6.5 grams; Add refrigerative polyethylene glycol 1000 vitamin E succinic acid ester liquid and hyaluronate sodium liquid; Add water for injection and be settled to 1000ml; Adjustment pH is 6.5～7.4, and high pressure steam sterilization promptly gets eye drop of the present invention.
Embodiment 3
Take by weighing 0.2 gram polyethylene glycol 1000 vitamin E succinic acid ester and be dissolved in the water for injection of 85 ℃ of 100ml, it is subsequent use to be cooled to room temperature; Taking by weighing hydroxypropyl methylcellulose 0.5 gram is dissolved in 4 ℃ of waters for injection of 100ml; Taking by weighing phosphoric acid-phosphate-buffered is dissolved in the 700ml water for injection reagent 6 grams and sodium chloride 5.8 grams; Add refrigerative polyethylene glycol 1000 vitamin E succinic acid ester liquid and hydroxypropyl methylcellulose liquid; Add water for injection and be settled to 1000ml; Adjustment pH is that the sterilization of 6.5～7.4,0.2 μ m membrane filtration promptly gets eye drop of the present invention.
Embodiment 4
Take by weighing 0.2 gram polyethylene glycol 1000 vitamin E succinic acid ester and be dissolved in the water for injection of 80 ℃ of 100ml, it is subsequent use to be cooled to room temperature; Taking by weighing hydroxypropyl cellulose 1 gram is dissolved in 4 ℃ of waters for injection of 100ml; Taking by weighing phosphoric acid-phosphate-buffered is dissolved in the 700ml water for injection reagent 5 grams and mannitol 6.5 grams; Add refrigerative polyethylene glycol 1000 vitamin E succinic acid ester liquid and hydroxypropyl cellulose liquid; Add water for injection and be settled to 1000ml; Adjustment pH is that the sterilization of 6.5～7.4,0.2 μ m membrane filtration promptly gets eye drop of the present invention.
Embodiment 5
Take by weighing 0.5 gram polyethylene glycol 1000 vitamin E succinic acid ester and be dissolved in the water for injection of 85 ℃ of 50ml, it is subsequent use to be cooled to room temperature; Take by weighing hyaluronate sodium 1 gram and be dissolved in 80 ℃ of waters for injection of 100ml, it is subsequent use to be cooled to room temperature; Taking by weighing phosphoric acid-phosphate-buffered is dissolved in the 700ml water for injection reagent 6 grams, sorbitol 0.1 gram, chloromycetin 2.5 grams; Add refrigerative polyethylene glycol 1000 vitamin E succinic acid ester liquid and hyaluronate sodium liquid; Add water for injection and be settled to 1000ml; Adjustment pH is that the sterilization of 6.5～7.4,0.2 μ m membrane filtration promptly gets eye drop of the present invention.
Embodiment 6
Take by weighing 1 gram polyethylene glycol 1000 vitamin E succinic acid ester and be dissolved in the water for injection of 70 ℃ of 50ml, it is subsequent use to be cooled to room temperature; Take by weighing hyaluronate sodium 2 gram and be dissolved in 80 ℃ of waters for injection of 100ml, it is subsequent use to be cooled to room temperature; Taking by weighing phosphoric acid-phosphate-buffered is dissolved in the 700ml water for injection reagent 6 grams, glucose 10 grams, levofloxacin 3 grams; Add refrigerative polyethylene glycol 1000 vitamin E succinic acid ester liquid and hyaluronate sodium liquid; Add water for injection and be settled to 1000ml; Adjustment pH is that the sterilization of 6.5～7.4,0.2 μ m membrane filtration promptly gets eye drop of the present invention.
Embodiment 7
Take by weighing 1.5 gram polyethylene glycol 1000 vitamin E succinic acid esters and be dissolved in the water for injection of 60 ℃ of 50ml, it is subsequent use to be cooled to room temperature; Take by weighing hyaluronate sodium 5 gram and be dissolved in 80 ℃ of waters for injection of 100ml, it is subsequent use to be cooled to room temperature; Taking by weighing carbonic acid-carbonate buffering is dissolved in the 700ml water for injection reagent 2 grams, sodium chloride 16 grams, diclofenac sodium 1 gram; Add refrigerative polyethylene glycol 1000 vitamin E succinic acid ester liquid and hyaluronate sodium liquid; Add water for injection and be settled to 1000ml; Adjustment pH is that the sterilization of 6.5～7.4,0.2 μ m membrane filtration promptly gets eye drop of the present invention.
Embodiment 8
Take by weighing 2 gram polyethylene glycol 1000 vitamin E succinic acid esters and be dissolved in the water for injection of 50 ℃ of 50ml, it is subsequent use to be cooled to room temperature; Take by weighing chitosan 8 gram and be dissolved in 4 ℃ of waters for injection of 100ml, it is subsequent use to be cooled to room temperature; Taking by weighing boric acid-borate buffering is dissolved in the 700ml water for injection reagent 10 grams, dextran 30 grams, diclofenac sodium 1 gram; Add refrigerative polyethylene glycol 1000 vitamin E succinic acid ester liquid and chitosan liquid; Add water for injection and be settled to 1000ml; Adjustment pH is 6.5～7.4, and high pressure steam sterilization promptly gets eye drop of the present invention.
Embodiment 9
Take by weighing 2 gram polyethylene glycol 1000 vitamin E succinic acid esters and be dissolved in the water for injection of 50 ℃ of 50ml, it is subsequent use to be cooled to room temperature; Take by weighing methylcellulose 10 gram and be dissolved in 80 ℃ of waters for injection of 100ml, it is subsequent use to be cooled to room temperature; Taking by weighing phosphoric acid-phosphate-buffered is dissolved in the 700ml water for injection reagent 20 grams, glycerol 6 grams, diclofenac sodium 1 gram; Add refrigerative polyethylene glycol 1000 vitamin E succinic acid ester liquid and methylcellulose liquid; Add water for injection and be settled to 1000ml; Adjustment pH is 6.5～7.4, and high pressure steam sterilization promptly gets eye drop of the present invention.
Eye drop of the present invention contains vitamin e derivative---polyethylene glycol 1000 vitamin E succinic acid ester; Has active group in its molecule; Can discharge active hydrogen, capturing free radicals, thereby blocking-up chain reaction; Make biological cell, tissue, organ can not receive the attack of free radical, keep biomembranous normal configuration.Therefore, the eye drop of adding polyethylene glycol 1000 vitamin E succinic acid ester has good effect to multiple ophthalmic diseasess such as treatment xerophthalmia, cataract, diabetic renal papillary necrosis, degeneration of macula, optic atrophy, ophthalmoplegia, corneal degeneration, keratitis.
Claims (8)
1. an eye drop that contains vitamin e derivative is characterized in that, the prescription of eye drop is:
In the 1000ml eye drop, contain watermiscible vitamin E derivant 0.01～2 gram, thickening agent 0.1～10 gram, pH regulator agent 0.1～20 gram, isotonic agent 0.1～50 gram, all the other are water for injection;
Said watermiscible vitamin E derivant is a polyethylene glycol 1000 vitamin E succinic acid ester.
2. according to the said eye drop that contains vitamin e derivative of claim 1, it is characterized in that said watermiscible vitamin E derivant is a polyethylene glycol 1000 vitamin E succinic acid ester; Thickening agent is one or more in hyaluronate sodium, methylcellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, chitosan, polyvinyl alcohol or the polyvinylpyrrolidone; The pH regulator agent is that carbonic acid-carbonate buffering cushions reagent reagent or boric acid-borate reagent, phosphoric acid-phosphate-buffered; Isotonic agent is one or more in sodium chloride, potassium chloride, mannitol, sorbitol, glucose, dextran or the glycerol.
3. according to the said eye drop that contains vitamin e derivative of claim 1, it is characterized in that, also can add antiviral class medicine, anti-microbial type medicine, non-steroid antiinflammatory drug or antiallergic class medicine in the prescription as required.
4. according to the said eye drop that contains vitamin e derivative of claim 3, it is characterized in that said anti-microbial type medicine is an antibiotics.
5. according to the said eye drop that contains vitamin e derivative of claim 4, it is characterized in that said antibiotics is levofloxacin, gentamycin sulfate, lincomycin or chloromycetin; Said antiviral class medicine is acyclovir or ribavirin; Said non-steroid antiinflammatory drug is a diclofenac sodium; Said antiallergic class medicine is a sodium cromoglicate.
6. the said method for preparing that contains the eye drop of vitamin e derivative of claim 1 is characterized in that may further comprise the steps:
(1) take by weighing vitamin e derivative and be dissolved in 50～90 ℃ of waters for injection, it is subsequent use to be cooled to room temperature;
(2) by the prescription of the said eye drop of claim 1; Take by weighing thickening agent, pH regulator agent and isotonic agent, in the vitamin e derivative solution that adding step (1) makes, add water for injection behind the mix homogeneously; Regulating pH is 6.5～7.4; Osmotic pressure is 280～340mOsM, with filtering with microporous membrane degerming or the high pressure steam sterilization of 0.2 μ m, gets eye drop of the present invention after the packing.
7. according to the said eye drop that contains vitamin e derivative of claim 1, it is characterized in that the application in dry eye treatment.
8. according to claim 3 or the 5 said eye drops that contain vitamin e derivative, it is characterized in that the application in cataract, retinopathy, degeneration of macula, keratitis or conjunctivitis auxiliary treatment.
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| CN2011100086812A CN102100665B (en) | 2011-01-14 | 2011-01-14 | Eye drops containing vitamin E derivatives and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| EP3673896A1 (en) * | 2018-12-28 | 2020-07-01 | Dr. Rolf Lambert Pharma-Consulting GmbH | Liposomial eye drops solution and uses thereof for the treatment of dry eye syndrome |
| RU2781131C1 (en) * | 2018-12-28 | 2022-10-06 | Др. Рольф Ламберт Фарма-Консалтинг Гмбх | Solution of liposomal eye drops and variants of its application for the treatment of dry eye syndrome |
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| CN102327650B (en) * | 2011-08-25 | 2014-01-22 | 高家旗 | Artificial lens implantation flexible hydrosol auxiliary agent and preparation method thereof |
| CN104398534A (en) * | 2014-11-04 | 2015-03-11 | 卫国刚 | Polyhexamethylene guanidine eye drops |
| CN105232454B (en) * | 2015-10-30 | 2018-02-23 | 上海昊海生物科技股份有限公司 | High-fidelity chitosan sodium hyaluronate eye drops and preparation method thereof |
| CN109431985A (en) * | 2018-12-14 | 2019-03-08 | 西安市第四医院 | A kind of eye drops and preparation method thereof being used for Dry eye treatment containing excretion body |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| EP3673896A1 (en) * | 2018-12-28 | 2020-07-01 | Dr. Rolf Lambert Pharma-Consulting GmbH | Liposomial eye drops solution and uses thereof for the treatment of dry eye syndrome |
| WO2020135940A1 (en) * | 2018-12-28 | 2020-07-02 | Dr. Rolf Lambert Pharma-Consulting Gmbh | Liposomial eye drops solution and uses thereof for the treatment of dry eye syndrome |
| RU2781131C1 (en) * | 2018-12-28 | 2022-10-06 | Др. Рольф Ламберт Фарма-Консалтинг Гмбх | Solution of liposomal eye drops and variants of its application for the treatment of dry eye syndrome |
| JP7280638B2 (en) | 2018-12-28 | 2023-05-24 | ドクター．ロルフ ランバート ファーマ－コンサルティング ゲーエムベーハー | Liposomal ophthalmic solution and its use in the treatment of dry eye syndrome |
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Effective date of registration: 20211214 Address after: 510663 No. a401, 403 and 405, zone a, Guangzhou International Business Incubator, No. 3, Juquan Road, Science City, Huangpu District, Guangzhou City, Guangdong Province Patentee after: Guangzhou Zhiyuan Biotechnology Co.,Ltd. Address before: 510640 No. five, 381 mountain road, Guangzhou, Guangdong, Tianhe District Patentee before: SOUTH CHINA University OF TECHNOLOGY |